16 |
2021-04-11 |
urinary incontinence |
Patient felt dizzy and passed out for a minute. Patient also urinated while passed out
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16 |
2021-04-14 |
blood in urine, urinary urgency, pain with urination, frequent urination |
The night she received the vaccine she developed dysuria, hematuria, urinary urgency, and urinary fr...
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The night she received the vaccine she developed dysuria, hematuria, urinary urgency, and urinary frequency
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16 |
2021-04-21 |
urinary incontinence |
pt started feeling really dizzy and nauseated immediately after taking the vax. she started having ...
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pt started feeling really dizzy and nauseated immediately after taking the vax. she started having a seizure and made a growling type of noise and urinated on herself. The nurse at the vax site helped bring her back and was told to take her to a doctor. She was monitored and released from the vax clinic when her BP was 107/76. She was taken to medical center where she saw. She was told she had Syncope due to the stress of the situation of getting the vaccination. She is resting today and seems to have some fatigue.
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16 |
2021-04-22 |
blood urine present |
Patient had fever, headache, body aches on 4/20/2021 by 4/21/2021 she had bloody urine, upon arrivin...
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Patient had fever, headache, body aches on 4/20/2021 by 4/21/2021 she had bloody urine, upon arriving in our office on 4/22/2021 she had 3+ blood in her urine analysis.
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16 |
2021-04-24 |
urinary tract infection |
After shot felt light headed, dizzy, Requested water. Sat down put head back started snoring loudly....
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After shot felt light headed, dizzy, Requested water. Sat down put head back started snoring loudly. Stating seizing, eyes rolled back in head. Nurse had to wake up with smelling salts. Low blood pressure 60/40 All happened within 10 minutes.
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16 |
2021-05-20 |
blood creatinine increased |
6 days following vaccination, patient was exercising for the first time. started feeling dizzy. She...
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6 days following vaccination, patient was exercising for the first time. started feeling dizzy. She had some water and realized that her skin was red. She had a rash on face and puffy lips. Mom came to get her she stood up and was extremely dizzy. Mom did not notice that her lips were swollen but did notice that her skin was rashy and red. Mom, who is a nurse, also thought she appeared pale and diaphoretic. By the time they got the ED she was hypotensive. She got a cocktail of meds in the ED including a couple doses of EPI. She got IV fluids. She started to improve quickly after giving the medications.
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16 |
2021-05-31 |
pain with urination |
Painful urination, urination urgency beginning in the evening one week after dose. Was seen by famil...
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Painful urination, urination urgency beginning in the evening one week after dose. Was seen by family physician next morning; urine test done; white blood cells seen; urine culture done; bacteria not found. Was given antibiotics while waiting for culture results (3 days;) some improvement, but not as expected. Discontinued antibiotics when urine culture found negative. Condition continued to improve, lasting about another 4 days.
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16 |
2021-06-08 |
incontinence |
Patient had a headache this morning. At 11:30am she felt hot, so we took her temperature which was ...
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Patient had a headache this morning. At 11:30am she felt hot, so we took her temperature which was 100.0. She then walked into another room and had a febrile seizure lasting 30 seconds. Her face was pale white, her eyes were open and staring off, she moaned initially and then her jaw was stuck open with her tongue making a clicking sound. She urinated herself and then the seizure ended.
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16 |
2021-07-17 |
urinary incontinence |
About 1 minute, or so, after her daughter received her COVID-19 Vaccine injection, her daughter pass...
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About 1 minute, or so, after her daughter received her COVID-19 Vaccine injection, her daughter passed out, and ended up in the ER; She said her daughter vomited twice after she passed out, and then vomited again in the Emergency Room; It was not normal for her daughter to gurgle like she was; Her daughter wet herself, clarifying her daughter involuntarily voided when she passed out.; Her daughter bit her lip really hard when she passed out; Her daughter had a really bad headache; Her daughter said she heard a nurse say as she was coming to that she was only breathing 6 breathes per minute; When her daughter received her 1st COVID-19 Vaccine, her daughter arched her back, and her daughter's arms drew in.; Her daughter may have been a little tired after getting her first COVID-19 Vaccine, but no more than normal; Her daughter said her throat was sore afterward (vomiting); This is a spontaneous report from a contactable Nurse. This Nurse (patients mother) reported for a female age 16 years old patient (reporters daughter) that patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number was EW0168), via unspecified route in right arm on 24Jun2021 13:21 as single dose for COVID-19 immunization. The patient medical history included mild asthma for a good 10 years. She did not even use an inhaler for the mild asthma, and the last time she used a rescue inhaler was in the last couple years and Dermatographia from 05Aug2020 and was ongoing she could be allergic to something, and then down the road, whether it be a few months or a few years, would not be allergic to it anymore. She had passed out from blood draws in the past, but that she would come to a few seconds afterwards. She would never get upset when she had blood draws. The patient concomitant medication included Cetirizine hydrochloride (ZYRTEC). On 24Jun2021 patient experienced for About 1 minute, or so, after she received her COVID-19 Vaccine injection, she passed out, and ended up in the Emergency Room and she vomited twice after, and then vomited again in the Emergency Room. It was not normal for her to gurgle like she was. She involuntarily voided and she bit her lip really hard when she passed out. She had a really bad headache. She heard a nurse say as she was coming to that she was only breathing 6 breathes per minute. When her daughter received her 1st COVID-19 Vaccine, she arched her back, and her daughter arms drew in. She might had been a little tired after getting her first COVID-19 Vaccine, but no more than normal and her throat was sore afterward. Patient was not given any treatment at the COVID-19 Vaccine facility but was taken by ambulance to the Emergency Room and the Emergency Room gave her daughter an Ativan 0.5mg tablet and placed an IV in her. An emergency Room ran an IV infusion of 999ml of Sodium Chloride 0.9%. On 24Jun2021 patient did an EKG, chest x-ray, urinalysis, and blood work and results of EKG, chest x-ray, urinalysis, and CBC were normal, but electrolytes were a little low. She had followed-up with her pediatrician after her Emergency Room visit. pediatrician scheduled an EEG for her daughter on 28Jul2021 because of her daughter losing her bladder control, and other things that happened when her daughter passed out. The outcome of event (sore throat, Fatigue) was unknown, event of (Passed out and bite wound) was unknown and event of (Dyskinesia, Respiratory rate decreased, Urinary incontinence and Abnormal behavior) was recovered on an unspecified date 2021 and event of (headache) was recovered on 25Jun2021.
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17 |
2021-04-07 |
urinary incontinence |
Events happened about 5 mins after shot was given. Patient experienced lightheadedness, loss of cons...
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Events happened about 5 mins after shot was given. Patient experienced lightheadedness, loss of consciousness for a couple seconds, uncontrolled urination, hot flashes, headache. Patient was given water and a snack to consume. After about 10 minutes of resting and consuming food, she feeling better afterwards, said it could have been to fear of getting injections, and was able to go home with her family.
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17 |
2021-04-11 |
urinary incontinence |
Patient and Father were at desk to schedule follow-up vaccination when patient fell to the ground. ...
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Patient and Father were at desk to schedule follow-up vaccination when patient fell to the ground. Writer and additional clinic manager responded to event. Patient was rigid, eyes rolled back and not responding. Writer and manager attempted to arouse patient, with no response. Per father, patient has passed out in the past with blood draws. Feet were elevated and ice pack applied behind neck. Patient's fists were clenched, teeth clenched, back arched and appeared to have urinary incontinence. Episode lasted approximately 1-2 minutes. ED responded. Patient regained consciousness and was able to interact with writer appropriately. Bp 124/78, pulse 80 bpm, oxygen saturation 100%. Patient assisted to stretcher and transported to ED
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17 |
2021-04-26 |
urinary incontinence |
At 2am 4/22 patient started to feel sick and sent a text that I didn't read until 630 as I was aslee...
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At 2am 4/22 patient started to feel sick and sent a text that I didn't read until 630 as I was asleep. She had severe muscle aches, hurt to move, hurt to breathe and felt like she was having a heart attack. She felt like she might pass out and had some blurred vision. At 630am, I saw her texts and immediately brought her 2 tylenol and a large glass of water. She went back to bed. She woke up around 10:45 and was feeling decent except for a headache but no fever or anything so we went to try on some Prom dresses. At the dress shop, she collapsed and had a seizure lasting around a minute. She lost her bladder and was completely confused and incoherent. She's never had a seizure before. I scooped her up, brought her to the ER where they ran every test and scan imagineable. Full blood work up and cultures, a chest xray, a CT scan of her brain and lungs. Her temp was high 103-104 and she had full body chills and a pounding headache. Her BP kept dropping and got as low as 81/36. They threw 2 bags of IV fluids into her and admitted her to the hospital. She had also developed a heart murmur. Over the course of the night, her BP stabilized but her temp continued to spike and come back down with Tylenol/Ibuprofen. She also had IV Tordahl for the headache. Her inflammatory markers were high at 15.3 which we were told should be less than 1. They reran labs in the morning but everything can back really low which they felt was a dilution effect from all the fluids so wanted us to follow up with her primary care on Monday. On Saturday night, he lymph nodes were swollen to the size of ping pong balls but have since slowly reduced in size although still there. Her labs were better from discharge and her white blood cell count was within range and her inflammatory marker was down to 1.7. Her blood sugar was a little low. She did pass out and have seizure like response to giving blood in the doctors office, lost bladder control again, shot pupils, etc. She is still stuttering over words, has some short term memory retention and has some motor function issues which they think is a result of the initial seizure and should resolve itself over time. Her liver function tests were totally normal in the hospital but are a high now so they will be checking her out again next week.
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17 |
2021-05-05 |
blood in urine |
4/23/2021 patient noted hematuria. Negative urine culture. + hematuria on dipstick. Tx with amoxil. ...
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4/23/2021 patient noted hematuria. Negative urine culture. + hematuria on dipstick. Tx with amoxil. Still having hematuria 5/3/2021. ASO titer POSITIVE. MOnospot POSITIVE and EBV panel positive.
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17 |
2021-05-06 |
urinary incontinence |
Numb sensation and urinary incontinence, tingling in feet and heightened sensitivity in body
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17 |
2021-05-20 |
blood creatinine increased |
Chest pains, difficulty breathing, outcome: diagnosed with myopericarditis and costochondritis as we...
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Chest pains, difficulty breathing, outcome: diagnosed with myopericarditis and costochondritis as well as inflammation in joints. Was in the hospital for 7 days and was on IV, morphine and then switched to hydro-morph for severe pain. Was given ketorlax via Iv for inflammation as well and steroids. Has been put on steroids for 1 month, Colchicine for 3 months, naproxen for inflammation.
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17 |
2021-05-26 |
urinary incontinence |
Less than 1 minute after received the shot, patient became clammy and pale while sitting in chair. H...
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Less than 1 minute after received the shot, patient became clammy and pale while sitting in chair. Her eyes rolled back in her head and her body went slack. Myself (parent) and the nurse who had given the shot braced her on either side while she appeared to fade in and out of consciousness for several minutes (she seemed to occasionally interact with us, mumbling responses to 'yes' or 'no' questions). The nurse did not want to lower her to the floor, but wanted to keep her propped on the chair. Her head kept rolling to the side. At one point, she began to jerk rhythmically. Just as I was about to bring this to the attention of the nurse, the patient returned to consciousness. Patient was moved to a rolling recliner chair and taken to a recovery area where I (parent) did not see her for another 30 minutes as I was receiving my own shot. The chair she had sat in was wet, but it was assumed this was due to sweat (patient had sweated profusely). On the way out of the clinic, noticing a wet stain on the back side of patient's pants, I asked if she had wet her pants (quietly) two separate times. Patient denied it both times. However, upon returning home, patient confirmed that she had wet her pants. Patient was monitored during the evening for similar adverse events ; none noted. Patient ate lunch approximately 1 hour before receiving shot and was given crackers while at clinic. Patient is a well-hydrated individual, and also drank water while on-site. No fever either before or after shot. A slightly elevated BP the next day (135/83). However, patient complained of headache, fatigue, and pain at injection location; elevated BP may be related to headache and/or ordeal from day of the shot.
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17 |
2021-06-18 |
urinary tract infection |
around 7:00 pm in the evening, she had a syncope episode. Video footage shows she is standing in lin...
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around 7:00 pm in the evening, she had a syncope episode. Video footage shows she is standing in line with other children, and just faints and falls to the floor. Initially she was not responding much to EMS and to FNP that received her, EKG was completed, and VS were within normal limits. She received lab work, UA, and CT of Head as she appeared to have hurt her head at time of fall. Few hours later, when FNP checked on her again, about 9:50 pm, she was more responsive, answering his questions and doing much better than when she initially arrived to hospital around 8 pm. She was verbal, and VS were within normal limits during my time with her at the hospital
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17 |
2021-07-04 |
urinary incontinence |
Immediately afterwards she passed out and peed her pants. Her mom was sitting next to her and was ab...
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Immediately afterwards she passed out and peed her pants. Her mom was sitting next to her and was able to catch her and support her.
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17 |
2021-07-12 |
incontinence |
Patient stated she was nervous and received the vaccine without incidence. After receiving the vacc...
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Patient stated she was nervous and received the vaccine without incidence. After receiving the vaccine while sitting the patient had what appeared to be a vasovagal response. She became pail and her eyes rolled back in her head. Patient appeared to have a seizure stuck both arms straight out and was incontinent. Patients was moved to the floor where her color returned and her pulse improved. Patient was taken to hospital via ambulance.
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18 |
2021-04-29 |
urinary tract infection |
For both doses of the Pfizer COVID Vaccine (1st - April 7th, 2nd - April 28th), I developed a Urinar...
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For both doses of the Pfizer COVID Vaccine (1st - April 7th, 2nd - April 28th), I developed a Urinary Tract Infection within 2 days of the vaccination. I was treated for the UTI caused by the first dose, and the infection had gone away prior to receiving the second dose of the vaccine, in which I then developed another Urinary Tract Infection following the second dose.
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18 |
2021-05-03 |
blood urine present |
She developed blood in urine. Was tested for UTI and the test was negative. She also slept 5 days
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18 |
2021-05-23 |
incontinence |
18 y/o F with PMHx of anxiety and panic attacks began to have upper extremity stiffening, wrist exte...
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18 y/o F with PMHx of anxiety and panic attacks began to have upper extremity stiffening, wrist extension and absent stare x 20 seconds. She became incontinent and lost postural tone shortly after. She states that she was very anxious about getting the vaccine; states that came into the parking lot of the facility yesterday and "psyched [herself] out" so much that she could not come in to get vaccinated. She was evaluated by EMS and clinical leads. Mother states that she tends to have a lot of panic attacks but has never had a reaction like this. Patient's mother also states that she is seeing a therapist for her anxiety and panic attacks but is not currently on any medications.
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18 |
2021-06-12 |
urinary incontinence |
The patient was in her usual state of health until the morning of Saturday 5/29/2021, when she woke ...
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The patient was in her usual state of health until the morning of Saturday 5/29/2021, when she woke up with an acute-onset right-sided headache and started screaming, followed by encephalitic presentation with urination on her mom's office desk and altered mental status. She also had right-sided facial droop. Patient was not oriented to person, place, nor time. The patient was started on acyclovir 650mg every 8 hours for 14 total days (day 1 = 5/30/2021) and had relatively rapid improvement over the course of the first 2-4 days despite negative HSV 1/2 PCR. She was continued on this treatment for the duration of her hospitalization as well as for one week as an outpatient via PICC line (final day = 6/11/2021). She has not had another episode of altered mental status since the onset of treatment and is now symptom-free with mild, transient headaches lasting a matter of seconds to minutes.
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18 |
2021-06-22 |
urinary retention |
4 days after receiving the initial vaccination she began to have nausea and vomiting. She had no si...
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4 days after receiving the initial vaccination she began to have nausea and vomiting. She had no signs of an infectious process. Weight prior to this was 123 lb. Current weight is 108 lb. She has persistent nausea, difficulty swallowing, constipation and urinary retention. Recent hospitalization with extensive work up could not identify and infectious, metabolic or anatomic cause.
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18 |
2021-06-24 |
urinary tract infection |
Pt arrived for first dose of Pfizer vaccine, no history of reactions to vaccines and no known allerg...
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Pt arrived for first dose of Pfizer vaccine, no history of reactions to vaccines and no known allergies. Patient did fine initially after her shot, dad denies patient feeling anxious and nurses noted patient seemed calm before and after her vaccine. Pt was sitting/leaning on dad towards the end of her 15 mins, he then felt her become heavy on his arm and noticed she had passed out. Observation nurse and another nurse working the clinic got the patient on her side (she was on a bench seat) and took vitals, put a cold water bottle behind her neck. Initially her bp was low (88/62) and progressively became higher, getting up to 146/98 at one point. Pulse/Respirations were WNL. Patient was in and out of consciousness so EMS was called and transported to Hospital emergency department. Patient evaluated with EKG, labs, and neurology consult. Urinalysis consistent with urinary tract infection. Patient discharged from emergency department with antibiotics and follow-up with primary care provider.
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18 |
2021-06-25 |
acute kidney injury, urinary retention |
A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possib...
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A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctors office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; A doctor's office visit on 4/28. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots).; no facilitated urination; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; Severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose; This is a spontaneous report form a contactable consumer (patient) reported for herself. A 18-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection Batch/Lot Number: EW0158) via an unspecified route of administration in arm right on 18Apr2021 as dose 2, single for covid-19 immunisation. Medical history included none history. Concomitant medications include levocetirizine (LEVOCETIRIZINE Batch/Lot number was not reported) via an unspecified route of administration from an unspecified date, at 5 mg for an unspecified indication. Historical vaccine includes bnt162b2 (Dose 1 lot number=EP7534 vaccine location=Right arm) on 26Mar2021 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 23Apr2021, the patient experienced a doctors office visit on 28Apr. Discussed the symptoms (minimal change disease-like symptoms, possible nephrotic syndrome, possible acute kidney injury, possible blood clots). Started to take 20mg furosemide for 7 days from 28Apr and 20mg prednisone for 10 days and 20mg furosemide on 04May. Even after finishing medication, there were no changes in symptoms. Continued leg swelling and no facilitated urination. There was severe swelling on both legs with sudden body weight increase (over 10 lbs) after about a week of second dose. After finishing both, the swelling in legs subsided and weight returned to normal. About 10 days later, moderate swelling in legs returned and body weight increased by about 5 lbs. The patient visited nephrologist visit on 02Jun and was prescribed 20mg prednisone, 3 tablets every other am for 20 days. Currently, patient have been taking the medicine since 03Jun. As of now 12Jun2021, the leg swelling partially decreased and the body weight decreased by 1-1.5 lbs. The clinical outcome of all the events was not resolved.
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18 |
2021-07-02 |
acute kidney injury |
Patient was admitted to the hospital with acute kidney injury (AKI) and possible colitis with hemato...
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Patient was admitted to the hospital with acute kidney injury (AKI) and possible colitis with hematochezia.
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18 |
2021-07-24 |
urinary retention |
Four days after receiving her vaccine, pt. began experiencing a progression of symptoms. Starting w...
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Four days after receiving her vaccine, pt. began experiencing a progression of symptoms. Starting with Nausea, then vomiting and constipation, extreme pressure in her chest, pain in her abdomen and difficulty swallowing / eating causing significant weight loss (123 lbs to 108 lbs). She has no or intermittent sensation to urinate and has had multiple catheters and is currently on a Foley catheter due to retetion. She has Gastroparesis and has not had a bowel movement since this all started. She began to experience Edema at the end of June and is currently experiencing tingling in her arms and legs since mid July.
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19 |
2021-04-10 |
urinary tract infection |
UTI resulting in fever, vomiting, nausea, and back pain
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19 |
2021-05-03 |
pain with urination, urinary tract infection |
woke up with symptoms of headache, chills, feeling like she was hit by a truck.
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19 |
2021-06-10 |
kidney stone |
kidney stones; severe left flank pain; extreme thirst; This is a spontaneous report from contactable...
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kidney stones; severe left flank pain; extreme thirst; This is a spontaneous report from contactable consumer (patient). A 19-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10May2021 14:00 (Lot Number: EW0168) as single dose (at the age of 19-years-old) for COVID-19 immunization. The patient was not pregnant at the time of vaccination. There was no medical history. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), cefalexin monohydrate (LEXIPRON), ethinylestradiol, levonorgestrel (VIENVA), all taken for unspecified indications, start and stop dates were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 19Apr2021 02:00 PM (Lot Number: EW0162) as single dose (at the age of 19-years-old) for COVID-19 immunization and experienced Heavy period off schedule from pill pack. The patient experienced extreme thirst since second dose (10May2021). Then, on 27May2021, had severe left flank pain causing an emergency room visit. Preliminary diagnosis is kidney stones. At ER, patient received pain medication, saline hydration drip. The outcome of the events was recovering. The event kidney stones was considered as serious (medically significant). Facility where the most recent COVID-19 vaccine was administered was the Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Follow-up attempts are possible; further information has been requested.
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19 |
2021-06-14 |
urinary incontinence |
Routine covid 19 vaccination using Pfizer requested by patient. All screening questions were answer...
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Routine covid 19 vaccination using Pfizer requested by patient. All screening questions were answered by patient and received the vaccination without incident. Approximately 3 minutes after she received vaccination she came back in the professional services room with her father, as he received his vaccination she complained of becoming dizzy and was told to go have a seat in the waiting area. She was sitting with her mother for another moment and her mom became concerned because the patient urinated on the floor while she was sitting there and seemed to lose consciousness. We responded to the patient who was awake but was extremely pale. Warehouse management was called over and they observed the patient and made the decision to call 911 based on the mother's concern. Paramedics arrived within 10 minutes and recorded very low blood pressure and were concerned she may have had a seizure. The decision was made to take the patient to the hospital because her blood pressure was still remaining low after approximately another 10 minutes. I called the phone number on her immunization consent form the next morning (6/15/21) and again in the evening but was able only to leave a voice mail.
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19 |
2021-06-22 |
urinary retention |
Threw up shortly after second dose, Extremely tired, Unable to eat for days, Lightheaded, Lesions on...
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Threw up shortly after second dose, Extremely tired, Unable to eat for days, Lightheaded, Lesions on vulva. Pain, unable to walk. Pain, unable to use bathroom. Unable to leave bed.
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19 |
2021-07-29 |
pain with urination, urinary tract infection, urinary urgency, blood urine present |
she went to bathroom to pee, it was cloudy and had blood in it; she has pain and has urge; she has p...
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she went to bathroom to pee, it was cloudy and had blood in it; she has pain and has urge; she has pain and has urge; Not able to pee; urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating; urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating; Left arm was swollen at injection site.; This is a spontaneous report from a contactable consumer. A 19-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0198), via an unspecified route of administration, administered in left arm (unable to confirm if given in the muscle) on 12Jul2021 at 20:20 (at the age of 19 years old) as single for covid-19 immunisation. Medical history included ongoing peanut allergy diagnosed when she was 1 year old. Concomitant medication included ethinylestradiol, norethisterone acetate (LOESTRAN), 1 tablet daily in the morning for 28 days for contraception from Jan2021 to an unspecified stop date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive additional vaccines on same date of the Pfizer suspect. She began to be experienced unconfirmed urinary tract infection symptoms including an urge to urinate, blood in her urine and difficulty urinating on 13Jul2021. She asking have this been reported after receiving the Pfizer Covid-19 Vaccine? She just took it two days ago and woke up not being able to pee and peeing blood and stated that it caused a UTI on 13Jul2021. She has never had one before in her life. This happened the night after she got the vaccine and it may be just a coincidence. Her left arm was also swollen and when she went to bathroom to pee, it was cloudy and had blood in it. She knew it had to be the vaccine because she never had that before. A couple of hours after the vaccine she noticed her left arm was swollen at injection site on 12Jul2021 at 22:00. Yesterday morning on 13Jul2021 at 08:00 she was not able to pee. It improved a bit, but she has pain and has urge. It feels like she just has to pee even though she just peed. She googled it and it said it was a UTI. She has not been formally diagnosed yet. She first stated the peeing blood started on 13Jul2021. At around 1:00 am, there was a little bit of blood when she got up to pee. She did not see any this morning, but does not know how it will be throughout the day. It has improved for now. She would like to find out if this has been reported before. The patient did not visit emergency room or physician office. No relevant tests were performed. The outcome of events was she went to bathroom to pee, it was cloudy and had blood in it, she has pain and has urge was unknown, while with other events recovering. Follow-up attempts are completed; no further information is expected.
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20 |
2021-04-20 |
kidney pain, blood urine present |
headache in my eyes so bad i couldn?t open them. terrible nausea that resulted in vomiting at 6:30 A...
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headache in my eyes so bad i couldn?t open them. terrible nausea that resulted in vomiting at 6:30 A.M. the next morning. Internal bleeding in kidneys that resulted in blood and foam in urine - blood cleared in 4 days; foam cleared in 4 days. Back pain where kidneys are located. Shortness of breath when lying down for 3 nights; had to sleep propped up.
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20 |
2021-04-21 |
abnormal urine color |
The first and second day I had pain in the arm, muscle aches. This morning, which is the third day I...
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The first and second day I had pain in the arm, muscle aches. This morning, which is the third day I had red urine.
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20 |
2021-04-23 |
incontinence |
Pfizer covid vaccine was administered to patient at around 2:10pm and was advised to stay in sight f...
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Pfizer covid vaccine was administered to patient at around 2:10pm and was advised to stay in sight for 15 min before leaving the store. At around 2:15pm patient started to faint. Patient was accompanied by her mother. Rph on duty rushed to the scene noticed that patient had lost consciousness and started to have a seizure. I also noticed that the patient had passed urine while unconscious. I notified my technician to call 911. I quickly grabbed an EpiPen and administered one dose into the patient thigh. I assisted the patient along with her mother until the patient regained consciousness. Paramedic arrived to the seen few mins later. They checked all vital signs and patient was responding better and but still exhibiting some tingling effect in her hands. Patient decided not to ride with the paramedics. I advised her to stay for another 30 - 45 min so that I could monitor her. She was feeling much better and was released to go home along with a EpiPen.
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20 |
2021-04-29 |
urinary incontinence |
20 yr old female here to receive her 2nd dose of COVID vaccine. She stated no reactions after 1st do...
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20 yr old female here to receive her 2nd dose of COVID vaccine. She stated no reactions after 1st dose. After receiving dose she went to sit in chair as instructed before leaving. Two minutes later RN was notified by pharmacy staff, pt not feeling well. On approaching, pt was very pale and resting her head on friends chest. RN asked if she was having trouble breathing, she stated "A little." 911 was called and an Epi pen was brought to scene. RN asked if pt wanted to lay down and assisted her to the floor, lifting her legs up on a chair. She was very weak and had urinated on herself. She stated she had not eaten anything today and only had a little water. She was given water but only had a small sip. RN stayed by her side while waiting for paramedics to arrive. Paramedics stated BP was low and took her to Medical Center.
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20 |
2021-05-04 |
kidney failure, blood creatinine increased |
Patient had a clinical illness consistent with MIS-C after the vaccine but also had confirmed COVID ...
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Patient had a clinical illness consistent with MIS-C after the vaccine but also had confirmed COVID infection. Hospitalized in ICU with high fever, rash, cardiomyopathy (myocarditis), renal failure requiring steroids and IVIG.
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20 |
2021-05-27 |
urinary retention |
Was awoken early ~ 16 hours after shot with severe nausea, back pain, hot and and cold chills. Initi...
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Was awoken early ~ 16 hours after shot with severe nausea, back pain, hot and and cold chills. Initially also only able to breathe shallowly, (has since resolved). Unusual sensation in bladder/ genital area. Repeated urge to urinate but unable to, also felt painfully swollen/ engorged in genital area, but no actual redness or swelling. Symptoms are still ongoing at about the same level 48 hours after the shot. Still disinterested in food and feels dehydrated despite trying to ingest fluids.
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20 |
2021-06-17 |
kidney failure |
Symptoms started with tightness of muscles and body aches, tightness of chest, increased blood press...
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Symptoms started with tightness of muscles and body aches, tightness of chest, increased blood pressure, herpes simplex A mouth sores - saw PMD received muscle relaxer, and antibiotic cream... in the 30 days prior to last event she had been having dizzy spells, chills, hot flashes, shortness of breqth, tightness of chest, darkened urine, muscle cramping and knotting, pitting edema, halo discoloration lower right extremity (she wasnt one to complain and thought her symptoms were from use of muscle relaxer) - woke AM 6/11/2021 with severe shortness of breath and was taken to ER - diagnosed with obesity, cardiomegaly, renal failure, severe anemia, hypoxia, and hypokalemia, she went into respiratory distress AM 6/12/2021 and then went into cardiac arrest. She died as a result.
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20 |
2021-06-27 |
frequent urination |
Extremely bad headache, body chills, very painful muscle aches, congested nose, frequent urination. ...
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Extremely bad headache, body chills, very painful muscle aches, congested nose, frequent urination. Symptoms lasted for 24 hours.
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20 |
2021-07-14 |
glomerular filtration rate decreased |
20 Y female with h/o of cardiac transplant in 4/29/20 for HCM with history of early ACR 5/2020 treat...
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20 Y female with h/o of cardiac transplant in 4/29/20 for HCM with history of early ACR 5/2020 treated with rATG and steroids and early CAV 1 (20% mRCA lesion) on prograf and zortress. Admitted on 7/13 with symptoms of chest pain, lower extremity swelling, chest pressure and orthopnea for rule out rejection. Found to be COVID positive on transfer. On 7/13 underwent a EmBx that revealed 1R/1A. Today, on 7/14, patient denies symptoms of chest pain. Due to COVID hospitalization, patient will be given EUA of Casirivimab and Imdevimab intravenous administration prior to discharge. Deemed stable for discharge. HX OF orthotopic heart transplant on 4/29/2020 at with hypertrophic cardiomyopathy - tacrolimus/everolimus/pred immunosuppression -- tac goal 8-10 -- everolimus goal 3-8 -- current prednisone dose 5 mg daily -- RTC in 1 month for OV -- lab work on Friday - OIP: -- CMV: D+/R+- valganciclovir -- Toxo/PCP: TMP/SMZ -- fungal: posaconazole (for 3 months after last rATG ~ 8/22/2020) -CV: on pravastatin - delayed d/t elevated transaminases - osteoporosis: zoledronic acid 5mg 5/11/2020 COVID positive --appreciate ID; Casirivimab and Imdevimab today -isolation precautions
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21 |
2021-01-21 |
frequent urination, urinary tract infection, urinary urgency, pain with urination |
Pfizer-BioNTech COVID-19 Vaccine EUA: Patient received second COVID-19 vaccination in the morning a...
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Pfizer-BioNTech COVID-19 Vaccine EUA: Patient received second COVID-19 vaccination in the morning and overnight developed fever (maximum temperature 103 degrees fahrenheit), body aches, and urinary urgency, frequent urination, and dysuiria. Patient reports fever and body aches after receiving the first vaccination for COVID-19 but did not last as long as they did with the second vaccination. The next day patient presented to urgent care, diagnosed with urinary tract infection, and prescribed antibiotics. At visit with primary care provider six days later all symptoms resolved and no new symptoms reported.
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21 |
2021-04-18 |
urinary incontinence |
WEAKNESS, NAUSEA, VOMITING, SYNCOPE WITH URINARY INCONTINENCE. DESCRIBED FEELING WEAK AND NOT GOOD ...
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WEAKNESS, NAUSEA, VOMITING, SYNCOPE WITH URINARY INCONTINENCE. DESCRIBED FEELING WEAK AND NOT GOOD BEING UP EVERY HOUR WITH NAUSEA. WOKE UP AT 7AM, VOMITED AND PASSED OUT ON BATHROOM FLOOR WITH INCONTINENCE OF URINE. ROOMMATE DESCRIBED SEIZURE LIKE ACTIVITY WHILE PT WAS ON THE FLOOR. PALLOR. DIZZINESS. PT GIVEN 1L NS, CT SCAN AND LABS.
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21 |
2021-04-27 |
pain with urination |
headaches starting after second vaccine persisting til current time, painful urination starting 4/21...
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headaches starting after second vaccine persisting til current time, painful urination starting 4/21 cause not confirmed by doctor
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21 |
2021-06-14 |
urinary tract infection |
12 hours after receiving 2nd dose of Pfizer Covid-19 vaccine, urinary tract infection symptoms showe...
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12 hours after receiving 2nd dose of Pfizer Covid-19 vaccine, urinary tract infection symptoms showed up, in addition to general aches and pains in the legs and lower back. After a 5 day completed course of antibiotics (nitrofurantoin), symptoms of UTI returned
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21 |
2021-06-20 |
renal impairment |
About 3 to 4 hours after vaccine I had a fever and started feeling nauseous eventually started vomit...
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About 3 to 4 hours after vaccine I had a fever and started feeling nauseous eventually started vomiting and that led to a systemic lupus reaction that covered me head to toe in hives. Injected with epinephrine about 16 hours later.
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21 |
2021-06-30 |
urinary tract infection |
Ophthalmology consult was subsequently obtained with diagnosis of acute optic neuritis. First dose o...
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Ophthalmology consult was subsequently obtained with diagnosis of acute optic neuritis. First dose of Pfizer Covid vaccine on 4/22/2021 with onset of symptoms approximately 2 to 3 weeks thereafter. Bilateral vision loss 2/2 optic neuritis that is new. Initially involving only the right eye, transient improvement with Solu-Medrol approximately 1 month prior to admission, but with recurrence and later with development of vision loss in the left eye as well for approximately 1 week prior to admission. Unclear etiology. MS felt less likely with negative oligoclonal bands, NMO antibody negative, though per neuro, still potential for neuromyelitis optica, MOG 1:40. Also consideration that may be a complication of having received COVID-19 vaccine, though relationship remains unclear. 2-3 weeks prior to symptoms patient received vaccine. Short time after was also diagnosed with Mono and UTI. Got IV methylprednisolone of 1 g daily x4 doses without significant improvement. Then required total plasma exchange over 2 weeks, resulted in mild symptom improvement. CDC reports optic neuritis may be related to vaccinations in general (52.4% of cases within 8 weeks of vaccination). No evidence for COVID vaccines at this time. Added Pfizer vaccine to allergy list per neuro recommendations.
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21 |
2021-07-14 |
urinary tract infection |
throwing up the night of the vaccine and multiple times in the following two weeks of my second dose...
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throwing up the night of the vaccine and multiple times in the following two weeks of my second dose, haven't thrown up in over a decade history of UTI's but haven't gotten one in months, got one the week after getting my second dose random body aches in the following two weeks after my second dose
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22 |
2021-01-27 |
blood in urine |
Started with gross hematuria 2 days after the vaccination. This persisted for 4 days.
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22 |
2021-01-27 |
blood in urine |
I was vaccinated with my second vaccine on 1/26/21. This morning, 1/28/21 I started experiencing gro...
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I was vaccinated with my second vaccine on 1/26/21. This morning, 1/28/21 I started experiencing gross hematuria.
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22 |
2021-03-15 |
urinary tract infection, abnormal urine color, blood urine present |
Within minutes of 2nd dose of vaccine, pt started urinating dark brown urine. This turned bloody / ...
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Within minutes of 2nd dose of vaccine, pt started urinating dark brown urine. This turned bloody / dark red in color. Over the next several days she had migraines, fever, nausea, diarrhea. She had a very heavy period that was not normal for her. She was treated twice for presumed UTI (once with macrobid and then with cefuroxime) in the days after the vaccine though cultures ended up negative. She was referred to me, a hematologist, when she was noted to have a dropping hemoglobin and platelet count. She appears to have a Coombs-negative hemolytic anemia and possibly ITP. She is feeling a little better but her labs remain abnormal. Please note this was reported on Pfizer website as well but I have not been contacted. Guidance would be sincerely appreciated. My cell phone was provided.
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22 |
2021-03-27 |
abnormal urine color |
Her Hgb has been dropping from 11.9 06Mar down to 8.3 11Mar; platelets have also dropped down to 59 ...
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Her Hgb has been dropping from 11.9 06Mar down to 8.3 11Mar; platelets have also dropped down to 59 11Mar from 80 on 06Mar; She had a max AST 206 09Mar down to 118 11Mar; ALT 93 10Mar now 86 11Mar; Coombs negative hemolytic anemia; Within minutes of 2nd dose of vaccine, pt had urination of dark brown urine; migraine; fever; nausea; diarrhea; This is a spontaneous report from a contactable physician. A 22-year-old female patient received second dose of BNT162B2 (BNT162B2) intramuscular, administered in Arm Left on 04Mar2021 at 11:30 (Batch/Lot Number: EN6205) as single dose for covid-19 immunization. Medical history included allergic rhinitis. Concomitant medications included ibuprofen (IBUPROFEN), cefuroxime (CEFUROXIME), clarithromycin (MACROBID [CLARITHROMYCIN]), ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE), spironolactone (SPIRONOLACTONE), acetaminophen (ACETAMINOPHEN), ondansetron (ZOFRAN [ONDANSETRON]) and topical tretinoin, oil of oregano, Olly probiotic/prebiotic. The patient received first dose on 11Feb2021 (lot number EL9267), 11:45 AM, Intramuscular to left arm. The patient experienced coombs negative hemolytic anemia (medically significant) on 04Mar2021 at 11:45, within minutes of 2nd dose of vaccine, pt had urination of dark brown urine on 04Mar2021 11:45, migraine on 04Mar2021 11:45, fever on 04Mar2021 11:45, nausea on 04Mar2021 11:45, diarrhea on 04Mar2021 11:45, her hgb has been dropping from 11.9 06Mar down to 8.3 11Mar on 11Mar2021, platelets have also dropped down to 59 11Mar from 80 on 06Mar on 11Mar2021, she had a max ast 206 09Mar down to 118 11Mar on 11Mar2021, alt 93 10Mar now 86 11Mar on 11Mar2021. It was reported that Within minutes of 2nd dose of vaccine, pt had urination of dark brown urine. This turned to dark red/bloody urine. She felt migraine, fever, nausea, diarrhea. She started having a very heavy period which is not normal for her. She was treated twice for presumed UTI but cultures were negative. UA had no RBCs, but Hgb urine was 3+. Her Hgb has been dropping from 11.9 06Mar down to 8.3 11Mar and it appears she has a Coombs negative hemolytic anemia (haptoglobin undetectable). Her platelets have also dropped down to 59 11Mar from 80 on 6Mar. WBC/diff are normal. Her LDH was 2019 10Mar, improved today 1728. Blood smear had no schistocytes, but ADAMTS13 is pending. Her creatinine remains normal and electrolytes are largely normal. She had a max AST 206 9Mar down to 118 11Mar and ALT 93 10Mar now 86 11Mar. Alk phos was 137 mild elev 09Mar, now normal. Her symptoms are slowly improving but she still feels poorly. Several other tests are pending and we are checking daily labs right now. The patient underwent lab tests and procedures which included alanine aminotransferase: 93 (unit unspecified) on 10Mar2021, alanine aminotransferase: 86 (unit unspecified) on 11Mar2021, aspartate aminotransferase: 206 (unit unspecified) on 09Mar2021, aspartate aminotransferase: 118 (unit unspecified) on 11Mar2021, blood alkaline phosphatase: 137 (unit unspecified) on 09Mar2021, blood creatinine: normal on an unspecified date, blood electrolytes: largely normal on an unspecified date, blood lactate dehydrogenase: 2019 (unit unspecified) on 10Mar2021, blood lactate dehydrogenase: 1728 (unit unspecified) on 11Mar2021, haemoglobin: 11.9 (unit unspecified) on 06Mar2021, haemoglobin: 8.3 (unit unspecified) on 11Mar2021, haemoglobin urine: 3+ (unit unspecified) on an unspecified date, adamts-13: with pending results on an unspecified date, platelet count: 80 (unit unspecified) on 06Mar2021, platelet count: 59 (unit unspecified) on 11Mar2021 and WBC: Normal on an unspecified date. Therapeutic measures were taken as a result of the events Coombs negative hemolytic anemia, Within minutes of 2nd dose of vaccine, pt had urination of dark brown urine, Migraine, Fever, Nausea, Diarrhea, Her Hgb has been dropping from 11.9 06Mar down to 8.3 11Mar, She had a max AST 206 09Mar down to 118 11Mar and ALT 93 10Mar now 86 11Mar. Outcome of all the events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of Coombs negative hemolytic anemia and other events due to temporal relationship. However, the reported events may possibly represent intercurrent medical conditions in this patient. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is 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.
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22 |
2021-05-04 |
blood urine present, urinary tract infection, abnormal urine color |
platelets have also dropped down; Hgb has been dropping from 11.9 on 06Mar2021 down to 8.3 on 11Mar2...
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platelets have also dropped down; Hgb has been dropping from 11.9 on 06Mar2021 down to 8.3 on 11Mar2021; LDH was 2019; Alk phos was 137 mild elevated; felt poorly; AST 206 on 09Mar2021 down to 118 on 11Mar2021; red/bloody urine; red/bloody urine; migraine; Fever; nausea; diarrhea; very heavy period; Coombs negative hemolytic anemia; Hgb urine was 3+; presumed UTI; This is a spontaneous report from a contactable physician. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), second dose intramuscular, administered in the left arm on 04Mar2021 11:30 (lot number: EN6205) as single dose (at the age of 22-years-old) for COVID-19 immunisation. Medical history included rhinitis allergic. The patient has no known allergies. Concomitant medications included ibuprofen; cefuroxime; clarithromycin (MACROBID [CLARITHROMYCIN]); ethinylestradiol, ferrous fumarate, norethisterone acetate (JUNEL FE); spironolactone; acetaminophen; origanum minutiflorum oil (OREGANO OIL); tretinoin; ondansetron (ZOFRAN [ONDANSETRON]) and "Olly probiotic/prebiotic"; all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of BNT162B2, intramuscular on the left arm on 11Feb2021 11:45 (lot number: EL9267) for COVID-19 immunisation at the age of 22-years-old. The patient did not have other vaccine in four weeks. The events started on 04Mar2021 at 11:45. Within minutes of second dose of vaccine, the patient had urination of dark brown urine. This turned to dark red/bloody urine. She felt migraine, fever, nausea, diarrhea. She started having a very heavy period which was not normal for her. She was treated twice for presumed UTI but cultures were negative. UA had no RBCs, but Hgb urine was 3+. Her Hgb has been dropping from 11.9 on 06Mar2021 down to 8.3 on 11Mar2021 and it appeared she has a Coombs negative hemolytic anemia (haptoglobin undetectable). Her platelets have also dropped down to 59 on 11Mar2021 from 80 on 06Mar2021. WBC/diff are normal. LDH was 2019 on 10Mar2021 and improved to 1728 on 11Mar2021. Blood smear had no schistocytes, but ADAMTS13 was pending (unknown results). Her creatinine remains normal and electrolytes were largely normal. She had max AST 206 on 09Mar2021 down to 118 on 11Mar2021. Alk phos was 137 mild elevated on 09Mar2021 and was now normal. Her symptoms were slowly improving but she still felt poorly. Several other tests were pending, and they were checking daily labs. The adverse events resulted in a clinic visit and a visit to the emergency room. The patient received unspecified antibiotics twice for presumed UTI, ER visit gave fluids, Tylenol and Zofran ODT. The patient had no covid prior to vaccination. The patient was not covid tested post vaccination. The patient has not recovered from the events.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events coombs negative haemolytic anaemia and aspartate aminotransferase increased and the suspect drug BNT162B2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
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22 |
2021-05-20 |
blood in urine |
Gross Hematuria
|
22 |
2021-07-03 |
urinary tract infection |
Chest pain, upper back pain, shortness of breath, O2 at 90% on room air, pain radiating from injecti...
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Chest pain, upper back pain, shortness of breath, O2 at 90% on room air, pain radiating from injection site down arm, headache, pain down left side of neck, nausea, UTI, rash
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22 |
2021-07-11 |
blood urine present |
Sore swollen arm, back and knee pain, symptoms of UTI, light bleeding in urine.
|
22 |
2021-07-27 |
urinary retention |
I began to have paresthesias in my lower extremities, which progressed to saddle anesthesia over abo...
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I began to have paresthesias in my lower extremities, which progressed to saddle anesthesia over about a week?s time. I then developed acute urinary retention. I could also not have a bowel movement at that time. In the ER, I was cathed and they also performed an enema, believing I was constipated but nothing came out, leading me to believe that it was a loss of nerve function. They also performed an emergency MRI which showed no nerve compression (ruling out cauda equina syndrome). I left because I believed I could urinate at home. I was not able to urinate until mid morning the next day. After this, I was seen by a neurologist who believed I may have multiple sclerosis. However, my work up came back negative. At the same time, the paresthesias continued to ascend into my hands and I could not sit due to overwhelming pain and saddle anesthesia/LE parenthesis. As this began to resolve, I woke up from sleep multiple times in a row for 3 nights gasping for air because I stopped breathing spontaneously (even with sitting up and changing positions). I recovered after this symptom resolved and have been completely fine since. I am a PA student and I truly believe that I had a Guillian Barre type reaction to the vaccine.
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23 |
2021-01-06 |
abnormal urine color |
Neon yellow urine.
|
23 |
2021-01-06 |
frequent urination, abnormal urine color |
Fatigue and overall lethargic feeling/Sore throat; Dark colored urine despite pushing fluids; Freque...
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Fatigue and overall lethargic feeling/Sore throat; Dark colored urine despite pushing fluids; Frequent urination; Migraine; Swollen joints and could not move arm that received vaccine in; Swollen joints and could not move arm that received vaccine in; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Stomach pains, nausea, diarrhea, swollen lymph nodes; Chills, body aches, spiked fever of 102.; Chills, body aches, spiked fever of 102.; Chills, body aches, spiked fever of 102.; Fatigue and overall lethargic feeling; Fatigue and overall lethargic feeling; Sore throat; The initial case was missing the following minimum criteria: Invalid for no adverse effect. Upon receipt of follow-up information on (31Dec2020), this case now contains all required information to be considered valid. This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EH9899, Expiry Date: Mar2021), intramuscular at Deltoid Left on 29Dec2020 07:20 at single dose for COVID-19 immunization. Medical history included covid-19 from Nov2020 to an unknown date (had covid in the middle of November), surgeries from an unknown date and unknown if ongoing (She also had previous surgeries and has foreign objects in her body. Those areas were super hot. Those antibodies were like rejecting those foreign bodies because they were super hot.) There were no concomitant medications. Received call from RN calling about the Pfizer COVID vaccine. She got the vaccine on Tuesday and had a terrible reaction to it and she called a couple of different hotlines and spoke with the people who administered it. She confirmed that she did not report to Pfizer though. The people at her work that she spoke with told her to go to an Urgent care. They told her she should not get it within 90 days of having COVID. She had COVID in the middle of Nov2020. She went ahead and got it on Tuesday and had this terrible reaction. She would like to know if she should get the second dose or wait until 90 days after she had COVID and start again. There was no prescriber. She received it as part of the (hospital name withheld) front line health worker precaution. She thought that this was a normal reaction, but was told it was not. Fatigue and overall lethargic feeling happened exactly 12 hours after receiving. She works night shift and that is her base line. Pretty much everything hit after that within an hour. She was told low grade fever was normal, but not 102. She never spikes fevers, so it is medically significant. It persisted for 24 hours and is better today. She is on the 48 hour mark now. Stomach pains, nausea, diarrhea, lymph node swelling all over, including swelled armpits and groin area, Migraine, Frequent urination, were also listed as side effects. She was trying to push more fluids but her urine was dark color more than normal, despite pushing fluids. Swollen lymph nodes in her groin and armpits were concerning. Her head is lumpy. Meaning, she can feel swollen lymph nodes in back of neck area. Migraine was consistent through 24 hours and now has improved. Urine color remains dark and she will keep an eye on color. She had swollen joints, but really terrible swollen joints, and she could not move the arm that she got the vaccine in. She could not lift to above shoulder height. AE Details and time of onset: Sore Throat 12:00 on 29 Fatigue and overall lethargic feeling 20:00 Chills, body aches, spiked fever of 102: 21:00 Stomach pains, nausea, diarrhea, swollen lymph nodes- 21:00 Migraine- 21:00 Frequent Urination 23:00 Dark colored urine despite pushing fluids 23:00 Swollen joints and could not move arm that received vaccine in: 21:00. ER or physician's office required: Went to urgent care 36 hours after administration. No treatment given. She just wanted to make sure no additional infection was causing anything weird. All test were negative. Prior Vaccinations (within 4 weeks): none. Events Swollen joints and could not move arm that received vaccine in, Stomach pains, nausea, diarrhea, swollen lymph nodes, Chills, body aches, spiked fever of 102 were serious with criteria of medically significant, while the other events were non-serious. The outcome of the event Fatigue and overall lethargic feeling/Sore throat (Condition worsened) was unknown, the outcome of the events Swollen joints and could not move arm that received vaccine in, Chills, body aches, spiked fever of 102., Migraine, Dark colored urine despite pushing fluids, Frequent urination was recovering, while the outcome of the other events was not resolved.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported events due to temporal association. 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.
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23 |
2021-01-24 |
frequent urination |
1/8/21 evening: arm swelling (baseball-size circumference surrounding vaccination site), onset of fa...
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1/8/21 evening: arm swelling (baseball-size circumference surrounding vaccination site), onset of fatigue 1/9/21 morning: onset of dehydration, worsening of arm soreness (limited ROM) 1/9/21 evening: fever--onset near 10PM (unsure of highest temp. Temp after 400 mg ibuprofen: 99.6 F. Fever broke after 3AM.), body aches (mild-moderate in both arms, all fingers, back, and both knee 1/10/21 evening: shortness of breath/coughing fits (required use of inhaler--3 puffs with symptom onset. Mild shortness of breath for remainder of day w/o need for inhaler), mild altered taste (only lasted approx.2-3 hours) 1/11/21: onset of arm itchiness surrounding site of vaccination, frequent urination (at least every hour) 1/12/21: worsening of arm itchiness (itches from shoulder to elbow), ROM improving at this point but still painful to touch 1/13/21 morning: worsening of dehydration (back pain, headaches, muscle cramps), arm itchiness improving at this point 1/13/21 evening: urination frequency returning to normal, back aches (from dehydration, less severe than morning), headaches continuing (less pain with ibuprofin, but on/off pain still present), nausea improving at this point 1/13-1/14: late start to menstrual cycle 1/14/21: most symptoms improving at this point, headaches and nausea still mild 1/19/21: first full day with no nausea 1/21/21: first full day with no headaches 1/22/21: symptom-free
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23 |
2021-02-28 |
urinary incontinence |
Within 10 minutes of receiving the vaccine, developed "blackening" vision and then lost consciousnes...
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Within 10 minutes of receiving the vaccine, developed "blackening" vision and then lost consciousness. Uncertain about time of loss of consciousness. Other symptoms included pallor, fast heart rate, sweating, nausea and loss of bladder function. No treatment required, seen in the ED and recovered without treatment. Because she was driving a car at the time, she rear-ended the car in front of her and the airbags deployed. Underwent evaluation for motor vehicle accident as well in the ED with no injuries noted.
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23 |
2021-03-02 |
blood creatinine increased |
Complaints of numbness to hands from knees down bilaterally after Covid vaccine. No shortness of bre...
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Complaints of numbness to hands from knees down bilaterally after Covid vaccine. No shortness of breath. Itching left side of cheek- mild throat tightness. Received Benadryl P.O. 25 mg and Decadron 10 mg P.O. Observed for 2 hours ? no reoccurrence of symptoms.
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23 |
2021-05-05 |
incontinence |
Patient reports, "On April 3rd, 2021 I experienced numbness and tingling of the left and right arm l...
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Patient reports, "On April 3rd, 2021 I experienced numbness and tingling of the left and right arm lasting about 2 hours. This occurred at about noon." Beginning on 4/11/21 patient reports experience balance impairment, loss of feeling in her toes, and weakness in her arms. She recently has began experiencing diarrhea and incontinence. These symptoms starting on 4/11/21 have not resolved. Client saw her Chiropractor on 4/13/21 and was recommended that she see a medical professional and report her symptoms to the Health Department. Patient is currently looking to find a provider.
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23 |
2021-05-28 |
kidney pain |
started to have hives all over her body, extra over in chest and stomach area; It was so kind of itc...
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started to have hives all over her body, extra over in chest and stomach area; It was so kind of itching this morning; Had little pain in side and they had been run for kidney; whole body ache mostly like her joints specially in her hips an her knee; she was groggy almost like entire day , sinus thing was going on; she was groggy almost like entire day , sinus thing was going on; her lymph node on her left arm was very swollen like for three days and before it finally went away; This is a spontaneous report from a contactable consumer (patient). This case is for 2nd dose. This case is split from AER# 2021552445 (BNT162B2, 1st dose). A 23-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0167), at the age of 23-year-old, via an unspecified route of administration, administered in Arm Left on 09May2021 at single dose for COVID-19 immunisation. Medical history included dormant asthma when she was kid. The patient received unspecified concomitant medications for birth control. The patient previously received the first dose of BNT162B2 (Lot number: EW0169), at the age of 23-year-old, via an unspecified route of administration, administered in Arm Left, on 18Apr2021 for COVID-19 immunization. The patient reported that she had been having some vaccine reaction she believed, but she went to the doctor today and they believed it to an environmental reaction but, she got the vaccine on Sunday, the evening before around 11 pm, she started to have hives all over her body, extra over in chest and stomach area and then she called registered doctor provider. They told me to take antihistamine so, took two diphenhydramine hydrochloride (BENADRYL) and the last night around 11 o' clock it came back still like around 24 hours and she took couple of more diphenhydramine hydrochloride (BENADRYL) and it was so kind of itching this morning, she took one more, but she was concern she went to the doctor, they said she reported these kind of symptoms. She had like reaction before (further clarification unknown) but this probably the most severe but she didn't believe that was an environmental was just the correlation between she getting the vaccine. Today when she went to the doctor, she had little pain in side and they had been run for kidney but like she didn't know that's the most recent one but she had other lab test in the past. She couldn't possible giving. It was reported that the diphenhydramine hydrochloride (BENADRYL) had made the hives go away but they usually like came back later in the night (further clarification unknown). The patient also received cetirizine hydrochloride (ZYRTEC) for the events. Consumer added, "they have since gone away but she had more symptoms day after when she received the vaccine. The day after woke up with whole body ache mostly like her joints specially in her hips an her knee and she was groggy almost like entire day , sinus thing was going on and her lymph node on her left arm was very swollen like for three days and before it finally went away." Event onset date was May2021. Treatment received for the events. The events resulted in Physician Office Visit. The outcome of the event hives was unknown, of the event swollen lymph nodes was recovered in May2021, of other remain events was recovering.
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23 |
2021-06-24 |
urinary incontinence |
Pfizer-BioNTech COVID-10 Vaccine EUA. Patient came to vaccine clinic. Patient told vaccinator that ...
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Pfizer-BioNTech COVID-10 Vaccine EUA. Patient came to vaccine clinic. Patient told vaccinator that she has a history of passing out with needles. Vaccinator administered the vaccine, patient was doing well and moved to the monitoring area. Patient was sitting in a chair for 15 minute observation period. She began to have soreness to arm about 5 minutes after sitting down then began to feel lightheaded and immediately had syncopal episode. Staff was present and reported legs shaking and loss of bladder during episode. Patient was lowered to the ground and Rapid Response was contacted. Patient was taken to KU ED.
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23 |
2021-06-28 |
urinary tract infection |
Minutes right after the vaccination, I had burning in my left eye, like a nerve in my head burning. ...
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Minutes right after the vaccination, I had burning in my left eye, like a nerve in my head burning. I was offered Tylenol by the pharmacist, which I denied. When I stood up, I got really light headed. I went back to work anyways and the symptoms lasted for 2 hours. I came home and noticed my left butt cheek started to ache and feel sore. I did not take any medications. I went to bed and woke up with full blown flu like symptoms- extremely weak, fatigued, body aches and soreness, muscle stiffness, headache, intermitten light headedness, and left eye could not focus properly. These symptoms lasted for about 24 hours and most went away, however I was still unable to focus with my left eye. On 6/5/2021 I had a very bad explosive severe headache, I had loss of balance, loss of vision in left eye and could not speak coherently and decided to go to the ER. In the car en route to ER, I felt like I was paralyzed and could not move. I was diagnosed with migraines, given a RX for Compazine, and to follow up with the PCP. I went to the doctor on 6/7/2021 with extreme fatigue, difficulty walking and balance, light headed and left eye focusing issues. I was referred to an opthamologist. On 6/8/2021 I went to the opthamologist and had an eye exam and retinal screening and was referred to a better hospital. On 6/9/2021 I went to a hospital to be seen by an opthamologist and neurologist and I did lots of blood work, an MRI of my head, neck and brain which showed my optic nerve was swelling and causing my brain to swell as well. I was diagnosed with inflammation of the optic nerve. I am being followed up by the neurologist. I have been having intermitten episodes of severe headaches and would have body paralysis for about 30 minutes and it would go away. I am having these episodes about once a week. Every time I have an episode, I would go see my doctor who would run more tests. I have been tested for epilepsy which is negative.
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24 |
2021-01-21 |
blood urine present, abnormal urine color |
15 hours after vaccine administration pt experienced sore arm, body aches, feeling feverish (did not...
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15 hours after vaccine administration pt experienced sore arm, body aches, feeling feverish (did not check temp) and feeling generally quite unwell. This improved approximately 11 hours after it started. 12 hours later she noted cola colored urine. Was evaluated today and urine improving in color and now a light pink color. Urine positive for protein and blood. Menses did finish a few days ago. CBC, CMP, ESR results pending.
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24 |
2021-03-25 |
blood urine present |
Blood in urine, period came three weeks early
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24 |
2021-05-23 |
urinary tract infection |
Within 20 minutes I felt like I couldn?t breathe my whole body went numb and I felt like I was gonna...
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Within 20 minutes I felt like I couldn?t breathe my whole body went numb and I felt like I was gonna pass out. I had chills, cough, nausea, body aches, loss of appetite , shortness of breath , accelerated heart, and chest pain. Since the day of the vaccine I have been struggling with my physical and mental health. I?ve been in and out of hospitals, doctors, specialist.
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25 |
2021-03-04 |
blood urine present |
I made sure to hydrate and eat well the day of the vaccine. I have had no allergic reactions to any ...
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I made sure to hydrate and eat well the day of the vaccine. I have had no allergic reactions to any medications/ injections in the past and I was not worried about this one. I didn't take any meds beforehand besides my normal morning modafinil. I have no fear of needles. I received the vaccine in the auditorium about 1:25pm. The RN did a fantastic job, went through all of the information, no pain at all with the injection. As I was sitting in my chair for monitoring, a few minutes in I began to feel very uncomfortable. I felt clammy/sweaty and kept shifting my weight in my seat. I didn't want to make a big deal of it at first because I worried it was all in my head. But I became more and more uncomfortable. I laid my head down on the little desk, no help. I closed my eyes, no help. About 10 minutes or so in I decided to ask if they had water available. I slowly got up and walked to the back of the room. I couldn't even get the question out of my mouth before the nurse told me to sit down. Apparently I was white as a ghost. They got a wheelchair and wheeled me to the space behind the auditorium. By then I was starting to feel like my throat was closing and I saw spots in my peripheral vision. It was kind of a blur from there. I tried to take deep breaths. I drank a few sips of water and poured some on a paper towel to wet my forehead (and spilled all over my lap because I was a little disoriented at this point). My BP was 60s/40s and then 60s/30s. A rapid response was called. They moved me to a cart flat on my back with my legs elevated. My fingers and toes were starting to go numb and my lips were apparently blue/ white. After laying for a few minutes in Trendelenburg my BP began to resolve and my breathing started to ease a bit. No further intervention was done by the rapid team. I was taken by the Rapid RN to the ED for monitoring. They eventually pushed the cart into a room and took some vitals and an EKG. They had me stand and move to a wheelchair. I felt horrible but improved from before. They had me sit in a wheelchair in the lobby for a few hours before taking me back and placing an IV and drawing labs (I believe it was 3 hours from the initial reaction). I gave a urine sample. They then put me in a wheelchair and wheeled me back into the lobby for some more time. Then, they wheeled me back to a room where they gave some lactated ringers and a PA and MD saw me. By then my BP and breathing was completely resolved. The MD said he wasn't fully convinced it was just a vasovagal episode because I haven't had issues with vaccines in the past and I was well hydrated and my HR was normal. It partly fit the picture for an allergic reaction/ severe immune response d/t the feeling of throat closing, the BP drop, and the elevated WBCs. They advised that I list the vaccine as an allergy and do not get the second dose, especially since I had COVID back in September.
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25 |
2021-05-10 |
urinary tract infection, frequent urination |
UTI symptoms and frequent urgency starting day after shot
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25 |
2021-05-17 |
urinary tract infection |
Presented to ED today with complaint of emesis onset this morning. Pt received her second dose of he...
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Presented to ED today with complaint of emesis onset this morning. Pt received her second dose of her Covid vaccine on 5/3. Endorses hx of DKA. Denies hitting head, fever, cough, dysuria, nausea, dizziness. She is initially called a sepsis alert secondary to SIRS criteria although I do not think she likely is septic as she has no other illness symptoms but rather either DKA or dehydration from vomiting from viral illness or her history of gastroparesis. Patient was treated with Benadryl Reglan fluid bolus Rocephin as part of the sepsis protocol and has had improvement in condition. The patient is given IV fluids along with antibiotics for what appears to be a UTI. She will be admitted to the CDU for ongoing observation and management of her blood sugar as well as her mental status. She has Reglan and Zofran at home but was given refills. She has follow-up with gastro.
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25 |
2021-06-20 |
blood in urine, blood urine present |
Gross hematuria 4 hours after the second shot of covid vaccine. Called pharmacy, they told me it?s n...
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Gross hematuria 4 hours after the second shot of covid vaccine. Called pharmacy, they told me it?s not related. But I did not change my habit at all. Went to doctor, they found blood and protein in my urine. The blood was visible for the next 3 days. Urine was sent for culture. Came back clean. 3 week prior, had physical penal done, bodily functions were in great shape. Last November I ever had ultrasound on my kidneys, nothing came back. I was sent to urologist,, blood was still present then. Then sent to Prime Diagnostic for CT scan. Waiting to hear back for that result.
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25 |
2021-07-21 |
urinary tract infection |
Fever for 2 days; Muscle ache only on the left side; Headache; Sudden UTI; This is a spontaneous rep...
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Fever for 2 days; Muscle ache only on the left side; Headache; Sudden UTI; This is a spontaneous report from a non-contactable other healthcare professional (patient). A 25-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0180 and expiration date was not reported), via unknown route administered on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization (Age at vaccination 25 years). The patient medical history included COVID-19 and concomitant medication was not reported. The patient was not pregnant at the vaccination time. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 03JUL2021, the patient experienced headache, fever for 2 days, sudden urinary tract infection and muscle ache only on the left side. The patient was not received any treatment for adverse event. The patient had COVID test post vaccination Nasal Swab and COVID test result was Negative. The outcome of event fever was recovered on an Jul2021 and headache, urinary tract infection and muscle ache was recovering., No follow-up attempts are possible. No further information is expected.
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25 |
2021-07-27 |
kidney pain |
has terrible pressure on her spine.; inflammation of spine; Difficulty breathing, no throat closing;...
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has terrible pressure on her spine.; inflammation of spine; Difficulty breathing, no throat closing; Coughing; Kidney pain; Tiredness; Muscle pain; Headache; injection site really, really sore; slept most of time; This is a spontaneous report from a contactable consumer. This consumer (patient friend) reported for a 25-year-old female patient that: A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EW0177 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm right on 19May2021 17:30 (age at vaccination was 25-year-old) as single dose for covid-19 immunisation. Medical history included attention deficit hyperactivity disorder from an unknown date and unknown if ongoing. concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for attention deficit hyperactivity disorder/ for mental health, 30mg, 1 tablet by mouth twice daily, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior or the same day and no problems with the vaccines in past. On 19May2021, it was reported on behalf of his friend, who got the first Pfizer BionTech vaccine yesterday and since then has been having most of the symptoms read about but had one that was not heard of. Has had terrible pressure on the lower spine, it feels like she got an epidural. Clarifies most symptoms patient experienced as inflammation of the spine, difficulty breathing, but no throat closing, more coughing, kidney pain, tiredness, muscle pains, headache, and the inject site was really really sore. When she first got it she was kind of tired and slept most of the time afterwards and this morning the spine pressure/inflammation started getting worse and worse as time goes by. Everything has gotten worsened. The patient did not visit Emergency Room and Physician Office. The outcome of the events was not recovered. Follow up needed, further information has been requested.
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