Moderna

Severe headache, Body Aches, Chills, night sweats, frequent urination and frequent stool. Slight fever at 100 degrees

What a nightmare. Moderna shot #1 caused rapid hair loss and arm soreness for a week and low grade nausea. But shot #2, holy moly... 12 hours post shot, I developed a fever, chills, violent shaking much of the night, weight loss, nausea, kept throwing up, massive migraine, heart rate racing, every cell in my body throbbing in pain, difficulty urinating, simply staying alive was exhausting. It faded a couple days after the shot, and in its place, fatigue, difficulty getting a full breath in. And now I have tinnitus--constant ear ringing. Absolute torture. And of course significantly more hair loss. So let's add anxiety and depression to the list because of this hell. What a regret it was to get injected with this poison. Rather just keep masking and avoiding people than be stuck with these permanent, life debilitating problems. I know it wont change anything, but I figure I'd report it anyway. What a nightmare. This crap should not be given to anyone with an autoimmune disorder.

15 hours after 2nd dose I experienced the following symptoms and I thought I was going to die. I couldnt get out of bed: 1) Extreme heart palpitations, my heart rate monitor was reading an extremely high stress activity for 2 days post shot. 2) Very Hot and Very Cold body chill and temp swings 3) Sweating profusely, I soaked through my pajamas on 3 different occasions when I woke up from napping. 4) My pee was orange and hurt to pee. 5) My entire body hurt the worst I've ever felt 6) All my joints were super painful, it hurt to walk and I couldn't sleep due to the pain. 7) I had the worst headache I've ever had.

Patient was fine and was able to answer all questions before the shot. After the shot was given He said he didn't feel well and passed out. His wife said this has happened to him before. He slumped over in the chair and became incontinent. he came to and then said he felt nauseous. he asked for the garbage can and threw up. I monitored his blood pressure that went to 160 over 100 and then came down to normal over the course of a few minutes. The patient stayed seated for about 30 minutes . After the blood pressure was good for 30 minutes his wife said she was going to drive him home. I explained that they should always tell any immunizer of his previous reactions

Patient observed to become unresponsive and slumped over in chair during observation at appros 15 minutes. He remained unresponsive to verbal and physical stimuli for approx 5 minutes. Once responsive, he c/o pain all over, abdominal pain with curling up as if cramping. no muscle spasms observed. Skin with mild tenting. vitals monitored, NS IV given, ~150 cc given prior to transfer to EMS. Lorazepam 0.5mg IV given for muscle spasms. Diphenhydramine 25mg IV administered Labs drawn. Oxygen saturation 99% initially with NRB, changed to NC and remained >94% on 2 lpm. patient remained somnolent, not answering questions, though conscious.

Bad kidney pain on right side vomiting drained achy fever lasted 3 days and still doesn't feel great very sluggish and still some pain.

Acute Liver and Kidney Injuries, severe fatigue, difficulty breathing, heart damage, body aches, etc.

Transverse myelitis resulting in bilateral leg weakness and urinary retention, weakness started 3 was after vaccine, mild abdominal pain started two weeks after vaccine. He was seen in the ED on 5/19 with abdominal pain and weakness, negative work up and sent home. Came again to the ED on 5/21, again with abdominal pain and weakness. Found to have urinary retention, required fully catheter for decompression which improved abdominal pain. Also significant weakness.

Day 1- pain and lack of range of motion at deltoid left arm , existed for about 5 days. Burning in chest, possibly lung. Shortness of breath, scanty urination/dark urine, problems with bowel movements. Days 2-4: dizziness, disorientation, gait changes, delay thinking, headaches, shortness of breath chest burning, whole body joint pain, neuropathy like sensations in arms, blood pressure spikes/ pulse rates dropped to 42.

Extremely sore arm at site of injection , onset 12 hours after injection. Lasted 24 hours. Body aches onset 12 hours after injection, lasted 24 hours. Slightly felt amped up as well 12 hours after injection, restless. Lasted 24 hours. Urinated more then average. Onset 12 hours after injection. Lasted 12 hours.

On Feb 14 developed Covid arm rash on left arm below site of injection. Rash spread over the course of 2 weeks and was red and hot to the touch. March 2nd left hand was achy and couldn?t open and close the left hand. March 4 rash spread to RIGHT upper forearm and is symmetrical with left arm. March 6 woke with swollen heel on right foot and painful and tender marking it difficult to walk.

41yo male with history of HLD, LBP, and tobacco use who presented to care initially at the with chest pain. He received the second dose of the Moderna vaccine on 18MAR21 at clinic and within 14 hours developed chills and myalgias. He denies any immediate onset of symptoms after receiving the vaccine. The following day he reports experiencing chest pain 24 hours after the vaccine was administered that progressively worsened over the subsequent 36 hours that finally prompted him to seek care. He describes the pain as a central non-radiating squeezing pain that worsened with movement and breathing. He waited to seek care because he reports several of the soldiers in his unit have experienced similar chest pain that eventually resolved. He reports being at his baseline health prior to receiving the vaccine and denies any fever, cough, rhinorrhea, congestion, malaise, vomiting, diarrhea, or rash. Upon initial presentation to care at clinic he was noted to have a Tropnon I of 0.9, WBC of 14, elevated CRP (7.3), and temp to 101.4. Patient was given ASA, Plavix, Lovenox, Tylenol, and Ceftriaxone. Since arriving to clinic and EKG was obtained showing ST elevation in lead 1 and avF concerning for ischemia and underwent a left heart catheterization which was clear of obstruction. Serial high sensitivity Tropnonin levels have been trended to peak of 465. Respiratory viral panel to include SARS COV-2 was negative. Cardiac MRI was consistent with myopericarditis, and show mildly reduced EF for 46%. Blood cultures have not grown any organism. His chest pain has resolved since starting Aspirin and Colchicine.

About 1 hour after injection I started feeling mild tingling in my face and throat. I then lost my voice for approximately 5 minutes. As the next few days started to progress I started noticing mild muscle spasms all over my body, mostly in my legs; waking up in the middle of the night, dry mouth, night sweat (1 occurrence), sudden onset of rapid and irregular heart beat (1 occurrence); kidney pain (right and left), upper abdominal pain (right and left). Prior to vaccine I did not experience any of these events.

Blood in urine. Happened after both shots. Didn?t think much of it after the first dose, but definitely happened after the second. Also had a fever (peak at 102.2). Blood in the urine does happen for me occasionally when sick in the past.

N17.9 - AKI (acute kidney injury) (CMS/HCC) R11.2 - Nausea with vomiting E11.10 - DKA (diabetic ketoacidoses) (CMS/HCC)

Per PCP visit note 4/28/2021: Patient reports has had some malaise, labile sugars, insulin resistance for past 2 weeks which he notes began about 2-3 weeks after initial Covid Moderna vaccine. He then reports over past 4-5 days has felt dehydrated, dark urine, and now with some abdominal distension, nausea, and fatigue. Normal bowel movements. Able to eat, no Tylenol or alcohol use. All meds stopped by Endo due to lab results except his insulin. Did find a note that states he received 2nd Moderna vaccine but also noted that his Endo suggested he should not get the 2nd dose. Our Immunization system did not pull in a 2nd dose. Also was some confusion as to whether he got Pfizer or Moderna, but the system did show Moderna given 3/30. Plan: CT scan, stay off all meds except insulin, PharmD review of meds and report to VAERs, schedule f/u with GI (will see in ~ 2months) CT Scan of abdomen/pelvis: no acute findings Will continue to f/u with PCP and watch lab to be sure numbers are improving.

N17.9 - AKI (acute kidney injury) N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia

Gross Hematuria four or five times over the following twelve days. Another two plus weeks have passed since then, with no further Hematuria.

After about 8 hours I start having extremely high fever then I started urinating blood with burning symptoms

Proteinuria about 0.5g/L. Hematuria about 200 ery/uL. Fever of 100.5F oral. Malaise. Patient has had similar proteinuria and hematuria in response to viral infections (influenza) before but it had resolved and not been seen in the last year prior to the vaccination. Suspected mild IgA nephropathy but not confirmed. Fever and malaise resolved in 36 hours. Hematuria resolved in about 4 days and proteinuria in about 6 days. No treatment other than tylenol for fever.

I received my first dose of the COVID vaccine on January 12, 2021. I had a headache on the night of Jan 15 so took two Tylenol pills. I woke up with a worse headache so took two Excedrin Migraine pills in the morning. At about 10 am I started a 10 mile run, which is not unusually long for me. I finished before noon and when I urinated , it was almost all blood, which has never happened to me before. I went to the emergency room. They gave me IV fluids and took some blood tests. My creatinine levels were abnormally high but the doctor felt I overexerted myself and was too dehydrated even though the workout was not unusually for me. On January 18th, I developed a quite painful lump in my left armpit, that lasted about a week. I saw my primary care physician on Jan 23rd for a follow up. He thought the lump was a swollen lymph node from the vaccine and was not concerned. He scheduled blood tests and an ultrasound of my kidneys, all of which came back normal. I received my second vaccine shot on Feb 9th. I developed a headache that night and have had a headache most of the time since. I have taken several pills of Excedrin Migraine over these few days. I also traveled to San Diego on the 10th and did a fairly long and arduous hike up a mountain on the 11th. Although it was intense, it?s the type of hike I do several times a year and not completely out of the ordinary. I was also a bit dehydrated again. I woke early morning on the 12th with another headache so I took two more Excedrin MIgraines and went back to bed. When I awoke about 6am, I urinated blood again. I urinated blood for several hours and have finally drank enough water to end the blood urination. I normally work out intensely several times a week and do have bouts of dehydration. But I have never urinated blood before. I can?t help but believe it?s no coincidence that the two times in my life I?ve urinated blood have coincided with COVID vaccine shots. Not sure how my exercises, dehydration, and use of NSAIDs have contributed but something is going on and it needs to be investigated.

Woke early one morning to a large painful lump on my right forearm. The lump was painful and felt like it was causing my arm to twist. Some hours later, my entire right arm was covered with large, painful, black and purple bruising. I had never experienced anything like this in my life. I often see blood in my urine, and during this time there was an unusually large amount. I don't know how to describe the feeling of lumps moving through my body, but I could definitely feel the movement through my arms and legs.

Symptoms started around a week after COVID-19 vaccine, when patient started having shortness of breath cough and nasal congestion. He was having yellow sputum production and he had chills. Upon arrival to the hospital on 4/18 the patient was tachycardic and chest x-ray that showed cardiomegaly with fluid overload. Progressively became severely hypoxemic and had to be emergently intubated and placed on mechanical ventilation. Patient developed cardiogenic shock which may be acute myocarditis and was placed on an Impella device and norepinephrine drip. The patient continued to worsen and developed acute kidney injury and hyperkalemia and was placed on CRRT. LFTs were also elevated. Patient also went into atrial fibrillation and was started on amiodarone drip. All of the above mentioned occurred within a 12 hour period.

This is a 42-year-old male patient with past medical history of hypertension presented to the emergency department today with complaints of nausea, vomiting, diarrhea over the last 5 days. Patient also noted having a nonproductive cough. Denies any fever, chills, chest pain, shortness of breath. Patient notes he got his 2nd CoVID vaccination on the 9th. Imaging done in the emergency department showed Left midlung infiltrates and probably also in the middle lobe. Patient's labs sodium 136, potassium 4.2, BUN 21, creatinine 2.87, glucose 154. Patient was started on IV antibiotics in the emergency department.

The patient began experiencing blood his urine 4 days post-vaccination. It happened twice on 5/8/2021, which is the day he reported it to the pharmacy. The patient advise to immediately contact his PCP for further follow up. No other symptoms or signs reported.

mild DRESS syndrome, rash, blood in urine. note it may have bene the doycycline, as simialr symptoms recurred later with a dose of doxy on jan 2nd, not hospitalized. pt is a MD

After second shot, I had the following adverse affects: tender/swollen testicles, burning sensation when I urinated . I had this after the first shot, too. I visited my local doctor. No UTI. Prostate was enlarged which I did not have before.

Patient reported fevers, chills and myalgia after 1st dose of Moderna COVID vaccine 4/22. Poor PO intake and had syncopal episode on 4/24 when standing from the recliner. Initially admitted at hospital, and developed fever, leukocytosis, AKI. Transferred to other hospital for further evaluation and eventually developed acute hypoxic respiratory failure requiring intubation and mechanical ventilation, found to have new onsert heart failure with reduced ejection fraction. He is currently being evaluated for auto-immune and underlying infectious causes, with concern for glumerunephritis, cardiomyopathy and coronary artery disease. Patient extubated to NC as of today but remains in the ICU.

5 days after first dose, extreme groin and kidney pain, gross hematuria, was diagnosed with multiple kidney stones. After second visit, another bout of gross hematuria, developed long term GI issues including bloating and constipation. CT scans show a enlarged spleen.

Hospitalization kidney failure heart failure respiratory failure had to be ventilated. Six days in Medical Center and 10 days in Medical Center

25 April - body aches and chills, no fever, these symptoms lasted for about 36 hours followed by general soreness throughout my entire body; 1 May - I woke up in the morning and was unable to urinate, I went to the ER and was given a catheter and sent home, I kept the catheter in place until Friday, 7 May when a urologist at hospital removed the catheter. I was able to urinate over the weekend but the symptoms returned 10 May. I returned to the urology clinic at hospital and I was given another catheter with instructions to follow up and conduct a hydroanalysis study with the urology clinic; Tuesday 11 May - I woke up with numbness and tingling in my hands, abdomen, and feet and pain throughout my entire body, scratching my chest made a burning sensation. I went to the ER and was admitted to the Neurology department at the same hospital. I stayed there for three nights and started to improve after receiving three daily doses of steroids, two days of IV steroids (1gram each), and one day of oral steroids (1 gram). I was discharged on Friday, 14 May and still had significant pain throughout my body and numbness and tingling in my feet, hands, and torso. I began to improve around 18 May with pain fading and numbness and tingling decreasing. As of 2 June, I still have some numbness and tingling in my hands, feet, and abdomen. It seems to slowly improve but not as quickly as it was in the aftermath of the high-dose steroids.

Severe hepatitis second Moderna vaccine 2/11/21 and felt feverish that night and the next several days. He took ibuprofen for a few days. His had subjective fevers after that that worsened in early March. His temperature was normal during these times. His urine got dark. His saw his PCP and labs showed increased LFTs. He was admitted. Liver biopsy 3/15/2021: Portal and lobular hepatitis with cholestatic features, negative for steatosis or fibrosis. Subsequent hepatology diagnosis was "All his symptoms started after COVID vaccine #2 but unable to identify any other DILI source."

Patient began experiencing extreme fatigue, increased frequency of urination, numbness and tingling in fingers and toes. He went to a nearby Urgent Care. Labs were drawn on 5/29/2021. When patient returned to that clinic for follow-up on 6/16/2021, he was given his results of glucose level of 300 and hemoglobin A1c of 12.0%. He was started on metformin 500mg twice a day. He was also started on empagliflozin 10mg daily and dose was tapered up to 25mg daily two weeks later. Patient had repeat labs done at our facility on 6/30/2021: glucose 94, A1c 10.2%. Patient purchased a diabetes monitor. His glucose levels from 6/30 to 7/13/2021 showed his average daily glucose was now only 89 and patient had 10 episodes of low glucose (<70). His highest glucose level was 147 and he did not have any levels above 180. Patient was taken of empagliflozin, kept only on metformin, and will be followed up in 2 weeks. Prior to vaccination, patient had no hospitalizations, illnesses, or any steroid treatments. He is a very healthy, patient with a BMI of 26 who works out 6 days per week.

Fever, chills, body aches, pain on site, bruise on site after 2nd day. slight dizziness , flushing and increased Heart rhythm on day log administration for about a minute and resolved. Have been having mild to moderate pain on right kidney area.

After the first day there was the typical site injection pain. Three Tylenol on the next day seem to take care of that but the pain quickly moved to the Front and top of the right pelvic bone. No amount of Tylenol has seem to do anything with that pain. After a week it seem to start to migrate to the left front top pelvic bone. These symptoms were mild and I was still able to carry out my daily activities in law-enforcement. Friday night January 22 is when I started to have pulsating pressure in the back of my head, chills, dizziness, excessive urination, diarrhea, and extreme fatigue. The symptoms have persisted through today but are starting to ease. I took a COVID-19 test on Sunday, January 24 the results came back today as Covid negative.

12/23/20 (Moderna #1) - Malaise, cough on 12/24, went to walk-in on 12/25 c/o cough, malaise, rx'd Augmentin x14d, Rapid covid negative (and PCR resulted negative). 12/27 slept all day, 12/28 back to work. 1/12/21 metallic taste in mouth, severe GI sx, malaise, aches, headache. 1/14 seen at walk-in and covid swabbed Negative. 1/21/21 exposed to parents who found out they were covid + on 1/22/21. 1/25/21 (Moderna #2) - Continued with persistent cough and GI sx. Then also developed urinary frequency and urgency. Seen at urgent care 2/1 c/o cough, dx URI, rx'd augmenting. Woke up morning of 2/2/21 abruptly, stood up, said something was wrong, and collapsed. CPR attempted immediately, EMS brought him to ER where he was pronounced dead.

Blood in urine and kidney ache. They same thing happened with the first dose and lasted about two weeks.

I felt decent; just some sore muscles and where I was injected up until about 2 pm the day after the 2nd vaccine. Then all of my muscles began to ache badly & by 4 pm I was suffering from on and off chills/ sweating ; this lasted all evening. I checked my temperature & only once was the temperature above 100F. I did have some chest pain at times as well. I drank mint tea, took tylenol at regular intervals & used icy hot on the sore back and neck. Following morning I'm feeling a little better but still quite a bit of soreness but as of 7 am , the chills/hots have subsided. I did pee a lot over night; at one point I went to the bathroom about 5-6 times within an hour to 90 minutes.

Approximately 3 weeks after receiving the 1st dose of the Moderna Vaccine, I started experiencing extremely painful erections which usually resulted in a steady stream of blood coming out of my penis instead of urine. After a few days of this bloody discharge, I noticed a substantial increase in the length and girth upon sexual arousal that I've never quite experienced ever before. The length of my erect penis before 2021 was approximately 7.5 Inches with a girth of about 3.5 Iches. However, after receiving the 1st dose of the Moderna Vaccine, the average length of my erect penis is now 9+ inches, with an average girth of 4.25 inches. I actually like the positive changes so this is the first time I am actually report it to anyone at all.

experienced stomach pain on 4/20/21 at 11AM, urine was purple colored, possibly with blood one time in the afternoon around 2PM. Continued to experience intermittent stomach pain and difficulty with bowel movements for the next month, along with intermittent dull back pain. Received second does of Moderna on 5/12, lot number 021C21A. On 5/24 around 9PM, a stone about the size of a grain of rice was passed while urinating. Pain in the stomach and back have not recurred since.

right shoulder soreness for the first dose for 1-2 days. left shoulder soreness after second dose, then approximately 8-10 hours later, I developed headache, neck ache, and by the morning, had skin sensitivity especially noticeable in touching my hair and genitals in the shower which was approximately 15 hours later. By 18 hours later my headache had worsened and i began to get light-headed. i drank tons of water and had no urination. I got hot and almost fainted. I had extreme uncontrollable shivering by 20 hours after injection. i nearly passed out at work. I also had nausea and burping. By the next day(more than 24 hours after injection), I was completely fine.

Patient reports squeezing kidney pain x 12 hours, red itchy flat rash on trunk, tachycardia, headache and warm red injection site.

On June 3 he developed a sore throat. His voice sounded like he had a frog in it. Early on June 4 he had to urinate about 10 - 15 times overnight in about a 6 hour timeframe. Later on Friday he left home and a short time later called 911 saying he couldn?t breath. When the paramedics arrived they couldn?t revive him and he died.

Patient went to Emergency Room d/t UTI, C-diff colitis, PE/DVT admitted treated with IV heparin, Vancomycin/flagyl, antibiotics for UTI

On March 20th had headache and dizziness. Had problem walking. On the 21st he turned pale and felt ill. On the 22nd he couldn?t walk or speak. Lost control of his bladder. Had extreme dizziness and headache. Sobbed uncontrollably. Took patient to primary for evaluation. They sent him bu ambulance to Emergency.

Kidney stone pain started 3 hours after vaccination. Stone passed 8 hours later. Only other stone was a small one 12 years prior.

lot: 026A21A NDC 80777-273-99.he started with symptoms after vaccine which progressed. SOBOE, N/V, fever & fatigue x 1 week in setting of recent COVID vaccine. admitted to hospital via ED with pleural effusion, AKI, Labs notable for +ANA, +smith/RNP, SSA/SSB,+Scl-70, dsDNA, low complements, lymphopenia, leucopenia, thrombocytopenia, rhabdo,worseing renal failure (now on dialysis) with PU, kidney biopsy largely unrevealing. Bone marrow biopsy concerning or HLH. DDx HLH 2/2 to new onset SLE with overlap syndrome/MCTD.patient needed to be transferred to a tertiary center, now at another facility in critical condition with encephalopathy.

I had a burning sensation every time I urinated, I felt a lot of urgency to go to the bathroom, I had to go to the bathroom up to five or six times a night, I felt the sphincter of the penis felt very sensitive and painful, Since the symptoms did not go away I had to go to a clinic where they did a urine culture, and days later I was called to start taking antibiotics for 7 days, most of the symptoms have passed but I continue with a little urgency when I have to urinate. I was taking Cefdinir 300 Mg twice a day for 7 days

TO ED ON 02/12 WITH KIDNEY STONE. ON LABWORK, PLATELETS NOTED TO BE LOW AT 85,000. I WAS NOTIFIED ON 02/16 BY THE UROLOGIST OF LOW PLATELETS WITH NO KNOWN CAUSE AND PATIENT/EMPLOYEE S/P COVID VACCINATION. ADMITTED TO HOSPITAL--DISCHARGED ON 02/14 AND PLATELETS 74,000 AT DISCHARGE. TO FOLLOW-UP OUTPT WITH PROVIDER TO RECHECK LABS.

52 hours after the injection I started to feel chills and occasional feverish ness. I was also nauseous and threw up a few times. The were also muscle aches. The symptoms were severe enough to leave me stuck in bed. The symptoms persisted for 4 days and on the night of the 4th day I suddenly developed a persistent pain in my lower back. In the morning I went to the emergency room where I tested negative for Covid and a cat scan revealed that my body going through the side effects of the vaccine knocked a centimeter sized kidney stone loose. I was prescribed anti inflammatories and anti nausea meds and told to follow up with a urologist.

He got his vaccine, he just had a little arm pain and some stomach problems, but nothing much. Then he noticed partial loss of taste and then Friday he was not able to close his eye and then went to the ER on Saturday has partial left sided facial paralysis, pain in his eye, drooling on the left side, and difficulty speaking. He was diagnosed with Bell's palsy. They gave him some steroid of Prednisone for 6 days and Valacyclovir for 7 days as well for treatment of this. He has had no improvement in his symptoms yet. Was told that it takes a minimum of at least 3 weeks.

Pt began to get tunnel vision, dizziness, migraine, upper back pain, and extreme fatigue approximately 6 hours after the dose was injected. He denied treatment and decided to rest instead - which helped. He drank about 5 bottles of water, but his urine remained dark. The tunnel vision lasted for about an half-hour. The rest of the symptoms remain, and he now has a fever as well.

Started having these symptoms which the doctor treated it as gout flareups and kidney failure. How ever it has been going for 4 months now that I know this is an adverse symptoms from the vaccine. After the first dose: inflammation of both feet, knee, elbow. hands and fingers. Fever, chills comes and goes After the 2nd dose: continued inflammation of both feet, knee, elbow comes and goes and fingers. Hives all over body Headache Feeling extra tired Feeling of body filled with fluid Blood shot eyes - fluid draining from both eyes Neck Pain Shoulder pain Pain all over body from head to toe (joints & muscle) Unable to stand at times

Initially, I felt fatigued and my left deltoid was sore. On day three after vaccination, I had one episode of hematuria. On day 4, I developed a fever and chills. On day 5, I developed dysuria, urinary frequency, urgency and hesitancy. I have also had some low back pain and purulent urine. I have never had any urinary or prostate issues in the past and have regular annual physical exams. I am an emergency physician and had to work, so I started myself on Bactrim DS (I am avoiding floroquinolones due to numerous black box warnings). I have had several other episodes of hematuria during my treatment. I am on day 13 of Bactrim and my symptoms are improving. I am not sure if this is a coincidence, but I have never had any similar issues and thought this should be reported.

Moderna Covid Vaccine - Received 2nd dose of vaccine and acutely developed fever, chills, diffuse myalgia, and fatigue. Patient felt week to the point he could not walk. Denies headache, photophobia, neck stiffness, SOB, chest pain, cough, N/V/D, abdominal pain. Denies recent illness or sick contacts. Wife and patients denied any symptoms prior to receiving Covid vaccination. Past Medical History includes: metastatic clear-renal cell CA; receiving nivolumab/ipilimumab. SoluCortef 15mgAM/5mgPM initiated on 12/31. Last chemotherapy received on 01/22/21; S/P left nephrectomy In the ED, patient was started on vanc/zosyn/azithromycin, SoluCortef 100 mg, IVFluid and levophed (for MAP 62-64). Patient was admitted to the MICU for undifferentiated shock. Hemodynamically stable after weaned off low-dose levophed . Etiology likely infectious vs Adrenal insufficiency vs reaction to COVID vaccine. SoluCortef decreased to 50mg q6H. Acute kidney injury; likely secondary to shock.

When to bathroom. Had blood in urine and was dark brown too drank 3 12oz bottles of water and cleared up but still yellow. I have abdominal Paine and headache and tired

Patient developed sob. Admitted on 2/16/21 with cardiogenic shock, acute renal failure and liver inflammation. Diagnosed with multisystem inflammatory disorder from COVID-19. Thought to be related to diagnosis on 1/25/21 but given recent receipt of vaccine reporting in case there are trends.

fever, chills, nausea, fatigue, onset about 6 hours following 2nd dose of his Moderna COVID vaccine (2/28/20). He reports dark coffee colored urine noted the next morning (18 hours), ongoing until 2 days later, when he also started having sometime red colored urine and sometimes dark coffee colored urine with dark particulate matter, occurred with every void x 1 week, then normalized. Pt in renal failure on peritoneal dialysis, but didn't mention it to his nephrologist until after symptoms resolved. No work up has been done. He sees the nephrologist next week.

1st injection: Sore arm at injection site that lasted for 2 days 2nd injection: Sore arm, cold sweats, fever, body aches, nausea, runny nose, sore kidney pain and joint pain Runny nose happened within 1 hour of injection. Could not eat because of nausea for 48 hours. Body aches, joint pain, sore arm, fever and cold sweats lasted for 2.5 days. Kidney pain started around 10pm on day 2 and lasted for 24 hours. For treatment I have taken 3 doses of Tylenol for pain and fever. Plus several hours in a warm to hot shower.

Pt received vaccine 5/11. Does not recall events thereafter. Admitted to hospital 5/13 due to altered mental status. MRI c/w encephalitis, and in rhabdomyolysis for several days with acute kidney injury requiring dialysis. Treated with high dose solumedrol and IgG and improving. Still requiring dialysis but hoping for renal recovery.

Sore left arm for 2-3 days following Vaccine. 06/09/2021 started to experience UTI symptoms, right flank pain, abdominal pain. UTI symptoms progressed rapidly to the point of not being able to void bladder. ER visit to have catheter placed. Testing confirmed UTI. Antibiotics , pain meds given for additional treatment. NO prior diagnosis of having any UTI, or related symptoms in the previous 48 years!

Approximately 8 hours after the shot, I began to feel flu-like symptoms beginning with intestinal discomfort and incontinence. Shortly after, fever developed over 100 degrees F. By +9 hours, fever reached 102, and I became disoriented badly, to include loss of balance and some speech issues. Went to bed, waking every 1-2 hours to drink 20-30 ounces of water. Frequent urination throughout the next 48 hours. Fever peaked at 103.7 at about 36 hours after shot. After 48 hours from shot time, fever was gone with fatigue remaining. Low-grade fever returned at 60 hours, and fluctated continuously ever since between 98.4 and 99.6. All temps via temporal sensor thermometer.

Strong internal bruise on day 1 (which might be the nurses mis-hit; struck some larger artery that blood almost ran down to my elbow.) General sickness so far making work rough enough to try to call out for the 2nd dose coming. Still ongoing. Nausea, Difficulty concentrating, General achiness starting from arm to ribs, then body wide. Brain Fog. Heavy fatigue, but it doesn't take as much to disable me more. Warm forehead, but temp taken today is normal at 96.6. Difficulty moving with aches. A few moments of wanting to vomit. No allergic reaction or rashes. Just a greater tax on the system. I just thought it's bad enough to report (and is still going on). Left arm pain all but done as of 3/15/21 at 7pm. Nothing life threatening, but concerned over second shot. Strange yellow "Floating oil" runs and dark urine.

Chills, body aches, joint pain, loss of energy, head aches, Kidney pain, shortness of breath and coughing. Teeth hurt, Point of injection sore ness

I awoke with a heart rate of 155 BPM, and BP of 131/81 (upper left arm) and the need to urinate. Over the next 40 minutes I needed to urinate 6 additional times, and my heart rate peaked out at 195 BPM, and BP of 139/84. My blood oxygen never went below 95. My hands and feet were extremely cold, but normal in color. After approximately an hour after I recorded the peak heart rate, my rate was 138 BPM. By about 8:45 AM, I was very close to mo normal heart rate and BP. I had no other notable symptoms other than the expected soreness at the injection site and a very slight headache.

Petechiae to arms, chest, abdomen, and back. Fever of 104 on 1/11/21. Elevated creatnine. Admitted to Emergency room for dehydration and diagnosed with covid 19. On 3/20/21 lost vision to left eye. Saw the doctor and diagnosed with optic neuritis. On 4/11/21 lost vision to right eye. Went to emergency room, at the local medical center emergency room and the doctor also diagnosed with optic neuritis.

Fever 102 for 2 days, 101 for 3rd day , 100 for the fourth day. Severe headache for 3 days, arm pain for 4 days, joint pain for 3 days, kidney pain for 2 days, chest pressure, fatigue for weeks - still don?t feel normal. heart discomfort occurred a few days after injection, still having the discomfort and fatigue. Saw doctor today and was referred to cardiologist for evaluation.

Myalgia, Arthralgia, Swelling/heat/redness/injection pain/ fatigue/lightheadedness/increased urination Narrative: Used OTC naproxen

8 hrs after shot felt extremely tired Sleeping that night had chills woke up in cold sweat Was combination of dreaming and hallucinating Next day entire body was soar. Notable pain in kidneys. Still every tired and head pressure

A few minutes after vaccination while in the 15 minute observation period the patient had a syncopal episode lasting 45 seconds with incontinence. On initial ALS assessment patient was found to be hypotensive with a Blood pressure of 60/P. Patient was Transported for further observation.

About 15 hours after vaccination, severe chills and tremors, chills lasted for approx 4 hours, tremors approx 1 hour. Bladder was very full twice during the night, not normal, I usually sleep through the night without needing to urinate. 20 hours post vaccination, body is sore and weak, headache, neck is sore. At present, still feeling dehydrated, head feels really heavy, very hungry.

Kidney stone that was already present for 2 years moved and passed. Started moving 48 hours after the vaccination.

I don't think that my reaction to the vaccine is super serious but it is perhaps worth noting if others are also experiencing similar symptoms. On the second day, I did have the expected arm soreness around the injection area on my right arm. That soreness faded by Saturday morning. However, on Saturday afternoon, I began experiencing some intermittent pain in my left kidney. I have had a few (3?) kidney stones since I was approximately 35 years old so it is a pain that I recognize almost immediately. I kept my spider senses awake to see where it was going to go. About an hour later, I had intermittent "flu like" pain in my arms and legs. I had been up on a ladder painting a wall and I became a bit dizzy and decided to halt the painting project. The rest of the evening was kind of crappy. Intermittent headaches, leg pain, arm pain and left kidney pain. I took 1 Alleve tablet around 8pm. It didn't seem to do much. I took a second one about an hour later (according to the instructions you can take two for you first dose) and that seemed to do the trick! I slept like a rock and so far today, all of the pain is gone including the pain in my left kidney. I have not taken any more Alleve besides the two that I took last night. Also, as of right now (2:44pm on Sunday 3/21), no kidney stone has passed. I have been urinating into a cup to see if one comes out. I cannot 100% say that any of these symptoms are related to the vaccine. However, being a Type 1 diabetic (since 1978) and the unusual kidney pain made me go, "huh." That is why I am providing this info in the event that there are others who are experiencing similar symptoms that can be tied to the vaccine and what to expect. I feel completely fine now. Yay. :)

I had Covid end of Nov recovered after 10 days. I got vaccine in Jan got vaccine on Sat at 4pm. started with a fever 103 for 36-42 hours. I went doctor had kidney tests, urinalysis and blood work I was told had hematuria. I had the exact same thing occurred after second Dose 2 with fever of 101 I treated with Tylenol.

Received Moderna COVID vaccination 4/1/21. About 27 hours later, he felt muscle spasming across his chest. He then developed neck pain, tingling that goes into right and left arms/fingers. Was started on oral steroids by his PCP on 4/6/21. Given worsening symptoms and new development of urinary retention. Patient was admitted to Hospital 4/8-4/11. Suspected to have cervical transverse myelitis. Re-admitted 4/12 due to worsening generalized weakness, significant numbness, gait/coordination issues, and several falls. Differential diagnosis includes guillain barre syndrome vs. transverse myelitis. No MS on brain MRI. No cord lesion. Treatment included IVIG 0.5g/kg daily x 4 days, B12, 1 mg IM daily x 3 days. bilateral neural foraminal stenosis at L5-S1. 4/7: MRI cervical spine: Small focal area of increased T2 signal within the central cervical cord at the C2 level without associated postcontrast enhancement. A demyelinating disease is leading differential consideration. 4/11: MRI brain: normal, no de-myelinating disease; MRI C-spine: severe cervical stenosis with flattening of spinal cord but no cord edema/enhancement.

SOUGHT CARE AT ER WITH C/O VOMITING, NOT BEING ABLE TO WALK, CHILLS, FEVER, COUGH, CONGESTION. NEGATIVE FOR COVID-19. ADMITTED FOR IV ANTIBIOTICS AND SUPPORTIVE OXYGEN THERAPY. DISCHARGED 2 DAYS LATER. TREATED WITH ZITHROMAX IV, ROCEPHIN IV, O2, ACETAMINOPHEN, HIGH-FLOW NEBULIZERS

The patient reports that he received his first dose of the Moderna COVID-19 vaccine on Thursday, February 11, 2021. Initially he reports having had a headache that is similar to his baseline migraines. Then on February 13, he developed right leg and foot numbness which spread to the left leg, then he felt as though his legs did not want to move. This started involving sensory loss in the right arm and then he presented to the emergency department. He was noted to have brisk reflexes, CT of the head was normal. Around 9 PM on February 13, the patient's symptoms progressed, he noted weakness on the right side and the left leg, and then on the 14th he started noticing numbness in the left hand he returned to the emergency department. Postcontrast MRI showed no abnormal enhancement, and mild to moderate cervical spondylolysis C5-C7. However a repeat scan 3 days later showed abnormal cord signal at C5-C6 and T1 suggestive of myelitis. He was also noted to have urinary retention. Examination showed diffuse hyperreflexia, Hoffmann sign, and bilateral Babinski signs. He did start showing improvement over his hospital stay, and was discharged to inpatient rehab. There are ongoing muscle spasms, spasticity, and decreased sensation.

Patient found unresponsive in chair and incontinent of urine. Returned to consciousness and oriented to surroundings. Patient still lethargic EMS took patient vital signs. Patient vomited. Wife was notified. Patient transported to emergency room via ambulance.

Moderna COVID-19 Vaccine EUA fever (99.9-101), chills, joint pain, body aches, fatigue, malaise, nausea, frequent urination - lasted about 14 hours; day 2 was just fatigue and some body aches later in day; day 3 no issues

Fever to 105.6 (infrared device), severe myalgias and arthralgias, chills, Headaches, dysuria and testicular pain. Improvement with Ibuprofen and acetaminophen.

Initial vaccination January 11, 2021 mild injection site soreness. Second dose vaccine 02/12/2021. Patient developed myalgias lasting for 1 day. 02/16/2021 patient developed fever chills and body aches. Temperature upwards of 104. Darkening of the urine. Symptoms persistent.

51 y.o. male from Facility. The patient was seen at his primary care physician's office for some left facial swelling. Apparently, he started getting more short of breath while he was there. He was sent in by EMS. His sats were initially in the upper 80s at his primary care physician's office. He denies any symptoms of URI, but does state he has a long history of COPD. The patient was given some DuoNebs and supplemental oxygen in the emergency room and shortness of breath basically resolved. However, he did have very significant left facial swelling. His CT did show facial cellulitis with possible abscess, but no fluid collection. His white blood cell count was almost 25. He had been having fevers at home. Because of all this the decision was made to admit for IV antibiotics. When I saw the patient, he was willing to stay for IV antibiotics for a few days. 3/11/21 remains hospitalized

Eighty four hours after vaccine I developed fever of 101-102 degrees, chills and night sweats. I was not able to work for two days. I also developed lower back pain and had Urinary Frequency with bad urine odor. This started 48hours after having the other symptoms. I started to take antibiotics Levaquin and tested negative for Covid-19. The urinary symptoms and other symptoms were reduced after three days. I felt like the illness was coming and going in three hour increments. I had mostly recovered by the sixth day. I got the second dose of the vaccine and had no symptoms that were similar.

Presents to our facility today with complaints of progressive weakness, inability to ambulate, abdominal pain, left thoracic wall paresthesias, inability to move bowels, and urinary difficulties. Reports he was also bitten by a spider on his left side recently and did not seek treatment, but decided to seek treatment when he developed same symptoms in his right side. Reports he has been experiencing symptoms for 1 week or more.

4 Hours After: Severe Headache 6 Hours After: Fatigue 8 Hours After: Fever, Chills 24 Hours After: Severe Lower Back / Kidney Pain Right Side 48 Hours After: Severe Lower Back / Kidney Pain Right Side, Swollen Lymph-nodes 72 Hours After: Lower Back / Kidney Pain Right Side, Swollen Lymph-nodes

Pt states had "severe kidney pain" that extended into lower back resulting in a trip to the doctor's office. He was using a heating pack/icyhot patch for pain and took ibuprofen. He also drank plenty of fluids to help with the pain. He stated the pain lasted for about a week at severe pain level. The doctor still advised him to get the second shot and continue to drink more fluids and use the icyhot patches as needed.

Aprox 4-5 hours later had burning painful urination. Next day aches, chills, pain, 101 temp., diarhea. Became very dehydrated. Sore arm at injection sight. Lasted 3 days or until Saturday evening.

Headache; Patient developed a cough on Friday; Patient reports he rarely has an appetite; urinary track infection/felt his urinary track and kidneys were being attacked/urge to urinate; urinary incontinence; patient had projectile vomiting after waking up; violet shaking the next morning; heavy sweat; passed out after vomiting; upper gum was numb; tip of tongue was tingling; feel like having a flu; neck was sore; odd supersmell; testicle started to hurt and are swollen; patient reports having lethargy; Patient reported blood in urine; Patient had fever of 101 F; having joint pain in knees and shoulder; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out after vomiting) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LISINOPRIL for Hypertension. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out after vomiting) (seriousness criterion medically significant), HYPOAESTHESIA ORAL (upper gum was numb), PARAESTHESIA ORAL (tip of tongue was tingling), INFLUENZA LIKE ILLNESS (feel like having a flu), NECK PAIN (neck was sore), PAROSMIA (odd supersmell), TREMOR (violet shaking the next morning), HYPERHIDROSIS (heavy sweat), TESTICULAR PAIN (testicle started to hurt and are swollen), LETHARGY (patient reports having lethargy), HAEMATURIA (Patient reported blood in urine), PYREXIA (Patient had fever of 101 F) and ARTHRALGIA (having joint pain in knees and shoulder). On 21-Apr-2021, the patient experienced URINARY TRACT INFECTION (urinary track infection/felt his urinary track and kidneys were being attacked/urge to urinate), URINARY INCONTINENCE (urinary incontinence) and VOMITING PROJECTILE (patient had projectile vomiting after waking up). On 22-Apr-2021, the patient experienced DECREASED APPETITE (Patient reports he rarely has an appetite). On 23-Apr-2021, the patient experienced COUGH (Patient developed a cough on Friday). On an unknown date, the patient experienced HEADACHE (Headache). On 20-Apr-2021, HYPOAESTHESIA ORAL (upper gum was numb) and PARAESTHESIA ORAL (tip of tongue was tingling) had resolved. On 23-Apr-2021, HAEMATURIA (Patient reported blood in urine) outcome was unknown. On 24-Apr-2021, DECREASED APPETITE (Patient reports he rarely has an appetite) had resolved. On 25-Apr-2021, COUGH (Patient developed a cough on Friday) outcome was unknown. At the time of the report, LOSS OF CONSCIOUSNESS (passed out after vomiting), INFLUENZA LIKE ILLNESS (feel like having a flu), NECK PAIN (neck was sore), PAROSMIA (odd supersmell), URINARY TRACT INFECTION (urinary track infection/felt his urinary track and kidneys were being attacked/urge to urinate), URINARY INCONTINENCE (urinary incontinence), VOMITING PROJECTILE (patient had projectile vomiting after waking up), TREMOR (violet shaking the next morning), HYPERHIDROSIS (heavy sweat), TESTICULAR PAIN (testicle started to hurt and are swollen), LETHARGY (patient reports having lethargy), PYREXIA (Patient had fever of 101 F), ARTHRALGIA (having joint pain in knees and shoulder) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment with ciprofloxacin for urinary tract infection and Flomax for prostate, were provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.

Seizure; Acute kidney failure, unspecified; Hypo-osmolality and hyponatremia; Thrombocytopenia, unspecified

Disable; Worried he is permanently disfigured; The pain is really bad; Cannot sleep; Rush; Joint pain; Headache; Nausea; Fatigue; Abdominal pain/right abdomen to his back felt like it was on fire, like he was being branded/fluttering in abdomen/incredible abdominal pain/abdominal pains are ongoing/severe abdominal pain/abdominal pains are ongoing; Urine was dark brown; A different stool color; Cannot go on long walks; Urine smelled like fish; Back Pain/ back right side pain/right abdomen to his back felt like it was on fire, like he was being branded; Life unlivable/ cannot continue with daily activities/For 18 days straight he cannot perform normal life functions; Been in pain for 29 days straight; Symptoms are severe because he cannot get out of bed; This spontaneous case was reported by a pharmacist and describes the occurrence of DISABILITY (Disable) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included ALPRAZOLAM (XANAX) for an unknown indication. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain/right abdomen to his back felt like it was on fire, like he was being branded/fluttering in abdomen/incredible abdominal pain/abdominal pains are ongoing/severe abdominal pain/abdominal pains are ongoing), CHROMATURIA (Urine was dark brown), FAECES DISCOLOURED (A different stool color), GAIT DISTURBANCE (Cannot go on long walks), URINE ODOUR ABNORMAL (Urine smelled like fish), BACK PAIN (Back Pain/ back right side pain/right abdomen to his back felt like it was on fire, like he was being branded), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Life unlivable/ cannot continue with daily activities/For 18 days straight he cannot perform normal life functions), PAIN (Been in pain for 29 days straight), INSOMNIA (Cannot sleep), RASH (Rush), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue). In January 2021, the patient experienced BEDRIDDEN (Symptoms are severe because he cannot get out of bed). On 05-Feb-2021, the patient experienced PAIN (The pain is really bad). On 07-Feb-2021, the patient experienced DEFORMITY (Worried he is permanently disfigured). On an unknown date, the patient experienced DISABILITY (Disable) (seriousness criteria disability and medically significant). The patient was treated with HYOSCYAMINE SULFATE (LEVSIN) for Abdominal pain, at an unspecified dose and frequency and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Abdominal pain, at an unspecified dose and frequency. In January 2021, CHROMATURIA (Urine was dark brown) and URINE ODOUR ABNORMAL (Urine smelled like fish) had resolved. At the time of the report, DISABILITY (Disable), ABDOMINAL PAIN (Abdominal pain/right abdomen to his back felt like it was on fire, like he was being branded/fluttering in abdomen/incredible abdominal pain/abdominal pains are ongoing/severe abdominal pain/abdominal pains are ongoing), BACK PAIN (Back Pain/ back right side pain/right abdomen to his back felt like it was on fire, like he was being branded), PAIN (The pain is really bad), DEFORMITY (Worried he is permanently disfigured), ARTHRALGIA (Joint pain), HEADACHE (Headache), NAUSEA (Nausea) and FATIGUE (Fatigue) had not resolved and FAECES DISCOLOURED (A different stool color), GAIT DISTURBANCE (Cannot go on long walks), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Life unlivable/ cannot continue with daily activities/For 18 days straight he cannot perform normal life functions), PAIN (Been in pain for 29 days straight), INSOMNIA (Cannot sleep), BEDRIDDEN (Symptoms are severe because he cannot get out of bed) and RASH (Rush) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient went to the imaging center for abdomen pain and awaiting for results. Patient experienced severe abdominal pain and after that he experienced anger. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. It is not clear if the disability is temporary or permanent. However, details including results of tests and diagnostics/ notes from HCP visit are required for further assessment. Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: Follow up received on 25_JAN-2021, is significant. The lab data, Concomitant(Xanax) and treatment(Levsin, Nexium) medication were added, new events were updated. On 29-Jan-2021: The follow up received on 29-JAN-2021, is significant. Outcome of the events Back pain and Abdominal pain were updated from unknown to not recovered.Outcome of the event Chromaturia was updated from unknown to Recovered/Resolved. On 08-Feb-2021: Follow up received on 08-FEB-2021, is significant. The new event is added disfigurement. On 19-Apr-2021: Follow-up information received on 19-APR-2021 contains non-significant information On 05-May-2021: Follow up received on 05-MAY-2021, is significant. Event outcome was updated. On 19-Jun-2021: Follow up received on 19-JUN-2021 is significant.. New events were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. It is not clear if the disability is temporary or permanent. However, details including results of tests and diagnostics/ notes from HCP visit are required for further assessment.

Patient is a 53 year old male who presented to Medical Center Emergency Department on 5/12/2021 with the chief complaint of fever. He is not under the care of a primary care provider and does not take any regular medications. On May 4th patient received his second Moderna COVID vaccine. Several hours later he developed a subjective fever with chills, body aches and a headache. These symptoms have been ongoing since onset. Since this time he has also developed a dry cough, generalized weakness and burning with urination. Denies any shortness of breath, chest pain, nausea, vomiting, or diarrhea. No bloody/dark stools. Wife is at the bedside who states that patient has recently developed "little red bumps" all over his body.

ON 1/14/2021 TYPICAL UTI SYMPTOMS FOR RESIDENT DEVELOPED INCLUDING FEVER AND RIGIDITY. RESIDENT IS NON-VERBAL. IV ANTIBIOTICS WERE STARTED. FREQUENT UTI'S ARE COMMON FOR THIS RESIDENT.

Blacked out dur to severe dehydration; Felt dizzy tired and went to sleep for a period of 4 - 5 hours; Drenched in sweat; Described his urine been very dark in color, almost black-ish in a way; Projectile vomiting of food; Night sweats; Diarrhea; Given ant nausea medications; Lot of fatigue; Felt pain in his at the injection site; Pain in his lower spine and hips; chills; Blacked out dur to severe dehydration; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out dur to severe dehydration) and DEHYDRATION (Blacked out dur to severe dehydration) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No recorded medical history). On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out dur to severe dehydration) (seriousness criterion medically significant), DEHYDRATION (Blacked out dur to severe dehydration) (seriousness criterion hospitalization), DIZZINESS (Felt dizzy tired and went to sleep for a period of 4 - 5 hours), HYPERHIDROSIS (Drenched in sweat), CHROMATURIA (Described his urine been very dark in color, almost black-ish in a way), VOMITING PROJECTILE (Projectile vomiting of food), NIGHT SWEATS (Night sweats), DIARRHOEA (Diarrhea), NAUSEA (Given ant nausea medications), FATIGUE (Lot of fatigue), VACCINATION SITE PAIN (Felt pain in his at the injection site ), ARTHRALGIA (Pain in his lower spine and hips) and CHILLS (chills). The patient was hospitalized from 05-Apr-2021 to 06-Apr-2021 due to DEHYDRATION. On 06-Apr-2021, LOSS OF CONSCIOUSNESS (Blacked out dur to severe dehydration), DEHYDRATION (Blacked out dur to severe dehydration), DIZZINESS (Felt dizzy tired and went to sleep for a period of 4 - 5 hours), CHROMATURIA (Described his urine been very dark in color, almost black-ish in a way), VOMITING PROJECTILE (Projectile vomiting of food), DIARRHOEA (Diarrhea), NAUSEA (Given ant nausea medications), FATIGUE (Lot of fatigue), ARTHRALGIA (Pain in his lower spine and hips) and CHILLS (chills) had resolved, VACCINATION SITE PAIN (Felt pain in his at the injection site ) outcome was unknown. At the time of the report, HYPERHIDROSIS (Drenched in sweat) and NIGHT SWEATS (Night sweats) had not resolved. Concomitant product use was not provided by the reporter. On an unspecified date, the patient went to sleep for a period of 4 - 5 hours. Upon waking up, he was drenched in sweat. The patient's mattress, pillow and body were covered in sweat. The patient was only able to stay awake for about 2 hours and the fell back asleep for about 4 -5 hours. This cycle of being up or 2 hours and sleep for 4 - 5 hours continued throughout the weekend. By Monday (05APR2021) morning, the night sweats continued, and contacted his primary care physician, who advised him to go to the nearest emergency room. In emergency room, while diagnostic tests were undergoing. The patient's symptoms began on Friday and ended except of the night sweat which were ongoing. Treatment for the event included anti-nausea medications. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

TWO lower GI tract infections, each one about two weeks after a vaccine shot. Other worries are confusion and bp oscillation. DETAILS: 1st dose only minor flu like symptoms then 14 days in, big GI tract infection tennis ball size in lower GI followed by UTI and Colo-rectal infections. Gas and no stool passing. 2nd dose down 24-72 hrs later with serious chills and internal fever in main body cavity. Slept it off and hydrated. Then consistent flu like symptoms but stronger and longer than 1st shot. Increasing confusion and maybe dementia? Some 3-D visual dreams too? lots of inflamation feel in body wherever old injuries were. Also blood pressure going high and low even though I cross checked with both electronic wrist version, and mechanical armband version of bp monitors. Consistent frontal lobe head pressure, bp oscillation, and flu like feelings (upset stomach, change in urine and stool color, wooziness, chills, etc.). Thank goodness for coffee! It helps clear up my mind a bit. Then again, 14 days beyond second shot roughly, and the only reason I filed the report, another lower GI tract infection. This time I hit it right away with potassium penicillin 800 mg. This worked the first time too. Just an FYI in case others are showing GI tract version/issues. I believe this was a secondary form of Covid symptoms in early Chinese data if that can be trusted. Still not in good shape but it sounds like second shot causes more issues. I will probably schedule general checkup with my doctor if I dont get better in a week or so.

I tested positive for covid on 1/08/21. I had the Moderna vaccine 1st dose 4/12/21 at 8:30am. No significant immediate reaction to the vaccine. Pain worsened at the injection point, but never significant, slight headache, tired, mild flu symptoms grew through the day. At 9:30PM I experienced Fever(101.6 at around midnight after fever had broke was probably higher between 9:30PM and 11:30pm). I experienced chills and violent shaking from approximately 9:30pm to 11:30pm, as bad or worse then the original covid from January. I was unable to sleep and finally took 2 Advil 200mg each at 3:00am. Advil helped and eventually fell asleep around 3:30am. Online information suggests that the 2nd dose generally has more severe reactions. I am concerned how much worse it will be and considering not getting the 2nd dose scheduled for May 10. Tuesday April 13 I experienced slight headache, body aches and exhaustion in the afternoon. Took Nyquil severe cold and flu Tuesday evening and sleep well. Wednesday experienced lesser symptoms. Thursday had lower back and kidney area soreness. Friday april 15 back to normal.

Chills, fever, muscle pain especially on the legs and the left side of the kidney. Tremors and has visited several emergency rooms as symptoms get worse. Patient had a prostate biopsy done on 4/26/21 a day before getting vaccinated. Patient is currently admitted to a Medical Center for symptoms related to the prostate. Bloodwork have been done and as of today he is presenting thrombocytopenia and low hemoglobin levels.

Muscle fatigue, pain, and spasms. General malaise and fatigue. Urethral spasms and burning. Symptoms lasted about 48 hrs and got better. I took IBU 600 mg x 2 doses

Patient manifested with flu-like symptoms (myalgias, fatigue, cough, abdominal discomfort, shortness of breath) with high-grade fevers (TMax 103F) approximately 4-6 hours following administration of 2nd Moderna vaccine on 5/4/2021 per patient's wife. The symptoms progressively worsened to the point that he presented to an outside hospital on 5/12/2021 at which time he was found to be tachycardic and febrile (T 103.1F). Labs at that time were notable for significant thrombocytopenia, elevated creatinine, elevated lactate, elevated procalcitonin. Chest imaging showed bilateral airspace disease. CT of the abdomen noted hepatosplenomegaly with no evidence of lymphadenopathy. Echocardiogram showed normal cardiac function. He was empirically started on broad-spectrum antibiotics. Labs on 5/13/2021 were notable for a markedly elevated ferritin level, fasting hypertriglyceridemia, elevated CRP, elevated transaminase levels, hyperbilirubinemia, markedly elevated CXCL-9 level, markedly elevated IL-18 level, normal natural killer cell function. Of note, while his blood and urine cultures were negative, he was found to have elevated EBV viral load on peripheral blood draw. He had a bone marrow biopsy which reportedly showed rare evidence of cells with what appeared to be erythrocytes within their cytoplasm, concerning for HLH. Given strong clinical and serological suspicion for HLH, he was transferred to our hospital for a higher level of care. Upon transfer to our facility on 5/18/2021, his inflammatory markers were persistently elevated. He unfortunately developed worsened renal and respiratory failure, and required both hemodialysis and intubation respectively. He was continued on empiric broad-spectrum antibiotics, however we additionally initiated high-dose steroids as well as anakinra for treatment of HLH. Given EBV viremia, we also began rituximab therapy. He was successfully extubated, however as of 5/26/2021 remains dialysis-dependent with continued improvement in urinary output. His post-intubation course has been complicated by encephalopathy of unknown etiology. We have consulted infectious disease to proceed with a diagnostic lumbar puncture to ascertain potential CNS pathogens explaining the cause of his altered mental status. MRI of the brain showed no evidence of pathology. CNS involvement by HLH remains on our differential.

I got my second shot of mederna on april 2 at about 130 pm, I got the shot and felt fine for about 4 hours at which time I got so tired and dizzy I felt like I was going to pass out, so I stopped what I was doing and went to bed. I slept for 4 hours and woke up in a pool of sweat and was so wet it was like I had just gotten out of the shower. I had the chills and felt cold in 84 Deg F, I went down stairs drank power aid and got out and set up a space heater and sat in front of it with it blowing the hot air on me but had hot and cold flashes, a mild head ach and joint stiffness and pain. I was only able to stay up for 4 hours before I was so exhausted I had to back to sleep and woke up the same way, this continued for the entire weekend. By monday morning my urine was so yellow it was almost black in color, I called my PCP office, they called me back and advised I go to the emergency room asap. I called my parents and got a ride to the hospital emergency room. I told intake what happened and sat down to be called in, they called me in 1 time then had me wait for diagnostic testing, I got vary dizzy just sitting their watching the tv. By the time they called me in for testing I told them I felt vary noxious and ended up passing out on the nurse after they took my blood. They transferred me from that chair to a bed in the blue pod, gave me nausea medication and hooked me up too 2 vary large IV bags and ran them at the same time. Then being up for 4 hours then sleeping for 4 hours and waking up wet in a pool of sweat continued for 6 days in total. the hot and cold flashes and sitting in front of a space heater went on for 12 days in total. waking up in a pool of sweat went on for about 28 - 30 days in total decreasing in severity along the course of time. The only side effect I still have is my sleep is all screwed up now. If I stay up untill 4 am I will sleep to 10;30 then wake up tired and stay in bed untill 11;30 am. if I go to bed at 2 am I wake up at 6;30 am have to use the bath room then can not go back to sleep for at least a hour then do not wake up untill 11 30 am. Normally, I used to goto bed at 2 -3 am and wake up at 9 -10 am every day. on wednesday april 7 th, the doctors office which is part of the same group as the hospital called me to go over the results from the emergency room, but the person calling did not seem to know I had called them on monday morning or they had called me back to tell me to go to the emergency room, so I do not know how much of a help the PCP will be, but I have proof of that in the phone call records. MY PCP is no longer with the practice, so I had to choose a new one

Fatigue, headache, acute low back pain, joint pain, chills, acute nausea, acute diarrhea, vomiting, fever, bloodshot eyes, loss of appetite, and blood in urine.

PER PATIENT, HE EXPERIENCES KIDNEY PAIN, BACK PAIN, FLUSHED CHEEKS, HEADACHE, THAT LASTED 2 DAYS (THE DAY HE RECEIVED VACCINE + ONE ADDITIONAL DAY). SYMPTOMS WERE GONE BY DAY 3.

VTE legs, large intestine, & lungs Narrative: Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was "perfectly healthy" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth

stomach was killing him; pee was cloudy; peeing blood; might have been blood in his diarrhea; calcium deposits in his kidney; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of DIARRHOEA HAEMORRHAGIC (might have been blood in his diarrhea) and NEPHROCALCINOSIS (calcium deposits in his kidney) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical history was provided. Concomitant products included TRAMADOL, HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN), ALPRAZOLAM (XANAX) and CEFALEXIN (CEPHALEXINE) for an unknown indication. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced DIARRHOEA HAEMORRHAGIC (might have been blood in his diarrhea) (seriousness criterion medically significant), NEPHROCALCINOSIS (calcium deposits in his kidney) (seriousness criterion medically significant) and HAEMATURIA (peeing blood). On 24-Apr-2021, the patient experienced ABDOMINAL DISCOMFORT (stomach was killing him) and URINE ABNORMALITY (pee was cloudy). At the time of the report, DIARRHOEA HAEMORRHAGIC (might have been blood in his diarrhea), NEPHROCALCINOSIS (calcium deposits in his kidney), ABDOMINAL DISCOMFORT (stomach was killing him), URINE ABNORMALITY (pee was cloudy) and HAEMATURIA (peeing blood) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication use included muscle relaxant. Patient reported that he went to hospital and was peeing blood. He also believes there might have been blood in his diarrhea. His pee was a little cloudy, and there were drops of blood. Symptoms are ongoing and patient will be seeing his urologist. At the hospital, patient nurse said he was second one to report similar symptoms after taking the vaccine. Patient notes he hasn't been drinking water and was told that he has calcium deposits in his kidney. Company Comment: This case concerns a 57-year-old male with serious unexpected events of diarrhea haemorrhagic and nephrocalcinosis, and nonserious unexpected abdominal discomfort, hematuria, and urine abnormality. Latency 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 57-year-old male with serious unexpected events of diarrhea haemorrhagic and nephrocalcinosis, and nonserious unexpected abdominal discomfort, hematuria, and urine abnormality. Latency 2 days after first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Soreness in shoulder as if I had been punched hard, rash oval/circle approx 5 inches in diameter, mild swelling under the rash, moderate fatigue, swelling of lymph node in arm pit opposite injection site like a squishy hand ball, severe sweats and chills, extreme urination, general body aches, general joint aches, aching of sports injuries less than 3 years old, mild nausea, mild dizziness, severe headache, swollen lymph nodes in both sides of neck, loss of taste, mild skin numbness around and above the rash. Most symptoms resolved after 4 days.

5/23- VERTIGO/NAUSEA (1-2 hours) ER room visit 5/26- VERTIGO/NAUSEA (24-48 hours) 2nd ER room visit 5/30-VERTIGO (30 minutes) while sitting, after swimming 6/5- VERTIGO/NAUSEA (10 hours) 3AM from my sleep

Noticed blood in urin 3 days after injection. Kept seeing color in varying degrees for about 12 hours after first discovery.

I63.9 - CVA (cerebral vascular accident) I63.9 - Stroke determined by clinical assessment N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia R29.810 - Facial weakness

Later the same day after I received vax, Around 8-8:30 i had body aches. Noticed that when my arm is to the side of my body, it started going numb- right arm. I also had to get up around 4 times to urinate a lot. I was getting night sweats. When I would get up, I had a slight head ache and dizziness. I still have it right now, the headache and dizziness. Even when I walk, I have to extend my pinky finger out so my arm will not go numb. As we are speaking right now, my pinky finger is going numb. Once I extend it out, it goes away, but when I put it down by my side, it goes numb. My whole body is sore as well.

Patient received 2nd covid-19 vaccine on 3/2 and day after had acutely altered mental status along with fever of 104 as measured by EMS. He reported feeling very weak and was found crawling in dirt outside. Was brought to hospital and T was 102, also found to have acute kidney injury on CKD. Fever resolved with tylenol and pt was treated supportively with IV fluids with improvement in mental status and resolution of fever. Weakness still present day after admission.

On 02/14/2021 developed fever, body aches. On 02/15/2021 I became delirious. Lost feeling in my legs and fell getting out of bed banging my head on the floor and banging my knees and hands. One day after release from Hospital on 02/21/2021 I had to return to Hospital because I could not retain urination and a catheter was inserted and I was told to follow up with my Urologist

Patient received first dose of Moderna COVID-19 vaccine. Vaccine given 1511. Patient complained of SOB and sweating. Patient had syncope, urinary incontinence, and nonbloody vomiting. Patient was seen by Dr. and EMS. Patient refused to be transported to ED. Patient's wife drove their car but within 20 yards, car stopped and patient vomited again. Patient re-encouraged to go to ED and got into EMS vehicle but then demanded to be let out and go home. Patient's wife then drove patient home.

sometime between 4:30 and 5:00 PM (1-1.5 hours after the vaccination) Patient felt bad and went to take his BP with a monitor. He passed out before he took it and woke up face down in carpet with a bloody nose and had urinated on himself. He called his daughter for help. Upon her arrival, he passed out several times, complained of severe headaches, had severe vomiting, has trouble breathing, pain shot up up his neck and face, his BP reading was around 83/60 with a heart beat of 45. The Ambulance service arrived an confirmed he was having an active stemi heart attack. He was taken to hospital where the heart attack was confirmed again and he was taken immediately to the Cath Lab to have a stent placed. He was placed in ICU

Gross Hematuria, increased proteinuria and reduced kidney function 2 days following second covid vaccine dose Suspect patient has IgA nephropathy as an underlying kidney disease although not biopsy proven.

Stage 5 renal failure; Abnormal renal function; Feeling weird; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Stage 5 renal failure) and RENAL IMPAIRMENT (Abnormal renal function) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced RENAL FAILURE (Stage 5 renal failure) (seriousness criteria hospitalization, medically significant and life threatening) and RENAL IMPAIRMENT (Abnormal renal function) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (Feeling weird). The patient was hospitalized from 28-May-2021 to 31-May-2021 due to RENAL FAILURE and RENAL IMPAIRMENT. At the time of the report, RENAL FAILURE (Stage 5 renal failure), RENAL IMPAIRMENT (Abnormal renal function) and FEELING ABNORMAL (Feeling weird) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal renal function (abnormal) Abnormal renal function. No concomitant medication and no treatment information was reported. It was reported that there were some pending tests at the time of report. On 2021, patient felt weird. Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Numbness tingling in left finger tips, progressing up arm. Few days later started in right arm. Arm weakness. Sharp shocking pain in neck and shoulders when arms raised. Weak legs, falling down, staggered walk. Frequent urgent urination. Constant tongue movement.

Blood in urine 1 day after vaccine 3 days post was cleared up Second shot on 2/13: same reaction Blood in urine

Got an increasing headache - annoying fuzzy and headache by 11pm and went to sleep. Had plenty of water/fluids throughout the night. urinated often about ever 1 3/4 hrs-I cath and good at it (big prostate) and use a bucket. Had a nasty headache by 3am and while cathing I stayed low because I felt real sick sweaty nauseous and went blind passed out, covered with half quart of urine, woke up on the floor with face against the wall-didn't know anything for a few seconds. Went back to bed-headache lasted for about four days.

About 12 hours after getting the second Moderna dose, while trying to sleep, my heart rate was 100-110, with the feeling of repeated PVCs in my heart. I knew this feeling because I had dealt with episodes of repeated PVCs (and later PACs) from about 2016 to February 2020. After being in the hospital in February 2020 for life-threatening sepsis, pneumonia, and strep, the arrhythmias stopped completely. I had been trying to control the episodes by taking atenolol 25mg/d; upon realizing that the PVC episodes had stopped, I terminated the medication. So at about 1AM on 3/7/2021 or so, I noticed the PVCs and the rapid heart rate and could not sleep. Fever went up to 102.4, thirsty and possibly dehydrated. Went to ER at 7am. Tests showed repeated PVCs. Kidney function was slightly abnormal. Started taking atenolol through Tuesday, 3/9. Heart monitor halter showed PVCs continued through Tuesday. By Thursday, 3/11, it was apparent that the PVCs had stopped and heart rate was normal. I stopped the atenolol and the irregular heartbeat has not returned.

syncope 2 hours after his vaccination. he felt nauseous and fainted. LOC lasted 30 seconds. no palpitations, dizziness, diaphoresis, chest pain. no seizure activity noted, but states he had urinary and fecal incontinence.

He?s complaining of pain all over hot and a terrible headache . He was crying when he called . He said that he was confused when he woke up and didn?t k ow where he was . He went to get his socks amd went to the refrigerator to look for them . He said he?s never felt this bad his entire life not even when he had his 8 mm disc bulge 10 years ago . Pain in every joint . Unknown temperature . Urinating a lot . A do I already pain unbelievable pressure in his head ears sinus and back of neck giving him a zing and zap sensation . The water in the shower felt like thousands of needles . I?ve never seen him like this .

This 57 year old male received the Covid shot on 4/21/21 and went to the ED on 4/27/21 and was admitted on 4/27/21 with the diagnoses listed below. J18.9 - Multifocal pneumonia U07.1, J12.82 - Pneumonia due to COVID-19 virus J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified

Patient presented to the ED after being found down outside. Initially hypotensive, was intubated in ED. Required increasing pressor support. Found to have profound anion gap metabolic acidosis with lactate peaking at >27. Initial workup also significant for WBC 40s, AKI with Cr peak at 2.5. Transaminitis likely 2/2 shock liver. Toxicologic workup was negative for alcohol, Tylenol, salicylates, urine drug screen. Blood cultures grew S. hominis. Other infectious workup including covid, hepatitis, hiv, rocky mountain spotted fever, respiratory panel, GI PCR, all negative. Also found to have a PE which was removed via thrombectomy. Developed DIC requiring multiple transfusions of cryo, FFP, and RBCs. Condition improved slowly with lactate downtrending currently and pressor requirement weaning.

Patient is a 57-year-old male currently in rehab facility with past medical history of heroin dependence, mood disorder, nephrolithiasis, history of 20 foot fall 5/21/2021 from fire escape to concrete floor with polytrauma , burst fracture L1 and L2 vertebral bodies, right lateral malleolar fracture, open right calcaneal fracture, sacrococcygeal fracture and left avulsion fracture of tibia, admitted to hospital, patient status post posterior fusion T11-L4, incision and drainage of right calcaneal wound and pinning, I&D left leg abscess, patient has resultant neurogenic bladder and neurogenic bowel post fall and has been self catheterizing, patient was initially discharged to current and rehab on 5/29/2021 and patient was discharged to rehab facility on 6/15/2021, presented to Medical Center emergency room with 3-day history of palpitation and shortness of breath, 2-day history of hematuria,, work-up in the emergency room at Medical Center included CTA of the chest which showed bilateral pulmonary embolism, CT scan of the abdomen pelvis showed multiple bilateral nonobstructive renal stones, bladder stones, fracture of L1-L2 vertebrae with postoperative changes, fracture of coccyx. Patient started on IV heparin, patient received 2 L of IV fluids and patient was also given Rocephin and cefuroxime initially hospital was contacted for transfer apparently they did not have any beds and patient was transferred to Hospital. When seen patient noted to be alert awake oriented x3 patient has a indwelling Foley catheter with gross hematuria, patient is on heparin drip, patient is complaining of pain lower back, numbness left foot.

Patient reports blood in urine 4 days after receiving the 1st dose of Moderna Vaccine. He was seen by his Dr and was advised that it was unlikely that vaccine caused the bleeding, and treated patient for a UTI and told him if further bleeding occurred that he would perform a Cystoscopy. Patient states he had mild tenderness over 1 kidney the day after the bleeding and no further issues. Patient was treated with antibiotics for UTI.

I am not sure if it the night after the vaccine or the morning after but I think I have a Shingles. It looks like bee stings bigger then a quarter 3 on my stomach and 3 on back. Lots of little bumps. It hurts very sensitive. I felt like my ribs and kidney were hurting but it is because of the nerves when I touch them. This is been about a week. I am going to call my doctor. The pain is not just one spot but the whole area around them.

The patient, who was a pharmacist, developed fatigue and shortness of breath hours after receiving vaccine. Two days later, on 01/28/2021, the patient went to local urgent care for worsening shortness of breath and was referred to Hospital for worsening dyspnea and hypoxia. The patient was admitted to the hospital We was found to have bilateral pulmonary infiltrates and treated for pneumonia with Rocephin and azithromycin. He was tested for COVID-19 multiple times, but each of the results were negative. Despite the negative results, there was high clinical suspicion for COVID-19 and the patient was started on Remdesivir and Decadron. The patient's oxygen requirements continued to worsen and the patient was transferred to another facility for higher level of care. There his hypoxia worsened and he required mechanical ventilation. Patient then developed hypotension and required vasopressors for blood pressure support. Furthermore, patient developed acute renal failure requiring hemodialysis. Despite mechanical ventilation with FiO2 100%, and for vasopressors, patient clinically deteriorated and family decided to palliatively extubate on 02/05/2021.

Pt arrives to ED via EMS with c/o blood in the urine, pain, and weakness since this morning. Pt states the staff noticed the blood this morning in his urine; pt denies any pain while urinating. Pt is incontinent per his normal. Pt states he received is first covid vaccination about 4 days ago, and yesterday he received his biyearly MS treatment. Pt states that one doctor told him to wait a month in between the vaccine and treatment, another said 2 weeks, and one said he could get it right away. Pt states that this morning, his MS flared up worse than its ever been. Pt states he is having severe muscle spasms and pain in the bilateral shoulders and right leg. Pt states that he has also been weaker

Abdominal pain, nausea and vomiting, shortness of breath, acidosis, hypoglycemia, death. Onset of abdominal pain was 30 minutes after administration of the vaccine followed by 20+ episodes of vomiting and dry heaving.

Per MD Clinical Note 3/14/21, "Further discussion with his daughter today-patient has not been able to walk and has had unclear mentation for approximately 8 years after an alcohol related decline. Was in a nursing home until he moved into his parent's house. His mother actually passed away and December and his stepfather has been trying to take care of him since. Patient may periodically stand but is a house where he is pretty much confined to his bedroom and bathroom. Patient received his COVID-19 vaccine at the prescription shop 03/04/2021 and since then he has had a steady decline starting with aches and pains to increased weakness and confusion and then collapse which brought him to the emergency room. Assessment and plan Syncope with altered mental status/toxic metabolic encephalopathy Acute on chronic respiratory failure with hypercapnia Sepsis Supratherapeutic Coumadin level INR greater than 9 Anemia Small hemoperitoneum Hypotension Chronic pain syndrome COPD UTI Enteritis Subsegmental atelectatic changes with nodule left lower lobe the-recheck 3 months Cirrhosis Nicotine dependence CHF-chronic diastolic Functional quadriplegia One week post COVID-19 vaccination Agitation Other: GI bleed, PAD, hypothyroidism, history of DVT left leg, neuropathy, depression, BPH, CAD, subdural hematoma, acquired thyroid disease, GERD, Wernicke -continue to trend the LFTs downward. Is on Precedex currently to allow him to further recover. He was using accessory muscles and poor inspiratory effort today but maintaining his oxygenation. BiPAP was reinstituted to avoid CO2 retention. One possibility is that the patient consumed a significant amount of Tylenol due to the discomfort exacerbated with the cirrhosis. LFTs are trending upward still. -hypercapnia patient consume both the benzodiazepine and morphine supported initially for the 1st 36 hours with BiPAP. Has had periods where he is off and answers appropriately. -consider rescanning in a.m. To further evaluate the hemoperitoneum. Continue broad-spectrum antibiotics and hemoglobins. Patient is NPO until further delineation Patient is a functional quadriplegic year and at home is fairly dependent on his stepfather for a total care family seeking long-term care which may mentally benefit the patient with broadening his activities -blood cultures pending. " Per Clinical note 3/13/21, "Assessment and plan Syncope with altered mental status/toxic metabolic encephalopathy Acute on chronic respiratory failure with hypercapnia Sepsis Supratherapeutic Coumadin level INR greater than 9 Anemia Small hemoperitoneum Hypotension Chronic pain syndrome COPD UTI Enteritis Subsegmental atelectatic changes with nodule left lower lobe the-recheck 3 months Cirrhosis Nicotine dependence CHF-chronic diastolic Functional quadriplegia Other: GI bleed, PAD, hypothyroidism, history of DVT left leg, neuropathy, depression, BPH, CAD, subdural hematoma, acquired thyroid disease, GERD -patient is more awake and wakening a hourly on BiPAP will remove 1 fully alert and functioning will use BiPAP overnight. Nicoderm avoid tobacco. NPO unless ammonia level is elevated. Continue empiric antibiotics. Last evening required to units packed RBC. If hypotensive and or increase in anemia will rescanned. Monitor for DTs and withdraws. Was advised by the nursing staff patient is following orders. Functional quadriplegic rotation every 2 hours had bed at 20-30 degrees to avoid aspiration. Patient and his family confirm DNR status. Long-term placement required as his stepfather is unable to care for him without assistance. Anticipate restarting diet in a.m.. One fully alert will ascertain if this was delivered or accidental. Drug screen was positive for both benzos and morphine. He has been and prescribed the morphine. The dual combination liver failure patient with depression likely ill-advised "

patient states he woke up at 0200 following vaccine with severe SOB, wheezing, body aches and fever; he had metallic taste in mouth and dark urine - lasted 4 days; spoke with patient on 4/1/2021 and he feels totally normal and back to baseline

Severe abdominal pain after the first and second vaccines, starting about 2-3 days after the vaccine. Hospitalized 3 times with acute pancreatitis which progressively worsened and became necrotizing pancreatitis with 8 cm cyst formation. Unable to eat and required placement of NJ tube for 3 weeks of enteral feeding. 20 pound weight loss.

That evening chills, fever, headache started, little nausea, more frequent urination. Continued into the next day. Dizziness started 03-20-21. Blacked out if stood up too fast, but didn't hit your head. Severe dizziness, fainting spells continued with fever. At that point went 2 PM.

Patient present with altered mental status and fevers, headache generalized body ache fever chills at the time of admission (4/21) generalized rash mild splenomegaly mild thrombocytopenia and elevated ferritin and CRP. He did not have any evidence of coagulopathy. His lactate and LDH are also within normal limits. Vasculitic workup and infectious disease workup till date have been negative. His CSF protein and glucose were within normal limits. He developed Worsening altered mental status as well as renal failure requiring hemodialysis. treatments for the most part have been supportive including steroids, intubation for altered mental status, antibiotics empirically, hemodialysis for renal failure. To date ( 04/27/2021) there has been no significant improvement in patient's status.

4/28 H&P: HPI: Hx obatined form chart review and wife. 58 y/o male patient with history of B-cell lymphoblastic leukemia who was treated with hyper CVAD then dasatinib s/p allogenic stem cell transplant in 2018 on remission and cGVH 5/19/2020 requiring prednisone 5 mg daily on chronic acyclovir, bactrim and fluconazole who follows up at UM with Dr., also pt with hx of hypothyroidism, hyperlipidemia and hyponatremia presented today complaining of weakness for the last 2 days and headache the day prior to admission. Pt was taking Tylenol for the headache, and per wife he had a temp of 99 F. Denies any GI, urinary or abdominal symptom. Pt was being treated for a toe infection (ingrown toenail) with clindamycin. Pt travel during the weekend for 2 days where he did not have contact with any infected person. Pt is compliant with his medications and follows for his medical care. Today at the ED pt was having headache and during the afternoon started with AMS, became agitated, with upper extremity tremors and nuchal rigidity. Ct head did not showed any acute abnormality. However, pt developed a fever. LP was performed pending results. Started on empiric treatment for meningitis: vancomycin, acyclovir and ceftriaxone. MICU was called to admit patient due to worsening of mental status. PMH: hyperlipidemia, primary hypothyroidism, hx ALL s/p bone marrow transplant and cGVH. Allergies: denies. Medications: Acyclovir 800 mg BID, amlodipine 5 mg daily, fluconazole 200 mg BID, levothyroxine 175 mcg, pantoprazole, prednisone 5 mg daily, bactrim 1 tab 3 times a week, terbinafine cream and triamcinolone. Social: form Miami. No hx of alcohol, smoking. Physical Exam: Nursing note and vitals reviewed. Constitutional: Vital signs are normal. Pt lethargic, disoriented, no following commands w/o respiratory distress. HENT: Head: Normocephalic and atraumatic. Eyes: Conjunctivae and EOM are normal. Neck: No JVD present. Cardiovascular: Regular rhythm, normal heart sounds and intact distal pulses. Exam reveals no friction rub. No murmur heard. Pulmonary/Chest: Effort normal and breath sounds normal. No respiratory distress. He has no wheezes. He has no rales. He exhibits no tenderness. Abdominal: Bowel sounds are normal. There is no abdominal tenderness. There is no rebound and no guarding. Lymphadenopathy: He has no cervical adenopathy. Neurological: Disoriented. Nuchal rigidity. Resting tremors. Hyperreflexia lower extremities. No clonus. Does not follow commands. Moves 4 extremities. Skin: Skin is warm. 4/29 ID note: 58yo M patient who comes with CC of 2 days of weakness and 1 day of headache. Progressive onset and no other associated symptoms, weakness referred as generalized by wife and headache really started on day of admission. He has an important history of B-cell lymphoblastic leukemia diagnosed 03/12/2018 ( +), treated with 2 cycles of hyperCVAD, and desatinib (latter stopped on 02/22/21 due to fluid retention), on remission. s/p allogenic stem cell transplant on 08/21/18 (CMV +/+) from brother (10/10 donor), which engrafted 09/01/2018. And chronic graft vs host disease diagnosed on 05/19/20 due to scleroderma of bl upper extremities, elevated LFTs and swelling of upper and lower extremities with decreased ROM, started on steroid initially 40mg bid and eventually 5mg qd since 03/16/21 He was on prophylaxis with Acyclovir, Bactrim 1 tab 3 times a week, and Fluconazole. In the ED patient found to be initially alert and oriented, but during the day became more agitated, eventually having altered mental status and becoming non verbal. He also presented fever. On evaluation physical exam showed a patient making incoherent sounds, with tremors which stopped, increased muscle tone and some rigidity and increased reflexes, nystagmus, not following command but retracting extremities when touched or moved, with possible kernig and brudzinski signs. Started on Ceftriaxone, Vancomycin and Acyclovir and changed to Cefepime, Vancomycin, Ampicillin and Acyclovir by MICU team. Acyclovir changed to Ganciclovir by ID. CSF without pleocytosis, normal glucose and only mild elevated protein. CT and MRI without acute findings. Assessment: 58yo M patient with history of ALL in 2018 s/p Allo-SCT (CMV+/+) at UM 2018, and complicated by chronic GVHD, currently on prednisone 5mg daily and prophylaxis with Bactrim three times a week, Acyclovir and Fluconazole, who presented with headache, fever and generalized weakness for 2 days. Became encephalopathic and was admitted to MICU. 1. Meningoencephalitis in immunocompromised patient - No changes since yesterday, leukocytosis 15.22 and Tmax 100.2- Negative HIV, RPR, - Culture CSF NGTD, Blood culture negative day 1, respiratory panel negative- Repeat LP- Pending additional studies, 2. Other problems- Hypothyroidism- Hyperlipidemia- Hyponatremia- Toe infection (ingrown nail) - 01/2021- CKD II and congenital solitary kidney -Baseline Cr 1.3 Plan: - Continue Ampicillin, Cefepime, Vancomycin and Ganciclovir- In process CSF HSV 1/2, CMV, culture- Ordered serum VZV,Crypoptococcus, Fungitell, Galactomannan, West Nile IgM, CMV PCR- Ordered Quantiferon-Gold- Needs LP and CSF - Measure opening pressure, Encephalitis panel, cryptococcus, Fungal, AFB, viral culture, HHV6 PCR, EBV DNA PCR, VZV PCR, West Nile virus, Adenovirus, NMDA- Plan for LP today, family agreed. 5/3 ICU update: Patient has been accepted at where he is well known to the heme/onc service. Will transfer today.

Rheumatoid arthritis flare up in left shoulder; Spinal cord injury; Neurogenic bladder; Right foot with neuropathy, Neuropathy of right foot; Area periodically develope warts; Bladder infection; This spontaneous case was reported by a physician and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in left shoulder), SPINAL CORD INJURY (Spinal cord injury), NEUROGENIC BLADDER (Neurogenic bladder), NEUROPATHY PERIPHERAL (Right foot with neuropathy, Neuropathy of right foot), SKIN PAPILLOMA (Area periodically develope warts) and CYSTITIS (Bladder infection) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Urinary tract infection, Urostomy and Catheter placement. Concurrent medical conditions included Foot infection (with Humira) since February 2021, Sulfonamide allergy and Latex allergy. Concomitant products included ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, METHOTREXATE for an unknown indication. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in left shoulder) (seriousness criterion medically significant), SPINAL CORD INJURY (Spinal cord injury) (seriousness criterion medically significant), NEUROGENIC BLADDER (Neurogenic bladder) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (Right foot with neuropathy, Neuropathy of right foot) (seriousness criterion medically significant), SKIN PAPILLOMA (Area periodically develope warts) (seriousness criterion medically significant) and CYSTITIS (Bladder infection) (seriousness criterion medically significant). At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis flare up in left shoulder) was resolving and SPINAL CORD INJURY (Spinal cord injury), NEUROGENIC BLADDER (Neurogenic bladder), NEUROPATHY PERIPHERAL (Right foot with neuropathy, Neuropathy of right foot), SKIN PAPILLOMA (Area periodically develope warts) and CYSTITIS (Bladder infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient experienced bladder infection in 2021. The patient was treated with Nitrofurantoin started approximately on 01 Mar 2021. Company Comment: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.

Passed 6mm Kidney Stone with violent symptoms: extreme pain, nausea, vomiting. Took in Emergency Care, painkillers including morphine, CAT scan. Discharged few hours later as stone had made its way to bladder

Red Dots over my body, and groin area in my eyes, infection in my eye lids, palipatation's, vision, more than usual pain in legs, urinating every 2 minutes, eye twitches, dizziness, rashes in groin and under eyes since a couple days after second vaccine still ongoing , Doctor gave me antibiotics thinking a bacteria infection on 05/11/2021 no difference as of yet anxiety bad a sometimes went to urgent care 05/22/2021 because of Eye Doctor said warm compresses and if not better in 48 hrs see an eye doctor so far it's worse. Sweating alot in groin area and rash in and around that area

no known cardiovascular disease. He has been feeling less well recently . About 1 month ago, he received the 2nd dose of the Moderna COVID-19 vaccine, and he developed an erythematous, non-raised rash involving the upper and lower extremities. This has subsided, but still persists on his thighs. He presented to the emergency department on 7/3 with worsening dyspnea. and diagnosed with pulmonary emboli. After a week in the hospital deteriorating with the following the patient expired. Pulmonary embolism Active Problems: Cardiogenic shock NSTEMI (non-ST elevated myocardial infarction) Cardiomyopathy Acute liver failure without hepatic coma Rheumatoid arthritis Renal failure Aortic stenosis Lactic acidosis Cardiac arrest Cerebral anoxia

presented to ED 3 days post injection with c/o palpatations and some SOB,. Patient was found to be in AFib with RVR. Labs showed severe hypokalemia. Three doses of potassium chloride were administered with improvement of potassium. Patient underwent a DC cardioversion Patient also reported positive COVID 19 test on 1/15/2021

Fever chills sweating weakness appetite diminished urine color change exhaustion heavy breathing cough

First thing I noticed was frequent trips to the bathroom. (EVERY TWO HOUR) All LARGE amounts of urine. The Second one is that Eye SITE was made a drastic change to the point I can barely see!

Brought in from ED, family concerned for altered mental status, hyperthermia, Tmax in 105. The patient stated that after the covid-19 vaccine on Friday, he experienced acute onset of R shoulder pain, constant, associated with decreased ROM. On PM Monday, he noticed first episode of chills, that lasted a few minutes, accompanied with sweating. This episode recurred 4 times over the week, then the family started noticed the patient was unable to answer questions and was somnolent. Blood Cultures in the ED were positive for MRSA 2:2. He was positive for endocarditis (previous dental work). Acute metabolic encephalopathy due to severe sepsis most likely 2/2 MRSA bacteremia complicated by NSTEMI and AKI in setting of newly diagnosed aortic valve endocarditis complicated by septic emboli to the bilateral cerebral hemispheres

Injection site turned red and became itchy and patient developed hoarseness within a few minutes of injection. Received Benadryl onsite that resolved itching. 4 days later patient still hoarse, chronic tinnitus worse, pain in right kidney, fatigue.

Fever, confusion. He received the vaccine about 10:30 AM. He worked in the yard during the day and seemed to be doing fine. After eating dinner, he seemed to be unusually drowsy. Over the course of the evening, the wife realized that he was very confused and was too weak to ambulate. She summoned EMS, and he was taken to ED. Of note, he had an episode of confusion lasting several days in 2/2021. No fever at that time. Evaluated in ED on 2/20/2021. CT Head and labs unrevealing. Released to home. Initial vital signs 4/30/2021 at 00:59: Temperature-100.4°, blood pressure-133/68, pulse-110, respirations-18, room air O2 saturation-97%. He subsequently had a T-max of 102.8°. He received empiric therapy with dexamethasone, vancomycin, ceftriaxone, ampicillin, acyclovir on the evening of 4/30. The morning of 5/1 he was afebrile, alert, oriented x3. Steroids and anti-infective discontinued. He was observed in the hospital for another 24 hours and had no recurrence of fever, confusion.

Patient received 2nd Moderna vaccination on 6/14/2021. Had labs drawn on 6/22 notable for AKI (Cr of 3.55 above baseline 1.6). Also had R calf pain and swelling. Presented to ER and found to have acute DVT of RLE femoral and popliteal veins. Given IVFs and AKI improved, and started on Apixaban for RLE DVT