Pfizer

left arm hurting; nauseous; UTI; whole body is hot; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date unknown), via an unspecified route of administration on the left arm, on 19Dec2020 at a single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she took the vaccine on 19Dec2020. On an unspecified date, patient stated that she had no side effects only her arm was hurting. She stated that her whole body is hot. Stated that she has no temperature and is a little nauseous. Stated that whererever she lays down at one can feel the heat. She stated that it was Pfizer BioNTech Covid 19 vaccine EUA is concerned. She stated that she went to the ER and they thought it was because she was taking a medication for urinary tract infection (UTI) and that she was having a reaction. She stated that her doctor told her that the second day she would have had side effects to UTI medicine. She stated that the doctor is stating that it is due to the vaccine. She wanted to know if she should go back to the ER. She stated that her doctor told her to call the place where the vaccine was received for them to monitor her. She stated that she went through her job off site and that this was her first shot. She clarified that she received the shot in her left arm and it was hurting. Outcome of the events was unknown. Information on lot/batch number has been requested.

11/07/2021-11/09/2021 Severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain and kidney pain

Pfizer-BioNTech COVID-19 Vaccine EUA, I don't know if this is a direct result of the vaccine but I started experiencing symptoms of a UTI in the middle of the night (frequent urge to urinate, pain when urinating). Symptoms continued but weren't as intense the following day.

Severe dizziness with upper and lower extremity numbness causing ER visit; Severe dizziness with upper and lower extremity numbness causing ER visit; Severe fatigue; slept for two days straight; Sore throat; Headache; Neck and shoulder pain; Neck and shoulder pain, Lower extremity joint pain; Kidney pain; This is a spontaneous report from a contactable other health professional. A 40-year-old female patient received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EJ1685), intramuscularly in the right arm on 29Dec2020 at 10:00 at 40-years-old at a single dose for COVID-19 immunization. : The patient did not get another vaccine in four weeks around the time of the suspect vaccine. The patient's medical history was reported as none. Concomitant medications were not reported. On 07Jan2021 at 05:00, the patient experienced: severe dizziness with upper and lower extremity numbness causing ER visit, severe fatigue, slept for two days straight, sore throat, headache, neck and shoulder pain, lower extremity joint pain, and kidney pain (2 days as reported); and the patient went to the emergency room. The patient underwent lab tests and procedures which included COVID-19 PCR-MHS: unknown (COVID test type post vaccination=Nasal Swab, COVID test name post vaccination=COVID19 PCR-MHS) on 07Jan2021, Rapid Strep with Reflex: negative (COVID test type post vaccination=other, COVID test name post vaccination=Rapid Strep with Reflex) on 07Jan2021. The clinical outcome of the events was recovered on an unspecified date in Jan2021.

I have a diagnosed urinary tract infection a week after the first shot. I have a burning sensation and frequent urination. I was tested and confirmed a UTI by my doctor.

Pt began feeling lightheaded after receiving her vaccine. Medical staff was notified and witnessed a syncopal episode where pt was seen with flexed arms and bladder incontinence. Pt was AOx4 after regaining consciousness with SBP in the 80s, diaphoresis, and nausea. Pt did report history of syncopal events associated with needles and SBP around 90s. Pt was monitored and later released by medical staff and EMS after symptoms resolved. PT was instructed to follow up with PCM regarding possible concerns for seizures and hypotension.

Loss of sensory waist down. Numbness and tingling waist down. Weakness in legs, heaviness in the legs. Bladder and bowel problems - urinating frequently, urinary incontinence and constipation.

Patient was initially seen on 4/16 in the ED and discharged after complaints of myalgias. She was tested for COVID and discharged home and instructed to take acetaminophen. On 4/20, she returned to the ED with continued complaints including abdominal pain, nausea, and diarrhea. She also complained of dizziness when she stands, and that her skin and eyes were jaundiced. The patient was hypotensive and was not responding to IV fluids. She was started on vasopressors. She was found to be in acute liver and kidney failure. She was emergently intubated and ended up being transferred to hospital. Due to the nature of her condition, the above therapies were continued and CRRT was started due to acidosis. A bicarb drip was started and was continuous. Arrangements were made to transfer the patient to hospital once stable enough. It was thought that she was in HLH. She was also empirically started on hydrocortisone, later changed to dexamethasone. She was started on antibiotics - cefepime, Flagyl, and vancomycin. She has now been transferred to hospital. Outcome unknown at this time. 4/22

Full body aches and pain in both the joints and muscles. Headache, fatigue, easily out of breath. These started the day after and went away the next day. Day after injection saw blood in urine. Has not gone away.

The cramping during my periods has become extremely painful, to the point that I'm sweating and vomiting for about five or six hours each day during the first three days of my period. I also had a UTI five days after the shot.

I had the usual symptoms the first day after, fever/chills etc. It?s now a week later and I have had heart palpitations for 4-5 days, blurred vision and an urgency to urinate. I have felt faintish as well. I am hoping this passes soon.

5/15/2021: Pain around the injection site. Chills, muscle pain, and fever over 101 degree . Taken acetaminophen twice. 5/16/2021: Urinary tract infection. Healthcare provider prescribed nitrofurantoin for 5 days.

Left side face numb, droopy; Huge cluster of cold sores left side face. Mouth and eye; Lips cherry red; Huge cluster of cold sores left side face. Mouth and eye; Left side face numb, droopy; Loss appetite; Kidney pain; mild body aches; tired and not wanting to do anything; simply not feeling well,; This is a spontaneous report from a contactable other hcp (patient). A 40-year-old female non-pregnant patient received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) at age of 40 years old as single dose for covid-19 immunization. Medical history included Asthma, allergies, Herpes Virus and Penicillin allergies. Concomitant medications included montelukast sodium (SINGULAIR); fluticasone propionate, salmeterol (WIXELA INHUB); salbutamol sulfate (PROVENTIL HFA); cetirizine hydrochloride (ZYRTEC ALLERGY); budesonide (RHINOCORT ALLERGY). No other vaccines received within 4 weeks prior to the COVID vaccine. No covid prior vaccination. Covid tested not done post vaccination. The patient previously took Amoxicillin and experienced allergies, first dose of bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) (Lot number: EW0185) on 08May2021 10:13 AM at Right arm as single dose for covid-19 immunization. Adverse events occurred after 1st dose from 09May2021 07:00 AM included mild body aches, no arm pain, tired and not wanting to do anything after few days, simply not feeling well, loss appetite and kidney pain. Acyclovir was received as treatment and not recovered. After 2nd dose, lips were cherry red next day. By end of day, huge cluster of cold sores left side face, mouth and eye. Left side face was numb, droopy. The patient still had no will do anything but didn't feel sick. Loss appetite and kidney pain progressed from time 1st dose to 2nd. The outcome of the events was unknown. Information on lot number/batch number was requested.; Sender's Comments: Based on temporal association, a contributory role of bnt162b2 to the event so facial droopy, huge cluster of cold sores left side face, mouth and eye cannot be 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.,Linked Report(s) : 2021530924 same patient/reporter/drug, different AE/dose

Right side of body tingling and heaviness; Right side of body tingling and heaviness; slurred speech; difficulty walking; difficulty concentrating; urinary incontinence; This is a spontaneous report from a contactable other health professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9262 and expiration date not provided), via intramuscular, in right arm, on 05Feb2021 10:30 (at the age of 40-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history included known allergies, and hypertension. Patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication was reported as "no". Patient did not receive other medications within 2 weeks of vaccination. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283 and expiration date not provided), via intramuscular, in right arm, on 15Jan2021 14:00 (at the age of 40-year-old), at single dose, for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 18Feb2021, the patient experienced right side of body tingling and heaviness, slurred speech, difficulty walking, difficulty concentrating, urinary incontinence. Patient was hospitalized for 2 days. Events result in Doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient underwent lab tests and procedures after the vaccination, which included COVID-19 test (Nasal Swab) was negative on 12May2021. No treatment received for events. The outcome of the events was not recovered.; Sender's Comments: Based on temporal association, a contributory role of BNT162B2 to the events of right side of body tingling and heaviness, slurred speech, difficulty walking, difficulty concentrating, urinary incontinence cannot be excluded completely. The case will be reassessed once more information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Committees and Investigators, as appropriate.

urinary tract infections; This is a spontaneous report from a contactable consumer (patient). A 40-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: En6206) via an unspecified route of administration into the left arm on 08Mar2021 03:30 PM (at the age of 40-year-old) as 1st dose, single for COVID-19 immunisation. The patient medical history included known allergies to tetracycline. Concomitant medications were not reported. No other vaccine in four weeks nor any other medications in two weeks. No covid prior vaccination nor covid tested post vaccination. The patient reported that she rarely gets UTI (urinary tract infections), and within 6 days of the first vaccine shot, on 14Mar2021, at around 02:30 PM, she tested positive for a UTI. Not sure if it was linked or not but wanted to report it just in case. This resulted in doctor or other healthcare professional office/clinic visit and received treatment with macrobid antibiotic. Outcome of the event was not resolved. No follow-up attempts are possible. No further information is expected.

Chills, sweats, nausea, headache, chest pain with deep inspiration, contacted 1 week after vaccination. Continued for another week, contacted clinic. Recommended ER, patient did not go. Reached out to her cardiologist who ordered labs and chest xray. CMP, CBC and Chest xray all normal on 4/12/21. Reached out after she returned from vacation and reported lingering cough. Rx'd Cheratussin and Albuterol inhaler. Patient was recommended respiratory clinic, instead she made her own appt to go to ENT. Patient had also reported worsening GERD symptoms- upset stomach and throat clearing- referred to her GI specialist who manages her GERD/Hiatal hernia. ENT saw patient on 4/30/21- dx'd with cough, reactive airway, GERD, globus sensation. Rx'd- Advair- 2 puffs BID, Nasal saline spray, Allegra 180 mg- daily, continue Protonix and referred back to GI. Called 5/5- reported mid right back pain that woke her up on Saturday AM (4 days prior). Recommend ER due to pain awakening her and also to follow up with her GI MD. She reports her GI ordered an Ultrasound but couldn't see her until August. Went to ER on 5/5 with dx of right sided thoracic pain. Sent home with no Rx, recommend NSAIDs, ice/heat, lidocaine patches. Patient reached out on 5/18 to discuss US results- informed there was mild splenomegaly. Continued with cough, upset stomach, back pain. PCP received US results on 5/24. Patient recommended to come in to see PCP for further management. Saw PCP on 6/2/21- Labs ordered today are ANA screen, BNP, CRP, CMP, COVID IgG, UA macro/mirco and culture, CMV antibody, EBV panel, D-Dimer, CBC, hepatitis panel, HIV, LDH, lipase, Quantiferon, TSH, RF and ESR. Referred to respiratory clinic- informed patient it was Pertussis- placed on Azithromycin. PCP switched RX to Levaquin. Healthline reached out to patient for elevated D-Dimer- patient refused ER. 6/9/21- CT- renal infarct, splenic infarct 6/10/21- Admitted. Bacterial endocarditis, renal and splenic infarct, ended with open heart surgery, valve replaced, replaced pacemaker

o Complaint The patient is a 41 year(s) old Female complaining of o Chief Complaint Quote Patient states she got her COVID vaccine today and rapidly started feeling SOB, dizzy and feeling tired. Per EMS, patient did receive one IM of Epi. o Time Seen 02-17-2021 11:49 o Historian patient o Objective Statement 41-year-old female brought to the emergency room by EMS for allergic reaction. Patient says just prior to arrival she received first dose of her Covid vaccination. She said she was waiting after she received her vaccination when she began to have difficulty breathing, lightheadedness and nausea. She was given a IM dose of epinephrine and sent to the emergency department for further evaluation. In the emergency department, she says difficulty breathing has improved. She said she is now having some chest pain. She says pain is across the anterior chest, pressure-like. She said she also feels nauseous. Headache, throat tightening, rash, pruritus, abdominal pain, vomiting, diarrhea, dysuria, paresthesias or focal weakness. She has never had an allergic reaction before. Review of Systems Constitutional: Negative for chills, diaphoresis and fever. HENT: Negative for congestion, facial swelling and rhinorrhea. Eyes: Negative for discharge and visual disturbance. Respiratory: Negative for cough. Positive for chest tightness and shortness of breath. Cardiovascular: Positive for chest pain. Negative for leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, blood in stool and vomiting. Endocrine: Negative for cold intolerance and polydipsia. Genitourinary: Negative for difficulty urinating, dysuria and hematuria. Musculoskeletal: Negative for arthralgias, joint swelling and myalgias. Skin: Negative for rash. Neurological: Negative for speech difficulty, numbness and headaches. Physical Exam Nursing notes and vital signs reviewed. GENERAL: No distress HEAD: normocephalic, atraumatic EENT: PERRL, EOMI. Conjunctivae normal color, sclerae non-icteric; moist mucous membranes. There is no pharyngeal erythema or edema, uvula midline no stridor, patient handling secretions with no difficulty NECK: Supple, non-tender; no meningismus LUNGS: Patient in mild respiratory distress, tachypneic, lungs CTA. Normal air movement. HEART: Tachycardic with regular rhythm, no murmur CHEST: No deformity; non-tender ABDOMEN: The abdomen is soft, and non-tender, no masses or bruits. EXTREM: Normal ROM; no deformity, no calf tenderness. Normal pulses palpable in all extremities. There is no pedal edema. SKIN: No rash; no diaphoresis NEURO: Alert; normal speech and cognition; CN's grossly intact; strength grossly intact without focal deficit. BACK: No CVA TTP. o ED Course 1250: On reevaluation, patient resting comfortably in the room. She said she is feeling much better. She is no longer having any difficulty breathing. Chest pain has resolved. Her vital signs have normalized. She is no longer tachycardic. CBC shows a mild leukocytosis. CMP does show hypokalemia. On her EKG she does appear to have some U waves. EKG shows sinus tachycardia, no ischemic changes. Chest x-ray unremarkable. Potassium was repleted. On arrival, patient was given Benadryl, Solu-Medrol, Pepcid. She was given epinephrine at the vaccination site so no additional epinephrine was given here and at this point I do not feel she needs an additional dose. We will continue to monitor the patient in the ED. 1520: On reevaluation, patient is resting comfortably in the room. Her vital signs remained stable. She is not having any symptoms. No chest pain or shortness of breath. We will discharge the patient home. We will give her prescription for an EpiPen. Discussed warnings indications to return to ED. Told patient she should contact her primary care provider to discuss whether or not she should receive the second dose. Patient understands and agrees with the plan.

Day of: fatigue, sob, weakness, coughing tasting blood, runny nose, watery eyes, pain at injection site, fever, chills, rash around injection site, down arm ans up shoulder and neck Day after and progression: muscle weakness to the point of falling down and inability to hold onto items, SOB, fatigue, blurred vision, ringing in ears, dizziness. Pain, numbness, tingling throughout body. Cough tasting blood, flank pain, intermittent urinary incontinence and increase urination at night, nightmares, anxiety, depression. Today: SOB, cough tasing blood, extreme fatigue, dizziness, tinnitus, nightmares, anxiety, depression. 03/02/21 New onset diagnosis: Severe Asthma I have not been able to work since 01/08/2021

Patient felt faint nearly immediately after but said she wasn't having problems breathing. She was told to breath deeply and she quickly started feeling "a little better" so she was helped to a chair with arm rests in the room. She said she had an orange in her bag, so she started eating her orange. Just a minute later she said she was going to pass out, so the pharmacist caught her. He held her up in the chair and tried to revive her for a few moments but noticed that the blood was draining from her face and her lips were turning blue so yelled for one of his technicians to call 911 and the other to grab an epi pen. He then lowered her to the floor in case he needed to begin to resuscitate while the technician brought him the epipen. While lowering her she urinated on herself. As the pharmacist went to check her vitals before administering the epipen and beginning cpr if necessary the patient suddenly gasped once and her eyes opened widely, but not continue to breath. Upon inspection in her mouth there was a piece of orange near the bottom of the throat. The pharmacist asked if she was choking and she did not response at all, but did not start visibly breathing either. So the pharmacist swiped the piece of orange out quickly, in case it was either previously lodged or patient would have to be resuscitated. She did not seem to enjoy this and this seemed to wake her up and she quietly gasped not choking. She started to quickly improve and admitted that she was feeling better, and had passed out before after getting blood drawn but never after a shot so didn't mention this. While this was happening a police office was going through the drive through so the technician called him in for assistance and he arrived around this time. He asked her a few questions like "what's her name, who's president, how many quarters are in a dollar" which she was able to answer. She said she was mostly embarrassed and was feeling much better. She sat up in the chair again about the time the emts came in. The checked her out, but she didn't want to go to the Emergency Room. She was driven home by her father. I called her later around 6 pm that night and she said she was feeling totally fine and I advised her to please call her PCP and discuss this incident with him or her.

Ringing in ears; Urinary incontinence; Urinary frequency; Flank pain; inability to control temperature; Sweating; she was having hot or cold; Wheezing; falling down stairs; Muscle weakness; Blurred vision; Double vision; Inability to work; Rash; Injection site pain; Runny nose; runny eyes; cough with taste of blood; Shortness of breath; Fatigue; Fever; Chills; Dizziness; This is a spontaneous report from a contactable Nurse. A 41-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EK9231), via an unspecified route of administration in left arm on 08Jan2021 at 08:00 AM (at the age of 41-years-old) at single dose for covid-19 immunisation. The patient received the first dose vaccine BNT162B2 (LOT: EK5730 and EXP: Mar2021) on 18Dec2020. The subject had a history of ongoing Migraine. Relevant concomitant medications were unknown. The patient stated that after her second dose on 08Jan2021, the reaction started at 06:00PM that night. She says she had a rash and injection site pain that went her arm to her shoulder and neck. She says she had a runny nose, runny eyes, cough with taste of blood, shortness of breath, fatigue, fever, chills, and dizziness that night. She says she did not do any treatment that night, she thought the fever would run its course. Caller says that the next day she had severe fatigue, shortness of breath, wheezing, runny nose and eyes, and she also started to fall down stairs and had muscle weakness. She says she had blurred and double vision, and ringing in her ears. She says she progressed from that in a week to having urinary incontinence, intermittent frequency at night, flank pain, and an inability to control her temperature. She says she was having hot or cold sweats and chills which continued quite a while. She also reported that she has gained back muscle control, though she still has days where she is extremely weak, and her dizziness comes and goes. She says that the ear ringing has stayed the same, and her shortness of breath has stayed the same. She says that as of Mar 2nd she has been diagnosed with severe asthma, and she has never had any type of asthma or breathing problems before. The reporter stated that that this was disabling, she hasn't been able to work since 08Jan2021. The reported events were inability to work (impaired work ability) on 08Jan2021, rash on 08Jan2021, injection site pain (vaccination site pain) on 08Jan2021, runny nose (rhinorrhea) on 08Jan2021, runny eyes (eye discharge) on 08Jan2021, cough with taste of blood (haemoptysis) on 08Jan2021, shortness of breath (dyspnea) on 08Jan2021, fatigue on 08Jan2021, pyrexia on 08Jan2021, chills on 08Jan2021, dizziness on 08Jan2021, falling down stairs (fall) on 09Jan2021, muscular weakness on 09Jan2021, vision blurred on 09Jan2021, double vision (diplopia) on 09Jan2021, ringing in ears (tinnitus), urinary incontinence, urinary frequency (pollakiuria), flank pain, inability to control temperature (body temperature abnormal), sweating (hyperhidrosis), wheezing on 09Jan2021 and feeling of body temperature change. Clinical outcome of the event inability to work was not recovered, while clinical outcome of all other events was unknown. Laboratory data included pulmonary function test, result: 40%.; Sender's Comments: Based on the current available information, the event Inability to work is most likely related to an intercurrent or underlying condition which is not related to the suspected drug. 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.

Severe Asthma; pain at injection site; Rash at I she tin site the went down left arm, up shoulder and into neck; SOB; weakness; Coughing with taste of blood; running nose; watery eyes; fever; chills; muscle weakness to the point of falling down and dropping item; pain; numbness and tingling throughout body; numbness and tingling throughout body; flank pain; intermittent urinary inconstance; increased urination at night; nightmares; dizziness; blurred/double vision; ringing in ears; irregular body temperature; anxiety; depression; extreme fatigue; visual disturbance; I have been not been to work since second shot; This is a spontaneous report receive from a contactable consumer (Patient herself). A 41-year-old non-pregnant female patient (patient was not pregnant at the time of vaccination) received first dose BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection with false Lot number: EK5730) via intramuscularly on 18Dec2020 at 08:00 am to right arm (at the age of 41-years-old) and second dose with lot number: EK9231 via intramuscularly on 08Jan2021 at 08:00am to left arm both at single dose for COVID-19 immunization. Medical history included Migraines. Concomitant medications were not reported. On 08Jan2021 at 06:00pm, the patient experienced pain at injection site, rash at injection site went down left arm, up shoulder and into neck, SOB, fatigue, weakness, coughing with taste of blood, running nose, watery eyes, fever, chills Day after and progression: muscle weakness to the point of falling down and dropping item, pain, numbness and tingling throughout body, flank pain, intermittent urinary inconstance, increased urination at night, nightmares, dizziness, blurred/double vision, ringing in ears, irregular body temperature, cough tasting blood, anxiety, depression Today: SOB, couch tasting blood, extreme fatigue, visual disturbance, nightmares, anxiety, depression and she said , that she had not been able to work since her second shot. On 13Jan2021 patient underwent lab test included swab test results as negative. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Mar21 new onset of severe asthma was diagnosed. Outcome of events was not recovered. Information about report seriousness has been requested; Sender's Comments: Considering the known safety profile of the drug and a plausible temporal association between the reported events and the suspect drug BNT162B2, a causal relationship cannot be 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.

Pelvic pain, pressure, discomfort, frequent urge to urinate especially at night. Swollen, throbbing lymph node right armpit with shooting pains.

10 minutes after pain in arm was shooting down to hand and to chest, 10 mins later stomach ache, 30 mins after adminstration tongue, face and throat swelled up. Hand of injection arm went purple, cold and numb. Toes went purple and cold. Had to get taken in ambulance to er hospital due to blood pressure and lack of oxygen. When arrived at hospital broken out in hive,blood pressure went up to 175/104 and severe pain in kidneys, stomach, lower abdominal, legs, arms. Day 2 high blood pressure, fever, hives, stomach, kidney and lower abdominal pain. Painful to urinate and poop.

Patient began stating that she felt dizzy and nauseated within a minute of getting the Pfizer vaccine. She asked to go to the bathroom to pee. Was accompanied to the bathroom. Struggled to get out of the bathroom as she was feeling so lightheaded. Was helped to a chair where she stated she felt like she was having a hard time swallowing. Was given some water. No evidence of stridor, LCTA. She explained to me while she was sitting that she has been having intermittent allergic reactions to something and last night had to take some benadryl for that. She asked if she could get some benadryl. She was given some and within a minute stated she felt fine. After waiting an additional 5 minutes she was allowed to stand and was accompanied as she walked around the clinic without further complaint.

About 15 mins after vaccine I felt a sudden onset of lightheadedness and feeling as if i would pass out, told the nurse I was going to throw up. I was given zofran and Dr monitored Vs. I continued to experience waves of dizzyness, nausea, abdominal pain. Shaking followed (I felt so cold), along with frequent need to urinate and urgency to have a BM (loose) for several hours. I was given fluids and monitored. They gave Ativan 0.5mg 2.5 hrs later? I was discharged home at 8:45p.m. by Dr and told not to get the 2nd Vaccine. Symptoms continued and worsened on day 3 with Shortness of breath, chest pain and tingling in my arms that spread to my legs, back and neck. The first week I could barley walk and was seen in the ER 2 times for chest pain, shortness of breath, dizzyness, tingling, heart racing, diarrhea, nausea, muscle weakness, insomnia due to shortness of breath (gasping) with heart racing, & unable to control my body temperature. Given Prednisone 40mg which exasperated symptoms. 1/13/21 In ER and given Benadryl 3 bags of fluids, potassium and sodium. Postural tachycardia was noticed. Referral to Neurologist.High D-dimer at ER on 1/16/21 CT scan performed to rule out blood clot in lungs. Reffered to Cardiologist. Metoprolol and Colchicine was started in Jan by Cardiologist Dr . Weekly visits with Dr for the first couple months. More meds started to decrease inflammation. Furthur referrals to Immunologist, infectious disease, and Rheumotology. At 3 months worsening of tingling in my neck and headaches/burning that felt like shocks and shooting down neck and ears. Neurologist performed 3 view MRI to rule out transverse Myelitis. In ER early April for new onset of Petechiae, CBC labs normal. Immunologist states he felt i experienced an allergic reaction followed by secondary anaphalaxis. He is testing me for Mast cell activation syndrome (not diagnosed yet). Now almost 4 months later still unable to work. Waiting results to rule out POTS. Currently battle daily fatigue, chest pressure/pain, lung SOB, heavyness/pressure, with any exertion. I am limited with daily walking/normal activities. Symptoms that come and go are tingling, nausea, diarrhea, flushing of frequent urination, neck pain, regulating temperature.

The second dose of the vaccine almost 8 hours after it was administered began to give me a lot of headache. After 10 hours of administration, I started vomiting throughout that night until the next morning I vomited 7 times. At 11 hours after administration I began with involuntary movements, to shake a lot. It gave me a fever of 40 degrees. The next day I couldn't get up. Body pain, I got dizzy from just walking, and I couldn't urinate, I had pain in the ovaries and pelvis area. That day that was the next, I continued vomiting and I couldn't get out of bed. I was given a saline solution for dehydration, and I took phenergan 50mg for vomiting. 36 hours later my hips and back and legs ached. At 48 hours I started diarrhea which to this day I continue with them (5 days after the vaccine). After 5 days of the vaccination I continue with diarrhea, I have controlled them with imodium and probiotics, I have a weak body, I get dizzy at times, and I continue with pain in the ovaries like menstruation that at the moment is not supposed to be because I was menstruating just 3 days before the vaccination. My body feels strange, my hips, back and head still hurt, and I continue with stomach pain, nausea and diarrhea. Medications were administered at home.

On March 6, 2021 when I received my first injection of the Pfizer Covid vaccine, I immediately began to feel sick about 5 minutes afterwards. I had instant dizziness, flush feeling, tired, weak and a little nauseated. When I got home I immediately laid down because I felt like I was going to pass out. I slept the rest of the day. Those exact symptoms lasted from March 6, 2021- March 13th, 2021. They began to dissipate the evening of the 13th. I thought all the symptoms were gone but I began urinating blood on March 18, 2021 and I haven't stopped as of yet. I have had constant kidney paid, leg soreness and cramping, dizziness, low blood pressure, chronic pain in my hands and feet, constant fatigue, intermittent headaches, loss of weight, loss of appetite, pain with urination due to the blood. I had a hysterectomy in 2016 so this is not an issue of a heavy period, I no longer have a uterus.

Chills, night sweats, fever of 103.5, brown urine, body aches, shortness of breath, rapid heart rate, eye twitching

I got kidney stones. I had 2 on the right and one on the left kidney. I got a liter of IV fluid to try to help flush them out and they started me on a new medicine. I went the Emergency room and then had a follow up with my Doctor. It started on 5/27/2021 at 5:15am and I work up with extreme pain on my right side with nausea and vomiting.

06-09-21 - Received send Dose Pfizer Co-Vid 19 Vac 06-10-21- Fever Chills Headaches 06-11-21-Heart Paint on and off during the day. 06-11-21- Urinating dark cola color and had small tiny red, look like small blood cloths 06-11-21 - Started having really bad anxiety 06-12-21- Anxiety continued, no more heart pain. 06-12-21 - Felt very exhausted

chills; fever/fever was 100.1; diagnosed with a UTI; soreness at the injection site; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer (patient). A 41-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN9581, Expiration date was not reported) via an unspecified route of administration, administered in arm left on 13Feb2021 as first dose, single for COVID-19 immunization in a vaccine clinic (patient age at time of vaccination: 41 years) (indication: she worked in healthcare, not first line, but occasionally she was seeing patients). The patient medical history and investigation assessment was none. Concomitant medication included vitamin d nos (VITAMIN D; she used to take it consistently through the winter) taken for an unspecified indication, start and stop date were not reported. No previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect and she had refused any other vaccination until after the COVID vaccine. They had asked her if she wanted the flu vaccine, but she declined it. No adverse events following prior vaccinations. The patient got the first dose of the Pfizer Covid 19 vaccine on 13Feb2021 and since then, she began having UTI symptoms, was diagnosed with a UTI (start date: 26Feb2021) and prescribed nitrofurantoin mono 100mg twice daily therapeutic measures for UTI. On 03mar2021 (today), the patient had developed fever and chills. Her second dose of the vaccine was scheduled for 06Mar2021. She did see a Nurse Practitioner for the UTI. No emergency room visit was done. She had soreness at the injection site and up until 03Mar2021 (today) that was all she felt was related to the injection. She was being treated for a UTI and 03Mar2021 (today) she had fever and chills; her fever was 100.1 (onset: 03Mar2021). She hadn't seen her primary care doctor in a while. Soreness at the injection site was within a few days of the injection it felt like someone punched her in the arm. Soreness at the injection site was the next day and the day after. It was mild discomfort. Soreness at the injection site had gone away by the third day after injection. The UTI symptoms started on 26Feb2021 (last Friday) and she was being treated with the antibiotic nitrofurantonin mono 100mg caps, started on 26Feb2021 (nitrofurantonin was in the pharmacy vial and she didn't see a lot number). She was taking it twice a day with meals. The patient was fairly certain the UTI wasn't caused by the vaccine and clarified that she wanted information about being on the antibiotic nitrofurantonin and receiving the second dose. The patient was asking if she will continue to the second dose of Covid 19 vaccine this coming 06Mar2021 and do we had any info about being on this antibiotic and taking vaccine. She was not sure if she was in the right place, she was experiencing some symptoms and not sure if they were directly related to the vaccine and she was due for the second dose on 06Mar202 (Saturday). The patient would like to file a report about her initial experience but didn't think what she currently was experiencing is in direct relation to the vaccination. The patient underwent lab tests and procedures which included Body temperature at 100.1 (fever 100.1) on unspecified date. The outcome for all events was unknown. Product Complaint: Yes; Description of Product Complaint: Reporting adverse event with Pfizer COVID19 Vaccine. The UTI symptoms started last Friday, 26Feb2021. She was being treated with the antibiotic nitrofurantonin mono 100mg caps. She was taking it twice a day with meals. She started nitrofurantonin on 26Feb2021. Today she had fever and chills. Her fever was 100.1. Nitrofurantonin is in the pharmacy vial and she didn't see a lot number. No follow-up attempts are possible. No further information is expected.

Urine infection; anxiety attack; panic/anxiety attack; Her body started tingling and was numb; her body started tingling and was numb; The end of her hand cramped up; I don't know how to breathe/short of breath; whole body started shaking; Racing heart beat; Feels like throwing up; had a fever; She reports she began to feel tired/she was weary and tired; didn't feel well at all; body felt warm; Hands hurt; Felt chilled; stomach was tight; She might have respiratory alkalosis; She woke up hungry and weak; She woke up hungry and weak; Sleepy; This is a Spontaneous report from a contactable consumer (patient husband) reported for a patient (reporter's wife). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration, in left arm on 08Jun2021 at 13:00 (at the age of 41-year-old) as dose 1, single for covid-19 immunisation. Medical history included ongoing high cholesterol. She did not take a medicine for that. It was genetic and runs in her family. The patient's concomitant medications were not reported. No additional vaccines administered on same date of the pfizer suspect. The patient did not receive any vaccines within four weeks prior to the vaccination. Caller was a consumer calling on behalf of his wife. Patient was present for this call. She was having a serious side effect from the Pfizer Covid-19 Vaccine. Wife reported that she received the first dose of the Pfizer Covid-19 vaccine on 08Jun2021 Tuesday at 13:00. Wife reported was getting home around 15:00 and went to shower. At around 14:30 she started to feel tired and her body felt warm. She was really really tired and can't stand up. It started when she came home after the vaccine. She got hungry and started shaking and it was hard to breathe again. She reported, she began to feel tired, did not feel well at all, took a nap and also felt chilled. She stated she didn't check her temperature. She reported she thought she would feel better the next day, but she felt worse. She stated she checked her temperature and had a fever, so she took some Tylenol. She reported she still felt tired. She reported that last Friday (11Jun2021 at 10:30) in the morning when she woke up, she felt like she did not know how to breathe and my stomach was tight. On Friday 4 days later (on 11Jun2021) she developed shortness of breath, It was about the same. She used brown bags to inhale and exhale and they didn't work. Husband reported, his wife started to feel short of breath, her body started tingling and was numb It started last Friday 11Jun2021 morning at around 10:30, the end of her hand cramped up. Her two hands cramped. It happened 3 or 4 times which was why they called the ambulance. He stated that was serious and we had to call an ambulance. He reported that the medic came and checked her temperature and oxygen and said she had no problem, and it was an anxiety attack. Husband reported he did not know why she had this as she had never had before now. She has had no anxiety problems or mental problems in her life. The doctor said to breathe slowly and relax. The hand cramps happen 4 or 5 times a day, and she had to try relaxing a little bit. It will calm her body shaking but she still had shortness of breath. Husband reported that after the medic left, she was still feeling uncomfortable about an hour later and they went to urgent care where the doctor reported she might had respiratory alkalosis. Caller reported that the doctor didn't do any blood tests but gave her hydroxyzine 50 mg for allergies and maybe she had a panic/anxiety attack that put her to sleep. She went to sleep and felt better, but as soon as she woke up she would shake and the shortness of breath would came back. She woke up hungry and weak, and when she had some food she will feel a little better but was not breathing well. Husband stated that was okay for 2 days. He reported that on Saturday (12Jun2021), they went to family doctor for check-up. That doctor also thinks she had an anxiety attack and gave her anxiety medication alprazolam 2.25 mg and gave her something for heartbeat and also propranolol for a racing heartbeat. The hydroxyzine, alprazolam, and propranolol are in amber colored pharmacy bottles. Alprazolam expiration date was Feb2022, Propranolol expiration date was Sep2022. She saw the doctor today. She was taking that medicine for her heart. Husband stated a medicine to slow down heartbeat. Husband reported she had a severe attack Monday (14Jun2021) again and went to the ER. He reported the hospital gave her lab tests to check on body and physically everything looked okay to them. He reported they did x-ray of lungs and organs and nothing seems wrong. He stated seems weird. Husband reported they went to family doctor again today (16Jun2021) and took more medication. The doctor advised wife to go to a psychiatrist. Husband reported they went there, and psychiatrist did assessment and thinks she did not have psych problems as psych problems wont give her fever and she reportedly had 11 days of fever until now. He stated, it did not go away, no one can help her, they had anxiety pill on their hands but nothing was helping her breathing, they did not understand what causes this. Wife reported her whole body started shaking every morning when she woke up and sometimes in the afternoon she started shaking again and took anxiety medication. Husband asked why the doctor did not give her breathing medication? We had inhaler but it did not help. Earlier they went to saw psychiatrist and the psychiatrist asked them to call pfizer to guide them what to do. Husband states we went to 3 different physical doctors and went to psychiatrist and it's not psych problem, psych problem won't give fever. They went to different departments and they had no idea what to do. They want to find out more about it. They seek help from different doctors but they did not have solution. Wife reported her temperatures around 100.6F, 100.5F, 100.1F, and 99 something. Wife stated a lot of time it was 99 something. She had the fever again the next day on 09Jun2021. Last night her temperature was 100.4 or 100.5, and this morning it was 99 something. She had not taken Tylenol yet. She didn't feel good at all. She felt cold and then was hot the next day. She felt really tired and checked her temperature. Her fever had continued for 11 days now. She took Tylenol before bed and it brought it back to normal 98 or 97. She went to the hospital on Monday (on 16Jun2021) and they said she probably had a urine infection. Today the family doctor gave her some antibiotics. Her stomach felt tight when she started getting shortness of breath. It was tight like she didn't know how to breathe. She felt like throwing up sometimes. It started Friday. When she came back after the shot she was weary and tired, chilly, sleepy, and her hands hurt. Then she couldn't breathe. She stated they didn't go anywhere this whole year not even grocery store, they shop online. They only went in the backyard that's it. Her first time was to get vaccine. Caller's question was if these symptoms have been reported before and what should they do? He read the description on the product and none of that what she experienced. She went to her family doctor and to the ER. She went to so many different doctors and also a psychiatrist with no solution. His wife was experiencing shortness of breath and her whole body was shaking. He asked if Pfizer has heard anything about these side effects before. Reporter seriousness for events reported as unspecified. The events resulted in emergency room and physician office visit. Patient was not hospitalised. Outcome of events I don't know how to breathe/short of breath, whole body shaking, her body started tingling and was numb, The end of her hand cramped up, She reports she began to feel tired/she was weary and tired, didn't feel well at all, had a fever, racing heart beat, feels like throwing up, hands hurt, body felt warm was not recovered and outcome of other events was unknown. Information on the lot/batch number has been requested.

lost 20 pounds; They said the vaccine is attacking the caller's kidneys; pain when she urinates; Patient was mentally distraught; urinating blood; urinating blood was reported as worsened; body aches; Night sweats; Cold; Fever; Chills; Nausea; Tiredness; arm soreness; blood clots are coming out of her bladder; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, Lot Number: EN6206), via an unspecified route of administration, in the left arm on 06Mar2021, as a single dose for COVID-19 immunisation. Medical history and concurrent conditions included hysterectomy in 2016. Concomitant medication was not reported. On 06Mar2021, patient had blood clots are coming out of her bladder, night sweats, cold, fever, chills, nausea, tiredness, arm soreness. On 18Mar2021, patient had urinating blood and urinating blood was reported as worsened and body aches. On an unspecified date, patient had lost 20 pounds and vaccine was attacking the patient's kidneys, pain when she urinates and patient was mentally distraught. On 18Mar2021 the patient started urinating blood and it has not stopped since then and has been in and out of the hospital because of this. All of these symptoms began after received the vaccine so she knows this was related. Patient had a hysterectomy in 2016 so she knows that this was not vaginal bleeding. She had cystoscopies, stents placed, ultrasounds, and 3 CTs. This has been hell and the patient was running up doctor bills trying to figure it out. They said the vaccine was attacking the patient's kidneys. On paper, the patient was okay but she was urinating blood and blood clots are coming out of her bladder. She has lost 20 pounds and doesn't know if it was from the vaccine or the stress of everything. This was scary as hell and very stressful because the patient doesn't know what the vaccine was doing to her body. Patient also has body aches was like a tightness in hands, feet and legs, it feels like arthritis and pain when she urinates because the clots are big enough. Patient has been taking pictures since this started, her urine was like merlot wine. Patient had seen a nephrologist, a urologist and primary care physician. The caller was never admitted to the hospital as a patient when she visited the emergency room. They would test and make sure she wasn't in imminent danger and then would send her home because of COVID. Patient went to emergency room the first time on 19Mar2021, because she noticed the blood in her urine, also emergency room on 22Mar2021. The patient ended up in the emergency room these times because the symptoms were severe or the bleeding was more. Lab test included on an unspecified date, blood work and result was blood looks like merlot wine. On 19Mar2021, X-ray result was normal. On 22Mar2021, ultrasound of kidney was done and result was normal. On 06Apr2021, bladder biopsy was performed, result was normal, CT scan was negative, cystoscopy and placed stents was normal and no cancer. On 12Apr2021, they removed the stents and did cystoscopy that was negative. On 22Apr2021, CT with contrast was negative. On 23Jun2021, ultrasound of kidney was normal. They did a test on 01Jun2021 where the urologist put a catheter inside and was trying to see if the had an obstruction. The doctor flushed water in and pulled the water out. Every 2 weeks the patient was getting blood work to make sure her kidneys aren't failing and her liver was okay. Patient received the 2nd dose on 27Mar2021, and went to the ER when the blood first started. Outcome for night sweats, cold, fever, nausea, tiredness and arm soreness on 13Mar2021, was resolved. Outcome for event urinating blood and urinating blood worsened and body aches was not recovered. Outcome for event lost 20 pounds, blood clots are coming out of her bladder and vaccine was attacking the patient's kidneys, pain when she urinates and mentally distraught was unknown.

I had the common side effects that lasted a day. Approximately, two weeks later, I developed muscle pain and aches that lasted for a few months. Then I developed carotid artery inflammation that lasted for approximately 2 months, and now, I have developed an issue with frequent urination for the past 3 weeks.

Severe pain/swelling on R upper arm, R lateral breast/axilla and R side of the neck starting the morning of 1/14/21. Pain got steadily worse to the point of full body myalgias, severe fatigue/weakness and severe nausea. Almost passed out at work and ended up being bedridden for the rest of the day on 1/14 and all day 1/15 and 1/16. Also had hematuria that developed on 1/15. Went to urgent care clinic on 1/16 and received one bag of IV fluids and zofran for the nausea. CBC, CK, CMP all normal but 1+ hematuria on U/A. Symptoms finally improved on 1/17

Diabetic ketoacidosis without coma associated with type 2 diabetes mellitus (CMS/HCC) (2/15/2021) POA: Yes Active Problems: Uncontrolled type 2 diabetes mellitus with hyperglycemia, with long-term current use of insulin (CMS/HCC) (5/6/2016) POA: Not Applicable Lactic acidosis (2/15/2021) POA: Yes Vaccination reaction - suspected (2/15/2021) POA: Yes Hyponatremia (2/15/2021) POA: Yes Was admitted to the ICU for further treatment

I developed the shingles shortly after my second dose of COVID19 vaccine. See continuation page for more information.

like blurry vision and then she lost her senses/loss of consciousness (fainting)/passed out; like blurry vision and then she lost her senses/loss of consciousness (fainting); tachycardia; mental confusion; loss of sphincter control (urinary incontinence)/pissed on herself; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 15Mar2021 13:15 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at the pharmacy. Medical history was not reported. There were no concomitant medications. The patient was not pregnant (including at the time of vaccination). On 16Mar2021 13:15, she came around to feeling really something bad in her body. She described this as she had loss of consciousness (fainting) which started to feel like blurry vision and then she lost her senses. She then passed out for 5-8 minutes and she had loss of sphincter control (urinary incontinence) as she pissed on herself. She also had tachycardia and mental confusion by that time. They called an ambulance and she was brought to the emergency or urgency department/room. The events [loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion] were considered as serious (medically significant). She also had several diarrhea (noted in 2021) episodes during one week. She had no COVID prior vaccination and not tested post vaccination. She would like to know if the reaction that she had with first dose vaccination was normal as she was afraid of the second one. The patient did not receive any treatment for the events of loss of consciousness (fainting), loss of sphincter control (urinary incontinence), tachycardia and mental confusion. Outcome of the event of diarrhea was unknown while recovering for the remaining events. Information on the lot/ batch number has been requested.

Radiating heat all over body. Sweats with 99.8 fever. horrible pain in all joints especially back. extreme thirst. brown urine. head ache. All began around 2am on Saturday and the most severe lasted until approximately 7am. From 7am to 8pm was able to start advil and tylenol rotation which helped stop the joint pain and the radiating heat. the sweats continued along with the thirst.

Shot given at 11AM by 6pm chills and shakes began, headache, fever coming on, sore arm, ache in body, nausea, puking, fever of 102, Advil taken at 10PM to help with fever, keytones present, elevated heart rate, insulin resistant, in the emergency room by 4:45AM, given 3 pages of fluids, including magnesium, heart rate as high at 156, chest x-ray and ekg taken. By 2:45pm, stabilized and released home, that night - night sweats, fever broke, and keytones finally released. Every side effected reported, I had after my second shot and it sent my diabetes spiraling into what appeared to be DKA, but luckily I was diligent and went to the ER and was able to get some help.

Day 1: Sore Arm Day 2: headaches, body aches, very sore arm, sharp pain through the L breast and L forearm Day 3: vaginal ulcerations-Behcets Day 5 (4/19/21): Intermitten heart pounding, vaginal ulcerations- hurts to void

back pain; high leukocytes and blood in urine; high leukocytes and blood in urine; little freaked out; veins were pronounced like she had inflammation throughout her body; veins were pronounced like she had inflammation throughout her body; Burning with urination/painful urination; lower abdominal pain/soreness in her lower abdomen/cramping in lower abdomen; Had some minor swelling in her joints./swelling in left elbow; Joint soreness; This is a spontaneous report from a contactable consumer and other HCP. A 42-year-old non-pregnant female patient started to receive BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for Injection, Batch/lot number: EN6201), via intramuscular route of administration in the right arm on 07Feb2021 at 11:30AM as a 1st dose, single dose for COVID-19 immunization. The patient's medical history was reported as UTIs, but hasn't had one in two years, Family history of Cancer, the patient reported that no prior vaccinations were taken within 4 weeks and concomitant medications were not reported. On 07Feb2021, the patient experienced some minor swelling in her joints, felt joints were kind of sore and stated it was still normal. On 10Feb2021-11Feb2021 was when the soreness really kicked in and ramped up after the vaccine Joint soreness. On Thursday, 11Feb2021, was the worst for her veins and in her elbow had swelling in left elbow. Then her veins were pronounced like she had inflammation throughout her body. Had soreness. Nothing horrible, but she was a little freaked out. Knew it could be a reaction. On Friday, 12Feb2021, the swelling kind of went away and she started feeling the lower abdominal cramping/pain. On Saturday, 13Feb2021, she woke up and had burning with urination and it was burning every time she urinated. Thought she had a UTI and maybe her body couldn't fight the infection because of the COVID-19 Vaccine. The patient went to urgent care. Took a urine sample that showed a high level of blood and leukocytes in her urine. There were no nitrates in her urine, which usually indicates a UTI. She was prescribed antibiotics Bactrim, standard dose(was unable to provide the exact strength ) as a Treatment for the adverse events but clarified that gave her no relief. No ndc/lot/exp to provide but has the Packaging sealed and intact. Got results back of urine culture and there is no UTI. She is not taking the antibiotic anymore. Still have pain when urinating. Still having lower abdominal and back pain. Feels like her organs are inflamed and swollen. Has a doctor's appointment on Thursday to follow up with her primary care. Thinking it could be a coincidence, but feels like she wouldn't be in this if she didn't have the COVID-19 Vaccine. She is concerned with the dull aching pain and also with a couple sharp pains yesterday. She feels pain when she urinates and as the day goes on, it gets worse. The caller asked if soreness and dull aching pain in her lower abdomen and painful urination a reported side effect of the COVID vaccine? Concerned if she should take the second dose, that something is going on, and if the COVID-19 Vaccine triggered it. Wants feedback. Outcome for the inflammation was recovered and other events were reported as unknown. No follow-up attempts are possible. No further information is expected.

Urinary Tract Infection. None of the usual symptoms, no need to urinate frequently, no burning sensations, just an abdominal pain. Urine showed high levels of white blood cells.

first night very high fever, headache, chill, body ache, sweating, no appetite. however specifically the pain was very intense in the lower back and sides almost like back labor and some lower abdominal and with nausea . then next morning the back pain was the same and still nauseous from pain and noticed a full on rash all over chest neck, back and stomach. called my doctor and they asked to go in and check with blood test and Urine sample. most items were normal on the test except blood in urine and low white blood cell counts which I have to follow up with a second test a week later bec my doctor want to make sure it is not due to vaccine. not sure if these are related. rash is still on , went down a little but not complete with Claritin however it looks like it has come back at the night time. and that is up to now so will see the rest later. ( very healthy normally , no issue before getting the vaccine ) also want to here mention first dose gave me horrible anxiety and depression and paranoia for few days starting few days after which I was told was due to hormone imbalance.

This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EM9809), via an unspecified route of administration in the left arm on 19Mar2021 at 15:30 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within 2 weeks of vaccination. The patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202), via an unspecified route of administration on 27Feb2021 at 16:30 as a single dose for COVID-19 immunisation. On 19Mar2021 at 23:00, the patient had little soreness in the injection spot. She went to bed around 21:30, but she was awoken around 23:00 because she was feeling extremely cold, even after putting on layers, her electric heating blanket at the highest temperature, and She was under a down comforter. Then the scary part was her organs started to feel heavy and sore. Her lungs, liver, heart, kidneys were weighing down inside. It was difficult for her to get up and walk because she felt like she would damage an organ(s). On 20Mar2021, the patient had a fever for most of the day, and her kidneys were in so much pain. The patient tried stretching, and sleeping it off. Did not work. She drank turmeric tea and a tall glass of water with sodium chloride, himalayan pink salt, and baking soda. The pain started to subside by evening. On 21Mar2021, the patient felt much better, but had a migraine all day and felt very weak. Her kidneys were sore. The patient did not receive any treatment for events. The clinical outcome of the events Feeling extremely cold, Organs started to feel heavy and sore, Liver pain, Organs started to feel heavy and sore, Lungs pain, Organs started to feel heavy and sore, Heart pain, Difficult to get up and walk, Kidneys pain, Migraine all day, felt very weak, Soreness in the injection spot and Fever were unknown at the time of this report. No follow-up attempts are needed. No further information is expected.

Noted that symptoms began about 1 week after second dose of Pfizer COVID-19 vaccine. Symptoms initially started with moderate hot flashes, constant migraine headache. Symptoms progressed to substernal chest pain that is somewhat positional however now has become constant. Pain radiation to right neck. Noticed decreased exercise tolerance such as walking moderate distances made her extremely sweaty. Went to ER on 6/29/21 after first being seen by primary doctor and found of ST depressions and was found abnormal EKG, normal D-dimer, troponin negative, placed in the rapid cardiology follow-up list. Went to ER on 7/4/2021 due to ongoing symptoms that are sharp, substernal, constant, worsened with bending over, intermittently radiating to right neck. Family history of MIs in the 40s. Patient does not smoke. Not a diabetic. New onset of right crampy groin pain and right calf pain. No history of DVT personally. Diagnosis in ER: Given the patient's clinical history, character and duration of symptoms, I am more suspicious for pericarditic equivalent rather than primary ACS. Recommend ibuprofen 400 mg 3 times a day. X10 days. We will arrange outpatient echocardiogram Once all symptoms are resolved may be in 3 to 4 weeks consider stress testing Will arrange follow-up in the office within a week DC planning from cardiac standpoint.

-Severe pain in joints and tendons in both arms (started on left side (injection side) then migrated to the right side as well and back pain -swollen lymph nodes in the left armpit lymph node increased to 2-3?. Both lymph nodes in throat (left and right side) significantly increased 1-2? (7/15/21 through today 7/17/21) -mild fever highest recorded 102F (11pm 7/14 through 7/16/21) -major sweat spells (7/15-7/17/21) -tinted -very light pink urine twice. First time 7/15/21, second 7/16/21. Seems like blood in Urine noticeable on toilet paper, odor similar to blood/metallic -throbbing pain in my lower right back not constant on 7/16/21, today currently not experiencing this -major body aches and chills 7/15/21-today -inside of mouth on the inside of my lips/cheeks tender and metallic taste -headache but today 7/17/21 major migraine -tired and low energy all days -nausea on/off all days -major

Blood in urine; Pain in all of her body/ body ache; Chills; This is a spontaneous report from a contactable consumer or other non hcp. A 42-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0186, Expiry Date: unknown), dose 1 via an unspecified route of adminstration, administered in Arm Left on 30Jun2021 at 12:30 (at the age of 42-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Family medical history relevant to AE was none. History of all previous immunization with the Pfizer vaccine was not considered as suspect. No additional vaccines administered on same date of the pfizer sus-pect. No other vaccinations was done within four weeks prior to the first administration date of the suspect vaccine. On 01Jul2021, the patient experienced blood in urine, pain in all of her body/ body ache and chills. The events did not cause Emergency Room or physician office visit. It was reported that yesterday the patient woke up with body ache, chills and blood on her urine. Today she has no longer have chills or body ache, but there is still blood in her urine and she wanted to know if it was normal. Blood in her urine is worst in the morning. When she cleans herself she can see the blood. She stated that she has been drinking a lot of water and it is about the same color now. She denied any medical conditions, medications, labs, testing or treatments relevant to events. Upon follow-up 0n 02Jul2021, vaccine information including lot number, start date, anatomical location was provided. This report is not related to a study or programme. Seriousness of the events were unspecified. NDC number of Pfizer Covid 19 Vaccine was unknown. Investigation Assessment was not provided. The patient provided her doctors name but did not provide contact information for her HCP. Vaccine was not administered at military facility. Outcome of the event blood in urine was not recovered and the outcome of the other two events were recovered on 02Jul2021.

Pinky toe pain on 1/21; fatigue 1/23; UTI 1/24; sacral pain 1/24-present; rash 1/24-present and still spreading; lateral joint foot pain 1/27

Severe body pain in head, neck, back, hips, knees, feet, teeth and eye sockets. Could not hold up head. Feet numb bilaterally. Nausea. Exhaustion. All lasting 24 hours. Profuse sweating as well for last 8 hours. kidney pain. I have never experienced such pain in my entire life.

Pfizer COVID-19 Vaccine EUA Pt received 2nd dose of COVID vaccine 1/15/21. A few hours after receiving vaccine, pt developed shoulder and neck pain. She felt feverish, chills that night but did not check temperature. Over next few days, she developed increasing generalized body aches, joint aches, headaches, weakness, fatigue. On 1/21/21 pt noted SOB and chest tightness, so she reported to ED. She checked her pulse ox and was 99%, was tachycardic to 140-150. She takes propranolol for essential tremor, so she took propranolol 40 mg PO x 1 and presented to ED on 1/21/21. In ED, pt was no longer tachycardic. Pt also states her concern for blood clot (mother had DVT in her 30s). She presented with moderate chest pain and tightness, as well as headache, weakness, SOB. Pt given APAP 1000 mg PO x 1, ibuprofen 800 mg PO x 1, orphenadrine 100 mg PO x 1. Nitroglycerin 0.4 mg SL x 1 ordered, but not given on MD's orders. Pt discharged home. 1/22/21: Pt f/u with hospital. DO says her elevated WBX and Cr were likely d/t vaccine and dehydration. DO offered to schedule f/u BMP and CBC on Monday 1/25. Pt also scheduled for outpt fluids at infusion center on Monday 1/25 in case BMP and CBC still indicate dehydration.

After 2nd vaccine the next evening had Body aches low grade fever. That was a Sunday I started feeling aches and short of breath from that point on. Mostly when I moved around I couldn?t breathe. Couldn?t walk up stairs without resting on each step. Went to urgent care where oxygen was 80 something percent. Took covid test it came back negative. Lung X-ray looked like I had pneumonia or something . Urgent care told me I had to go to the emergency room. Went to the emergency room and was admitted for two days from June 3 until the fifth. They wanted me to stay an extra day but I had to work so I left. They said it was bacterial pneumonia, but there nobody was for sure. While there I developed blood clotting under my left eye and I started urinating blood as well. I was putOn a lot of antibiotics and steroids while I was there and when I went home.

pt tested covid positive 6/21/2021 pt admitted to hospital 7/1/2021 - fever, sore throat, difficulty swallowing, leukocytosis, low potassium

Menses bleeding increased immensely right after vaccine Almost passed out Nausea White lips, gums, eyes

In February I had swelling in my glands. A couple days I tried to get the swelling down. I decided to see one of my colleagues and they order lab work. My lab work as fine. It has since then gone down on its own. On June 22nd I developed severe pain in my abdominal and nausea and vomiting. I went to the ER, and I was diagnosed with a kidney stone. I had an appointment today with the urologist and I still have the kidney stone, and I am being treated for them.

Pulmonary Embolism. Emergency open heart surgery. Coded for 4 minutes. In ICU and Hospital. Kidney failure.....Total blockage of left lung. 9 inch clot in right ventricle.

woke up with fever of 102, and had horrible flu-like aches & chills. Due to being under chemotherapy at the time, was recommended to go to ER because of the fever. There, I was treated with IV fluids. Labs showed incidental finding of urinary tract infection, so also received IV antibiotics and an NSAID. Later in day after back home, fever was more mild, around 100. I continued to feel like I had the flu for 2 days total. No energy, very achy, and no appetite.

Patient completed her second dose on 3/9/21. Pt presents to ER on 5/9/21 with CC of urinary frequency, urgency, and vaginal discharge. Patient tested positive on 5/9 and admitted to the inpatient ward for dysuria.

kidney pain; This is a spontaneous report from a contactable consumer (patient). The 44-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 31Mar2021 16:30 (Batch/Lot number was not reported) as SINGLE DOSE and dose 2 via an unspecified route of administration on an unknown date as Single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included calcium carbonate (CALCIUM AL); vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]); melatonin; ascorbic acid, biotin, calcium pantothenate, cellulose microcrystalline, copper sulfate, folic acid, magnesium stearate, nicotinamide, pyridoxine hydrochloride, riboflavin, silicon dioxide, thiamine disulfide, vitamin b12 nos, vitamin e nos, zinc oxide (CENTRUM B). 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. The patient experienced kidney pain on 01Apr2021 05:00. Reported as: Seems to be kidney pain. I never had any kidney problems. The pain started on the second day and continued for 5 days.The same happened after the second dose. I never looked for a doctor, but took pain medicine and got better on day 6 after the medicine,The same is happening after the second dose. The event was reported as serious with seriousness criteria Congenital anomaly. Since the vaccination, the patient has not been tested for COVID-19. No treatment received (pending clarification). The outcome of the event was recovered. Follow-ups are needed. Information about Lot/Batch number is requested.

I had a UTI 2 days after each dose of the vaccine; This is a spontaneous report from a contactable pharmacist (patient). A patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: En5318), dose 2 via an unspecified route of administration, in Left Arm on 25Feb2021 as 2nd dose, single for Covid-19 immunisation. The patient medical history included allergic to sulfonamide. The patient did not receive any other vaccine in four weeks of vaccination. Patient was not diagnosed to COVID, prior vaccination. Patient did not test for COVID, post vaccination. The patient had received first dose of bnt162b2 (Solution for injection, Batch/Lot Number: En5318) via an unspecified route of administration, in Left Arm on 04Feb2021 as 1st dose, single for Covid-19 immunisation. The patient concomitant medications were not reported. The patient had experienced a UTI 2 days after each dose of the vaccine" on 27Feb2021. The event led the patient to doctor or other healthcare professional office/clinic visit. Patient received the treatment as ciprofloxacin for the events. The outcome of the event was not recovered. No follow up attempts are possible. No further information is expected.

I just received my first dose of the Pfizer covid19 vaccine yesterday morning. I'm reporting this reaction because what I experienced is not listed as a common side effect. Approximately 3-4 hours after receiving my shot at the pharmacy, I started feeling an unusual sense of urgency just before urinating and within less than an hour, it progressed to pain similar to a urinary tract infection that I have had in the past. However, compared to the two UTIs I have experienced in the past, the pain was not felt deep in my urinary tract in my abdomen. Rather, the pain was focused right inside the urethra. There were two types of situations where I would feel the pain. The first type of situation was while I was doing nothing in particular and did not feel the need to urinate (sitting, lying down, anything), and the painful sensation would come on as a throbbing pain and then stop. Then it would start again maybe 5 minutes later. The second type of situation where I felt the pain was when I sat down on the toilet to urinate, just before the urine passed through the urethra. I would feel the throbbing pain as I felt the urine get to my urethra and then right when the urine would start coming out, the pain would stop and what I felt instead was the sensation of swollen vulva and urethra but not pain. In the past, a UTI would take several days to clear up. I would be in pain urinating for at least the first 3 days. This time, however, the pain got very intense and frequent lasting into the night, then within 14 hours of the onset of symptoms, it had stopped altogether. I'm certain it was related to the vaccine as it came about within a couple of hours after my shot and went away after 14 hours. I am not someone who gets UTIs frequently. I have only had 2 in my lifetime, and the last one was 11 years ago.

After the vaccine, my lymph nodes grew, low temp fever and body aches. I only took Tylenol. In May, I was diagnosed with shingles. This month (June) I was diagnosed with kidney stones and fatty liver and enlarged liver. Also, something growing in my uterus, not a tumor, but something growing under the muscle.

peed the bed and on second day the patient had entire bladder leaks; This is a spontaneous report from a contactable consumer, the patient. A 44-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8732) via unspecified route of administration in the left arm on 24Mar2021 at 08:45 am (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no allergies to medications, food or other products. 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 did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included amlodipine (MANUFACTURER UNKNOWN) used for unknown indication. On 25Mar2021 at 00:00 (on first night of the vaccination), the patient peed the bed and on second day the patient had entire bladder leaks. The patient did not receive treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event was not resolved. No follow-up attempts are needed. No further information is expected. Amendment: This follow-up report is being submitted to amend previously reported information: event description and vaccination facility information updated.

Sleepiness; pain at site for >24hrs less than 48hrs; itching on arm below injection site; headache; petichiae on site arm below injection site; sneezing; vivid dreams; swelling in legs; lower appetite; thirsty; more frequently urination with larger amounts; more frequently urination with larger amounts; This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 04Jan2021 at 15:45 on arm at single dose for COVID-19 immunization. Medical history included Chronic sinusitis and had known allergies with Gluten and Sulfa. Prior to vaccination, patient was not diagnosed with COVID-19. The patient's concomitant medications reported as none. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took tizanidine hydrochloride (TANIN, reported as tanins) and had known allergy. The patient experienced sleepiness, pain at site for more than 24hours less than 48hours, itching on arm below injection site, headache, petichiae on site arm below injection site, sneezing, vivid dreams, swelling in legs, lower appetite, thirsty, more frequently urination with larger amounts on 04Jan2021 at 19:00. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was recovering. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No. Information on the lot/batch number has been requested.

Got it yesterday at noon, totally fine until 10pm. Worsening chills until midnight, then complete body ache, muscles, joints, everything, terrible headache. Was on couch and walked upstairs. By the time I got there, I was nearly vomiting and on the verge of losing consciousness. I laid down on the cold tiles and tried to stay conscious. I couldn't even talk. Saliva was pouring out of my mouth uncontrollably. After awhile it let up enough to scoot into the bedroom and climb into bed. Then an entire night of worsening chills, fever, aches, eye pain, sore throat, pulsating ringing in my ears. Little if any sleep. I tried to get up and sit in a chair this morning at 3am and within minutes was so nauseated and light headed I had to lay back down flat. Tried to drink some hot tea and Gatorade at 5am. Thought I heard someone walking around the house and then realized it was heartbeat pounding in my ears. This morning my feet are super sensitive, I have urinary frequency and urgency, and the pulsatile tinnitus is back. Later today had episode of sharp chest pains front to back that resolved after about five minutes. Treatment has been rest today.

Stress on body; Little over weight- usually about 150 sometimes 162 around this time she was 162; Stage 3 kidney failure; High/Increased blood pressure; Outbreak of genital herpes; Hip pain bilateral; Extreme fatigue; on and off headaches/Intermittent headache; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EK9231; expiration date not provided), via an unspecified route of administration (anatomical location: arm left) on 04Jan2021 at SINGLE DOSE for COVID-19 immunisation. Patient's medical history ongoing included sickle cell trait (diagnosed as a child, sickly as a child, found out in 2016. It was reported that patient has the sickle cell that mimics the disease), ongoing high blood pressure, and ongoing genital herpes, and pre-diabetes, all diagnosed prior to vaccination, and 'blood pressure'. Concomitant medication included chlorthalidone from 2018 and ongoing for 'blood pressure'. It was reported that patient got her first dose of Covid vaccine on 04Jan2021. Patient stated that she has been experiencing some effects, started maybe 2 days after, she began experiencing fatigue (06Jan2021). Patient also stated that she has genital herpes diagnosed before the vaccine, and stated that she usually doesn't have an outbreak unless there is extreme stress on body. On 08Jan2021, patient clarified she experienced a genital herpes outbreak and thought that it may associated. Patient stated that she treated it with valaciclovir (VALTREX) and some cream and it went away. States that she had another outbreak after, treated it again, and it went away and now she is struggling with another outbreak of genital herpes. Patient also reported that she has on and off headaches (also reported as intermittent headaches) on 04Jan2021, states this could be due to her high/increased blood pressure which she first experienced on 14Jan2021 (as reported). Patient mentioned that her blood pressure has been higher than it ever has been after the vaccine. Patient also stated that she noticed that after the vaccine it was out of control, that she got a blood pressure cuff and it was 149/103, she contacted her nephrologist, stated she is treating it with her usual diuretic and the doctor just prescribed her amlodipine (NORVASC). Patient further stated that she is still struggling to get the diastolic blood pressure in the 90s, stated this is abnormal for her. Also is experiencing severe hip pain bilateral on 08Jan2021 after the vaccine. Patient further reported that she was a little over weight - usually about 150 sometimes 162 around this time she was 162. Patient clarified that her current weight is 159.2 and stated that she was diagnosed with sickle cell trait and stated that she has the kind that mimics the disease and will have a lot of side effects of sickle cell disease. Patient further added that she also has stage 3 kidney failure on 18Jan2021 due to either her high blood pressure or sickle cell trait and is also pre-diabetic. Patient also thought that the outbreak was associated with stress on body. Patient wanted to know if she refuses the second vaccine, if the first vaccine will do anything. Outcome of the events 'Stage 3 kidney failure', 'High/Increased blood pressure', 'Outbreak of genital herpes', and 'on and off headaches/Intermittent headache' was not recovered, outcome of the event 'extreme fatigue' was recovered on 06Jan2021, outcome of the event 'hip pain bilateral' was recovering, outcome of the remaining events was unknown.; Sender's Comments: The reported stage 3 kidney failure was due to either the pre-existing high blood pressure or sickle cell trait or prediabetic condition, and was unrelated to the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE).

In discussion with Dr., medical director at Detox, she arrived night of 2/3/21 was quite intoxicated so was not going through any withdrawal. She was getting vitals and CIW checked regularly. First dose of chlordiazepoxide 25mg was 2/4 at 1:25pm for CIWA 9. She had repeat vitals at 5:50pm, CIWA 1, vitals: P 67, 118/79, 94% on RA, T 98.3. she had complained of some "pressure in her head" and feeling anxious, but otherwise denied other complaints. she was talking with others in the group, then other patients report she suddenly started having seizure like activity around 6:45pm, med techs came to help and found her stiff, gurgling. they tried to get vitals on her, called 911, noticed that at 6:54pm she had lost a pulse and they started CPR. paramedics arrived at 7:08pm and she was brought to ED. Pt BIBA in cardiac arrest. Pt was at Detox Center when she was reported to have seizure-like activity followed by collapse. She was found to be pulseless and CPR initiated by staff members. EMS arrived and performed approx 15 min of CPR and gave pt epi x 3 and bicarb. No shocks administered but they did not report a rhythm. In the emergency room the patient arrived and was found to be pulseless with PEA arrest, CPR was initiated, patient was intubated. ROSC ultimately achieved, patient remained very acidotic despite ventilator adjustment, head CT revealed cerebral edema. Pt also found to be profoundly anemic with a hemoglobin of 5 and platelets of 37, she was thought to be GI bleeding so medications for this were initiated. Patient then became more hypoxemic with bradycardia, consultation with neurosurgery and critical care medicine at tertiary care center deemed ongoing CPR futile. Patient arrested at 2:30AM on 2/5, pronounced dead at 2:48AM.

acute right flank pain and difficulty breathing a few minutes after vaccine. Onset was quick and within 5 minutes of initial flank pain, I was unable to take a full breath in. It felt as if someone was stabbing my right flank - bra level - and taking a breath in was very difficult. minor relief was experienced when leaning forward and applying tension (I was leaning forward and pressing my arms against the seat of the chair to apply tension to the area. I was unable to sit straight, stand, walk or move very well without acute stabbing pain in my flank. I was transported by ambulance to the emergency room where I was told that I has a minor UTI and had "pulled a muscle." This "alleged" pulled muscle happen while I was sitting perfectly still in a waiting area on a conference. As a note, I am not nervous of injections or of the vaccine. I was feeling great before, during and immediately after the injection until the pain began. At onset, I felt an intense heat at the injection site that radiated throughout my upper arm around the injection site followed by uncomfortable flank pain and shortness of breath. Within minutes, the flank pain became acute and it was difficult to catch a full breath without pain - likely due to the acute flank pain. I was released from the emergency room at approximately 3:00pm with a prescription for antibiotics for the UTI and muscle relaxers..

Swollen eyes, mouth, hands Labored breathing Kidney pain Elevated HR Treated with benadryl and rescue inhaler

Initially, I felt fine. Several hours later I began to feel run down, like a cold. I then began to have an ache near my right kidney that I attributed to laying weirdly. However, I also began experiencing a sort of menstrual cramping on my right side as well. This has persisted since Friday night. Today (4/12/21) at about 02:30 pm, I got my period 10 days early! This isn't normal for me. Right now it is as if I'm spotting (dark discharge to warn that full-on bleeding will happen soon). I don't usually spot. My period is rather predictable and I have been dutiful in my tracking as my cycle has shortened over the years, going from a 28 day to 25 day cycle. The malaise and aches are consistent with my PMS, but I just wasn't expecting my period right now. I really don't understand how this is happening.

15 minutes after the injection I had an intense allergic/anaphylactic reaction. I was watched and treated on site by EMS for 2 hours with Benadryl, oxygen and rest. We did not use epi because I was still able to breath (minus some wheezing, coughing, hoarseness and lung irritation). I felt the reaction hit when I started seeing green spots and my vitals dramatically increased (BP 181/111, HR 142 and weak). I then experienced the following symptoms: rash/hives on neck and chest, fatigue and weakness, dizzy and lightheaded and needed wheelchair for moving around, chills and shaking, blurry vision, nausea, stomach pain, headache, chest pain and increased urination. I also had elevated glucose (147). During those two hours my vitals decreased a little, but the rest of my symptoms persisted. I was not getting better and my vitals started to increase again at the two hour mark so EMS called an ambulance and transported me to hospital. I was treated with solumedrol and observed for several hours. The meds helped enough to send me home. (I did have to continue taking Benadryl at home that night and the next day because I continued to have an allergic response). I also had severe injection site pain and bruising.

Pt c/o sore arm, left sided m=body malaise 8 hours after vaccine, then diffuse body pain and malaise. took IBU 800mg. CBC and CMP clinically unremarkable with no elevation of white blood cell count. HOWEVER, urine with 388 white cells/36 red cells/few bacteria and positive leukocyte esterase/nitrites. Chest x-ray without abnormalities. EKG showed sinus tachycardia at 108. No acute ST or T abnormalities. No ectopy. Renal ultrasound showed a non-obstructing stone in the kidney, but no hydronephrosis. COVID and Respiratory Panel were all negative. ER COURSE: Patient had already be given IV fluids/Tylenol/morphine prior to my evaluation and was feeling slightly better, but was still having generalized body aches and malaise... Blood cultures were drawn, and IV Rocephin was given. A second dose of morphine and Benadryl was needed to get the patient somewhat comfortable, but was still having severe body aches and malaise MEDICAL DECISION MAKING: Initial thought was adverse reaction to COVID vaccine, but patient also with significant UTI, febrile, and severe body pain requiring multiple doses of IV narcotics for control... Question of adverse reaction to vaccine and or UTI/early pyelonephritis or combination of both... Hospitalist was consulted to evaluate the patient... Will admit for observation status and continued IV medications. Date of hospitalization = 4/24/2021

Blood in urine, vertigo, pins and needles on legs. Blood in urine visible on urine for 2 days and no longer visible but still on microscopic test. Vertigo stopped lasted for 5 days. Pins and needles on legs still present on day 10 after vaccination

it could have been a seizure; Unconscious/Collapsed/ diagnosed her as having a Syncopal Episode; Urinated on self/Wet her pants; Headaches; Feeling light headed; Felt her heart beat faster; Sore arm; This is a spontaneous report from a contactable nurse (patient mother). A 45-year-old female patient received bnt162b2 (BNT162B2, lot number EW0150 and expiration date was not provided), via an unspecified route of administration first dose on 05Apr2021 15:00 at single dose for covid-19 immunisation. The patient's medical history included ongoing Hypertension (Patient diagnosed in her late 30's), ongoing Hypothyroid (Patient diagnosed when she was around 20 years old), ongoing Allergies, ongoing Gastrooesophageal reflux disease (The patient was exposed to a chemical in her 20's that caused this condition), ongoing Birth control, ongoing Allergic to eggs (States patient has never received the flu vaccine due to her egg allergy), and ongoing Allergic to shellfish. The patient's concomitant medications included ongoing levothyroxine at 150 ug, 1x/day for Hypothyroid, ongoing Hydrochlorothiazide at 12.5 mg, 1x/day for hypertension, ongoing omeprazole at 20 mg, 1x/day for gastrooesophageal reflux disease, ongoing losartan at 100 mg, 1x/day for hypertension, ongoing norethisterone (SHAROBEL) for Birth control. On 06Apr2021 13:00, the reporter stated that her daughter fainted at work, lost her urine, and was unconscious and was taken to the Emergency Room. Primary Care Physician told her daughter she should have no problem getting the second vaccine. States that she was not certain if her daughter should get the second shot. It was scheduled for next week. Also, reported that after lunch reporter stated that her daughter fainted in her office at work. She had urinated on herself and was unconscious. Caller was concerned it could have been a seizure. Her daughter was taken to the Emergency Room and they diagnosed her as having a Syncopal Episode. On 06Apr2021, the patient had headaches that continue since these events. The reporter stated that her daughter's doctor told her daughter that the blood work and electrocardiogram done at the Emergency Room were normal. The Emergency Room and her daughter's doctor acted like her symptoms were not serious. The reporter looked at the Vaccine Adverse Event Reporting System website and it said that a syncopal episode is a reportable event. Says that her daughter's doctors did not report this event. Says doctors need to have training on the importance of reporting events. The reporter called the Food and Drug Administration last week but she hasn't heard anything from them. States they told her it could take 5-7 business days. Says she called Pfizer today to see if there was any further information or guidance she could get as she is concerned about her daughter. She says her daughter has her own office so she was in there alone when she collapsed. Someone found her on the floor. The reporter was asking for guidance on administration of the second vaccine dose following a syncopal episode after the first. The patient received her first vaccine dose on 05Apr2021 15:00 and she was fine, she had a sore arm, but went to work the next day (06Apr2021) and after lunch she reported feeling light headed and felt her heart beat faster and went to get up and a colleague later found her on the floor and she had wet her pants. They took her to the ER around 1 pm the day after her vaccination and diagnosed her with a syncopal episode stating that they didn't think it was from the shot. The events syncope, urinary incontinence, seizure, and headache were considered as serious (medically significant) by the reporter. The events syncope, and urinary incontinence caused emergency room visit and physician office visit. The outcome of the events syncope, urinary incontinence was recovered on 06Apr2021. The outcome of the event Headache was not recovered. The outcome of the remaining events was unknown.; Sender's Comments: Based on the information currently available, a causal association between the reported events and bnt162b2 cannot be fully excluded.Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and investigators, as appropriate.

I was taking medication for hypertension. While it has been slowly getting better over the last year, it was still high enough to take meds, generally around 160/100 without. After the first vaccine it went very low, like 90's/50's, very rare for me. After second dose it went up and I took a pill that next day as it was 178/105. That night it went VERY low, and that is the last medication for hypertension I have taken. My BP has remained low, and most all nights it gets to the 90's/50's. PCP, Nephrologist, and myself are monitoring. I also have had issues over last two weeks such as hot flashes/sweats (thought it was due to low BP), and started having blood in my urine last week, with some feeling like it was my period. I haven't had a period since my transplant 22 years ago, so this is odd and I have a dr appoint scheduled for next week to look into it.

Pt rec'd 2 doses Pfizer/BioNTech, 2nd dose May 9,2021 at outside facility. Presented to hospital on 06/08/21 after cardiac arrest, sudden collapse at home, refractory PEA with ongoing CPR >4hrs, cardiogenic shock (EF20%), refractory DIC, MOSF and coma. Uncertain antecedent history, pt had tolerated vaccine well w/o untoward reactions, was possibly "sick" in the 2 days prior to admission 06/08, but limited history available. SARS2 PCR and resp path PCR panels negative, no clear bacterial source of shock/collapse initially identified, thus concern for primary myocarditis resulting in refractory shock (perhaps also with ischemic CVA); Tpn not c/w type I ACS/MI. Workup negative for PE, hemorrhagic stroke, PTX/tamponade, etc. 6hrs after death (in evening 06/08/21) BCx x2 resulted Grp A strep, thus pt may have had TSS at home then collapsed in PEA, however source of TSS is uncertain. Notably patient usually healthy, active, no medications, favorable lipid panel, no illicits; + EtOH binge-drinking last several months but no cirrhosis/ESLD previously doubt primarily Etoh-related process. Pt had ongoing PEA arrests with brief ROSC for approx 7 hrs in field -> ED > ICU until death declared.

First Pfizer Dose was administered to patient via right arm injection at 3:00pm on June 24,2021. Around 7pm same day patient began experiencing abnormal vaginal bleeding. The bleeding was about the same amount as the start of a menstrual cycle. Patient has not had a menstrual period since 2015 due to the surgical removal of all her reproductive organs including uterus , ovaries , fallopian tubes. Cervix was surgically stitched shut. Patient had to have her reproductive system removed due to a diagnosis of breast cancer back in 2013 to her left breast which required her to undergo chemo and hysterectomy of her breast and reproductive organs. Post vaccination patient abnormally experienced vaginal bleeding that cannot be explained being that she has no reproductive system. The bleeding lasted till next day.

Right after 2nd shot for 4 hours after I had tachycardia up and down. Then almost 2 weeks later I got an uti, that within 3 days turned into a severe kidney infection into sepsis. My liver enzymes were in the 500?s. My right kidney was swollen and I spent 4 days in the hospital and it took a month to return to normal. Then 3 weeks later I get diagnosed with pancreatitis on June 21. Symptoms subsided now they are back again. Fever, abdominal tenderness, flank pain, aches, and diarrhea and nausea. Took covid test always comes back negative.

Urinary Tract Infection. Completed course of Cephalexin for 4 days, which almost cleared it up but not completely. Eventually it went away on its own. No previous history of UTI

I developed a left kidney stone unexpectedly on the morning of December 31st. I did not have a history of kidney stones prior to this. I was seen in the emergency room. I had a CT scan that showed I passed a stone during my time in the ER. I was treated with pain and anti-nausea medications. I was in the ER for 4 hours.

2/6/21 at 12:00pm: sudden onset of chills, no fever at this time, joint pains, blood streaks in urine 2:00 pm: chills and uncontrolled shivering, fever (102.7-103.4), blood streaks in urine progressed to bloody urine; Tylenol taken, increased fluid intake, and slept 10:00 pm: Fever down to 100.8F; bloody urine continued 2/7/2021 at 8:00pm: Normal temp, no bloody urine but with urinary urgency, symptoms similar to UTI (note: I haven't had UTI since I was in my 20's which was a one-time incident, there are no conditions in my current situation that predispose me to developing UTI but since I was too uncomfortable, I sought online consult as urgent care was closed to get antibiotic prescription).

Patient was admitted s/p hysterectomy, found to have PE and AKI. Patient treated with heparin drip, transitioned to Eliquis and discharged

On the following day of my vaccine, which was 01-13-2013 I started to have body aches and on 01-14-2021 trough 01-16-2021 I began to pee blood.

Body aches, kidney pain, headache, lethargy beginning 12 hours post shot, beginning 24 hours post shot painful lymph node pain under left arm and side of breast

I had extreme headache and could not focus I got dizzy and fainted and lots consciousness. I ended up lose muscle control and urinated . Afterwards, I could not speak well. I continued to have massive headaches

Frequent Urination (every 20 minutes) and severe pain in right ear cartilage Twin sister and daughter experienced the same issues.

patient fainted as lost consciousness; patient fainted as lost consciousness; patient urinated in her pants; Felt dizzy after 12 hours; patient had problems with concentrating; massive headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 09:30 (lot number: 1; pending clarification) at the age of 46 years old, as single dose for covid-19 immunization. Medical history included allergy to metals (titanium metal). Concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 09Mar2021 21:00, the patient experienced massive headache. After 12 hours (09Mar2021 21:30), the patient felt dizzy. On 10Mar2021, around 10 am, the patient fainted as lost consciousness, urinated in her pants and had problems with concentrating. No treatment was given for the adverse events. Since vaccination, the patient has not been tested for COVID-19. The patient was recovering from all the events.

passed out and went completely unconscious; Nauseous; felt weak like someone sucked all her energy out; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration at the age of 46-years-old, administered in Arm Left on 01Apr2021 13:30 (Lot Number: ER8734) as single dose for COVID-19 immunization. Medical history included ongoing High Blood Pressure, hyperthyroidism from 28Mar2021 and ongoing, allergy to Cheese and penicillin. Everyone in her family has done fine with the vaccine except her. Concomitant medications included thiamazole (METHIMAZOLE) taken for hyperthyroidism from 28Mar2021 and ongoing; atenolol, chlortalidone (ATENOLOL AND CHLORTHALIDONE) taken for hypertension from an unspecified start date and ongoing; amlodipine (AMLODIPINE) taken for hypertension from an unspecified start date and ongoing. On Thursday 01Apr2021, the patient had her first shot and she stayed for 30 minutes. After she was allowed to leave, she passed out and went completely unconscious and she was rushed to the ER. She sat for the 30 minutes, then got to her car and it took 10 minutes to get to department store and with in 7 minutes of being at department store she started feeling nauseous then came the fatigue and she felt nauseous and felt like she was going to pass out so she sat down, she didn't know what was going on. It started with her feeling nauseous and then she started to feel weak like someone sucked all her energy out. She states in between going unconscious and coming to, she threw up and peed on herself and had shaking and chills. The EMS took her to the ER. The adverse events occurred on 01Apr2021 14:30 (as reported). The ER let her go home Thursday night. They gave her an IV and did lab work and the lab work came back fine. It was a combination of her meds and the vaccine or it was just the vaccine. Her primary doctor said it was the vaccine. She is scheduled 22Apr2021 for her second one and she is calling to see if there is any advice or anything she needed to do for the second shot. Her doctor told her that when she takes it, she needs to be close to the ER so a doctor can monitor her. Treatment for events included IV fluids to help from being dehydrated and throwing up, Emergency Room, possibly Benadryl. The events required a visit to Emergency Room on 01Apr2021 and to the Physician Office on 05Apr2021. The outcome of the events passed out and went completely unconscious and felt weak like someone sucked all her energy out was recovered on 02Apr2021 while for the rest of the events was recovered on 01Apr2021. The events were considered as serious (medically significant). No Prior Vaccinations (within 4 weeks), no adverse events following prior vaccinations. Information on Lot/Batch number was available. Additional information has been requested.

kidney stone irritation; chills; aches and pains; dehydration; low white blood cell count/ White blood cells: Before: 4.9 and After: 2.4; Neutrophils, before 2.9, after 1.6; Lymphocytes: before 1.2, after 0.4; This is a spontaneous report from a contactable consumer (patient). A 46-year old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 46 years, administered in Right arm, on 18Apr2021 13:15 (Lot Number: 8737) as single dose for covid-19 immunisation. Medical history included ongoing Kidney stones. The patient was not pregnant at time of vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at age of 46 years in the Left arm on 27Mar2021 15:30 (Lot Number: 8734) as single dose for COVID-19 immunisation. Concomitant medications were not provided. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient, on 19Apr2021 01:30, had typically reported side effects (chills, aches and pains), plus dehydration which caused kidney stone irritation and resulted in ER visit. While there, noticed really low white blood cell count during labs. Here are labs two days before and two days after vaccine: White blood cells: Before: 4.9 and After: 2.4; Neutrophils: Before: 2.9 and After: 1.6; Lymphocytes: Before: 1.2 and After: 0.4. The adverse event result in "Doctor or other healthcare professional office/clinic visit" and "Emergency room/department or urgent care". The patient received treatment for event that included Hydration, pain/nausea meds for kidney stones. The patient was not diagnosed with COVID-19 prior to vaccination and not been tested for COVID-19 since the vaccination. Events outcome was recovering.

Approximately 40 minutes after getting my second dose of the Pfizer vaccine I developed severe abdominal pain and chest tightness. I could not take in a deep breath and became diaphoretic with cold and hot sweats. My ring and pinky finger, both hands, became numb and were tingling with the numbness traveling down to my elbows. I became lethargic and had a feeling of extreme uneasiness followed by a bout of diarrhea. I then fell asleep for approximately 2 and half hours without moving. When i woke up the numbness was gone but I was still fatigued and had intense abdominal pain and still having the feeling that something wasn't quite right. I went to the ED the following day for the pain and general feeling of being unwell. At the ED I had high blood pressure, tachycardia, large amounts of blood in my urine and high WBC in addition to the above symptoms. For approximately two weeks after the initial onset of symptoms I still had abdominal pain and distention and extreme bloating.

Apps 15 hours after- 102 fever, fever of 100; extreme chills; 26 hours after, sever body aches; especially though arms; neck ache; ache kidney area; fatigue, no fever but still tired; This is a spontaneous report from a non-contactable consumer or other non-HCP. A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Lot number: EN5318), dose 2 via an unspecified route of administration in left arm on 10Feb2021 at 07:15 (at the age 46 years) as 2nd dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of BNT162B2 on an unspecified date for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. On 10Feb2021 at 10:00, (15 hours after) patient experienced 102 fever and extreme chills. On an unspecified date in Feb2021, (26 hours after), patient experienced severe body aches especially though arms, neck, and kidney area, fatigue and fever of 100. On an unspecified date in Feb2021 (48 hours after), patient experienced slightly achy, no fever but still tired. The treatment was not received for the adverse events. The patient has been tested for COVID-19 (SARS-CoV-2 test): negative on 11Feb2021. The outcome of the events was recovering. No follow-up attempts are possible. No further information is expected.

The next day I developed extreme bladder incontinence which has been a problem for several months (possibly since I started getting vaccinated but not sure there is a correlation), but after this 3rd dose I lost complete control of my bladder. Friday, May 28 I went to see Dr. She ordered bloodwork but I haven't gotten it back yet. She put me on Oxybutynin which has been very effective. It has only been 2 days since I started the medication so I don't know how long I will need it or if it will be needed longterm.

Fever started within 6 hours of receiving the second dose of the vaccination. Within the first 4 days post vaccination I had body aches, headache, fatigue, 1 day of vomiting and diarrhea. All other symptoms besides the fever and fatigue where gone by day 5 but fever persisted for 2 weeks and 5 days. On day 19 I had bloody urine that showed high white count, blood and traces of protein on the urinalysis.

That SUnday Feb the 7th of 2021 during the night I experienced nausea and diarrhea. That Monday the 8th I was still feeling nausea and feeling hot flashes like I was going to pass out. I ran outside because I didn't want to pass out in the house alone so I had run outside. I did not know what was going on it was out of nowhere. On Feb the 10th 2021 I went back to work and around 7am I developed a sharp pain on my left side so I went to the ER and they ran tests and said a UTI and possibly a cyst. From 2/10/21 to the rest of the month I was in excruciating pain and had a CAT scan of my abdomen. My DRs sent me to the OBGYN and they said it wasn't the cyst. My DR said maybe it's the reason why I was having the GI problems. I got a EG test and a colonoscopy. They said I had organs displaced on the side but that would not cause all these issues. I went to the ER again and they treated me for UTI. Finally I was not satisfied with the results I was getting so I saw DR. I got ultrasound of my Kidney and they still couldn't see what was wrong. On March 12 2021 around 3AM I woke up in excruciating pain and ambulance came and brought me to the hospital and I went to the ER again and they called the on call OB and they wanted to do surgery and they said I was bleeding internally all this time. My left ovary was bleeding and they had to remove my ovary. I had that left ovary removed on March 12 2021. This has never been an issue before. I am now in physical therapy but I am not really recovered.

lots of clots; Heavy menstrual-like bleeding; recurring urinary tract infection symptoms; intense lower back pain.; This is a spontaneous report from a contactable consumer (patient). A 46-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EP7534, age at vaccination 46-years-old) via an unspecified route of administration and administered in left arm on 18Mar2021 08:00 as first dose, single for COVID-19 immunization. The patient's medical history included thyroid cancer survivor and allergies to Ciprofloxacin. The patient concomitant medication included levothyroxine sodium (UNITHROID) prior 2 weeks 112mg. The patient had no covid prior to vaccination. The patient did not take no other vaccine in four weeks. The patient experienced heavy menstrual-like bleeding, lots of clots, recurring urinary tract infection symptoms and intense lower back pain on 28Apr2021. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for events. Covid was not tested post vaccination. The patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP7533), dose 2 via an unspecified route of administration and administered in left arm on 08May2021 10:00 am. The outcome of events was not resolved at the time of this report. Follow-up(30Jun2021): Follow-up attempts completed. No further information expected.

Approximated 58 hours after my second vaccine, I went to go to the bathroom to void. My vagina felt itchy and then immediately afterward a very painful and swollen further inside. That was Friday night. for the remainder of the weekend I had terribly painful urination. I called my OB/GYN and scheduled an appointment for January 19. I prescribed Valtrex for possible herpes and Ciprofloxacin for possible bladder infection. The results came back as Oral herpes that were in my vagina. I would like to add that I did have a strong immune response to the second covid vaccine and had muscle aches, chills and malaise.

After receiving the vaccine patient presented for routine lab draw and evaluation of her ascites. She was found to have Acute kidney injury in the setting of chronic kidney disease, thought to be unrelated to the vaccine, but related to recent diarrheal illness one week prior.

N17.9 - AKI (acute kidney injury) (CMS/HCC) N17.9 - Acute kidney injury (CMS/HCC) R42 - Dizziness R42 - Lightheadedness I95.9 - Hypotension Z45.02 - AICD discharge

Patient was given her first dose of the pfizer vaccine at around 915 am she had mentioned that she had an allergy to penicillin but it wasn't an anaphylactic reaction. After the shot she went and sat in the chairs out front and shortly after someone called out that she needed help nurse ran to her side and she was unresponsive with shallow breathing and sweating and we called 911. As nurse was checking on her nurse 2 grabbed the epipen and administered right away. She came to after the epipen and we were able to talk to her a bit she mentioned that she has fainted a few times. We noticed that she had urinated at some point not sure if it was before or after epipen. The 911 operator suggested that we get her on the floor and have her lay down so we got her on the ground and laid her down as we were doing this she was going in and out of responsiveness. We attempted to take her blood pressure but the machine errored out a couple times. As we were trying to get the blood pressure the ambulance showed up and they took over care. She was transported to Clinic ER. She called later in the afternoon to let us know that she was doing okay and that she appreciated what we had done for her.

kidneys started hurting; UTI; heart pain; nausea; heart racing; blood pressure started going up; cold sweat; weak/did not have energy to talk; blood pressure was too low; This is spontaneous report from a contactable consumer reported for self. This 47-year-old female patient (not pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot#: ER8732) at single dose in left arm on 30Mar2021 01:45 PM for COVID-19 immunization. Medical history included nephrocalcinosis. Patient had allergies to contrast of iodine, had an anaphylaxis when they injected with iodine for checking her kidney, it was over 20 years ago. Concomitant medication included ethinylestradiol/ferrous fumarate/norethisterone acetate (LO LOESTRIN FE) for birth control. 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. On 30Mar2021, with a minute taken the covid vaccine, patient started feeling nausea and heart racing. Her blood pressure started going up. The facility kept checking blood pressure and oxygen. After a bit, patient had no idea of time she felt a cold sweat and very weak. Patient did not have energy to talk. However, patient saw the nurse with an epi pen and she was able to tell that she was breathing. Doctor said that her blood pressure was too low. It had dropped to low 80. Patient kept trying to relax and suddenly it went all the way up again. Her normal blood pressure was 110/70 or 120/80 and it was 150/98. Patient started getting heart pain was taken to the ER and an ECG was made and her heart was ok. Her blood pressure stayed high. Patient kidney disease. Specifically, nephrocalcinosis; however, her kidney function still good. In the second day after the vaccine, on 31Mar2021, her kidneys started hurting and she felt like she was having an UTI (urinary tract infection) what she did not have had in the last year or so. All the adverse events result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment received for all events was reported as unknown. The outcome of events was resolving.

7 minutes after vaccination: shortage of breath, high blood pressure 148/96, irregular and intense heart beat, intense body shaking. I was taken to emergency hospital right away for next 6 hours and then released home. Following day after vaccination: pain in the kidneys' area started, light pressure in the heart area Second day after vaccination: pain in the kidneys' area, lower and upper back pain, low blood pressure part of the day (94.5 F) Kidney area still in pain.

I experienced urinary retention and muscle spasms in my torso/midsection. It lasted about 1-2 weeks. I visited many doctors. The doctors did not find anything unusual.

Left arm pain Hand pain left hand Numbmess from shoulder to hand left side Neck pain left side Chest pain left side Jaw pain left side Kidney pain left side Headache Was given Nitro pill and 3 1/2 baby aspirin by paramedics at testing site. Another Nitro pill in ambulance on the way to hospital. Treated for heart attack dueto Vaccine

SWELLING IN BILATERAL LOWER EXTREMETIES, FACIAL EDEMA AND HANDS, UTI, NEW ONSET ANEMIA, LEGS FELT LIKE THEY WERE GOING TO POP AND SOME SOB

Intense soreness/pain in muscles ( arms, under breasts rib area, thighs, lower legs and ankles), blood in urine, pain in all major joints. difficulty walking and limited range of motion. Symptoms showed up after 7 days after vaccine was received. Presented to urgent care after test were don't I was hospitalized inpatient for 4 days. I was diagnosed with RHABDOMYOLYSIS, ABNL LIVER FUNCTION STUDY. CREATINE KINASE TEST OUTCOME WAS AT 41000.

Onset of symptoms was 24 hrs after vaccine. First symptoms were fatigue, abdominal discomfort, loss of appetite, mild dizziness, swollen injection site, arm soreness. Starting 48 hours after the vaccine: jaundice symptoms, including: itchiness on the feet and palms, large patchy bruises on the legs, clay-colored stools, extreme fatigue, yellowing of the eyes, dark-colored urine. Later, small, round, skin lesions emerged and spread , starting around March 11, 2021. By the 23, red, itchy, patches had expanded over the chest, abdomen and groin areas.

3 minutes - racing heart, then dry mouth 7 minutes dizziness and legs weak with low BP, 15 minutes headache and photophobia, 12 hours worsening weakness moving into arms, following day diarrhea, blurred vision, by the 2nd day constipation dysuria, worsening ataxia by day 3, 1 week after unable to move R leg, admitted to hospital 4/1 and discharged next day. Readmitted 4/6 unable to move arms and move bowels/urine.

12midnight severe chills started. Excessive urination once an hour although I wasn't taking in any fluids. 630am 4/10/21 headache (felt like a sinus headache on steroids) chest pain when breathing. Excessive tiredness and body aches.

flare of myasthenia gravis requiring hospitalization for IVIG patient also has a UTI (culture not available) which may be responsible for flare

The patient said she vomited once today (4/25/2021) and has been having excessive thirst and urination. She has chills and dizziness. Patient received her 1st Pfizer COVID-19 vaccine dose on 4/15/21@ 1530. @ 2100 the same day she had swelling between lips and nose and she started feeling chilly. On 4/16/21 her symptoms went away. Last February she said her glucose was 211 mg/dL when she went to the ED. She said she was not diagnosed with diabetes, but she does check her blood sugar daily. The patient has excessive thirst and finds her self drinking a lot of water. The patient was wondering if vomiting a side effect of the Pfizer COVID-19 vaccine? glucose = 172 mg/dL @ 2200 Saturday night 4/24/21 glucose = 77 mg/dL @ 2330 Saturday night 4/24/21 glucose = 90 mg/dL @ 0115 4/25/21 Follow Up with Patient Around 0700 o 4/25/2021 the patient reported her thirst has come down some. Has still been drinking plenty of water but has not had any further vomiting. States she has had an issue with GI sxs since February.

Within the first hour, elevated blood pressure. Elevated glucose, headache, nausea, dizziness, difficulty catching breath, overheating from shoulders up, extreme thirst and blurry vision. Throughout the same day, continued headache, swollen face, nausea, dizziness, elevated glucose, warmth on spine, weak, kidney pain, back pain, tired and blurred vision. Next couple of days, same as above including brain fog and swelling of all 4 limbs (feet and hands). Continued highly elevated glucose above 400 for fasting reading. After 3rd day, I felt a little better but continued swelling. Still elevated glucose, pain all over body, swelling of joints, pain in joints, could think a bit better, but overall ill feeling. 1-2 weeks after, continued swelling, pain in joints, headache and continued elevated glucose.

Starting 6 days after the vaccination, I began to have itching, burning, discomfort and aching in the muscles of both buttocks symmetrically. It progressed bilaterally down to the soles of both feet over the course of 10 days. I had numbness in a saddle distribution, with multiple patches of cutaneous anesthesia from waist down. I lost feeling in my genitalia. I had urinary frequency, urgency and nocturia. I became constipated with little to no bowel movements for almost 2 weeks. Laxatives did not provide relief. It was very painful to sit at first. 7 days into the progression of symptoms it also hurt to stand. I could not extend my legs at the knee.

One day after my second vaccine I began to have burning, pain and pressure in my pelvic and back area. My urine color turned black/purple color.The color lasted for about six days and I am still having pelvic pain.

Left arm and hand swelling; shingles; kidney pain; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in left arm on 09Mar2021 11:00 (batch/lot number: EN6206) as 2nd dose, single for covid-19 immunisation. Medical history included breast cancer and Lyme's disease. The patient was not pregnant. Concomitant medication included trastuzumab (HERCEPTIN). The patient received first dose of bnt162b2 on 16Feb2021, 01:00 for covid-19 immunisation. On 09Mar2021 17:00, the patient experienced left arm and hand swelling, shingles and kidney pain. The events were considered serious due to disability. The patient received treatment for the events. The patient underwent lab tests and procedures which included ultrasound with unknown results on an unspecified date. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Outcome of events was not recovered.

Around 2:00pm, I was feeling tired. I went home to take a nap. Upon arriving at home,, I started to feel light headed and the room began to spine,. I realized I was about to pass out. I made my last call to my daughter for help. When she came home I was unresponsive. She called 911 and started doing what the 911 operator was instructing her to do. I came to for a few seconds and pasted out again. I woke up with my sister pounding my chest area. I passed out again and work to EMTs asking me questions. I lost my bodily function when I passed out. On the way to the ambulance, I began to throw up. I passed out again and woke up on February 14. I say up work because I have no recollection of what happened to me after I got in the ambulance. I was taken to Hospital. They ran all types of tests. I know my heart was elevated. I ended up leaving the hospital on dialysis and a implanted defibrillator. I have 1342 pages of medical records that I can share.

+10 mins, strange taste in mouth, excess saliva +25 mins, numbness in lower half of face and lips, twinge/cramp feeling in heart area +30 mins, sinus clearing and drainage (still continuing 5 hours later) +45 mins, itching under left side of tongue in thin line from base to tip, might be a nerve, arm getting sore +1 hr, gastro symptoms started, unusual feeling in intestines +2 hr, fatigue, tiredness +5 hr, chills +8 hr, dizziness +9 hr fatigue, tiredness +12 hr lower back pain and tenderness in kidney area, both sides +15 hr severe fatigue, tiredness, arm soreness/pain, other muscle pain +24 hr arm soreness, fatigue, tiredness +25-29 hr severe fatigue, tiredness, fever, couldn?t stay awake +54 hr severe fatigue, tiredness, fever, couldn?t stay awake Days 1-5: gastro system upset, nausea, diarrhea

Pt developed SOB on the same day of receiving vaccine and she was admitted to the hospital for Pulmonary embolism, elevated troponin, AKI

On April 22nd and 23rd, I woke up early that morning and I was very sick, vomiting, and had stomach pains. I went to the doctor and they did a cat scan. They said I had a bowel obstruction. I started to have diarrhea. The surgeon said it would not be a bowel obstruction. They proceeded to do every test to check. April 23rd, all the test came back negative. I didn't have a fever. After 3 days, I was bale to eat and not throw up stuff. I had diarrhea still. I got discharged from the hospital, and I still had nausea again. The doctor tested me again for C difficle and the test was positive on May 12th. The diarrhea stopped, but I have not been okay since taking the vaccine. I can not eat salads or fresh vegetables because I would start vomiting. I was tested for parasites and that was negative. I had tested positive for a Occult early May . I was scheduled a colonoscopy. It showed I had diverticulosis with moderate severity throughout my entire colon. There is still no real explanation as to why I am nauseous everyday. I have been constantly nauseated and would sometimes have diarrhea ever since taking the vaccine. When I went to mall one day, I was hot and sweaty. I went to the parking lot, and I started throwing up and it was pure bile. I went back to ER and they gave me IV fluids. Now if I take Zofran and Imodium, I am nauseous. I can eat, but still can't eat vegetables. In April and last Friday, my stomach was so bloated I had petechiae on my stomach, but no fever. I have had a little bit of bloating but not as severe when I had took myself to the ER. The last time I went to ER I had a cat scan that was clear except a 2mm kidney stone that showed.

In the first 72 hours: muscle pain, fever, exhaustion, headache, nausea After 72 hours: pain radiating down my arm into my thumb to the point I can't bend my wrist without shooting pain. Urinary tract infection, then an ear infection, then a sinus infection. Persistant sores in my gums. Exhaustion. Food tastes strange. Difficulty regulating body temperature--hot flash then chills. Overall muscle stiffness. Daily headaches.

difficulty thinking; brain fog; Injection site pain and swelling; Injection site pain and swelling; axillary lymph node swelling; wrist pain and swelling/joint pain; wrist pain and swelling; muscle and joint pain; skin pain; kidney and liver pain; kidney and liver pain; dizziness; nausea; weakness; fatigue; chilling; This is a spontaneous report from a contactable nurse (patient). A 49-year-old female patient (not pregnant) received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided), intramuscular in right arm on 22Dec2020 14:30 at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included asthma. Prior to vaccination, the patient was not diagnosed with COVID-19. No allergies to medications, food, or other products. Concomitant medication included fluticasone propionate, salmeterol xinafoate (ADVAIR). The patient experienced Injection site pain and swelling, axillary lymph node swelling, wrist pain and swelling, muscle and joint pain, skin pain, kidney and liver pain, dizziness, nausea, weakness, fatigue, chilling, difficulty thinking, brain fog on 23Dec2020 01:15. Symptoms lasting x 6 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. No treatment received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The outcome of events was reported as recovering. Information about lot/batch number are requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the difficulty thinking, brain fog and other reported events due to temporal relationship. There is limited information provided in this report. Additional information is needed to better assess the case, including complete medical history, diagnostics including head CT/MRI and chemistry panel, counteractive treatment measures and concomitant medications. This case will be reassessed once additional information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.

Received Inj on 01-14-2021. That evening had chills, fever, muscle aches began. Took Tylenol and went to bed. Awoke on 01-15-2021 with severe congestion, dyspnea, fever, chills, diarrhea, muscle aches, back pain, kidney pain, headache, felt exhausted all of which I had when I was Covid positive and to the same severity. Injection site extremely sore, swollen, warm, unable to lay on the injection site. Symptoms began to subside on 01-20-2021 and I returned to work on 01-21-2021. Employee Health representative advised me to complete this form.

30 hours post second dose of Pfizers- Biontech COVID-19 vaccination EUA I noted left arm tingling /altered sensation down to fingers. Headache, Left foot/heel pain/ weak knees, fatigue/temp 100 , left flank pain and bladder incontinence over night. Headache continued during the day and evening of 2/10/21, I also did have some transient pins/needles to both hands after dose 1 but thought it was related to sleeping position....then this developed after 2nd dose and I started becoming concerned this was a neurological/nerve related side effect of vaccination.

very bad dry mouth starting after first vaccine shot, worsening after second dose, gradually starting to subside 1 week after 2nd vaccine . urination urgency. starting 1 week after the 1st vaccine shot. increasing for 1 week. continuing after second dose. gradually subsiding 1-2 weeks after second vaccine dose. eye pain, sensitivity to light only lasting 1-2 days 10 days after second dose. Pervasive anxiety either from circumstances or vaccine. i dont know. and a one time vaginal bleed a week after 2nd dose.

3/23/21 ER HPI:49 y.o. female who presents with chest pain. Patient reports she was laying in bed this morning around 4:00 a.m. when she started developing pain to left side of her chest. Patient describes her pain as a sharp pressure that radiated to the left shoulder and jaw. Patient reports pain currently 8/10 and worse was 9/10. Patient reports associated shortness of breath, mild lightheadedness, and nausea. Patient denies any vomiting or diaphoresis. Patient has no known history of coronary artery disease and had a heart catheterization approximately 2 years ago that was negative. Patient's cardiac risk factors include obesity, smoking, and family history. Patient denies any history of DVT or PE

intense abdominal pain 2 days after followed by intense nausea ( no vomitting) , dehydration, inability to urinate Went to ER at approx. 1:30 am on 4/15 after hours of abdominal pain Immediately diagnosed with high liver enzymes, CT scan of belly completely normal, EKG normal, ultrasound normal AST 1765, ALT 1569, checked 6 hours later AST 4755, ALT 4359 was accepted by hospital waiting on bed - no hospital would take me except large big hospital as I needed liver team started on NAC per poison control recommendation every 4 hours for approx 2 days and liver specialist ( acute injury consistent with medical toxicity ) did not take any new meds and liver enzymes on checkup 6 weeks prior were completely normal all liver tests came back negative (hepatitis, CPK, viruses etc. ) started on IV antibiotics immediately and fluids Hospital added potassium to treatment labs checked every 6 hours were continuing to go down after NAC treatment Discharged on Monday night 4/19 ALT 797, AST 104 with instructions to get labs checked several times this week current labs ALT 377, AST 34

Full Body Aches; Freezing Chills; Headache; Frequent Urination; Constant Yawning; Swollen Lymph Node In Injection Arm; Fatigue; This is a spontaneous report from a contactable Other Health Care Professional, reporting for a 49-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9262, Expiration date: unknown), via intramuscular, administered in left arm on 26Jan2021 at 16:45 (at the age of 49-year-old) as 2nd dose, single for COVID-19 immunization. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EJ1686) intramuscularly in left arm on 05jan2021.The patient medical history includes diabetes mellitus, obesity and smoker and concomitant medications include Metformin, Glipizide, Atorvastatin, Amlodipine, Omeprazole, Vitamin D, Fish Oil, Baby Aspirin. The patient had history of lisinopril allergy. Patient was not tested Covid-19 positive prior vaccination. On 27jan2021, 15hours 30 minutes after the vaccination, the patient experienced Full Body Aches, Freezing Chills, Headache, Frequent Urination, Constant Yawning, Swollen Lymph Node in Injection Arm, Fatigue. The reporter assessed all events as non-serious. The outcome of the events was recovering. No follow-up attempts possible. No further information expected.

four hours after injection: tightness and itchiness in throat; respiratory symptoms 2 days after injection: fever, thrombocytopenia, flank pain and dark urine

I had the expected fever and headache the day after the vaccine. I woke up vomiting during the night. I had ongoing GI problems. One week after the vaccine I fainted one day during a walk with my husband. I woke up and I had lost control of my bladder but I was unaware of the fact that I was unresponsive. I lost consciousness for 2-3 minutes. I had Gastrointestinal problems for one month after the second dose of the vaccine. My stomach was upset and I had Diarrhea as well as a raw feeling in my stomach. I have never had those problems before. I recovered after one month approximately .

Within a few minutes of getting the vaccine her head started pounding and her eyes felt like they were going to pop out of her head. Paramedics came to her aide. Her blood pressure was ski high (170/100). Paramedic told her to sit there and drink water. Went home and laid down until evening. Then when she went to the bathroom she had a lot of bubbles in the toilet. She had not had that since her kidneys failed. That continued through the weekend. She called the doctor Monday morning and he told her to get lab work done on Tuesday morning because she had already taken her morning meds. Wednesday morning the lab called her to tell her to go straight to the emergency room because her kidneys were failing again. They were trying to save the kidney. They said there was a lot of fluid, so they rushed her to surgery to put in a drainage bag. She was admitted for a week. They determined after a few days that the drainage bag was not working and took it out. Then they out in a stint. She kept the stint in for a month. But while she was in the hospital they performed a kidney biopsy to see if the kidney was still working. They determined it was not working. She has a family member now that is getting tested to see if she can donate a kidney. She is now in dialysis 3 days a week, 3.5 hours each time. Has been in and out of the hospital since for multiple reasons. Has had to have catheters replaced and placed on multiple medications.

The day following her second injection, she developed axillary adenopathy. Over the next 2 weeks she developed symptoms of headache, nausea, fatigue, frequent urination and dyspnea.

Got booster shot on Wednesday the 20th, came home and was fatigued. Thursday had horrible headache that would not be relieved with tylenol. I took a plane and arrived at 1130 pm. I went to bed shortly after arriving at my daughters house. Friday morning, I was unable to be woken up and my daughter called 911. I was in a coma. I suffered cardiac arrest during a CT to check for clots. I was resuscitated and put on life support. CT scan for clots, strokes, heart attacks were all clear. I was admitted to the C-ICU and on life support, on the ventilator, and was on 3 different medications at max dosage to keep my blood pressure barely surviving. The doctors told my daughter not to expect me to survive because they had no idea why I was suddenly so ill. A doctor then told my daughter that my kidneys were failing, and my liver was damaged. I also developed a high fever and had a high white blood cell count. They gave me Vancomycin and another antibiotic, and then the next the day a kidney doctor gave me lasix to flush out all of the excess fluid. I woke up on Saturday not knowing what had happened and was completely terrified and confused. My daughter was allowed into the ICU to see me and keep me calm, thankfully. She explained to me what happened. I am still in the hospital, as they are keeping me for observation and trying to determine if my kidneys will start working properly again. Prior to this, I have only ever had a kidney infection, and I thought before I might have had the start of a UTI. I do have chronic high blood pressure as well, a long term side effect from open heart surgery 10 years prior for an aneurysm, but aside from that I am relatively healthy 50 year old.

Noticed bloody urine in toilet at approximately 3PM, 4PM, and 9PM on Friday 1/29/2021. Awoke Saturday morning to severe abdominal pain and extreme bloody urine.

Please see weekly and daily updates. They are about 1 week behind timeline. Sxs started same day. Various sxs from high fever 103.1, body pains to complete spine, hips, various toes and left lower back over kidney felt sore.. Now shoulders hurt. Asked job for FMLA forms.

Started 2/15 with joint pain. On 2/20 started with high fever, chills and headache, frequent urination and dehydration. On 2/22 started to vomit continued with other systems. Went to emergency clinic. They thought it was a UTI and prescribed an antibiotic. Antibiotics not working. Admitted to hospital on 2/23. All above symptoms continues. Met with internal dr and infectious disease dr. They believe this is a bladder infection plus a virus. Have been in hospital for three days now. Dr ordered more labs and waiting on outcome.

I had severe flu like symptoms: headache and body aches, on and off fever. The injection site where my steroid shot was extremely sore, joints sore, nausea, acid reflux, constant urination and bowel movement, extreme dizziness and light-headedness.

I had my first dose of the Pfizer COVID Vaccine on 12/23/20. I was exposed to COVID-19 on 12/28 and positive on 1/3/21. I had a mild infection, but my chronic constipation was resolved and had easy stooling that week. On 1/7/21 I was having right upper quadrant abdominal pain, radiating to bilateral kidney pain and it resolved by the 8th or 9th. I asked for a health care visit because the discomfort was strong. I received the second dose of the COVID Pfizer vaccine on 1/13/21. No immediate problems but intermittent pain in upper right abdomen into my kidneys. By 1/25/21 I had constant pain in my kidneys and in general my abdomen was bloated and tender. I thought I had a kidney infection and was prescribed abx. By the next day the pain was becoming more severe and I went to the ER the night of 1/26. CT showed a mass in the live and extensive stool throughout the bowel - even though I had been eating and stooling normal for me with hx of chronic constipation. I had to stop eating and completing clean out my colon. The swelling in the my abdomen took about 2 weeks to subside and I was unable to eat for several days. I was diagnosed with mild diffuse fatty liver disease, which had not been previous an issue. MRI determined I have a cyst on my ovary also.

Headache, chest pain as pins and needles, shortness of breath, swollen throat, tounge, limpthotic nodes, difficulty to breath and to swallow, weakness, disoriented, pain in body, difficulty to urinate, dizziness, blurry vision, nausea, tachardia, pulse rate increase, blood pressure increase, fatigue, body and muscle pain.

after scheduling her second dose appointment patient reported feeling lightheaded, was sitting on the floor. Moved patient to an exam room for privacy and elevated her feet. She asked to lie down because she was getting ready to pass out and then did. Patient was out for approximately 1 minute, was snoring. Applied a sternal rub and eventually patient came to. Patient was very disoriented afterward and discovered patient had urinated. Patients husband was with her, but in the parking lot, brought him in. She reports a history of fainting. BP 134/87, pulse 77. Patient also reported nausea, but states she had not eaten this morning because she doesn't normally eat breakfast. Gave patient a coke to sip on. Patient was recovered when she left.

On 4/5/21, two days after my second injection, I was sitting at my desk working (at home) when I noticed my vision wasn't clear even with my glasses on. I had been feeling nauseous for a few hours and then my eyes started bouncing back and forth uncontrollably. I was unable to see correctly or move from my chair. Once my eyes stopped moving my vision became tunnel vision and everything around it became foggy. I felt weak and dizzy. I started getting a headache. I didn't think I could even call out for help as I was unsure my voice would work. Once it all calmed down I figured it must be part of a migraine, even though nothing this extreme had ever happened before. I moved to my bed as I was suddenly completely exhausted, and immediately fell asleep for almost 3 hours. Once I got up I was still very groggy and had to force myself my. I stayed up for about 3 hours and went back to bed for the night. The next morning I woke and was feeling better so I figured it must have been a migraine. However a few hours later the same problems started back up again. I was having a hard time seeing my computer screen, I had a foggy head and was finding it hard to concentrate and do work. My headache started again and my vision started as foggy and became tunnel vision again. This time my eyes did not bounce, but my lips started tingling. This lasted for about 1 minute. This time with everything I was making sure to take a mental note of everything going on because I was scared I was going to have to call 911. Because I was home alone I opened my phone to dial if it got any worse. The event backed off enough that I took myself to the ER. By the time I was in the waiting room my head felt like a balloon and my whole body just felt "off." I can't explain how it felt, it just didn't feel normal. My headache never got overly severe like it does with a migraine, but I was worried about a stroke. The ER did a CT scan and did rule out a stroke, but was unsure of what it exactly what it was, but guessed it was an abnormal migraine attack and told me to follow up with my PCM in a couple of days and to keep my appointment with my neurologist on April 15th. The symptoms lasted a full week off and on every day, with a tampering down of severity of symptoms.

24hrs after the second vaccine I had the usual reactions: fatigue, nausea, body aches. On the 2nd day I woke up without any discomfort and was fine for 6-7 days. SEVEN DAYS AFTER THE 2ND VACCINE: Jabbing, throbbing pain, itching and "running ants" located in: hands, (knuckles, wrists, palms, both sides), forearms, armpits and under breasts, upper back between shoulder blades, upper ribs, thighs, behind knees, and bottoms of the feet. Ongoing, all over, both sides of the body going on now for 48hrs. I do not have any history of fibromyalgia. Constant urination. Difficult to sleep. Fatigue.

?Pfizer-BioNTech COVID-19 Vaccine EUA: patient present to clinic staing one day after vaccination experienced swollen, purple, and burning lips. Patient administered diphenhdramine and symptoms resolved over 1-2 days. Patient also reports nausea, decreased appetite. diarrhea, body aches, and frequent urination. Patient denies shortness of breath or fever. Patient advised to continue home management.

Patient was treated on 3/10/21 w/ 3 days of Bactrim for UTI. First COVID vaccine 3/18/21, that day developed redness and swelling of face, low back, chest, feet. Rash is persistent to this date with no imprvovement. She had bloodwork to rule out, RA, Lyme, thyroid disease all within normal limits. Skin biopsy was done 4/1/21 which showed likely hypersensitivity reaction to drug or ssytemic allergic versus a connective tissue disease. Stains that were done argue against Lupus.

I received the first Covid vaccine on 2/25/21. I had bloodwork drawn related to my yearly physical on 3/11/21. They ran a CBC and basic metabolic panel. My CBC was normal and my levels specifically my Creatinine was completely normal. I received the second vaccine on 3/18/21. On 3/20/21 I started feeling a lot of pain in my abdomen area and was feeling really bloated. I was having a little difficulty breathing. I went to my PCP on Monday 3/22/21. They ran a CBC and a basic metabolic panel again. That afternoon, my PCP sent me for a CT scan of my abdominal and pelvic area. On the morning of 3/23/21, my PCP called me my Creatinine level ran the day before was at 5. Also my CT scan had come back. I also had moderate ascites (fluid in my abdomen). I also had a large right pleural effusion. On 3/23/21, my PCP sent me to the ER for hospital admission. I was in the hospital for 12 days. I was in acute kidney failure. They drained the fluid from my abdomen. They inserted a temporary port and I had 4 rounds of dialysis. On my 9th day in the hospital, the kidney doctor started me on 80 mg of Lasix per day. My urine output increased dramatically and my creatinine levels began to drop. I had not had any issues prior to the kidney failure that would typically cause it to happen. The only new medicine or change had been the Covid vaccine administration. The kidney doctor and the hospitalist dismissed this idea. I am reporting it because it was the only thing new and my levels had been normal less than 2 weeks before.

anal bleeding/when she pooped and there was blood/it was only on her rectum; blood in her stool; anal bleeding/when she pooped and there was blood/it was only on her rectum; she peed and the water was red like she was on her period/ went to pee and there was blood; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot Number: EW0161), via an unspecified route of administration, administered in Arm Left on 05May2021 10:00 at single dose for COVID-19 immunisation at the age of 50-year old. Medical history reporter as none. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot number: ER8733) in the Arm Left on 05Apr2021 at the age of 50-year old for COVID-19 immunization. The patient was not received additional other vaccines on same day of the BNT162B2 vaccination. The caller received her second dose of the vaccine yesterday 05May2021 at 10:00 am. Stated caller woke up today 06May2021 at 05:00 a.m. and noticed she was bleeding. Stated she first noticed it when she pooped and there was blood, she didn't specify if the blood was in the water or in the stool. A few minutes later, she peed and the water was red like she was on her period. Caller said anal bleeding but didn't specify more. Caller clarified, at 5:00 a.m. in the morning, when she went to the bathroom and evacuated she realized there was blood in her stool and a moment ago she went to pee and there was blood, like she was on her period. Caller stated when she peed she didn't have any blood coming out of her vagina, it was from her rectum because when she was cleaning the vagina, there was no blood, it was only on her rectum. Treatment: None. Caller stated this had never happened to her before, and the only thing that was different was the vaccine. Stated she thought it was due to that because she hasn't ingested anything. Stated she wanted to make an appointment with her doctor but he doesn't open until 1:00 p.m. The events were not resulted in Emergency Room or Physician Office visit. Family Medical History Relevant to adverse events reported as none. Relevant Tests reported as none. Event onset date reported as 06May2021 05:00. No treatment received for the events. The outcome of the events was unknown.

urinary incontinence; coughing; This is a spontaneous report from a contactable consumer or other non hcp. This report was received via a sales representative. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number and expiry date was not reported), dose 1 via an unspecified route of administration on 25Jan2021, single dose for covid-19 immunisation. Medical history included tobacco user from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On Thursday 28Jan2021 late evening patient began new onset constant coughing-"profusely" which led to urinary incontinence. Cough got improved and patient does not have a prior history of persistent cough. The outcome the event cough was recovering on unspecified date of 2021. The outcome the event urinary incontinence was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained

She reported headache, body aches, fatigue after her shot when I talked to her a couple of days after to check on her which we expected with the covid vaccine. She told me this past Thursday that she developed a UTI; blood in urine, frequency and pain with urination two weeks after getting vaccine

immediate headache and numbness in left arm sick for a week went to diabetic doctor and obgyn and have labs to be drawn

injection site soreness; night sweats; itchy, hive-like rash on both arms 48 hours after shot; very mild pain during urination for a couple weeks; moderate arm pain the day after injection; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA Vaccine; Lot number: ER8734), via an unspecified route of administration in the left arm on an unknown date in Apr2021 at 14:15 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies. Concomitant medications included flax seed oil (MANUFACTURER UNKNWON) and multi vitamin (MANUFACTURER UNKNOWN) for unknown indication from unknown date. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced injection site soreness and moderate arm pain the day after injection at 00:00, night sweats from second night and continued for 7 days, itchy hive-like rash on both arms 48 hours after shot (lasted for 2-3 days), no medical attention needed and urination pain for a couple weeks, all on an unknown date in Apr2021. The clinical outcome of vaccination site pain, itchy rash, night sweats, pain in arm and urination pain was recovered on an unknown date in Apr2021. No follow-up attempts are needed. No further information is expected.

8 days after receiving the vaccine, I started menstrating . but I have been in menopause over a year; I'm also experiencing urinary pain; Not only was it painful but the rush was more than I've had in over 13 years; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18May2021 (age at Vaccination 50-year-old) (Batch/Lot Number: EW0-182) as dose 1, single for covid-19 immunisation. Patient was not pregnant at time of Vaccination. Medical history included hashimotos thyroid disease, latex allergy, ginger allergy, egg whites allergy, garlic allergy and patient had been in menopause over a year. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medication(s) included levothyroxine, liothyronine, ergocalciferol (VIT D), magnesium taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 26May2021, 8 days after receiving the vaccine, patient started menstrating but she had been in menopause over a year. Not only was it painful but the rush was more than she has had in over 13 years. She was also experiencing urinary pain. Patient was not hospitalized. She did not received treatment for adverse events. The outcome of the events was not recovered. Follow-up attempts are completed. No further information is expected.

Pt. states after receiving the 2nd Phizer dose 02/22/2021, ER visit 06/18/2021 due to abdominal pain, slight fever, suffering from 5 kidney stones. Surgical efforts due to blockage from kidney stones. Outpatient surgery.

Her stomach is still weirded out/sour stomach; feeling sick; arm pain; She was sick to her stomach; kidneys were hurting; body aches; tested positive; tested positive; The arm wasn't swollen it was just burning.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL1284) via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. Medical history was none. The patient's concomitant medications were not reported. At first, she thought she was having a reaction, but then she started feeling sick so she got tested. She was positive so she wasn't having a reaction. She was scared from the pain of COVID. She experienced sickness. Her stomach was still weirded out. She did experience arm pain from the vaccine. Her doctor told her it was fine that it needed to air out. She left the bandage on too long. She didn't have a prescribing doctor. She received the vaccine on the 29Dec2020. She tested positive 02Jan2020. The arm wasn't swollen it was just burning. She was sick to her stomach when she got the stomach. The sick to the stomach lasted maybe two days, but then she got COVID. The burning was around the arm. It wasn't that bad. It lasted for a day. It started the day she got the shot (on the 29Dec2020). On 07Jan2021, she went to the hospital because her kidneys were hurting. The doctor said her kidneys were good. They did labs which were good. She was still going through body aches. She was told she was currently in the worst part of the virus. She still had a sour stomach going on from the virus as well. The outcome of the body aches and sour stomach was not recovered, for other events was unknown.

malaise/ feeling of severe unwell; migraine; neck pain; heart racing; blurry vision; muscle spasms; muscle pain; nausea; dizziness; swollen entire left arm injection arm; joint pain; kidney pain; unable to think clearly; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246), via an unspecified route of administration on 13Jan2021 12:00 PM at a single dose on left arm for COVID-19 immunization. The patient medical history was not reported. No known allergies. There were no concomitant medications. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on 23Dec2020, 05:00 PM at a single dose on left arm for COVID-19 immunization and experienced cold frostbite like hands and feet, dizziness when warmed up too quickly, racing heart rate, trouble finding words, with extreme fatigue, nausea, achiness at joints, and swollen lymph nodes. The patient experienced malaise, feeling of severe unwell, migraine and neck pain, heart racing, blurry vision, muscle spasms, muscle pain, nausea, dizziness swollen entire left arm injection arm, joint pain, kidney pain, unable to think clearly on 14Jan2021. AE resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of muscle pain and nausea. The outcome of the events was recovering. The patient was not pregnant. No other vaccine in four weeks. Not diagnosed with COVID prior vaccination. Not tested for COVID post vaccination.

**Pfizer-BioNTech COVID-19 Vaccine EUA** 1/25/2021 - was found unresponsive with left upward gaze deviation at midnight and admitted to hospital (last seen normal around 7 pm 1/24/2021). Intubated in ED, ABG 6.98/17/186 on 40%, Bicarb <5, Scr 1.4, Lactate 1, Wbc 20.3, BP 101/45-- >95/41, Temp 94.3, RR 23-32. Acidotic and initially required norepineprine for hypotension management (stopped 1/26/2021 0400 am) 1/26 to 2/1/2021 - supportive care for encephalopathy (anoxic vs. ischemic brain injury), ARF, HTN, MSSA growth in resp culture (no respiratory distress, on antibiotic) 1/28 GCS:E4VTM4; 1/29 GCS: EV4VTM4 with intact protective reflexes, extubated 2 pm 2/1 arousable, follows very simple commands, non verbal

Headache; Bodyaches; Confusion; Nausea; No Appetite; Fatigue; Malaise; Loose stools; Joint pain; Muscle Pain; Kidney Pain; Watery eyes; This is a spontaneous report from a contactable other hcp (patient). A 51-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EJ1685) intramuscularly in left arm on 29Dec2020 16:15 at single dose for COVID-19 immunization. Medical history included Hashimoto's Thyroiditis, Hypothyroidism, known allergies to pineapple. Concomitant medication included thyroid (ARMOUR THYROID), naltrexone. The patient previously took levofloxacin and experienced allergies, amoxicillin and experienced allergies, levonorgestrel and ethinyl estradiol (reported as LEVONORGESTREL-ETHINYL) and experienced allergies. The patient experienced headache, bodyaches, confusion, nausea, no appetite, fatigue, malaise, loose stools, joint pain, muscle pain, kidney pain, watery eyes, all on 05Jan2021 13:00. No treatment received. No other vaccine in four weeks. No covid prior vaccination. The patient underwent lab tests and procedures which included Nasal Swab with result of negative on 10Jan2021. The outcome of the events was recovered in Jan2021.

Had the first COVID vaccine on 1/8 and did a hike on 1/9 that was about 2-3 miles and did fine and then developed severe exhaustion on 1/10 while hiking 2-3 miles and had trouble getting back due to exhaustion. She then had to stay in bed due to exhaustion for about 2 weeks. Also developed 2 days after the vaccine, symptoms of nausea, shakiness and sweating. Brain fog, decreased short term memory loss/trouble with word finding with tachycardia started about 10 days after the vaccine. Baseline, has a mild stutter which she does not think worsened with her symptoms, but was not sure. Difficulty with word finding and memory most unusual for patient that she is a scientist and a poet. She developed symptoms of dysuria and incomplete bladder emptying on January 13. I saw her for a telephone visit on January 20, ordered urine tests and empirically treated for UTI with Augmentin.

Shortly after receiving vaccine; whole right side of her face went numb. Pt took Benadryl after injection afraid it was an allergic reaction. Pt seen by MD in office; noted with right facial dropping .

o Mild headache, nausea 8 hrs post vac, which resolved next day o Itchy systemically, urination urgency 10 hrs post vac, both resolved by next day o Slight wheezing 32 hrs post vac, which resolved within few hrs

103.9 temp after Tylenol doses and then bloody urine leaked and have had blood/mucus with each urination since. Tylenol, hydration and rest only treatments

Left upper extremity "cellulitis" began within 24hrs of vaccination. At time of presentation to ER on 4/12, patient was complaining of warm, erythema, tenderness. Soft tissue US showed soft tissue edema without distinct fluid collection. She was treated with Keflex 500mg Q6H x7 days starting 4/12. Patient also had acute onset dyspnea on 4/12 associated with chest heaviness, which is what prompted her to go to the ER on 4/12. Troponins were neg x3 with no EKG changes, but she did have an AKI, which was treated with gentle IV fluids. LHC was offered during her hospitalization, but patient declined due to poor kidney function

No adverse event to vaccine but developed covid and need to be hospitalized, unsure if GI symptoms were related to covid? 5/4 11am- spoke to patient states on 4/21 developed vomiting abdominal pain and diarrhea and was seen in ED. Was going to be admitted and have endoscopy and PCR came back positive. ID saw her in hospital and could not say whether her symptoms were caused by covid. was sent home and has to wait to have endoscopy. states still having GI symptoms and during night spiked 101 temp and has been taking tylenol. The following day saw primary diagnosed with UTI

Urinary Tract Infection. I have to use antibiotics for treatment. I had no changes in my daily life, other than vaccine, to potentially trigger UTI.

Have to pee constantly.; Pain and burning while urinating; This is spontaneous report from a contactable consumer (patient). A 51-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Ew0178 and expiration date not provided), via an unspecified route of administration, in arm left, on 26May2021 18:15 (at the age of 51-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history and concomitant medications were "none". Patient was not diagnosed with COVID-19 prior to vaccination. Patient had no known allergies, no other medical history. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. On 27May2021, the patient had to pee constantly, and had pain and burning while urinating. The adverse event result in doctor or other healthcare professional office/clinic visit. Patient had not been tested for COVID-19 since the vaccination. Therapeutic measures were taken as a result of events and included treatment with antibiotics. The outcome of the events was not recovered.

Numbing from head down to whole body, throwing up, could not walk, paralysis. Spouse had to take her to ER. She was treated with fluids, Mg, antibiotics. She was diagnosed with bladder infection .Later developed blister in the mouth

On day 2 after the 2nd dose vaccine, that evening I had sweats, chills and fever was 104. I took Tylenol and alternate with Motrin every 6 hours. I woke up the next day, I had severe flu-like symptoms-body aches, weakness, migraines, fever, chills, dizziness, nausea and loss of appetite. I stayed in bed to rest and sleep. I went to see the doctor on 7/1/2021 because I developed a urinary infection and pneumonia. I had shortness of breath, fatigued, low grade fever, urinary pressure and frequency and urgency. They did blood work, urine culture and CT scan which confirmed pneumonia and UTI. I was prescribed Levaquin which has resolved both my UTI and pneumonia. I am still suffering from symptoms and side effects from the vaccine. I have daily full body pains and aches, headaches, fatigue, chills, loss of appetite and unable to work or do normal daily activities.

7/12/21: headache, tiredness 7/13/21: sore throat, headache, fever 100.6, neck/shoulder pain 7/14/21: fever 100, back/ kidneys in pain, no appetite 7/15/21: headache, tiredness, back ache, lost 4 lbs 7/16/21: upper back pain 7/17/21: tested positive for COVID-19 7/18/21: upper back pain when breathing, go to ER: pleurisy, other tests negative 7/19/21: lost sense of smell, congestion 7/20/21: congestion w/ mucus 7/21/21: tiredness, congestion with mucus

Day after vaccine, severe arm pain to the extent left arm was minimally functional. Moderate arm pain 2 additional days. Minor arm pain for few more days. Fatigue, general tiredness, sore throat for a week, although still experiencing sore throat. Unsure if that's environmental. Back pain (kidney area) beginning few days after injection, lasting several days. Non-muscular pain, more internal such as kidney pain. Worst symptoms: Itching, redness, swelling, inflammation below the injection site, approx 3"Hx7"W band across my left arm,beginning about 2" below the point of injection. Today is day 12 and I'm still experiencing this. Moderate itching 24 hrs, mild swelling, red, hot, inflamed. Symptoms are less severe at this point.

2pm felt mild tired, muscle soreness. 8:30pm developed severe fatigue, chills. 10pm developed swollen golf ball size knot. Tired but couldn't sleep. For 2 days severe hip bone pain, couldn't walk. day 2 H/A. Had constant severe urination. SOB, Low back pain. Entire skeletal system felt like she was in a car accident. Took 800mg ibuprofen. Had no energy 48 hours. 3rd day started to recover. Could not eat meals for 2 days.

I had an abscess tooth that became infected; UTI; headache; stomach bloating; pressure and discomfort; blood in my urine; This is a spontaneous report from a contactable consumer (patient herself). A 52-year-old female received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EL3247), via an unspecified route of administration in the left arm on 18Jan2021 at 10:30 AM as a single dose for COVID-19 immunization. The patient had no relevant medical history. The patient ha d no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination, has not been tested for COVID-19 since the vaccination, and was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine and also did not receive any other medication within two weeks of vaccination. The patient had a headache on 22Jan2021 for 5 days. She also had stomach bloating and pressure and discomfort on 22Jan2021. It was reported that when she saw blood in her urine, she went to a walk-in and was diagnosed with a UTI on 22Jan2021. She did 7 days of an antibiotic. Then on 30Jan2021, she had an abscess tooth that became infected. It was reported that the patient received antibiotics for both infections. It was reported that the events result in a doctor or other healthcare professional office/clinic visit and an Emergency room/department or urgent care. Outcome of the events was recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).

Headache, chills, nausea, vomiting, aches and pain, severe pain in kidneys, eye pain, weakness, loss of appetite,

One day after receiving the vaccine, patient noted lower back pains, diffuse joint pains, fatigue, and gross hematuria. Symptoms persisted for 3 days but then resolved. Of note, Pt received first dose of Pfizer vaccine without incident.

Mar 29-6pm Left arm injection site began to hurt and painful to touch Neck muscles on right side of neck and tongue began to swell Extreme fatigue took over body Mar 29-8pm Rash and itching in following regions: Around collar area/bra line/buttocks/back of thighs/lower back/behind knees/in elbow crease/back of arms Injection site swollen and painful Mar 30-2am Painful abdominal bloating and gas nausea frequent urination chills/arms and feet would not warm up muscle pain joint pain Mar 30 2:30-3:30am vomiting-multiple times and loose stool elimination/turning to diarrhea continued chills and inability to warm up hands and feet complete fatigue Continued muscle pain/joint pain and injection site pain/swelling Mar 30 2:30pm Low grade fever (99.8) all other symptoms remain and limbs begin to warm up Slept from Mar 30th @ 7pm-Mar 31st-7am Mar 31 Woke at 7am and felt much better Injection site on arm still tender, but improving Fever gone/temperature normal (97.5) rash dissipated Joint and muscle pain lingering (reported side effects to Pfizer reporting mid day of Mar 30

9:30- started body aches, chills, cold hands 11:00-started fever, 100.5, headache, pain in every joint, skin painful to touch, especially my legs These events lasted through the next 24 hours Temperature went up to 101.9. Frequent and sudden need for urination, (hourly for about 16 hours) On 3/11/2021 I woke with extreme pain in my jaw joints that lasted about 4 hours. Around 12:00 pm fever, headache and chills subsided. By approximately 4:00 pm all symptoms had stopped.

Injection was at 12 PM. At 12:15 PM I started to feel a furry throat like I had a hairball in my throat and a tickle. Within a minute or so I got a cough, a dry cough with a high pitch. I could not stop coughing. My face felt hot and was flushed, my lips tingly, and I started to sweat a lot. I was short of breath when I tried to talk. The staff on site put an oximeter on and my oxygen was fine but my pulse rate was around 130. My nose was dripping snot and my eyes were running. We walked over to ER which was just around the corner, And sat in the waiting room for about 10 minutes wondering if the cough and symptoms would update. I Peed my pants a little bit. I started to feel very nauseous and little bit scared, even though this has happened to me before. I was brought to a room and soon given a dose of Epi as well as Pepcid (about 1pm) soon after some Zofran. The epi took care of my symptoms within about five minutes. About 90 mins later symptoms came back full on and I was given another dose of Epi at almost 3pm. And agin at 630pm.

PFIZER VACCINE- DOSE 1 -4/30/2021 5/7/2021- SUDDEN ONSET UTI- UNSPECIFIED HEMATURIA- SUGAR IN URINE LEG CRAMPING/PAIN FATIGUE SEVERE PELVIC PAIN SEVERE BACK PAIN SHORTNESS OF BREATH HEART PALPITATIONS DURATION- STARTING 5/1/2021- CURRENTLY 5/14/2021 SUDDEN ONSET- UTERINE/VAGINAL BLEEDING -PROFUSE!!! DURATION- 5/14/2021- 5/17/2021- PROFUSE/HEAVY 5/18/2021- 5/22/2021 (AS OF THIS SUBMISSON)- LIGHT SPOTTING (NOTE- LAST MENTRUAL CYCLE- 2/2021- DID NOT MENSTRUATE 3/2021 OR 4/2021) DIZZINESS/RACING HEART/LEG PAIN/CHEST PAIN/SHORTNESS OF BREATH/THIRST/EXTREME WEAKNESS AND FATIGUE

received the vaccine as an inpatient in our hospital on 5/21/21. Patient went into cardiac arrest on 5/22/21 at approximately 9:00am

Presented to ED with significant exacerbation of fibromyalgia symptoms severe GI discomfort (3 days after Covid vaccine). She states that her pain feels similar to when she was admitted in December 2020 for diverticulitis. She denies urinary symptoms and hematochezia. She has been taking generic Bentyl with minimal relief to her symptoms. She took an Oxycodone this morning with moderate relief to her symptoms. Patient admitted. Urinalysis shows obvious infection. There is some squamous cell contamination. Bicarbonate was 15. Pregnancy test was positive and her quantitative hCG is 16 which is negative. CBC did not have leukocytosis or thrombocytopenia. She has baseline, chronic anemia with a hemoglobin of 10.9. CT imaging of the abdomen pelvis was performed without contrast secondary to renal dysfunction. She does have what appears to be early diverticulitis. Patient started on Invanz which will be continued. Gentle fluid, diet as tolerated, as needed antiemetic, as needed analgesic and antipyretic. Added Xifaxan 550 mg BID x 3 weeks to discharge regimen. General surgery was consulted given this is pt's 3rd bout of diverticulitis in less than a year. At this time, they recommended ABX mgt and referral to AMC with a GI surgeon given her complex status with the kidney transplant and CKD. GI was also consulted at pt's request. Rec 3 weeks of rifaxamin in addition to whatever standard diverticulitis treatment. Pharmacy reviewed pt's allergy list and thought moxifloxacin 400 mg daily would be sufficient (it also has anaerobic coverage).

UTI; Severed upper arm shoulder started approx 6 weeks post second dose; tightness in chest; humming in ears (slight)

Multiple blood clots (DVTs) to BLLE with gross edema, decreased mobility, stasis ulcers, kidney stones and ?fluid on kidneys? (NOS), hematuria, wound clinic treatments required, loss of ability to work, increased depression and stress r/t above.

Lupus - lungs tight, cough/breathless out of nowhere, crushing headaches, vertigo, goop in nose and throat, extremely low (96s) body temp, shaking chills, sleep troubles, fatigue, seeing ?black spots?/almost passing out, balance off where had to lean against walls. I am VERY fit, do high intensity workout, hike tall mtns 15-20 mi day hikes and never get sick. Had these cycling symptoms the DAY I got the second vax after just minimal arm ache with the first vax. I had newer job as mortgage lender - working 45-50 hrs on phone 9-10 hrs a day selling loans company wanted at least 150 calls a day - high stress and pressure. Have been on medical leave since this started as no way can work; get awful cough fits if even talk for a few mins and memory gets like a sieve and I have gotten disoriented in my own home. It is very disabling and I was FINE before and am VERY durable.

severe Bladder urgency and pain blood in urine. Was treated for uti even though there was no bacteria in urine. symptoms went away but came back a month later worse than before. went to er but again found no bacteria. both times there was blood in urine. was referred to urologist. Urologist found no bacteria and Vesicare was prescribed for Over active bladder. I never had these symptoms before this vaccine.

Dizziness; Heart palpitations; Mild numbness; Tingling of tongue; Mild lower lip swelling; Frequent urination; Fever of 99; Wrong site of drug administration; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL9269) via an unspecified route on left leg (wrong site of drug administration) on 21Mar2021 at 13:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included hashimoto thyroidism and celiac disease. The patient was allergic to wheat, dairy, nitrous oxide and codeine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included B12 shot (MANUFACTURER UNKNOWN) for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Since the vaccination, the patient was not tested positive for COVID-19. On 21Mar2021 at 13:15, the patient experienced dizziness for about an hour, with heart palpitations, mild numbness, tingling of tongue, mild lower lip swelling, frequent urination (urinated 8 times in one hour) and fever of 99 (units unspecified). The events not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment received for the adverse events. The clinical outcome of the events dizziness, heart palpitations, mild numbness, tingling of tongue, mild lower lip swelling, frequent urination and fever of 99 were resolved on 21Mar2021. The clinical outcome of the event wrong site of drug administration was unknown. No follow-up attempts are possible. No further information is expected.

05/18/2021 around 2AM I woke up in the middle of the night with severe chills and I took my temperature and it was 100.8 degrees. For me, I'm usually at 97.2 degrees. Everything in my body hurt. I stayed home from work the next day and the fever didn't break. I never got sweaty but it just didn't break. I treated it with either ibuprofen or Tylenol. It eventually went away and I was fine. A week later on 05/25/2021 the same thing happened where I woke up in middle of night shaking and a fever of 101.3 degrees. Every part of my body hurt, behind my eyeballs hurt. I called my doctor and because I had a fever and she said I couldn't come into the office. My heart was fluttering as well and she said just go to the ER and get checked out and have them do a COVID test even though I'm fully vaccinated. I went to hospital and they did a rapid PCR COVID test which came back negative but my blood work, liver was off, proteins were off. The doctor did not come anywhere near me and told me I had UTI, gave me antibiotic, and sent me home. I've had UTI's before and I know what they feel like and this didn't feel like that. The next day 05/26/2021 I did a video visit with my doctor and I still didn't feel right. The fever part of it broke but she said that since I was still having the weird heart thing just go straight to ER so I said ok. The next morning my heart was fluttering so I went to the ER again but I went to a different hospital ER. They did blood work, EKG, Epstein-Barr, but no COVID test this time. My doctor had said to me that I really sound like I had COVID regardless of negative test. Again, the liver function was high, they did hepatitis ABC that all came back negative. Epstein-Barr came back high but not hugely high. They just said they didn't know what was wrong with me. They said it might be hepatitis or Epstein-Barr but I didn't have symptoms of mono. I did have tiny cough sometimes. They did a chest x-ray on me and didn't find anything mysterious. Over next few days they kept re-running blood and liver function test and it was still off for another 2 weeks. They sent me to cardiology because of shortness of breath and chest pain along with palpitations. He ordered more blood work and a stress echo. This past Tuesday 07/06/2021 he did angiogram thinking he would find blockages but he found nothing. He said my heart looked good but no explanation. I have never had heart palpitations before in my life. By 06/24/2021 my liver enzymes were back to normal but they're still not sure what is going on with my heart but from what he told me I don't have any blockages and my heart looks fine. My next appointment with cardiology is on 07/22 or 07/23. I was also having some vaginal bleeding and I was at the time 7 months into menopause. I went to Gynecology and they found polyps and I am going into have procedure to have polyps removed.

1st, i got sore throat, about 6 hours later, I got my 1st UTI in my life after the 2nd dose. Saw the doctor, got antibiotics. Then, for the next 3 weeks, I got chest pain ( I can feel my heart tight even when I sat, walking made heart more pain for a week. The 2nd week only had heart pain when walking, the 3rd week had heart pain if running), also severe headaches. I wanted to call my doctor, but close to July 4th week, so I didn't call. Also I don't know if doctor can do anything to make it better.

I decided to sit for 30 mins after the 2nd vaccine. At about 15 minutes after the vaccine, I was lightheaded, and my heart started to beat bad. I also had extreme chest pain. They took my vitals and I started to sweat profusely. Based on my vitals and my symptoms they thought I was having a heart attack. They took me over to the ER, and I started to experience kidney pain. The pain from that was so bad I thought I was going to vomit. They took me back into one of the rooms and they started all the test to see if I was having a heart attack. I started to have trouble breathing. My pulse was okay. All the tests came back inconclusive. My EKG came back abnormal. They discharged me to go home. I went back to the ER less than a week later because I was experiencing COVID like symptoms. I was tachycardic and had hard time breathing. I had swelling in my arm where the injection was given. I was unable to dress like normal and I could not even walk my dog without being out of breath. I went to the Urgent Care and they diagnosed me with a Pleurisies' and System Inflammatory. They prescribed me a steroid and I was told to take it for 10 days. They also gave me an inhaler as well. They did not do anything. I went back to the doctor after the steroid, and I was still having difficulty breathing. I had joint pain, headaches, I was still unable to take a deep breath. I was sitting at my kitchen table and passed out. I woke up on the floor. I drove myself to the ER and they were going to admit me, and they treated me for a migraine. They decided to a migraine cocktail. I had extreme pain in my lower legs. They were afraid of me having a DVT. They did an ultrasound and did not find a DVT. They decided to send me home. Between the last visit to now I have had between 5-7 more visits to the ER and urgent care due to not being able to breath and the joint pain. I have Dilated Aortic Root Valve and I am also Tachycardic neither of which I had before. Now I am better, but I do at times have difficulty breathing.

This is a Literature report from Kidney International, 2021, Vol 100 (1), Pgs 238, entitled "A case of gross hematuria and IgA nephropathy flare-up following SARS-CoV-2 vaccination". A 52-years-old female patient received second dose of bnt162b2 (PFIZER-BINTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. Medical history included iga nephropathy from 2017 to an unknown date, URI from 01Apr2019 to an unknown date following shingles vaccine, Vasculitis flare-ups following vaccinations have been reported in the past. Concomitant medication included lisinopril (LISINOPRIL) taken for an unspecified indication. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation and experienced no adverse event, first dose, developed no symptom. The patient previously received Shingrix vaccine and experienced gross hematuria, exacerbations since diagnosis, following the first shot. The patient previously received influenza vaccination annual, no symptoms. On an unspecified date, the patient experienced delayed-type hypersensitivity reaction, gross hematuria, iga nephropathy flare, fever, myalgias, body aches, lower back pain bilaterally. Patient developed gross hematuria within 24 hours of receiving a second dose of the Pfizer vaccine. Table 1 summarizes clinical data. Her workup was notable for proteinuria of 4.2 g/g of creatinine with serum creatinine at baseline. Of note, SARS-CoV-2 antibody testing prior to vaccination was negative, and she developed no symptoms after the first vaccine dose. Repeated testing within 1 week demonstrated resolution of hematuria and improving proteinuria. Interestingly, she developed gross hematuria following the first shot of the Shingrix vaccine 2 years prior but no symptoms following annual influenza vaccinations. The IgA nephropathy flare in our patient following the second SARS-CoV-2 vaccine dose without known prior exposure to SARS-CoV-2 suggests it was mediated by a delayed-type hypersensitivity reaction. Patient symptoms improved within a week without any intervention aside from continued renin-angiotensin-aldosterone system blockade. It has been reported that severe coronavirus disease 2019 (COVID-19) illnesses can trigger an IgA response in the bronchial mucosa. However, it was unclear how a non mucosal vaccine triggers this response. Suggested that nephrologists closely follow their patients after COVID-19 vaccination to evaluate for varying degrees of flares, particularly after the second dose of an mRNA vaccine without prior exposure to SARS-CoV-2. Patient symptoms and details of workup: Hematuria 5 d after Pfizer second dose, Resolved. The patient underwent lab tests and procedures which included biopsy: proven iga nephropathy, baseline Cre: 0.7-0.8 g/dl, serum creatinine: at baseline, urine proteine: improving, RBCs in urine: yes, SARS-CoV-2 antibody testing: negative prior to vaccination, last urine microalbumin/Cre before exacerbation: baseline always less than 1000 mg/g, except exacerbations, 633.1 mg/g on unspecified date in 2020, Urine microalbumin/Cre 48 h after Pfizer second dose: 2411.3 mg/g, Urine microalbumin/Cre 5 d after Pfizer second dose: 1441 mg/g, urine protein/creatinine ratio: 4.2 g/g on unspecified date, gross hematuria: yes, resolution on unspecified date in 2020. Seriousness of delayed-type hypersensitivity reaction was medically significant. No treatment received for delayed-type hypersensitivity reaction and gross hematuria. The clinical outcome of gross hematuria was recovered on an unspecified date, delayed-type hypersensitivity reaction was recovering and other events were unknown.; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and the events hypersensitivity, hematuria and IgA nephropathy cannot be completely excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.

Sharp headache, fever, muscle pain (very sharp pain in the legs), loss of appetite, stomach pain, chills, sleepiness, severe pain in the arm of the vaccine, thirst, constant desire to urinate.

Patient c/o light headedness, diaphoresis, and sweating shortly after receiving vaccine. Symptom onset ~1145a, vaccine time ~1140am. She was incontinent of urine. No loss of consciousness. Neuro intact entire time - no seizure activity. No facial swelling, difficulty breathing, rash. No chest pain. She did complain of left trapezius pain. All extremities with normal movement. Patient was laid flat on cot - no injury sustained. 15L O2 NRB placed.Vitals: 1150: 116/50, HR: 51, Spo2 99%, 1155: 115/65, HR 62, 97%. Blood glucsoe: 110 mg/dl. ECG SR. Patient did feel better once laying flat. 911 was called at symptom onset. EMS arrived at 12:05p. Reports provided. Patient transported to Hospital ER.

Bilateral kidney pain - sharp throbbing began several hours post injection and has gradually diminished to intermittent occurrences two days post injection.

rash covering most of torso; Passed out; unable to hold urine; diarrhea; extremely weak; sweating profusely; temp of 101; trembling uncontrollable; freezing; terrible headache; lethargic; This is a spontaneous report from a contactable consumer (who is also the patient). A 53-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8732), via an unspecified route of administration in the left arm, on 07Apr2021 10:30, as single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had no known allergies and was not pregnant at the time of vaccination. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6207) received at age 53 years, via an unspecified route of administration in the left arm, on 16Mar2021 11:00, for COVID-19 immunisation. The patient did not receive other vaccines in four weeks. On 08Apr2021 at 03:30, the patient woke up trembling uncontrollable and was freezing. She had a terrible headache. At about 04:30, the patient got out of bed to get some Advil and go to the bathroom. She almost got to the bathroom but was unable to hold her urine and had sudden diarrhea as soon as she sat down. She then became extremely weak and passed out. She was sweating profusely and had a temp of 101. She took Tylenol and Advil and her temp broke an hour or two later. She then had a headache and was lethargic all day on 08Apr2021. On 09Apr2021, the patient felt much better but reported she was still weak, she also had a rash covering most of her torso. Treatment for the events trembling uncontrollable, freezing, terrible headache and temp of 101 included Tylenol and Advil. No treatment was taken for the remaining events. The outcome of extremely weak was not recovered; and the outcome of the remaining events was recovering.

Started with 100.6 fever at 3am- 10pm following day 5/15/21 along with stomach ache, nausea and headache 5/16/21 right underarm lymph node began slightly. Dark yellow pee, once. 5/17/21 - woke up with swollen lymph nodes, underarms and left side neck, right arm lymph node, painful.

have some spotting blood in urine at night; This is a spontaneous report from a contactable consumer(patient). The consumer reported similar events for herself with two doses. This is the first of two reports. The 53-year-old female patient(not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021 10:15 (Lot Number: Er8732) as 1st dose, single for covid-19 immunization. Medical history included paroxysmal nocturnal haemoglobinuria(PNH anemia) from 2006 to an unknown date , Latex allergy, bactrim allergy. Concomitant medications included iron (FE 10), cyanocobalamin (B12-VITAMIIN) and one a day women vitamins. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced minor side effects after first dose but did have some spotting blood in urine at night. (She was a PNH anemia patient). There was physician office visit for event. Outcome of event was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021547423 same patient/drug, similar AE, different dose of vaccine

Bleeding starts 1 day after dose given; large blood in urine output at night; increased lethargy; WBC and Hgb drop; WBC and Hgb drop; This is a spontaneous report from a contactable consumer (the patient). The consumer reported similar events for herself with two doses. This is the second of two reports. A 53-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0161) via an unspecified route of administration, administered in Arm Left on 21Apr2021 10:15 at age of 53-year-old at single dose for COVID-19 immunisation. Medical history included PNH anemia since 2006 and known allergies: Latex, sulfamethoxazole trimethoprim (BACTRIM). The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Concomitant medications (received within 2 weeks of vaccination) included iron, cyanocobalamin (VITAMIN B12) and one a day women vitamins. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Er8732) via an unspecified route of administration in left arm on 26Mar2021 10:15 AM at age of 53-year-old for COVID-19 immunisation. Minor side effects after first dose but did have some spotting blood in urine at night. Told MD and was told to proceed with dose 2. After second dose on 22Apr2021 23:00, large blood in urine output at night and increased lethargy. Bleeding starts 1 day after dose given. Lasted less than 1 week but white blood cell (WBC) and haemoglobin (Hgb) decreased/drop (22Apr2021). The events resulted in: Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The outcome of the events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021529122 same patient/drug, similar AE, different dose of vaccine

severe Dysuria tested positive for HSV1 Genital; Low WBC count and low lymphocytes; Low WBC count and low lymphocytes; patient developed 102.6 fever; nausea; Swollen groin lymph nodes; kidney infection; severe UTI; the patient experienced bad leg pain; rash on legs; This is a spontaneous report from a contactable other hcp (patient). A 53-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Right on 22Apr2021 13:30 (Batch/Lot number was not reported) as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history included breast cancer and Hashimoto disease. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 at the age of 53-years-old on 01Apr2021 12:30 in the arm right for COVID-19 immunization. On 02May2021 22:00, the patient experienced bad leg pain, rash on legs, flowed by severe UTI and kidney infection. On 05May2021, day 3, the patient developed 102.6 fever, nausea, swollen groin lymph nodes, severe dysuria tested positive for HSV1 Genital, with bad lower pelvic pain, low WBC counts and low lymphocytes. The patient had 2 trips to ER in 3 days, missed 8 days of work due to the events. The patient received IV fluids, IV antibiotic, IV pain meds, anti-nausea as treatment for the events. The outcome of the event was recovered with sequel. Information on the Lot/Batch number has been requested.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, A possible causal relationship between reported events and suspect drug BNT162B2 Cannot be 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 Committees, and Investigators, as appropriate.

Hemiplegic migraine; Forgetful; Peeing more often; Heavy tongue; Slurred speech; Aura; Bleary vision; Left eye twitching on and of; black and blue eye; Hands shaky; swollen black and blue eyes; Depth perception problem on right side; Headache; Fatigue and very tired; This is a spontaneous report from a contactable patient. A 53-years-old non-pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot/Batch no: unknown) via unspecified route of administration on 04Mar2021 at 10:30 am (at the age of 53- years) as a single dose for COVID-19 immunisation. The patient's medical history included asthma, seasonal allergy, Transient Ischemic Attack (TIA) in 2014 and migraine. The concomitant medication includes erenumab aooe (AIMOVIG) for migraine from unknown dates. Patient previously took botulinum toxin type A (BOTOX) for migraine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 07Mar2021 at 08:00 am, the patient experienced fatigue for 1-3 days, headache, until she had gone to urgent care. The patient also reports swollen black and blue eyes, tiredness, left eye twitching on and off, blurred vision, slurred speech, was forgetful, depth perception problem on right side and heavy tongue, hands shaky, aura, peeing more often (sometimes she had to sit longer) and hemiplegic migraine. It was also reported that, the events migraines and headache she had after the vaccine was intolerable. At the time of report the events of mild headache and blurred vision was ongoing. The adverse events resulted into healthcare professional office/clinic visit and emergency room/department. Therapeutic measures for the reported adverse events included treatment with metoclopramide, methylprednisolone and "nr" from unknown dates. The clinical outcome of the events of fatigue, headache, swollen black and blue eyes, tiredness, left eye twitching on and off, blurred vision, slurred speech, was forgetful and heavy tongue, hands shaky, aura, peeing more often and hemiplegic migraine was reported as recovering. No follow-up attempts are needed; information about lot/batch number cannot be obtained. Amendment: This follow-up report is being submitted to amend previously reported information: Updated reporter details (reporter name, for correspondence contact in slide#2, Health care professional leave blank; Protect confidentially and Correspondence contact was checked). Patient details added (Patient's first name and age/units). For concomitant drug "amogiv" was considered as typo and coded as Aimovig. Concomitant therapy leave blank since the concomitant drug was coded via WHO drug in product tab already. Deleted duplicate reported Indication of BNT162B2. Lot# UNKNOWN was removed from dosage regimens tab. Best doctor/Health care professional information such as phone number and email were added in vaccine administration tab. Treatment received was ticked as Yes for events. Physician Office Visit and Emergency room visit were checked. "Depth perception problem on right side" was added as AE.

before vaccination she has not have her menstrual cycle for quite a while, and it then started yesterday.; her periods were "heavy, flooding" with "cramps"; her periods were "heavy, flooding" with "cramps"; gums that have been bleeding easier than normal; a weird pain in her upper legs, at the "top part", which started in her left leg and radiated to the right one, last night.; Interstitial Cystitis anyway, flare it up; excessive, frequent and urgent urination; excessive, frequent and urgent urination; excessive, frequent and urgent urination; the arm where she was vaccinated was "cold to touch and sore; the arm where she was vaccinated was "cold to touch and sore; her "little finger and ring finger in both hands" were "numb and tingling", which then spread to her arms.; her "little finger and ring finger in both hands" were "numb and tingling", which then spread to her arms.; intermittent headaches; waves of nausea; This is a spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received the first dose for BNT162B2 at single dose at Arm Left on 28May2021 at 17:58 for COVID-19 immuniation (53-year-old at vaccination). Relevant history included positive ANA, Interstitial Cystitis and Ocular Rosacea. Relevant concomitant drug included Doxycycline at 50 mg twice daily for ocular rosacea since 1 week before getting the vaccine to 27May2021. She noticed an increase in urination after starting it. Was told it was okay to get the vaccine while on it. Stopped it due to irritation in her stomach. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). No family medical history relevant to AE(s). The patient explained she has experienced various side effects from the first dose. She reported having "excessive, frequent and urgent urination", which lasted for three hours the night she was vaccinated. She mentioned the arm where she was vaccinated was "cold to touch and sore." Her "little finger and ring finger in both hands" were "numb and tingling", which then spread to her arms. She then listed the following as additional symptoms: "intermittent headaches, waves of nausea, and gums that have been bleeding easier than normal". She then explained before vaccination she has not have her menstrual cycle for quite a while, and it then started since 09Jun2021 (reported as yesterday). She specified this morning, her periods were "heavy, flooding" with "cramps", which she had never experienced "at that level" before/ "more than typical". Lastly, she reported a weird pain in her upper legs since 07Jun2021, at the "top part", which started in her left leg and radiated to the right one, last night. She described this weird pain as "deep in" her legs, "not a muscular pain" but one that is either related to her "blood vessels or nerves". She said this pain is "not constant but shooting". She asked if these symptoms are normal after getting the vaccine. The patient further specified that evening she had excessive, frequent and urgent urination; she was drinking more that day, but not that much more. That same night, her left arm was cold to the touch and sore. She also woke up during the night with numb and tingling fingers on both hands; it was her little finger and ring fingers on both hands; it would start in her hand and go up her arm. She had intermittent headaches and waves of slight nausea. States that she has not had a full menstrual cycle for some time, but yesterday she started her cycle and last night it got heavier, and today it's really heavy, like it's flooding. She also has really bad cramps. Her gums have been bleeding easier as well for the past couple days, but she did not see any blood today when she brushed her teeth. Also, she has leg pain; it started in her upper left leg on the 7th, deep in a vain, almost like a nerve pain, but last night it was in her right leg; it comes in waves. The pain is in the top inside part of her legs. It's either a nerve thing or a blood vessels thing. When she was experiencing the frequent urination, she started wondering if the vaccine was all leaving her body, so now she doesn't know if she has the protection from the vaccine. Is there a way to check that? She has Interstitial Cystitis anyway, and there are a lot of things that can flare it up, but this just lasted longer. States that it lasted about 3 hours, and now she is back to her normal. While it was occurring, it was excessive, she went to the bathroom about 8-10 times an hour and her pee was clear. States she was trying to drink more water to make sure she didn't get dehydrated, but as soon as she drank, she would have to go again. She stated the intermittent headache and slight nausea, she expected to have after the vaccine. The cramping from her cycle is easing up, but the flow was really heavy earlier today, but in the last hour is has slowed a bit. On the night of 08Jun2021, her gums were really bleeding when she was brushing her teeth, and last night they were bleeding, but this morning there was no bleeding at all, so hopefully it's stopped but she won't really know until she brushes her teeth tonight. The events did not result in Emergency Room or Physician Office visit. No relevant tests performed. The outcome of event pain in leg, gums have been bleeding was resolving. The outcome of other events was resolved. The patient was due to get her 2nd dose on 10Jun2021, but she was nervous to get it. She has auto-immune concerns; she has a positive ANA. Her doctor told her that she definitely needs to get the vaccine. She had her second dose scheduled on 18Jun2021. Information on Lot/Batch number was available. Additional information has been requested

Went to bed with racing heart and chills on the 23rd of March. Felt weak on the 24th and couldn't go to work. On the 27th, took my Lyme antibiotic, Tinidazole. Felt weak on the 28th. Better on the 29th and took second antibiotic - Azithromycin - in the AM. Early that evening, began feeling burning skin, pins & needles in arms and upper body, severe chills with no fever, frequent urination and bowel movements, chest wall pain and high anxiety. Tried to go to bed, was unable to sleep because chills lasted throughout the night. Went to hospital at 7AM on the 30th. Was released same day. They didn't prescribe anything. Spent the next two weeks on bed rest due to severe weakness and fatigue. Went back to work on Tuesday, 4/13/21, for four days. On Saturday and Sunday was bedridden again. Went into work on 4/19/21 and was sent home due to racing heart and weakness. On Saturday, 4/24/21, went back into hospital with racing heart, chills, weakness, nausea, chest wall pain, high anxiety. Release same day. Didn't go to work from 4/26-4/30. Took leave of absence from work (I am an elementary school teacher) from May 3-June 23, 2021.

Hair on head is falling out/thinning; gums bled more than usual during dental cleaning; slight incontinence that seems to be worsening (not associated with toileting).; This is a spontaneous report from a contactable nurse (patient). A 53-years-old female patient (Non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6208), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 at 10:30 (at the age of 53-years-old) as a dose 2, single for covid-19 immunization. Medical history included type 2 diabetes mellitus from an unknown date and unknown if ongoing. The patient previously took keflex [cefalexin monohydrate] and and sulfa [sulfacetamide sodium] and experienced drug hypersensitivity. Concomitant medications taken within 2 weeks of vaccination included canagliflozin (INVOKANA [CANAGLIFLOZIN]) and metformin (METFORMIN) both were taken for an unspecified indication, start and stop date were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EL9267), dose 1 via an unspecified route of administration, administered in Arm Left on 25Feb2021 at 01:00 PM as a dose 1, single for covid-19 immunization. After dose 1, Patient experienced there was pain in my joints (knees and hip) and hematoma-like bruising on my palm after using a hammer (it disappeared after a couple days and left no residual markings). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date, the patient experienced Hair on head is falling out/thinning, gums bled more than usual during dental cleaning, slight incontinence that seems to be worsening (not associated with toileting). Outcome of the events were not recovered. No follow-up attempts are needed. No further information is expected.

AFTER 1ST 10 MINUTES, PAIN IN UPPER RIGHT THIGH. LACK OF APPETITE, CONSTANT SLEEPING, CONSTANT SLEEPING, AND EXCRUCIATING HEADACHE THROUGHOUT THE WEEKEND ALONG WITH NAUSEA AND GOING TO BATHROOM..HEADACHE INTO MONDAY NOT LETTING UP NO MATTER WHAT..SEVERE MUSCLE PAINS IN LEGS AS WELL

Sunday 3/7 at 4 pm began extreme fatigue, nausea & headache. Did not work on 3/8 due to continued nausea & migraine. Tuesday 3/9 went to ER with same symptoms. Was admitted to hospital on 3/9 with acute kidney injury, nausea & Migraine. Was discharged from hospital on 3/14. Followe up with primary doctor on 3/17. Primary DR requested more bloodwork. Had low potassium. Ended up back in ER 3/17 with nausea and vomiting. They pushed more fluids and sent me home. Will have follow up blood work on 3/26 and next Dr appointment on 4/19. Returned to work for 1/2 day on 3/22. Absent 3/23 for extreme fatigue.

Rec'd vaccine at 12:30pm. Next couple hrs were normal, except tasted a fume-like vapor in back of throat. By 6 pm I started feeling aches, especially my joints and muscles. Was at a laundrymat and pulling clothes out of dryer -felt impossible to hold them up...burning and aching in shoulders and neck. Feel waves of fatigue. Left, went home...felt hot and clammy. Took temp- it was 101.7. Took tylenol, gabapentin, and went to sleep in recliner. Woke up at 11 pm, severe muscle weakness...so much that by the time I got out of the recliner...and on my feet...I already began to urinate on myself. It was like I could not control my body...I had very little ability to get up and out of recliner...everything was so HEAVY....my arms and legs were "weighted". After using restroom...it took 15 min just to change out of soiled clothing and clean up...and re-dress. I laid down in the bed, but was very uncomfortable...so went back to recliner. Was physically unable to get the lid off the tylenol after trying very hard....I fell back to sleep. At 3:15 am I woke up needing to pee, and once recliner was at normal seated position...I struggled to use my arms to lift myself up...my right arm, where I got vaccine hurt badly...it felt like PAIN...like beyond sore. I pitched to floor cuz legs wouldn't hold me. My fever was 103.7... J feel hard-pressed to finish cuz I got a warning im about to time out. Guess I hope someone contacts me. I hav

About 10:30 PM, started getting a slight headache with accompanying symptoms of a urinary tract infection. The urgent need to go to the bathroom and the sensation of pins and needles at the end of urinating. Trying to drink a lot of fluids but it?s not helping much. Not seeing any blood on the tissue paper at the end as with typical UTIs

Stopped breathing while sleeping, my husband said I was snoring very loudly (which is not typical) and I just stopped. He tried waking me and I didn't wake right away. He got up, turned on the light, noticed that I had wet the bed and he continued to shake me and called my name several times, then I opened my eyes. My speech was a bit slurred at first, I got out of bed, felt nauseous, and my ears were ringing very loudly. I sat up for a while, then went back to bed. I didn't connect it to the vaccine, but wondered about the connection. Then I heard it happened to someone else, so I thought I should report it. I did not seek medical care.

abdominal pain got worse every day until Friday after midnight, it became unbearable so went to ER. Did Cat scan and showed evidence that looked like kidney stones had just passed. Today is Monday and she is still in pain on right side abdomen front and back.

I woke at midnight. I was all sweaty & felt like I couldn?t breathe, my heart was pounding. I ran downstairs and outside to get air and the earth felt like it was spinning under me and everything was moving. I felt nauseous and confused and had racing thoughts. I fell back and hit my head and got up and tried to come inside and ended up falling again and urinating while on the floor. I believe I lost consciousness. I couldn?t stand and vomited several times in the ER.

passed out; trouble flexing her right hand open and closed; not feeling well, she feels very bad; sores in her mouth and nose; sores in her mouth and nose; anal hemorrhoid sores; had difficulty speaking, with her words; has been dropping things, she has broken glass; her eye felt heavy and her eye was drooping; Dizzy; Fall; Slight fever; Fatigue; extreme pain through right side (right side means her shoulders, neck, torso, arm, and entire leg); first dose given 14Jan2021, and second dose given 07Mar2021; first dose given 14Jan2021, and second dose given 07Mar2021; Shortness of breath; severe nerve pain; Vomiting; had a feeling of urination, like she had to urinate when she didn't, that feeling of urination; Disorientated; eye pain like pins and needles; skin is burning and painful to the touch; Headache; joint and muscle pain; joint and muscle pain; Nausea; horrible lack of appetite/couldn't eat anything other than soup; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer-sponsored program called COVAX US Support. A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 07Mar2021 (Lot Number: EN6204) as single dose for covid-19 immunization. The patient's medical history included history of three spinal surgeries (takes no pain meds, she is not on pain meds, she has never been on or kept taking them); and has "neuropathy and nerve related issues" that were not this bad since ten years ago in 2011, clarified that what she has is not actually neuropathy, something with the peripheral nerve, she says she doesn't remember actual verbiage), since ten years ago in 2011, and the only difference was this vaccination, it was not this bad until this vaccination. She doesn't react well to pharmaceuticals anyway (unspecified). Her medications are that she takes the minimum amount of medications, very minimal (unspecified). There were no concomitant medications. There was no other products. Also, she has not had any other recent vaccinations or started any new medications. For past drug, she didn't take anything other than 5mg of zolpidem tartrate (AMBIEN) to sleep at night because of her spine. Patient previously also took pregabalin (LYRICA) and was off it, was also on gabapentin or neurontin (patient did not have those medications to provide NDC/LOT/EXP for either of them because she took them back to the pharmacy or turned them in to the police station because she doesn't keep medications in her house if she isn't taking them, and she couldn't take that medication). Historical vaccine included first dose of bnt162b2 on 14Jan2021 (at the age of 54-year-old; Lot Number: EN5318) in Arm Right for covid-19 immunization, and for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. She received both doses of vaccine. Her first dose was LOT: EN5318 and was given 14Jan2021, and her second dose was LOT: EN6204 given 07Mar2021. The patient was reporting for Pfizer COVID-19 vaccine, for she was having a horrible reaction to it "45 days" (as reported) after taking 2nd dose, and had been in the ER, and her temperature still hasn't gone back down to her normal, her oral temp is still raised and her rectal is raised even more. She was not feeling well, she felt very bad, she would never get a vaccine again, that is how bad it was. Since "45 days" later she was still having significant pain and trouble flexing her right hand open and closed. For events treatment, she took over the counter Tylenol for fever and pain, strength unknown. Patient said she had not had this kind of disabling symptoms or anything before this vaccination. She had a slight fever almost the whole "45 days". On 08Mar2021, her oral temp was over 98 degrees Fahrenheit when her norm temp being 97.2 or 97.3degrees Fahrenheit. Her rectal temp stayed at 100 degrees Fahrenheit. The next day, actually on the 09Mar2021 (which was two days after her second dose), she had the slight fever, fatigue, and extreme pain through her right side. She said her right side means her shoulders, neck, torso, arm, and entire leg. She also had shortness of breath, and severe nerve pain. She called her primary care provider who said to wait 5 days to be seen. On day 5, or actually the whole five days (reported as in Mar2021), she was in bed and didn't leave her apartment because she was in bed and she was vomiting. On day 2 or within 6 hours of vaccination, she had a feeling of urination, like she had to urinate when she didn't, that feeling of urination was equivalent of having contrast dye (NDC/LOT/EXP: Unknown) put in her IV which makes her feel like she is peeing her pants but she did not, and that feeling has not gone away. On day 5 (11Mar2021), she was dizzy and fell. In Mar2021, she was disorientated and vomiting, she couldn't eat anything other than soup. On day two (Mar2021) she had some kind of eye pain that is still there "45 days later", it feels like pins and needles. Her skin was burning and painful to the touch, she couldn't keep an IV in her when she was in the ER. She was not admitted to the hospital. She was having headaches, and joint and muscle pain. She had nausea and vomiting at different times. She continued to have shortness of breath. She had a horrible lack of appetite. She had sores in her mouth and nose. She had anal hemorrhoid sores. Last night (05Apr2021 )she had a headache that was severe like someone put a knife behind her right eye, and when she got up (06Apr2021) her eye felt heavy and her eye was drooping. She also had difficulty speaking, with her words. She says she had passed out, and had been dropping things, she had broken glass. She has been to a neurologist and a gastroenterologist. She clarified that all of these events were after her second dose, for her first dose the only thing was a sore arm, it was very sore, and she only experienced a slight bit of fatigue after her first dose. None of her doctors know what to do, her gastro doctor was giving her an anti inflammatory suppository and was going to do some tests. She had blood done from neurologist and at the ER and no one knows what to do, they keep referring her to other doctors. She wished someone could explain to her, but no one know and they said it was uncharted territory, they didn't know what to do. She is now back on Lyrica which she was off of but the ER prescribed her 300mg three times a day. She wanted to know what the hell is going on with this vaccine, and that she doesn't think having these side effects "45 days" out is normal. She wanted to be transferred to speak with someone about what to do because her doctor's don't know anything. The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.

might have bladder or kidney infection; might have bladder or kidney infection; blood in her urine; She felt like she had to urinate but only a few drops of urine would come out; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ER8727), via an unspecified route of administration administered in the right arm on 25Mar2021 11:15 at a single dose for covid-19 immunisation. Medical history reported as follows: The patient has had trouble with her bladder since 2008 when she had a bladder sling put in. The patient stated that the company knew there were problems with the bladder slings, and they were still allowing the bladder slings to be put inside of people. There were times when the patient could not urinate and the bladder sling had to be cut and finally taken out of her. The doctor couldn't remove all the bladder sling because some of the bladder sling grew inside of her body. She had to wear a urinary catheter for months strapped to her leg. She had a back surgery and a doctor messed her up on the left side. Her doctor does manipulations on her back and helps her with her pain. Additionally, she had a bladder infection in Oct2020. The patient's concomitant medications were not reported. There were no prior vaccinations within 4 weeks. The patient received her first dose on 25Mar2021. The patient stated that she had a doctor's appointment for her back (medical history). The night before the appointment she was fine, but on the next day (08Apr2021) it was horrible. While she was there in the appointment, she had a urine test and her doctor found blood in her urine on 08Apr2021. She felt like she had to urinate but only a few drops of urine would come out on 08Apr2021. Her doctor told her that the last time she had a bladder infection was in Oct2020 (medical history). Since she might have a bladder or kidney infection on 08Apr2021, she was prescribed Macrobid 100mg take one every 12 hours for 7 days. She's scheduled to receive her second Covid-19 vaccine tomorrow, 15Apr2021. She wanted to know if the antibiotic will cause any problems with getting the second Covid-19 vaccine. The adverse events required a visit to the physician's office. The outcome of the adverse events was unknown.

After receiving the first dose on 4/1/21 Lot# ER8733, I had light spotting for 2 days. Second dose given 04/23/21 and by 04/28/2021 I started bleeding again And by the second day I was soaking through pads and huge clots were coming out. This has never happened to me before. After 7 days of bleeding heavily I woke up on May 5th at 4:00 a.m. with intense abdominal cramping The only way I can describe was labor. I felt back labor, pelvic pressure, frequent urination and intense pain. I reached out to my gynecologist And he immediately told me to remove my estrogen patch and later that morning he started me on progesterone treatment for 10 days to stop the bleeding. After 7 hours of pain on May 5th, I went to the emergency department and an ultrasound revealed a blood clot. From ultrasound results "there is a complex area in the area of the cervix measuring 5.7 x 3.6 x 2.6 cm." After several hours I was released from the emergency room taking toradol for pain. That evening I passed a huge blood clot! I'm very grateful it was where it was and I could expel it. But there's no doubt the second vaccine caused this issue that has never happened to me before. I still get my periods though irregular and very light. So this event was highly unusual and very painful

all side effects still happening and have been for over a month breast pain (have implants from 1999 and have hysterectomy since 15 years ago) weight gain fatigue infection in body, mostly in bladder area but at this point unidentified blood results all significantly off from recent CBC tests done in 2021 lymphocytes, monocytes, WBC high RBC low, sodium low glucose high, basophils (have at least 4 results to compare to over past 6 months, cbc and chem panel) low tsh headaches heart issues tightness hypertension trouble breathing

Pt received vaccination on 05/13. The following day developed fever. On 05/15 she developed sore throat and vomiting. Her sore throat progressed where she could not speak or talk. She was seen in the ER and in respiratory failure. She was intubated and developed septic shock. Labs notable for WBC 0.1, platelets 32. INR elevated at 2.2. She had renal failure and shock liver and evidence of DIC. Blood cultures grew gram negative rods. She eventually died from septic shock.

Five hours after receiving the vaccine I developed a headache, nausea, I started to stutter and I couldn't think clearly. That evening I had really strange dreams. I could hear my husband talking on the phone out in the living room. I was dreaming, but I knew that I was awake. I just couldn't wake myself up. I had those dreams for 2-3 nights. I was screaming in my sleep. I was conscious about what was going on, but my body was in REM cycle, and I couldn't wake up. Around 03/15, I started vomiting, had chills, diarrhea and developed fevers. I couldn't stop vomiting and my doctor thought that I may have had COVID. I went into the ER on 03/15. I was put into an isolated room because they thought I had COVID. I received a couple COVID tests completed and the PCR came back negative. At this point, they thought I may have a secondary infection coming on. I was told I had a UTI, but then they thought it might have been a kidney stone that was stuck. They performed a CT scan and I had 7 kidney stones that were there. I was told that maybe my body was trying to pass a stone when I received the vaccine. The doctor gave me oxycodone, Zofran and I had 3 bags of IV's (one with antibiotics in it.) After I went home they changed my antibiotics to a much stronger one, Ciproslaxon, for 14 days. I recently had laser surgery and lithotripsy surgery to remove the kidney stones. They noticed that there were more kidney stones on the other side. I have to have a second surgery to remove them. I have to have a third surgery because they found a gall bladder stone. I have also noticed that I have been having problems with congestion. I have never had any allergies with pollen or having to take allergy medication. I am having difficulty swallowing and I am coughing more. I've noticed that my memory is foggy also.

N17.9 - Acute renal failure (ARF) (CMS/HCC) N17.9 - Acute renal failure, unspecified acute renal failure type (CMS/HCC)

was on steroid dose pack for sore throat and viral URI and antibiotics. All of this started after the second covid shot - "my immune system is now crap", c/o pain in areas of her scars in low abdomen s/p kidney removal "pain like when i was postop from kidney removal", cystoscopy came back inconclusive, urinary burning frequency started up again. Patient claims she feels like she was a healthy person before she got the covid vaccine. Pt has been seen for multiple visits since vaccine r/t to bladder UTI like symptoms.

10 days after the second injection, I went to the hospital because I had abdominal pain and had been throwing up. They found blood in my urine, but no other reason for the right flank pain or abdominal pain. At one point my arms were swollen and would wake me up with intense pain - tingling and numb Lyme Disease - Doxy for a 4 weeks - no help, not retested for it 2 UTIs - Ciprofloxacin (500 mg - 10 days) and another antibiotic before that

bruises on her ribcage; heart stopped; weakness; uncontrollable urine; dehydrated; couldn't get up off the floor/having trouble walking; they weren't sure what was going on with her, her bladder; downhill from there; couldn't get out of car; can't hold the phone very long, and can't sit up for very long either; hearing loss and can't hear the consonants; superficial blood clot in left leg; L5 compression fracture; claustrophobic; had a hard time pronouncing the letters; affected all of her nerves/all the nerve damage; arthritis everywhere; scaring her; very painful/physical in pain; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received the second dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: EW0179), at the age of 54 years old, in left arm on 14May2021 at single dose for COVID-19 immunisation. Medical history included post-traumatic stress disorder (PTSD) (diagnosed in 1995, 1996, 2000, been for years, unsure of exact year), bipolar disorder (a mental disorder; a cross between bipolar disorder and PTSD; last hospitalization for this was in Jan2019), carpal tunnel in right and left hand (being treated for this prior to the shot), lower back injury (took paracetamol (TYLENOL) for a lower back injury from about 30 years ago, she fell down a flight down of stairs with her daughter, when she was first born, states her daughter will be 34 at the end of this month. Caller stated she saw an orthopedic doctor, who said not to do anything about it, just keep taking what she's taking), blood pressure abnormal (diagnosed about 5-7 years ago), diabetic non-insulin dependent from 2015 (also provided hypoglycemia as a medical condition), sleep apnea (diagnosed about 15 years ago), history of blood clots, allergies to two muscle relaxers (unknown drug name), fall in Apr2021 (Sunday, being treated). Concomitant medications included lorazepam (ATIVAN) taken for PTSD and mental disorder at 0.25 mg three times a day as needed, paracetamol taken for carpal tunnel, general pain and back injury at 1000 mg every day in the morning, and furosemide for blood pressure abnormal at 40 mg daily as needed; usually takes half, 20 mg. The patient previously received the first dose of BNT162B2 (lot number: EW0169), at the age of 54 years old, in left arm on 23Apr2021 at single dose for COVID-19 immunisation and experienced some events. Caller stated she took the first shot on 23Apr2021, and didn't have too bad of reaction, just like a little bit of the flu. Caller stated in between first shot and just before the second shot, she had some reactions, and in and out of the hospital quite a few times, trying to figure out what was going on. Caller stated she was at hospital on 13Apr2021, 14Apr2021, and then 15Apr2021. Caller stated they had to code her, she'd been unable to work, it had set off arthritis from the top of her head to the bottom of her feet, it's pretty much crippled her to point to where they'd figured out that it was the covid shot that the side effects. Caller stated she just saw her family doctor yesterday, finally able to go in and see her physically, and she had piles of paperwork she'd having to go through, and that was why she started back with paperwork from hospital, dated 15Apr2021. Caller stated she had the shot on 23Apr2021. Caller confirmed first shot was 23Apr2021. Caller stated there was more, it was just started a bunch of things, she was got stacks of papers, and she was sicker than a dog right now, because she got an infection just after, not sure if it was tied into this. Caller stated she was having trouble thinking at times, had caused nerve damage, where she could barely hold the phone. Caller stated she was pretty much grounded; this was the first time she'd been able to get into her apartment, because she couldn't get up the stairs, so she had all the time in the world right now. Caller stated she was a home health aide, clarifies not a nurse. But she'd recently been working, and was emailed papers for the type of leave for COVID-19, and extended leave of absence from work. Caller stated the last time she worked was 05Apr2021, seventh, ninth, tenth, something like that. Caller stated she could't think right now; she'd in and out of it due to medications. Caller provided a health department as healthcare professional site. Caller added on 15Apr2021, she had family and her boyfriend, someone tested positive, so from 13Apr until 27Apr, she quarantined herself in a hotel, close to her work. Caller initially provided date of second dose as three weeks after first dose on 15May2021, but then clarified correct date as 14May2021. Caller stated she was just taking her normal medications, and stated she did not want to go through those at this minute. Caller stated she had an appointment to get first shot, but they spelled her name wrong, and a VIP thing had to be done. Before she went to get the shot she was trying to ask the medical doctor some questions because she had concerns, but before she could tell them any part of her history, the doctor just said to go ahead and gave her the shot. Caller stated the reason she got the number for Pfizer was from when, on 15Apr2021, they tested her for covid, and gave her instructions, she was off of work. Caller clarified she never got a phone call, when agent asked for test results of the test. Caller confirmed this test was done before her shot. Caller stated she got first shot and a couple days later, it was the normal flu-like body aches; she was told to got to store and get stuff for allergies, and for the flu, but she already had paracetamol and diphenhydramine hydrochloride (BENADRYL) for allergies. Caller clarified she was told this by the site which gave the shot, had them sit down and wait 15-20 minutes, then let them go, and told them what to do. Caller stated these symptoms only lasted a couple of days. Caller stated that she didn't remember if she actually took the paracetamol and diphenhydramine hydrochloride as treatment for the flu-like body aches. Caller stated that she had all this paperwork that was going back to 15Apr2021, and she did not remember at the moment what she took for treatment of symptoms. Caller states she had everything journaled written down, stated in between the first and second shot, she was in and out of emergency rooms, trying to figure out what was going on. States she had to go back she was having reactions, she was in the emergency room for weakness, and other things, and had to be checked for blood clots, so she had to go back. She was there on 13May2021, 14May2021, they did a venous doppler on everything because she was having all kinds of pain in legs. Then on 15May2021, she had to go back to be checked for something, right after she got out of emergency room, and after she had the test, she was medically transferred to get the second shot (corrected on 14May2021), and after she got the second shot, it's been downhill from there. Caller stated she was admitted into a hospital and was in and out of the hospital. Caller stated she coded, they had to do CPR on her, and this had affected all of her nerves. Caller stated they gave both shots in her left arm and it had set off everything and all the nerve damage. Caller stated this was scaring her because she was the only family member who had the Pfizer shot. Everybody else was out of the state, and had the Johnson and Johnson or all the other vaccines, and she was the only one who'd this shot, and the one who had the most damage. Call handler made multiple attempts to clarify information provided and get further details but asked to move on because all the questions were setting her off. Caller stated maybe she should have had the case worker call. Caller clarified she did not have arthritis prior to this. Caller stated 31May2021, she was rushed to a hospital because she couldn't get up off the floor, they weren't sure what was going on with her, her bladder, so they put her on prednisone for a week. Caller did not finish statement regarding her bladder. Caller stated all hospitals she had been in, with exception of one. Caller provided a hospital when agent asked for spelling or clarification. Caller stated she could't hold the phone very long, and she can't sit up for very long either. Caller stated she had a hard time pronouncing the letters, when agent asked her to spell the hospital name. Caller stated the problem was agent was on a headset and her phone was set up for handicap for an ear that could't hear properly, so she stated the agent being on a headset was why agent could't hear her. Caller stated she had hearing loss and could't hear the consonants. Caller stated she was due to take medicine and could't take it while on the phone. Caller asked if there a fax number to fax the rest of this to. Caller stated all of the hospitals were all under a health, it was a whole medical group with all different hospitals in different towns. Caller stated prior to emergency room visit, she was in a hospital because she couldn't walk, was having trouble walking. She coded while they were admitting her; her heart stopped and they had to code her. Caller added she had not had a paycheck since 09Apr2021 or tenth, stated landlord hadn't thrown her out but she'd close to being evicted because she hadn't worked, it was been determined the side effects have caused more damage. Caller stated 15Apr2021 she got Pfizer's phone number when she was tested for covid. Caller stated that was when they did the test, but she never heard anything back regarding the results of the test. She quarantined at a hotel and had to be away from work. Caller stated it was been a hospital where it started. Caller stated maybe agent needed to call back and finish report because she had all of hospital papers dissected with dates. Caller stated she was given a huge packet on 15Apr2021, when she was tested for covid. Went to the only local medical facility, and she went there on 15Apr2021 because her boyfriend's sons' girlfriend tested positive, and they gave her a note for her work with instructions. Caller clarified they gave her a huge packet so that was where she got all the paperwork in Apr2021 before she got the shot. Caller stated after the first shot she had 48 hours of hot flashes, the chills, typical flu-like symptoms; only lasted 48 hours, and then from the twenty third she had different symptoms, and had been in an out of hospitals, trying to figure out what was going on with her. Caller stated she was healthy and working until 07Apr2021, 08Apr2021, or 09Apr2021, was the last time she worked. Then she quarantined from 13Apr2021 until 27Apr2021, and then they had to get vaccinated, so she registered, and when she went there, they spelled her name wrong, she started asking questions trying to give medical history before the shot. She had not given any of her history and doctor said to just give it. They gave the shot in her left arm and from then on, the damage hit and it has been one thing after another. Caller stated she previously had a test done in 2017, electrical shock from toes to head, and acupuncture same day, and only thing showed up was carpal tunnel in right and left hand. She was being treated with 1000 mg paracetamol, and she was fine working since 2018. Caller stated she was physically fine and is 54 years old, the oldest one working there and now she'd been back and forth from hospitals. Caller stated she was in the hospital with weakness 10Jun2021 or 07Jun2021. Caller stated this had been a continuous thing going to hospitals for weakness, bladder is just letting go like just having uncontrollable urine, she got dehydrated. She only had to be inpatient at hospital. Caller stated right after admitted there, primary doctors found a superficial blood clot in left leg and started her on rivaroxaban (XARELTO), and they discharged her and transferred her by med car from main hospital to the emergency room satellite. She was there to do an MRI and had to sedate her because she was claustrophobic. They found an L5 compression fracture, which caller clarified was new since the shot. Caller stated the back specialist said not going to do anything it, it will heal on it was own. Caller stated she was sent to get her car and had a major allergic reaction to a drug given while in hospital but the nurse didn't listen, they let her drive her car, which is satellite for hospital. Caller stated she stopped, paid for diphenhydramine hydrochloride and had to park the car while she took two diphenhydramine hydrochloride for having major symptoms. Caller stated when she felt she was ok, she drove back to hotel, but when she got there, she couldn't get out of car so the manager called 911, and withheld came and assessed her. Her cognitive level was fine, but she was sitting in urine and couldn't get out of car, so they rushed her to a hospital and she was admitted on an orthopedic floor, this was 20May2021 or 21May2021, and she went unresponsive while they were admitting her, so they coded her. Caller stated that she still had bruises on her ribcage. A cardiologist came and actually he listened to her. They did three different cat scans and determined that she now has arthritis everywhere. It's very painful. States that she is sitting with 5 piles of paperwork from 15Apr to her most current one which would have been at hospital just a couple of days ago. She has been diagnosed with so many different things because the doctor's couldn't figure out what was going on. Call handler attempted to query the name of the medication that caused her allergic reaction. Caller stated that there are 4 medications that she reacts to, two are muscle relaxers that she was allergic to, and one of them was given to her at a hospital. Caller stated that the problem was that people looked at your mental disabilities first, they did't look at your other history, and nurses were over worked, so even though she told the nurse to call her doctor because she was having a major reaction and she knew what it was, they were still discharging her. Call handler again asked for the name of the product. Caller became upset and stated that she was physically in pain. No follow-up attempts are possible. No further information is expected.

heart stopped, had to code her; weakness; Caller states she is pretty much grounded/because she couldn't get up the stairs/couldn't get up off floor/having trouble walking; pretty much crippled her; superficial blood clot in left leg; having trouble thinking; compression fracture L5; hot flashes; chills; set off arthritis from top of head to the bottom of her feet; arthritis in every bone ever broken; Dehydrated; Uncontrollable urine; nerve damage, where she can barely hold the phone; because she was having all kinds of pain in legs.; the normal flu-like body aches / just like a little bit of the flu; she had family and her boyfriend, someone tested positive; This is a spontaneous report from a contactable consumer (patient). This 54-year-old female patient received the first dose of BNT162B2 (, Lot No. EW0169) at Left arm at single dose for COVID-19 immunisation on 23Apr2021 (54-year-old at vaccination). Relevant history included PTSD (diagnosed in 1995, 1996, 2000, been for years, unsure of exact year), Bipolar disorder (a mental disorder; a cross between bipolar disorder and PTSD (Post-traumatic stress disorder); last hospitalization for this was in Jan2019), Carpal tunnel in right and left hand (being treated for this prior to the shot), lower back injury (took Tylenol for a lower back injury from about 30 years ago, she fell down a flight down of stairs with her daughter, when she was first born, states her daughter will be 34 at the end of this month. Caller states she saw an orthopedic doctor, who said not to do anything about it, just keep taking what she's taking), Blood pressure abnormal which was diagnosed about 5-7 years ago, diabetic non-insulin dependent, also provided hypoglycemia as a medical condition, Sleep apnoea which was diagnosed about 15 years ago, history of blood clots, fall in Apr2021 (Easter Sunday, being treated). Relevant concomitant drug included lorazepam (ATIVAN) for PTSD and mental disorder, paracetamol (TYLENOL) for carpal tunnel and general pain and she had a lower back injury, and furosemide for blood pressure abnormal. On 23Apr2021, the patient took the first shot, and didn't have too bad of reaction, just like a little bit of the flu. Caller states in between first shot and just before the second shot, she's had some reactions, and in & out of the hospital quite a few times, trying to figure out what's going on. Caller states she was at place on 13Apr, 14Apr, and then 15Apr. Caller states they had to code her, she's been unable to work, it has set off arthritis from the top of her head to the bottom of her feet, it's pretty much crippled her to point to where they've now figured out that it is the covid shot that the side effects. Caller states she just saw her family doctor yesterday, finally able to go in and see him physically, and she has piles of paperwork she's having to go through, and that's why she started back with paperwork from # Hospital, dated 15Apr. Caller states she had the shot on 23Apr. Caller confirms first shot was 23Apr2021. Caller states there's more, it's just started a bunch of things, she's got stacks of papers, and she's sicker than a dog right now, because she got an infection just after, not sure if it's tied into this. Caller states she's having trouble thinking at times, has caused nerve damage, where she can barely hold the phone. Caller states she is pretty much grounded; this is the first time she's been able to get into her apartment, because she couldn't get up the stairs, so she has all the time in the world right now. Reporter details: Type: Caller states she is a home health aide, clarifies not a nurse. But she's recently been working with #, and #, and was emailed papers for the type of leave for COVID-19, and extended leave of absence from work. Caller states the last time she worked was 05Apr, seventh, ninth, tenth, something like that. HCP details: Caller states she can't think right now; she's in and out of it due to medications. HCP Email: Caller declines to provide. Patient details: Caller provided name at the beginning of call as #. Height: States, depends on who's measuring it, five two, five three, five one. Caller clarifies as five two. Product: Caller confirms the product as Pfizer covid shot. Caller states she had to get vaccinated because it was required. First dose: 23Apr2021, Lot EW0169, NDC and Expiration Date: Unknown, Left arm Second dose: 14May2021, Lot EW0179, NDC and Expiration Date: Unknown, Left arm. Caller adds on 15Apr, she had family and her boyfriend, someone tested positive, so from 13Apr until 27Apr, she quarantined herself in a hotel, close to her work. Caller initially provided date of second dose as three weeks after first dose on 15May2021, but then clarifies correct date as 14May2021. History: Caller states she was just taking her normal medications, and states she does not want to go through those at this minute. Caller states she had an appointment to get first shot, but they spelled her name wrong, and the # had to do a VIP thing. Before she went to get the shot she was trying to ask the medical doctor from the # some questions because she had concerns, but before she could tell them any part of her history, the doctor just said to go ahead and give her the shot. States the reason she got the number for Pfizer was from when, on 15Apr, she went to #, to begin with, and they tested her for covid, and gave her instructions, she was off of work. Caller clarifies she never got a phone call, when agent asks for test results of the test. Caller confirms this test was done before her shot. Event details: Caller states she got first shot and a couple days later, it was the normal flu-like body aches; she was told to got to store and get stuff for allergies, and for the flu, but she already had Tylenol and Benadryl for allergies. Caller clarifies she was told this by the #; they gave the shot, had them sit down and wait 15-20 minutes, then let them go, and told them what to do. Caller states these symptoms only lasted a couple of days. States that she doesn't remember if she actually took the Tylenol or Benadryl as treatment for the flulike body aches. States that she has all this paperwork that is going back to 15Apr, and she does not remember at the moment what she took for treatment of symptoms. Caller states she has everything journaled written down, states in between the first and second shot, she was in and out of emergency rooms, trying to figure out what was going on. States she had to go back to medical facility because she was having reactions, she was in the emergency room for weakness, and other things, and had to be checked for blood clots, so she had to go back. She was there on 13May, 14May, they did a venous doppler on everything because she was having all kinds of pain in legs. Then on 15May, she had to go back to be checked for something, right after she got out of emergency room, and after she had the test, she was medically to get the second shot, and after she got the second shot, it's been downhill from there. Caller states she was admitted into # Hospital, and was in and out of the hospital. States she coded, they had to do CPR on her, and this has affected all of her nerves. Caller states they gave both shots in her left arm and it has set off everything and all the nerve damage. Caller states this is scaring her because she is the only family member who has had the Pfizer shot. Everybody else is out of the state and had the Johnson and Johnson, or all the other vaccines, and she's the only one who's had this shot, and the one who has had the most damage. Call handler made multiple attempts to clarify information provided and get further details, but asks to move on because all the questions are setting her off. Caller states maybe she should have had the case worker call. Caller clarifies, she did not have arthritis prior to this. Caller states 31May2021, she was rushed to Place because she couldn't get up off the floor, they weren't sure what was going on with her, her bladder, so they put her on prednisone for a week. Caller did not finish statement regarding her bladder. Caller states all hospitals she has been in have been #, with exception of one in #. Caller provides #, when agent asks for spelling or clarification. Caller states she can't hold the phone very long, and she can't sit up for very long either. States she has a hard time pronouncing the letters, when agent asks her to spell the hospital name. Caller states the problem is agent is on a headset and her phone is set up for handicap for an ear that can't hear properly, so she states the agent being on a headset is why agent can't hear her. Caller states she has hearing loss and can't hear the consonants. Caller states she is due to take medicine and can't take it while on the phone. Caller asks if there a fax number to fax the rest of this to. Caller states all of the hospitals, #, are all under #, it's a whole medical group with all different hospitals in different towns. Caller states prior to emergency room visit, she was in # Hospital because she couldn't walk, was having trouble walking. She coded while they were admitting her; her heart stopped and they had to code her. Caller adds she has not had a paycheck since 09Apr or tenth, states landlord hasn't thrown her out but she's close to being evicted because she hasn't worked, it's been determined the side effects have caused more damage. Caller states 15Apr2021 she got Pfizer's phone number when she was tested for covid. Caller states that's when they did the test but she never heard anything back regarding the results of the test. She quarantined at a hotel, and had to be away from work. Caller states it's been # Hospital where it started. Caller states maybe agent needs to call back and finish report because she has all of hospital papers dissected with dates. Caller states she was given a huge packet on 15Apr, when she was tested for covid. at medical facility which is the only local medical facility, and she went there on 15Apr because her boyfriend's sons' girlfriend tested positive and he's in #, and they gave her a note for her work with instructions. Caller clarifies they gave her a huge packet so that's where she got all the paperwork in Apr before she got the shot. Caller states after the first shot she had 48 hours of hot flashes, the chills, typical flu-like symptoms; only lasted 48 hours, and then from the twenty third she's had different symptoms, and has been in an out of hospitals, trying to figure out what was going on with her. States she was healthy and working until 07Apr, 08Apr, or 09Apr, is the last time she worked. Then she quarantined from 13Apr until 27Apr, and then they had to get vaccinated, so she registered, and when she went there, they spelled her name wrong with a # instead of #, she she started asking questions trying to give medical history before the shot. She had not given any of her history and doctor said to just give it. They gave the shot in her left arm and from then on the damage hit and it has been one thing after another. Caller states she previously had a test done in 2017, electrical shock from toes to head, and acupuncture same day, and only thing showed up was carpal tunnel in right and left hand. She was being treated with 1000 mg Tylenol, and she was fine working at #, and #, since 2018. States she was physically fine and is 54 years old, the oldest one working there and now she's been back and forth from hospitals. Caller states she was in # in the hospital with weakness 10Jun2021 or 07Jun2021. Caller states this has been a continuous thing going to hospitals for weakness, bladder is just letting go like just having uncontrollable urine, she got dehydrated. She only had to be inpatient at #Hospital in #. Caller states right after admitted there, primary doctors found a superficial blood clot in left leg and started her on #, and they discharged her and transferred her by from main hospital to the emergency room satellite. She was there to do an MRI and had to sedate her because she's claustrophobic. They found an L5 compression fracture, which caller clarifies is new since the shot. Caller states the back specialist said not going to do anything it, it will heal on it's own. Caller states she was sent to get her car and had a major allergic reaction to a drug given while in hospital but the nurse didn't listen, they let her drive her car from ##, which is satellite for # Hospital. States she stopped at a #, paid for Benadryl and had to park the car while she took two Benadryl for having major symptoms. Caller states when she felt she was ok, she drove back to hotel, but when she got there she couldn't get out of car so the manager called 911, and # they came and assessed her. Her cognitive level was fine, but she was sitting in urine and couldn't get out of car, so they rushed her to # Hospital and she was admitted on an orthopedic floor, this was 20May or 21May, and she went unresponsive while they were admitting her, so they coded her. States that she still has bruises on her ribcage. A cardiologist came and actually he listened to her. They did three different cat scans and determined that she now has arthritis in every bone ever broken. It's very painful. States that she is sitting with 5 piles of paperwork from 15Apr to her most current one which would have been at # Hospital just a couple of days ago. She has been diagnosed with so many different things because the doctor's couldn't figure out what was going on. Call handler attempted to query the name of the medication that caused her allergic reaction. Caller stated that there are 4 medications that she reacts to, two are muscle relaxers that she is allergic to, and one of them was given to her at # hospital. States that the problem is that people look at your mental disabilities first, they don't look at your other history, and nurses are over worked, so even though she told the nurse to call her doctor because she was having a major reaction and she knew what it was, they were still discharging her. Call handler again asked for the name of the product. Caller became upset and stated that she is physically in pain and is getting ready to pee herself right now. Caller started yelling that there are 5 medications that she is allergic to. No further details provided. Caller stated that the next call is going to the governor of #. Call was abruptly disconnected. The outcome of events was unknown.

Noticed that she staring getting fatigued 5/24/21 took time off work noticed fatigue in legs that she attributed to recent foot surgery stopped being able to do gardening, Was not able to use stairs. Had nausea vomiting, Went to ER 6/25/21 Troponin levels 2000 diagnosed with renal failure and Myocardial infarction on EKG. Angiogram was normal Heart was functioning at 40-45% . Dx with Takotsubo Cardiopathy. Also noted rash on top of both feet . Was given blood thinner shots in ErR and noted brown vaginal spotting . Also reports two weeks post second vaccine. uncomfortble weird pain in neck bone located at base of skull can not feels anything protruding. Feels clicking when she moves her head pain started after vaccine and has not gone away.

Pt presented with symptoms of UTI along with dry cough, SOB, and fever. CXR showed lingular pneumonia. Pt did not require oxygen on admission. Pt discharged on levofloxacin (to complete 5-day course).

Couldn't breath; went to the restroom and peed 4 times, too much the first night; something happened to her heart; This is a spontaneous report from a contactable consumer (Patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0164, Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 17Apr2021 12:50 (age at vaccination 54 years) as dose 1, single for covid-19 immunisation. Medical history included ongoing high blood pressure. Concomitant medication(s) included amlodipine (AMLODIPINE) 5mg by mouth one time daily taken for hypertension and ongoing (started at 39 years old, increased to 10mg, then back to 5 mg; unspecified water pill (started one year ago) and ongoing taken for blood pressure was too high, fluoxetine (FLUOXETINE) 40mg, one tablet by mouth one time per day (started 3-4 years ago. Maybe 2016. Patient cannot remember). The patient previously took amoxicillin and experienced allergy (She has severe allergy to amoxicillin). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 20Apr2021 the patient experienced couldn't breathe, went to the restroom and peed 4 times, too much the first night on 20Apr2021, something happened to her heart on 17Apr2021. Patient stated, she experienced a strange thing. Last night and the night before. she is overweight. 2 nights ago, she was sleeping and woke up and couldn't breathe. Her nose and mouth were stuck, and she drank water, and she was ok. It happened 2 times where she felt she couldn't breathe. It was horrible, she had to drink a little bit of water to get better. Her mouth and nose were closed and she doesn't know how it happened. It happened 2 nights ago, 4 times total. It occurred 3 times the first night and last night she didn't drink water, but the first times she needed water. Reporter added the breathing is improving but doesn't know if it will occur tonight. She traveled too long to receive her vaccination. She did not take her water pill yesterday, because she finished the medicine. she have to wait now for like 1 week. The name of the medicine starts with Tr and she cannot remember. She is a engineer, a designer. She was abused at work. They didn't expect a broken English speaking and a woman in their department. She was good at her job. After surviving 6 months, she started taking Fluoxetine. The outcome of event Couldn't breath was resolving, Frequency urination was resolved on 20Apr2021, something happened to her heart was resolved on 17Apr2021. No follow-up attempts are possible. No further information is expected.

viral pinkeye; cold sores covering lips and skin around mouth; symptoms of urinary tract infection (UTI); Chills; elevated temp 99 degrees,/elevated temp 101.4 degrees,; This is a spontaneous report from a contactable other health care professional (patient). A 55-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), via an unspecified route of administration at left arm on 08Jan2021 12:45 at single dose for covid-19 immunization. The vaccine was administered at hospital. Medical history included migraine headaches. The patient had no allergies to medications, food, or other products. Concomitant medication included vitamin d3 and sumatriptan. No other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 via an unspecified route of administration on 18Dec2020 12:45 PM at Left arm at single dose for covid-19 immunization. On 09Jan2021, the patient had chills and elevated temperature of 99 degrees; on 10Jan2021, the patient had chills and elevated temperature of 101.4 degrees, symptoms of urinary tract infection (UTI); on 11Jan2021, the patient was prescribed cephalexin for UTI; on 12Jan2021, the patient had cold sores covering lips and skin around mouth; on 13Jan2021, the patient was prescribed antiviral for cold sores, the patient was developed and diagnosed with viral pinkeye, prescribed steroid eye drops. The adverse event result in doctor or other healthcare professional office/clinic visit. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering. Information on the lot/batch number has been requested.

frequent urination; sudden extreme fatigue; headache/headache began receding from the front to back of head and down back of neck; sore injection site; heavy metallic taste; no appetite; This is a spontaneous report from a contactable nurse (patient). A 55-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration on 11Jan2021 08:30 at single dose in right arm for COVID-19 immunization. The patient medical history included obesity and known allergies to sulfa and penicillin. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 21Dec2020 11:30 at single dose in left arm for COVID-19 immunization and experienced mild metallic taste and arm soreness (including extreme burning for 10 min following vaccination, the patient believe this was poor administration tech), slight metallic taste 24 hrs post vaccination, lasted a few hours. Concomitant medications in two weeks included metoprolol, colecalciferol (VIT D3), Calcium, ascorbic acid (C) and probiotic. The patient had no covid prior vaccination. It was reported that after the second vaccination, the patient had no burning at site, on 11Jan2021 09:30 the patient had heavy metallic taste approximate 40 mins post vaccine and lasted approximate 12 hrs, at 12 hrs post vaccine (on 11Jan2021 20:30) sudden extreme fatigue, 15 hrs post vaccine (on 11Jan2021 23:30) frequent urination began and lasted approximate 18 hrs. The patient woke up with headache 6/10 that medication would not touch, no appetite but ate and drank anyway hoping would help with headache (it didn't) (reported on 11Jan2021 09:30), approximate 32 hrs post vax headache began receding from the front to back of head and down back of neck. Slept well and woke up 48 hrs post vax feeling normal but with sore injection site (reported as on 11Jan2021 09:30). The patient underwent lab tests and procedures related to covid included nasal swab and PCR with negative result on 04Jan2021. No treatment was received for the events. The outcome of the events was recovered in Jan2021.

March 2, 2021 (3days after injection) 12:30pm sudden onset of severe (incapacitating) dizziness, nausea and headache. Loose stool. Fatigue. Muscle pain. Joint pain. Dry eyes. March 3 same as previous day with the addition of moderate kidney pain and extreme thirst. March 4:same as previous day with addition of severe migraine

Developed a urinary tract infection, despite the fact that I drink a lot of water and ensure proper hygiene. Although the symptoms became noticeable on Wednesday 3/30, the clinic's nurse practitioner stated I had blood in my urine and believed the UTI started sooner. I don't know if "vaccine 1" was responsible, but wanted to report the illiness.

fatigue from waist to feet posteriorly and bilaterally; gfr 47; headache; nausea; dizziness; facial tingling/bilateral hand and foot tingling; double vision; disorientation; joint pain; orthostatic hypotension; chills; photophobic/photophobia; This is a spontaneous report from a contactable nurse (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 2 via an unspecified route of administration, administered in left deltoid on 26Jan2021 15:00 (Batch/Lot Number: EL1283) as single dose for covid-19 immunisation. The first dose was received on 05Jan2021 15:00 (lot number: EL1284) on the left arm. Medical history included herpes simplex virus (HSV), Superior Oblique Myokymia, and Lyme Disease; from an unspecified date and unknown if ongoing. Patient was not pregnant. Concomitant medications included calcium citrate, magnesium citrate (CAL/MAG CITRATE), ergocalciferol (VIT D), fish oil (OMEGA 3), and paracetamol (TYLENOL). The patient previously took VICODIN and flu vaccine as a child, and experienced allergies. The patient experienced headache, nausea, dizziness, facial tingling, double vision, disorientation, joint pain, orthostatic hypotension, chills, photophobic from 27Jan2021 05:00. On 02Feb2021, she experienced dizziness, headache, nausea, photophobia, facial tingling, bilateral hand and foot tingling, GFR 47 all other CBC, cmp normal. There was headache, nausea, photophobia, facial tingling on 07Feb2021 and on 10Feb2021, tingling and fatigue from waist to feet posteriorly and bilaterally. She had lab test drawn and blood work done when she was sick and her GFR came back as 47, so everything else was normal, and her GFR was 47 which was out of range. On 03Feb2021 was the first test and it was 2 weeks that she had to repeat test just to make sure it was back in normal range which it was. Thee patient was still experiencing the events but 'not as bad', and stated she can still function. Her side effects were improving but she still have a daily headache and paresthesia. The events resulted in physician/ healthcare professional visit. Patient was recovering from the events. ZOFRAN was given as treatment for the events. Patient stated she takes Tylenol but her doctor want her not to take medication for a while but she had to take Tylenol. Patient had no covid prior to vaccination and has been tested (nasal swab) post vaccination on 29Jan2021 with negative results.

4 days after my second vaccine dose I came down with an extremely painful UTI, I haven't had one of these in the past 20 years or more. Two friends of mine in their 50's also came down with a UTI infection within 2-4 weeks of second covid vaccine dose.

rectal bleeding; colitis; abdominal pain; UTI; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm left on 01Apr2021 10:30 at the age of 55-years-old (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history included known allergies. There were concomitant medications in two weeks. The historical vaccine included 1st of BNT162B2 on 10Mar2021 09:30 am at left arm for COVID-19 Immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced severe abdominal pain and rectal bleeding 4 days after the shot (05Apr2021 00:30) and on the 4th day went to emergency room had multiple tests done including but not limited to bloodwork and urine work up and CT scan, finding colitis, rectal bleeding and urinary tract infection (UTI). Therapeutic measures were taken as a result of events. The events outcome was unknown. No COVID 19 diagnosed prior vaccination, since the vaccination the patient hadn't been tested for COVID-19. Information about the Lot/batch number has been requested.

After the 1st dose, I had sore arm and days later I had itchy rash around my right arm pit and my gland with swollen in the arm pit. After 2nd vaccine, sore arm and was tired for about 48 hours. Days later I'd noticed little itchy bumps on my left eye lid. On the night of 4/23, now both eye lids were itchy and a bit red. Throughout 4/24, eye lids got a little more swollen and still itchy and red, and by the evening my lips started to tinkle and a little bit swollen (it felt like I'm getting a cold sore) and I had noticed a few little bumps on the edge of my upper left side of lip (in a straight line). Throughout 4/25 my eye lids and lip were a little more swollen and feels like I'm having cold sore/sunburn. I

inflammation of the jaw muscle; dizzy; nausea; right side of my face swollen; her lips tingle a little bit; head felt heavy above her eyes; Paraesthesia oral; had a minor UTI; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EP7533), via an unspecified route of administration in right arm on 07Apr2021 at 12:20 as single dose for COVID-19 immunization. Medical history included carpal tunnel syndrome (from: Jan2021), ear trouble predating vaccination. Concomitant medications included atorvastatin calcium (LIPITOR) 10mg taken once daily by mouth for cholesterol (taking for two years), cholecalciferol 2000IU; take once daily by mouth for vitamin D low (taking for two or three years). There was no prior Vaccinations within 4 weeks. On 07Apr2021 (A few minutes later, about 20 minutes after the vaccination), she felt dizzy and nauseous. Later on she noticed when she looked in the mirror, the right side of her face looked swollen. Adds her lips tingle a little bit at the same time as she got the dizziness and nausea. She called her doctor since this was immediately and not 24 hours later. Now weeks have passed and the right side of her face is still swollen; she is still dizzy and the nausea comes and goes. Adds her head felt heavy above her eyes too when she first felt the dizziness and nausea. It was reported that she went to the emergency room about week ago. They did a CT scan, EKG and drew blood and they told her the CT looks good; everything was normal except she had a minor UTI, urinary tract infection, and she was treated with antibiotics. Then later she went to visit her doctor and she said it looks probably like migraines triggered by the vaccine, and mentioned a lot of other theories, she can not remember them all. Adds she never gets the flu shot and the last vaccination she had was 30 years ago. Her doctor had a lot of theories and told her not to take any medication and to give her body a chance to recover. Caller added she also went to the dentist who did x rays and said everything looked fine. Then yesterday she went to the ENT, Ear, Nose and Throat specialist doctor for the dizziness and her face. The ENT doctor did some tests and said it was not vertigo or migraine because migraine comes and goes but hers does not go away. Then the ENT said he thinks it is inflammation of the jaw muscle. Caller adds her ear does not feel good sometimes. The ENT doctor said if connected jaws are not the same that can cause dizziness. He told her to take Aleve but she has not started it yet. She read somewhere today that in Israel other people have reported muscle inflammation, like heart muscle, and she is asking has that happened before with other people. The ENT also mentions she may be tightening her your teeth at night but she doesn't think she does that. Caller clarifies she had problems with her ear when she was very young and very rarely her ear is not comfortable when she sleeps on her side. But she does not sleep on her side anymore because her arms get numb. Adds she has carpal tunnel in both arms starting in Jan2021, predating treatment with the vaccine. Stated she was doing bike exercising and it caused the carpal tunnel. With regard to the swelling in the right side of her face, she stated no one can see it but if you touch it you can tell it is swollen and her husband can tell it was not big swollen but sometimes it gets bigger. Her doctor told her not to get the second dose until all the side effects go away or we know more. Mentioned her left arm was swollen from the carpal tunnel and the sports medicine doctor told her to take Advil. She took two weeks of Advil and her hand was fine. But then three weeks passed and her hand did not feel good again and looked a little swollen so she took Advil again for three days but she interrupted it 48 hours before the vaccine. She has not taken anymore Advil since then and she has not started it back. She was told to take ten 200mg daily but she only took two at lunch, one in the middle and one at night and it worked. The week before the vaccination, she took only 3 a day for 3 days then stopped it 48 hours before the vaccination. Provides for the Ibuprofen she took UPC 096619088041; lot SEP2021; expiration date P116896. This was the product she referred to as Advil. Caller asks isn't it the same thing. Caller mentioned she thought maybe it was a bad batch, referring to her vaccination, and adds she contacted someone that she knew who had the vaccine at the same location two hours later and they did not have any trouble; did not feel anything at all. A clone report is created to document the daughter's experience. It was reported that Pfizer COVID 19 vaccine; treatment first dose 7Apr2021; provides lot number from vaccination card but does not see NDC or expiration date. No specific results were provided other than the UTI. Patient visited to emergency room and physician office visit. Patient was not admitted to hospital. Family history included the patient mother had moderna with no side effects, brother had both Pfizer doses with no side effects, one daughter had one dose of the Pfizer with nothing and the other daughter had both Pfizer doses and had fever but nothing major. A clone report is created to document the daughter's experience. This is report 1 of 2. Caller was provided with phone number, option 3, and hours of operation for COVID-19 Vaccine only, Monday through Friday 8a-8p Eastern Time and Saturday and Sunday 9a-3p Eastern Time; prior to transfer to hold line due to high call volume. The outcome of the events dizzy, nausea, right side of my face swollen, head felt heavy above her eyes was not recovered and outcome of the other events was unknown. No follow-up attempts are needed. No further information is expected

Elevated blood pressure; heart rate was 125; thyroid is low; very sick; panic attack; chest is tight; irritable and having mood swings; anxiety or panic attack; irritable and having mood swings; pounding head; nausea; horrible body aches; Cramps; Shaking; shivering; gets violently hot; sweating profusely; arm turned dark red, went numb and tingly; arm turned dark red, went numb and tingly; arm turned dark red, went numb and tingly; blood in the urine; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 (Batch/Lot Number: ER8736) as 2nd dose, single for covid-19 immunisation. Medical history includes post-menopausal. The patient has a family history of low thyroid (mother). Concomitant medications included fexofenadine hydrochloride, pseudoephedrine hydrochloride (ALLEGRA-D 12HR) taken for an unspecified indication and paracetamol (TYLENOL EXTRA STRENGTH) taken for pain, start and stop date were not reported. The patient previously received first dose of Bnt162b2 on 13Apr2021 (lot number: ER8729) in the left arm for Covid-19 immunization. After she got the second dose in May2021, she did get very sick for about 48 hours, with a pounding head, nausea, and horrible body aches, cramps and shaking. She clarifies these symptoms lasted for about 24-48 hours. She has been much, much, much worse now since the second dose. It looks like some things were thrown off in the blood tests and stuff that were done in the ER. It's even showing that her thyroid is low and they immediately put her on Synthroid thyroid medication which made her a little nervous. She is not sure that what is showing up is something that is systemic with her or if this is something effecting what is systemic with her or if she is having some reaction. She is a little terrified right now to have her heart rate and blood pressure be up so much all the time. The level it was on Friday (209/100) scared her to death. Last Friday, after she took a shower, she was feeling like she was going to die. She does not know how else to explain it. She does have a blood pressure cuff and she decided to take her blood pressure. Her blood pressure was 209/100 and her heart rate was 125. Her blood pressure has been hovering around the 160s and 170's for the top number. She explains she and her doctors cannot get her to calm down. She called her doctor and she was sent to the Emergency Room. Some of the heart palpitation stuff and other things is coming in waves, it's not like its constant. But the blood pressure being elevated is constant. Also, when she has these waves, she also has perfused sweating. The waves last for about 5 minutes and the perfuse sweating takes a long time to stop. Her body is wet and she is instantly drenched. She is post-menopausal for like 2 years, it's not like hot flashes or anything weird showing up at the same time. She feels like she is in the middle of some sort of panic or anxiety attack 24 hours a day. She is also experiencing a lot of shaking and shivering. All of sudden, she gets violently hot and starts sweating profusely until she is drenched. She wakes up drenched in the middle of the night with her heart beating and high blood pressure, it wakes her up violently in the middle of the night. These symptoms have been continuing the entire time and she thinks it is getting worse. Friday was the highest her blood pressure has ever been. When she tried to use blood pressure cuff, her arm turned dark red, went numb and tingly, and she had tons of pain. She thought her arm was going to explode. She has never had that happen. She thinks the blood pressure was so high that the cuff caused that to happen. This made her think her blood pressure was close to heart attack level. Her blood pressure was 209/100 and her heart rate was 125. Her arm had never done that before. She clarifies she only went to the emergency room and she was never admitted into the hospital. She tried to get them to admit her because this has been going on so long and it's not correcting itself but they did not want to admit her. Clarified she went to the ER on Friday 14May2021. Several things were showing up weird in her blood tests. One of the things that showed up was that her thyroid was slightly low. She clarifies the TSH level was elevated, which meant hypothyroidism (thyroid is low). She was immediately put on Synthroid even though she was telling the doctors she was not so sure if what was happening to her was systemic and that it may be something that is exacerbated by or caused by the vaccine. She had to call into an endocrinologist because wanted her to see the endocrinologist immediately. In the hospital, her heart rate was okay while she was there, this kind of goes in waves. A wave of her heart beat going really, really hard and really, really fast. She states "you can see it through my clothes". The sweating starts at the same time. However, on the regular, like at the time of report, she has been shaking and she can tell her blood pressure is elevated. She has taken her blood pressure twice this morning and it was in the 180s over 90s range and then in the 160/80's range. Constantly, she feels like her heart is racing around and her blood pressure is racing all day long. It feels like what an anxiety attack would feel like. It's like she just can't get her body to calm down. Her heart rate calms down a little bit, she is constantly hearing the pounding in her ears when her heart beats. She is just riled up all of the time and her chest is tight. It's not like a breathing issue, her body is just tight, it feels like when she is scared or alarmed. She also has become very irritable and having mood swings. She thinks that is more coming from her body feeling like her body is on high alert or overly sensitive. It feels like every little thing is gigantic. She has never felt that before. She is normally a fully high functioning person. Because her blood pressure is so high and this isn't stopping. She is literally debilitated and cannot function. The patient underwent lab tests and procedures on 14May2021 which included albumin globulin ratio: 1.1, lowest of recommended low, anion gap: 5, slightly low, blood glucose: 111, elevated, potassium: 3.4, slightly low, blood pressure measurement: 209/100, blood thyroid stimulating hormone: 3.820, slightly elevated (low thyroid), globulin: 3.9, slightly elevated, heart rate: 125, platelet count: 448, slightly elevated, protein total: 8.2 (right at recommended normal high level), blood UA positive 1+ and blood pressure measurement: 171/101; heart rate: 109 both on 17May2021. The patient added that her endocrinologist ran all of her tests last Sept2020 and her thyroid was not even an issue. Some traces of blood in the urine was found in blood UA. Nothing that should be causing that because there is no menstrual cycle or anything else they know is going on. The outcome of event chest tightness was not recovered; all other events was unknown. Information on Lot/Batch number was available. Additional information has been requested.

Initial fever with neck, back and right thumb pain. Eventual diagnosis of sepsis. Four day hospital stay. Discharged home on Keflex antibiotic and meds for back pain. Four weeks later diagnosed with low EF of heart. Receiving meds to improve EF.

55 y.o. female with a lifetime history of insulin-dependent diabetes that presented to the emergency room just a few hours after she started having a left-sided neurologic deficit. The patient reports that she had a stroke several years ago but for some reason was told to not take aspirin and was not started on Plavix. Irregardless, the patient came in with a very significant left-sided neurologic deficit. She states that she could not speak, she had left facial droop, left arm weakness, and left leg weakness. She initially had an NIH stroke scale in the emergency room of 11. Initial CT of the head showed nothing acute. Consultation with neurology was obtained and the patient was sent for a CTA of the head and neck. No large vessel occlusion was identified and shortly after this the patient's NIH stroke scale reduced to 2 and shortly after this the neurologic deficit completely resolved and stroke scale return to 0. At that point, the patient was diagnosed with a TIA and admitted to the hospital for observation. This morning she states she feels fine. She has no neurologic deficit whatsoever. She denies any sensory or strength deficits this morning at all. The patient sugars have been a little bit high, but otherwise she had an uneventful evening

I felt a pain on my right side of my kidneys and they did a physical test and everything came back sick. I was in so much pain. I was running a fever and I spent 8hrs there. I had bruises all over my legs.

Patient presented to the on 4/26/2021 for cystitis, cellulitis. Patient hospitalized on 4/30/2021 for vulvar abscess and cellulitis. These visits are within 6 weeks of receiving COVID vaccination.

Sadness; Congestion; Really bad diarrhea; Kidney pain; Dizziness; Cough; Headache; Thirst; Difficulty sleeping; Neck pain; I have burning in the back of my neck; This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional. A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0191 Expiration date: unknown) dose 1 via an unspecified route of administration, administered in Arm Right on 06Jun2021 11:00 (at the age of 55-year-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported. patient did not received any other medication within 4 weak Prior to Vaccinations. The patient experienced neck pain, headache, thirst, depressed mood, cough, and difficulty sleeping on 06Jun2021, have burning in the back of the neck on Jun2021, Really bad diarrhea, Dizziness, kidney pain, on 07Jun2021, Sadness, Congestion on 08Jun2021.neck pain: Caller states neck pain was almost immediate after vaccine.She believes this pain resolved about a week later. when probed for the outcome, the caller explains she was okay right now. She feels she has recovered completely, Burning in the back of the neck started about two to three days after the vaccine, Headache: was almost immediate and resolved about maybe two weeks later, Thirst: Was almost immediate. She was drinking a lot of water.The thirst resolved maybe 2 weeks later. She has been hydrating on and off with Gatorade, Powerade and of course water, diarrhea: lasted about a week and a half, Cough: Was almost immediate. It was about maybe three hours after the vaccine, Dizziness: Resolved probably about two weeks later. The outcome of event Neck pain, Headache, Thirst, Sadness, Dizziness Recovered on Jun2021, outcome of burning in the back of my neck, recovered on 12Jun2021, while outcome of event Kidney pain, Congestion, Cough, Difficulty sleeping not recovered, outcome of other events was unknown No follow-up attempts are possible. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021820899 similar report from same reporter

pain daily kidney area up to my shoulders to mid back; pain daily kidney area up to my shoulders to mid back; pain daily kidney area up to my shoulders to mid back; Headache; pain; exhaustion; This is a spontaneous report received from a contactable consumer, the patient. A 55-year-old [non-pregnant] adult female received the second dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose in the left arm on 12Apr2021 at 11:15 (at 55-years-old) for COVID-19 immunization. Relevant medical history included endometriosis, cysts, tumors, food allergy (bell pepper) and drug allergies (ciprofloxacin and nitrofurantoin). Concomitant medications included letrozole from unspecified date for an unspecified indication; and unspecified thyroid medications. The patient previously received COVID-19 immunization with the first dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose in the left arm on 22Mar2021 at 11:15 (at 55-years-old). The patient was not pregnant at the time of vaccination and the patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccine within four weeks of this vaccine. The patient reported that on 13Apr2021 at 06:00 she experienced headache, pain, and exhaustion. The patient explained that now she has pain daily in the kidney area up to her shoulders and mid back. The patient stated that she is currently on an anti-inflammatory intravenous (IV) serious to try to stop the pain. The patient reported the events resulted in visit to doctor's office though denied that the events resulted in death, was life-threatening, caused/prolonged hospitalization, was disabling/incapacitating or resulted in congenital anomaly/birth defect. The outcome of the events headache, pain, exhaustion, and pain daily in the kidney area up to her shoulders and mid back was not recovered. Information regarding the lot/batch number has been requested.

Unable to urinate after the injection with presentation next day to the Hospital ER on 12/19/2020. On evaluation, an in/out catheterization was required to empty the bladder with 1 liter output. She then was discharged home. She is a nurse and had to self catheterize once more prior to being able to urinate spontaneously. She is currently experiencing UTI symptoms of dysuria and urgency.

Facial flushing/sporadic facial flushing; HTN; Tachycardia 90-120 x 30 hrs; Headache; Body aches; Painful urination; Bilateral eye pain; Chills/sporadic chills; This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), lot number: EL3246, via Intramuscular on left arm on 12Jan2021 12:00pm as SINGLE DOSE for COVID-19 immunisation. Medical history included asthma, hypothyroidism, supraventricular tachycardia, Sulfa allergy, dust allergy, Maple trees and Pine Trees allergies, gastrooesophageal reflux disease. Concomitant medication included sertraline, metoprolol, estradiol, levothyroxine, pantoprazole, fexofenadine hydrochloride (ALLEGRA), fluticasone propionate (FLONASE), paracetamol (TYLENOL), and ibuprofen (ADVIL). The patient previously took Augmentin and experienced drug hypersensitivity. Historical vaccine includes first dose of BNT162B2, lot number: EH9899, on22Dec2020 08:15 AM, via intramuscular on Left arm. On 13Jan2021, the patient experienced facial flushing, HTN, Tachycardia 90-120 for 30hrs, headache, Body aches, painful urination, bilateral eye pain, chills. Then, another 48 hours of sporadic facial flushing and sporadic chills. The patient underwent COVID-19 testing via Nasal Swab post vaccination on 16Jan2021 with negative. The outcome of the events sporadic facial flushing and sporadic chills was recovered on 16Jan2021; while the rest of the events were recovered on 14Jan2021. The patient is not pregnant at the time of vaccination. No treatment was given for the events.

Employee noted adverse effects began 1/15/21, the day after vaccination. She experienced chills (00:00 - 04:30), frequent urination, diaphoresis (09:00-12:30), and "brain fog" (09:00-13:30). She also reported loss of appetite (00:00-16:00). All events occurred on 1/15/2021. She took acetaminophen 500 mg twice (10:00, 12:30). She reported resolution of symptoms around 15:00, 1/15/21.

56 year old female presents with complaint of tingling and numbness that she noticed to her lower left jaw. It occurred yesterday around 3 PM after she received her Covid vaccination. She states that then started to move up to her left cheek but has now gone back down just to the lower left jaw. It is in a specific region of that area. She states also that she is having a fever today and generalized body aches that are moderate in nature. She also notes some urinary frequency without dysuria or hematuria. Patient took Tylenol this morning around 6 AM. She initially tried to swallow the pill and felt like she was going to choke on it and spit the pill up. She then sat down for a few minutes and was then able to take the pill. She denies any actual stridor or wheezing. No focal weakness or numbness of one arm or leg. No change in speech. Differential diagnoses include but are not limited to: CVA, TIA, anxiety reaction, paresthesia, metabolic process, bleed, vaccine reaction. 56-year-old female with paresthesia to the left chin. Otherwise normal neurologic examination. The TPA window given symptoms started yesterday. I will get a head CT but I do not feel the patient needs an MRI. Given the fact the patient does have autoimmune disorder, blood cultures and lactic acid obtained. I suspect that her fever is in response to her Covid vaccine yesterday. Covid test negative. Urinalysis no evidence of UTI. Chest x-ray is clear. Head CT negative. On reevaluation after Motrin patient feels much improved. At this time I think she is stable for discharge to home. I do not think this is Bell's I am finding no facial weakness on my examination. Follow-up and return precautions discussed patient understood

1/25 L sore shoulder. 1/26 L sore shoulder. 1/27 L burning sensation running down arm from shoulder to wrist. 1/28 L forearm and wrist began to swell and be very painful, complete loss of all wrist range of motion this continued thru Monday 2/8 This was so painful that I sought medical treatment from a MUSC health, Lanc MD on 2/5. He examined my wrist and sent me for an X-ray, X-ray was negetaive. Monday 2/8 the pain was subsiding from my wrist and began to start in my L shoulder. Wed 2/10 The pain had moved under my breast radiating from my L front around my back, severe along with shortness of breath. I went to ER for a complete work up including a CT to rule out a blood clot. All test negative all blood work normal. Except it did reveal that I had a UTI. I have never had a UTI in my life. I was started on a anitibiotic for the UTI. I still have the pain under my L breast. Unknown reason.

Pt received dose #1 of COVID-19 vaccine (Pfizer-BioNTech) on 12/18/20 and dose #2 ( Pfizer-BioNTech) on 1/8/21. On 1/30, patient was evaluated at urgent care due to back pain. No bloodwork done; metronidazole prescribed for 7 days. On 2/8, patient was admitted to outside hospital due to ongoing symptom progression. At time of admission, hgb 5 g/dL and plt 9k. Per Dr. (hematology/oncology), pt with schistocytes, LDH 1500, and elevated reticulocyte count consistent with thrombotic thrombocytopenic purpura (TTP). SCr >2 mg/dL. Patient immediately treated with plasma exchange and steroids, however continued to decline. Patient expired on 2/14/21.

Prior to receiving vaccine, vaccinator stated patient had increased ?anxiety? making statements such as ?I?m going to die! This vaccine is going to kill me!? Immediately after receiving vaccine (less than 3 seconds) patient slumped down in chair, writer to the patient, patient stating ?I can?t breathe, its going dark, I?m going to die! What about my daughter!? Writer and vaccinator attempted to talk patient down, ineffective. Patient V/S 100/60, 66-HR, 98%-O2, 22-Resp. Patient became limp in chair, unresponsive, episode of urinary incontinence, EMS activated. ~90 seconds into episode patient regained consciousness, A&Ox4, stating ?I?m back. I?m back.? Patient reports this last happened to her ?in college?. Patient also states ?my doctor told me not to get the vaccine, to wait until August since I have Lyme Disease.? Patient to ED with EMS.

Patient received her covid vaccination at 1950, right deltoid. She was escorted to the 30 minute waiting zone as she has had anaphylactic reactions in the past. At 2008 patient stated she felt hot. She had a rash developing on her neck, noted a dry mouth and thickening tongue. EMS brought in for evaluation. Blood pressure 204/102, pulse 65, oxygen 100% on 2L nasal cannula. 50 mg benadryl administered IM left deltoid 2011. 20g PIV started left antecubital, 125 mg administered. Ambulance on site. Patient able to speak clearly, verbalized the need to void her bladder. Patient accompanied by 2 RNs to the restroom. She was stable on her feet, escorted back to EMS stretcher. She was taken to hospital. VAERS submitted.

CKD; CKD; Everything is usually normal except for the GFR; large amounts of blood in the urine; This is a spontaneous report received from a contactable consumer (patient herself). A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on Left arm on 28Feb2021 at 11:15 at single dose for COVID-19 immunization at an other facility. Medical history included high blood pressure and CKD both are ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Buproprion, THYROID (wp thyroid), Probiotice, vitamin D, Pro within 2 weeks of vaccination. It was reported that patient did a daily home urinalysis due to recently diagnosed CKD/ Chronic kidney disease. Everything is usually normal except for the GFR/ Glomerular filtration rate abnormal. Today, on 01Mar2021 at 07:00 AM on two occasions, the urinalysis stick showed large amounts of blood in the urine/ Blood urine present. Nonvisible in the toilet though. No treatment was received for the adverse event large amounts of blood in the urine. Event Chronic kidney disease was considered as medically significant. Outcome of the events was unknown. Information on the lot/batch number has been requested.

LOSS OFBLADDER CONTROL; IRREGULAR HEARTBEAT; This is a spontaneous report from a contactable 56-year-old female healthcare professional reported for herself that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscula, administered in Arm Right on 07Jan2021 (Batch/Lot Number: EJ 1686) as SINGLE DOSE for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. The patient experienced loss of bladder control and irregular heartbeat on Jan2021 with outcome of not recovered. The patient underwent lab tests and procedures which included heart rate: irregular on 2021. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as not recovered.

LOSS OFBLADDER CONTROL; IRREGULAR HEARTBEAT; This is a spontaneous report from a contactable other hcp. A 56-year-old female patient started to receive bnt162b2 (BNT162B2, Solution for injection, Lot # EL9261), via an unspecified route of administration from 29Jan2021 to 29Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On Jan2021, the patient experienced loss of bladder control, irregular heartbeat. The action taken in response to the event for bnt162b2 was not applicable. The outcome of the event was not recovered.

Headache, Tiredness, bodyaches, very warm feeling inside body day of shot. Today is day two symptoms seem worse and develop the 100.9 fever till next morning. Entire body of bones and skin is aching. Breathing is shallow and my ribs are hurting, when I move I get sharp pains as well in the rib area or what organs are under the ribs. I could hold my bladder when I got out of bed. I didnt know I was urinating myself until I felt it going down legs.

After about 15 min I started to get numbness, tingling , and swelling on my entire left side. It included difficulties seeing and lack of hearing on the left side. I could feel the "blood flow" in my head, which was super uncomfortable, because I was afraid of getting a stroke. I went to report to the Medical Doctor on side at the Convention Centre. They kept monitoring blood pressure and my responses. Nothing really was done. Symptoms stayed for about 1.5 hours the same. After that they decreased but my side was still numb and swollen (not back to normal). However, I left to go home. After about 24 hours those symptoms were gone and only headache, fatigue remained. I received my second vaccination on 04/04/2021 at about 1:15P: Pfizer, Lot#ER8733 There, I used my right arm. Same thing, after about 15 min, I started to get tingling, numbness, difficulties hearing and seeing. Headache was worse than the first time. Again I remained under observation for about 1h. No results. Symptoms lessened. I went home. At night I developed nausea, severe kidney pain, had to vomit several times, and had a weird hot feeling inside my body=could feel my blood flow. It felt as if it was really hot. it was extremely scary, as I again was afraid of developing a stroke. Now, 2 days later, I still am feeling extremely weak, nauseous, headaches, some numbness.

Cloudy urine 11+ days Smelly urine 11+ days Orange urine 9 days Body Temperature fluxuations 10 days Achy back 11+ days Fever over 102.1 2+ days Vomiting 2 days Shaking Chills 10 days Night Sweats 11 days Shakiness 10 days Slowness10 days Stiffness 10 days Unsteadiness 10 days Extreme Fatigue 11 days Diarrhea 2 days

Vomiting; joint pain; muscle pain; nausea; feeling unwell; tiredness; kidney and lung pain; kidney and lung pain; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female patient received the second dose of BNT162B2 (lot number: EW0107), via an unspecified route of administration in right arm on 30Apr2021 13:15 at single dose for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included estrogens conjugated (ESTROCON), colecalciferol (VITAMIN D), oenothera biennis oil (EVENING PRIMROSE), and fish oil (O3 OMEGA 3). The patient previously received the first dose of BNT162B2 (lot number: EW0158) in left arm on 09Apr2021 13:15 for COVID-19 immunisation. The most recent COVID-19 vaccine was administered in workplace clinic. Patient experienced vomiting, joint pain, muscle pain, nausea, feeling unwell, tiredness, kidney and lung pain on 01May2021 01:00. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for these events. Outcome of the events was not resolved. No follow-up attempts are needed. No further information is expected.

Within three minutes of getting the injection, I felt a surge, like adrenaline, going through my body, then my heart started pounding rapidly. I also had shallow breathing, like panting. I drank water and it gradually subsided. As it subsided, I felt a tingling in the left corner of my mouth. It then went entirely numb. After ten minutes, my heartbeat went back to normal. Also, although I had urinated at 6:10 p.m., I had to urinate again at 6:30. This was not due to drinking the water, since I only drank about four ounces of water.

aches; vomiting the day following vaccination for about 12 hours; Severe UTI on the second day; Fever; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9266), via an unspecified route of administration, administered in left arm on 02Mar2021 15:30 (at the age of 56-year-old) as single dose for COVID-19 immunization. Medical history included Diabetes II. Concomitant medications included Metformin, Rybelsus, Glipizide, Atorvastatin, B12 (Cyanocobalamin). The patient previously took Motrin (ibuprofen) and experienced drug hypersensitivity, Erythromycin and experienced drug hypersensitivity, bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number- EL8982) administered in right arm on 09Feb2021 for COVID-19 immunization. On 04Mar2021 15:00, the patient experienced fever, aches, vomiting the day following vaccination for about 12 hours, severe UTI on the second day. If COVID prior vaccination and COVID tested post vaccination was reported as no. The patient did not receive treatment. The outcome of all events was not recovered. No follow-up attempts are possible. No further information is expected.

Urinary tract infection; Escherichia coli infection; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: EN6208), intramuscularly, on 09Mar2021, as a single dose for COVID-19 immunisation. The patient received Adalimumab (HUMIRA 40MG/0.4ML, Solution for injection in pre-filled pen) at an unknown dose subcutaneously from an unspecified date in May2021 for rheumatoid arthritis. Medical history included ear infection (started Jan2021), non-tobacco user, non alcohol user and sulfa drugs allergy manifested as rash. Concomitant medications were not reported. The patient previously received first dose of BNT162B2 (Lot Number: EN6201), intramuscularly, on 16Feb2021 as single dose for COVID-19 immunisation with no reaction on previous exposure to vaccine. The patient's past medications include SULFA and Etanercept (ENBREL). In Jun2021, the patient experienced urinary tract infection and Escherichia coli infection. The patient went to an urgent care due to urinary tract infection on 09Jun2021. Physician asked her to skip Adalimumab when was informed about the infection. On 04Jun2021, therapy with Adalimumab was discontinued. She had a shot of COVID 19 vaccine before at least one symptom happened therefore COVID-19 VACCINE was considered as co-suspect product. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with Clarithromycin (MACROBID). Relevant Laboratory & Other Diagnostic Tests included Dipstick culture performed in Jun2021 that confirmed there was Escherichia coli and urinary tract infection. Outcome of the events was unknown. The reporter's causality for the events of urinary tract infection and Escherichia coli infection with BNT162B2 was not related and with Adalimumab was no reasonable possibility. No follow-up attempts are needed. No further information is expected.

Around the first of May, I noticed leakage of urine - I had a little prior to the vaccination, but by May 1st, it was much more pronounced and accompanied by urgency and frequency of urination. I have to wear a pad at all time now.

Inability to raise arm without incredible pain; Bruising and swelling from breast to shoulder on right side; Bruising and swelling from breast to shoulder on right side; Kidneys sore; Sick to stomach; Headache; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the right arm on 01Apr2021 at 16:00 (at the age of 56-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously took flu shot on an unknown date for immunisation and experienced that her body did not tolerate the flu shot. Prior to the vaccination, the patient was 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 02Apr2021 at 04:00, the patient experienced inability to raise arm without incredible pain, bruising and swelling from breast to shoulder on right side, kidneys were sore, sick to stomach and headaches. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. The clinical outcome of the events inability to raise arm without incredible pain, bruising and swelling from breast to shoulder on right side, kidneys were sore, sick to stomach and headaches were not resolved at the time of this report. No follow-up attempts are needed. No further information is expected.

She received 2nd COVID vaccine on 1/7//21. On 1/13/21, she developed sore throat, earache, dizziness, dyspnea, diarrhea, vomiting and fever. She required hospitalization on 1/18/21 for Acute hypoxic respiratory failure secondary to bilateral Pneumonia with left pleural effusion. Sepsis secondary to Gram-Positive bacteremia (strep pneumococcus). UTI. Acute Kidney Injury

After being on menopause for two years (no menstruation), I started with all signs of ovulation: vaginal secretion, breast sensitivity and pain, acne. And after almost two weeks I had the feeling I was going to start my period. And I noticed pink after urinating and apparently a period is starting (menstruation). After 3 years of no menstruation.

Second vaccine fever and frequent urination and jittery feeling; Second vaccine fever and frequent urination and jittery feeling; Second vaccine fever and frequent urination and jittery feeling; This is a spontaneous report received from a contactable consumer (Patient). A 57-year-old female patient (not pregnant) received bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine), dose 2 via an unspecified route of administration, administered in Arm Left on 30Mar2021 11:00 (Lot Number: ER8737) at single dose for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Public Health Clinic. Medical history was none, no allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VITAMIN D 3) taken for an unspecified indication, start and stop date were not reported; biotin taken for an unspecified indication, start and stop date were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received the first dose of bnt162b2 (lot number: EN6206) on 08Mar2021 04:00 PM for covid-19 immunization and experienced sore arm. The patient experienced second vaccine fever and frequent urination and jittery feeling on 31Mar2021 12:00. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was not recovered. Seriousness criteria was no. No follow-up attempts are needed. No further information is expected.

Right after face tighting 2.5 weeks of flu like strmptoms,severe stomach pains, horrific diarrhea, vomiting, nausea, headache, could not think clearly. Malise, rheumatoid arthritis severe flare up Been sick again for 9 days started 3/28/2021 Severe kidney pain, nausea, headache, lethargic, right calve feels like it is in a fire. Could not figure out what was going on Diagnosis Shingles 5/5/2021

57 YO female pt presented to outside institution on 5/22 with acute respiratory failure, found to be COVID positive, also w AKI on admission (Cr 4.9). Denies cough, sputum production or fevers at home prior to presentation. She was intubated on arrival to outside institution 5/22 and admitted to ICU. She has been treated with dexamethasone 6mg IV and Remdesivir x1, convalescent plasma. Treated with empiric vanc/zosyn since admission for possible superimposed bacterial PNA. Also were empirically treating for PE due to elevated D-dimer though no CTPE. Transferred to this institution on 5/28. Pt is s/p mRNA vaccination on 4/13 and 5/4, but on immunosuppression with mycophenolate + sirolimus + prednisone...

I almost died when I arrived at the hospital. I was admitted and stayed there for 6 days for treatment. My blood pressure was 30/50. The Doctors did not know what was wrong and ended up being diagnosed with a septic kidney and the Dr. said that normally that occurs from a UTI and I have never had a UTI; however, now, I have three and I just came from the Dr.'s office today with another checkup.

hemorrhagic cyst; Breast pain and tenderness began after 2nd shot; Breast pain and tenderness began after 2nd shot; uterine tract infection; abdominal pain; swelling; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 57-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on an unspecified date (also reported as on 28Mar2021, pending confirm) (Batch/Lot Number: ER8731) as 2ND DOSE, SINGLE for covid-19 immunization, at the age at vaccination of 57 years old. Patient was not pregnant. Medical history included Colon surgery in 2017, followed by colon cancer chemotherapy in 2017- 2018, follow up CT scans performed every 6 months. CT scan on 04Apr2021 showed no observation of cyst on ovary. Historical vaccine included first dose of COVID 19 vaccine (Brand: Pfizer; Lot number: ER8733; Vaccine location: Left arm) on 28Mar2021 11:00 AM). Concomitant medications included cetirizine hcl (CETIRIZINE HCL) 10 mg taken for an unspecified indication, start and stop date were not reported. The patient experienced hemorrhagic cyst (medically significant), breast pain and tenderness began after 2nd shot, uterine tract infection, abdominal pain, swelling, all on 19May2021 with outcome of not recovered. The patient underwent lab tests which included CT scan: no observation of cyst on 04Apr2021, ultra sound Retroperitoneal of uterine, ovaries, kidneys, bladder, a complex lesion was identified in right ovary measuring 14.3 x 15.7 x 8.2 cm on 25May2021. Adverse event reported as: Breast pain and tenderness began after 2nd shot and lasted approximately 30 days. On 19May2021 had symptoms of uterine tract infection, abdominal pain, swelling. On 25May2021, primary care doctor ordered an ultra sound Retroperitoneal of uterine, ovaries, kidneys, bladder and a complex lesion was identified in right ovary measuring 14.3 x 15.7 x 8.2 cm, may represent a hemorrhagic cyst. Left ovary not visualized. Followup is planned with gynecology surgeon. AE resulted in: Doctor or other healthcaremprofessional office/clinic visit. The treatment received for events included: antibiotic to treat infection. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Additional information is requested.

Started with back spasms on first day; subsided. Returned again the next day; subsided. On third day pain became unbearable, went to Hospital ER - they diagnosed kidney stone. Had various blood and urine tests. CT scan confirmed. Administered a lot of IV meds. Was admitted for observation. Stent was put in place and kidney infection discovered. Sent home for 10 days to take antibiotics. On day 14 had urinalysis. On day 18 had stone surgically removed, stent replaced. On day 29 had stent removed.

UTI-like symptoms (irritation and burning); UTI-like symptoms (irritation and burning); This is a spontaneous report from a contactable consumer (husband reported for his wife). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an intramuscular route of administration, administered in Arm Left on 08Apr2021 (at the age of 57-year-old) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were none. Family medical history Relevant to AE(s) was none. Patient medical history (including any illness at time of vaccination) was none. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number: not reported), via an unspecified route (injection) of administration, administered in Arm Left on 21Mar2021, as single for covid-19 immunisation. Additional vaccines administered on same date of the Pfizer Suspect were none. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine were none. AE(s) following prior vaccinations was not provided. On 28Apr2021, the patient experienced UTI-like symptoms (irritation and burning). The clinical details of the events as follows: Reporter stated that he and his wife received their second Pfizer Covid vaccine doses on 08Apr2021. They have both been experiencing UTI-like symptoms including irritation and burning) that have not resolved. Reporter stated that his wife symptoms began around the same time as his. It was pretty much identical. Started at the same time and are ongoing and persisting. Reporter stated she mentioned something to him about it just in the past Sunday. The patient went to the gynecologist for Urinary tract infection symptoms, where no blood work or urinalysis were performed. She was trying to go to her regular doctor for testing. No Relevant Tests performed. The events did not result a visit to Emergency Room. No Investigation assessment provided. The outcome of the events was not resolved at the time of this report. Information about lot/batch number cannot be obtained. Additional information has been requested.

Usual: aches, pain at site, headache Unusual: fever >103, gross hematuria (no history of UTIs or kidney stones)

This is a spontaneous report from a contactable consumer. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus. Concomitant medication included metformin from 2012 and ongoing for diabetes. The patient stated on 21Dec2021 "I received my first dose of the COVID-19 vaccine, I was supposed to get the second dose yesterday, I couldn't go because I am home sick on 10Jan2021, I don't know if I have COVID or not." Her job gave it to her. She started having chills yesterday on 11Jan2021. On 11Jan2021, it was reported that he has hot and cold sweats, she has body aches and a slight headache. She is weak. She is frequently urinating every hour. She has a light headache. Her body feels weird like she cannot stand because she is really weak. She is in pain. She was supposed to get the second dose 11Jan2021. She took the vaccine for her safety. The outcome of the event sick was unknown, while not recovered for the other events.

Lower abdominal pain and lower back pain. My whole left side was painful to the touch, slight nausea for three days. Felt like I had bladder infection and yeast infection all in one. Had a hard time standing up. Has resolved now. 101.4 fever. my teeth were sensitive and sinuses hurt really bad. 01/05/2020 first vaccine.

5 days after my FIRST COVID shot, I experienced symptoms identical to what others have reported following the second shot: extreme fatigue, headache, achiness, night sweats, and fever. I did have a UTI at the time but I believe the symptoms are unrelated to that. It was a mild UTI and cleared up quickly on antibiotics, while the other symptoms persisted for 3 days.

Patient had swollen lymphnodes the size of baseballs the next days and her kidney function decreased after getting the 1st dose.

3/22/2021 - took double usual dose of hydrocortisone (20mg) prior to receiving vaccine, 7 hours after vaccination - chills, body ache, headache, lethargy. 3/23/2021 - woke with nausea and anorexia, took triple usual hydrocortisone dose (30mg) with yogurt, very lethargic, brain fog with cognitive difficulty, anorexia, stayed in bed all day, eating drinking veyr little. 3/24/2021 - woke with worsening lethargy, generalized weakness, nausea, took hydrocortisone 30mg with yogurt. by noon, very dizzy and weak, unable to get out of bed, friend drove her to Hosp. Emergency Room. Noted hypotension systolic BP 80, clinically dehydrated, Na 129, K 3.2, cr 1.2 (nl 0.97) Diagnosed Adrenal Crisis admitted 3 days to 3/27

Toes cramping severely once then progressed to extreme pain like a wave starting at toes then moving up entire body from 7 pm at night until the next day around 5 pm, this is not the worst. I did not feel well for over a month after 2nd shot. I had my annual physical feb 8 one week after shot. Those lab results reported I had stage 3a kidney failure. My GFR results were 51. as in stage 3a kidney failure! And my MCHC level was 31.7. I never had issues with either of these before. I have been retested March 8 and am back to normal results.

Patient had extreme pain, fatigue, chills, fever. Patient developed lump in arm pit, approx 1 cm that is still there currently. Patient could not get out of bed for over 24hrs post 2nd dose. Reporting kidney pain and full body pain.

developed kidney stone; This is a spontaneous report from a contactable nurse (who is also the patient). A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EW0150), via an unspecified route of administration in the left arm, on 31Mar2021, as single dose, for COVID-19 immunisation. There were no medical history and concomitant medications. On 06Apr2021, 6 days after the vaccination, the patient developed kidney stone which was a 6x2 mm stone. The patient stated that she never had a history of stone. She was wondering if anything has been reported like this and mentioned that she was unsure if this could be a side effect. The patient was recovering from the event. The patient reported the event as serious (medically significant).; Sender's Comments: The event kidney stone is considered unrelated to suspect vaccine BNT162B2 as there is no known plausible mechanism. The reported event most likely represented intercurrent medical condition. 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.

4/25 Pt presented to urgent care with complaint of HA and earache. Her pulse ox was in the 80's and she was sent to the ED for further evaluation and admission. D/C summary from 4/26 : Patient is a 58 y.o. female patient of, DO with history of OSA cannot tolerate CPAP, depression, rheumatoid arthritis, chronic pain syndrome, obesity, diabetes type 2, CAD, hypertension, hyperlipidemia, TIA who presents with shortness of breath. Patient was placed on 4 L NC but quickly weaned off. She tested positive for covid on 4/25. She was started on dexamethasone and covid cocktail for 10 days. Her CTPA and venous duplexes were negative for blood clots. There was bronchitis on CTPA so pt was placed on albuterol, mucinex and advised to use IS. Her Cr was elevated to 1.52 and improved to 1.25 this morning. Her hydrochlorothiazide was held. Her AST was 186, ALT 245 previously normal. Her atorvastatin and metformin were held. She was tolerating po and her VS were stable so she was discharged home. She was advised to have repeat labs with her PCP in 1 week and if at that time her Cr, AST, ALT improved, then her hydrochlorothiazide, atorvastatin, metformin could be resumed at her PCP's discretion. She was at home for one day and presented to another ED with CP and SOB. Admitted 4/27-5/1 D/C Summary :Clinical Summary Patient is a 58 y.o. female with a history of positive covid test 4/25/21, CKD, CAD s/p PCI, depression OSA rheumatoid arthritis morbid obesity, HTN and DM2 who just discharged from hospital 4/26/21 after diagnosis of COVID and starting on dexamethasone. She presented to hospital 4/27/2021 with chest pain and shortness of breath. CXR negative 4/27/21, CTPA negative 4/26/21, LEVD negative 4/26/21 labs stable from last admission. 1. COVID 19 Pneumonia: Suspected re-infection. Husband reported was positive mid - January. Continued dexamethasone to complete 10 days (started 4/25/2021). Remdesivir not started with LFT elevation on admit. 2. Acute hypoxic respiratory failure: with increasing O2 requirement 4/28/2021. CXR 4/28/2021 with underaeration of lungs. ABG 4/28/2021 without hypoxemia. Likely d/t COVID, resolved 3. Chest pain: Suspect in setting of COVID infection and component of costochondritis. CTPA and LEVD negative 4/26/21. Troponins stable from last admission in setting of CKD, ekg without acute findings on admit. 4. Elevated LFT: on admit AST 186, ALT 245, total bilirubin 0.2. likely d/t COVID. Improving, AST 93, ALT 163 4/30/202.1. will need outpatient repeat in 1-2 weeks with PCP 5. CKD3: Baseline creat 1.2-1.5. Cr on admit 1.52, improved 0.99 4/30/2021. Repeat chem in 1-2 weeks 6. T2DM: Per history, on Januvia at home (held on admit). A1C 8 1/29/21. Hyperglycemia on admission, improved with SSI, discussed continuing on discharge while on steroids and following up with PCP in next week

Horrible nausea and vomiting, high fever, chills with shaking, body aches all over my boy especially where I have had previous injury or surgeries. Really bad headache. I could not drink much even though I was thirsty. I could only do a small sip at a time or risk vomiting. My urine started to turn brown due to lack of hydration most likely. I was really sick for 3 days and mildly for 2. I still feel very weak and have brain fog.

R65.10 - SIRS (systemic inflammatory response syndrome) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC)

bladder infection; This is a spontaneous report from a contactable consumer via a Pfizer-sponsored program. A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on 13May2021, as a single dose for covid-19 immunization. The patient medical history included asthma. The patient's concomitant medications were not reported. The patient previously took penicillin for Lung stuff and experienced Anaphylaxis. On May2021, the patient experienced bladder infection. It was reported as received her first dose of the vaccine on 13May2021 and started taking antibiotics for a bladder infection on Monday. Her antibiotic regimen will last for 5 days. Reports her reaction to penicillin was a long time ago, she has asthma and was always treated with penicillin for lung stuff, but that was a long time ago. Caller states since then, she never took penicillin, even the pills, she tries to avoid that. Stated earlier she got the first dose of the vaccine and right now she was taking antibiotics and she was scheduled for the second dose on 03Jun2021. Transferring agent states the caller is wondering if that was okay if she can get the second dose. The outcome of the event was unknown. Information about batch/Lot number has been requested.

This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EW0171), via an unspecified route of administration on 28Apr2021 as 1st dose, single dose for COVID-19 immunization. Medical history included immune deficiency 2 months prior in 2021. The patient's concomitant medications include unspecified medications that the patient has been taking "forever". The patient did not start any new medications recently. She did not have any other vaccinations the same day as the Pfizer COVID-19 vaccine or in the four weeks prior. She says she hadn't had a vaccine in years. The patient reported that she got the vaccine then went grocery shopping and felt great, her arm didn't even hurt, and she didn't feel the shot going in. She says she went to bed and got up 4:00AM to get ready for work, and as soon as her alarm went off on 29Apr2021 she felt really weird. On 29Apr2021, she went to stand up and went to her knees since she couldn't walk and had to crawl to the bathroom. She was in the worst pain in her life/pretty bad pain. Her body was cramping. She was having cramps to her legs and just like every muscled from her foot to her hips and in her hips were cramping, severe cramping, the whole leg. She says she lost feeling and still has some numbness. Patient says her brain is a little foggy as well. The patient took pain medications and Neurontin which is helping her numb feet and tingling in extremities. She also had an icy feeling in her legs, though they are warm always although they feel icy, if she touches them they are warm, like normal body temperature. Patient clarified Neurontin as gabapentin 300 mg, says the doctor has started her out one at night before bed, and she just was given it, so she has only taken two days of it. She says they wanted to see how it affected her, and wanted her to call so they could decide how much to give her, so they started her at the lowest place. She says it didn't effect her worse than she already was, but she thinks they were holding off to see what the neurologist came up with too. The patient also had a little incontinence of bowel and bladder on an unspecified date in 2021. She says she went to the emergency room the day she woke up with the adverse reaction, on the "29th". She says that they gave her Morphine IV. She says that they did no tests, or blood tests, then they sent her home with pain meds and said that this will probably get worse before it gets better, and to follow up with her doctor. She says she followed up with her doctor the next morning. She says that the pain meds made her sleepy, but did not take care of the pain. She says that she went to see her doctor, who sent her to a different hospital, and there she was admit from emergency. She was given an unspecified muscle relaxer which was the one she threw out, her pain wasn't muscle, it was nerve, so she threw it out. She was given Hydrocodone, substituted for Norco. They also gave her, maybe a Tramadol pill, in the hospital. She says she spent 7 days in the hospital, had two ER visits, and doctor visits. The patient underwent lab tests and procedures which included antinuclear antibody: positive 2 months prior in 2021. The patient had her "proteins" tested which were good and also did a spinal tap and were still good in her fluid both on an unspecified date in 2021. The other neurologist wanted to do an EMG (not yet done), because sometimes it can still be fine and not higher proteins. She says mostly they have been going by her symptoms. She has not been diagnosed yet with Guillain-Barre, since she still needs to see a neurologist for the conduction study. She added she will consult with her neurologist, continue to take her Neurontin, and have the physical therapy. The outcome of the events was unknown.

N17.9 - Acute kidney failure, unspecified R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction VOMITING PERIPHERAL EDEMA

Patient stated after she got vaccine she waited 30 minutes, and an hour after she left the facility, she started having pains in her side, and her injection site started hurting and swelling. Patient had nausea and dizziness and itching. Patient stated that her right side (where pain was) was swollen, and she had a severe headache. Patient also reported pain in legs and feet. An hour later, patient used restroom and urinated blood. Patient also reported sore throat. Patient stated she bled this way for 3 days after vaccine. Patient has been trying to contact PCP with no answer. Patient reported severe cramping every 30 minutes. Patient is still having severe headaches, and pain in legs and feet, and body aches. Patient stated that lower abdominal pain doesn't come as often anymore. Patient stated that she went to restroom on 06/15/2021 and her urine was reddish colored.

blood in urine; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old non-pregnant female patient received bnt162b2 (Lot Number: 6206), dose 1 via an unspecified route of administration, administered in right arm on 12Mar2021 at 12:00 PM (at the age of 58 years old) as single dose for COVID-19 immunization. Medical history included asthma, thyroid, mild kidney disease, allergies, infertility, carpal tunnel, trigger finger, known allergies included Erythromycin. Concomitant medications in two weeks included Omeprazole, fluticasone propionate (FLONASE), famotidine, fluticasone propionate/ salmeterol xinafoate (ADVAIR), biotin. The patient had no other vaccine in four weeks. The patient experienced two events so far of blood in urine. First was the following day which was approx 23 hours after shot (13Mar2021 10:30 AM), then second noticed event of blood in urine was the next morning, approx 44 hours after shot. The patient had not COVID prior vaccination and did not have COVID tested post vaccination. No treatment for the event. The outcome of event was unknown. No follow-up attempts are possible. No further information is expected.

Bladder infection; This is a spontaneous report from a contactable consumer (patient). This 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ET6955 with Expiration Date Jul2021), via an unknown route, on 19Mar2021 (at the age of 59-year-old) as single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. After vaccine, in Mar2021, the patient had bladder infection. The event was reported as non-serious. She was consuming water and Cranberry juice for bladder infection. She was also prescribed nitrofurantoin 100 mg. The outcome of the event was unknown. No follow-up attempts are needed. No further information is expected.

kidney failure, dehydrated , fever, chills, night sweats, paleness, , ER VISIT, STILL IN HOSPITAL, kidney biopsy.

She states that as she was walking, they felt like cement, got very heavy; arm where she got the shot swelled up, was red, and pain was there; arm where she got the shot swelled up, was red, and pain was there; arms started hurting; really bad pains in her legs and feet; really bad pains in her back and side on the right side; side started hurting really, really bad; lower abdomen started hurting/ Lower abdominal pain; head started hurting really, really bad like it was going to explode; whole right side swelled up; started feeling nauseous; throat was also hurting; it was like she was dizzy; started peeing blood; Joint pain; body was aching; skin was itching; arm where she got the shot swelled up, was red, and pain was there; Sinus congestion; basically dropped to her knees. Caller states she was in so much pain; she had recently found out her son and his wife contracted the COVID vaccine/Clarified with caller that she was referring to the COVID virus.; This is a spontaneous report from a contactable consumer(patient). A 58-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0183; Expiration Date: Aug2021) via an unspecified route of administration, administered in Arm Left on 21May2021 12:30(at the age 0f 58-year-old) as single for covid-19 immunisation. Medical history included nephrolithiasis from 2021 and ongoing, Kidney stones, lupus-like syndrome from Nov2019 and ongoing, lupus, rheumatoid arthritis from Nov2019 and ongoing, rheumatoid arthritis, gastroenteritis radiation from Feb2019 and ongoing, chemical colitis, haematuria from 30Jan2021 and ongoing, Recurrent haematuria, arthralgia from Aug2020 and ongoing, Joint pain, ocular hyperaemia from 22Jun2020 and ongoing, Floaters in her eyes, cardiac failure, Heart failure.The patient's concomitant medications were not reported. The patient experienced she had recently found out her son and his wife contracted the covid vaccine and she clarified that she was referring to the covid virus. on 21May2021 arms started hurting, really bad pains in her legs and feet, really bad pains in her back and side on the right side, side started hurting really, really bad, lower abdomen started hurting/ lower abdominal pain, head started hurting really, really bad like it was going to explode, whole right side swelled up, started feeling nauseous, throat was also hurting, it was like she was dizzy, started peeing blood, joint pain, body was aching, skin was itching, arm where she got the shot swelled up, was red, and pain was there, sinus congestion, basically dropped to her knees and patient stated that she was in so much pain. she stated that actually is trying to reach her doctor and she couldn't take the shot on Friday, 11Jun2021, says the doctor told her not to take the shot until she could see her regular physician about everything, including the peeing incident. she wants to see her doctor and ask to see a gynaecologist, says those are things she's going to do before she takes the second shot. The patient underwent lab tests and procedures which included computerised tomogram: kidney stones. They diagnosed her kidney stones and haematuria or whatever it was about a month ago. The outcome of the events headache was not recovered, nausea was recovering and remaining events it was unknown.

Started with smelly urine which I thought was an odd reaction from the vaccine but it began right after the vaccine for a week or so. Then started getting a strange side ache. Went to my doctor, I had a Bladder Infection ( I am not prone to either UTi,s or bladder infections) I still feel I need to go back to the doctor to follow up; I don?t feel exactly right. Also definitely body aches that have lingered, lower energy levels and some brain fog. I waited to report because I had convinced myself that these symptoms were not related to the vaccine. But now I think they are. More and more people are reporting similar side effects.

runny nose; migraine headache; Slight headache; Muscles hurt; Little bit of chills; UTI; cough; This is a spontaneous report from a contactable consumer reporting for herself. A 58-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0164; Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 14Jun2021 11:00 (at the age of 58-years-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were reported as none. The patient did not have prior Vaccinations (within 4 weeks). Family Medical History included cancer, high blood pressure, heart attack, kidney cancer, breast cancer. The patient previously took first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EW0186) in left arm on 24May2021 13:00. The patient experienced cough on Jun2021, runny nose on an unspecified date, UTI (urinary tract infection) on 16Jun2021, slight headache on 17Jun2021, muscles hurt on 17Jun2021, little bit of chills on 17Jun2021, migraine headache on an unspecified date. Caller wanted to know if the adverse events that she is experiencing are included among the commonly reported adverse events from getting the Pfizer Biontech covid-19 vaccine. She was mostly concerned about the cough and runny nose. In response, patient was given overall safety summary that in clinical studies, adverse reactions in participants 16 years of age and older included fatigue (62.9%), and chills (31.9%). No specific information for coughs and runny nose being a effect, patient was referred to HCP. Caller stated that she was unsure if the cough and runny nose that she was experiencing were the signs of covid-19 or an AE of the Pfizer BioNTech Covid-19. The vaccine was at 95% efficacy 7 days after the 2nd dose of the Pfizer Biontech covid-19 vaccine. It may not protect everyone from covid-19. Patient was requested to speak to her doctor/hcp for some guidance as the cough/runny nose she was experiencing may require extensive evaluation to assess if it was an AE of the vaccine or a symptom of covid-19. Upon follow-up on 21Jun2021, patient reported additional events she experienced which included UTI, slight headache, muscles hurt, little bit of chills. Reason for the patient taking Covid Vaccine was that she was hearing a lot of announcements that Covid has been reported as decreasing. Patient had the second shot of the Covid vaccine on 14Jun2021. Her doctor prescribed her medication two days later for a UTI. She was just calling about this cough too and asked if that is normal after the Covid vaccine. She had a cough off and on and sometimes gets sniffles. She was going back to work the day later this report. She asked if that was okay since she had the shot last week. The medication the doctor gave her for the UTI was Nitrofurantoin and the next day to this report was her last day on it. She was taking 1 tablet twice a day. The cough started Saturday and it was off and on. She called Doctor's office, then she guessed her assistant called back and said she should call Pfizer and where she went to get the vaccine. She should ask them if it was normal to cough this way after the vaccine. Cough started the past Saturday or Sunday, 19Jun2021 or 20Jun2021. Thursday, she had a slight headache, her muscles hurt, and a little bit of chills. She slept all day. She still had a slight headache, but she was thinking that was because of the UTI medicine which can cause some headaches. She was trying not to take Tylenol or anything because she didn't want to kill the vaccine in her. It was not like a migraine headache, and she only feel it when she was sleeping. The muscle pain and chills went away on Friday, and she had recovered completely from both. She found out she had a UTI when she had her wellness visit and they gave her blood test results. She found out on Wednesday 16Jun2021. She didn't have any symptoms, they just found it during her annual visit. Everything as far as her other results were normal. That was the only thing they found. She was hearing a lot of announcements that Covid has been reported as decreasing and how it is safe to go back to work and those who are vaccinated can have no mask. It was reported that history included that the only medicine she was taking is the one for her UTI. She wanted to call because her boss said it was worse, she would have to call her primary physician, and he said to call administration site. When she had her lab results from her annual wellness visit, they found the UTI, she had no symptoms. Event onset time (24-hour clock) for slight headache, muscles hurt, chills was reported as 1500 or 1600 and for cough was towards the evening. AE(s) did not require a visit to emergency room or physician office. Patient was not hospitalized. Relevant tests included none. Clinical outcome of the events muscles hurt, little bit of chills recovered on 18Jun2021, events of cough, slight headache were not recovered and for the other events was unknown.

Metallic taste in mouth, lasting 2-3 weeks; symptoms of Urinary Tract Infection (urgency, burning, tender bladder area, frequency of urination). No treatments were provided by my doctor.

7:00am- 1- 24 hr zyrtec & 2 tylenol 8:07 received shot 8:10 immediate intense shooting shocks through left arm down to fingertips... 8:30- shooting shocks through left arm and starting to throb down through hand ... shooting up through next and base of head 9:00am- random shocks throughout my whole body. shoulder pain. 10:30- shocks stopped somewhat, shoulder and arm still achy, extreme fatigue/weakness, fogginess, blurry vision 11:30- extreme fatigue/weakness, fogginess, kind of blurry vision, severe shaking rt hand, had to sit down. Needed to hang on to things to walk. 12:00pm- continued severe fatigue and brain fogginess & still minor blurry vision, and a few shooting shocks in arm, shoulder , neck, 1:00pm? still great fatigue/weak, body aches-more like shocks than aches Neck is especially sore? back of neck up through head 1:10pm- severe fatigue, eyes hurt, foggy vision and cannot focus? off and on? chest pain for a period of time 1:40pm- twinges through body, still extreme fatigue? fogginess, back of neck is super sore.. Shoulder is slightly sore? 2:00pm- shoulder sore, severe fatigue but other symptoms seem to be getting less?. 2:45pm- shocks in left arm? 4:00pm- went home from work? hard to drive and focus.. severe fogginess, disorientation, 4:20- laid on the couch? slept in between nausea, buzzing in my head, severe arm pain going down into my hand, random shocks throughout my body, could not focus, brain was fuzzy, random severe itching, neck pain, eye pain, extremely irritable, extremely thirsty, bad taste in my mouth, extremely cold, no fever, super sensitive to sound & touch, no appetite, trouble peeing, felt extremely dehydrated. Needed to hang on to things to walk. Fri, Feb 5 6:00am- next day? better, but still buzzing, ringing in my head, extremely exhausted & weak, arm pain radiating to hand, hard to focus, coughing, chest heaviness like an elephant sitting on it, sore, scratchy throat, drainage out of head but not stuffed up?, eyes hurt. Severe nausea & bloating, rt hand shaking badly, no appetite 9:30am- everything is a bit better, coughing & chest discomfort gone, still bad taste in my mouth, slight nausea, bloated, eyes hurt, extremely tired, entire arm sore, buzzing in my head?random twinges or jolts in my limbs? 11:00am- still super tired, still not peeing?... weird for me who pees every 2 hrs or so? Still really bloated? still buzzing in my head, 1:30pm- feeling better, no buzzing, no zinging, super tired and drinking a lot but not much peeing? 4:00pm- home and bed.. hard to sleep because of jolts though my body.. Sat, Feb 6 Normal body aches.. finally able to pee decently, arm and hand on shot side sore (this is my good hand side), shooting pain, and hand aching. Fatigue, This has continued into Monday.. arm and hand pain are off and on. Everything is getting better?

Patient had gradual onset of urinary retention and a mix of upper/lower motor neuron dysfunction. Currently going under workup for acute demyelinating polyneuropathy. Currently admitted to Medical Center, receiving Solumedrol, undergoing plasma exchange.

3/6/21 ER 59 y.o. female who presents with SHORTNESSS OF BREATH FROM NURSING HOME. EMS STATES THAT PT HAD COPIOUS ORAL SECRETIONS AND WAS IN REESPIRATORY DISTRESS UPON THEIR ARRIVAL.EMS PRE-ARRIVAL TREATMENT: IV ATTEMPTS UNSUCCESSFUL, PLACED ON BIPAP AND SATS CAME UP TO 98% Presented by EMS from facility with altered mental status confusion Desat 85 on 02 3L NC foaming at the mouth is What nursing home staff reported; EMS unable to get IV access but did apply CPAP at 10 with sat of 99%; patient will wake up with painful stimuli. Nursing Home reports patient wears BIPAP S.T. rate 20/8/10 at night and 2 hours during the Day COVID vaccination Pfizer patient received 1/7/2021 and 1/28/2021 Took insulins this morning and guaifenesin, blood sugar accu check 221 Transferred to higher level of care

?Pfizer-BioNTech COVID-19 Vaccine EUA? - Neurological issues - loss of short term memory, tremors, possible seizure, tinnitis, pressure in frontal cortex, brain fog, inability to urinate for 1 day, headache, exhaustion-constant sleeping, rapid heart rate, problems speaking-slow and deliberate, dehydration, motor skills slower, sinus's and whole brain feels dry, time going by really fast, ears hurt, teeth hurt, right and left neck hurt, left arm hurt, right shoulder hurt, hot flashes day and night. MEMORY ISSUES SUBSIDED TODAY, still brain fog, still RAPID HEARTBEAT and shaky. If all of this brain fog/rapid heartbeat doesn't subside by Monday March 29, 2021, an EEG will be ordered to look at the brain. I'm on my 2nd weeks bedrest with no exercise and Tylenol every 6 hours, the tylenol every 6 hours seems to help with some of the brain fog and the rapid heart beat, if I forget to take it I am soon reminded as my heart races and the brain fog reappears.

Urinary tract infection; She didn't know who she was or what she was doing for 3 days; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot: EN6201; expiry: 30Jun2021), via an unspecified route of administration in left arm on 19Feb2021 (at the age of 59-years-old) as single dose for covid-19 immunisation. The vaccine was not administered at a military facility. No additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). The patient had no medical history, no concomitant medications and no investigation assessment. The patient experienced urinary tract infection in Mar2021 which was considered serious due to hospitalization from Mar2021 to Mar2021 for 5 days. She was diagnosed with a urinary tract infection. She didn't know who she was or what she was doing for 3 days. She was then kept an additional two days. The patient was supposed to go back on 12Mar2021 to receive the second dose. She was in the hospital at that time and did not receive the second dose. She was asking if she needed to start over since it was past the time for her to get the second dose. The event urinary tract infection required an emergency room visit. The outcome of the event urinary tract infection was recovered on 22Mar2021 while for disorientation was unknown.

3 days after the first shot I felt achy lower back pain in the area of my kidneys. 10 days after, I felt feverish and woozy at the end of the day, and when I arrived home and took my temperature, it was 100.7. 20 minutes later, it was 101.6, which remains the highest recorded. By the time I went to bed about 3 hours later, it was back to 98.8. The next morning at 9:00 am, it was 99.9 and hovered between there and 99.3 for most of the day. By 6:00 that evening, it had returned to 97.7, which is in my normal range. I was tested for COVID during that day, and received a negative test result the next day.

getting cramps in my abdomen; blood in my urine; blood flow/ still getting dark (gross) spotting; This is a spontaneous report from a contactable consumer(patient) reported for herself. A 59-year-old female patient (Non Pregnant at the time of vaccination) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 24Mar2021 12:15 PM as single dose for covid-19 immunisation. Medical history included Graves Disease and seasonal allergy. Concomitant medications received within 2 weeks of vaccination included levothyroxine, liothyronine and seasonal allergy, etc. Allergies to medications, food, or other products: penicillin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Late night on Saturday 27Mar2021 23:45, the patient started getting cramps in abdomen, then she noticed blood in urine. Cramps subsided after Advil but work up the next morning with a blood flow. It's been 5 years since her last menstrual period, with very little spotting in those 5 years. It's been a week since the cramping and she was still getting dark (gross) spotting. This was very unusual for her body. Not sure if she should take the 2nd Pfizer shot. No treatment was received for the adverse event (except cramps in abdomen). Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of cramps in abdomen was resolved with sequel. The outcome of others was unknown. No follow-up attempts are needed. No further information is expected.

Cervical vertebra #8 through Lumbar vertebra #5 is very, very painful; in excruciating pain; muscle tenderness; muscle tightness; pain feels like someone kicked her in her kidneys; pain feels like it's punching her lungs; pain is a 10 plus in both flanks; back pain; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm right on 20Apr2021 08:26 (Lot Number: ER8732) as single dose for COVID-19 immunisation. Medical history included ongoing asthma, ongoing hypertension, ongoing mitral valve prolapse, ongoing Tarlov cysts and ongoing mobility issues and problems standing and sitting. The patient had a neurological condition caused Tarlov Cysts. These cysts populated right outside of the dorsal root nerve system. In her, it's cervical vertebra #5 all the way down her spine bilaterally. In May2018, she had a surgical procedure, not an aspiration, for 8 of the nerves in her sacrum. She has had complications ever since. Cervical vertebra #7 and #8 have been giving her the most problems. Concomitant medications included ongoing oxycodone hydrochloride, oxycodone terephthalate, paracetamol (PERCOCET) 10mg every 4 hours taken for pain, and her doctor recently changed it; ketorolac tromethamine (TORADOL) injection and something for acid reflux but she did not think that's relevant. The patient previously received the first dose of bnt162b2 (lot number: EN6208) in arm right on 16Mar2021 9:48AM for COVID-19 immunisation at the age of 59-year-old and she had no problems just soreness in her arm. There were no Prior Vaccinations within 4 weeks. She had her second Covid 19 vaccine yesterday morning, 20Apr2021. Cervical vertebra #8 through Lumbar vertebra #5 was very, very painful from 20Apr2021. She didn't know or hasn't heard if the Covid 19 vaccine is associated with her back pain. This pain that she's having now didn't feel like the pain she had related to her Tarlov cysts. Before the Covid 19 vaccine she had no problems until late last night (20Apr2021) and early this morning (21Apr2021). She was in excruciating pain. She reported it's complicated for her to make that mind adjustment. She texted her cousin this morning at 6:30AM (21Apr2021) because she had to let her cousin know what was going on. If her cousin texts and she doesn't respond, her cousin will do a welfare check. She doesn't want a welfare check so she told her cousin to just let her sleep, let her see how she feels when she's up again. She reported sometimes when the Tarlov cysts were bothering her she could lay on her back and it would soothe her pain. This time that was not working. She reported she had her vertebra and her discs and then her outer muscular system to the flank, that is where it was painful. She didn't know if this is normal. She was hearing normal side effects like tiredness and fatigue, she was not having those because she was not normal. She was 1 in 2 billion with her Tarlov cysts. She has complications with her Tarlov cysts. She has mobility issues and problems standing and sitting. She has Tarlov cysts from Cervical vertebra #5 bilaterally down. She had multiple cysts. She didn't know if the Covid 19 vaccine was aggravating her back. She reported she has 2 nervous systems, her parasympathetic and her sympathetic nervous system. She reported this is in her parasympathetic nervous system. She reported sensory, if she touches something hot, she knew it was hot. She reported this is so important. She had muscle tenderness and muscle tightness from 20Apr2021and that's it. She knew what she was taking about because she was using medical terminology. The pain felt like someone kicked her in her kidneys. The kidneys, where the waist is on her back to the top of her sacral area and up the spine to where her first rib is and go outward, that's where her pain was, from thoracic vertebra 12 to lumbar 5. The only different thing she's done was get the Covid 19 vaccine. She was trying to triage herself. She didn't know what else to do. The Percocet was not even fixing it. She wanted to make sure the Covid 19 vaccine wasn't exacerbating her disease. She thought that's what's happening. She was in a lot of pain. Her pain was the same before and after when she took the Percocet. Normally the Percocet calmed her down to where she's functional and the Percocet was not. Percocet was 10-325mg, oxycodone and acetaminophen. Take one 4 times daily as needed for pain. The Percocet was a pharmacy bottle. In order for her to have a quality of life she also took Ketorolac or Toradol. She hadn't taken that today (21Apr2021). She picked her prescriptions up at the same time she received her Covid 19 vaccine. She can lay on the ground on her back sometimes and her pain will be alleviated. Now laying on her back exacerbates her pain. She didn't know if it's muscular. If she was diagnosing herself, she would say it's not muscular. She knew enough about Tarlov cysts that she knew how to rule it out. She reported her felt feels like it's punching her lungs. She reported it's so hard to explain. She's trying to separate the pain she has from her Tarlov cysts from what she's experiencing now. She reported her pain was a 10 plus in both flanks. She stated people will call flanks "the sides". The only reason she knows it's a flank is because she had learn anatomy real quick with her Tarlov cysts. On the date of her first Covid 19 vaccine she had a steroid injection and a Toradol injection. With her second Covid 19 vaccine she had a Toradol injection. The pharmacist told her there would be no conflict in receiving the Covid 19 vaccine. she has to suffer through it until her pain subsides. It feels like it's kicking the heck out of her back. When she lays supine she can alleviate some of the pain associated with the Tarlov cysts but that's not working. She can't stand or lay supine, all of that is out the window. Meaning it's not working. This pain has to be the Covid 19 vaccine. She's in a lot of pain and she didn't need the vaccine to exacerbate her pain. There were no vaccines administered on same date with the Pfizer vaccine considered as suspect. The adverse events did not require a visit to Emergency Room or Physician Office. The outcome of events was not recovered. No follow-up attempts are needed. No further information is expected.

o ED Course Medical decision making arrival to ED 5:54 am on 5/10/21 Patient with altered mental status from an unknown cause. Her pupils were dilated and slow to react and she was in some respiratory distress and very diaphoretic. At this point airway was controlled 5 oh endotracheal intubation using the glide scope and during the intubation patient was noted for copious amounts of dark brown vomitus coming from her esophagus which was guaiac positive. Her blood pressure was low she was sedated initially with propofol etomidate was used for the intubation however because of her hypotension the propofol was slowed and she was given Versed which did seem to control her agitation and maintain her blood pressure. Patient had IV fluid initiated wide open and CT scan was obtained of head chest abdomen pelvis given the fact that her altered mental status could be from some kind of intracerebral catastrophe and the patient's abdominal exam being unobtainable certainly possible that her GI bleeding could be from a perforated viscus. CT scan of the brain does not demonstrate any stroke that appears to be acute however there may be some ischemia present although it may be remote and an MRI will need to be done when the patient is more stable. CT of the chest abdomen pelvis shows what is likely an aspiration pneumonia on the right as well as a perforated viscus in her abdomen. Radiology feels is probably somewhere in the right colon terminal ileum. At this point the patient was given Cipro and Flagyl and that should also aid with her aspiration pneumonia. Her blood pressure did start to decrease her temperature was noted to be elevated at 101.8. She was given Tylenol rectally and fluids were allowed to run wide open. Her blood pressure continued to decline and Levophed was instituted. Case was discussed in detail with surgery and she will go to the OR immediately. Her temperature continued to rise and was 104.5 upon transfer to the operating room as blood pressure was 78 systolic ED COURSE: o ED Course Medical decision making Patient with altered mental status from an unknown cause. Her pupils were dilated and slow to react and she was in some respiratory distress and very diaphoretic. At this point airway was controlled 5 oh endotracheal intubation using the glide scope and during the intubation patient was noted for copious amounts of dark brown vomitus coming from her esophagus which was guaiac positive. Her blood pressure was low she was sedated initially with propofol etomidate was used for the intubation however because of her hypotension the propofol was slowed and she was given Versed which did seem to control her agitation and maintain her blood pressure. Patient had IV fluid initiated wide open and CT scan was obtained of head chest abdomen pelvis given the fact that her altered mental status could be from some kind of intracerebral catastrophe and the patient's abdominal exam being unobtainable certainly possible that her GI bleeding could be from a perforated viscus. CT scan of the brain does not demonstrate any stroke that appears to be acute however there may be some ischemia present although it may be remote and an MRI will need to be done when the patient is more stable. CT of the chest abdomen pelvis shows what is likely an aspiration pneumonia on the right as well as a perforated viscus in her abdomen. Radiology feels is probably somewhere in the right colon terminal ileum. At this point the patient was given Cipro and Flagyl and that should also aid with her aspiration pneumonia. Her blood pressure did start to decrease her temperature was noted to be elevated at 101.8. She was given Tylenol rectally and fluids were allowed to run wide open. Her blood pressure continued to decline and Levophed was instituted. Case was discussed in detail with surgery and she will go to the OR immediately. Her temperature continued to rise and was 104.5 upon transfer to the operating room as blood pressure was 78 systolic CRITICAL CARE: o Critical Care Indication patient was critically ill... o Critical Care Indication Patient was critically ill with a high probability of imminent or life threatening deterioration. o Critical Care Time Spent 75-104 minutes (1 hour 15 minutes-1 hour 44 minutes) 2 hours and 50 minutes ED WORKING DIAGNOSIS: Perforated abdominal viscus (R19.8): Status: Active Septic shock (A41.9): Status: Active DISCHARGE/ADMISSION/TRANSFER DISPOSITION: o Disposition admitted o Admit To To OR CONDITION ON DISCHARGE/ADMISSION/TRANSFER: o Condition Critical Date of OR Procedure o Date of Procedure 05/10/2021 10:01 Pre Op Dx, Post Op Dx, Procedure o Pre Operative Diagnosis: Perforated viscus o Post Operative Diagnosis: Ischemic bowel, most likely from shower emboli. Most of the small intestine and large intestine was affected. o Procedure: Exploratory laparotomy, ICG injection for evaluation of perfusion Indication and Consent Findings: . Findings: Even after the ICG injection. There was spotty tissue necrosis from mid jejunum all the way through sigmoid colon. Most areas were blackened with a foul smell. There was some highlighted areas secondary to the ICG but not a significant amount that would lend for an anastomosis. Black ascites was present throughout the abdomen. Unfortunately after much contemplation there was no surgical intervention. Procedure Procedure: Patient was placed in supine position. Was intubated in the emergency room so, we were able to proceed with resuscitation through our anesthesia team. Patient's abdomen was prepped and draped in usual fashion. Proceeded to make a midline incision. The blood supply in the subcutaneous tissues did not even bleed. Appeared to be darkened and almost coagulated. As we entered through the fascia we were able to open the peritoneum between 2 hemostats. The large rush of free air through from the abdomen. We then proceeded to open the abdomen for the length of her incision. This was done with electrocautery. From here there was a black ascites present within the abdomen. There was a large amount of dead intestine that we could immediately see. I worked my way to the ligament of Treitz. There was no adhesions so this was easily found. That intestine did appear to be pink. It lasted for about a foot. After that area everything was either black or purple in color with a few pink spots in between. This went all the way down to the terminal ileum where pneumatosis was visualized. We then looked at the colon from cecum through rectum. It appeared to be blackened as well. Not knowing whether all of this intestine was dead or not especially with patient being hypotensive I injected ICG dye approximately 2 cc. This was to evaluate perfusion. Unfortunately perfusion was no better than what I could visualize. I could not even find enough room of the colon or small intestine to make an anastomosis. Was very hard decision, however, we did not resect any bowel. I closed the patient's abdomen. Patient will be taken to ICU on ventilator. Discussed with daughter with pastor present.

This is a spontaneous report received via medical information from a contactable consumer (patient's spouse). A 59-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729), via an unspecified route of administration in the left arm on 07Apr2021 (at the age of 59-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 10Apr2021, the patient experienced shingles and kidney function is impaired. The clinical course of events was as follows: The patient received the first dose of the Pfizer Covid-19 vaccine on 07Apr2021 and was diagnosed with shingles 3 days later (10Apr2021). The reporter stated that the patient's kidney function is impaired when the doctor ran lipid panels (unknown results) and urine panels in which the patient had "strange, high readings" on 10Apr2021 with her BUN was 26 (High), referencing at 24; creatinine level was 1.54 mg (High), referencing 1.00 mg; GFR (glomerular filtration rate) filtration rate was 37 ml/second (abnormal), referencing at >59 ml/second. The reporter stated she received more testing on 28Apr2021, in which the lab values had improved, but have not returned to her baseline on 28Apr2021 with her GFR was 64 ml/second (normal) and creatinine was 0.97 mg/deciliter (borderline). The reporter stated her GFR in November(2020) was 96 ml/second (Normal) and her lab values were all within normal range at her last doctor's appointment on 01Dec2020. The reporter states the only thing that has changed in her regimen was receiving the Covid-19 vaccine. He is concerned if his wife will make a full recovery and if her kidneys are damaged due to the vaccine. The patient has not fully recovered from shingles and still has aches, pains, and skin lesions that have not fully disappeared. He was also asking if she needs to recover fully before receiving the second dose. The clinical outcomes of the event "kidney is impaired" was resolving while the event "shingles" was not resolved.

5/16/21 Pt presented to a free standing ED with complaints of cough, body aches, nasal congestion and otalgia that started around 5/11/21. In the ED she had audible wheezing, mild tachypnea (RR19) and her RA pulse ox was 88-943%. She was placed on oxygen and found to be positive for SARS-CoV-2. CXR showed possible pneumonia and she was transferred to a tertiary care facility for admission. She was discharged on 5/21/21 Acute hypoxic respiratory failure, resolved Covid-19 Virus Infection Date of onset of symptoms: Approximately 7 days prior (5/15/2021) Symptoms present on admission: Nasal congestion, myalgias, productive cough of yellow-green sputum, diarrhea Date of covid positive test: 5/16 Vaccination status: vaccinated, received only first dose Imaging: CXR with lobar pneumonia Oxygen requirements on admission: 2 L Current oxygen requirements: None Medical therapy: Oral prednisone, not a candidate for remdesivir Inflammatory markers: CRP 18.1, ferritin 111, D-dimer 0.62, LDH 174 Community-acquired pneumonia Given lobar appearance on CXR and productive cough of green/yellow sputum I do feel it prudent to cover the patient for community-acquired pneumonia Treated with Azithromycin, Augmentin Acute on chronic kidney disease Baseline serum creatinine approximately 1.1-1.2, presenting serum creatinine 1.94 Prerenal versus intrinsic renal 2/2 infection Creatinine trending down to 1.24 at time of discharge COPD with acute exacerbation IV Solu-Medrol initially, transition to oral prednisone Schedule bronchodilators Started Symbicort per hospital formulary, and held home Flovent while hospitalized Antibiotic coverage as above

Chief Complaint Patient presents with ABDOMINAL PAIN Pt reports right sided abd pain almost to right flank area since last night with urinary frequency and soft stools x 2 days HPI Per patient during my interview: Patient presents emergency department as noted above. Patient with right-sided flank and abdominal pain since last night. Patient notes lately evening and kept her up most of the night. Notes she had difficulty sleeping or finding a position of comfort due to discomfort. Had to lay on her left side. Reports pain persistent mainly when taking a deep breath. Also somewhat tender in the right upper quadrant. No nausea or vomiting. No fevers or chills. No lower abdominal pain. Denies any urina HPI Per patient during my interview: Patient presents emergency department as noted above. Patient withm right-sided flank and abdominal pain since last night. Patient notes lately evening and kept her up most of the night. Notes she had difficulty sleeping or finding a position of comfort due to discomfort. Had to lay on her left side. Reports pain persistent mainly when taking a deep breath. Also somewhat tender in the right upper quadrant. No nausea or vomiting. No fevers or chills. No lower abdominal pain. Denies any urinary complaints. No vaginal complaints. No recent cough or URI symptoms. She works from home and denies any Covid contacts. No prior history of gallstones or kidney stones. She states she is uncomfortable however denies having taking any medicine at home. Has had normal bowel movements and did so this morning. Did not relieve her pain. Felt like she had trapped gas. Denies alcohol. She is otherwise in her baseline health. Physical exam: Constitutional: BP 126/46 | Pulse 75 | Temp 98.6 °F (37 °C) | Resp 18 | Ht 1.6 m (5' 3") | Wt 91.6 kg (201 lb 15.1 oz) | SpO2 96% | BMI 35.77 kg/m² No acute distress. Does not appear ill. Speaking clear and coherent sentences. Pleasant and articulate. No cause was found. No treatment was provided. The pain slowly went away on its own over several days.

After receiving the shot my arm was tad bit red. I felt okay at fine and 1:00am I woke up and my head was hurting terribly. I took Tylenol thinking it would help my headache. I checked my blood pressure and it was 182/118. My eyes were very heavy. When I got to work I felt so nauseous.

found on the floor between the toilet and wall.; Shortness of breath; has a cough and is bring up cold stuff; She was so sick; Diarrhea; Chills; Fever; Nausea; Headache; couldn't get out of bed; remembered getting up and going to the bathroom but doesn't remember much after that; She was told she was allergic to the shot; pain in pelvis area; she was dehydrated; she was not able to give urine; This is a spontaneous report received from a contactable consumer (patient). A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered into the arm on 01May2021 (at the age of 59-year-old) as 1st dose, single for COVID-19 immunisation. Medical history included ongoing chronic obstructive pulmonary disease for 5 years, ongoing asthma for 5 years and smoking. The patient's concomitant medications were not reported. On 03May2021, patient was reportedly so sick, she was having diarrhea, chills, fever, nausea, headache and couldn't get out of bed; the patient remembered getting up and going to the bathroom but doesn't remember much after that, her husband found her on the floor between the toilet and wall. The ambulance was called and patient was brought to the emergency room. Patient was told that she was allergic to the shot. Patient underwent MRI and X-ray to check her pelvis because she was in pain in the pelvis area but with unknown results on 03May2021. It was reported that due to dehydration she was not able to give urine on 03May2021. It was also reported that on 03May2021 she had shortness of breath, has a cough and is bring up cold stuff, that is why she was using a breathing machine. The patient received treatment for the events "found on the floor between the toilet and wall", "she was dehydrated", "she was not able to give urine" and "Nausea"; patient was kept for 12-13 hours in the emergency room treated with antibiotics and other medications. Outcome of events "shortness of breath", "has a cough and is bring up cold stuff", "headache" was recovering; events "found on the floor between the toilet and wall", "she was so sick", "remembered getting up and going to the bathroom but doesn't remember much after that", "she was dehydrated", "she was not able to give urine" and "was told that she was allergic to the shot" recovered on an unspecified date; the outcome of all other events recovered on an unspecified date in May2021. Information on the lot/batch number has been requested.

Back between shoulder blades went numb had tingling left hip and both ankles and under left arm. The pain left all areas except back. Doctor stated left side wasn't functioning; kidney function went down to 50%. Kidney function has also been increasing. Recommended not taking second dose.

Trigeminal neuralgia; UTIs; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 59-year-old female patient received the BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, at age of 59 year sold, no pregnant), dose 1 on 22Mar2021 01:00 (Lot Number: 02242639) and dose 2 on 22Apr2021 02:00 (Lot Number: EN6208) both via an unspecified route of administration, administered in left arm as a single dose for covid-19 immunization. Medical history included rheumatoid arthritis, neck issues. Prior to vaccination, the patient was not diagnosed with COVID-19. No known allergies. Concomitant medications included morphine sulfate (KADIAN); diazepam; adalimumab (HUMIRA); topiramate (TOPAMAX). The patient I had UTIs for 2 months on 03Apr2021, ended up in ER with Trigeminal neuralgia on an unspecified date. Seeing Neurologist now on many additional medications now. Still have not recovered. Since the vaccination, the patient not had been tested for COVID-19. Treatment received included Steroids, antibiotics, CT scan, face Steroids inje. The AE resulted in Emergency room/department or urgent care. The outcome of the events was not recovered.

After vaccine gained 20 pounds in a short time. Doctor checked kidney function and creatine and GFR numbers were not good. she doubled kidney meds and 6 pounds came off in a week, went back to normal dose and those 6 pounds plus 2 more came on in a matter of a few days. She has put me on double kidney meds 4 days a week and triple kidney meds 3 days of week to get the fluid overload off. She also had me consult heart doctor and they have done testing as well. She did not like the sress test results and we are waiting for insurance approval to a heart CT.

Urgent frequent urination; 100 degree fever; This is a spontaneous report received from a contactable consumer (patient) via COVID-19 Adverse Event Self-Reporting Solution. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 27Mar2021 at 14:00 (at the age of 59-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was not allergic to food, medication or any other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 14:00, the patient experienced urgent frequent urination. This was elaborated as sometimes so urgent, that was unable to make it to a bathroom, even at home. The patient also experienced 100-degree fever. Immediately upon receiving the shot, felt the need to urinate when there was no need to prior. On 27Mar2021 at 14:00, the patient underwent body temperature measurement and the result was 100-degree fever. The patient was not treated with any medication for the events. The adverse events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of urgent frequent urination and 100-degree fever was not resolved. No follow-up attempts are needed; information about lot/batch number cannot be obtained.