Pfizer

Pfizer COVID Vaccine; ADR developed after 5 min. Patient became lightheaded and developed tunnel vision. Had a witnessed syncopal event in her car. Unconcious x1 min, had urinary incontinence, and vomited; Not postictal; developed episode of tunnel vision few hours after 1st dose as well

26 y.o. female with a copper IUD who received second dose of Pfizer vaccine. Developed vomiting, myalgia, and fever next day. These symptoms resolved but then developed pink colored hematuria two days post vaccine, and was seen in clinic that day. Urine sample collected with 4-10 RBCs and moderate amount of blood found from lab. Last menses two weeks ago. She did have similar issues years ago, but past lab results were not available. Was referred to urology.

RECEIVED 1ST DOSE OF PFIZER COVID-19 VACCINE ON 02/11/21. ON 02/18/21 WENT FOR BURNING WITH URINATION AND DIAGNOSED WITH ACUTE UTI. ON 2/19/21 CALL REQUESTING CHANGE IN ANTIBIOTIC FOR UTI. LATER ON MESSAGE SENT ABOUT URINE CULTURE SUGGESTING NOT A TRUE UTI. ON 02/21/21 WENT ER COMPLAINING OF DYSURIA, RT FLANK & BACK PAIN. DIAGNOSED WITH LOWER ABDOMINAL AND CVA PAIN AND INSTRUCTED TO FOLLOW UP WITH UROLOGY.

I was 34 weeks at the time of vaccination. Initially, I only had pain at the injection site. I woke up the next day with diarrhea that lasted about 6 days. I had no other symptoms besides dehydration and back pain. On Day 3, I was instructed to take Imodium, which I took for about 2 days, but it didn't help. Around Day 5, I was given fluids, my urine was tested and multiple GI tests were run. I was placed on antibiotics for a UTI. PVCs were also discovered at visit, but it's not connected to the vaccine.

Friend in vehicle stated participant briefly lost consciousness, when awoke was lethargic; incontinent of urine; B/P 90/60, pulse ox 98% Denise hx. of seizures ; EMS assessed participant; participant refused to go to E.D. with EMS, however, stated would have boyfriend take her to E.D. In f/u phone call, stated had lab work done on E.D. and fluids administered, and released home with no further issues.

Nurse administered vaccination 1 min. later or less, client had face in steering wheel, passed out and urinating on herself. Client stated she thinks this happened because of the anxiety of getting vaccine. Client given ammonia inhaler and stabilized awaiting EMS arrival.

Urinary tract infection. Pain in bladder area and burning sensation while urinating. Frequent urge to urinate. Contacted telehealth for treatment.

UTI progressing to kidney infection (burning with urination, increased frequency of urination, back pain), progressively worsening from Saturday until 1.5 days after beginning antibiotics.

Body aches, pains and chills - 12 hours after vaccine until 24 hours after Lower back pain, numb sensation in rectum and genitals - 36 hours after vaccination Formation of genital ulcers on inner labia - 48 hours after vaccination Inflammation and irritation of genital ulcers - 48 hours after vaccination Pain urinating - 48 hours after vaccination

Almost 3 weeks after vaccine, experienced heavier and more painful than normal menstrual cycle. Suddenly developed a server UTI with high fever (102.8 highest), body/back aches and pains, extreme fatigue and nausea.

Jaundice of skin and eyes, symptoms of anemia (shortness of breath, extremity tingling, difficulty exercising), dark urine, yellow tinged stool, yellow tinged body fluids, shortened menstruation. Physically noticed symptoms in early February 2021. Symptoms did not improve so scheduled a clinic visit. Lab tests revealed critical low H&H with no signs of hepatic malfunction or disease. ER visit and consultation with hematologist pointed to diagnosis of Warm Autoimmune Hemolytic Anemia. No family history of autoimmune disease, no previous history of condition, no previous cancer, no prescription medication. Suspect that the vaccine caused condition. Current treatment is high dose prednisone. Treatment ongoing.

I started experiencing urinary pain and abdominal cramping. I went to urgent care and they said it was a UTI.

At first I had a headache and nausea. I was trying to concentrate on work, I felt tired and dizzy, and My headache was really bad. i left work early. When I got home I had body aches, I couldn't eat because of nausea. I developed fever of 102 and chills, It flared up my RA whole body hurt to move, tingling all over it hurt to even blink my eyes. It hurt to pee. I developed vertigo. On the third I went to work still had headache, body aches, and nausea. It it took a week for me to feel better.

Body aches in arm, back and pelvic area. Fatigue and body weakness after first vaccine for two days. Diarrhea, stomach discomfort, mild fever and body aches after second vaccine. Month following adverse reaction to vaccine, new allergies to food and products, GERD, diarrhea, mild fever, fatigue, dehydration and body ache at vaccine sites on arms. Diarrhea was continuous during the months of April, May and June as a result to certain food. Specific food was eliminated from diet. Such as carrots, broccoli and egg. Diet consisted of fruit smoothies, turkey/ham with crackers and steak tacos. In continuation, body aches/pains and shortness of breath developed as a result to certain food. New diet restrictions were placed in accordance to food allergy test that showed new food allergies. Constipation was treated after using bismuth. Treatment for GERD, body aches/pains, mild fever, allergies, dehydration, UTI: pantoprazole, Tylenol, allergy liquid medication, antibiotic, IV and cranberry D-mannose.

Fifteen minutes following injection, the left arm broke out in hives and had numbness and tingling. Then I became dizzy and pale. I was laid down and vital signs were taken. My heart rate was in the 110s and 120s and stayed elevated for about four hours. The hives resolved and did not spread to the bilateral arm or anywhere else. The following two days I felt incredibly weak and had urinary frequency. I was told to go to the hospital by the health clinic staff but I declined.

Injection sight and left arm pain started immediately. Nausea started around 10:20am, increasing as time passed, started hot flashes , cold flashes and shakes around 11am, right kidney (?) area on back started to hurt around 11:30am pain increasing as well. All persistent until about 5:30pm where the kidney (?) pain subdued followed by the hot and cold flashes around 7pm. Nausea and shakes passed by 1/30/21 am after I woke up. Full Left arm pain continued all day 1/30/21.

Rash to face started 2/9/21 evening incontinence of urine, 2/9/21 overnight nausea, stomach pain 2/8/21 daytime/afternoon

Fever, headaches, tiredness, muscle pain, pain in general, lower back pain and urine of like pink color. Symptoms started with tiredness in general followed by fever. The treatment has been resting, hydrating myself and acetaminophen 1000 mg every 6 hours. I then lowered it to 500 mg every 4 hours. Fever has diminished but the symptom that worries me the most is the color pink on my urine.

Exactly 14 minutes after injection, felt dizzy and nauseous. Fainted, had convulsive syncope for 1 minute, lost voluntary control of bodily function (urinated), woke up, and vomited multiple times. Vomiting lasted from 10:35am - 1:10pm. Also had diarrhea twice in between vomiting, and was shaking occasionally.

I began having extreme thirst around 3pm on Tuesday 3/16. I have drank multiple glasses of water and with little to no relief. It seems to have gotten worse as the day went on. I have also been experiencing frequent urination and fatigue.

Had fever x 1 day, cough, body aches, fatigue, vomiting with first vaccine Had fever x 6 days, cough, body aches, fatigue, diarrhea, vomiting, chills with second vaccine. Also had incontinence (urine & feces) for first 3 days after vaccine. Had arm swelling in axilla that began 3 days after vaccine (same side as vaccine). Continues currently, Not painful or red. Also realized after reported illness after 2nd dose that her doses were timed at 13 days apart, not the recommended 19-42 days.

Sudden hematuria that appeared sometime 12-24 hours after receiving my second dose of the vaccine. Urine output seemed normal, but color was pink and orange. Urine remained pink and/or orange on Saturday (March 20) and all day Sunday (March 21) and persisted until Monday mid-morning. Color completely returned to a more normal color and all apparent symptoms were resolved by Wednesday. There was no flank pain or pain with urination at any point during the time course of these symptoms.

Bladder infection and bacterial vaginosis likely unrelated to vaccine. 29 weeks pregnant at time of shot one, almost 30 and 5 days pregnant during visit involving infection. Recovered from infection with antibiotics

Intense kidney pain. I could barely walk or sit. Lasted 10am-9pm the day after I got the 2nd dose of the vaccine. I also had diarrhea, stomach cramping, and joint pain in my knees but I think those are more common.

Chills, body aches, fever, headache - treated with ibuprofen, self-resolved within 32 hours. Blood in urine - did not self-resolve, went to primary care physician office on 03/19/2021

3/18: Chest pain. It woke me up in the middle of the night with some dizziness. At first, I disregarded it, then I tried falling asleep again, but I was jolted awake again with worse symptoms - vertigo, palpitations. I measured my HR, it was all over the place and irregular. Went to the ER, they didnt find anything substantial on my EKG other than arrhythmia with short PR. No treatment was given, instructed to follow up with PCP. Left ER between 4AM-5AM. Was able to go back to sleep, but the chest pain woke me up around 7 AM. The chest pain remained fairly constant with severity changing throughout the day. Symptoms were worse at night and more: inability to sleep, sometimes restlessness - the need to move, increased chest pain/tightness/burning, palpitations. Saw PCP on 3/19, she didnt have any of the lab results, but prescribed metoprolol - this medication was misunderstood as to when I was supposed to take it, therefore didnt start it until another visit that I had with my PCP on 3/22. Over the weekend, I took some ibuprofen to try to lessen the chest pain, it helped a little bit but not for long. Began taking metoprolol 3/22. I didnt sleep more than 2-3 hrs from 3/18-3/22

UTI symptoms began rapidly around 5:30am with mild blood in urine. Treating with AZO maximum strength 95mg 3x a day until symptoms have improved.

INTENSE PAIN AND FLU-LIKE SYMPTOMS AFTER 12 HOURS, BUT ALSO EXPERIENCED UTI AND YEAST INFECTION LESS THAN TWO WEEKS AFTER SECOND DOSE, CLEARED WITH MEDICATION PRESCRIPTIONS.

tongue and lip tingling then swelling sweaty palms nausea bladder and fecal incontinence black out/ loss of vision vision coughing labored breathing complete throat swelling burning all over resulted in epi pen usage then admitted to the emergency room

pregnancy test on 31Jan and was positive; pain in every joint; increasing pain all over body; Elevated liver enzymes; low WBC; UTI symptoms; blood in urine; not felt well; This is a spontaneous report from a contactable nurse (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 28 years of age), dose 1 intramuscular, administered in arm left on 19Jan2021 18:00 (Batch/Lot Number: EL3248) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy. Concomitant medication included vitamin d3 (VITAMIN D3), vitamin b complex (VITAMIN B COMPLEX) and prenatal vitamins which the patient received with 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was pregnant. It was reported that after receiving vaccine, the patient had not felt well on 20Jan2021. She went into urgent care on Saturday 23Jan2021 for UTI symptoms. She had blood in urine, went to primary care appointment on 27Jan2021 had more blood in urine per urinalysis. She went into the emergency room for increasing pain all over body. CT scan was done, lab work done (both unknown results). She had elevated liver enzymes, low WBC, blood in urine on 28Jan2021. She had extreme pain all over body, pain in every joint on 29Jan2021, was essentially bed bound through 31Jan2021. She took at home pregnancy test on 31Jan2021 and was positive. She was also prescribed MACROBID for UTI from the urgent care, completed the course per primary physician- even though no UTI was determined- just blood in urine. The patient underwent lab tests and procedures which included urine analysis: blood in urine on 23Jan2021, more blood in urine on 27Jan2021 and blood in urine on 28Jan2021; hepatic enzyme increased on 28Jan2021; and white blood cell count: low on 28Jan2021. Therapeutic measures were taken as a result of uti symptoms (urinary tract infection). She was tested for SARS-CoV-1 test through nasal swab on 29Jan2021 with negative result. The events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Therapeutic measure was taken as a result of UTI and no treatment received from other events. The events are reported non-serious. The outcome of not felt well was recovering while unknown for other events.

Began with cramping, pains, and prickling in left leg and foot 4 days after receiving vaccine. That was followed by pain all over (possibly lymph), sore eyes, sinus pain, stomach burning, migraine with numbness on one side, neck and chest pain and burning began 10 days after vax followed by painful/swollen tongue that turned numb and tingly, buzzing throughout body. Day 11 after vax I?m coming down with tingling and numbness in jaw and head and a pinny feeling in parts of head followed by numbness in throat, zapping up the neck, prickling pain when I pee. At Day 11 mucus is flowing down my throat. Chest and neck hurt at 12 days after start of symptoms. Body overcome by numbness, tingling, burning, and pain. Chest pain and palpitations cause me to seek emergency care the morning of May 7 and am referred to neurologist. Later that day I have uncontrollable shakes, burning in back of head that started in back and then spread to front and then turned to numbness, numbness/tingling spread to face, neck, chest, arms, and legs, pain in joints, swelling nose. May 8 I have bleeding gums, clumsy walking, burning sensations in face and chest, neck, and knees, followed by heart pain and intense heart palpitations that feel like my heart is clenched in a fist and isn?t being let go and uncontrollable shaking. Went to ER in ambulance. Have not felt symptoms since being treated with Prednisone, Famatodine, Benydryl, and Valium. Still some residual pain however. Other notable symptoms: water tasting sweet and metallic taste in mouth.

ear ringing; stomach and kidney pain; stomach and kidney pain; nausea; achiness; inflammation; light headed; vasovagal response; some chest pain; collapsed/fainted; low grade fever; congestion; chills; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports. A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 06May2021 11:00 (Batch/Lot number: EW0170) as 2nd dose, single, at the age of 28-years-old for COVID-19 immunization. The patient is not pregnant. The patient had no known allergies. Medical history included a few kidney stones and one surgery to remove stones. She reported she was very healthy and active otherwise and hadn't had any sort of cold or illness in 2 years. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 15Apr2021 09:45 AM in the left arm as 1st dose, single for COVID-19 immunization. The patient did not have any other vaccine in four weeks and no other medications in two weeks. At 06May2021 9:00pm (10 hours after her 2nd shot), she started having a low grade fever, congestion, and chills. She went to sleep at 12:00am, chills and fever were more intense at this point. At 2:00am on 07May2021, she woke up with a fever of 103, no chills, but intense ear ringing (a volume of 9/10) in her left ear, extreme stomach and kidney pain, nausea, and achiness. The ringing in her ears was the worst symptom. She sat up and drank water for the next 5 hours, to try to get the inflammation down. She went to the bathroom every hour and her ear ringing started to lessen. At 7:00am she went to the bathroom for the 5th time and began to feel extremely light headed. She had a vasovagal response and collapsed/fainted (luckily, she had a family member who was monitoring her). She went back to rest and have had on and off low-grade fever, some chest pain, and aches since then. She has a twin sister, who got her shot on the same day and time, and she also had a vasovagal response, but not nearly as many of the other symptoms. The patient had no prior vaccination and was not tested for COVID post-vaccination. No treatment was received for the events. The outcome of the events was unknown. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : PFIZER INC-2021521315 same reporter/drug, similar event, different patient

4 days after the vaccine I developed UTI symptoms that became increasingly painful.; Flushing of face and chest 30 minutes after receiving the vaccine.; This is a spontaneous report from a contactable consumer (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 23Apr2021 14:30 (Batch/Lot Number: EW0161) at the age of 28-year-old as SINGLE DOSE for covid-19 immunisation. The COVID-19 vaccine was administered at Hospital. Medical history included allergies to Sulfa, amoxicillin sodium;clavulanate potassium (AUGMENTIN). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The patient's concomitant medication included Birth Control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. The patient experienced Flushing of face and chest 30 minutes after receiving the vaccine on 23Apr2021 15:00. 4 days after the vaccine on 28Apr2021, the patient developed Urinary tract infection (UTI) symptoms that became increasingly painful. After teledoc visit patient started an antibiotic (macrobid) and the symptoms continued to worsen. Patient saw her Obstetrics and gynaecology (OBGYN) office and was given Ciprofoxacin and a culture test. The culture came back negative for infection. The pain became severe 7 days after the initial pain and were severe until 11 days after the initial symptoms. After about 13 days it was tolerable, but still uncomfortable. There were burning, pulling, pinching and pressure sensations during this time and it was incredibly painful to urinate, adverse event resulted in: Doctor or other healthcare professional office/clinic visit. The outcome of the events was recovering.

3 hours after 2nd vaccine I felt Lower Urinary Tract Symptoms and Hematuria. The symptoms are frequency urinating, burning and pain peeing and blood in urine.

Woke up the neck day with a headache, chills, body ache, back pain, and sensitive skin. Got worse throughout the day. Temperature at 10:00 pm (14 hrs after injection) was 99.1 degrees Fahrenheit. Went to bed and woke up the next day feeling better. Slight sensitive skin, sore neck, and headache. Did not urinate for 9 hours.

Pain. It began as lower back pain at 1800 on 1/8/2021. By 0230 1/9/2021 pain progressed. Anterior sharp bilateral pain noted in kidney region (below ribs). Lower back pain continued to worsen. Pain began to subside by 1000 1/9/2021. No pain by 1400 1/9/2021. Tylenol taken. Did not weaken the symptom. Additional signs and symptoms: Headache. Fever (range 99.2-101.6). Lasting 1/8/2021 (0230) through 1/9/2021 (2000). Tylenol taken for all signs and symptoms. every 8 hours. One pill.

Patient complained of dizziness and was recommended to go to the ER. Patient did end up going to the ER and complained of dizziness and lightheadedness worse with sitting and standing. Patient treated for UTI and released from ER with no other treatment.

1/15-1/16: dry cough 1/17: dry cough, feeling as if there is something stuck in throat, chest pressure/pain, lung pain, took Albuterol (INH) once 1/18-1/20: fevers 100.5 to 101.7, started 1000mg Tylenol/every 6 hours, started motrin 800mg/every 8 hours, took Albuterol (INH) once 1/18-1/23: shortness of breath, dry cough, seen in ER on 1/19, seen in ER again on 1/21, admitted on 1/21 for observation, impending doom, nausea/dry heaving, hot feeling inside body from head to toe and feeling of loss muscle tone and control in bowels and bladder, hives, dizziness/lightheadedness, joint pain in knees and ankle, headaches and migraines, extreme weakness, chest pressure, lung pain. 1/20: one episode of diarrhea 1/21-current: facial redness on cheeks and nose, hives 1/23: started benadryl 25mg/4-6 hours, pepcid 20mg/twice a day 1/23-1/25: shortness of breath improved, continues to have headaches, extreme weakness/fatigue, nausea, chest pressure, lung pain, dry cough, joint pain, extreme dizziness 1/24: started Aleve/twice a day 1/26: started prednizone, three hours after shortness of breath returned, took Albuterol (INH) once 1/26-current: hand/feet/facial numbness

Fever, Chills, severe Headache, fatigue, weakness, nausea, vomiting, back pain, mouth ulcers, UTI, body aches, muscle pain, dizziness, etc.

Symptoms 01/24/2021- numbness, weakness, tingling bilateral legs. Lost inability to walk and bladder control Admitted to hospital 01/24/2021-1/26/21. Not diagnosed. Had 4 MRIS and a lumbar puncture 02/3/2021- was in ED at hospital due vision issues/double vision- discharged same day. Repeated 4 MRIS and blood work, and lumbar puncture. 02/09/2021- patient was seen at a neurologist, due to numbness in bilateral hands and arms. And was admitted to Medical Center until 02/13/2021. Ruled out MS, GB, repeated 4 MRIS and LP. Was sent home with home health and PT. Saw PCP 02/19/2021, Did paperwork for disability and removed from work until 04/30/2021. PCP ordered more blood work up to 35 tubes of blood done on 02/17/2021. Will not be ready until 14 days post draw. Patient is still complaining of tingling on bilateral hands and feet, and weakness. Mainly sensory nerves related symptoms.

Dizziness, Lightheaded, Chills, the first time I had to stop because couldn't drive, I had spasm's around the injection site, Generalized Numbing, the symptoms of the fisrt dose lasted one week. I don't like to take medicine and I had no choice but take Panadol every 4 hours and apply ice to treat the muscular pain. I went to emergency and was told that I had an urine infection (which is very rare on me), and was treated with antibiotics. With the second dose I took acetaminophen 500 mg befor the vaccine, that helped because the day of the shot I didn't have pain, but the numbness was like if I couldn't connect my body to the brain. Couldn't talk properly, sleep 2 hours during the day, is funny that I applied ice on the injection site (Me thinking) but the pain doesn't go away, when the ice melts I notice that I applied the ice on the wrong arm. That's what I mean when I talk about numbness. Fever of 39.8F and Chills even today . Some cough and dry throat (Dryness can be because I'm a teacher) and constant tiredness.

6 hours after vaccine developed bilateral upper extremity numbness and weakness. R arm symptoms resolved in 30 minutes. L arm symptoms persist. Awoke with a headache 2/27/21 with headache-severe R sided temple. Had brief urinary urgency but did not urinate. L arm weakness and numbness persistent. Arm function returned but has persistent inability to move / use L hand and has loss of sensation L hand /forearm in glove distribution to mid forearm.

Patient reported history of queasiness after injection. Patient fell weak, diaphoretic after injection. Patient was escorted to a chair when she fainted and became unconscious for approximately 1 minute, had an episode of incontinence. EMS service was ordered. Patient's BP was recorded by the EMS and was hypotensive. Patient refused to go to ER and was escorted to the car where her family member was waiting to take her home.

29 y/o female presented to hospital with complaints of SOB, skin flares secondary to history of discoid lupus, protracted vomiting, and joint pain. Side effects began 2 days after her 2nd COVID vaccine. Pt was transferred to hospital from another institution due to O2 sat in the 60s (room air), leukocytosis, and AKI. Patient was treated empirically for sepsis/pneumonia as well as lupus flare. She was also initiated on high dose steroids. Possible reaction to vaccine. Chest CT showed diffuse ground-glass opacities and no signs of pulmonary embolism. Pt was transferred from hospital to another facility given progressive organ failure, most specifically liver failure.

Patient described myalgias, headache and dyspnea at ER visit on 4/1/21 at 2:37 am. Patient was discharged. Patient returned the same day at 15:40 cyanotic, altered, hypoxic and hypotensive. The patient was found to have profound metabolic acidosis, liver failure, renal failure. She went into cardiopulmonary arrest, was revived, rearrested and died. Patient was treated for possible sepsis, shock, liver failure.

Exhaustion, slept for four hours. Woke up feeling exhausted and nauseous. Couldn?t eat anything for 6+ hours, when I tried to eat instead I threw up until there was nothing in my stomach. Lots of bathroom urgency through the day and night

I received the second dose of the Pfizer vaccine on Friday April 9th at 6pm. I did not feel any adverse effects beyond arm soreness around the injection site until the morning of Sunday April 11th, at which point I had exacerbated joint pain (likely an inflammation response). In the evening of the 11th, I noticed the soft tissues of both my mouth and vulva felt more raw/sensitive than usual. On the 12th this feeling persisted, with canker sores/mouth ulcers forming in my mouth/throat and a continued stinging/irritated feeling in my vulva. On the 13th this manifested as vulval ulcers, which were painful on their own and with pain dramatically increased while urinating. During the night of the 13th/morning of 14th I also woke up several times feeling either chilly/clammy or overheated, and took 800mg ibuprofen and slept through to the morning of the 14th. By the time I woke up I no longer had chills/fever symptom, but mouth and vulval ulcers had both progressed. The appearance of the vulval ulcers was crater-like patches with a white coloration surrounded by raised red rims, with several touching/against each other and surrounding tissue also inflamed/sensitive. On the 15th I made an appointment with urgent care as I was unable to use the bathroom without extreme pain and was unable to wipe the area and had to rinse in the shower to stay clean instead. From the Urgent Care clinician I was prescribed a 5% topical lidocaine ointment, a 4% over the counter lidocaine alternative option, and an antiviral course of Acyclovir. Bloodwork was done to rule out STIs. Applying the ointment 4-5 times a day before using the bathroom was the most effective part of treatment, although constant discomfort and inability to wear tight clothing/wash the area normally persisted for the following week. At peak, there were 10 visible ulcers ranging from 0.3cm-0.8cm in diameter, located on both inside sides of the labia and with some presenting as "kissing sores". After April 20th, they slowly grew smaller and began to recede although intense pain persisted. At this point my mouth sores had also diminished and were fading at a faster rate than the vulvar sores, with minimal disruption to function besides avoiding particularly sharp/spicy/salty foods. I kept up use of the topical numbing cream on the vulvar ulcers until April 26th, at which point most sores had healed and I was able to urinate and bathe in a normal manor, although I still needed to be gentle/the area still felt sensitive. At the time of writing this report (April 28th), I still see some redness/potential scarring but there are no longer open sores and there is no noticeable pain/sensitivity.

guillian barre syndrome; symptoms of lower extremity weakness began about 12 hours after getting the second vaccine. lower extremity weakness progressed to bladder incontinence, which prompted her to come to the hospital. areflexic in the lower extremities upon arrrival.

Guillain Barre Syndrome; nerve pain; legs were numb; woke up thirsty with her heart racing; woke up thirsty with her heart racing; she fell and had a urinary incontinence.; she fell and had a urinary incontinence.; This is a spontaneous report from a contactable consumer. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown), via an unspecified route of administration on 07May2021 as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection: Lot number: unknown), via an unspecified route of administration on an unknown date as single dose for COVID-19 immunisation. The patient is a 29 year old female who received her 2nd dose of the Pfizer BioNTech COVID 19 Vaccine on 07May2021. It was reported that patient was admitted (hospitalized) on 08May2021 at around 5AM. As of 1:10AM today (12May2021), caller reported that the patient developed symptoms overnight. She reported nerve pain and that her legs were numb. She woke up thirsty with her heart racing and as she was getting water, she fell and had a urinary incontinence. Patient was diagnosed with Guillain Barre Syndrome, Vaccination Initial Encounter and was still hospitalized as of today. It was reported that the patient was uninsured and needs medical attention and physical therapy in order to return back home. The outcome of the events was unknown. Information on the lot/batch number has been requested.

Discolored urine; Lower right abdominal pain; GI discomfort; 11 day early Menstruation bleeding/spotting; chills; fever; fatigue; foggy; ichy throat; This is a spontaneous report from a contactable healthcare professional (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6201, Expiration date was not reported), via an unspecified route of administration (administered on the right arm) on 02Mar2021 08:30 AM (at the age of 29-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included irritable bowel syndrome and depression from an unknown date. The patient has no concomitant medications. The patient has no reported allergies. The patient was not pregnant at the time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. On 02Mar2021 10:30 AM, the patient experienced discolored urine, lower right abdominal pain, gastrointestinal (GI) discomfort, 11 day early menstruation bleeding/spotting, chills, fever, fatigue, foggy and ichy throat. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.

Discolored urine; Menstrual bleeding (early period/ spotting); Lower Abdominal Right side pain; Constipation; Chills; slight fever; ichy throat; foggy; tired; This is a spontaneous report from a contactable healthcare professional (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN6201, Expiration date was not reported), intramuscularly (administered on the right arm) on an unspecified date in Mar2021 08:30 AM (at the age of 29-years-old) as 1st dose, single for COVID-19 immunisation. Medical history included irritable bowel syndrome and depression from an unknowregnant at the time of vaccination. Prior to vaccination, the patient has no other medications in two weeks and has not been date. The patient's concomitant medications were not reported. The patient has no known allergies. The patient was not pn diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. On 02Mar2021 01:00 PM, the patient experienced discolored urine, menstrual bleeding (early period/ spotting), lower abdominal right side pain, constipation, chills, slight fever, ichy throat, foggy and tired. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered. No follow-up attempts are possible. No further information expected.

The morning after my vaccine (5/18/2021), I woke up with a mild headache and achiness in my joints. I took ibuprofen to alleviate the pain and my headache came back later that afternoon. I started feeling nauseous in the evening before going to bed. The following morning (5/19/2021), I woke up with the same headache and was feeling nauseous still. After about an hour, I got out of bed thinking I was going to vomit. I was sitting on the bathroom floor and became lightheaded and my stomach started hurting worse. I got tunnel vision and passed out. My boyfriend was there and said that I started seizing for about 10 seconds and was cold. He said that I started to urinate and then regained consciousness after about 15 seconds. He called 911. I felt shaky and dizzy for about 15 min after. The ambulance showed up. My blood pressure was low, blood sugar was good, heart rate was good. I was able to walk to the ambulance and they took me to the ER. They gave me anti-nausea medication and fluids via IV. At the hospital, I received a CT scan for my head and another to check for clots in my lungs. Both tests came back negative. I had chills and body aches and was extremely tired. After about a couple of hours, I started feeling nauseous again and they gave me more anti-nausea medication. They did a urine sample and said I had a UTI, but other than that there was nothing wrong. They referred me to a neurologist to follow up about the seizure. They prescribed an antibiotic for the UTI and anti-nausea medication and I was discharged after about 5 hours.

I received the vaccine on 04/27/2021. I had a high resting heart rate (100+) with shortness of breath and went to the Emergency Department two days after receiving the vaccine (04/29/2021). They gave me fluids and monitored my heart rate until it came down into the 80s. However, since then, I have continued to have a high resting heart rate with occasional chest tightness and followed up with my primary care doctor who recommended seeing a cardiologist. On 05/09/2021, I also had a skin rash on my face, lips, arms, and hands (I think part of my chest/abdomen as well). I went to the Immediate Care Center and was prescribed hydroxyzine. With the medication, the rash went away within a few days.

Guillain Barre syndrome; could not walk/Can not walk/Unable to walk/not able to walk; have lost all my movement of my leg and arm and my body/couldnt move my arms or anything; Cant do full movement on my arms or legs; Can't hear; cannot hear you properly; Can't hear properly, having a lot of issues with my ears; Lot of back pain/Back hurting; peed myself without knowing; peed myself without knowing, needed to get to the restroom. tried to get up and fell to the ground; Neck pain; feeling very thirsty; Chills; really bad headache; Now I could move my arm but they are still tingly and I feel sometimes really heavy; Now I could move my arm but they are still tingly and I feel sometimes really heavy; Arm and legs they are really numb; Williams-Beuren syndrome; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 2 via an unspecified route of administration, administered in Arm Left on 07May2021 at 08:30 (Batch/Lot Number: EW0171) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical Vaccine includes bnt162b2 Dose 1 on 16Apr2021 Lot # ER8731. Anatomical site of injection: left arm. The patient experienced Guillain Barre syndrome, could not walk/Cannot walk/Unable to walk/not able to walk, lost all my movement of my leg and arm and my body/couldn't move my arms or anything; Can't do full movement on my arms or legs, Williams-Beuren syndrome, Arm and legs they are really numb, Now I could move my arm but they are still tingly and I feel sometimes really heavy on May2021; cannot hear you properly, can't hear, having a lot of issues, with my ears on an unspecified date; Chills, really bad headache on 07May2021; Lot of back pain/Back hurting, peed myself without knowing, needed to get to the restroom. tried to get up and fell to the ground, neck pain, feeling very thirsty on 08May2021. Therapeutic measures were taken as a result of Guillain barre syndrome (Guillain-Barre syndrome). The adverse events Movement disorder, unable to walk, Guillain-Barre Syndrome resulted in an emergency room visit and the patient was hospitalzied. Consumer Stated, She is receiving treatment (a lot of medication) but she does not know the name of the medications. Patient stated Part of my body they are improving but some other parts they are consistent. The patient reported she has had lost of lab tests but no additional information was provided The clinical outcome of the events was unknown. The clinical course was reported by the patient as follows The patient received the vaccine on 07May2021 on Friday at 8:30. A couples of hours after the vaccine the patient started with the headache. Around 8:30 at the night, she started with chills, she went to sleep and 1 o clock in the morning on Friday, woke up with the really bad headache and neck pain and my back hurting, She was feeling very thirsty. She got up from the bed to get the water and 'the movement that I made to get out of the bed' and peed herself without knowing, She needed to get to the restroom. She try to get up and fell to the ground. Her son helped her to get up again and in the bed. Consumer asked if being not able to walk that is one of the side effect. The patient called the hospital and went to the emergency room. When he got to the hospital she could not walk anymore. The caller stated she is presently in the hospital because she could not walk, lost all my movement of leg and arm and body and they told her that she had Guillain Barre syndrome after the administration of vaccine. Consumer also stated 'they told me that I had a Williams-Beuren syndrome after administration of vaccine' Consumer stated, I could not walk like for a whole day, right now I am getting off the bed but I cannot do full movement on my arms or legs and my doctor detected Guillain-Barre Syndrome after the administration of vaccine. Since that day the patient also reported she has had a lot of back pain and headache and arm and legs they are really numb and I could not move them, right now (at the time of the call) she could move my arm but they are still tingly and I feel sometimes really heavy but I can move them.' Caller mentioned she does not have medical insurance and inquired if Pfizer could do something like to help her to pay on for rehab.' Consumer stated they are sending her to rehab. Caller reported Some parts of my body have little improvement but some are the same. My arms I can move now, which I couldn't do before. The clinical outcome of the events was unknown.

This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 19Feb2021 at the age of 29-years-old (Lot Number: EL9266) as single dose for COVID-19 immunization. Patient was not pregnant at time of vaccination. Medical history included vaginal delivery on 16May2020; known allergies to Bactrim, sulfa; historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) 1st dose on 27Jan2021 at the age of 29-years-old, Lot number EL8982. Concomitant medications included minerals NOS, vitamins NOS (PRENATAL VITAMINS); lecithin (reported as sunflower lecithin). Back pain, urinary urgency and frequency began 25Apr2021. Went to urgent care and was prescribed antibiotic. 28Apr2021, extreme back pain with nausea and vomiting occurred, so presented to the emergency department and was admitted. Abdominal CT scan was performed in Apr2021, revealing kidney stones, one stuck in the left ureter 2 mm in size, an additional 2 mm stone in the left kidney with other smaller stones; left kidney was swollen and right kidney was unremarkable. Multiple pain medications, Flomax, and Zofran administered throughout the hospital admission. Left ureteral stent placed on 30Apr2021 and discharged from the hospital that evening. Stent removed 10May2021 in urology clinic. Additional kidney stones still in fact. Pending follow up ultrasound and 24 hour urine profile due in 5-6 weeks. AE treatment included medications and left ureteral stent. The outcome of events was recovering.

Patient was found unresponsive at home on 5/22, admitted to another institution, found to be in DKA, multisystem organ failure (renal failure, liver failure), new R femoral DVT, elevation of ferritin, LDH and CRP. Over the course, platelet count continues to drop while on anticoagulation, and continued progression of thrombi, and transferred to our institution for further workup, including hepatic failure, concern for HLH and Castro trophic antiphospholipid syndrome. Based on chart review, patient had non-specific symptoms for a few weeks prior to the presentation, including GI distress, dysphagia and neck/sinus pain. CTH done with cerebral edema but not intracranial venous thrombosis. CT chest and abdomen with no PE, but presence of R popliteal vein thrombus, and portal vein thrombus. Heparin Ab (PF4 -ELISA test) was negative (at both referring hospital and current hospital). Serotonin release assay is pending at the time of report. While the symptoms are not consistent VITT that were reported (Heparin ab negative, received mRNA vaccines), however this possibility cannot be ruled out. IVIG was started on 5/27 - 5/28 to treat empirically for concern for heparin induced thrombocytopenia vs VITT.

Early AM 6/16/21: I began noticing petechia on my feet. A bloody sore developed on my lip and my mouth was bleeding a little. Late afternoon 6/16/21: The petechia moved up my legs and the bleeding in my mouth hadn't stopped. I was incredibly tired. 6/17/21: The bleeding in mouth worsened. I was having to walk around with gauze in my mouth to control the gum bleeding. More big, black, bloody sores developed in my mouth. The petechia was now covering most my body, including inside my ears and mouth. 6/18/21: I was no longer able to eat without sever pain. I was bleeding profusely when I urinated. Petechia had moved into my eyes. I was incredibly fatigued and I had a migraine that was progressively getting worse over the past 3 days. My mother rushed me to the ER at noon. I was admitted to the hospital within 30 minutes of arriving. They began running tests immediately. I lost track of the amount of blood they took to test. I received a CT Scan and MRI to ensure I wasn't bleeding from my brain or had a stroke. By 7:30PM I was in the main hospital. I was given a COVID test at this time. They informed me that my platelet count had dropped to 5,000 and they would be giving me bagged platelets(1 bag) and IVIG (8 glass bottles). 6/19/21: I was woken up around 6:30AM and given a dose of Dexamethasone and B12. They drew more blood a couple hours later. By noon the doctor informed me that my platelet count had increased to 9,000. That evening I had another dose of 7 glass bottles of IVIG. 6/20/21:I was woken up around 6:30AM and given a dose of Dexamethasone and B12. They drew more blood a couple hours later. By noon the doctor informed me that my platelet count had increased to 125,000. 6/21/21: I was released from the hospital due to my platelet count continuing to go up. It was up to 400,000. I was given a prescription for one more dose of Dexamethasone, Sumatriptan for my migraines and told to continue taking B12. 7/1/21: Had a follow up appointment with the hematologist from the hospital and I was informed my platelet count was okay but that I am now anemic.

The first day, I noticed a lot of saliva passing through my throat and then it went away. I also noticed a lot of exhaustion days later and throughout the whole month. After my second dose, I noticed I started having edema. I struggled with that for about a month. Then I ended up being diagnosed with nephrotic syndrome, minimal change disease and acute kidney injury. The cause was pretty much unknown. I don't have a history or kidney disease or anything like that.

Sudden onset cough, shortness of breath, and wheezing. A fever of 100.6 was noted but unsure as to when that occurred as I did not have chills. Feber has subsided. Cough, shortness of breath and intermittent wheezing remain as well as some chest pressure, sore throat, headache and chills. Coughing fits are bad enough to cause urinary incontinence but I did give birth 4 months ago so this may not be significant. No signs of allergic reactive such as redness, urticaria or swelling.

Systemic: Exhaustion-Mild, Systemic: Nausea-Severe, Systemic: Rise in BP, Dizziness, Kidney Pain-Medium

mild discomfort to my urethra; UTI symptoms; Burning upon urination; pain upon urination; urgency; frequency; This is a spontaneous report from a non-contactable healthcare professional (patient). A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL0140) solution for injection, via an unspecified route of administration in left arm on 28Dec2020 15:45 at a single dose for Covid-19 immunization. Medical history included Hashimoto's Thyroiditis. Patient was not pregnant. The patient's concomitant medications included levothyroxine, unspecified daily multivitamin, and collagen. The patient previously took trimethoprim/sulfamethoxazole (BACTRIM) and had allergies. The patient experienced UTI symptoms, burning upon urination, pain upon urination, urgency, and frequency on 29Dec2020, and mild discomfort to her urethra on an unspecified date. The patient visited her physician. Patient received antibiotic - Keflex. The patient underwent lab tests which included culture: no bacterial growth on an unknown date, Covid-19 rapid swab: negative on an unknown date, and urine analysis: urine had leukocytes and blood present on an unknown date. Outcome of the event mild discomfort to my urethra was unknown while the rest was recovered. No follow-up attempts are possible. No further information is expected. Information about lot/batch number has been obtained.

Loss of consciousness, bladder control, loss of awareness and sense of confusion, loss of motor function (couldn?t feel legs or arms) for an estimated total of 15 mins. Assisted by EMT and nurse, monitored breathing and heart rate control. Cause of unconsciousness undetermined

Arm pain that radiated down arm and up shoulder and neck and fatigue started a few hours after shot. Later in the evening I felt very tired and body aches. Frequent urination. That night I got sweats and chills and more intense body aches. The following day symptoms got worse, even more chills, lots of sweating requiring changing clothes multiple times a day, frequent urination, dehydration, fever, severe body aches and weakness, severe nausea. It was difficult to get out of bed and walk. Low appetite. Cough and slight difficulty breathing. These symptoms continued at same rate for 48 hrs and started to get better then, fever went away but symptoms continued for at least 72 hours. Lingering cough continued past 2 weeks. When symptoms were most severe, I considered going to urgent care or ER but lacked ability to do so by myself.

I was diagnosed by my OBGYN with a UTI and yeast infection, those symptoms arise within a week, and I was diagnosed within 2 weeks after. I was treated with Amoxicillin for the UTI and Monistat 7 for the yeast infection. In both cases some symptoms persisted following the end of those courses of medication. I have a low level of the symptoms of the UTI and they got worse after the second dose. They did a urine test and vaginal culture. 6 weeks after the second dose they did a urine test. The initial vaginal culture and urine test were within 2 weeks of getting the vaccine. My OBGYN recommended taking a cranberry supplement as additional aid for dealing with the UTI. I have done that until recently when I found out it contains something I am allergic to, so I stopped taking it. I had slight brain fog following the first dose and soreness. But following dose 2 I had very intense pain, chills, fever, body aches that began 12 hours after getting the vaccine. Then I had a low level migraine.

I received the second dose of the COVID-19 vaccine on January 13, 2021. In early March, I began experiencing some health concerns. I have a history of Dysautonomia and Anxiety. The dysautonomia has been controlled with lifestyle modifications for over 5 years. Symptoms experienced with it include low blood pressure, tachycardia, pre syncopal feelings and syncope. The occurrence of these symptoms became more frequent after receiving my second vaccination. In addition to above symptoms, my anxiety has worsened (which has been well controlled on the same medication for over 5 years), more syncopal episodes, acute weight loss, increased fatigue, lower baseline blood pressure, hair loss, temperature instability, and intermittent chest heaviness. In June, I had a dental procedure in which local epinephrine and lidocaine was used. I drove myself as I was told this would not be an issue since nitrous or general anesthesia was not used. I left the appointment to drive 20 minutes home. Within 5 minutes of my house, I began with pre-syncopal feelings (dizziness, blurred vision, pounding headache). I pulled off on side of road and within seconds, I had loss consciousness. I was by myself so unsure as to how long before I regained consciousness. When I woke up, I notified my spouse. I noted that I had loss bowel and bladder control during this episode, which has never occurred during my syncopal episodes. My foot was also cut from the foot pedals. My spouse said it took approximately 45 minutes for me to return to baseline. This episode was concerning for seizure activity, in which I will be evaluated by a Neurologist. I have no history of seizure activity. I have been evaluated per my primary and cardiologist. Cardiology believes my dysautonomia has worsened and is being exacerbated and feels as if this may have caused a rebound reaction to the local meds. But why now? Why is my dysautonomia worsening when I'm an otherwise healthy, young adult.

she cannot pee; she missed her menstrual cycle for the entire month of June; autoimmune deficiency; her hands have been freezing up; Muscle pain; lymph nodes are swollen; she shakes really bad; she cannot swallow/ can barely eat; she gets weaker; She is scared every night; she can barely have a bowel movement; Her muscles are tight; felt like it was shutting her body down; she was so sad; This is a spontaneous report from a contactable consumer (patient). A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 26Apr2021 (Batch/Lot number was not reported) at the age of 30 years as single dose for covid-19 immunisation. There were no medical history or concomitant medications. Historical vaccine included the first dose of BNT162B2 for covid-19 immunisation. Patient stated she was having bad side effects and didn't know what to do. She felt like it was shutting her body down. Since the second dose she missed her menstrual cycle for the entire month of June. She had been to the hospital 15-20 times. Said her hands had been freezing up, she had muscle pain, lymph nodes are swollen, she shaked really bad, she cannot swallow, she cannot pee. She kept going to the hospital; stated she was scared for her life and kept going to the emergency room but cannot get an answer. Patient said she was healthy before the vaccine. They told her she had an autoimmune deficiency after the shot. Stated she had never had anything autoimmune before. They tested her for was though and all the tests were negative. Said they did a CT scan of her stomach and tested her for everything. Stated she got weaker everyday. It just kept getting worse and she didn't know what to do. It had worsened gradually over time. Stated she felt there was no guarantee that she would live. She was scared every night. Her muscles were tight, she was in and out of the emergency room. Said the emergency room kept sending her away. Stated she can barely have a bowel movement or eat. Stated this all happened after the vaccine. She was a perfectly healthy 30 year old woman before the vaccine. The vaccine was ruining her life. She had gradually gotten worse over time. Everyday she felt worse and she was so sad. Patient had mentioned testing for autoimmune deficiency that was negative earlier in the call. She had also mentioned a CT Scan of her stomach and being tested for everything. No results provided by the caller. Outcome of events were unknown. Information about lot/batch number has been requested.

Fever - 103 F; Urine Infection; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Apr2021 at 10:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 10:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in 2021, the patient experienced fever-103 F and urine infection. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of fever-103 F and urine infection and included treatment with unspecified antibiotics. The outcomes of the fever-103 F and urine infection were recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Pfizer-BioNTech COVID-19 Vaccine. Pregnancy- 5w2d at time of vaccination. Started to have generalized joint pain starting about 12 hours after vaccination. Developed headache, chills, sweating and nausea throughout the next day and fever, low grade between 100.3-101. Had mild dysuria. Improved about 36 hours out from vaccine. Now almost 48 hours out, I continue to have a headache and mild joint pain but otherwise feeling better.

RECEIVED VACCINE AT 359PM AND AT 415PM BECAME DIAPHORETIC, PALE, EPISODE OF URINE INCONTIENCE,MOMENT OF "RIGIDNESS AND EYES ROLLED BACK" AND "HAD A BRIEF EPISODE OF NON REPONISIVENESS AND CAME THRU" (PER EMS). PROVIDER ASKED TO EVALUATE PATIENT AFTER EPISODE, IN TENT. PER PROVIDER SEND PATIENT TO HOSPITAL OF CHOICE FOR HIGHER LEVEL OF CARE. NO PO MEDS PROVIDED TRANSFERRED AT 1641PM IN STABLE CONDITION( TO HOSPITAL) , IN STABLE CONDITION.

Abdominal Pain, Dyspnea, Throat Irritation Narrative: 30 yo F with PMH multiple allergies, chronic pain syndrome, cervical and lumbar radiculopathy, and chronic plantar fasciitis, presenting with c/f anaphylaxis after receiving COVID-19 (Pfizer) vaccine. Had scheduled COVID-19 vaccine appointment at a medical center. Shortly after (about 1 minute) of administration she noted some GI upset initially and some dizziness on standing Then developed lip and finger tingling, some throat discomfort and tightness and SOB where she felt that she was not able to get any air out. Was instructed to come to the ED for further eval. Has an epi-pen at home but did not administer. She said this felt very similar to prior allergic reactions she has had in the past. In the ED, was tachycardic to the 120s, vitals otherwise wnl. Labs notable for Cr 1.3 (baseline 0.8), hypokalemia to 3.0, d-dimer and trop neg. Given solumedrol 125mg IV, Benadryl 50mg IV and 0.5mg Ativan and symptoms significantly improved. Epi ordered but not given. Her symptoms improved after medication admin. Transferred to the floor for further eval. She has an extensive allergy history to azithromycin, morphine, peanuts, red dye, shellfish/seafood, oranges. She saw an allergist as a child but has not for some time. She has had similar reactions to this episode with exposures and usually take Benadryl/famotidine with resolution. Also has history of allergic rhinitis and chronic sinus issues. Patient's symptoms improved with overnight evaluation, although noted 2 episodes of emesis and EKG with sinus tachycardia. Patient stable with planned discharge with outpatient evaluation of sinus tachy. Per medical team this development is not likely related to acute event due to persistence.

I passed out and had convulsions while sitting in a chair at a nail salon. During this event I peed myself. Prior to the event I had some minor body aches, but no fever. Following the event I returned home and began running a fever of 100.5.

She reports about 5 minutes after receiving the vaccine she went to stand up, felt lightheaded, next thing she knew she was on the ground with staff around her. Of note patient was called as a rapid response initially to the vaccination area. Few compressions had been done as the nurse who initially noted her to be down had difficulty filling a pulse. However patient had not lost the pulse. Patient does however report that she did lose some control of a small amount of urine which is never happened her before. No seizure activity was noted by staff and patient reports no prior history of seizure activity. States that she did used to faint frequently when she was a child in the setting of shot/pain. But reports she has not had to have vaccinations in many years. Rapid response team came to vaccine observation area and pt went to emergency department.

hives all over body; UTI; huge cold sore on nose; This is a spontaneous report from a contactable Other HCP (patient). A non-pregnant 31-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982), via an unspecified route of administration at Left Arm on 26Jan2021 17:30 (at age of 31 years old) at single dose for COVID-19 immunisation. Medical history included allergies: Sulfa. Concomitant medications included fluoxetine hydrochloride (PROZAC); vitamin d nos; clarithromycin (MACROBID). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Ek9231) on 07Jan2021 05:30 PM at left arm at 31 years old at single dose for COVID-19 immunisation. No COVID prior vaccination. Nasal Swab on 09Mar2021 was Negative. On 26Jan2021 09:00 PM, within 5 hours of getting my second vaccination, patient broke out in hives all over body. Patient called doctor and was prescribed steroids to help with the hives as antihistamines were not helping. A few days later patient woke up with a huge cold sore on nose which patient never had before. The same day patient was experiencing symptoms of a UTI and was prescribed Macrobid which had taken several times before. Within an hour of taking it patient's body was covered in hives and throat started to close. Patient immediately went to urgent care where received a shot of Benadryl. Patient was confident this reaction would not have happened if patient had not had this vaccine. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment (Prednisone and a shot of Benadryl) received. The outcome of the events was recovered in 2021.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Hives, UTI, Cold sores cannot be excluded. The case will be reassessed if additional information becomes 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.

31 year old female who presented to the ED on 4/17/21 complaining of generalized weakness. She reports that since receiving the Pfizer Covid vaccine approximately one month ago she's been feeling unwell. She received Covid vaccine on 2/19 & 3/12. Over the next week she developed began having episodes of nausea vomiting and diarrhea. She was considering issues such as pregnancy and had at least 10 pregnancy test over the last 2 weeks her symptoms worsened and she began having weakness and general malaise. She reports the weakness originally started with the lower extremities and then she was unable to walk and required 2 people to help her stand. She denies any chest pain or shortness of breath, she does have some dizziness and lightheadedness. She does report that she had palpitations over the last week that were gradually worsening increasing in both frequency and duration. Also reports a rash that started on 4/17/21. She has notable lower extremity edema. Clinical course worsened requiring hemodialysis, intubation and a transferred. Hospital on 4/20/21. Assessment indicates patients primary issue is the cardiomyopathy, as there is no evidence of thrombocytopenia, questionable viral cardiomyopathy with subsequent multiorgan dysfunction syndrome . Pt was vaccinated at hospital.

48 hours after receiving the vaccine, I started experiencing symptoms of an overactive bladder - had to urinate much more frequently than normal. 72 hours after the vaccine, I had a visible herpes outbreak in the genital region.

Vasovagal. Lost bladder control Improved on her own. Called 911 but canceled Has fainted in the past

At 22 hr mark, had a seizure and began vomiting. Vomiting continued throughout the day. No fever or other adverse symptoms besides the vomiting. Went to bed at 10pm with low grade fever (100). Had a complicated seizure at 10:56pm, incontinent, grossly disoriented and agitated, garbled language. Called 911. Then drove my daughter to local hospital, to ED, just prior to midnight. Discharged 4/12/21 (about 3 hrs at ED)

I woke up the morning of the 25th, with some lower abdomen cramping and and low back pain - lasted a few hours - and I was having contractions. I was not dilatated and labor had not progressed past early contractions. Gave me a IV of fluid - Liter; monitored babies heartbeat; They sent me home with antibiotics - for kidney or bladder infections - something along those lines that was irritating my uterus. It subsided (AE) that afternoon - I did 7 days of Macrobid. Pregnancy history - first pregnancy; Estimated date of delivery: June 10, 2021.

UTI symptoms that began day after vaccination - urgency, frequency, dysuria. Chills. Axillary lymphadenopathy. Fatigue.

KIDNEY FAILURE; Neurological disorder; Headache; anosmia; COVID-19; 2nd dose on 01Jan2021; 2nd dose on 01Jan2021; This is a spontaneous report from a contactable physician. A 31-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot Number: EL8982), dose 2 intramuscular, administered in Deltoid Left on 01Jan2021 as an unspecified dose for covid-19 immunisation. Patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Batch/Lot number: EL0142) on 29Dec2020 via R deltoid intramuscular as unspecified route for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had a history of diabetes: Borderline and the patient was a non-smoker/former. It was stated patient have a positive test for SARS-Cov2 and New infection Dxdt RT-PCR was done on 06Jan2021 and patient have SARS-CoV2 antibodies at diagnosis was unknown. Patient willing to be contacted again by Pfizer on the reported adverse event. It was reported that patient experienced Covid a week after the 1st dose of the vaccine. When to get the 2nd dose/tested positive for COVID 04Jan2021. There was a Renal failure on unspecified date. And no other details were provided and Neurological is Yes, and no details were provided. Other provided as Yes as headache, anosmia. The patient was not hospitalized and the patient was not admitted to an Intensive Care Unit. The patient display no clinical signs at rest indicative of severe systemic illness. The patient does not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Patient does not have Mutliorgan failure, Respiratory, Dyspnea, Tachypnea, Hypoxemia and COVID-Pneumonia was Unknown, No Respiratory failure and no Acute respiratory distress syndrome (ARDS). Patient had no Cardiovascular, Heart failure, Cardiogenic shock, Acute myocardial failure, Arrhythmia, Myocarditis, Gastrointestinal/Hepatic, Vomiting, Diarrhea, Abdominal pain, Jaundice, Acute liver failure, Other, Vascular, Deep vein thrombosis, Pulmonary embolism, Limb ischemia, Vasculitis, Renal and Unknown Acute kidney injury. The was no altered consciousness, Convulsions/Seizures, Encephalopathy, Meningitis, Cerebrovascular accident. There was no Hematological, Thrombocytopenia, Disseminated intravascular coagulation, Other, Dermatological, Chillblains, Erythema multiforme. patient had not received any additional therapies for COVID-19. the event does not require the initiation of new medication or other treatment or procedure. Patient did not retest from the SARS-CoV2 diagnosis before the SARS-CoV2 antigen test became negative. It was reported that Laboratory Test or Diagnostic Studies: Test for SARS-CoV-2 by PCR, or other Performed on 06Jan2021 Results with units as Positive. The patient has not been taking any medications routinely prior to the event being reported. Patient do not have any pre-existing diseases worsened during the SARS-CoV2 infection. The patient had not been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination. The outcome with COVID-19 was recovered and the remaining events were unknown. No follow-up attempts are needed. No further information is expected.; Sender's Comments: Based on the information available and a close temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of Renal failure,covid 19 anosmia,headache. The case will be reassessed once new 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 Committees, and Investigators, as appropriate

Extreme pain in the kidneys; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot number was not reported) via an unspecified route of administration administered in left arm on 01Feb2021 18:30 as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not test covid-19 positive prior to vaccination. The patient had not been tested for covid-19 since the vaccination. Other vaccine date detail was reported as same date vaccine date 01Feb2021. The patient experienced extreme pain in the kidneys on 02Feb2021 16:30. No treatment was received for the event. Outcome of the event was reported as not recovered at this point of time. Information on the lot/batch number has been requested. Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.

Within 18 hours of the vaccine, I experienced: arm pain, fever, sore joints, skin hurt to the touch, UTI sensation when urinating Within 2 days, I experienced: sore joints, skin hurt to the touch, UTI sensation when urinating, sore throat Within 3 days, I experienced: skin hurt to the touch, UTI sensation when urinating, sore throat, sores inside of mouth Within 4 days, I experience nausea and still had sores in my mouth

Vaccine given and within 20 hrs, my urine turned reddish brown. Since I have a history of IgA nephropathy, I contacted my nephrologist and he ordered blood work and a urinalysis. The UA showed here was an increase in proteinuria and hematuria directly following the second dose of the COVID vaccination. Kidney function bloodwork appeared to be within normal limits. No treatment was necessary. Follow up blood work ordered within 5-7 days.

bladder infection/UTI/Antibiotics; blood in my urine; This is a spontaneous report from a contactable healthcare professional (patient). This healthcare professional reported similar events for two patients. This is the first of two reports. A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on the right arm on 13Jan2021 13:00 at a single dose for COVID-19 immunization. The patient has no medical history. The patient's concomitant medications were not reported. The patient reported that on 27Jan2021, exactly 2 weeks after the 1st dose of the vaccine, she came down with a UTI and bladder infection which caused her to have blood in her urine. This also happened to the patient's father who suffered the same thing 2 weeks after his first vaccine. Antibiotic was given as treatment for the patient. Lab data include nasal swab COVID test: negative on 18Jan2021. The outcome of the events was recovered in 2021. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : same product and event, different patient

A few weeks after the vaccine I noticed my legs were covered in Peticia which began spreading up the legs. I was sent to the ER for a CBC but was sent home. My Dermatatologist performed 2 Punch Biosypies. I began having joint pains in my legs and stomach pains. The peticia begin going and coming. And the test results for the Punch Biopsies revealed I had HSP "Henoch Schonline". I began having GI issues with bloody stool, blood in my urine which prompted I be started on a high dose Steroid of Prednisone. On 3/24 I saw a Nephrologist who advised there was still blood in my urine and a kidney biopsy may have to be perfomed if the steroids does not improve or resolve the issue. Ive been having nose bleeding also but is unsure if its associated as well and I am scheduled to see and ENT for on 4/2 for that.

High fever up to 103.3 starting within 12 hours of the vaccine, high fever lasted for 12+ hours and was back to normal about 50 hours after the vaccine. Treated with April and ibuprofen. Symptoms also included chills, arm pain, body aches, dizziness, decreased appetite, increased urination, and migraine quality headache lasting 72 hours.

rash on face, back, shoulders, and stomach (dry, red, peeling skin--not itchy) extreme burning and stinging of urethra and vestibular tissues prickling of external vulvar tissues (labia majora and minora, perineum) swelling and redness of mans pubis and labia majora burning and stinging when urinating and deficating excoriated vulvar and vestibular tissues white, nonodorous vaginal discharge that comes back negative for every infection and virus

2 days after the first vaccination I had pain while urinating, lower back pain on the right side pain just below the ribs and the kidney area on the right side and right side pelvic pain, lower abdomin pain around bladder area. Doctor thought it could be a UTI so I was prescribed antibiotics I've never had a UTI. After finishing the antibiotics there is no relief pain was worse. I received the second vaccination on 4/28. After receiving that vaccination my left side started hurting and the right side pain continued. After much testing with no results that came up with any issues I was sent to see a urologist. Who after hearing my symptoms and the timing of them believed that it was an adverse effect to receiving the covid vaccination. He put me on some pain medication to help me sleep as I had not slept in a month and now I am feeling much better. Symptoms started on 4/9 and it is now 5/27 and I am starting to feel normal again.

7 days after 1st dose I experienced blood in my urine for 2 days. 2 days after my 2nd dose I experienced blood in my urine for 2 days.

I am experiencing heavy vaginal bleeding (12 days and counting) since the third day after the injection. With the fisrt dose received at a Hospital on April 14th, 2021 I was bleeding for 28 days since the fourth day after the first dose of the COVID vaccine. I developed anemia (10.6), a high count of white blood cells (15,000), chills, low blood pressure, fever, persistent muscle and joint aches and an urinal infection. I had to wait two months to receive the second dose and even then I started to experience the same symptoms 3 days after getting the second shot.

This is a spontaneous report from a contactable consumer or other non hcp (patient) reporting herself. A 32-year-old female patient received BNT162B2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration, administered in Left upper Arm on 11May2021 18:30 (at the age of 32-years-old) (Batch/Lot Number: EW0170) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included ongoing systemic lupus erythematosus diagnosed since age 16, about 14 years ago they think it spiked around age 14 but it was not diagnosed until age 16 , ongoing Ehlers-Danlos syndrome started around age 18 or 19 She has had it her whole life and they didn't know what was going on with her but was diagnosed at age 18 or 19 , ongoing fibromyalgia Since age 16 , ongoing colitis ulcerative around age 16 , ongoing migraine age 16 to 18 , ongoing tachycardia diagnosed age 24 or 25 but thinks it started with lupus , ongoing narcolepsy diagnosed around age 23 or 24 , ongoing raynaud's phenomenon diagnosed around age 16 , ongoing sjogren's syndrome diagnosed around age 16. Concomitant medications included hydroxyzine pamoate (HYDROXYZINE PAMOATE) taken for sleep apnoea syndrome, feeling of relaxation from an unspecified start date and ongoing; tramadol (TRAMADOL) taken for pain from an unspecified start date and ongoing; cyclobenzaprine (CYCLOBENZAPRINE) taken for muscle relaxant therapy from an unspecified start date and ongoing; methotrexate (METHOTREXATE) taken for immunosuppressant drug therapy from an unspecified start date to 20Apr2021; prednisone (PREDNISONE) taken for inflammation from an unspecified start date to 20Jun2021. While providing concomitant medications, caller states she had been on high doses of Prednisone since this to get the inflammation off her brain. She stated she had been on again and off again to get the inflammation off of her brain. Caller does not have NDC/Lot/Exp for prednisone. Product strength: Take tablets by mouth: 80mg for 2-3 days then 60mg for a couple of days then 40mg for 1 day then 20 then 10 then off. count size dispensed: not provided Is a sample of the product available to be returned, if requested (Y/N): not provided Packaging sealed and intact or not provided. The patient previously bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Left upper Arm on 20Apr2021 (at the age of 32-years-old) (Batch/Lot Number: ER8731) as DOSE 1, SINGLE for covid-19 immunisation. The patient stated that she had horrible, horrific side effects. Caller states she hallucinated for four days (on 11May2021), brain was so swollen it wasn't getting oxygen to it (on 11May2021). On 11May2021, patient spikes with blood pressure and visuals all over again. On 12May2021, patient pretty sure she died and met angel. She had a rare autoimmune and rare genetic disorder called Ehlers Danlos Syndrome. "They" thought it might be the trigger - they said they've never heard of it. It took her a week before getting to ER. They gave her a counter inflammation medication to get swelling off brain. She experienced brain damage on an unspecified date. They did two doses of Benadryl then a cocktail the second time around. She knew the cocktail was Benadryl and throw up medicine and something else. Then she got hives all over her body (on 26May2021). She still had hives almost a month later and was still having bad migraines (on 26May2021) and everything was inflamed. Caller had Lupus and was finally for the first time in 32 years in remission before the shot and now everything had started (on on 26May2021). On an unspecified date, patient laid in bed, gasping for air, and blacked out. Caller states she was really really really sick, headaches and high fevers. She mentioned her joints ached. She now had blood in her urine again. She did something with activity that made heart rate go up and hallucinate. The patient underwent lab tests and procedures which included blood test: unknown on 25Jun2021. The outcome of events hallucinated for four days, brain was so swollen wasn't getting oxygen to it was recovered 14May2021, spikes with blood pressure and visuals all over again and having bad migraines recovered on an unspecified date in May2021. The outcome of got hives all over body was not recovered while outcome of rest event was unknown.

Urinary Tract Infection - painful urination and frequency symptoms. I was treated with antibiotics (Cephlex) for 10 days. I started those on the 11th (February). By day seven or eight, I wasn't feeling better so they switched my antibiotics (might have been Bactrim) to a different kind and that didn't help either. I was still taking antibiotics when I had my second dose of the vaccine on the 17th of February. On the 22nd of February, I went in to the doctor's and they gave me one single dose of antibiotic (Monurol) that was super strong and that it would work. I took that and it stopped my symptoms right away.

She also added that she has had the COVID disease; She also added that she has had the COVID disease; Chest pain feeling like heart attack; she feels like she is going to die; Woke up 12Jul2021 at 01:00 in excruciating pain; Having severe muscle cramps now/severe muscle cramps now was reported as worsened; Dealing with slurred Speech; Has memory loss; Losing sense of balance; Has really severe kidney pain on the right side as well; Felt a little bit tired; This is a spontaneous report from a contactable consumer (patient). A female patient of 32-year-old age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was WAG13871 ), first dose via an unspecified route of administration on left arm on 11Jul2021, 15:00 at unknown dose single for COVID-19 immunization. Medical history includes seizure disorder, 20 major surgeries, ortopedic bone surgery, heart attack, post op pain, vision impaired. Family Medical History includes patient father died of heart attack. No concomitant medication reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine . On 12Jul2021 patient start experiencing excruciating pain, , having severe muscle cramps, dealing with slurred Speech, memory loss, Losing sense of balance, Has really severe kidney pain on the right side, The tiredness about 3 hours later, Chest pain. She was tested positive after vaccination. She cannot afford to go to the emergency room or the physicians office right now. She comes from a HCP family and is HCP herself. When asked to specify what type, she mentioned withheld. She is a resident of withheld, currently in withheld. She mentioned she is aware of the expected side effects with the Pfizer BioNTech. Outcome of she had covid disease, losing sense of balance, chest pain feeling like heart attack, she feels like she is going to die was unknown, recovered from fatigue, outcome of pain, Dealing with slurred Speech, has memory loss, has really severe kidney pain on the right side as well was recovering, outcome of having severe muscle cramps now/severe muscle cramps now was reported as worsened was not recovered Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.

Headaches; Chills; Feeling cold; She felt a heavy arm, and pain at the injection site; Arm was sore; She felt tired, a lot of weakness, fatigue; Mild swollen throat; Flushing of the face; feeling warm a couple of times like almost a fever but it wasnt one, she didnt check her temperature because she had no thermometer. She feels her face, head and forehead very warm; Swollen lymph nodes; felt incontinence, it was difficult to go, she couldnt urinate, her body felt the need to go; She felt tired, a lot of weakness, fatigue; Painful urination; Diarrhea; Dehydration; Mild swollen face; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0170) via an unspecified route of administration, administered in Arm Left on 14May2021 (Age at Vaccination 32-year-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced she felt tired, a lot of weakness, fatigue, painful urination, headaches, chills, feeling cold, she felt a heavy arm, and pain at the injection site, arm was sore, mild swollen throat, flushing of the face, feeling warm a couple of times like almost a fever but it wasnt one, she didnt check her temperature because she had no thermometer. she feels her face, head and forehead very warm, swollen lymph nodes, felt incontinence, it was difficult to go, she couldnt urinate, her body felt the need to go. The patient experienced diarrhea and dehydration on 15May2021 and mild swollen face on 14May2021. It was reported, Patient is 32 years old, she got the first dose of Pfizer's COVID-19 vaccine on Friday 14May2021. After getting it, she experienced multiple symptoms diarrhea, less than 24 hrs after the dose, very early on Saturday morning, and a couple of days later but not every day, around mid-week maybe on Tuesday or Wednesday. She had dehydration, and painful urination, she felt incontinence, it was difficult to go, she couldnt urinate, her body felt the need to go. She also had mild swollen face, it was not spontaneous, it took hrs from the vaccine to get the mild swelling, within 5 hrs on the cheek area, also on Saturday she felt the swelling, her face was swollen, but not extremely, she thought it was normal until a relative told her she looked swollen, her family helped her not to panic. She had a lot of strong headaches, chills, she was feeling cold, and her arm was sore, she felt a lot of soreness for a couple of days, she felt a heavy arm, and pain at the injection site, but not extremely painful. She experienced flushing of the face, feeling warm a couple of times, like almost a fever but it wasnt one, she didnt check her temperature because she had no thermometer. She feels her face, head and forehead very warm. She has had a mild swollen throat and swollen lymph nodes as well. She felt tired, a lot of weakness, fatigue, she couldn't go exercise or take a walk, she felt really tired. After the vaccine, she has experienced something every day, it was tough. She saw an allergy doctor who recommended her to take over-the-counter medicine, Pepcid, and told her it was not an allergic reaction to the vaccine. She was concerned because with flu shots (unknown manufacturer) in the past she's had no symptoms, or she has had typical symptoms like weakness, fatigue, tiredness, muscle aches. Patient wass better after a week. Her doctor said it was because she was dehydrated. She has gotten other flu shots and things before, and never had extreme side effects like this or dehydration. In less than 24 hours, she had diarrhea for 2 days. She also had headaches that were very strong from the normal headaches she has. It was like a toothache headache with no toothache. She had lymph node swelling in her throat for less than 24 hours. It was not as bad swollen as her face. She was more concerned with her face than her throat. She could breathe fine. The outcome for event Diarrhea on 18May2021 while Dehydration, recovered on an unknown date in 2021, Mild swollen face recovered on 16May2021, while rest of event outcome was unknown and event Headaches and Swollen lymph nodes recovered on an unknown date. Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.

fever of 105.6 15 hours from injection. Headache at a 10 of 10, chills, fatigue, shaking from fever, loss of bladder control due to uncontrollable shaking from fever, body aches. Fever up and down. Currently 48 hours out from vaccine and still overall not feeling well and currently febrile at 100.9

Approximately 10 mins post Pfizer vaccine patient notified EMT she was going to have a seizure. She was placed in a safe position, seizure lasted about 30 seconds. Mild body movement, patient urinated, no physical injury. Mother was present, primary historian. Described course of seizure as regular and last seizure 6months ago. As EMT began taking vitals, she expressed feeling nauseous, and vomited. Afterwards patient stated feeling very tired and wanted to leave. Refused paramedics to be called. Patient wanted to rest, left at 3:00PM. Alert and oriented, no complaints besides feeling tired, able to walk with steady gate. Counseled patient to follow up with provider as soon as possible.

She received her second dose of COVID 19 vaccination (Pfizer) in left deltoid the afternoon of February 23, 2021. That night and since then she has been experiencing insomnia. The day after she received the injection she developed head pressure, and head ache, body aches, rash around the injection site, pain at the injection site, and her arm is very sensitive. She went to the emergency room with complaints of abdominal pain and headache. She is not sure if the abdominal pain is related to the vaccination. Imaging studies performed in the ED revealed she has a cyst on left ovary, and a kidney stone in left kidney. She was prescribed cefdinir 300mg, take one tablet by mouth twice a day for seven day, and acetaminophen-codeine 300-30. She is taking cefdinir 300mg, one tablet by mouth twice a day. She is not taking acetaminophen-codeine 300-30. The day after she was seen in the ED she found a lump at the bottom of her left underarm. The lump is hard and the size of a quarter.

Patient felt lightheaded and dizzy Patient had syncopal episode which followed immediate urination; episode witnessed by staff nurse Patient seen by medical team and vitals were stable Patient refused medical transport and signed AMA form Patient?s husband will be picking patient up

Immediately following the vaccine, had a sore arm for one day. I experienced bacterial vaginosis and UTI on 04-01-2021. They prescribed me 2 antibiotics, Metronidazolle, 2x a day for 7 days and Cephalexin 2x a day for 7 days. I am currently 24 weeks pregnant, and the baby is doing well.

Two weeks after receiving my second dose of the Pfizer vaccine I began to have an urgency to pee that I thought was a UTI. There was no smell, no urine discoloration, but a consistent urge to pee even right after having used the bathroom and especially at night. I went to the doctor twice and did two rounds of antibiotics but no UTI was detected (also all tests for STIs came back negative). The doctors did not see any evidence of infection. After talking with friends, multiple women all in the 30-40 age bracket have reported similar symptoms.

After the second shot, I had chills, body aches, & headaches. My legs hurt really bad. I also had hyper arousal that seemed very abnormal. I then had a UTI. I went to Urgent Care and I was prescribed Bactrim. A few days after that, I had a fever. My face felt like it was on fire on the left side. I went to Urgent Care again. I was told I had Covid-19, but the test came back negative. I was given Cipril afterwards. Every time I stood up I felt like I couldn't breathe. I was then put on Prednisone. I couldn't breathe well after that. I was then diagnosed with bronchitis. I called my doctor again and I took another Covid test. It came back negative.

1. June 24th (24 hours): Mouth lesions. Headache. Vaginal bleeding 2. Sunday June 27th (96 hours): Severe oral blistering and cheilitis. Odynophyagia. White plaques on tonsils. Painful lymphadenopathy in the neck. T max: > 38 degrees. Reduced to liquid diet. ER Visit Sunday June 27th. Provisional dx of HSV. But HSV swap negative. Sent home with supportive care. 3. Tuesday June 29th (134 hours): Virtual consult. Rx Magic mouth. Oral Rx for Valacyclovir. 2000 mg PO x 2 doses. 4. July 2nd: Lesion on lips still present. Some improvement in pain. 5. July 7th: Oral lesions gone. One crack/fissure in the lower lip remained.

slight headache; Brain fog; Urine feel hot; can't sleep; felt like had flu; felt every hot in the inside; sweating; Knees became week; vision go black twice when I blinked; tingly sensation around mouth area; Burning sensation in back of head, left side of neck and back of neck, on arms and legs; Random leg pain; Pressure on back of head which comes and goes; Eye twitches; Fatigue; weakness; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL 9264) via an unspecified route of administration in the left arm on 17Mar2021 at 10:00 (at the age of 33-years old) as a single dose for COVID-19 immunisation. Medical history included Vitamin D deficiency. The patient did not have any known allergies to medications, food, or other products. The concomitant medications included multiple vitamins and VITAMIN D nos 50,000UI. The patient did not receive any other vaccines within 4 weeks prior to COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 17Mar2021 at 11:15, the patient experienced tingling sensation in mouth area, burning sensation in the back of head, back and left side of neck in arms and legs, leg pain, tingling sensation of lips, pressure on the back of head which used to come and go, left eye twitching, fatigue and weakness. On 23Mar2021 the patient felt the knees to be very weak and used to get a feel of falling, while walking in the room the patient on blinking felt the vision to go black twice. On 24Mar2021 patient felt to have flu like symptoms were feeling hot was experienced from inside and was sweating and had fatigue with a normal temperature. On 25Mar2021, the burning sensation was there all day long which prevented the patient from sleeping, slight headache, foggy brain, feeling hot from inside and having a sensation of hot urination. The patient was prescribed to take BENADRYL but it didn't help much for the patient. Therapeutic measures were taken as a result of reported events and included treatment with BENADRYL. Since the vaccination the patient was tested for COVID-19 nasal swab test (HDPCR SARS-CoV-2) on 23Mar2021 and the result was negative. The events resulted in doctor or other healthcare professional office/clinic visit. The clinical outcomes for the events such as tingling mouth, burning sensation, leg pain, tingling lips, head pressure, eye twitching, fatigue, weakness, joint weakness, vision went black, feeling hot, sweating, headache, foggy feeling in head, painful urination and sleeplessness were unknown at the time of reporting. No follow-up attempts are needed. No further information is expected.

Dark and painful urination; dark and painful urination; Pain in back of left thigh; Fatigue; This is a spontaneous report from a contactable consumer. A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left at age of 33-years-old on 05Jul2021 10:45 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included depression, anxiety, post-traumatic stress disorder, scoliosis. Pregnant: No. The patient previously received first dose of bnt162b2 at age of 33 years old on 14Jun2021 for COVID-19 immunization. Concomitant medications included paracetamol (TYLENOL); ibuprofen; duloxetine hydrochloride (CYMBALTA); trazodone; hydroxyzine taken for an unspecified indication, start and stop date were not reported. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dark and painful urination, pain in back of left thigh, fatigue on 06Jul2021 15:30. No treatment was received for the events. Outcome of events was not recovered. The patient was not tested covid post vaccination. Information on the lot/ batch number has been requested.

I had COVID-19 in November, diagnosed via PCR 11/11/20, (no symptoms). Took a COVID antibody test 12/20/20, which was negative, so decided to get vaccinated at my place of work 12/30/20. A few days after the second dose, 1/19/21, I began feeling tired, nauseous after eating, with dark urine. I reached out to my PCP, who ordered a liver panel. My AST was 1600 and my ALT was 800. They ruled out all other possible explanations (Hepatitis, HSV, autoimmune disorders, Wilson?s) and I took an ultrasound which was unremarkable. The diagnosis was transminitis. Since this happened so soon after my second dose, and I had had COVID, and since I work with a lot of Internal medicine doctors who thought I should report this, it was thought to be an autoimmune reaction to getting vaccinated so soon after having COVID and then the vaccine.

I had dizziness/lightheaded 10 minutes after dose. Dizziness went away 40 minutes later. 24 hours after dose had body aches. 2 days after dose I had blurred vision in Rt eye and then noticed that Rt eye was fully dilated and Lt eye was normal. Rt eye not responding to light. Went to ED and had 2 CT scans that were normal. They sent me where I had a third CT scan which was normal. I saw ophthalmology and my optic nerve was normal and eyes looked good, but Rt eye still didn't react to light. they ruled out pharmacological and said that it is something neurological. They still don't know exactly what is going on. While at the hospital, I started having urinary retention and now have a foley placed. I have follow ups with neurology, urology and ophthalmology and have orders for MRI of brain and neck.

Right arm pain and injection site x 3 days, headache, right side body aches x 3 days. Kidney pain x 2 days.

On 02.24.21 in the evening I began experiencing body aches. The following day I had a fever of 100.8 and saw an Urgent Care provider who referred me to the hospital. Upon arrival my fever spiked to 102.3, bloodwork showed elevated lactate at 2.4 and pulse rate was over 119. I was admitted with sepsis symptomatology.

Headache; lethargic; Headache/lethargic, continued and progressively got worse; neck pain; kidney pain; This is a spontaneous report from a contactable nurse reported for herself. A 34-year-old non- pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown), at 34 years of age, via an unspecified route of administration on 22Jan2021 14:00 at single dose, for COVID-19 immunization. The patient medical included PCOS (Polycystic ovarian syndrome). Patient had sulfa allergy. Concomitant medication included Levothyroxine, metformin, spironolactone and vitamin. On 23Jan2021, the patient experienced Headache, lethargic, continued and progressively got worse over the past 2 weeks, neck pain, kidney pain that comes and goes. The events were considered as non-serious. Events were treated with Compazine, fioricet, flexerol and Tylenol. Patient did not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19 and COVID-19 test shows negative results. The outcome of the events was not recovered. Information on batch/lot number was requested.

Urinary Tract infection set in within 48 hours of covid shot. Recovered Then got second round of shot and the same thing happened again.

After the 1st dose I had an extremely severe headache within 4 hours, light sensitivity and eye pain . For the next 72 hours I had severe body aches, chills, intense joint pain (starting at ankles, knees, femurs and then hips. Radiating pain in each section about 30 minutes at a time). Sweating at night. I was light headed and had extreme fatigue. The first 4 nights I had extreme stomach pain all over from under my rib cage felt it moving through my entire stomach track. Even my uterus hurt and I had intense diarrhea, always occurring after 1am but no later than 5am. For a week after the first dose i continued to experience side effects, but not as intensely. Mostly severe fatigue, headache, sensitivity to light, eye pain, muscle stiffness and diarrhea. Yesterday i received my 2nd dose and initially only experienced a slight headache and moderate fatigue. But at 2am I awoke with EXTREMELY INTENSE pain in my kidney area and lower back. It felt very similar to my stomach pain in that there was a throbbing and a sensation of squeezing of the kidneys and surrounding muscles. The pain was so acute that it affected my breathing patttern and now the morning after my lower back muscles are very sore, indicating there was a physical component to the 2am incident that affected the lower back and kidney area.

My arm pits and lymphoid got big as softballs and I felt very fatigue and I ran a fever and bad migraines. I had pain in my lower back around my kidneys.

Severe Hematuria, about 18 hours after vaccine. Severe chills about 12 hours after vaccine. Nausea, headaches, body and flank pain, severe fatigue lasting 5 days from vaccine. Hospitalization 2 days after due to Hematuria .

- Pt recieved second Pfizer vaccine 5/4 - Developed chest pain on 5/13/21 without shortness of breath. Mother passed away 3 weeks ago and she is also anxious. - Chest pain was severe enough to interfere with her leaving the house. Taking a deep breath made pain worse. Hunching over made her pain less severe. Took GABA supplement and felt better. Pain was worse with getting her daughter dressed. No personal or family history of heart disease. Chest is tender to touch. - Chest pain eventually resolved. - Pt passed kidney stone 5/15/21

This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non pregnant female received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 30Mar2021 at 19:30 (at the age of 34-years-old) as a single dose for COVID-19 immunization. Medical history stated NADA (no abnormalities detected no apparent distress). Concomitant medications included cannabidiol (MANUFACTURER UNKNOWN) and gummy multi vitamins (MANUFACTURER UNKNOWN). The patient was not allergic 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 21:30, the patient experienced shooting pain to left kidney. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. There was no treatment received for the adverse event experienced. The clinical outcome of the event kidney pain was unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

fatigue; Yellow urine; injection site pain; This is a spontaneous report from a contactable pharmacist (patient). A 35-year-old female patient received the first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, lot number: BL0142), intramuscular on the left arm on 31Dec2020 at 19:30 at a single dose for immunization. Medical history was not reported. There were no concomitant medications. The patient had no other vaccine in four weeks, no Covid prior vaccination and has not been tested positive for Covid post vaccination. The patient had yellow urine, injection site pain, and fatigue on 01Jan2021, and received Tylenol or ibuprofen as treatment for the events. The events had not resolved.

On Saturday, January 23, 2021 I woke up around 5:30 in the morning with itchy hands and feet, after my second dose/ Just as I did with my first dose- Which subsided with Benadryl. However the second dose was given Thursday, January 21. The progressing of the itchy hands and feet lead to my bottom lip swelling excessively large , my tongue begin to swell, my upper lip begin to swell, my lungs begin to burn in my airway begin to tighten. I took two Benadryl and called my family to call 911 and take me to the emergency room. My blood pressure was very low pulse was very high. I had genital pain and swelling, dizziness , nausea vomiting, and extreme body pain. I was given epinephrine, breathing treatments, steroids, Benadryl, and IV fluids. Labs were drawn and my creatinine was high. After about four hours the swelling has gone down and I was able to go home. I have to take steroids for three days, Benadryl for seven , and famotidine. I have no history of severe allergies, in fact I was tested for food and environmental allergies about a year ago and everything came back negative. I have no history of reacting to any vaccine at any time.

102+ degree fever Chills Body aches Nausea Vomiting From 15 hours after vaccine to 36 hours after second dose Also now I have a uti which may or not be related to vaccine

About 5 minutes after first dose, patient complained of feeling weak, tired, and lightheaded. Staff noticed she looked pale. She was transferred to a wheelchair, became unresponsive and slumped, and had decorticate posturing for about 15 seconds. Patient awoke and was immediately oriented. Patient was taken from clinic to ED via wheelchair. Of note, patient stated she has a history of syncope, which is worse when needles are involved, and has had similar episodes with phlebotomy in the past. Discharged home in stable condition.

Thursday 4/15/21 7pm: out of no where, marked increase in thirst/urination and dry mouth, tip of tongue numbing. Increased breathing/heart rate, random body chill and clammy handswith some tingling . Lasted ~1-2 hours. Friday 4/16/21: intermittent episodes of the same described above throughout day. Saturday 4/17/21: still experincing intermittent episodes, went to urgent care for exam as for 20 minutes hard to catch breath [was having anxiety at this point]. Calmed down and nothing foumd on exam. Sunday 4/18/21 still feeling off, but syptoms less intense. Monday 4/19/21 felt more normal, then had episode of vision spotting then complete blurriness in left eye for 10 minutes, followed by head pressure/headache for couple hours. Tuesday 4/20/21. Mild dry mouth all day and some jaw soreness in evening. Wednesday 4/21/21 felt normal all day. Thursday 4/22/21 sinus pressure for few hours/head congestion and dry mouth again. Today 4/23/21, still mild dry mouth.

dizziness; headache; pain; fatigue; nausea; vomiting; Menstruation delayed; Urinate every 5 to 10 min; This is a spontaneous report from a contactable consumer (patient). A 35-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on 20Apr2021 at 14:45, at single dose, for COVID-19 immunisation. Medical history was none. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications were not reported. The patient previously took hydrocodone (unknown manufacturer) and the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced dizziness (hospitalization for 1 day) in 2021 with outcome of recovering, headache (hospitalization for 1 day) in 2021 with outcome of recovering, pain (hospitalization for 1 day) in 2021 with outcome of recovering, fatigue (hospitalization for 1 day) in 2021 with outcome of recovering, nausea (hospitalization for 1 day) in 2021 with outcome of recovering, vomiting (hospitalization for 1 day) in 2021 with outcome of recovering, menstruation delayed (hospitalization for 1 day) in 2021 with outcome of recovering, urinate every 5 to 10 min (hospitalization for 1 day) in 2021 with outcome of recovering. The patient has not been tested for COVID-19 since vaccination. The information on the lot/batch number has been requested.

Developed darker discolored urine Monday afternoon of my 2nd vaccine (orange to tan in color). This persisted throughout the day and night of Tuesday but resolved Wednesday morning. I also had a sore arm, headache and some intermittent nausea and slight fatigue. Had another (single episode) discolored orange using the evening of Monday May 10, 1 week post vaccine.

night sweats; Sick; got an infected salivary gland. Also experienced night sweats without fever and fever from time to time; got an infected salivary gland. Also experienced night sweats without fever and fever from time to time; malaise; body aches; migraine; bladder infection right after infection.; This is a spontaneous report from a contactable consumer (patient). A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 20Apr2021 08:00 (Batch/Lot number was not reported), age at vaccination of 35-years-old, as single dose, for covid-19 immunisation. Medical history was none; the patient was not pregnant and was not pregnant at the time of vaccination. The patient had no allergy. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Left arm on 14Mar2021 08:00 , age at vaccination of 34-years-old, for covid-19 immunisation. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Apr2021 (07:00) the patient experienced malaise, body aches, migraine, bladder infection right after infection fever from time to time, sick with bladder infection for a month even with antibiotics. After bladder infection went away, the patient got an infected salivary gland. The patient also experienced night sweats without fever on an unspecified date. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient was treated with bactrim, prednisone (poison ivy) and cipro. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the event bladder infection on an unspecified date while was recovering from the other events. Information on the lot/batch number has been requested.

Dizzy w/ HA, Nausea-passed out in chair. Aprox 2 mins immediately came too when moved to wheelchair. Previous Hx of passing out with IV's. IUD removed today at 11:00am. No recall of event prior to passing out. Urinary incontinence. Vitals 107/71; 71; 99%SaO2.

I had fever, chills, body aches, headache, stomach ache and blood in urine for 2 days. I still have blood in urine.

After I received my first dose within 5 minutes I lost feeling in both of my arms and my legs (similar feeling of when your arm falls "asleep"...it was a tingling feeling). Then is started to go to my face a little bit. 10 minutes after my teeth started chattering and I started to get cold. Followed by severe shaking which lasted a few hours. Required me to go to the ER or evaluation.

1258 pt with loss of bladder control , diaphoretic, unable to obtain manual B/P x2, RR14, 02 SAT 89%. BLS provided. 1300 supervisor notified 911 called assisted to floor from chair. skin warm and dry resp even and unlabored, 02 applied @ 3 l /min via n/c . 1303 VS 115/80, 67, 99% on 02 3 l. 1308: EMS arrived. 1312: 100/63, p 62, 98% R/A. 1315 Accucheck by AMR. 1317: Pt refusing further treatment. Educated in seeking medical attention if symptoms return. 1320: PT left .

6 year old female received the 1st dose of the Pfizer COVID-19 vaccine at facility on 04/17/2021 @ 10:30. The same day, 04/17/2021, pt started experiencing pain in the arm at the injection site and fatigue. The pain in the arm resolved in 2 days, fatigue is still occurring. 04/20/2021 pt started experiencing dizziness, vertigo, nasal congestion, ears feel clogged, diarrhea, and paliptations, which are still occurring. Pt went to a hospital on 04/27/2021 and 04/30/2021 and had CAT scan of lungs and head. CAT scans were normal and kidney function was discovered to be low. Pt saw ENT, who stated the ear is swollen and prescribed Promethazine and Vancycovir. Pt is asthmatic and has a UTI. Pt takes Sulfamethoxazole-Trimethoprim, Metronidazole, Meclizine, Promethazine, Valacyclovir, and vitamins. Pt denies any allergies. Pt was advised to consult with ENT in regards to symptoms. SPI was consulted and Dr. was notified.

Urinary urgency and weakened bladder function. Feels like a UTI when I don?t have one. Having to pee allll the time and barely being able to hold it Dizziness and vertigo

I walked around the store for about 20 seconds. My arm started burning and throbbing. I walked into the aisle and sat my phone my card and keys on the shelf. I got light headed and told my friend that I felt weird. I grabbed the shelf and next thing I remember is him telling me to get up and trying to help me. I had passed out and was going into a seizure. I lost all functions of my bladder. Because I urinated on myself when I fell out. I was soaked in urine and sweat. I didn't report it. And just walked out because I was in shock I guess. But it's been 2 hours and I still feel sick. Nausea's

Prior to receiving the Covid 19 vaccine, I was pretty much in remission with respect to interstitial cystitis ("IC"). Shortly after the vaccine, I have experienced a constant flare up. I am in debilitating pain daily. The only new thing, was the vaccine. I have never experienced a flare up to last this long and not go away. Everyday I now struggle with a stabbing pain in my bladder, constant urge to urinate. There is no relief after urinating. The pain is constant. I have been tested and have no UTI.

102 degree fever -7pm day of injection - dissipated after 5am Severe body aches - 7pm day of injection - lasted all night into Monday afternoon Constantly having to urinate - since 10pm night of injection to current date - Thursday Kidney/back pain - since 10pm night of injection to current date - Thursday Slight fever and body aches Tuesday night to current day - Thursday

1/7/21: had thee COVID vaccine on 1/5/20 and developed symptoms an hour after administration chills, sweats and bodyaches. Also developed nausea, diarrhea and chest pain. Woke up this morning with cough and congestion. 1/10/21: called this morning to give us an update on her symptoms and see about a COVID swab. states that she is currently hooked up to an IV due to dehydration and no urine output. she has had zofran and pain medication for her severe abd pain. They have strep swabbed and flu swabbed but have not COVID swabbed. Encouraged getting a COVID. She states she will ask them for one and will call us with an update either today or tomorrow. 1/10/21: called and left voicemail stating that she was being discharged. they did COVID 48-72 hours for results. On ABX and Phenergan and Zofran alternating. Got two bags of LR has UTI and Kidney infection. CT with contrast lungs clear. Negative for flu and strep. Strep culture pending. added to spreadsheet since she was COVID tested. 1/14: Called regarding her Covid test. It was reported as negative. is still very sick with fever, sore throat, congestion, nausea. I spoke with Doctor regarding the extent of her symptoms following the vaccine. Doctor recommended that she be seen by her PCP as she has not improved. 1/14: called and went to her PCP as advised by Doctor. now has a UTI and URI. She is on Macrobid and Levoquin as well as Zofran and Phenergan. Her BP was 117/60 and dehydrated. Her PCP told her to monitor her BP and return to ER if not improved and also return to ER if symptoms became worse. will call on Monday 1/18/2020 and update us on her condition 1/17:COVID tests were negative, over 48 hours since a temp above 100.4, 99.1 was the last temp doing better. No more vomiting and no diarrhea. still has a cough and is still on ABX from all of her symptoms. Is on a cough suppressant so recommend her working from home since she is able and will update us towards the end of the week on how she is doing. 1/20: Received the COVID vaccine on 1/5/21. Released yesterday to work from home. No longer has vomiting or diarrhea. COVID, FLU and strep tests negative. Diagnosed with allergic reaction to COVID Vaccine. had kidney infection and UTI. CT of abdomen done with contrast. CXR to r/o pneumonia. continues to have a runny nose, no fever. Continues to have laryngitis and fatigue. called today to get released. Encouraged to call back when she gains more strength and can return. My PCP diagnosed me with a severe allergic reaction to the covid shot. I had the rapid covid test ran twice and the test sent out twice, all 4 tests came back negative. I had the flu test ran and it came back negative. So did the strep culture. I had 2 full lab workups ran and they both came back normal including my vitamin levels. The only thing that was out of alinement was my white cell count was high due to an infection. Today, I am currently running a fever of 99.4. I still have a cough that is rather irritating. I still do not have a voice. I am retaining color back in my skin. I am still tired and weak but have managed to work and do small things around the house such as cook dinner, wash laundry, clean dishes, and shower. These were daily tasks that I wasn't able to do during the first 2 weeks after taking the shot.

pain; Non-sexually transmitted severe genital sores; genital aphthous ulcers of unknown etiology with consequent severe dysuria; genital aphthous ulcers of unknown etiology with consequent severe dysuria; This is a spontaneous report from a contactable physician, the patient. A 37-years-old female patient (physician) received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EK9231), via an unspecified route of administration 13Jan2021 as a single dose for COVID-19 vaccination. It was Unknown if the patient was pregnant at Time of Vaccination. The facility in which the vaccination was administered was a Hospital. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medication included Vitamins. No other vaccines were given within 4 weeks. Since the vaccination the patient had not been tested for COVID-19. On 14Jan2021 at 22:15, The patient experienced non-sexually transmitted severe genital sores/genital aphthous ulcers of unknown etiology with consequent severe dysuria, pain, disabling from walking, sitting. The adverse events resulted in a physician's office/clinic visit. No treatment was given for the events. The clinical outcome of the events non-sexually transmitted severe genital sores/genital aphthous ulcers, severe dysuria, pain, disabling from walking, sitting was not recovered.

This is a 37 y.o. woman who developed an episode of acute self-limited hemolysis just over a week following her second injection of the Pfizer COVID-19 vaccine. She has been treated with ciprofloxacin and phenazopyridine immediately prior to the episode for a urinary tract infection. She had no history of hemolysis prior to this episode. She was in her usual state of health and received COVID-19 vaccines on 12/24 and 1/14 with the Pfizer vaccine and had no serious side effects at that time. She then developed dysuria and was seen by telehleath by her primary care physician who prescribed ciprofloxacin and phenazopyridine for her for 3 days ending 1/22. She took these and her dysuria resolved, however the day after developed what appeared to be blood in her urine. Then in the following 2 days which were a weekend this worsened and she started feeling poorly. She also noted that she appeared yellow. On Monday 1/25 her boyfriend took her to urgent care and she was subsequently sent to an ER at the hospital that referred her to our hospital. There she was evaluated for gross hematuria with no evidence of urinary bleeding and found to be anemic due to hemolysis. Her hemoglobin was in the 5's and she received 2 units of PRBCs. She was transferred here to Medical Center for further management. After the initial transfusion she did not require blood transfusion and her hemoglobin continued to increase until it was 10.4 on 2/1 which was the day of discharge. At a follow up appointment on 2/8/2021 she was recovering and feeling well. Her jaundice had resolved. No treatment was given from the hemolysis aside from the blood transfusion and it was self-limited. It is most likely that her acute hemolysis was due to the phenazopyridine as this agent is known to cause hemolysis and she took it for 3 days prior to the onset of hemolysis. She has no prior history of drug induced hemolysis and had not taken this medication previously. As this occurred just over a week following her second vaccination I cannot exclude that is could be related to the vaccine.

Pt was here for 1st dose of COVID vaccine. Had received vaccine approx. ten minutes before incident. Pt noted to be slumped in chair, hives noted to forehead, diaphoretic, arms rigid, non-responsive to stimuli, Incontinent of bladder. Pt lowered to ground Zoll applied, COR called. Vital signs: 108/58 100% RA 77 26. Pt given EPI-Pen @ approx. 1352. COR Team arrived, pt mildly responsive. Assisted to Backboard and sent to ER with ED Provider. Pt was monitored in the ED for 3 hours with no recurrent symptoms. Pt advised to follow up with PCP and an allergist and avoid getting the 2nd dose of the covid vaccine.

Within minutes I had pin prick red dots on my right arm. We were at a drive through clinic waiting the 15 minutes in the parking lot before leaving and had the paramedic from the ambulance come look. I leaned into the seat to let my husband photograph my dots, and where my shoulder was leaning into the seat, I immediately had a smattering of red pin prick dots. They began showing on my left arm. We were advised to go to the ER. My hemoglobin was fine (though clotting factors were off), and he?d see a few reactions like that, so we were sent home. I had diarrhea, abdominal pain, and severe nausea, but nothing scary or bad. I woke to not being able to urinate, and that was followed with complete incontinence. I cannot control my bladder at all, cannot urinate on demand, and often don?t realize I?m urinating until I feel the warm gush.

MINOR HEACHACHE BEFORE VACCINATION. POUNDING SEVERE HEADACHE SHORTLY AFTER IMMUNIZATION. SEVERE FATIGUE LASTED 4 DAYS AFTER IMMUNIZATION. SENSITIVE EMOTIONALLY/ FULL BLOWN PMS FOR 1 WEEK AFTER VACCINATION. ON MARCH 22ND, HAD BREAK THROUGH BLEEDING ON DAY 19 OF CYCLE. BREAK THROUGH BLEEDING LASTED 1 DAY, IN THE MORNING, FEELING PRESSURE SIMILAR TO UTI, OR DEHYDRATED. TOTAL OF 3 TIMES FELT PRESSURE ON BLADDER LIKE HAD TO URINATE. MENSES ON TIME NOW, APRIL 1ST PERIOD STARTED NORMALLY. PATIENT HAD SEVERE NAUSEA ON FRIDAY 3/26 FOR A FEW HOURS THEN NAUSEA REAPPEARED NEXT DAY FOR 15 MINUTES. PATIENT IS NOT PREGNANT.

Left arm numbness, headache, all over muscle pain, kidney pain, chest pressure, nausea, vomiting, dizziness

5-10min post injection: metallic taste in mouth 1 hr post injection: sudden dry skin, increased thirst, increased urination, pulse at mid 80s, oxygen saturation at 98 12hrs post injection: diarrhea for 1 hr 18hrs post injection: fever/chills , headache, dizziness & nausea develop; pulse increases to high 90s and oxygen dropped to low 90s 24hrs post injection: fever at 102.4-102.8, increased pulse, oxygen dropped to high 80s. 28-33 hrs post injection: pulse at low 100s, oxygen saturation between 86-90, squeezing chest pain on some beats, handheld ekg monitor detects multiple possible vpb RonT , blood pressure 128/68 45 hrs post injection: oxygen saturation in low-mid 90s, fever dropped to 100-101, No abnormal beats detected on EKG monitor. Nausea gone. 48-54 hrs post injection: fever drops to 99.

Severe UTI symptoms . Went to minute clinic. Got negative for UTI in store urine test. When send to culture, it had little step. Got antibotics in 2days. By the time i got my symptims went down. I took antibiotics for 3 days . I still have uti sysmptoms once a day. Not sure what it is.. i had uti before in my life but this time the symptoms are different and very bad . Over the counter medication is of no use .

UTI Symptoms , like Blood in Urine with fever and Headache. Headache with ear pain and Nerve at back side of the ear swollen . Bell's Palsy to the right side of the face.

Sharp pain between should blades, pain eased slightly with trunk extension (laying on a foam roller on floor). The following day the pain in back disappeared, but had bilateral kidney pain that lasted 2 days.

Symptoms, most severe to least: Seizure (non-epileptic): 3:05-3-45pm, May 12th, 2021 2:55-3:25am, May 15th, 2021 Approx 1-2pm, May 27th, 2021 4:45-5:20, June 6th, 2021 These are a half-hour+ of jerking (arms and legs) many times a minute, back arching, muscle locks, and muscle spasms. I retain consciousness and control between jerks, usually, though they are very painful and exhausting. Note: I do have a medical history of Tourette?s, so these non-epileptic seizures are not new to me, and are generally manageable at home with hydration and safety practices unless they last more than a few hours. But I hadn?t had any in a couple years prior to the shot, as they are far more rare than they were a decade ago. Weakness (cannot walk or stand unsupported, cannot lift heavy (and sometimes even light) objects, wobbly legs, shaky arms, etc.) 2:50pm, May 12th to present This weakness rapidly increased from wobbly legs in the waiting room to unable to walk on my own or stand unsupported. It was extremely bad the first few days, then from May 17th seemed to slowly get a bit better day by day as I could walk a few steps and lift a jug of milk, then relapsed and has varied in terms of how extreme it is day by day. Currently I am using a walker to get around the house, except on days where I am too weak for that and have to stay mostly in bed. Weakness on evening of Jun 1st was so bad that my head felt like a bowling ball I was trying to balance, and I could not hold my head up unassisted as it would fall forward, backward, or to the side. I went to bed early (7:30 about) and in the morning I could move my head again normally. Lots of falls and partial falls (Often body ?locks down? after a fall and I cannot move my legs, and sometimes arms, to get up again unassisted, so I?ve been on the floor 5+ minutes.) Most falls from standing or walking position, but a few have been from sitting or kneeling. Some of these feel like legs or back giving out due to weakness, others feel like my legs or back just stopped working right. Dizzines: 2:45pm, May 12th to Evening May 14th It?s been on/off since, but has mostly cleared up. Severe Fatigue: 3:00pm, May 12th to present Very tired, need a lot of extra sleep, hard to focus on things. Even climbing stairs or walking a bit with the walker can be exhausting and I need a long break of sitting to recuperate. Some days am so weak and tired I have to stay in bed, and can?t get much done. Pain: May 12th to present. It increases with activity and sometimes at night in back/right hip/left wrist especially. Left wrist is the most severe in persistence ? it will often buckle in pain if I try to support myself with it or catch myself from a fall with it. Pain in my right leg was also so bad the night of the 13th it was difficult to sleep. My spine, left wrist, and right hip/pelvis seem to have the worst on/off pain, though my back and legs often ache a lot in the early morning. ?Glitchy? muscles: May 12th to present, worsening. Goes along with the weakness, but it feels like a muscle (especially legs) will glitch out and not work right. This slowly got worse for about a week after the shot, and has been pretty bad since. While sometimes the glitching causes my legs to buckle or I?ll drop something because my hand releases, it more commonly is just weird things like my legs and feet turning sideways or pointing weird. Minor to moderate stabby headache: 2:50pm 12th to present, intermittent, managed by Tylenol. It was worse the first week after, but now seems to be every few days. Earaches: ~May 17th to present. On and off, often accompany headaches - every few days. Both ears, sometimes just right. Sore arm: From injection around 2:40pm May 12th to morning of the 14th There are spots in the upper left arm which are still sore when pressed. As mentioned under the pain section, my left wrist still hurts immensely when weight is put on it. Minor Fever (estimate 99-100 degrees max) and/or Hot/Cold flashes: Had chills and low fevers? It seemed on and off for a few days after the vaccine, so more than just recorded. Night of the 12th, broke around 2am on the 13th Night of the 14th, broke around 2:45am on the 15th Afternoon of the 15th, broke around 6pm June 9th, some of the day on and off Abdominal Cramps & nasuea: 12th-14th (not on period or pregnant at that time.) Bowl issues: Mild Diarrhea for a couple of weeks after the shot. It also was more difficult to go pee/empty my bladder, as muscles seemed week and it could take 20 minutes to empty my bladder incrementally. I also had some minor leaking. This cleared up, though, no current bowl issues. Shortness of breath: Mild shortness of breath after the shot for a couple days where I could not speak at extra volume, read aloud or talk for a length of time, or take ?deep? breaths. This has mostly resolved though sometimes I will briefly get a little short of breath. Muscle twitching and jerks: Since childhood. Since May 12th it has been worse than in the past few years, though. Started calming down a bit about June 10th. Brain fog: For about a month after the shot, it was really hard to focus or keep on top of things. It got to the point my kids would literally move my head towards them and say, "mommy, you aren't listening!" to get my attention, and my sister and others also complained that I wasn't focusing on them. It was really hard to manage paperwork and arranging doctors as well.

Infected tooth nerve 12 days after first pfizer vaccine. No history of tooth issues. UTI 14 days after 2nd pfizer vaccine. No history of UTI or infection.

Kidney Function dropped to 50% as of 4/19/21, diagnosed with Stage 3 Kidney disease; This is a spontaneous report from a contactable other hcp (patient). A 37-year-old female patient received bnt162b2 via an unspecified route of administration, administered in right arm on 19Apr2021 (Lot Number: Er8735) as dose 2, single at the age of 37-year-old for covid-19 immunization. Historic vaccine was bnt162b2, via an unspecified route of administration, administered in right arm on 29Mar2021 (Lot Number: Er8734) as dose 1, single at the age of 37-year-old for covid-19 immunization. The patient was not pregnant. Medical history included graves disease (in remission) from an unknown date. The patient had not gotten period since 19Mar2021, even after taking medroxy progesterone prescribed by OB/GYN to start period. The patient had known allergies to adhesives, zolpidem tartrate (AMBIEN), and codeine. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lurasidone hydrochloride (LATUDA), aripiprazole (ABILIFY), lorazepam, eszopiclone (LUNESTA), and paracetamol (PA.), all taken for an unspecified indication, within 2 weeks of vaccination. 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 had not been tested for COVID-19. The patient experienced Kidney function dropped to 50% as of 19Apr2021, diagnosed with Stage 3 Kidney disease on 19Apr2021 (pending clarification). The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included renal disorder kidney function dropped to 50% as of 19Apr2021. The outcome of events was not recovered.; Sender's Comments: Based on currently known drug safety profile, the reported event more likely represented intercurrent illness, but not related to bnt162b2. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.

Frequent urination days after receiving first dose vaccine; urgent urination days after receiving first dose vaccine.; This is a spontaneous report from a non-contactable consumer, the patient. A 37-year-old non pregnant female patient received a first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318), via an unspecified route of administration in left arm on 06Feb2021 at 10:15 (at the age of 37-years-old) as a single dose for COVID-19 immunisation. Medical history included none. The patient was allergic to the drug benzole peroxide. Concomitant medications were not reported. The patient had not been diagnosed with COVID-19 prior to the vaccination. The patient underwent lab tests and procedures which included nasal swab test in Mar2021 and tested negative. The patient had also received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in left arm in Mar2021 as a single dose for COVID-19 immunisation. On 10Feb2021, at 10:00 the patient had experienced frequent urination and urgent urination after receiving the first dose vaccine. No treatment was received for the adverse events. The clinical outcome of the events frequent urination and urgent urination was not recovered at the time of report. No follow-up attempts are possible; No further information is expected.

On Saturday May 22nd 2021, I was 5 weeks and 5 days pregnant. I had my second Pfizer vaccination at around 9am. Approximately four hours later, I experienced problems trying to empty my bladder. Severe abdominal pain developed. We went to urgent care, they sent me to the nearest ER. I was advised to stay overnight. The pain persisted. The following morning, urine was drained from my bladder with a urinary catheter. We were told it was near to 2 liters in volume. It was deemed a case of urinary retention. I had to continue wearing a catheter on leaving hospital. A urologist later suggested self-catheterization. I tried it. It was painful and distressing. I opted for an indwelling catheter to go back in. I wore a catheter until June 29, 2021. That's more than five weeks after the day of occurrence. No previous pregnancy. Due date: Jan 17, 2022.

Evening of 1-17-21 felt like I was having horrible vaginal infection symptoms. Saw a primary care physician on 1-18-21 and was found to have a raging yeast infection, bacterial vaginitis and urinary tract infection. I haven't had any of these in 15+ years. I was started on antibiotics. Next morning (1-19-21) felt extreme lower abdominal fullness and pressure and extreme nausea. I got in with my OBGYN at 9am same day and he discovered I had an ovarian cyst. He sent me down for an ultrasound and the results showed I had a ruptured ovarian cyst on my left side and an ovarian cyst on my right side. I have never had an ovarian cyst in my life. The next day (1-20-21) the right cyst ruptured. Having all three infections and two ovarian cysts (when I've never had one before) lead my OBGYN and I to feel it warranted filing a VARES report

2/12/2021 Vaccine 2/13/2021 Weakness, oral ulcers 2/17/2021 Brought to ER for loss of consciousness, altered mental status, rectal bleeding; work up showed sepsis, UTI, anemia, pneumonia, pleural effusion, pancytopenia, hypotension; persistent hypotension and respiratory failure 2/18/2021 Passed away at 5:54AM

# AKI with non-nephrotic range proteinuia and microscopic hematuria # Neutrophilia # Fevers # Normocytic anemia # Thrombocytosis # Coagulopathy # RUE Superficial venous thrombosis # Subconjunctival hemorrhage # Flame hemorrhage R fundus # Mild iridocyclitis # CRP elevation # Procalcitonin elevation # D Dimer elevation # Anasarca # Elevated BNP # Hypoalbuminemia # Small pericardial effusion # Elevated alk phos, bilirubin (direct predominant), and AST # Elevated lipase # Hypocomplementemia with low CH50 # Elevated IL2 Receptor (8540) # Aseptic meningitis w CSF with lymphohistiocytic predominant pleocytosis (25 nuc cells with 49% lymphs, 35% histiocytes, 16% pmn, glucose 41, protein 155 with neg meningoencephalitis panel)

Fatigue, blurred vision, increased thirst, increased urination after receiving second vaccination (Started 2/10/21)

The first night I had sever kidney pain on my right side, I thought I was going to have to go to the hospital. Since then, I have had Chills and a headache and severe nausea.

Brain fog, severe headache, blurred vision, constant urination, fatigue , leg cramps, trouble breathing and irregular heart beat. that have lasted since day of vaccine. Still suffering from some symptoms

still have neck pain on left side where injection was administer; Vaginal labia manora are swollen and skin is sensitive to touch; Vaginal labia manora are swollen and skin is sensitive to touch; I cannot walk or urinate since vulva is irritated; I cannot walk or urinate since vulva is irritated; I cannot walk or urinate since vulva is irritated; I cannot walk or urinate since vulva is irritated; ER diagnosis said I have a acquired disorder of genital organ.; Within 1.5 hr of vaccine started experiencing vaginal pain; Also experienced swollen lymph nodes under arm pit to enlarge; This is a spontaneous report received a contactable other healthcare professional, the patient. A 38-year-old [non-pregnant] adult female received the second dose of BNT162b2 (solution for injection; Lot unknown and expiry information not provided) as a single dose via unspecified route in the left arm on 20Apr2021 at 10:00 (at 38-years-old) for COVID-19 immunisation. Relevant medical history included Autoimmune Hashimoto's, penicillin allergy and known allergies to gluten, soy, dairy, wheat, malt and eggs. Concomitant medications sans therapy dates included levothyroxine sodium (TIROSINT) for thyroid; and liothyronine sodium (CYTOMEL) for thyroid. The patient previously received Covid-19 immunisation with first dose of BNT162b2 (Lot unknown) in left arm on 30Mar2021 at 10:00 (at 38-years-old). The patient denied COVID-19 prior to the vaccine and the patient was not pregnant at the time of vaccination. The patient denied receiving any other vaccine within four weeks prior to this vaccine. On 20Apr2021 at 12:00, reported as about one- and one-half hours after receiving the vaccine, the patient began to experience vaginal pain. The patient reported that she also experienced swollen lymph nodes under arm pit to enlarge, still have neck pain on left side where injection was administered. The patient explained that her labia majora are swollen, and the skin is sensitive to touch. The patient explained that she went to the emergency room (ER) because she could not walk or urinate as her vulva was irritated. The patient reported that the only thing that she did this week was get vaccinated and the ER diagnosis said she had an acquired disorder of genital organ and advised an obstetrical /gynecological consultation. The patient stated she never had this problem. The patient assessed the events serious (Disability or permanent damage). Relevant testing included a negative post-vaccination COVID-19 test via nasal swab on 20Oct2020 (as reported). There was unspecified treatment received for the events. The outcome of the events vaginal pain, swollen lymph nodes under arm pit to enlarge, neck pain on left side, labia majora are swollen, skin is sensitive to touch, vulva was irritated, was not recovered. The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.; Sender's Comments: Based on chronological connection to the vaccine a causal relationship between reported events and BNT162b2 vaccine cannot be completely excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

The morning following my vaccination, I began experiencing gross hematuria. This condition has continued for 24 hours now.

Started with constipation, chest pressure, nausea, vomiting and malaise about 6 hours after vaccination. Symptoms persistent for one week then developed jaundice and dark urine. These symptoms persisted for 3 days then self resolved.

urinary urgency, lumbar pain, leg paresthesia, arthralgia, gonalgia, genital area paresthesia, urine retention

Lymph Nodes swelling, fever, body aches, nausea, UTI, heavy menstruation, missing skipped menstrual cycle in month of May.

I got the second vaccine and I had severe abdominal pain and I went to the UTI and they sent me to the ER and they taught it was appendicitis but it was not and they sent me home and it turned out to be COVID again and I had fever and severe abdominal pain.

Pt states the day after her vaccination she had body aches, headaches, flank pain, severe fatigue, hematuria and proteinuria most symptoms resolved 3-4 days after onset.

UTI; some issues with continuing to empty bladder; This is a spontaneous report from a contactable consumer (patient herself). A 38-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EW0180) via an unspecified route of administration at (upper) arm left (at the age of 38-year-old) on 07Jun2021 10:00 as single dose for covid-19 immunisation. Medical history included ongoing ehlers-danlos syndrome (she was diagnosed with this many many years ago since it is genetic). Concomitant medications were not reported. The patient had no AE and Prior Vaccinations (within 4 weeks). On 07Jun2021, patient had first dose last week on Monday which was given at approximately 10:00 am and by late afternoon and after that she reported that she had some issues with continuing to empty her bladder which resulted in really bad UTI and she has been struggling with it ever since. The patient stated this significantly worsened and so she saw an urgent care doctor and they were not sure if the antibiotics would be strong enough because there was a possibility of it going to her kidneys. The patient also stated for UTI, it has improved since getting (unspecified) antibiotics. The patient did not visit to emergency room. The patient went to the urgent care. The outcome of the event some issues with continuing to empty bladder was not recovered and urinary tract infection was recovering. No follow-up attempts are possible. No further information is expected.

Seven minutes after the patient received the Pfizer Dose 1 COVID-19 vaccination, patient started to feel nervous and hot. While waiting to receive some water she started complaining of being dizzy and wanted to lie down. The pharmacist escorted her to the immunization area and the patient became weak and started loosing her balance. She was put in a sitting position on the floor with her legs out. She then went into a blank stare to the ground, her hands flexed to her side, and wet herself. She became alert within seconds and was talking and acting normally. We called EMS and they transferred her to an emergency room for evaluation.

Painful and frequent urination; Painful and frequent urination; This is a spontaneous report from a contactable consumer(patient). A 38-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Jun2021 (at the age of 38-year-old) as 2nd dose, single dose for covid-19 immunization. Medical history included high BP. Concomitant medication included amlodipine besilate (AMLOPRES) 5 mg taken for hypertension, start and stop unknown. The patient previously took Varicella for chicken pox in the left shoulder near the armpit on 22Apr2021, BNT162B2 (BNT162B2, solution for injection, Batch/Lot: EW0173) administered in left arm on 09May2021 as 1st dose, single dose for covid-19 immunization. On 04Jun2021, after 2 days of vaccination actually patient experienced side effect of painful and frequent urination. She wanted to understand is this normal, how long the side effects be like that only or she has to check with her doctor. Lab tests: patient stated, "Not recently, last month actually, before the vaccination, before the first shot, just preventive checkups, like to check our immunity.". Outcome of the events was unknown. Follow up attempts are needed. Further information has been requested.

I woke up in severe pain and itching two days after getting the first injection. There was a shooting pain in my neck down the spine, hands l, feet and left buttock. I realized later that morning that I was covered in hives. My hands and feet were swollen, very red and sensitive to the touch as well as a sensitivity to heat. I took benadryl and Aleve to help with itching and pain for 3 days and it never got any better so I went to urgent care. The provider told me that I was having a allergic reaction to the vaccine. He also told me that I appeared to have cellulitis on my buttock and a UTI. I was given two steroid shots, antibiotics and hydroxyzine and warned me not to get the second dose of the vaccine. Four days went by and the pain and itching seemed to get worse. While I was at my daughter's Dr office (Allergy Asthma and Immunology) for an appointment, the nurses noticed my rash was purple and told me that they wanted to have someone look at it for me. The provider gave me another steroid injection and oral steroids and again advised me not to take the next injection until I have been skin tested. This seemed to help calm my skin. Then I began to peel all over and I am still peeling. June 9th I followed up with my PCP and was told again that the rash was a allergic reaction to the vaccine and that it had actually cause burns. What the urgent care provider thought was cellulitis on my buttock was actually a second degree burn. It is slowly healing.

Systemic: Fever-Medium, Systemic: Hypertension-Severe, Systemic: Tachycardia-Severe, Additional Details: Heart flutter, very high blood pressure and heart rate, 103 degree fever, skin pain, painful urination - patient went to ER

Diarrhea; vomiting; insomnia; muscle aches/ all over body pain 5 days; muscle aches/ all over body pain 5 days; kidney and bladder cramping pain 2 days; kidney and bladder cramping pain 2 days; chills; low grade fever 101; headaches; Dose Number 1(19Apr2021); Dose Number 2 (03May2021); This is a spontaneous report from a contactable consumer (patient). A 38-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: 2W0175 or ZL0175) via unspecified route in right arm single dos for COVID-19 immunization on 03May2021 18:15, at 38-year-old. The patient medical history was not reported. Concomitant medications included echinacea angustifolia root, echinacea purpurea root, hydrastis canadensis root (ECHINACEA & GOLDENSEAL); herbal nos, minerals nos, vitamins nos (WOMENS ULTRA MEGA). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8730) in right arm for COVID-19 immunization on 19Apr2021 18:15, at 38-year-old; codeine and experienced allergies. The patient had diarrhea 72 hours, vomiting 6 hours, insomnia 4 days, muscle aches/ all over body pain 5 days, kidney and bladder cramping pain 2 days, chills 2 days, low grade fever 101- 6 hours, headaches more than 6 days; all were on 03May2021 20:00, resulted in doctor or other healthcare professional office/clinic visit, with outcome of recovering after receiving treatment (palliative care, over the counter remedies). Outcome of the other event was unknown. No follow-up attempts are possible. No further information is expected.

Abnormal urinalysis; Bilateral flank pain; Gross hematuria; Hematuria, unspecified type; Nausea; Ureteral calculus

Since February- dizziness, lightheadedness, brain fog, migraines, depression, anxiety, memory loss, difficulty finding words, elevated HR, palpitations, shortness of breath, incontinence, nausea, vomiting, diarrhea, continuous tremors, muscle spasms, neuropathy, joint pain, swollen lymph nodes

I received my first COVID 19 Pfizer Vaccine on 7/22/21. I woke up at 5am on 7/23/21 having pain with urination. I?ve had a UTI before (approximately 2-3 years ago) and recognized the symptoms. I bought cranberry juice, Azo, and cranberry extract capsules. I am currently treating it at home but will visit a doctor if symptoms don?t clear up in a day or two.

I have been getting severe migraines. I was getting them once or twice a month after the vaccine but in the last month, I have had four or five a week (prior to vaccine I would get light sensitivity and bad headache but that was once every three-five months). When I'm having the migraines, I have no recollection of what I am doing or where I am. I have full conversations with people but they don't make sense, I ask "Did you remember the spaghetti for Thanksgiving?" To me, the sentence makes sense. I can be in the middle of the sentence and I pass out. Medication for the migraines, I was put on Fioricet and Phenalgin for nausea and Ubrelvy (migraine preventative pill, can take it when I start to feel one coming on). Doctor just put me on a monthly shot. Aimovig, that's a one-time monthly injection. At the time of the event, they help but overall no they are not stopping it. I've had ER visits, two, both were at the same hospital and they did bloodwork and imaging. One was in January and the other one was April 15th.

I received my vaccine at 8:40 am on 1/6/20. By that evening I noticed I was having decreased urine output. Starting Thursday morning I had very minimal urine output for18 hours. I also had flank pain. During this time I also had a fever, body aches, etc. I am an ED nurse and knew to hydrate myself. I hydrated all day and evening. Thursday night I had no urine output for 6+ hours. Starting Friday morning I had minimal urine output and it was brown tinged. As the day progressed my output increased slowly and changed from brown to pink/orange. I continued to hydrate drastically. Saturday morning my urine was pale yellow and clear and my pain was gone. I believe I had an acute kidney injury. Fortunately I knew to drastically hydrate and maintain that.

developed UTI very quickly; Puffy face and eyes; Puffy face and eyes; Burning inside digestive tract; Diarrhea; Dehydrated; arm pain; Headache; At bedtime neck stiffness began and worsened; This is a spontaneous report from a contactable healthcare professional. A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number EL3246/expiration date unknown), dose number 1, via an unspecified route of administration on 02Jan2021 10:30 at a single dose on the left arm for COVID-19 immunization. The patient had no relevant medical history. Concomitant medications included alprazolam (XANAX). The patient experienced arm pain and headache 4 hours post injection requiring Excedrin. At bedtime, neck stiffness began and worsened. She was treated with lidocaine patches and Aleve. She developed diarrhea 33 hours post injection. She went ER because she was dehydrated. She developed UTI very quickly by hour 35 post injection. She had puffy face and eyes, and burning inside her digestive tract. She was treated with Benedryl at home for allergic reaction, Toradol for pain, IV fluids for dehydration and Keflex for infection. The patient was not diagnosed with COVID-19 prior vaccination and was not tested for COVID-19 since vaccination. The outcome of the events was recovering.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of event Dehydration cannot be totally excluded. The case will be reassessed if additional information becomes 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.

Shaking from chills and fever, extreme thirst followed by vomiting, moderate headache, body ache, kidney area pain. Fatigue following. Missed work the following day.

Patient had the initial Pfizer COVID vaccine on December 18th. She started to having arthralgias, myalgias, fever, fatigue and weakness starting on December 20th. The patient continuously had arthralgias, myalgias and weakness for the next few weeks. Patient follow up with physical therapist once a week to work on muscle weakness. The patient continuously had arthralgias and myalgias until January 10th. Primary care provider on January 7th orders CBC, autoimmune and thyroid panel since patient was having ongoing myalgias and arthralgias. Patient postpone 2nd dose because side effects from previous vaccine were ongoing. Patient got 2nd dose vaccine on January 12th at 4:30pm. On January 13th at 11am the patient initially had nausea and arthralgias. Patient took Zofran 4mg ODT about 11:15am. 30mins later the patient tongue swelled. No lips swelling and no SOB. Patient immediately took liquid Benadryl 50mg to 75mg PO. Patient immediately drove to ED. Patient was observed until 2pm for signs and symptoms of allergic reaction. Patient was discharge and advised to take Benadryl 25mg to 50mg every 4 to 6 hrs prn allergic reaction, Patient took famotidine 20mg at 4pm along with 25mg of Benadryl PO. Tongue swelling began to decrease. Patient also had fever, myalgia and arthralgias at 4:30pm. Took Tylenol 1,000mg and symptoms subsided (fever, myalgia and arthralgias).

1 week after receiving the first dose, in the afternoon i had loose stool followed by some mild abdominal cramping for the rest of the day. I took some ibuprofen. The following morning (Wednesday), the pain was on my right abdomen and right flank area only. It was persistent, achy, soreness. My insides felt very tender to put any pressure on my right abdomen or flank. The pain on the right side of my back became more intense as the day went on. I had sharp right flank pain when lifting my right leg after showering to get dressing and use lotion. When I was walking up the stairs I turned to the left and had a sharp pain in the right flank again, taking my breath away for a moment. Around 4pm I took ibuprofen. About an hour later my eyes felt hot and tired. My cheeks were pink. My temp was 99.2. I generally just didn't feel good from this achiness. I took Benadryl and went to bed at 7pm, and slept for about 12 hours, waking once at midnight. The following day (Thursday) I felt 99% better and contacted my doctors office. When putting pressure on the same areas I could feel very slight tenderness if I pushed hard. That evening and into the next morning (Friday) I was mildly achy on my right side but barely at all. I didn't feel any more discomfort until this past week on the 22nd or 23rd. During sexual intercourse I felt that same mild internal tenderness on my right side. At this time, I don't believe I have any pain. My urine seems unusually clear, light colored, and smaller volume but this is very subjective. I have some abdominal swelling but this has been present since my breast reconstruction in January of 2020 and seems to get worse or better depending on the days activities or meals so it's hard to know what causes what. Labs were done on 1/22 showing decreased kidney fuction. Pending tests include an ultrasound of the Right Ovary that remains after the hysterectomy, bladder, and kidney. In addition to a 24 hour urine and some other urine studies.

Severe nausea/vomiting began ~6 hours after receiving vaccine. (Tuesday 1/26 at 3 p.m.) Vomiting continued around the clock until Friday 1/29 at 4 p.m. when I went to Urgent Care. At that time I had not urinated in more than 24 hours. I received 2 liters of normal saline and 1 dose of IV Zofran and was sent home with a prescription for oral Zofran. The vomiting began again after the IV Zofran wore off and I could not keep oral Zofran down. (1/29 at 9 p.m). Vomited through the night and presented to ER Saturday 1/30 at 7 a.m. Given 1 liter normal saline as well as IV Zofran and IV Reglan to stop vomiting. They also did ultrasound of large lump on back of neck that was painful and had started after receiving vaccine. Had labs drawn. Sent home with phenergan suppositories. Currently Sunday 1/31 and have not vomited since 1/30 at 7 a.m. but have been taking phenergan/Zofran /meclizine around the clock. Severely nauseous with anything in stomach. Tolerating 1/2 popsicle every 2-3 hours only.

Progressive body numbness and tingling from chest down, unable to feel when urinating or have a bowel movement, tight girdle banding feeling on and around chest and back, hand malfunction with drawing, unable to walk without cane/walker, feeling of walking on a bounce house as walking

Pain in arm was so bad I was unable to use my arm for several hours. Was treated five times for a bladder infection, was determined that their was blood in my urine. Being referred to urology. Had to take Benadryl and ibuprofen for swelling of face and neck. Burning of urinary tract has been extremely bad and still has not subsided. Still having very bad flare ups of these symptoms including severe nauseas and dizziness (vertigo). Having to eat bland foods and take Pepto everyday. Severe Fatigue. 10 days ago I was sent home from work due to feeling bad and looking ill (very pale). Hospital wanted to keep me overnight.

The day I received the vaccine, I noticed that I feel thirsty later in the day. I didn't really take much into it and it seemed to be ok the next couple days. 5 days later, I woke up to extreme thirst and a very salty taste in my mouth. This continued until the day after two weeks after receiving the 2nd dose. It has now gone away so I think it was related. My doctor ran my AIC (fasting and not) the first week and several blood work on electrolytes, thyroid etc. Everything was normal and my blood sugar is controlled (as it was before the vaccine). I also had COVID in December (a mild case) and recovered fully. I also noted my urine was yellow (not scary, hospital) yellow but dark. No matter how much water I drank, it did not change. I also drank Gatorade etc. and that didn't change anything. After receiving the 2nd dose, two weeks later is when I noticed it start to be a little better and then two more days later, it went away.

Right leg numbness and unable to move it, partial right arm numbness and left leg numbness unable to walk. Bladder infection secondary at time. Severe back pain.

Urgency to urinate. No infection or prior history of UTI or cystitis prior to second vaccination dose.

I experienced the common side effect (flu-like symptoms, sore arm, fatigue) starting the evening of the shot and through the next day. Treated with Acetaminophen and Ibuprofen. About twenty-six hours following the dose, I began to see blood in my urine. I had no UTI symptoms at all (frequency, urgency, discomfort), nor any back or abdominal pain that would indicate kidney stones. I made an appointment with my gyn on 4/23 and followed up with a visit to an urgent care center on 4/24.

First pregnancy - EDC 09/18/21, RH negative (spouse is positive), Advanced maternal age - First adverse event on 09/11/21 included minor spotting while using the bathroom 2 days after 2nd dose of the Pfizer shot - pregnancy at 17 weeks, 1 day. I contacted my doctor via the online message system and advised her of the spotting. She instructed me to rest and take fluids. - Second adverse event on 09/13/21 (17 weeks, 3 days pregnant)- I woke up with a swollen right eye, which was crusted shut with mucus. My first thought was that it was either debris in my eye or pink eye. I made an appointment with the eye doctor and he said that it's likely a stye forming and to use a warm compress. - Third adverse event on 09/16/21 (17 weeks, 6 days pregnant) - I tried using the bathroom to pass a stool and was finding myself a bit constipated (which hasn't been uncommon in this pregnancy). I experienced enough bleeding to have blood in the toilet and continuous blood while wiping. I went immediately to the ER for treatment.

legs were heavy and numb; weakness in legs; bladder was now the problem/brain doesn't tell the body to go to the bathroom she is leaking because the bladder is filling up filling over; reason for hospitalization;her kidneys; totally became paralyzed from the waist down; legs were heavy and numb; Patient was a little nervous; painful tingling feeling she have that kind of feeling in her legs; This is a spontaneous report from a contactable consumer (patient's mother) from a Pfizer-sponsored program,. A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 20Apr2021 at 19:30 (Batch/Lot number was not reported) as single dose for covid-19 immunization and pregabalin (LYRICA), via an unspecified route of administration from an unspecified date at 100 mg, 3x/day for neuropathy. Medical history included neuropathy from 2020 and ongoing. The patient's concomitant medications were not reported. It was reported that the patient got the vaccine and she was taking pregabalin as well and after vaccination, she experienced an adverse event, her legs were heavy and numb and also her bladder was now the problem she was actually now at the emergency room. Patient was a little nervous. The patient was still in the hospital and she was not getting any care. What happened at the beginning was that she totally became paralyzed from the waist down, when your foot fall asleep you get painful tingling feeling she have that kind of feeling in her legs not able to move any part of her anywhere from her waist down later on that night, after she took pregabalin, went to sleep about an hour she was able to move her left toes and able to drag one leg a little bit. She was supposed to take pregabalin 3 times a day and they were giving her a difficult time about it, she took one at 12 O' clock on Wednesday and the hospital they did not give another one until 11 o clock that evening because she was supposed to take 3 times a day. After she no longer feel from the waist down, she took a pregabalin and it didn't help her it didn't work and her physician told her to take 3 times a day and then at 10 O' clock yesterday morning she was still asking the hospital to give her another one. When asked to repeat the concern, patient stated "weakness in her legs that felt very heavy like she was dragging. The date of hospitalization was reported as 21Apr2021. The reason for hospitalization was reported as numbness in her legs and weakness in legs, became paralyzed from the waist down, and her kidneys. So her brain doesn't tell the body to go to the bathroom she is leaking because the bladder is filling up filling over and the body doesn't know to get it out its leaking because it is filling up it is so full. The patient underwent lab test in the hospital. The action taken with pregabalin in response to the events was unknown. Outcome of the events was unknown.

pampers were grey, like grey pee; This is a spontaneous report from a contactable consumer (patients mother). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EWO171 Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 25May2021 as 1st dose, single dose for covid-19 immunization. Medical history included quadriplegic cerebral palsy (she was born with this), heart beats fast; she has always had this. Concomitant medications included vitamin c:ascorbic (500); buspirone(200 mg) taken for pain; ibuprofen. The patient experienced pampers were grey, like grey pee on May2021. Caller stated that she was calling about her daughter. Caller confirms she was calling about the Pfizer Covid-19 Vaccine. The day before yesterday, her daughter got the Pfizer vaccine and she had quadriplegic cerebral palsy and did not walk or sit. Caller noticed that her daughter wears pampers and it was grey. It was grey, like pee, or whatever. The Pamper was grey. There was no blood or anything, it was just greyish. States she has nothing else to add to the report and that her daughter just told her, ma, you and people to the bathroom and pee. Adds that she, the caller, took the shot and nothing happened to her and her friends but her daughter said that they were peeing in the bathroom and do not look at their urine to see if it was grey and when it was in the water. It was noticeable because her daughter was in a Pamper, she uses Pampers and not the bathroom. Stated that her daughter had been on these for years. Caller just wants to make sure this was reported, because she was so scared and said maybe people urinate in the bathroom and they do not notice because it goes into the water. The outcome of event was not recovered. Information on lot/batch number was available. Additional information has been requested.

Balance issues; nauseau; alterations to sense of smell; inability to focus; constant feeling needing to urinate/ inability to feel when I need to urinate; headache; joint pain; exhaustion; muscle aches; This is a spontaneous report from a contactable consumer or other non hcp. A 39-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) , dose 1 via an unspecified route of administration, administered in Arm Left on 24Feb2021 at 13:00 (Batch/Lot Number: EN6198) as single dose for covid-19 immunisation. Relevant medical history was not reported. Concomitant medications included probiotics and ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]). The patient previously took gluten and experienced drug hypersensitivity. On 24Feb2021 the patient experienced balance issues nausea, alterations to sense of smell, inability to focus, constant feeling needing to urinate/ inability to feel when I need to urinate, headache, joint pain, exhaustion, muscle aches, all with outcome of not recovered. Therapeutic measures were taken as a result of events. No follow-up attempts are possible; no further information is expected.

I woke up at 3 am that Sunday with large (quarter sized) blood clots in my urine. I had lower abdominal discomfort. As the day progressed I began to have lower back pain, cramps and spasms and felt generalized aching. I had burning in my urethra area when voiding. I felt fatigued. I went to urgent care on Sunday when they opened and there they did a urine dipstick and treated me for a UTI. I was started on Ciprofloxacin and phenazopyridien. On Monday I was feeling better. I had very small blood clots in my urine still and mild burning and fatigue. By Tuesday I felt almost completely back to normal with only mild fatigue.

She got her vaccine, she was dizzy and she had a headache. She could not drive because her arm was so numb, she could see it on the steering wheel but could not feel it. She could not hold onto anything. On Saturday she was not able to go to work as she was vomiting, nausea, diarrhea and then started with constant urination to the point that she was not able to make it to the bathroom. She is still having it constantly, and having the urge to go even though she has just relieved herself. Her arm is still numb, and also has numbness in her face on the face, she is biting the side of her mouth due to the numbness and pain coming around her shoulder girdle and onto her breast, and not able to lift her arm above her head due to the pain. Her arm was swollen all the way to her elbow, but has gone down some. The area where the vaccine was is extremely itchy. She did take a couple of Tylenol and that was all. She does not like to take pills. She is going to call and get an APT with her doctor to be seen for the issues of urination. She is extremely concerned about the constant urination and the numbness in her face. She recently had appointments with her PCP and her Gynecologist and had no issues and everything was fine.

Since the beginning of June, I've had a series of health problems that are unusual for me -- 1) UTI symptoms followed by 2) symptoms like a Yeast infection paired with 3) chills and 4) nausea. About the same time, I started experiencing 5) lower back pain and 6) numbness and sluggishness in my right leg accompanied by 7) knee pain in my right leg and 8) acute pain in my lower left abdominal area. Most of these symptoms have resolved after antibiotics and other meds ,but the knee pain and nausea remain.

Fever, light chills, headache, fatigue. Arm pain at injection. Swollen lymph nodes in armpit on arm that was injected. Frequent urination. All symptoms lasted 2 days

pain in my kidneys on both sides; Fever of 103, usually averages around 96.7 to 97 degrees; Chills; body aches; horrible headache; vomiting; diarrhea; nausea; The arm that received the shot was extremely sore; Still feeling weak and exhausted after day 5; Still feeling weak and exhausted after day 5; Kidney infection; This is a spontaneous report from a non-contactable consumer. A 39-year-old female patient received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number ER2613) via an unspecified route of administration on 26Mar2021 at 09:00 (at the age of 39-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included hypothyroidism, gastroesophageal reflux disease (GERD), generalized anxiety disorder (GAD), atrial fibrillation, and psoriasis. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. The patient was not diagnosed with COVID-19 prior to the vaccine. Concomitant medications included levothyroxine, birth control, propranolol, escitalopram oxalate (LEXAPRO), naproxen (naproxen sodium), and loratadine (CLARITIN) from unknown dates for unknown indications. The patient previously received dose 1 of BNT162B2 (lot number EN6198) on 08Mar2021 at 11:30 as a single dose in the left arm for COVID-19. The patient previously received oxycodone hydrochloride, paracetamol (PERCOCET) from an unknown date and experienced allergy. On 26Mar2021 at 09:00 (as reported), the patient experienced fever of 103, usually averages around 96.7 to 97 degrees, chills, body aches, horrible headache, vomiting, diarrhea, nausea, the arm that received the shot was extremely sore. These symptoms lasted over 3 days. The patient was still feeling weak and exhausted after day 5 (30Mar2021). The patient had pain in her kidneys on both sides that started on day 4 after getting the vaccine (29Mar2021). The patient visited a doctor as a result of the event. The patient received treatment for a kidney infection. The patient's symptoms started within 3 hours of the second shot and continued for over 3 full days. The outcomes of fever, chills, body aches, horrible headache, vomiting, diarrhea, nausea, the arm that received the shot was extremely sore, weak, exhausted, kidney infection, and kidney pain were not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.