Moderna

At 4:00pm the patient became anxious immediately after receiving the COVID-19 Moderna vaccine and after a minute of being observed he complained of sweats, feeling feverish, light headedness, muffled hearing. seeing spots and sudden urge to urinate. Blood pressure was 132/80 at time of event. Immediately he was given Gatorade and water and visibly became less diaphoretic and anxious after five minutes. By 4:20 pm the patient stated he was feeling "back to normal" and was assessed by a physician and was released after 30 minute of observation.

@3hrs injection site soreness, @12hrs chills, @ 18 hrs fatigue, @20 hrs general malaise, headache nasal congestion, armpit nearest injection site mild pain, fever 100°f, 24 hrs all symptoms persist and intensify. @32hrs fever peak 102°f, injection site pain decreases. Headache increases. 500mg aceteminophen taken. Nasal congestion increases, @40hrs chills, malaise and congestion decrease, fever99.9°f , throat soreness appears, Kidney pain appears. Headache increases. @48 hrs kidney pain persists, armpit pain persists. All other symptoms decrease.

This is my 2nd VAERS related incident to the Moderna COVID Vaccine(previous VAERS incident #271354 from 1/29). From late Thursday 2/4 to Saturday 2/6 I experienced palpitations, warm sensations, insomnia, weak appetite, excessive dry mouth, irregular heart rate, mild chills, infrequent urination(range from low to heavy urination), mild weakness/fatigue, increased TMJ/bruxism issues,BP spike, excessive thirst sensation(despite hydration). I was seen at hospital ER on Feb 6,2021.

1033 patient received vaccine. 1035 patient reported not feeling well, he was noted to be pale, disoriented, diaphorietic, and loss of bladder control. Vital signs of B/P 107/53, HR 45, RR 16, SpO2 100%. He was transferred to a cot. He was alert and orientated but very anxious, 911 was called. EMT arrived at 1100. Patient reported he was feeling better, vital signs of B/P 128/86, HR 67, SpO2 100% on room air, Blood sugar was 174. The patient stated he was feeling better and declined to go to Emergency department. He called his father who arrived and picked him up at 1130, patient stated he was feeing fine and walked out of clinic with his father to drive him home.

HISTORY OF PRESENT ILLNESS Patient is a 29 y.o. with a history that includes # Asthma # Diabetes, recently diagnosed # Obstructive sleep apnea # Remote pulmonary embolism, no longer on anticoagulation who presented to the ED with worsening shortness of breath in the setting of known COVID-19, since admitted to Hospital for acute hypoxemic respiratory failure secondary to COVID-19 viral pneumonia. History herein is derived from patient interview and review of the electronic medical record. patient developed fever, cough, and shortness of breath approximately one week ago. These symptoms developed very shortly after he received his first dose of the Moderna vaccine. He initially attributed these symptoms to side effects of the vaccine. When they persisted, however, he called his primary care physician who recommended that he seek evaluation. He was evaluated at an urgent care on 3/30 where he tested positive for COVID-19. His shortness of breath progressed, and he presented to the ED on 3/31 for evaluation. CTPE was negative for PE but did demonstrate viral pneumonia. Ambulatory pulse oximetry was negative for desaturation. He was discharged home. Since discharge, his symptoms have continued to progress. He was planned to receive monoclonal antibody earlier today, 4/2, however when he presented for his infusion he was found to be hypoxic to 89% and tachycardic to 130s. He was sent to the ED for evaluation. He continues to have diaphoresis and chills although believes his fever has improved. He has some chest tightness with deep inspiration. He otherwise denies unusual headache, sore throat, productive cough, chest pressure, abdominal pain, flank pain, dysuria, and diarrhea. He reports that his PE was provoked by obesity and a lengthy plane flight in 2017. He was on anticoagulation for 8 months and has since been off. On arrival to ED, VS AF, HR 122, RR 30s, BP 120/90, SpO2 97% on RA. He was in significant respiratory distress and was therefore placed on HHFNC with improvement. VBG 7.42/39 and lactate 3.9. CMP w/ AST 40, ALT 40, AG 15. Serum creatinine elevated at 1.13 from baseline 1.0. CBC w/ WBC 5.6, HGB 17.7, PLT 257. HS troponin 10 -> 8. Given his hypoxemia and history of pulmonary embolism, CTPE was performed and negative for PE however did demonstrate bilateral consolidations consistent with COVID-19 viral pneumonia. Procalcitonin was negative. He was given dexamethasone. He was also given 500 mL LR with clearance of lactate. He was admitted to Hospital in stable condition.

Mild dry cough beginning Wednesday (about 24 hours after vaccination) and becoming a moderate cough on Thursday into Friday, calming back into a mild cough later on Friday and nearly gone as of now (Saturday afternoon). Throat felt dry during the same period, leading to unusually high water intake and frequent urination, and briefly some discomfort and slight pain around the front-right part of waist that I assume was due to too much water and urination. Also Thursday night, I had some potential chills ? but no fever when I checked Friday morning. Also during this three-day period I felt fatigue, and lay in bed most of the day Friday. Also during this three-day period I was congested and had a runny nose, but I have had those for weeks presumably due to allergies Today I feel mostly but not quite healthy.

The day after the vaccine I had a fever and body aches, nothing too significant and it subsided after about 12 hours. The following day, about 48 hours after vaccination I experienced blood and protein in my urine. This happened with both doses. Dose 1 was administered April 6th at the same facility. Timeline was of event was consistent with dose 2, fever 24 hours later and blood in urine 48 hours later. Dose 1 I did an online visit with a doctor, to discuss issue and they informed me see if issue goes away in a day and if it does to not be concerned. This did happen so I continued onwards. Dose 2 I experienced blood in urine again and went to my family Doctor to be treated. They found high amounts of blood and protein in urine and sent me to the lab for diagnostics. about 32 hours from original onset urine appeared to be normal. On Monday the 10th I went in for an ultrasound. Results came back normal with no sign of issue. Due to the same complication occurring with identical timelines, I feel the vaccine interacts with my body negatively and possibly caused some type of acute kidney injury. My physician is hesitant to diagnose, but I am hoping the CDC can help me understand further what is going on. At minimum, I want to know if I should avoid further COVID vaccines, mRNA vaccines etc. and if I need to take any preventative measures protecting my kidney or body due to possible complications related to these events.

Patient lives with family in private residence with parents and 2 siblings. Spends most of time in own room. First family member diagnosed with COVID-19 on 12/21 2020, the other 3 family members diagnosed with symptomatic mild COVID on 12/26/2020. Parents are healthcare providers and used specific informed diligent protective strategies to prevent infection in patient with minimal close contact and gloves, masks. Patient never had symptoms and was not tested for COVID.. Had first vaccine dose on 1/16. On 1/17 had shaking chills with temp to 101.3F, gone on 1/18.. No other overt reactions. Subsequently in usual state of health. On 2/15 he developed vomiting and fever with progressive abdominal pain and transient wheezing. Outpatient testing for SARS-CoV2 was negative and full respiratory pathogen panel (including SARS-CoV2) also negative. With worsening fever to 40.2C and abdominal pain, was admitted on 2/18. Found to have high leukocyte count, low lymphocyte count and transaminitis. CT imaging with terminal ileitis, thought possibly infectious but extended GI pathogen panel negative. Experienced persisting daily high grade fevers to up to 39.1.C. Developed transaminitis and hypotension and was transferred to intensive care unit on 2/21. Was intubated for hypoxia, agitation, required levophed, large volume resuscitation and empiric antimicrobials. Had transient AKI. Antimicrobials stopped on 2/22 with negative cultures. Colonoscopy performed with leal biopsy of identified ulcerative disease with focal active enteritis without specific etiology identified by stains. Ferritin rose to 24,000 with hypertriglyceridemia and thought to have possible HLH and underwent bone marrow biopsy which showed leukocytosis and lymphopenia, and rare hemophagocytosis. Dobutamine was started for low LVEF and levophed weaned. High dose dexamethasone started on 2/23 and pressor further reduced, dobutamine weaned to off on 2/25. Extubated on 2/24. Febrile still to 39 on 2/24 and with leukocytosis but transaminases, ferritin and triglycerides improving. Discussion ongoing about HLH vs macrophage activation syndrome. Currently meets 4 criteria for HLH with soluble IL-2R and NK activity pending.

Next day unstable 1/26-1/27-1/28 Seizures 1/26- 1/27 -1/28 Behaviors 1/26-1/27-1/28 Total incontinence 1/26-1/27-1/28 Eye swelling 1/28-1/29 Red bicep 2/8 - 2/12

Patient received Moderna Covid vaccine on. 4/26/2021 approximately at 10:30am. After 10:00 am the next day, 4/27/21. Patient said he went to the restroom and noticed dark red clots in his urine. Patient took a picture which is on his phone. Patient says he has some discomfort in the lower left pelvic area. Patient stated that he has the urge to use the restroom to urinate more frequently. I advised the patient to see a doctor right away for diagnosis.

Gross hematuria with clots. AKI with elevated creatinine to 2.18 (Baseline <1.0). UA with moderate blood, positive nitrite, moderate LE, >50 rbcs Urine lytes WNL, Pr:Cr 3.3, Al:Cr 1,245 C3/C4 WNL US with mildly echogenic kidneys, a nonspecific indicator of medical renal disease.  No hydronephrosis. Thick-walled nondistended urinary bladder. Hgb decreased to 12.9 from 15 Pt underwent a kidney biopsy, pathology is still pending. He received aggressive IVFs and was monitored for 2 days. He was discharged following the kidney biopsy. At that time he was still having hematuria although it was improving and his hemoglobin was stable.

patient ambulated to the observation area after receiving the COVID-19 Moderna vaccine and experienced what appeared to be a syncopal episode that lasted for approximately 10 seconds with incontinence. Patient stated "everything went black". He said this has happened to him every time he has a blood draw or an injection but this is the first time he was incontinent. vital signs were stable throughout event. Transferred to local hospital by emergency medical responders and emergency vehicle.

Soon after the vaccine developed severe back pain, myalgias. . 4 days later ended up in emergency dept due to pain and inability to eat/drink. Also was unable to urinate. Work up there and in my office was fairly unremarkable

Gave patient his dose (2nd covid shot) around 12:50pm and about a minute after going over possible adverse reactions the painted said he did not feel good. He blackout but I quickly got him to lay flat on floor. During that time (about a minute) he had some jerking and wet himself a bit. I elevated his feet and called my technician just in case needed to call 911 and perform CPR/Epi but we didn't need to go that route. He loss his consciousness and quickly regained it after about a minute. I had him continue to remain laying down for 15 mins and then after patient felt comfortable I helped him back into seat inside vaccine room to monitor patient for another 20 minutes. After monitoring he was fine and left thanking me that I stayed calm to help him.

headache, chills, vomiting, extreme exhaustion, body aches, lack of appetite, brown urine, chills, hot flashes Symptoms lasted 5 days, on and off throughout each day.

patient states he was very nervous and worked himself up, patient then describes blacking out and urinating on himself, he did not request assistance and left after 15 minute wait time without notifying vaccine/clinic staff. His wife called later to notify us of his adverse effect.

Developed severe lethargy, chills, fatigue. After feeling this way, 1-2 weeks later, I got labs which indicated severe AKI and I was hospitalized for 30 hours and given fluids. Fortunately, I have near resolution of kidney function at this time.

gross hematura for 6 days starting on 2/26- painless told platelets 57K, no others s/s of bleeding or bruising self limited after 6 days to GU, renal sono nomal, scheduled for cystoscopy in May repeat cbc hct 40, plts 160K dx covid in January 2021 vaccine dose #1 on 1/5/21

Pt became diaphoretic, dizzy, tinnitus 5 minutes after immunization. Pt was sitting down and had a syncopal episode, urinated on himself. Lasted 30-45 seconds. Pt was disoriented afterwards. Didn't fall. After water and sitting down, pt became oriented and started feeling better. Pt is stable.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Additional Details: Patient received vaccine. Had not eaten anything that day prior to vaccination. Said he felt tired and closed his eyes for a minute but lost control of his bladder. Seemed shaky and sweaty. Blood pressure taken was low 90/50 initially at 222pm. Gave patient water and a protein bar. Blood pressure at 238pm 109/72. Blood pressure at 253pm 119/86. Seemed much improved after 30 minutes.

Systemic: Dizziness / Lightheadness-Severe, Systemic: Seizure-Mild, Additional Details: PATIENT STATED THAT THEY WERE DIZZY, THE PHARMACIST APPROACHED THE PATIENT RIGHT AWAY TO ASSESS. THE PATIENT HAD A MUSCLE CONVULSION AND THE PHARMACIST HELPED HIM TO THE FLOOR PREVENTING THE FALL FROM THE CHAIR. THE PATIENT ALSO URINATED. THE SYMPTOMS PASSED, BLOOD PRESSURE WAS TAKEN 122/82 BP, HR 99. ON A SCALE OF 1-10 (FEELING GREAT=1 , FEELING REALLY SICK =10) PATIENT FELT # 3., THEN #2 AFTER 10 MINUTES. INSTRUCTED PT TO GO SEE A PHYSICAN AT A WALK IN CLINIC TO BE ASSESSED.

Fix weeks after the vaccine I started to have severe abdominal pain, fever and blood in the Urine. It started with abdominal pain and the next day I had a fever. I went to the ER it was discovered that I had elevated Liver Function tests and Eosinophilia. There was Bilirubin in my Urine. I was discharged the next day. The fever persisted and I returned to the ER. My levels were much worse and my Eosinophil levels were climbing. I also developed a rash on my hands and feet. After extensive testing nothing definitive was found. I have not had any problems like this before.

On 5/31 patient developed acute abdominal pain and n/v. Evaluated 6/2 in hospital with fevers and dark urine, found to have elevated LFTs including bilis. Ultimately rehospitalized 6/6-6/13 for FUO, jaundice, transaminitis, fatigue. Also had conjunctivitis. No heart/lung issues. Had eosinophilia to 1000s. Ultimately required liver biopsy which showed hepatic congestion as if had cholangitis (but did not) and eosinophils. Ultimately discharged when LFTs and CBC stabilized.

Symptoms includes: Chills Vomit Nausea Diarrhea Tiredness Headache Muscle pain Dry heaving Dehydration Shortness of breath 20 pound weight loss in 15 days Has been in the hospital two times since the vaccination. Both times on a slow drip IV to keep him hydrated urine was the same color as apple juice (Real apple juice not from concentrate or watered down whiskey if you will). Did CAT scan of lungs found 4MM nodules that weren?t there before.

headache temperature of 100.4 temporary nausea (less than 30 minutes); no desire to eat/drink (ate egg, sausage, toast/ drank lemonade, fruit punch, and water) soreness at injection site (long-lasting) as well as noticeable weakness in left arm tiredness (not necessarily sleepiness, though did sleep on-and-off throughout the day); bizarre dreams, difficulty getting comfortable chills; teeth chattering and bodily shaking (uncontrollable); stayed in bed much of the time frequent urination, even with little fluid consumption temporary pain in the region of both kidneys (approx. 4 hours)

Severe chills, severe headache, body/muscle aches, 101+ degree fever, fatigue lasting 36 hours Sharp lower back pain on left side in the general area of kidney, dark yellow/brown urine output continues to present time.

Patient woke up on March 11 with vomiting and diarrhea, continued feeling ill through to the morning of March 15, when he was found to be lethargic and unable to communicate. I took him to urgent care where he was immediately rushed to the hospital emergency room at local hospital. He went into cardiac arrest for 20 minutes while in the ER. Besides the cardiac arrest patient presented with the following: Acidosis, acute renal failure, acute respiratory failure, shock, severe sepsis, septic shock, sepsis, right ventricular enlargement, pleural effusion bilateral, pericardial effusion, etc... Patient was in ICU and on a ventilator for 1 week, then 5 days in telemetry. He was released when stable as a diagnosis could could not determined. Discharge instructions were to follow up with primary care Dr for additional tests. Patient was discharged on March 26, 2021. He went to hospital March 30 for blood work for a primary care appt on April 2. Patient's blood pressure was again very low and his sodium level was dangerously low, he was again admitted to the hospital. After exhaustive tests it was determine he has Addison's autoimmune and Hashimoto's autoimmune diseases. He was discharged from hospital on March 5, 2021. Patient was put on hydrocortisone, fludocortisone, and levoxothorine. He is now doing fine on the medication.

After vaccination, patient was fine. He sat down for observation. 5 minutes passed and I heard "SOMEONE HELP". Patient was tensing up and unresponsive (looked like a mini-seizure). Patient peed on himself and after 3-4 seconds patient was fully responsive. Patient stated he was fine and didn't know what happened. Patient did not want me to call an ambulance and person with him told me not to call. We waited a little longer, patient complained of feeling really hot. He laid down on the floor and I gave him some water and a lollipop to increase sugar levels. After 3-5 minutes patient sat down on the chair and stated he was feeling much better. After a few minutes, he complained of wanting to vomit. As soon as I was able to give him a bag, he violently threw up. Patient stated that he was now feeling much better. He went to the bathroom and cleaned up. After a little longer observation, patient said he was fine and wanted to go home. They left. I called patient an hour later and he stated he felt fine and was just resting. Will follow up with patient tomorrow.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: Urinated on himself

About 2 minutes after receiving vaccine patient was seated on bench outside pharmacy, fainted and fell forward onto cement floor hitting his jaw. Patient was unresponsive for about 20 seconds while being attended to. Once he regained consciousness, he was helped to sit back on bench. He was diaphoretic and claimed to have a racing heart and right hand tingling. He lost consciousness on the bench again and lost bladder control. EMS was summoned and was on scene in 5 minutes. Patient did not claim to have difficulty breathing. Pharmacist called patient about 3 hours after the event and he was still in hospital with apparent problems keeping his blood pressure adequate.

PATIENT COMPLANED OF LIGHT HEADEDNESS AND THEN PASSED OUT TURNED COMPLETLY PAL ONCE AWAKEN STARTED HYPER VENTELATING AND URINATED ON SEL. AFTER BEING ASSESED BY EMS AND MP HE WAS STILL FEELING DROWSY

Woke up with feelings of "electric jolts" to right side of face, neck and down both arms. Accompanied by dizziness and loss of motor function (both legs and arms/hands). Loss of balance and inability to walk properly. More back and neck pain weakness and nausea. Discomfort in spine. Feelings of loss in urinary control.

Initially, patient stated a sore arm after vaccination. after 24-27 hours elapsed, pt states having some radiating pain from the shoulder to the neck of the left side, and radiating pain from the right knee to the right food. Each bout of pain would last to a maximum of 30 seconds, with varying lengths of time per bout. The pain radiating to the foot was pulsating per patient. Patient stated very sensitive chest feeling when the urge to urinate came. Through the emptying of the bladder, the sensitivity continues, and is gone after urination is finished. There can be some radiating pain from kidneys to the bladder at this point too.

Urinary tract infection symptoms. Feeling of urination urgency, burning sensation, testicular inflammation. Diagnosed as acute right epididymitis by urgent care clinic. Treated with a single shot of Ceftriaxone plus 7 day treatment of Doxycycline 100mg twice per day. Still under treatment, symptoms improving but still present.

Became sick, dizzy throwing up, Kidney hurting. Went to doctor was sent to hospital was found to have enlarged prostate. Then had a lump come up under left arm same arm shot was given and was told my lymph nodes were swollen.

3/19 Resting Pulse 105-120, Walking Pulse 120-140, Pulse Ox: 95, Temp: 100.0 3pm ,101.1 4pm. Throbbing on and off head aches in Parietal, and Frontal Lobes, started at 5-6PM. Upper body Pain in joints and lymphatic system. Lower Body pain in Right knee at 8pm. Renal/Flank pain most likely due to dehydration. Memory confusion and General Confusion, dizziness, foggy memory. Swollen Right Deltoid, subcutaneous heat at the injection site that can be felt through a polo shirt. 3/20- Flank and Kidney Pain. Memory confusion and General Confusion and Foggy memory still remains . Swollen Right Deltoid, subcutaneous heat at the injection site that can be felt through a polo shirt. 3/22- Memory confusion and General Confusion and Foggy memory still remains. Swollen Right Deltoid, subcutaneous heat at the injection site that can be felt through a polo shirt still present. 3/20- Memory confusion seems to be improving but foggy memory still remains. Swollen Right Deltoid, subcutaneous heat at the injection site that can be felt through a polo shirt still present.

Gross blood in urine lasting 2 weeks. Trace amounts of blood still present. Metallic taste and smell.

After my first dose of the Moderna vaccine on 12/31/2020 I had symptoms of a urinary tract infection, which I did not think was related at the time and considered it a fluke. Today, however, after the second dose the symptoms are worse (more pain while urinating, lots of blood in urine, frequent urgency). I have an appointment in the morning to see a doctor about the cause but this happened after both vaccine doses.

Blood in urine, resolved after the aforementioned medications for 3 days, returned after second dose of Moderna COVID19 Vaccine. Additionaly flu like sxs were in evidence.

numbness on face and tongue, pain on both sides of kidney area, headache darker orange urine, joint pain specially still have pain on knees joints and they make noise when bending.

Symptoms: Extreme fever, body aches, chills, sweats, fatigue, dark urine/blood in urine Duration: Saturday night - Sunday night (ongoing fatigue, aches, and dark urine/blood in urine)

Started with feeling really cold, unable to warm up. Checked my temperature and it went to 102.7 stayed above 101 for 14 hours. Severe leg and lower back/kidney pain for 8 hours. Chills on and off all day. Severe dry mouth no matter how much I drank. Headache

elevated liver enzymes since moderna vaccines/ ALT/AST both elevated since vaccine. Pt notes that he is still not feeling well. He notes that he has had a slight fever (99.5-101F) along with chills. He notes that he was able to go to golf and play however, he still feels sluggish. He notes that when he breathes, his back is in a lot of back, all over, and his urine is very dark in color and very strong smelling. Denies urinary burning, frequency, or urgency. No loss of smell, no loss of taste. Denies shortness of breath, chest pain, nausea, or vomiting.

Vaccine administered on 3/3/21 . One 3/4/21 pt stated that he had a headache but figured it was due to getting the vaccine as described during education about the vaccine. On 3/8/2021 patient awoke with nausea and vomiting. Upon void he stated his urine was dark brown. Contacted medical services. Medical assessed and the patient was then transported to Medical Center.

During the waiting period after receiving the immunization, the patient had a syncopal episode in the waiting area. The syncopal episode lasted only a few seconds and the patient had loss of bladder control. This was witnesses by the waiting area staff. The patient was immediately evaluated by an RN and EMS that was present at the facility. The patient stated that he has had similar reactions to vaccinations in the past except the loss of bladder control was new. The patient quickly recovered and stated he felt fine but embarrassed and wanted to call his wife and go home. He refused further treatment stating that he feels fine now and that this has happened before. After observing the patient for approximately fifteen more minutes and ambulating him to the restroom to clean up, the patient's wife arrived and he ambulated out to the car without difficulty.

On 4/13/2021, strong chills and mind racing followed by fatigue. Then on or about 5/3/21, onset of severe anxiety, panic attacks, raised blood pressure, buzzing in left thigh muscle, loss of appetite, frequent urination, strong urge to urinate, not able to sleep, feel on edge at all times, cannot focus, brain fog, fatigue. On 5/7 GP increased desvenlafaxine to 100 mg and prescribed lorazepam .5 to 1 mg to sleep. On 5/14, no improvement of symptoms, added buspirone 3 times a day. As of 5/24, no improvement in symptoms, muscle buzzing is worse, and hands are unsteady. Still no real appetite, constant cold sweats and headache.

June 13, 2021. Went to hospital for shortness of breath and chest tightness. Temp 99.2. DX: )Acute non-ST segment elevation myocardial infarction, Acute coronary syndrome ; Pulmonary edema Transferred to Medical Center Negative Covid test on June 13, 2021. Positive Covid test June 16, 2021 at Medical Center

Same day of vaccination later on at night I got a fever of 105F, felt very nauseas, every time I stood up I felt like I was going to pass out & my blood sugar was high. This event lasted about 48hrs but I'm also experiencing swelling & problems with unration. I'm still waiting to get in contact with my doctor. Have not fully recovered from advers event waiting to get lab work done.

passed a kidney stone in his urine.; elevated temperature at night.; back pain in his left side.; throw up every hour from waves of pain/vomit every time his pain increased; nausea and vomiting that correlated to the dull burning pain; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (passed a kidney stone in his urine.) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) 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 medical history reported). On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (elevated temperature at night.), BACK PAIN (back pain in his left side.), VOMITING (throw up every hour from waves of pain/vomit every time his pain increased) and NAUSEA (nausea and vomiting that correlated to the dull burning pain). On 24-Mar-2021, the patient experienced NEPHROLITHIASIS (passed a kidney stone in his urine.) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (passed a kidney stone in his urine.), BODY TEMPERATURE INCREASED (elevated temperature at night.), BACK PAIN (back pain in his left side.), VOMITING (throw up every hour from waves of pain/vomit every time his pain increased) and NAUSEA (nausea and vomiting that correlated to the dull burning pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was included One extra strength Tylenol, three naproxens, water and Pedialyte Based on the current information available and the temporal association between the product use and the onset of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current information available and the temporal association between the product use and the onset of the events a causal relationship cannot be excluded.

Patient with cardiogenic shock due to severe myo-pericarditis, severe inflammatory response with high fever up to 104. Cardiogenic shock requiring placement of Impella support.

Adverse events on 4/22 was arm pain, fever and headache Adverse events on 4/23 was arm pain, headache, change in urine color Adverse events on 4/24 was red rash near injection site

myocarditis; abdominal discomfort; fever; chills; malaise; fatigue; chest pain; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of MYOCARDITIS (myocarditis), ABDOMINAL DISCOMFORT (abdominal discomfort), PYREXIA (fever), CHILLS (chills), MALAISE (malaise), FATIGUE (fatigue) and CHEST PAIN (chest pain) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Glioblastoma multiforme (in remission) in 2018 and CVA in 2018. Concomitant products included TEMOZOLOMIDE (TEMODAR) for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion hospitalization), ABDOMINAL DISCOMFORT (abdominal discomfort) (seriousness criterion hospitalization), PYREXIA (fever) (seriousness criterion hospitalization), CHILLS (chills) (seriousness criterion hospitalization), MALAISE (malaise) (seriousness criterion hospitalization), FATIGUE (fatigue) (seriousness criterion hospitalization) and CHEST PAIN (chest pain) (seriousness criterion hospitalization). At the time of the report, MYOCARDITIS (myocarditis), ABDOMINAL DISCOMFORT (abdominal discomfort), PYREXIA (fever), CHILLS (chills), MALAISE (malaise), FATIGUE (fatigue) and CHEST PAIN (chest pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Acute kidney injury: unknown (Inconclusive) unknown. In 2021, Angiogram: abnormal (abnormal) Bilateral lower lobe patchy and ground glass airspace opacities and mild degree of ground glass opacity within the peripheral right middle lobe.. In 2021, Echocardiogram: abnormal (abnormal) severe Hypokinesis of the mid to distal segments and apex, hypercontractile base--> estimated EF = 30% (Last known baseline 3/2019 EF 65%).. In 2021, Electrocardiogram: abnormal (abnormal) abnormal. In 2021, Fibrin D dimer: increased (High) increased. In 2021, Hyponatraemia: abnormal (abnormal) abnormal. In 2021, Leukocytosis: abnormal (abnormal) abnormal. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Transaminases increased: abnormal (abnormal) abnormal. In 2021, Troponin: abnormal (abnormal) elevated troponin of 12. 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. Treatment was unknown. Continued to be hypotensive despite fluid and initiated on Levophed. Taken to cath lab with no evidence of coronary disease, LVEF down to 10% on LV gram, right heart catherization with evidence of elevated pulmonary capillary wedge pressure, patient was placed on Impella CP support. 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.

Admitted to hospital with rhabdomyolysis and renal failure. Also reported severe headache and abd pain prompting CT scans.

For the next 36 hours, my urine turned a dark amber to brown color. It was darkest in the 12 hours following the injection, and gradually returned to normal color within 48 hours. It was deeply dark, with what I would describe as a alkaline or sharp scent to it. Again, it returned to normal within 48 hours of receiving the vaccine.

Complaining of "not feeling well" the night after the vaccination and progressively got worse in the next days to come. Patient stated that he had been having black tarry stool and after a urine dip he was identified to have blood in his urine.

Patient had pallor and dizziness. He then experienced a syncopal event with subsequent seizure. The seizure was accompanied by loss of bladder control. Patient rapidly regained consciousness and had minimal post ictal state. He has no history of previous seizure though his mother had a seizure disorder. Patient was sent to the emergency department where he was given IV fluids, and bloodwork was noted to be normal. Was discharged in 1 to 2 hours to home. He states he is doing well this morning.

I received my first shot on 1/12/21 and felt weakness and lethargy initially. I was not able to lift the same amount of weight nor stay on a cardio machine as I once did (I exercise daily). It never improved. After my second shot on 2/9/21 I began to develop symptoms of DKA (diabetic ketoacidosis). I was awaking up at night, drinking a 40oz bottle of water and urinating every hour during hours of sleep. I lost a significant amount of weight as well (I was questioned at work about it). I have no family history of diabetes and I have always been lean and fit. I went to the doctor on 2/27/21 because symptoms became overwhelming.

I was diagnosed with UTI. They said there was small traces of blood in my urine. They gave me prescription to this. It seem to clear up. I had served pain on July 5th in my groin area. It felt like I was passing a kidney stone. I went to the ER. They did blood work. They gave me a CT scan, that was fine. They gave me pain medicine. They did not know what is causing it. I had a cystoscopy done, that can back negative. They did another urine sample, negative on infection. They gave me antibiotic just in case. They thought that my prostate was inflammation. They gave me medicine for that, and it seem to help.