Pfizer

Patient with severe, cyclical vasovagal syncope with urinary incontinence, full LOC x at least 3 witnessed episodes, and inability to protect the airway. The patient was stabilized with the assistance of EMS with positioning and IV fluids. The patient has a history of similar episodes as a child with injections, though remote. We discussed compensatory approaches for the second dose. After intensive monitoring, the patient had returned to baseline and was returned home with his mother as the driver.

Patient passed out after administration. While he was unconscious he also urinated. After a minute he came to and was able to walk away without assistance

Patient blacked out briefly while in waiting area and urinated. Patient was seated the entire time and did not fall to the floor.

Patient had syncope, dizziness, flushing/sweating, seizure, urinary incontinence. BP 119/79 -- > 103/53 -- > 108/50, HR 47 -- > 38 -- > 37 -- > 64 -- > 62, RR 16, O2 100%, Temp 97.3F. EMS called at 17:06, arrived at 17:13.

Pt had Pfizer vaccine, lost consciousness briefly and had seizure and lost control of bladder. EMS was called, pt declined to go to ED. Documents were signed and since pt had seizure and lost consciousness, report was filed. Pt was informed. Pt's friend picked up patient. Pt was urged to followed up with PCP and go to ED.

Constant urinary urgency / urethra irritation that still persists to this day. I think partially is my fault because around the same time I was doing aggressive masturbation up to 5 times daily which I think caused the issue. Normally I recover within a week from urgency symptoms after such behavior, but now it's been months and I have not recovered, even after minor urology intervention while in a foreign country I'm not sure if vaccination was directly involved, or if I caught covid around the time of second vaccination without realizing it, but it started around the same time which is why I am logging out of an abundance of caution. Treatment: - Was prescribed a 21 Day Course of treatment: - Levofloxacin 750mg after breakfast - Doxazosine 8mg daily after dinner During this course of treatment I realized symptoms could be less if I delayed myself to peeing no more than once hourly.

Patient had vasovagal response to injection. Has history of vasovagal response to needles. Pt became lightheaded, diaphoretic, pale. Was incontinent of bladder. Denied hx of seizures. Patient stated he woke up late and didn't eat breakfast or drink fluids. Assessed by onsite paramedics -HR 83, SPO2 100% on room air, BP 132/84. Pt was observed for 30 minutes and provided with water. Refused transport to hospital for further assessment. Advised patient to seek emergency help if symptoms return. Pt verbalized understanding.

gross hematuria, new nephrotic syndrome, possible AKI all one-day after receiving 2nd Pfizer vaccine. Patient has a history of intermittent microscopic hematuria x2 when he was a teenager.

Trying to stay hydrated; noticed a bit of pinkish red when he went to the bathroom; He woke up with a lot of pain / renal pain; kidney stone; This is a spontaneous report received from a contactable consumer (patient). This 28-year-old Male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot: EW0172, Expiry: 31Aug2021) via an unspecified route of administration, administered in left upper arm as single dose for COVID-19 immunisation on 24Apr2021. The patient medical history included seasonal allergies (From Unspecified to Ongoing) around 10 or 11 years old and allergic with tree pollen mainly, cedar trees and animal fur (usually took Tylenol, Claritin and Zyrtec). The patient concomitant medications included 10mg oral cetirizine hydrochloride (ZYRTEC) for seasonal allergies so that he can breathe normally. Patient was diagnosed with kidney stone on 24Apr2021, same day evening when he got the first Covid-19 vaccine. The patient was trying to stay hydrated, noticed a bit of pinkish red when he went to the bathroom, he thought it was just a side effect. Woke up with a lot of pain and after some testing, they told him he had a kidney stone. He was fighting a kidney stone and taking medication for span of time between first covid-19 vaccination and second vaccination. He doesn't think it is related. The doctor gave a couple medications just for monitoring things, the next day after 13May2021, he went for a CT and haven't felt anything since from the kidney stone. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. Treatment therapy included 0.4mg oral tamsulosin HCL taken for kidney stone from 03May2021 to 13May2021, hydrocodone and acetaminophen taken for renal pain from 03May2021 to 13May2021 (patient only took when he was in drastic pain (pain for kidney stone). Not as a daily medication). The outcome of event kidney stone was resolved on 13May2021. The outcome of other events was unknown.

Immediately after receiving Pfizer vaccine, pt experienced loss of consciousness for approximately 3 minutes, tongue swelling, incontinence of urine. Epi pen given x1, pt regained consciousness immediately after receiving epi. Vital signs as follows: BP 144/69, HR 63, O2 100% then approx 8 minutes later BP 113/63, HR 74, O2 99%, blood sugar 101. Provider assessed pt and recommended to call an ambulance for possible seizure. Pt refused to go to hospital. After incident occurred, pt stated that he has had a reaction to vaccines in the past but was unsure which ones. Pt chart stated that patient had an adverse reaction (seizure) after receiving flu, Tdap, and HPV vaccines in 2015.

12/17 vaccination 12/20 Wen to use restroom. Reddish hue in urine. Went to urgent care. UTI was negative. Positive for blood in urine. Next day, urine back to normal. Arm soreness

Abnormal diuresis from 8am to 10pm; Urinating 1-2 time per hour; woke up for midnight trauma/woke up 4 times in between; woke up for midnight trauma; Felt very jittery, although HR was 75.; extremely nauseous; lightheaded; This is a spontaneous report from a contactable nurse (patient). A 29-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EL0140), intramuscular at left arm on 08Jan2021 07:15 at single dose for COVID-19 immunization at a hospital. The patient's medical history included 1 kidney stone in 2019. No known allergies to medications, food, or other products. There were no concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EJ1685), intramuscular at left arm on 18Dec2020 07:15 for COVID-19 immunization at a hospital. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested for CPVOD-19 since the vaccination. It was reported that the patient was vaccinated at 07:15. The events started on 08Jan2021 08:00. Detailed clinical course was reported das follows. Abnormal diuresis from 08:00 to 10:00. Urinating 1-2 time per hour, 300-500 ml per time. He went to sleep from 22:00 to 23:30, woke up for midnight trauma. He felt very jittery, although heart rate (HR) was 75. In the middle of surgical case, he became extremely nauseous and lightheaded. He left the operating room (OR) for 20 minutes and drank 50 oz of water and felt slightly better. He finished case at "an". He slept from 04:00 to 07:00. He woke up 4 times in between and urinated 300 500ml each time. He drove home from 07:00-08:00, felt nauseous. Laid in bed from 08:00 to 09:00 and urinated 3 times 300-500 ml each time. Slept from 09:00 to noon, felt better, urinating every 4-6 hours, appears back to normal routine. Treatment for the events included fluids. The outcome of the events was unknown. The reporter consider the events as non-serious.

Headache; fatigue; irritable bowels; diarrhea; nausea; stomach cramps/stomach pain; arm soreness; kidney pain; the first dose of BNT162B2 was administered in the left leg; This is a spontaneous report from a non-contactable pharmacist, the patient. A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left leg on 23Dec2020 at 13:00 (at the age of 29-years old) as a single dose for COVID-19 immunization. Medical history included gastrooesophageal reflux disease. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 01Jan2021 at 15:00, the patient experienced headache, fatigue, irritable bowels, diarrhea, nausea, stomach cramps/stomach pain, arm soreness, and kidney pain. The patient took lopearmde (MANUFACTURER UNKNOWN), sucralafate (MANUFACTURER UNKNOWN), and calcium carbonate (TUMS) as treatment. The clinical outcomes of the headache, fatigue, irritable bowels, diarrhea, nausea, stomach cramps/stomach pain, arm soreness, and kidney pain were not recovered. It was reported that the patient received the second dose of the BNT162B2 on 11Jan2021 (at the age of 29-years old; Lot Number: EL3302) in the right arm. No follow-up attempts are possible. No further information is expected.

First day after had sore arm and 101 fever. Woke up next day and fever was gone, then went to sleep and high fever came back ranging between 102 and 103.5 for the next 4 days. Had difficulty urinating due to inflamed prostate and UTI and fever that only lowered mildly from medicine

Patient experienced nausea, then a seizure 5 minutes after receiving the vaccination. He was incontinent and postictal. He remembers his arms tingling and difficulty opening his right hand. Patient went to the ED. His CT scan was negative for bleed. EKG showed sinus bradycardia 48. Patient did have a head injury at the age of 18 but no prior history of seizures. He was discharged but told to follow up with neurology.

Patient experienced significant swelling of arm, back, and facial region, headache, reports kidney pain and lip and throat numbing, as well as overall body aches. Patient took Benadryl 50mg to reduce swelling with success. Symptoms subsided completely after 4 days.

Initially chills and fever. Woke with diffuse, severe myalgia--most severe in quadriceps bilaterally.

Syncope post vaccine. Dizziness, nausea, jerking motions upon event last few seconds, incontinence, Vomited. Pt left with girlfriend at 2:45. symptoms resolved

Unusually extreme hematuria w/ the other side effects including mild fever, chills, joint pain, and pain under arms. The hematuria was very dark starting ~ 24hr. after second dose.

Given second dose of covid vaccine on friday in the right arm 04/23/2021. The day after the covid vaccine I ran a high fever from about 7:30am until about 9pm on Saturday 04/24/2021. During Saturday I drank lots of water to combat the fever but I noticed blood in my urine. The blood got worse through out Saturday into Sunday and I noticed slight pain in my lower back and lower abdomen. On Sunday morning (04/25/2021) my urine was a dark burgundy color. This was quite alarming as it was very thick and not as light as the day before. I drank lots of water on sunday and made sure to watch my urine. The urine stayed red in color. I called a telehealth nurse on Sunday and they suggested I go to Urgent care in the morning. I woke up on Monday (04/06/2021) with less blood in my urine but still went to urgent care to be safe. At Urgent care I received a Urine analysis. The doctor told me there was blood and protein in my urine. He ruled out a UTI or an STD. The doctor said there may be kidney damage since there is protein present but it cannot be confirmed with the levels. The doctor advised that I continue to drink liquid and watch for worsening signs. The doctor said I should contact him immediately if the blood or pain gets worse. The doctor also stated I should fill out this VAERS form. Today (04/27/2021) there has been less blood in my urine but there is still some pain in my lower abdomen. I will contact the doctor at the end of the week to let him know what has happened to my symptoms, he requested I keep him informed.

Stabbing pains in both kidneys every time I would inhale, stabbing pains in stomach every time I would exhale; lasted approximately 1 hour. Intense throbbing pain in the head. Sporadic pain and ringing in both ears. Stabbing pain in left armpit. Fever dreams / delirium. Chills, fever. Sensitivity to cold. Spasms of abdominal muscles. Spasms and ?tics? of neck and shoulder muscles. Spasms of leg muscles. Nausea. Extreme weakness of upper body.

Patient presented to ED after receiving covid vaccination the month prior, with hemoptysis, petechiae, blood in stool and urine, and platelets . Prior to this, patient presented to the ED on 4/30 with kidney stone, no other significant PMH and prescribed medications mentioned on prior page. Suspected ITP, patient received IVIG x 3 days and prednisone x 4 days while admitted. On morning of 5/11, patient had AMS, became unresponsive and was evaluated for stroke. Patient had large intra-axial hemorrhage with significant midline shift, transferred to the Hospital and died the same day.

Light headedness, weakness, and subjective fever onset during the morning of 6/6 following injection of second COVID-Pfizer vaccine on 6/4 at approx. 4:30 p.m, and the initial even also included minor muscular spasms, headache, heartburn, and abdominal pain. These symptoms worsened throughout the day. My pulse felt weak. My breathing became rapid and shallow, even though it was not difficult to draw breath. The major symptoms on 6/7 were headache, with a sense of my motion being affected. My urine throughout this time was excessively dark, even though I was drinking more water than normal. The following day, 6/8, most of my joints began to heart, and I became very stiff; this sx lessened after taking a long, slow walk. On 6/13 another event involving slowed heart rate, subjectively weak pulse, and shortness of breath ensued. There had been no unusual or excessive physical activity, and as I had not experienced this phenomenon before receiving the second vaccine dose on 6/4, I believe that the 6/13 event was also linked to the vaccination.

Injection Site Mild discomfort on 0d . Arthritis Flare up on 7d. Arthralgia, right hand joints swollen, numbness, stiffness. Nerve pain on right arm, left hand joint pain at 8d

Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted for about 1 minute, urinated during fainiting. Paramedics checked patient vitals, everything was norma-blood pressure, heart rate. Pt has history of fainting in the past. Followed up with pt at 6 pm 7/25/21, pt is doing well with some headache. Before vaccination pt did not eat and he exercised. Pt received Pfizer Covid vaccine at 12;15 pm. Pt also said that he felt dehydrated, he only consumed caffeine in the morning.

Bloody urine; UA indicated red blood cells and bilirubin in urine; UA indicated red blood cells and bilirubin in urine; Basic Metabolic Panel indicated dehydration; Dose Number 1, Date of start of drug (21Dec2020) / Dose Number 2, Date of start of drug (13Jan2021); Dose Number 1, Date of start of drug (21Dec2020) / Dose Number 2, Date of start of drug (13Jan2021); This is a spontaneous report from a contactable pharmacist. This 32-year-old male pharmacist (Patient) reported for himself that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EL1284), via unspecified route at left arm on 13Jan2021 10:00am at single dose for COVID-19 immunization. Medical history was not reported. Concomitant drugs included Vitamin D3. Historical vaccine included the first dose of BNT162B2 (lot number= EH9899) on 21Dec2020 02:30 pm at left arm for COVID-19 immunization. Facility type vaccine was hospital. No other vaccine in four weeks. On 15Jan2021 01:30 pm, patient had bloody urine, he was otherwise normal health, he visited healthcare provider within 3 hours of the incident. Point of care urine analysis (UA) and blood draw was done. UA indicated red blood cells and bilirubin in urine. Basic Metabolic Panel indicated dehydration, otherwise unremarkable. Events resulted in emergency room/department or urgent care. No treatment was received. Outcome of events was recovered in Jan2021. No COVID prior vaccination. No COVID tested post vaccination.

Fever 100-101 degrees F; Severe chills at night; Irregular urination; Rusty colored urine; Fatigue; Kidneys felt sore; This is a spontaneous report from a contactable other healthcare professional reported for himself. A 32-year-old male patient received first dose BNT162B2 (reported as PFIZER BIONTECH COVID 19 VACCINE, Lot number: EL3249, Vaccine location: Left arm), via an unspecified route of administration on 16Jan2021 15:45 at single dose for covid-19 immunization. The patient had no medical history. The patient did not have allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Roughly four days after vaccination (21Jan2021 04:00 AM) the patient developed a fever 100-101 degrees F, severe chills at night, irregular urination (including rusty colored urine), fatigue, and his kidneys felt sore. These events did not result in death, was not life threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, was not congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient did not have been tested for COVID-19. The patient was not received treatment for the adverse events. Facility where the most recent COVID-19 vaccine was administered was other. The outcome of the events was resolving.

During the safety briefing by staff, participant became unresponsive; participant was administered Epi Pen 0.3 mg in left thigh. EMS was called. Participant then aroused and was assisted by staff to observation tent. Initially denied history of passing out with injections, however, later stated he had. Participant was incontinent of urine. Oxygen saturation - 99%, pulse 66. EMS arrived and assessed participant, BS 112, & offered to take to E.D. for further evaluation, however, participant declined & left with wife. Called to f/u on 3/3/21 and stated he had visited his physician and had no further concerns.

Fainted, urinated, nauseated, chest pain start @ 2010. Evaluated by EMS- Transported to Emergency room/department or urgent care.

After administering the shot I was explaining to wait for 15 minutes, as we were speaking patient stated he was feeling light headed then he slumped forward and became unresponsive for a few seconds during that period he urinated on the chair and floor I had a customer get the pharmacist and the patients wife came to him. The patient remained shaky, as we retrieved a towel and some water for him. The patient remained sitting and resting for about 20 mins during this time we offered to call 911 to which the patients wife stated that something similar to this happened before and declined the call to 911.

Patient received 'steroid' injection from allergist and 3 days later received 1st dose of Pfizer COVID-19 vaccine, then 3 days later received another 'steroid' injection. Patient then developed headache associated with fever and chills for 1 day. The patient travelled at which time his symptoms came back now with nausea, vomiting and diarrhea. Patient also noted to have erythema and itchiness for 3 days prior to coming to the hospital. Patient has a rash on left arm, as well as bilateral lower extremities. Patient was admitted for septic shock with an AKI. Patient received IV fluids, Levophed, vasopressin, IV Fentanyl, IV antibiotics, and IV steroids. Patient is now off of vasopressors and is improving.

The patient fainted and urinated. He said he was feeling pain briefly in his neck. He also said he had pain in his right chest. He laid down for 40 minutes. He did not want us to call an ambulance. He had someone pick him up and he said he was going to the emergency room.

weak; Low kidney function; Low platelets/platelets numbers are low; kidney numbers are low; Fever up to 102.5F; This is a spontaneous report from a contactable consumer. A 32-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03May2021 08:00 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date. Patient previously received the first dose of BNT162B2 for covid-19 immunization. There were no concomitant medications. Consumer is the sister of the patient that after getting the second dose of the Pfizer covid vaccine is experiencing after several days fever up to 102.5F on 04May2021, low platelets and low kidney function. her brother who is too weak right now to call. He got his second vaccine and right now it will be 2 weeks ago, he got it on 03May2021, he had the COVID virus in Nov, it has been 2 weeks since the second dose as of tomorrow and he has had 102 degree fever the whole time throughout the day and night. She is trying to understand if this is something to be concerned about. He had blood work done and his platelets numbers are low and his kidney numbers are low and she is looking for peace of mind of if this is commonly reported adverse event or maybe the steps to be taken. She says she works for (Company) so she familiar with having to report adverse events. Her brother is also awaiting chest x-ray results, he was negative for mono, flu, and negative for COVID.The patient underwent lab tests and procedures which included body temperature: 102.5 fahrenheit on 04May2021, chest x-ray: unknown results, influenza virus test: negative, investigation: low on 13May2021, mononucleosis heterophile test: negative, platelet count: low on 13May2021, sars-cov-2 test: negative. Outcome of events was unknown. Information on the lot/batch number has been requested.

Low blood pressure Sweating all the time Loss of energy Dis colored urine All systems are still on going I don't have health insurance and no one will see me

Patient received the vaccine at the pharmacy, waited around in the parking lot for 10-15 minutes (did not follow advise of remaining on site for direct observation); then drove off to go home. While driving he had an suspension that something was going to happen, and managed to pull into a random parking lot. Suddently/quickly he passed out (without putting his car into park) and moment later (about 5 minutes), he regained consciousness hunched in the front seat of his truck and he truck up against a curb. He also claimed that he loss control of his bladder. Patient called his parents THEN the pharmacy immediately in which he was advised to calll 911 or seek medical attention. Patient made it home around 830pm safey and say he was really tired and was going to eat dinner to see how he feels. Patient still feels disoriented and does not want to seek medical attention at this time as of 840pm.

Dark urine/The color of urine has gone between a dark yellow or barely orange to a little bit lighter and then back; This is a spontaneous report from a contactable consumer (patient). A 33-year-old male patient received the second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. EW0164) at single dose, in the left upper arm, on 19Apr2021, at 09:00, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included fast heart rate and gastrooesophageal reflux disease. The patient previously, on 26Mar2021, at the age of 32-years, received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Lot. ER8732) at single dose, in the left upper arm, for COVID-19 immunisation. Concomitant medications included atenolol 50 mg once a day, from an unspecified date (he started it probably 10 years before this report) and ongoing, for fast heart rate and pantoprazole 40 mg once a day from an unspecified date (he started it probably 10 years before this report) and ongoing, for gastrooesophageal reflux disease. On 19Apr2021, at 19:00, the patient experienced dark urine and other symptoms (unspecified). The adverse event was described as "patient had the second dose of the vaccine on Monday morning 19Apr2021, and he noticed the dark urine Monday evening. The color of urine has gone between a dark yellow or barely orange to a little bit lighter and then back. It has fluctuated a little bit during the last day and a half but hasn't gone away at any point. Most of his other symptoms he had were in line with what he had read about with the vaccine". No seriousness criteria reported. Physician office visit and emergency room visit were not required. Clinical outcome of the adverse event at time of this report was unknown. No follow-up attempts are needed. No further information is expected.

Seizure with loss of consciousness, but without passing out, lasting shorter than 2 minutes with no prior history of seizures. Other present symptoms included: aura including heightened fear, visual and auditory abnormalities, loss of awareness, loss of muscle control in face and neck, staring episode, breathing difficulties/gurgling, and loss of bladder control. All symptoms subsided upon regaining consciousness/awareness.

Other diseases of bronchus, not elsewhereclassified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Acute respiratory failure with hypoxia Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Hypertensive heart disease with heart failure Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Heart failure, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 ABG (arterial blood gas) abnormal Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Acute kidney failure, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Polycythemia Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 Hyperglycemia, unspecified Onset: 20-Apr-20213:06 Comments: Onset Date: 20210417 ARDS (adult respiratory distress syndrome) Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Shock Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Acute respiratory failure Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Aspiration pneumonitis Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Abnormal CXR Onset: 18-Apr-202116:37 Comments: Onset Date: 20210417 Cardiogenic shock Onset: 17-Apr-202114:26 Comments: Onset Date: 20210417 Cardiac arrest Onset: 17-Apr-202114:26 Comments: Onset Date: 20210417 Pulmonary infiltrate Onset: 17-Apr-202112:23 Comments: Onset Date: 20210417 Acute respiratory failure with hypoxia Onset: 17-Apr-202112:23 Comments: Onset Date: 20210417 Aspiration into airway Onset: 17-Apr-202112:23 Abnormal EEG Onset: 25-May-202112:11 Comments: Onset Date: 20210419 Encephalopathy Onset: 25-May-202112:11 Comments: Onset Date: 20210419 Acute thrombosis of right cephalic vein Onset: 19-May-202111:49 Comments: Onset Date: 20210425 Cardiomegaly Onset: 30-Apr-20216:24 Comments: Onset Date: 20210426 Ventricular fibrillation Onset: 29-Apr-20212:21 Comments: Onset Date: 20210427 Coma Onset: 27-Apr-202114:09 Comments: Onset Date: 20210422 Postoperative hemorrhage involving circulatorysystem following circulatory system procedure Onset: 26-Apr-202112:27 Comments: Onset Date: 20210421 Personal history of ECMO Onset: 26-Apr-202112:23 Comments: Onset Date: 20210419 Presence of ventricular assist device Onset: 26-Apr-202112:23 Comments: Onset Date: 20210419 Frequent PVCs Onset: 24-Apr-202112:49 Comments: Onset Date: 20210424 Presence of other vascular implants and grafts Onset: 24-Apr-20215:43 Comments: Onset Date: 20210418 Obesity, unspecified Onset: 24-Apr-20214:58 Comments: Onset Date: 20210417 Body mass index [BMI] 45.0-49.9, adult Onset: 24-Apr-20214:58 Comments: Onset Date: 20210417 Hyperthermia Onset: 23-Apr-202121:40 Comments: Onset Date: 20210419 Ventricular tachyarrhythmia Onset: 23-Apr-202112:14 Comments: Onset Date: 20210423 This code is used to indicate to the billing staff thatservices have been rendered and the chargeneeds to be coded. Onset: 22-Apr-202113:08 Comments: Onset Date: 20210421 Cardiomyopathy Onset: 22-Apr-202111:48 Comments: Onset Date: 20210422

Sore left arm, muscle soreness, fatigue waking up the next day. Around 24 hrs after vaccination, headache started, and lasted for ~8 hours. I took some advil around an hour before the headache stopped (really wish I'd taken it when I first felt the headache). I could feel the muscle soreness go away before the headache did. The headache felt like it moved from behind my eyes to the back of my head. I decided to only eat bits and pieces of stuff when I was feeling my worst because I was concerned that would make me feel nauseated (never did feel that way, so no idea if that made a difference). I drank probably 200oz of liquid throughout the day, but still felt dehydrated, even though I wasn't sweating. Did pee a lot though. Generally it was what I expected, but a friend who works at a hospital said I should report the info.

RN assessed patient. Pt presented cyanosis of lips, diaphoretic, incontinent, bp: 76/48, hr: 68, temp 35.1, o2 sat: 75% wife of patient reported pt passed out in observation and that patient took Xanax 0.25 mg at 1400 and again at 1615. fire dept arrived around 1800- pt left ama per fire dept .

Patient came in for 1st dose of Pfizer vaccine today. During his post-vaccination observation period, the client became extremely diaphoretic, dizzy and possibly lost consciousness (unwitnessed). Client experienced immediate urinary incontinence. Onsite EMS was called, client had very low blood pressures and pulse measures (below). Ambulance was called and client was transported to the hospital for further assessment and intervention.

Client was moved to observation for 15 minute wait time. Client was anxious about receiving vaccine. While sitting in chair in observation, client fainted and fell to the ground. Client was sweating and loss control of bladder and bowel. Client bent big toe nail back during fall and was bleeding. Client was moved to another area and vitals were checked once client came to, vital signs stable. Ambulance was called but client declined treatment.

Frequent urination; UTI; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 11Mar2021 12:30 PM and 2nd dose on 08Apr2021 12:30PM, both at single dose via an unknown route in left arm for Covid-19 immunization. Medical history included Attention deficit hyperactivity disorder (ADHD), Nonalcoholic fatty liver disease (NAFLD), Obsessive-compulsive disorder (OCD), allergies to ammonium chloride and watermelons. Concomitant drug was "none". The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. About a week after the first vaccine a developed a need to urinate frequently, every 5-20 minutes. Patient presumed it was a UTI and took steps to treat it. Event onset date was 16Mar2021 01:00. The symptoms abated about four days before the second vaccine. The symptoms returned on 21Apr021, four days after the second vaccination. Treatment received for the adverse event included antibiotics, pain reliever, antihistamines. Outcome of the events was resolved with sequel. Since the vaccination, the patient was not been tested for COVID-19. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Heart attack; he is in the hospital, fully on life support; he has his kidneys and liver are failing; he has his kidneys and liver are failing; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old male patient received bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 15Jun2021 as dose number unknown, single for covid-19 immunization. Medical history included Anxiety, depression. Concomitant medication included gabapentin (GABAPENTIN) taken for an unspecified indication, start and stop date were not reported. patient did not receive any other vaccine within 4 weeks Prior to Vaccine. Reporter stated, is it possible for heart attack to happen 8 days after the vaccine. reporter want to report a reaction, because reporter think it was vaccine reporter wanted to make sure, repoters brother is 34 and he had a heart attack yesterday and he received his vaccine (Confirmed as Pfizer Covid 19 vaccine) 8 days ago, he received his vaccine before his heart attack. Reporter stated, patient has his kidneys and liver are failing, he said they did the lab work really done, he is still waiting to get echo that for his heart. Patient is completely on life support, he still in the hospital. The patient underwent lab tests and procedures which included echoencephalogram: unknown results, Therapeutic measures were taken as a result of heart attack. The outcome for the events he has his kidneys and liver are failing was reported as unknown and for remaining events outcome was reported as not resolved. Information on the lot/batch number has been requested.

History of Present Illness 34-year-old male with history of end-stage renal disease secondary to lupus nephritis (dx 2018) on MWF dialysis, morbid obesity, CHF with EF 45%, htn, SLE, who presents to the ED for shortness of breath and hemoptysis. Patient states that he has been missing dialysis for around 12 days. He does still make urine around 1/2L daily. He was brought into the ED by his uncle who he lived with. His uncle just got back to town and noticed that Javone had difficult time breathing, thus, brought him to the ED. Patient reports that he also has been having diarrhea, hemoptysis, fever, and shortness of breath for the past 2-3 days. He had Covid vaccination on 5/01 and 5/22. In the ED, he was found to be at 75% oxygen on 10L in the ED, improved to 84% on 15L non-rebreather. He was quickly started on BiPAP. VBG was significant for metabolic acidosis with respiratory compensation pH 7.304, pCO2 27.2, and HCO3 13.1. Labs were notable for Hgb 10.9, K 5.5, Cr 22.3, trop 60, and BNP 7281. Patient was admitted for acute hypoxic respiratory failure suspect secondary to fluid overload 2/2 missed dialysis vs Covid pneumonia.

Patient thought he sat in chair in observation area but he fell on the ground and began to seize. Multiple nurses and EMTs responded and found the patient in tonic-clonic seizure. Pt continued to seize for about 10 seconds and upon exiting the seizure he reported that this happened about 4 years ago The patient repeatedly declined to be transported to the hospital.. He was incontinent and finally he agreed to be transported to a nearby hospital to be checked out.

Site: Redness at Injection Site-Mild, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chills-Severe, Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Fever-Medium, Systemic: Urinated in the event of fainting-Medium, Systemic: Flushed / Sweating-Severe, Systemic: Shakiness-Severe, Systemic: Visual Changes/Disturbances-Severe, Systemic: Weakness-Severe

Very frequent urination. Did urnianalysis 2 times which is normal. Also did Urine culture twice which is also negative.

Patient was brought to the medical observation after a experiencing a feeling of faint and diaphoresis. He had syncopal episode with incontinence while at the medical observation. He was put on a stretcher with head of bed lowered to allow adequate supply of blood to the brain. Vital signs were checked adequately. Ems were contacted for patient to be sent to the hospital for evaluation.

2-3 days after shot I became so thirsty drinking up to 2-3 gallons of water a day! My vision has now became blurry and I?m having to urinate 10 times a night. I was in the hospital 2 weeks prior and my chart was fine I?m in the hospital as we speak and I haven hyperglycemia!! Now diabetic after the shot my life has changed!!!

4/16/21 Patient presents to ED w/chest pain. he was found to be + for SARS-CoV-2. He was placed in observation and was discharged to home the next day after IV hydration and lowering blood sugar. Chest and abdominal myalgias In context of COVID-19 infection, he has no additional symptoms of Covid. CPK is unremarkable Likely secondary to COVID Covid-19 Virus Infection Date of onset of symptoms: ?? Date of covid positive test: 4/16/2021 Symptoms: Myalgias, no fever, no GI or respiratory symptoms Special isolation precautions implemented: yes Oxygen requirements on admission: None Current oxygen requirements: None Medical therapy: not indicated

He is seeing his urine color as red after the vaccine. He is having the problem still today. Every time when he passes urine he sees the color red.; Dose 1: headache; This is a spontaneous report from a contactable consumer (patient, self-reported). A 35-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0186 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 28May2021 at 6:45 pm -7 pm (age at vaccination: 35 years), as a single dose for COVID-19 immunization. The patient took covid 19 vaccine because everybody was getting the vaccine and he might go back to the office. The patient's medical history and concomitant medications were not reported. The patient reported that on an unspecified date in Jun2021, he was seeing his urine color as red after the vaccine. He was having the problem still today. Every time when he passes urine he sees the color red. The patient was not sure if what he was experiencing was a normal side effect of the vaccine. He hasn't seen his experience listed on the list, so he just wanted to check. The patient also stated that he has seen this before when he has had a beet root, but for the past two days he has never had a beet root. He had a headache 3 or 4 days before he received the second vaccine (Dose 1: headache). He took Tylenol for the headache. Headache occurred in the evening on Monday or Tuesday before the vaccine, he was not really sure. He stated maybe 6:14-6:15 pm for onset. Complete recovery the same day. Outcome of the events was recovered on an unspecified date in Jun2021. Information on the lot/batch number has been requested.

approximately 3-5 minutes after receiving dose, client states he felt a surge of warmth rush over him. Client loss consciousness and fell out of his chair. Client was laying prone with both arms down by his sides. Assume client hit his head when he fell. After approximately 10-20 seconds, client awoke, confused as to what happened, but oriented to person, place, and time. Client remains pale and diaphoretic. Client sat for 3-5 on the floor, recovering, then moved client to a wheelchair to escort him to the medical eval area. Upon transport to eval area, client stated he felt it happening again. He then fell unconscious again, with is head falling forward, client panic. Started to seize with body going stiff and sliding out of wheelchair. 4 staff assisted client safely to the floor, placing a blanket under his head. Approximately 10 seconds of so activity and client awoke again confused as to what happened, but oriented to person and place. Client had bladder inconvenience. 911 called at 1854. BP 130/84, stats 97%, HR 70 s, breathing non labored, 16-20 breaths per minute. Report given to EMTs. After 10 minutes client moved to chair. Vitals remain stable. After 20 minutes client stood up and walked around. Taking water and crackers. Color is better. Client refused ambulance to the ER. Called his friend, an RN, who will take him home. Client encouraged to stay with a friend if he chooses not to go to the ER. Also encouraged client to talk to his provider before receiving his 2nd dose.

I had the 1st shot on Wednesday March 10th. On Sunday the 14th, just before going to bed at about 11pm, I went to pee. The urine was very dark brown. Didn't appear to have any red for blood. The next day I felt like water was being retained and it felt that I couldn't empty the bladder and pee was coming out slower than usual. Late Monday the 15th before bed I peed another dark brown urine and a red blood clot came out. At that point I became very concerned and sent to see the doctor on the 16th. Referred to a kidney specialist for March 31st. Between March 14th to March 29th , somedays I felt like I was retaining water, most days felt like I couldn't empty my bladder with slow flow. With the recent news of the concerns of blood clots with vaccines, I felt that I should report this.

10 min post vaccination patient became unconcious With clear signs of siezure *Incontinence *Cyanosis with postictal *headache *nausea *drowsiness *Airway management 30-60 sec *Tireness *Sleeppy *presentacion PT required

Patient presented to outlying hospital on 3/31 for a 4 day history of nausea, vomiting, and confusion. Blood pressure in the 200s. Admitted for hypertensive urgency, renal failure, encephalopathy. By 4/3, patient was agitated and unable to recognize anyone but his mother. Fever 102.1. Intubated on 4/5 as he continued to worsen and responded only to painful stimuli. Patient transferred on 4/5. MRI demonstrated mutlifocal bilateral cerebral infarcts with vasogenic edema. Small infarct in the left cerebellar hemisphere. All workups so far have been negative. TEE being performed 4/20 to evaluate possible cardiac embolic source. Providers are unsure of etiology of infarcts and edema. Reporting per infectious disease physician's request.

blood drops in my urine and possibly passed a blood clot.; blood drops in my urine; When I woke up to use the bathroom, I noticed some blood coming out of my penis.; This is a spontaneous report from a contactable consumer. A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 21Apr2021 13:45 (at the age of 36-years-old) (Batch/Lot Number: ER8735) as SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. The patient received first dose of BNT162B2 for COVID-19 immunization on 31Mar2021 (Product=COVID-19, Brand=Pfizer, Lot number=ER8734, Lot unknown=False, Vaccine location=Left arm, Administration date=31Mar2021, Administration time=14:00 PM, Dose number=1). Concomitant medications included ibuprofen (ADVIL [IBUPROFEN]); cetirizine hydrochloride (ZYRTECNO). On 22Apr2021 06:30, When the patient woke up to use the bathroom, he noticed some blood coming out of his penis. At 06:45, it was reported, The morning after his second dose, he had blood drops in his urine and possibly passed a blood clot. The outcome of the events was unknown. The event "blood drops in my urine and possibly passed a blood clot" and "When I woke up to use the bathroom, I noticed some blood coming out of my penis" was assessed as serious (medically significant).

Getting scratches and not healed up; Getting scratches and not healed up; Some blood coming in urine; This is a spontaneous report from a contactable consumer (reporting for husband). A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via an unspecified route of administration on 10Apr2021 (Lot Number: EW0150; Expiration Date: Jul2021) as single dose for covid-19 immunisation. Patient History and Investigation Assessment were reported as none. Concomitant medications were not reported. The patient got his first Pfizer dose for Covid on 10Apr2021 which was on Saturday and after that like another 24 hours after his first dose. He had some blood coming in his urine. It was not too much; it was less but it was there. At least for 24 hours or may be 26 hours. It was 10Apr2021 only. Like he got his vaccine in the afternoon and towards the evening he noticed that. He had beet root also that afternoon like it might and also not sure if that was the thing. But he saw that in the evening and approximately in the night and then next morning it was fine. After that he did not had any issues but he was getting a lot of scratches even if his daughter scratches him he was getting a scratch and that was not getting healed up. It had been like two days he had got a scratch and that was not getting healed up that was they got a little worried. No treatment was received for events. They were wondering if they need to go and get any blood work done before the second dose because he would have his second Pfizer dose on 28th. The outcome of events was unknown. No follow-up attempts are needed. No further information is expected.

Fever, Chest Pain, Fatigue, Blurry vision. diarrhea, frequent urination, congestion, muscle aches, body aches, headache starting the morning after the vaccine was received

Pt is 36 yo male with PMH of renal transplant 2/2 IgA nephropathy, CKD IIIa, OSA, GERD, morbid obesity who presented with cough and shortness of breath on 4/25/2021. He was found to have COVID-19 pneumonia and AKI. He is s/p Pfizer dose #1 vaccination on 2/23/2021 and dose #2 vaccination on 3/16/2021. He is immunosuppressed on mycophenolate, prednisone and balatacept monthly which may have affected immunogenicity to vaccine. Pt admitted and completed 10 day course of remdesivir. Also received dexamethasone. Improved VTE score of 1 so did not meet criteria for prophylactic Eliquis. Difficulty in weaning patient off of O2. Was discharged on 5/5/2021 on 4L oxygen and will follow up with Pulmonary as outpatient.

Strong Headache, Strong Body Aches, Pain while urinating, heavy congestion and discharge, pain in various areas of my body which moved throughout the day (jaw, arm, etc), upset stomach

I started feeling sick around 8:00 that evening - more than just sore. I ended up with fever of 102 by 11:00 or midnight; chills and burning up and what prompted me to call my doctor, in the middle of the night, I have a watch with heart rate monitoring and it had woken me up with signal of abnormal heartrate. It was over 130 (normal rate is between 55 and 60 during sleep ) and I had a telemed visit and Dr. said to take Ibuprofen after 24 hour mark. The only other side affect, my bladder side was feeling small and I had to pee every hour. Ibuprofen helped break the fever. The symptoms were resolved by about the following night. My stress level measured by my watch was back in the normal range after I woke up the second morning.

Patient started breathing heavily a few minutes after receiving the vaccine, was able to say words not full sentences. said he was feeling hot. he lost muscle control and uncontrollably urinated. EMR was contacted; patient retained muscle control and got back to normal in about 2 minutes after the start of the adverse events. and was able to walk with the EMR outside to get medical check.

The patient experienced a generalized seizure lasting approximately 30 seconds with urinary incontinence. The patient remained unconscious for approximately 1 min post seizure and remained in a post-ictal state for approximately 3 minutes until normalization of mental status. The patient was transported to the hospital via ambulance for further evaluation.

hard to get a breath; anxious; my heart began to race; felt the urge to use the bathroom; This is a spontaneous report from a contactable consumer. A 37-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in arm right on 25feb2021 at 16:15 as single dose for covid-19 immunisation. Medical history and concomitant medications were not reported. No Known allergies. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. No covid tested post vaccination. On 25Feb2021 16:15 after about 1 minute she began to fill anxious, her heart began to race, and she noticed it was hard to get a breath. She also immediately felt the urge to use the bathroom. She raised her mask up slightly and was able to take deep breaths and she tried to calmly read the vaccine pamphlet as she thought maybe she was just nervous as she have never had a reaction before. No treatment received. The events outcome was recovered. No follow-up attempts are possible; information about lot/batch number cannot be obtained.

patient experienced uncontrolled urination about 60 seconds after the vaccine administion. He thinks he may have passed out briefly but remained in his chair. Administration was at 2:25pm 7-3-21. He had not eaten much today other than fritos & cheetos according to his spouse.

Patient states on 2/23/2021 at about 0130 am , he began feeling " restless , body aches, and headache". Patient took some Excedrin at that time for headache. Sudden onset of pain to left kidney area as per patient , with chills and continued body aches. Denies urinary symptoms or hematuria. Onset of fever at about 5 am which was 99.7 temporal , at 1130 am patient stated his temperature was " 107.2 temporal" . Patient asked about high fever and states he was alert and oriented and repeated temperature at about 12pm and was 103 F. orally. Took 800mg of Motrin , called his PCM who instructed patient to go to Emergency Department. Stated his pulse on arrival to ER was 117 beats /minute , blood pressure was 101/55. States had a provider evaluation and was discharged from ER.

On 4th day I began urinating blood. Was diagnosed with a secondary infection of the left kidney, bladder and testicle (orchitis and epidymitis). It was antibiotic resistant until 3 week course of ciproflovaxin. Still ongoing. Ever since, blood pressure and HR wont regulate - shifts between 150/110 and 100/60 bp and 50-90HR every 15min. Uncontrollable anxiety. All of my veins are bursting, legs are blue and purple

Awoke 14 hours after injection with high fever, cold sweats, intense kidney pain, and severe nausea. Could not stand without experiencing dizziness, tunnel vision, and fainting sensations. Symptoms began to improve within 12 hours of onset, but patient had to stay home from work due to inability to perform basic functions in an office environment. Kidney pain and low fever persisted for 2 days.

My Urine had blood in it for a day and was very painful. The next day the blood stopped and the pain has greatly decreased

Dizziness, fatigue, blood in Urine, Chest and Stomach burning, joint pain, irregular heartbeat and numbness on both the hands Blood test - Normal ECG - Normal Echo - Normal Cardio Monitor (72 Hrs) - Normal Blood in Urine - It was normal after 15 days. Taking Meclizine 25 MG for dizziness.

Member got first COVID Vaccine and report to ER with "Kidney Pain". Member received second COVID Vaccine and was diagnosis with MONO. Pt was informed that COVID Vaccine can reactive Mono. Pt had mono in the past.