Pfizer

Within a few days of the first dose of the vaccine patient noticed extreme thirst, then increased urination frequency. Patient noticed unintended weight loss starting 2 weeks after first dose, and totaled 20 pounds in 5 weeks. Patient noticed some burry vision at night. Symptoms seems to lessen 2-3 weeks after first dose, but returned with increased intensity after second dose. Patient consulted a physician and lab work and blood sugar testing was ordered. Blood sugars were as high as 400 and A1C of 11. Patient went on a low extremely low carb no sugar diet for three days while waiting to see physician. Patient continued to monitor blood sugars. Blood sugars started to lower remained in the 170-260 range. Physician ordered repeat lab work and suspects Adult Onset Type 1 diabetes. Patient was placed on a long acting and quick acting insulin on 2-15-21. 23 Days after second dose.

began with dehydration - frequent urination, low fever - up all night due to stomach issues very tired all of the time, drinking unreal amounts of water developed dangerously high blood sugar over the next week - diagnosed with diabetes on March 1

After 5-6 days I broke out into sever shingles in the buttocks area, several other symptons as well like difficulty urinating, chills, migraine

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to urgent care reporting shortness of breath, cough, and chest pain. Transferred to emergency department then admitted to current facility for a management of new onset heart failure with possible etiologies of myocarditis or sarcoid. Also found to have LV thrombus, anemia, and lymphadenopathy. Patient initiated on medications to manage heart failure and anemia and anticoagulated. Patient improved and discharged to home medically stable.

Lab values came back out of normal ranges. GFR normally around 58 came back 39 on 5.28.21 and 45 on 5.29.21 and 35 on 6.10.21. Also showing elavated creatine labs. Concerned this may be vaccine related.

Patient stated he had experienced usual side effects from the vaccines including fatigue, frequent urination (every hour) and blurred vision. Those symptoms only lasted 3 days after his first covid vaccine, but persisted since he received his second dose on 6/8. He denied having shortness of breath, irregular heart rate, hives or any other anaphylaxis reactions. No new medications or health conditions as he was aware of. He will continue monitor more symptoms and he has scheduled an appointment with his primary provider in couple weeks

Extremely High Fever, Chills, Urination burning, Nausea, Headache, Sore Throat, Extreme Fatigue, Mental fog and unusual thoughts.

Hallucinated after 1st shot then blacked out. Lost control of bladder functions. Disoriented and unable to speak or hear for several minutes. Transported to emergency room. Still have hearing issues and headache a week later.

Transverse myelitis presenting with Urinary retention and hyperreflexia as well as left sided weakness. Treated with high dose steroids

Kidney Failure; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Mar2021 at 14:30 (batch/lot number was not reported) as a single dose for COVID-19 immunisation. The patient has no medical history and no known allergies. The patient's concomitant medications were not reported. Facility type vaccine was other. No other vaccine in four weeks. The patient experienced kidney failure on 25Mar2021 at 06:30. The adverse event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event), disability or permanent damage. The patient was hospitalized for kidney failure for 7 days. Treatment was received for the adverse event. The patient underwent lab tests and procedures which included Covid test nasal swab: negative on 25Mar2021 and negative on 07Apr2021. The outcome of the event was recovered with lasting effects. Information about lot/batch number has been requested.

Ive been diagnosed with ADEM by findings from a MRI inflammation of cervical spine and brain , symptoms began around a week after 2nd shot and got worse for about a month , pain in neck ,tingling though body , headaches, sunburn feeling in torso , fatigue , bilateral numbness in hands, loss of bladder pressure, erectile dysfunction

41 yo male patient with history of renal transplant on immunosuppressive therapy, diabetes, CAD, CHF, HTN, HLD, OSA presents with a 9 day history of fatigue, congestion and a 2 day history of nausea/vomiting and intermittent fevers, but no respiratory symptoms. Pt received Pfizer COVID-19 vaccination: first dose 3/18 and second dose 4/8. Pt tests positive for COVID on 4/24; CXR on 4/30 showed no acute findings. Admitted for additional hyponatremia, AKI, and hyperkalemia. Pt remained on room air. Received 2 doses of remdesivir while inpatient and felt significantly improved afterwards. He was set up for outpatient COVID follow ups via telehealth and given a COVID home monitoring kit.

My brother started with some swelling in the legs/feet, followed by chest pains that led him into a heart attack, followed by cardiac arrest. He was shocked back to life where he lay in a coma. His kidneys stopped functioning followed by his lungs and liver?he was kept alive on life support and dialysis, he died after having 4 more heart attacks back to back on June 4, 2021.

About 1-week post second injection, patient developed Pulsatile Tinnitus in (R) side. This has continued for two (2) months after the second injection. Additionally, patient has complained of excruciating headaches on the right side of the head, behind the eyes and behind the ear. Patient has throbbing head pain, and becomes lightheaded easy. Blood pressure has increased to a perceived new normal of 140/90+ on most days, even at rest. Patient is normally very active, exercising at least six (6) days per week doing cardio and strength workouts, however has not been feeling well since the second shot. Patient is very fatigued by the end of the day, which is not normal. Patient wakes up in the morning to pounding headaches, pain level 5-7, every single morning with a perceived fast heart rate. Pulsating tinnitus is very loud for patient, and he cannot hear out of that ear, and difficult to understand speech or other sounds. No change in diet, working conditions or lifestyle other than receiving the COVID-19 vaccination. Patient has been monitoring blood pressure at home with a machine and at the clinic. Average blood pressure is 143/90 with some readings as high as 160/95 and as low as 118/80 (after waking up on day 3 of a hospital stay). Patient was admitted to a hospital on 21JUN21 for abnormal ECG, high blood pressure and complaint of chest tightness, debilitating headache as well as pulsating tinnitus in head.

Started with Tingling in Upper Right Leg, Chest Pain and Shortness of Breath, Constant Headaches. Passing out, Light headed and dizziness. Joint Pain and All Day Headaches. More recently Been having Sharp pain in kidney areas and back pain and Constant headaches. Tingling throughout whole body at times.

42 yo male with history of congenital kidney disease s/p renal transplant in 1990; stable on myfortic, Neoral, and prednisone. He developed COVID symptoms on 7/15 and tested positive that day with cough, fevers, but no hypoxia or work of breathing. He completed his full Pfizer COVID-19 vaccination:first dose 2/18/21, second dose 3/11/21. He presented and was admitted to the hospital on 7/20 for abdomen tenderness and AKI. Due to his immunocompromised state, he was started on remdesivir for COVID-19.

Threads of blood discharge during urination; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the arm left on 03Apr2021 at 10:30 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. Concomitant medication was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 04Apr2021 at 13:00, the patient experienced threads of blood discharge during urination. It was unknown whether the patient received any treatment for the event. The clinical outcome of the event threads of blood discharge during urination was unknown. No follow-up attempts are needed. No further information is expected.

Scaled 0-10 Pain at the injection site (6): Can not raise left arm higher than shoulder level Fatigue (8) New or worsened muscle pain (8) New or worsened joint pain (8) Nausea (9): took zofran Vomiting (8) Fever (7): 101F: took tylenol 650 mg Q3 hours since 23:00 on 1/6/2021, 3:00, 6:00, 8:00, 11:00 Chills (8) Other: Burning on urination, eyes burning, left side face tingling,

for roughly 40 hours I experienced a fever as high as 102.9, shaking, chills, body aches, headache, right kidney pain

soreness at the point of administration of his left arm; Muscle soreness/muscle soreness at the point of injection spread to his whole body; it was like aches all over his body; Fatigue; Frequent urination; Cognitive fuzziness; This is a spontaneous report from a contactable consumer (patient) reported that a 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiration date 31May2021), intramuscular on the left arm on 28Jan2021 16:15 at a single dose for Covid-19 immunization. Medical history included attention deficit hyperactivity disorder (ADHD), mentioned he was a patient facing drug addiction counselor in training, smoke cigarettes but he has cut down to a half a pack a day, at most. The patient previously received flu vaccine on an unspecified date for flu vaccination and experienced soreness at the point of administration of his left arm. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken from an unspecified date for ADHD. The patient received his first COVID-19 vaccine this past Thursday, 28Jan2021. The next morning (29Jan2021), he woke up with real soreness at the point of administration of his left arm, well beyond what he remembered for a flu vaccine. The second night (30Jan2021), the soreness progressed. It was hard to sleep on his left arm. It was like he had been punched. He had to sleep on his right side versus his left side. On 29Jan2021, the muscle soreness at the point of injection spread to his whole body, it was like aches all over his body. The soreness has gotten a little bit better day by day. He confirmed he got a rapid nasal molecular COVID swab test because he was just covering his bases and he tested negative for COVID-19 on 02Feb2021. He also experienced fatigue. The fatigue really started to set in on Friday evening (29Jan2021), it was like he got hit by a truck. He was typically a high energy person and its very out of the ordinary for him to feel this way. He normally has class on Saturday from 9-noon but he had to cancel going with the amount of fatigue he was experiencing. He also had some cognitive fuzziness on Jan2021. His fatigue was still there, but it has gotten a little better. He was normally very high energy, but he missed two classes and skipped his internship today. He doesn't feel like himself. He also has had frequent urination which he noticed probably Friday night (29Jan2021), all the way up until now. However, he has been drinking a lot of water. The patient received a test/report showing he has no chromosomal issues and no likelihood of issues on an unspecified date. The outcome of soreness at the point of administration of his left arm and Frequent urination was not recovered; Muscle soreness/muscle soreness at the point of injection spread to his whole body and fatigue was recovering; it was like aches all over his body and cognitive fuzziness was unknown.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presents to emergency department (ED) from urgent care (UC) reporting six days of vomiting, fatigue, shortness of breath, dizziness, constipation, and polyuria starting one day after receiving vaccination. Initial vital signs blood pressure 127/96 mmHg, heart rate 119 beats per minute, temperature 35.9 degrees Celsius, respiratory rate 18 breaths per minute, oxygen saturation 97% on room air. Patient diagnosed with new adult-onset diabetes, diabetic ketoacidosis, and acute kidney injury and admitted to the hospital. Administered intravenous fluids and insulin with improvement in symptoms and lab values. Currently hospitalized.

While in waiting area client experienced loss of consciousness and seizure-like activity lasting approximately 48 seconds per nurse that responded to incident. Loss of bladder control noted. Squad responded and transported patient to the hospital via ambulance. Patient was coherent prior to transport. He states he was admitted to the hospital and Observation x 24 hours. He had a CT scan and bloodwork, both normal. Neurologist at the hospital told him he experienced syncope and no seizure activity was suspected. He states a history of feeling faint when he sees blood. He sates the Neurologist advised he get the second dose and lay down after the shot.

Patient warned us before his covid vaccine that he has a severe needle phobia and has fainted after vaccines. I gave him his immunization quickly and he did well. He stood up and watched as I immunized his wife. He said he was feeling okay afterwards so both him and his wife left the immunization room. Shortly after leaving he must have started getting dizzy, because next thing I hear is that there is an unconscious man in the waiting room. He is sitting in a chair with his head back unresponsive. His wife if rubbing his arms and lightly slapping his face. He comes to, and we decide to move him to the room that the clinic uses (we have a walk in clinic staffed with a NP). He lays on the floor, and within a minute he proceds to vomit approximately 4 times. He also lost control of his bladder. He was pale with cold and clammy skin. we moved him so we could put his feet up on a chair and allowed him to rest. Someone went to get him an ice pack to put on his head and chest. His blood pressure was low (90/50ish). He still was not feeling better after 30 minutes so we called the ambulance. He did not want to go to the hospital so the paramedics monitored him. his blood pressure slowly started going up and normalizing, and he left with his wife.

Abdominal pain; Diagnosed with Acute Kidney Failure; This is a spontaneous report from a contactable consumer, reporting for himself. A 42-year-old male patient received the first dose of the bnt162b2 (BNT162B2), via an unspecified route of administration, administered in the left arm on 13Apr2021 at 10:00 at a single dose for covid-19 immunisation. Medical history included ongoing asthma (diagnosed when he was serving around the year 1999-2000). Concomitant medications included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) taken for asthma. In Apr2021, the patient was diagnosed with acute kidney failure, which required physician office visit and emergency room visit. On 14Apr2021, the patient experienced abdominal pain, which required physician office visit and emergency room visit. As reported, he took the vaccine about 3 weeks ago and immediately the next day he had abdominal pain. The patient reported that he stopped everything when he experienced the pain. The pain started mild and then increased and he went to the emergency room. The patient wasn't admitted to the hospital but after they checked his blood and urine with unknown results, he was given an IV. When he was released he was told to follow up the next week with his primary care provider. The pain still had not gone away and was in the right side of his abdomen. The pain changed day by day. He had been drinking a lot of water and had maybe 1-2 days where the pain was worse than normal. He had been in and out of the doctor's office and his kidney levels are a little bit high on an unknown date. Every 2 weeks, blood and urine tests were taken to measure his kidney levels to see how it is doing. CAT scan was performed and did not see anything. The patient reported that something was observed in blood and urine and that's how an issue with his kidneys was determined. The clinical outcome of the events was not recovered. The batch/lot number for the vaccine, btn162b2, was not provided and will be requested during follow up.

Heart Palpitations; severe Angina was completely out of the norms; Heart Palpitations; severe Angina was completely out of the norms; Kidney Problem; This is a spontaneous report from a contactable consumer. A 42-year- old male patient received BNT162B2 (sPFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot no: EW0183), via unspecified route as dose 1, single, on on 18Jun2021 for COVID-19 immunisation.The patient had had Covid in Feb2020 and he sustained at the time that he had really severe kidney pain. The patient concomitant medication was not reported. On 18June2021, the patient stated that Within 3 hours of vaccination, he experienced heart palpitations raised, severe Angina because that completely out of the norms for him and he never had a heart problem that kind of result and he was in the Emergency Room of the Hospital The patient was out of the Emergency Room by 10 o clock (18Jun2021) but now he has same kidney problem that he had half and Year ago, severe kidney pain. He had been experiencing that kidney issue all over again. When probed for any treatment for the problems (events), reporter stated, The local Hospital said to take Ibuprofen, lots of water and bed rest but he has not taken anything yet and also on Pedialyte Electrolyte. He was released from the Hospital at 10 o clock on 18Jun2021 because the heart palpitations and severe Angina resolved itself over about the period of about 4 hours. The outcome of events kidney pain was reported as unknown. No follow-up attempts are possible. No further information is expected.

Urine is dark red, I mean like dark orange; This is a spontaneous report from a contactable physician (patient). A 43-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot/batch number and expiration date not reported, via an unspecified route of administration from 22Dec2020 to 22Dec2020 as single dose (into the deltoid) for COVID-19 immunization. Medical history included Hair loss. Concomitant medication included finasteride 2.5 mg, daily for Hair loss. The patient stated, "So, I got the COVID 19 Vaccine on Tuesday, and I had no fever or anything like that. It was the first shot I got it into the deltoid and today (25De2020), I noticed my urine is dark red, I mean like dark orange. I didn't know if it's a common side effect or not?" Physician stated, "I never had it before, it's very unusual. When asked for treatment, physician stated, "No, I didn't. Just water.". The outcome of the event was unknown. Information on the lot/batch number has been requested.

Dizziness and weakness, "Numbness and tingling; Hypertoniciy in legs, ringing in ears, riaght hand very numb, loss of bladder contorl, basically every MS exacerbation symptom I've ever had showed up simultaneously."

Patient developed acute psychosis w/ transient changes in cognition, sleep, mood, and psychomotor activity.

Fatigue, body aches, fever of 103, intermittent dizziness starting 5/6 am, all of which are significantly improved today, 5/7. By the evening of 5/6 he began having gross hematuria, which is still present. Mild bilateral CVA tenderness on exam.

Patient developed acute kidney injury 3 days after he received the vaccine. He initially presented with emesis, myalgias and weakness and then found to have acute renal failure

Gross hematuria on 20Jun2021. This occurred immediately after running ~ 5 miles. Unlikely to be related to vaccination as this AE was nearly 5 weeks after vaccination (10May2021). Reporting because an AE is an AE, not necessarily related to vaccination.

After I get the second dose of vaccine, I assume my body began it's immune response immediately. I felt fine. But 5 days later my whole body was sore as a result of inflammed kidneys. A week later my kidney function was at 18%. While I have a history of IgA nephropathy, I have no other medical conditions and had not had any kidney episodes in over 2 years (I don't get sick.) But the immune response from the covid vaccine resulted in significantly dimished kidney function - considerably worse than any previous episode. The theory is that the vaccine triggered an immune response causing IgA to build up in my kidneys at a much higher rate than any previous time.

Acute kidney failure, unspecified Hypocalcemia Hyperkalemia Syncope ARF (acute renal failure) Abnormal EKG Elevated troponin Elevated LFTs

Patient passed away on 4/13 after presenting to local hospital with near syncope and AKI. Records from local hospital are unavailable, unclear regarding cause of death and circumstances thereforth.

Awoken the very next day by body aches and headache. Weakness. Over the next day or so, started to experience light pain in scrotum area (first two weeks strong pain), and unable to empty bladder completely (always an urge to urinate even right after urinating). This bladder issue is ongoing, joint pain at times.

Patient is a 44 y/o gentleman with acute renal failure, elevated BNP and LE edema. Pulmonary consulted for medical management. Thrombocytopenia: - plt count stable today, Hgb stable - hematology consulted, appreciate recs: plan to send for serum antibodies to test for drug induced thrombocytopenia for carbamazepine and valproic acid - will hold protonix as possible offender - peripheral smear (Mercy OKC, 5/8/21): macrocytic red blood cells, moderate thrombocytopenia, rare focal platelet clumping present - less likely vaccine induced TCP---usually this is seen with the AstraZenca and Johnson and Johnson vaccine, not in Pfizer vaccine - if plt remains stable, may d/c home with plan for f/u with Dr outpt COVID-19: - case discussed with Health Department, COVID test for variant testing sent 5/6 - for now, will cont care in isolation - patient with positive COVID-19 test - positve COVID-19 test in January 2021, negative COVID-19 screen in April 2021 - pt with no active respiratory sx AMS: unchanged - waxing and waning mental status - improved AMS with improved renal fxn Acute renal failure: improving - Cr: 1.64, cont PO intake LE edema: - unchanged, low albumin levels, need to increase protein intake Chronic systolic heart failure: stable - cont to hold diuresis Disposition: - cont care in COVID unit, Pulmonary to follow Estimated length of stay is 5 day(s).

This is a 44 M with NIDDM, HTN, HLD, Schizophrenia here with c/o fever and generalized body aches for about 7-8 days. Says was having body aches for about 8 days, had COVID 19 vaccine first dose on 5/14/21. Since then, had worsening body aches and also started having fever(not sure how much). Urine color changed to brown in the past week. No change in appetite or nausea or vomiting prior to admit as per him. No new medications and does not consume recreational drugs. Not an alcoholic, no recent trauma, does not work out and was not exposed to extreme heat or cold recently. In ER, patient was found to having AKI, shock liver, CK level which is too high to be calculated, had 1 episode of high-grade fever. He was therefore started on IV fluids and admitted for further management of rhabdomyolysis. Overnight had no urine output and having poor urine output since this a.m.. Had 1 episode of nausea and vomiting this morning. No more fever since on the floor. Complaining of epigastric pain that woke him up from sleep this afternoon.

I was driving home from my town to another town. About 15 mins I thought I had to take leak and my groin area was warming up on the inside and then it started to burn up on the inside and it was painful I was thinking what could have caused and it then I realized I had the pfizer vaccine and then I have implant all of sudden I loss use of arms and it took about 20 mins for me to get use in them and then they started to burn up on the inside. Later on that night I started to cough really bad and my lungs had a hard time keeping me breathing and then I knew I had got the covid from the shot and it was much worst than the actual covid. This was the first dose of the pfizer that I got these reactions and plus I heard about how the vaccine has been sterlizing people from having kids. I knew that the pfizer vaccine is 100% unsafe for anybody to take and that it was a bad batch or wrong vaccine. But I am letting you know that you need to keep money set aside for damages from the vaccine. But please do not be like the other states giving people money, guns, trucks for getting the vaccine. I am warning people not to get it because I almost die in the first dose of the pfizer vaccine.

I was required to stay 15 minutes and was very dizzy. I was having severs pains in kidney and lungs. 7 days after vaccine I took my medication (Fasenrapen) I had been on for a year my throat swelled up.

palpitations, chest tightness/heaviness, scratchy throat/frequent throat clearing, head heaviness, blurred vision, elevated blood pressure. Evaluated in ED received solumedrol, benadryl. Discharged home and returned to hospital as direct admit due to continued symptoms. Pertinent labs reveled AKI, elevated LFTs. AKI and LFTs improved with IVFs.

45-year-old male follow-up from the ER. He received a COVID-19 vaccine on 1/22/2021. This was his first dose. He began having bilateral lower extremity pain the following evening. In addition to the pain, he has been dealing with headaches, dizziness, auditory hallucinations, and large areas of redness and warmth on the left upper extremity and bilateral lower extremities. He went to the ER on 1/27/2021. Upon review of those records, he had microscopic hematuria. The patient states that he passed some kidney stones this week. Other abnormal labs include very elevated liver enzymes which the patient has not had before. He does not drink any alcohol. No new medications. He also had thrombocytopenia. O) Gen: Patient is in a wheelchair during today's exam. This is the first time he ever been in the exam room in a wheelchair. He required assistance to stand up. He says the pain is what makes it so difficult to stand up. Skin: On the left forearm, there is a large area of redness and swelling. The redness is relatively faint. On the lateral aspect of the right thigh, there is a large area of redness and swelling which is more prominent. ASSESSMENT 1. Severe myalgias 2. Elevated liver enzymes 3. Thrombocytopenia PLAN 1. Check sed rate and CRP. 2. Recheck CMP along with viral hepatitis panel and lipase. 3. Recheck CBC with differential. 4. Further recommendations based on these results. ADDENDUM Patient called on 2/1/2021 and reports his pain is getting worse to such an extent that he has been unable to make it to the bathroom fast enough and has been having accidents.

fainted; nausea; left arm began to tingle; dizziness; Broke out in a cold sweat; chills; Lost control of my bladder.; This is a spontaneous report from a contactable consumer (patient). A 45-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL6269), via an unspecified route of administration in Left arm on 04Feb2021 15:00 (at the age of 45-years-old) at SINGLE DOSE for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. 51 hours after receiving the vaccine, the patient was sitting down watching a film. His left arm began to tingle, and he felt a wave of dizziness and nausea come over him. He stood up, walked a few steps and sat back down. He broke out in a cold sweat, chills, and saw stars. He leaned forward with his head in his hands, and apparently fainted for a moment and lost control of his bladder. All events started on 06Feb2021 06:00 PM. No treatment received for the events. The outcome of the events was recovered in Feb2021. No covid prior vaccination, no Covid tested post vaccination, no known allergies.

27 MAR: Received dose #2. Gradual onset of headache and unusually fatigued. 28 MAR: Slight headache, achy joints, sore lower back (kidneys), diarrhea, congestion and runny nose, slight fever (100), unusually fatigued. 29 MAR: Significantly improved, but severe congestion on left side while extremely runny nose on right side. 30 MAR: Regression - complete congestion (only able to mouth-breathe all day). By mid-day, achy joints returned. 31 MAR: Still heavy congestion, but able to breathe through nose. Very sore lower back. Minor achy joints. Mild sweating (with no fever - 98.5) shortly after waking up.

- In the early morning of 4/14/21 Pt called Kaiser help line complaining of cold hands/ feet, restlessness, pallor, R arm pain. - Telephone visit 4/14/21 complained of chills, nausea, vomiting, abdominal cramping, diarrhea. Fluids and rest recommended. - 4/15/21 presented to Kaiser with chest pain, shortness of breath, abdominal pain. Diagnosed with late presentation of acute coronary syndrome / anterior ST elevation MI. Echo with low EF < 25%, LV apical thrombus - 4/16/21 heart catheterization showed 100% occlusion of LAD treated with PCI / DES x 2, IABP. Endotracheal intubation for respiratory failure.

Pt presented to the hospital after a cardiac arrest. Work up showed renal artery thrombosis b/l causing renal failure and hyperkalemia. ROSC was achieved and pt coded multiple times after. We were unable to obtain CT A 2/2 to pt being unstable so only U/S imaging with doppler was used for diagnosis. Pt was treated with heparin gtt., hematology work up was sent but cause not identified. ECHO did not show thrombosis in the heart. CCRT was attempted but pt expired.

A little more than 5 minutes after receiving shot had a seizure. Told me his wife he didn't feel right and hands were very sweaty cold his eyes rolled back in head. Lost his color loss control of bodily functions( urine). Throwing up hard. EMT were called vitals were alright. Once we were home vomiting subsided and he slept hard.

No side effects after the 1st vaccine. No noticeable side effects until 58 hours after the 2nd vaccine. Fatigue most likely started until 48 hours after the shot. At hour 58 post-vaccine and for the next 36 hours: fever up to 102F, chills, cold sweat, muscle pain. Headache (pain level 4). At hour 96 post-vaccine and for the next 36 hours: urinary incontinence, cluster headaches (pain level 8, which required a tele visit and a Diclofenac prescription). An easy exercise outdoor (a walk) was attempted on day 6 after vaccine; abandoned after 0.25 of a mile due to chest tightness and a discomfort in the heart area. Slow return to easy exercises attempted again on day 8 after the vaccine. Max athletic output at 50% of capabilities prior to the vaccine. As of June 10th chest tightness and dull pain in the center/right side of the chest still experienced, which was reported to the primary physician during the annual checkup. As of June 21th chest tightness and dull pain in the center/right side of the chest still experienced; in addition ? a dull pain in the shoulder blade area when air was inhaled and held. As of June 25th max athletic output at 80% of capabilities prior to the vaccine.

Headache, full body aches, fatigue, cold sweats/chills, increased urine output and frequency. Treated with rest, acetaminophen for pain, fluid replenishment.

Bright yellow urine; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient reported received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 25Jan2021 at 46-year-old. Medical history and concomitant medication were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient had bright yellow urine after second dose of COVID-19 vaccination taken on 25Jan2021. Action taken for BNT162B2 was not applicable. Outcome of the event was unknown. Information on the lot/batch number has been requested.

46 year old male with history of depression, polio, HTN/HLD, chronic lung disease 2/2 remote PNA, and cirrhosis suspected 2/2 schistosomiasis, who presents with 1wk of dyspnea, w/ waxing waning subjective fevers. Per ED Note: Endorses chronic fatigue until 4/16 when he received first dose of Covid vaccine (Pfizer). Since then, pt reports persistent dyspnea, worsening fatigue. Reports 2 days of left-sided chest pain w/ periumbilical abd pain and enlarging abdomen. Pt believes these are 2/2 covid vaccination. Chest pain is described as constant generalized discomfort under left breast that worsens with pressure. Also worse with deep inspiration. No radiation or migration since onset. Pt describes abdominal pain as periumbilical tightness, "pain". Describes subjective, unmeasured fevers that "come and go" over last week. When asked to repeat the story of what happened on arrival to the unit, wife speaks for the patient since he is slightly dyspnic. States this morning, went to small clinic, husband had a headache and slight fever. Clinic said to come in to the big hospital. Fever and pain in legs and head, started a few days after he got the covid vaccine. The fever came and went. Didn't measure the fever. Also has some problems with Abdominal pain - doesn't know how to describe it. Feels like stomach ache. Stomach pain is getting better. Has since gone away since arriving to the hospital. He denies any cough, denies chills, denies nausea or vomiting. States he took some medications at home for constipation because he felt like he couldn't go. From the conversation it appears he does not take lactulose for HE, more for constipation. ED workup included an Xray, CT C/A/P with multifocal lung lesions suspicious for multifocal pneumonia. Lactate of 16. Na of 124. Noted to be anemic and thrombocytopenic. UA cloudy, pyuric, w/protien >100. Chest and abdominal pain resolved by the time pt was examined on the floor. Still tachypnic and tachycardic. Stated most bothersome was feeling anxious. Has anxiety at a baseline. Not complaining of any pain at the moment. Cannot describe chest pain in more detail, put his hand over the right side of his chest and presses on it but does not say if it hurt more when he would press on it, does not say it was reproducible. Not painful when he touches or presses on it now. Per chart, patient recently re-established care after long-time from follow up during pandemic. At visits last month c/o gingival bleeding, fatiguem & found to have Hgb drop from 13 in 2018-> 9.7 on 3/2/21. Referred for EGD but cancelled due to anxiety. I am the Infectious Diseases attending asked to see him for septic shock. He developed septic shock and respiratory failure requiring mechanical ventilation and 3 vasopressors. He has evidence of DAH, DIC, acute renal failure, progressive liver failure and he has Klebsiella pneumoniae bacteremia.

transverse myelitis - potentially related to immunosuppression from Humira, the herpes simplex virus or the vaccine (or combination of all 3). Sx included areflexia, bilateral paresthesia (legs and feet), double vision, cord damage from cervical region to conus of the cord. Also developed urinary retention.

1st vaccination date: 04/10/2021 2 Kidney stone 6 days after vaccination. Both stones passed with severe pain within 12 hour of each other. 2nd vaccination date: 05/01/2021 at 9:30 AM 2 kidney stones on 4 days after shot. first with mild pain. 2nd with severe pain and bloody urine. 1 kidney stone passed 6 days after shot with mild pain. No stones required hospitalization and passed at home. No further pain at this time - will continue to monitor. Only 2 prior events of kidney stones in 2017. NO other kideny stone events during lifetime.

NORMAL COMMON SYMPTOMS FIRST THREE DAYS, EVERY 4 OR 5 DAYS FLU LIKE SYMPTOMS NO FEVER. WEEK THREE HIVE LIKE BUMPS ON BOTH ARMS SMALL BUMPS ON FOREHEAD, LOSS OF APPETITE, KIDNEY, LIVER PAIN, BACK ACNE. COGNITIVE CLARITY LOSS.

chills and uncontrollable shakes, no fever initially; within a few hours temp was 101.6; cultures and labs showed urinary tract infection; sensitivities showed resistant to rocephin and ceftin; bactrim didn't prove strong enough; improvement finally began with levaquin; fever persisted 8 days; ibuprofen was required around the clock

Dose 1: 4/10/21, Dose 2: 5/3/21 hx obtained 6/24/21: per wife: was out of town, came home 6/13. 6/17 went to casino, came back 6/18. ate a bag of sausage. dog bite that Friday. stomach felt weird. 3 days of HA, stomach ache, vomiting started Monday, went to urgent care the 21st - noticed some nystagmus, given tdap, given meclizine. was told if still not better, to ER. ER yesterday - was told dehydration, got IV fluids, got zofran IV, no imaging, had bloodwork and urine (WBC normal, h/h normal, abn neutrophils/lymphocytes. normal CMP), per wife was told blood in urine. since yesterday, continued HA, nausea, vomited in ER x 1. after zofran no vomiting today was ok, was getting out of car, felt like tripped, then almost fainted. no head trauma, no LOC. heaving. no chest pain, no shortness of breath, has not eaten today. Did take Tylenol today. 325 mg x 1. and ibuprofen 200 mg x 1. 730 am. since out of town, has been drinking couple drinks per day. marijuana gummies. marijuana from dispensary. no other drugs, no cigarettes. no hx of HA or lightheadedness sometimes when flying gets sinus HA on landing. no fever did have 99F when sleeping/hot, normal since then no blood in stools. primary sx is HA - constant throbbing 10/10 (currently 6/10) b/l frontal HA, nonradiating, better with lying down. +light sensitivity. no sound sensitivity. +nausea, +vomiting, several times per day. 2 episodes in 24 hours. no abdominal pain. has had lower back pain. tolerating PO. has had zofran and Tylenol. 2 days ago also had meclizine x 1. per pt always had low HR. no other changes to diet/medications. no facial droop, no one-sided weakness no speaking nonsense. several weeks ago "my heart felt like constant adrenaline" thought was stress - felt like something scared you adrenaline, lasted several days, coming on for several minutes at a time. last dose tadalafil was 1 week ago Pt sent to ER after this visit, but was then discharged home. pt presented to urgent care couple days later and was transferred to hospital after findings below

Swollen under arm and a knot/upper part of shoulder and chest area was swollen.; Nauseated; Real dehydrated; Kidneys started hurting and felt like kidneys were overworking; Mouth dry; Kept having to go to the restroom; Kept using restroom and had to pee a lot; He is a little sore, but the pain is not as bad; Pain in kidneys woke him up from sleep.; Arm is still swollen but swelling went down; red spot under his arm that looks irritated; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received bnt162b2 via an unspecified route of administration in upper right arm on 02Jan2021 between 07:00-07:30 at single dose for covid-19 immunization. Medical history: None. There were no concomitant medications. The patient experienced swollen under arm and a knot/upper part of shoulder and chest area was swollen on 03Jan2021 18:00, nauseated, real dehydrated, kidneys started hurting and felt like kidneys were overworking, mouth dry, kept having to go to the restroom; kept using restroom and had to pee a lot, he is a little sore, but the pain is not as bad, pain in kidneys woke him up from sleep all on 03Jan2021. Got COVID Vaccine on Saturday. Was swollen up under arm. Over kidneys, started hurting. Swelling went down. Took Naproxen and Ibuprofen. Mouth was really dry. Felt like kidneys are overworking. Keeps drinking water and going to the restroom. Kidneys started hurting. Received through work. Employed at a mental health and mental retardation school. Arm swollen with a knot. Got off Sunday morning, 03Jan2021. By 18:00, under arm was swollen. Thought he slept wrong or he had an issue with an artery. Under arm and into upper part of shoulder and chest area was swollen. He was nauseated. Felt really dehydrated. Kidneys started hurting. Felt like kidneys were overworking. Felt similar to when he previously had a kidney infection. Knew something wasn't right. Kept using restroom and had to pee a lot. Kept drinking. Kidneys were hurting from 03Jan2021 to yesterday. He is a little sore, but the pain is not as bad. Was drinking water, cranberry juice, and orange juice to flush the COVID vaccine through. Pain in kidneys woke him up from sleep. Is a little swollen. Pain is better than what it was. Between 02:00-03:00 it was done. Swelling was really bad. Start taking Naproxen and Ibuprofen. He was hurting too. Arm is still swollen but swelling went down. There is a red spot under his arm that looks irritated. Supposed to receive second COVID Vaccine on 30Jan2021 but was not going to take it. Clarified he took Naproxen with Ibuprofen in it for the anti-inflammatory. Confirmed he was only referring to one product. Naproxen was just bought from the store. Unable to provide NDC/Lot/Exp because he does not have product at time of call. Formulation: 200mg per pill, took two pills then six hours later took another two for Voluntary; high number of COVID Cases at his work. Scared to take second COVID Vaccine. The patient underwent lab tests and procedures which included Covid Test: unknown results on an unspecified date (He has to take COVID tests twice a week). The outcome of events was unknown. Vaccination Facility Type: which is a mental health and mental retardation school. He has to take COVID tests twice a week. No additional vaccines administered on same date of Pfizer suspect. The event was not required a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. Prior vaccinations within 4 weeks was none. Adverse event follow prior vaccinations was none. Relevant tests: none. Information about Lot/Batch number has been requested.

About 4 am the night after the vaccination, I developed significant left arm pain. Hurt; throbbed and didn't want to use it. Went to work but about 7:00 am- I noticed my right arm began to work as well - almost in the the same severity. Spell- lose consciousness alost- had bad headache; - it abated and it happened again - almost lost consciousness. It left. And it happened again a third time and went to a stretcher - nurse took my BP 220/110 - blood pressure - very high for me and laid on the stretcher and had nurses hook me up ot monitors; No change on cardiogram and my oxygen saturation level never altered and never dropped; My BL remained elevated - significantly. 180/90 before I went home. Continued to check my BP when I went home - queasy; nauseated - upset stomach and then fever the following day - remained for 4-5 days. Fever was one day and got 100.5 and then was gone after that day. BP continued to check regularly through next few days - it did improve a bit but was still elevated - 180/150 (systolic) and 110/95 (Diastolic) - Slowly got back to normal by day 7 after vaccination. Went to work the 30th the day before New Year's Eve, finally and had dizziness never got quite as severe - 50% but left arm pain very very painful - almost numb; right arm hurt some, too. Blood 190/110 .Oxygen Saturation remained good. Arm pain very bad - ordered EKG - was normal Admitted my self to ER - Had a full work up - repeated EKG - negative; two sets of troponins - negative; chest x-ray - nothing - BMP - elevation in my creatine which I've never had before. CBC - normal; They treated me with fluid hydration; Tylenol; fentanyl and hours later I felt a bit better. Things calmed down and I was released. BP remained elevated for next two days. I got better after two days _ enough to work - but still would get a little disequilibrium not enough to pass out but just like an odd feeling and then it would go away after a few seconds. And that is only recently disappeared - within the last week or so. I feel better now but my BP remains elevated - 160/140 (systolic) over 105/95 (dystolic) - that's al new for me. I have declined the second vaccination. Have sort of recovered but it did come back after time and so it may come back again - don't know. I may have been exposed to COVID the week before my vaccination. About 4 days after the severe symptoms that lead to my leading to take off work; I took test for COVID - PCR at CVS (returned positive) and COVID test PCR and rapid antigen (returned negative) at Public Health -

Patient reports receiving first dose of COVID-19 from Hospital (was not given vaccine card as their policy is to wait until after second dose). The day after vaccination, patient was complaining of fatigue with subjective fevers and rigors with associated headache and neck stiffness and on the day of presentation he complained of increased fatigue and general malaise for which he left work early and was ultimately found poorly responsive in his private vehicle with concern for possible seizure activity. He was brought to ER by ambulance. He reported numbness in hands and legs, rigidity, and an episode of urinary incontinence. He was started on empiric antibiotics for possible CNS infection, lumbar puncture completed. Found to have acellular CSF and antibiotics were discontinued. Patient remains in hospital at this time with course complicated by post-LP headache.

3/31 pt call: Pt states he's has progressively worsening nausea for over a week. Woke up this morning and could hardly get out of bed. Denies abdominal pain but feels nauseated and has been vomiting off and on all day. No other GI sx. Pt has known hiatal hernia but doesn't take anything for GERD right now because he doesn't have heart burn sx. Denies chest pain. Gets sweaty randomly and chilled, but this is more chronic. Sees neuro for early onset parkinson dx but no change in medicine in over a month. No new supplements. Denies dark stools. Pt taking all his medications with compliance. Has been getting more headaches lately too but thinks this is stress and from wretching. Has chronic headaches. Pt has OSA and has been wearing his Cpap with compliance. Gave patient zofran, prilosec, carafate for suspected gastritis sx. Recommended he come get labs in the morning as well. Pt agreed. 4/1 ER HPI: 47 y.o. male who presents with complaints of nausea vomiting abdominal pain ongoing now for the past day reports that is better with rest worse with movement denies any other complaints issues 4/1 Admission HPI: 47 y.o. male that was recently diagnosed with Parkinson's disease. He presented to the emergency room with the a several day history of fluctuating blood pressure and nausea/vomiting and generally feeling very poorly. He has been having a lot of new onset health issues lately and so his wife and family were concerned. He was brought into the emergency room. He denies any severe abdominal pain. However, he states he has been feeling extremely nauseous. He is vomited at least once a day for the last 5 days. He does admit that he is under an extraordinary amount of stress between his new onset Parkinson's, his insurance business, and his full-time job as a pastor. The patient also does have a history of alpha-gal allergy. He states it is possible he ate some cross contaminated meat, but states that this nausea and vomiting does not act like his typical response to eating something that he is allergic to. The patient states that about a month and a half his neurologist did increase his Requip up from 0.5 mg 3 times a day to 1.5 mg 3 times per day. However, it has never made him nauseous before. He denies any definite chest pain. He denies any exertional dyspnea. He does admit that his blood pressure has been fluctuating for quite some time. He states he was having a skin biopsy done last week and they almost abandon the procedure because his blood pressure was so high. He currently takes a combination of Benicar and hydrochlorothiazide. In the emergency room his lipase was found to be a little bit elevated. Creatinine was found to be a little bit elevated. His blood pressure was very elevated in the systolic 170 range and he did require some IV labetalol. The patient states he really has not missed any doses of his medications.

Patient experienced abdominal distention about a week after receiving the COVID vaccine, with progressive jaundice, feeling unwell and eventually went to the hospital, found to be in cardiogenic shock with bi-ventricular failure, acute liver failure and acute kidney failure. Currently still hospitalized for workup of his cardiomyopathy.

Pt complained of blurry vision for four days, went to Urgent Care. At UC, blood glucose was >600 and pt stated that his PCP was investigating possible type 2 DM. Pt was sent to ED. Blood glucose 652 in ED. Pt admitted to hospital with dx hyperosmolar hyperglycemic state.

Pt describes feeling unwell that night, nausea and vomiting next day, general body aches, hypothermic, 3 days later seen in ED, hypotension, septic shock, and DKA/AKI. Also noted to have mild prominence of right oropharyngeal well with normal epiglottis and larynx on CT. There is noted uvular edema of unknown etiology

difficulty walking; headache; chills; aching of bones; tiredness and weakness; tiredness and weakness; loss of weight; loss of appetite; my joints got pain; it's the pain at the injection site; Muscle pain; Fever; Nausea; Feeling unwell; Restless; congestion; dizzy; swollen; constantly using the bathroom, having bowel movements; peeing a lot; can't stand up; I can't get out of the bed; my legs are so weak; I can't even stand now; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0191), via intramuscular route of administration in right arm on 01Jun2021 at 01:00PM as single dose for covid-19 immunisation. The patients medical history included large prostate, gold stones in 2014, high blood pressure, operation on Gall Bladder (gall stones that were in gall bladder in 2014). Concomitant medication included lisinopril (20 mg, 1xday) for blood pressure measurement. Patient had the Pfizer covid vaccine on 01Jun2021. Patient went to get the Moderna but he got the Pfizer. Nurse told him that everybody was different, and it work in different kind of ways and she said that once he got the vaccination to fight the COVID, it just maintains that. On 03jan2021, Patient did not get out of the bed, he became dizzy, weak, his legs were so weak, lost massive weight (dropped to 145kg/2 pound) and the pain at the injection site, feeling tired, had a headache, got muscle pain, had the chills, joints got pain, bone aches. He had a fever, nausea, congestion, feeling unwell, swollen, was restless and pain to walk. He did not stand up. Took tylenol (spoonful, once a day, orally) for the headache and the fever. Had also been using the bathroom a lot. his most recent weight was 135 after he took the shot at 1:00pm on 01Jun2021. On 22Jun2021 to patient has get the second one but did not feel like taking it. Patient did not had any prior vaccinations within 4 weeks. The outcome of the event cannot stand was unknown and other event was not recovered. Information on Lot/Batch number was available. Additional information has been requested.

Noticeable jaundice "yellowing" of the skin and sclera within 6-8 hours of first dose, and darkening urine color within 24 hours of the first dose

It started with three days of mild fever and then on day four 02/08/2021. I lost function of my muscles, I couldn't walk, I couldn't lift my arms, I couldn't chew and my kidneys shut down and quit working. My blood pressure was 80/50 at the hospital. There is a heart enzyme troponin its supposed to be 4 if it reaches 40 you're having an active heart attack and mine was 37. I was in the hospital for four days. In a weird series of events during this time they found some heart conditions that I had. Had I not been hospitalized they would have never found these heart conditions. The condition I had was similar to the reaction I have had to steroids before hence why I don't take steroids.

I was urinating bright red blood. This was not dark urine, it was blood that was seeping through my underwear. No other symptoms to report.

On 3/24/2021 about 1 hour, after I received the shot I started to have lower stomach cramps, they got more server as the night progressed. I could not sleep with the pain. Then on 3/25/2021 at about 2 am in the morning I started getting a headache while still having stomach cramps. At about 7:00 am I had a fever of about 99.5 degrees then at about 11:00 am I had a fever of about 100.2 degrees and the stomach cramps were still there. I drank lots of water and Pedialyte to stay hydrated but had a very difficult time urinating. it was very little. At about 10 pm the cramps started to subsided but were still lightly present. my appetite went to almost nothing but soup for 2 days, I have had leg and arm cramps off and on during this process as well. I did not want to eat. today 3/27/2021 is the first day I have started to feel normal.

Patient experienced acute atraumatic rhabdomyolysis with paraspinal myositis as well as secondary AKI requiring dialysis. Patient initiated on dialysis 4/16 and continued onto discharge.

-Presented to ED with complaint of fever onset yesterday. Had the 2nd COVID-19 2 days ago. He has been having fever since yesterday morning running 102.7-103.9F. Called PCP and was advised to present to the ED yesterday but he did not. He fell after losing his balance today. Endorses nausea, confusion. Has extensive medical history. Patient has signs of sepsis with likely bacterial infection acute cystitis/pyelonephritis. His lactate and procalcitonin are unremarkable and vitals remained stable however he does have an elevated total bilirubin as a possible sign of a more serious systemic response. The patient does have chronic cirrhosis and persistent fever and tachycardia. Given these clinical findings he is referred for admission for IV antibiotics and further close monitoring. Unfortunately, urine cultures were not sent. His blood cultures however did grow 2 of 2 bottles positive for Klebsiella pneumonia. These are both sensitive to Levaquin. In the course of his hospitalization, he has improved. He is now requesting discharge. Will discharge home on p.o. Levaquin. Is discharged in improved condition.

Severe pain left kidney (left side), Moderate to Severe Kidney (Right side); This is a spontaneous report from a contactable Other Hcp. A 48-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: eh9899), via an unspecified route of administration, administered in left arm on 29Dec2020 (at the age of 48-year-old) as a Single Dose for covid-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to COVID Vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. After the vaccination the patient tested for COVID-19. The patient past Medical history included Type 1 diabetes mellitus. Concomitant medication included insulin lispro (Humalog), Ramipril, Carvedilol and Atorvastatin. There were no allergies were reported. on 01Jan2021,3Day after the administration of vaccine the patient experienced severe pain left kidney (left side), moderate to severe kidney (right side). No seriousness criteria were reported. Therapeutic measures were taken. The Lab test includes: CT scan (computerized tomogram): Result was Pending. On 29Jan2021 Nasal Swab (SARS-CoV-2 test) result: Negative (Lumiradx-SARS-COV 2 AG Test). The patient received second dose of BNT162b2 (Lot number: EL3246), via unspecified route administered on left arm on 19Jan2021. The even outcome was Not recovered. Follow-up attempts are completed. No further information is expected.

Bladder problem; Cystitis; He has been really sick for 3 months after the second dose; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 03Apr2021 (Lot Number: ER8735) (at age of 48-year-old) as 2ND DOSE, SINGLE for covid-19 immunization. Patient took the first dose of vaccine on 15Mar2021 (Lot Number: EN6204) (at age of 48-year-old) for covid-19 immunization, no reactions until the second shot. The patient medical history was none. Family Medical History Relevant to AEs was also none. Concomitant medications were not reported. Prior Vaccinations (within 4 weeks), there was no other vaccinations. The patient experienced bladder problem (hospitalization) in Apr2021 with outcome of not recovered, cystitis (hospitalization) in Apr2021 with outcome of unknown, He has been really sick for 3 months after the second dose (hospitalization) in 2021 with outcome of unknown. The second shot was on 03Apr2021. Bladder problem was two weeks after. It was 3 months back from this date. It was ongoing, his quality of life was gone. It was persisting. He sought out treatment from anywhere and everywhere he could. He has a bladder problem and he has several problems he didn't have before. It created what they call cystitis he thinks its IC for men. Cystitis stated the same time. It has worsened. Treatment was reported as "Yes, no just leave it at that". He has been really sick for 3 months after the second dose. The adverse events resulted in Emergency Room Visit and Physician Office Visit.

My first symptoms from COVID developed in Apr 2020 after having been presumed positive with COVID. I had never had problems with nausea before, but have needed nausea meds ever since for every meal since that time. No change since then. Vaccine dose 1 given Mar 18. On Mar 24 began having body temperature regulation issues. For example my feet would be freezing and buzzing, similar to restless leg/body, but my upper body would be so hot I couldn't rest my hands on my chest. This happened every time I would lay down. Walking around or sitting up made it netter, but laying down the symptoms would begin quickly. This made it impossible to sleep without taking some type of strong medicine that would relax my body enough to even it out. Luckily I was taking morphine for back pain and that seemed to help. Normal OTC pain killers would not make any effect. This still occurs nightly, or even daily if I'm trying to nap during the day. Without morphine or something similar in my system at the time my body temperature and buzzing / restless body feeling continues. On Mar 27 I began experiencing a worse inability to stay asleep than I have ever experienced. This continues to this day. I awake every hour to an hour and a half regardless of how exhausted I am. Without a significant sleeping pill, which I am not currently prescribed, I cannot remain asleep through the night. Xanax has helped but does not always keep me asleep. I am still searching for a sleep doctor to assist to help address this sleep issue which was largely controlled by my CPAP once I finally was diagnosed and treated with sleep apnea. But now I am having nightly issues of awakeness, what appears to be called "coronasomnia" in some places, which makes me exhausted during the day. Finally, I ended up in the ER for kidney stones on Apr 8, the day I was scheduled for my second vaccination shot. I have never had kidneybstones before. Though I understand they would not develop so quickly, I understand there have been many reports of kidney stones making themselves known shortly following COVID vaccinations. I have not received my second vaccination and do not plan to do so given the effects I've had so far.

Hematuria, Blood in urine. Initial signs on 2/28, urine orange Most severe on 3/1, urine red Symptoms tapering urine tinged light brown/yellow, pushing lots of water on 3/2. Discoloration not visible on 3/3, but blood detected during Dr. appointment. (See Item 19)

Had a very strong erection through night most of the morning; Very horrible side effects; very unusual side effects, Was pretty crippling; Lost my voice; Left groin is terribly painful; I go urinate and it would come back; was very really weird; Groin is so tender; Leg is uncomfortable; couldn't walk/Balance was off; I was on the floor; couldn't even make me anything to eat; Lethargic; I pee pretty frequently; Head, the base of head is very uncomfortable; Had sweats last night really strong; Couldn't sleep; Left buttock and all the way down to my toes was extremely painful; Body aches and chills; Glands swollen; Headache; Sick most of the day; This is a spontaneous report from a contactable consumer. A 49-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 19Feb2021 15:00 (Batch/Lot number was not reported) at singe dose for covid-19 immunisation. Medical history included genital herpes, TBI (Traumatic brain injury), chronic laryngitis, low blood pressure, seasonal allergy, appendix taken out, sinus surgeries, no sense of smell, tonsils removed, allergy. It was reported that he got her vaccine (unspecified Vaccine) Friday afternoon at 3 o'clock pm mountain standard time. He was fine on Friday and Saturday, he was horrible, very horrible side effects, that's why he thought he need to call, very unusual side effects he had typical, he was really struggling to talk today. On on 19Feb2021 23:00 he lost my voice, my glands were swollen, body aches he experienced. He got my shot in my left arm, my left buttock and all the way down, all the way to my toes was extremely painful and it cuts through my groin area. My left groin which is terribly painful. patient left buttock, all the way down to the toes extremely painful and that continued into my groin. And he had erection, he had a very strong erection through night, most of the morning. He go urinate and it would come back that was very really weird. That was when he knew it was really weird. And he knew that Pfizer was the one that makes Viagra. And my groin is so tender. When he pee, he pee pretty frequently. He think that was the most unusual side effects. His head, the base of my head was very uncomfortable. He had sweats last night really strong. Today, he woke up, he could not sleep, he went to the bed early. He had no energy today, he was doing a lot (not clarified over the call). He do have a headache today and obviously my voice hasn't come back completely and my leg is uncomfortable, he couldn't walk he was like if he was drunk yesterday, he couldn't, my balance was off. He was on the floor. He couldn't even make me anything to eat. It was pretty crippling that it made me feel like. He was very lethargic and he was sick most of the day. he was just hoping to give you information. He waited for long time on the phone to share experience. I hope this information helps you, I mean the other people if having the same problems or maybe not. Consumer also stated, he cannot locate the card that was given to me. He could not locate today. He was doing my laundry today maybe it is in my pocket. he dig into my pocket, he guess could not find it. They gave me card but he was not sure if he had it. Date when started experiencing the events: Consumer stated, I would say the date of the vaccine 19Feb2021. It probably towards the evening, I would say late at about 11 o'clock. Still experiencing Consumer stated, I am experiencing mild headache. I am experiencing dull pain at the base of my neck. I am experiencing the tenderness in my left groin. I am experiencing a little pain when I pee. I am experiencing a little bit of body aches, chills. I haven't fully gotten my voice back. I feel so sick. The erection has subsided but my penis is painful, it is uncomfortable. For treatment Consumer stated he did today he took this afternoon about maybe 3 pm, he took 4 Ibuprofen. Outcome of the event had a very strong erection through night most of the morning was recovering, outcome of the events lost my voice, left groin is terribly painful, groin is so tender, left buttock and all the way down to my toes was extremely painful, body aches and chills, headache not recovered. Outcome of the other events unknown. Information about lot/batch number has been requested.

Thrombocytopenia (CMS/HCC) Hypomagnesemia Alcohol abuse Alcoholic hepatitis Hyponatremia Renal insufficiency Symptomatic anemia

Mild headache about 2 hours after shot; increased urination about 2 hours after shot and continuing at least 2 days; soreness; tiredness; groggy

3/30/21 at 1:30 am until 4/1/21 approximately noon: 103 F fever, chills, joint aches, extreme fatigue, loss of appetite, difficulty sleeping, headache, brain fog. 4/1/21 until present: tachycardia / racing heart rate as high as 125 bpm, feeling flushed as though I have sunburn but without any sun exposure, forgetfulness / trouble focusing / brain fog , Insomnia and frequent awakenings from sleep, feeling dehydrated and head achy or thirsty frequently, more frequent than normal urination, urine clear or pale yellow.

Starting night of 2nd vaccine, started having low grade fever, fatigue, arm pain. Continued for an additional day. Started experiencing lupus flare symptoms 3 weeks after 2nd vaccine - rash, hair loss (alopecia), joint pain/swelling, low grade fever, worsening kidney function (elevated proteinuria). Continued to have symptoms for 2 months - led to change in medications with rheumatologist.

The patient experience a vasovagal reaction approximately 8 minutes after his injection. He reported he felt fine, then started feeling dizzy, then fell out of his chair in the waiting room after passing out. He came to quickly. He looked pale and had lost control of his bladder. After a few minutes his color returned and he was able to sit up. His blood pressure, taken about 4-5 minutes after his incident, was 141/78. He returned to a chair where he waited an additional 10 minutes before leaving.

R34 - Oliguria R79.89 - Elevated serum creatinine N17.9, N18.9 - Acute renal failure superimposed on chronic kidney disease, unspecified CKD stage, unspecified acute renal failure type (CMS/HCC)

Patient readmitted on 5/19 who was just discharged on 5/15. Patient initially presented with fever, SOB, lymphadenopathy, diffuse maculopapular rash. He had his first dose of COVID vaccine (Pfizer) on 4/23, and his symptoms began on 4/29. He was itchy all over, but when he developed fever and SOB he came to the ER on 5/2 and was discharged on prednisone. His symptoms continued and so he came back to the ER and was admitted. He had a lymph node biopsy to rule out lymphoma (pathology returned negative for lymphoma). He was treated empirically with ceftriaxone and doxycycline. He tested + for EBV IGG but not IGM. EBV PCR was pending upon discharge. He had a borderline positive lyme serology. He was discharged on doxycycline and steroids with improved symptoms. He returned to the ER with again worsening SOB, night sweats, worsening rash, recurrence of fever. He denies sore throat or any sick contacts. He reports a normal appetite. He was found to be hypotensive and in AKI.

Post vaccine #2 on 5/18 he developed hives, shortness of breath and reportedly did not feel with fatigue. Symptoms worsened and he was admitted to ICU on May 21st via the ED for multiorgan failure including respiratory failure with R pneumonia, Shock, Renal failure, Disseminated intravascular coagulation, shock liver failure requiring invasive vent support and treatment for septic shock including vasopressor support and antibiotic therapy. He was started on CRRT on the 22nd. His INR continues to rise and Hb dropping consistent with worsening DIC. Blood cultures are positive for MRSA. He will likely die from progressive septic shock and MSOF.

One I got my initial shot on 3/23/21 I had a metal/chemical taste in my mouth that went away in about an hour. After I received my 2nd shot on 4/13/21, I have had the same metal/chemical smell and taste since and it it more noticable on certain drinks and foods. Also my urine has this strong smell and dark and cloudy.

hypotension; acute renal failure; fever; rigors; persistent rash; He had an IgG and PCR positive for EBV; This is a spontaneous report from a contactable pharmacist. A 49-years-old male patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine), at the age of 49-years-old, via an unspecified route of administration on 23Apr2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Pharmacist stated that a patient received the first dose of the Pfizer Covid-19 vaccine on 23APR2021 and a week after he presented fever, rigors and persistent rash. He was the discharged and then presented acute renal failure and hypotension on 19May2021. He had an IgG and PCR positive for EBV. Pharmacist would like to know if there are reports of EBV (Epstein-Barr virus) reactivation. They have a patient who was admitted to the hospital and was wondering if Pfizer has any reports of reactivation of EBV after receiving the vaccine. She is not sure if it is related to the vaccine or not. The first hospital admission was because of continued fevers, rigors and rash. Patient received first dose on 23 Apr 2021, and then rash started on 29 Apr 2021. It is unknown when fever and rigors started. Patient was readmitted for same thing and is sicker. She then clarified that this admission was for hypotension with acute renal failure. The patient is now in ICU. The rash is still there and it is worse. The patient still has fevers. Reporter seriousness for Persistent Fevers, Rigors and Rash: Hospitalization. Patient was in hospital for Persistent Fevers, Rigors and Rash from 2 May 2021 to 15 May 2021. Reporter seriousness for Hypotension and acute renal failure: Hospitalization. Patient was in hospital for Hypotension and acute renal failure from 19 May 2021 to Ongoing. Event outcome of fever and rash was not recovered, the other events was unknown.; Sender's Comments: Based on the narrative information provided and the known drug safety profile, the reported events Pyrexia, Chills and Rash are considered as related to bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine). A causal association between the reported events Hypotension and Acute kidney injury and bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine) cannot be totally 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 RAs, Ethics Committees, and Investigators, as appropriate.

SMV: Pfizer Dose 1 (EN6206, exp 6/30/2021) on 3/25/2021 SMV: Pfizer Dose 2 (ER8731, exp 8/31/2021) on 4/15/2021 Symptom onset 06/10/2021 (same day as admission to inpatient) of sore throat, fatigue, cough, nausea/vomitting, and headache. Hospital records request shows treatment for DM2 uncontrolled with hyperglycemia, AKI, Dehydration, and uncontrolled hypertension. COVID Pneumonia listed as active diagnosis: 1 dose of dexamethasone on June 11, 2021 and then dexamethasone was discontinued. Patient is also not on remdesivir. Patient denies shortness of breath or cough.

Had a vaccination in the morning. Took a nap before work that evening and woke up with a nose bleed. That night discovered blood in the urine.

Woke up with a nose bleed that afternoon; discovered blood in the urine; This is a spontaneous report from a contactable nurse. A 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EK 4176, intramuscular, in the right arm, on 02Feb2021 09:00 at SINGLE DOSE for covid-19 immunization. Patient has no relevant medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported. On 02Feb2021,the patient woke up with a nose bleed that afternoon then went to work that night and discovered blood in the urine. The outcome of events was unknown. The patient did not receive any treatment due to the events. Follow-up attempts are completed. The information on the batch/lot number has been obtained.

First: I had the coronavirus infection at the end of December/beginning of January. Second: I received my First dose of the Pfizer shot on May 24th. Got a fever and body aches for about 24 hours. Thursday June 24th: T-0: Received PFIZER-BIONTECH COVID-19 VACCINE (Link is to the Pfizer Factsheet) T-11.5: Began having fever of 100°F and chills. Took a dose of Nyquil. T-14: Woke up in a daze and was half sleep walking around the room. While walking around in the room I passed out and fell to the floor. Was out for about 10 seconds. My wife woke me. I then passed out a second time and experienced a mild incontinence for about 15 seconds, came out of it and then went to the bathroom. When in the bathroom I passed out on the toilet for about 30 seconds, I experienced incontinence of everything left in me, bowel and bladder, I experienced convulsions and altered state(thousand yard stare). When I came too I began vomiting and had extreme body shakes. Some of this information was relayed to me by my wife obviously. T-15.3: Arrived at hospital and during check in I had another episode. (15 seconds) T-25: In hospital bed I had another episode duration unknown, no one saw me go out but I recall regaining consciousness. T-29: In hospital bed I had another episode duration unknown, no one saw me go out but I recall regaining consciousness. I passed out a total of 6 times.

experiencing moderate pain and discomfort in kidneys and bladder.; experiencing moderate pain and discomfort in kidneys and bladder.; experiencing moderate pain and discomfort in kidneys and bladder; experiencing moderate pain and discomfort in kidneys and bladder; This is a spontaneous report from a contactable consumer, the patient. A 50-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 13:15 hours (at the age of 50-years-old) as a single dose for COVID-19 immunisation. The patient did not have relevant medical history. The patient was allergic to opiates. The patient did not receive concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021 at 19:30 hours the patient experienced experienced moderate pain and discomfort in kidneys and bladder within 6 hours of vaccination. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event moderate pain and discomfort in kidneys and bladder was not recovered. No follow-up attempts are needed; information about lot/batch number cannot be obtained.

Report symptoms of dry mouth 2 days post vaccination. Treatment: drinking water. Outcome: Report increase urination due to drinking water.

The patient is a 51 yo old reservist with a history of hypercholesterolemia with an onset of illness 10 days after Pfizer vaccine (lot #2 ELI283) on 6 JAN 2021, where he was on 87 day active duty orders with Medical Task Force - COVID mission. He denies any AE after dose #1 (Dec 17 lot #ELD140). He denies any immediate symptoms suggesting IgE event(pruritis, urticaria, SOB, wheezing, oral, facial throat, tongue swelling etc.) and denies any local site reaction. He reports about 10 days later he experienced severe nausea vomiting and diarrhea, CP and SOB. He was seen in ER 3 times where he was found to have Acute Kidney injury, and treated with IVF, odansetron meclizine dicyclimine. After the third ER visit he was admitted where he subsequently developed GI pain. He has continued to have significant health issues, but no unifying diagnosis has been identified. He would like to know if this was related to his Covid vaccine receipt. He reports no one else in his group will ill and they were otherwise isolated for travel related Covid quarantine. Per review of records he presented to ER 17 JAN 2021 (day 11) with complaints of nausea global weakness, watery diarrhea, and shortness of breath . He had a acute kidney injury with cr 1.4. A non contrast ABD CT was normal. He was diagnosed with viral gastroenteritis, treated with hydration, Zofran and Bentyl. He returned to ER 19 JAN (day 13) with a complaint of same with severe dizziness. A noncontrast head CT was normal He had a positive Dix-Hallpike and he was diagnosed with benign positional vertigo. On 1/20/21 (day 23) he continued symptoms with tachypnea on minimal exertion noted in ER. CXR demonstrated lateral RLL opacity and he was treated with Rocephin and azithromycin. He developed vague abdominal pain and was transferred to MTF. 26 JAN 21 GASTROENTEROLOGY: EGD - 'marked chronic active gastritis' - blood, stool sample and gastric biopsies are negative for H pylori infection - Protonix 40mg BID CT of kidney showed cyst on the left and nonobstructive 3mm stone and creatinine on is 0.9 (0.7-1.2).

ALOPECIA AREATA UNIVERSALIS: I have complete hair loss of my entire body. Head/ scalp, eyebrows, eye lashes, nose hairs, mustache, some armpits, chest hair, pubic/ groin hair, arm/ legs. 1. DEPRESSION/ sadness with no head/ scalp hair, eyebrows, eyelashes. Dramatic change of identity. I am BALD and my family/ friends/ patients think I have cancer b/c I have a CHEMO HEAD/ SCALP. 2. EYES/ NOSE/ THROAT irritation due to NOT having eyelashes or nose hairs. Watery eyes/ eye sensitivity due to dust/ environament, nasal congestion and irritation due to NO nose hairs. Time: 1st injection Dec 20, 2020 noticed some hair loss but after 2nd dose Jan 8, 2021 -> ALL HAIR GONE AFTER 1 WEEK. HAD PRIMARY CARE PHONE CALL JAN 27, 2021 TO REPORT W/ LABS (SEE BELOW) AND EARLIEST APPT WITH DERMATOLOGIST Feb 8, 2021: DX of alopecia areata universalis . TREATMENT AND STILL ON TREATMENT: 1. VITAMIN D2 1250 MCG WEEKLY, 2. 300 MG PREDNISONE PO EVERY 30 DAYS, ALLEGRA 120 MG DAILY, MINOXIDIL 5% TWICE DAILY

Dehydration; Pain in kidney area; Soreness in left arm; Costochondritis flare up; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN6206), via an unspecified route of administration administered in left arm on 06Mar2021 at 10:30 AM as SINGLE DOSE for COVID-19 immunisation. The patient had no other vaccine in four weeks. The patient had no COVID prior vaccination and was not COVID tested post vaccination. Medical history included heart attack 3 years prior and a prior kidney stone event. The patient had no known allergies. Concomitant medication included atorvastatin. On 06Mar2021 at 12:30 PM, the patient experienced soreness in left arm starting about 2 hours after administration of the vaccine. On 06Mar2021 at 18:30, the patient experienced dehydration and pain in kidney area on left side starting about 8 hours after vaccination, lasting through the next day. Felt similar (though not as intense) to a prior kidney stone event, but slightly higher and in front left side. Costochondritis flare up overnight after the vaccine on 06Mar2021. There was no treatment given for the events. The patient was recovering from all events.

About 2 and a half hours after the vaccination, I started to have pain in the body, I was shaking, headache, tired, chills. During the course of about 4-5 hours after the vaccination, I had other symptoms such as an urge to urinate, accompanied by pain and burning. Pain in the ribs, back, left arm, diarrhea, felt like inflamed lungs and shortness of breath. Today and 3 days later I still have diarrhea, headache, fatigue and pain when urinating.

It started feeling current in the posterior part of the body, then it started pain in the whole body that continued to increase and burning sensation in the skin, chills, felt like was burning, marked respiratory difficulty, sensation of asphyxia, pain in the ribs, urinary retention, hematuria, liquid diarrheas, trembles, pain in the ribs and pain in the left arm (contrary to the one injected). Took Tylenol 500 mg 2 tabs q 4 hrs

Hematuria started the morning after the 2nd dose of the Pfizer COVID vaccine. The same thing happened after my first dose. Prior to this, I have no history of hematuria. Just like after my first dose of the Pfizer vaccine, the hematuria started the following day and lasted for about 3-4 days.

Chest pain Acute kidney failure, unspecified DOE (dyspnea on exertion) Hypoxia Bilateral pleural effusion Chronic obstructive pulmonary disease, unspecified COPD type Chronic kidney disease, unspecified CKD stage Acute on chronic heart failure with preserved ejection fraction

Extreme joint pain tiredness fingers felt cold and ached to touch anything sore neck in lymphnode area then the headaches started a few days later like 5 days i felt very tired weak not sick to stomach but felt like blood was dirty hard to explain right kidney hurt then weeks of headaches felt like head was bleeding it hurt so bad chest felt like just got over a chest cold or bronchitis or ran out in cold weather and also very cramped feet some of this still happening but most has subsided . The scariest part was the feeling of my headache terrible .i never went to a er or doctor but almost did.

N17.9 - Acute kidney failure, unspecified J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia

Organ Failure following Second Shot - otherwise healthy person - Kidneys showed failure on 5/3/2021 at an ER visit- Blood Pressure became elevated- Kidneys have been failing since second shot

adverse reactions appears 5/21 after first dose received 5/9. Reactions include peripheral vasculitis, the size of a quarter, appearing above interior of right wrist. Site also has some pain similar to that of a bruise. Also had blood in urine, which did not reoccur after initial incident.

Gross Hematuria, proteinuria, evidence of acute kidney injury with creatinine of 1.7 Urologist notes: "I believe his hematuria is secondary to a nephropathy secondary to his Covid immunization. The timing, the protein, and his acute renal insufficiency are consistent with this diagnosis." No prior history for kidney disease or other urological problems prior to vaccine.

rash around the body/rash all around body was reported as worsened.; sore throat/sore throat was reported as worsened; sweating; shaking; weakness; pain around the kidney; Pain around back; muscle pain in his back; a little scared.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 29May2021 (Batch/Lot Number: FW0187) as 1st dose, single for COVID-19 immunization. No medical history and concomitant medication were reported. The patient experienced the following symptoms: weakness on 29May2021, pain around the kidney on 29May2021, muscle pain in his back in 2021, sweating on 29May2021, shaking on 29May2021, rash around the body on 30May2021/rash all around body was reported as worsened and sore throat on 30May2021/sore throat was reported as worsened, a little scared in 2021, pain around back on 29May2021. Clinical course: A couple hours after the first vaccination, he started to feel weakness and pain around his kidney and back part. Also, some symptoms that are very common. He felt sweating and shaking and stuff like that. That night he noticed he started to have a rash all around his body and day by day it has been getting worse. On 01Jun2021, he went to the hospital emergency room and they gave him some medicine. He received a shot of diphenhydramine hydrochloride (BENADRYL) in the hospital. They also gave him an IV to flush out his body. Then the doctor gave him three prescriptions. He was released from the emergency room yesterday as well. 1. Aluminium hydroxide gel, dried, magnesium carbonate (PEPCID) 20 mg Expiration- Nov2022 in a pharmacy bottle, No lot number; 2. diphenhydramine hydrochloride (generic one) 25mg Expiration- Nov2023 in a pharmacy bottle, no Lot number; 3. Methylprednisolone tablet 4mg (NDC: 68001-005-01; Lot number: 20P0432, Brand: Bluepoint). Dose details: 6 days- First day to take 6 together, second day to take 5 together, fourth day to take 4 and so on for 6 days. So far, he has just taken the first dose which is 6 together. When he woke up today, he noticed that his rash was even worse. He didn't know how far the rash will go. The rash was like a burn and watery. The rash was all around his body. It started on his head; under his head and all around his face, then stomach, back and legs. His primary doctor and the emergency doctor suggested for him to not get the second dose because the second dose of BNT162B2 was going to have a stronger reaction. Some event details described as follows: weakness: Experienced 5 hours after receiving the shot. Considering how it has worsened his daily activities, from zero to 10, was like a 4. Pain around kidney: Like a muscle pain around kidneys that started about 8-10 hours after the shot. That pain came and went. It's not that much pain but still with him. Zero to 10 is like a 4 or 5 on pain level. Pain around back: pain was like a muscle pain. He experienced this 10 hour after vaccine. The pain has sort of improved. It was almost resolved. Sweating: He experienced on first night. 12 hours after. It came and went, but still ongoing. It was not that much, but still he still had it. Shaking: He experienced this on same night as the sweating. 12 hours after. It was almost recovered. It has happened one or two times over the past two days. Rash all around body: He noticed this a day after his shot. It was a couple of them around his body. It started from his head and spread all around body, but it was not that much at first. Day by day it has been getting worse and today is the worst day so far. The emergency room doctor checked his kidneys just in case. They told him everything was fine with the kidneys. It seems like it is a problem with the muscle. Also, he had a sore throat. It started 3 days ago. When he drinks or eat something, he felt burning. He noticed it the first time at nighttime. The emergency room doctor is assuming he had a vaccine reaction. Reporter seriousness for events weakness, pain around kidney, pain around back, sweating, shaking, rash all around body and sore throat was provided as unspecified. The outcome of event muscle pain in his back and a little scared was unknown; of event shaking and pain around back was recovering; of rest events was not recovered.

Inflammation of mucosal linings in body. Diarrhea, throat burning when eating, burn when urinating, sinuses burning, bronchospasm.

Dizziness; Nauscious; fluorescent orange urine; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 31Mar2021 (Lot Number: ER8732) at the age of 52-year-old as single dose in arm left for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. No allergy to medications, food, or other products. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and hasn't been tested for COVID-19 since the vaccination. The patient experienced Dizziness, Nauscious, fluorescent orange urine on 31Mar2021 09:45 AM. No treatment received for the events. The events were resolved on 31Mar2021. No follow-up attempts are possible. No further information is expected.

4 episodes of nausea/vomiting/diarrhea, then found by spouse with altered mental status and nonresponsive/snoring. Taken to Emergency department for stroke evaluation. Ruled out for stroke, intubated for airway protection and cerebral edema with meningeal enhancement observed on CTA. Admitted to ICU.

On May 21st @ 10:25am, I received my 1st dose of the Pfizer Covid vaccine. There were no immediate reactions during the 15 minute "holding period", but the following morning, May 22nd @ ~09:00am, I was urinating blood and blood clots with very little urine evacuating. Proceeded to the Urgent Care facility to which they immediately directed me to the ER. Upon arrival, they had me give a urine sample which was blood red, and put me on a picc line and pushed fluids, then performed a CT and an ultrasound of my pelvic area. During this time, my urge to urinate began to become very painful because my bladder was now fully blocked and I could only pass a small amount of blood clots. They then had to install a large 3 way catheter to relieve the urine and allow the passing of the large blood clots coming from my hemorrhaging left kidney. After being in the ER for ~8.5 hours, they released me with the catheter still installed with a mobile bag. I stayed laid up for 2.5 days until Monday when all of the blood clots had passed and my urine had returned to a normal color. They then removed the catheter and sent me on with medication to continue to take. I have a follow up appointment, but I am still having restrictions when I urinate and now when I try to ejaculate, so I am very concerned that this has permanently injured me. I have had ZERO issues in the past and consider myself a very healthy individual who works very hard to stay healthy. I maintain a weight of 206-210 lbs @ 6'1" through a daily rigorous exercise program, diet, and supplements. I don't smoke, do drugs, or drink excessively. This event has cost me money for my deductible (because I don't use it), plus the costs of the copays, medications, and 1 day of missed work. I have all of the paperwork from both the ER visit and Urology visits... Please advise what I can do to recoup my out of pocket costs for a vaccine that the Government has directed the population to receive. You can reach me at this email. Thank you.

Received 2nd vaccination in series on 11 JAN 21. By next morning started to experience some muscle and joint symptoms. By afternoon of 12 JAN 21 experienced sudden onset loss of bladder control for first time in his life, followed a few hours later by blurry vision, vertigo, motion sickness, emesis and cold sweats that drenched his clothes. Taken to ER by paramedics, and admitted for further observation and evaluation for underlying neurologic vs. cardiogenic problems. Given positional treatments by PT for possible otoliths. Feels much improved on afternoon of 13 JAN 21, but symptoms not fully resolved. Will likely be discharged from hospital on 14 JAN 21 if problems continue to resolve.

kidney stones; This is a spontaneous report from a contactable consumer (patient). The 53-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 03Mar2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization at the age of 53 years old. The patient medical history and concomitant medications were not reported. The patient experienced kidney stones on an unspecified date. Reported as: His second dose was scheduled for 22Mar2021 but he missed it because he was hospitalized with kidney stones. He rescheduled his second dose for the 08Apr2021. He lost his card with the bar code and was wondering how to retrieve it. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number has been requested.

N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia DIZZINESS BLURRED VISION HYPERGLYCEMIA

Hypo-osmolality and hyponatremia Acute kidney failure, unspecified Unspecified convulsions Hyponatremia

Seizures back to back to back/cause him to have more seizures; Wetting himself; This is a spontaneous report from a contactable consumer (patient's father). A 53-year-old male patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE), dose 2 via an unspecified route of administration on 01May2021 (Lot Number: EW0161; Expiration Date: 31Jul2021) as 2nd dose, single for covid-19 immunization (keep him alive and healthy). Medical history included ongoing sugar (diabetes) that was diagnosed with sugar 15 years ago (2005), heavy (overweight) been heavy for years. (biggest at 250 and is down to 236-238 now. It was stated that he lost weight before the shot and they do not know why), ongoing seizure all his life (he has had seizures all life), cholesterol (blood cholesterol abnormal), son that is special needs and high functioning and on vagus nerve apparatus. The patient received the first dose bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE) via unknown site on 10Apr2021 (Lot number: EW0158) for Covid-19 immunization. Concomitant medication included unspecified medications for seizures and has a VMS (unspecified). The reporter stated that has a son that is special needs and high functioning. The father stated that he has had seizures all life, so he wanted to know if the shot cause him to have more seizures. The father mentioned that he is having seizures back to back to back and wetting himself. The father does not think this has anything to do with the shot, but his mom does. The reporter mentioned that the patient's mom looked online and saw something that stated it causes seizures. The reporter inquired if there were any reports of having seizures for special needs or anybody. He added that the patient had four seizures back to back in his sleep on May2021. The reported further stated that he has an apparatus that was put in his chest that slows the vagus nerve to seizure activity which he has had it since 2004. It was mentioned that that two weeks ago (May2021) when he was with his mom and last night that the seizures started in his sleep. He also was wetting himself which started two weeks ago (May2021) when he was with his mom. The reporter mentioned that he has blood work every 90 days (unknown date) for seizure medications and cholesterol but does not wish to provide (unknown). The father mentioned that the treatment included the patient taking his medication for his seizures as for the wets himself, he got cleaned up and puts fresh clothes on. The outcome of the event convulsions aggravated was recovered on May2021 while the outcome of the other event was recovered on 12May2021.; Sender's Comments: Based on available information the reported seizures and urinary incontinence are unrelated to bnt162b2. These are due to the patient's underlying seizure disorder. Case will be reassessed if additional information is received.

At 5:30 am the day following vaccination woke up with severe new unset right flank pain. Went to ED and was found to have a kidney stone on CT scan. Was treated with hydration and Toradol. However, spiked a fever (possibly due to vaccine) and was pan-cultured (blood x2 and urine) and given IV antibiotics for possible UTI/pyelo. Blood and urine cultures were negative and was discharged after overnight observation. Did not have a history of kidney stones before this event.

Recipient reported sudden worsening of urinary retention following the 1st dose of Covid19 vaccine. The symptoms did resolve within 24 hours and did not reoccur with the second dose administration.

Intense chills and sweats; Multiple body aches including joint pain and headache; Multiple body aches including joint pain and headache; Multiple body aches including joint pain and headache; Restless sleep; Frequent urination; Intense chills and sweats; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number:1686 (as reported)), via an unspecified route of administration on 05Jan2021 at 13:00 at single dose in left arm for COVID-19 immunisation. Age at vaccination was 54 years. The patient was vaccinated at hospital. No other vaccine was given within 4 weeks prior to the COVID vaccine. The patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was diagnosed with COVID-19. The patient's concomitant medications were not reported. On 05Jan2021 at 21:00 the patient experienced intense chills and sweats, multiple body aches including joint pain and headache, restless sleep and frequent urination. These symptoms started approximately 12 hours after injection (clarification requested) and lasted for approximately 14-16 hours. The events were non serious. No treatment was received for the events. The events resolved in Jan2021. Since the vaccination, the patient has not been tested for COVID-19.

received dose one of vaccine on Sunday around 6pm. On Monday evening I started to have some lower bowel or intestine pain. It got worse through the night and had bad cramping in morning. I tried going BM and could not. After getting up and moving around a bit I was able to have a solid stool, but it did hurt a little. It also hurt when I went to urinate. Later that day I had 99 to 100 fever. For the next 2 days I was better but I did have some lower abdominal pain and tenderness.

Suspected Guillain Barre Syndrome. With bowel incontinence, urinary retention, motor and sensory weakness. Seems to all be involving S1-S5 nerves only. Had some mild foot drop on 3/25/2021 but then developed severe symptoms starting 4/15/2021 with rapid progression leading to hospitalization on 4/17

Leukocytes in urine; urinating blood; Dark colored urine; couldn't sleep; anxiety; sweat; arm pain; lightheaded; Abdominal Discomfort; prostate infections; This is a spontaneous report from a contactable consumer reporting for himself. A 54-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 24Mar2021 at 14:30 (at the age of 54 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history included benign prostatic hyperplasia (BPH) and cholesterol. The patient was diagnosed with BPH a few years back 2016 or 2017 and had a uralist in 2019 and that resolved his issues. The patient had been on no BPH meds and back to normal since that procedure. Co-suspect medication included atorvastatin (LIPITOR) from an unknown date to 01Apr2021 at 40 mg, 1x/day for blood cholesterol. On an unspecified date in Mar2021, the patient experienced prostate infections, and abdominal discomfort. On 25Mar2021, the patient experienced arm pain, and was lightheaded. He described the arm pain as he had deltoid pain but he also had pain like he had been hit from his right pectoral down his arm to about 4-5 inches above his wrist. On 31Mar2021, the patient experienced couldn't sleep, anxiety, sweat, urinating blood, and dark colored urine. The patient was concerned with the dark urine so he stopped taking atorvastatin, and called his physician who said he didn't need it anyhow. The patient visited the urologist office and was prescribed ciprofloxacin (CIPRO) as treatment for dark colored urine, urinating blood and prostate infection. On 06Apr2021, the patient experienced leukocytes in urine. Relevant lab data on 06Apr2021 included a urinalysis which resulted in leukocytes and blood +3. The action taken in response to the event dark urine with atorvastatin was permanently withdrawn. The outcome of the events prostate infection, and abdominal discomfort was recovered on an unspecified date in 2021. The outcome of the events arm pain, and lightheaded was recovered in 26Mar2021. The outcome of the events couldn't sleep, anxiety, and sweat was recovered on 01Apr2021. The outcome of the events urinating blood and dark colored urine was recovered on 06Apr2021. The outcome of the event leukocytes in urine was unknown.; Sender's Comments: Based on the current available information, the serious events Prostate infection, Blood in urine, and Urine color abnormal are most likely related to an intercurrent or underlying condition which is not related to the suspected drugs. Relevant medical history of benign prostatic hyperplasia (BPH) may provide a plausible explanation for the events. 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) : US-PFIZER INC-2021450744 same patient/SD, different AE/dose

SATURDAY HE BEGAN WITH TIREDNESS AND LOSS OF APPETITE.,PT BEGAN HAVING HICCUPS, HEADACHE, ABDOMINAL DISTRESS, BLOOD IN HIS URINE, STOOL AND EMISIS.

Context: Patient is a 54-year-old male who presents with right-sided flank pain, low back pain and right upper chest pain. Patient has had the discomfort in the right flank radiating up into the right chest for about 2 weeks. He states the pain in his chest is right upper chest, worse with breathing in and out. He also has right flank pain and right lower lateral chest pain worse with breathing in and out. Patient just developed dysuria with urinary frequency over the past 1 to 2 days. He has had subjective fever, chills and significant diaphoresis at night. He does have a history of multiple myeloma. This was treated with a stem cell transplant in February of this year. Patient and his wife report that recent laboratory data was concerning for possible recurrence and he had a bone marrow biopsy done about a month and 1/2-2 ago. He is to have a repeat bone marrow biopsy tomorrow Patient denies any midsternal chest pain. No shortness of breath. No cough or congestion. Patient denies a history of blood clots. Does have a history of heart disease, hypertension, hyperlipidemia. Patient is morbidly obese. Patient sees Dr. - oncology

On 12/31,1/1 exp flu like symptoms. Then on 1/3 got dizzy,sweaty and sat down nurse nearby took my pulse 65. The ambulance was called went to a hospital there was no CT scan capability therefore transferred to another hospital.

Pt received vaccine on 7 jan. 2021 Twelve days later, on 19 January 2021, Pt developed symptoms of COVID (cough, sore throat, fever, myalgias), on 20 Jan, pt admitted to hospital for worsening symptoms. Pt tested positive for COVID 19. Pt admitted to ICU where pt had complicated hospital course to include ARDS secondary to COVID pneumonia, nonSTEMI, with biventricular heart failure, on multiple pressor, rhabdomyolysis with acute kidney injury, requiring CRRT. Pt was in hospital for 10 days; he passed away on 31 Jan 2021.

2/2/2021- seen in Ed with c/o intermittent fever following 2nd dose. Redness to bilateral upper extremities, c/o some pain with urination, weak. V/S stable, afebrile in ED. Assess for infection. No significant abnormal labs (see below), hydrated and discharged. 2/4/2021- arrived in ED with c/o vomiting, seen earlier by PCP that day labs drawn. Shortly after arriving in the ED copious amouts of emesis noted, the patient went into full cardiac arrest and CPR was started. -Please see HPI above, in addition after intubation the patient coded again. More epinephrine and lidocaine were given. CPR was resumed. We did obtain ROSC and targeted temperature management was pursued. He is placed on a lidocaine drip and a right femoral central line was placed by myself. At this time, norepinephrine drip was initiated given his continued hypotension. Post intubation chest x-ray suggests possible abdominal pathology and once the patient was stabilized further, he was sent to the CT scanner where CT head without IV contrast and CT chest, abdomen and pelvis with IV contrast was obtained. He did lose pulses once in the radiology suite. This was brief. IV fluids were initiated and he received over 2 L of crystalloid therapy. He continued to be hypotensive in the emergency department and vasopressin was added. He also had a single dose of Neo-Synephrine and IV push fashion to help bring his blood pressure up. CT scan reveals probable bilateral aspiration pneumonia/pneumonitis and dilated loops of small bowel without a transition point and pneumatosis involving loops in the left upper quadrant. I did try to initiate consult with critical care and possible transfer, however he continued to be unstable and coded requiring CPR multiple times. He was given IV bicarbonate given his prolonged CPR state and pH. Ultimately, the family decided to make the patient comfort measures only given his critical illness. Shortly after making this decision he did pass away in the emergency department. RADIOLOGY DIAGNOSTIC - CHEST PORTABLE 02/04 2051 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2059 IMPRESSION: 1. Findings highly suspicious for portal venous gas which can be seen in the setting of bowel ischemia. Consider CT for further evaluation and/or surgical consultation. 2. Endotracheal tube 3.7 cm above the carina. 3. Low lung volumes with mild patchy perihilar opacities. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 8:55 PM Impression By: MD CT SCAN - CT HEAD WO 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2200 IMPRESSION: Negative for acute intracranial process. No evidence of mass effect, acute hemorrhage or definite acute cortical infarct. Final Report Signed by: M.D., Sign Date/Time: 02/04/2021 9:57 PM Impression By: - MD CT SCAN - CT CHEST/ABD/PELVIS W 02/04 2140 *** Report Impression - Status: SIGNED Entered: 02/04/2021 2214 IMPRESSION: 1. Ill-defined patchy opacities within the bilateral upper lobes, right middle lobe, in consolidative opacities within bilateral lower lobes which could represent aspiration, and/or multifocal pneumonia. 2. Small right trace left pleural effusions. 3. Diffusely dilated small bowel without a transition point and mucosal hyperenhancement involving the colon with areas of pneumatosis involving loops of small bowel within the left upper quadrant and portal venous air consistent with hypoperfusion complex. There is a small caliber appearance of the aorta and a flattened appearance of the IVC is well. 4. Intravascular air within the IVC and bilateral iliac veins could be secondary to right femoral central lying injection. 5. Somewhat abnormal enhancement pattern of the kidneys with hypoenhancement of the medullary pyramids which may suggest hypoperfusion injury as well. 6. Probable nondisplaced rib fractures on the right at ribs 2 through

Patient was tested for covid on 2/2/21 with positive resulted. Presented to Hospital ER on 2/10/21 with c/o of abdominal pain. Diagnosed with gastritis, prescribed metoclopromide and famotidine and dc home. Returned to ER on 2/13/21 with c/o of weakness, diarrhea, foot ulcer, and loss of appetite. Diagnosed: 1) Dyspnea and hypoxia secondary to Covid-19 2) Extensive bilateral lung infiltrates secondary to Covid-19 3) Increased Cr 4) Increased LFTs, ferritin, d-dimer, troponin secondary to Covid-19 5) Elevated procalcitonin placing the patient at high risk for sepsis 6) Chronic appearing Right foot wound without signs of secondary infection Patient transferred to a different hospital in another city.

Pfizer-BioNTech COVID-19 Vaccine EUA: patient presented to emergency department (ED) reporting fatigue, malaise, and anorexia. Patient was hypoxemic (oxygen saturation 90%) and tachycardic (pulse 108 beats per minute). Diagnosed with COVID-19 and acute hypoxemic respiratory failure, admitted to hospital, received remdesivir, steroids, anticoagulation, and oxygen. Patient improved and was discharged two days later medically stable.

Starting on 5/16/2021, I was very weak, I was headed to work the following Monday, I was urinating a lot, sic, feeling better until the next day I experienced the same symptoms again, this went on for 5 days, The following Monday I wasn't feeling better so I called Doctor. I decided to go to urgent Care and they said I was Jaundiced, they wanted me to go to the hospital, I spent 4 days in hospital, they said I was having an auto immune response to something, did scan on liver and it looked fine, however liver biopsy did not look good, they won't tell me what I have to go in for more testing. My doctor consulted with a specialist and they concluded it may be an auto immune reaction and I was told my gallbladder is also inflamed, but it looks fine , my bilirubin numbers were off the chart. I am going to see a liver specialist at medical center at the end of July. My blood sugar has since raised into diabetic range due to steroids. I had no reaction to my first dose of covid vaccine.

DATE: 02/07/2021 This nurse received a call from CLA/CMT at 0823 stating client is grunting and wheezing while breathing with a SpO2 of 86. This nurse instructed CLA/CMT to call 911 and get complete vitals. CLA/CMT called back with CVS: 149/106, 130, 97.7, 86. Residental support director was notified at 0828, Executive Director was notified @ 0843. Parents were notified via telephone call by this nurse @ 0922. 1109: Residential Support Director states via text ?. (name) called. (name) will need to wait for ambulance. Labs and lungs are good. Probably side effect from vaccine.? This nurse updated the parents and the ED. 1205: Ordered cvs every 4 hours and through the night with cvs reported to RN x 24 hours. 1230: returned from the ED with order for albuterol MDI 2 puffs every 4 hours as needed for coughing and wheezing. This nurse spoke to (name) at PCI. Requested chamber at cash price. Staff aware to call nurse when delivered.

Blood in my urine, kidney pain, shortness of breath. Fast heart beat that went into atrial fib. 145 BEats a minute for 4 hours. Difficulty breathing for 2 weeks following vaccine.

I cannot urinate although I feel I need to / painful and no urine; I cannot urinate although I feel I need to / painful and no urine; This is a spontaneous report from a contactable consumer (patient himself). A 56-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported) via an unspecified route of administration in right arm on 25Mar2021 13:30 as a single dose for COVID-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing. He did not have allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine but received other medications (unspecified) within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient stated "I cannot urinate although I feel I need to. Very painful and no urine" on 26Mar2021 14:00. No treatment was received for the events. Outcome of the events was not recovered. The patient had not been tested for COVID-19 since the vaccination. Information on the lot/batch number has been requested.

Patient was admitted for acute kidney injury in the setting of cirrhosis and c. diff. Thought to be unlikely related to vaccine.

This is a spontaneous report from a contactable consumer (patient) and another contactable consumer (patient's wife). A 56-year-old male patient received the first dose of bnt162b2 (COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 08Apr2021 at 08:30 (Batch/Lot Number: ER8729) as single dose for covid-19 immunisation. Medical history included ongoing heart patient, and penicillin allergy from an unknown date. Ongoing concomitant medications included carvedilol, lisinopril, clopidogrel bisulfate (PLAVIX), and acetylsalicylic acid (ASPIRIN (E.C.)). The patient experienced wiped out, tired and slept on 08Apr2021, left arm tenderness on 08Apr2021, lower back pain, pain in his abdomen, pain in his shoulders, vomiting, lightheaded and dizzy, really super flushed and turn almost a reddish purple on 10Apr2021, kidney pain on 11Apr2021 at 04:00, parotid cheek gland pain and yellow pus coming out of it on 13Apr2021. The events required physician office visit. Seriousness was not reported for events. Clinical course: The reporter stated her husband got his first dose of the vaccine on 8Apr2021. States on the 8Apr2021 and 9Apr2021, he was wiped out, which was normal. He developed kidney pain, lower back pain, pain in his abdomen and pain in his shoulders. He also developed an area in his cheek gland inside of his mouth that had disgusting yellow stuff coming out of it. He was at a doctor's appointment at Hospital being seen by a specialist for it now because it was so painful. The patient was tired and slept and had left arm tenderness from 8Apr2021-9Apr2021. The patient had vomiting from 10APR-13APR2021. He would get really super flushed and turn almost a reddish purple and lay on the ground to make it go away and also complaining of pain. The patient would start feeling lightheaded and dizzy, and had to run to the bathroom and throw up and then he would be okay for an hour or two and then it would come again. The pain was off and on, certain times he was doubled over in pain and it started again. It was the gland inside of his cheek, up by his upper gum line on the inside of his cheek gland, and it had yellow pus coming out of it. He had a stone removed from that cheek gland 3 years ago but he has had zero problems since then. States it was the parotid gland that came out of the salivary gland where it came in to the mouth. States that was where it has pus on the inside of his cheek. The outcome of events wiped out, tired and slept, left arm tenderness was resolved on 09Apr2021, outcome of events vomiting, lightheaded and dizzy, really super flushed and turn almost a reddish purple was resolved on 13Apr2021, outcome of other events was not resolved. No follow-up attempts are needed. No further information is expected.

Patient received his second Pfizer COVID vaccine on 6/4/21. Notes afterward he started with symptoms of a 'chest cold' and was having pain in left rib/lung/chest area. One morning walking at work and was noticing increased phlegm and chest congestion, spit up a wad of blood. Sharp left lung pain with taking a deep breath. Notes after episode, coughed up darker blood a few more times. Went to ER on 6/14/21 - imaging found with pulmonary embolism/blood clot in left lung. Discharged with Eliquis started pack 2 tab BID for 7 days, then 1 tab BID. New patient consult on 6/16/21 with myself, APRN - continuation of blood thinners initiated, referred for hematology consult, and echocardiogram ordered.

Patient was hospitalized for complicated UTI/pyelonephritis, developed epigastric and chest pain while in hospital.

After receiving the vaccine within 15 mins I had a metallic taste in my mouth. I exp fatigue and couldn't sleep I went to ER HR 180/10, elevated HR/BP, muscle joint pain and tremendous back pain. After I followed up with my PCP still elevated BP 140/70 as a result I'm on blood pressure medication. I was advised to stay on this new medicine until I receive the second dose of the vaccine. Also was told to take Benadryl and Tylenol before taking 2nd Covid vaccine.

3 days after receiving the first dose of the vaccine on 12/21/2020, experienced flu-like symptoms that lasted 24 hours. About 17 hours after receiving the second does on 1/11/2021, flu-like symptoms reoccurred. The following day (1/13/2021) severe chills, and difficulty breathing occurred. Patient was admitted to Medical Center, where blood work, EKG, and oxygen were given and ordered. After overnight observation, the patient was discharged and informed that he had a severe reaction due to the Pfizer vaccine for Covid-19. As of 1/17/2021, patient still recovering and feeling generally weak and tired without much appetite.

see blood in urine few hours of vaccination of the 1st dose of Pfizer covid 19 vaccine at clinic. Continiue to see blood till now (Saturday afternoon). Had kidney stones in the past and last time I saw blood in urine is 3 /4 yrs back.

Symptoms started with frequent urination night of receiving vaccine(got up at least 4-5 times in the middle of the night to pee, felt like I couldnt get it all out.), cramping in the bladder area, blood in the urine(pink urine). Little cramping but not urinating blood for now Drank a lot of water and went away This more than likely unrelated. The next step you would need to take is to go to your primary care physician to get checked, if you have any updates on this please give us a call.

3/29/2021 Pfizer COVID vaccine #1. Reports feeling poorly since that day. 4/3/2021 ED visit for complaint of SOB, fever, body aches. Admitted for sepsis. 4/4 intubated. 4/12 extubated. 4/14 remains hospitalized. Workup negative for infectious cause. Oncologist consulted, does not appear cancer related. MD suspects reaction to vaccine.

within 2 hours of the shot I had nausea, vomiting and diarrhea the following day about 1pm(24 hours after the shot) I had severe lower back pain, it felt like kidney stones which I have had in the past.

Received vaccine #2 07/09/2021; 07/22/2021 had sharp abdominal pains in a.m.. These worsened til evening when he presented to Hospital ER and was found by CTAngiogram to have thrombus in Celiac, Splenic and Hepatic arteries. Transferred to another Hospital

The day after the second dose of the vaccine this person woke up with fever, chills, muscle aches, frequent urination, and facial swelling especially around eyes.

Developed fever of 101-103, violent chills, uncontrolled shaking and extreme headache. Lasted 3 solid, then fever began to drop day 4, but headache persisted along with sweats and violent chill. No real appetite. Also experienced body ache, but not as bad as other symptoms. No, or little bowel movement during this time. On day five (today) urine output is dark, but went 18 hours without Tylenol. Piot to that i need 2 extra strength Tylenol every 5 hours for 4 days straight. No nausea or vomiting associated with any of this. I have extreme fatigue due the extreme headache pain keeping me awake. Headache on the left and right side of the head, not front or behine the eyes, more over the ears. Today I just feel wiped out by it all, but much improved. I have never had any reaction to any vaccines previously, including allergy, flu, shingles and pneumonia.

March 10, 2021: 1st dose of Pfizer COVID-19 vaccine March 11: pleurisy-type symptoms and difficulty urinating began March 19: still symptomatic, urgent care visit with chest x-ray and blood draw March 20: told to go to ER, concern for pulmonary embolism. Sent home the same day, told to take pain medications and tamsulosin prescribed from urgent care visit. Received chest x-ray, blood draw, and CT scan. March 25: another doctor visit, still symptomatic, prescribed prednisone and hydrocodone for pain and trouble breathing April 1: Seen by renal specialist, blood pressure medication dose changes, elevated potassium As of April 12, 2021, still symptomatic with pain (in the back), unable to sleep and taking pain relievers every 4 to 6 hours

I lost vision in my right eye for no reason, I went to the ER. They did a CAT scan ran blood test etc. searching for the reason i lost vision in my right eye.

After first injection on the 1st night has the chills all night. After the 2nd injection kidney pain with having to urinate at all hours of the night and day. Along with frequent urination and loss of bowel control.

death J18.9 - Pneumonia, unspecified organism K92.2 - Gastrointestinal hemorrhage, unspecified N17.9 - Acute kidney failure, unspecified

Day after the shot my left kidney started twitching about once a hour. next day it was very painful and lasted about a month. A week after is subsided my right kidney started hurting and is still painful when I move around.

Pfizer-BioNTech COVID-19 Vaccine EUA Pt chronic schizophrenia with subsequent mild cognitive impairment over the past year who was brought to hospital after 4 days of food/medication refusal, withdrawal from care and more recently disorientation and tremor. Pt was recently transitioned from haldol decanoate to clozapine. Last dose haldol decanoate was on 2/16/21. First dose clozapine 12.5 mg was on 2/24/21. Increased to 12.5 BID the following day. Increased to 25 mg BID on March 2, without reported side effects or other issues. Pt got his first dose of Pfizer COVID vaccine on March 4, and that night was less engaged with staff, felt feverish. Did not spike a temp per bedside accompaniment who was with him that day. The following day, he barely ate any food and did not get out of bed all day. This continued for the entirety of the weekend - bed bound, turning to look at staff when called but did not engage/respond verbally. He was incontinent of urine over the weekend. Treated for Neuroleptic malignant syndrome 2/2 clozapine Uncertain if vaccine contributed to event, but recent case report published relating clozapine toxicity and Pfizer COVID vaccine, so submitting to VAERS for evaluation

My face is swollen, I also have a sharp pain on the left side of my kidney and almost like is hitting my heart. My breathing is like if I have asthma and my eyes feel like if I have sand in them.

3/28/21 Patient presented to the ED with peakness, poor po intake and diarrhea. In ED, RA pulse ox wa 88%. Pt was placed on O2 and admitted for COVID pneumonia. He was outside window for Remdesivir. Was started on IV Decadron. He gradually worsened ind required higher O2 concentration. He was proned. Imaging showed worsening infiltrates. ID was consulted and recommended adding Tocilizumab.-administered 4/1. He had significant improvement and was discharged to home on oxygen 2L per NC on 4/2.

Fever, Chills, Generalized body-aches. Frequent burning micturation with hematuria. Treated with antipyretics (max. strength Tylenol), IV antibiotic, and a regime of antibiotic (ciprofloxacin) treatment for 2 weeks. Fever and body-aches have subsided. Some residual discomfort in urinating, but other symptoms have subsided.

MUSCLE PAIN THAT STARTED THE DAY AFTER THE SECOND DOSE OF PFIZER COVID VACCINE AND IS PERSISTING AND WORSENING WITH TIME. WE ARE OVER THREE WEEKS OUT AND HIS MUSCLE PAIN SEEMS TO BE SPENDING. THE PAIN STARTED IN THE LEFT SHOULDER AND IS NOW IN BOTH SHOULDERS AND ARMS.

stroke on 5/2 8:45 am hospitalized 5 days no physiologiical explanation. 3/4 of right cerebellum is dead. at onset nausea vomiting vision loss, loss of balance and coordination BP bottomed out low heartrate while sleepiing

The patient presented to the emergency department with 2 weeks of worsening bilateral lower extremity pain, erectile dysfunction and urinary retention. 24 hours prior to presentation he had been experiencing new neck pain/headache. He had no chronic history of these symptoms apart from arthritic pain in both knees and hips.

s/p 2 doses of Covid-19 vaccine. Pt presented for weakness, SOB, fatigue progressive over the past month prior to admission. Found to be pancytopenic with bone marrow biopsy consistent with MDS. He was started on chemo but stay was complicated by neutropenic fevers, epistaxis, retinal hemorrhage, AKI, fluid overload, hypoxic respiratory failure, atrial fibrillation with RVR, and shock. He ultimately had a heart attack while admitted and was transitioned to comfort care after medical interventions could not stabilize hemodynamics.

AST 916; ALT 1865; TB peaked at 5.5; AP 134; jaundice; headache; chills; acholic stools; dark urine; This is a spontaneous report from a contactable physician on behalf of patient. A 59-year-old male patient of received bnt162b2 (Pfizer COVID 19, formulation: solution for injection Batch/Lot number was not reported), via an unspecified route of administration on 08Feb2021 (at the age of 59-year-old) as dose 2, single for COVID-19 immunisation. Medical history included sleep apnoea syndrome. The patient had no allergies. Concomitant medications were not reported. The patient previously took 1st dose of BNT162B2 for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccine within four weeks prior to the COVID vaccine. The clinical course of the events was reported as: on an unknown date in Feb2021, the patient experienced jaundice and went to the physician. The reporter stated that first saw him on 25Feb2021. His initial presentation included headache and chills. He completed the second Phizer COVID vaccination on 08 Feb2021. He never had abdominal pain but he did develop icteric sclera, jaundice, acholic stools and dark urine. A workup included a negative viral hep panel including two HAV IgM (anti Hepatitis A virus immunoglobulin M), negative ANA (Antinuclear antibody), A1AT (Alpha-1 anti-trypsin) and a normal CT (Computerised tomogram) with normal GB (Generalised bullous) and bile ducts. TB (Tuberculosis) peaked at 5.5 with AST (aspartate transaminase) 916, ALT (alanine transaminase) 1865. He began to feel better the last week of Feb 2021 and repeat labs on 10Mar2021 showed TB 1.3 AST 29 ALT 102 ap 134. It was unclear if this was an infectious process that was not captured but the reporter worried enough that this could be related to the vaccine he received 1.5 weeks earlier enough to send this report. Since the vaccination the patient had not been tested for COVID-19. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment. The outcome of the events was recovering. Information regarding the lot/ batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the event increased AST, ALT and TB test positive and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Committees, and Investigators, as appropriate.

Since vaccination I did a lab test which found protein in my urine. Pain around kidney area and urine is foggy.