Moderna

Mild fever, increased pain in my neck and shoulder that were previously a bit sore from an old injury, my hand felt "tight and sore" and so did the "bones in my head". I do suffer from that when we have a storm and one was on the way, but it was more intense than normal. I had 4 bouts of very urgent needs to urinate that is not normal for me and the urine was very dark, not the typical light yellow. I was not otherwise ill or dehydrated that perhaps would've caused that to happen.

Tuesday in the early am, I woke up and I took my temperature - it was 101.2 (I had taken Ibuprofen 5 hrs prior). I got something to eat and then I took 800 mg of Ibuprofen. I bundled up - h ad chills and fever. Left arm was killing me. I went back to bed. I could hardly move my left arm. I oculdn't lay on it - the ibuprofen didn't work. I had to call out of work. I cancelled Tuesday. I was in bed. I drank a lot of water before the vaccine and after the vaccine. I had soup broth, tea, juice, cider. I slept 3-4 hour nap in afternoon. Diarrhea and cramps late tuesday night - bathroom and bed all of Tuesday. Had a fever again on Wednesday night - 101 (oral). Tired. Left arm was killing me. I continued 800 mg ibuprofen every 6 hours on Tuesday. I started VIT DE again. I was mostly exhausted and my arm still hurt badly. on Wednesday and Thursday. Thursday didn't take any ibuprofen - pushed through the day. On the 5th of February, for the first time in my life - left flank pain; sharp left lateral pain. I couldn't pee for three hours. I was drinking three quarts of water. For the most part, it didn't hurt a lot to move my left arm but it hurt. Bladder was not full even though I couldn't pee. I went to URGENT CARE - Doctor on Duty - (Friday, the 12th) UA - no nitrates; large amount of blood but everything was normal. No growth after 48 hours. Flomax - dialator and started to urinate. I didn't have any sense that I had to pee. Friday, the 5th, I took the Flomax once a day - 0.4 micrograms - I took it Friday and Saturday. I did abdomen warm compresses in my abdomen and back. I did it on Sunday twice, two. I started back up on Ibuprofen on Friday, Saturday. Monday - I got my PCM - Monday the 15th - He did a UA and I had no blood. I stopped Ibuprofen on Monday. He is going to do a renal ultrasound. I had never had a kidney stone but he has put in a referral to get that done. Tuesday (after President's day) - UA results - negative and no blood and he wasn't going to send it for culture. I still have minor left flank pain here and there.

Tingling back of head. Numbness cheeks, upper lip, gums, nose. Loss of peripheral vision right eye. Taste like lidocaine in saliva. Fluid retention. Extreme thirst and lack of urine. Brown urine. Swelling tongue. Lacy red rash on abdomen and legs. Headache. Dry skin with itching forehead.

Soreness at injection site immediately post vaccination. This was followed by extreme joint pain the next day and back spasms, which persisted for multiple days. Developed a urinary tract infection within 24 hours of vaccination, which required treatment by primary care physician.

Urinary tract Infection; Kidney Infection; did not receive second dose; A spontaneous report was received from a consumer, who was also a 60-years-old Female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who had Urinary tract Infection, did not receive second dose (Product omission issue) and Kidney Infection. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 04 Feb 2021, prior to the onset of the symptoms, the patient received her first of the two planned vaccine doses of mRNA-1273 (Batch number: 010M20A) via an unknown route in the left arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient was admitted to hospital for two days for urinary tract infection and kidney infection. On an unknown date, the patient was discharged, and treatment for the events included higher antibiotics and other treatment during hospitalization and post discharge from hospital. Higher antibiotics was continuing at the time of report. It was reported that the patient was due for her second of the two vaccine doses on 03 Mar 2021, however, she did not receive the second dose. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, Urinary tract infection, Kidney Infection, and did not receive the second dose, was not reported.; Reporter's Comments: This report refers to a case of Product omission issue for mRNA-1273, lot # 010M20A. Additionally, patient experienced Urinary tract infection and Kidney infection and was hospitalized. Based on the current available information and infectious nature of reported event both events were assessed as unlikely related. The subject's gender can be a confounding factor in leading to increased risk of UTI.

On day 7 I noticed what looked like a mosquito bite on upper left arm and same on right arm. By the next day, there were numerous marks on my left arm including my hand. The marks were very itchy. It resembled chicken pox or poison ivy. The marks continued up the left of my face and and into my hair line and up my ear. I was also feeling an itchy painful burning in my private area. It was very painful to pass urine or have a bowel movement. The rash continued to break out all over my body for 5 or 6 days. I was put on Prednisone for 17 days. I did not feel the prednisone helped. At 2 1/2 weeks I still have the rash although it is fading.

After a few minutes started feeling sluggish, pain in abdominal, ribs, bladder, not feeling well for x2 weeks. Cystitis flared up, gastroenteritis, auto immune worse. 2wks not feeling better went to MD and started on Augmented x4 days with no relief. Went to see holistic MD and prescribed herbs that helped.

Severe headache that woke me from sleep at 15 hours post vaccination; then at 24 hours post vaccination, typical side effects began with chills, aches and tiredness. However, at 28 hours post vaccination, my fever climbed to 102. I had such severe body aches, I needed assistance to get up and was nearly impossible to walk or move. I had no appetitie. I decided to take 2 extra strength tylenol to aid in the fever/chills and severe headache. Unfortunately, two days prior to vaccine, I was diagnosed by CT scan that I had a kidney stone. It was being treated with Toradol, which I only took at bedtime with the also, prescribed Flomax. The Toradol did little to assuage my body aches, incidentally My fever only came down to 101.4 . It remained between 101.4 and 102 until 48 hours post vaccination, when it finally went down to 99.2. I could only get out of bed to use the bathroom. I drank at least 2.25L of water daily because I was flushing a kidney stone, so my fluid intake was very strong. I knew that many of my friends/relatives have had the 2nd shot, so I messaged with them, but nobody had had a fever over 102. I knew if I did not take anything, it would've easily been 103F. I was confused and couldn't gather my thoughts. Things had to be repeated to me, but fortunately, I slept a lot and the worst of the symptoms was during my sleep at night and I had horrid nightmares. By 56 hours post-vaccination, I could function, but I was severely exhausted. By 72 hours post-vaccination, I had tried to resume low level activity, but was too exhausted and took a 3 hour nap in addition to sleeping 12 hours/night since I had the vaccination 5 days ago. My arm is still very sore, but not as immobile as first shot. I still have very little appetite and my headache lasted 3 days. I'd consider myself general recovered from the worst of the fever, body aches and fatigue.

Patient presented to with 4 day history of progressively worsening pitting edema and swelling in bilateral lower extremities. She reports mild shortness of breath. She also reports flank pain and dysuria. Cardiac murmur and rales noted on exam. Patient found to have a heart failure exacerbation and UTI. Patient is being treated with levofloxacin and furosemide and is admitted to the hospital.

101 fever for 6 hours, 99 fever for 15 hours, severe fatigue, body aches with muscle spasms, no appetite, no taste, frequent urination, headache. Self care at home. Most improvement within 24 hours but appetite has not fully returned not taste.

Patient had severe bloating, abdominal swelling, inability to urinate, loss of appetite, vomiting, vomiting blood, bright red rash that looked like a severe sunburn on stomach, chest, neck, arms, and back, dizziness, trouble walking or standing.

Dark urine 5 days Tinitus ongoing Low grade fever hot feeling inside ears resolved 3 days Lymph node swollen R armpit and both sides of throat resolved 5 days Pain overall intense off the charts body pain I had to take medication resolved 3 days

been bleeding since I get the shot; felt like peeing and blood start pouring out; My left leg felt like it was coming apart,other staff is coming from my body; This spontaneous case was reported by a consumer and describes the occurrence of GENITAL HAEMORRHAGE (been bleeding since I get the shot) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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 GABAPENTIN for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GENITAL HAEMORRHAGE (been bleeding since I get the shot) (seriousness criterion medically significant), URINARY INCONTINENCE (felt like peeing and blood start pouring out) and PAIN IN EXTREMITY (My left leg felt like it was coming apart,other staff is coming from my body). At the time of the report, GENITAL HAEMORRHAGE (been bleeding since I get the shot), URINARY INCONTINENCE (felt like peeing and blood start pouring out) and PAIN IN EXTREMITY (My left leg felt like it was coming apart,other staff is coming from my body) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for pain in extremity included Tylenol. 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. This case was linked to MOD-2021-163847 (Patient Link).; 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.

Started with flu like symptoms. Gradually got worse. Joints hurt. Migraines worse, hands shaking , head shaking, nausea, menstrual like cramps (menopause done for over 10 years), hot flashes so bad I vomited lower back hurt,, kidneys hurt. Started gaining weight. I have gained 30 pounds since being vaccinated. 4 days after 2nd shot I gained 19 pounds in one day. My blood test from obgyn says my ovaries are producing estrogen again therefore I will have to through menopause again. Once was bad enough

Shortness of breath began the first week of April. Thought I had caught Covid. Shortness of breath became increasingly worse throughout the month of April. Could not breathe at night. Went to emergency room May 5. Diagnosed heart failure 30% function. No known medical issues before vaccination. Currently wearing defibrillator. Kidney function stage three. Had a very active busy lifestyle, upstairs apartment Before vaccination. Now fighting for my life.

Kidney function and platelets low; Chest Pain; A Lot of coughing; Phlegm; Feeling that something is sitting on my chest; Shortness of breath; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of RENAL IMPAIRMENT (Kidney function and platelets low) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history provided by the reporter. Concomitant products included LOSARTAN, ATORVASTATIN and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced CHEST PAIN (Chest Pain), COUGH (A Lot of coughing), PRODUCTIVE COUGH (Phlegm), CHEST DISCOMFORT (Feeling that something is sitting on my chest) and DYSPNOEA (Shortness of breath). On 27-May-2021, the patient experienced RENAL IMPAIRMENT (Kidney function and platelets low) (seriousness criterion medically significant). At the time of the report, RENAL IMPAIRMENT (Kidney function and platelets low), CHEST PAIN (Chest Pain), COUGH (A Lot of coughing), PRODUCTIVE COUGH (Phlegm), CHEST DISCOMFORT (Feeling that something is sitting on my chest) and DYSPNOEA (Shortness of breath) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Oxygen saturation decreased: low (Low) low. On 27-May-2021, Platelet count decreased: low (Low) low. On 27-May-2021, Renal function test: abnormal (abnormal) abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The labs include blood tests, chest scans, x-ray, CT scans, and echocardiogram whose results are not provided. Treatment information not given. The patient visited an urgent care, followed by Emergency department for the events and discharged on same day. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

the first vaccine i was just with a headache and a bit tired , after the second vaccine , i felt it coming on 3 hours , by 6 hours later i was getting achy , by 12 midnight which was 12 hours later i had sort of like flu symptoms , then shaking and teeth chattering uncontrollably ,i had a fever not sure how high it went . i took extra strength tylenol. i was feeling crumby still on day 3 but was much better then prior 12 to 24 hours. also very sore shoulder on both vaccinations. last night which was july 1 i woke and for a brief moment my teeth were chattering ,then it stopped. i have no sign of fever even tho i have a uti . i am on day five of antibiotics.

Covid positive 1/29/21. 2/1/21, hypoxia, tachycardia. Admitted to hospital 2/1/21. Diagnoses: UTI, Covid-19 infection, hypoxia, sepsis.

I woke up and I couldn't take a deep breathe as the day went on It was harder and harder to breath. It felt like a stabbing pain in my back by my kidney. I hadn't done activity that day. I toughed it out till Monday and went to the walk in clinic. I was given anti-inflammatory and muscle relaxers. Symptoms went away in 24 hours.

2 days post-vaccination developed rash, muscle aches, nausea, diarrhea, vomiting and fever. 10 days post-vaccination admitted to hospital with acute kidney injury and hypotension. Released on oral steroids for presumed hypersensitivity reaction. Admitted second time 36 days post-vaccination rapid worsening of rash, nausea, vomiting, diarrhea, fever and hypotension. Discharged to community on oral steroids

I started developing a fever of 100.2 around 11:30pm on 2/3/21, 13 hours after receiving the vaccine. My fever rose to 101.3 by the following morning. It started to drop to 100.2 again by 9:30pm on 2/4/21 and was 99.5 by 10am 2/5/21. I had a severe headache that started as gentle pressure about 2 hours after being vaccinated and escalated to feeling like my head was in a vice through the morning of 2/5/21. I had severe hip and knee joint pain and muscle pain all of 2/4. I was unable to walk because it hurt badly to put weight on my joints. I had a stiff neck and couldn?t turn my head more than 45% in either direction. I slept no more than 20 mins that night due to the pain. On 2/4 I developed nose bleeds and incontinence. Those symptoms went away by 2/5. Dizziness and lightheadedness, fatigue and headache stayed with me for 2 weeks. I am still more tired than usual.

Systemic: Patient started with a fever overnight beginning at 9pm, got up and went to work and started developing shortness f breath and chest pain. She worked for 6 hours and went to the ER. She was diagnosed with a UTI and elevated troponin levels-Severe, Additional Details: Her BP on admission was 178/100, troponin levels went down, she was NPO the next day and then went home.

Pt had first Moderna Covid vaccine (015M20A) 3 weeks on 2/14/21 ago and second one last Sunday 3/14/21 (024M20A). Initial vaccine - reports an immediate HA prior to sitting down for 15 min post injection waiting period as well as arm redness, and abd pain that felt like "spastic colon or diverticulitis" with pain and diarrhea. Does not have these medical conditions. 2nd vaccine - Again developed immediate HA, arm redness that was worse, fatigue, myalgia, fever Tmax 100.4. Yesterday she was at store and got dizzy, developed back pain, then rash, and then bladder, frequent urination, and dysuria. )

High fever, dark urine and not able to urinate efficiently even though well hydrated for approximately 3 days. Have been having similar reactions to flu vaccinations.

Middle of the night last 8ghr stabbing pains in area of stomach and abdomen. Also intense nausea. Pain so bad I could nearly death...couldnt move. Tried to take long breathes and slow things done but it was far too intense. I have major GI issues and have had an ERCP. Monday the day before I had a four hour gastric emptying test with nuclear aspects that was in some of the egg whites I ate. They said there would not be any side effects...i do thing that related to the vaccine side effects and created the perfect storm for an over 3 hour stomach attach. Couldn't have bowel movement although I felt like it was needed. Couldn't throw up yet I was extremely naseaus. Very sore and swollen arm today where vaccine was given...very very thirsty today.

severe arm pain 3 days, dizziness, nausea, irritated urination, severe stomach pain, pinching in bladder, double vision, chills

Blood in stool; Stomach Pain; Blood in Urine; Uncomfortable; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool), ABDOMINAL PAIN UPPER (Stomach Pain) and BLOOD URINE PRESENT (Blood in Urine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced HAEMATOCHEZIA (Blood in stool) (seriousness criterion intervention required), ABDOMINAL PAIN UPPER (Stomach Pain) (seriousness criterion intervention required), BLOOD URINE PRESENT (Blood in Urine) (seriousness criterion intervention required) and DISCOMFORT (Uncomfortable). At the time of the report, HAEMATOCHEZIA (Blood in stool), BLOOD URINE PRESENT (Blood in Urine) and DISCOMFORT (Uncomfortable) outcome was unknown and ABDOMINAL PAIN UPPER (Stomach Pain) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication not reported. Patient went to ER and was treated there on 01Apr2021. 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.; 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.

The patient received the Moderna vaccine on Monday 4/12/21 and called today 4/14/21 stating they were experiencing side effects they believed to be related to the moderna vaccine. Side effects include per the patient problems with holding urine, felt really sick, and troubles walking (need to use their walker more often).

pain at injection site - cough- fever- headache- nausea- vomiting- chills- unbalanced walking- the need to sleep constantly for 20-plus hours

Became acutely ill early morning of 12-30. I was then seen in ER by DNP with diagnosis of covid pneumonia, UTI, high CRP and shortness of breath.

Sudden frequent urination and incontinence post 4 hours after 2nd dose. Continuing through next day post injection. Currently unresolved.

Currently in hospital as of 06/ 05/ 21 kidney blockage/ surgery needed, Uti, pneumonia, possibly more. Daughter also was in hospital with lung problems...got shots at same time.

Left side of body - left breast sensitive, left kidney pain, whole left side numb after sleeping on that side. Arthritic pain increased significantly. Numbness went away after a couple days. All other symptoms except arthritic pain subsided but still feel a little. Significant arthritic pain still the same as of now.

about 14 hours after the second dose I had gross hematuria for 48 hours it continued to show up in lab tests for 2 months following however in trace amounts. Tested for kidney stones and one was found in the left kidney. It may be the cause of hematuria but it is unknown.

Day 1: Fever, chills, sweating, incontinence, diarrhea, vomiting, extremely cold hands and feet, swollen left arm with large red raised area 6" x 8". Continued through day 3. Day 3: cold sores, bleeding gums and mouth sores,. Week 2: itchy rash on lower left arm,

High fever and chills lasting 3 days. Extreme body pain (level 8) lasting 2 days. Level 10 pain in both legs. Extreme swelling in both feet and ankles with small white blisters on top of both feet. Level 10 headache still have it. Diarrhea beginning 07/24/2012. Loss of appetite. I have not eaten for 3 days, Very tired, I slept for 2 days. Extreme pain, level 10 now in lower back. Constant urination, 12-15 times in 24 hours lasting 3 days.

Started getting the chills, a severe headache and fever of 101.3. Nausea the next day was unable to eat, chilling all day with a fever, extreme tiredness, back pain, diarrrhea and eyes hurting, fever rising to 101.5. Fever on Monday dropping to 99.9 and chilling with no energy. Tuesday back still hurts, no energy, had dark urine in the am. diarrhea in the afternoon. Lost 7 lbs.

24 hours after the vaccine I had a 102 fever overnight. The next day, my feet were hurting, like burning. They continued like this but with fluctuating severity. My calves and shin muscles began to be sore. I sought out acupuncture and myofascia release work to help. It did help temporarily. I started to have left ankle pain, not like a sprain, like tendonitis or inflammation. It continued to hurt to walk and the muscles more painful. I started having darker urine about 4 days after the vaccine. I drank cranberry juice and took a kidney/bladder supplement, increased fluids, but it continued dark. I went to the Urgent Care on January 7th c/o muscle pain and dark urine. My blood pressure was elevated, 179/100..unusual for me, and my urine was neg so it was sent for culture and blood was drawn for CBC and metabollic panel and Creatine Kinase

The first day I had some heart palpitations in the afternoon about 3:00 -3:30 P.M. I also was tired. Five days later I was sick and vomiting and my blood pressure was elevated, but I was uncertain if that was caused by the vaccine.

Lower back pain and kidney pain that started in the evening after receiving 1st Moderna COVID19 dose on 1/22/21, and has continued (1/25). Patient was advised to call public health COVID-19 hotline to call and visit a local clinic for followup.

Metallic taste post injection Fever 102 degrees (by 8pm eve of shot) Tylenol only reducing fever to 101 Severe chills/shakes Insomnia Confusion Dizziness Tachycardia (125 bpm) persistent the first night) Loose stools Incontinence

About 9PM after the receiving the vaccine I started had riggers which lasted for about an hour. I couldn't reach for my phone or call for help. I either passed out or fell asleep. Around 1AM I woke up and checked my temperature 102.7. Some point after I took some Tylenol but don't remember when. I finally had to call for help from my family in the morning because I was not able to pee or drink. Tuesday was my fever was still 102.7 with taking Tylenol and Advil it would just go back up. Tuesday I had Riggers again about 5:30 it only lasted 3-5 minutes. Wednesday my fever went down to 101.4-101.5. Have had difficulty swallowing when the fever is high, did not feel as if I had a allergic reaction or that my throat was sore it was just hard to swallow. I have a weird bruise on my arm I have clue where I got it. I didn't urinate for 9 hours. Headache. Pulse OX was at 93-94 for Monday and Tuesday but then it came it up 95-98 yesterday. As of today I still pretty weak no fever when I woke up.

Bad headaches, severe achee body, peeing constantly all night, felt sick to stomach started fading away slowly by Wed night

Day 1 (1/19/2021) First symptom was vomiting at 12:30 p.m. then more symptoms developed after vomiting including chills, headache, achy from head to toes, pain radiated from injection site to fingers after vomiting episode. At 2:30 p.m., event of diarrhea. At 3:30 p.m. 100.2F temperature recorded Severe tiredness and increased thirst which led to increased urination Fever broke at 8:00 p.m. and temperature recording was 98.5F Next morning: symptoms of swollen face, difficulty breathing (band around chest feeling), post nasal drip, body aches After 3 days, symptoms gradually went away.

Renal pain, throbbing like calculi, intermittent, recurring. today is Feb, 21 and it is still happening. I am pushing fluids and taking Tylenol.

I am experiencing blood in my urine. After the first covid shot, I noticed my urine was slightly pink and this cleared after one day. After this second shot, the blood is more prevalent and my urine is darker. I do not have any other signs of a UTI. I had a fever yesterday but nothing today. There is no pain when I urinate. I do not have a history of UTI's at all.

Approx. 20 hours after 2nd dose: Woke up feeling nausea, fatigued, fever, chills. After 1 episode of nausea, I started experiencing more than mild muscle cramps. Could not lay on either side. Darkened room because light/ sound was adding to already severe headache. Used cold washcloths on forehead. Was having trouble trying to walk, use restroom, frequent urination but could only sip water. Over the next 24 hours...just slept and used bathroom. Severe muscle cramps, chills, fever, headaches. Called my Dr.'s nurse-she advised to hydrate and to go to ER if needed. 24 hours later, I realized I would be okay...but took me another 24-36 hours to feel 80% normal. Lost 8LBs. during 48 hours. Experienced extreme dreams/delusions.

Return of mild aches and pains associated with internal inflammation of upper and lower abdomen and pelvic area. Similar aches and pains experienced when recovering from the abdominal surgery. Difficult to urinate and move bowels again. Began taking an anti-inflammatory again.

102 Fever, Hives, muscle aches, joint pain, dizziness, lethargy, nausea, chills, diarrhea, eye pain, headache, neck/back pain, swollen at injection site and armpit, loss of bladder control 1st night, excessive urination.

Severe muscle weakness, chills, burning eyes, dark orange urine, kidney pain, migraine headache, nausea, chest heaviness but not short of breathe. 27 hours in bed except to go to the bathroom, weakness so severe it hurt my whole body to turn on my side.

new report continuing from VAERS Report # 379858.....swollen glands, pink urine, dizziness, continued weakness, swelling nose, nostril sores forming,

A spontaneous report was received from a consumer concerning a 62-year-old, female patient who felt like a needle in her kidney/renal pain, feve/pyrexiar, fatigue, tiredness/fatigue, chest pain, upset heart/cardiac disorder, headache and inflammation of heart muscle/myocarditis. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine, metformin, glimepiride, simvastatin, losartan. On 16 Mar 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number: 001B21A) intramuscularly for prophylaxis of COVID-19 infection. On 16 Mar 2021, 5 minutes later she experienced felt like a needle in her kidney. On 17 Mar 2021, she had fever. On an unknown date in Mar 2021, she had fatigue and tiredness. On 20 Dec 2021, she had chest pain and upset heart. On 21 Mar 2021, she had a headache and fever. On 22 Mar 2021 she had chest pain and went to the doctor and was diagnosed inflammation of the heart muscle. The event inflammation of the heart muscle was assessed medically significant. Treatment for the event included acetaminophen. Action taken with mRNA-1273 in response to the events was not provided. The events felt like a needle in her kidney was resolved on 16 Mar 2021. The events fever and headache were resolved on 21 Mar 2021. The outcome of the evens fatigue, tiredness, chest pain, upset heart and inflammation of heart muscle were unknown.; Reporter'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.

Arm became sore at 8pm on the day of the 2nd shot, and was progressively worse throughout the evening and night. Around 11:30, severe shivering began and lasted around 3 hours, which stopped after covering myself with a blanket (they started again every time I was uncovered). Also, every 30 to 45 minutes, I had to urinate (seemed to be about half a cup of liquid each time). Next morning (21 hours after the second dose) shivering and constant urination have decreased but arm is still sore.

Received her first COVID vaccine on Thursday, March 18. On 3/23/21 she started to have new onset of generalized muscles aches and weakness. She started feeling some pain in her back, which then spread to arms and legs. She is now beginning to feel weakness in her core and extremities. Having difficulty lifting arms above head. She is still able to walk without difficulty but legs do feel weak. Increase in SOB as well. Myalgias and chest pain resolved within a week, however she continued to feel weak, tired, and had DOE. She developed "brain fog" and talked to her boss about taking short-term disability as it had been hard to work. No appetite. On 4/1/21, she presented to the ED with 2 weeks of worsening generalized weakness, SOB, lightheadedness, dizziness and found to have acute anemia. Was admitted for further workup. Hgb at admission was 5.4. This admission diagnosed her with a new warm autoantibody hemolytic anemia. This is new since the COVID vaccine was administered. Upon admission there was no thrombocytopenia, so there was low suspicion for microangiopathic hemolytic anemia, TTP/HUS, or DIC. Peripheral blood smear at that time suggested a leukoerythroblastic blood picture (could be Bone Marrow recovery post chemo) but with marked normocytic, normochromic anemia, and with increased circulating erythroid precursors and increased red blood cell regeneration; spherocytes and fragments are present supporting hemolysis. DAT positive (both IgG and C3) along with other hemolysis lab including elevated LDH, Bilirubin, haptoglobin 3, and PBS c/w hemolysis; no evidence of MAHA. So warm autoantibody hemolytic anemia is the most likely explanation. She had negative cold agglutinin antibodies <1:32 on 4/9. Started on methylprednisolone on 4/2/21, but Hgb continued to steadily decline despite treatment. Continued on methylprednisolone 87.5mg daily. Rituxan 375mg/m2 was started on 4/6/21 with plans for weekly infusions for a total of 4 weeks. there was concern for a GI bleed on 4/10-4/11 due to bright red fluid appearing like blood in the toilet after a stool. This led to her receiving roughly 5 units of pRBCs. After these 5 units she started urinating red urine and we became highly concerned for hyperhemolysis. She did not have any further stools so we did not think a GI bleed was likely. She was given 1 dose of Eculizumab (Soliris) (4/12). This treatment is for complement mediated intravascular hyperhemolysis. Unfortunately it did not appear to help her. On 4/14, we were thinking TTP could be contributory with numerous schistocytes on peripheral smear. Her T bili was up to 7.8, and her hemoglobin plasma was trending up, in the 380 -- > 610 and in the 800s today. Cr was worsening. Platelet count was dropping. With her worsening condition and concern for both hyperhemolysis and possible TTP, we decided to start her plasma exchange followed by her second dose of Rituximab. Unfortunately she became disoriented/confused following line placement and while receiving plasmaphoresis. CT head returned without acute findings. She then had an allergic reaction with a rash during PLEX which was stopped (4L completed with a goal of 5L). Improved with benadryl. She was then administered rituximab. Then she developed worsening sinus tachycardia and HTN. Her respiratory status deteriorated and she eventually required high-flow oxygen to maintain saturations > 90%. CXR showed bilateral opacities, not drastically changed from previous films. Rituximab was stopped halfway through its infusion in case this was an adverse effect to the drug. She was given 20 mg IV Lasix per the nighttime sign-out. She was initially given ceftriaxone and azithromycin IV to cover CAP but later ABx were broadened to vanc and Zosyn with rising lactate of unknown source. Ultimately she had acute respiratory failure with hypoxia and need BiPAP. She was eventually intubated and a code blue was called. She unfortunately died shortly after intubation.

4/8 migraine, severe lower back pain, debilitating fatigue 4/11 &12 violent diarrhea 4/12 (eve) severe back pain returned, painful urination at times passing blood lower abdominal pain, pelvic pain back, pelvic pain, fatigue ongoing

She was transferred from one ER to another for intraparenchymal bleed and subarachnoid hemorrhage with midline shift. On the week of April 11th she was seen by her periodontist of a bone graft in preparation for a tooth implant. She took minimal ibuprofen and norco after this procedure. However, she also began to feel very nauseated which led to anorexia and worsening malaise. This prompted the pt to present to ER on 4/16 evening, where was given Phenergan, and discharged to home. Symptoms worsened and she re-presented to ED where she was admitted and diagnosed with UTI and colitis. She was started on ciprofloxacin. She denied having had any dysuria or diarrhea. Patient's son says that at 0130 on 4/19 his mother was using both sides of her extremities equally. She had been complaining of headache and leg pain, but by 0130 on 4/19 family did not notice any other obvious changes in patient's movements or behavior. However, at 0730 on 4/19 nurses noticed that patient was unable to move her L arm or leg. She had a CT scan done, which revealed multiple intraparenchymal hemorrhages bilaterally as well as subarachnoid hemorrhage with midline shift. The transferring physician told me that patient had not been on any anticoagulation. Patient and her family deny any history of falls or trauma, denied family history of coagulopathies, and use of blood thinners (including aspirin). No records, labs, or inpatient med list was sent with patient upon transfer. Family says that patient had her first Moderna COVID19 vaccine 3 weeks ago and was due for her second vaccine on 4/23. Labs on admit here are significant for leukocytosis with WBC of 21.9, Hgb of 12.1, platelets of 306, sodium of 140, potassium of 3.1, Bicarb of 22, creatinine of 0.7, glucose of 126, magnesium of 1.8, INR of 1.2. Patient is normotensive, afebrile, and satting well on room air. Angiogram showed multiple cortical vein thromboses. Will send hypercoagulable work up, HIT antibody given COVID vaccine 3 weeks ago (Moderna).

Fatigue started 4/20, then fever and chills and shaking, cough 4/21-24 with runny nose, nausea and ice pick head aches, shortness of breath and wheezing. Rapid Covid test negative on 4/23. Continued coughing and after 4 days of ice pick head aches almost constantly, went to ER on 4/25 at 9:30 am. IV pain meds stopped ice pick headaches after 40 minutes. Meds for cough and urinary tract infection. Discharged from ER after 5 hours. Continue to have fatigue, sleeping most of the day, low grade head ache, nausea, shaking, and one episode of vertical nystagmus.C

kidneys and bladder overworking; kidneys and bladder overworking; yeast infection due to "kidneys and bladder overworking; This spontaneous case was reported by a consumer and describes the occurrence of RENAL IMPAIRMENT (kidneys and bladder overworking) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0171B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes. Concomitant products included METFORMIN for Diabetes, VENLAFAXINE HYDROCHLORIDE (EFFEXOR), EMPAGLIFLOZIN (JARDIANCE) and SITAGLIPTIN PHOSPHATE (JANUVIA [SITAGLIPTIN PHOSPHATE]) for an unknown indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Apr-2021, the patient experienced RENAL IMPAIRMENT (kidneys and bladder overworking) (seriousness criterion medically significant), HYPERTONIC BLADDER (kidneys and bladder overworking) and FUNGAL INFECTION (yeast infection due to "kidneys and bladder overworking). At the time of the report, RENAL IMPAIRMENT (kidneys and bladder overworking), HYPERTONIC BLADDER (kidneys and bladder overworking) and FUNGAL INFECTION (yeast infection due to "kidneys and bladder overworking) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. concomitant medication includes unknown once weekly injection. 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. Diabetes could have played a causative factor on the event renal impairment; 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. Diabetes could have played a causative factor on the event renal impairment

atrial fibrillation (not sure when started, still continuing, scheduled for cardioversion on May 27, 2021) minor side effects - chills, nausea, extreme fatigue (probably due to a-fib), also (don't laugh) a lot of burping (not normal for me), frequent need to urinate for about 24 hours - these minor issues all cleared up within 48 hours other than fatigue

Uticaria (not at site of vaccination), beginning third day after Moderna COVID-19 vaccination and progressively worsening over 3 weeks. Initially treated with OTC Zyrtec and beginning 4/22 added Hydroxyzine HCL 25mg and a 5-day course of Prednisone 20mg. Uticaria. Uticaria cleared on Prednisone, but began to recur 2 days later. Obtained 2nd Moderna COVID-19 injection on 4/30/21 and uticaria returned in full force, rapidly spreading throughout the body. Remain on Zyrtec and Hydroxyzine HCL and waiting until two weeks after 2nd vaccination (i.e., 5/14/21) to restart Prednisone so as not to interfere with vaccine efficacy.

Fever of 101 plus Fatigue, muscle and body aches. Stomach upset. Urgency to urinate. for first 24 hours. low grade fever on and off for next 11 days. Day 12, woke up with low fever and rash on chest and back. Day 13, woke up with low fever and rash spreading to neck, face, ears, underarms and all of torso.

Renal failure; Liver failure; Unresponsive; Died; Stomach pain; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of UNRESPONSIVE TO STIMULI (Unresponsive), DEATH (Died), RENAL FAILURE (Renal failure) and HEPATIC FAILURE (Liver failure) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Primary biliary cirrhosis. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach pain) and NAUSEA (Nausea). On 08-Apr-2021, the patient experienced UNRESPONSIVE TO STIMULI (Unresponsive) (seriousness criterion hospitalization). On 23-Apr-2021, the patient experienced DEATH (Died) (seriousness criterion death), RENAL FAILURE (Renal failure) (seriousness criterion hospitalization) and HEPATIC FAILURE (Liver failure) (seriousness criterion hospitalization). On 23-Apr-2021, RENAL FAILURE (Renal failure) and HEPATIC FAILURE (Liver failure) had resolved and NAUSEA (Nausea) outcome was unknown. The patient died on 23-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, UNRESPONSIVE TO STIMULI (Unresponsive) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown. The concomitant medication included liver medications, as reported by the reporter. On 07Apr2021 around 1230pm, the patient experienced stomach pain and nausea which the family attributed to her liver medications. The patient went to sleep later that evening. The next day, 08Apr2021, the patient was found to be sleeping around 8am but was unresponsive around 1:30pm. She was taken by ambulance to the local hospital. The patient was eventually placed on life support and passed on 23Apr2021. No other treatment medication were reported. Company comment: Very limited information regarding this events has been provided at this time. However, based on the 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. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, based on the 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. Further information has been requested.; Reported Cause(s) of Death: unkown cause of death

Trouble breathing, tightness chest - Blood pressure 200/100. Called EMS, EKG . Blood pressure rose 215/100. Sent to ER ER Record The patient presents with chest pain and shortness of breath. She states that 10 minutes after getting her first Covid vaccination, she started feeling chest pain and shortness of breath. An ambulance was summoned to the store where she was getting the immunization. They gave her 4 baby aspirin and evaluated her. She opted to come by private vehicle. The patient says that she thinks she has a UTI and that maybe the vaccine made her feel worse. She is not having any GI symptoms. She states that she felt hot and a little dizzy.

Bilateral saddle pulmonary embolus 12 days post 2nd Moderna vaccination, Shortness of breath worsened 6 days after vaccination, lasting 1 week until presentation to hospital ED. Was found with severe hypoxemia, and bilateral PE and right heart strain requiring interventional radiology procedure and catheter directed thrombolytic therapy, subsequent treatment and follow-up in the ICU Initial Moderna vaccine given 04/12/2021: Vial number 0 3 0 B21A Second Moderna vaccine given 05/10/2021 file number 031 B 21A Patient described mild shortness of breath beginning 1 month prior to 1st vaccine, but significant and severe shortness of breath developing less than 1 week after 2nd vaccine

Pt developed severe urinary urgency several days after the second dose of the Moderna that has been present for 9 weeks. No prior history of this symptoms

I received the first Moderna vaccine on March 15, left arm hurt to touch, couldn't lift it overhead, had sound halucinations and fatigue. On the eleventh day things got ugly. Sharp chest pain and jaw pain, blood pressure 130/104 (my normal is 125/60), for four days couldn't eliminate but a small amount of urine, dizzy spell-almost passed out, vitreous detachment in eye, lost taste and smell 24 hrs (test for covid-19 was negative), blood pressure jumped to 180/112, temp 94.4, TMJ/node pain and swelling three weeks, teeth didn't occlude four days and couldn't get floss between any teeth for a day (so weird), severe shooting wrist pain, couldn't hold a pen or type for 24 hrs, hand tremors, sound halucinations of metal scrapping, hammering, thumping when laid down, super itchy rash under armpit one week, occipital node swollen, top of head painful to touch, ankle swollen, pounding heart beat, dry cough, oxygen readings of 88, sub- normal temperature 94.8 to 95.8 for several days and a month of very high blood pressure readings with tinnitus, fatigue, cloudy thinking and speech. Most reactions lasted a day up four days, all were on the right side of my body, most resolved before the next started. The longest ongoing issue is high blood pressure. Finally went down to 124/66 but not consistently. Spent three weeks around 138/104 and when walking uphill, heart would start pounding, felt faint, nauseated, head ached and had difficulty breathing. Alcohol and salt triggered a reaction or made blood pressure jump to 180/104. Leaning forward to do yard work or and strenuous activity like walking made heart pound violently, head ache, and blood pressure go up. Laying down makes heart flutter. Most of the symptoms listed are for myocarditis. Once the CDC reported that kids were having these issues I reduced activity and and more bed rest and am feeling slightly better.

AFTER GIVING SHOT IN 10MIN , PATIENT STARTS FEELING UNWELL, HER JAW LOCK, STARTING UNCOUNCIOUS, SHE WETS HER PAINT, HER TOUNGE OUT, UNRESPONSE, HER EYES WIDE OPEN , BLOOD PRESSURE DROP LOW

After arriving home at 5:15 I became very fatigue and needing to lay down asap. I was awoken around 3:30am on the 6th with the shakes, chills, severe head and back ache and body aches. Urgent and frequent urination. This continued from that point all through Sunday evening on the 7th. Symptoms started to go away later in the evening except for headaches which are still present at this time.

02/08/21--2 days after vaccine--Resident stated that she "didn't feel good" (She is developmentally delayed and less able to communicate how she feels than those in the community) and stopped eating most foods; also had fatigue. Vitals, coloring, & behavior were normal. 02/09/21--Belly was firm and mildly distended (although she stated it didn't hurt); she coded this evening and CPR was performed before EMT could transport her to the hospital. 02/10/21--Resident passed.

Bladder spasms and pressure, frequent urination began one or two days after vaccine. Tested, and NOT an infection.

Patient developed significant muscle and joint aches on 3/12/2021. She also noticed swelling , redness and pain at the injection site. She experienced urinary frequency on 3/12/2021 that resolved within 24 hours. The muscle aches and pains slowly resolved over 48 hours. The injection site redness and pain has worsened since onset. She was treated on 3/15/2020 with oral antibiotics and topical steroid cream for the reaction at the injection site.

CHILLS. FEVER ,NASUEA, LOSS OF APPETITE, TIRED , BOTH SHOTS - LASTED 1 DAY 2ND SHOT ALL THE ABOVE LASTED TWO FULL DAYS AND NIGHTS BUT FOR 8 HOURS LOST CONTROL OF BODY FLUIDS , WEAK NEEDED HELP

Pt had her first Covid shot on 03/29/21. She had soreness and slight tenderness in her arm. On 4/11/21 she noticed she was having swelling, redness, warmth, and hardness at injection the site. It sounded similar to "Covid arm". Pt was instructed to use an ice pack, take tylenol/advil, and call the doctor if the swelling or redness got worse. Pt also got bactrim for a UTI on 4/8/21.

On Sunday evening, day after receiving vaccine, started having urinary frequency, urgency, urine pink and cloudy. Urination mildly painful. I have never had a UTI in my life, but had one now. I drink at least 8 liters of water per day, so definitely not dehydrated.

feel a little weakness; my arm was swollen, painful for two days; my arm was swollen, painful for two days; initially being unable to urinate; This spontaneous case was reported by a patient and describes the occurrence of URINARY RETENTION (initially being unable to urinate) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: TYLENOL. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced URINARY RETENTION (initially being unable to urinate) (seriousness criterion medically significant). On 14-Apr-2021, the patient experienced ASTHENIA (feel a little weakness), VACCINATION SITE SWELLING (my arm was swollen, painful for two days) and VACCINATION SITE PAIN (my arm was swollen, painful for two days). On 13-Apr-2021, URINARY RETENTION (initially being unable to urinate) had resolved. On 16-Apr-2021, VACCINATION SITE SWELLING (my arm was swollen, painful for two days) and VACCINATION SITE PAIN (my arm was swollen, painful for two days) had resolved. At the time of the report, ASTHENIA (feel a little weakness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Historical medication included vitamins . she takes cholesterol medication, Tylenol and vitamins. Patient was scheduled for second dose on 28-May-2021 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.; 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.

DVT of bilateral lower extremities and bilateral pulmonary edema. Treated with apixaban 5 mg per standard dosing. Hospitalized 4/27/2021 and discharged 5/4/2021. Patient convalescing at home. Tentative return to work date 5/24/2021. Follow-up hematologist consult due on 5/10/2021 and follow-up pulmonary consult due on 5/19/2021.

Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Urinated on herself-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Additional Details: Immediately after vaccination she started to feel "awful" and unable to describe exactly what was wrong. She was lightheaded, shaky and dizzy. She lost consciousness for about 1-2 minutes and paramedics were called. Once consciousness was regained, she lied down and started to feel better. She continued to lie down until paramedics showed up and assessed her. She was feeling better and was not taken to the hospital.

After second vaccination: Initially: Sudden experience of very low BP - 91/41 - fatigue, shortness of breath, dizziness, unable to go to work. Vertigo. One week later and continuing: heart palpitations, a fib, fluttering, shortness of breath, dizziness, fatigue, nausea, low BP, and unable to go to work.

Site: Pain at Injection Site-Mild, Systemic: urologic symptoms-kidney pain, urinary pain, repetitive urination-Medium

Jaundice and dark urine was noted on May 22,2021, went to the doctors and had blood work and a CAT scan done. I had liver enzymes as high as 600-700, CAT scan showed edema of the portal valve and a slightly enlarged liver. I also was diagnosed with Hemolytic Anemia. I never had any symptoms in my life like these, no family history either. My blood work now shows that everything is going back to normal with no treatment at all.

Guillan-Barre Syndrome - with slow neurologic recovery. Residual deficits include significant generalized weakness, dysphagia and dysphonia, trach dependent and PEG tube dependent. Also with urinary retention and poor rectal tone requiring intermittent disimpaction. Continue supportive care including PT/OT, indwelling Foley catheter and daily disimpaction/stool softeners as needed. Fortunately, patient has had some evidence of minor improvement (evidence of flexion extension of the right arm and flexion of the right wrist). Transferring from our facility Hospital today 7/14/21. Accepting physician.

I started having leg cramps in the middle of the night and had to ice both shoulders. I previously had problems with my rotator cuff earlier in the year - I had to ice both even though I didn't do anything with the arm that didn't have the shot. I also had to ice my neck, which is when I decided to go to the doctor. It's like having menopause again but worse. I was already wearing a pee pad but instead of every 12 hours at night I would have terrible cramps and before being able to go to the bathroom I would already pee. And I work at Amazon in the warehouse and do manual labor so I know the difference in the feeling of being worn out but I didn't do anything and had all these cramps. I had a low grade fever a lot, which is still continuing. I checked with the doctor to make sure I wasn't having an infection. I had exhaustion beyond the regular and headaches. problems with my feet, foot fungus that's getting worse and things that used to fix it aren't. Not getting enough sleep, irrigatable.

10:03Throat felt like going to closing like after other reaction to rocephin. 10:05Swallowing ability felt like going to be difficult. 10:06 Immediately to ER from vaccination area at hospital. 10:10 Then coughing from bronchospasm lasting over a minute repeating until ER meds kicked in . Meds- solumedrol 125 mg IV , Benadryl 50 mg IV , xophenex 1.25 nebulizer

felt very dizzy, tightness of chest and stiffnes of neck, palpitations, cold extremities. constant urination and bowel movements during attack.

Day 3. Post vaccination developed Gross Hematuria. Was seen at Clinic . Bloodwork and Urinalysis, urine also sent for culture.

Pt. presented to the ER with abd pain and septic shock. Pt. reported to feel ill shortly after receiving the vaccine.

Overnight after the injection woke every 30 minutes to urinate in extremely large volumes. Resolved by next morning. Significant amount of urination never previously experienced. Glucose was 118 at the time. Also had headache, fever, aches.

She reports some fatigue, loss of appetite and dizziness, and went to bed early on the night of her 2nd vaccination. On Feb 12th, she reports receiving Botox and Juvaderm facial fillers. She reports she felt fine until Feb 11th or 14th, when reports feeling fatigue which gradually worsened in the following weeks. She reports around this time going to MD Now Urgent Care. Around Feb 13th to the 17th, she developed N/V and loss of appetite, which also gradually worsened in the following weeks. She reports she stopped eating around this time due to the symptoms. She drank alcohol daily until February 18th. Between Feb 18th to 25th, she noticed that a hematoma developed on the site of injection and bruises on other places. She reports onset of productive cough with white sputum and yellow diarrhea which occurred (several times daily). Both of these symptoms also gradually worsened in the following weeks. On Feb 27, she couldn't tolerate oral intake. She was admitted to Hospital on Feb 28

Patient received first vaccine dose on 3/10/21, waited for approximately 1 hour in Pharmacy after. Was walking to her vehicle and became short of breath. Patient got to her vehicle and called 911 due to severe shortness of breath. Rescue arrived on scene at approximately 11:00am, found patient in distress and administered epinephrine, methylprednisolone, and diphenhydramine. Patient placed on CPAP in rescue en route to ER, became unresponsive, frothing pink sputum. Intubated by paramedics en route with iGel device. Patient arrived to ER at 11:22am, went into cardiac arrest at 11:24am. Patient continued to be unstable, had multiple rounds of cardiac arrest and ROSC. Patient ultimately did not survive arrests, and pronounced dead at 2:37pm. Medications received during course in the ER - epinephrine 1mg x18 doses, sodium bicarbonate 50mEq x4 doses, calcium chloride 1g, insulin regular 10 units x1, furosemide 80mg x1, epinephrine titrated infusion, sodium bicarbonate infusion.

I was hospitalized with an acute kidney injury. (In ED they told me I must have gotten dehydrated but I was not dehydrated and had specifically drank lots of fluids in the 2 days after the vaccine in an attempt to prevent problems!)

Feb 26, 2021 12 am - extreme vaginal itching commenced; some anal itching as well; Extreme itching for 2 days - went to Urgent Care - diagnosed with small UTI and possible vaginal yeast infection. Treated with Fluconazole and Cephalexen; Itching increased - rash and hives spread over body from neck to upper thighs. Tried various otc topical creams, etc... Went to Dr - referred to dermatologist - put on 4 Zyrtec - 2/am- 2/pm plus benadryl at bedtime. Still trying various otc creams for continued itching on different parts of the body but mostly in the vaginal area.

Developed a Urinary Tract Infection; little soreness at the injection site; A spontaneous report was received from a consumer, a 64-year-old female patient, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and developed urinary tract infection and little soreness at the injection site/vaccination site pain. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031M20A) intramuscularly in her left arm for prophylaxis of COVID-19 infection. On an unknown date, the patient developed urinary tract infection after the vaccine and she was prone to get urinary tract infection. The patient went to the doctor and received antibiotics. The patient also had little soreness at the injection site on an unknown date. Treatment for the event of urinary tract infection included cefuroxime axetil. The action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, developed urinary tract infection and little soreness at the injection site were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Patient being prone to develop urinary tract infection was considered a confounder for the event of urinary tract infection.

Fever 103.7, chills, vomiting, jerking movements and tremors, back pain, unsteady gait, dark brown urine Fever was brought down with ice and Tylenol and time Jerking movements and unsteady gait continues to get better with time , anti nausea. meds were called in to pharmacy, back pain is getting better each day Urine has returned to normal color

Passed one stone that week on Saturday after shot; Fever was almost 102degF; Woke up at 5am with chills; Normally sore in my right arm/all the way down to right elbow; Extreme pain in right kidney; Extreme back pain between my shoulder blade; A spontaneous report was received from a consumer concerning a 64-years-old female patient (weight: 240 lbs.), who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore in my right arm, all the way down to right elbow/pain in extremity, chills, extreme back pain between my shoulder blade/back pain, extreme pain in right kidney/renal pain, passed one stone/nephrolithiasis, fever was almost 102degF/pyrexia. The patient's medical history was not reported. Products that have been known to be used by the patient were not reported. The patient received the first of planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection on an unknown date. On 04 Mar 2021, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 010A21A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 04 Mar 2021, the patient experienced soreness in my right arm, next day at 5 am with chills, extreme pain in right kidney and fever was almost 102-degree F. On unknown Saturday, the patient passed one stone. The patient also experienced extreme back pain between shoulder blade and all the way down to right elbow. Treatment information was provided as ice packs, heating pads, pain killers. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events were considered as unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

arm swollen up; red pinkish all to elbow; she couldn't move, talk, reach her arm AND head, leg and body not working; no control of her body; had no feeling in her body; pee in her pants; mouth was hanging open, couldn't move; horrifying; so ill; "i'm going to hit myself"; not felt good; chills; fever; A spontaneous report was received from a consumer concerning a 64 years old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypotonia, mental distress, hypoesthesia, malaise, dyskinesia, feeling bad, arm swelling, chills, fever and arm erythema. The patient's medical history was not provided. Concomitant product use was not provided. On 14-Mar-2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 14-Mar-2021, patients had fever and chills. On 15-MAR-2021, she was so ill, lost all function of her body, she could not move, talk, reach her arm. She thought she was going to die. She did not felt good, went to bed and 5 minutes later she thought she was going to hit herself because she had no control of her body, her head in the bead, she pee in her pants. Her mouth was hanging open, could not move. The patient mentioned her head, leg and body not working, had no control of her body, she described the situation horrifying, so close to death, had no feeling in her body. Se did not want to go to the ER.. Husband stayed with her and she improved 3 hours later without treatment. On the next day, they contacted her physician who prescribed over the counter treatment. Laboratory test were not reported. Treatment included Benadryl, Advil and Tylenol. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events, hypotonia, mental distress, hypoesthesia, malaise, dyskinesia, feeling bad, arm swelling, chills, fever and arm erythema were not reported.; Reporter'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.

I had ringing in my ears, bilateral headache, chills and sweats, no appetite with nausea, my urine was brown on two occasions, my mouth is dry, I was anxious especially at night, I was unable to sleep for very long. And I was very weak and exhausted. I am only feeling a little better today.

65 y.o. female who presents with possible stroke-like symptoms. Patient reports a prior history of a CVA approximately 6 months ago. Patient states she has been left with some mild decreased grip strength in the right hand due to that stroke. Patient reports she went to bed feeling weak and fatigued last night. She reports she woke up at 3:00 a.m. and noticed her lips were numb and tingly. She stated she then noticed her right hand was slightly tingly as well. She states she went into the bathroom and looked at herself in the mirror. She did not observe any facial droop or slurring of her speech. Patient denies any headache, chest pain, or palpitations. Patient reports her symptoms are improving. Her right hand tingling has resolved and the numbness and tingling to her lips are much better. Patient does report she has been under a lot of stress and worry lately. She is uncertain that the symptoms are stroke related or due to stress and anxiety.

Day 2- fever blister, day 3 right eye, dry, red, swollen, day 3 back pain, right hip pain, right knee pain, burning pain upon urination, and tingling nerve pain all on right side of body per patient.

Patient arrived to Emergency department of Medical Center 4/18/21 around 5:00 PM and reported that she had received a COVID vaccine dose #2 at outside clinic a day before this and today is experiencing significant side effects. She presents here with dizziness, headache, myalgias, and urinary incontinence. Around 1:00 PM today she had started to develop body aches, headache, myalgias in the hips, back and arms, chills and sweats. She had a urge to urinate but was unable to get up from reclining due to weakness in her legs and pain when moving. She states it took her an hour to get off the couch and then had difficulty walking due to severe dizziness, and she fell to the floor in her bedroom and fell back and hit the back of her head on the ground but denies any loss of consciousness. She has no visual changes, no nausea or vomiting, no chest pain, no shortness of breath, or hematuria or dysuria, also no numbness in the groin. She states it is painful to move.

Patient claims "3 days" after vaccination she developed headache that worsened over the next two days to include dizziness, photophobia, scotomata. However, the state tracking system lists her date of vaccination 10 days prior to the symptom onset. Below is a more detailed description: This is a 64-year-old female nurse practitioner with coronary artery disease, uncontrolled (untreated) type 2 diabetes, obesity, and remote history of kidney donation who presented yesterday with a 5-day history of nausea and frontal headache with new recent dizziness /lightheadedness when standing. She describes her headache as starting out as temporal and periorbital and then persisting as a frontal discomfort radiating to the back and down the neck. Associated with this were complaints of blurry vision, photophobia and scotomata. She denies any focal weakness or numbness/tingling. There was no vomiting or reports of seizures. She denies no recent problems finding words or bouts of confusion. She denies a history of arrhythmia or palpitations. Patient received the first dose of the Moderna COVID-19 vaccination on 4/14/2021 into her right arm, 5 days prior to admission (But state records list 4/7/2021 as the date). She did not take any medication to pre-empt side effects such as NSAID, aspirin, H2 blocker, or Tylenol. Initially she developed a sore arm the night of the vaccination. Three days later the headache developed that did not respond to Tylenol PM although it helped her sleep. She noted taking more than the recommended dose and had mouth dryness. Patient denies any past history of COVID exposure and any illness c/w COVID where she was not tested. She has never had her antibody titer checked. She recently had a dental procedure for an exposed nerve and had a temporary filling placed. No antibiotics were given and denies having a dental abscess She described that one of her sisters developed "blood clots from her heart due to atrial fib" after her Pfizer vaccination. She denies rashes or stigmata of endocarditis, no fevers, chills, or night sweats. She describes vaginal itching a few days ago and self treated with an anti-yeast cream (Monistat) that relieved symptoms and does not currently have dysuria, frequency or urgency. On admission, her UA was abnormal and culture is pending but she received one dose of Rocephin and is still without urinary symptoms. After admission CT scan and MRI of the brain revealed focal areas of likely small subacute embolic infarcts. (See report) Since admission she had a reassuring ECHO and no further worsening. No evidence for A flutter or fib Review of Systems Constitutional: no fever, no chills, no sweats, mild General weakness Skin: no Jaundice, no rash, no lesions, no petechiae ENMT: no ear pain, no sore throat, moderate congestion, no hoarseness Respiratory: no shortness of breath, no cough, no orthopnea, no wheezing Cardiovascular: no chest pain, no palpitations, no edema Gastrointestinal: mild nausea, no vomiting, no diarrhea, no GI bleeding Genitourinary: no dysuria, no hematuria, no discharge, no pain Musculoskeletal: no back pain, no trauma; Some neck discomfort bilaterally R>L Neurologic: moderate headache, mild dizziness, no numbness, mild weakness Psychiatric: mild sleeping problems, no irritability, Describes herself as high strung type A Heme/Lymph: no bleeding tendency, no bruising tendency, no petechiae, no swollen nodes Allergy/Immunologic: moderate seasonal allergies, no food allergies, no recurrent infections, no impaired immunity Additional ROS info: Except as noted in the above Review of Systems and in the History of Present Illness all other systems have been reviewed and are negative or noncontributory Problem List/Past Medical History 1) Uncontrolled diabetes with a hemoglobin A1c greater than 11; She stopped metformin and has tried to control it with diet alone. She does not have a PCP 2) Coronary artery disease with 4 stent placements in 2017; noncompliant with aspirin 3) Hyperlipidemia on Crestor 4) History of kidney donation to her late husband. She reports a stable creatinine 5) Obesity with a BMI of 34.8 Physical Exam Vitals & Measurements T: 36.4 °C (Oral) TMIN: 36.4 °C (Oral) TMAX: 36.5 °C (Oral) HR: 86(Peripheral) RR: 18 BP: 115/72 SpO2: 92% WT: 92.4 kg General: alert, no acute distress Skin: warm, dry Head: no trauma, normocephalic Neck: Trachea midline, no adenopathy, no tenderness; No bruits Eye: normal conjunctiva, sclera clear Cardiovascular: regular rate and rhythm, normal peripheral perfusion. No carotid bruits Respiratory: Lungs CTA, respirations non labored Chest wall: no deformity Gastrointestinal: non distended, Extremities: no deformity, no trauma Neurological: oriented x 4, LOC appropriate for age, CN II-XII intact, motor strength equal & normal bilaterally upper extremity, sensation equal & normal bilaterally, speech normal Psychiatric: cooperative, affect appropriate for age, normal judgement, normal psychiatric thoughts Assessment/Plan This Visit Diagnosis 1. ASB (asymptomatic bacteriuria) R82.71 - No antibiotic treatment recommended - Do not act on pending urine culture 2. Embolic cerebral infarction I63.40 - Unclear source as echo was clear; no stigmata of endocarditis - No carotid study as of yet - She has multiple risk embolic stroke (DM, age, hyperlipidemia, smoking, obesity) - Unclear if COVID vaccine initiated this process (has a low threshold for a cerebral event) - There are no national reports regarding this type of side effect in an mRNA vaccine 3. Adverse effect of viral vaccines T50.B95A - Received COVID Moderna vaccine and symptoms developed 3 days later - Unclear if vaccine cause symptoms 4. Diabetes mellitus E11.9 - Poorly controlled with Hbg over 11 5. Body mass index (BMI) of 38.0 to 38.9 in adult Z68.38 - Current weight 92.4 kg 6. Tobacco use Z72.0 - Small amount 7. H/O unilateral nephrectomy Z90.5 - Creatinine is currently 6.0 Plan: * I will report the possible vaccine adverse event to the national system (VAERS) - This was shared with the patient and she can also file a report - Recommend that the sister also file a VAERS report * Await neurology opinion regarding carotid studies * No further antibiotics since she has no symptoms

Extreme fatigue lasting more than 1 week, headache for several days, back pain, abdominal pain, joint pain so bad it was hard to get dressed, urinary tract infection (about 36 hours later)

Had typical adverse effects with 1st dose, which lasted approximately 36 hrs; however, with this dose had not only extremely red area in arm, rashes on interior of arm, diarrhea, nausea, headache, chills, fever, exhaustion, also had chest pain, vomiting and ultimately vomiting blood,, which led to ER visit elevated wbc, blood in urine, basic metabolic Panel, CBC and Differential, Hepatic Function Panel, Tropinin 3 hr, baseline, & serial, ECG, XRay, raised blood pressure, IV and toradol and phenergan diagnosis@ ER systemic adverse effect of COVID-19 vaccine

She got the vaccine and later that evening she got the shakes so bad that the bed was shaking, achy. the next day same reaction, and had the itchy rash that was 3" down from the shot site and went down near her elbow. Then, a week after that on 4/4/21 she started getting a rheumatoid flare up which has never had one like this before, which has lasted now about a month. On 4/9/21 she started with back pain and went to her PCP and diagnosed with a UTI. You then continued with the same problems, and called her rheumatologist on 4/12/21 and was put on Prednisone. On 4/14/21 the lower right forearm had a blotch that looked like cellulitis but was not, and felt that it was an allergic reaction/possibly related to the RA flare up. The flare was in multiple joints and kept moving around. On 4/22/21 she was started on a 2nd dose of steroids and it didn't work. Everything has swollen to the point that she had to have her wedding band cut off due to the extreme swelling on 4/28/21 she had her last pill of steroids. She ended up getting an IV while in the ER of Methyl prednisolone, which did help her and today she is a different person. They also gave her a Toradol shot and now on a steroid pack, but this has been almost a month reaction and was having no symptoms before the vaccination. She does take Humira for her RA.

VERY considerable urination morning after vaccine - caused significant dehydration. Resolved with electrolytes.

Moderna COVID-19 Vaccine EUA: one day after immunization patient admitted to hospital for weakness and confusion. Patient tachycardic but afebrile. Diagnosed with urinary tract infection, administered antibiotics and intravenous fluids, clinically improved and discharged home medically stable.

Curenntly having bleeding ,sensitive gums,mouth ulcers, skin rashes, burning on urination.Treated w/medrol dose pack, magic mouthwash,CBC and CMP drawn and results normal,skin rah has resolved, gums still sensitive, mouth ulcers resolving, and awaiting urine c/s results.

transabdominal liver biopsy was obtained and showed mixed portal inflammation, bile duct injury and endotheliitis consistent with ACR (Rejection Activity Index [RAI] score 4) with central venular dilation and sinusoidal congestion; possible hepatic venous outflow obstruction; sinusoidal obstruction syndrome; darkened urine; malaise; Reduced sense of smell; elevated liver tests; fatigue; mild myalgias; local soreness at injection site; reduced range in motion at injection site; reduced sense of smell; This non-study case was reported in an article and describes the occurrence of TRANSPLANT REJECTION (transabdominal liver biopsy was obtained and showed mixed portal inflammation, bile duct injury and endotheliitis consistent with ACR (Rejection Activity Index [RAI] score 4) with central venular dilation and sinusoidal congestion), VENOOCCLUSIVE LIVER DISEASE (possible hepatic venous outflow obstruction) and VENOOCCLUSIVE LIVER DISEASE (sinusoidal obstruction syndrome) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cirrhosis of liver, Hepatitis C, Hepatocellular carcinoma and Infection (Cured with direct acting antiviral medications four years earlier.). Concurrent medical conditions included Liver transplant (Received from a decreased donor.) since 18-Aug-2020. Concomitant products included TACROLIMUS, AZATHIOPRINE SODIUM (AZATHIOPRINE [AZATHIOPRINE SODIUM]) and PREDNISONE for Immunosuppression NOS. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TRANSPLANT REJECTION (transabdominal liver biopsy was obtained and showed mixed portal inflammation, bile duct injury and endotheliitis consistent with ACR (Rejection Activity Index [RAI] score 4) with central venular dilation and sinusoidal congestion) (seriousness criterion medically significant), VACCINATION SITE PAIN (local soreness at injection site), VACCINATION SITE MOVEMENT IMPAIRMENT (reduced range in motion at injection site), HYPOSMIA (reduced sense of smell), MYALGIA (mild myalgias), CHROMATURIA (darkened urine), FATIGUE (fatigue), MALAISE (malaise), HYPOSMIA (Reduced sense of smell), LIVER FUNCTION TEST INCREASED (elevated liver tests), VENOOCCLUSIVE LIVER DISEASE (possible hepatic venous outflow obstruction) (seriousness criterion medically significant) and VENOOCCLUSIVE LIVER DISEASE (sinusoidal obstruction syndrome) (seriousness criterion medically significant). The patient was treated with METHYLPREDNISOLONE (METHYLPREDNISOLONE WITH AZATHIOPRINE) (intravenous) for Sinusoidal obstruction syndrome, at a dose of 3 day course; MYCOPHENOLATE MOFETIL for Sinusoidal obstruction syndrome, at a dose of 1 dosage form and IMMUNOGLOBULIN ANTI-THYMOCYTE at a dose of 1 milligram/kilogram once a day. At the time of the report, TRANSPLANT REJECTION (transabdominal liver biopsy was obtained and showed mixed portal inflammation, bile duct injury and endotheliitis consistent with ACR (Rejection Activity Index [RAI] score 4) with central venular dilation and sinusoidal congestion) was resolving, VACCINATION SITE PAIN (local soreness at injection site), VACCINATION SITE MOVEMENT IMPAIRMENT (reduced range in motion at injection site), HYPOSMIA (reduced sense of smell), MYALGIA (mild myalgias), VENOOCCLUSIVE LIVER DISEASE (possible hepatic venous outflow obstruction) and VENOOCCLUSIVE LIVER DISEASE (sinusoidal obstruction syndrome) had resolved and CHROMATURIA (darkened urine), FATIGUE (fatigue), MALAISE (malaise), HYPOSMIA (Reduced sense of smell) and LIVER FUNCTION TEST INCREASED (elevated liver tests) 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 considered TRANSPLANT REJECTION (transabdominal liver biopsy was obtained and showed mixed portal inflammation, bile duct injury and endotheliitis consistent with ACR (Rejection Activity Index [RAI] score 4) with central venular dilation and sinusoidal congestion), VACCINATION SITE PAIN (local soreness at injection site), VACCINATION SITE MOVEMENT IMPAIRMENT (reduced range in motion at injection site), HYPOSMIA (reduced sense of smell), MYALGIA (mild myalgias), CHROMATURIA (darkened urine), FATIGUE (fatigue), MALAISE (malaise), HYPOSMIA (Reduced sense of smell), LIVER FUNCTION TEST INCREASED (elevated liver tests), VENOOCCLUSIVE LIVER DISEASE (possible hepatic venous outflow obstruction) and VENOOCCLUSIVE LIVER DISEASE (sinusoidal obstruction syndrome) to be possibly related. Patient was advised to begin tapering off concomitant medication prednisone; she decreased it to 2.5 mg daily for two weeks starting one day after vaccination and then discontinued it entirely. The liver test elevation did not improve after intravenous steroid therapy, and a repeat liver biopsy showed similar histology to the initial biopsy, with persistent ACR (Reject activity index (RAI) score 5) and slightly reduced central venular dilation and sinusoidal congestion. Patient was treated with anti-thymocyte globulin 1 mg/kg daily for a 6-day duration, and the liver tests gradually decreased. A third liver biopsy after completion of anti-thymocyte globulin showed improved ACR (RAI score 2) and no central venular dilation or sinusoidal congestion. Fifteen days after vaccination, Aspartate aminotransferase (AST): 229 U/L, Alanine aminotransferase (ALT): 199 U/L, Alkaline phosphatase (ALP): 576 U/L, Bilirubin: 6.0 mg/dl, Albumin: 3.3 g/dl, Tacrolimus, 12-hour trough: 8.3 ng/ml; negative for Cytomegalovirus DNA, Hepatitis C RNA, Herpes Simplex Virus-1/2 DNA, Adenovirus DNA, SARS-CoV-2 RNA, Donor Specific Antibodies, SARS-CoV-2 Spike Protein Antibodies Receptor Binding Domain; positive for SARS-CoV-2 Spike Protein Antibodies S1 Subunit. Twenty-one days after vaccination, AST: 191 U/L, ALT: 195 U/L, ALP: 522 U/L, Bilirubin: 4.9 mg/dl, Albumin: 2.0 g/dl, Tacrolimus, 12-hour trough: 7.0 ng/ml. Twenty-five days after vaccination, AST: 188 U/L, ALT: 245 U/L, ALP: 449 U/L, Bilirubin: 5.5 mg/dl, Albumin: 2.6 g/dl, Tacrolimus, 12-hour trough: 8.3 ng/ml; negative for Donor Specific Antibodies, SARS-CoV-2 Spike Protein Antibodies Receptor Binding Domain; positive for SARS-CoV-2 Spike Protein Antibodies S1 Subunit. Twenty-nine days after vaccination, AST: 125 U/L, ALT: 229 U/L, ALP: 467 U/L, Bilirubin: 5.2 mg/dl, Albumin: 2.6 g/dl, Tacrolimus, 12-hour trough: 11.3 ng/ml. Thirty-six days after vaccination, patient's AST: 94 U/L, ALT: 145 U/L, ALP: 437 U/L, Bilirubin: 2.7 mg/dl. Company Comment: Transplant rejection is the body's inherent response to foreign body, veno-occlusive liver disease , elevated liver enzyme test, involves a pre-existing underlying condition , Con-med Tacrolimus is a high risk for chromaturia and as such these events are unlikely related to mRNA-1273. The remaining events show temporal association with product use and as such cannot be excluded although malaise and fatigue are confounded by patient's condition and treatment for condition.; Sender's Comments: Transplant rejection is the body's inherent response to foreign body, veno-occlusive liver disease , elevated liver enzyme test, involves a pre-existing underlying condition , Con-med Tacrolimus is a high risk for chromaturia and as such these events are unlikely related to mRNA-1273. The remaining events show temporal association with product use and as such cannot be excluded although malaise and fatigue are confounded by patient's condition and treatment for condition.

After receiving the vaccine, I had severe shakes and severe flu symptoms. I ended up very badly dehydrated and body aches. I felt ill for about a week and I ended up being diagnosed with gross hematuria and urothelial carcinoma. Had surgery on the 15th of April and another scheduled for 10th of June

About six weeks after the second Moderna COVID vaccine, I started experiencing thirst, more frequent urination and noted some weight loss. This continued and then by end of April 2021, I started experiencing other symptoms including white flakes in urine, cramps in calves, and dry mouth. I sought medical care for these odd symptoms and despite having normal blood glucose at annual physicals, including in July 2020, my blood glucose run on 6/10/21 was 379. I do not have any history of diabetes nor is it in my family history, parents, siblings, grandparents and aunts/uncles on both sides. I have been started on glucose monitoring and insulin as of 6/18 with my primary care physician. I have a follow up with an endocri

Swelling, nausea, hard time breathing, caused kidney stones and diverticulitis , ER visit, 2nd shot vax felt like it tracked down inside of her arm. said nurse put shot into top part of arm near shoulder. Caused hyperventilating .

Shortly after shot, 104 degree fever, nausea, fatigue, extreme aches, did not immediately seek treatment (live in rural area). All of those things have persisted, 102 fever every night, 100 fever. Kidneys shut down since April 1st. Blood pressure and breathing difficulties (especially bad because living at elevation)

6/18/21: Guest experienced episode of hypoxia. Was able to be corrected with use of )2. Chest X-ray and bloodwork completed. 6/28/21: Seen by NP for weight loss. Ongoing issue prior to vaccine r/t poor appetite 7/1/21: Incident of hypoxia that required increase in 02, SOB, and lethargy. Sent to the hospital. Guest did end up passing at this hospital

increased fatigue with exercise and being out in the sun; memory is shot, memory problems; trouble with sleep at times; double vision episode, had some double vision; bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water; big crowds cause her stress; wording is getting worse; worsening bladder control; drunken walk, she was like walking in like she's drunk, and running into the door way; steroids gave him black sticky diarrhea; speech has been slurred; dry mouth; nurse was not able to clarify some cognitive issue; severe cold/ bad cold; she was hospitalized for a blood infection; filed for disability worsening of her MS; bruising; hair loss or bald spots/hair thinning; feel the burning in both feet; numbness on bottom of both feet; steroids gave him black sticky diarrhea; balance disorder; had a lapse on therapy, was out of medicine for about a week; dizziness; felt like a train ran over her; underdose of the medications; had an ulcer in her stomach, which was new to her and bleeding also; started breaking the medication in half/ has been braking 14mg in half to make it last longer; had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and; This spontaneous case was reported by a health care professional and describes the occurrence of FEELING ABNORMAL (felt like a train ran over her), BALANCE DISORDER (balance disorder), GASTRIC ULCER HAEMORRHAGE (had an ulcer in her stomach, which was new to her and bleeding also), SEPSIS (she was hospitalized for a blood infection), MULTIPLE SCLEROSIS (filed for disability worsening of her MS), CONTUSION (bruising), DIZZINESS (dizziness), FATIGUE (increased fatigue with exercise and being out in the sun), MEMORY IMPAIRMENT (memory is shot, memory problems), INSOMNIA (trouble with sleep at times), DIPLOPIA (double vision episode, had some double vision), PERIPHERAL COLDNESS (bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water), SOCIAL ANXIETY DISORDER (big crowds cause her stress), APHASIA (wording is getting worse), URINARY INCONTINENCE (worsening bladder control), GAIT DISTURBANCE (drunken walk, she was like walking in like she's drunk, and running into the door way), FAECES DISCOLOURED (steroids gave him black sticky diarrhea), DYSARTHRIA (speech has been slurred), DRY MOUTH (dry mouth), COGNITIVE DISORDER (nurse was not able to clarify some cognitive issue), NASOPHARYNGITIS (severe cold/ bad cold), PARAESTHESIA (had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and), ALOPECIA (hair loss or bald spots/hair thinning), BURNING SENSATION (feel the burning in both feet), HYPOAESTHESIA (numbness on bottom of both feet), DIARRHOEA (steroids gave him black sticky diarrhea), PRODUCT DOSE OMISSION ISSUE (had a lapse on therapy, was out of medicine for about a week) and WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (started breaking the medication in half/ has been braking 14mg in half to make it last longer) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products TERIFLUNOMIDE for an unknown indication, BUPROPION HCL for an unknown indication and WARFARIN SODIUM (COUMADIN) for an unknown indication. The patient's past medical history included Rheumatic fever, Application site reaction, Diplopia and Cardiac valve prosthesis user in 2007. Concurrent medical conditions included Allergy to animal, Drug hypersensitivity (Triple antibiotic), Iodine allergy (Iodine dye), Polyuria, Dermatitis contact, Drug hypersensitivity (Dilantin) and Multiple sclerosis. Concomitant products included LEVOTHYROXINE, IRON, METOPROLOL, FUROSEMIDE, PRAVASTATIN, WARFARIN SODIUM (JANTOVEN), VITAMIN D3, ACETYLSALICYLIC ACID (ASPIRIN COX [ACETYLSALICYLIC ACID]) and SERTRALINE for an unknown indication. On 15-May-2014, the patient started TERIFLUNOMIDE (unknown route) 14 milligram once a day. On 14-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form, BUPROPION HCL (unknown route) 1 dosage form and WARFARIN SODIUM (COUMADIN) (unknown route) at an unspecified dose. In March 2015, the patient experienced PARAESTHESIA (had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and) (seriousness criteria hospitalization prolonged and disability). In January 2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (started breaking the medication in half/ has been braking 14mg in half to make it last longer) (seriousness criteria hospitalization prolonged and disability). On 14-Feb-2021, the patient experienced GASTRIC ULCER HAEMORRHAGE (had an ulcer in her stomach, which was new to her and bleeding also) (seriousness criteria hospitalization prolonged, disability and medically significant). On 14-Mar-2021, the patient experienced FEELING ABNORMAL (felt like a train ran over her) (seriousness criteria hospitalization prolonged and disability). 14-Mar-2021, the patient experienced UNDERDOSE (underdose of the medications). In May 2021, the patient experienced DIZZINESS (dizziness) (seriousness criteria hospitalization prolonged and disability) and PRODUCT DOSE OMISSION ISSUE (had a lapse on therapy, was out of medicine for about a week) (seriousness criteria hospitalization prolonged and disability). On 19-Jun-2021, the patient experienced BALANCE DISORDER (balance disorder) (seriousness criteria hospitalization prolonged and disability). On an unknown date, the patient experienced SEPSIS (she was hospitalized for a blood infection) (seriousness criteria hospitalization prolonged, disability and medically significant), MULTIPLE SCLEROSIS (filed for disability worsening of her MS) (seriousness criteria hospitalization prolonged, disability and medically significant), CONTUSION (bruising) (seriousness criteria hospitalization prolonged and disability), FATIGUE (increased fatigue with exercise and being out in the sun) (seriousness criteria hospitalization prolonged and disability), MEMORY IMPAIRMENT (memory is shot, memory problems) (seriousness criteria hospitalization prolonged and disability), INSOMNIA (trouble with sleep at times) (seriousness criteria hospitalization prolonged and disability), DIPLOPIA (double vision episode, had some double vision) (seriousness criteria hospitalization prolonged and disability), PERIPHERAL COLDNESS (bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water) (seriousness criteria hospitalization prolonged and disability), SOCIAL ANXIETY DISORDER (big crowds cause her stress) (seriousness criteria hospitalization prolonged and disability), APHASIA (wording is getting worse) (seriousness criteria hospitalization prolonged and disability), URINARY INCONTINENCE (worsening bladder control) (seriousness criteria hospitalization prolonged and disability), GAIT DISTURBANCE (drunken walk, she was like walking in like she's drunk, and running into the door way) (seriousness criteria hospitalization prolonged and disability), FAECES DISCOLOURED (steroids gave him black sticky diarrhea) (seriousness criteria hospitalization prolonged, disability and medically significant), DYSARTHRIA (speech has been slurred) (seriousness criteria hospitalization prolonged and disability), DRY MOUTH (dry mouth) (seriousness criteria hospitalization prolonged and disability), COGNITIVE DISORDER (nurse was not able to clarify some cognitive issue) (seriousness criteria hospitalization prolonged, disability and medically significant), NASOPHARYNGITIS (severe cold/ bad cold) (seriousness criteria hospitalization prolonged and disability), ALOPECIA (hair loss or bald spots/hair thinning) (seriousness criteria hospitalization prolonged and disability), BURNING SENSATION (feel the burning in both feet) (seriousness criteria hospitalization prolonged and disability), HYPOAESTHESIA (numbness on bottom of both feet) (seriousness criteria hospitalization prolonged and disability) and DIARRHOEA (steroids gave him black sticky diarrhea) (seriousness criteria hospitalization prolonged, disability and medically significant). The patient was treated with OXYBUTYNIN ongoing since an unknown date for Urinary incontinence, at a dose of 1 dosage form; PARACETAMOL ongoing since an unknown date for Insomnia, at a dose of 1 dosage form; DIPHENHYDRAMINE ongoing since an unknown date for Insomnia, at a dose of 1 dosage form and BENZOCAINE ongoing since an unknown date for Hypoaesthesia and Burning sensation, at a dose of 1 dosage form. On 23-Feb-2021, GASTRIC ULCER HAEMORRHAGE (had an ulcer in her stomach, which was new to her and bleeding also) had resolved. At the time of the report, FEELING ABNORMAL (felt like a train ran over her), BALANCE DISORDER (balance disorder) and SEPSIS (she was hospitalized for a blood infection) had resolved, MULTIPLE SCLEROSIS (filed for disability worsening of her MS), CONTUSION (bruising), DIZZINESS (dizziness), FATIGUE (increased fatigue with exercise and being out in the sun), MEMORY IMPAIRMENT (memory is shot, memory problems), DIPLOPIA (double vision episode, had some double vision), PERIPHERAL COLDNESS (bottom of my feet, they are cold, like I am stepping in ice water. sensation of walking in ice water), SOCIAL ANXIETY DISORDER (big crowds cause her stress), APHASIA (wording is getting worse), URINARY INCONTINENCE (worsening bladder control), GAIT DISTURBANCE (drunken walk, she was like walking in like she's drunk, and running into the door way), FAECES DISCOLOURED (steroids gave him black sticky diarrhea), DYSARTHRIA (speech has been slurred), DRY MOUTH (dry mouth), NASOPHARYNGITIS (severe cold/ bad cold), ALOPECIA (hair loss or bald spots/hair thinning), DIARRHOEA (steroids gave him black sticky diarrhea), PRODUCT DOSE OMISSION ISSUE (had a lapse on therapy, was out of medicine for about a week), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (started breaking the medication in half/ has been braking 14mg in half to make it last longer) and UNDERDOSE (underdose of the medications) outcome was unknown and INSOMNIA (trouble with sleep at times), COGNITIVE DISORDER (nurse was not able to clarify some cognitive issue), PARAESTHESIA (had tingling off and on for the past 2 month in her hands and feet, had tingling on bottom of her feet/ tingling on hands off and), BURNING SENSATION (feel the burning in both feet) and HYPOAESTHESIA (numbness on bottom of both feet) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood count: low (Low) Low. On an unknown date, International normalised ratio: 6.28 (Inconclusive) 6.28. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. 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. 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. Further information has been requested.

nerve damage; entire body became inflamed - Huge inflammation; can't move arm/can't hold on to anything/can't move left leg/can hardly move; Shaking; Bad reaction; coagulation problem; Tremors in the head (brain); Blood pressure went to roof - high blood pressure "169"; cannot walk down; unable to work for a month and half; wrists are swollen - right knee is swollen; Feeling awful; In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts; whole-body hurts; Passing out; kidneys are shutting down; Von Willebrand disease (spelled it out on phone as"gon wille brand'l"; paralyzed; This spontaneous case was reported by a patient and describes the occurrence of LOSS OF CONSCIOUSNESS (Passing out), RENAL IMPAIRMENT (kidneys are shutting down), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l") and PARALYSIS (paralyzed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029A21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (Passing out) (seriousness criteria disability and medically significant), RENAL IMPAIRMENT (kidneys are shutting down) (seriousness criteria disability and medically significant), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l") (seriousness criteria disability and medically significant), PARALYSIS (paralyzed) (seriousness criteria disability and medically significant), NERVE INJURY (nerve damage), INFLAMMATION (entire body became inflamed - Huge inflammation), MOBILITY DECREASED (can't move arm/can't hold on to anything/can't move left leg/can hardly move), TREMOR (Shaking), VACCINATION COMPLICATION (Bad reaction), COAGULOPATHY (coagulation problem), HEAD TITUBATION (Tremors in the head (brain)), BLOOD PRESSURE INCREASED (Blood pressure went to roof - high blood pressure "169"), GAIT INABILITY (cannot walk down), IMPAIRED WORK ABILITY (unable to work for a month and half), JOINT SWELLING (wrists are swollen - right knee is swollen), FEELING ABNORMAL (Feeling awful), PAIN (In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts) and MYALGIA (whole-body hurts). At the time of the report, LOSS OF CONSCIOUSNESS (Passing out), RENAL IMPAIRMENT (kidneys are shutting down), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l"), PARALYSIS (paralyzed), NERVE INJURY (nerve damage), INFLAMMATION (entire body became inflamed - Huge inflammation), MOBILITY DECREASED (can't move arm/can't hold on to anything/can't move left leg/can hardly move), TREMOR (Shaking), VACCINATION COMPLICATION (Bad reaction), COAGULOPATHY (coagulation problem), HEAD TITUBATION (Tremors in the head (brain)), BLOOD PRESSURE INCREASED (Blood pressure went to roof - high blood pressure "169"), GAIT INABILITY (cannot walk down), IMPAIRED WORK ABILITY (unable to work for a month and half), JOINT SWELLING (wrists are swollen - right knee is swollen), FEELING ABNORMAL (Feeling awful), PAIN (In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts) and MYALGIA (whole-body hurts) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood creatinine: 0.50 (Inconclusive) Patient stated her creatinine was 0.50. On an unknown date, Blood pressure measurement: 169 (High) high blood pressure 169. On an unknown date, C-reactive protein: 34/7 (Inconclusive) huge inflammation with c-reactive protein. C-reactive protein at 34.7. On an unknown date, Computerised tomogram: inconclusive (Inconclusive) chest suggested no blood clots per patient. On an unknown date, Fibrin D dimer: 3.89 (Inconclusive) Patient reported that D-dimer (which was usually found after blood clot was present and was in process of breaking down). On an unknown date, Haematocrit: 32.9 (normal) normal. On an unknown date, Haemoglobin: 10.8 (Inconclusive) It was 14 before 3 week ago and was normal and 14 (Inconclusive) It was 14 before 3 week ago. On an unknown date, Monocyte count: 0.91 (High) monocytes are high. On an unknown date, Pain assessment (1-10): 10 (abnormal) hurts at 10 on pain scale from 1-10. On an unknown date, Red blood cell sedimentation rate: 69 (Inconclusive) Sedimentation rate was 69. On an unknown date, Sepsis: negative (Negative) tested negative. On an unknown date, X-ray: inconclusive (Inconclusive) right knee is swollen per x-ray. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered LOSS OF CONSCIOUSNESS (Passing out), RENAL IMPAIRMENT (kidneys are shutting down), VON WILLEBRAND'S DISEASE (Von Willebrand disease (spelled it out on phone as"gon wille brand'l"), PARALYSIS (paralyzed), NERVE INJURY (nerve damage), INFLAMMATION (entire body became inflamed - Huge inflammation), MOBILITY DECREASED (can't move arm/can't hold on to anything/can't move left leg/can hardly move), TREMOR (Shaking), VACCINATION COMPLICATION (Bad reaction), COAGULOPATHY (coagulation problem), HEAD TITUBATION (Tremors in the head (brain)), BLOOD PRESSURE INCREASED (Blood pressure went to roof - high blood pressure "169"), GAIT INABILITY (cannot walk down), IMPAIRED WORK ABILITY (unable to work for a month and half), JOINT SWELLING (wrists are swollen - right knee is swollen), FEELING ABNORMAL (Feeling awful), PAIN (In pain/hurts at 10 on pain scale from 1-10 and whole-body hurts) and MYALGIA (whole-body hurts) to be related. Concomitant product use was not provided by the reporter. No treatment information was provided. The patient stated that she had gone to hospital on 14th and 16th of June 2021 and on 06 Jul 2021. The patient stated that her doctor told her that if she was not treated within a week or 2, she will be gone. The patient stated that due to coagulation problem, she should not have gotten the vaccine per patient and said it was her doctor's fault. The patient stated that she will have to go to ER if anything happens and stated that Moderna vaccine gave her all symptoms and the patient stated that she did not get Covid and was now scared that she will die. Company Comment: Very limited information regarding the events has been provided at this time. Additional information required. Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up received on 9 Jul 2021 contain new serious and non serious events , suspect product dose details, lab data and narrative updated.; Sender's Comments: Very limited information regarding the events has been provided at this time. Additional information required.

After the second dose of the vaccine I had a rash around the shot and a headache the day after but no other side effects. Ten weeks after the vaccine I got a bladder Infection. I have gotten bladder infections in the past but this was more severe. I had urgency, discomfort and blood in my urine. I took one course of antibiotics but the symptoms returned. I returned to the doctor when the discomfort returned and I had a lot more blood in my urine. I received a second course of antibiotics and those seem to have worked. I got the first dose of the shingles shot one month before the first dose of the vaccine. I got the second dose of the Shingles vaccine two months after the second dose of the Covid-19 vaccine.

Upper respiratory symptoms with cough and mild fever. Anorexia. 1/28/21, initially returned from ER but sent back to ER 1/29/21, for persistent symptoms and poor oral intake.

Pt states she awoke during the night and was very confused. Pt became incontinent and had unsteady gait. Pt was taken back to bed by husband. Duration of event took about 15-30 minutes. Pt states she has never had these symptoms in the past and has not experienced these symptoms since the event.

Urinary tract infection 48-72 hours after vaccine. Hematuria, with WBC's. Given course if Macrobid for 7 days.

bladder felt full, like they could not empty it; limited bowel function; vomiting that day; limited appetite; dry mouth; felt very dizzy; extreme tiredness for 3 weeks; A spontaneous report was received from a healthcare professional concerning a 65-year-old, female patient, who experienced urinary retention, dizziness, vomiting, fatigue, decreased appetite, dry mouth and limited bowel function. The patient's medical history, as provided by the reporter, included two time cancer survivor . Concomitant medications reported included Carvedilol for high blood pressure, acetamide for cholesterol, potassium, multivitamins, zinc, calcium, Vitamin D. On 05 Feb, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) in the left arm for prophylaxis of COVID-19 infection. Patient was ok at midnight, but when they woke up, they felt very dizzy, were vomiting that day, and experienced extreme tiredness for 3 weeks, now they feel relatively recovered, like 90%, but still somewhat tired, probably related to not been able to eat on account of having very limited appetite. They mentioned they had limited bowel function, and their bladder felt full, like they could not empty it. Patient states they had a dry mouth from the beginning of the symptoms. After a week of these symptoms, on Saturday, the patient went to a clinic and they did some bloodwork and found that the liver enzymes were elevated and 5 more values were not normal and that their kidney function was not normal. They consulted with their oncologist and they believed these could be an extreme immune response to the vaccine, since the lab work conducted on the 23Dec2020 was normal. Last Friday they have some blood tests and the values were back to normal. Treatment for the events included paracetamol and ibuprofen alternating; and Prednisone. Action taken with mRNA-1273 in response to the events was not reported. The events, dizziness, vomiting, fatigue, dry mouth were relatively recovered, like 90%, but still somewhat tired. The outcome events, urinary retention, decreased appetite, and limited bowel function are unknown.; Reporter'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.

After chills low grade fever March 8th first night of vaccine, the second day March 9th severe headache neck stiffness/pain, dark urine on waking in am. Heart bounding with some skipped beats. At 12:30 wave of nausea, sat on bathroom floor then awakened outside of bathroom on floor. Got to couch and checked my oxygen saturation with husbands pulse oximeter with no reading showing. My fingers were yellowish and nailbeds pale slightly bluish. I put my husbands oxygen on nasal cannula at 2liters and oxygen saturation came up to 96% and I felt better. Left oxygen on till evening. Drank as much water as I could. March 10th still dehydrated heart rate 100 with some skipped beats and still bounding oxygen saturation 94% room air. Still some nausea. Urine less dark but cloudy. March 11th. Still stiff neck. New left face pain and yellow bruising near left jaw below temple with 2 small blood filled pimple like spots. Better now.

Extreme fatigue by 6pm after shot at 9am, weakness for 64+ hours, nausea, loss of appetite, muscle & joint aches, pain at kidneys and later in low back, headache, difficulty focusing, mild dizziness

Recvd dose 10 am event started 7pm. chills, high fever, arthralgia, myalgia, sweating profusely (odd texture to sweat) change in urine color to tea-colored, severe headache, decreased energy level.. Event lasted FOUR DAYS with all of the above symptoms then resolved.

pt states that 11 hours after taking the 2nd dose she collapsed falling to the floor and was paralyzed and had urinary incontinence for 20 hours. EMT came to put pt back in bed. EMT came once again and put pt in wheelchair to get her to a car so she can be taken to Hospital ER. They did blood work which potassium was low, urinalysis test showed bladder infection, and CT was normal. Pt released after 4 hours and told to FU w/ her neurologist. Pt saw Neuro Dr. on 3/17/2021 said she must have had some sort of reaction to the vaccine.

65 year old female (DOB: 06/30/1955) received the 2nd dose of the Moderna COVID-19 vaccine at County Fairgrounds on 03/09/2021 @ 11:00. Pt started experiencing body chills, body aches, fever, nausea, and headache on 03/25/2021 evening. Pt was scheduled for an elective surgery, bunion removal on left foot on 03/26/2021 @ 08:30. Pt was declined the elective surgery due to fever. Pt's fever peaked at 101.8F. Pt called primary doctor and doctor recommended pt go to ER. Pt was admitted to ER on 03/26/2021 @ 10:00 and discharged on 03/26/2021 @ 13:00. Pt tested (-) for COVID-19 and ER diagnosed pt with UTI and prescribed Cefalexin (Keflex) 500 mg for treatment. Pt is diagnosed with breast cancer and takes Anastrozole (Arimidex) 1 mg and multivitamins. Pt takes Tylenol for symptoms, but receives mild relief. Pt is still experiencing body chills, body aches, fever, nausea, and headache. Pt asked when should the elective surgery be scheduled. Pt was advised to talk to primary doctor and oncologist regarding the elective surgery and symptom management. SPI was consulted and Dr was notified.

Her legs and feet became paralyzed and she also became incontinent.; Her legs and feet became paralyzed and she also became incontinent.; Bladder infection; A spontaneous report was received from a consumer concerning a 65-year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced legs and feet paralyzed after 2nd shot/diplegia, became incontinent after 2nd shot, blood potassium was low and bladder infection/cystitis. The patient's medical history was not provided. Concomitant medications were not provided. On an unmentioned date, the patient received their first of the two planned doses of mRNA-1273 (Batch number: unknown) for the prophylaxis of COVID-19 infection. On 08 Mar 2021, prior to the events, the patient received their second of the two planned doses of mRNA-1273 (Batch number: 023m20a) in the left arm for prophylaxis of COVID-19 infection. On 08 Mar 2021, 11 hours after the mRNA-1273 shot, her legs and feet became paralyzed and she also became incontinent. The EMT's came twice and she said she ended up in the ER. Bloodwork was done and found her potassium was low and that she had a bladder infection as well. Lab tests mentioned were a CAT scan and nothing significant was found. Events legs and feet paralyzed after 2nd shot and bladder infection were assessed as medically significant as per IME. Treatment information mentions potassium pills and antibiotics. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. The outcome of the events, legs and feet paralyzed after 2nd shot and became incontinent after 2nd shot was reported resolved on 08 Mar 2021. The outcome of the events, blood potassium was low and bladder infection/cystitis was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Headache, muscle and lymph node pain, nausea, dizziness. fog, chills, loss of bladder control, sense of semiconsciousness, from 7am Tue until 7am Wed

Within 10 minutes, nausea. Faded, Returned once home, treated with ginger ale. Through course of event drank water and gingerale. 17 hours after injection (2:00 a.m.), awoke with very sore arm, aches, and fever of 98.6 (normal temp in 97.5 range). 20 through 28 hours after injection, aches increased, dry cough, very significant headache (right side into right eye and front center), deep heavy pain in between shoulder blades, upper back both sides (kidney area) and left side under lower ribs, deep dull pain in diaphragm, up into chest. Temp increased to 101.8. Ice cold hands. 30 hours after injection, cognitive issues: started a load of bedding in wash, then later found the laundry washed and dried and on the bed. Had no memory of doing it. Husband reports I kept repeating myself. Remember having problems focusing. 35 hours after injection, temperature drop to 99.9. Diarrhea. Ate small dinner but don't remember doing so. 42 hours after injection, temperature at 97.6. Body aches gone. Toes hurt. Pain left side under lower ribs. NO vomiting or chills during event.

She got her vaccine, and started out with the sore arm, but she was sitting in the bathroom sometime after 11:00 preparing to do a peritoneal dialysis exchange and blacked out. She grabbed onto the towel bar on the wall and fell hitting her left hip, left ankle and left upper arm. She does not remember too much after that, but that she was in and out of consciousness until about 12:30 PM Saturday when she remembered being alert but nothing made any sense to her. Her son came in and found her on the floor, she could not get up, she had a skin tear on her right elbow and she had been incontinent of bowel and bladder. He started to ask her the orientation questions and got them all wrong, but she knew that she was confused and disoriented. She could not get up on her own, called the paramedics and they took her to the hospital. The confusion and disorientation lasted into early Sunday morning 3/28/2021 at about 3:00 AM when she started to answer questions appropriately. As the day went on things got better, but still exist to this point today 4/6/21. It was more severe as she came out of the confusion. She has brain fog, inability to sequence thoughts, a little bit of expressive aphasia. She had two CAT scans and an MRI that were negative for subdural or CVA's. I had urine specimen and blood cultures to rule out a UTI or sepsis and those were negative. Her kidney labs were normal. She ABG's drawn and those were normal. They placed her on oxygen and she sat for 3 days and then they released her to home. Today, she is still having the brain fog, still the not able to sequence thoughts, general fatigue. She is black and blue from shoulder to elbow due to the fall.

Dose 1 - Fever 104.1 degrees, severe chills, dizziness, temporary loss of bladder control (12 hrs. duration), weakness, muscular body aches all over. Symptoms commencing eleven (11) hours after dose 1. Ended in about 24 hours. Dose 2 - Myocardial infarction, Acute Congestive Heart Failure commencing eleven (11) hours after dose 2. Hospitalized 3 days. Symptoms of m/i: couldn't breathe, dizziness. 911 summoned.

Pt stated she completed the Moderna vaccine series on 3/13/21 and 4/13/21. She has been in bed for the last 3 days. The first day she was unable to move from the bed and had a fever of 102, headaches, incontinence. She is able to move some today but states her legs are rubbery which is a feeling she has never felt before. She said she has been very confused the last few days and dreaming a lot more than usual. She is improving but still not back to herself at this time and plans to discuss with her neurologist later today.

Wednesday, March 31, 2021 Moderna vaccine, 2nd shot at 4:00pm. Arm began to feel sore about 10pm. Blood pressure and oximeter reading remained normal throughout. Thursday, April 1, 2021 Insufficient sleep, sudden increase in sinus congestion, muscle soreness and increasingly sore arm upon arising. Fatigue, Imbalance and Brain Fog rapidly increased. Urinary incontinence 3 times - once upon awakening and twice in the afternoon. Temperature began rising and reached 100.2°F by 3:00pm (normal temp 97.5°F). Resting pulse rate 74 at 10pm (normal 54). Headache and weakness in the evening. Friday, April 2, 2021 Insufficient sleep, sore arm, sinus congestion, sneezing, moderate headache, moderate imbalance, muscle soreness, weak, moderate brain fog. Resting pulse rate 64 (normal 54). Temp at 7:30am 99.4°F (normal 97.5°F). NEW today: joint pain in both hips and Tinnitus suddenly spiking high. 10:00pm noticed mood began to change, feelings of irritation then anger for no apparent reason. *Saturday, April 3, 2021 Insufficient sleep. Temperature at 12:30pm 98.1°F then continued to fall until it reached normal range (97.7°F) at 10:00pm. Resting pulse rate 68 (normal 54). Increasingly painful hip joints, sinus congestion still high, sneezing, mild headache, canker sores, tinnitus spiking, brain fog, increased imbalance. *NEW today: 7:30am-10:00am mental confusion, hallucinations, auditory, increased imbalance. Afterwards, feelings of fear, anger and paranoia that persisted through Sunday. Evening: increasing blurred vision and diplopia (both chronic conditions but usually very mild). Injection site suddenly red and more swollen, itching. Still feeling uncharacteristically emotional at bedtime. Sunday, April 4, 2021 Insomnia. Volatile emotions - anger, agitation, crying - kept me awake Saturday night; slept 2:30am-8:30am Sunday morning. Brain fog, imbalance, sinus congestion, sneezing, right arm itching, hip joint pain, canker sores on tongue, spiking tinnitus continue. Temperature normal all day; resting pulse rate still high 64 (normal 54). Monday April 5 through Thursday April 15: Most symptoms continued to gradually subside over the next ten days. Spiking tinnitus, canker sores and injection site itching were the most persistent and lasted until April 15. Imbalance subsided on April 12. NEW Symptoms: Anxiety dreaming began on April 6th. Most nights had insufficient sleep. Concern about the cause of the episode of delirium on April 3rd continues. Good news, no COVID-Arm like I had with the 1st vaccination. General observations: It seems as though my body's response to the 2nd vaccination was to temporarily trigger some of the symptoms of my chronic health conditions like MCAS, Dysautonomia and Diplopia, without causing an actual flareup of those conditions. This was quite unexpected and disconcerting. The episode of delirium was something I've never experienced and hope to never experience again.

woozy, poor balance; extreme weakness and stiffness; slipped off bed--unable to bend joints. Extreme muscle rigidity. Flare-up of M.S. symptoms and UTI.

Had moderate fatigue/malaise and mild progressive respiratory shortness of breath within 2 weeks of the first vaccine, then progressed to severe after the 2nd vaccine and was hospitalized on 4/9/2021 with acute pneumonitis for 2 days with steroid treatment and Oxygen, discharged 4/11/21.

Patient is a 66-year-old female with complicated past medical history including uncontrolled diabetes, colovaginal fistula status post resection with end ileostomy in 2017, open cholecystectomy 2019, chronic pain, CAD status post stents on Plavix and COPD that presents to the hospital today complaining of abdominal pain. Patient states that her abdominal pain began a few days ago. Is been in the middle of her abdomen. Is worsened over time. She states that all her operations were done by the Dr. Postoperatively she had no complications. She was told that she could not have her ostomy reversed and has been doing with the end ileostomy since then. She states that she just emptied her bag again this morning. She has been having trouble eating secondary to the abdominal pain. This prompted her visit to the emergency room today. Upon evaluation by the ED physician she underwent a CAT scan which showed a small bowel obstruction. For this were consulted. Of note patient was also found to have a UTI and was made a septic alert by the ED. I met the patient upon my arrival into the emergency room. Upon my arrival into the emergency room patient was sitting upright in bed. She is squirming around in the bed stating that she is having abdominal pain. States that she does not know her medications. Her husband usually takes care of this for her. She is able to relate her surgical history to me. ED physician spoke with the Dr. He is unavailable to come see this patient. According to the ED physician the Dr. asked us to take care of the patient while he is away.

ringing in the ears increased after side effects after 2nd vaccine. Had severe chills and high fevers for 8 hours. Then the ringing increased. Contact Dr and he said not unusual when someone has ringing in ears that it increases after being ill. Also had 3 weeks of glucose spikes that were not normal. Back under control now. Dehydration for 7 days. Increased urination.

Within one hour; my arm was sore. I started my day on 5/14 at 0500. I felt woozie so I sat down for a few minutes. When I got up, I passed out onto the kitchen floor. I got and and started to vomit. I went back to bed. I work every few hours to continue vomiting and dry heaves. I was better on Saturday morning but very weak. My kidneys hurt on Saturday and I spilled blood in my urine. My uring was clear by Sunday morning. I was able to keep food and fluids down as of Saturday morning. As of this morning, 5/18 I am still weak.

Noticed bleeding in the mouth/gums. Looked inside and found bloody holes in my cheeks about 1/2" big. I noticed the top of my hands we also very bruised although I did not get hurt. I went to the ER and they took me in and ran blood tests. They diagnosed me with Immune Thrombocytopenia Purpura. My platelet level was at 8,000, and 6 months prior I was at 180-200,000. They began giving me platelets and were working up to giving my Immunoglobulen. After 2 doses of platelets they gave me 2 doses of benadryl intravenously and I had a scary reaction (I've never had a reaction to benadryl prior to vaccine). My body went numb, it felt like my muscles fell asleep, I felt like I could not breath. It's as if my body attacked anything that came in. Then I was given a sedative to calm down. As the sedative faded I began feeling immense pain in my abdomen, they thought it was internal bleeding, but after a CT scan they found 3 kidney stones. I was then put on fluids. Due to pain, my blood pressure went up and stayed up for about 8-10 hrs at around 255. I was given about 3 does of blood pressure medication throughout that time to lower it as well as morphine to help with the pain. The next morning (Day 3) I was finally given the Immunoglobulin (3 bottles = 1 dose). platelets went up to about 60,000. Then I was given a second dose and released on day 4 (but the second dose was not completed in full, only 1 or 2 bottles of the 3 were given. I was released and came back after 2 days for a blood test. I was given steroids to take for a few months. My platelets were at 120,000. I thought that I was getting better, but then a few days letter came in for another blood test and it showed I was back at 60,000 platelets. Thats where I am now.

On 3/21/21 experienced Increased coughing, shortness of breath, rapid heart beat even when resting, fatigue, high blood pressure, difficulty sleeping, increased asthma, chest pain Went to on 3/24/21 Primary Care Dr. who prescribed using Advair 250/50, Albuterol Sulfate, and Ipratropium bromide Inhaler four times per day. she ordered blood work and COVID testing 3/26/21 Went to ER with severe chest pain and difficulty breathing and was treated by both the ER Dr. and Cardiologist Doctor . The EKG did not show a heart attack. They applied oxygen and Suggested I see a pulmonologist and follow up with Cardiology. Passed a kidney stone on 3/31/21 and brought it in for analysis on 4/6/21 4/6/21 met with APRN in Cardiology to review symptoms, she ordered a limited Echo. Subsequently she ordered a Zio Patch Heart study to collect data over a 2 week period 4/22/21 met with Pulmonologist Dr. she suggested that I needed to meet with ENT to rule out allergies and she increased the Advair to 500/50 and she ordered blood work which was done on 4/26/21 4/29/21 met with APRN in ENT Dr. office for a scope to determine if allergies, Acid Reflux, or sinus issues existed. The scope showed only a bit of scare tissue may be pressing against the voice box which might cause a cough so she ordered a CT scan of the neck (scar tissue from previous intubation 15 years ago) 5/18/21 ZioXT Patch installed 5/18/21 at 1:50 to be worn for 2 weeks to record unusual events with the heart 5/19/21 Revisited Dr. who summarized that blood work was normal. 5/21/21 had Limited Echo Cardiogram which showed no significant difference from previous echo done one year prior. 5/25/21 follow scheduled with primary care Dr. 6/17/21 follow up scheduled with Dr. in ENT to do a further study of the scare tissue found below voice box 7/9/21 flow up schedule with Dr. 7/19/21 Follow up scheduled with Dr. Patient (me) is feeling better, still experiencing cough and heart chest pain and breathing issues but not as difficult as before.

Stage four kidney failure; organ shutting down; Dress syndrome; leiomyosarcoma; loss of appetite; itching; Patient is very sick since 1 dose; Did not received 2 dose; rash that went from her neck, chest, abdomen, and upper thighs; very fatigued; felt throat was closing up; very thirsty; she "started not feeling well"; This spontaneous case was reported by a consumer and describes the occurrence of DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome), LEIOMYOSARCOMA (leiomyosarcoma), RENAL FAILURE (Stage four kidney failure) and ORGAN FAILURE (organ shutting down) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L204) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Blood cholesterol increased. Concurrent medical conditions included Blood pressure high, Immune disorder (NOS) and Osteoarthritis. Concomitant products included ATENOLOL and LEVOTHYROXINE for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, the patient experienced MALAISE (she "started not feeling well"), THIRST (very thirsty), THROAT TIGHTNESS (felt throat was closing up), RASH (rash that went from her neck, chest, abdomen, and upper thighs) and FATIGUE (very fatigued). On an unknown date, the patient experienced DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome) (seriousness criterion medically significant), LEIOMYOSARCOMA (leiomyosarcoma) (seriousness criterion medically significant), RENAL FAILURE (Stage four kidney failure) (seriousness criteria hospitalization and medically significant), ORGAN FAILURE (organ shutting down) (seriousness criterion hospitalization), DECREASED APPETITE (loss of appetite), PRURITUS (itching), ILLNESS (Patient is very sick since 1 dose) and PRODUCT DOSE OMISSION ISSUE (Did not received 2 dose). The patient was treated with PREDNISONE at a dose of 60 mg. At the time of the report, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (Dress syndrome), LEIOMYOSARCOMA (leiomyosarcoma), RENAL FAILURE (Stage four kidney failure), ORGAN FAILURE (organ shutting down), MALAISE (she "started not feeling well"), DECREASED APPETITE (loss of appetite), THIRST (very thirsty), THROAT TIGHTNESS (felt throat was closing up), ILLNESS (Patient is very sick since 1 dose), PRODUCT DOSE OMISSION ISSUE (Did not received 2 dose) and FATIGUE (very fatigued) outcome was unknown and PRURITUS (itching) and RASH (rash that went from her neck, chest, abdomen, and upper thighs) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded. However, very limited information is available regarding concomitant diseases and medications that could be confounders for the events. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: A Followup received on 25 May2021 has information on Newadverse events and concomitant medications were added. Contact information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the start date of the events, a causal relationship cannot be excluded. However, very limited information is available regarding concomitant diseases and medications that could be confounders for the events. Further information has been requested.

On the day of vaccination I had pain in elbow and light headed with dizziness, rash on lower part of arm that came and went, my lets now have a red rash that doesn't itch but it's there, now my legs swelled up , high BP, swollen legs, chills, my feet swollen and continue to get huge and I can't bend my toes or ankles, now I've started having incontinence. Also the pain is unbelievable.

The evening I received the 2nd dose, I began having severe pelvic pain,bil. hip pain and stiffness, bil. hand pain and stiffness, right arm (deltoid) swelling, right axillary lymphadenopathy. I was unable to sleep for 36 hrs. The following day had fever, myalgia, severe epigastric pain, N/V. I felt awful for about 5 days (pains continued, fatigue and low grade fevers) and then had an acute renal calculi and ED visit on 03/3/2021.. To date, (6/7/21), I continue to have bil. hip pain and stiffness, pelvic pain. Left gastrocnemius is painful and stiff also.

Memory loss, can?t walk, incontient of bowel and bladder, hallucinations, no balance ,fine motor skills diminished,

3/28/21: 3 days after the shot, started having extreme heart palpitations that was painful and kept the patient up at night. Lasted for 3 days Shortly after the heart related adverse event, patient started experiencing pain in her side that would "come and go" for months until 6/6/21, when the pain did not go away but was so severe that she started becoming nauseous from it. Patient went to the hospital where they found a clot to her kidney that cut circulation, resulting in the loss of part of her kidney

6/2/21 HA, MYALGIA, ARTHRALIAS, FATIGUE, SOB 6/4/21 Admitted via ED to ICU. Doxy Cefepime 6/4/21 O2 6L. Dexamethasone Improved 6/9/21 D/C from ICU 6/10/21 D/C home. Dexamethasone. No O2

Stomach/ abdominal pain; Looks like it got a sunburn over her shoulder; Rash to the back; Kidney Stone; Feeling Shaky; Feeling sick/not well; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (Kidney Stone) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product DUPILUMAB (DUPIXENT) injection for Atopic dermatitis. Concurrent medical conditions included Rash pruritic since 2020, Rash (At the time of the event, the patient had a rash that comes back intermittently, it's still coming back, it was black, dry and itchy, it's on her abdomen, shoulder, back of neck, and her face under her nostrils, she has allergies to many several things, the rash has been on and off for about a year.) since 2020, Hypersensitivity since 2020, Allergy (Patient is allergic to several things.) and Sleep disorder. Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleep disorder, HYDROCORTISONE ACETATE (HYDROCORT [HYDROCORTISONE ACETATE]) for an unknown indication. On 04-May-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 mg once. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced TREMOR (Feeling Shaky) and MALAISE (Feeling sick/not well). On 20-May-2021, the patient experienced NEPHROLITHIASIS (Kidney Stone) (seriousness criterion medically significant). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Stomach/ abdominal pain), RASH ERYTHEMATOUS (Looks like it got a sunburn over her shoulder) and RASH (Rash to the back). The patient was treated with PARACETAMOL (TYLENOL) for Nervousness and Feeling sick, at an unspecified dose and frequency. At the time of the report, NEPHROLITHIASIS (Kidney Stone), TREMOR (Feeling Shaky), MALAISE (Feeling sick/not well), ABDOMINAL PAIN UPPER (Stomach/ abdominal pain), RASH ERYTHEMATOUS (Looks like it got a sunburn over her shoulder) and RASH (Rash to the back) outcome was unknown. The patient reported that she was participating in a patient support program and was receiving dupilumab injections subcutaneously for atopic dermatitis every other week. Post the second dose of m-RNA 1273 vaccine, she reported feeling shaky and being not well. The nurse from the doctor's office advised her to take Tylenol and after two days the patient reported feeling better. On 18-May-2021, she missed her maintenance dose injection of dupilumab as she was feeling sick with rash to the back and stomach pain. On 20-May-2021, the patient went to emergency room due to abdominal pain and was noted to have kidney stones. Treatment included nurse from the doctor's office advised to take Tylenol (acetaminophen), then 2 days later, she was better. No other treatment mentioned. 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. Further information has been requested. This case was linked to MOD-2021-215094 (Patient Link).; 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. Further information has been requested.

HIVES, RASH UPPER BACK, SHINGLES, COVID ARM SORENESS AT INJECTION SITE, SWELLING, EXTREME FATIGUE, DIARRHEA, SEVERE CONSTIPATION, EXTREME OR SEVER JOINT PAIN, HIGH BLOOD PRESSURE. RINGING IN INNER EARS, INSOMNIA FREQUENT URINATION, BLURRY VISION, GUM SORENESS, PRE DIABETES.

Notes: The Frequency, Duration and Intensity of all my preexisting symptoms, plus 9 new symptoms, increased exponentially on the 3rd day after I received the 2nd Moderna coronavirus vaccination on March 31, 2021. For five weeks the symptoms were every day; now they wax and wane randomly every 2-3 days. The symptoms present randomly (i.e. not in the constellation of symptoms I would normally get with an MCAS flareup), which initially was confusing and disorienting. It feels as though something got turned on in my brain and hasn't turned off. This has seriously and detrimentally affected my quality of life. I now carry a medical Alert device because I have fallen due to the disequilibrium. Symptoms listed in alphabetical order: Items marked with @ are new, never before experienced symptoms. ? Anxiety ? @ Breathing, sometimes dysregulated ? Brain fog ? @ Cognitive: Word finding, rambling, losing track of conversations. 1st shot during acute phase; 2nd shot acute phase then continuing intermittently ? @ Delirium: ? Symptoms: ? Confusion: 1 Day ? @ Emotions, Heightened, sudden onset with no provocation ? @ Hallucinations, Auditory: 1/2 day ? Lightheaded: 1 day. Only during acute phase of delirium (feeling disconnected) ? Onset: Began with heightened emotions (anger, fear, crying/tearful, depression, joy) late afternoon. The next morning auditory hallucinations, disequilibrium, and confusion; insomnia (slept 2:30-8:30am and intense anger the night before followed by fear then paranoia. The acute phase ended as suddenly as it began about 10:00am - total acute episode lasted about 12 hours. However the heightened emotional state - anger, fear, paranoia, - continued. My handwriting was large, loopy for 2 days. ? Complication: followed by fear of repetition, concern because cause unknown, and anxiety dreaming for 2 weeks ? History: I had disequilibrium, confusion and cognitive symptoms in combination only once before, when I had the flu in 2019; duration 1 day ? Disequilibrium ? Emotionally labile, random: tearful, sad, depressed, scared. Began with delirium but has continued intermittently with flare-ups ? Fingers, Icy cold: began during acute phase on same day as delirium, and lasted 4 weeks; continues wit cold fingers during intermittent flare-ups ? @ Heart rate, resting, rapid - 10-14 beats above normal for 2 weeks ? Incontinence and urgency: urinary and gastro ? Senses Heightened or changed: ? Light (photophobia) and Sound (hyperacusis) sensitive ? @ Smell heightened (hyperosmia) ? Taste, Metallic ? Sexual arousal, low level, random and unexpected: briefly for a few minutes several times during acute phase; a few times during intermittent flare-ups ? Sleep, disrupted: Insomnia and Insufficient ? @ Swallowing, difficulty: suddenly unable to swallow water (it got 'stuck') usually on days I have dysregulated breathing ? Tinnitus, increased exponentially: Volume, Duration and Spiking; began fter 1st shot and became even worse after the 2nd shot. I have not yet returned to baseline ? @ Tremors, hands and arms: after mild exertion and/or fine work such as sewing or using mouse to edit photos. ? Vision: Blurred, Diplopia (I have Adie's Tonic Pupil): Increases during acute phase; intermittent with flareups. Other: ? Sudden onset Sinus Congestion, edema, itching and sneezing 12 hours after 1st and 2nd shots and lasted about 4-5 days. ? Fatigue, edema, joint pain, muscle pain, Rosacea flare, canker sores flare all continuing during flareups. ? To reiterate: Symptoms became exponentially heightened in Frequency, Intensity and Duration, and occur randomly - not in the constellation that I'm used for MCAS or Dysautonomia or Tinnitus.

Pt had mild Gi illness diarrhea and vomiting for 2 days, then was not producing urine. Found to be in kidney failure. Had to start hemodialysis

Chest tightness; After two to three weeks later still dizzy; Groin pain; Tired un able to get up; Vomiting; Vertigo; couldn't get out of bed/ couldn't move; shakes really bad; Sore throat; Urinary tract infection; Yeast infection; Bladder not in control/ Difficulty in holding urine; other arm hurt more than the arm i got shot in, vaccination site pain; Headache; Fever; Chills; Pain and Myalgia; Coughing; Bladder pain; Bladder always feels bloated; Sensation of throat closing; Nausea/vomiting; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection), FUNGAL INFECTION (Yeast infection) and URINARY INCONTINENCE (Bladder not in control/ Difficulty in holding urine) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B212A and 040B27A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Sensation of throat closing), BLADDER DISCOMFORT (Bladder always feels bloated) and BLADDER PAIN (Bladder pain). 14-May-2021, the patient experienced NAUSEA (Nausea/vomiting). On 15-May-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion medically significant), FUNGAL INFECTION (Yeast infection) (seriousness criterion medically significant), URINARY INCONTINENCE (Bladder not in control/ Difficulty in holding urine) (seriousness criterion medically significant), MALAISE (couldn't get out of bed/ couldn't move), TREMOR (shakes really bad), OROPHARYNGEAL PAIN (Sore throat), PAIN (Pain and Myalgia), COUGH (Coughing), VACCINATION SITE PAIN (other arm hurt more than the arm i got shot in, vaccination site pain), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills). On 20-Jun-2021, the patient experienced VERTIGO (Vertigo). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest tightness), DIZZINESS (After two to three weeks later still dizzy), GROIN PAIN (Groin pain), FATIGUE (Tired un able to get up) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at a dose of 1 dosage form. On 17-May-2021, MALAISE (couldn't get out of bed/ couldn't move), TREMOR (shakes really bad), OROPHARYNGEAL PAIN (Sore throat), VACCINATION SITE PAIN (other arm hurt more than the arm i got shot in, vaccination site pain), HEADACHE (Headache), PYREXIA (Fever) and CHILLS (Chills) had resolved. On 28-May-2021, URINARY INCONTINENCE (Bladder not in control/ Difficulty in holding urine) had resolved. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) and FUNGAL INFECTION (Yeast infection) had resolved, VERTIGO (Vertigo), CHEST DISCOMFORT (Chest tightness), OROPHARYNGEAL DISCOMFORT (Sensation of throat closing), DIZZINESS (After two to three weeks later still dizzy), PAIN (Pain and Myalgia), BLADDER DISCOMFORT (Bladder always feels bloated), BLADDER PAIN (Bladder pain), GROIN PAIN (Groin pain), FATIGUE (Tired un able to get up), NAUSEA (Nausea/vomiting) and VOMITING (Vomiting) outcome was unknown and COUGH (Coughing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Body temperature: 101.6 (High) Fever 101.6. On 19-May-2021, Urine analysis: abnormal (abnormal) UTI-Yeast infection.. On an unknown date, Body temperature: 101.9 (High) 101.9. Concomitant product was not reported. Reporter was provided treatment information that include 7 day course of antibiotics, yeast infection medicine, over the counter yeast infection medicine and vertigo medication. Company comment: Based on the 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. This case was linked to MOD-2021-231189 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow-up received and added new events.; Sender's Comments: Based on the 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.

Dark brown cola colored urine. Spiked temp at 8:00 am 102, lasted for 24 hours. Urine discolored for 7 days.

Dark brown urine, which lasted for 8 days. Temperature of 102 for 48 hours. Vomiting and weakness 3 days.

Initially started as shortness of breath followed by fevers, aches, muscle cramps. Ultimately ended up in the hospital with hypoxemia, pleural effusions. Laboratory values showed evidence of acute renal insufficiency, eosinophilia. Physical exam consistent with pulmonary edema and lower extremity macular rash. Entire presentation concerning for DRESS syndrome

Within 4 minutes of receiving the vaccination I felt excruciating pulsating pain in the flank area. I felt as if something was gripping, or seizing my internal organs. Radiating from the area of the kidneys or adrenals. Pain was so intense I was not able to catch my breath.

Developed Cystitis in arm due to no lymph nodes under arm. Did not realize I could get vaccine in thigh.. So far I have received 3 Infusions of Rocephin. I am also on day 3 of oral Bactrim. The redness and swelling seems to be getting better. I am to continue the Bactrim for 7 days. I will contact the Doctor Monday to see if I need another Rocephin infusion.

Resident received 2nd Covid 19 vaccine from Moderna on 1/26 in Rt deltoid. Immediately felt a little lightheaded during the 15 min window afterward but was able to ambulate independently with walker just afterward. After taking a nap, she woke with a headache, chills, a little shaky and feeling very tired. She was able to eat and take Tylenol at the time. For the rest of the day, she felt under the weather. The next morning she was very weak, unable to ambulate and tachycardic prompting nursing staff to send her to the hospital for assessment.

Possible kidney infection; Possible bladder infection; A spontaneous report received from a Consumer concerning, 66-year-old female patient who received first dose of the Moderna COVID-19 vaccine and experienced possible kidney infection and possible bladder infection (Cystitis) The patient's medical history was not included. Patient's concomitant medication was not included. On 27JAN2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in unknown arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Patient stated she received her first dose of the Moderna COVID-19 vaccine on 27Jan2021. Patient stated on 30Jan2021, she started to smell an odor and believes that she has a bladder or kidney infection. Patient stated that her doctor cannot see her for several days. Patient would like to have the doctor call in a ZPack or other antibiotic but wants to know if this will interfere with the Moderna COVID-19 vaccine. Patient stated that she does not have a fever. Treatment information was not provided/ unknown. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the events was unknown/not reported.; Reporter's Comments: This report concerns a 66--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and experienced possible bladder and kidney infection. Very limited information regarding this event has been provided at this time. Further information has been requested

On the morning after receiving the vaccine I had severe pain in my left hip, across my shoulders and lower back. I had a golf trip planned so I drove friends from and played 9 holes of golf that afternoon. I took Tylenol every four hours and the pain eased. I felt tired that day but the next day the pain was minor and I was not as tired.I played 18 holes of golf and played 9 on the following day and drove home. The first day of my trip when I had a bowel movement I noticed a strange acidic smell. All that day every time I ate I had a bowel movement, which is RARE for me. I usually go once in the morning. Also when I had to urinate I had to go IMMEDIATELY. The urination issue improved after the 3rd day but I continue to have the bowel problem and a mild headache and just don't feel well. I am mostly concerned about the bowel problem. I have to go every time I eat. Sometimes it is somewhat normal and sometimes it is like diarrhea.

Horrible body aches, burning joints, fatigue, headache, earache, malaise, loss of appetite, constipation and difficulty urinating 102.1 left ear, 101.9 right ear, lasted 24 hours, felt like I was dying Thursday all day and night. Friday felt very weak, constipation continued, tired.

chills beginning night of vaccination. Then around 1:00am urgent need to urinate and again around 2:00am. After the 2:00 bathroom visit I found myself on the floor of the bathroom between the toilet and the shower. I tried to get up but couldn't and managed to get out of the spot I was in but unable to get up. I continued to try but was unable to. after two hours of moving, trying to get up and resting where I was I managed to get to my bedroom (a distance of under 12feet). I felt like my muscles weren't working properly. I called 911 to help me get off the floor and was taken to the closest ER. By 7am on March 12th I was able to get up and walk on my own. Although my arms and legs are bruised I feel much better today.

Partial loss of bladder control (sudden onset of inability to hold urine) and loss of feeling in my feet. Bladder control returned on 3/17, Feeling in my feet returning on 3/17 but some residual at time of this report.

Kidney Stone; Pain; Terrible Headaches; A spontaneous report was received from consumer concerning 66 year old, female patient who developed kidney stone/nephrolithiasis, terrible headaches/headache, pain. The patient's medical history included a procedure for colonoscopy. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on 9 Mar 2021 intramuscularly at right arm for prophylaxis of COVID-19 infection. On 9 Mar 2021 the patient experienced terrible headaches and pain; therefore visited emergency department. Upon arrival to ED, the patient was diagnosed with kidney stone and discharged the same day with Ondansetron and Ibuprofen. The headaches and pain did not subside, so the patient visited ED again on 10 Mar 2021 and was once again discharged after few hours. The patient visited the ED 3rd time on 12 Mar 2021 and was given IV fluids and Ibuprofen. She was discharged on 13 Mar 2021. The medically significant event is kidney stone. Treatment for the event included IV fluids, Ondansetron, and Ibuprofen. Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the events kidney stone, terrible headaches, and pain were considered Resolved.; Reporter's Comments: Based on the information provided which includes a strong temporal association between the reported events and the administration of mRNA-1273 vaccine and based on the known safety profile, a causal association cannot be excluded for the event of fever. Kidney stone and pain are assessed as unlikely based on the known etiology of the disease.

66-year-old woman with a past medical history of rheumatoid arthritis, fibromyalgia, hypertension, hyperlipidemia, GERD and recent COVID-19 vaccination who presented from home with vomiting and altered mental status. Patient was reportedly in her usual state of health until receiving her second COVID-19 vaccination on 3/24/2021. She reportedly developed the above symptoms and her son called 911. She was brought to the ED for further evaluation and management. In the ED, routine vital signs were obtained which revealed patient was febrile to 103.6, heart rate 80, respiratory 18, blood pressure 116/73, O2 saturation 91% on room air. Routine labs were obtained which revealed a normal CMP with the exception of a GFR 47, creatinine of 1.2, lactic acid 1.8, white blood cell count 6.1, hemoglobin 12.2 and platelet count of 144. Urinalysis was obtained and was suspicious for UTI. Rapid influenza and COVID-19 antigen were both NEGATIVE. Blood cultures were drawn in the ED. Chest x-ray revealed a suspicion for infiltrate involving the right upper lung and right perihilar region. CT of the head no acute findings. Patient was felt to have signs and symptoms consistent with pneumonia, and received IV azithromycin and ceftriaxone. Follow up chest xray the following day showed resolution of the right upper lobe findings arguing against pneumonia. Antibiotics were stopped and the patient was discharged home after a 1 day stay.

Started about 12 hrs after injection: unable to sleep but sleepy, nauseas, migraine right eye affected, body ake, dizziness, and itchy in the morning my throat started hurting and tongue swelling, gums and teeth hurt, right fingers swelled, under right arm lymph nodes hurt, painful to touch, liver tender and bladder gave way- (urgency without notice) first time peeing in pants! Took blood pressure and very low reading . Started to feel like a human being again on April 2nd.

1st COVID Vaccine 2/13/2021- Fatigue only 2nd COVID Vaccine 3/13/2021- High fever and severe back pain for 3 hours.

patient went into acute renal failure and presented to Hospital with a BUN/Cr 85/10.9. she ended up having a kidney biopsy and had to have hemodialysis. her biopsy was consistent with acute tubulointerstitial nephritis. she was seen by the nephrologist and she was started on prednisone 30mg daily.

About 12 days after my vaccine I got a UTI from serratia marcescens. This particular infection is unusual and usually occurs in people that have a compromised immune system. I was completely healthy and the only unusual thing was the vaccine.

1:25 am 4-25-21 Temperature 97.5 (0.2 degrees lower than normal on the testing equipment) Right front lower gut pain. (not usual for me) both elbows in pain shot in arm in pain dry mouth heat in arm, in and around area of shot urine darker yellow and more profuse than expected 98/73 blood oxygen some stomach nausea. Nausea is not usual for me. 3:14 am 4-25-21 98.1 temp (my usual temp is 97.5-ish 3"35 am 4-25-21 Temperature 98.4, nearly one degree higher than usual. Feeling feverish. Heat in throat. Possibly starting on a sore throat. Extreme nausea. Actually vomited. (It was all water or water-ish). Vomiting for me is highly unusual. Through-out all 3 of these times, I was severely impacted by extreme fatigue; inability to think, move or do things. 11:53 am 4-24-21 Temp 99.5 (this is two degrees higher than my normal temp taken by the same equipment. Extreme fatigue, sore ears, mild head ache (back of the head on both sides. Another bout of chills. 16:38 pm 4-25-21 99.9. My head doesn't feel hot, but my cheeks do. I don't feel nauseated. I do feel like I want to sleep, so I'm going to. I've successfully sat up to type into this report, which is more than I could do this morning. So, when I wake up, I'll take note of how I feel then.

Headache first, motion sickness, Severe lower back pain to where I can't do anything, Severe weakness in legs especially left leg, Was able to walk 300ft with the use of cane now can only walk 6ft then pain becomes unbearable, Loss of appetite and thirst , extreme bloating and weight gain, Hardly urinate and diarrhea, Side aches, chest is sore to touch, respiratory is harder to control, Can't keep swelling down in legs unless I lay down all the time, Whole body feels swollen and puffy, losing hair, trouble sleeping, severe drooling, eyes burn and hard to focus even with glasses

I have excruciating pain in joints and back, that has not gone away, by Friday 3//5/201 I was doubled over in pain on 3/5/2021 I had had to go to the ER where they diagnosed kidney stones, the left kidney stone passed, and still have a small kidney stone in right kidney. I still over a month after the shot, I am in a lot of pain and I have loss of energy. The pain is in my lower back, my joints radiating to my abdomen and upper legs. I find it difficult to do any activity. This all happened after the second Moderna shot. I contracted Covid-19 March 7 2020 and had the same pain for months.

Increased weakness, shortness of breath, falls, dyspnea and orthopnea, acute kidney injury, bilateral lower extremity swelling, nausea, abdomen pain. Treated at ER 3/10/2021 - discharged home so patient could recieve dose 2 on 3/11/2021. Admitted 3/20/2021 for worsening of all symptoms and Cardiac cathe performed. Discharged to rehab facility 3/30/2021

cystitis; Headache; fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CYSTITIS (cystitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (fatigue). On 08-Apr-2021, the patient experienced CYSTITIS (cystitis) (seriousness criterion medically significant). At the time of the report, CYSTITIS (cystitis), HEADACHE (Headache) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Urine analysis: abnormal (abnormal) urinalysis Blood 3 plus. In 2021, Urine analysis: abnormal (abnormal) urinalysis Blood 1 plus and nitrates (infection) Follow up. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment included Cipro 2 courses. Concomitant information not 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. This case was linked to MOD-2021-105169 (Patient Link).; 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.

On Saturday, April the 3rd, my wife's left leg became numb, and she had a tingling feeling. I took her immediately to ER, where they perform CT and MRI. She was internally transferred to the hospital, where she stayed there until April the 14th, when she was transferred to (the Rehabilitation Institute) to begin physical and occupational therapy. As of today, mi wife doesn't have proprioception in neither of her legs nor her belly (she has no control on bowel and bladder).

per medical report from hospital- "presented to emergency room at outside facility secondary to worsening shortness of breath. The patient states that about 1 week ago she started feeling ill directly after receiving her first covid vaccine. the patient states her medical issues actually began approximately 2 months ago when she developed sudden onset positional urinary retention as well as urinary incontinence and constipation. She states that she thought maybe her known spinal stenosis had worsened causing her bladder dysfuntion.She states she tries to sit on a commode or a toilet and is unable to void however when lying flat she has to wear adult briefs as she has no control over her bladder at all. There is no p

Cystitis; Blood in urine; Headache; Fatigue; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CYSTITIS (Cystitis) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Feb-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). On 08-Apr-2021, the patient experienced BLOOD URINE PRESENT (Blood in urine). On an unknown date, the patient experienced CYSTITIS (Cystitis) (seriousness criterion medically significant). At the time of the report, CYSTITIS (Cystitis), BLOOD URINE PRESENT (Blood in urine), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Apr-2021, Urine analysis: 3+ Blood 3 plus. On an unknown date, Urine analysis: 1+ Blood 1 plus and nitrates (infection). For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient reported that they completed the vaccination dose series and experienced events after both the doses. The patient post receiving their second dose of vaccine had headache, fatigue, and had blood in their urine which the patient experienced even after receiving their first dose of vaccine. The patient consulted their Health care professional and was diagnosed with Cystitis. No Concomitant product use was reported. Company comment : This case concerns a 66-year-old female with a serious unexpected event of cystitis, and nonserious unexpected Blood urine present, and expected headache and fatigue. 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. Treatment medication included two rounds of antibiotic Cipro (2 courses). Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-095681 (Patient Link).; Sender's Comments: This case concerns a 66-year-old female with a serious unexpected event of cystitis, and nonserious unexpected Blood urine present, and expected headache and fatigue. 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.

"Moderna COVID-19 Vaccine EUA" -- patient hospitalized with covid19 after receiving one dose moderna vaccine. 66 y.o. female with hypertension and diabetes admitted with sharp abd pain, nausea, vomiting for several days. CT abd with cecal distention, findings concerning for cecal volvulus. Extended resp panel positive for SARS-CoV-2 (received 1st dose of COVID vaccine on 3/22). Went to OR for exploratory laparotomy, lysis of adhesion and right colectomy. Patient was also found to be Covid-19 positive and needed supplemental oxygen in ED (3L NC at the time). Imaging showing bilateral pulmonary infiltrates/effusions (and also cecal volvulus, as stated above, pt underwent exloratory laparotomy, lysis of adhesion, right colectomy with ilecolostomy). Patient was recovering on medical floor when she clinically decompensated and needed increased oxygen and had a drop in blood pressure (confused, hypotensive, hypoxic). Labs notable for BUN 37, creatinine 2.16, procalcitonin 17.62, Hgb 6.4 (10 on admission). ABG 7.35/ 28/ 73/ 16/ 94% on nasal cannula. 1 unit PRBC given. BP continued to be borderline and was placed on vasopressor briefly. Empiric antibiotics vancomycin/cefepime/Flagyl, and patient was also started on remdesivir and dexamethasone. Nadir O2 sat was 82% on 3/31/2021. T=102.2 on 3/31/21. Patients had multiple family members with Covid-19. Treatments as stated above included Remdesivir and Dexamethasone. Cultures negative - exact source of sepsis unclear: bacterial pneumonia vs. covid vs. intra-abdominal source In ICU from 3/31 to 4/3. Medical floor 4/3 to 4/7. Patient was discharged home 4/7/21.

Asthma attack; Bladder infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHMA (Asthma attack) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHMA (Asthma attack) (seriousness criterion hospitalization) and CYSTITIS (Bladder infection). At the time of the report, ASTHMA (Asthma attack) and CYSTITIS (Bladder infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications listed. The treatment medications included steroids, antibiotic, and asthma medication. Very limited information regarding these events (PT/Asthma and Cystitis) has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events (PT/Asthma and Cystitis) has been provided at this time. Further information has been requested.

Patient reported suicidal thoughts after receiving vaccine. Since vaccination, she reports fecal and urinary incontinence. She has stated that she called her cardiologist and went to PCP. Patient has referral to psych.

face swelled up & skin peeled off inside nose- 1.5 weeks after 2nd moderna vaccine stomach hurt x1 week. Passed blood for a few days. Did have fever body aches. fatigue, hives all over body and head on 1st and 2nd covid

initially shooting pain from to hand post 4 hr., 15 hour after extreme fatigue, 24 hr after fever 101, 30 hr after shooting pains in extremities all night. 44 hr after dizziness, nausea, vomiting. One week after diagnosed with diverticulitis. Diagnosed with UTI 1 month after.

decline in condition, complaints of shortness of breath, recent unwitnessed falls, edema to bilateral lower extremities, incontinence of urine, tearfulness, low heart rate Pedal edema

Systemic Lupus Erythematosus, cardiac arrest for 6 minutes requiring CPR, global heart dysfunction, respiratory failure, received ECMO therapy Patient originally presented with new symptoms of diarrhea, rash, proximal weakness, and functional decline. Her outpatient workup included positive ANA and anti-SSA. She was then referred to Rheumatology for new diagnosis of Lupus. 6/11/2021 she was referred to the hospital for management of acute lupus flair. On admission she was found to have acute kidney injury and thrombocytopenia. AIR team was consulted given concern for active lupus, she was started prednisone as well as Plaquenil. On 6/17/2021, she brought emergently to MICU for lethargy, WOB, hypoxia, and new onset A-Fib. She was intubated and continued to clinically deteriorate with persistent lactic acidosis. An ECHO showed severely depressed EF and right heart dysfunction. On 6/17/2021 she experienced PEA arrest with 6 minutes of CPR. She was placed on VA ECMO with Impella. Patient was extubated on 6/19/2021 and was reintubated on 6/20/201 for hemoptysis. A CT on that day showed RP bleed on the left with extension into the left thigh and ground glass opacities throughout suggestive of ARDS. She tolerated a slow ECMO wean and was explanted successfully on 06/23. She was extubated on 06/25. Over the next several days she was able to be successfully weaned from HFNC and was transitioned to NC. On 6/28 she passed her swallow evaluation and was okayed for a PO diet. Plan is to transition patient to the floor in the next few days

No symptoms on 1/8. Saturday 9pm inj site was sore. 1/10, 3pm, began to get a headache, terrible, banger of a headache, took Tylenol. Headache all night long. 1/11 2am got nauseated to the point of vomiting. Runny nose and coughing. Finally woke up this am with muscle pain. The headache is better, but still feels pressure. Feels bad all over, flu like, flushed, feverish. Right kidney pain, started today.

12 hours after injection I became very ill with vomiting, diarrhea, incontinance, severe chills, fever, pain in arm radiating up to the left side of my face. The pain and lightheadedness continued for 48 hours. I tried to take pepto and ibuprofen but couldn't keep it down.

1/18/21Moderna injection on 1/18/21 1/21/21ER- right flank pain/kidney: Blood in urine?prescribed Naprosyn 1/27/21 Dr /for pain right kidney/ Blood in urine/ prescribed Ciproflaxin 500 mg/2 times daily for 7 days and Phenazophridine 200 mg tab every 8 hrs as needed 2/7/2021 clinic /red eyes and urine pain/ antibiotic eye drops

Lost control of bladder; Could not walk; Paralyzed from the waist down for about 24 hours; Received the 2nd dose on 22Jan; Diarrhea; Vomiting; A spontaneous report was received from a consumer, concerning a 67-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced paralyzed from the waist down for about 24 hours/PT: Paralysis, received the 2nd dose on 22 Jan 2021/PT: inappropriate schedule of product administration, lost control of bladder/PT: urinary incontinence, could not walk/PT: gait inability, diarrhea/PT: diarrhoea, and vomiting/PT: vomiting. The patient's medical history was not provided. Concomitant medications included omeprazole, fluoxetine hydrochloride, propranolol, colestipol, acetylsalicylic acid, and calcium. The patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) on 28 Dec 2020. On 22 Jan 2021, the same day as the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 032L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, following the second vaccination, the patient experienced vomiting and diarrhea. On 23 Jan 2021, the patient could not walk, was paralyzed from the waist down for about 24 hours, and lost control of her bladder. Treatment information for the events was not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events was not applicable. The outcome of the event, paralyzed from the waist down, was considered recovered/resolved on 24 Jan 2021. The outcome of the event, received second dose on 22 Jan 2021, was considered resolved on 22 Jan 2021. The outcome of the events, vomiting, diarrhea, could not walk, and lost control of bladder, was unknown.; Reporter's Comments: This case concerns a 67 year old female subject, who experienced a serious unexpected event of paralysis after second dose of mRNA1273 (Lot# 032L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.

diarrhea low gas pain chills / sweating dry mouth sleepy no apatite cough with phlegm dizzy loss of bladder control blood clots in nose mucus

Pt got very hot & flushed then had a sudden urge to urinate. Heart then started racing. Feeling passed quickly and she relaxed and started feeling better. Stayed for about 20 minutes in pharmacy area and was feeling well when she left. I called her later that evening and she was fine

I had a health physical on 11/30/2020. I had lab work on 2/01/2021. My Creatinine readings both times were in the normal range of 1. After having the Moderna injection on 2/11t2021, I had flu like symptoms on 2/12/2021. On 2/13/2021 I assumed my daily activities. On Sunday the. 14th of February around 6PM, I became very weak. I could only get out of bed to use the restroom. I was to weak to do my normal activities. I was bed ridden for the next 11days. On 2/22/2021, I went to Medical Practice. They treated me and sent me home. On the 25th of February at or around 5PM, I went to Hospital. My Creatinine number was 9 and they admitted me. Eventually i was diagnosed with Kidney Failure.

On 2/25, right arm was sore and had fatigue. On 2/26, woke up feeling stiff and achy. On 2/27 in the evening, inner thighs and arms developed a red rash with itchiness. On 2/28, went to ED where Dr. prescribed 3 tab (60 mg total) of prednisone for 5 days. On 3/1, rash continued to spread over entire body. On 3/2, saw primary physician who ordered blood work. He adjusted prednisone schedule, prescribed hydroxidine, and epipens, and requested followup status. On 3/4, rash and itchiness dramatically subsided. Today the rash is gone.

Started feeling woozy and nauseous within 15 min. Spike in pulse O2 good thought it was poss. hypoglycemic reaction Provided with Orange juice. Daughter came to drive me home. At her house started extreme tremors beyond chills lips tingling confusion and heart racing. Extreme urination . beyond fluid intake for morning. Daughter called ambulance and was taken to Jasper hospital > EMT administered nausea med IV. In ambulance had extreme left ear, neck, and jaw pain. extreme headache and uncontrolled shakes tremors esp on left hand arm. Er admit and treatment until released to daughters care. 24 hrs nausea even with meds. Severe headache and body aches as of this time-frame 3:20 PM 3/7/2021

1 and half hour after 1st shot on 2-10-2021 started legs aching, then felt pain everywhere stomach and gallbladder burning with acid, headache, chills, constant urination, no fever, tired, arm hurts, nauseous and a little hard to breath. lasted 2 days 3 hours after 2nd shot on 3-10-2021 started legs aching, then felt pain everywhere, stomach and gallbladder burning with acid, headache, chills, constant urination, no fever, tired, arm hurts, nauseous and a little hard to breath. 24 hours still sick

Patient reported having fever, prolonged chills, kidney pain that was significant enough that her chronic pain meds did not cover it. Ongoing pain 12 days after first dose. Patient consulted pcp and pcp told her it was a reaction to the vaccination. Her and her pcp are still determining if she will get the second dose.

Pt was vaccinated on 2/28 and on 3/2 began to experience worsened sob from baseline, development of sternal chest pain, abdominal bloating, nausea and fatigue. She presented to the hospital on 3/9 c/o intractable pain and nausea/vomiting that was worsening. Imaging revealed no change in her cancer from same imaging in jan 2021. PE ruled out. No sepsis. She had acute kidney injury/dehydration. started on ivf. renal imaging normal. echo normal. ekg normal. she rapidly progressed to anuric renal failure and died 3/13/2021. oncology ruled out tumor lysis. she was not felt to be a candidate for dialysis.

Patient reported that she started feeling bad the night of the vaccination. Patient went to the hospital and was admitted. Patient was told she had COVID-19 and a UTI. She says she was given convalescent plasma for COVID-19. She said she had pneumonia, fever, cough, fever and chills.

Extreme nausea, headache and vomiting. Restless legs, general itching, frequent urination, orange urine!

The evening of the vaccine, at about 10pm I suddenly was unable to get up from the couch and I had an episode of incontinence. I had to shout for my husband who was asleep in the bedroom to come help me. He had me hold onto his neck and he lifted me, transferred me to a chair, pushed me into the bedroom and transferred me to the bed. Overnight I experienced incontinence again, was still not able to stand or walk and my husband had to help me to the bathroom. The next morning I was not able to walk and was very tired and weak. My husband pulled me into a chair and pushed me to the dining room. I had a small amount of yogurt and after 2- 3 hours needed to go bad to bed and slept to evening. After waking I was still weak and had not appetite. During the second night I was able to go to the bathroom unassisted. After three days I was feeling back to normal.

Vaccine given at 9:05 am - by late afternoon felt sluggish, chilled, headache, achy During the night, I went to the bathroom several times. Each time I felt very "sick," aches and pain all over, headache, weak, hard to walk, fever of 100 (usually run 97.4.) Last trip to the bathroom, felt very weak and tried to get back to my bed. I blacked out, fallingl in the floor. I have no idea what part of my body hit the floor first, but my entire right cheek and under my chin, right shoulder, right hand all bruised and very sore. Both knees hurt from the fall. Still experiencing facial bruising/soreness, chin area, right shoulder, right hand and knees.

On day 4 from day of the vaccine, I woke up with a headache. I soon became extremely nauseated, runny nose, diarrhea, frequent urination, dry heaves. Some of this was expected, but actually none of this was said to be a side affect. None of this was advertised. I had heard that the vaccine makes you sick (thru the grapevine). Didn't think it would be as bad as it was and that the Pfizer vaccine was not as reactive. I live alone and am 67 years old . My chest began to hurt. After 4 hours of being sick I called 911.

4/5/21 triage: Pt was in ED with son who was a pt today. Pt walked outside where she became light headed & briefly loss consciousness. This nurse witnessed pt knees begin to buckle & son lowered her to ground. Pt states "sometimes I get light headed if I haven't had enough water". Pt alert/oriented @ this time. C/o upper back pain that she states is new for her. orthostatic positive HPI: 67 y.o. female who presents with a near syncopal episode just PTA. She feels that she is dehydrated. No chest pain. Some cough, no dyspnea or fever. No hx of CAD. elevated troponin 1.28; 2.27 transferred to other HCF hpi: History of Present Illness: The patient is a 67 y.o. female with a past medical history notable for diabetes mellitus, hypertension, glaucoma who presents with chief complaint of "short of breath." Patient lives at home.Patient code status is: Full code status. Patient reports she has been battling a head cold over the past 2 weeks. Patient has had low-grade fever of 99° F. Otherwise, patient has done well. Patient had brought her son to the hospital emergency department. When patient was getting ready to leave his room in the emergency department she says she felt sudden shortness of breath and dizziness. Patient reported that she said ?I do not think I can make it.? Patient then proceeded to get weak and syncopized. Patient's son was already at her side and laid her on the ground. Patient never hit her head. When patient had return of consciousness, she continued to feel short of breath and dizzy. Patient reported that sometimes she feels a sensation at home when she is dehydrated and has not drink in enough fluids. Patient denies having any chest pain, fever, nausea, or vomiting. Patient presented to the ED with the following vital signs: Temperature 97.5°, heart rate 88, blood pressure 183/99, respiratory rate 24, oxygen saturation 85% on room air. EKG was read as normal. Laboratory findings reported as troponin I 0.11, repeat troponin I 3 hours later revealed 1.28. Other laboratory findings significant for glucose 127, BUN 30, creatinine 1.2. Chest x-ray was read as unremarkable. Patient given the following medications in the emergency department: IV fluids x2 L bolus, 324 p.o. Aspirin, nitroglycerin ointment, treatment dose Lovenox. During my evaluation of patient, patient denied having any chest pain. Patient reported that she was feeling okay. Patient was admitted to Internal Medicine service for further management of NSTEMI.

oral intake reduced; Acute Renal Failure; Thrush in mouth and gums; Bed ridden, barely hold her head up and barely drink; felt tired, not normal tired; Barely hold her head up; weakness; flu like symptoms; Fever; chills; Body aches and soreness; This spontaneous case was reported by a consumer and describes the occurrence of ACUTE KIDNEY INJURY (Acute Renal Failure) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (Fever), CHILLS (chills) and MYALGIA (Body aches and soreness). On 14-Feb-2021, the patient experienced BEDRIDDEN (Bed ridden, barely hold her head up and barely drink), FATIGUE (felt tired, not normal tired) and HEADACHE (Barely hold her head up). On 22-Feb-2021, the patient experienced ORAL CANDIDIASIS (Thrush in mouth and gums). On 25-Feb-2021, the patient experienced ACUTE KIDNEY INJURY (Acute Renal Failure) (seriousness criterion medically significant). On an unknown date, the patient experienced HYPOPHAGIA (oral intake reduced). At the time of the report, ACUTE KIDNEY INJURY (Acute Renal Failure), ASTHENIA (weakness), INFLUENZA LIKE ILLNESS (flu like symptoms), BEDRIDDEN (Bed ridden, barely hold her head up and barely drink), ORAL CANDIDIASIS (Thrush in mouth and gums), HYPOPHAGIA (oral intake reduced), PYREXIA (Fever), CHILLS (chills), MYALGIA (Body aches and soreness), FATIGUE (felt tired, not normal tired) and HEADACHE (Barely hold her head up) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood creatine: 1 (Inconclusive) 1. On 25-Feb-2021, Blood creatine: 9 (Inconclusive) 9. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Prior to getting the 2nd dose of the vaccine, patient had sinus infection and was prescribed antibiotic and steroid on 10-FEB-2021. Patient was prescribed Nasal Spray and Nystatin. Patient is now on dialysis 3 times a week and on 6 different pills a day and on high dose of steroid. The patient was treated with Percocet 325-10 mg, Lyrica 150 mg, Prevacid 40 mg as required for GERD. The patient is also on dialysis 3 times a week and is on six different pills a day and on high dose of steroid. 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.; 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

Started with extreme pain in right shoulder injection site. Urinated about every hour, fever of 99.8, extremely nauseous, excruciating headache, rigors throughout my body, teeth chattering, dizziness, weak, muscle aches. Could not get any relief from Tylenol or aspercreme. I did not sleep all night on 4/08/2021 until 7am 4/09/2021. The extreme shoulder pain lasted for 3 days. For 2 days I felt very weak and dizzy with a slight fever of 98. Since my symptoms went away after 3 days I did not contact a Dr. My son stayed with me in case of an emergency.

Patient told us that his throat felt like tightening. Developed lactose intolerance. Urinated a lot. Back pain. Tiredness that lasted for weeks. Stool color changed. It felt like heat in the body for about a week. Felt weaker, without strength. When the vaccine was administered to him, he became dizzy and blurred vision.

Had UTI. Got myself over the counter meds. I knew what to get because I had same thing with my 1st Moderna vaccine. Same number of days later! Have not had one since.

mentally overwhelmed; missed her 2nd dose; headache on and off; staggering fatigue/hard to stay awake where her eyes always wanted to close; felt uneasy; dizzy; she did not make it and urinated on the floor; passed out on the toilet; nervous; jittery feelings; Hands started to shake; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out on the toilet) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis (Left knee). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), KETOROLAC and HYDROXYZINE for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NERVOUSNESS (nervous), FEELING JITTERY (jittery feelings) and TREMOR (Hands started to shake). On 13-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out on the toilet) (seriousness criterion medically significant), DIZZINESS (dizzy), INCONTINENCE (she did not make it and urinated on the floor), FEELING ABNORMAL (felt uneasy), HEADACHE (headache on and off) and FATIGUE (staggering fatigue/hard to stay awake where her eyes always wanted to close). On an unknown date, the patient experienced EMOTIONAL DISTRESS (mentally overwhelmed) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose). On 12-Mar-2021, TREMOR (Hands started to shake) had resolved. On 13-Mar-2021, LOSS OF CONSCIOUSNESS (passed out on the toilet) and INCONTINENCE (she did not make it and urinated on the floor) had resolved. At the time of the report, NERVOUSNESS (nervous), FEELING JITTERY (jittery feelings), DIZZINESS (dizzy), EMOTIONAL DISTRESS (mentally overwhelmed), FEELING ABNORMAL (felt uneasy), HEADACHE (headache on and off) and FATIGUE (staggering fatigue/hard to stay awake where her eyes always wanted to close) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (missed her 2nd dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment of these events were not reported. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Shortness of breath increasing; lethargy; Hyperkalemia; Acute kidney injury; metabolic encephalopathy; Uremia; metabolic acidosis; protein calorie malnutrition; Hyperuricemia; Hyperphosphatemia; Hyponatremia; Anemia; Substernal chest pain aggravated; increasing abdominal girth; Abdominal Pain; Weakness; Nausea; multiorgan failure; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiorgan failure), DYSPNOEA (Shortness of breath increasing), LETHARGY (lethargy), HYPERKALAEMIA (Hyperkalemia), ACUTE KIDNEY INJURY (Acute kidney injury), METABOLIC ENCEPHALOPATHY (metabolic encephalopathy) and AZOTAEMIA (Uremia) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer stage IV since March 2019, COPD since an unknown date, GERD since an unknown date, Hypertension since an unknown date, Tobacco user since an unknown date, Transaminases increased since an unknown date, Peritoneal carcinomatosis since an unknown date and Metastatic bone disease prophylaxis (Lumbar spine pelvis and proximal femurs) since an unknown date. Concurrent medical conditions included Acute renal failure (Due to Foley catheter placement) and Pneumonitis. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiorgan failure) (seriousness criteria death and medically significant), DYSPNOEA (Shortness of breath increasing) (seriousness criterion hospitalization), LETHARGY (lethargy) (seriousness criterion hospitalization), HYPERKALAEMIA (Hyperkalemia) (seriousness criterion medically significant), ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criterion medically significant), METABOLIC ENCEPHALOPATHY (metabolic encephalopathy) (seriousness criterion medically significant), AZOTAEMIA (Uremia) (seriousness criterion medically significant), METABOLIC ACIDOSIS (metabolic acidosis), MALNUTRITION (protein calorie malnutrition), HYPERURICAEMIA (Hyperuricemia), HYPERPHOSPHATAEMIA (Hyperphosphatemia), HYPONATRAEMIA (Hyponatremia), ANAEMIA (Anemia), CHEST PAIN (Substernal chest pain aggravated), WAIST CIRCUMFERENCE INCREASED (increasing abdominal girth), ABDOMINAL PAIN (Abdominal Pain), ASTHENIA (Weakness) and NAUSEA (Nausea). The patient was hospitalized on 09-Mar-2021 due to DYSPNOEA and LETHARGY. The patient died on 13-Mar-2021. The reported cause of death was Multiorgan failure. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (Shortness of breath increasing), LETHARGY (lethargy), HYPERKALAEMIA (Hyperkalemia), ACUTE KIDNEY INJURY (Acute kidney injury), METABOLIC ENCEPHALOPATHY (metabolic encephalopathy), AZOTAEMIA (Uremia), METABOLIC ACIDOSIS (metabolic acidosis), MALNUTRITION (protein calorie malnutrition), HYPERURICAEMIA (Hyperuricemia), HYPERPHOSPHATAEMIA (Hyperphosphatemia), HYPONATRAEMIA (Hyponatremia), ANAEMIA (Anemia), CHEST PAIN (Substernal chest pain aggravated), WAIST CIRCUMFERENCE INCREASED (increasing abdominal girth), ABDOMINAL PAIN (Abdominal Pain), ASTHENIA (Weakness) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, Blood culture: negative (Negative) Negative. On 12-Mar-2021, Blood gases: abnormal (abnormal) Compensated mixed respiratory and Metabolic alkalosis. On 12-Mar-2021, Blood pressure measurement: 96/52 (Inconclusive) 96/52 mmHg, 100/50 (Inconclusive) 100/50 mmHg and 88/58 (Inconclusive) 88/58 mmHg. On 12-Mar-2021, Blood test: normal (normal) WBC-2.9 Normal, Hg-Normal, Platelet count-Normal. On 12-Mar-2021, Body temperature: 36.1 (Inconclusive) 36.1degrees Celsius, 35.9 (Inconclusive) 35.9 degrees Celsius and 36.2 (Inconclusive) 36.2degrees Celsius. On 12-Mar-2021, Brain natriuretic peptide: normal (normal) normal. On 12-Mar-2021, Chest X-ray: normal (normal) No acute thoracic pathology. On 12-Mar-2021, Computerised tomogram: abnormal (abnormal) revealed a right sided pleural effusion bony metastatic disease and hepatic metastatic disease, as well as small amount of ascites in the upper abdomen. On 12-Mar-2021, Echocardiogram: inconclusive (Inconclusive) Ejection fraction 60-65% and otherwise no significant findings. On 12-Mar-2021, Heart rate: 92 heart beats per minute (Inconclusive) 92, 86 heart beats per minute (Inconclusive) 86 and 90 heart beats per minute (Inconclusive) 90. On 12-Mar-2021, Oxygen saturation: 96 (Inconclusive) 96 percent, 93 (Inconclusive) 93 percent and 98 (Inconclusive) 98 percent. On 12-Mar-2021, Prothrombin time: normal (normal) normal. On 12-Mar-2021, Respiratory rate: 16 (Inconclusive) breaths per minute, 18 (Inconclusive) breaths per minute and 19 (Inconclusive) breaths per minute. On 12-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 12-Mar-2021, Troponin: normal (normal) normal. On 12-Mar-2021, Urine analysis: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MULTIPLE ORGAN DYSFUNCTION SYNDROME (multiorgan failure), DYSPNOEA (Shortness of breath increasing), LETHARGY (lethargy), HYPERKALAEMIA (Hyperkalemia), METABOLIC ENCEPHALOPATHY (metabolic encephalopathy), AZOTAEMIA (Uremia), METABOLIC ACIDOSIS (metabolic acidosis), MALNUTRITION (protein calorie malnutrition), HYPERURICAEMIA (Hyperuricemia), HYPERPHOSPHATAEMIA (Hyperphosphatemia), HYPONATRAEMIA (Hyponatremia), ANAEMIA (Anemia), CHEST PAIN (Substernal chest pain aggravated), WAIST CIRCUMFERENCE INCREASED (increasing abdominal girth), ABDOMINAL PAIN (Abdominal Pain), ASTHENIA (Weakness) and NAUSEA (Nausea) to be possibly related. No further causality assessment was provided for ACUTE KIDNEY INJURY (Acute kidney injury). Concomitant medications were not provided. Treatment for the events included proton pump inhibitors, oxygen, Tylenol, and comfort care. Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Reported Cause(s) of Death: multiorgan failure

tested positive for Covid-19; I took her in to see the Dr for a urinary tract infection; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) in a 67-year-old female 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 information was reported. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 30-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for Covid-19) (seriousness criterion medically significant) and URINARY TRACT INFECTION (I took her in to see the Dr for a urinary tract infection). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for Covid-19), URINARY TRACT INFECTION (I took her in to see the Dr for a urinary tract infection) and PAIN IN EXTREMITY (sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. It was reported that the patient had been feeling weak a few days before getting the vaccine. Patient was treated with one dose of IV Bamlanivimab etesevimab to treat Covid.and was sent home. Company comment: SARS-CoV-2 test: positive is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-138839, US-MODERNATX, INC.-MOD-2021-138859 (E2B Linked Report).; Sender's Comments: SARS-CoV-2 test: positive is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-138859: US-MODERNATX, INC.-MOD-2021-138839:Crosslink

I got my second vaccine on 2-24. For 2 days after the vaccine, I experienced chills, a high fever (102), sweats, and overall body aches. By 2-28, I was feeling tired but no symptoms. By March 3, I started to experience severe exhaustion again, plus unusual brain fog, and paresthesia. I went to ER and was checked for stroke. Given MRI and blood tests. Some energy returned by 3-6. On 3-9, severe fatigue returned along with increased cognitive confusion. I was unable to function as I was sleeping up to 15 hours a day 3 or 4 x's a week. I had to stop working. I was referred to a rheumatologist in March and started getting blood tests. Blood tests show high titers of AMA, ANA,RNAl.Doc suspected AI disease and begin elimination testing. In May 2021, I had a liver fibroscan, ultra sound, and biopsy. Biopsy showed bile duct inflammation. In early June 2021, a gastroenterologist, gave Dx of Primary Biliary Cholangitis. Rx Eursodiol. (Rheumotologist had Rx Hydroxychlorquine before PCB Dx but I never started that.) I have been taking Ursodiol for 2 weeks. Still battling fatigue but it is lessening. I still get fatigued if I do simple adult activities like grocery shop, do light house cleaning, go out for simple dinner.

Patient presented to the ED and was subsequently hospitalized on 3/6/2021 with ataxia and acute kidney injury. Patient received second dose on 3/12/2021. Patient presented to the ED and was subsequently hospitalized on 3/29/2021 with acute cystitis with hematuria. These visits are within 6 weeks of receiving COVID vaccination.

Headache, chills, body ache, upset stomach, stomach pain, blood in urine, constipation, kidney stones

So about a month later after the vaccine, I woke up with chills, felt very cold and my heart was beating fast. I took my pulse and it was going up to 123. My oxygen saturation was good 96-98%. I took my temp and I had a low grade fever. I bought a BP monitor and my BP was as high as 145/88 and fluctuated throughout the day and would go back down. I went to an Urgent Care. I got an urinalysis and it was positive for UTI. I was prescribed a medication called Macrobid for the UTI and referred to a cardiologist. By the time I went to see the specialist, most of my symptoms had subside. I went to the cardiologist and did an ECHO and had to wear a monitor. Everything came back normal and all my symptoms has subsided except a little short of breath.

1) 2nd dose Moderna administered 09:39 a.m., Wednesday, 24 Feb a) Within 5 hours of the 2nd vaccine i) Dizziness ii) Slight nausea iii) Extreme soreness at injection site iv) Muscle aches v) Weakness, unable to lift injected arm b) After 8 hours post 2nd vaccine / overnight i) Chills / uncontrollable shaking / teeth chattering ii) Dehydration iii) Severe headache iv) Tinnitus v) Increased nausea vi) Delirium vii) Cold sweats viii) Whole body pain ix) Unable to sleep (due to pain) x) Too weak and too painful to move xi) Cold sweats xii) Chest pulsations- felt like air bubbles in blood line pumping through heart 2) Thursday, 25 Feb a) Unable to rise from bed b) Extreme weakness c) Hard to breathe d) Took one+ hour

Pt admitted for AKI on CKD COVID 19 swab positive as as screening test in the ED, repeat COVID test was negative on the same day (7/14/21) Hospitalized at Hospital

Fever malaise no appetite muscle aches X 5 days. Hospitalized for dehydration fever chest pain decreased kidney function Hospital stay 5 days Treatment: IV fluids observation

Pt. was admitted to hospital on 1/6/21 with fatigue, weakness. Pt. was Covid positive in November of 2020. Impression upon admission was fatigue may be due to her aortic stenosis and some hypertensive issues with blood pressure changes. She was anemic. WBC was elevated to 19.2, HBG 10.5, NA-131, K+ - 3.1, Rule out bacterial infection. Potential source could be her heart valve. Also noted to have acute renal failure with BUN of 47 and Creatinine of 2.2 noted. Pt. was transferred to Hospital on 1/8/2021 with dx of aortic stenosis, bacteremia, ARF, Dehydration and anemia. Discharged with dx. of sepsis. Pt. expired on 1/18/21 with dx. of severe sepsis, complete heart block, staphylococcus epidermidis bacteremia.

10 minutes after vaccination patient became unresponsive, staring forward with stiff body, arms flexed and hands fisted. She required sternal rub without response. She was incontinent. Episode lasted 1-2 minutes. She had no recollection of the episode. Paramedics assisted, with Temp 97.1, HR 80, B/P 122/80, pulse ox 98%, fingerstick 101. She was transported by ambulance to Hospital. Laboratory assessment was unremarkable for for CMP, CBC, Troponin, Lactic acid. EKG, CXR and CT head were also unremarkable. She was discharged with diagnosis of possible vasovagal syncope episode and instructed to follow-up with her pcp.

Beginning about 9pm increasing soreness and pain in arm -by midnight arm was too sore and stiff to lift above waist Beginning about 11pm headache, full body joint pain, full body body aches, chills, fever approaching 99 (NB - my typical body temp is 97.2 - 97.4). As night progressed the symptoms worsened - about 2am intense back pain between shoulder blades radiating to chest, heart was pounding, temperature increased to 101 About 3am was in extreme pain throughout entire body, severe chills/shaking, fever was 102.2, experienced minor urinary incontinence About 3:30am I finally had to take 2 Advil - within an hour the symptoms had lessened and temp had dropped to 100 By noon (22 hours after injection) I was experiencing only mild body aches, temperature was normal, left arm remained sore but I could move it - other side effects had resolved I am very stoic and have a fairly high pain tolerance. I had no side effects after shot 1. After shot 2 I was sicker than I have ever been in my life ?- for several hours I was concerned I was going to die.

Kidney stone; A spontaneous report was received from a consumer, concerning a 68-years old female patient, who was administered Moderna's COVID-19 vaccine and developed kidney stones. The patient's medical history was not provided. The patient was not taking any concomitant medications. On 20 Jan 2021, approximately 30 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) in the right arm for prophylaxis of COVID-19 infection. The patient stated that she went to Emergency room (ER) on 18 Feb 2021 for kidney stone. The patient was treated with flomax, tylenol with codeine, motrin 600mg, zofran ODT. The patient wanted to know if she can still take her Flomax and get 2nd dose. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, kidney stone was unknown.; Reporter's Comments: This case concerns a 68-year-old female who experienced serious unexpected event of Nephrolithiasis. The events occurred 30 days after the first dose of mRNA-1273. Treated with Flomax, Tylenol with Codeine, Motrin, Zofran. Event outcome 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.

March 9 severe headache, chills lasted one day. March 9 trouble urinating in am, red itchy bumps on left elbow, lower back, right leg. Itching stopped on March 10 however have hard lump where bumps were. March 10 and continuing more itchy bumps on left hand, both legs, lower back. Benadryl 25mg 2x daily. Bumps still appearing

Sent: 3/4/2021 7:55 AM Subject: Non-Urgent Medical Question For a full week now, I have been battling diarrhea and a very hyperactive stomach and intestines. Provider prescribed some bentyl Sunday to ease my cramping. At early onset I had some nausea too. I'm wondering if I don't need some blood work, whatever you think and maybe recheck my TSH too. Dr. already ordered a UA with culture which were both negative. That was done because of back pain over left kidney a couple of weeks ago. Diagnosis: Theo. My intestines have never been right since my surgery, but this gassiness and hyperactivity is much more extreme. I tried Metamucil and it blew my guts up even worse. I know I'm due for a CT scan. I see Dr. March 22. I'm trying to hold off until then because I want to discuss with him why I prefer to have all scans at specific facility. I just wanted to get your advice since it's been a week now. I did get my second Moderna vaccine on February 15 and Fulvestrant injections on Feb. 22. My issues started on Feb. 25. Oddly, right now as I'm typing this, my gut is much calmer. Yesterday was my worst day with diarrhea. 3/13/21 ER for back pain - transferred to second hospital - remains admitted there as of 3/16/21 History of Present Illness: Patient is a 68-year-old female with known metastatic ovarian cancer under active treatment since 2004, currently on fulvestrant after a massive debulking surgery by Dr. last July (2020). Patient presented to outlying emergency room with flank pain & transferred here with severe bilateral hydronephrosis on imaging. Patient had severe left flank pain about 2 weeks ago. Treated with tylenol, motrin, and heat and pain eventually dissipated. Then Tuesday and Wednesday pt did a lot of yard work and lifting. Thursday patient woke up with excruciating right flank pain. Nothing has made it better. Patient has tried ice, heat, tramadol Tylenol, Motrin, steroids and pain persists. Additionally patient having nausea and vomiting. She has started to have burning with urination. Pain is excruciating stabbing. Radiates to the groin. Patient has also started running fevers today. She feels pretty miserable. Also patient notes difficulty with her bowels since her last surgery. Prior to surgery she took Linzess every day. Since surgery it has been suggested she does not need this medication. Patient does note little to no notice when her bowels decide to move. Severe significant gas. Other times patient feels quite constipated. UA suggests possible infection with positive nitrites, 1+ leukocyte esterase and 3+ blood. WBC 2.1, Cr 1.0, K 3.0 CT scan with multiple abnormalities, but most notably severe bilateral hydronephrosis without obvious obstructing lesion. Multiple scattered nodular densities concerning for metastatic disease. Patient transferred for higher level of care and urology consultation.

03/15/2021: Presented to the emergency department with left flank pain. The patient was admitted with an obstructing kidney stone with associated hydronephrosis. The patient had a ureteral stent placed and discharged the next day with outpatient follow up.

First night complete exhaustion chills and diarrhea for four days Impaired eyesight Pain in the region of left kidney

Not requiring emergency care Concerned about second dose Irritation bronchial tube, pain and decreased function joints of knees Sore throat, general nausea, unable to take deep breath, needing to sit to rest long term,heavy flu-like symptoms incontinence lasting 40 hours inability to use abdominal muscles to defecate lasting 40 hours Difficulty rising to standing position Extreme fatigue compounding that from having Covid in 04/20 which never cleared BP 100/70 for 40 hours (usual 135/78 on Amlodipine) No treatment/ contacted physician office

After the first inoculation I had some transient pains in my head, and a few hive like welts, some tiredness. Then I had the second inoculation. The morning of 3/11/21 I woke up sweating with a fever and this very strange feeling was rolling through my body, from my head, down to my toes, then back up to my head and on and on. I took my temperature and it was 100.5 F. Also, I had begun breaking out in a few hive-like red welts on my legs, arms, stomach, back, maybe 8 to 10, hard to tell, but strange looking, unusual, and uncomfortable. Then around that Wednesday, the 16th, my urine was brownish and smelled smoky. I had not taken any supplements in days. The next day it was beige, smoky, then the next day bright yellow. The next day it went back to normal. More welts. EXTREME exhaustion. Then on the 18th I developed chills and more itching and welts. One on my face. One or two on my scalp. More around my waist, arms, neck, and legs. I am still having intermittent chills and hives/welts, and EXTREME tiredness. I have a cold sore in my mouth or throat, I can't tell exactly where.

Got the vaccine and they had her pull over as she had already had a reaction to the first one. All of a sudden she felt like her lip was swelling, and her tongue swelling, her face was a little red. She then had trouble breathing, and thought it may have been anxiety. She also has had headaches which have lasted for about 11 days, and depression. Her breathing was getting worse and the nurse came over and told her that she was having problems breathing and started coughing. She had Benadryl with her and she was advised to take that, and took 2 puffs of her inhaler. She stopped coughing as much, and was able to drive home within 10 minutes. She went home and realized that she was hyper, advised to take more Benadryl. It did not make her sleepy and did help with the allergic reaction. A friend saw her and told her that she was wired. She keeps having the coughing fits and breathing problems, and was thinking she was going into anaphylaxis. She also has had some confusion. She then went to the doctor on 3/25/21 due to urinary symptoms and had a UTI. Within the first couple of days she was having coughing bouts and was wondering if she should go the UC or not, wheezy type feeling. Her doctor gave her antibiotics and told her to use inhalers. She went back to the doctor on Monday 3/29/21, did a chest x-ray which was clear. She still thought that she was wheezy and ordered a new inhaler which she has been using, and still having coughing fits even today. She has been taking Benadryl every night since the vaccine which has not made her sleepy. The antibiotics seem to have helped the chest symptoms, but she is still coughing.

Suddenly felt very ill 20 min after getting vaccine. Shaking, heart racing, difficulty breathing,dizzy, weak, elevated blood pressure, frequent urination

The day after the vaccine (2/11) felt achy and feverish. This resolved after about 5 days, had some sinus symptoms. 3/5 had comp apnel done with many abnormal labs, esp cr 6.2. In 10/20 Cr was .96

Unexpected incontinence struck mid morning, continued a full day: Bladder urgency despite not eating or drinking all night. 4AM - had violent bile-only dry heaves 5:30 AM through 8 AM - able to sip 1/2 Cup of plain water and ate a half Saltine cracker plain 10:30 AM - bladder urgency went on and off all day about every 45 minutes, 90 minutes at most, even if the urine output was very minor. Repeatedly couldn't make it to the toilet on time, had to change pants. Remained home a full additional day to be sure it wouldn't continue. Stopped happening as suddenly as it began.

Moderna COVID-19 Vaccine EUA Burning with urination, urgency to urinate. Symptoms lasted 7 days. Additional symptoms of sore arm, headache, elevated temperature, and fatigue began at the same time, but lasted only 1 day.

Upon awakening: severe aching all over body similar to flu; a feeling of deep lethargy, mental fog, and difficulty in moving and rising from bed due to a feeling of heaviness. Left upper arm VERY stiff, painful and difficult to raise, although I had applied an ice gel pack to it on and off on the day of receiving the injection. No redness or swelling. Soles of both feet burning, very painful to walk. Occasional twinges of very sharp stabbing pain where big toe adjoins right foot, about once or twice per hour, pains lasting about 20 seconds each. Unusual urinary urgency and frequency, with difficulty holding it back before getting to the bathroom. Uncomfortable feeling of fullness and burning in left breast.... Due mental fog and some dizziness, and pain with walking and moving about, I was unable to do most normal daily activities or work at my job. I spent the whole day in bed and tried to sleep as much as possible. Also applied a heating pad intermittently to left upper arm to help with pain. All symptoms worsened throughout the day and evening. After dozing in bed throughout the day, I fell soundly asleep between 7:00 and 7:30 PM on April 9 with all symptoms still fully present. After sleeping soundly for approximately 6 hours, I awakened at 1:00 AM on April 10 and immediately realized that every symptom described here had disappeared. There was absolutely no trace of any of the symptoms, not even any residual soreness left in my arm. I felt perfectly well and strong and normal and that has continued. The only strange thing was that when I awakened at 1:00 AM on April 10 feeling well, even though I was perfectly cool upon awakening and had also not registered ANY fever when taking my temperature throughout the whole day of April 9, my entire body was drenched with perspiration upon awakening, including my hair, which was dripping wet, comparable to what might be experienced after a high fever.

68YF Small bowel obstruction within 1 week of vaccine Patient had incarcerated incisional hernia with SBO, preserved bowel on March 19 2021. Patient with alcoholic cirrhosis who presented with abdominal pain, nausea, and vomiting. She was found to have a small bowel obstruction and an umbilical hernia. She had electrolyte derangements including hypokalemia and AKI and was admitted to hospitalist service with surgery consulting. She improved with NG tube decompression, IV fluid resuscitation, and electrolyte repletion. On 3/19 she underwent umbilical hernia repair and was found to have an incarcerated umbilical hernia. On day of discharge she tolerated advancement to regular diet. Her AKI and hypokalemia resolved. She does have chronic thrombocytopenia due to her cirrhosis, with last available baseline platelet count in the 50s. She did not have any significant bleeding postoperatively. She did not have any signs of decompensation of her cirrhosis. MELD Na is 13, with less than 2% 90-day mortality. Patient drinks 1-2 times a month now and did not have any signs of alcohol withdrawal. CT abdomen and pelvis showed a right lower lung nodule at the base. This should be monitored as an outpatient. She was discharged to home in stable condition. Upon 4/13/21 Ambulatory Clinic visit: Patient is recovering well from surgery.

second dose of Moderna vaccine reported she had fatique that has been ongoing since vaccine was given. Began day after vaccine. She also had nausea and headache but they subsided after a couple of days but fatique has never subsided.

Generalized very itchy rash Worsening tinnitus Glomerular filtration rate went from 61 in Dec 2020 to 54 in May 2021

5/15 sustained syncope, fall hypoxic respiratory failure COPD pneumonia vomiting/diarrhea admitted to the hospital acute kidney injury 5/15--ED--cervical fracture, acute MI, elevated troponin multiple cardiology appointments, follow up appointments since then another emergency room visit on 6/10/21.

Approximately 3 weeks of watery diarrhea with hypotension and increased serum creatinine. Hypotension may have been exacerbated by about 25 pound gradual weight loss over course of prior 15 pandemic months without adjustment of BP meds in addition to acute dehydration with diarrhea. Resolved with low residue diet and elimination of amlodipine and chlorthalidone and vitamin B12 sequentially over course of 2-3 weeks.

Pt presented to the emergency department with complaints of myalgias after receiving the vaccine. She noted that she had vomiting the night prior. She denied any chest pain, shortness of breath, abdominal pain, headaches, fever at that time. Pt was left in room by herself for approximately 5 minutes and was found unresponsive. Code Blue was called. Pt was found in asystole. ACLS was initiated. Return of circulation occurred after 7 minutes of resuscitation. Pt is currently intubated and sedated.

Patient presented to ER on 2/16/2021 after getting covid vaccine 4 days prior. According to patient's family, she was moving slowly, not eating, experiencing some weakness and fatigue ever since. Patient was determined to have UTI and given 7 day course of cephalexin 500 mg three times daily. Followed-up with Health & Wellness on 2/17/2021. Patient went to ER again on 2/21/21 due to continued issues including altered mental status.

Vomiting 104 temp Loss of strength couldn?t sit up and couldn?t stand. Fell. Could pull myself up for hours Uncontrolled pee

Bladder urgency that began night of second dose, 2/24/21, and has continued since. Reports mild improvement since 3/2/21.

At 12 hours after injection: high fever, chills so bad teeth chattering, aches muscles in in neck, back, ankle (areas that have problems or injured in past, Hourly urination with intense pain and muscle spasm of muscle holding the urination - these stopped at about 5:00 am; Then a fever of 99 and cold clammy feeling for a day - was not able to stand for more than a few minutes without feeling off balance and then just exhausted. For a week I was mentally cloudy and my vision was at times a little blurry. Now...2 weeks later I have developed a UTI and Bacterial Vaginosis. I feel fine otherwise.

Patient reports having severe pain while urinating and notices blood clots in urine. First noticed this adverse reaction on 3/7/21

Patient got vaccine dose #2 on 3/23/21 (Tues) approx 10am. Per family reports patient went to hospital 3/24/21 (Wed) for unspecified pain and temp of 102f. Family states a "scan" was done and came back with nothing. P was treated for UTI and sent home. Patient was reportedly laying down at home about 8:15 or 8:30am complaining of a bad headache. Patient was found later that am deceased in her bed.

Moderna COVID-19 Vaccine EUA. I had a fever of 99.5 for 2 days and diarrhea for 2 days. Fatigue and weakness during the whole week after the vaccine. I couldn't eat or drink for 2 days and couldn't go for my usual walk for 4 days, and even then I wore out. No desire yet to do anything but sleep. I was diagnosed with a UTI on 03-24-2021, so am having pain from that now, too. Haven't had one of those since 2019, so there could be some correlation there...I just don't feel well, like I used to.

1. At 1:30 AM, I had to urinate; I went back to bed and slept, only to wake up every hour after that to urinate. 2. 8:00 AM-I had severe edema. My neck, shoulders, arms, thighs, and back were swollen; I had difficulty moving from one side to the other because of pain and swelling; 3. Ibuprofen did nothing. I took two every four hours. 4. By 8:30 AM, today, Saturday, I began to feel better. I took three Ibuprofens instead of two. Edema went down; only my back is a little swollen and achy. I was able to eat breakfast and walk around a little.

Nausea the night of the vaccine. Severe nausea and vomiting the following day. She went to the Urgent care on 4/6/21. The sent her to the ER. The nausea and vomiting lead to hypokalemia, and acute kidney injury. She was admitted to the hospital from 4/6/21-4/8/21. Her nausea improved. She was seen by PCP on 4/19/2021. She was feeling much better but not back to her baseline yet.

Burning pain when injected and lasting for 2 days, Fever, chills and muscle aches through 4/6/21. Blood in urine beginning approximately 4/8/21 through 4/14/21.

Chief Complaint Fever History of Present Illness This is a 69 year old female with breast cancer status post left mastectomy, diabetes mellitus, hypertension, and past transient ischemic attack who presented to ED for fever. The patient reports that she began experiencing sudden onset of fever and chills last night (05/15/2021), and she additionally complains of persistent sore throat and cough beginning the previous week. She has undergone radiation and chemotherapy treatment for breast cancer in the past but these treatments have been suspended for several months with mammography performed on 03/10/2021 failing to identify any malignant growths. In the ED, the patient was found to have acute bronchitis due to COVID-19, fevers and systemic inflammatory response syndrome. Review of Systems Constitutional: Positive for chills and fever. HENT: Positive for sore throat. Respiratory: Positive for cough. Negative for shortness of breath. Cardiovascular: Negative for chest pain and leg swelling. Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting. Genitourinary: Negative for dysuria. Musculoskeletal: Negative for gait problem. Neurological: Negative for syncope. All other systems reviewed and are negative. Vitals Blood pressure 123/75, pulse 95, temperature 37.1 °C (98.7 °F), temperature source Oral, resp. rate 29, height 1.651 m (5' 5"), weight 106.6 kg, SpO2 95 %. Physical Exam Vitals reviewed. Constitutional: General: She is not in acute distress. Appearance: Normal appearance. She is well-developed. She is morbidly obese. She is not ill-appearing. HENT: Head: Normocephalic and atraumatic. Nose: Congestion present. Mouth/Throat: Mouth: Mucous membranes are dry. Dentition: Abnormal dentition. Pharynx: Oropharynx is clear. Cardiovascular: Rate and Rhythm: Normal rate and regular rhythm. Pulses: Normal pulses. Heart sounds: Normal heart sounds. Pulmonary: Effort: Pulmonary effort is normal. Breath sounds: Normal breath sounds. Chest: Comments: Port in place to the upper right chest. Abdominal: General: Bowel sounds are normal. There is no distension. Palpations: Abdomen is soft. Tenderness: There is no abdominal tenderness. Musculoskeletal: General: Normal range of motion. Cervical back: Normal range of motion and neck supple. Skin: General: Skin is warm and dry. Comments: Chronic venous stasis changes to the bilateral lower extremities. Decreased skin turgor throughout. Neurological: General: No focal deficit present. Mental Status: She is alert and oriented to person, place, and time. Plan Admit to hospital ? cardiac telemetry unit Continuous pulse oximetry and telemetry monitoring Control pain, nausea and vomiting as needed Respiratory treatments (MDI) and supplemental oxygen prn IVF hydration; serial neurological checks every four hours Initiate dexamethasone therapy 6 mg IV once daily Ascorbic acid, zinc sulfate, and vitamin D3 supplementation Serial BMP, Mag, CBC, hepatic panel; ESR/CRP, PT/INR Serial lactic acid and procalcitonin; check respiratory PCR Follow up on blood cultures as available; check urinalysis Electrolyte correction/replacement as indicated Fall precautions; PT/OT evaluations during this visit FSBS and SSI every AC/HS for glycemic control Resume selected home medications with hold parameters DVT prophylaxis ? SCDs only GI prophylaxis ? Famotidine

I had tested negative on 5/24/2021. I got my second/last shot on 5/25/2021. That night when I lay down to sleep, my entire body was riddled with pain and each time I stood up to go to the bathroom I urinated on myself. The next day I was find?! I'm still extremely tired.

large blood clot in the right lung/smaller blood clot in the left lung; blood clot in the calf of the left leg; Baker's cyst behind the left knee; "I still didn't feel right or good"; "problems with my kidneys"; dull pain; "really bad chest pains"; "knee got swollen up"; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung) and THROMBOSIS (blood clot in the calf of the left leg) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included LOSARTAN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), OMEPRAZOLE, EZETIMIBE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), VITAMIN D [VITAMIN D NOS], CALCIUM, MULTIVITAMINS [VITAMINS NOS] and APIXABAN (ELIQUIS) for an unknown indication. On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced JOINT SWELLING ("knee got swollen up"). On 26-Apr-2021, the patient experienced PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung) (seriousness criteria hospitalization and medically significant) and CHEST PAIN ("really bad chest pains"). On an unknown date, the patient experienced THROMBOSIS (blood clot in the calf of the left leg) (seriousness criterion medically significant), SYNOVIAL CYST (Baker's cyst behind the left knee), MALAISE ("I still didn't feel right or good"), RENAL PAIN ("problems with my kidneys") and PAIN (dull pain). At the time of the report, PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung), THROMBOSIS (blood clot in the calf of the left leg), JOINT SWELLING ("knee got swollen up"), SYNOVIAL CYST (Baker's cyst behind the left knee), MALAISE ("I still didn't feel right or good"), CHEST PAIN ("really bad chest pains"), RENAL PAIN ("problems with my kidneys") and PAIN (dull pain) 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. Company comment: Very limited information regarding this events has been provided at this time. 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. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. 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. Further information has been requested.

Patient is a 69-year-old female with a past medical history significant for type 2 diabetes, hypertension, RA, GERD who presented from a rehab facility with fevers, hypotension, tachycardia and diarrhea. This is the patient's third hospitalization in the last month. She was initially admitted on 5/4/2021 for she suffered to syncopal episodes resulting in a motor vehicle accident x 2. From 5/4-5/6. During that admission her gabapentin dose was decreased and she was given 5 days of Macrobid on discharge for a possible urinary tract infection. We also arrange follow-up with cardiology for loop recorder and to see orthopedics as an outpatient the etiology for her syncopal episode was unclear. It was not felt to be seizure related. She went home with home health care. She unfortunately was readmitted on 5/29-6/3 new onset acute pancreatitis with an unknown etiology and was ultimately discharged to rehab. During that hospitalization patient reported that she was seen by cardiology for her 2 syncopal episodes that occurred earlier in the month and a cardiac cause of her syncope was ruled out and they recommended she be referred to neurology. She returns back again for admission on 6/8 for encephalopathy, hypotensive, septic shock, NSTEMI and was subsequently admitted to the intensive care unit on pressor support. She was given Cipro, Flagyl, Vanco and Levophed and IV fluids. Her septic shock was felt secondary to urinary tract infection. The urine culture that was resulted on 5/30 grew Klebsiella pneumonia that was resistant to Macrobid. She was not sent out on any antibiotic therapy as she was not felt to be symptomatic during her last hospital course. She also had a CAT scan during this hospital course which showed colitis. Urine culture from this admission was of mixed flora Greater than 100,000 colony-forming units no organisms were grown out however. She was treated with 7 days of Cipro. Again patient's CAT scan of the abdomen and pelvis done on admission showed colitis she was seen by gastroenterology during her hospital stay and underwent an endoscopy. It was ultimately felt that the patient's colitis was likely ischemic in nature. Patient was also noted to be thrombocytopenic on admission which was felt to be possibly from sepsis or dilution was ultimately resolved at the point of discharge. She also again was found to have acute blood loss anemia with no source found. she had hematochezia noted on admission but resolved by the point of discharge. EGD did not reveal any source of bleeding other than a tiny esophageal ulcer. Aspirin therapy was discontinued. She did not need transfusion during her hospital stay. The lowest her hemoglobin went was to 7.3. Patient's acute tubular necrosis resolved her metabolic acidosis and metabolic encephalopathy resolved and at this point she is stable for discharge to rehab. Patient's lisinopril aspirin, hydrochlorothiazide have been discontinued at this point. Her blood pressure is 121/61 she is afebrile respirations are normal O2 sat is 95% on room air. Patient's hemoglobin is 8.1. She is no longer having an abdominal pain and is tolerating p.o. She is not having any diarrhea. the cause for the patient's colitis is likely ischemic in nature. she was discharged to rehab on 6/15

The day she received the second dose she started with flu like symptoms. She also had tingling hands and feet her condition did not get better and was rushed to the ER. She was there for 4 days and sent to a long term facility where her condition worsen. She started having breathing issues went back to the ER with chronic breathing complications. At the hospital she had low oxygen level, lung complications, kidney failure and went into cardiac arrest. She was resuscitate and put on a ventilator for 3 days. She started breathing on her own and was taken off the machines. She was sent home a few days later and nine days later went into cardiac arrest again and this time did not make it.

I had the second dose on 6/22/2021 and my symptoms got worse after the COVID shot, it exacerbated everything that was wrong with me, my kidneys function went down, they got compromised, I was not peeing much, I had pain on my neck, horrible ear symptoms of ringing and high pitch sound. It lasted for a day. Hip and joint pain, my knee hurt me a lot. I was weak and unable to do a lot of things. My heart rate went down, my potassium went up. I ended up in the hospital and they admitted me for 4 days. They kept taking blood every day and my sugar levels. They gave me heparin.

7/12/21 er @ hospital: 69 y.o. female who presents with increasing shortness of breath. Patient reports increasing shortness of breath for the past 3 days. She denies any runny nose or sinus congestion. Patient does report a dry cough but states it is no different from her typical COPD cough. Patient denies any chest pain or palpitations. However, patient on bedside monitor is in AFib with RVR. Patient does voice a history of intermittent atrial fibrillation. Patient denies any current palpitations, chest pain, or edema. Of note, patient reports she sustained a stroke approximately 6 weeks ago. Patient reports she experienced left-sided weakness. She reports that left-sided weakness has since returned to completely normal. She did not seek medical care for her stroke at the time of the stroke. (pt is a retired nurse) Transferred to another healthcare facility where she remains admitted as of 7/13/21

shoulder pain, back pain, numbness and tingling of fingers, dizziness, acute renal failure, hyperkalemia

1/5/21 VACCINE 1/14/21 - FINGER TIPS AND FEET ESPECIALLY COLD NEEDING EXTRA SOX AND GLOVES 1/15/21 INTERMITTENT BOUTS OVER 3-4 EPISODES OF SEVERE CHILLS LASTING 30 MIN - USED HEAT MAD, BLANKETS, SOCKS 1/15/21- 1/16/21 INCONTINENT OF URINE, DRY MOUTH, LOSS OF APPETITE, WEAKNESS, BALANCE, VISION DISTORTIONS. 1/16/- PRESENT- HYPPERSENSITIVITY TO SALT AND SUGAR, WEAK, COGNITIVE AND WORD RECALL, LEFT EYE VISION DISTOTIONS, BRAIN FOG.

Pt with h/o myasthenia gravis presents to ED with 3 week h/o worsening weakness. Unclear exact timing on onset relative to vaccine administration but appears to have been a few days later. During these 3 weeks, patient also diagnosed and treated for a UTI but patient had worsening of weakness leading to falls x2 a few days before presenting to hospital ED. On admission to hospital, pt diagnosed with myasthenic crisis treated initially with non-invasive mechanical ventilation and plasmapheresis. DDx included UTI with encephalopathy and confusion related to it.

She is very active in her daily life as she continues to train race horses. She reports she had been feeling well. She received her 2nd COVID vaccine on 2/22/2021. On 3/3/2021 she began feeling achy, foods no longer tasted good to her, over the next day or so she developed nausea with dry heaves, diarrhea, and burning with urination. She then stopped eating. She has a dry non-productive cough. She denies any melena, hematochezia, hematemesis, chest pain, fevers, chills, shortness of breath. She is now complaining of generalized weakness. She denies any abdominal pain, but admits to some tenderness in the right side of her back. She denies any known ill contacts. She and her Husband mostly stay at home since COVID began. She reports they have not even traveled with the horses since COVID started. 3/15/21 In the ED she was found to have a right pyelonephritis, acute kidney injury, elevated LFT's, leukocytosis. She had an abdominal CT that showed concern for dilated CBD. She went later for a gallbladder US. This showed no dilations of CBD. 3/16/2021: Today there was a significant improvement in leukocytes. Her blood pressure has dropped and is low to low normal. She continues to feel generalized weakness. She is eating ice chips and tried a jello this morning that she has kept down. She denies any further diarrhea or active vomiting overnight. She denies any abdominal pain, but does have tenderness to the epigastric area with palpation. Creatinine is unchanged this morning. I gave an IV fluid bolus this morning to support BP. She does continue to have the dry cough. She reports she had a rash to her right arm around the COVID injection site that was itchy for a couple of days. It has resolved. She denies any other rashes, joint inflammation or redness. She denies any shortness of breath. Eosinophilia, with 1600 AEC. Concerning for possible delayed hypersensitivity to COVID vaccine. Will continue to trend. Cough non-productive. Continue to monitor respiratory status/sx. CRP. LDH, ESR, and CRP added on to labs. Will draw D-dimer tomorrow morning as well.

3/17/21 Chills from 12;30 am until 7:30 am. 7:30 am felt very very ill. had temp of 101.7. All of a sudden I had Urinary incontinence. I started peeing in my bed. Asked my husband to help me to bathroom because I felt so sick. I fainted in his arms Got back into bed and had a horrible migraine. had to have my eyes covered and dark room I felt as though I was going to throw up for hours. Did not eat anything until 8 pm. some toast and tea. 3/18/21 Still sick but not as bad. Stayed in bed for 1/2 day. it was a slow go. 3/19/21 Still not myself. 3/20/21. Felt more myself.

Besides the reported side effects of fatigue, headache, muscle pain, joint pain, chills, nausea and a slight fever she also had severe lower back pain, frequent urination with larger than normal volume of urine, pain on the upper left and right arm, the urge to have a bowel movement and she did have a bowel movement once, and difficulty keeping her eyes open. She took Aleve for the pain. These symptoms started hours after her second Moderna shot on March 23, 2021 at 11:20 am. She started feeling ill at about 4 pm. At around 10 pm she started to feel really sick and these symptoms lasted for about 36 hours but the the worst was the fist 24 hours.

3:30 am woke with massive headache, lot of body aches, no urination for hrs, unable to sleep due to all over pain. Arm extremely sore; took fluids and then had some nausea. This went on for 2 days. Still very tired, arm still sore.. Used Tylenol for pain. helps just a little bit. Did not seek any treatment.

headache around 3p, went to bed at 8p couldn't sleep due to heart racing then pain in back, arms , had to urinate 5 times during night, still unable to sleep . got up 8am took tylenol for pain, valium to sleep, slept till 330pm. .2nd day still headache and all over body ache. foggy

Audible Hallucinations / Delusions Insomnia Anxiety Fluctuating Blood pressure Urinary Tract Infection

4/4/21 ER HPI: 70 y.o. female who presents with complaint of weakness, shortness of breath worse with exertion the started this morning. Patient was said to be fine yesterday. Patient denies chest pain, nausea vomiting or abdominal pain, no headache or dizziness. Patient is also said to have pale conjunctiva. No fever or chills and no cough. triage note: Patient presents to er with daughter from home with complaints of increased weakness, increased shortness of breath. States upon waking today daughter states "she was more confused and more difficulty with ambulation. States she was off balance today with stumbling more than normal. Daughter states she was "verbally exhausted today." Patient unable to answer questions.

Urgency and frequent need to urinate. Felt like I had a UTI but got urine culture at minor emergency clinic and had no infection. Another friend happened to have a vaccine the next week and said she had the same symptoms afterwards! No UTI found for her either! I think that a lot of people may have this and just not put the two together. I would not have linked it to the vaccine unless my friend had not happened to have the same symptom! Please investigate with other people who have Covid vaccine!

Heart beat of 200 bpm; Heart attack; Flu like symptoms; frequent urination; Dry heaves; Heart fluttering; Atrial Fibrillation; fever; Little flutter; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (Heart beat of 200 bpm), MYOCARDIAL INFARCTION (Heart attack) and ATRIAL FIBRILLATION (Atrial Fibrillation) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cardiac catheterisation (Found blockages which resulted in 2 stents.) on 17-Mar-2021. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PALPITATIONS (Little flutter). On an unknown date, the patient experienced HEART RATE INCREASED (Heart beat of 200 bpm) (seriousness criterion hospitalization), MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms), POLLAKIURIA (frequent urination), RETCHING (Dry heaves), CARDIAC FLUTTER (Heart fluttering), ATRIAL FIBRILLATION (Atrial Fibrillation) (seriousness criterion medically significant) and PYREXIA (fever). The patient was hospitalized on 16-Mar-2021 due to HEART RATE INCREASED. At the time of the report, HEART RATE INCREASED (Heart beat of 200 bpm), MYOCARDIAL INFARCTION (Heart attack), PALPITATIONS (Little flutter), INFLUENZA LIKE ILLNESS (Flu like symptoms), POLLAKIURIA (frequent urination), RETCHING (Dry heaves), CARDIAC FLUTTER (Heart fluttering), ATRIAL FIBRILLATION (Atrial Fibrillation) and PYREXIA (fever) outcome was unknown. Patient went to the hospital in an ambulance. Treatment information was not provided. On 26 Mar 2021, the patient had to wear holter monitor for 1 month for observation of atrial fibrillation. This case was linked to US-MODERNATX, INC.-MOD-2021-056770, US-MODERNATX, INC.-MOD-2021-056770 (E2B Linked Report). Reporter did not allow further contact; 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 US-MODERNATX, INC.-MOD-2021-056770:1st Dose Case US-MODERNATX, INC.-MOD-2021-056770:2nd dose case

Lumbar pain left side starting early morning of 02/17 needed hotpad to sit or sleep mostly to distract the nerves. Worse pain on morning of 02/18. Took a leftover vicodin and advil. Pain down front of thigh by 10:30 am getting more severe over next few hours. By noon had trouble walking and was nauseous from the pain. In addition to left side back pain had continued severe burning pain in front of left thigh and groin & could not initiate urination. Reduced movement and kept taking vicodin and advil and applying heat until doctor's appointment on Wednesday 02/24. Doctor prescribed Prednizone pack and physical therapy. Immediate improvement. Fixed in 4 weeks.

a low functioning kidney; a low functioning liver; Little clumpies; black/brown raised and itchy; itchy; Headache; Felt nauseated; experienced sickness; Unusual bowel movements- occurred approximately 5-6 times a day; Stool was cream/pale colour; Got really tired; appetite totally disappeared; Really fast heart beats; Blood pressure stayed 160 for a week, every day and night; This spontaneous case was reported by a patient and describes the occurrence of RENAL IMPAIRMENT (a low functioning kidney), HEPATIC FUNCTION ABNORMAL (a low functioning liver), DECREASED APPETITE (appetite totally disappeared), HEART RATE INCREASED (Really fast heart beats) and BLOOD PRESSURE ABNORMAL (Blood pressure stayed 160 for a week, every day and night) in a 70-year-old female patient who received Vaccine 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 reported medical history). On 05-Mar-2021, the patient received first dose (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DECREASED APPETITE (appetite totally disappeared), HEART RATE INCREASED (Really fast heart beats), BLOOD PRESSURE ABNORMAL (Blood pressure stayed 160 for a week, every day and night) and FATIGUE (Got really tired). On 06-Mar-2021, the patient experienced ILLNESS (experienced sickness), FREQUENT BOWEL MOVEMENTS (Unusual bowel movements- occurred approximately 5-6 times a day), FAECES DISCOLOURED (Stool was cream/pale colour), HEADACHE (Headache) and NAUSEA (Felt nauseated). On an unknown date, the patient experienced RENAL IMPAIRMENT (a low functioning kidney), HEPATIC FUNCTION ABNORMAL (a low functioning liver), SWELLING (Little clumpies; black/brown raised and itchy) and PRURITUS (itchy). At the time of the report, RENAL IMPAIRMENT (a low functioning kidney) and HEPATIC FUNCTION ABNORMAL (a low functioning liver) outcome was unknown and DECREASED APPETITE (appetite totally disappeared), HEART RATE INCREASED (Really fast heart beats), BLOOD PRESSURE ABNORMAL (Blood pressure stayed 160 for a week, every day and night), ILLNESS (experienced sickness), FREQUENT BOWEL MOVEMENTS (Unusual bowel movements- occurred approximately 5-6 times a day), FAECES DISCOLOURED (Stool was cream/pale colour), SWELLING (Little clumpies; black/brown raised and itchy), PRURITUS (itchy), HEADACHE (Headache), NAUSEA (Felt nauseated) and FATIGUE (Got really tired) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure systolic: 160 (abnormal) No diastolic reading. On an unknown date, Liver function test: low functioning (Low) Low Functioning. On an unknown date, Renal function test: low functioning (Low) Low Functioning. Treatment information was not provided. Concomitant medications were not reported. HCP advised, against receiving the second dose. 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.A causal relationship cannot be excluded for the events of fatigue, headache, pruritus and nausea.

Patient received second dose of Moderna vaccine on 5/10/2021. Patient had routine lab work done prior to an MRI with contrast on 5/11/2021. Patient reports BUN and Creatinine were elevated. Labs were redrawn on 5/12/2021 and remained elevated. Patient reports she had routine lab work with physical six months ago and labs were within normal range. Patient is under the care of her primary doctor. Her labs will be redrawn on 5/18/2021.

HEADACHE & HTN REQUIRING EMERGENCY ROOM VISIT AT APPROX 9PM, 5/26/21. NEGATIVE CT OF BRAIN. UNKNOWN IF ANY TREATMENT WAS ADMINISTERED AT THE ER. RESIDENT WAS RETURNED TO NURSING HOME AT APPROX 1AM ON 5/27/21 WITH NO DISTRESS NOTED.

I just woke up and I was completely sweaty. This was the morning after my vaccination. I had my son here and he thought I was going to have a seizure. It was almost like the chills, it would not stop. I was nauseas, I was achy and so sore. I took Tylenol and kept putting cool clothes on my body as best I could. This lasted for about 4 days, I was in bed for those four days. Extreme fatigue. And when I saw very sweaty, my son had to change my sheets for me because they were so wet. A few weeks after that I got extreme pain in my abdomen and I had to have my appendix removed. At that time I was informed that I had the beginning of kidney stones. We have not addressed them because I have had one problem after the next. I did not contact my doctor during that time but did see them afterwards. I was aware of the side effects and figured that was it. I had no energy, no appetite or anything. I did get sick vomiting for four days as well. I still have sore joints, but not as bad. I am trying to cut back on carbohydrates to cut back on inflammation. I handle pain very well usually. My daughter wanted me to go to the hospital. I went to the DR for appendicitis and I ended up very sick from all the antibiotics as well.

Arm was hurting at injection site; got a fever that evening. I started feeling really really tired. I went to bed. I woke up the next morning, I had an uncontrollable urge to go to the bathroom - bladder was screaming like mad - I was holding the bottom of my stomach as it felt like it was going to fall out. Bladder started leaking before I got there. When finished, I had to shuffle to the foot of my bed (couldn't pick up my feet). And that was last time I remember when I came to on the opposite side of bed on the floor. Then I tried to get up off the floor and my knees kept collapsing. The weight of my body would shift every time I would try to do something. Scars on my forehead, top of head, knees and elbows from trying to get up. And I couldn't. I pulled the charging cord to my phone off the night stand and called my daughter. She came and asked me the time and I thought it was 7 something. It was 9 something by then. There was not a muscle in my body that would hold me up. I was a rag doll. She put my arms over her back and stood up and pushed me on to the bed and had to take the rest of the body and turn it right on the bed because I couldn't move it. Spent the first week in bed. The biggest thing was to go to the bathroom and it took forever. I was shuffling so slow, I was using my toes to make my feet move. I couldn't sit up in bed - I would just slide down. Couldn't get in to see my doctor - spoke to him on the phone. Dr called the Paramedics/fire dept. I was trying to go from my bedroom to my front door to undo the security lock thing for the building but I didn't get there before they did and they found a way to unlock my door. They did check up with vitals - blood pressure; heart rate; temperature. They didn't find anything wrong. I had to promise them that my daughter would take me March 23 - Urgent Care that night. I shuffled back to their COVID Urgent room; doctor checked me over and said he needed to take bloodwork and x-ray to see my head. Went to facility right across the street for that. Visually they could see something was wrong but the tests don't show anything wrong. He (my doctor) thinks that what happened was caused by a clash between the vaccine and the Neurontin (Gabapentin). They don't know what to do to undo what has happened. Still have a loss of muscle strength -it has improved about 25% from what it originally was.

In the days following the vaccine, patient developed decreasing responsiveness and presented to the hospital 4 days after vaccination with leukocytosis acute renal failure

I woke up at 6 AM and had pressure on my chest. I walked 2 miles and came home. I took my BP, which is normally 120/70, but this time it was about 167/92. I kept checking it throughout the day. The highest it got was 212/94. The next day, on 6/23, I went to the doctor. They took my BP, which was still high. The nurse practitioner asked me questions. I had an EKG and blood work done. Nothing abnormal showed up on the EKG. I was then sent to the ER. Another EKG was done and more blood work was done. My blood pressure was 215/102 at the ER. I was given nitroglycerin, which brought the BP down. I was kept under observation for a couple of hours and then sent home. The next day, I got a call informing me I had a UTI. I was given fluconazole, nitrofurantoin mono. I took them for 5 days. I'm still having a little pressure on my chest, but maybe it's the heat. I'm still walking and using my exercise bike. I decided to fill out the VAERS report, because I know of 2 other people who developed a UTI after getting the vaccines. During the follow-up doctor visit on 6/29, my BP was taken and he talked to me, but no tests were done.

chest hurt; pulmonary issues; heart failure; kidney failure; Cardiac arrest; flu like symptoms; tingling in arms and feet; rashes in the body; itchy; weakness to the point that she could not walk; passed away; cardiac arrest; hurting arm; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away), CARDIAC ARREST (cardiac arrest), CARDIAC FAILURE (heart failure), RENAL FAILURE (kidney failure), CARDIAC ARREST (Cardiac arrest), INFLUENZA LIKE ILLNESS (flu like symptoms), PARAESTHESIA (tingling in arms and feet), RASH (rashes in the body), PRURITUS (itchy), ASTHENIA (weakness to the point that she could not walk), LUNG DISORDER (pulmonary issues) and CHEST PAIN (chest hurt) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 038A21A) 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) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms) (seriousness criterion hospitalization), PARAESTHESIA (tingling in arms and feet) (seriousness criterion hospitalization), RASH (rashes in the body) (seriousness criterion hospitalization), PRURITUS (itchy) (seriousness criterion hospitalization) and ASTHENIA (weakness to the point that she could not walk) (seriousness criterion hospitalization). 21-Apr-2021, the patient experienced PAIN IN EXTREMITY (hurting arm). On 27-May-2021, the patient experienced CARDIAC FAILURE (heart failure) (seriousness criteria hospitalization and medically significant), RENAL FAILURE (kidney failure) (seriousness criteria hospitalization and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization prolonged and medically significant) and LUNG DISORDER (pulmonary issues) (seriousness criterion hospitalization). On 05-Jun-2021, the patient experienced CHEST PAIN (chest hurt) (seriousness criterion hospitalization). On 14-Jun-2021, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criteria death and medically significant). On 27-May-2021, CARDIAC ARREST (Cardiac arrest) had resolved. The patient died on 14-Jun-2021. The reported cause of death was Cardiac arrest. It is unknown if an autopsy was performed. At the time of death, CARDIAC FAILURE (heart failure), RENAL FAILURE (kidney failure), INFLUENZA LIKE ILLNESS (flu like symptoms), PARAESTHESIA (tingling in arms and feet), RASH (rashes in the body), PRURITUS (itchy), ASTHENIA (weakness to the point that she could not walk), LUNG DISORDER (pulmonary issues) and CHEST PAIN (chest hurt) outcome was unknown and PAIN IN EXTREMITY (hurting arm) had resolved. No relevant medical history was reported. No concomitant medication provided. The patient was having respiratory problem few days after the 2nd dose along with other issues. She was administered with asthma medicines. The name was not specified. Action taken with mRNA-1273 in response to the events was not Applicable. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: cardiac arrest

After the 1st vaccine, I had a lot of pain in my left arm. This pain lasted for at least a week. I felt well enough and went to get my 2nd dose 5/1/2021 ( lot 032B21A IMRA). I had the same symptom of arm pain that lasted about a week and I felt recovered. On 6/15/2021 at 5AM I had awoken with severe pelvic pain and lower back pain, chills and sweats. I called the ambulance and was taken the ER (Wilmington Hospital). At the hospital, they did an ultrasound and found a kidney stone. I was discharged to go home and rest and drink a lot of water. I made an appointment to see my doctor and saw him on 7/1/2021 and was prescribed Tamsulosin to help flush out my kidney stone. I still have my kidney stone which has not been flushed out yet. I am going to follow up with my urologist.

Leading up to my adverse event, I had been feeling more and more tired. I did not have any problems breathing, I just felt tired. I ability to walk had decreased. I noticed it had been going on for some time. I noticed it, but I didn't get concerned because it could have been related to the muscles from my eye condition. I started to feel a decrease in energy all around. The day, 05/30/2021, my husband was not home. I was home alone. I had a zoom call, with some of my friends, and as we were hanging up on the call, I started to feel as if I were going to faint. I did not have any other symptoms besides fainting. My mind felt clear. I had my cell phone next to me, and I texted my friends and told them how I was feeling. I ran to my bathroom because I had to use the restroom. I sat there and felt like I was fighting fainting. My friends called me and I was having problems speaking. I told them I was fainting and I needed their help. They called an ambulance for me, but they are out of state, so there were problems. I contacted someone closer to me to make a call for an ambulance. I was only able to text by dictation, I couldn't type anything. My friend who I called, came over to my house right away. I had to get myself out of the restroom and make it to my front door to let her in. It was difficult. She called 9-1-1 when she got to my house. The paramedics gave me a baby aspirin right away. I felt that I could talk better after taking it. They gave me nitroglycerin as well. They put me in the ambulance and I stayed awake and alert the whole ride. They took me to The Hospital and took me right in for surgery. I was experiencing a heart attack. I had a couple of stints put in and they did it through the groin area. I was alert through this surgery. I felt sensations, but I did not feel any pain. I am now taking a baby aspirin, carvedilol (coreg) 3.125 mg (2 in the AM, 1 at PM), Plavix 5mg (1 per day) and Rosuvastatin 20mg (1 per day). Since I have had the surgery, I noticed that I have had some blood in my urine. I am following up with a Urologist to see what is going on. She wants to put a scope up my urethra to see if she can find anything. As of today, I feel so much better than I did. I can walk better and move more quickly now. I'm very thankful for the doctors at the hospital and how they handled me.

I have a small tumor on pancreas; dark urine; Blond stools; yellowing skin; hilar cholangio carcinoma; small tumor on my liver; Persistent itching all over body/Itching moves; This spontaneous case was reported by a consumer and describes the occurrence of CHOLANGIOCARCINOMA (hilar cholangio carcinoma) and HEPATIC NEOPLASM (small tumor on my liver) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic leukemia, Bile duct cancer and Liver spots (Spot on liver). On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced PRURITUS (Persistent itching all over body/Itching moves). On an unknown date, the patient experienced CHOLANGIOCARCINOMA (hilar cholangio carcinoma) (seriousness criterion medically significant), HEPATIC NEOPLASM (small tumor on my liver) (seriousness criterion medically significant), PANCREATIC NEOPLASM (I have a small tumor on pancreas), CHROMATURIA (dark urine), FAECES DISCOLOURED (Blond stools) and YELLOW SKIN (yellowing skin). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, CHOLANGIOCARCINOMA (hilar cholangio carcinoma), HEPATIC NEOPLASM (small tumor on my liver), PRURITUS (Persistent itching all over body/Itching moves), PANCREATIC NEOPLASM (I have a small tumor on pancreas), CHROMATURIA (dark urine), FAECES DISCOLOURED (Blond stools) and YELLOW SKIN (yellowing skin) outcome was unknown. No concomitant medication reported. Treatment included, anti-histamines couple of times a day and steroids prescribed by the doctor was reported Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Cholangiocarcinoma, Hepatic neoplasm and Pancreatic neoplasm which could not have been caused by the vaccine and had to be pre-existing along with the patient's statement that they had GI symptoms pre-dating the first vaccine. This case was linked to MOD21-035148 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow up document contains new events.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the events of Cholangiocarcinoma, Hepatic neoplasm and Pancreatic neoplasm which could not have been caused by the vaccine and had to be pre-existing along with the patient's statement that they had GI symptoms pre-dating the first vaccine. MOD21-035148:

36 hours after injections uncontrollably chills for 2 hours, temp of 102.8. Continued temp of 102 for 2 days, no appetite severe fatigue ending up with severe dehydration resulting in urgent and ER visits. Received 2 liters of I V fluids. Continue also now with low grade temp in evening, nausea and diarrhea

PATEINT FELT FINE ON THE HOME FROM PHARMACY, STARTED FILLING ILL (NOT QUITE HERSELF) BEFORE BED. SHE AWAKENED AT 5:45 AM. FELT AS IF SHE WAS GOING TO FAINT. SAT DOWN AND PASSED OUT AND HAD A SEIZURE. SLID OUT OF THE CHAIR AND URINATED ON HERSELF AND THE FLOOR. WAS TRANSPORTED BY AMBULANCE TO HOSPITAL.

Severe chills, fever, vomiting, headache, loss of all urinary control, exhaustion. Lasted 3 days. (Tapered off after about 8 hours). Called doctor and was told to take Tylenol, which I did.

Loss of control of my bladder. Couldnt walk. Taken to urgent care. Cardiogram was done. BP was over 300. Taken to Hospital, CAT scan confirmed that I was NOT having a stroke. after 4 days I was fine

Could not drink from a cup. Left side of my face was drooping. Eye Problems. The day of shot I got a bad headace on my left side of neck and back of head Diagnoses Predisone Bells Palsy Valacycolvir Renal Insufficiency

kindeys started to fail; blood pressure 60/24; red spots around the injection site; nausea; vomiting; diarrhea; cellulitis at the injection site; A spontaneous report was received from a nurse who was also a 61-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24. Medical history included type 2 diabetes mellitus, lung disease, and high blood pressure. Concomitant medication included unspecified cholesterol medicines, unspecified heart medicines, levopridsone, and unspecified type 2 diabetes mellitus medicines. On 29 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot number 057G20A) intramuscularly n the left deltoid for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient experienced cellulitis at the injection site. On 02 Feb 2021, the patient experienced red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24 (no units or reference range provided). The patient was hospitalized from 04 Feb 2021 to 07 Feb 2021. Treatment for the events included hydration, unspecified antibiotics, and levid for blood pressure. Action taken with the mRNA-1273 was not reported. The outcome of the events of cellulitis at the injection site, red spots around the injection site, nausea, vomiting, diarrhea, kidneys started to fail, and blood pressure 60/24 was unknown.; Reporter'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.

Neurology consult note 2/16: The patient is a 72-year-old woman, who states that last Friday she began to notice a strange fullness and numbness and perhaps a mild degree of weakness in her right leg and came to Emergency Room. She was seen by ER doctors. Diagnosis was unclear. She was offered admission to get physical therapy, but she did not wish to stay for the weekend and returned home on Friday the evening only to come back to the ER on Sunday, 2 days later with progression of further right leg weakness, right leg numbness and a hint of new left-sided symptoms that had not begun before Sunday. None of her symptoms involve the arms or face and everything was below the waist. There was no significant pain. She has not had a bowel movement since Thursday and has lost the ability to void. Her MRI scan of the lumbosacral spine was reviewed by me on the computer monitor and was unrevealing except for mild DJD. Thoracic MRI scan shows possible spinal cord infarction versus myelitis occurring within the thoracic spine at the dorsal surface of the cord at the T5 and T6 vertebral body levels to the right of midline. This was a faint finding and not clearly infarct or myelitis and could be artifact. It appears that she has hydronephrosis on her scans too and now is using a Foley catheter. She does have a history of high cholesterol for which she takes a statin at home and was taking a baby aspirin a day when the above symptoms occurred. In summary, the patient has a 72-year-old woman, who presents with progressive right lower extremity weakness and now evolving left lower extremity weakness. This may be related to an autoimmune process such as myelitis or less commonly cord ischemia. Normally, I would start her on Plavix, but I think she may need to undergo spinal tap tomorrow if MRI scan of the brain and cervical spine are unrevealing. Patients with mild hyperglycemia can develop a diabetic amyotrophy or lumbosacral plexopathy simply related to diabetes, which is a diagnosis of exclusion. Speaking against this would be that her reflexes are intact at both knees at 2+ to 3 and slightly brisk, 1+ at both ankles and 1+ and symmetric in the upper extremities. We will hold aspirin for today. Consider LP for tomorrow, but have not ordered as we will try to avoid and hopefully the imaging studies I have ordered will be sufficient. We will continue to follow. While admitted to this facility, she was treated with IV dexamethasone 2/14-2/21 She was admitted to an inpatient hospital 2/14-2/23 and discharged to an inpatient rehab unit at a different health system.

about 8 hrs after shot stomach ache, unable to eat dinner. a few hours later, mild chills. next day, fatigue, lots of napping, and repeat of evening stomach ache, more severe, and also ache at kidneys on back. later chills. third day still fatigue, another evening stomach ache, no dinner, bland snack, less severe. later chills. 4th day, less fatigue, stomach ache but milder, no chills. 5th day no symptoms, more energy, almost normal.

Next day after shot, 3/6/21, I woke up with a severe back pain. When I walked to bathroom I was not able to sit on Toilet to urinate and not able to hold the urine back causing me to urinate all over my clothes.

Pt got her first dose of Moderna covid vaccine on 3-3-21 at 3:45pm - was fine at pharmacy and waited 15 mins, then went to the next store and started to feel unwell, her bp was high after with high pulse, is now sick with sinus congestion, flu symptoms, and fatigue. She is now having incontinence issues after the vaccine as well, is on medication that was working just fine prior. Pt now has swelling, redness, and blood vessel flare ups in her left ankle that hasn't occurred in a long time. Feels like the vaccine has exasperated some of her medical conditions.

Suspected that pt developed aggressive immune activation after Vaccination that resulted in hepatitis flare and breakthrough viremia despite having completion viral suppression for years on Entecavir. I saw pt on 3/17/21. She reported symptoms of fever, and dizziness after the shot which confirms immune response from Moderna.

Began to feel feverish around or slightly before 9:30, when chills & shivering began. Could not sleep due to shivering. Got up around 1 AM to go to bathroom- was VERY weak & needed help. Also while getting to bathroom began to lose control over kidneys and was urinating involuntarily. Had urge to to go the bathroom again around 3; 30. This time could NOT walk at all & was once again urinating involuntarily. Tried to just go back to bed, but did not seem to have any control over my body. Around 4:30 I got as comfortable as possible on the floor & slept off & on until around 8:30. When I woke up I was able with help to get back into bed. I had continued to urinate involuntarily during the time I was sleeping prior to 8:30. The symptoms seemed to gradually subside after this point. Called Neurologist, thinking that my radiation induced nerve damage was involved in my reaction and she agreed.

pt states that she woke up next day w/ severe epigastric pain, nausea, vomiting, loss of appetite, dark urine, pale stools. pt was very sick from 3/5 to 3/13. She had an appt w/ PCP on 3/19/21 for her annual exam. Labs showed her liver enzymes were elevated. Her labs were all high on this date but normal one year ago. Dr. told her the vaccine caused her to have vaccine induced hepatitis. Pt to FU w/ PCP on 4/22/21.

2/25/21-Headache, body ache, fever of 102 (two days), incontinent, severe chills, loss of balance(lasted one day). 2/26/21-Diarrhea 2/27/2(lasted 2 days) Petechiae-from ankles up to knees bilaterally(lasted one week) Patient was COVID positive 12/24/20 patient has still not regained sense of smell and taste.

1./25/21 Racing heartbeat 5 minutes after vaccine lasted about 10 minutes 1/31/21 -2/1/21 Palpitations and erratic heartbeat continuous and lasted about 14 hours then became intermitent. Cardiologist was seen on 2/2/21. Wore heart monitor for about 8 days. DX: Afib 2/20/21 awoke at 6:00 am. The room was spinning, I became nauseous, had dry heaves and my legs began shaking uncontrollably. 911 was called and I was transported to the ER. A CT scan, chest xray, blood test, and urinalysis was performed. DX: dehydration. I was given meds for nausea and bactrim for a slight UTI (although I had no symptoms.

Thrombocytopenia (CMS/HCC) Hypercalcemia Chronic anemia AKI (acute kidney injury) (CMS/HCC) DKA, type 2 (CMS/HCC)

Moderna Covid 19 Vaccine EAU severe flu-like symptoms escalating to incontinence, cumulating in fainting and being unable to move any body part except one index finger. After that subsided, foggy brain, fever. Eventually a day of diarrea.

blood in her urine with clots; urine was dark like the color of syrup and it was a brown thick stream; sharp severe headache; chills; fatigue; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE URINARY TRACT (blood in her urine with clots) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) 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 reported medical history). On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced HEADACHE (sharp severe headache), CHILLS (chills) and FATIGUE (fatigue). On 08-Apr-2021, the patient experienced HAEMORRHAGE URINARY TRACT (blood in her urine with clots) (seriousness criterion medically significant) and CHROMATURIA (urine was dark like the color of syrup and it was a brown thick stream). On 09-Apr-2021, HAEMORRHAGE URINARY TRACT (blood in her urine with clots) and CHROMATURIA (urine was dark like the color of syrup and it was a brown thick stream) had resolved. At the time of the report, HEADACHE (sharp severe headache), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. Not Provided No relevant concomitant medications were provided. The patient received acetaminophen for symptoms. She is currently seeking help from her health care provider regarding this situation and is undergoing some tests in the meantime such as a renal ultrasound. Action taken with mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the event (headache, chills, and fatigue), a causal relationship cannot be excluded. Very limited information regarding the events (Haemorrhage urinary tract, chromaturia) has been provided at this time. The subject's medical history and concomitant medications are required for analysis. 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 event (headache, chills, and fatigue), a causal relationship cannot be excluded. Very limited information regarding the events (Haemorrhage urinary tract, chromaturia) has been provided at this time. The subject's medical history and concomitant medications are required for analysis. Further information has been requested.

Pt reports she was in Hospital until 2 days ago when she received 2nd Moderna COVID vaccine. She states that several hours later she began feeling globally weak and with coordination difficulties intermittently (gives example that she would be feeding self, then have difficulty getting utensil to mouth and noted sudden collapse of LE when standing, "they just gave out" and feels that difficulty coordinating her legs led to inability to stand- adamant that it is coordination rather than fatigue or weakness at issue). She feels symptoms in extremities are bilateral and symmetric. Denies prodrome prior to falls, denies LOC but states she fell onto her face and did not "catch" herself "it happened too fast". She has been able to ambulate with assistance to bathroom and in her house in recent days. Denies paresthesias, numbness to groin or perineum. She has been constipated, which is new for her with last BM 4/17 no GIB. Pt denies dysuria or difficulties with urination, though she tells me she has not voided since yesterday. She states she has been eating without n/v or early satiety. No change in chronic cough or DOE. She has not had fevers or chills, denies myalgias or arthralgias.

Pt presented to the ED from home for b/l lower extremity swelling x 2 weeks. She was reportedly in her recliner for approximately 12-18 hrs prior to being brought in via EMS. In the ED her b/l LE extremity was cold to touch and mottled. Her toes were white and nail beds blue. No pulses were found on Doppler on either extremity. She was also noted to be in a.fib with RVR. Doppler of LE showed extensive occlusive thrombus. Bedside echo showed the RV severely dilated with mobile thrombus and EF 20-25%. Given these findings there is a very high probability of massive PE, however given current situation of AKI and instability CT was unable to be performed. She was given TPA and admitted to ICU. Pt was started heparin gtt, as well as levophed and dobutamine for obstructive and cardiogenic shock as her troponin, kidney function, lactate and liver function all were elevated. Of note pt lives in a hoarding situation and lives a sedentary lifestyle and reportedly only gets up from recliner to use the bathroom. Pt also has a 96 pack year history but was noted in her medical chart to have quit smoking in 2017.

Acute renal Failure; This spontaneous case was reported by a physician and describes the occurrence of ACUTE KIDNEY INJURY (Acute renal Failure) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) for an unknown indication. The patient's past medical history included Myelofibrosis (FGFR1 myelofibrosis) on 11-Aug-2018 and Bone marrow aspiration (bone marrow aspiration / biopsy (BMA/Bx) were negative for disease on 11-JUL-2019.). Concurrent medical conditions included Diabetes mellitus since 1999 and Urinary tract infection (chronic urinary tract infections was reported.) since 15-Jan-2021. Concomitant products included PEMIGATINIB from 29-Mar-2019 to 30-Mar-2021 for Myelofibrosis, CALCIUM ACETATE from 07-Jun-2019 to 04-Mar-2021, BIOTIN from 10-May-2019 to an unknown date, GLIMEPIRIDE from 16-Feb-2020 to an unknown date, VITAMIN D3 from 27-Nov-2019 to an unknown date, IRON from 23-Mar-2020 to 30-Mar-2020, SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) from 29-Jan-2021 to 12-Feb-2021, ALBUTEROL [SALBUTAMOL] from 20-Jan-2021 to an unknown date and GABAPENTIN from 03-Jul-2019 to an unknown date for an unknown indication, ACETAMINOPHEN from 30-Mar-2014 to an unknown date. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 20-Mar-2021, the patient started CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) (unknown route) at an unspecified dose. On 26-Mar-2021, the patient experienced ACUTE KIDNEY INJURY (Acute renal Failure) (seriousness criteria hospitalization and medically significant). The patient was treated with NORMAL SALINE 25-Mar-2021 at a dose of 1 liter. On 02-Apr-2021, ACUTE KIDNEY INJURY (Acute renal Failure) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Mar-2021, Blood creatinine (0.60-1.30 mg/dl): 1.43 mg/dl (abnormal) creatinine level (CR) 1.43 mg/dL, was reported.. On 05-Mar-2021, Blood urea: 16 (Inconclusive) 16 milligram per decilitre. On 05-Mar-2021, Blood uric acid: 5.10 (Inconclusive) 5.10 milligram per decilitre. On 05-Mar-2021, Glomerular filtration rate: 36.10 (Inconclusive) 36.10 ml/min. On 05-Mar-2021, Urine analysis: yellow (Inconclusive) color yellow, cloudy, trace blood, positive nitrate, Leuk +3, WBC >or=60 and moderate bacteria.. On 24-Mar-2021, Blood creatinine (0.60-1.30 mg/dl): 3.32 mg/dl (abnormal) 3.32 milligram per decilitre. On 26-Mar-2021, Blood creatinine (0.60-1.30 mg/dl): 5.9 mg/dl (abnormal) 5.9 milligram per decilitre. On 26-Mar-2021, Blood urea: 445 (Inconclusive) 445 milligram per decilitre. On 26-Mar-2021, Blood uric acid: 8.40 (Inconclusive) 8.40 milligram per decilitre. On 26-Mar-2021, Glomerular filtration rate: 7.03 (Inconclusive) 7.03 ml/min. On 26-Mar-2021, Urine analysis: normal (normal) Straw, clear, 1.006, blood +3, pH 6, WBC 2-5, rest normal. On 29-Mar-2021, Blood creatinine (0.60-1.30 mg/dl): 5.69 mg/dl (abnormal) 5.69 milligram per decilitre 1.30. On 29-Mar-2021, Blood urea: 9.0 (Inconclusive) 9.0 milligram per decilitre. On 29-Mar-2021, Glomerular filtration rate: 7 (Inconclusive) 7 ml/min. On 30-Mar-2021, Ultrasound kidney: unremarkable (Inconclusive) Unremarkable.. On 02-Apr-2021, Blood creatinine (0.60-1.30 mg/dl): 3.62 mg/dl (abnormal) 3.62 milligram per decilitre. On 02-Apr-2021, Blood urea: 41 (Inconclusive) 41 milligram per decilitre. On 02-Apr-2021, Glomerular filtration rate: 12 (Inconclusive) 12 ml/min. On 07-Apr-2021, Blood creatinine (0.60-1.30 mg/dl): 2.53 mg/dl (abnormal) 2.53 milligram per decilitre. On 07-Apr-2021, Blood urea: 22 (Inconclusive) 22 milligram per decilitre. On 07-Apr-2021, Blood uric acid: 4.10 (Inconclusive) 4.10 milligram per decilitre. On 07-Apr-2021, Glomerular filtration rate: 18.69 (Inconclusive) 18.69 ml/min. On 08-Apr-2021, Blood creatinine (0.60-1.30 mg/dl): 2.25 mg/dl (abnormal) 2.25 milligram per decilitre. On 08-Apr-2021, Blood urea: 22 (Inconclusive) 22 milligram per decilitre. On 08-Apr-2021, Blood uric acid: 4.1 (Inconclusive) 4.1 milligram per decilitre. On 15-Apr-2021, Blood creatinine (0.60-1.30 mg/dl): 1.4 mg/dl (abnormal) 1.4 milligram per decilitre. On 15-Apr-2021, Blood urea: 18 (Inconclusive) 18 milligram per decilitre. On 15-Apr-2021, Blood uric acid: 3.9 (Inconclusive) 3.9 milligram per decilitre. On 15-Apr-2021, Glomerular filtration rate: 38 (Inconclusive) 38 ml/min. On 15-Apr-2021, Urine analysis: normal (normal) Normal. On 20-Apr-2021, Blood creatinine (0.60-1.30 mg/dl): 1.57 mg/dl (abnormal) 1.57 milligram per decilitre. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient received the first dose of oral INCB054828 4.5mg QD on 29MAR2019. The last dose of INCB054828 prior to the Serious Adverse Event (SAE) was taken on 29MAR2021. Treatment with 1L of normal saline was initiated intravenously on 29-MAR-2021. 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.; 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.

unresponsive to stimuli; urinary tract infections; candida in her throat; dehydrated; neuropathy in both legs and has fallen 3 times; She had lost 25 lbs but she had gained back 3 lbs; nausea; vomiting; fever; chills; diarrhea; started using a cane and progressed to a walker; fallen 3 times; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of UNRESPONSIVE TO STIMULI (unresponsive to stimuli) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Essential tremor and Kidney transplant. Concomitant products included CEVIMELINE for Dry mouth, VITAMIN B3, VACCINIUM MACROCARPON FRUIT (CRANBERRY [VACCINIUM MACROCARPON FRUIT]), CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), TACROLIMUS, MYCOPHENOLIC ACID, PREDNISONE, PRIMIDONE, RABEPRAZOLE, ROSUVASTATIN CALCIUM and FLUOXETINE HYDROCHLORIDE (PROZAC) for Kidney disorder, LORAZEPAM (ATIVAN) for Nerve pain, ACETAMINOPHEN for Pain, FLUTICASONE PROPIONATE (PROAIR [FLUTICASONE PROPIONATE]) for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced WEIGHT DECREASED (She had lost 25 lbs but she had gained back 3 lbs), DIARRHOEA (diarrhea), NAUSEA (nausea), VOMITING (vomiting), PYREXIA (fever) and CHILLS (chills). On 13-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (neuropathy in both legs and has fallen 3 times) and DEHYDRATION (dehydrated). In March 2021, the patient experienced WALKING AID USER (started using a cane and progressed to a walker) and FALL (fallen 3 times). On 12-Apr-2021, the patient experienced ORAL CANDIDIASIS (candida in her throat). On 20-May-2021, the patient experienced URINARY TRACT INFECTION (urinary tract infections). On an unknown date, the patient experienced UNRESPONSIVE TO STIMULI (unresponsive to stimuli) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 12-May-2021 to 16-May-2021 due to UNRESPONSIVE TO STIMULI. The patient was treated with PARACETAMOL (TYLENOL) on 13-Mar-2021 for Fever, at an unspecified dose and frequency; ONDANSETRON (ZOFRAN [ONDANSETRON]) for Candida of mouth, at an unspecified dose and frequency; PROMETHAZINE HYDROCHLORIDE (PHENERGAN [PROMETHAZINE HYDROCHLORIDE]) on 19-Apr-2021 for Candida infection, at an unspecified dose and frequency; DOXYCYCLINE for Urinary tract infection, at an unspecified dose and frequency; FLUCONAZOLE (DIFLUCAN) at an unspecified dose and frequency and PHOSPHORUS at an unspecified dose and frequency. On 09-Apr-2021, PYREXIA (fever) had resolved. On 14-Apr-2021, ORAL CANDIDIASIS (candida in her throat) had resolved. At the time of the report, UNRESPONSIVE TO STIMULI (unresponsive to stimuli), NEUROPATHY PERIPHERAL (neuropathy in both legs and has fallen 3 times), WEIGHT DECREASED (She had lost 25 lbs but she had gained back 3 lbs), WALKING AID USER (started using a cane and progressed to a walker), FALL (fallen 3 times) and URINARY TRACT INFECTION (urinary tract infections) outcome was unknown and DIARRHOEA (diarrhea), DEHYDRATION (dehydrated), NAUSEA (nausea), VOMITING (vomiting) and CHILLS (chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-May-2021, Blood magnesium: low (Low) low. On 14-May-2021, Blood phosphorus: low (Low) low. On 14-May-2021, Endoscopy: candida in throat (abnormal) candida in throat. On 14-May-2021, Renal impairment: normal (normal) normal. On 14-May-2021, Sigmoidoscopy normal: normal (normal) normal. By 19 Apr 2021, the transplant team office was called as she was not responding. They ran bloodwork and found the Diflucan had caused issues with the tacrolimus which she takes for the kidney transplant. They went to the hospital on 10 May 2021 and 11 May 2021 but could not wait. She was finally admitted on 12 May 2021. On 14 May 2021 another endoscopy showed that the candida was better. Bloodwork indicated her phosphorus was critically low and magnesium was low. She was given fluids and phosphorus. Her kidney function test was normal. She was released on 16 May 2021. 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 subject's use of steroids can be a confounding factor to oral candidiasis. Furthermore the interaction between Diflucan and Tacrolimus can also be a confounding factor. This case was linked to MOD-2021-169089 (Patient Link).; 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 subject's use of steroids can be a confounding factor to oral candidiasis. Furthermore the interaction between Diflucan and Tacrolimus can also be a confounding factor.

71-year-old female with history of chronic obstructive pulmonary disease, CVA, type 2 diabetes hypertension who presented with hypoxia and altered mental status. At baseline she is alert and oriented to self, she has a guardian. It appears she was noted to be more somnolent than usual at her facility and found to be hypoxemic so was sent to ER for further evaluation. She required 4L oxygen via nasal cannula to maintain saturation. On arrival to ER, her labs were notable for mild AKI, troponin elevation, leukocytosis and positive COVID19 PCR. Chest xray was consistent with patchy bilateral lower lobe airspace disease. CT Head showed a chronic large right MCA infarct without acute hemorrhagic changes

I got the shot and i was ok the first day but the next day I felt groggy and week. I went and had breakfast and then i got the chills, then i started sitting up but i felt awful so i went back to bed and dizziness weakness headache, redness around injection site. My whole left side felt like it was achy and almost like it was numb. I lost bladder control, I had a couple of accidents. I stayed in bed until next day, couldn't get out of bed, couldn't eat. Got up Saturday, not feeling good, queasy, diarrhea but not as bad as Friday. Every time i would try to do something i would fall asleep. went and had covid test for surgery. Sunday I felt better but not to par. Today i feel the best so far. Put antibiotic cream on injection site because it was itching, and it is still hard and warm to touch. Today i have a small cough that I didn't have before.

That afternoon I walked, but cut it off at just over 2 miles as I was getting tired. Around 6 I had bad chills, a low fever 99.9, Around 8 nauseous and headache, 9:30 I started throwing up with urination at the same time.. This happened maybe 4 times until around 3 am.. I was really weak. Over temp around 101. On 29th: Took 2 Advil and kept the water down. Slept all day and weak, Hurt all over especially the entire left arm and hips. Temp 102.6 overnight.. On 30th, Temp stayed just over 100, took Advil, ate soup and slept most of day. Around 4 pm temp down to 99. On 31th, Sunday, I will could do much, but did sit up much of day and ate light meal. Fever broke in the afternoon. I did not call a doctor as I always thought I would be better soon. On Monday, Feb 1, I went for my previously scheduled Mammograms. The next day I received a call that I needed to come back. When I went in on the 8th for more mammogram views and ultrasounds, they found 3 places of concern. I am scheduled for a needle biopsy on this Thursday.. I told them that I had received my Covid19 vaccinations and they mentioned that they have seen differences in tissue after the shots. I did not see a doctor on the first and not sure if the breast tissue or mass is a consequence or not.

On Monday night, Day 4, I woke at 11 p.m. with chills and shaking, temperature of 99.9 F. Went to the bathroom, urinated, took Tylenol and went back to bed. Woke again at 2:00 a.m, still chilled, and tried to stand up and my legs wouldn't hold me. I managed to lift myself to my feet and clutching furniture get to the bathroom, with complete loss of bladder control on the way. Took more Tyleonol, drank more water, put on clean pajamas but couldn't lift my knees to step into them, had to put them on the floor and pull them up. Went to sleep eventually. When I woke at about 5 a.m., all was completely normal. No fever, legs fine, usual bladder control.

Patient reports feeling symptoms later the same evening the day of receiving her 2nd dose of Moderna. Her twin sister, also reported similar symptoms after receiving her 2nd dose of Moderna the same day (3/5/21). Patient reported feeling nausea and having "extreme" chills that evening. The next morning at 8 a.m. Patient called her sister, at 8 a.m. When she arrived at her sister's house she found patient unresponsive. She was taken to the hospital and remained there for 5 hours. Patient reports passing out, losing control of her bodily functions and hitting her head on a heavy resin figure. "Blood was all over the place." She reports that 2 spots on her scalp were bleeding and subsequently treated at the hospital. Patient currently is still experiencing extreme fatigue following the vaccination.

PT reports starting symptoms at 11:30 p.m. after receiving vaccine at 1 p.m. the same day. She reports frequent urination "all night," nausea, dry heaves, chills and teeth chattering. Of note is that her sister reported similar symptoms after receiving her vaccine the same day.

Malaise, weakness, diarrhea at 2-3 days post vaccination, acute renal failure at 9 days post-vaccination.

Extreme chills from 2:00 until 7:30. Took hot bath. Got debilitating headache. Had to go to bed. Applied cold compress to head. Better in morning after taking extra strength tylenol. 8 April again got chills but not as bad. Bad headache but not as bad. Then I believe it to be a UTI with bleeding that looked almost like period but I am 72 years old. Still a little blood in urine today 9 April.

1st round:Headache chills loss of appetite( 2 days 2nd Round: (april7th) chills headache weak loss of appetite incontince sore muscles shortness of breath

Hallucinations; Skin turned "yellow"; body smelled like "old Urine"; her urine was the color of "coffee"; Fever; Chills; Fatigue; This spontaneous case was reported by a nurse and describes the occurrence of HALLUCINATION (Hallucinations) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 03-Dec-2020. Concurrent medical conditions included Scleroderma. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced HALLUCINATION (Hallucinations) (seriousness criterion medically significant), YELLOW SKIN (Skin turned "yellow"), SKIN ODOUR ABNORMAL (body smelled like "old Urine"), CHROMATURIA (her urine was the color of "coffee"), PYREXIA (Fever), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Mar-2021, HALLUCINATION (Hallucinations), YELLOW SKIN (Skin turned "yellow"), SKIN ODOUR ABNORMAL (body smelled like "old Urine"), CHROMATURIA (her urine was the color of "coffee") and PYREXIA (Fever) had resolved. At the time of the report, CHILLS (Chills) and FATIGUE (Fatigue) had not resolved. 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. No concomitant medications were reported. The treatment information was not 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.; 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.

scary muscle weakness. difficulty holding my urine. frequent episodes of irregular heartbeat that caused anxiety

The next day after vaccine on 01/15/2021, I felt nauseous. Later on in the day around 3 PM I started having a burning in stomach, back, and chest. I took over the counter TUMS but it continued to get worse. That evening I started having a runny nose but no fever. Several days after that, I felt burning in chest and lots of pain in my back. The next four days, I had pain in right side, chest pain, back pain, twisting pain. The pain continued until the 01/25/2021, and then on the 01/26/2021 I had this very bright orange urine with red in it. I went to urgent care and they did EEG and urinalysis that came out fine with nothing abnormal. By 01/27/2021 I was fine.

kidney stones; skin got painful; skin got red; skin got damp; little bit of phlegm; redness to shoulders, neck/gotten worse characterized by it seems to have spread and is more red in color; rash to the front side of the body, bilateral legs, underneath bra area, the rash has spread to the back area as well as the front; This spontaneous case was reported by a non-health professional and describes the occurrence of NEPHROLITHIASIS (kidney stones) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products DUPILUMAB (DUPIXENT) for Atopic dermatitis and ALENDRONATE SODIUM (FOSAMAX) for an unknown indication. Concomitant products included TERIFLUNOMIDE for an unknown indication. On 04-Oct-2019, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 milligram. On 12-Nov-2019, DUPILUMAB (DUPIXENT) (Subcutaneous) dosage was changed to 300 milligram. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ALENDRONATE SODIUM (FOSAMAX) (unknown route) dosage form. On an unknown date, the patient experienced NEPHROLITHIASIS (kidney stones) (seriousness criterion medically significant), PAIN OF SKIN (skin got painful), ERYTHEMA (skin got red), COLD SWEAT (skin got damp), PRODUCTIVE COUGH (little bit of phlegm), CONDITION AGGRAVATED (redness to shoulders, neck/gotten worse characterized by it seems to have spread and is more red in color) and RASH (rash to the front side of the body, bilateral legs, underneath bra area, the rash has spread to the back area as well as the front). The patient was treated with PREDNISONE for Pain of skin, Skin red and Cold sweat, at a dose of UNK dosage form. At the time of the report, NEPHROLITHIASIS (kidney stones), CONDITION AGGRAVATED (redness to shoulders, neck/gotten worse characterized by it seems to have spread and is more red in color) and RASH (rash to the front side of the body, bilateral legs, underneath bra area, the rash has spread to the back area as well as the front) outcome was unknown, PAIN OF SKIN (skin got painful), ERYTHEMA (skin got red) and COLD SWEAT (skin got damp) was resolving and PRODUCTIVE COUGH (little bit of phlegm) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 04-Oct-2019, it was reported that the patient experienced widespread rash and erythema, post loading dose of dupilumab and the condition worsened. On 19-Dec-2019, the patient experienced kidney stones, following dose of dupilumab. Additional information was received on 26-Dec-2019 included a new event, a little bit of phlegm, experienced by the patient. The case was upgraded to serious, and alendronate sodium was added as co-suspect product. Additional information received on 18-May-2021 from patient included the new events, skin got red, skin got painful, skin got damp. On an unknown date, the patient received Moderna covid-19 vaccine. The patient reported that after taking vaccine, and then taking dupilumab, skin got painful, red and damp. Treatment medication included prednisone. Reporter causality for alendronate sodium was reported as related for kidney stones. 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.; 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.

I was very sick to my stomach, I had severe stomach pain. I started throwing up and was dry heaving, when I got to the hospital I found out I had C diff, a UTI, and the hospital admitted me I spent 3 weeks in the hospital. I was in 2 separate hospitals for a total of 7 weeks. I had serious complications, I went into A fib with my heart, I got neuropathy from my chest down I was numb all over. I had severe UTIs, they kept putting catheters in me. I was so sick I couldn't eat and I lost 35lbs. I thought I was going to die.

Profound weakness begining approx. 12 hrs post vaccination. Patient unable to get up off toilet. Improved approx. 6 hours later after sleeping. Since that time, weakness continued, gait unsteady and brain fog symptoms present. Some level of anosmia and taste aberration. Patient began PT twice weekly in late April and continues now with weekly only. Memory and brain fog symptoms intermittent Taste aberrations ongoing Lab tests on 06/02/2021 WNL, Covid test Negative

Moderna COVID19 Vaccine EUA Admitted inpatient 4 days for pyelonephritis, mild dehydration and Acute kidney injury.

Acute kidney injury; CHF (congestive heart failure); COVID-19 virus infection; Chronic hepatitis C without hepatic coma; Edema leg; Essential hypertension

Patient arrived to ED via ambulance a few days after first COVID-19 vaccine (manufacturer unknown). First COVID shot on Friday, has been experiencing myalgias , weakness, fevers and chills Has been drinking water to try and stay hydrated She has been laying around because she has not been feeling well She tried to get up to answer phone, had dizzy spell and fell forward and hit her right side of head on table. No LOC Now head, neck, low back pain Patient ambulated on her own

At 3 am I woke up and had to go to the bathroom, I sat on the edge of the bed then stood up and opened my eyes. The room was spinning, I fell down, vomited and peed. I laid there for a while until I realized if I closed my eyes the room would stop spinning. I got up off the floor, back into bed and stayed there for about 5 hours. When I woke up, I was still dizzy, but not nearly as bad. The dizzyness and nausia still hits me several times a day.

Patient states she woke up at her usual time and on the way to the kitchen blacked out. She woke up and crawled to the kitchen then blacked out and and peed herself.

Moderna COVID-19 Vaccine EUA 2/27/21: Pt received 1st Moderna vaccine 2/4/2021. She states that her symptoms 1st started out as a slight postnasal drip, which turned into a hoarse voice with a cough, which turned into a head cold, which has turned in due shortness of breath, diarrhea, and cough with associated chills. After 17 days of cold-like symptoms, pt was tested on 2/26 for COVID and tested positive. 2/27, pt worsened and presented to ED. Upon arrival to the emergency department, the patient's temperature is 100.2° F, heart rate 96, respiratory rate 24, saturating 84% on room air with blood pressure 164/84. The patient's laboratory studies were significant for BUN 17, CR 1.47, lactate 2.2, D-dimer 6.79, and phosphorus 2.2. The patient's chest x-ray showed no acute findings. CT chest showed extensive acute bilateral pulmonary emboli involving most of the lobar and segmental branches, right greater than left with no saddle embolus. Findings borderline for right heart strain, correlate with echocardiogram. Peripheral ground-glass airspace opacities consistent with atypical/viral pneumonitis. Reactive mediastinal and hilar lymphadenopathy. EKG showed normal sinus rhythm, heart rate 93 with inferior infarct-age undetermined. The patient was administered 1 L IV NS, ceftriaxone 1 g IV, azithromycin 500 mg IV, and heparin IV bolus and drip for PE indication. Remdesivir started. 2/28/21: Pt on 3 L oxygen. Azithromycin, ceftriaxone, remdesivir continued. Vancomycin started. 3/1/21: 1 L oxygen via nasal cannula. Small, nonproductive cough. Pt complains of SOB. 3/2/21: 1/2 blood cultures from 2/27 positive for CoNS. Vancomycin discontinued. Pt feeling much better. Still on 1 L oxygen via nasal cannula. More alert. 3/3: 5 day remdesivir course and azithromycin, ceftriaxone course completed. Patient weaned off oxygen. Pt discharged home with oxygen as a precaution. Pt also enrolled in COVID Safe At Home telehealth program.

emergency room HPI 73 y.o. female who presents with dizziness and loss of consciousness. Patient reports that she was sitting outside in the sun this afternoon and became hot, she then went inside and came back outside to sit in the shade. She reports that she became "dizzy," lightheaded, nauseous, and that her vision began to go black. Reports that she awoke to her sister shaking her in the chair and calling EMS. Unsure of LOC time, but believes it to be short-lived. She then had one episode of vomiting. Denies vertigo, hitting head, trauma, headache, chest pain, palpitations, shortness of breath, and edema. Denies recent illness or sick contacts. Denies h/o similar episodes.

03/04/21- 11:30pm chills, 03//05/21 AM- pain and swelling at injection site and whole left arm lasting 2 days, fever late in the day of 03/05/21 gone morning of 03/06/21. with this came the urgency to urinate. Had no side effects with first vaccine give 02/04/21.

Pt developed vomiting, syncope, urinary incontinence the evening of 3-2-21 at 9:00pm. She continued to vomit through the night and had 1 syncope episode when trying to get up. on the morning of 3-3-21, pt was ambulating with assistance to the restroom and had a syncopy episode, confusion and fell and hit her head on a chair. 911 was called and pt was transported to ER, pt was found to be dehydrated and had elevated blood sugar( < 300) per daughter. ) admitted overnight for observation.

following evening back pain lower left side for 2 days. Moved to stomach on left side and back. At this time urine was orange in color and had a foul Oder for 3 days followed by stomach pain still but more intense and dysentery. Called Dr office when I had blood clots the size of quarters or better, Nurse suggested I go to emergency. I did not, this continued for 3 days and then subsided. I still am having chills and a temp of 96.7.. At this point I am concerned to get the second vaccine on the 29 th of this month.

The shot hurt when administered, didn't feel the first one. About 2 minutes after shot, felt light headed and like the shot contained adrenalin or epinephrine. That subsided by the time I left the site, although I remained slightly light headed all evening. Went to bed at 10:00 with an extremely sore arm, beginning of body aches and fever of 99.3. Awoke at 1:00am with 101.9 temp, extreme muscle and joint pain, and every time I moved anything, even a finger I would feel the sensation of a chill or slight electric shock. Urinated every hour from 1:00am and 5:00 am. When I awoke at 5:00 I was so weak, nauseated and dripping sweat I barely got my dog fed and let out for the morning. The nausea passed quickly but I thought I was going to have to lie down on the floor during that wave.Went back to bed, slept until 7:00 and was pretty much a zombie until 6:00pm last night(March 10) when all exhaustion and muscle pain disappeared and I have been fine since then.

UTI after second dose; Sweats; Unable to walk; Fever; This spontaneous report was received from a consumer concerning a 73-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced Urinary Tract Infection, fever (pyrexia), sweats (hyperhidrosis), and unable to walk (gait inability). The patient's medical history and concomitant medications were not reported. The patient received the first of two planned doses of mRNA-1273 (Lot/Batch number: 007MZ0A) on 30 Jan 2021. On 27 Feb 2021, prior to onset of symptoms, the patient received the second of two planned doses of mRNA-1273 (Lot/Batch number: 013A21A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, after first dose of vaccine, the patient felt sick with fever, had sweats and was unable to walk. Post second vaccination administration, the patient experienced same symptoms of feeling sick with fever, had sweats and was unable to walk. After second dose, the patient also experienced Urinary Tract Infection (UTI) and was hospitalized for three days. The patient reported that the people at facility were not wearing gloves when she received both doses. Treatment for the events was not reported. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome for the events, Urinary Tract Infection, fever, sweats, and unable to walk was unknown.; Reporter'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.

Severe lethargy after receiving the shot. Constant sleepiness and malaise, nausea, confusion, loss of appetite, dizziness, Blood vessels/clots formed in her eyes. Acute renal failure and eventually death on March 18, 2021.

I wasn't feeling well after the injection and on the 2nd day, I went to my Dr. I had not urinated in about 18 hours. I had total renal failure. I was sent to the ER in our small town and was then sent by ambulance to a hospital. I was in ICU for 2 or 3 days and then in a regular room for the next 5 0r 6 days.

fever fatigue Acute kidney injury (CMS/HCC) Sepsis due to urinary tract infection (CMS/HCC) Severe sepsis (CMS/HCC) Hydronephrosis Endometrial cancer (CMS/ Urinary tract infection

On Friday morning began suffering horribly with retching vomiting, brief periods of unconsciousness, and complete incontinence. Awoke Saturday morning with numbness on whole left side of body. Called Dr. and he advised go to ER immediately. Went to Hospital ER and they diagnosed a very small Lacunar stroke had occurred (ran MRI of brain). Prescribed 81mg Aspirin regimen and directed to follow-up with a Neurologist (a doctor's name and facility was provided. Made appointment and will see Dr. on 4/15/21.

Renal failure; Hypercalcemia; Missed Dose; A spontaneous report was received from a pharmacist concerning a 73-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypercalcemia (hypercalcaemia) and renal failure. The patient's medical history was not reported. Concomitant medications taken by the patient were not provided. On 13 Jan 2021, 20 days prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 2 Feb 2021, the patient was hospitalized for hypercalcemia and renal failure. The reporter reported that these events were not related to the vaccine. The patient did not see her regular doctor for this. The patient did not receive her second dose since she was hospitalized at the time and was at day 61. Treatment for the events was not provided. The patient was discharged from the hospital on 21 Feb 2021. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, hypercalcemia and renal failure, was unknown. Follow up: Follow-up received on 15 Mar 2021, included email id of reporter, the hospitalization details, cause of hospitalization.; Reporter's Comments: Based on the 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.

delirious/uncontrolled laughing; loss of memory; 102 F fever; pied on self; dizzy; headache; A spontaneous report was received from a Consumer, concerning herself of 73 years old female, who received Modena's COVID-19 vaccine, and experienced headache, delirious/uncontrolled laughing, 102F fever, lost memory, peed on self, dizziness. The patient's medical history was not provided. Concomitant medication included Gabapentin for pain 80 mg 3 times a day, Amlodipine, Esomeprazole twice a day 40 mg, Furosemide 40 mg 2 in the morning, Citalopram 20 mg, Pentosan polysulfate 100 mg 3 times a day, Renoxin 1000 mg twice a day, potassium 20 mq twice a day, Atorvastatin twice a day, Trazodone 150 mg once a day, Linaclotide once in a while 290 mcg, vitamin D once a week, Clonazepam twice a day, Diphenhydramine, Alirocumab injection. On 03 FEB 2021, the patient received their first of two planed doses of mRNA-1273 (Batch number 012M20A) on right non-dominant arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, 2 days after vaccination, the patient had headache and a day after had memory loss and fever ranging from 102 to 103, pied on self, dizzy, uncontrolled laughing and delirious, all of which lasted for 3 days but treated only for headache. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events were reported as resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

COVID arm. Hot, swollen, hard,, red, itchy, sensitive to touch. 9 days later had sore back, that worsened and became like a kidney stone/ infection.

Progressive weakness & episodes of dizziness/fall, septic shock from unknown source, acute renal failure secondary to septic shock, metabolic acidosis, mild DKA, SIADH, newly diagnosed diabetes

vomiting with fruity odor, BG 417, weakness & SOB, Torsade de pointe & received CPR, DKA, sepsis, lactic acidosis

Blood clot in large intestines which caused loss of blood supply and oxygen so it rotted which in turn rotted her small intestine and bowels which all had to be removed shut down her kidneys and liver

could not urinate; no sleep; lost 9 pounds; pulse rate is high in the 90s; could not defecate; constant pain in the colon on the left side, pain in my intestines; This spontaneous case was reported by a consumer and describes the occurrence of URINARY RETENTION (could not urinate) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 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 reported medical history.). On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URINARY RETENTION (could not urinate) (seriousness criterion medically significant), INSOMNIA (no sleep), WEIGHT DECREASED (lost 9 pounds), HEART RATE INCREASED (pulse rate is high in the 90s), DYSCHEZIA (could not defecate) and ABDOMINAL PAIN (constant pain in the colon on the left side, pain in my intestines). At the time of the report, URINARY RETENTION (could not urinate), INSOMNIA (no sleep), WEIGHT DECREASED (lost 9 pounds), HEART RATE INCREASED (pulse rate is high in the 90s), DYSCHEZIA (could not defecate) and ABDOMINAL PAIN (constant pain in the colon on the left side, pain in my intestines) outcome was unknown. The patient used blood thinners as concomitant medication. Patient states she took laxatives and other over-the-medications as treatment. Action taken with mRNA-1273 in response to the event was not applicable. Company Comment: This case concerns a 73-year-old female with a serious unexpected event of urinary retention, and non-serious unexpected dyschezia, abdominal pain, weight decreased and insomnia. Event onset with unknown latency after second 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 73-year-old female with a serious unexpected event of urinary retention, and nonserious unexpected dyschezia, abdominal pain, weight decreased and insomnia. Event onset with unknown latency after second 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.

1. Bulging veins appeared the day following first vaccination. From inside the left nostril onto the upper lip. on right temple above end of eye brow and between hair line, legs, behind the right knee. Behind the left knew were several large clots. 1.a. Had vein work done from November 2020 to January 2021. Clots had disappeared. 1.b. Feb. 27, 2021 clot on right temple was "in" or on top of area treated. There was pain that lasted for three days. 1.c. Told primary care doctor and saw Vein Doctor. Then there was not much concern about clots. 2. Eyes: 02/26/2021 through 02/27/2021 shooting pains around and through the eyes. Started right after vaccination. 3. Two bulging painful masses Center of forehead right and left of center of nose. 4. Lega and feet swelled 5. Toes: 03/03 toes separated and cramped on feet. Each foot two toes went left stuck together and two went right. 6. Feet 03/03/21 sore spots on top of feet. Pain made it hard to walk. Pain extended toward and over ankles and wrapped around heel.. I use a walker 7. Dizzy when looking down, shortness of breath. Contacted cardiology 8. Belching and air bubbles originating in the chest area 9. Sleep: Slept almost around the clock for first 5 days. 10. Very thirsty even after drinking water 11. Urinated more than usual. some burning. Reported to doctor. 12. Vaginal etching and dryness for 2 weeks 13. Joint Dryness; All joints but very painful and extra dry rough feeling in right hip. For 3 days 14. Stubbled when waling March 11, 12, 13, and 14 2021 15. Mind and body not working to

Patient received 2nd dose of the COVID-19 vaccine on 2/10/21 and was considered fully vaccinated two weeks later on 2/24/21. On 6/10/21 patient was hospitalized with a possible upper GI bleed. Overnight the patient began to have increased oxygen needs and crackles on auscultation. She was transferred to the ICU, had an abnormal chest x-ray, and tested PCR positive for COVID-19. The patient had acute kidney failure and respiratory failure with a DNR and DNI. She expired on 6/11/21.

Passed out-was totally out for a couple of second; UTI; PVCs; very very dizzy; Vasovagal reaction; Arm was sore-not hurting much; A spontaneous report was received from a 74-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced dizziness, passed out, vasovagal reaction, urinary tract infection, premature ventricular contractions and arm pain. The patient's medical history included back problems with osteoarthritis in the spinal column neck and lower back. Products known to have been used by the patient, within two weeks prior to the event, included celecoxib and nortriptyline. On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient reported she got very dizzy and passed out. Her husband relays that she was totally out for a couple of seconds. She went to the emergency room and was diagnosed with a vasovagal reaction and urinary tract infection. Premature ventricular contractions were also discovered and was not known prior to this event. Patient reports a normal blood pressure of 114-120/75. Patient also stated her arm was sore the day after vaccine but not hurting much during her usual four mile walk. Treatment for the event included intravenous medications in the emergency room, cephalexin, and a heart monitor. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events passed out, dizziness, vasovagal reaction and arm pain were resolved. The outcome of the events, urinary tract infection and premature ventricular contractions were unknown.; Reporter's Comments: This case concerns a 74 year-old, female patient, who experienced events of dizziness, passed out, vasovagal reaction, urinary tract infection, premature ventricular contractions and arm pain. The events occurred the next day after the first and last dose of mRNA-1273 vaccine administration. Based on the current limited available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded and the events are assessed as possibly related. Further information have been requested.

Patient complained of incontinence and knee pain the day following vaccine administration. Patient stated she drank lots of water the night after receiving the vaccine. Patient also has history of prior knee replacement surgery. Pain lasted for a day and a half following the administration of the vaccine/.

Admitted to hospital in acute kidney and liver failure. Pre-existing conditions but not advanced. Only change in routine was vaccine. Still in hospital trying to diagnose cause and get organs functioning correctly.

passed out; urinated on herself; could not sleep; chills; fever; A spontaneous report was received from a consumer concerning a 74 year old female patient who received Moderna's COVID-19 vaccine and experienced loss of consciousness, chills, pyrexia, urinary incontinence and insomnia. The patient's medical history was not provided. Concomitant medication included unspecified blood pressure medications. On an unspecified date, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection. On 02-Feb-2021 the patient received the second of their planned doses of mRNA-1273 (Lot number 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 02-Feb-2020, the patient experienced chills, some fever, and could not sleep. On the morning of 03-Feb-2021, the patient passed out twice and urinated on herself. No treatment information was provided. Action taken with the mRNA-1273 in response to the events was not applicable. The outcome of the events of loss of consciousness, chills, pyrexia, urinary incontinence and insomnia were was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.

morning after vaccination urine had a strong odor that smelled like bacon. I don't eat bacon and had not had anything unusual to eat. urine was paler than usual during rest of day but returned to normal the following morning. Also experienced the common soreness at injection site, tiredness, aches--like a mild flu. All reaction disappeared by third day following vaccination

I broke out in a rash on face and legs, had extremely severe headaches, one day of incontinence, 2 days of heart palpitations and shortness of breath. Also, I ate some peanuts and my throat swelled up. This is the FIRST TIME I have ever had a rash, incontinence, net allergy, or shortness of breath.

Weak, tired, cold, nausea, off balance, migraine headache, eye pain, blurry vision, foggy brain, face pain, trigeminal neuralgia, neck and face hot and red, sweating and shaking, threw up like acid, insomnia, frequent urination, diarrhea.

Body felt hot but no fever, like my blood was hot in my veins, blood sugar 147, pluse 144, arm very painful, felt weak, urinated about every 1/2 hr. felt a little nauseous, the next day didn?t want to eat, left lymph node felt like a golf ball Right now my right lymph node hurts a little during the day and night

Vomiting, body aches, weakness, confusion, headache urinating frequently, fever 101.1 entire day following vaccine. Took Tylenol alternating with ibuprofens

pt states that the next day she had low grade fever, fatigue, nausea and malaise. Pt had incontinence, diarrhea and fever never broke. Pt contacted her PCP and he suggested she may have Covid so she got tested. The results were negative. Pt ended up getting worse so contacted her PCP and she was told to the ER hospital to get labs drawn, test for Covid again which was negative. Fever was 102.3. Chest XRAY showed she Pneumonia. Pt was admitted to hospital where she was given antibiotics and fluids. She went into respiratory failure and her Pneumonia turned into bilateral infection. She was unable eat and diarrhea. After 5th day her fever broke and was released on the 6th day. She was on O2 for two weeks after going home. On 3/8/2021 Pt is better now but still tired.

Fever of 101.5 Soreness in arm Slept throughout day Had trouble standing. Slid off couch and couldn?t get up. Had to get help getting up. Happened only once.. Was incontinent many times.

weakness started at 9:00-9:30 pm, she said she started having trouble standing up to go to the bathroom. ?hit me like a ton of bricks?. she was able to get back in bed and sleep but she called me at midnight saying she was stuck half on and half off the bed. she was having difficulty sitting up, had tried to get up and got stuck diagonally half on and half off of her bed. her heart rate was 110, but she said that?s not unusual for her. she was sweaty, possibly had a fever, and said she had thrown up. she was having trouble holding her bladder, which she said she usually is able to make it to the bathroom but couldn?t last night. this morning she tried to get up and her feet couldn?t support her and she went down to her knees and got stuck until we got help to get het back up. this morning she is still nauseous, weak, and has a bad headache

Intense chills, racing heart for 8 to 10 hours, nausea, headache, fatigue, general malaise (urinated on the bathroom floor).

Approximately 3-4 days after her first immunization, patient became ill. She contacted our triage line 6 days after immunization with report of chills and weakness. She presented to Medical Center Emergency Room where she was admitted for hypoxia. She was subsequently diagnosed with COVID by PCR. She developed respiratory failure, worsening kidney failure necessitating dialysis, c diff colitis, GI bleed, and acute heart failure. Despite maximal efforts by the ICU/hospitalist team and specialists her conditioned worsened. She was made comfort care and died on 2.26.21

Experienced complete Loss of bladder control, twice, 5pm and within a couple hours after that. There was no indication of urgency for either event. Assessed for UTI, negative.

Late Saturday afternoon starting not feeling well. Sunday didn't feel good , cold and then I started coughing, asthma, and none of my usual meds helped. Late evening Sunday the fever broke, but not the coughing and this continued until Thursday morning. I have a massage therapist friend that thought she could help the lymphatic system with a massage and it did. I saw her again Saturday morning and the cough stopped. Sunday afternoon started a UTI infection and had to get antibiotics on Thursday and still have to get more since it didn't clear up. In the meantime my whole body ached and when I went to the dentist my BP was elevated. 4/2 I felt the worst of all the days since the shot. On the 3rd started feeling better and yesterday my BP was good and just took it and it up again, but hadn't been elevated prior to the shot. In fact I felt fairly well prior to the shot. Based on how I've felt since the shot I'm electing not to take the 2nd shot.

3/8: Admitted to hospital dx chest pain; 3/9 transferred to a different hospital, dx gallbladder necrosis. Hospital course: 74 y.o. female admitted on 4/8/2021 for abdominal pain. Notable PMHx: aortic valve replacement, HTN On morning of admission, patient woke up with severe epigastric pain. Describes pain as a pressure. Has had vomiting. Had bowel movement after pain started. Patient came to the emergency room. Patient received an antiemetic and Demerol. Patient has continued to have pain in got a dose of morphine as well. Pain eased some but was still 7/10. In the ER, blood pressure was very elevated with systolic in 200s. Cardiac enzymes negative. EKG look good with normal sinus rhythm. Patient has aortic valve replacement and is on Coumadin with INR goal of 2.5-3.5. INR was elevated at 4.3. D-dimer was negative. Amylase and lipase negative. Creatinine normal at 0.9. Chest x-ray done which showed no acute disease. On the floor, we ordered a CT abdomen. It did show gallstones, but nonobstructing. It showed kidney stones in the renal pelvis, but none obstructing. No other inflammation or signs of bleeding. Blood pressure came down after medicines in the ER. Did have some lower blood pressures through the afternoon evening which was felt to be a combination of blood pressure low in medicines in the ER and pain medication. From 11:00 p.m. onward blood pressures were controlled. Patient continued to have severe abdominal pain. Hemoglobin down to 9.0 from prior 12.4 yesterday. Creatinine up from 0.9 yesterday to 1.8. White count up from 8.3 yesterday to 14.4. INR from 4.3 yesterday to 4.2. Coumadin was held yesterday. CT abdomen was repeated. CT abdomen was read as worrisome for necrotic gallbladder and small bile leak Contacted transfer line at hospital. Surgery accepted and wanted transfer to go through the ER. Patient has PCN allergy. Surgery said that if reaction was not severe, they wanted Invanz given before she left. Patient says that she had a itching rash in the 70s. No trouble breathing or swallowing. No other reaction. Dose of Invanz ordered. IVF were increased. HPI from hospital: 74 y.o. female who presents with Chief Complaint Patient presents with? Abnormal Scan Patient presents via EMS as a medical transfer from hospital after having gallbladder necrosis seen on CT imaging. She was given IV Invanz there. General surgeon was contacted by that facility and he accepted the patient for transfer to this facility. Apparently, the patient began having abdominal pain yesterday. Timing of onset was gradual. Severity is rated as severe at maximum intensity. Quality is described as aching abdominal pain. Symptoms have been improved after IV pain medicine. Symptoms worsen with nothing, and improve with IV pain medicine. History was provided by patient, EMS, transfer paperwork and EMR, and I spoke with treating doctor in general surgery who accepted the patient for transfer.

Patient started having some low-grade chills and aches around 3/2/21. Her first COVID-19 vaccine was received on 3/1/21, so she was originally attributing these symptoms to the vaccine. She has had some diarrhea. Mild headache, muscle aches. However, she started to develop some dyspnea on exertion and mild cough that is nonproductive. When she realized her sister was having symptoms of COVID and tested positive and she had had some mild exposures to her, she realizes she might have active COVID infection and was tested positivity on 3/6. She has had poor appetite and poor oral intake compared to average. On 3/12, she became weak, fatigued, having diarrhea, and a difficult time urinating, advised to ED by PCP. So, patient was admitted for COVID-19 pneumonitis on 3/12. Received dexamethasone 3/12 to 3/21. Discharged home on 3/19/21 with supplemental oxygen.

Confusion 6 days after shot. Within a week lost ability to walk, became urinary incontinent. Major chest congestion, slept all the time. Rushed by ambulance at day 12.. Diagnosed with pneumonia amd uti. Cardiac arrest at day 14, never woke up. Taken off life support 3/20/21.

Tightness in chest about 5 hours after the shot. Over the following few days the condition escalated to breathlessness and moderate intermittent chest pain (I have no previous history of respiratory issues. I couldn't run or walk up stairs or a slight grade without getting out of breath. I sought medical attention on 4/27/2021. The Dr. heard wheezing and chest sounds for which he prescribed Flovet. I have never taken an inhaler before this time. Concurrent with the shortness of breath, I had a urinary infection. I have not had one in at least 30 years. I was prescribed Sulfamethoxazole, and took two rounds. I had a second positiveurinalysis, and prescribed Ciprofloxacin HCLon 04/29/2021.

Pt had dose 1 Moderna on 5/3 within 24 hours had back pain and urinary incontinence unable to ambulate. Hospitalized overnight.

Since receiving the first dose of the Moderna until the present day, and yet unresolved, I have suffered daily headaches, bladder infections, lethargy, and periodic muscle aches.

J18.9 - Pneumonia, unspecified organism N17.9 - Acute kidney failure, unspecified D69.6 - Thrombocytopenia, unspecified

Right side of her body was paralyzed, couldn't move; Couldn't feel her face; Urinated herself; This spontaneous case was reported by a consumer and describes the occurrence of HEMIPLEGIA (Right side of her body was paralyzed, couldn't move) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, the patient experienced HEMIPLEGIA (Right side of her body was paralyzed, couldn't move) (seriousness criterion medically significant), HYPOAESTHESIA (Couldn't feel her face) and URINARY INCONTINENCE (Urinated herself). At the time of the report, HEMIPLEGIA (Right side of her body was paralyzed, couldn't move), HYPOAESTHESIA (Couldn't feel her face) and URINARY INCONTINENCE (Urinated herself) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Blood pressure measurement: normal (normal) normal. On 13-May-2021, Body temperature: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The caller thought her mother was experiencing a stroke. They denied any numbness, fever, coughing and lethargy. No medications were taken for the symptoms and no concomitant medications were provided. The second dose of the vaccine is scheduled for 12-Jun-2021. Company comment: Very limited information regarding this event has been provided at this time.; Sender's Comments: Very limited information regarding this event has been provided at this time.

HEARD NOISES, HAD HALLUCINATIONS, AND HAD HEADACHES PATIENT CURRENTLY HAD A UTI AND WAS EXPERIENCING SYMPTOMS FROM IT.

May 18 I received my first Covid Moderna Vaccination. 4 hours later when I went to urinate there was blood on the toilet paper. It only lasted about 3-4 minutes. 2 hours after that I went to the bathroom again to urinate and it burned really bad. I called my doctor and was able to see her the next morning ( May 19) She sent my urine in for a culture and it came back as a Urinary Tract Infection. She treated me with Cipro for 3 days. She felt that I should see my GYN regarding the bleeding and felt that it is Post Menopausal Bleeding. I saw my GYN on June 7. She did a Pap Smear and it came back normal but it showed that I have a Bacterial Vaginitis infection and treated me with Metronidazole Vaginal Gel for 5 days. Today June 14 is my last day for that. But when I went to the bathroom to urinate there was some blood again on the toilet paper. I don't know if all this is a coincidence or if this is a reaction to the vaccination. My doctor doesn't think it is a reaction but I want to make sure since I was fine till I was vaccinated. I am concerned because I had no sign of the bleeding or the burning before I got the vaccination. I am also concerned because my next vaccination is tomorrow June 15. If I don't get the second one then is the 1st one not going to be valid. If I do get the second one could I have a worse problem with bleeding and UTI? Due to the bleeding I have to have a vaginal ultrasound and depending on the results I might have to have an endometrial biopsy.

I went to the emergency room with kidney stones and they discovered a liver mass. The doctors put me on nausea and pain medication. Lomax to help pass the stones and an antibiotic. I was referred to a Urologist for follow up for an MRI to evaluate my liver.

moderate stomach pain, night of March 15, then by March 18 Emergency visit for severa stomach pain. Tenderness increasing on right side of waist. Incorrectly diagnosed as UTI. Next visit on Sunday, March 21, diagnosed with shingles.

U07.1 - COVID-19 J12.82 - Pneumonia due to coronavirus disease 2019 N17.9 - Acute kidney failure, unspecified

Patient presented to the ED and was subsequently hospitalized for hyperkalemia and renal failure within 6 weeks of receiving COVID vaccination.

I began feeling achy around 4:00 PM. It progressed to chills, headache, burning eyes, fever. My fever was 103.2 when I went to bed at midnight. Between 9:00 PM and midnight I also had difficulty with bladder control. I slept 12 hours and today I fell 100%.

Around 4:00 PM I started feeling achy. As the evening progressed I had chills, burning eyes, aches, fever. I was also having bladder control issues. When I went to bed at midnight my temperature was 103.2. I slept 12 hours and today I am 100%. No symptoms.

She developed symptoms of headache, malaise, and UTI 48 hours following vaccination and then continued developed worsening fatigue, shakiness, and weakness which is ongoing to date, now three weeks following vaccination and successful treatment of UTI.

Had no reaction to 1st dose of Moderna COVID vaccine 1/6/2021. 2nd dose Moderna COVID vaccine 2/4/2021 had no immediate reaction but developed fever and fatigue that lasted 36 hr 1 d after vaccination. On 2/7 had redness and local swelling at site of injection. Next day 2/8 rash on chest then broke out face, neck , abdomen, back. Was seen in local ER where she was diagnosed with an allergic reaction to the vaccine. Treated Solumedrol, Toradol, lorazepam, Benadryl and Pepcid and dishcarged with Rx for Prednisone and advised to continue Benadryl and Pepcid. Rash worsened, became purple and morbilliform on face, arms, legs, back and abdomen over next 3 d. Was seen by PCP on 2/11. Prednisone increased to 40 mg x 3 d. Rash improved with this and was resolving by the time I examined her on 2/15/2021. Face was beginning to peel but had no mucosal surface involvement.

My mother, the patient, received the shot at 3:00 pm on a Wednesday. By 3:00 am Thursday morning, my mother became very weak and was unable to walk to the bathroom. She needed to be carried. The next morning she was very weak and needed to be dressed. She was also very subdued and "loopy". She ate breakfast and hearty bean soup for lunch, but by 4:00 pm Thursday she became nauseous and was running a low fever around 99. We gave her a NyQuil dose which she quickly vomited. From there she continued to vomit and her temperature went up. When she needed to use the restroom, I escorted her, but by the time we reached that area she could not follow instructions to sit down and was holding onto the door jamb. She had soiled herself while standing there. Eventually I was able to get her to sit down and was able to clean her up and change her clothes. But she could not follow instructions to stand up. With a second caregiver, we were able to get her to stand up, but within three steps of the toilet her knees buckled and she was unable to stand. We sat her in a walker with a seat and rechecked her temperature. It had gone up to 103. At this time, we considered calling 911, but instead we put a cool cloth on the back of her neck and monitored her (with three people all standing round). After a while we were able to move her back to the family room where she insisted upon sitting on the couch. She was able to stand up from the walker and move a few steps to the couch. By 10 pm she was starting to drift off to sleep sitting up and her temperature was back down around 99. When we were putting her to bed, she had no memory of where the clothes had come from or why she was not in her original outfit. Following that she slept and did not have another worrisome episode. She did complain of her arm hurting for several days and that it was itchy at the injection site. I did not observe any swelling or rashes on her.

During the night following the vaccination, I experienced chills, aches, loss of bladder control and extreme fatigue the following day. I have since had interim dizziness and rapid heart rate. My left arm is slightly swollen, red and sore.

On the evening after her second dose she experienced disorientation, vomiting, incontinence, confusion. Symptoms persisted for days and she lay prostrate in bed. Comes to the office 6 days later, oriented x 5 but 24/30(prior mini-cog 4/5), mild elevation of LFTs and platelet clumping.

Patient admitted for nausea and vomiting as well as acute cystitis. Pt was treated with IVF, antiemetics, and antibiotics. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

Office visit - NP Chief Complaint: seen today, 3/4/2021, complaining of or following up for Fever (started today), Nausea (has nausea today), Abdominal Pain (c\o upper and lower abd pain has been constant for the last 3 days started on monday), Diarrhea (states she had diarrhea all day yesterday but has had no bm today), and Fatigue (pt states she is feeling very week today) . HPI Patient comes in to the office complaining of severe abdominal pain. States the pain started on Monday and was less severe, stating the pain has escalated to a 9/10 today and "unbearable." Pt. States she had diarrhea for a 24 hour period yesterday, but denies any bowel movement today. Patient also complains of severe fatigue and states nausea with emesis a "few times over the last 4 days." Patient states that on Tuesday her pain became "a little better," but states since that time it has worsened and is severe at approximately 1230 this morning." Patient states she did not go to the ER because she "knew she had an appointment today." BP 134/84 Pulse 104 Temp 101.6 °F (38.7 °C) Resp 20 SpO2 94% Abdominal: General: There is distension. Palpations: Abdomen is rigid. Tenderness: There is generalized abdominal tenderness. There is guarding and rebound. Comments: Tinkling bowel sounds noted to RLQ and RUQ with hypoactive bowel sounds to LUQ and LLQ. Abdomen is rigid and guarding and rebound pain are noted with examination. triaged to Emergency room: HPI 75 y.o. female who presents with complaints of right upper quadrant pain since Monday reports is moderate to severe sharp better right upper quadrant without radiation better with rest and worse with movement FINAL IMPRESSION ICD-10-CM ICD-9-CM 1. Calculus of gallbladder and bile duct with acute cholecystitis without obstruction K80.62 574.60 2. Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (HCC) A41.9 038.9 995.91 Final Disposition Transfer to Another Facility current inpatient at Hospital

extreme dizziness during the night; drop in blood pressure--Mon., 3/1, 7 a.m. 73/45 (67); 3/9, dizziness, 10 a.m. 79/44(74). This is very unusual for me. Until I was dizzy & checked my blood pressure on March 1, I didn't attribute the drop in Bp to the vaccine. But then I recalled the dizziness I experienced the night following the vaccine.

After painful hospital overnight visit was found also to have shingles. Following week went back to emergency room in same hospital for severe shingles pain

Night following shot, I slept badly and felt cold all night. When I wanted to get up to go to the bathroom around 5:30 AM, I could not get myself off and out of the bed. It was like my legs wouldn't work. When I was finally up, I had no control of my bladder and urinated all the way into my bathroom. When I was done on the toilet, I started to stand up and lost my balance. I tried to reach for the door jam but missed and fell backwards onto the toilet and sat hard and hit my back very hard against the top of the toilet. I helped back to bed by boyfriend but had to get up several more times that morning and had the same weakness in my legs and no control over my bladder. My boyfriend had to leave to go home, so I called my sister to come and stay with me in case I couldn't get up again. One she was here, I ate a small amount of roast chicken and slept most of the afternoon. I slept thru the night and felt stronger the next day. I felt very tired and sleepy for the next couple of days, but (3 days later) am now feeling and moving in a more normal manner.

Urinary tract infection; Allergy (anaphylaxis) to levofloxacin; Hives; Difficult breathing; Felt awful; Sluggish; Light-headed; A spontaneous report was received from a consumer concerning herself, a 75-year-old female patient, who received 2 doses of Moderna's COVID-19 vaccine (mRNA-1273) and experienced allergy (anaphylaxis) to levofloxacin (anaphylactic reaction), hives (urticaria), difficult breathing (dyspnoea), felt awful (feeling abnormal), sluggish, and light-headed (dizziness). The patient's medical history, as provided by the reporter included urinary tract infection (UTI).Medications included levofloxacin and nitrofurantoin to treat urinary tract infection. On 19 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 010M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 05 Mar 2021, the patient took levofloxacin 500mg to treat urinary tract infection (UTI). Soon thereafter patient had a severe allergic reaction to levofloxacin. Treatment included Emergency Room drug-induced anaphylaxis treatment.Later Patient took nitrofurantoin for 5 days for the UTI and developed events sluggish, and light-headed hives,felt awful and difficult breathing. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event, allergy (anaphylaxis) to levofloxacin was resolved on 05 Mar 2021. The outcome of the event, hives, difficult breathing, felt awful, sluggish, and light-headed, were unknown.; Reporter's Comments: This case concerns a 75 Y/O F who had NS unexpected urinary tract infection and serious unexpected anaphylactic reaction with NS unexpected urticaria, dyspnea, dizziness, feeling abnormal, sluggish. Anaphylaxis on Day 18 after first dose mRNA-1273 was considered possibly related to levofloxacin for UTI. Anaphylaxis resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient presented to ED on 3/27/21 with 3 day history of weakness and diarrhea. COVID test was positive following 1st COVID vaccination. Patient diagnosed with diverticulitis with secondary cystitis. Patient was treated with antibiotics, steroids, oxygen, and remdesivir. Patient recovered and discharge to home.

kidney failure; not feeling well; shaking; pale; weak; headache; 101.5F fever; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (kidney failure) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Kidney failure on 14-Apr-2021. On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 14-Apr-2021, the patient experienced RENAL FAILURE (kidney failure) (seriousness criterion medically significant), MALAISE (not feeling well), TREMOR (shaking), PALLOR (pale), ASTHENIA (weak), HEADACHE (headache) and PYREXIA (101.5F fever). At the time of the report, RENAL FAILURE (kidney failure), MALAISE (not feeling well), TREMOR (shaking), PALLOR (pale), ASTHENIA (weak), HEADACHE (headache) and PYREXIA (101.5F fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5f (High) 101.5F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 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. Reporter did not allow further contact

Within one hour, urge to urinate frequently. Painful urination followed and increased. Tolerated until seeing PA on morning of 3/12/2021. PA identified blood in urine and prescribed Notrofurantoin Mono/Mac, 100 mg capsules, 1/day for 7 days. Infection cured.

always had normal kidney functions lab normals for EGFR; greater than 59ml/min, lab normals for creatine 0.57-1.00 . routine EGFR done 12/20/2020 67ML/min prior to 1st moderna. creatine 0.86 2/25/2021 5 days after second Moderna dose EGFR 56 ML/min, creatine .99 Repeat EGFR 5/21/2021 56 ML/min, creatine .99 may be permanent damage to kidneys

Pt presented to acute care on 5/21/21 following 2 weeks of SOB, intermittent low grade fever and fatigue. Labs and chest XR ordered. Diagnosed with UTI and placed on Omnicef 300 mg BID x 7 days. Follow up in clinic on 5/24/21 for continuation of symptoms: SOB, intermittent low grade fever/chills, dry cough. Pt prescribed albuterol and labs ordered. Follow up in clinic on 5/26/21 for ongoing SOB, intermittent low grade fever, dry cough, anemia, abnormal liver function. Ordered ECG 12 lead and sent to emergency department. Admitted to hospital 5/26/21 : During hospitalization patient was diuresed with Bumex, she put out a net of approximately 2.4 L and then developed an AKI suggestive of intravascular depletion. Diuretics were stopped, confirmed that BNP down trended and was within normal range. Patient had negative troponins throughout hospitalization. Her free T4 and TSH was within normal limits. She had mild electrolyte disturbances secondary to diuretics which were replaced. She had a respiratory viral panel completed, did not identify any source. Patient is Covid negative. ANA and ANCA screen were sent out unfortunately they will be delayed. #SVT: Patient went into an SVT rate of 150 required adenosine which showed underlying sinus rhythm. Started on amiodarone drip briefly which did help maintain sinus rhythm although she had hypotension with that. Cardiology was consulted during hospitalization. Despite SVT troponins remain negative. TSH and free T4 within normal limits. #Acute on chronic combined systolic and diastolic heart failure #Suspected viral cardiomyopathy #Acute respiratory failure with hypoxia Patient remains with good saturation off oxygen. She is net -2.0 L from diuresis. Weight is down approximately 4.4 kg. Started on metoprolol, unfortunately due to hypotension had to decrease the dose to 25 mg daily. Aspirin 81 mg daily was provided. Currently holding diuretics but may need to be reassessed for restarting this in the future. ANA and ANCA pending. #Leukocytosis #Increase inflammatory markers #Sepsis with organ dysfunction No clear-cut source of infection but she did have pyuria with leukocyte esterase. She could also have had atypical pneumonia. The concern is that patient could have an underlying inflammatory process versus autoimmune process contributing to it end organ damage. At this point I cannot tell so started empiric treatment with ceftriaxone during hospitalization, complete 5 of 7 days course as well as 3 of 3 days of azithromycin. Despite this leukocyte continues to be elevated and inflammatory markers continue to be elevated. #Hypertension: Patient was briefly hypotensive in setting of amiodarone, metoprolol continue to 25 mg after discontinuation of amiodarone. Will need to be retitrate to goal-directed therapy. #Hypothyroid: TSH and free T4 within normal limits given the tachycardia holding levothyroxine for 5 days #Suspected UTI Day 5 of 7 of ceftriaxone currently, initially had 50?100 WBCs positive for pyuria, leukocyte esterase positive no bacteria seen. #Atypical pneumonia suspected: Completed 3 days of azithromycin #Elevated LFTs #Elevated alk phos: Unclear as to potential source other than congestive hepatopathy LFTs normalized alk phos downtrending #Anemia of chronic disease: Possible viral syndrome unclear etiology at this point. There may be some underlying iron deficiency. No indication for transfusion during this hospitalization. Patient remained on sodium restricted 2 g daily, and 2 L of fluid restriction diet. She is a full code and enoxaparin was used for DVT prophylaxis. Hospital transfer today, 6/2/2021 to St. Michaels with no clear unifying diagnosis. Maybe a pericarditis: Patient continues to have ST changes on EKG, elevated inflammatory markers, significant JVD, evidence of heart failure on echocardiogram, after speaking with cardiology will likely need a right heart cath

Tied & in bed by 6pm that same evening. Second day concussion, third day, throwing up, not feeling well at all. Called on call nurse twice in this 3 day period & they said to go to ER within an hour. She had an underlying UTI hospital said & her body was working ?overtime? with vaccine & UTI. Still was sick for another 2-3 weeks. Took to dr several times to check. Second vaccine - tired, body aches. Has slept much, much more since vaccine. Seems confused & just not THE SAME! Went to hospital 6/3/21 by ambulance because she wasn?t feeling well - throwing up yellow bile, extremely clammy (sweating), confused, bp when ambulance got to her, 89/60. ER can every test - urine, blood, cat scan, stroke, heart attack. NOTHING. Came back all normal. A mystery. This is 5 months since first vaccine.