Pfizer

Patient was vaccinated for SARS-CoV-2 on 6-Jan-21 at his site of employment, a Nursing Home. Patient presented to Urgent Care on 15-Jan-21 complaining of left sided chest pain that started the evening before with an associated slight cough. Pt was afebrile with a heart rate of 88 and an O2 sat on room air of 98% in triage. His EKG showed a sinus tachycardia of 114 with a slightly prolonged QTc of 463 ms. Physical exam was significant for bibasilar crackles and X-ray showed bibasilar infiltrates consistent with COVID pneumonia but bacterial pneumonia could not be excluded. The patients BP was documented as 97/64. He was treated with Zofran for nausea and tylenol. He was prescribed a five day course of Azithromycin, an Albuterol inhaler, guaifenessin with codeine cough syrup, and Zofran. Labs were drawn and he was discharged. His lab results were reported after his departure and were significant for a white blood cell count of 1.33, platelet count of 73, 2% myelocytes, 1% metamyelocytes, an absolute neutrophil count of 0.75 K/ul, a creatinine of 1.83, total bilirubin of 1.3, with direct bilirubin of 0.8, alkaline phosphatase of 294 and AST of 112 with ALT noted to be within normal limit. His COVID nasopharyngeal swab from the visit was reported as negative and a swab performed at his employment on 13-Jan-21 was also reported to be negative. Patient could not be reached by phone after discharge from Urgent Care about these labs. On the evening of 16-Jan-21, Police Department received a 911 call about an adult at the patient's address who was found unresponsive. Upon arrival on scene, the patient was found to be deceased and a decision was made not to attempt to resuscitate. The death was deemed to be non-suspicious and the patient's body was transported to a funeral home. On 19-Jan-21, I contacted the State Medical Examiner's Office. They have decided to perform an autopsy and have recovered the CBC and chemistry specimens obtained for further testing.

Loss of taste; right kidney pain severe; injection site pain; This is a spontaneous report from a contactable consumer (patient). This 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; dose 1) via an unspecified route of administration on 25Jan2021 at 10:00 (at the age of 60-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included chronic back pain, scoliosis, kidney stones, 3 double hernias, venous deficiency, fibromyalgia, 2 torn ligaments right foot, diabetes, and diabetic neuropathy. The patient did not receive any other vaccines within four weeks prior to the vaccine. The patient did not have COVID-19 prior to vaccination. The patient received unspecified concomitant medications. The patient previously took morphine from an unknown date for an unspecified indication and experienced allergy. On 25Jan2021 at 10:15 the patient experienced loss of taste, right kidney pain severe, and injection site pain. The patient was not treated for the events. The outcome of the events was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19. The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.

Rapid heartbeat (90-115bpm) for 2-3 days while laying in bed. Low pulse ox (88) Fever (101-102F) and chills Related difficulty urinating and frequent urination due to prostate inflammation Loss of memory (Brain Fog?) in which I had no memory of events occurring from 3/7-3/9 and little memory on 3/10. Memory was close to normal on 3/12. Two Covid tests with negative results (taken on 3/8 and 3/11) Some lung congestion which could be due to bloody sinus mucus and post nasal drip I did retain my sense of smell and taste but had no appetite and did not eat or ate very minimally from 3/7pm until 3/11pm Very fatigued and weak with knee, hip and general joint pain. Increasing levels of fatigue started on 3/2 with little energy from 3/7-3/11. Fatigue is mostly gone as of 3/23.

Immediately I lost my sense of taste - that lasted for four days. I had a little swollen in my arm- I felt nauseous but I wasn't sick. I had a fever but just slightly elevated. Two days after vaccine, my kidneys were in pain. It took a couple of days for it to go away and then it stopped. Called the doctor but he had said just to wait it out -and I kept taking my regular meds but no additional.

numbness and weakness in my legs; numbness and weakness in my legs; difficulty urinating; This is a spontaneous report from a contactable consumer (reporting for himself). A 60-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Leg Left on 11Mar2021 at 05:30 (Batch/Lot Number: EN6208) as single dose for COVID-19 immunization. Medical history included transverse myelitis. The patient's concomitant medications were not reported. The patient previously took acetylsalicylic acid (ASPIRIN) and terbinafine, both for unspecified indication and experienced allergies. On 11Mar2021 at 10:30, the patient experienced numbness and weakness in his legs and some difficulty urinating. The patient was hospitalized. The patient did not received treatment for the events. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Mar2021. The outcome of the events was recovering. Information about Lot/Batch number has been requested.

Pfizer-BioNTech COVID-19 Vaccine EUA Pt presented to ED on 4/10/21 @0523 with c/o SOB, F/C and cough. Admitted to ICU with acute hypoxic respiratory failure on BiPAP, non-STEMI, acute decompensated heart failure, acute kidney injury and suspected severe sepsis. Reportedly received 2nd dose of COVID-19 vaccine 2 days prior. Shortly after admit, pt developed worsening respiratory status requiring intubation @1045. Pt with continued hypoxemia despite 100% FiO2 and PEEP of 15. Pt experienced cardiac arrest with PEA @1100 with return of spontaneous circulation. Repeat arrest with PEA@1135 with return of spontaneous circulation. Family decision to change code status to DNR CCA, repeat arrest- time of death 1203.

Lower back and left leg spasms (LLE spasms q/min or <), patches of BLE dermatomes. Bilateral anterolateral thigh muscle burning sensation during prolonged exertion. Difficulty standing from a crouched position. G.U. Urgency. Symptoms similar to viral transverse myelitis diagnosed in 2013

Pt developed fever, cough and production of yellow phlegm for 4-5 days prior to clinic visit. When Pt was examined and labs draw he was found to have blood and protein in his urine. labs from 5/21 BUN 16 Cr 1.77, 5/25 BUN 17 Cr 2.01. Labs prior to vaccine from 02/2020 wer BUN 15, Cr 1.07

On Friday, 5/28/2021 I had my second Covid vaccine. My first vaccine in my left arm on 4/30/2021 was accompanied by a sharp soreness under my left arm and 12 hours of iritis in my right eye. Both symptoms were mild. For my second Coivd vaccine in my right arm on Friday, 5/28/2021, my symptoms included a headache and fatigue which lasted for Friday and Saturday. I also had a bad night on Saturday. I had trouble sleeping, was achy and may have been running a slight fever. I have been slightly more sweaty than normal. Today, 5/31/2021, I had some blood in my urine.

POLYARTICULAR REACTIVE ARTHRITIS, swollen and extremely sensitive and painful joints, affecting all fingers in right hand, right wrist, right elbow, right knee, left big toe. Treatment with Prednisone, initially 40mg daily, boosted to 50mg, partially effective after 2 weeks

Patient presented to the ED with dizziness/lightheadedness and nausea, was diagnosed with TIA and elevated serum creatinine within 6 weeks of receiving COVID vaccination.

Death 7/25/21 N17.9 - AKI (acute kidney injury) K92.2 - Gastrointestinal hemorrhage, unspecified gastrointestinal hemorrhage type

anxious, restless, weak, dizzy, felt "horrible". Continued to C/O symptoms,. At 01:15, patient lost consciousness , then stopped breathing and lost pulse. Narrative: Patient was first vaccinated for COVID 19 on 1/8/21. On 1/24/21: 61 year old presents to E.R. with CC of chest pain/sob, with multiple medical conditions including hypertension, atrial fibrillation on apixaban, cardiomyopathy with poor EF, dyslipidemia, COPD, CVA, lung CA s/p radiotherapy, PTSD, depression, Churg Strauss Syndrome, Sjogren's syndrome presented with chief complaint of chest pain or shortness of breath. He has been having worsening shortness of breath the past few days, also complains of cough productive of yellowish sputum, no hemoptysis. He complains of left upper chest pain with no radiation. There is no diaphoresis, palpitations or lightheadedness. He denies fever or chills. He complains of having fallen a few times recently, thus he passed out. Could not say if there were seizures activity. Admitted to 3D Tele. On 1/27, Pt advises he had episode of substernal CP this am. RN advises pt was in afib w/ RVR at a rate >140 at time of CP. Pt CP improved w/ prn NTG. Pt HR improved after daily medications. Pt sts his CP has resolved. Pt admits to continued dyspnea. Increased trop, transferred. 1/28, struggling with orthopnea and cough. He has no peripheral edema. He does have intermittent chest pain. Patient having periods of A-Fib RVR with non-sustained rates of 140's-150's 1/29 more chest pain at 04:00, relieved with NTG. HR = AF, with RVR 145. At about 08:00, Cardiology sees patient and signs off, "shortness of breath and cough not due to heart failure as evidenced by orthostatic hypotension and no improvement in symptoms with diuresis. Consider underlying lung disease vs acute pulmonary disease." No pulmonary consult noted. 1/29 Patient received 2nd dose COVID19 vaccine at about 3:30-4p. No notes from staff on this event. No notes from MD that this was discussed and still part of the plan. 1/29 nurse's note: At around 2240 Pt was able to rest briefly but is now restless and anxious again. Tachypneic, stating he feels so weak and dizzy and overall just feel horrible. Continuing to get up frequently to have small soft bowel movements with assistance. Pt also stated ever since he got "that shot" he hasn't felt well. When asked what shot pt replied "COVID shot." Pt did receive 2nd dose of COVID vaccine 1/29 at 1530. Around 2250 Spoke w MOD to relay above information and overall concern for pt, asked for MOD to come to bedside to evaluate pt. MOD states he's handing off to oncoming MOD and they will come to bedside to see pt. Around 2300 oncoming MOD called and all above and previous information discussed Around 2310 MOD came to bedside to see pt. Will continue to monitor closely. 01/30/2021 ADDENDUM Around 0115 pt called for help to use bedside commode to urinate and have BM. Assisted x2 to BSC. While sitting on BSC pt's eyes rolled back and pt made postures consistent with a seizure, body became very rigid. Pt was unresponsive still with pulse. Lifted patient back to bed with 3 staff assist. Pt stopped breathing and lost pulse. Chest compressions started immediately and Code Blue called at 0120. 1/30 Hospitalist note: Called for CODE BLUE AGAIN AT 4:53. While on Vent after s/p Code blue for reasons not clear patient went into Asystole and code called second time. Patient had a prolonged CPR and was actually called off at 5:17 but he started having pulse and agonal resp. he was placed on Levophed and D5NS. He got a total of 9 amps of epi, 3 amps od Bicarb and 1amp of D50. Trope bumped from 0.12 to 0.43 prior to this he already was on ASA, Apixiban for afib. Cards are on board for his CHF for his pulmonary edema Lasix ordered. Hid lactic acid is elevated. Blood cultures pending. Started Zosyn and is on Levophed. Continue to monitor. Updated patients Mom and she requested to do everything at this point. Coded again at 5:40, survived, but AOD writes a death note(?) Coded for the 4th time at 08:18. Family at beside, Mother asks for code to be stopped.

1/04/2021, 1/25/2021 Pfizer ej1685, en5318 Reports that he "passed out" on 1/6 at work, taken to ER and was diagnosed with kidney failure & hyperkalemia, also positive for covid. Hospitalized till 1/13, underwent dialysis. Received 2nd vaccination 1/25, once again "passed out" in breakroom while at work. Pt was awoken after approx 1 hour, unable to move arm at that time, went home and did not seek medical care at that time. Pt was re-hospitalized on 2/2/2021 due to difficulty breathing & AMS. Dx with pneumonia & hyperkalemia at that time, discharged home 2/11/2021. Continues on hemodialysis 3x/week.

Grand mal seizure, wife found patient lying on the ground with eyes fixed and loss of urine. Wife called EMS around 2:22 and patient came to about 15 minutes later.

Hematuria. Severely thickened urinary bladder with blood clots in organ and urine . Please note 1st Doze of Covid-19 vaccine was on 03/25/2021 and 2nd doze was on 04/15/2021.

Kidney pain in left kidney. (1st shot done in lf arm). Lasted about 2 days. Very painful when trying to bend over, or when trying to get up from a sitting position, and when trying to sit down. No pain when standing straight up. Did not seek treatment.

ED to Hosp-Admission Discharged 4/3/2021 - 4/10/2021 (7 days) Hospital MD Last attending ? Treatment team Severe sepsis with acute organ dysfunction Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Date: 4/10/2021 Admission Date: 4/3/2021 Length of stay: 6 Days PCP: MD Discharging provider: MD Admission diagnosis: Primary Admission Diagnosis Hospital Problems POA * (Principal) Severe sepsis with acute organ dysfunction Yes Left hip pain Yes Primary osteoarthritis of left hip Yes Intractable vomiting with nausea Yes Acute metabolic encephalopathy Yes COVID-19 virus infection Yes Gastrointestinal hemorrhage with hematemesis No Urinary tract infection associated with indwelling urethral catheter Yes HPI: Admitted with severe left hip pain and altered mental status. patient with history of stroke Was also found to have Covid positive at the time of admission Hospital Course: Following issues were addressed during this hospitalization Acute encephalopathy: At the time of admission Most likely secondary to gabapentin Held medication during this hospitalization and also stopped at the time of the discharge. Patient was started on this medication recently due to his left hip pain. COVID-19 infection D-dimer was elevated at the time of presentation. CT chest ruled out pulmonary embolism. Ultrasound did not reveal any DVT. Patient did not qualify for any convalescent plasma remdesivir during this hospitalization as he is saturating well on room air. Possible catheter associated urinary tract infection Patient with chronic indwelling Foley catheter. Urine culture grew Staphylococcus hemolyticus and Enterococcus faecalis faecalis. Patient was started on ampicillin during this hospitalization he completed the 5-day course. Sepsis ruled out at the time of admission Acute kidney injury present at the time of admission Suspect underlying chronic kidney disease Patient needs to follow-up with the PCP for the follow-up on the creatinine in 1 week. Left hip pain Patient underwent extensive work-up during this hospitalization. MRI of the left hip showed high-grade tear of the iliopsoas tendon. Patient was seen by orthopedics recommending continued therapy and pain management. Acute GI bleed, presented as coffee-ground emesis Acute on chronic anemia Iron deficiency anemia Underwent extensive work-up during this hospitalization. CT angiogram of abdomen pelvis revealed suspected bleeding in the stomach. Patient underwent EGD which showed severe esophagitis most likely cause of the bleed. Gastroenterology recommending continuing pantoprazole twice daily. Patient hemoglobin remained stable during this hospitalization. Biopsy did not reveal any H. pylori infection. Patient was seen by PT OT during this hospitalization who recommended acute inpatient rehab. But patient and family decided to take the patient home patient was discharged home in stable condition with home health.

sore in arm shot the next day, slight fever the next day, fatigue the next day, frequent urination the night of vaccination

Creatinine levels above normal at 1.47 for the first time in my life EGFR 51 Creatinine clearance 44

Received the first Pfizer COVID vaccine (ew0161) injected at 4:30PM on 29 April 2021 at the Pharmacy. He became weaker, more tired and sleep afterwards, He developed decreased oral intake. He was unable to recall his name, so family brought him to the ER. In the ER he was noted with significant anemia Hgb 6.5 and thrombocytopenia with platelet of 6. There is question of hemolysis with reticulocyte 8, LDH 1757, total bill 3.8. There is elevated D-dimer and renal function. Hematology consultation was placed for possible TTP versus COVID vaccine induced thrombocytopenia. PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times PT was placed on plasmapheresis and found to have ADAMST13 def. PT received S/p plasmapheresis 11 times on 4, 5, 6, 8, 9, 10, 11, 12, 13, 17, 19 May 2021. Received Rituximab 375 mg/m2 = 731 mg IV weekly X 4 on 5, 13, 19, 26 May 2021. Completed high dose steroids 1000 mg x 3 days AMS and seizures 2/2 TTP related metabolic encephalopathy(i mproved), Small R parietal subdural hematoma­ likely related to TTP. No focal deficits. Treated for TTP with plasmaphoresis.initially alert but not oriented. Had an episode of seizure, intubated for airway protection Patient was hospitalized for 15 days 4-19 May 2021. He was in ICU for 1 week and 8 days in general ward. He was unconscious for the first week experienced 2 episodes of seizure. He has been comatos since he developed the first episode of seizure on 5/5/21. He developed another episode of seizure after the brain MRI on 5/5/21. PT discharged on 19/5/21 and continued blood works and Ritoximab therapy as out patient. Assessment: TTP, based on his clinical features including altered mental status, fe1er, hemolytic anemia and thrombocytopenia, renal insufficiency, and peripheral smear with 7-8 schistocytes per HPF (5/4/2021). Adam Ts 13 activity <3 Hemolytic anemia, severe thrombocytopenia 212 TTP with AdamTs13 deficiency In setting of hemolytic anemia, thrombocytopenia, AKI and AMS Hgb 6.5, Bili 3.8, LOH 1757, ARC 3.6 significant for hemolytic anemia on adm Peripheral smear showed anisocytosis, microspherocytosis and possible 1 schistocytes Platelet 6, multiple petechiae, no active bleeding, guaiac negative. Received 1U PRBC. Direct Coombs test -ve , Tbili elevated Plasmic score 6 Acute kidney injury 212 TTP vis Prerenal (Resolved) , Hyponatremia (resolved) FENA 0.5 Hematology followup: TTP (THROMBOTIC THROMBOCYTOPENIC PUPURA) 5/14/21 He developed a new ulcer in the mid of tongue. He coughs and sputum is clear. He feels better. Sip plasmapheresis and rituximab infusion yesterday. 5/13/21 He continues improling. Good appetite. He still coughs with blood streak, slightly pinkish sputum. 5/12121 His mental status is back to baseline. He is able to eat regular food and walk inside his room. Clo cough with blood streak, slightly pinkish sputum. 5/10/21 Fully alert and awake, but reported confusion and forgetful episodes. Eating better. Clo tightness in arms 5/9/21 More alert and awake. Started eating. Feeling tired. Clo mild pain at shoulders. Sip 1 unit PRBCs 5/8/2021 Mild improvement. Wife is at bedside. No acute overnight events. Still has intermittent confusion. Surgery re-placed left IJ Shiley for PEX 5/7/2021 He has intermittent confusion and irritation, mixed with short-term of AAO x 3. He pulled out his PEX line and has urinary incontinence. He is NPO and remains sleeping most of time. 5/6/2021 Sip extubated. He appears tired, but arousable, follows commands and carries normal communication with b/I symmetric strength with no motor deficits. Afebrile since last night. 5/5/2021 He developed 1 episode of seizure. Sip Ativan and 1 dose of propofol for intubation. He has been in comatose since then. Brain MRI was performed this afternoon. He developed another episode of seizure after the brain MRI. Sip 1 unit packed RBC 5/4/2021 and 1 unit packed RBC 5/5/2021. He de1.eloped mild bleeding from the bronchial suction and Foley catheter. He de1.eloped fe1.er temperature 101 during the first plasmapheresis. Temperature was 104 about 2 hours after the first plasmapheresis. He has had persistent high fe1.er since then. 5/4/2021 Lab showed WBC 7.1, Hb 6.5, pit 6, MCB 92.1, neut 68%, re!8%, PT 14, PTT 30. 5, D-dimer 2.19, fibrinogen 490, CMP normal except Ca 8.1, Glu 189, BUN 47, Cr 1.57, T bili 3.9, direc!0.9, and AST 56. LOH 1757, TSH 4.828, serum HIV and hepatitis panel negati1.e, COVID-19 Ag, SARS-CoV2 Rapid and Flu Ag negati1.e. 5/5/2021 WBC 21,500, hemoglobin 6.2, platelets 17,000, neutrophils 69%, PT 14.9, PTT 28.3, D-dimer 5.5, glucose of 296, BUN 63, creatinine 2.18, total bilirubin 2.5, albumin 3.6, LOH 891, AST 57, ALT 32, alkaline phosphatase 51. Laboratory results: WBC H 13.2 (MAY 14) H 11.6 (MAY 13) H 13.4 (MAY 12) H 16.8 (MAY 11) ? Hgb L 9.9 (MAY 14) L 11.3 (MAY 13) L 10.8 (MAY 12) L 10.4 (MAY 11) Hct L 30.2 (MAY 14) L 33.3 (MAY 13) L 31.5 (MAY 12) L 31.2 (MAY 11) Pit L 92 (MAY 14) L 58 (MAY 13) L 63 (MAY 12) L 74 (MAY 11) Risk Assessment: Denies Alcohol Use Substance Abuse Risk As sessment: Denies Substance Abuse Tobacco Risk Assessment: Denies Tobacco Use

Non-ST elevation (NSTEMI) myocardial infarction Acute kidney failure, unspecified Thrombocytopenia, unspecified

pt was hospitalized Final Diagnosis: Acute renal failure Adm Diagnosis: Acute renal failure & Disease caused by severe acute respiratory syndrome coronavirus 2 (disorder)

PATIENT REPORTED A SORE ARM THE DAY FOLLOWING THE VACCINATION. THE PAIN SUBSIDED BY THE END OF THE SECOND DAY. ON DAY 4, THE PATIENT AWAKENED WITH FEVER, HEADACHE, BODY ACHES, CHILLS, SEVERE FATIGUE, SOB AND COUGH. ON MONDAY, JANUARY 4, THE WAS GOT FEELING ANY BETTER AND WITH TO SEE A PROVIDER AT MEDICAL CENTER. HE WAS GIVEN A CHEST X RAY AND LABS. HE WAS GIVEN A RAPID FLU AND COVID ANTIBODY PCR TEST BOTH NEGATIVE. HE DID NOT REPORT TO THE HEALTH DEPARTMENT AND THE HOSPTIAL DID NOT THINK FEEL THE SYMPTOMS WERE RELATED TO COVID VACCINATION. HEALTH DEPARTMENT ONLY FOUND OUT TODAY DURING F/U PHONE CALL WITH PATIENT. PATIENT IS RECOVERING AT HOME. AS OF TODAY, HE FEELS HE IS GETTING BETTER.

By nightfall on the day of my second dose, I was extremely jaundiced. The following morning, my urine was darker than it has ever been - a dark amber/brown color. These are symptoms that I do experience routinely as someone with CAD. Hemolysis causes these same symptoms, but it seems the vaccine accelerated the hemolysis for some reason. Perhaps it activated complement. Regardless, this event did not last beyond the weekend, and has not been an issue since. I just thought it should be recorded as an adverse event.

Patient started having decreased urine output, painful urination, and dark brown urine 5 days after receiving his first Pfizer COVID vaccine. These symptoms were accompanied by migraine and nausea. UA on 4/13 consistent with a UTI and started on Bactrim. On 4/14 he started having chills and weakness with kidney pain on the left side. CT abdomen and pelvis on 4/14 showed a left kidney calyceal diverticula with calcification in the superior pole that could have been a nidus for infection with symptoms showing 5 days after COVID vaccine. Increased suspicion for pyelonephritis and antibiotic changed to Macrobid. After a few days of increased hydration and antibiotics, urinary symptoms improved. Will continue monitoring kidney infection. Still had flu-like symptoms as of 4/15. Heart rate was first recorded on 4/13 at 113 and again on 4/16 at 111. Patient stated it had been elevated all week. Left lower lobe had decreased breath sounds. Working up for possible PE.

Pain in lower abdomen closest to penis. Extreme urgency and frequency (every 15 minutes) in urination. No actual pain during the act of urination. It's almost like there was a blockage. Flow was very weak with lots of dripping. Only lasted for 24 hours (thankfully). Not that this is germane probably but I am Type O+. I did have Covid with 11 days of symptoms March 17-28 2020. Lastly, in this episode I did also experience fever, chills, fatigue, and body aches, and I know those are known AE's

About two weeks after receiving the first Covid-19 vaccine dose, patient had yellow-red urine for a day. No dysuria, or any other symptoms.

past history of diabetes, hypertension, hyperlipidemia and recent diagnosis of COVID-19. Apparently the patient received his initial dose of COVID vaccine on 03/31/2021 and subsequently developed loss of taste and smell. He was tested for COVID-19 at local Pharmacy and received notification that his result was positive. He subsequently had improvement in his symptoms and was retested 2 weeks subsequent with negative results. On for 01/20/2021 he received his 2nd COVID 19 vaccination and subsequently developed recurrence of feeling ill 2 days afterwards. He progressively had feeling of shortness of breath along with nonproductive cough. The patient then developed complaints of chest pain and rib discomfort. He presented to the emergency department where he was found to be hypoxic along with abnormal labs including a creatinine of 1.84 BNP of 12,699, elevated transaminase levels, hemoglobin of 8.9. Chest x-ray showed patchy airspace disease to the right lung consistent with COVID-19 pneumonia. At time of admission he was given IV Lasix and started on Rocephin and Azithromycin. The use of steroids as well as any antiviral treatment was withheld because of presumptive symptoms related to bacterial pneumonia (secondary to COVID 19.) He also did not require oxygen supplementation during his stay.

Swelling of prostate causing inability to urinate.; Swelling of prostate causing inability to urinate.; This is a spontaneous report from a contactable consumer (patient). A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration in the left arm on 10Mar2021 at 11:15 (at the age of 62-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and severe pollen allergy causing food allergy to melons and bananas. The patient was taking unspecified concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 14Mar2021 at 02:00, the patient experienced swelling of prostate causing inability to urinate. Therapeutic measures were taken as a result of adverse event and included visit to emergency room/department or urgent care and treatment with a catheter. The clinical outcome of swelling of prostate causing inability to urinate was recovering at the time of this report. Follow-up (20May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

tested positive for COVID19.; tested positive for COVID19.; caller developed several kidney stones; This is a spontaneous report from a contactable consumer (patient). A 62 years old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Mar2021 (at age of 62 years old) at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. However post-vaccination, caller developed several kidney stones and tested positive for COVID19. Following his intent to travel internationally, he would like to know if he can still get his 2nd dose or does he have to re-do it given that it was over 70 days (79 days) from his first dose. The outcome of the events was unknown. Information on the lot/batch number has been requested.

2nd vaccine- 01-04-2021; initially started to feel loss of appetite, a lot of weakness and just feeling sick. I got to the point where I could not sit in my wheelchair, literally had no core strength in me. I went to the ER and they gave me a rapid swab for covid. They decided to do blood cultures, were getting ready to plasma when an infectious disease doctor came in and said to that I did not have covid but rather a UTI and my UTI went into sepsis. I was hospitalized, 2 ½ months. I believe that this started with the Pfizer vaccine. I also went to a rehab place to regain my strength. I continue to have today with weakness to my body and struggle with core strength. I do not have lot# to provide.

About 2 weeks after vaccination received, patient states he began to have more fluctuations in his glucose levels as well as heart palpitations. Reports that his glucose levels do not generally go above 180. As glucose levels kept increasing, patient began exercising more. In early July, started to have levels in the 400s. Started to feel more dizzy & weak and had polydipsia and increased frequency of urination. He went to the Emergency Room on 7/8/2021; glucose level was 373. He was given IV fluids and 6 units of regular insulin. Glucose level came down to 252 prior to being sent home and instructed to follow up with his Doctor. Patient had follow-up labs on 7/12/2021, which show hemoglobin A1c of 10.0% and glucose level of 272. Prior to vaccination, patient's hemoglobin A1c was 6.5% and glucose level 135 on 1/29/2021. Historically, this patient's A1c has been between 5.3 and 6.5 since 2014. His BMI is 28, actively exercises and has been adherent to his diabetes regimen of metformin 500mg twice daily.

COVID-19 PCR test/he was positive per the PCR test; COVID-19 PCR test/he was positive per the PCR test; Sweating; Fever; running to bathroom with urination every 15 minutes with a large amount of urine; running to bathroom with urination every 15 minutes with a large amount of urine; Heart pounding; tired and fatigue; Weight loss; Chills; pain all over the body; Sluggishness; This is a spontaneous report from a contactable consumer. A 63-years-old male patient received his first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EH9899, expiry date was unknown), via an unspecified route of administration on the left arm on 21Dec2020 14:40, at a single dose for Covid 19. The patient's medical history and concomitant medications were not reported. The patient has no prior vaccinations -within 4 weeks. The patient is an EEG technician. On 22Dec2020, the patient reported the next day he started to feel sluggish, chills, tired/fatigue, pain all over his body, patient mentioned he has lost weight everyday since he got the shot from 153 pounds to 142 pounds; then on Wednesday evening 23Dec2020, it was a nightmare, he got sweating; fever with a high of 101.4 Fahrenheit; he was running to bathroom with urination every 15 minutes with a large amount of urine; and he was so tired and fatigued. Added when he was getting up all that night he was having night sweats up to five times a night and chills; and his heart was pounding. The urination, heart pounding resolved the next day. All of these events have improved at the time of report (now) or gone away but he is still sweating once at night for the last two days and he is tired and fatigued. He stated that he is scheduled for the second dose on 11Jan2021 and he is concerned if he should take the vaccine. He mentioned that he was tested for COVID 19 on 18Dec2020 and the result was inconclusive. He went again 23Dec2020 they called him on 25Dec2020 and informed he was positive per the PCR test. He treated himself with 500mg acetaminophen (UPC 0904672059; lot OBE2896 and expiration Oct2021) and azithromycin Z-Pack (NDC 65862-641-69; Lot ZYSA20012-A; and expiration date Mar2022). The sample of the product is not available to be returned. Predisposing factor was that the patient's wife was at home and was sick too at the same time. She was tested Sunday with no results yet. The outcome of the events of fever recovered on 28Dec2020, sluggishness recovered on 29Dec2020, pain all over the body was recovered on 02Jan2021; running to the bathroom with urination every 15 minutes with a large amount of urine and heart pounding were recovered on 24Dec2020, weight loss was not recovered, and for other events was recovering.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (4 days in this case). However, a causal relationship between event "COVID-19 PCR test/he was positive per the PCR test" (coded to Drug ineffective / SARS-CoV-2 test positive) and BNT162B2 vaccine cannot be completely excluded

pt states he started feeling pain in the left arm about one hour after the vax. He had a little back pain that night but could not get out of bed the next morning. He said it feels like the pain is all over his lower back and in the kidneys. Pt will contact his PCP.

body ache; feeling worse; when I went to bed, got chills and shivers real bad; headache; Mild fever; mildly sore arm; Bad prostate and bladder infection; Bad prostate and bladder infection; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team and Pfizer-sponsored program COVAX US Support. A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/ lot number: EL9269, Expiration date: Unknown, NDC number: Unknown), via an unspecified route of administration in left shoulder area on 08Feb2021 16:30 at single dose for COVID-19 immunisation. The patient's medical history included ongoing asthma for about 60 years, ongoing high blood pressure for about 3 years and was on blood pressure medication, issues with thyroid for about 3 years and was on thyroid medication (ongoing). Concomitant medication included ongoing thyroid medication. Patient's medical history (including any illness at time of vaccination) was none. Family medical history relevant to adverse events was none. Prior vaccinations (within 4 weeks) was none. Adverse events following prior vaccinations was none. Additional vaccines administered on same date of the Pfizer suspect was none. The patient experienced bad prostate, bladder infection, sore arm on an unspecified date in Feb2021. On 11Feb2021, the patient experienced body aches, feeling worse, shivers, headache, mild fever. It was reported that, caller received his first dose of bnt162b2 on Monday 08Feb2021. He's reporting adverse events and would like to know: If he takes Tylenol to treat his symptoms, would it decrease the effectiveness of the vaccine or not. Also, if he were to go for a COVID-19 viral test, would the fact that he was received the vaccine interact with the test and cause a false positive result or not. Patient was reporting that yesterday, day 4, he started with body aches, headache, and "when he got in bed, he had chills and shivers real bad, little chilly" so possibly a mild fever. Enquired could these all be side effects of the vaccine or not. If he go for the COVID test - would it be positive or not. He also states he has a history of asthma and has been hypervigilant about avoiding COVID infections. Caller, reporting on the COVID vaccine and who explains that he got the first shot on Monday and he had a mildly sore arm- this lasted 2-3 days, no big deal. Then 5 days later he had really bad body aches and a headache. He went to bed cause he was feeling worse but before going to bed he noticed he had shivers really bad, uncontrollably almost which lasted over an hour. He presume they are fairly normal side effects but wants to confirm this could happen after five days. Also, he was told not to take Aspirin or Tylenol before getting the vaccine because it could affect the efficacy, but he wants to know could he take a Tylenol now 5 days later for the headache and body aches. He was better now than he was doing. Caller clarified the event was 4 days after the shot, the shot was Monday and events started Thursday. On Thursday evening, 11Feb2021, was when he had the bad body aches, headache, and shivers. At this point he still has the headache and body ache. He felt like, last night, he had a fever, but he didn't check it. At the same time, he had the chill and the shivers. Those feelings were resolved by this morning. Caller received COVID vaccine on 08Feb2021-Internal Infection-Bad prostate and bladder infection. Adverse events did not require visit to emergency room and physician office. No relevant tests. No investigation assessment. The events were considered as non-serious by the consumer. The outcome of the events mild fever, feeling worse, bad prostate, bladder infection was unknown, recovering for body aches, headache, recovered on 12Feb2021 for shivers, recovered on an unspecified date in Feb2021 for sore arm.

Classic kidney stones symptoms in person with no prior history, and on no medications; headache; fatigue; This is a spontaneous report from a contactable physician. A 63-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), (Batch/Lot Number: EN6203), intramuscular, administered in left arm on 26Feb2021 at 10:15, at a single dose, for covid-19 immunization. Medical history included early stage prostate cancer more than 2 years ago; surgery only, no meds. 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 hasn't been tested for COVID-19. The patient's concomitant medications were not reported. On 02Mar2021 at 8:00, the patient experienced classic kidney stones symptoms, with no prior history and on no medications. All other symptoms were more typically reported for the vaccine (ie. headache, fatigue, etc). Patient has pending doctor appointment. The outcome of events was unknown. No follow-up attempts possible. No further information expected.

10 minutes after received shot, left arm went numb, then both arms turned blood red. Two hours later had H/A, fever, chills, increased heart rate, 102.8, nauseous, caused UTI. Wife had to help him get into the car due to feeling of illness. No shortness of breath or difficulty breathing

Less than two days after the vaccine was administered, I developed difficulty urinating and a burning sensation while urinating. This occurred again after the second vaccine and required hospitalization.

can't eat; patient woke in a pool of sweat that was so ubiquitous; extreme chills; massive kidney pain; This is a spontaneous report from a contactable consumer (patient). A 63-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 03Apr2021 09:30 AM in left arm as single dose for covid-19 immunisation. Medical history included Seronegative RA and glomular nephritis. Patient not diagnosed with COVID-19 prior to vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. On 04Apr2021 05:30 PM, 32 hours after the vaccine, patient could feel kidneys working overtime. He went into extreme chills and massive kidney pain, heat and clothes did not help. 38 hours after injection he couldn't stand the chill or the kidney pain so he took 800 mg ibuprofen and slept for 2 hours. 40 hours after injection patient woke in a pool of sweat that was so ubiquitous it went to the mattress. Since then (51 hours after injection) patient had bedridden with massive kidney pain. He can drink water but can't eat. Patient had not been tested for covid-19 since the vaccination. The events outcome was not recovered. No follow-up attempts are possible; Information about lot/batch number cannot be obtained.

blood clots; urinating blood; arm pain; fatigue; he started bleeding from the second one; This is a spontaneous report from a contactable consumer, the patient. This 63-year-old male patient reported that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6206) on 17Mar2021 (at the age of 63-years-old) via unspecified route as a single dose for COVID-19 immunization. Medical history included enlarged prostate, urinary health issues (gets up in the middle of the night), has glasses as he had cataract surgery last year (2020) so he lost his close-up vision. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: EL3249) on 18Feb2021 (also reported as 17Feb2021) (at the age of 63-years-old) via unspecified route as a single dose for COVID-19 immunization and experienced urinating blood and blood clots profusely, UTI, bleeding, arm pain, and fatigue. The patient received his second shot on 17Mar2021 and almost to the date three weeks later, had the same incident with urinating blood and passing blood clots. He waited an extra day because he could not go to the bathroom and then he went to the ER that same day so that they could flush him out. He also had an appointment on that same day with his urologist. A CT scan was done at the ER and then in the afternoon he went to the doctor. The doctor did a catheter flush. The patient was unclogged but he was passing blood. The patient also reported that he did have the normal arm pain and fatigue the second day or the day after the shot. He has no other adverse reactions at this time. The patient reported 11Apr2021 or 12Apr2021 was when he started bleeding from the second one (shot). He went to the hospital on 14Apr2021. The patient confirmed he was not admitted. The patient reported he is going to the doctor today (21Apr2021) to see the urologist but the urologist is going to do a scope in his bladder because that is the only thing that they cannot see. The clinical outcome of the events urinating blood, blood clots, bleeding, arm pain, and fatigue was unknown. The patient stated he does not know if this is an issue, however, it coincided with both of his shots. The patient was calling to see if this is something that has been seen or if it is in his head.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021470922 same patient/reporter, different AE/first dose

urinating blood; might be a UTI; arm pain; fatigue; blood clots; he started bleeding after the first shot; This is a spontaneous report from a contactable consumer, the patient. This 63-year-old male patient reported that he received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EL3249) on 18Feb2021 (also reported as 17Feb2021) (at the age of 63-years-old) via an unspecified route as a single dose for COVID-19 immunization. Medical history included enlarged prostate, urinary health issues (gets up in the middle of the night), and has glasses as he had cataract surgery last year (2020) so he lost his close-up vision. Concomitant medications were not reported. On 18Feb2021, the patient got his first shot. Three weeks later, he had an episode of urinating blood and blood clots profusely. The patient stated the amount of blood and blood clots was scary at best. The patient reached out to his daughter who is a nurse who advised him to go to the Emergency Room (ER). He reached out to the nurse hotline as well, which recommended that he go to the emergency room that day as well. He went to the ER (it was a Sunday). They did a blood test, a sonogram or some kind of sonogram, and a urine sample. They also flushed the patient's bladder out with a catheter. This emergency room visit determined that it might be a urinary tract infection (UTI) and started him on antibiotics. The patient confirmed he was not admitted to the hospital. The patient then made an appointment with his doctor because that was on a weekend. He saw his doctor who referred him to a urologist. The patient also reported that he did have the normal arm pain and fatigue the second day or the day after the shot. The patient reported 11Mar2021 or 12Mar2021 was when he started bleeding after the first shot, he was unsure of the exact date, and stated he went to the hospital on 14Mar2021. The patient reported he is going to the doctor today (21Apr2021), to see the urologist but the urologist is going to do a scope in his bladder because that is the only thing that they cannot see. The clinical outcome of events urinating blood, blood clots, UTI, bleeding, arm pain, and fatigue was unknown.; Sender's Comments: Linked Report(s) :PFIZER INC-2021471072 same patient/reporter, different AE/2nd dose

He got his vaccine, immediately had dizziness. Within 30 minutes could not move real good due to the Parkinson's. He got more confused, more dizzy, and worsening of his Parkinson's. He was very thirsty and drank a lot of water (4 liters of bottled water). He was then urinating and sweating a lot as a way of his body trying to get rid of something in his body. He was urinating more than he normally does. He started getting harder for him to breath. He noticed he had a bad taste in his mouth similar to when he had the COVID virus. He got a horrible splitting headache/migraine type that kept coming and going. He still has the taste in his mouth, and it affected the taste of food. These were all symptoms similar to when he had COVID. The headache was worse than when he had the virus. No appetite still, but still continuing to drink the water and not urinating like you did the first day and a half. He is not having to drink as much as he did before and not feeling like he was dehydrating. Does have the soreness from the vaccine or any rashes. He did have chills and low grade fever of about 100-101, which have resolved. He also had a sore throat which he still has. He had a very bad case of the COVID virus 3/1/21, which lasted for a week or two. He still has some residual symptoms from the virus with balancing/dizziness or worsening of his Parkinson's disease. His neurologist told him that he would recover from the cognitive effects from the COVID with his Parkinson's, but his motor skills may not return.

Within 2 hours of 1st Pfizer COVID injection pt had sudden onset left-sided paralysis with facial droop and slurred speech and then brief loss of consciousness with loss of bowel and bladder function. This happened on 5/21/2021. His wife is here giving the history. Him and his wife have the first Covid injection by Pfizer on 5/21/2021 at 3:30 PM at pharmacy. Within 2 hours they were back home sitting on the porch relaxing and he had the sudden onset of stroke like symptoms as noted above. EMS was called. Apparently by the time EMS arrived he had recovered to baseline and they advised him he did not have to go to the hospital for evaluation if he did not want to apparently. Since that time he has had no further stroke like symptoms but has continued to feel a bit foggy in the head with a slight dizziness.

discomfort in left shoulder blade area. pain in taking breath in back. tiredness, sweats, and discomfort in both kidney areas.

COVID-19 Infection Narrative: Patient received dose of Pfizer COVID-19 vaccine on 2/23/21. On 3/5/21 the patient presented to the emergency department with fever of 102.4 F, chest pain, dyspnea on exertion, non-productive cough and diarrhea. Pt was tested and found to be positive for COVID-19 infection. Patient initiated on remdesivir and dexamethasone for treatment of COVID. Remdesivir discontinued due to new onset acute kidney injury. Patient completed course of dexamethasone. Patient discharged home on 3/9/21. Has not received second dose of vaccine.

Kidney stone; Blood all over him; Falling down; Wobbliness; No energy; Could not sleep at all; Sweating like crazy; No appetite; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), first dose (at the age of 64-years old) via an unspecified route of administration in the left arm (reported as injection in left shoulder) on 11Mar2021 at 13:00 (Batch/Lot number UNKNOWN) as a single dose for COVID-19 immunisation. Medical history included colitis ulcerative from 1982 and ongoing, ongoing seizure (he had seizures for about 6 years and they got worse, probably it has been 6 or 7 years he has had seizures), high blood pressure, heartburn and insomnia (comes and goes). Concomitant medication included atorvastatin (manufacturer unknown, Tablet) 40mg strength, oral administration, 20 mg daily (half a tablet at bedtime) taken for an unspecified indication from an unspecified start date and ongoing; cholecalciferol (manufacturer unknown, Tablets) oral administration, 2 tablets in morning taken for colitis ulcerative from an unspecified start date and ongoing; escitalopram (manufacturer unknown), oral administration, 20 mg once daily taken for seizure from an unspecified start date and ongoing; lacosamide (manufacturer unknown) oral administration, 200 mg twice daily taken for seizure from an unspecified start date (for approximately a couple of years) and ongoing; lisinopril (manufacturer unknown), oral administration, 20 mg daily taken for high blood pressure from an unspecified start date and ongoing; mesalazine (MESALAMINE, Tablet), oral administration, 4 tablets a day taken for colitis ulcerative from an unspecified start date and ongoing; omeprazole (manufacturer unknown) oral administration, 20 mg as needed (two or three pills daily as he feels like he needs) taken for heartburn and ulcerative colitis from 2001 (approximately 20 years ago) and ongoing and zonisamide (manufacturer unknown) oral administration, 100 mg twice a day taken for seizure from an unspecified start date (for a couple of years) and ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient received the vaccination on 11Mar2021. After he received his first dose of the vaccine he experienced a bunch of symptoms which he listed as sweating, he could not sleep at all the first night, he was falling down, he had no appetite, and had no energy that same day. This occurred after the 15 minute window of waiting after getting the vaccination. On 11Mar2021, after the vaccination, the patient went to the store to buy groceries and started sweating like crazy. He could hardly carry the groceries to the car. He also had wobbliness. On 11Mar2021, the patient fell down and passed out coming home that night and he had blood all over him. He later clarified that he did not pass out, he got into the house and fell down and somehow landed on the recliner. He was covered in blood and all kinds of stuff. On 11Mar2021, he could not sleep at all that first night and his prescription Melatonin (Manufacturer Rugby) 3mg did not help at all. The falling down occurred roughly that same night on 11Mar2021. The patient stated that they told him they thought he was having seizures again but he was not. He had imaging which showed no seizures and Xray of his brain with unknown results in Mar2021. He had to have another Xray to make sure he did not have bleeding on the brain. Xray of his stomach showed kidney stones on 12Mar2021. The patient was not admitted to the hospital. The patient was scheduled to return for the second dose 01Apr2021. The patient inquired if he should get the second dose of the vaccine. The outcome of events kidney stone, blood all over him, could not sleep at all and wobbliness was unknown. The outcome of events sweating and falling down was recovered on 11Mar2021 and no appetite was recovered in Mar2021. The outcome of no energy was recovering. The lot number for the vaccine was not provided and will be requested during follow up.

SEVERE CHEST PAIN emanating from solar plexus area. Head/Neck/Body aches, chills/fever, nausea, loss of appetite, difficult to breath, sleep and urinate. Dr. told me I have a virus (unknown). COVID-19 Rapid Test- None Detected. LAB RESULTS - 11 anomalies; P02 Venous-23 low, 02 Saturation-43% low, RBC-3.77 low, Hemoglobin-11.7 low, Hemocrit-39.5% low, MPV-7.3 low, Potassium-3.3 low, CK-293 high, Alkaline Phosphate-29 low, Amylase-108 high, Leukocyte Esterase- Trace. Script for 2 days med for nausea and released after 4hours. Symptoms lasted 8 days.

On Sunday, April 11, 2021 morning, I noticed that my left side towards the back was hurting. I normally have a cup of tea and do some mild calisthenics and walk around the house. The pain escalated over time. The next day, April 12, I called my primary care physician and we had a zoom health care visit. My primary care provider and she prescribed 800 mg ibuprofen, I told her that I had taken the covid vaccine on April 2, 2021. The pain subsided temporarily but came back once the meds wore off. It's 4 days now, and the right lateral right side towards the back (approximately where the Kidneys are is still tender and hurting once the meds wear off. I am waiting a urine analysis results to confirm if this an infection or a kidney stone.

4/5/21 Patient presented to ED w/fever, weakness, cough and SOB. Initial temp was 103 and RA pulse ox 87%. Signs of AKI with cr up from baseline of 0.9 to 1.49 and he was hyponatremic (Na 130). Pt was admitted on O2 per NC, IVF, Decadron and Remdesivir. He completed a 5 day course of Remdesivir. AKI and hyponatremia resolved. he was not able to be weaned off oxygen. H was discharged on 4/13 on oxygen 2L per NC and Decadron to complete a 10 day course.

On 4/21 patient was seen at urgent care with symptoms for several days: history of fever up to 101, abdominal pain, nausea, vomiting, diarrhea and body aches, 1 week post 2nd dose of vaccine. Patient admitted to ED on 4/30 with high fever up to 104, generalized body aches and a lack of energy. Patient was diagnosed with AKI on CKD, secondary to sepsis and polycystic kidney disease, patient was given fluids and ceftriaxone. discharged 5/3

Body rash on foot 4/3/2021 Edema/fluid in lungs 5/7/2021 Kidney Failure w dialysis 5/16/2021 CRRT & ECMO 5/28/2021

Fully vaccinated patient admitted through ED with COVID positive test upon admission. Admitted 06/28/21 for weakness, confusion, difficulty urinating, and decreased oral intake. Found to have MSSA bacteremia. No s/s of COVID throughout stay.

Out of hospital cardiac arrest and refractory shock, acute kidney injury, shock liver, respiratory failure leading to death

Day 8 thought I was getting a urinary tract infection. Started experiencing chills. The next day same symptoms. A couple days later went on for a week with fever and muscle ache.

C/O numbness and edema in both legs and inability to walk since Wednesday night. States"I'm crawling around because it feels all mushy when I try to walk" Pt states he got the 2nd Covid vaccine on Tuesday morning. States I had something like this when I took Hepatitis C medication" Pt states he had nausea and body aches on Tuesday. The patient called nurse triage 4/1/21 and was sent to the Emergency room 4/1/21 for a possible allergic reaction to the vaccine. DIAGNOSIS at time of disposition: 1. Renal insufficiency 2. Elevated liver enzymes 3. Leukocytosis, unspecified type 4. Vaccine reaction, initial encounter 5. COVID-19 ruled out by laboratory testing 1721 Arrived 1739 Sodium Chloride 200 mL/hr 1814 Complete Blood Count w/Differential 1839 COVID-19 PCR, Rapid 1913 Sodium Chloride 1000 mL 1937 Comprehensive Metabolic Panel (CMP) Lactic Acid, Blood Level Lipase, Blood Level Magnesium, Blood Level NT - Pro BNP (B Natriuretic Peptide) Blood Level 2052 Discharged

Fever, chills, muscle contractions in lower back and stomach for two days. Loss of appetite, lower back pain. My urine was deep orange in color and bowel movements were very loose (not formed). Extreme fatigue for almost 8 full days before I felt any sense of feeling normal.

First covid vaccine on 3/3 and presented to the ER on 3/22 with CP. Second covid vaccine on 4/3 and presented to the ED on 4/15 with complaints of shortness of breath, lower extremity swelling, and 20 pound weight gain x 2 weeks. ED Workup: NT Pro BNP: 558 Hs-cTroponinT: 17>16 CXR: No acute findings EKG: NSR First Degree AVB D-Dimer: 1830 CTA: negative for PE Admitted for HFpEF exacerbation. Treated with IV diuretics, ECHO ordered. Stress test for CP with exertion - negative. Patient still admitted on 4/17/21. ECHO pending.

urinating constantly; up all night, back and forth; This is a spontaneous report received from a contactable female consumer (Wife) reported for her husband (Patient). This consumer reported similar events for two patients. This is the second of 2 reports. A 65-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 28Mar2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient received first dose bnt162b2 on 05Mar21. On 28Mar2021 patient got his last shot with wife. The wife and patient have been urinating constantly, up all night, back and forth. The event outcome was not recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021374640 Same reporter/ product, similar event, different patient

DEATH. Narrative: Patient died after receiving COVID vaccine dose #1. 07/18/20: admitted to hospital for weakness/lightheadedness causing legs to give out and fall backwards, resulting in hematoma 12/15/20: seen by PCP, stable 02/03 seen in ID clinic for HIV follow up, nothing out of the ordinary 03/02 COVID vaccine dose #1 03/14 Pt died Cause of death unknown and undocumented at this time. Patient did not have an ADR immediately after vaccine or hospitalized before or after vaccine. Last hospitalization was July 2020 due to fall and associated hematoma. Death not likely due to vaccine, but due to comorbidities, including active HIV infection with detectable viral load. No known previous COVID infection.

History of hypertension and COPD presents to the ED 4/23/21 with complaints of fever, nausea, dizziness, muscle aches, diarrhea, urinary urgency, and shortness of breath that started 4/20/21. SARS-CoV-2 COVID-19 resulted positive 04/22/21 23:40 on PT admitted 4/23/21. PT received dose 1 Pfizer vaccines on 2/25/21 LOT EN6200. Pfizer dose 2 received 3/18/21 LOT EN6207. PT discharged 4/25/21.

Same day symptoms fever, myalgia, arthralgia, shortness of breath, leg swelling, transaminitis, hyponatremia. Found to have pericardial and pleural effusions. Proteinuria and hematuria on urine test. Kidney biopsy performed confirmed diagnosis of fibrillary glomerulonephritis. Diagnosed with serum sickness like reaction

I63.9 - Stroke (CMS/HCC) I63.9 - Cerebral infarction, unspecified N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness

Urinating blood; very depressed; tired for one week; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old male patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 27Feb2021 10:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history was unknown. The patient's concomitant medications were not reported. On 06Mar2021 06:00, the patient experienced urinating blood and very depressed and tired for one week. The treatment received for events was unknown. The outcome of the events recovered. No follow-up attempts are possible. No further information is expected.

Subsequently, on February 19 I exhibited slight paralysis, by late evening on February 20th was convinced I was having a strok, went to ER and was admitted for apparent stroke due to presence of multiple fine bloodclots transiting area of brain controlling my right side (mostly arm/shoulder/hand paralysis), accompanied by irreguar heartbeat, leakage of heartvalves - these weer all new, never before reported symptoms. Examination and blood tests showed sudden elevation of blood pressure, cholesterol, glucose, throid, liver and kidney values, all of which subsequently decline and returned to usual levels after treatment and release from hospital (02/24/2021). Arrythmia has not been detected since and other measurement/blood indicators are back down/under control. Only residual symptoms are slight loss of speed of operation f/righ arm/hand and confirmed "moderate leakage in both heart valves".

diarrhea; Severe joint pain in knees; lower back pain kidney area; kidney pain; pain in his thigh muscles and buttocks; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), solution for injection: Lot number: EN6205) via an unspecified route of administration on 10Mar2021 at 02:00 pm on the left arm as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The medications patient received within 2 weeks of vaccination included : Lisinipril, coreg hydrocodone, Cialis and sertraline. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. On 10Mar2021, at 09 30 pm, the patient experienced severe joint pain in knees, lower back pain and kidney area. The caller also stated that he experienced severe pain in his thigh muscles and buttocks. He had terrible pain in his knees. He also had pain in his kidneys for 4 days. The patient took Meloxicam for inflammation, Hydrocodone for pain and Flexeril for a muscle relaxer. The caller stated that he can deal with his muscle and joint pain but is concern was about the kidney pain and he didnot want kidney failure. The caller stated that he also had diarrhea on the 5th and 6th days. The caller stated that he was scheduled to get the second shot tomorrow. caller has read that the second dose was worst than the first. The caller stated that he doesn't know whether he should get the second dose and his doctor advised him to speak with Pfizer or where he received the first vaccine or to go to the emergency room. The outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.

Tingling/numbness in feet on 3/27/2021. By 3/29/2021 woke up and could not stand. Went to local ER. Transferred to other hospital that evening. Put on ventilator 3/30/2021 for 2 weeks. Diagnose Guillian Barre Syndrome. Adverse reaction to GBS treatment caused kidney failure and many complications. In ICU 2 months then dies on 05/29/2021.

Well it started with severe chest pains, I had to go to the ER. I was diagnosed with pericarditis and inflammation in the kidneys. I was going into kidney failure. It took 2 months to come up with diagnosis. I had to have a kidney biopsy.

I got the shot at 5pm. When home and I was relaxing watching tv. At 8pm, my heart was racing very fast and took blood pressure, It was very high, 152/105 pulse 74. I called 24hr nurse on call. She said call 911. Ambulance was on site within 5 minute and transported me to hospital. I was in the ER at least 6 hours, moderating my heart. They said I had an A FIB attack. They got it down and admitted me to the hospital. I also experienced pain in my bladder, I could not urinate. They had to drain it 2 times. I was released from the hospital at 8pm the next day. Any questions, don't hesitate to ask me or my doctor.

12/21/2020 I had my first Pfizer COVID-19 vaccine and the second on 1/13/2021. Two days after my second vaccine on 1/15/2021 at 8:50 PM I had a scintillating scotoma in my right visual field in both eyes consisting of a bright flash of light in the center of my visual field that cleared but then it expanded into a C-shaped series of zig-zag lines that slowly expanded into the periphery of both right visual fields. It ended at 9:20 PM. I had no headaches afterward. While I have had migraines when I was younger, I haven?t had one in several decades and I never had an aura before it. I went to the ED where I was evaluated for a possible TIA and then admitted into Hospital. While there my platelet count was 400% of what it usually was. Other than the platelet count and anemia (I donated 2 unit of packed red blood cells on 12/17/2020) the rest of my blood work was unrevealing. The scintilating scotoma only lasted 30 minutes but the elevated platelets (although slowly coming down) continues to this day.

Chills, nausea, vomiting , headaches, sweats, frequent urination, over all joint pain started at 0400 this morning.

Patient with coughing and vomiting starting on 4/10/2021. Patient presents to ER for symptoms and found with elevated BUN/creat. During hospitalization he was dx with C-ANCA vasculitis. Patient with worsening symptoms leading to stroke and need for dialysis.

Pt was hospitalized with severe sepsis and septic shock with hypotension, hypothermia, bradycardia, AKI, pancytopenia requiring pressors on 3/11/21. This was 14d after the initial vaccine. He received his second vaccine on 4/2 and was hospitalized with severe sepsis again on 4/27/21 with similar symptoms. First episode c/o diarrhea but no pathogen identified. Second episode with bilateral multifocal pneumonia but no pathogen identified.

I61.9 - ICH (intracerebral hemorrhage) (CMS/HCC) I63.9 - CVA (cerebrovascular accident) (CMS/HCC) I63.81 - Right-sided lacunar stroke (CMS/HCC N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness

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

I am angry and it is effecting my sleep, it's effecting my job and my sleep; I am angry and it is effecting my sleep, it's effecting my job and my sleep; Could not sleep last night/ It is effecting my sleep; It felt like someone socked me in the head/ Feel bad; Neck pain/ right side of my neck is painful and radiates down to my right shoulder area to my rotator cuff and up to the back of my head/ Strained Neck, Neck Pain; Headaches/ it is like a crown headache; Nauseated; Flu-like symptoms; Kidney Stones 2-3 weeks after Vaccine; This is a spontaneous report from a contactable consumer (patient). A 66-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 28Feb2021 (Batch/Lot Number: EN6203) at the age of 66-year-old, as single dose for covid-19 immunisation. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Feb2021 (Batch/Lot Number: EL9264). Medical history included, nephrolithiasis from Dec2020 to Dec2020, ongoing sleep disorder, pain from an unknown date and unknown if ongoing. Concomitant medication included eszopiclone (LUNESTA) taken for sleep disorder from an unspecified start date and ongoing; tamsulosin hydrochloride (FLOMAX RELIEF) taken for nephrolithiasis from Dec2020 to an unspecified stop date; hydrocodone bitartrate, paracetamol (NORCO) taken for pain, sleep disorder from Dec2020 and ongoing. The patient reported that he received his 2nd Pfizer vaccine dose on 28Feb2021 and after 10 - 12 hours it felt like someone socked me in the head. The patient has had neck pain and headaches ever since the 2nd dose on 28Feb21. He stated: 'I am angry, and it is effecting my sleep, it's effecting my job and my sleep. Somedays the neck pain may go away a little, but never completely and the headaches are terrible. I have tried applying ice and applying heat, I have been to the chiropractor to treatments.' Patient is a self-employed and this was affecting his ability to work. He stated that the left side ok and the right side of my neck was painful and radiates down to my right shoulder area to my rotator cuff and up to the back of my head. It is like a crown headache. I have never had problems with headaches before this vaccine. The reported adverse events were: kidney stones 2-3 weeks after vaccine (nephrolithiasis) on 2021 with outcome of unknown , neck pain on 28Feb2021 with outcome of not recovered, headache on 28Feb2021 with outcome of not recovered , nausea on 28Feb2021 with outcome of recovered, flu-like symptoms on 28Feb2021 with outcome of recovered, insomnia on 02May2021 with outcome of unknown, feeling abnormal on 28Feb2021 21:00 with outcome of unknown, anger on an unspecified date with outcome of unknown , and impaired work ability on an unspecified date with outcome of unknown. Therapeutic measures were taken as a result of neck pain and headache. Information on Lot/Batch number was available. Additional information has been requested.

ED to Hosp-Admission Discharged 4/16/2021 - 4/20/2021 (4 days) Last attending ? Treatment team Pneumonia due to COVID-19 virus Principal problem Discharge Summary Internal Medicine HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Patient: Date: 4/20/2021 DOB: Admission Date: 4/16/2021 MRN: Length of stay: 4 Days PCP: Discharging provider: Admission diagnosis: Primary Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) Pneumonia due to COVID-19 virus Unknown Acute on chronic renal insufficiency Yes Diabetes mellitus type 2 in nonobese (CMS/HCC) Yes Cardiomyopathy (CMS/HCC) Yes Overview Addendum 3/23/2021 10:42 AM Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; NEG REGADENOSIN STRESS 6/2017; Formatting of this note might be different from the original. Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; NEG REGADENOSIN STRESS 6/2017; Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; NEG REGADENOSIN STRESS 6/2017; Note: TACHY-BRADY 1/2015; EMBOLIC CVA 1/2017; SYSTEMIC ANTICOAGULATION 1/2017; NEG REGADENOSIN STRESS 6/2017; Persistent atrial fibrillation (CMS/HCC) Yes Acute respiratory insufficiency Yes Hospital Course HPI: 66-year-old male admitted with COVID-19 infection on 4/15. COVID-19 infection: In setting of immunosuppressive therapy. Patient was hypoxic on admission. He was treated with remdesivir?completed 5-day course on 4/20. Was treated with convalescent plasma. Patient was weaned off oxygen during hospital stay?his saturation was 96% on room air. He was not getting desaturation on activit during his hospital stay. He will not require dexamethasone on discharge. Atrial fibrillation: Patient remained in atrial flutter?patient recent pacemaker placement done. He was having tremors in extremities and so amiodarone was decreased to 200 mg once a day after discussing with cardiology team. He will follow-up next week for device check and subsequently with electrophysiologist. He was maintained on anticoagulation for stroke prophylaxis. Hypertension: Remained stable?patient will be off clonidine. He was advised to continue with Imdur, carvedilol, nifedipine?blood pressure was ranging between 100?140s systolic. History of renal transplant?renal function remained stable. Patient was maintained on immunosuppressive therapy with CellCept and tacrolimus. Patient will discharge on 4/20?agrees with plan of care.

Clot in bladder; little blood in urine; Got third shot 23Apr in a fib and fever; Got third shot 23Apr in a fib and fever; Got third shot 23Apr in a fib and fever; This is a spontaneous report from a contactable other HCP (patient). A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 3 via an unspecified route of administration at age of 66-year-old on 23Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included axitinib (INLYTA) from 29Mar2021 to 2021. The patient previous took fist dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), both at age of 66-year-old as single dose for COVID-19 immunisation and 2nd shot was not viable (as reported). Patient got third shot 23Apr2021 in a fib and fever, CA levels, creatine levels. On 27May2021, patient went to oncologist, little blood in urine. Hospitalized (in 2021) due to clot in bladder and haven't been on Inlyta for last 5 days, doctor wanted to get him back on it. Patient was to be released from the hospital and has an appointment on 03Jun2021 with his oncologist. The outcome of the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Based on information available, the reported urinary bladder haemorrhage and fibrillation were likely due to intercurrent/concurrent disease, and unlikely causally related to the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE). The case will be reassessed should additional 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.

Diarrhea; Severe Headache; Dizziness; Some Blood In Urine; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6201), via an unspecified route of administration in the right arm on Mar2021 at 23:45 (at the age of 66-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination the patient was not diagnosed with COVID-19.Since the vaccination, patient had not been tested for COVID-19.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have any allergies to medications, food, or other products. On 06Mar2021, the patient experienced diarrhea, severe headache, dizziness, and some blood in the urine. The patient did not receive any treatment for the events. The clinical outcomes of the evente diarrhea, severe headache, dizziness, and some blood in urine were recovered. No follow-up attempts are needed. No further information is expected

Patient had an acute cognitive decline less than 24 hours post 1st vaccination. This includes: weight loss, confusion, loss of ADLs (inability to dress, shower without assistance, with urinary and bowel incontinence), agitation, personality change, and impulse control issues. Unable to determine if patient will recover from this decline and may end up in hospice.

U07.1 - COVID-19 J12.82 - Pneumonia due to coronavirus disease 2019 N17.9 - Acute kidney failure, unspecified

In the morning of Dec 30: Red urine - blood (bright red) - (Lower urinary tract) - didn't have pain. One episode. I did a Urine Dip Stick at my office (I'm a doctor) - positive for blood; Went to lab - He Took LAB -blood in the urine (microscopic) -Dec 31 days -MicroAlbumin - checked that, too, and it was negative for that. No proteins in the urine. I dip sticked my urine in the office this Monday (18th) or Tuesday - no blood - negative. I think it's resolved now.

Isolated fever to 103.2 on 2/4 - resulted in hospitalization. He was febrile to 102 on arrival with WBC count 11.9 with a L shift, leukocytosis resolved within 2 days, no further fevers documented afte rthat. CXR with most likely atelectasis. Pt unable to provide history, staff not observing respiratory symptoms, pt on room air. Initially started on vanc/zosyn despite negative procalcitonin -> AKI -> repeat procalcitonin minimally elevated (likely due to vanc/zosyn combination), stopped antibiotics, AKI resolved and procalcitonin again normal.

Started with headache , fatigue and muscular aches.later fever of 100.4 3rd day.. fever, low blood oxygen (90) increased heart rate, rigors Called 911 Taken to ER. Lab results revealed mild urinary tract infection Kidney stones ruled out. Intravenous Levaquin. Fever subsided. Returned home after 6 hours. Next day still having difficulty urinating Dr increased dose of Levaquin. Improvement by 5th day

Fever and chills worse than ever previously experienced, body aches, headache, urinary tract infection.., Extreme fatigue. First 3 days were excessive..nearly went to emergency Dr. Prescribed antibiotics for uti..improved in 1 to 2 days Other Symptoms eased but lasted 7 days, including extreme fatigue

Pt received COVID-19 vaccine on 2/23. He felt tired and unwell after. He had a syncopal episode on 3/4 and presented to ED. He was in complete heart block. Pacer placed. No CAD on coronary angiogram. Normal heart function. Discharged home. Presented unwell to ED with chest pain and elevated troponin on 3/16 found to have cardiomyopathy EF around 25% (medically managed, sent home) Repeat left heart cath done at the time showed no CAD. Presented to ED 3/22 with cardiogenic shock, EF 10%. Proceeded to have multiorgan system failure, impella placed, had cardiac arrest, transferred to another facility for further support. Was placed on VA ECMO. Heart biopsy done 3/25 revealed giant cell myocarditis. Pt is in critical condition and not expected to live d/t sequelae from cardiogenic shock: shock liver, AKI, ischemic bowel with ecoli bacteremia.

I was treated for a urinary infection with the antibiotic Keflex. Within hours of taking the first dose I had an extremely bad reaction to the antibiotic. I can't describe the feeling because it was unlike any I have ever had. But I felt the worst I have ever felt in my life. The reaction was intense for 36 hours. It was so bad I could not even sit up. The reaction was not so dramatic after 36 hours but I was still feeling miserable until I quit taking the drug. Then I felt fine.

a 67-year-old male with past medical history hypertension, CVA on aspirin and Plavix, diabetes mellitus on Metformin who presented to ED 3?30?-30-2021 secondary to shortness of air. Patient son is at bedside and states he has had complaints of cough, chest pain and shortness of air for the past 3 to 4 days. He has associated subjective fevers at home. Patient son states that his daughter checks the patient's blood sugar daily. He has not missed any of his medications or had a change in medications. His blood sugar was checked this morning and noted to be high and he thus presented to ED for further evaluation. Patient was ill-appearing on arrival to ED with respirations in the 30's as well as tachycardia and mild hypoxia. He was placed on 2 L with O2 stats stable. He states he has some relief with IV fluids but continues to have chest pain and shortness of air. He is tachypneic with Kussmaul respirations noted. Pertinent ED labs: Elevated lactic 3.0, potassium 6.8, glucose 760, BUN 33, creatinine 1.8, WBC 16, D-dimer 2636, decreased GFR 38, sodium 124, bicarb 5 VBG with pH 6.97, CO2 25, bicarb 6 Patient started on insulin drip, 2 L IV fluids, IV antibiotics, calcium in ED.

loss of appetite, abdominal pain, weight loss, death Narrative: 02/12/21: GI VISIT-ASSESSMENT: 1-R/O Gastric or Cecal Cancer with Peritoneal Carcinomatosis is most the cause of his weight loss and early satiety. Liver and Pancreas on CT Scan unremarkable. 2- Weight loss and early satiety may be due to Gastric Mass with metastasis or Colon Mass. 02/17/21: ED VISIT AND ADMISSION w/ CC 4 weeks of poor appetite and 2 weeks of inability to hold down food and abdominal pain, decreased BM and decreased urination Assessment on admission: acute kidney insufficiency, Possible partial Gastric outlet obstruction 2/2 malignancy, GI malignancy with peritoneal carcinomatosis as per CT scan 2/11, asymptomatic bacteruria hyperkalemia and AKI during admission 02/21/21: pt signed out of hospital AMA due to 'personal problems' 02/22/21: pt returned to hospital for continuation of care and was readmitted with same c/o 02/24/21: pt tachycardic and hypotensive w/ altered mental status; rapid response team called, transferred to icu; impression: acute severe sepsis with uremia; during procedure to place nephrostomy tubes, pt goes into wide complex vtach then vfib and ACLS done w/ compressions, ROSC @ 2255 w/ BP 70-41, Norepi started; pt intubated 02/25/21: pt extubated 02/25/21@2106: pt with inferior lateral stemi 03/01/21: pt w/ sudden deterioration with decreased LOC and increased WOB., intubated, found to be profoundly hypoxemic, developed severe metabolic acidosis and hyperkalemia, severe refractory hypotension 03/02/21: pt unresponsive without pulse or respirations, NOK declined autopsy no prior covid infection noted, no immediate reaction after covid vaccine, pt was hospitalized leading up to death with unrelenting abdominal pain, AKI, metabolic abnormalities. It is unlikely that vaccine led to patient's death.

DEATH Narrative: 66 yo male with PMH of HTN, HFpEF, COPD, T2DM, CKD, tobacco use disorder and bipolar disorder was found dead in his home on 2/16/2021 after police did a wellness check per request of patient's sister. Patient received the covid19 vaccine (Pfizer) on 2/9/2021, vaccine was administered without complications. No prior positive for covid19. After patient received his covid19 vaccine, he was seen at same day access for increased SOB/DOE, worsened orthopnea. Per progress notes, at this last appt, patient had expressed a number of medications which he was not willing to take, attributing his worsened health to their effects. Pt has continued spironolactone despite being advised to stop it by his medical provider. At the time of visit, provider noted that this kidney function was declining (patient does have CKD). Provider discussed the importance of medication adherence and patient was started on torsemide. Hctz was discontinued, minoxidil was increased due to patient preference. Prior to this same day access/express care visit, patient was hospitalized from 1/26 through 1/28/2021 for hypertensive urgency (211/105) and that at that time, pt already had orthopnea, SOB, and dyspnea. Patient was also admitted from 1/7 to 1/8 and left AMA. While inpatient, his MRI revealed a pontine lacunar infarct that was found to be chronic. It was recommended that patient be treated with aspirin/plavix for 21 days then aspirin alone but patient declined.

Pfizer-BioNTech COVID-19 Vaccine EU. Excessive urination started about 12:30 am 4/8/2021 (about 14 hours after 2nd dose. Had to urinate 12:00 midnight, 12:30am, 2:30, 3:30, 4:30, 5:00, 5:30, 7:30, 9:00, 10:00. Didn't sleep much because of it. Normally I have to go 2-3 times a nite, not nearly as much as this. It's starting to get better mid day 4/8/2021. Nothing too serious, just wanted to inform.

Patient began getting dizzy within 24-48 hours after vaccine. Within 2-3 days developed persistent fevers as high as 103. Was found to have febrile neutropenia & thrombocytopenia. AKI developed, now requiring hemodialysis. Patient also required mechanical ventilation. Has been diagnosed with Hemophagocytic lymphohistiocytosis now being treated with dexamethasone & etoposide. He remains intubated.

Peed myself twice today, once in the morning and once in the afternoon. I had no control at all & I have never had this happen before. I had no sensation of peeing, it just flowed on it own volition.

N17.9 - Acute renal failure, unspecified acute renal failure type (CMS/HCC) E87.1 - Hyponatremia N17.9 - Acute kidney injury (CMS/HCC)

R56.9 - New onset seizure (CMS/HCC) R56.9 - Unspecified convulsions N17.9 - Acute kidney failure, unspecified

ED to Hosp-Admission Discharged 5/3/2021 - 5/5/2021 (2 days) Hospital MD Last attending ? Treatment team COVID-19 virus infection Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine HOSPITAL INPATIENT DISCHARGE SUMMARY HOSPITALIST GROUP . Patient: Date: 5/5/2021 DOB: Admission Date: 5/3/2021 MRN: Length of stay: 2 Days PCP: MD Discharging provider: MD Admission diagnosis: Primary Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) COVID-19 virus infection Yes Gout Yes Hyperlipidemia Yes Hypertension Yes Transaminitis Yes COVID-19 Yes HPI: 67-year-old man admitted with COVID-19 pneumonia Hospital Course: This patient was admitted for COVID-19 pneumonia. He was treated with convalescent plasma and dexamethasone. He was not given remdesivir because of elevated liver function tests. On this regimen the patient did very well and by the day of discharge she was feeling much better. He continued to be hypoxic and a home oxygen evaluation showed he required 1 L at rest and 4 with exertion. We have set this up for him and will he will continue oxygen at home. I will finish out his course of dexamethasone. He should follow-up with his family doctor within the next week for an oxygen check and to be sure that he is getting better. His family doctor can tell him when it is safe to discontinue his oxygen therapy. I educated the patient on self isolation until he is no longer infectious. He is in agreement with this plan. He feels much better and is very eager to go home today.

Starting 2 weeks after the shot, he started getting strange pains from the lower back and down his legs, felt like a severe sciatica but also presented with severe hip pain. Then he started losing strength in legs, had about 7 days of extreme leg weakness, had trouble getting into and out of the chair, even noticed visual muscle loss in his legs . Then after 7 days the strength started coming back. Then 2 weeks later described "awful urinary symptoms" getting up every 20 minutes during the night, had to pee dozens of times in the day and night, this has started to abate

Per family pt became more somnolent, gaining weight, jaundiced after 2nd covid vaccine dose. Pt was admitted to the hospital on 3/23 with decompensated cirrhosis and ecoli bacteremia and died on 3/25.

weakness, fatigue, body ache Narrative: 67-year-old male with past history of diabetes type 2, hyperlipidemia, left BKA, who presented to hospital 2/14/21 with generalized weakness, fatigue, body aches and left leg pain for the past 5 days. He reported it started after receiving his COVID-19 vaccine on 2/09/21. He also had associated nausea, vomiting, diarrhea. He denied fever, chest pain, shortness of breath, abdominal pain. Labs showed mild leukocytosis 12k, AKI with Cr 4.6, K 3.2, Bili 2.9, trop 0.01, lactate 2.2. He was given 3L IVF, vanco blue in ED at 18:35. Asystole on monitor. ACLS initiated and once eventually stabilized he was transferred to ICU. Pt again coded 2 more times while in ICU with were halted due to medical futility.

68-year-old gentleman presented with dyspnea and found to have bilateral PE, right lower extremity DVT. He was started on IV heparin, Coumadin. Patient was found to have acute kidney injury and urinary retention, bilateral hydronephrosis. Foley catheter was placed, this resulted in improvement in renal function and resolution of hydronephrosis. First cath urine was bloody but subsequent urine has been clear. A CT urogram did not reveal any other abnormality of the urothelial system. Prostate is enlarged.

Blood clots in lungs and UTI; Blood clots in lungs and UTI; This is a spontaneous report from a contactable consumer. A 68-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE (at the age of 68 years) for covid-19 immunisation. Medical history was none. Known allergies was none. The patient did not have Covid prior to vaccination. No other vaccine was given in last four weeks. There were no concomitant medications. The patient experienced blood clots in lungs on 31Mar2021 with outcome of recovering and UTI (urinary tract infection) on 31Mar2021 with outcome of recovering. Adverse event blood clots in lungs and UTI resulted in Emergency room/ department or urgent care and then hospitalization for 6 days. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on 11Apr2021. Therapeutic measures were taken as a result of blood clots in lungs and UTI and included blood thinner. Information about lot/batch number has been requested.

Body chills; Body aches; Blindness; Septic shock due to serratia infection (not sure how the infection came to be); Septic shock due to serratia infection (not sure how the infection came to be); Kidney failure; This is a spontaneous report from a non-contactable consumer. A 68-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 13Feb2021 (Lot Number: EL9266) as single dose for COVID-19 immunisation. Medical history included type 2 diabetes, stage 4 kidney disease, high blood pressure. Concomitant medications included unspecified drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. On 14Feb2021, the patient experienced body chills, body aches, blindness, septic shock due to serratia infection (not sure how the infection came to be), kidney failure. The events required a visit to the emergency room. No treatment required. The patient was hospitalized due to the events for 18 days and condition was life threatening. The final outcome was fatal. The patient died on 06Mar2021. An autopsy was not performed. Cause of death was septic shock. No follow-up attempts are possible. No further information is expected.; Reported Cause(s) of Death: Septic shock

death R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - Acute kidney failure, unspecified SHORTNESS OF BREATH LEG SWELLING ASCITES

very tired; still can't function; My urine stream became half of what it normally is; severe stomach pains/ pains around outside of stomach; Pain in right kidney; Chills/hot; Hands shaky; Slight confusion; Couldn't eat; Couldn't sleep or sit for more than 10 minutes at a time due to pain; Couldn't sleep or sit for more than 10 minutes at a time due to pain; bloat; This is a spontaneous report from a contactable consumer(patient). A 68-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot/batch no: EN6199) via unspecified route of administration in left arm, as single dose on an 06Mar2021 16:45 for COVID-19 immunization (at the age of 68-years). The patient medical history and concomitant medications were not reported. The patient did not receive any other medication in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient had no known allergies. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, he has not been tested for COVID-19. On 06Mar2021 22:00, patient started to get severe stomach pains, couple hours after, patient got pains outside of stomach, pain in right kidney, chills/hot, handy shaky, slight confusion, could not eat, drank water and could not sleep or sit for more than 10 minutes at a time due to pain. Patient started to bloat. Less severe on Monday 08Mar2021 and finally slept a full night from 7 pm to 3 am Monday into Tuesday. Patient stated that symptoms have decreased but still could not function and was very tired yet at 10 am Tuesday (09Mar2021). Patient stated that urine stream became half of what it normally was. Patient had been drinking lots of water, had some crackers, had five teaspoons of broth last night and finally ate a bowl of oatmeal. The events resulted to visit doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of, my urine stream became half of what it normally is. The outcome of all the events was recovering except urine stream became half of what it normally was, which was recovered on 08Mar2021. No follow-up attempts are possible. No further information is expected.

Acute kidney failure diagnosed after second PFIZER injection. Kidneys were not in acute stage before PFIZER injections.

Pain in the back becoming so severe level 8. Went to local doctors in Healthcare for four weeks trying to get help. Could not walk after the fourth week. Went to medical center and diagnosed within two hours of having acute osteomyelitis. On the verge of sepsis.

Pfizer first vaccine- high fever, body tremors, chills, delirious, oxygen 82 heart rate 130, blood pressure extremely high, ambulance called and he was rushed to critical care ER. He has sepsis, kidney function worsened, on BiPap. He was absolutely fine prior to vaccination. He is still. in isolation Hospital as of the date of this report. May have aneurysm in leg as well.

Acute respiratory failure (CMS/HCC) CHF (congestive heart failure) (CMS/HCC) Renal insufficiency NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) Pneumonia due to COVID-19 virus Covid-19

admitted to the ICU with acute respiratory failure. h/o DM and HL, prior h/o smoking and EtOH and opium abuse (none x 28 yrs, per family). Received second dose of the Pfizer COVID vaccine in AM of 3/16, having had severe adverse reactions (fever up to 104, n/v) to the first dose three weeks earlier. Experienced recurrent fevers (up to 103) beginning by the evening of 3/16, for which he took acetaminophen. Awoke at 3 AM w/ recurrent fevers, for which he took ibuprofen. Felt better in AM, had breakfast, and retired back to bed. Awoke shortly after noon w/ severe n/v and AMS. Was brought to the ED by the EMS. Febrile (T 39.6) w/ rigors, tachycardic, tachypneic, and poorly responsive on arrival. Continued to experience episodes of emesis, and was felt to have possibly had a seizure episode ("looked to the side and was shaking"; no clear tonic-clonic movements noted). Was thus intubated for airway protection. Initial laboratory w/u revealed presence of mild leukocytosis (WBC 12.6, 47p49L0Eo), lactic acidosis (LA 5.2), hyperglycemia (glu 297), elevated lipase level (161) renal insufficiency (Cr 1.23). extubated on 3/19. received antibiotics for positive blood culture (streptococcus parasanguinis). diagnosis: ADVERSE EFFECT OF CORONAVIRUS COVID-19 VACCINE

Left leg basically numb and rubbery/ leg had just gone to sleep; Tried to stand up and fell; Urinating almost non-stop; going about every 2 hours and going a lot; he had no strength except a smidgen of strength in the right leg; trying to learn how to walk/ He can't walk to the commode very well; Weight: States 201; then mentions that during the night he thought about how much he was urinating and got on the scale out of curiosity and it said he weighs 191; Afraid he was having a stroke; he had trouble holding his fork/Like a cramp in hand; Sore Arm; This is a spontaneous report from contactable consumer (patient). A 69-year-old male patient received his second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199) at the age of 69-years-old, via an unspecified route of administration in right arm on 12Mar2021 at single dose for COVID-19 immunization. Medical history included blood clots (reported as blood thinner). Concomitant medication included apixaban (ELIQUIS) from 2019 and ongoing as blood thinner. The patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6199) at the age of 69-years-old, via an unspecified route of administration in right arm on 16Feb2021 at 14:00 at single dose for COVID-19 immunization which gave him severe diarrhea, nausea, gastrointestinal distress, a sore arm and it wore him out. After the second dose of the vaccine on 13Mar2021 which was administered in a public health department, the patient experienced sore arm. He was concerned because around 02:00 on 19Mar2021, he got up to go to the bathroom and noticed his left leg was basically numb and rubbery. As soon as he tried to stand up, he fell. He thought the second vaccine was the one everyone says will be harder than the first. They even gave him a sheet of paper that scared the hell out of him. Thought he was okay after the second vaccine until around 02:00. At first, he thought his leg had just gone to sleep. It was like having noodles for legs. The patient has been urinating almost non-stop which also started around 02:00, this was what woke him up. He had to crawl on hands and knees after falling to get into the bathroom, he had no strength except a smidgen of strength in the right leg. On 18Mar2021, while eating dinner, he had trouble holding his fork and did not think much about it. He had a cramp feeling in right hand. Today, while eating lunch with a fork, he also had a difficulty. The patient eats with his right hand. The patient has been trying to learn how to walk since early this morning. He has worn out his wife since she was cleaning up after him in the bathroom and helping him walk. He couldn't walk to the commode very well, couldn't hold his water, and has been making a mess all day. He was at first afraid he was having a stroke but had no stroke symptoms. The patient reported that his weight was 201, then mentioned that during the night he thought about how much he was urinating and got on the scale out of curiosity and it said he weighs 191. At this time, his leg weakness persists but he was able to stand and hold his own body weight. Issue with holding fork and cramp feeling in right hand was persisting. Urinating was persisting and stated he was going about every 2 hours and goes a lot. The outcome of the event pain in arm was recovered on 17Mar2021; unknown for stroke, fall, and weight loss; and not recovered for all other events.

One day after receiving Pfizer COVID-19 vaccine dose #1 at vaccine clinic patient seend by PCP reoprting fever, fatigue, chills, cough, urinary incontinence, and worsening back pain. Lab results consistent with AKI: patient admitted to HRH, urinary catheter placed, received IV fluids and antimicrobials, and discharged to home three days later medically stable.

This 69 year old black male received the Covid shot on 2/27/21 and went to the ED and admitted on 4/18/21 with the following diagnoses listed below. G51.0 - Bell's palsy N17.9 - Acute kidney failure, unspecified

Other pulmonary embolism without acute cor pulmonale Pneumonia, unspecified organism Acute kidney failure, unspecified Pulmonary embolism Acute renal failure (ARF)

Blood clots; Delirious; Oxygen was down to 80%; Sepsis; E. coli/sepsis with cultures of E. coli; C-diff; sick; Shaking uncontrollably; Achy; Extremely high fever/a high fever of 103 F; Chills; Aneurysm in his leg; Bleeding from somewhere; weak; missed his second dose of the Pfizer COVID-19 vaccine; Caller says her husband's kidney was failing too while he was in the hospital; This is a spontaneous report from a contactable consumer reported for her husband. A 69-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in arm on 11Mar2021 18:00 (Lot Number: EV6206) as single dose for covid-19 immunization. Medical history included Kidney transplant from 1998, same kidney all these years, on immune medication, polycystic kidney disease from 1998, the transplant saved him in 1998, blood pressure high went along with the polycystic kidney disease, had it for a while, Type 2 diabetes mellitus this was diagnosed probably about four years ago and immunocompromised. There were no concomitant medications. The patient had the first dose of the Pfizer vaccine on 11Mar2021, "he felt okay first evening, Friday was okay, Saturday 13Mar2021 achy, Sunday running a high fever of 103 F, he started to get chills. Then Around 3am (Early Monday on the 15Mar2021) called the ambulance, oxygen was down to 80% he was shaking uncontrollably, temperature was still 103 F when they took it and even at the hospital was the same temperature. He was delirious on 15Mar2021. When he got to Emergency Room he was in critical section, had to put on BiPAP with 100% oxygen, When in the ambulance they tested for covid and was negative each time he was tested for covid he was negative. He was in the hospital from 15Mar2021 to 24Mar2021, in critical care unit. He Turned out having sepsis, E.coli, had to put him on strong antibiotics. He developed CDIFF on 15Mar2021, and an aneurysm in his leg in Mar2021 and needed a blood transfusion. They were trying to rule out blood clots and did sonogram and found it. His blood was going down, he was bleeding from somewhere and had to have a transfusion. They did a procedure on the leg to break up the aneurysm twice. On BiPAP for a few days and then did the medium one and then able to take off oxygen when he went home. He came home on antibiotics and tons of medication. Should he get the second vaccine? Is it related? Is it to late to get the second vaccine? following Sunday he had an extremely high fever and was shaking uncontrollably on 14Mar2021. He was told to get the shot by his provider. She had to call an ambulance, he almost died, and she didn't know if it is related to her husband getting the vaccine. They put her husband on a BiPAP with 100% O2 when he went to the hospital by ambulance and was admitted on 15Mar2021, which he was on the BiPAP a couple days then went on to the second level, then right before he came home he was weaned off of oxygen. They kept testing him for COVID every day, because the symptoms were similar but they tests kept coming up negative. On 15Mar2021, the patient had sepsis, with cultures of E. Coli, and very contagious C-diff, he was sick from the 15th to the 24th for all those things. She didn't know if the vaccine brought it on if it was brewing in him before that, or if it had to nothing to do with vaccine. He also had an aneurysm in his leg and had a medical procedure where they had to go in and take care of it to break up the aneurysm. The patient's kidney was failing too while he was in the hospital. The patient missed his second dose of the Pfizer COVID-19 vaccine due to his hospitalization from 15Mar2021 to 24Mar2021. She would like to know if it would still be recommended for the patient to get the second shot of his COVID-19 vaccination since he is past the deadline to get it, is it going to be too late for him to get the second dose to be fully vaccinated and effective to get it after waiting this long? His first dose was injected about 06:00PM in unknown arm. The patient had a fever Saturday evening, clarified to being 13Mar2021, which was higher the next day on 14Mar2021 and reached 103 degrees Fahrenheit, and he went to the hospital by ambulance at 03:00AM 15Mar2021. His fever started getting higher late Saturday to Sunday and he got progressively worse. The patient had had serious complications before related to his health problems, but she had never had to call an ambulance before this. The patient had chills on Saturday 13Mar2021 and then Sunday evening he was shaking and it wouldn't stop so she gave him Tylenol, then she called the ambulance Monday morning. The patient can't take anything more than Tylenol, and he never usually takes anything. The patient's kidney function was getting bad while he was in the hospital, his Creatinine went high and was 3.8, which is high for someone with a transplant. The patient was doing better, he was still very weak, he was under a doctor's care, he was on very strong antibiotics for a month, Vancomycin and other medications which also make him weak. The patient was on IV antibiotics at the hospital and then came home on oral. The 3.8 for the Creatinine was probably at the beginning when he went into the hospital. The outcome of the event Sepsis was Resolved with Sequel and the outcome of the other events was unknown.

Death A41.50 - Gram-negative sepsis, unspecified K81.0 - Acute cholecystitis E86.0 - Dehydration E83.42 - Hypomagnesemia N39.0 - Urinary tract infection E87.2 - Respiratory acidosis R06.89 - Hypercarbia T85.518A - Cholecystostomy tube dysfunction, initial encounter D72.829 - Leukocytosis, unspecified type

First vaccination 04/14/2021, sore arm for two days. Second dose 05/05/2021, 24 hours later I am peeing by the drop. Treated myself, Perdisone 2X 10mg day, no help. Treated myself Cephalexin 500mg 2X day, 3 days, no help. Talked to doctor on 05/11/2021, Picked up Macrobid 100mg, Reluctant to try, can give you a heart attach. Tried two days, Ceph & Mac, 1ea. dadocty, day 3, tried 2ea. Macrobid per day, BP went to 170/102. Could kill me, stopped all meds. Still pee by the drop. 05/29/2021, Piller Cyst on my head ruptured, leaking puss, origional removal consultation, 04/12/2021 w/Dr. Only had it for 20+ years. Schedualed removal 05/21/21. 29 Days after the second dose

Pt had the second Pfizer covid shot Mid April. By end of April, he was starting to put out very Dark urine which I think because was accumulating bilirubin in his system. Two weeks after that started to notice that he was Jandiced. I saw him in the Emergency room on May 30. Hi Bilirubin total was 20. He had Cat Scan of the abdomen reveiling dilated intrahepatic ducts. He had a MRCP, by the GI doctor . had a swelling or tumor at the out flow to the intrahapatic ducts. Brushings were taken. Brusings were taken an examination under microscope. Some atypical cells that were but no mention of cancer. These same cells sent for staining to an outside lab. With the stain they were favored, but not definatly called cancer cells. At the time that I saw the pt, his impression ( the pt ) was that his new symptoms were a direct result of having the Pfizer Covid shot.

PAIN IN LOWER RIGHT LEG (STARTED 6/03/2021) CLOTS FOUND VIA ULTRASOUND SCAN (6/08/2021) LOVENOX INJECTIONS FOR 7 DAYS (120MG SUBCU) ELLIQUIS RECOMMENDED FOR 3-6 MONTHS (5MG 2X/DAY ) CURRENTLY STILL UNDER TREATMENT AS OF 6/19/2021

Urine turned red, skin turned yellow, lost significant strength & got winded walking to the bathroom. Went to ER at Hospital on 02/20/2021. Hemoglobin level had plummeted to 7.6; it eventually fell to below 5.0. I was admitted to the ICU and, after a couple days, was transferred to the med/surg unit. I was administered whole blood, but my hemoglobin level would not stay above 7.0. On 02/27 I experienced a cardiac event due to my low RBC count and was moved back to ICU. From there, I was transferred by ambulance to ICU at Hospital in order to start Rituxan therapy. I was in ICU for a day and then transferred to the cancer care unit. I remained there until

Pt admitted 22 Jan 21 with (HFpEF) heart failure with preserved ejection fraction; AKI (acute kidney injury); Acute kidney injury superimposed on chronic kidney disease; Acute on chronic diastolic congestive heart failure; Acute on chronic heart failure with preserved ejection fraction; Acute respiratory failure with hypoxia; Anemia due to stage 3 chronic kidney disease, unspecified whether stage 3a or 3b CKD; Anemia, unspecified type; COVID-19; Chest pain; Chronic pain syndrome; Gastroesophageal reflux disease without esophagitis; History of COVID-19; Hypertension, essential; Hypertensive heart and kidney disease with HF and with CKD stage II; Hypoxia; Peripheral vascular disease due to secondary diabetes mellitus; Prostate cancer; Shortness of breath; Type 2 diabetes mellitus with stage 3 chronic kidney disease, with long-term current use of insulin, unspecified whether stage 3a or 3b CKD as of today still hospitalized

Hospitalized for community-acquired pneumonia and sepsis 6 days following administration of COVID-19 vaccine, complicated by acute hypoxemic respiratory failure and acute kidney injury requiring. Admitted to ICU, treated with intravenous antibiotics and initial pressor support. Intubated on hospital day #3, extubated on hospital day #8. Remains in ICU at time of this report.

Three days after receiving dose #1 of COVID-19 vaccine, patient had a first potential seizure event. Patient reports waking up with LLE pain and weakness and a bite mark on the right side of is tongue. He also noticed he had urinated on himself (a small amount). Pt presented to ED on 1/22 where seizure work-up performed. MRI brain showed "non-specific gliosis along the L cerebellar hemisphere along with chronic BG infarcts." Unremarkable EEG. Started on levetiracetam 500 mg BID at discharge and continues to follow with outpatient neurology.

First shot, the following morning it felt like I had a 20 lb weight on my chest.. Latter on that morning I had a sever headache and knees and shoulders ached. I had to pee about every half hour and that hurt. These symptoms lasted for four days. The second shot was similar but the symptoms but lasted two days. No treatment was taken other that acedimetafin (sp).

Chest pain, shortness of breath, feels like he can't catch his breath. presented to the emergency department with episodes of palpitations and chest pain. Around 530 this evening, the patient was in a store when he started feeling palpitations and irregularity to his heart rate. He states at that time, it did give him a mild anterior chest wall pressure. He denies any diaphoresis, pain radiation or lightheadedness at that time. Symptoms resolved after several hours.

Monday evening 11:20 pm nausea and stomach pain which dissipated 2 hours later: dark brown urine continues into day 2

On 2/19/21 @ 11PM he was fine and had been talking laughing and playing his trumpet right up until bedtime Less than 2 hours later his wife was alarmed to hear him struggling to breathe When he tried to urinate he could only pass blood She called 911 @01:00 AM 02/20/2021 They administered oxygen and transported him to ED {this form won't let me fill in any of the shaded boxes} EMS said his lungs sounded like he had pneumonia Extensive testing focused on his lungs and kidneys as the source of infection and inflammation Please note that no source could be found! He was discharged home with strong steroids and antibiotics and instructed to use a inhaler 4x a day on 02/25/2021 5 days

Fever, low oxygen saturation, severe encephalopathy, kidney failure, bilateral pulmonary infiltrates, sepsis, tachycardic, acidotic, intubated on ventilator since admission, paralyzed/sedated, ABG results showed high CO2 and O2 retention, edema, electrolyte imbalance, ARDS, low hemoglobin and hematocrit levels, blood transfusion needed

CHEST PAIN WEAKNESS - GENERALIZED Hyperkalemia Lactic acidosis Hyponatremia SEPSIS EKG abnormalities Acute kidney injury (CMS/HCC) Neutropenia (CMS/HCC) DEATH

Pt reported he was in his usual state of health, back to work following his surgery in Dec 2020 for intraabdominal abscess s/p small bowel resection when he reported sudden nausea developing the day after his second covid 19 vaccination which continued to progress to then development of abdominal pain resulting in ER visit on 3/20/2021 with resultant hospitalization(still hospitalized as of 4/2/21 with working diagnosis of mesenteric ischemia and AKI.

Late that night I started to ache in every joint it seemed. No fever, no respiratory problems, continuing with fatigue, and increased frequent urination throughout the day on April 8th Felt almost normal by dawn Friday 9th of April.

I26.99 - Pulmonary emboli (CMS/HCC) J18.9 - Atypical pneumonia N17.9 - Acute kidney injury (CMS/HCC) R73.9 - Hyperglycemia A41.9 - Sepsis (CMS/HCC)

Acute episode of delirium with diagnosis of encephalitis, specifically, Immune mediated encephalitis. Patient had acute confusion beginning 10 days after his second Pfizer Covid Vaccine dose. Extensive work for metabolic encephalopathy was negative. CSF studies showed autoimmune encephalitis. He was treated with Plasmapharesis for 4 days, High dose steroids, 1000mg three day Sina row and then weekly, IVIG and Ritiuxan without any resolve. Patient remains in delirium state. He was initially in hospital in (HOME CITY) then a specialist clinic.

4/22/21 Patient admitted to hospital for COVID D/C summary: Clinical Summary a 70 y.o. male with a history of HTN, prostate cancer, chronic pain, T2DM, OSA noncompliant with CPAP who presented to ED 4/22/2021 with scant hemoptysis. Found to be COVID+ and hypoxic requiring 2L NC. Cr. 1.4. He was transferred for further evaluation and management. Improved with Remdesivir and steroid therapy. Patient completed 3 doses of remdesivir, recommended completion of steroid therapy (5/2) and repeat outpt CT Chest. 1. Acute Hypoxic Respiratory Failure: requiring 2-3L NC on admission in setting of COVID-19 pneumonia. CTPA with no PE, patchy multifocal ground glass opacities, mildly enlarged mediastinal and hilar LAD, likely reactive. Pulmonary hygiene. Weaned off of O2 4/24/21. Home o2 evaluation with patient desaturating to 91% with exertion. 2. COVID-19 Pneumonia: symptoms began 4/20/2021 with headache, fever, chills and diarrhea. Presented with scant hemoptysis. COVID + 4/22/21. Febrile to 101 on admission. CTPA as described. Hypoxia as described. Started decadron (stop date 5/2), scheduled albuterol, mucinex. Monitor respiratory status. Pulmonary followed, initiated Remdesivir 4/23 following improvement in renal function. Recommended completion of 10 days of steroid therapy. Recommend repeat CT chest in 4-6 weeks for resolution.

Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Severe, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe, Additional Details: Daughter states patient did not feel well in the days after his vaccine. He was weak, had nausea/vomiting, and was unable to eat/drink. About a week later, patient was hospitalized with acute renal failure, likely due to excessive loss of volume. Daughter states that his doctors believe he had underlying renal issues and because he wasn't able to eat or drink for several days, this led to the renal failure. Daughter says that 2 months later, patient is on dialysis.

feverish and chills; feverish and chills; arm was a little sore and a little black and blue; frequent urination / he started to pee every 20 minutes; arm was a little sore and a little black and blue; the site bled a little bit; little site soreness like a flu shot; This is a spontaneous report from a contactable consumer (Patient). A 70-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9262 and Expiration date was not reported), via intramuscular route, administered in Arm Right on 29Jan2021 14:30, as single dose for COVID-19 immunization. Medical history included shellfish allergy (had a weird shellfish allergy, he said that he can eat cooked shrimp and lobsters. He said that he was peeling raw shrimp and his fingers started to itch, he started to swell, and his eyes started to swell. He said that this happened twice and once with lobster. He was treated with Benadryl IV), diminished kidney function which was diagnosed in 2015 and ongoing (kidney issues run in his family, had a uncle on dialysis), kidney stone had it for years and ongoing and stated that they monitor it every once in a while and enlarged prostate. Concomitant medications included FLOMAX [MORNIFLUMATE], 0.4 mg, one capsule orally in the evening taken for enlarged prostate from an unspecified start date and ongoing. His next vaccine is due on 18Jan2021 at 14:30 (as reported). The patient did not receive additional vaccine on the same date of Pfizer vaccine and also he did not receive any vaccine within 4 weeks. On 29Jan2021, about 8 hours after receiving the vaccine, the patient started to pee every 20 minutes and this went on for most of the night about 05:30 30Jan2021. He wanted to know if this was a reported side effect of vaccine. He stated that he was overdue for urology appointment. He also enquired if it is more common to experience, increased side effects after second dose. He said that normally he would get up about every 3 hours to go pee. He stated that the next day he was fine. On 29Jan2021, the patient arm was sore and a little black and blue. He stated that he had a little site soreness like a flu shot that lasted about 2 days and was still a little blue and black. On 30Jan2021, that he felt slightly feverish in the middle of the night and little bit of chills. He stated that the next day he drank a bunch of water and he was fine. He stated that the feverish and chills was at about 03:00 in the morning 30Jan2021. The patient reported that the lady administering the vaccine said that the site bled a little bit, but he said that it was nothing. The patient did not go to emergency room or physician office as a result of adverse events. The patient did not underwent any relevant tests. The outcome of the events recovered for feverish and chills, arm was a little sore and a little black and blue on 30Jan2021, frequent urination / he started to pee every 20 minutes on 30Jan2021 05:30, little site soreness like a flu shot on an unspecified date. Follow-up (27May2021): Follow-up attempts completed. No further information expected.

Patient states he got the covid vaccine in the morning on 4/30/2021 and by afternoon he was having difficulty walking - states he was having trouble picking his feet up. Patient states he was feeling weak and the next day had to start using a cane (walked without assistance prior to vaccination). Patient states he started losing feeling/strength/movement in feet and legs 4/30/2021, with the weakness/paralysis moving up the legs over the course of a month. Patient states he went to primary doctor approximately 3 weeks after his vaccination and reported his symptoms but his doctor "wasn't concerned". On arrival to the ER 5/31/2021 patient was totally unable to sit up unassisted and stated his decreased sensation and loss of movement had risen to bilateral hips. Patient had to be lifted to the stretcher by four staff as he was unable to help at all, with legs dangling/flaccid paralysis obvious. Patient also reports loss of bowel/bladder control since vaccination - states started losing that control as decreased sensation/movement ascended to hips/pelvic region.

I had problems over the years with my prostate. After the vaccine I had been urinating every hour with little output. I had to be catharize because of urinary obstruction, which means my bladder was not releasing urine. Extreme pressure in my abdomen because the is no urine output. The condition has persists, I now have to self catharize daily. Which has prompted me to have prostate surgery this coming Friday 06/11/2021.

At around 11:40am resident was observed to be unresponsive. resident noted with pulse and respiration. Not in any distress. lung sounds clear. Vital Signs BP162/82 P86 R18 T97.1 O2 Sat 96%, fingerstick is 133mg/dl .Resident received COVID 19 vaccine at 11:25am. O2 via 2l NC initiated. Nurse Stat call, 911 initiated, MD at Bedside. Resident awake and responsive. EMT responded and resident left with EMT to be transferred to hospital, remains awake and not in any respiratory distress.

walking is still very bad; lower back pain; he reported lower back pain, that has migrated more to the right hip and into the glute; he reported lower back pain, that has migrated more to the right hip and into the glute; it might be kidney pain; arm pain; This is a spontaneous report from a contactable other Health Professional (HCP). A 71-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3302), intramuscular on 22Jan2021 15:10 at 0.3 mL, single (0.3ml by intramuscular injection left shoulder) for COVID-19 prophylaxis. Medical history included ongoing high blood pressure (diagnosed about 21 years ago), ongoing gout (Diagnosed about 2 years ag), ongoing ankle spur right foot, ongoing diminished cartilage both knees, joint pain. The concomitant medications included torsemide. The patient reported adverse event (AE) after his first Pfizer-Biontech covid19 vaccine at 15:10 on 22Jan2021. He reported arm pain starting 3 hours after vaccination until noon the next day (23Jan2021). When he woke up on 23Jan2021 he reported lower back pain, that has migrated more to the right hip and into the glute. The pain inhibits walking, standing, etc. He did note that he is >300lbs and has had joint pain in the past, but the hip pain is new. He also thought it might be kidney pain, as he takes a daily diuretic. He stated he has been treating with Aleve twice a day, but that walking is still very bad. The patient is an optometrist that was calling about the Covid-19 vaccine and said that he did not know if the Lot number written on the vaccination card is EL3302, E13302, or EI3302. He got the vaccine on 22Jan2021 and reported that he got a sore arm about 3 hours after receiving the injection. He woke up with a sore lower back pain. He is 5ft 9.5 and 310 lbs and he is on Torsemide, a pretty strong diuretic. He woke up with the back pain and stated that it moved right and middle to his buttocks, a little lower than the end of his spine and to the right. He did not think it was his kidneys. He said that Torsemide can make kidneys work overtime. His knees were pretty shot, the left worse than the right. No further details provided. He was upset to know that he has shrunk a 1.5 inches over the years. He has been taking 2 Aleve a day since Saturday, this morning was his 4th pill. He said that it is really odd when he stands equally on both feet his lower back hurts. He has to sleep on his right side and that it hurts more when he sleeps on his back and on his left side. He was fearful doing eye exams next to his patient and how the lower back pain would affect him. Reporter considered seriousness for Lower back pain was Medically significant. The outcome of event lower back pain was not recovered; of event arm pain was recovered on 23Jan2021; of other events was unknown.; Sender's Comments: Based on the time association, the possible contribution of suspect vaccine BNT162B2 to the event low back pain cannot be excluded. The ongoing gout and concomitant drug torsemide may also play contributory roles to the event. 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.

General aches and pains that also aggravated my prostate, causing urgency, pain upon urinating. All symptoms abated after 24 hours.

HISTORY OF PRESENT ILLNESS: The patient is a 71-year-old male patient with a complex medical history with multiple problems and cancers and debilities. He received a second dose of COVID vaccine yesterday about midday. Shortly thereafter, he started having shivers and shakes. The concern that I had when he called the office was a possible bacteremia. He was sensitive emergency room for evaluation. He was noting that he was chilled and was unable to get warm. He said his temperature was up to 100.5. He had generalized weakness and inability to get up and walk and had malaise. He has no known exposures to pneumonia or other illnesses. He has basically been homebound for the past year with the COVID. He was evaluated in the emergency room and found to have an elevated white blood cell count on the right upper lobe pneumonia on portable chest x-ray. Blood cultures and urine culture were obtained since he had a urine abnormality as well. The patient was admitted to observation while we wait on cultures and we treat the pneumonia with antibiotics.

The adverse effects of fever, urine burn, aching back and dizziness for one day after the vaccine given. Approximately, four days later the same symptoms returned.

Burning during urination; Headache; body aches and pains; joint fatigue; Very restless and difficult sleep; Very restless and difficult sleep; This is a spontaneous report from a contactable consumer (the patient). A 71-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration in the right arm on 04Feb2021 08:30 (at the age of 71-years-old) as a single dose for COVID-19 immunization. The patient's medical history included: asthma but no food or medicine allergies but seasonal allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included: atorvastatin, losartan, and metoprolol ER (extended release). The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration in the right arm on 14Jan2021 09:15 (at the age of 71-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any other vaccine on the same date as the COVID vaccine. On 04Feb2021 22:00, the patient experienced headache, body aches and pains, joint fatigue, very restless and difficult to sleep first night. The patient experienced burning during urination the next morning (05Feb2021). No treatment was received for the events. The clinical outcome of the events was recovered on an unspecified date. It was also reported that since the vaccination, the patient had not been tested for COVID-19. Information of lot number has been requested.

Cardiac arrest; Pulmonary embolus; Renal failure; Fever; Dehydration; Not eating or drinking; COVID-19 confirmed by positive COVID-19 test / COVID pneumonia; blood clot; blood pressure was low; Respiratory arrest; Respiratory failure; Hypoxemia; ventricular tachycardia; This is a spontaneous report from a contactable nurse reporting on behalf of the husband. A 71-year-old male patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL9264) on 10Feb2021 at about 19:00 (at the age of 71 years), in left deltoid, for COVID-19 immunisation. No other vaccines were given on the same day or within 4 weeks. The patient declined flu vaccine and pneumococcal vaccine (PNEUMOVAX), he had never had another vaccine except maybe his childhood vaccines. Medical history included rotator cuff surgery and cataract removed in 2020. The patient exercised regularly, he was healthy, he walked for miles and didn't eat any non-sense, he did not eat out, he did not smoke. The patient's mother was 100 years old and fully competent. The patient had two sisters older than him, the oldest one had hypertension the second sister did not have anything that they were aware of. The patient's father lived until he was 98 years old. The patient concomitant medications were none. The patient was told to take vitamin D 50,000 units but didn't even take them (he still had 9 of them in the bottle and they gave him 13). The patient experienced fever on 11Feb2021, renal failure on 14Feb2021, pulmonary embolus on 28Feb2021, cardiac arrest on 04Mar2021, dehydration and not eating or drinking on an unspecified date in Feb2021. These events required ER visit and were reported as serious as involved hospitalization from 14Feb2021 to 04Mar2021 and as fatal events. The patient died on 04Mar2021. Clinical course of the events included the following information. The patient received the first vaccine on 10Feb2021, the next day he developed a fever. The reporter spoke with the patient's doctor who told to give the patient paracetamol (TYLENOL) thinking the fever was from the vaccine. On 12Feb2021 and 13Feb2021, the patient's temperature was 102. Then the doctor advised to take the patient to the hospital. The patient's temperature was still 102, he was in renal failure, and they had to dialyze him. The patient was otherwise healthy, the patient's last physical was in Dec2020 and the only thing it showed was that his A1C was 5.7. The patient had no cholesterol or hypertension. The doctor advised the patient to decrease sugar and carbs because the holidays were coming up. The patient's follow up was scheduled on Mar2021. The reporter felt that the vaccine has something to do with the patient renal failure. The reporter spoke with the doctors at the hospital who didn't want to commit to anything. The reporter believed this was an adverse event. The caller mentioned that she had her vaccine before and she was fine. The patient was admitted on 14Feb2021 and by Wednesday he was not eating or drinking, he was dehydrated. The patient's admitting diagnoses was elevated temperature and ruling out COVID. The patient tested positive for Covid on 14Feb2021 (COVID-19 PCR test). The patient's temperature was 99.8 and then kept creeping up, on Saturday it was 102. The caller gave the patient Tylenol cold and flu (lot T0CL001021, expiry date Oct2021) took the edge off but in three hours the temperature was back up again. The patient never complained of pain and didn't want to take Tylenol. On 15Feb2021 the patient's numbers were getting better after the fluid challenge and then his numbers kept creeping up after that. The patient had the fever a week until they had it under control. The fever went away, it was gone for like 5 days, then it spiked again. The patient was started on piperacillin/tazobactam (ZOSYN) for like 3 or 5 days and the fever went away but then it kept getting worse. On 28Feb2021, the medical personnel thought the patient had a pulmonary emboli but because of the renal failure, they couldn't do a computerized tomography on the patient. The doctors mentioned that the patient was in renal failure and they thought they heparinized the patient and he had a blood clot who led to pulmonary embolus, cardiac arrest, and death. The patient was diagnosed with a pulmonary emboli on 28Feb2021. The patient started de-saturating and the doctors intubated and sedated him that whole time until this. Dialysis was started on 01Mar2021 and the patient received it every day except 04Mar2021. The patient's blood pressure was normal, it hardly ever went above 120. The patient was on the medical floor from 22Feb2021 to 04Mar2021. When the patient was on the medical surgical floor, he was on high flow 5 liters. After the patient started desaturating, he went to the intensive care unit and was put on a non-rebreather on 45%. The patient's highest heart rate was after intubation was 135, but the patient's blood pressure was low so they started him on some vasopressors. They did the fluid challenge on the patient and his labs were a little better than the labs kept creeping up until the doctor inserted a shiley catheter for dialysis. Respiratory: Respiratory arrest and then cardiac arrest. Respiratory failure, they intubated the patient. The reporter assumed dyspnea because the patient was intubated. Tachypnea was when the patient was in the intensive care unit already intubated. Hypoxemia, they intubated the patient so the caller guessed it was for the oxygen saturation drop. Covid pneumonia: yes. Chest x-ray showed mild pneumonia. The caller requested a follow up x-ray and the doctors said they were going to do another one but the caller is unsure if they did or when. The patient received additional therapies for COVID-19: remdesivir. Other radiological investigations: unable because of the patient's kidney function. They were looking at the D dimer and BMP to come up with the embolus since the patient couldn't have the scan. ARDS: no. Cardiovascular: The patient had a heart attack on 04Mar2021. The reporter thought it was from the pulmonary embolus which led to cardiac arrest. Arrhythmia: the caller guessed so, the patient was being worked on for 10 minutes before the caller got there. The caller saw a rhythm strip which showed a flat line and then she noticed ventricular tachycardia, then a flat line. The patient did not have SARS-CoV2 antibodies at diagnosis. Gastrointestinal/Hepatic, neurological, hematological, dermatological: none. Vascular: pulmonary embolus: yes, deep vein thrombosis, limb ischemia, vasculitis: no. Renal: renal failure: yes, acute kidney injury: no. The patient was scheduled for his second vaccine dose on 03Mar2021 at 04:15 but did not receive it. Time of death was 4:15 in the afternoon on 04Mar2021. The reporter considered renal failure, fever, dehydration, not eating or drinking, cardiac arrest and pulmonary embolus as fatal and related to the suspect vaccine. The outcome of the other events was unknown. Cause of death was unknown. No autopsy was performed.; Sender's Comments: Based on current information available, the company considered there is a possibility that all reported events are consequence of COVID-19 pneumonia on the basis of advanced age. The positive COVID-19 test occurred 4 days after the first injection of suspect vaccine BNT162B2. No complete effect can be achieved for short time interval. The COVID-19 is more likely pre-existing colonization or intercurrent condition, unrelated to suspect vaccine 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 RAs, Ethics Committees, and Investigators, as appropriate.; Reported Cause(s) of Death: Renal failure; Fever; Dehydration; Not eating or drinking; Cardiac arrest; Pulmonary embolus

Bright red blood and blood clots in urine on 4 consecutive days; Bright red blood and blood clots in urine on 4 consecutive days; This is a spontaneous report from a contactable nurse (patient). A 71-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 71 years of age), dose 2 via an unspecified route of administration, administered in arm left on 18Apr2021 10:30 (Batch/Lot Number: ER8733) as a single dose for COVID-19 immunisation. Medical history included hypertension and penicilline allergy, both from an unknown date and unknown if ongoing. Concomitant medication included bisoprolol taken for an unspecified indication, start and stop date were not reported. Historical vaccine included BNT162B2, dose 1 via an unspecified route of administration, administered in arm left on 22Mar2021 14:30 (Batch/Lot Number: ER8737) (at 70 years of age) for COVID-19 immunisation. The patient had no other vaccine in four weeks prior to covid vaccine. He had no covid prior vaccination. He had not been tested for covid post vaccination. It was reported that the patient experienced bright red blood and blood clots in urine on 4 consecutive days. The events started on 19Apr2021 10:30 AM with outcome of not recovered. The patient had not received any treatment for the events.

This 71 year old male received the Covid shot on 3/26/21 and went to the ED on 4/21/21 and was admitted on 4/21/21 with the following diagnoses listed below. I21.4 - Non-ST elevation (NSTEMI) myocardial infarction N17.9 - Acute kidney failure, unspecified D69.6 - Thrombocytopenia, unspecified Fever Vomiting

Massive hematuria noticed approximately 10 hr after dosing (10 pm); This is a spontaneous report from a contactable other (patient). A 71-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 26Mar2021 11:30 AM (Lot Number: EN6204) as 2nd dose, single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Medical history included diabetes, heart disease, kidney stone, Pine pollens only. Concomitant medications included Clopidogrel bisulfate (PLAVIX); acetylsalicylic acid (ASPIRIN (E.C.)); metoprolol succinate (METOPROLOL); metformin; glimepiride. Historical Vaccine included the first dose of BNT162B2 on 05Mar2021 11:30 AM (Anatomical Location: Left arm, Lot Number: EN6202) for COVID-19 immunization. The patient experienced massive hematuria noticed approximately 10 hr after dosing (10 pm) on 26Mar2021 22:00. Urine was clear immediately before vaccination. Hematuria resolved by next morning (8 am). No pain or other symptoms. Past history of kidney stones, but event was completely absent severe pain associated with past stone passage. Hematuria not observed after first vaccination, only after 2nd shot. Called doctor but have not done any follow-up given rapid resolution. Just checking to see if the patient should have additional follow up on kidney function, disease etc, and/or if acceptable to get Pfizer vax at some future time. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was resolved without treatment on 27Mar2021 08:00.

flu; felt like he was back having the COVID-19 virus all over again; Urine was a bright yellow color; soaking wet sweating; fever of 101; tiredness; headaches; chills; He slept the whole day; joints; shortness of breath; weakness; lower back was hurting; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/ Lot number: On CDC vaccine record card reporter thinks Lot is EN6206, pretty sure but could be EV6206) (pending for clarification), via an unspecified route of administration on 15Mar2021 (reported as Monday) (at the age of 71-year-old) at around13:00-13:30, at a single dose for COVID-19 immunization in clinic. Patient had a history of COVID-19 virus around onset about the last day of Sep2020 or Oct2020.Down and out for about 14 days before totally turned it around (when he had COVID-19 virus they turned him away from his normal doctor and told him to go get tested on his own so the whole process was handled through emergency urgent care testing) and had a blood disorder, does get blood clotting. The patient had no relevant concomitant products or other medical conditions. Nothing relevant; he has just been taking the medicines he has always taken; mostly a lot of vitamins and stuff and he takes a full acetylsalicylic acid (ASPIRIN). Patient had his last blood work and testing done in Oct2020 when they gave him clearance, told him he was no longer positive for COVID-19 virus, no bloodwork taken since then. Patient had undergone height measurement and resulted as 5 feet, 9 inches, probably 5 feet, 8 inches because he shrunk getting older but thinks 5 feet, 9 inches. Patient had no exposure that he was aware of other than his own history of COVID-19. He went and asked if he should get the Pfizer-BioNTech COVID-19 Vaccine and was told yes because it was over 90 days since he was cleared of COVID-19. On 15Mar2021, patient had some issues with first shot. After his vaccine by the end of the day he felt like he was back having the COVID-19 virus all over again and had all the symptoms he had before, like weakness, shortness of breath and everything. He stated he was really got effected at the end of the evening but did not know until the following morning when he woke up and was soaking wet sweating and had a fever of 101. He slept the whole day and by the end of the second day he felt much better but still had a fever. He sweat that evening and the next morning felt good again. This all lasted a total of maybe 24 hours until he felt good again. He had something different after the Pfizer-BioNTech COVID-19 Vaccine that he did not have when he had COVID-19 virus which was his urine was a bright yellow color from 16Mar2021 to 17Mar2021. His urine looks normal again today (18Mar2021), but he did not have urine symptom when he had COVID-19 virus previously. Patient reported that he had the flu on an unspecified date. He asked because he is slated for the second dose of the Pfizer-BioNTech COVID-19 Vaccine on 08Apr2021, he stated he knows the first shot was supposed to give him 50 percent immunity, he does not think he should go do it again, it makes him real nervous about the results he had from the first dose of Pfizer-BioNTech COVID-19 Vaccine; asked if he should or should not get the second dose relative to these events. Everyone else said it was a piece of cake, but it wasn't for him. He was ok all day after the Pfizer-BioNTech COVID-19 Vaccine was administered 15Mar2021, felt pretty decent the rest of the day and evening. On 16Mar2021 his whole world changed, felt like he was back having the COVID-19 virus all over again starting 16Mar2021 he had exactly all the same things, feeling like he had before, that he experienced when he had COVID-19. He woke in the middle of the night with sweats, really hot-his wife took his body temperature, and his body temperature was 101; he slept most of the day on 16Mar2021. He had tiredness; headaches; chills; joints; fevers; the whole thing for about a 24 hour period until event finally subsided, clarified as improved the patient was started feeling a little better 16Mar2021, but he sweat like crazy that evening so that must have broken the fever. It was not until morning of 17Mar2021 that he felt functional. He still once in a while gets a little headache but that is minor. The only thing was on the second day after the first dose of the Pfizer-BioNTech COVID-19 Vaccine was administered, after events onset, patient received a couple of Aspirin because his lower back was hurting, probably from sitting so long. The reporter assessed the events as non serious. The outcome of the events urine was a bright yellow color was recovered on 18Mar2021, lower back was hurting was unknown and the rest of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

Six weeks after taking the 2nd dose I had to go to the emergency room. I was experience itching all over my body. I had urcicaria. A week after I woke up with chest pain. I had an emergency cardio Cath and had 2 stints put in. 2 weeks after that I had to get 2 more stints and a angioplasty. Since then my blood pressure is out of control, my kidney function is declining, and I've had an allergic reaction that is currently being monitored.

I26.99 - Other pulmonary embolism without acute cor pulmonale N17.9 - Acute kidney failure, unspecified

Patient is a 70 year old male with RCC s/p left nephrectomy (2018), marginal zone lymphoma (2018) s/p 6 cycles chemotherapy, diabetes, HTN, CAD, esophageal strictures with multiple dilations, esophageal perforation causing constrictive carditis necessitating a cardiac window, and recurrent RCC from lymph node biopsy now on Cabozantinib who presents to the ED after one day nausea and vomiting. Patient reports he is doing well until yesterday when he begins to have some abdominal pain on his left side radiating into his back. He has chronic back pain but feels like this pain is different. He did tolerate diet yesterday. This morning, he had 3 vomiting episode and watery bowel movement. He also endorses burning pain when urinating today. He states that he had several UTIs previously. Patient has chronic productive cough from COPD history but denies increase or worsening of cough. In the ED, he was found to be tachycardic HR 106 and febrile T 38.4. Labs notable for Hgb 11.1, lactic acid 1.8, and mild transaminitis (chronic). UA showed WCC, blood, leukocyte, and RBC. Patient was given 1L IVF and started on vanc and meropenem. CXR was unremarkable. Troponin negative. Covid from RPP came back positive. Patient stated that he had Covid previously in Jan 2021 and had both Covid vaccines on January. Of note, patient was diagnosed with marginal zone lymphoma on Jan 2019 and was on 6 cycles of bendamustine and rituximab previously in 2019, with current plan of observation. He was also diagnosed with left cell renal carcinoma on Sept 2018 s/p L nephrectomy 2018, SBRT. Metastatic disease was confirmed on Jan 2020 and patient is currently on cabozantinib. He has notable side effects while on treatment including neuropathy and thrombocytopenia.

First dose of Pfizer COVID-19 vaccine on 3/22/2021, followed by the 2nd dose on 4/12/2021. 7/14/21: Patient arrived to ER with COVID symptoms after testing positive on 7/7/2021. Per ER records, the patient received the positive result on 7/10/21 and went to see his PCP who prescribed the patient a Zpack and cough medicine. The patient finished the Zpack but was still having body aches, shortness of breath, fever, loss of appetite, and fatigue. 7.15.21: in the ED patient found to have hyperglycemia, anion gap metabolic acidosis, worsening kidney function, and multifocal pneumonia. Diagnosed with acute hypoxic respiratory failure due to COVID-19 pneumonia, sepsis secondary to COVID pneumonia. started on remdesivir

fever, I was shaking like I was freezing, I took aspirin and covered up with a heavy blanket. I fell asleep and woke up every few hours. I took aspirin at 8 am, I felt like I needed to pee, when I tried it, it hurt too much so I tried not to. I drank glasses of water, but I was still not able to pee more than a little.

Blood in urine; This is a spontaneous report from a contactable consumer (patient). A 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; batch/lot number and expiration date unknown), via an unspecified route of administration on left arm on 12Jan2021 10:00 at a single dose for Covid-19 immunization. The patient's medical history was not reported. The patient has no allergies to medications, food, or other products. 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 and since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included clopidogrel bisulfate (PLAVIX), losartan (reported as "losortan") and rosuvastatin calcium (CRESTOR). The patient experienced blood in urine on 12Jan2021 10:00. The event was not treated and reported as non-serious. The outcome of the event was not recovered. The patient received vaccine on workplace clinic. Information on the batch number has been requested.

Narrative: Vaccine received 1/20/21. Pt reports feeling tired starting the following day (expected), however, blood sugars went up over 400. Went to ER for evaluation and treatment. Found to have elevated CR and markedly elevated liver enzymes (AST/ALT over 1000) which slowly improved after hospitalization, IVF, and insulin. 1/28/21 labs showed CR back to normal. ALT down to 555 AST 304. Blood sugars 200s.

Fever, loss of equilibrium, weakness, feelings of needing to urinate but can't. Inability to stand, walk, or move around. Pour apatite. Fell while trying to make it back to my daughters car. Got home and laid down with ice pack. Fell again on my way to bed. Remained in bed for most of the time but fell again when I tried to get up. Was given Tylenol for the fever, ice packs and icyhot for the bruises.

Covid 19 vaccine was administered at 2:45 pm on 2-21-21. By 2:55 pm patient began to experience Confusion and loss of short term memory. He suddenly did not know where is was, how he got there, or why he was there. He continuously asked those questions throughout the balance of the day. The nurses on duty in the clinic got a wheel chair and escorted us to the hospital ER in the same building. He was immediately taken to a room where a doctor met us and began asking him questions. The Dr quickly ordered a multitude of tests. Results shown in item 19

At some point after the 2nd vaccine the patient had increased weakness and shortness of breath. He presented to the ER and was noted to have acute kidney injury. Patient was admitted from 2/23- 2/27.

About 13 minutes post vaccination veteran stated he was not feeling well when he began to stop responding and speaking, eyes staring off into distance, both arms and legs with stiff minor tremoring. About one minute later head dropped, cold to touch, vet no longer responding at all, three person assistance to ER via stretcher, vet became incontinent and had episode of emesis during transport.

death Narrative: Patient was a 71 y/o gentleman with PMHx schizoaffective-bipolar, major neurocognitive disorder, hx covid- 19 in 12/15/20, chronic insomnia, BPH s/p LUTS, OA/DJD at unspecified joint, and acquired hypothyroidism who presented to the clinic for hospital follow up and monitoring while on clozapine. Pt received covid19 vaccine on 2/16/2019 while inpatient, right before his discharge on 2/17/2021.Of note, pt was put on hospice care at the time of discharge to patient's home. He passed away on 2/26/2021. I could not find the death notice in the chart (which usually contains the medical cause of death). This was reported to us from an staff. The following describes his hospitalization: At facility, was noted to be dehydrated and reported to not have been taking his medications or having good PO intake. Per reports from nursing home, patient wasnoted to have difficulty swallowing" and spit up meals and medications. SLP evaluation with concerns for mastication and dysphagia. At time of hospitalization his Na was at 153, also noted to have AKI2. His hypernatremia, aki, and dehydration resolved with fluid replacement. His potassium was also replaced. His constipation resolved with laxatives which also improved his abdominal discomfort. Also, his olanzapine was changed to disintegrating tablet which helped with his intermittent agitation. Currently, he was calm, amenable, and with medication compliance. To help with his poor appetite, his mirtazapine dose was increased to 30 mg from 15 mg. Pt was discharged on 2/17/2021 when family decided to place him under hospice care.

No energy no interest in anything Want to go to bed as soon as possible cough infection in scrotom Urininating with great frequency

This is a spontaneous report from a contactable consumer. A 72-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 23Mar2021 (Batch/Lot Number: EL9267) as an unspecified dose for COVID-19 immunization. The patient's medical history included diabetes mellitus from 2005 and ongoing Verbatim: Diabetic, pancreatic carcinoma from 2011 to an unknown date Verbatim: Pancreatic cancer, whipple procedure.He says he is a cancer survivor. There was a whipple procedure done and he was given chemo and radiation treatment and he has not had a recurrence or another outbreak of that particular issue, it was pancreatic cancer. There were no concomitant medications.The patient experienced he had normal soreness in the arm, a little discomfort in his body, he took his temperature and it was 99.3 on an unspecified date, he was urinating tremendously, like 1-2 times every hour/frequent urination, he was unable to sleep on 25Feb2021, had about with some diarrhea on 26Feb2021. The caller is calling about the vaccine stating that he received the vaccine 23Feb2021 and he had normal soreness in the arm and a little discomfort in his body, then last night after about 11PM he started having to go to the bathroom, he was urinating tremendously, like 1-2 times every hour, he was unable to sleep. He is a diabetic but his sugar was no high it was in the 120s, he knows that if it is like 200 or 300 it could make him urinate but his sugar was way away lower and on top of that he took his temperature and it was 99.3. Three hours later or about 2.5 hours later he had a bout with some diarrhea. He says he had not eaten anything unusual or different than he normally eats, he couldn't find anything wrong with that so he has been resting and lying down and hydrating a lot because this was on the direction of his PCP and he says so far he seems to be okay. He doesn't know whether it was a side effect but there was nothing else unusual in they past few days that could explain it, it was an unusual occurrence. He confirms his first dose was on the 23 Feb 2021 and he began having frequent urination around 11 PM 25 Feb 2021. He says it does not seem to be ongoing right now it lasted through the night and seemed to be gone today. He had diarrhea about 9-9:30 this morning, that does not seem to be ongoing right now. The patient underwent lab tests and procedures which included body temperature: 99.3. The outcome of the events he had normal soreness in the arm, a little discomfort in his body, he was urinating tremendously, like 1-2 times every hour/frequent urination, he was unable to sleep, he took his temperature and it was 99.3, had a bout with some diarrhea was unknown. No follow-up attempts are possible; information about batch/ lot number cannot be obtained.

4/16/21 Severe Headache 4/17/21 Severe Headache 4/18/21 Severe Headache, high fever, body aches, joint and muscle pain, these symptoms continued until 4/22/21. On 4/22/21 spiked a high fever, headache, body aches, chills, joint and muscle pain. Went to urgent care, had negative chest x-ray, negative strep test and negative Covid test. Was given steroid and antibiotic injection and a RX for Zpack . I was told if I wasn't better in 24 hours go to the Emergency Room. 4/23/21 Fever at 102.9 with all other symptoms still the same. Went to Emergency Room, given 2 liters of fluid, lab work collected and Chest X-ray. Kidney functions were not normal and told to follow up with a Nephrologist on 4/26/21. Went to Nephrologist on 4/26/21 where more labs were drawn, I was told to discontinue my blood pressure medication until my pressure returned to at least140. All symptoms still the same at the time of appointment on 4/26/21. The fever didn't break until 4/28/21. I continue to have muscle aches and joint discomfort.

After 1st vaccine frequent urges to urinate with an episode of blood. After 2nd vaccine patient had panicky immediate frequent urges to urinate, which then subsided after a few days, no blood this time. Symptoms have resolved.

5/29/2021 Breathing Problem DIB, pulse ox 68% on RA Source of Information: Patient and Available medical record History of Present Illness: This is a 72y.o. male with extensive pmh as mentioned below Hypertension D.m. Copd on home o2 chf Cad Sleep apnea ckd and multiple other presented to ed with cc of sudden onset of sob and chills which started night before the presentation and associated with body aches.paitent was requiring bi pap on arival and was hypoxic Patient receive both doses of covid vaccine. Work up in er shows elevated d- dimer aqnd cta was not done because of his elevated kidney functions. Patient was tested positive for covid and id and pulmonary were consulted. troponins were elevated and cardiology also was consulted. Recommendations form the consultants were noted

Asymptomatic screening for admission for AKI ED to Hosp-Admission Current 6/22/2021 - present (3 days) MD Last attending ? Treatment team AKI (acute kidney injury) (CMS/HCC) Principal problem Review of Systems Constitutional: Negative for chills and fever. General weakness. HENT: Negative for ear pain and sore throat. Eyes: Negative for pain and visual disturbance. Respiratory: Positive for shortness of breath. Negative for cough. Cardiovascular: Positive for leg swelling. Negative for chest pain and palpitations. Gastrointestinal: Negative for abdominal pain and vomiting. Genitourinary: Negative for dysuria and hematuria. Musculoskeletal: Negative for arthralgias and back pain. Skin: Negative for color change and rash. Neurological: Negative for seizures and syncope. All other systems reviewed and are negative.

new onset granulomatous polyangiitis with Acute renal failure, + CANCA, + proteinase 3, sinus disease, nasal ulcers, but bland UA

Resident appeared to be jaundice with yellow skin and eyes. Resident also complained of not feeling well. Urine was dark yellow. Resident short of breath. Resident was admitted to hospital and diagnosed with post-covid pneumonia.

Bloody stool; Blood in urine; This is a spontaneous report from a contactable consumer reported for himself. A 73-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL8982 (reported as looks like EL8982 or 1982), on 29Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. Patient got his COVID shot on Friday and he have no problem with the shot as far as the shot itself. On Sunday which is two days later, he had first blood in his stool when he went to the bathroom, no fever and then this morning went he urinated, at the end of the urination he has some blood there too, like that. The only adverse effect he have was bloody stool and blood in his urine. Yesterday (31Jan2021), he had no temperature, no fever stuff like that, only blood in his stool and urine, then this morning, next day, three days, blood in his urine. No Investigation Assessment. no treatment for the events. Outcome of the event was unknown. Information about batch/lot number has been requested.

My dad received the Pfizer vaccination on 2/5/21. He was admitted into the hospital the next day for C-Diff bacterial infection. He had been on dialysis treatments for kidney failure treatment since 2017 and had recently been diagnosed with stage 3 colon cancer in June 2020. He had completed his final treatment of chemotherapy on 2/4/21 and several weeks prior had been determined cancer free. On Tuesday 2/9/21 he was released from the hospital and went home. Early Thursday morning 2/11/21 @ approximately 1:30 am CST his eyes rolled back in head and he stopped breathing and was non responsive. My mother called 911 and attempted CPR. Paramedics arrived and were able to successfully get a pulse then transferred him to the hospital. He was put on a ventilator @ the hospital and then transferred to a different hospital a few hours later. He lost pulse/heartbeat several times @ the 2nd hospital he was transferred to. We were not allowed to travel with him or see him b/c of all of the COVID restrictions. We were communicating with the ICU doctor by phone who ultimately communicated to us that there was nothing further that could be done to save his life. He subsequently passed away @ approximately 8:55 am CST on 2/11/21.

First dose received 01/22/2021 and second dose on above date (02/11/2021) These events may have no relation to the vaccination but due to their concomitance, I eventually felt it might be best to report them. Three days following the first dose, I started to experience hematuria as well as constipation. It has happened before as a result of radiation treatment back in 2005/2006. Saw my urologist on 02/02/2021, and had several tests, ruling out any return of cancer. Antibiotics improved the situation, which was getting closer to normal prior to getting the second dose. Again, three days following the second dose, hematuria returned and still prevails at various degrees. Also experience fatigue and weight loss.

Urinary tract infection; when the doctor pushed on his bladder it hurt; tightness in his head; cold sweats; fever/went up to 101, 101.8, 101.9/temperature would go up to 100 or 101; Headache; Flu-like symptoms; stiffness of his body; dizziness/woozy; dizziness occurred when he stood up to leave/had dizziness and it went away and possibly occurred because he got up too quick; This is a spontaneous report from a contactable consumer (patient). A 73-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284), intramuscularly on the left arm, on 12Jan2021 14:00, at single dose, for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient and his wife went to the local senior citizen center on 12Jan2021 to get the vaccine. After which the patient noticed a slight dizziness on 12Jan2021 which was minimal, and the dizziness was something that was normal for him. The dizziness started within 15 minutes time frame after receiving the vaccine. The dizziness occurred when he stood up to leave on 12Jan2021; now the dizziness has recovered. He stated he had dizziness and it went away and possibly occurred because he got up too quick. He also felt a little woozy on 12Jan2021 and it was under control. The next day, on 13Jan2021, after receiving the vaccine he experienced fever, headache, almost flu-like symptoms, and stiffness of his body. His fever went up to 101, 101.8, 101.9 that night of 13Jan2021; earlier in the afternoon of 13Jan2021 around 15:00, he noticed a weirdness as he had a tightness in his head and then discovered he had a fever. He also had cold sweats, on the night of 13Jan2021, and his clothing was soaked - this occurred on a couple of evenings since then. Furthermore, he noticed in Jan2021 there was a cycle that continued where he did not have high temperature in the morning, his temperature was around 99 after breakfast and then his temperature would go up to 100 or 101 towards the evening. The fever lasted quite a while until 21Jan2021, about 8 days. He had a virtual visit on 21Jan2021 with his primary care provider since he had a fever. He also had a covid test that was negative on 21Jan2021. He then added that he also had a negative covid test on 18Jan2021; it was not the rapid test but a test that started with a "p". With these, his primary care provider was very much concerned, and he had a battery of tests done then he was discovered to have a urinary tract infection (UTI) on 22Jan2021. He informed that his primary care provider asked him to go into the office since the primary care provider was convinced that it was something more than just a reaction to the Pfizer covid vaccine. He had more tests on 22Jan2021 and that was when he was diagnosed with a UTI. It was a minimal UTI, not of any consequence, that when the doctor pushed on his bladder it hurt on 22Jan2021. He then received an intravenous antibiotic in the emergency room for the UTI but confirmed that he was not admitted. He stated that he has never had a reaction to any medication he has taken before. He then asked if he should get the second dose, the "booster" of the covid vaccine. He admitted he was quite reluctant to get the second dose that was scheduled for 02Feb2021 and his primary care provider advised against getting the second dose. The outcome of the event dizziness/woozy and dizziness occurred when he stood up to leave/had dizziness and it went away and possibly occurred because he got up too quick was recovered on 12Jan2021. The outcome of the event fever was recovered on 21Jan2021. The patient was recovering from UTI. The outcome of the events tightness in his head and when the doctor pushed on his bladder it hurt was unknown. The outcome of the events headache, flu-like symptoms, stiffness of his body and, cold sweats was recovered on Jan2021 (duration reported as "-12 day"). All adverse events resulted in an emergency room visit and a physician office visit.

The morning after receiving second dose, I awoke with a headache, no strength at all and no bladder control. It took me forty five minutes to get out of bed after numerous attempts. I also experience dizziness, balance issues. In all honesty, it was as if I had gotten Covid all over again. I had it in late August and all of September. The second day after the shot, I experienced lack of strength, but not as bad as the first day, and whole body muscle aches. The third day after, was about the same and after that, things started getting a little better.

Chief Complaint: CRAMPS, STOMACH ACHES, INDIGESTION, CHILLS & WEAK1ST COVID SHOT 1/182ND = 2/18. Onset of symptoms: JAN 18TH. Additional information: HAD BOTTOM TEETH REMOVED - JANUARY 5 & COULDN'T EAT SOLIDS UNTIL LAST WEEK, LOST LOTS OF WEIGHT(WEIGHT TODAY INCLUDES HEAVY BOOTS)DARK YELLOW URINE ON 'BAD DAYS'. History of Present Illness -- Patient is seen today, really has not felt well for a while. This is been especially the last month or more. Has had several things going on this winter, actually contracted COVID-19 illness in December. Says this was pretty much like having the flu but I think at the time felt.

Syncope, weakness, lightheadedness, somnolense, confusion, hallucination, acute kidney injury, gross hematuria

Blood in urine D68.9 - Coagulopathy (CMS/HCC) R31.0 - Gross hematuria D64.9 - Anemia, unspecified type

received his second COVID 19 Pfizer shot on March 1 and began feeling bad with cough, aches, no energy and his urine turned brown the day he received the second shot. The next week after getting worst he went to the hospital. They first diagnosis him with pneumonia ad kidney failure. They admitted him to the hospital and began running test. He was then diagnosed with anti-GBM or Goodpasture's Disease. He had gone to the doctor on the Friday before his second shot on Monday, March 1st and he was very healthy and very active with no health issues. The second COVID Pfizer shot is the only thing he had done different that week.

"positive" covid-19 after first covid 19 vaccine; "positive" covid-19 after first covid 19 vaccine; kidney function levels going down "blood work"; This is a spontaneous report from a contactable healthcare professional and a consumer. A 73-year-old male patient received first dose of BNT162B2, via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. Medical history included psoriatic arthritis. Concomitant medication included tofacitinib citrate (XELJANZ XR) from 29Oct2020 and ongoing for psoriatic arthritis. The patient reported new symptom of kidney function levels going down "blood work" so he was seeing a specialist. Specific results of tests not available. The patient reported he had recent "positive" covid-19 after first covid-19 vaccine with symptoms, lasted a few weeks. The patient recovered from "positive" covid-19 after first covid 19 vaccine on an unspecified date while outcome of other event was unknown. Information on the lot/batch number has been requested.

74 year old male with a past medical history of CHF, CKD stage III, paroxysmal atrial fibrillation treated on Xarelto, hypertension, hyperlipidemia, history of alcohol abuse who presented to hospital postacute care with hypoxemia and worsening shortness of breath over the previous week. He noticed a progression of the shortness of breath and subsequently developed cough without productive sputum. Due to his worsening shortness of breath and cough he underwent PCR testing for COVID-19 was found to be positive. He reports that he received 2 doses of the Pfizer Covid vaccine the last of which was 6 weeks ago. The patient had an extensive hospital stay that included acute decompensated heart failure, ARDS with COVID, intubation, cardiogenic shock, and AKI on CKD requiring CRRT. His family ultimately made the decision to transition to hospice care and the patient passed away 7/12/21.

delirious; hypoxic; fever; ataxic; incontinent; confused; Chills; HA; anorexia/had no appetite; myalgias; extreme fatigue; slept all and had no appetite; This is a spontaneous report from a contactable physician. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Dec2020 16:00 at single dose for COVID-19 immunization. Medical history included diabetes mellitus (DM). The patient has no known allergies. The patient's concomitant medications were not reported. He was an ER doctor and the medical director of his hospital. The patient was asymptomatic when he got the vaccine on 15Dec2020. 3 hours after the vaccine he began to get chills, HA, anorexia, myalgias, and extreme fatigue. This worsened and he slept all and had no appetite. On 19Dec2020 he woke up delirious with a fever and was ataxic, hypoxic, incontinent, and confused. The patient was hospitalized due to the events on 15Dec2020. The events also caused prolonged hospitalization due to the events. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID via nasal swab post vaccination with unknown results. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The outcome of the events was not recovered. Therapeutic measures were taken as a result of the events as the patient required oxygen, plasma, and remdisivir. The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of reported serious events might not be excluded, considering the plausible temporal relationship. Fever, chills, headache, fatigue and muscle pain are the known adverse event profile of the suspect product. More information such as detailed underlying medical conditions and concomitant medications are needed for fully medical assessment. 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.

Previously well controlled non-insulin dependent type 2 diabetic (A1c 6.9 on 12/10/2020) developed polydipsia, polyuria, extreme fatigue, feeling off balance to point he does not feel comfortable driving (son drove him to appt). CBGs 330s-530s since. Less than 1 mo ago when here for DM his CBGs were 115-130s. No other medication, dietary changes, or illness to account for the abrupt change. Also reports he had vision loss on drive home following the vaccine administration. Vision loss resolved spontaneously after approx. 30 min. Presented to clinic for evaluation 01/05/21 for above listed symptoms. Concern for possible HHS/DKA so was sent to ER. Labs ruled out DKA/HHS, was given IVF and insulin, discharged home to to follow up in next few days.

Had a mild a heart attack and mild stroke; had a mild a heart attack and mild stroke; urinary tract infection; Blood infection; A1C was 6.5; there was a little blood in his urine; he fell out of bed and couldn't get up; he was flushed; he had a fever of 101; This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient (husband) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number: EL1283) at 0.3 mL single on 20Jan2021 for COVID-19 immunization. Medical history included thyroid; hypertension, was under control with the medication; dementia, taking memantine as a treatment for dementia, no other impairment other than what he normally has from his dementia. Concomitant medications included levothyroxine; memantine for dementia; fish oil tablet; Vitamins. Patient had a mild heart attack and a slight stroke and he did have urinary tract and blood infection on 24Jan2021. They both had the first dose of the Pfizer covid vaccine on 20Jan2021, Saturday night into Sunday. He was a dementia patient, alert to his name. On 24Jan2021, he fell out of bed and couldn't get up, he was flushed, so patient's wife took his temperature, he had a fever of 101. Patient's wife couldn't move him, so called the paramedics and they took him to Hospital. Patient's wife just found out that he had a very mild heart attack and slight stroke, no impairment other than what he normally had from the dementia. Patient's wife was wondering should he get the second shot and what was the timing of the 2nd dose of vaccine. Reporter seriousness for mild heart attack, slight stroke, urinary tract and blood infection was hospitalization. They also have him on some sort of penicillin derivative for a urinary tract infection. Since he had been to the hospital, he had at his doctor's office about 2 weeks ago today, he had a blood test, a urine test. His A1C was 6.5, there was a little blood in his urine. For that since Sunday (24Jan2021) he was having MRI, he had a couple of PET scans, he had an electrocardiogram. The neurologist came in to check on him. He was in hospital now. Hospitalization date was 25Jan2021 early in the morning. The outcome of events was unknown.

Received 1st. Pfizer vaccine shot at 10:00 am Thursday 2/10/2021 At approximatly 6:00 pm same day I started to have severe pain in my side shortness of breath and could not lie down to go to sleep. Had to go to bed sitting up with three pillows on my back. The next morning went to doctor who ordered blood test and chest X-Ray. Chest X-Ray indicated Pulmonary Embolism. Doctor started me on Eliquis blood thinner to hopefully desolve the blood clot on my lung. Doctor suggested I report Pulmonary Embolism occuring same day as my first vaccine shot. Do not know if shot caused Pulmonary Embolism or just a coinsidence. In addition doctor found blood in my urine and a CT of Bladder has been ordered

Significant chills began while sleeping 15 hours after the injection, frequent urination--every 45-75 minutes from 3am to 9am. No sweating, checked temperature at 9am, it was 99.5. Significant muscle and joint aches, neck and shoulders especially on right side, both hands, lower back, knees, and feet. Sharp ear ache lasting for 3-4 hours, but only intermittant. I tested positive for Covid-19 in March, 2020. Very sick for 5 days, but not hospitalized. The last time I donated plasma, on February 2, 2021, I still tested positive for Covid-19.

Initial feeling of moderate deep pain at injection site, not dissimilar from the first injection. On this second of two injections. Approximately 12 hours later, feelings of hyperpyrexia, chills, tachycardia, and moderate to extreme dizziness. Increased with rising to go to bathroom. Urine normal in amount and color. Symptoms limited to feelings of fever, heart rate, and dizziness. Now, at 28 hours post injection, Pulse of 90 seated, 120 on rising, dizzy on rising. BP 118/78 P-95 seated. BP 137/77 P-161 by home automated device.

Extreme weakness, constipation, decreased appetite. Shortness of breath with activity. How many living in to Atrial Fibrillation and heart failure.

Headache, Loss of appetite, incontinence, stuffy nose (blood in mucus), weak (unstable walking), lackadaisical, chills, soreness at injection site After 24 hours of unsent of symptoms began feeling better.

Death Narrative: 73 yr old male with a history of CAD, HTN, HFrEF, CKD stage 4, COPD, HCV Cirrhosis and opioid dependence who presented with incarcertated ventral hernia 3 days post OP from ex lap, reduction of SB, closure of hernia primarily. He was off pressors but remained intubated due to poor mental status with unclear etiology. It could be related to liver failure, vs neurological insult vs renal failure. Head CT 4 days prior on the 2/24 were without acute intracranial pathology. Hepatology was consulted and did not believe the liver was the main etiology behind poor mental status. Patient progressively declined with continuously increased IV pressor requirement. ABG showed worsening lactate acidosis and was anuric. Patient's family was notified of decline and agreed for the patient to be transition to comfort care early 2/28. Bedside RN notified pronouncing physician of cessation of respiration and cardiac activity.

01/30/21 Left arm red, sore; 02/01/21 general malaise, headache, rash on left shoulder and upper back; 02/05/21 joint soreness, knees, hips, shoulders; 02/08/21 muscle weakness, shaky; dizziness, loss of balance, diminished proprioception; 02/12/21 Orthopedic consult - 02/13/21 full body message - some relief; 02/15/21 Chiropractic adjustment - some relief; 02/24/21 PCP - steroids PO 5 days; 03/09/21 pain management - right hip steroid injection - some relief; 03/10/21 no relief from oral steroids, 03/16/21 pain management SI injection, some relief;still dizzy, loss of balance

chills; muscle spasms; every bone hurt; nausea; vomiting; fatigue; frequent urination; This is a spontaneous report from a contactable consumer. A 74-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EN9581), via an unspecified route of administration, administered in Arm Left on 08Feb2021 09:45 as single dose for covid-19 immunisation at hospital. Medical history included drug hypersensitivity (Penicillin) from an unknown date and unknown if ongoing. The historical vaccine included patient's first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection, Batch/Lot Number: EL3249), via an unspecified route of administration, administered in Arm Left on 21Jan2021 05:30 PM, as single dose for covid-19 immunisation. Concomitant medication included atorvastatin calcium, 20 mg and lisinopril 10mg. On 09Feb2021 12:30, the patient experienced chills, muscle spasms, every bone hurt, nausea, vomiting, fatigue, frequent urination. The action taken in response to the event for BNT162B2 was not applicable. The outcome of event was recovering.

March 11 in the evening after my daily walk I had blood in my urine. It was a dark red and was quite a bit. The bleeding gradually decreased over night and by the end of the next day blood was not visible in the urine. 2nd Pfizer injection was on March 25 The next day (March 26) in the evening I again had blood in my urine. It was not nearly as bad as the first incident, and by morning the bleeding was again decreasing and by the end of the day my urine was visibly clear. April 2 ? again slight bleeding in the evening and by the next morning the bleeding was again decreasing and by the end of the day my urine was visibly clear. April 3 ? at 3 in the morning (April 4) I had slight bleeding when I got up to go to the bathroom. Slight bleeding was still present in the morning April 4 but cleared by the end of day.

DEATH Narrative: Patient passed away after Covid Vaccine. 2/8/21: brought to the ER for evaluation for leg weakness and a recent fall associated. He was in a facility- per patient he fell when standing from the bed, he though he could do it and did not ask for help. He has been with hip and pelvic pain since then. The CT/XR shows evidence of lytic lesions, an IR bone biopsy was done and came positive for metastatic bladder carcinoma. 02/17/21: transferred to the facility for PT and pain management, originally for short stay rehab then changed to hospice care. 02/19/2021: received covid vaccine 03/05/21: discharged from facility on home hospice 03/23/21: pt passed away at home Patient with prior covid infection; tested positive last on 9/25/2020. Vaccine did not likely contribute to patient's death, as he was on hospice due to malignant cancer. No evidence of reaction immediately after vaccination or before date of death.

Patient is a 74 year old male with a history of afib who was admitted on 2/18/2021 with malaise, weakness, and poor appetite. Patient also reported a cough with mild shortness of breath. CRP was near normal but SCr was elevated above baseline likely due to dehydration. SCr trended down with IV fluids. Patient tested positive for COVID-19 on 2/15/2021. Steroids and remdesivir not indicated during admission. Patient discharged to home on 2/19/2021

1/7/21: Patient is a 74 y.o. male presenting with hematuria at MD office. Wife of pt states pt had Covid Vaccine yesterday and today appears to be confused. Wife states he is usually ambulatory. Pt has hx of Kidney cancer and renal stones. Pt is having trouble ambulating and wife states does not appear to be his normal self. presenting with hematuria onset 2 days ago. Gradual onset, progressively worsening, moderate severity, associated urinary urgency, fever, chills, confusion, fatigue. Wife reports pt was dx with a UTI on 1/5 but no abx were given. Seen in the ED, Abx started for possible UTI. VS significant for T 101.4F. PEx WNL

urinary tract infection; 21Feb2021 tested positive for covid-19; 21Feb2021 tested positive for covid-19; had been sick and got sicker; This is a spontaneous report from a Pfizer-sponsored program via consumer (patient). A 74-years-old male patient received the first dose of BNT162B2 (Solution for injection, Lot number EL9262) on 26Jan2021. The patient experienced for a couple of weeks not feeling well with headaches, shortness of breath and congestion. On 21Feb2021, the patient tested positive for covid-19. Patient has been in bed and sick ever since. He has been sick for a total of over 3 weeks. Between 16Feb2021 and 22Feb2021 he had been sick and got sicker. The patient asked if it is ok to get the second dose on 09Mar2021. The events were treated with an antibiotic for a urinary tract infection. The outcome of the events was unknown. The patient was unable to make it back for the second vaccine on 17Feb2021 due to weather and power outages in his area then got the Covid virus during that time which postponed the second vaccine for the second time. They rescheduled the second dose for the following Monday, 22Feb2021. The patient underwent lab test which included COVID-19 test and the patient was tested positive for COVID-19.

Patient went to a pharmacy in the area on 2/11/21 to receive his B12 shot and pfiser vaccine. In error pt was given 2 covid-19 pfiser vaccines that same day at the same pharmacy from different lot numbers. Pt had vaccine cards for proof. Pt then received a 3rd dose on 3/5/21 at a medical facility. Pt then returned to the same pharmacy where he had been given the first (2) shots on 4/17/21 and was given a 4th pfiser vaccine. Pt has proof of all of said administrations. On one vaccine card pt states that when he returned to first pharmacy a staff member tore the sticker off of one of his vaccine cards and shows that indeed the vaccine card seems to have been altered and something torn off. Pt came to clinic on 4/28/21 where writer had nursing visit with pt for dizziness, body aches, urinary incontinence, dry mouth, burning sensation of skin, worsening leg edema.

Patient was admitted to Hospital on 7/14 after after two weeks of weakness and found to have AKI and cholestatic liver injury of unknown origin. His clinical course was complicated by progressive liver failure (bili to 20s, LFts >6K), hypoxemic respiratory failure, renal failure requiring dialysis), and a CK >120K. He had an extensive workup including MRCP, Pan CT, liver and muscle biopsy which did not reveal definitive dx. Leading diagnosis is statin -induced immune mediated necrotizing myositis, though biopsy not quite consistent and his labs are beyond what has been reported in the literature. He passed away on 7/28 despite treatment with IVIG, pulse dose steroids, broad spectrum abx. Cause of acute decompensation still unknown, autopsy pending. But wife noted he received covid vaccine doses x2 a few weeks prior to hospitalization, which warranted reporting due to unexplained etiology.

Six days after injection, expressed 10 cc's of bright red hemorrhage in urine. One episode only. After drinking two bottles of water, the urine was clear of blood. In the two days afterward, there were no additional hemorrhagic discharges. No fever or sickness of any kind was experienced before or after this incident. There has never been an incident of blood in my urine. There is no history of kidney stones or bladder infections. No treatment, except for drinking large volumes of water, has been done since the incident.

Began to feel numbness, lack of sensation and loss of strength to the left limb from the waist down. Also noted weaker grip strength to the left hand. Loss of bladder and bowel control. This persisted throughout 2/5. On saturday 2/6 the right leg began to feel weak and numb as well although not as severe as the left limb. He was admitted to the hospital on Saturday evening, 2-6

About 27 hours after vaccine, my husband?s arm hurt. He also experienced the inability to get up easily off the couch and walk down the hall. He was taking small steps and could barely walk and control his movements. I held on to him as he tried to get to the bathroom. All evening he had trouble walking and was unable to control his urination. He could not hold it and peed down his pant legs. This incontinence continued all evening and into the night. He got up three times to use the bathroom that night while sleeping and could not hold his urination. The next morning these reactions passed and he was able to walk and urinate normally. He experienced fatigue over the next few days. I would say he felt normal by Friday of that week.

congestive heart; renal failure; very weak; This is a spontaneous report from a non-contactable consumer. A 75-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Feb2021 at single dose for COVID-19 immunisation at the age of 75-year-old. Medical history and concomitant medications were unknown. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Jan2021 at single dose for COVID-19 immunisation at the age of 75-year-old. On 07Feb2021, patient became very weak; the patient was hospitalized with renal failure and congestive heart. It was unknown if any treatment was administered due to the events. The patient did not recover from the events. The patient did not have Covid-19 before vaccination; it was unknown if Covid was tested post vaccination. No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.

The patient is a 75 yr/o male with a history of COPD presents with multiple constitutional symptoms have been present over the past week since getting his second COVID-19 vaccination. Patient states he has had fever and chills, generalized fatigue, body aches, increased sleepiness, and some burning with urination. Patient states his wife took his blood pressure this morning and that it was abnormal prompting the visit to the ER. The patient states all the symptoms started about a day after getting his second COVID-19 vaccination and have been persistent since that time. He states that he has a longstanding history of shortness of breath due to his COPD but no worsening shortness of breath over the past week. Patient denies any chest pain, nausea, vomiting, bowel issues. Patient denies any headache, dizziness, vision changes. Patient does wear corrective lenses. Per Triage: HOT Fatigue (wife states BP was 67/48 this AM at home, 2nd COVID vaccine 2/19) Fever (all week since wednesday off/on) Final diagnoses: AKI (acute kidney injury) (CMS/HCC) Elevated CK Body aches Fatigue, unspecified type Transient hypotension

Patient presented to ED with black stool and anemia, hemoccult positive, Hgb 6.2. Patient received 1 unit packed blood and IV protonix. Pt admitted. AKI improving on floor. Patient currently still admitted. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.

Received second vaccine on 2/3/21 and on 2/4/21 developed nausea, vomiting, chills and low grade fever. Presented to the emergency department on 2/7/21 due to refractory nausea and inability to tolerate PO intake. Denies symptoms of epistaxis, hemoptysis, bruising, petechiae, active signs of bleeding. Labs notable for AKI w/ CR of 1.7 (baseline CR 1.0) and cholestatic liver enzyme elevation (AST 144/ALT 237/ALP 295/T bili 6.1/direct bili 4.0) and thrombocytopenia (nadir to 13). Discharged on 2/13/21. Of note, he had 2 similar admissions in June 2018 and Oct 2019 with unrevealing workup of mixed liver injury. All 3 admissions were after some type of viral antigen exposure: June 2018 after shingles vaccine 2nd dose, Oct 2019 with sapovirus gastroenteritis, and current admission after COVID vaccine 2nd dose.

Rigid right thigh muscle to the point of almost unable to walk, very very poor urinary sphincter control . Lasted around 30 hours.

Extreme muscle weakness, not able to walk without a walker, slurred speech, blurry vision, loss of smell & taste, muscle spasm in hands, extreme fatigue & chills.

03/24/21: Patient presented and was admitted through the emergency department for CC of Shortness of Breath, generalized body ache and low-grade fever for last 2 days. Patient has a past medical history of Atrial fibrillation, Cancer, COPD, CRI , Diabetes mellitus, , HTN , Hyperlipidemia, On home oxygen therapy. Labs were remarkable for a leukocytosis of 18.2, hyperglycemia of 336, and an AKI with creatinine of 1.38. Chest x-ray was performed and revealed bilateral patchy opacities. COVID-PCR negative. In the ED the patient was seen to have A. fib. Per the EUA, Hospitalizations are to be reported irrespective to attribution to vaccine

Progressively following vaccine on 3/4/21 became more fatigued until taken to hospital on 3/13/21. Found to have lesions on liver and in lungs on scans. Told to follow up with Oncologist on 3/16 but instead had to go to ED due to worsened fatigue and confusion. Liver enzymes noted to be very elevated on admission and progressively deteriorated in to liver failure and subsequent kidney failure over 3 day hospitalization. Unable to biopsy lesions due to risk of bleeding. Discharged to hospice facility on 3/19/21 and died 3/20/21 early AM.

This 75 year old white male received the Covid shot on 3/27/21 and went to the Edand admitted on 4/13/21 with the following diagnoses listed below. CEREBROVASCULAR ACCIDENT I63.9 - Stroke (CMS/HCC) N17.9 - Acute kidney failure, unspecified R29.810 - Facial weakness

migraines, left hip pain (progressively worsening), constant diarrhea, fatigue despite sleeping 14 hours, sweating during sleep, neck pain, SOB, painful and difficult to start urinating

inappropriate schedule of vaccine administered; kidney problem; it is causing me some real concern; Magnesium becomes low; GFR is low; minerals are going low; strange sensation; This is a spontaneous report from a contactable consumer. A 75-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL8982), dose 1 via an unspecified route of administration, administered in Arm Left on 17Jan2021 as (At the age of 75-years) DOSE 1, SINGLE, dose 2 via an unspecified route of administration, administered in Arm Left on 02Jun2021 (Batch/Lot Number: EL8982) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included simvastatin 20 milligrams; alopurinol; indapamide 2.5 milligrams; levothyroxine100 micrograms; digoxin; metformin, and Potassium Pill, Potassium COER 20 mEq. It was reported that he was not diabetic at metabolic syndrome at the extended release 500 that effect last A1C was 4.8. No Prior vaccination within 4 weeks. It was reported that patient had no Family medical history related to adverse event. The patient experienced kidney problem, it is causing me some real concern, magnesium becomes low, gfr is low, minerals are going low (mineral deficiency), and strange sensation on 25Jun2021. It was reported that patient got the situation rising, it was causing some real concern. It was reported that he was vaccinated the corona virus in early February and then in the early mid-April he had some blood lab with again some worrying results and today he has follow up with that then he got information on and results are more concerning like those concerns involve kidney problem. It was reported that When probed whether consumer took first dose of the vaccine or both doses, Consumer stated, he got the second shot in February. Later patient reported that It will be good, and he should mention also that one of just when he got that final vaccination, he had some strange sensation afterwards and he reported those, and they sent some paper works but he did not see on anything going on at that time. So, he didn't follow up with it. It was reported that patient was not exactly sure when the onset was. He was seeing it that was between the date of the vaccination and date of the first blood test on 13Apr2021. So, that would say March, somewhere in March, this year. That would be 75. first Starting date of Adverse Event, he noticed there was a problem that's when he had the first blood test done and that was on 13Apr2021. It was reported that There are probably 20 or 30 different tests on each one of these sheets, he got the first one here, Monocyte absolute 0.9, the next one, Potassium level is 3.1, and here most concerning one GFR 59. It was reported that Magnesium becomes low 1.5 that is only the first test Monocyte was now 1.0, potassium is 3.3, GFR is still 59, bilirubin is now 1.8, there was one more magnesium was 1.7, Phosphorous is 2.1. It was reported that GFR is low, and the minerals are going low one by one and the bilirubin that's the most recent now, it was high which was this is going, it's bad and now better looking again. The patient underwent lab tests and procedures which included blood bilirubin: 1.8 on 13Apr2021, blood magnesium: 1.7 on 13Apr2021, blood phosphorus: 2.1 on 13Apr2021, blood potassium: 3.1 on 13Apr2021, blood potassium: 3.3 on 23Jun2021, glomerular filtration rate: 59 on 13Apr2021, glomerular filtration rate: 59 on 23Jun2021, monocyte count: 0.9 on 13Apr2021, monocyte count: 1.0 on 23Jun2021. Treatment: Consumer stated, "There is no treatment that I still continue because there is more here. Magnesium becomes low 1.5, Okay that is only the first test. So, here GFR went down and minerals are the one went down, Now, the second one, so, this is for the date of 6/23/21. Monocyte is now 1.0, potassium is 3.3, GFR is still 59, bilirubin is now 1.8, there is one more magnesium is 1.7, Phosphorous is 2.1. So, hang on more page, that should cover. So, what you see happening here is the GFR is low and the minerals are going low one by one and the bilirubin that's the most recent now, it was high which was this is going, it's bad and now better looking again. The outcome of events was unknown. No follow-up attempts are possible. No further information is expected.

blood in urine 10 days after vaccination.; This is a spontaneous report received from a contactable consumer, the patient. A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the left arm on 17Mar2021 at 12:30 (at the age of 75-years-old) as a single dose for COVID-19 immunisation. Medical history included left nephrectomy in 2010, irritable bowel syndrome (IBS). Concomitant medications included thyroid (ARMOUR THYROID) and tamsulosin hydrochloride (FLOMAX); both from an unknown date and an unspecified indication. The patient was a known allergic to opiates and lactose. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Since the vaccination, the patient had not tested for COVID-19. On 26Mar2021 at 17:30, the patient experienced blood in urine ten days after vaccination. The event resulted in doctor or other healthcare professional office or clinic visit. The patient received antibiotics as treatment for the event blood in urine. The clinical outcome of the event blood in urine was recovering. No follow-up attempts are possible; information about lot number cannot be obtained.