Moderna

Patient received COVID-19 vaccine at assisted living facility. Had myalgia symptoms from 01/08/21-01/21/21. Has resolved since.

Fever, fatigue, headache, muscle pain, chills, pain at the injection site. Still have some side effects 6 days later. Sleep for 10 to 13 hours each night. Totally exhausted.

About 8pm I began t experience total body itching. At 11pm the itching was too much to allow for sleep. I took two Gabapintin 300mg. At 4AM I went to sleep. I contactedmy dermatologist. He suggested the vaccine may have started a Grover's response. He asked that I add Zyrtec (over the counter) to my meds. He asked that I continue hydrating my skin with Vanicream cream. I folllowed his advice. The itching stopped on Sunday. I continued with the Zyrtec but stopped the Gabapintin. Today, Tuesday, I am having muscle tightening, especially in my legs.

Patient Began experiencing shakiness, tremor, feeling of ?rush? approximately 15 minutes after the vaccination. He was immediately assessed by EMS crew. Blood pressure 156/72 initially. Pulse is 64, respirations 20. He said he had a tight feeling in the neck and felt flushed. Oxygen saturation was 99%. Patient was given 25 mg oral Benadryl after five minutes of symptoms. He continued to be monitored. His symptoms improved mildly, But he continued to complain of a rush like sensation. It was recommended that the patient be transported to the hospital for at least six hours of monitoring. The patient declined and signed an AMA form. Patient monitored for a total of 45 minutes before allowed to be escorted out of the building with his wife, with instructions to present to the ER mediately if any symptoms worsen or did not improve within the next five hours.

Unable to use legs, extreme pain on both hip joints, nausea, very sore left arm, very weak left arm, needed assistance in and out of bed

Pain in left shoulder, Sleeping for hours, Out of control shakes and chills, Hot face. High blood pressure, Temp 98.2

Days 1-3: flushed, temp of 99-100, extreme pain in joints and muscles, dizziness, weakness, elevated blood sugar (400s), elevated blood pressure, couldn't stay awake. Treated with OTC cold/flu meds, no appetite~ Days 4-13 same plus wheezing cough, difficulty catching breath, difficulty talking, difficulty comprehension, focus, etc. Low oxygen level. Went to the ER on Day 8 with all of the above. Given oxygen and IV (of what another person had--as was my understanding), prescriptions: Promethazine-DM;methylPREDNISolone; albuterol;azithromycin. Currently--still difficulty breathing, coughing, difficulty focus, very weak. Treatment: walking, lots of water, cough syrup and albuterol

I began having chills, a low-grade fever, sore muscles and soreness at the point of injection at 9 PM on the day of the injection. All of the symptoms except soreness at the point of the injection wore off at about 6 AM the following day. The soreness at the point of injection wore off later the following day.

day after vaccination pt experiencing leg severe muscle pains, pt is not able to move much without using a walking stick, and has to have assistance to get around

Moderna COVID-19 vaccine EUA General side effects : fatigue, headache, muscle aches and pain, and chills.

Muscle and joint aches, shot site ache, headache, chills, fatigue, no appetite Treating with Tylenol. No abatement yet (9 hours later)

fever, muscle and joint pain, significant high fever, severe sinus headache, exhaustion. Symptoms started about six hours after injection. I had a significant fever that lasted for 18 hours. The first night I was unable to sleep because the body soreness and pain would not allow me to get comfortable. I started taking Tylenol shortly after the symptoms started but it did little to mitigate the symptoms during the first 24 hours. By the end second day following vaccination, symptoms were beginning to subside. On the morning of the third day, I pretty much back to normal.

this morning, 2/11/ 21 was fatigued., then had dizziness when gettin up to urinate, had fever 101.8 , gave him 2 tylenol both shoulders hurting ( he has had some shoulder ache in right shoulder for some time)

Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized, Systemic: Fever, Systemic: Joint Pain

Beginning 1/24/21 - legs began feeling heavy- unsteady gait - weakness - stiffness - confusion . Parkinson meds appears to be no longer working- symptoms worse.

About 1:35 am I was experiencing acid reflux, I prepared some alka-seltzer. As I was beginning to drink it I started to feel faint, My legs started to give out, my glass dropped into the sink, and a was flat on my back on the floor. I got up and went to bed. As I lay there uncovered I began to perspire, but that soon stopped. After 10 minutes I pulled the sheet over me and 30 minutes later I pulled the blanket over me. At about 2:30 am I was feeling normal except for the reflux. I took a full dose of alka-seltzer and have had no more problems since then. I believe the acid reflux was from eating and drinking wine that evening. I don't know of the fainting was from the vaccine or a touch of flu for one hour.

Patient called 2/17/2021 to report he had a very stiff arm (unable to lift arm) and arm was very painful after injection 2/16/2021. Patient took acetaminophen through the night and arm was still stiff and sore morning of 2/17/2021. He required assistance doing his farm chores/work.

Patient woke up Tuesday 2/16/2021, 2 days after vaccine, and had aches in all his joints plus noticeable swelling in Left Knee and Left Wrist. Left side is where his vaccine was injected.

Injection site sore for two days, joints ached for two days, slightly elevated fever for two days, reduced energy for three days

1. Intestinal upset and no appetite. Re-flux, Stomach Ache, excessive gas in stomach and colon. 2. Muscle and joint aches strong enough to remain in bed or a chair "attempting Not to move" 3. Momentary and random loss of balance in excess of normal events in both severity and frequency

Had postponed quarterly steroid shot for inflammatory arthritis and stopped Celebrex 500 mg BID three days prior to shot to maximize response to vaccine. On fourth day following vaccine, woke to terrible arthritis pain in left shoulder and across back and chest. Pain continues to present but helped some by tramadol 50 mg . Not sure if it was vaccine related or if stopping anti-inflamatory meds allowed arthritis pain to resurface. Have scheduled shoulder replacement.

First 24 hours had cold feet, cold hands sleepy hands and chills ..very fatigued, Within the next 6-hours developed fever---slight fever of 101 that was taken care of with Tylenol. Muscle- aches and slight redness at area of injection. After 48 Hours felt a lot better. No fever--nothing!

Fever, achy all over, arm and shoulder pain, other pain consistent with joint inflammation, fatigue, headache. Concerning event was chest pain in the center and of my chest and a bit to each side.

pneumonia; Tired; Achy; Muscle weakness in left arm; Arm was swollen; This spontaneous report was received on 10FEB2021 from a consumer which refers to a 76-year-old male patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced injection arm swelling, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and pneumonia. The patient's medical history was not provided. Concomitant medications were not reported. On 15JAN2021, prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 intramuscularly (Lot number: 026L20A). On 16JAN2021, the patient noted a start date for Pneumonia. On 10FEB2021, the patient called the medical information call center and reported, "he is on antibiotics for pneumonia. His 2nd question is can he delay the 2nd dose since he is suffering from pneumonia. Patient was administered 1st dose of vaccine on 15/Jan/2021 in his left non dominant arm. The lot# was provided, but expiration date is unknown. Patient experienced some expected side effects, which he is not concerned about". The event(s) were arm swollen, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and tested positive for pneumonia 1 day after receiving the vaccine. The action taken for Moderna COVID-19 (mRNA-1273) Vaccine was reported by the patient as Tylenol. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the events of fatigue, arm swelling, myalgia, muscle weakness, a causal relationship cannot be excluded. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Pneumonia is assessed as unlikely related. Further information has been requested.

Flu like without fever. Extreme ache overall; Extreme muscle weakness, joint ache/pain, headache, labored breathing, eyesight slightly blurred, arthritis pain increased.

Pt developed severe fevers, myalgias, headache, inability to take PO day after vaccine, developed significant AKI and required hospitalization - overnight observation. Was hospitalized 2/23 - 2/24 and had resolution of symptoms, improvement in AKI and was stable for discharge home.

weight loss, muscle weakness, abnormal crp level and liver test, loss of appetite, bed bound, falls, and unable to get up from floor. unable to make meals, dependent on care giver for food meals

stiffness soreness across both shoulders, shoulder blades and base of neck - started about six hours after injection but worsened in bed overnight. Began to ease off after 26 hours. Awakened 20 hours after shot with sense of lassitude, sluggish thinking - like the drowsiness an antihistamine may cause. Just felt strange almost not really present in the moment sensation. This is still still ongoing after 30 hours but easing off significantly. no fevers, chills, myalgias or flu feeling. no local swelling or redness at injection site. This odd feeling did not interfere with daily 10000 step walk. Feel much improved after exercise.

Patient states 10 days after his first injection, he experienced sore arm, muscle/joint aches and diarrhea x 3 days, and went to the ER.

Starting afternoon after vaccine, extreme fatigue, sore muscles, achy, fever 100%, oxygen level lower than norm (95%). No appetite.

Stiff neck with pain, also pain top of right shoulder down into middle-right of upper back more acute when turning head to the right or left. This appeared early the day after receiving the first Moderna Covid-19 vaccine shot and continues today, although maybe less pain but still the stiffness. This is occurring into the fifth day after the shot.

The morning after the second Covid 19 shot I woke up with soar joints, fatique,. dizzy. Throughout the day chills, then hot, no energy.

Approximately two weeks after receiving my first dose of the vaccine, I started experiencing upper body bilateral joint pain, primarily in shoulders and wrists. This pain has continued since then for approximately six weeks now. In addition, my right arm, hand, and fingers are swollen, and the tips of my fingers on the right hand feel slightly numb. I have been taking acetaminophen, ibuprofen, and naproxen, but still have the symptoms described above.

Developed a real stiff neck above the left arm, above the vaccine location. Don't know if it's related to the vaccine, or not.

3 - 4 hours after dose ( Dose approx 1030 am reaction 2-230 pm) Light headed then dizzy blood pressure dropped to As low as 85 over 48 then appeared to have a small seizure and passed out. He recovered before ambulance arrived and blood pressure returned to 112 over 68. Then higher when EMT took it after arrival. Today (1day later) he has a bit of a sore neck and is still a little tired. Blood pressure 133 over 70 which is slightly higher than is normal.

Moderna COVID-19 Vaccine EUA 3-March to 7-March: sore left arm, then later sore neck, chills, aches all over body and general blahs. Took Tylenol Extra Strength 500 MG as needed 8-March to 15 March : forehead and left side of upper face swollen, red and slightly itch . I Put some Polysporin ointment on and it seemed to help a little. Called my doctors office on 12-March, they these symptoms were due to the Moderna shot and that I should ride it out until they went away.

The first three day I felt achy all over, if the afternoon felt chilled. My right arm was sore to movement ,like triceps/bicep area. It was very sore when I moved them. I did have a stiff lower back, sore when I get up and down. I did see my PCP and she put me on a topical cream and arthritis medication, but doesn't believe it's related to the vaccine. It seems like it's getting better, but I will make a move and will hurt again.

7 hr after receiving 2nd Moderna vaccine, developed pain in shoulder without redness or swelling. Eval by physician 3/11/2021 and prescribed Diclofenac gel 1% appy to affected area 3 times/day. He has used it for 5 days with no improvement. He is contacting his physician for f/u today.

Moderate pain in joints over 3 week period. Pain in fingers, shoulders, elbows, wrists, Jaws, .... 2nd Moderna shot, one week of joint pain

Significant muscle pain starting in the upper right chest and then migrating to the left side about day 4. Sharp, stabbing pain occurred when moving affected muscles, especially after being in lying position.

Patient reported swelling of left hand and forearm started 2 days after vaccination. Was evaluated by PCP on 3/11/21. Noted swelling left hand, wrist, forearm. few small areas of patchy erythema. u/s negative for DVT. inflammatory markers elevated, uric acid elevated. Given prednisone burst and taper with some improvement in symptoms, but not full resolution. Seen by rheumatology on 3/24/21 with broad differential and plan to monitor/close f/u. recommended against second vaccine dose for now.

Patient and caregiver report redness 7" x 4" around site, hardness, heat to left deltoid with tenderness that developed 3/18 accompanied with low appetite, muscle weakness, and fatigue. Arm symptoms were reported on 3/22 and improving by 3/23. Other symptoms reported on 3/23. They report that on 3/23 symptoms were still present but starting to improve.

Patient developed chest pain at 0500 on 3/26. He took 3 doses of Nitro without relief, mildly diaphoretic, left scapula pain. Emergency responders were called. EMTs performed EKG in ambulance and reported AFib. He arrived at hospital, and symptoms resolved prior to exam. EKG, Troponin checked twice, and patient discharge to home with recommendation to return if symptoms recur and to f/u with Cardiology.

Pt diagnosed with COVID-19 despite 2 COVID vaccines (first given 1/15/2021. Pt developed respiratory symptoms, including dyspnea, which progressed over 3.5 weeks and then systemic symptoms of myalgias, malaise. He was admitted 3/21/2021 and had positive NP swab for SARS-CoV-2 x 2. He required admission to ICU and died of respiratory failure on 3/28/2021.

Soft tissue infection; Still having problems using his arm; Elbow was huge and swollen, moved up towards the injection site; Rendered elbow immobile; A spontaneous report was received from a consumer (patient), concerning himself, a 76 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced soft tissue infection, knot under the skin below the elbow which has increased in size (soft tissue swelling), elbow was huge and swollen, moved up towards the injection site (joint swelling), still having problems using his arm (vaccination site movement impairment), area under his elbow was huge and swollen/moved towards injection site (joint swelling), and rendered elbow immobile (joint disorder). The patient's medical history was not reported. Concomitant medications reported were unspecified blood thinners, unknown medications for heart and high blood pressure. On 27 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscular in upper right arm for prophylaxis of COVID-19 infection. The consumer stated that the events started from 30 Jan 2021. He noticed a knot under the skin below his elbow. The patient stated that he rubbed alcohol on the injection site in the spot on his elbow to see if it would help. The next morning, on 31 Jan 2021, the area under his elbow has increased in size, was huge and swollen, rendered elbow muscle. It had moved up towards the injection site and was about five inches long by two-three inches long. The consumer stated that he had met with urgent care via video and they think that it could be in the lymph nodes. The consumer stated that the doctor wrote him a prescription for an antibiotic to treat a soft tissue infection, but he has not picked it up yet. The consumer stated he was still having problems using his arm. Treatment medications included was ibuprofen, acetaminophen, alcohol, ice packs and hot packs. Action taken with second dose of mRNA-1273 in response to the events was unknown. The outcome of events, soft tissue infection, knot under the skin below the elbow which has increased in size, elbow was huge and swollen, moved up towards the injection site, still having problems using his arm, area under his elbow was huge and swollen/moved towards injection site, and rendered elbow immobile were considered as not resolved.; 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.

a couple of days after the shot, I started getting muscle pain, a fever and chills that would come & go and headache with nausea. On april 8th, after lunch I had to lay down on the floor because I thought I was going to pass out. After about ten minutes & breaking out in a sweat, I was ok.On saturday the 10th, I sat down for supper & could only eat a few bites before I thought I was going to throw up.

Per patient and spouse: 2nd dose of Moderna received on 04/01/2021. (This facility does not have record of administration). Patient seen in ED 4/11 after 5 days of bilateral lower extremity weakness, gait problems and numbness. Patient admitted and evaluated. Neurology consulted and on 04/13/2021 diagnosed with likely acute inflammatory demyelinating polyradiculoneuropathic form of Guillain-Barre syndrome.

Lethargy, widespread muscle soreness, nausea lasting 4 days. Signs slightly less severe each day until at day 5 (today) almost normal

STARTING ON THE THIRD WEEK: SEVERE PERPETUAL LEFT-SIDE HEADACHE WITH LEFT BRAIN MODERATE CONTRACTION. NOT SURE AT FIRST BECAUSE OF SLEEPLESSNESS PROBLEM. OVER THE COUNTER COMBO TYLENOL IBUPROFEN ASPIRIN, THEN ADVIL, NOTHING WORKS AS BEFORE AFTER SEVERAL ATTEMPS OVER SEVERAL DAYS. THEN OUT OF THE BLUE WHILE SITTING TWISTING MY BACK TO CHANGE POSTURE, SUDDEN SHARP PAIN AROUND THE WAIST ON THE BACK NEEDING HELP TO WALK UP TO LIE DOWN WHICH USUALLY WILL RECOVER SOON, BUT NOT THIS TIME. TRIED THAI ASAIN BALM[CREAM] RUBBING ON THE BACK WAIST PAIN AREA AND USUALLY THE BALM'S MEDICINAL HERBS SMELL WILL FILL THE AIR AROUND THE BODY, BREATHING IN THE BALM AROMA USUALLY HELP FASTEN THE RECOVERY, SOMEHOW ALL ACHE/PAIN JUST STOP. SOMEHOW PERHAPS COINCIDENTLY ALL ACHE/PAIN JUST STOP FOR SEVERAL HOURS, SO DID NOT THINK IT WAS FROM THE VACCINE. AT THE END OF THE THIRD WEEK HEADACHE CAME BACK THOUGH NOT SEVERE WITH MILD BRAIN CONTRACTION THIS TIME UNTIL NOW THE FOURTH WEEK APRIL 19, 2021 AND SEEM PERPETUAL AS NO PAIN MEDICINE CAN CURE IT, JUST REDUCE THE PAIN A BIT. THAT IS WHEN I THINK IT IS FROM THE SIDE-EFFECT OF THE VACCINE, HENCE THIS REPORT. THE SECOND SHOT WILL BE THIS SATURDAY APRIL 24,2021; SHOULD I DO THE 2ND VACCINATION? TASTE, SMELL NORMAL THROUGHOUT WITH MILD FEVER, NO ACCURATE THERMOMETER AT HOME, STILL SLEEPLESSNESS EVEN INCREASE DUE TO THE HEADACHE WITH FEW MINUTES SLEEP DURATION IN BETWEEN HERE AND THERE THROUGH DAY AND NIGHT. BY THE END OF THIS WRITING HEADACHE REDUCED MUCH MORE AND DO HOUSE CHORES FINE.

About 2 or 3 days after the second Moderna shot, I developed painful joints/muscles in my shoulders and hip joints

Leg swelling and discomfort. Saw primary care provider who thought this was varicose veins and referred to vascular surgery. Venous duplex revealed DVT involving left leg. Patient treated with at least six months of apixaban.

I have pain in my knees, hips and shoulders. I also have pain in my legs and some time have cramping. I usually walk 2-3 miles per day and my legs never relax. They remain tight at all times. I have pain in my legs when sitting and arising from a chair. The aforementioned joints ache in bed to the point that I have to roll over constantly because of pain caused by pressure. I have tried to stretch daily to loosen the muscles and joints to no avail. I never had any of these problems before. I recognize that the symptoms arose a month after my 2nd shot. After the first dose, 2/8/2021, i had leg fatigue on the forth day only. The next day I had no symptoms and none until 4/10/2021.

48 hours after 2nd COVID injection, severe shortness of breath. Unable to perform any activity, including getting dressed , walking from room to room any physical activity without sitting or lying down to catch a breath. Also during this time experienced chills, body aches, muscle weakness.

SHIVERS, SHAKES, hot forehead, cold sweats, dizzyness, unbalance, mussel weakness, joint weakness, flu-like symptoms, bed-ridden, for 2 days,

All the classic systems of PMR . Doctors at the Urgent Care diagnosis was PMR and I was called into The Medical Center, and the Doctor also said it was PMR at which time she put me on Prednisone.

Patient presented to hospital evening of 1/27/21 with acute onset weakness and buckling of knees, admitted to medicine service and neurology consulted. Patient diagnosed with acute motor axonal neuropathy, a variant of Guillain Barre Syndrome. Patient received IVIG 1/28-1/31. Despite IVIG treatment, patient with progressive worsening of motor weakness, resulting in diaphragmatic weakness requiring intubation on 1/29. Patient has remained ventilator dependent and is now s/p tracheostomy.

pt states his right leg had pain and tightness from the inner thigh to the knee. It was painful to touch. Pt went to his PCP Dr. on 2/22/2021. He had blood work and ordered a sonogram for legs to check for blood clot. He was told to use a topical cream Voltaren which did not help. The sonogram showed that he had multiple blood clots on this inside of this leg down to his calf and was prescribed Xarelto. The blood clots disappeared after a couple of weeks.

Arthritis symptoms in both knees. Pain is excruciating, to the point patient remained in bed for over 3 days. Patient had a phone appointment with his family Dr. Dr was asked if the symptoms could be related to the vaccine, as he has never had such excruciating pain in his knees. He also has pain in most of his joints. The worst being his knees and shoulders.

SEVERE joint pain......both shoulders, knees, hips, ankle, hand, SR joint inhibiting movement & causing extreme pain. ongoing till May 26 , 2021 still ongoing, after 3 months, but improving with methylprednisolone

MRI of brain showed I had two strokes, one recent and one older; Difficulty walking/limp; Numbness; Stumbling; Weird feeling; Left leg was very weak; Arm weak feels heavy/left arm felt heavy; Episode of vertigo with difficulty walking; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stroke. Concurrent medical conditions included Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 26-Mar-2021, the patient experienced VERTIGO (Episode of vertigo with difficulty walking). On 18-Apr-2021, the patient experienced LIMB DISCOMFORT (Arm weak feels heavy/left arm felt heavy) and MUSCULAR WEAKNESS (Left leg was very weak). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older) (seriousness criterion medically significant), GAIT INABILITY (Difficulty walking/limp), HYPOAESTHESIA (Numbness), GAIT DISTURBANCE (Stumbling) and FEELING ABNORMAL (Weird feeling). The patient was treated with Physical therapy (Prescribed balance exercise) for Vertigo. At the time of the report, CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older), VERTIGO (Episode of vertigo with difficulty walking), GAIT INABILITY (Difficulty walking/limp), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Arm weak feels heavy/left arm felt heavy), GAIT DISTURBANCE (Stumbling), FEELING ABNORMAL (Weird feeling) and MUSCULAR WEAKNESS (Left leg was very weak) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Cardiac monitoring: normal (normal) normal- no AF. On 22-Apr-2021, Echocardiogram: normal (normal) normal. On 22-Apr-2021, Magnetic resonance imaging head: abnormal (abnormal) Showed two strokes. On 22-Apr-2021, Ultrasound Doppler: abnormal (abnormal) Showed two strokes. Treatment information were not provided. Action taken with mRNA-1273 in response to the event was not applicable. 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.

within days the pain and weaknesses that were reported to be common became far worse and long lasting (now in my seventh week), affecting my neck, head, shoulders and legs, especially my quads. I could not turn my head left or right, I had pain shooting up the backsides of my neck into my head, had head pain, shoulder muscles pain, and severe leg pains. I initially was told by my doctor that it would go away, and it hasn't, although not as severe now in my neck or shoulders, and I have more, but limited neck turning movement. My legs are i terrible shape and cause me a LOT of pain, for which I went a couple of weeks ago to an Urgent Care place, who said I need to go to a specialist, but recommended I try taking a NASID for two weeks first regularly, to see what happens. I am nearing the end of that period, having taken ALEVE twice a day. It has helped cut down on the pain, but the basic problems still persist. I feel like I have aged 10 or more years, although I had been healthy and vigorous before taking the 2nd Moderna shot, and I am expecting that the "doctors" do not know how to handle this. I am frightened.

The day after receiving the second dose he was working outside and after coming inside he started complaining of pain in his lower back and legs. He said the pain was not consistent at first. It would come and go. Over the next few weeks it progressively got worst. The pain had increased making it hard for him to walk, sit on lay to sleep. On 4/2 he went to the ER at Hospital because the pain was very bad. He was treated with IV muscle relaxers and steroids. He as discharged with diclodenac, methocarbamol and prednisone for Radicular pain. He has progressively gotten worst as he has lost over 50 pounds. He recently visited the ER at second Hospital where an extra showed diffusers increase bone density. He was discharged with 600mg IBprofen , Dexamethasone and prednisone. He continues to get worst. He is now hardly eating and in pain all the time. He is week and have trouble walking

Started feeling stiffness and pain in arms and legs. Then pain and stiffness moved throughout the body rendering almost immobile. As of June 13, 2021 has not fully recovered and is still under a doctors care. Diagnosed with Polymyalgia Rheymatica.

Seven weeks after the first dose I began to feel unwell. One week later I had fallen down the night before. I felt like my legs were very weak. My wife noticed that I was hallucinating. We went to Urgent Care and my D Dimer was high as well as my blood pressure. I had a slight fever. I was hospitalized on 05/26/2021. I was diagnosed with Pneumonia,, Community Acquired and ended up being hospitalized for 12 days. My blood pressure was hard to control and my hospitalization was extended. I had fluid in my Lungs. During the stay, I had bleeding in my stomach. It has been eight weeks and I have lost 24 lbs and my Stomach is still upset. I am still receiving Home Health Care.

'lost feeling of the left side'; still has some shingles; laid on his floor and went to sleep/passed out for 2 hours; got a stroke within 9 hours; got really tired; a small clot in the right side; lost feeling of the left side, couldn't walk, and couldn't do anything; lost control of his bladder/urinated in his pants; left arm went numb; the muscle was sore for about a week; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours), LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours), THROMBOSIS (a small clot in the right side) and HEMIPARESIS ('lost feeling of the left side') in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Injury, Back surgery, Gallbladder operation, Heart valve replacement and Heart valve disorders. Concomitant products included METHYLSULFONYLMETHANE (MSM 1000) for Joint disorder, CHONDROITIN SULFATE SODIUM, GELATINE HYDROLYSATE, GLUCOSAMINE SULFATE, HYALURONIC ACID (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GELATINE HYDROLYSATE;GLUCOSAMINE SULFATE;HYALURONIC ACID]), CALCIUM, ZINC, COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], COLECALCIFEROL (VITAMIN D3), LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), VITAMIN E NOS, VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;COLECALCIFEROL;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] and FISH OIL (FISH OIL OMEGA 3) for an unknown indication. On 10-Jun-2021 at 5:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced HYPOAESTHESIA (left arm went numb) and MYALGIA (the muscle was sore for about a week). On 11-Jun-2021, the patient experienced THROMBOSIS (a small clot in the right side) (seriousness criterion medically significant), GAIT INABILITY (lost feeling of the left side, couldn't walk, and couldn't do anything), URINARY INCONTINENCE (lost control of his bladder/urinated in his pants) and FATIGUE (got really tired). On 11-Jun-2021 at 2:00 AM, the patient experienced CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours) (seriousness criterion medically significant). On 11-Jun-2021 at 3:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours) (seriousness criterion medically significant). On 22-Jun-2021, the patient experienced HERPES ZOSTER (still has some shingles). On an unknown date, the patient experienced HEMIPARESIS ('lost feeling of the left side') (seriousness criterion medically significant). The patient was treated with GABAPENTIN at a dose of 100 mg three times a day and LORAZEPAM at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours), LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours), THROMBOSIS (a small clot in the right side), HEMIPARESIS ('lost feeling of the left side'), HERPES ZOSTER (still has some shingles), GAIT INABILITY (lost feeling of the left side, couldn't walk, and couldn't do anything), URINARY INCONTINENCE (lost control of his bladder/urinated in his pants), HYPOAESTHESIA (left arm went numb), MYALGIA (the muscle was sore for about a week) and FATIGUE (got really tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: didn't find anything wrong (Inconclusive) didn't find anything wrong and patient mentioned the small clot in the right side.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 72 hours after receiving the first dose of the Moderna COVID-19 vaccine, the patient got shingles. He still had some shingles, and stated "it is leaving but still numbness in a belt from the stomach center to the back of the left side, front side is well, and back is numb". He was taking Gabapentin 100 mg three times a day for the shingles, which was the only prescription medication he was currently taking then. He was also prescribed pain medicine for the shingles which he no longer took as the pain had left. One of the pain medications is lorazepam. The patient received the second dose, and he stated his left arm went numb. The injection was in the top part of the shoulder, and it did not hurt up there, but the muscle was sore for about a week. In addition, the patient stated he "got a stroke within 9 hours" at 2AM on 11 Jun 2021 and lost feeling of the left side, couldn't walk, and couldn't do anything. He went to the bathroom and lost control of his bladder. He urinated in his pants and got really tired, so he laid on his floor and went to sleep at 3AM. He also described this as "passed out for 2 hours". At 5AM in the morning, he woke up and was fine. He went to the doctor on 18 Jun 2021, who told him that he had a TIS or a small stroke. The MRI didn't find anything wrong, and patient mentioned the small clot in the right side. He was never hospitalized. Prior medical history included spine injury, 2 back surgeries, gallbladder surgery, an artificial valve in his heart, and a clogged aortic valve in the patient's heart. He has taken vitamins and supplements daily for the past 20 years. 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. This case was linked to MOD-2021-231546 (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.

2nd moderna vaccine given 7/12, that night developed some mild low back pain. The next morning the pain was more severe and associated with left leg pain (throbbing). He developed a rash as well (purpura with some bulla) on the buttocks which then traveled down his leg and into the left foot (not painful/pruritic). No fever, chills or other adverse SE.

Right elbow swole vup to two to three times its normal size. Both feet swole up and was so sensitive I could not touch the floor or stand. Was hospitalized for a total of eleven days.

not much sore ness from the shot at all. on the 1-11-2021 I felt a little flue like symptoms. head ace, low temp 97degres, aches in shoulders, small lymph node under left arm solen , I went to bed and the next morning it was gone. Tonight I feel a little of the aches. not bad but wanted you to know. Im ready for the next shot on the 1-28-2021.

Don't know if these are adverse events -- they are described in take home information as "General side effects:" Chills, headache, joint ache, muscle ache, extreme fatigue -- lasted about 36 hours. No treatment required other than ibuprofen and sleep (lots of the latter).

Moderna COVID-19 Vaccine EUA Weakness in knees which lasted approximately 2 to 3 seconds. Almost feel before sitting down

Felt well until later that night of the vaccination, Saturday. About 11 pm I began to have chills, fever, shoulder and back muscle pain and vomited. Slept through the night and felt relatively well the next day. Sunday, felt extremely fatigued but slept well. Monday felt better, less fatigued but at 4pm came down with the chills for 2 hours and then fever up to 102.7 and muscle pain in my hip muscles. Have been drinking electrolytes and water dur to vomiting. Tuesday awoke with minimal muscle pain and only 99.2 fever. Currently feel better had light breakfast and lunch and temperature is 98.9.

Moderna COVID-19 Vaccine EUA First Maderna COVID vaccine No Symptoms at all Second Maderna COVID vaccine on Monday Monday: 12 hours after: Headache Some soreness at injection site Could not sleep at all that night Muscle, joint soreness Chills Tuesday Headache Fever Muscle ache Nausea, little appetite Lethargy Napped in the afternoon for a few hours Could not sleep that night. Took 2 Advil at 10:30pm, then slept Wednesday Felt normal on awaking. No headache A few sweats, so probably some fever. Thursday Normal in every way.

Swelling and pain in arm for several days. About 1 week after the vaccination, I developed chills, headache, muscle aches,fatigue, swelling of the knees and difficulty walking. I began to improve after 2 days, but recovery was slow.

chills Narrative: When patient presented for covid vaccine dose #2, patient reported the day after covid vaccine dose #1 patient experienced extreme headaches, muscle aches and chills. Patient did not report taking any treatment medications.

Excruciating pain in shoulder . First night was unbearable. Still hurts after three days. Also had flue like condition for about thirty hours. I noticed that the injection was inserted in the top of my shoulder and not on the side. The injection hurt more than any shot I have ever had, and I have had many. I don't know if my shoulder pain was caused by the way the needle was inserted of because of some reaction. I am in excellent health and have the long term covid antibodies.

By 1:30 am on 2/4/2021; patient was shaking uncontrollably. This continued about 1 1/2 hrs. then he could not get out of bed to go to the bathroom; thus wetting himself multiple times during the night; Patient was restless for about 5 hrs. but still could not get up even with me (his spouse) trying to help. He also could not understand how to help move his body to keep from falling out of bed (never fell out but I could not get his entire body on the bed until our daughter arrived around 9:30 am. It took our grandson who is 6'5" tall & 275 lbs. to help get patient up and walked him into our sunroon. throughout the day, patient could not stand without help & continued to urinate on himself. He could, however, feed himself breakfast & lunch. At 7:30 pm grandson and daughter had to walk patient into bedroom. patient could not walk without us telling him how and pushing his feet forward. It took both grandson and daughter to pull him onto the bed as he collapsed when he got to the bed. Patient slept until approximately midnight. at that time our daughter helped him to the bathroom and helped to change his underwear and tshirt which was wet from having a fever. Afterward, patient was able to go to the bathroom by himself but was very tired. He was able to walk outside with the help of a cane on 2/5/21 2 pm. On 2/6/21, patient complained of his back hurting and itching. We discovered he had shingles! Not a full body rash but shingles on his left side around his waist.

Two days after administration, patient developed pain in his neck similar to "kink" in his neck. Used topical Lidocaine. Has not helped. The "kink" in his neck continues until the date of this report 2/8/2021.

Shoulder joint pain, Swelling at various places near injection site, upper arm, and shoulder Neck pain and tightness

HEADACHES, ACHY BODY AND JOINTS, UNCONTROLABLE CHILLS AND SHAKING, ELEVATED BODY TEMPERATURES. SIDE EFFECTS HAVE PERSISTED FOR 6 DAYS

I had my (Moderna) first dose yesterday. Within ~6 hour the soreness level of the shoulder joint (but not especially the site of the jab) zoomed up to intense. So much so, that simply lifting my arm slow-motion to the level of my eyes caused intense pain spasms. Last night and this morning were equally severe. Within the last hour or so, the pain level has diminished a bit. NOTE: I know how people rate pain is super subjective. In my case working as a geologist in a quarry a number of years ago, I was struck and pinned by a large boulder. The ER crew would not give me a pain killer, so that they could monitor how the Jaw of Life was working (it broke, the boulder was too heavy), so I not surprisingly passed out several times from the pain level before being extricated. Needless to say, this compound fracture of the tibia and fibula accident was a 10 of 10 pain level. Yesterday's CV-19 jab pain level was an 8-9 of 10. Nothing I read before yesterday's jab, Fauci et al, prepared me for this pain level. So, is this normal??? My POV is, I think, atypical in this matter of pain. Should I be concerned about a return to normalcy right now (today / tomorrow) as well as for the second dose?? I HOPE THAT A MEDICAL PERSON WILL RESPOND TO THIS EMAIL - NOT SOME BOILER PLATE WORDS. If you want more details, feel free to phone me

RN gave IM injection too high on the arm resulting in severe pain and immobility x 5 days. Patient felt pain very soon after injection and circled the needle mark of the injection site. Patient reported to public health department on day 6 after injection to ask if this was an expected reaction after a vaccine or if it was because the injection was too high. The location that the patient marked was indeed over the shoulder and not in the deltoid muscle. The RN who gave the injection has not done patient care in 20+years. The injection was co-signed by public health department staff. Patient reports that on day 6 the pain had decreased a small amount and that strength is returning to his hand.

Morning after, left leg was partially paralized, for about 20 minutes. Left elbow was same way except didn't last but about 5 minutes. Under front of nose there was a weird sensation that lasted until the second day. Felt like something was messing with nose but nothing was there that could be seen. Now this is day 8 and there is swelling abouve my left ankle probably about 2 inches up. The leg and elbow and nose seem to be ok. I don't think I want to take vaccine #2 because of these effects that happened.

1/28/21 - 9 pm nasal stuffiness/congestion; 1/29/21 - 2 am low grade fever 100.2; continued symptoms of malaise, weakness and joint soreness; around 12 pm increased lethargy, weakness unable to get up from chair - needed to use wheelchair. Difficulty breathing - pulse ox 87-90%. Dipped to 85% twice. Most symptoms including SOB resolved within 6-7 hours.

Headache, Chills, Hot Flashes, Fatigue, Nauseous, Muscle and joint pain. No Fever. These symptoms have continued with no improvement for approx 20 hours since injection.

Patient reports at least two falls following COVID vaccine. Requiring assistance to stand up. Legs reported as "giving out" resulting in falls. Reports being shaking within 24 hours following vaccination. Reports extreme weakness and needing to be lowered to the floor at least twice. This is new for him. Did not report feeling dizzy; blood sugar was reported as normal during the time. No confusion or feeling out of it reported at the time. Ended up with abrasions. Patient has been having bilateral leg weakness since Friday evening, patient had Covid-19 vaccine on Thursday. Wife called Sunday at 0130 after 2nd episode of leg weakness and fall (see previous note). His first fall was Friday evening around 2030. Saturday his wife reports that he was walking on his own without his walker but did have complaints of fatigue and decreased appetite, which she attributed to his Covid-19 vaccine. Sunday morning at 0130 was his second fall, an ambulance was called and patient refused ED after being assisted by EMS. Patient did not have any dizziness or syncope, just states that his legs were too weak and gave out. Wife states that patient has improved today, is using his walker and walking without difficulty. Yesterday she states that she pushed food and fluids due to decreased urine output. Urine output has returned to normal last night and today, appetite and fatigue have also improved. Assessment 1. Fall from standing, initial encounter 2. Multiple abrasions 3. Adverse effect of vaccine, initial encounter 4. Generalized weakness PT EVAL AND TREAT 5. Decreased strength, endurance, and mobility PT EVAL AND TREAT I suspect his falls and weakness are due to Covid-19 vaccine reaction. I think he has more baseline weakness than he realizes- recommended PHYSICAL THERAPY for strengthening and he agrees- already planning to see them for shoulder pain. Feeling better overall today. Recommended getting up every 2 hours to walk around, use walker for now. Call if more falls or continued extreme weakness.

Pt presented on 2/22/21 reporting right sharp and stinging arm and shoulder pain for 3-4 days. Pain was worse with touch/pressure. On 2/21/21 he developed a lesion on his shoulder. Provider found 2 vesicular lesions concerning for shingles. She started pt on gabapentin an valcyclovir and will follow up as needed.

1/23/21 First shot: sore arm only. 2/20/21 Second shot in afternoon. By evening, fever 102.8 (then took Tylenol and fever reduced to 101). Fever, nausea, severe leg pain, moderate low back pain, severe fatigue. 2/21 morning through evening: 101 to 102, nausea, fatigue. 2/22 fatigue, temp 100 to 101. 2/23 fatigue, low temp 99.0.

Moderna COVID-19 Vaccine EUA. Several hours later develop sweats, feeling hot and cold, felt like a fever but temperature was normal, severe muscle and joint pains, unable to sleep, very tired next two days. Most symptoms have resolved although joint pains persist.

morning after vaccine woke up with the worse headache and left are soreness. The following morning headache and body aches from the hips and both legs. In the following days pain got progressively worse until it was very difficult to walk. After a week of this the pain settled into my left hip. On the 9th day of pain and difficulty walking went to see my PCP. Treated me for bursitis of the left hip with a steroid injection to the left hip joint. Pain has gotten better but still painful. The vaccine was given at Urgent Care. Post vaccine visit was with PCP

Increasing severe lower back pain - ache all the time - difficult to walk as of a week after shot - -putting topical relief measures to no avail . continued to get worse - as of 2/12 - could not walk without crutches . went to E. R. on 2/13/21 in ambulance - could not walk - could not get up out of a chair at all .... tests done - said severe inflamation in lower back - arthritis - inflamed - - disc impacted .The patient had no symptoms of this condition prior to the vaccine . normal walking - driving , going up and down stairs just fine before vaccine .

2/24/2021 admitted to hospital with hypoxia, lethargy, rash, altered mental status with HA. Altered mental status with HA, could be due to metabolic encephalopathy and reaction to COVID-19 vaccine. Will check ABG, CT head. Hold gabapentin. Check depakote level. Rash, likely due to allergic reaction to COVID-19 vaccine, hx of reaction to first COVID-19 vaccine with fever needing hospitalization. Start patient on Solu-Medrol and Pepcid. Benadryl p.r.n. Suspected right lower extremity cellulitis, start patient on Ancef. Check MRSA, will rule out right DVT Abn CXR, Bilateral LE edema, CXR seems stable to me, clinically no pneumonia. He does not have "hypoxia" when I was in room, however assisted living reporte 2/24/2021 admitted to hospital with hypoxia, lethargy, rash, altered mental status with HA. Altered mental status with HA, could be due to metabolic encephalopathy and reaction to COVID-19 vaccine. Will check ABG, CT head. Hold gabapentin. Check depakote level. Rash, likely due to allergic reaction to COVID-19 vaccine, hx of reaction to first COVID-19 vaccine with fever needing hospitalization. Start patient on Solu-Medrol and Pepcid. Benadryl p.r.n. Suspected right lower extremity cellulitis, start patient on Ancef. Check MRSA, will rule out right DVT Abn CXR, Bilateral LE edema, CXR seems stable to me, clinically no pneumonia. He does not have "hypoxia" when I was in room, however assisted living reported he was hypoxic this AM, wife said he was wheezy on Sunday could be due to acute on chronic diastolic congestive heart failure, IV Lasix x1. reeval in AM. Echo TTE is pending Abdominal pain and distension, CT abdomen without contrast to rule out other etiology that can cause altered mental status Hx of COVID-19 pneumonia, history of CVA with dense right hemiplegia and expressive aphasia, chronic atrial fibrillation, depression, Will reorder home meds after pharmacist reconciles medication list Generalized weakness, PT/OT DVT prophylaxis warfarin and SCD

On 2/24/21 woke up around 10 AM due to the need to urinate. He was rigid (straight as a board) and unable to sit up in bed and barely able to move. After about 30 minutes he was able to sit up, stand and walk with a walker and assistance. generally has difficulty walking, but the concern was the rigidity and inability to bend for such a long period of time. After that he seems to be the same as he was prior to the vaccine. Also, on 2/22/21 shortly after getting his vaccine he had a tremor in his hand (not sure which one) which stopped shortly after getting the vaccine.

felt like crap; became hot; left hand suddenly started jerking and left hand was having spasms; Vasovagal Syncope, Post Immunization Reaction; became cold; sweaty; sore arm; achy; A spontaneous report was received from a consumer concerning a 77-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vasovagal syncope, post immunization reaction (syncope vasovagal). The patient's medical history, as provided by the reporter, included chronic cough, acid reflux, minor allergies, hypercholesterolemia and a penicillin allergy. Concomitant product use included esomeprazole, atorvastatin, famotidine, cetirizine, Montelukast, Vitamin D, zinc, fiber pills and antacids. On 10 Feb 2021, several hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #:030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. After the injection in the evening on 10 Feb 2021, the patient reported experiencing a sore arm. During the night, he became cold, sweaty and achy. On 11 Feb 2021, the patient stated he "felt like crud" and was still achy and his left arm hurt more. The patient sat down at the table and again became "hot" and "sweaty." His left hand suddenly started jerking and having spasms, and the patient's head went back and then forward and he became unresponsive for approximately 2 to 3 minutes. After the episode, he went to a sofa chair and fell asleep for 1 to 1.5 hours. The patient's wife called a nurse at the Hospital to report the events, and the nurse suggested to take him to the emergency room (ER) immediately. At the ER, a series of tests/labs were performed including complete blood count (CBC) differential with platelets, COVID-19 test, cardiac panel-acute, comprehensive metabolic panel, electrocardiogram (EKG), and chest x-ray. All test results were normal. The patient's COVID-19 test was negative. Treatment for the event included IV fluids (sodium chloride IV). The patient was discharged from the ER 2 to 3 hours after treatment with a discharge diagnosis of "vasovagal syncope, post immunization reaction." The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The event, vasovagal syncope, post immunization reaction, was considered recovered/resolved.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events, a causal relationship cannot be excluded.

Starting about 5 or 6 hours after the injection I became extremely tired and that persists through today, 7 days later. At times, I found even a small exertion like walking up a couple of flights of stairs to be exhausting. At times my head felt buzzy, although I haven't had a fever. At times I also felt fine but then would relapse. My sleep has also been erratic, although not very good normally. Arthritic joints are more painful.

Very sore left arm, About 9 hours after injection began to feel cold, shaky, leg muscle ache and increasing temperature.

Patient states that a day after having the vaccine, he developed severe stiffness in his hips and shoulders, muscle aches, had a headache on and off, chills, felt tired, had night sweats, lost his appetite, and taste was off. There symptoms lasted 10-12 days. He was tested for Covid 19 on 2/28 with an antigen test and was negative and tested again on 3/2 with a PCR and was negative . He is starting to feel better now. Called his physician who felt that these symptoms were due to the vaccine, encouraged him to go ahead and get second dose.

He received the vaccine and after 2 hours he went home and was paralyzed from the waist down. He tried to stand up and then he passed out on the floor for about 10-15 minutes. He went to sleep and woke up around 5 hours later. He then tried it again and urinated on himself and he fell down on the floor, passed out without getting up until the morning. He did call his doctor who was not available, spoke to the nurse and advised to go to the hospital. He is weak and cannot drive so he did not go to the hospital. He slept the rest of that day and the following day. Then when he saw his doctor about 2 days ago, he described his reaction and told to report the reaction and that he would report it himself. He was advised not to take the 2nd vaccination. He is no longer having the heavy reaction, his muscles are aching and his vision is blurred, especially on his back and the shoulder. His doctor did do blood work at the office visit.

Moderna COVID-19 Vaccine EUA Soreness at the injection site. Fever (101). Stiffness and pain in every joint in my body. Duration 24 hours.

After receiving the Moderna COVID-19 Vaccine EUA, my left arm from shoulder to wrist became very sore the next evening. It was very sore for about one week. The soreness gradually dissipated over the next week, but then began to get worse over several days. Beginning the third week after this dose, the soreness is mainly in my shoulder.

The day after vaccination (4March21) pt. slept all day, and had the chills. Got up next morning (5March21) feeling better. By noon felt lethargic and slept the remainder of day. He experienced incontinence while sleeping. He had trouble walking, and could not make it to the bathroom without support. While in the bathroom he went to the floor, (did not fall), could not get up. I had him crawl on his hands and knees to the living room. It's a though his muscles went soft. Remained lethargic the remainder of the day. Did not see a doctor. Stayed at home and waited for symptoms to pass.

Moderna COVID-19 Vaccine Around 8 hours after the shot, my left shoulder started to hur, when I raised my arm. Over the next few hours I grew more tired than usual with a very low-level, generalized ache. I went to sleep at 11. I woke up at 2 in quite a bit of generalized pain, left shoulder so painful I could not lie on my left side, unable to get comfortable in any position, feeling worse and worse. At 2:30 I got up, which immediately made me feel a bit better. I took an acetominophen, a half codeine acetominophen #3, and around 5 ml promethazine/codeine syrup. At around 4:00 I had some cheese and bread. At around 4:30 I was able to go back to sleep. I got up at 8:30, still achy/hurting, but distinctly better. I am writing this at 11 a.m. One other thing to note: after the shot I seemed to be having a very odd, mild allergic reaction intermittently, when I ate some foods that I eat every day. Mostly it was a case of my hard palate itching.

Severe Chills Fever Full body ache - joints/muscles Lost Balance - fell twice Incoherent Confusion ulcers in mouth and on tongue Swollen lips no strength - could not stand up on my own dehydration

patient reported that he started to experiance: vomiting, diarrhea, difficulty breathing, muscle sorness, difficulty swallowing, and headache on 03/03/2021 @2230.. patient reported that today 03/07/2021 he is doing fine and all his symptoms are getting better.

Had muscle and joint pain and low fever for 2 days after vaccination. Stayed in bed. 4 days after vaccination a bubble the size of 3/4 of a golf ball popped up on the tip of my left elbow, Olecranon Bursitis. The pain was minimal but I could not put the elbow on a table or the arm of a chair without sudden pain. Bubble stayed the same for 4 weeks and then slowly went down over 10 days. Elbow is still sore when hit or put on a table. Got vaccinated 2nd time in the right arm on 02/22/2021. Right knee started hurting after 4 days. Could only walk by keeping the leg straight. Went away as suddenly as it came after 4 days.

Malaise, muscle & joint aches, brain fog, unusual memory lapses, night sweats...the issues have been experienced since evening of the 2nd vaccination...the only side effects after 1st vaccination was a sore left arm.

Pt received the vaccine with no side effects for approximately 36 hours. He woke up on the second day after the vaccination with intense pain in his knee. He was unable to bend the knee and was barely able to walk.

At this point I am going to give you an account of my past 14 months health and how I know it is related to the covid virus. i am sure i have had long covid from december 2019 or january 2020 to the present based on symptoms i incurred on these dates. On my first night I ended up vomiting my guts out at 2:00 in the am. The following 2 weeks I had constant diarrhea. At the end of those 2 weeks, i ended up in emergency room. And this all happening when i haven't' vomited in over 30 years. vital signs and blood work were good at the hospital and the drs were confused as to why i felt so bad. i returned home the next day where our permanent home is, and 3 months later the covid thing surfaced. at first being thought of as a respiratory disease. then in the past months it is surfacing that it may now be considered a gastrointestinal disease that progresses to a respiratory disease. after checking the five main symptoms of long covid i discovered that i have at least 3 of the 5 common symptoms for this. Those being extreme fatigue, joint pain, and cough. In addition to the long covid symptoms, I have encountered tasting issues on and off again. I have had many discussions with my primary care doctor, and no results or conclusive information came from my inquiries. Then on feb 12, 2021 I got my first moderna shot. About 2-3 weeks later I encountered a sharp pain in a muscle in my neck left side. Shortly thereafter I got very light headed. Then another week later while driving a motor home, I encountered a frightening experience with my eyes, and the neck pain and soreness was still there. My vision was very blurred and I was seeing double vision at different angles. I ended up at the medical center and was admitted for 4 days. Before I was admitted, I saw a local ophthalmologist here and he diagnosed me with a condition known as ?edema in optic nerve, inferior, consistent with optic nephropathy?. The symptom I had to get me to the doctor was I was losing eyesight in my left eye. After hd steroid treatment for 4 days, and a plethora of tests, including spinal tap, multiple mri?s, and probably over 20 blood tests (11 at one draw), I was released 3-18-2021 and still can?t see above the equator line of my left eye. And I also am extremely sensitive to light. I also have sensitivity inside my eye as best described as a soreness, especially when I try to look upwards. I have a follow up appt with the ophthalmologists that I first saw that advised me to get to the hospital. And that is on mar 26th 2021. to mention another point of interest, my granddaughters boyfriends mother is a charge nurse at the emergency ward at the hospital, and she has said that they also have recently encountered emergency patients, who have recently received moderna, and are also having issues with eye problems. What problems in particular, I haven?t a clue at this time. This is at the very least, extremely alarming to me, and I have no idea whether I may completely lose all function of my left eye., or not. But I adamantly feel this should be investigated by the cdc and any and all other agencies that should be involved. I would be willing to have further discussions via phone or whatever to help you out with an investigation.

adverse events: multiple joint swelling, redness and pain, plus bilat led edema Treatment: steroids oral and injected, Outcome: improvement at first but wrist pain and swelling came back requiring injections

About 1-2 weeks after first COVID Vaccine, he started to experience breast and axillary tenderness + swelling which are still present.

severe , unbearable pain starting in lower back within five days of vaccine - , tranversing to both shoulder blades , left and right sides of neck , ankles , and moving back and forth to each area over and over . have been seen in E.R . chropractic office,/ pain specialist , neorologist nd have another appointment on Wed. March 24th with a different neurologist./ HAVE TO USE A WALKER TO WALK ANYWHERE - CANNOT STAND ALONE FOR OVER 30 SECONDS ...CANNOT SLEEP ON LEFT OR RIGHT SIDE - PAIN SEVERE IN SHOULDERS , NEED SOLUTION TO THIS NIGHTMARE - NOW ....

disabling myalgia for two weeks, resonved with high doses of prednisone, fully resolved after 4 weeks

stroke like symptoms: severe ataxia, left side flaccid, could not walk, could not understand spoken word, fever 100.2F, hands contracted, could only speak 2 or 3 words. symptoms lasted about 4-5 hours intensely, not recovered until next day.

On 03/16 he developed progressive onset of symmetric lower extremity weakness. He states this is similar to the weakness he experienced with his Guillain-Barré syndrome in 2019. Currently on IVIG (Gamunex) day 4 of 5 and his weakness is improving.

started with just injection spot swelling and red bumps, after 2wks its full upper body. Including arms, elbows, back, groin area, buttocks, belt line/waist, down the tops of the legs.

patient was hospitalized for weakness, dehydration, rhabdo, arf, dizziness-low probability of it being the vaccine

sore arm for 3 days. I have a psoriasis flare up in areas I dont normally have flare ups in. I also have an arthritis flare up

Patient was admitted to hospital on 3/27/21. It was discovered he did not get his second Moderna Vaccine and it was beyond 42 days. since he had the vaccine. His first Moderna Vaccine was given on 2/11/21. On 3/30/21 the second dose of the Moderna Vaccine was given here at hospital. He began to have symptoms that at first seemed like a normal but severe reaction to the vaccine including, fever and myalgias. His labs showed neutropenia. He tested positive for COVID-19 on 4/3. It was determined he had Covid-19. While this is not truly a reaction to or caused by the second vaccine we considered this was good information to make known. Patient who had one dose of Moderna vaccine contracted Covid. His symptoms are mild and he is improving. He has several comorbidities that put him at risk. We moved him to an isolation negative pressure room and we continue to monitor.

Approximately 20 hours following the injection I was suffering from extreme fatigue and fever. Slept for twenty hours straight and then felt okay. Almost five years ago I was diagnosed with spinal stenosis and have been pain free during that period, almost five years. Following the second Moderna injection I experienced severe pain in my left hip and X-Ray showed acute right-sided low back pain due to spinal stenosis. It's interested that the flair up and pain was dormant until the second dose of vaccine was administered. I assume the vaccine triggered the flair up but it did occur quickly after the second injection.

Patient received second dose of COVID-19 vaccine on 3/22/2021. Patient presented to ED on 03/29/2021 at 7:45AM complaining of dyspnea on exertion for 1 week since COVID-19 vaccine. Patient also complains of R lower ribcage pain on inspiration for 3 days. Patient became unresponsive and was revived twice. Patient became unresponsive a third time and could not be revived.

Pt to ED on 3/1621 with : "pt c/o left sided chest and rib pain. pt states that other symptoms along with the pain started today. Pt is c/o SOB, numbness and tingling in bilateral upper extremities, bodyaches and "feeling cold." PT dx with PE of unknown origin

Started experiencing a bad headache behind the right eye on Wed 1/27 at night, and on Feb. 7th could not get out of bed, his left shoulder blade became so painful went to the ED Feb. 8. Sent home the next day. The pain was so bad he thought he was having a heart attack. Took NTG did not help. Returned to ED on the 10th - stayed in in hospital for 8 days. Specialists were seen and nothing could help with the pain. Consulted with cancer doctors, and neurologists, doing tests to diagnosis. Dr. gave a nerve block and a week later the pain started to get better a week later on a holiday. Pain still comes and goes. Pain Started getting worse today 4/23/21. Must lie down on right side to get any relief. Has lost 50 pounds is very weak and getting weaker every day. and it is very painful to walk 40 steps to the garage. The TENS unit is not helping with the pain. Getting a spinal test.

Information obtained from clients wife. patient received his first dose of Moderna 2/24/21 lot 024M20A with no reported issues except for a sore arm. patient received his second dose of Moderna on 3/24/21; Lot# 006B21A. No immediate effects from the vaccine. On day 2 post vaccination, patient became to have chills, per wife; did not check temperature and denied any symptoms such as flu-like symptoms. Day 3 post vaccination; patient began to have weakness in the legs. March 31st; patient was unable to stand and the rescue squad was called. patient was taken to the Hospital; where he was evaluated and released home. Pt collapsed at 1am 4/1/2021 and died 4/1/21.

After a couple days, the patient because nauseous for a day or two and then developed stiffness in his arm, neck, back, and clavicle area. He has had these symptoms for about 5 weeks. Suspected administration being too high and accidental injection into the shoulder joint resulting bursitis.

Patient stated they felt extreme muscle aches in lower back which radiated to chest. Feel shortness of breath and a dry cough

Felt like he had COVID; Balance was off; Could not walk straight; Fell against wall, Busted left elbow from fall; Big bruise on left elbow from fall; Felt so bad, like he was going to die; Couldn't taste food; Couldn't smell food; seemed to have AFIB; Fever; Chills; Body hurt all over; Right arm was swollen; Right arm was red; Right arm hot like a firecracker fom the shot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (seemed to have AFIB) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red) and FEELING HOT (Right arm hot like a firecracker fom the shot). On an unknown date, the patient experienced ATRIAL FIBRILLATION (seemed to have AFIB) (seriousness criterion medically significant), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over). The patient was treated with Bed rest for Suspected COVID-19. At the time of the report, ATRIAL FIBRILLATION (seemed to have AFIB), PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), FEELING HOT (Right arm hot like a firecracker fom the shot), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: up (High) up. On an unknown date, Heart rate: 130 (abnormal) 130 per minute. On an unknown date, Hepatic enzyme: slightly elevated (High) slightly elevated. On an unknown date, White blood cell count: slightly elevated (High) slightly elevated. The patient was under doctor's care at the time of report.; 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.

Crohn's flare up; body aches; This spontaneous case was reported by an other health care professional and describes the occurrence of CROHN'S DISEASE (Crohn's flare up) in a 77-year-old male 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 ADALIMUMAB (HUMIRA) for Crohn's disease. No relevant past medical history was provided. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced CROHN'S DISEASE (Crohn's flare up) (seriousness criterion medically significant) and MYALGIA (body aches). At the time of the report, CROHN'S DISEASE (Crohn's flare up) and MYALGIA (body aches) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. concomitant product 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.

The patient has had severe joint pain since receiving the vaccine. He rates the pain at 3/10 when not moving. When up and moving it is hard for him to walk because he is stiff and sore. and it makes it difficult to do those tasks of ADLs.

He is falling asleep all the time and continues to get worse, not better; He is falling asleep all the time and continues to get worse, not better; Freezing cold all the time; feeling horrible; walking feebling at times; He has lost at least 10#, and lost three inches in waist,; stomach is bloated; he shuffles his feet-like his legs are stiff; balance is worse than ever; balance is worse than ever; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Freezing cold all the time) in a 77-year-old male 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 information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOTHERMIA (Freezing cold all the time) (seriousness criterion medically significant), VACCINATION COMPLICATION (feeling horrible), GAIT DISTURBANCE (walking feebling at times), WEIGHT DECREASED (He has lost at least 10#, and lost three inches in waist,), ABDOMINAL DISTENSION (stomach is bloated), MUSCULOSKELETAL STIFFNESS (he shuffles his feet-like his legs are stiff), BALANCE DISORDER (balance is worse than ever), CONDITION AGGRAVATED (balance is worse than ever), DECREASED APPETITE (no appetite), SOMNOLENCE (He is falling asleep all the time and continues to get worse, not better) and CONDITION AGGRAVATED (He is falling asleep all the time and continues to get worse, not better). At the time of the report, HYPOTHERMIA (Freezing cold all the time), VACCINATION COMPLICATION (feeling horrible), GAIT DISTURBANCE (walking feebling at times), WEIGHT DECREASED (He has lost at least 10#, and lost three inches in waist,), ABDOMINAL DISTENSION (stomach is bloated), MUSCULOSKELETAL STIFFNESS (he shuffles his feet-like his legs are stiff), BALANCE DISORDER (balance is worse than ever), CONDITION AGGRAVATED (balance is worse than ever), DECREASED APPETITE (no appetite) and CONDITION AGGRAVATED (He is falling asleep all the time and continues to get worse, not better) outcome was unknown and SOMNOLENCE (He is falling asleep all the time and continues to get worse, not better) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Stool analysis: negative negative (Negative) Stool sample was negative for blood. No concomitant medications were reported. Treatment information was not provided. Very limited information regarding the events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-125899 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

21 days later i was out walking my oxygen level began dropping down to 80 and I started throwing up. then i and took my blood pressure it was 125/80 and I tried to eat a cookie and I threw up. I went straight to ER. He gave me EKG, and he sent me straight to the Operating Room. 10 minutes after I saw the doctor he started the stint and that's when the oxygen dropped to 0, They knocked me out completely and I was in surgery and that is all I remember. I had a full blown heart attack on the table, called a widow maker- means the main arteries shut down completely, and my oxygen dropped to 0. The doctor put a stint in. Since then I started taking baby aspirin and brilinta 90 mg - 2x day, both are blood thinners. I took the 2nd Moderna shot on 5/18/21, which was advised by my doctor to wait 90 -100 day. I didn't have AE just a little swelling in the arm. I'm recovered from the AE from the 1st Dose, but my arms and legs are still a little. Not able to build up the muscles to were they were.

Patient was diagnosed with Guillain Barre Syndrome in late May. Symptoms began in early May. Lower extremity weakness and paresthesias. He did not have any other proceeding illness that might be expected to cause GBS. I do not necessarily believe the COVID vaccination he received in Jan and Feb caused his GBS. On the other hand I don't have another explanation and thought it should be reported to VAERS

Patient came into the clinic today to report the following: He states he received his first Moderna injection on 1-26-2021 and the second on 2-23-2021. One week after the second shot he began to have severe joint pain in his hands, knees and shoulder. 2 nd week after the last shot he had the shingles. The 3 rd week after the shot he was diagnosed with blood clots in both lungs and was hospitalized for 3 days. They gave him blood thinner in the hospital and sent him home with more to take. States as of today (6-4-2021) he is still having problems with fatigue and swelling/ pain in his hands, knees and shoulders.

Joint pain in fingers legs knee, muscle weakness in calves for 3 to 4 days. Reappeared 3 weeks later with the muscle weakness.

I took over the counter pain relief meds. Really bad neck ache all the way out to my shoulder. It was in my left arm and the pain was on the same side of the shot. It was the worst pain that I have ever had. It even went down into my back. I went back to where I got the vaccine and ask the nurse about my pain in my neck and she stated that she had the exact same symptoms. I ask her what did she do and she told me to take some over the counter pain aide. It's just the side effect. She told me that it will go away. It did go away after 3 days but than it return. The pain would leave but return again and again. The next thing I did, I call Moderna and I got a doctor and I explain to him what happen and he advise me that it is one of the side effect.

condition aggravated; attempt to rise from bed difficult and painful; attempts to walk were difficult; severe pain in body joints / in constant knee pain; Malaise; sleepiness; soreness at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (attempts to walk were difficult) and CONDITION AGGRAVATED (condition aggravated) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Spinal stenosis (His Spinal Stenosis is worse.) since 1999, Osteoarthritis (He is scheduled for a right knee replacement on 04 Jun 2021. Both knees will have to be replaced.) since 1999 and Pollen allergy. Concomitant products included METOPROLOL, LISINOPRIL, THEOPHYLLINE, FAMOTIDINE, FINASTERIDE, ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and MECLIZINE HCL for an unknown indication. On 10-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness at the injection site). On 10-Feb-2021, the patient experienced MALAISE (Malaise). 10-Feb-2021, the patient experienced SOMNOLENCE (sleepiness). On 11-Feb-2021, the patient experienced GAIT DISTURBANCE (attempts to walk were difficult) (seriousness criterion disability), MOBILITY DECREASED (attempt to rise from bed difficult and painful) and ARTHRALGIA (severe pain in body joints / in constant knee pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (condition aggravated) (seriousness criterion disability). The patient was treated with OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (attempts to walk were difficult), MOBILITY DECREASED (attempt to rise from bed difficult and painful) and ARTHRALGIA (severe pain in body joints / in constant knee pain) had not resolved and CONDITION AGGRAVATED (condition aggravated), MALAISE (Malaise), SOMNOLENCE (sleepiness) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown. 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.

Two weeks after shot, patient reported severe head and neck pain resulting in ER visit. He underwent CAT scan , received pain meds for one week. Patient followed up with primary 5/3-recieved nasal spray. On 5/7, ER visit -head/neck pain-CT scan, xray, medication given-nothing found on tests. On 5/17, ER visit due to left eye lid unable to close and lip twitching-Xray and CAT scan diagnosed with Belle's Palsy, which has since resolved but patient continues to be in pain. Following up with neurologist in future

Received Moderna vaccine on 05/21/2021. On 05/23/2021 upon awakening at 6 am both arms at the shoulder joints and upper arm muscles were extremely sore. I had limited movement in both arms although I received injection in left arm only. The soreness lasted for about 2 weeks and subsided entirely by the time I was to receive my second Injection. On 06/18/2021 I received my second Moderna Injection and on 06/19/2021 both of my upper arms ached severely and were immobile. I couldn't lift a fork to eat or a cup of coffee. It is now 06/23 and my upper arm muscles and shoulder joints are in excruciating pain and I still have limited movement due to sore muscles and joints. I have a Dr's. appointment tomorrow to get some relief.

Weakness in legs for a couple of months, lower back pain, followed by weakness in arms. After consulting several doctors went to hospital on June 27. Took 5 days of nonstop testing to finally identify it as a motor neuron disease, ALS. In a rehab center now. Cannot walk or stand.

I took my first shot 01/13/2021, second shot 02/11/2021 Moderna 029L20A Moderna 024M20A I had the standard sore arm about 4-5 inches below the site. This went on to be pain down my left arm extending to my left ring finger and middle finger. I have had cramps muscle pain over my chest left rib area. Pain down my left side ribs. pain down my back over my ribs. Neck pain muscle tightness left side. Pain on my left shoulder turned into a muscle pain/cramp shoulder down my back lasting 12 hours. The muscle was standing up over 1 inch. I called my doctor he wasn't available, went to the ER the next day. I saw Dr. 07/01/2021 he said he couldn't do anything for me. He said he could treat the symptom. He gave me

I received my second shot on 02/05/2021. About a month later I developed muscle pains. These progressed over the course of the next several weeks. On June 30, 2021, I visited my physician and was diagnosed with polymyalgia rheumatica. I was put on a small dose of prednisone, and my symptoms subsided promptly.

Sore injection site, fever, chills,extreme muscle fatigue 24 hours after injection. Full ?recovery ? by 1/8(Friday)

on day of vaccination experienced "heavy duty shaking , HA, sore muscles, fever 101 - similar to symptoms of previous COVID+ event S/S lasted 1 day - Most concerning to patient is the insomnia and hallucinations he experienced the night of the vaccine, none since

Patient is extremely comprised due to a kidney transplant 7.5 years ago. The first day patient just had a sore arm. The next the day the 14th had chills, shaking then to bone pain and muscle pain and headache over a period about 4 or 5 days. Then patient started with very bad diarrhea, it was uncontrolled multiple times a day, about 3 days, he was getting dehydrated and muscle weakness. Patient went to the hospital 1/20/2021 and was admitted and the doctors are still trying to determine the cause of the diarrhea. Patient is extremely dehydrated and is still has the diarrhea. Patient is right now is hallucinating due to being so dehydrated. A stool culture has been preformed.

AROUND 9:30 PM I BECAME VERY WEAK AND FEVERISH. I HAD CHILLS AND I COULD NOT EAT OR DRINK. I COULD NOT GET OUT OF BED TO GO TO THE BATHROOM. I THREW UP TWO DIFFERENT TIMES. THE NEXT DAY I WAS STILL VERY WEAK. I TRIED TO GET OUT OF MY CHAIR AND I FEEL. I WAS UNABLE TO GET UP WITHOUT ASSISTANCE. THE WEAKNESS AND FEVER CONTINUED FOR THE NEXT THREE DAYS. I AM STILL VERY WEAK AND CAN'T HARDLY WALK. MY HIP FLARED UP AND CAUSED ME GREAT PAIN AND IMBALANCE. ALL THE AREAS THAT I HAD OCCASSIONAL OSTEOARTHRITIS I AM NOW IN CONSTANT PAIN. I CAN NO LONGER SLEEP ON MY RIGHT SHOULDER. BOTH OF FEET FLARED UP AND HURT ALL THE TIME.

Injection site soreness, headache, fever to 101 F, myalgia, fatigue Duration of symptoms 18 hours Back to normal 48 hours after injection

Severe and rapid onset of two chronic conditions, sciatica pain in glutes and upper legs. As well at the same time a rather severe onset of GERD symptoms. Next day all day bad symptoms, 3rd day much improved, 4th day both almost all gone. Prior history of COVID-19 event for myself in March 2020.

Pt received his first Moderna injection on 2/6/21. On 2/7/21 he developed chills and fever in the afternoon. Pt woke up on 2/8/21 and had pronounced weakness. Nursing Home/Assisted living reports falls x 2 this am. First at 4 am and the second at 6 am. Pt normally is ambulatory and still capable of driving a car. Reports today generalized weakness. He is having difficulty walking and lifting his extremities. He also is having difficulty lifting his head off the pillow. He reports generalized body aches and lower back pain. He presents to the ER with a rectal temp 100 degrees. His vital signs are normal otherwise. He had a septic work-up in the ER that included labs, urinalysis and imaging. Only abnormal lab was a elevated lactic acid. Pt received IV fluids and was admitted to the hospital for further monitoring. He is routinely tested for COVID in the NH. Last time was Friday 2/5 21 and was negative. The patient had rapid COVID testing repeated in the ER again the results were not detected. He has no swallowing issues and he is able to move extremities but again demonstrates pronounced weakness.

SEVERE headache, chills throughout night of inoculation and into 1/2 next day, with moderate temperature and muscle aches.

immediate sensation in left chest and down left side at the moment on injection. Sore shoulder developed during the next hour. Difficult to sleep that night. Painful to lift my left arm all day today.

About 4 hours after his vaccine, the injection site starting hurting, but not bad. He could not sleep on it at night as he felt like he was sleeping on a red hot pocker. On Saturday he was extremely tired in the afternoon. Had to come in from yard work as he could not function. He also had pain in his neck and shoulders. On Sunday he the feelings were going away, but his muscles started aching. On Monday he felt really strange, felt like he was in a fog, and his muscles ached. He could not get relaxed, did his normal Monday chores, laundry and house cleaning. He then tried to relax but his muscles and nerves were very tense. He went to bed around 9:30 on Monday, fell asleep and awoke at 2:00 AM and could not go back to sleep his muscles in his arms and legs were in spasm and his arm would jump like a shock reaction and jump off of the mattress, as well as his leg. It was worse on the left side than the right arm. This went on every 10-15 minutes for about 3-4 hours. Around 4:00 AM this morning it eased off to sleep and woke up at 10 and felt better today. He hasn't had any more of the seizure type feelings in his arms or legs. He did speak with Moderna who told him that he was the 4th one with this reaction and to report this to us.

Sore and inflamed left arm and red rash. headache medium, fever 100.4 thru 100.8 for about 42 hours starting early Saturday morning after a Friday inoculation, and ending Sunday evening. Woke up Monday feeling well and no after-effects. Took some tylenol during the event.

muscle ache at injection site and fatigued and tired at the end of the 1st day and throughout the 2nd day. 3rd day i was fine

Awoke at 0500 with lower back ache assuming it was associated with flu like symptoms. Had my usual two ups of coffee and small orange juice. Took my meds at approx 0730 with small glass of water. From 0800 until 1030 I had frequent visits to the bathroom to urinate. My backpain was more associated with my Kidneys as the frequent urinating was causing mild pain. After 1030 I had one at aprox 1230 and did not pass any urine until aprox 1830 that evening. I did hydrate with water during that time. After 1830 I had no issues.

7-hour duration of general lethargy, joint pain, chills, temperature of 101.2 Went to bed that evening and woke up just fine following morning........

My mid back is aching and sleep is difficult. I have not experienced this type of back ach in the past. I am taking ibuprophen to help with ach. This may get better but I wanted to report the problem in case it gets worse. Don't know the cause.

Fever of 104.3. Legs heavy. Occasional cold chills until 10:00 PM. Drank fluids. Covered up with blanket

LEFT HAND BECAME WEAK. HARD TO GR1P OR HOLD THINGS. A BIT NUMB. COULDN'T SENSE BEING HIT. OTHER WISE,, JUST THE NORMAL ACHES AND PAINS IN THE NECK AND SHOULDERS AS NOTNONED IN FACT SHEET

22 days after injection, my right arm muscle started to hurt seriously. Any movement caused pain. On the second day, the pain comes only when I flex that muscle. There is no pain in my other my arm.

Developed a fever of 101, pain and swelling in my shoulder, sluggish feeling. Fever was gone the next day. The only residual was pain in the shoulder.

redness at an angle 2 inches wide and 6 inches long and has increased in size since first noticed but about the same today. Maybe somewhat redder today

2/16 10PM felt soreness in neck and shoulder area. Soon developed chills. Had trouble sleeping. Took temperature at 2AM (2/17) - 100.4. Got out of bed 7AM - temperature 100.3. Took 2 full strength asperin. By noon on 2/17 temperature down to 98.8, still soreness neck and shoulders and very tired. Less discomfort at 10PM and got good night sleep. Still somewhat sore and tired 2/18 and 2/19. No ill effects at all by 8AM on 2/20

The following day after the vaccine at 5:00 AM he had joint and muscle pain and weakness, not able to move his legs. He would sit down in a chair and needed help to get back up. Headache, dizziness. He had a low grade fever of 100.1. This got progressively worse and then by evening got better. His wife called the visiting nurse that they had coming who she believes notified the doctor, and told them it would go away. By the next morning it was basically gone. He took Tylenol for the symptoms.

Extreme weakness to the point of being unable to stand, lightheaded, numbness, bilateral limb weakness progressing to stroke-like symptoms which persisted for approximately one day; palpitations and frequent PAC and PVCs which have persisted past initial treatment to current date. Patient was treated in the ER and given steroids, anti-histamines, and possibly anticoagulants for stroke-like symptoms, however ER notes not available and going off patient's verbal report. He was sent home on steroids and antibiotics and diagnosed with Vaccine injury from Moderna COVID19 vaccination.

Fever over 100 degrees with muscle aches. Took tylenol to treat the fever and aches. Both fever and aches persisted for 1 day. Next day I had no problems.

severe back pain, pelvic pain for one week and hard time walking. irregular heart beat for 5 hours after the vaccine.

Approximately 15 hours after shot chills, aching body/joints, weak legs, headache. This lasted one day.

weakness Narrative: 77 y/o male patient with h/o Parkinson's disease, CAD (s/p stents), supraventricular tachycardia, received first dose of COVID19 (Moderna) vaccine on 02/11/21. On 02/12/21, legs were weak and shaky, had a fall. On 02/13/21, continued to feel weak. On 02/14/21, fell and felt chest pressure. Ambulance called and was taken to outside facility and found to be in afib RVR, treated with diltiazem. Had cardiac cath on 02/15/21 which showed NSTEMI due to extensive CAD, not a surgical candidate therefore medical management optimized. Started on amiodarone for afib. Discharged on 02/17/21. Has no prior ADRs to vaccines or anaphylactic reactions to medications. No prior COVID19 infection.

OK FOR 2 DAYS AFTER 2ND SHOOT THEN SEVERE PAIN DEVELOPED IN RIGHT HIP AND LEG MUSCLES AND THEN SPREAD TO OTHER LEG OVER 1-2 DAY PERIOD. SEVERE PAIN CONTINUES NOW IN BOTH LEGS AND HAS NOT SIGNIFICANTLY DIMINISHED. PAIN HAS BEEN AND CONTINUES TO BE SUFFICIENT TO INTERRUPT DAILY ACTIVITY AND SLEEP. TEMPORARY MINOR RELIEF ACHIEVED WITH MAX DOSES OF OTC PAIN MEDS BUT STILL DISRUPTIVE. INTEND TO CONSULT WITH FAMILY DOCTOR TOMORROW. VERY UNPLEASANT!

Patient started feeling weak, stomach pain, neck pain, respiratory problems, confusion, low blood pressure which led to death on February 21, 2021, 7 days after the vaccine was given.

severe muscle and joint pains lasting up to the present and continuing indefinitely., fatigue, fever, and chills,

arm pain, fatigue, headache, muscle pain, fever 102.4, severe chills, nausea, dizziness, fast heartbeat

chills @ 24 hrs to 36 hrs; muscle pain @ 36 hrs to 72 hrs; redness of skin over muscle area @ 72 to present

Moderna COVID-19 Vaccine EUA. Day 1 after injection: fever (100.4), constant headache, very sore at injection site, general fatigue and muscle soreness. Day 2: woke at 3:00 am, all symptoms gone except sore arm. Day 3: mild tenderness at injection site.

Rheumotoid arthritis autoimmune compromised person who was told by multiple doctors that he should get the shot anyway. He had not had a RA flare for months but 1-2 days after shot he started having joint pain in hips, low back, between shoulders and neck. Pain shooting up head, random numbness in left pinky, wrist, and up to elbow which has not occurred before. Shortness of breath and heart racing. Went to PCP and they directed him to go to ER. 2 EKGs, Chest Xray, Bloodwork, Stress Test. Seeing Neurologist, Rhuemotologist and Cardiologist as symptoms are ongoing.

Severe muscle spams in lower back, painful but not debilitating, took some Advil at noon and beginning to get around much better. Had trouble getting out of bed this AM but walking Ok with discomfort now.

THURSDAY STARTED WITH CHILLS AND SEVERE BACK PAIN ALONG THE BELT LINE. HE CALLED (PCP). COMPLAINED OF SOB (SHORTNESS OF BREATH). NO FEVER. AUDIBLE SOB SO HEALTHCARE PROVIDER INSTRUCTED THE PATIENT TO GO TO THE URGENT CARE OR CALL DR. ASAP.

day 1- Mild soreness Day 2 -more soreness-boneache Day 4-11- intestinal distress and high volume Day 10-14-Renewed soreness in shot area

He could hardly walk, legs gave out and he fell and could not get up; Can't lift legs; No strength in the legs and arms; A spontaneous report, was received from a consumer (patient), a 78 years-old male patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced he could hardly walk, legs gave out and he fell and could not get up (monoplegia), can't lift legs (muscular weakness), and no strength in the legs and arms (muscular weakness). The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown), intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient stated that the morning on 13 Feb 2021, after the vaccine was administered, the patient could hardly walk legs gave out and he fell and could not get up, no strength in the legs and arms, and can't lift legs. The patient was now able to feel everything normal as of this morning on 14 Feb 2021. No treatment details were provided. Action taken with second dose of mRNA-1273 in response to the events was not reported. The outcome of events he could hardly walk, legs gave out and he fell and could not get up, can't lift legs, and no strength in the legs and arms were considered resolved on 14 Feb 2021.; 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.

He was fine until 2/22/2021. He suddenly started having left leg weakness. He started becoming more dizzy next day and skipped his daily walk. On 2/25/2021, his left leg weakness became worse. His wife gave him cane and took him to PCP who diagnosed him with BPPV and gave him meclizine. Next day, he started having jaw stiffness and had difficulty in brushing his teeth. He was complaining of blurry vision in both eyes. He denied any double vision. He stated he could not read things which he was able to read 2 days ago. A day before he presented to Hospital, he was not able to walk at all and he required walker. According to his wife, when she went to see him at Hospital around 7 PM on 03/05/2021, his oxygen saturation dropped twice and internist decided to transfer him to ICU. Later on, the decision was made to transfer him to Medical Center. Pt was intubated, developed diffuse segmental myoclonus, required intense sedation; /ivig ineffective, now giving plasmapheresis. pt underwent imaging of CNS, LP and extensive laboratory testing.

3/7/21 ER to inpatient Admission (covid positive 3/7/21) 3/11/21 Transferred to higher level of care Date of Service: 3/8/2021 Chief complaint: Chest congestion HPI: Patient is a 78 y.o. male with PMH significant for hypertension, obesity, coronary artery disease and CKD admitted to acute care from ED peR Dr with pneumonia due to COVID-19. Patient presented to ER brought in by EMS from local residence. Was complaining of chest congestion. Patient had been seen in ER earlier same morning complaining of cough. Was afebrile at that time. Oximetry 95%. Rapid COVID positive. Patient given Decadron 6 mg IV, albuterol inhaler, zinc and BAM(bamlarnivimab 700 mg) IV x1. Patient discharged home. Return later that evening per EMS with shortness of breath. Complaining that congestion was getting worse. Was now febrile & had fallen trying to get out of recliner. Vitals upon arrival-temp 102.8° pulse 87 respirations 24 blood pressure 169/71 oximetry 99% on 2 L. patient given Rocephin 1 g IV piggyback, azithromycin 500 mg IV piggyback, normal saline bolus 1 L & acetaminophen 1000 mg IV in ER. Labs revealed mild leukocytosis white blood cell count 12.5. Glucose elevated to a 9 but patient had received Decadron previously. BUN 32 creatinine 1.8. D-dimer 1240. No CT chest obtained due to patient's renal status. Patient subsequently admitted to acute care for further evaluation and treatment to include IV antibiotics supplemental oxygen pulmonary hygiene. Patient has received 1st COVID vaccine and due to have 2nd vaccine on March 20. Upon admission patient was continued on Rocephin and azithromycin IV piggyback & Decadron 6 mg IVPB. Continued hydration fluids normal saline at 100 cc/hour. Started on IV Remdesivir with loading dose. DuoNeb nebulizers q.6 hours. Patient continued on home regimen less Plavix. Was started on Lovenox 40 mg subcu daily for DVT prevention. Patient maintaining oxygenation on 2-3 L. Had initially been on 2. Was increased to 3 this morning due to decrease in oximetry down to 92%. Patient continues with exertional dyspnea. Does have loose nonproductive cough. Is complaining of pain to the left lower chest wall with cough. Describes as sharp. Denies any actual chest pain. No nausea vomiting. Last BM yesterday described as normal. Blood cultures pending no growth at present. Is currently resting in bed. Is in negative air pressure room. COVID precautions observed. CASE DISCUSSED WITH DR

Difficulty breathing. Inhaling and exhaling. Two visits to the ER. Swelling arm, ankles, swollen arm , very red. Breathing treatment, inhaler, antibiotics. I have a Dr appointment Monday to see my primary. Still struggling to breathe

I experienced weakness in all of my muscles, chills, temperature was 100.4 Monday morning; dizziness; extreme fatigue. I am continuing to experience slight weakness, slight dizziness, and am still extremely tired as of Tuesday late morning, March 16th.

First day of shot had fever of 101, joint aches, breathing difficulty. Lasting for 3 days. Didn?t feel normal for a week.

Feeling spacey; severe diarrhea; Sweats; severe body aches; Chills; A spontaneous report was received from a consumer concerning a 78 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe body aches, severe diarrhea, sweats, chills and feeling spacey. The patient's medical history was not reported. Current condition included lung cancer. Concomitant products included chemotherapy pill for lung cancer. On 05 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 05 Mar 2021, 3 hours after receiving vaccine, the patient developed severe body aches, severe diarrhea, sweats, chills and feeling spacey. Treatment information was unknown. The event of feeling spacey was considered to be serious with criteria of important medical event and the rest events were considered as non-serious. Action taken with mrna-1273 in response to the events was unknown. The outcome of event, feeling spacey was considered resolved on 08 Mar 2021 and the remaining events were considered resolved on 07 Mar 2021.; 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.

Extremem muscle weakness, especially in legs, unable to stand, low grade fever, disoriented, confused, no appetite. Had to have 2 people help me up off the floor.

Lost 50% of left hand and finger strength If I am cold while working outside or in garage, another 25% of strength is lost. And finger dexterity is greatly decreased. I have very light trembling or vibration from shoulder to tips of fingers. The above continue unchanged every day. Extreme fatigue all day on some days, moderate fatigue all other days

Very little after Dose #1. The day after Dose#2: achiness (back, chest, head and of course the injected arm). These are NOT severe enough to seek help immediately. However, patients ought to be aware of the potential.

The patient had an ischemic stroke (confirmed by MRI) on Friday, 4/2, approximately 24 hours after the 2nd dose of the Moderna vaccine given on 4/1. The symptoms of the stroke began in the evening on 4/2 and consisted of left face, arm, and leg weakness.

"On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights."; "He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"; woke up sweating; Inappropriate schedule; Extremely hurt; Last couple of nights could not sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights.") in a 78-year-old male 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 Bone fracture (not spontaneous) (The patient broke his collar bone and pacemaker was placed on the left side.) in August 2020, Neck pain (The patient was hospitalized for bad neck pain and couldn't sleep for 3 nights.) on 12-Mar-2021, Cerebral haematoma (On the day of hospitalization, It was thought that he had dried blood in his brain.) on 12-Mar-2021 and Pacemaker insertion (cardiac) in August 2020. Concomitant products included ATORVASTATIN, CARVEDILOL, CHOLECALCIFEROL, ENALAPRIL, ESCITALOPRAM, FISH OIL, GLIMEPIRIDE, METFORMIN HYDROCHLORIDE (METFORMIN SANDOZ), OXYBUTYNIN, TAMSULOSIN, PANTOPRAZOLE, ACETAMINOPHEN, MULTIVITAMINS [VITAMINS NOS], TADALAFIL, ATORVASTATIN, CARVEDILOL, CHOLECALCIFEROL, ENALAPRIL and ESCITALOPRAM for an unknown indication. On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights.") (seriousness criterion hospitalization). On an unknown date, the patient experienced RIB FRACTURE ("He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"), HYPERHIDROSIS (woke up sweating), INSOMNIA (Last couple of nights could not sleep), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule) and VACCINATION SITE PAIN (Extremely hurt). At the time of the report, NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights."), RIB FRACTURE ("He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"), HYPERHIDROSIS (woke up sweating), INSOMNIA (Last couple of nights could not sleep) and VACCINATION SITE PAIN (Extremely hurt) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule) had resolved. Based on the case description and the patient's prior medical history, the events are assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the case description and the patient's prior medical history, the events are assessed as unlikely related to mRNA-1273.

Pt was called 24 hr for f/u on vaccine, pt stated not doing to good this time, joints hurt, flu like symptoms, also stated having dizzy problems

very sore arm with a burning sensation in the muscle that is still present at this time. I will discuss it with my GP in my quarterly visit in May 2021

3 days after injection developed left arm pain, swelling. persisted when presenting for second injection 4 weeks later which was deferred. evaluated next day in clinic. reported feeling feverish, left arm pain weakness which was in a sling. noted have swelling with moderate edema in hand. tender left lateral shoulder, hand. decreased strength in arm, hand possibly due to pain. no lymphadenopathy. afebrile. WBC normal.

First Night, High Fever had to take PJs off to get cool, Next day, Cold,very Cold.Arm ached, had red colot going from injection towards elbow on outside for 6 inches. about 1-12 inch wide. Tired and slept except to get up for bathroom, eat a little, go to bathroom. Kidneys hurt, could feel pulse in Kidneys. Was weak. Back and legs ached. Legs felt almost numb. Hard time walking from back pain and had to sit ina chair for about 30 minutes to get relief from kidney pain. This continued until the 9th @ noon. Arm stopped aching then. Kidneys still hurt. Back strain started getting better. Bak and kidneys still hurt hen I first get out of bed. Have to sit in chair till it goe away. If the Kidney pain continues, I will se

Patient received 2nd dose of vaccination on 03/01/2021 and developed symptoms on 03/03/2021. He presented with bilateral numbness in feet ascending to his mid shins and weakness complicated with multiple falls due to severe ataxia. He did not report any head injury or loss of consciousness. He also reported mild dysphagia, changes in voice and left arm weakness. Neurological examination showed bilateral leg strength 4/5 and numbness. The patient was admitted to hospital and given IVIG for 7 days before transfer to an acute inpatient rehab facility. The patient was discharged from rehab facility on 04/05/2021 and still has some residual weakness and numbness.

bladder infection; Not feeling good in general; Chills; muscle aches and pain; low fever; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (bladder infection) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bladder cancer. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (Not feeling good in general), CHILLS (Chills), MYALGIA (muscle aches and pain) and PYREXIA (low fever). On 12-Jan-2021, the patient experienced CYSTITIS (bladder infection) (seriousness criterion medically significant). At the time of the report, CYSTITIS (bladder infection), FEELING ABNORMAL (Not feeling good in general), CHILLS (Chills), MYALGIA (muscle aches and pain) and PYREXIA (low fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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. Further information has been requested.

Call this afternoon regarding safety of in setting of recent Moderna COVID-19 vaccine receipt. Question related to autoimmune heparin-like thrombotic thrombocytopenia as currently in the news related to J&J vaccine. Reported incidents that led to FDA pause of J&J vaccine related to arterial events with overt thrombocytopenia and PF4 antibody positive. Limited data available to suggest link to mRNA vaccines at this time but data being collected daily regarding therapies. Reviewing chart, patient has several risk factors for VTE development (OSA, hx prostate cancer, age, PMR +/- steroids; there is also a mention of unilateral edema in which patient was referred for Doppler but date of this request is unknown to writer so unable to determine if occurred prior to or after vaccine receipt. Also mention of knee pain back to 3/2021 OV with Dr. so unclear if mobility issues although participants in cardiac rehab. Labs reviewed and mild thrombocytopenia today (148k) and 171k on 10/2020. Naranjo score 2, suggesting possible correlation but low score overall. Overall, given presentation and information provided, appears anticoagulation for acute PE is safe. Theoretically would consider enoxaparin 80 mg SQ BID over UFH infusion but defer to medicine. Additional notes: 2D echo: EF wnl, impaired LV diastolic filling bilat LE dopplers; negative for DVT He was transitioned to eliquis RX for PE treatment Discussed AC treatment with on call cardiology, as no stents are in place that I am aware of and the patient denies placement of stents, only CABG in 1995, then stop asa/plavix and continue only with eliquis at this time Recommend f/u with hematology/oncology in the next 2 weeks for PE management and evaluation Recommend f/u with Cardiology in the next 2 weeks for further management AC precautions was reviewed with the patient and his wife prior to discharge and including when to seen medical attention due to increased risk of bleeding events. They both verbalized understanding.

patient's both legs and ankles started to become swollen; patient's both legs and ankles started to become swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (patient's both legs and ankles started to become swollen) and JOINT SWELLING (patient's both legs and ankles started to become swollen) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031a21a) for COVID-19 vaccination. The patient's past medical history included No adverse event (Relevant medical history not reported). On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced PERIPHERAL SWELLING (patient's both legs and ankles started to become swollen) and JOINT SWELLING (patient's both legs and ankles started to become swollen). At the time of the report, PERIPHERAL SWELLING (patient's both legs and ankles started to become swollen) and JOINT SWELLING (patient's both legs and ankles started to become swollen) outcome was unknown. Not Provided Patient reported concomitant medications which include diabetic medication and goat (gout?) medications. No further detail was provided. No treatment information was provided for the 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 events, a causal relationship cannot be excluded.

Date and time adverse event started: 1st Moderna dose 1/6/2021 time unknown but ADEs occurred on 1/7/2021, and then 3 days it reoccured. 2nd Moderna dose 2/3/2021 time unknown but sxs occurred same day. 1st Moderna dose 1/6/2021 time unknown, pt reported he experienced dizziness on 1/7/2021 (which went away), then 3 days later the dizziness came back and he also had weakness. 2nd Moderna dose 2/3/2021 time unknown but sxs occurred same day, pt reports the second dose the dizziness and weakness is more pronounced than the from the 1st dose and he is feeling shaky. The dizziness, weakness and shakiness is still occurring; pt reports neck is hurting when turning his head, and get more dizzy with slight head movements. Pt has been seen by his PCP (did MRI - no findings of anything). Also seen by specialists (ENT, Cardiologist, Neurologist). Pt is scheduled for an inner ear exam on 5/10/2021. Pt advised no one was able to help him with his symptoms, more tests are ordered. Additionally, pt reported he had reached out to Moderna and they were unable to provide him with any assistance. Pt reports that he stays hydrated and tired vertigo exercises recommended by his chiropractor for the past 3 weeks. Nothing has helped. 4/18-Follow up call by JD- Patient continues with dizziness and weakness. Doctor has prescribed scopolamine patch but is has made dizziness worse. Advised to continue to stay hydrated, get up slowly when standing from sitting position. Will be following with ENT doctor on 5/10/21.

My father experienced an acute stroke, 1month +7days after receiving his 2nd shot. We are reporting this because when we mentioned the stroke to members of our church, there were at least 2 others who knew of someone in my fathers age group who also had a stroke 1 month after their 2nd covid vaccine shot. My father is currently at hospital, and is being moved to Rehab Center today. (April 28, 2021) On Saturday, April 24th, he woke up with wobbly legs around 3am, accompanied with an odd sensation in one of his arms, and legs. He went on about his day, but felt off. He fell around 2:20pm, I was called by mom. My husband and I arrived about 10 minutes later. He was up, and walking at that point, but his speech was very slurred. We checked his blood levels (159), and went through the stroke symptoms, and drove him to Hospital, where they immediately took him in under stroke protocols. It was determined he had an acute stroke.

Muscle pain, weakness, headache, and fever x 4 weeks post vaccine. Unable to walk x 2 days post vaccine due to pain and weakness. This week patient is starting to feel "like himself" again.

SPOUSE REPORTS THE FOLLOWING FOR PATIENT 4/21/2021 @ 9PM GENERAL MALAISE 4/22/2021 APPROX 4AM SEVERE HEADACHE TOOK IBUPROFEN 4/23/2021 AFTER LUNCH, PATIENT WAS UNABLE TO WALK AS PREVIOUS AND HAD 4 FALLS, ALSO COMPLAINED OF A SORE THROAT. 4/24/2021 DID NOT FEEL WELL, TEMP UP TO 100.4, NAUSEA AND VOMITTING X 1 AND CHEST PAIN, CALLED EMS AND WAS TRANSPORTED TO MEDICAL CENTER ER. 4/26/2021 PATIENT WAS DISCHAGED HOME AFTER TREATMENT FOR RHABDOMYOLYSIS AND RETURNED TO THE HOSTPITAL AGAIN ON 04/27/2021 WITH RHABDOMYOLYSIS AS PRIMARY DIAGNSOSIS. RESIDENT DISCHARGED TO SNF ON 04/28/2021.

Vaccine site left arm. Left hand joints at pointer finger and thumb are swollen and have sever pain. Right arm elbow pain. Can not lift right arm to even shave. Symptoms started 2 days after vaccination. Three weeks later with no improvement.

This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NEPHROSTOMY (nephrostomy bleeding) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Urostomy, Nephrostomy and Colostomy. Concurrent medical conditions included Lymphoma (stage 4 lymphoma cancer), Renal failure (stage 4 renal failure) and Neuropathy NOS (chemo related neuropathy). On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (arm pain), DYSPNOEA (labored breathing), ASTHENIA (very weak), RASH (got rash on both of his forearms), HEADACHE (headaches), FATIGUE (fatigue) and CHILLS (he had chills). On 27-Apr-2021, the patient experienced NEPHROSTOMY (nephrostomy bleeding) (seriousness criterion hospitalization prolonged) and DEHYDRATION (he was dehydrated). On an unknown date, the patient experienced MYALGIA (hurting all over). The patient was hospitalized on 28-Apr-2021 due to NEPHROSTOMY. At the time of the report, NEPHROSTOMY (nephrostomy bleeding), DEHYDRATION (he was dehydrated), PAIN IN EXTREMITY (arm pain), DYSPNOEA (labored breathing), ASTHENIA (very weak), RASH (got rash on both of his forearms), HEADACHE (headaches), MYALGIA (hurting all over), FATIGUE (fatigue) and CHILLS (he had chills) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. After the patient got the vaccine, he was very fatigue for a few days. He had a lot of arm pain. The doctors noticed that he got rash on both of his forearms. He complained of headaches and it was hurting all over. He was very weak and had chills. He had labored breathing. His nephrostomy was bleeding a lot in the tubes so they had to hospitalize him. He went to hospital on 27-Apr-2021 and was currently in the hospital. He had blood transfusions and he was very dehydrated. He was put on IV saline. He took Eliquis but doctors wanted to stop it because his kidneys were not in good shape. Company comment: Based on the information provided which indicates patient's underlying history of nephrostomy, a causal association between the event of nephrostomy bleeding and dehydration and the administration of mRNA-1273 and the events is assessed as unlikely as the event is common local complication from nephrostomy tube placement, The other events are temporarily associated with the product use and a causal relationship cannot be excluded.; Sender's Comments: Based on the information provided which indicates patient's underlying history of nephrostomy, a causal association between the event of nephrostomy bleeding and dehydration and the administration of mRNA-1273 and the events is assessed as unlikely as the event is common local complication from nephrostomy tube placement, The other events are temporarily associated with the product use and a causal relationship cannot be excluded.

Gained 18 pounds in about 1 week with pitting edema around both ankles and lower legs. Pitting edema resoved after second shot and weight gain is slowly resolving. I have lost about half of it at this time

Patient presented to the ED on 3/18/2021 with superficial venous thrombosis of left arm. Patient had second vaccination on 4/9/2021. on 4/27/2021 patient presented to the ED with myalgia. He was admitted on 4/28/2021 with fever and chills. These visits are within 6 weeks of receiving COVID vaccination.

Patient reported to pharmacy to tell the pharmacist he had been having some pain in his chest (pectoral muscle) and armpit radiating to his back. He explained that he has lung issues from an injury he received as a younger man so he thought it may have been associated with that. I asked him if the pain felt muscular or internal/visceral, he said it felt muscular and noted that it really started after doing his 40 push ups for the morning, but that it has been 2 weeks since his second dose of Moderna covid-19 vaccine. I advised him to try acetaminophen for the pain and to reach out to his doctor if it does not get any better or if it worsens.

Patient received second dose on 3/13/21. In mid-april, patient started experiencing numbness, tingling, parasthesias, and weakness in the lower extremity. This progressed upwards over a period of 2 months with worsening weakness. Due to the symptoms the patient fell and broke his ankle. The patient eventually could no longer walk as the weakness progressed. On MRI the patient was found to have an extensive transverse myelitis and was admitted to the hospital 06/18 for steroid treatment.

Approximately 75 days later I awoke with swollen hands and could barely close my fingers to make a fist. Knucles were painful and swollen.

Reports he had muscle tenderness, swelling and redness after shot was given. Reports he still has muscle soreness and some limitation of movement if he moves his arm a certain way

L arm pain, fever, chills, muscle ache, weakness, No treatment other than Tylenol and bed rest. All symptoms began about 24 hrs after vaccine administered and less arm pain still exists 48 hrs later

Vaccine at 10:45 am. At 2 am patient awoke with severe chest, left arm, back of the head, neck, stomach and shoulder pain and was breathing heavily, in a panic attack. Said he feared he was having a heart attack. I gave him an extra strength tylenol, rubbed his neck, back of head, shoulders and suggested he was having a vaccine reaction. After about an hour, he fell asleep. He awoke around 8:30 am with a slight headache but otherwise feeling fine.

PATIENT EXPERIENCED HEADACHE, MUSCLE ACHES, SWEATING, JOINT PAIN, LOSS OF BOFILY FUNCTION THAT REQUIRED EMT SERVICES.

Starting noticing at 4:00 PM noticing pain in the shoulder. The pain in the shoulder got worse to where he had tightness in his chest, but was shaking uncontrollably shivering sensation but was not cold that continued for several hours. Today is still having the pain in his shoulder, and while laying down has the neck stiffness. While sitting up has pain in the shoulder and is applying ice on it now. He took some Acetimenophen as he was told to wait 24 hours before taking anything. Has chronic back pain for which he takes that as well, but now for the shoulder pain as well.

BRAZO, HOMBRO, TOBILLO, PECHO, CUELLO, PARTE DE DONDE LA CABEZA SE JUNTA CON EL CUELLO UN DOLOR COMO CUANDO LE PONEN LAS INJECCIONES DE VITAMINAS. HE PERDIDO LA FUERZA. NO HE PERDIDO SENSIBILIDAD PERO NO HAY FUERZA MUSCULAR. CUANDO VIRO EL CUELLO ME DUELE. EL PIE SE HA MEJORADO, PERO EL TRONCO DEL MULO ME DUELE. EL PECHO ME DUELE CUANDO TOSO. NO TENGO NINGUNA FUERZA NI MOBILIDAD EN MI BRAZO IZQUIERDO Y UN DOLOR "CANSADO" EN EL CUELLO.

I helped facilitate scheduling for his COVID vaccine and received notification from his wife that he passed away unexpectedly this morning. She reported he had been experiencing a rheumatoid arthritis flare and was on steroids. His diabetes was not well controlled as a result. He did not have any reactions in the days immediately after the vaccine.

Chills and fevers (102), muscle weakness (needed assistance to stand and walk); Tylenol and Motrin. after a day the symptoms were gone.

The day after the second Moderna shot I had a fever of 100.8, aching bones throughout my body. Arms ,neck back, legs and feet. Headache and burning and stinging eyes. I called the hospital and they advised that I follow up if there was no improvement. I have very little energy and am resting.

Five hours after no reaction to the vaccine chills commenced, nausea, vomiting, loss of appetite and severe muscle weakness; unable to ambulate even with walker; lost control of bowels and bladder functions; fatigue. Was bedridden for 36 hours . At about 28 hours upon recommendation from oncologist, took one Benadryl and within 2 hours started to improve. Took 1 Benadryl every six hours for next 48 hours and was feeling better except for residual whole body weakness. Would have been helpful to know about Benadryl before hand. Will take Benadryl 30 minutes prior to getting 2nd shot on March 5. Thanks. Hope this information is helpful to others.

Patient began throwing up at 3:00 a.m. 2/12/2021, had severe chills, blacked out. Extreme fatigue, headache, joint pain. Patient has been sleeping for approximately 14 hours at this time (5:45 pm PST). He is able to slowly walk to bathroom, couch, bed. He is slurring his speech.

2/10/21 Vaccine 6 pm. 2/11/21 10pm swollen hand, extremely painful inflamed right hip. 2/12/21 1 am recurring inflamed hip and right upper leg. 2/13/21 same issue as 2/12/21.

My arm got sore within an hour of me driving home and got progressively worse throughout the day, I took advil. The next day I had severe chills, and tired, fatigued, and then my body aches. I had a bit of a sore throat. I also had joint pain. I had symptoms for three to four days.

HE WOKE UP AT 4:30 CONFUSED, TALKING OUT OF HIS HEAD, THEN WENT BACK TO SLEEP AND WOKE UP AT 0630 WITH HARD SHAKING CHILLS, JOINT PAIN (SHOULDERS AND KNEES), ALTHOUGH HE HAS HAD 2 TOTAL KNEE REPLACEMENTS), HEADACHE, FATIGUE AND MALAISE, AND TEMPERATURE OF 101,5(NOT RESPONSIVE TO EXTRA STRENGTH TYLENOL) 20BENADRYL 25MG EACH , PEPCID 20MG AND GATORAID. . COULD NOT RAISE EITHER ARMS AND STATED THAT THE "BALL JOINTS" IN SHOULDER WERE VERY PAINFUL. AT 4;20 PM TEMP WENT DOWN TO 101.4, AT 6;30 TEMP 100.3 AND 8:45PM TEMP 99.3. AFTER THIS HIS SYMPTOMS SUBSIDED EXCEPT FOR SORE ARM AND SHOULDERS, SIDE EFFECTS LASTED ABOUT 14 HOURS. BUT STRANGE THING HAPPENED ON 02/21/21 HIS ENTIRE MIDDLE FINGER ON LEFT HAND TURNED VERY RED, BUT NO SORENESS OR PAIN. , AND NO OTHER FINGERS WERE RED AND RESOLVED ON 2/22/21

Muscle aches to groin and knee, worsening muscle aches yesterday, fatigue and weakness. Referred to primary provider if symptoms worsen. Patient has appt with provider next Wednesday.

Flare up of all arthritis pain, fever , sweating, chills. Took normal medications , plus Tylenol, went to bed early, fatigue on Friday

Moderna Dose #1: The only adverse event was a mild ache in my arm at the injection site. Moderna Dose #2: About 7 hours post-injection I experienced a temperature (101 F peak) and mild chills, a short-term mild headache, mild muscle /joint aches, and an ache at the injection site. These effects lasted for about 36 hours and then were gone. I would compare them to a mild 2-day case of the flu.

Both knees hurt and had pain. Both wrist (back side of thumb) hurt /pain. Had fatigue for 3 days. Had the moderna vaccine. Felt strange for 3 days. No energy

Patient had dark urine and high CK level and was diagnosed with acute rhabdomyolysis. Patient received IV fluids and nephrology was consulted. Patient was discharged home when stable.

During the early morning hours of Friday, February 19, approximately 12 hours after the vaccination, I awakened to a 102 degree temperature, chills, nausea (triggering dry heaves), strange dreams, and very weak legs. Over the course of the day I alternated taking Ibuprofen (200mg) and Acetaminophen (500mg) every two hours for eight hours to drive down the temperature. I also pushed water, and took naps. I continued this treatment throughout the day of Feb. 19, and once on Saturday, Feb. 20. I experienced a deep degree of lethargy beginning these days and continuing for several days later. I did not "feel like my old self" until Friday, Feb. 2, eight days following the vaccination.

patient received moderna covid-19 vaccines on 1/22/2021 and 2/24/2021. he presented to the ED on 2/26/21 with fall and shortness of breath. patient had been generally weak and having difficulty ambulating for some time and was worse the last 2-3 days. patient fell in the evening and could not get back up due to weakness. he was found the following morning and EMS was called. patient was brought to the ED. he was admitted for acute respiratory failure with hypoxia, COPD, pneumonia, NSTEMI, and rhabdomyolysis. also treated for type 2 DM, HTN, and paroxysmal atrial fibrillation. some concern that covid-19 vaccine may have contributed to the patient's rhabdomyolysis. per physician note on 3/3/2021: "Covid 19 infection November 2020, got vaccinated in mid January and then again in February and got a bad reaction which was somewhat to be expected to lead to more marked myalgias and muscle weakness left him lying on the floor unable to get up and he developed rhabdomyolysis." patient is still currently admitted, though CK levels have improved.

I received the vaccine at 4:30 PM on the 26th of Feb 21. At 11:PM I started to get ready for bed. Felt uneasy...wobbly. Irritating small pain the full length of my spine. Laid down and attempted to sleep no luck. I checked my pulse...very week and uneven. Missing beats...3-small beats in a row many times. Very erratic. It was like that till 5:AM in the morning. I must have finally fallen to sleep and by the time I got up at 8:30AM...my heart beat was back to normal again. Small muscle pains now but nothing else.

Fever ( temp 100.5 ), chills and body shaking Legs very week, barely walk and legs collapsed twice so went to bed for most on day. Slight metal taste in mouth. Didn't want to eat. Shot on Sun., down for count on Mon.,felt better on Tues and Ok by Wed.

Within 4 hours of vaccination my arm swelled up noticeable, became very stiff and sore and made it painful to move my left arm. By 8:00pm I began to feel weak, tired and poorly. By 11:pm I had developed a fever and aches and pains in most joints and muscles which mimicked flu symptons. During the night I became chilled and found it hard to sleep from all of the discomfort. Most of these symptons were almost gone by the next night except for the swelling, which took another 2 days to go down. I have had no other symptons since then.

After the Moderna Shot #2, and on the second day, all the joints and muscles in my body start to hurt. This has continued and my hips and muscles hurt when I walk, both of my shoulders hurt and cannot be lifted above the should without a lot of pain. My hands hurt a night along with my arms and knees. I did not have any of these issues before the 2nd Moderna Covid shot.

Mild fever beginning sometime in the early morning of March 11 and mild acheyness in joints, which became noticeable by mid-morning. Temperature rose to 100.5 by noon. Took one Aleve gel tablet then slept for two-three hours. When I awoke, the fever and acheyness were both gone. No other side effects since then.

79 year old male here for evaluation of possible allergic reaction to Moderna COVID-19 vaccine. 1.Allergic reaction, Urticaria Pt received hist first dose of the Moderna vaccine on Tuesday, March 9th at 11am in his left arm. On Wednesday he began experiencing chills, felt cold and developed a fever of 101.9. Today his symptoms from yesterday resolved however he developed a pruritic urticarial rash on his upper thighs bilaterally, upper arms bilaterally, lower back and abdomen. He took one tablet of Benadryl this morning which did not improve his symptoms. He is not experiencing any shortness of breath, cough, sore throat, difficulty swallowing or wheezing. He has not tried applying any topical creams or ointments. No new medications, laundry detergents, body wash, perfumes or bedding. No history of allergies to food, environment or medications. He has a history of COVID-19 and was hospitalized 2nd to COVID-19 pneumonia for 25 days in 12/2020. - Take OTC Claritin during the day and OTC Benadryl at night for one week - Take 20 mg Pepcid once daily - Start medrol pack - Increase fluid intake - Apply moderate strength triamcinolone ointment to rash - Labs drawn today will call with results - Will report allergic reaction to public health department - VAERS - Reviewed previous labs, HGB low - ER/red flag precautions given. Followed up with patient today 3/12/2020 over the phone: Called pt to follow up. He reports the rash worsening this morning and spreading behind his knees, behind his thighs and behind his calves mostly on his left leg. He applied the steroid cream this morning and he reports the rash greatly improved afterward reducing to about 10-15% remaining. States his rash is almost gone. Patient has been taking all of his medications as prescribed: Medrol dose pack, steroid cream, Claritin, Benadryl, Pepcid. Advised pt to continue to finish full course of medications as prescribed. PT denies any wheezing, cough, SOB. Advised pt that if symptoms worsen or do not improve over the weekend to go to urgent care or ER if life threatening. Red flag signs and symptoms provided. Pt verbalized understanding.

Chills 1:20 am Very stiff right arm 1:20 am Lethargy for 6 days Mild diarrhea days 1 and 2 Urine more frequently than usual

KEY POINTS Had the first dose of the Moderna vaccine on Mon. Jan 11. Symptoms started Tuesday, January 19, 2021 1st hospitalization, January 27, 2021 o Discharged, January 29, 2021 o Diagnosis: High leukocytes, inflammation. Diagnosis, acute pancreatitis. 2nd hospitalization, February 2, 2021. o Discharged February 4, 2021. o Diagnosis: Diagnosis, Deep vein thrombosis (DVT) of popliteal vein and pneumonia Details in notes section. NOTE This is an updated and correctly filed version of a form that I attempted to email to the regulatory authority. No evidence that it went through. Use this version if you have the earlier version. DETAILED DESCRIPTION OF EVENTS AFTER VACCINATION PROGRESSION OF SYMPTOMS TUES. JAN 19: At night, felt like hunger pangs – but not really relieved by eating. In the morning tried 2 Tums. Had temporary relief for about an hour. Had symptoms for the last three days. Chronic, varied between almost negligible to mildly annoying. Bowel habits usually very regular. WED. JAN 20. Had major bowel movements in the middle of the night THUR. JAN 21. Had major bowel movements in the middle of the night FRI. JAN 22. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) SAT. JAN 23. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) SUN. JAN 24. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) MON JAN 25. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) TUES. JAN 26. Problems persisted and got worse. On Jan 26, Daughter GP suggested getting blood analysis to test for inflammation. WEDS, JAN. 27. Hospitalized. Findings: High leukocytes, inflammation. Diagnosis, acute pancreatitis. THURS. FRI. JAN 28. Hospitalized. FRI. Jan 29. Discharged. Wt 193 lbs! Usual, ~176-183. MONDAY FEB 2. Readmitted to hospital. Felt feverish, easy fatigue, bilateral stiffening of the calves, some edema. Diagnosis, DVT of popliteal vein and pneumonia. Given an iv bolus of a broad spectrum antibiotic. Started on Eliquis two 5mg pills twice a day for one week and the one tablet am and one pm. Given Lasix bolus and then started on 5 mg Lasix/day. Swallowing tests more or less OK WEDNESDAY FEB. 4. Discharged. MONDAY, MARCH 8, Check up with GP, Blood pressure 127/76. Lasix discontinued. THURSDAY, MARCH 11, Check up with GI doctor, Blood pressure consistently 150/90. Sent to adjacent cardiologist's office (next door). High BP reading confirmed and reconfirmed the next day. Dose of Metropolol succinate increased to 5 mg 2xday. Note 1: Still have the DVT. Note 2: Received 2nd dose of Moderna vaccine on Feb 11. Note 3. All medical records available either through hospital, GP or by contacting me. Note 4: This is not a crank report. I have had 50 years teaching and doing funded research in 3 medical schools rising to the rank of full Professor in each.

Patient reports experiencing chest discomfort, shortness of breath, and congestion after vaccine dose 1 and dose 2. Patient seen for televisit after recieving 2nd covid vaccine 4 days ago. He has a little trouble breathing and has pain around his chest with some muscle pains. He reports that the pain is increased in his upper chest. He is more short of breath walking up stairs, coughs up a little bit, does use advair, has rescue inhaler. Patient was directed to seek further care at immediate care. Has hx of chest pain and tightness prior to vaccine most recently documented in 3/2020

Patient reports continued pain at L shoulder joint after receiving first Moderna vaccine. This was reported when coming to receive his second dose from writer today. pain started resolving 1-2 days ago in the L shoulder and pt believes it is slowly getting better.

belching queasiness slight vomitus, feeling cold no fever, nasal congestion and left lower back and hip pain.

Weakness, Fall, Rhabdomyolysis Narrative: Patient presented following a fall at home within 24 hours of the second COVID vaccine. Pt reported chills, weakness leading to fall, subsequently developed rhabdomyolysis requiring hospitalization due to weakness/prolonged period down after fall.

Severe night sweats, every night since first injection up until now. In beginning, enough sweat to wring out of an undershirt. Aching in previous areas affected by gout--wrist and foot.

Patient became weak and unable to hold his head up one day following injection. Following day, low appetite. Day 2, had vomiting and unable to take in any PO. Day 3, was able to start eating. Day 4 and 5, he had improvement of neck pain. Day 5, had drop in blood pressure into the 70-80s systolic and 40-50s diastolic at home and then again in the clinic with no other signs of illness. Day 6, found to have Acute Kidney Injury on his CKD with creatinine rising into the 5's with baseline creatinine of 1.4-1.6. His liver function was abnormal also with elevated bilirubin to 6 (baseline normal 1), Alk Phos 522. He was hospitalized 2/25-2/28/2021 for these issues.

Arthritis flared up very strongly after vaccination, to a disabling extent. Both my primary and I think this was coincidence.

Swelling and erythema of the right forearm after second COVID-19 vaccine along with shoulder pain. Symptoms started on 3/14/21.Pt was admitted to the OBS Unit and subsequently diagnosed with Right Upper Extremity Cellulitis.Tx in hospital was Rocephin IV for failed po Keflex tx. and subsequently discharged home on Doxycycline 100mg po BID x10 days .Pt. was also in the ED on 3/17/21 for same c/o and discharged on po Keflex.

pt states he had a sore left arm that hurt for about 3 days. Pt says his both ankles were swollen and as of today 4/7/2021 they are still this swollen. He has developed fatigue a couple of days later. He still has these symptoms and will reach out to his PCP for medical advice.

About 4 days after the second dose my lymph nodes near the injection site started to hurt. Over the next few days the pain got worse so that I couldn't lie on that side of my body. The symptoms progressed towards my shoulder and neck and other lymph nodes became painful. The next phase a few days later was red spots and blisters around the injection site on my chest near my neck on my left side. At the present time the blisters have mostly gone away but they've been replaced by welts where the red spots were these are swollen and red. All of these symptoms are accompanied by fatigue and muscle pain also around my left shoulder. I have been treating it for the past 3 days with ice and am now taking an antihistamine Benadryl.

chest pain; Shaking legs/ Tremors in hands; legs buckled; anxiety; Weight loss; fell to ground; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain), TREMOR (Shaking legs/ Tremors in hands) and LIMB DISCOMFORT (legs buckled) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 038K20A) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced FALL (fell to ground) and WEIGHT DECREASED (Weight loss). On an unknown date, the patient experienced TREMOR (Shaking legs/ Tremors in hands) (seriousness criterion disability), LIMB DISCOMFORT (legs buckled) (seriousness criterion disability) and ANXIETY (anxiety). On 04-Apr-2021, CHEST PAIN (chest pain) had resolved. At the time of the report, TREMOR (Shaking legs/ Tremors in hands), LIMB DISCOMFORT (legs buckled), FALL (fell to ground), ANXIETY (anxiety) and WEIGHT DECREASED (Weight loss) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) Normal. In March 2021, Computerised tomogram: normal (normal) Normal. In March 2021, Weight: 148 (Inconclusive) Inconclusive. On 06-Apr-2021, Weight: 125 (Inconclusive) Inconclusive. On an unknown date, Blood pressure measurement: elevated (High) BP Elevated. On an unknown date, Heart rate: elevated (High) Elevated. The patient underwent CAT scan of the stomach, complete gastro work-up and complete blood work up. All tests were result normal. On 3 Apr 2021 he experienced severe chest pain and was transported to the hospital they concluded it was not heart related but he was hospitalized overnight. His BP and heart rate were also elevated. Concomitant product use was not provided.Treatment information was unknown. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

24 hrs of Flu like symtons. Sever joint pain that endures to this day 4/23/21. I can barely curl my fingers and pain in both elbows. wrists and shoulders I was given steroid shots and knock down the pain last given on 4/18 but pain is back. I am nearly a cripple

Ankle swelling with extreme foot pain(has neuropathy) No symptoms in 15 minutes after injection on both injections After the second injection had complaints of being shaky, not feeling well with generalized weakness

soreness of the arm, radiates to his elbow. the past 5 days patient reported that he developed muscle soreness in cheeks, knees, front leg, thigh, lump inside of the arm

101.5 Fever, chills, headache, lower back pain on April 25,2021. Received Covid Rapid test on 4/25/21 - Result was negative. Was advised to follow-up with Primary Care Doctor. Went to Primary Care FNP on 4/26/21 and was given blood test and scheduled CT ABD/PELVIS W/O IV No Oral Con (Stone Protocol)

Dyspnea and fatigue and low back pain starting 4/26. Seen at Urgent Care 5/1 and recommended to go to ED for ACS rule out. Declined. Followed up on 5/3 with persistent dyspnea, no hypoxia or tachypnea but visible increased work of breathing in office.

extended moderate diarrhea and lower back ache (not pain) from soon after second shot to current time

After the second shot, earlier the next morning I received a severe pain in my neck, similar to a "crick" in my neck that has lasted more than two months now. I need to know how to relieve the severe pain in my neck or what should I do about it. Please call me as soon as possible and let me know what I should do about this pain. The doctor prescribed Prednisone and Cyclobenzaprine but they have not helped the pain.

Lost the function in right side/ could not write; Tremor; Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid; Hematoma on the left side of the brain/ slight hematoma on the right side of his brain; Could not hold anything at all in right hand even a spoon, almost like he had a stroke; Dragging right foot; Headache; Total fatigue; Totally wiped out, took everything out of him to go to the bathroom; Could hardly get up and had no control in his fett; He was not acting right; Something going on with his eye, movement to the eyes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMATOMA (Hematoma on the left side of the brain/ slight hematoma on the right side of his brain), MOBILITY DECREASED (Lost the function in right side/ could not write), TREMOR (Tremor), CRANIOTOMY (Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid) and LOSS OF CONTROL OF LEGS (Could hardly get up and had no control in his fett) in a 79-year-old male 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 COVID-19 pneumonia on 03-Nov-2020. Concomitant products included FINASTERIDE. In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CEREBRAL HAEMATOMA (Hematoma on the left side of the brain/ slight hematoma on the right side of his brain) (seriousness criteria hospitalization prolonged and medically significant), CRANIOTOMY (Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid) (seriousness criterion hospitalization prolonged) and EYE MOVEMENT DISORDER (Something going on with his eye, movement to the eyes). On 20-Apr-2021, the patient experienced FEELING ABNORMAL (He was not acting right). On 22-Apr-2021, the patient experienced LOSS OF CONTROL OF LEGS (Could hardly get up and had no control in his fett) (seriousness criterion medically significant) and ASTHENIA (Totally wiped out, took everything out of him to go to the bathroom). On an unknown date, the patient experienced MOBILITY DECREASED (Lost the function in right side/ could not write) (seriousness criterion hospitalization prolonged), TREMOR (Tremor) (seriousness criterion hospitalization prolonged), MUSCULAR WEAKNESS (Could not hold anything at all in right hand even a spoon, almost like he had a stroke), GAIT DISTURBANCE (Dragging right foot), HEADACHE (Headache) and FATIGUE (Total fatigue). The patient was treated with BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Physical therapy for Mobility decreased. At the time of the report, CEREBRAL HAEMATOMA (Hematoma on the left side of the brain/ slight hematoma on the right side of his brain) and MOBILITY DECREASED (Lost the function in right side/ could not write) was resolving, TREMOR (Tremor) had resolved, CRANIOTOMY (Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid), LOSS OF CONTROL OF LEGS (Could hardly get up and had no control in his fett), MUSCULAR WEAKNESS (Could not hold anything at all in right hand even a spoon, almost like he had a stroke), EYE MOVEMENT DISORDER (Something going on with his eye, movement to the eyes), FEELING ABNORMAL (He was not acting right), GAIT DISTURBANCE (Dragging right foot), ASTHENIA (Totally wiped out, took everything out of him to go to the bathroom) and HEADACHE (Headache) outcome was unknown and FATIGUE (Total fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Magnetic resonance imaging: abnormal (abnormal) Hematoma on the left side of the brain. On 20-Apr-2021, Scan: hematoma reduced in size No hematoma was present on the base of the spine. On 22-Apr-2021, Scan: improved Scan showed improvement. Patient stayed in the intensive care unit for 5 days then in critical care unit for 1 day and then sent home. On 20 Apr 2021 patient was again taken to Emergency Room. They gave him pain medicine which helped with the headache and send him home. On 22 Apr 2021 patient was again taken to hospital due to some conditions along with fatigue. and given medication for sleep. On 18 May 2021 the patient was seen by the neurosurgeon. Hematoma did not go away by now. Patient is in physical therapy to regain the use of his hand, can write now, sensory issues have cleared up. 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.

During 3 1/2 months subsequent to the 2nd Moderna vaccination (i.e. thru present date) I have experienced joint pain in my back, hips, shoulders, and knees; additionally, I have experienced muscle pain in my legs, back, neck, and left foot.

3/10/21 experienced fever, body aches, sore arm. 3/17/21 bilateral hand weakness 4/8/21 2nd injection. 4/9/21 fever, body aches, pain in shoulders, elbows, wrists - very intense felt like on fire. 4/18/21 seen in local ER - joint pain over a month. given toradol and prednisone by PCP. 5/18/21 Returned to ER with complaints of bilateral arm, shoulder and wrist pain since COVID vaccines. Given prednisone. His primary care physician has done complete work up and feels patients complaints are due to vaccine. 6/10/21 Spoke to patient still has weakness bilateral hands and arms and constant muscle aches.

On the next day, 06/02/2021 and lasting 4 days, I experienced the following: painful left shoulder/arm, headache, extremely tired, uncontrollable diarrhea. Note: Daughter living in another city also had trouble over 4 days with the second shot. My Mother had Guillen-Barre Syndrome over 40 years ago and was incapacitated for a year.

daily fatigue pain in the right leg from the thigh and knee Knee is swollen went to doctor and told to get sonogram on June 17 after results of sonogram doctor prescribed Xzrelto

Pt received initial dose of vaccine on March 16, 2021. Pt received the second dose on April 15, 2021. Pt had CVA on April 16, 2021 affecting right hand and lower arm with generalized weakness. Pt was fully cognizant at this time. Pt developed pneumonia and was hospitalized in ICU on April 29,2021, requiring ventilation support. Pt died May 6, 2021.

Has DLBCL; lymphoma had metastasized; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL), SPLENOMEGALY (spleen was double in size) and METASTATIC LYMPHOMA (lymphoma had metastasized) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included THYROID (ARMOUR THYROID), LISINOPRIL, SIMVASTATIN and TAMSULOSIN for an unknown indication. On 13-Feb-2021, the patient 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. In March 2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL) (seriousness criteria hospitalization and medically significant), METASTATIC LYMPHOMA (lymphoma had metastasized) (seriousness criteria hospitalization and medically significant), and MYALGIA (Sore arm). The patient was hospitalized from 22-Mar-2021 to 27-Mar-2021 due to DIFFUSE LARGE B-CELL LYMPHOMA and METASTATIC LYMPHOMA. At the time of the report, DIFFUSE LARGE B-CELL LYMPHOMA (Has DLBCL), METASTATIC LYMPHOMA (lymphoma had metastasized), FATIGUE (Fatigue) and MYALGIA (Sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood calcium: 10.6 (Inconclusive) Inconclusive. In January 2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 08-Apr-2021, Positron emission tomogram: abnormal (abnormal) Test show damage or stunning of kidneys. In 2021, Biopsy: abnormal (abnormal) Bone marrow and lymph nodes biopsy shows large B-cell lymphoma.. In 2021, Blood calcium: 14.4 (High) Calcium level high. In 2021, Platelet count: 81-82 (Low) low platelet level. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Treatment information was not provided.; Sender's Comments: Very limited information regarding the events has been provided at this time. An alternative explanation is that the events were more consistent with the increased risk due to advanced age related factors. Further information has been requested.

Muscular and joint pain in shoulders and upper arms (bilateral). First observed about 36 hours after injection. Persists as of 1543 EST, 15 JAN 2021

As a 1a health provider I received my vaccination a weekend half ago resulting in dizziness, difficult mentation eg, administering my clinic, headache, a firey, red, rash over 90% of my upper body and 30% of my lower body, joint pain and muscle ache, worsening So far all the medical help I have received advices cortisone for the itch but I am really trying to understand what I need for my immune system and should I, or should I not get the 2nd dose

HUGE lower backache. Writhed on the bathroom floor out of bed. Hobbled with a chair for a walker. Called family GP. Recommends OTC stuff. Some better on day 2. Still not walking right. Minimum movement.

Moderna COVID-19 Vaccine EUA Adverse Events: (one day later) Severe back pain & general muscle fatigue Nausea & Vomiting Bloating stomach Took full strength Asprin pills 2 times, and slowly recovered the next day.

Racing heart rate >100 woke him up out of a sound sleep around 10pm on day of vaccine. (Vaccine was given approx 1:40pm) lasted about 30 minutes then it calmed down to more normal heart rate. Next morning bad headache 5-10am. Took Tylenol for it. Also, pain at injection site, across shoulder and lower neck for approx 24 hours after shot.

He had slight fever and chills, diarrhea, muscle weakness, arrhythmia asserted itself. Home health nurse came out and checked on him and put him on bed rest.

no reaction until 30 hr after vaccination. Then had severe shivering lasting perhaps 2 hr followed by exhaustion and stiffness lasting through next day. Third day after vaccination, shivers returned, fever no higher than 101 degrees, followed by heavy perspiration. Not sure when it will stop.

blurred vision chills white hands fever muscle pain confusion swelling and redness in limbs headache

Pt presented to ED 1/25/2021 with 1 week history of bilateral shoulder pain, started on right, left involved later, wore with movement. NKI. He was given IM ketorolac 30 mg and seen in Clinic by chiropractor with some relief 1 day. PT consult placed and is still pending. Known hx osteoarthritis right shoulder by x-ray 12/10/20 Pt returned to urgent care/walk-in clinic 2/8 with worsening bilateral shoulder pain. ROM of both shoulders quite limited. NKI. Treated for PMR.

Patient developed profound weakness in his legs and arms the following day. Had 2 mechanical falls which necessitated activation of EMS to get him off the ground.

Chills then fever and joint and muscle pain beginning about 12 hours post vaccination and lasting about 24 hours. Dr. said that this is a common side effect to Covid vaccinations

2 1/2 days after the shot - chills, low grade fever, muscle aches, head & chest congestion. Lasted overnight. Following day minor head & chest congestion remained.

Patient with achiness that eventually progressed to severe muscle pain with movement and experienced elevation of CK to 6546 on 2/14 and required hospitalization.

A few hours after receiving first dose of vaccine, developed extreme leg weakness (unable to stand). This persisted for two days and pt was sent to emergency room. Initial evaluation at ER revealed leg weakness only. After 24 hours observation, it was noted that the patient had left sided weakness and slurred speech. MRI confirmed acute infarct in right pons area.

About 26 hours after the vaccine experienced severe lower back where he had surgery 5 years ago. His daily back pain with activity is usually a 3 on a scale of 1-10. The pain after the vaccine was so severe he was unable to stand up or sit down without help and he rated his pain with activity as an 8. Today the pain is still an 8 with activity. He has not done any type of unusual activities that would cause the sudden increase in pain. The doctor's office has been closed due to the holiday and he is going to call the doctor's office today.

80 year old male history significant for multiple cormorbities who presented to the ER with reports of shortness of breath and pleuritic pain. He reports sudden onset of back pain in his thoracolumbar spine which was associated with shortness of breath. He notes the pain was intermittent and sometimes positional but exacerbated with deep inspiration. Due to concern for aforementioned symptoms he presented to his PCP earlier who referred him to the ER. Subsequent workup with CT revealed right sided subsegmental PE. Etiology of PE remains elusive as patient denies recent trauma/immobilization, denies history of prior PE/VTE or coagulopathy

had a sore arm, so sore that he ended in the hospital for 2 days; he couldn´t move his arm; it still hurts and goes into his neck; A spontaneous report was received from a consumer concerning, an 80-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a sore arm, he couldn't move his arm, and it still hurts and goes into his neck. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 ([LOT# not provided]) intramuscularly for prophylaxis of COVID-19 infection. The patient's wife stated that the patient had the vaccine and then 5 days later he had a sore arm, so sore that he ended up in the hospital for 2 days (dates not provided). The patient couldn't move his arm and it still hurts and goes into his neck. The patient did not plan on receiving the 2nd dose of the vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events of he ended in the hospital for 2 days, he couldn't move his arm and it still hurts and goes into his neck were not resolved.; 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.

Muscle aches and pains, fever 100.4 few hours later atrial fib low blood pressure, fall, admit to ED then admit to hospital. Care continuing in hospital at this point.

STARTED AROUND 630PM WITH NOT FEELING WELL; BY 900PM ACHES IN SHOULDERS AND BACK; ALL NIGHT LONG ACHES BECAME WORSE UNTIL AROUND 800AM; AROUND 300AM TEMP 100.6; STAYED LISTLESS UNTIL AROUND 400PM; WHILE FEELING "BETTER" AROUND 600PM. STILL TIRE EASILY.

bilateral thigh pain, leg pain with whole body aches 10 days after vaccination follow by weakness of both lower limbs

Approx, 4 hrs after receiving 2nd dose, started c/o pain in the rt shoulder joint. Pain continues today. Pt. Cannot even raise his arm. I want to emphazie the pain is in the shoulder joint not in the muscle

Mild shoulder pain. Mild dizziness, not enough to cause staggering. Drowsiness and causing many naps. Unusual fatigue during ski training at 7200 ft.

Severe muscle pain, stiffness in shoulders, hips and knees; ibuprophen; slowly improving 6 weeks after

Patient is an 80-year-old male that is admitted for observation status for recent TIA symptoms and bradycardia. He was seen in the emergency room this morning at approximately for complaints of posterior head and neck pressure, right arm numbness and tingling as well as a mild blurry vision in his right eye. Patient states that the symptoms from the right arm and eye blurriness lasted less than 1 hour. And has completely resolved at this time. Patient states that he still does have some posterior neck tightness. But most of this is on the left side at this point. Patient denies any increase in physical activity that he could attribute to the onset of the neck pain. Patient states that it does feel tight when he turns his head from side to side. Patient states that he no longer has a headache. He does have a history of a possible mini stroke approximately 10 years ago. He has had no other recent cardiac problems, or any other strokelike symptoms since that time. Patient takes medications for his cholesterol and a baby aspirin daily. Patient is fairly active and continues to drive a semi-5 days a week. TIA Neurochecks every 4 hours Carotid Dopplers 3/2 Bradycardia Echocardiogram 3/2 Last echo 1/4/2019, EF 60% Discharged home 3/2/21.

Had shortness of breath, chills, and fever up to 102 for the first day and half. On Sunday it came back to normal finally. Night sweats that are still continuing. Just during the day and get hot flashes. Flushing, upper body clamminess and then goes away and then has chills. His breathing has improved but is still not real steady on his feet. He is about 80-85% on his balance, 95% on his breathing. His biggest problem at this point is the hot flashes and the chills. He also has had loss of appetite and has had weight loss.

fever 102 , chills , myalgias on day after vaccine symptoms persisted for 12 days CBC done on 3/3/21 shows PANCYTOPENIA referred to hematology and plan is for monitoring of CBC for now fever has improved

Acute onset of bilateral thigh (quadriceps) wealness resulting in lower extremity immobility for about 10 hrs.Assoc. with fevereishness.

Soreness at injection site, Muscular & joint soreness, extreme fatigue. Tylenol taken for 2 days. Slept 2 nights and next morning slight lingering of affects. All gone after 3rd day. NOTE: No adverse affects after injection 1.

one episode of heavy sweating...followed by 5 days of not being able to walk in my home more than 10 feet without having to sit due to severe pain and cramping in upper part of both les. Also unable to lift either or both arms above my waist without sever pain or cramping. this lasted for 5 days before subsiding. three days later both ankles and my lower left leg became swollen. this has presisted for 10 days.

Back ache getting progressively worse until second shot on March 3, 2021. Then back ache progressed to back pain that would be a sharp jab to mid thoracic area. Pain was much worse after second dose. Paid has become less severe by 3/17/21. Less severe side effect has been dizziness that is mild but still persists as of 3/17/21.

Muscular pain in the upper and mostly lower arm muscles of the left arm which is the arm that received the vaccine shot. Symptoms have continued to date, waxing and waning over this period. Do not recall straining or otherwise injuring left arm muscles.

One day after the first Moderna vaccine, this gentleman developed hand and wrist pain. There was then hand numbness and swelling across the right wrist and MCP joints. He had pain in the hands, wrists, shoulders, and hips. He felt weak in hands and with rising from a chair or climbing stairs.

Got the vaccine, yesterday afternoon he went to the bathroom and felt a little light headed, and was not able to move, but did not collapse. He did not have any muscle control and not able to stand up. He then went down on the floor, not able to get up and called an ambulance and they took him to the hospital, had a temp of 101.4, after Tylenol went down to 99.4 and checked him out, and was having heart arrythemia. They then suspected the adverse reaction to the vaccine and he was checked out of the hospital. They told him to take Tylenol. Told him to FU with his PCP.

You probably after using my time will have some reason for not allowing me to report this field 18. Why have you been keeping me from reporting it? Four four weeks after the second Moderna Covid 19 vaccine I gained five pounds a week with no change in diet except I may have eaten less. Finally, I was wheezing one morning . I told a friend of mine who is also a retired Doctor. He checked me over and told me I was retaining water and was carrying at least 15 pounds of water in my legs alone. i was also carrying excess water in my abdomen. He took me to my doctor, but I was not allowed to be seen until they shove a stick up my nose until I gagged. After I received the negative results I was allowed to see my doctor. Should have never told them I wheezed. Anyway, after seeing me x-rays were ordered and the next day my doctor contacted me. I am retaining water, IMHO, as a result of the second Mocerna Covid 19 vaccination. I am now on a water pill. Weight has come down about 15 pounds in one week. Only 7 pounds more than what it was when I received the second Moderna COVID-19 vaccine. I feel I will be able to shed the rest of the water being retained as a result of the second Moderna COVID-19 vaccine. Cordially, patient Wonder if I will be allowed to report this or be stopped as before.

Rapid onset in fever and myalgia. Dyspnea and hypoxia developed over days, and eventually patient was hospitalized with bilateral pneumonia consistent with COVID-19, however patient had multiple negative tests for SARS-CoV-2, both antigen and PCR. Patient eventually diagnosed with interstitial lung disease prior to expiring on 4/7/2021.

Pt reports continued fatigue and muscle aches sine day after vaccine given. Currently being followed by PCP Numerous scans, and blood work for work up by PCP

ruptured appendix; Cramps in his lower intestine; Shoulder started getting a little sore; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS PERFORATED (ruptured appendix) in an 80-year-old male 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 ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SIMVASTATIN, ALLOPURINOL and TOPIRAMATE for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced ARTHRALGIA (Shoulder started getting a little sore). On 13-Jan-2021, the patient experienced GASTROINTESTINAL PAIN (Cramps in his lower intestine). On an unknown date, the patient experienced APPENDICITIS PERFORATED (ruptured appendix) (seriousness criterion hospitalization). At the time of the report, APPENDICITIS PERFORATED (ruptured appendix) had resolved and GASTROINTESTINAL PAIN (Cramps in his lower intestine) and ARTHRALGIA (Shoulder started getting a little sore) outcome was unknown. The patient took Tums antacids which helped for a little while and he took milk on 14-Jan-2021. For ruptured appendix, patient had surgery in the hospital. Although a temporal association exists, based on the current available information, the mechanism of action of mRNA-1237 vaccine and the pathophysiology of appendicitis, the event of appendicitis perforated is assessed as unlikely related. The event of gastrointestinal pain is in consistence with the symptoms of appendicitis perforated. The causality of the event of arthralgia is assessed as possibly related. Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: An event ruptured appendix was added with treatment information.; Sender's Comments: Although a temporal association exists, based on the current available information, the mechanism of action of mRNA-1237 vaccine and the pathophysiology of appendicitis, the event of appendicitis perforated is assessed as unlikely related. The event of gastrointestinal pain is in consistence with the symptoms of appendicitis perforated. The causality of the event of arthralgia is assessed as possibly related.

stiffness; rigidity; swallowing disorder; freezing phenomenon; worsened blood pressure fluctuation; Dementia aggravated; wrong technique in product usage process; stoma site pain; Abdominal pain; complication associated with device; stoma site granulation; pain in arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Weight loss in December 2019, Aspiration pneumonia since 06-Feb-2021, Stomach ulcer, Chronic pancreatitis, Anxiety, Arthritis, Dementia, Pulse pressure wide, Urination impaired, Parkinson's disease, Abdominal pain since 21-Jan-2021, Abdominal discomfort since 21-Jan-2021, Abdominal bloating since 21-Jan-2021, Device migration since 21-Jan-2021, Distended abdomen since 21-Jan-2021, Nausea since 21-Jan-2021, Dementia aggravated and Blood pressure fluctuation. Concomitant products included CARBIDOPA, LEVODOPA (DUOPA) for Parkinson's disease, LINACLOTIDE (LINZESS), MACROGOL 3350 (MIRALAX) and ACETAMINOPHEN for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 08-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant), COMPLICATION ASSOCIATED WITH DEVICE (complication associated with device) and STOMA SITE PAIN (stoma site pain). On 10-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process). In March 2021, the patient experienced STOMA SITE HYPERGRANULATION (stoma site granulation). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), MUSCLE RIGIDITY (rigidity), DYSPHAGIA (swallowing disorder), FREEZING PHENOMENON (freezing phenomenon), BLOOD PRESSURE FLUCTUATION (worsened blood pressure fluctuation) and DEMENTIA (Dementia aggravated). On 10-Mar-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process) and STOMA SITE PAIN (stoma site pain) had resolved. At the time of the report, ABDOMINAL PAIN (Abdominal pain), COMPLICATION ASSOCIATED WITH DEVICE (complication associated with device) and PAIN IN EXTREMITY (pain in arm) had resolved, STOMA SITE HYPERGRANULATION (stoma site granulation) and DEMENTIA (Dementia aggravated) outcome was unknown and MUSCULOSKELETAL STIFFNESS (stiffness), MUSCLE RIGIDITY (rigidity), DYSPHAGIA (swallowing disorder), FREEZING PHENOMENON (freezing phenomenon) and BLOOD PRESSURE FLUCTUATION (worsened blood pressure fluctuation) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Computerised tomogram: abnormal Abdominal: Revealed the internal retention plate of the G tube was rubbing up against the abdominal wall causing the pain. On 08-Mar-2021, X-ray: abnormal Abdominal unclear; PEG J Placement was okay. On 10-Mar-2021, Computerised tomogram: abnormal Abdomen: Balloon was pushed up against the stoma. On 10-Mar-2021, X-ray: abnormal Abdomen: PEG J Placement was okay. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (pain in arm) to be probably related and ABDOMINAL PAIN (Abdominal pain), STOMA SITE HYPERGRANULATION (stoma site granulation), COMPLICATION ASSOCIATED WITH DEVICE (complication associated with device), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process), STOMA SITE PAIN (stoma site pain), MUSCULOSKELETAL STIFFNESS (stiffness), MUSCLE RIGIDITY (rigidity), DYSPHAGIA (swallowing disorder), FREEZING PHENOMENON (freezing phenomenon), BLOOD PRESSURE FLUCTUATION (worsened blood pressure fluctuation) and DEMENTIA (Dementia aggravated) to be not related. Treatment: The patient's PEG tube was moved back in from position 2 to position 4. The patient received treatment with silver nitrate and trimethobenzamide (Tigan).

Had the COVID shot and two days later he can't use the arm. Right shoulder hurts very badly. Also the shoulder joint hurts. Top of shoulder can't use the arm. Painful, very sore.

The Patients leg gave out and he fell. Per doctors at hospital, he did not hit his head. He could not get up and he vomited. Ambulance was called and he was taken to the Hospital. The family was told that he had a brain bleed near the thalamus. A few hours later the patient was unresponsive. He was intubated and taken to neuro ICU. Within less then 24 hours from first symptom the patient died.

5 days following vaccine - fever/chills/complete loss of strength... 30 days following vaccine COMPLETE LOSS OF STRENGTH.. patient fell twice - no strength to get himself up ... sent to hospital ... then to rehab facility

Patient stated he could not walk in the morning and this lasted for about 12 hours after the second dose of Moderna.

Regularly get chills every day. Muscle soreness. Discomfort at injection site. Difficulty lifting right arm.

Patient is having joint pain since receiving both Moderna vaccines. Patient saw his provider and further lab work has been ordered. 1st dose 02/12/21 & 2nd dose 03/19/21

did not get second dose due to side effects from first dose; blood clot in lung; Really bad back pain; breathing was difficult; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (blood clot in lung) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PULMONARY EMBOLISM (blood clot in lung) (seriousness criterion medically significant), BACK PAIN (Really bad back pain) and DYSPNOEA (breathing was difficult). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get second dose due to side effects from first dose). The patient was treated with APIXABAN at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (blood clot in lung), BACK PAIN (Really bad back pain), DYSPNOEA (breathing was difficult) and PRODUCT DOSE OMISSION ISSUE (did not get second dose due to side effects from first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products information was not provided. Patient experienced "really bad back pain" and "breathing was difficult". Went to see his doctor who then stated he had a blood clot in his lung. Caller stated he was then put on Eliquis and the doctor said he would have to take it for the rest of his life. Caller wanted to know if this was true or if he can eventually stop taking the Eliquis. He also wanted to know what caused him to get a blood clot. Company comment: Very limited information regarding the events has been provided at this time. Further information is expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is expected.

Symptoms start evening 2-1-2021 slight fever 2-2-2021 fever 99.6 muscle pain legs 2-3-2021 fever 99.7 extreme muscle pain whole body, headache, difficult to sleep, aspirin, Tylenol did not help 2-3-2021 fever 99.9 extreme muscle pain whole body, headache, difficult to sleep, aspirin, Tylenol did not help 2-4-2021 fever99.4 muscle pain whole body easing 2-4-2021 fever, pain gone called Urgent Care, told to take Tylenol did not see a doctor, under lock down in this state,

The clinic gave me the shots --But the doctor at Medical Center checked by hearing losss. Shoulders hurt very bad and could not sleep on side. Still hurt now. My hearing went bad between my two shots. I did have hearing add's but after shots it really got bad and Doctor says I am a candidate for hearing implants now.

Per MD & RN notes from Emergency Dept Records: "Of note, patient received first COVID vaccine two days ago 1/14/21 and has had chills, sweats, and malaise over the past 24-48 hours." Pt also reports "not drinking enough water" leading to dizziness & syncopal episodes x3, with T-spine compression fractures secondary to at least one of these falls. Denies loss of consciousness, headache, vision changes, tinnitus, Nausea/vomiting, numbness/tingling/weakness in extremeties except for brief feeling of knees "giving out" just prior to falls. Pt admitted to Medical Ctr on 1/16/2021, w/ T7, T9 & T11 fractures, & comorbidities. Planned discharge for 1/25/2021.

two days after vaccination shoulder ache, cough, 4 days after RT calf upper muscle pain which moved into RT ankle, 5 days later previous symptoms gone, 8 days later same calf pain again but in LT, pt also noticed heart arrhythmia's occurring, pt took a beta blocker and symptom subsided

Next morning after injection, woke up not feeling well. Temperature, shakes, internal quivering, chills, tired, aching joints. This went on for 2 more days. Temperature ranged from 100.2 to 101.6. Friday morning (2/5) woke with fever of 101 but soon dropped down to 99. As the day went on temperature became normal and has stayed that way. Lost 3 pounds and still feeling very tired. Arm at injection site was swollen and very hard.

SORE ARM AND SHOULDER, VERY LETHARGIC, CHEST CONGESTION, NO APPETITE, HEADACHE, UPSET STOMACH. DID NOT SEEK MEDICAL ATTENTION.. GETTING BETTER. ACCEPTED AS PART OF IT SINCE I HAD HEARD STORIES THAT THE SECOND VACINE WAS GOING TO BE WITH MORE SIDE EFFECTS.

pt stated that the night after the vax he started getting pain in his left knee and he fell. He has to walk with cane since this.

January 20 received first shot-Moderna 005J20-2A at the hospital. Arm sore for about a day c. January 22 onward-slight headaches January 26 began having severe chills. These lasted for about 4 days. They were most severe on January 29. Concurrent with chills was the onset of fatigue. c. January 29-severe pain in hips and shoulders rendering me almost immobile. It was very difficult to get out of bed and to walk. I used a cane for support. Also the onset of diarrhea and loss of appetite. Tried extra strength Tylenol, but it did not help. Never had a fever, respiratory symptoms, of loss of taste or smell. Had nasal Covid test of February 1 which was negative. Saw Doctor on February 4. He ordered blood tests, one of which was to check potential source of joint pain. The test was negative for that, but showed some lessening of kidney and liver function. February 8-blood test showed considerable improvement on kidney and liver function. All symptoms except the fatigue have gone away. I did lose about 5 pounds during this reaction period. The fatigue is improving.

The following day I had soreness in my left shoulder. Then two days after that the 11th I had a really bad headache. The following day I started feeling like my equilibrium was out of balance. I can not even walk a straight line. The headache and soreness in my shoulder went away but I am still experiencing equilibrium issues. This is making it hard for me to walk. It feels I have been on ship. I called in to my ARNP this morning; She and I are waiting on a return call from her.

The first day, he did not feel real good, felt weak. On Saturday had fever, no appetite. Sat down and couldn't get up, joint pain had no balance. The fever kept going and down. Felt weak, didn't feel like moving and slept most of the time. Felt better on Sunday, a little weak.

5 days after vaccination started getting small red splotches on arm below the injection site. In 3 days the pinkish/red area was 3 1/4" and 2 1/4" wide. Surface itched and sore in the muscle. Doctor's nurse advised to just watch it and if gets worse to call back. After another 7 days it went away other than a very faint outline.

Flue like symptoms, dizzy, aches in shoulders joints, chills and fever for several hours. took two 500 mg acdmediphane tablets at 2AM.

Developed weakness/numbness in the entire hand within 24 hours of being given the vaccine. Patient was seen on 2/19 and while some of the numbness had resolved, she did have findings consistent with ulnar neuropathy (weakness in hand and numbness in 4th/5th digits)

Two days after the vaccine I received inordinate back and midsection pain every time I tried to sit, bend or lay down to sleep. This has continued through today although it shows some, but not complete, but complete signs of subsiding.

On 02/17/2021, patient received the second dose of COVID-19 Moderna vaccine in the left arm. Approximately 3 days post-administration, patient developed pain, swelling and erythema of the shoulder extending to the posterior/proximal anterior sections of the arm. Patient was unable to move arm due to swelling and presented to the Medical Center Emergency Department on 02/22/2021. A CT of the extremities revealed cellulitis, myositis, and possible fasciitis without abscesses. Subsequent MRI found myositis and cellulitis without evidence of osteomyelitis. Patient began to develop erthematous blotches and an Infectious disease consult was placed. Patient was started on broad-spectrum antibiotics (Ceftriaxone, vancomycin, and clindamycin). After cultures were obtained, patient was de-escalated to ceftriaxone. Two sets of blood cultures taken prior to antibiotics and a left arm swab showed no growth (finalized). On 02/26/2021 patient underwent incision and debridement of left arm with findings of edematous soft tissue without abscess or necrosis. On 02/28/2021 all antibiotics were discontinued per Infectious Disease provider due to lack of concern for infection.

Extreme loss of strength and energy at 2pm followed by and hour long bout of chills and uncontrolled shaking starting at about 9:15pm. On the following day (2/24) I felt extremely weak and fainted at about 7:00am. So weak it took about 15 minutes before I could raise myself up from the floor. Felt weak and unsteady all day and had muscle aches all over. Slept on and off for most of the day.

The pt reports having swollen hands three days after the first vaccine (1/22) so started to have symptoms 1/25. PCP did not think this reaction was due to the covid shot. Pt then got second dose 2/19 and now both hands are swollen and some back pain is noted.

Patient was vaccinated on 2/24/21. On evening of 2/25/21, patient began to experience balance problems. On 2/26/21, patient began to experience tingling and weakness in lower extremities. On 2/27/21, patient required walker to ambulate.

Neck muscles & shoulder muscles in the back hurt, significant pain lasting 3 days Throat irritation and productive cough all thru the day & night

02/26/2021 my father woke up with a headache, chills, pain across his shoulders and his arm felt like it had lead in it. In the afternoon, around 3:30pm he was in the bedroom to change clothes and got severely weak and fell. He felt like he was going to vomit too. He was so weak that he could not get up off the floor by himself. My son lifted him up. He also noticed Friday night that there was a bubble where the vaccine was given in his arm. 02/27/2021, the bubble had burst and liquid was coming out. It was an open wound which was sore and really red. He also had a headache and continued weakness. 02/28/2021, he still had a headache and the arm was sore. 03/01/2021, felt pretty good.

Extreme somnolence, slept 18 hours the next day after shot, muscles hurt. Then over the next few days, developed gradually increasing intermittent pain and stiffness in both hands as well as intermittent paresthesias in finger tips. Also can't make a fist.

1hr after vaccine chills started. Within another 1 hr started achey. Cintinued to worsen At 1:30 am he was so weak could barely get to bathroom. Had to hug the walls to walk. Sever pain at this point. All his joints had shooting pain. Started getting better by morning but still very achy and very fatigued. Slept most of day. Ate very little. Probably didn?t drink enough water. Still weak on 3-10-2021. By evening of 10 th seemed normal. This man normally walks 5 miles a day, does 150 push-ups daily. Never sick. Very healthy. Then on 3-17-2021 during the night he got sick again. Joint pain, temperature at 100.4. Severe weakness. Wobbly when walking.

Joint pain in shoulders, hips, lower back, muscle weakness, fatigue; also limitation on range of motion in legs and arms; tylenol then aleve then predisolone; still on perdisolone which has eliminated all symptoms except pain in shoulders in morning and after noon fatigue

Injection site is sore and tingles. Muscle in arm aches. Difficulty using arm to hold objects at angle.

Sore shoulder; Extreme Diarrhea; Extreme vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Extreme Diarrhea) and VOMITING (Extreme vomiting) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). Concomitant products included LOSARTAN, GABAPENTIN, GLIMEPIRIDE, FLUOXETINE, ATORVASTATIN, OMEPRAZOLE, VITAMIN D2 and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (Extreme Diarrhea) (seriousness criterion medically significant) and VOMITING (Extreme vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder). At the time of the report, DIARRHOEA (Extreme Diarrhea), VOMITING (Extreme vomiting) and ARTHRALGIA (Sore shoulder) outcome was unknown. Concomitant drug included Pilomisitone 50mg. Treatment medication included equate anti diarrhea (loperamide, and its controlling the symptom). This case concerns an 81 Y/O M with a serious unexpected event of severe diarrhea and vomiting along with nonserious unexpected arthralgia. Event onset on day 2 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 an 81 Y/O M with a serious unexpected event of severe diarrhea and vomiting along with nonserious unexpected arthralgia. Event onset on day 2 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.

Slight fever 1 point elevated. Muscle, body aches, fatigue, tiredness, slight headache, joint pain, sore Rt. arm, sore injection site. Side effects have subsided after approximately five (5) days. None of the side effects were considered severe!

Patient came into the pharmacy complaining of right shoulder joint pain on 4/8/21. He expressed that the pain started 4 days after his first Moderna Covid19 vaccine on 2/12/21 and has not subsided. He has lost range of motion and expresses that the pain shoots down to his elbow joint. Pain is surrounding the joint, area is not visibly inflamed or red. He reports that vibration massage, heat and Tylenol help. He did not have this problem with his second vaccine on the left shoulder. Could potentially be caused by SIRVA, recommended that the patient takes ibuprofen on top of his current regimen and talk to his PCP.

broke into hives; cannot walk; muscles were stiff; diarrhea; throwing up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050A21A and 022M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided). On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced URTICARIA (broke into hives) (seriousness criteria hospitalization and medically significant), GAIT DISTURBANCE (cannot walk) (seriousness criteria hospitalization and medically significant), MUSCULOSKELETAL STIFFNESS (muscles were stiff) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization) and VOMITING (throwing up) (seriousness criterion hospitalization). The patient was hospitalized from 24-Mar-2021 to 25-Mar-2021 due to DIARRHOEA, GAIT DISTURBANCE, MUSCULOSKELETAL STIFFNESS, URTICARIA and VOMITING. At the time of the report, URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Computerised tomogram: fine normal (Inconclusive) CT Scan was fine.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication list was not provided by the consumer. On 24Mar2021 around 2:00PM, he broke into hives, cannot walk, muscles were stiff, was throwing up and had diarrhea. An ambulance was called and he was taken to a hospital where he stayed until 4:00AM today (25Mar2021). Blood works and computerised tomogram (CT) scan was done. They were informed that the CT Scan was fine. He was prescribed with Flexeril (cyclobenzaprine) and Tylenol (paracetamol) and was sent home. At around 11:00am (25Mar2021), they again called 911 for the same symptoms. They were about to go the hospital when the call was made. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050A21A and 022M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided). On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced URTICARIA (broke into hives) (seriousness criterion hospitalization), GAIT DISTURBANCE (cannot walk) (seriousness criterion hospitalization), MUSCULOSKELETAL STIFFNESS (muscles were stiff) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization) and VOMITING (throwing up) (seriousness criterion hospitalization). The patient was hospitalized from 24-Mar-2021 to 25-Mar-2021 due to DIARRHOEA, GAIT DISTURBANCE, MUSCULOSKELETAL STIFFNESS, URTICARIA and VOMITING. At the time of the report, URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Computerised tomogram: fine (Inconclusive) fine. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication list was not provided by the consumer. On 24Mar2021 around 2:00PM, he broke into hives, cannot walk, muscles were stiff, was throwing up and had diarrhea. Treatment information included an ambulance was called and he was taken to a hospital where he stayed until 4:00AM today (25Mar2021). Blood works and computerised tomogram (CT) scan was done. They were informed that the CT Scan was fine. He was prescribed with Flexeril (cyclobenzaprine) and Tylenol (paracetamol) and was sent home. At around 11:00am (25Mar2021), they again called 911 for the same symptoms. They were about to go the hospital when the call was made. 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.

Patient stated he had been given vaccine via drive thru clinic. Patient stated symptoms of swelling and pain started in administration site and then went to elbow and then to wrist within the week of getting the Moderna vaccine

sudden high fever (101-104) sudden confusion sudden extreme exhaustion sudden extreme leg weakness (couldn't walk) pneumonia kidney infection

Patient received Moderna vaccine on 3/16. Developed myalgias prompting hospitalization at Hospital 3/18-3/24. He was subsequently transferred to ER for management of anemia/bleeding and found to have Factor VIII inhibitor. It is not clear if the Moderna vaccine was associated with the Factor VIII inhibitor, but given the possibility, we are filing the VAER.

myasthenic crisis, with worsening neck weakness, proximal muscle weakness and dyspnea, beginning 24hr prior to presentation. Treatment required IVIG, PLEX, brief intubation for respiratory support and eventual Rituximab dosing.

Patient presents with multiple complaints. He complains of all of his symptoms started after his Moderna vaccine in 1/2021. He complains of fatigue, and in particular muscle fatigue, muscle wasting, urinary frequency, urinary urgency (but denies dysuria), myalgias involving his legs, leg weakness, unsteady gait, frequent falls, nausea without vomiting, dyspnea walking across the room. He is wheezing a lot this morning, it started after the Moderna vaccine.He had a recent heart cath that did not show any significant blockage. He had a recent MRI of his head that was normal. He reports his wife had covid 19 in the latter part of 11/2020. He never developed symptoms. He was not tested after she became ill. He admits to significant reaction his first covid 19 vaccine in 1/2021. All symptoms resolved except for his complaints as listed above. He is a very active 81-year-old. He states he was winning weightlifting contests. He would do 3 sets 50 pushups, bench press 150 pounds and do pulled downs with 160 pounds daily. He now experiences dyspnea and muscle fatigue walking across the room.

Vaccine was given on 4/1 and the next day nauseated, dry heaves, cannot eat and lives on protein shakes and he's lost 20lbs and he's weak and been in the hospital twice and the doctors cannot find why. He has passed out four times. He is a cancer surivor but nothing shows that the cancer has returned.

Patient presents to ER with chest pain that is constant, achy, occasional sharp stabbing, sometimes worse with deep breath and radiates to his back for the last 2-1/2 hours. He said it started at 10 PM. He said he has not had anything to eat since about 5 PM and says it does not feel like heartburn. Work-up included a CT angiogram of the thorax which showed findings consistent with pericarditis. Patient was noted to have diffuse but mild ST elevations on ECG. Cardiac enzymes remained negative however. Cardiology was consulted, and the patient was admitted to the hospital where he was started on colchicine and NSAIDs. Serial cardiac enzymes remained negative. The patient's chest pain steadily improved, and by last night it had completely resolved. He does have chronic shoulder pain due to osteoarthritis, and this is at its baseline. The patient will finish a 3-month treatment course with colchicine. I am discharging him on as needed ibuprofen for breakthrough pain. It should be noted that the patient did have a brief period of paroxysmal atrial fibrillation which resolved with 150 mg of amiodarone IV. The patient has been continuously monitored on telemetry, and atrial fibrillation has not recurred. After discussion with the patient and his wife, I have elected not to start the patient on aggressive anticoagulation as the period of atrial fibrillation was quite limited and occurred during an acute viral pericarditis episode. Patient's CHA 2 DS 2 score is 4. I recommended that he further discuss this with his primary care provider. Recommend considering an extended Holter monitor.

passed out 4 times; Withering away and is dying/wont live long enough; lost 20 pounds; He is still experiencing dizziness and too weak to get out of bed; Weak; Nausea; dry heaving 3-4 times/day; Swollen arm; Stopped eating; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 4 times) in an 81-year-old male 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. No Medical History information was reported. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), RETCHING (dry heaving 3-4 times/day) and NAUSEA (Nausea). On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 4 times) (seriousness criteria hospitalization and medically significant), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed) and ASTHENIA (Weak). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough) and WEIGHT DECREASED (lost 20 pounds). The patient was hospitalized until 23-Apr-2021 due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (passed out 4 times), GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough), WEIGHT DECREASED (lost 20 pounds), PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed), RETCHING (dry heaving 3-4 times/day), ASTHENIA (Weak) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment with Reglan and magnesium oxide pertained to the events experienced. 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.

24 HOURS LATER HE BECAME RIGID, BODY BEGAN TO DISCHARGE URINE AND BOWELS WITH NOT CONTROL I CALL 911 AND HE IS STILL IN THE HOSPITAL.

mild leg muscle pain; difficult to walk; legs feel heavy; stability problems; couldn't walk; leg pain has gotten worse over time; became a disability; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (became a disability) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Knee replacement (The patient underwent 2 knee replacements.). On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 ml. On 04-Mar-2021, the patient experienced PAIN IN EXTREMITY (leg pain has gotten worse over time). 04-Mar-2021, the patient experienced DISABILITY (became a disability) (seriousness criterion medically significant). On 06-Mar-2021, the patient experienced WALKING DISABILITY (couldn't walk). On 08-Mar-2021, the patient experienced GAIT DISTURBANCE (difficult to walk), LIMB DISCOMFORT (legs feel heavy) and BALANCE DISORDER (stability problems). On an unknown date, the patient experienced MYALGIA (mild leg muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (leg pain has gotten worse over time), WALKING DISABILITY (couldn't walk), GAIT DISTURBANCE (difficult to walk), LIMB DISCOMFORT (legs feel heavy), BALANCE DISORDER (stability problems), DISABILITY (became a disability) and MYALGIA (mild leg muscle pain) outcome was unknown. No concomitant medications were reported.; 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.

passed away; dry, persistent cough; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Medical history was not provided. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), UBIDECARENONE (COQ10 [UBIDECARENONE]), LISINOPRIL, METOPROLOL TARTRATE and OMEPRAZOLE for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced COUGH (dry, persistent cough) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, COUGH (dry, persistent cough) and MYALGIA (Body aches) had not resolved. This a case of death in 81-year-old male patient who received mRNA-1273. Very limited information regarding death (cause unknown) has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the events cough and myalgia, a causal relationship cannot be excluded. The event myalgia is consistent with the safety profile of the product. This case was linked to MOD-2021-060909 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Contains patient death information. Case upgraded to serious.; Sender's Comments: This a case of death in 81-year-old male patient who received mRNA-1273. Very limited information regarding death (cause unknown) has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the events cough and myalgia, a causal relationship cannot be excluded. The event myalgia is consistent with the safety profile of the product.; Reported Cause(s) of Death: unknown cause of death

Shortness of Breath, Difficulty Breathing, Difficulty Swallowing, Extreme wait loss, Low energy level. Progress over 2 month period

about 3 days after shot, except sore arm. Then pain started in shoulder joint down through the muscle and side of the bone to the wrist. Both sides of my wrist hurt. The pain was constant and moving was unbearable. Tried to use heat, cold, and vibrator to relieve the pain. Pain in the morning started as bearable but it would get worse as the day went on.

Heart rate went from a normal rate to 144-150. At same time I took a serious cold and achy joints and muscles. Doctor has me taking Digoxin, Diltiazem and Eliquis to try and bring the heart rate down.

Adverse Event - High temperature, too weak to stand and walk, confused Treatment - Taken to hospital by ambulance - hospital treatment unsure ( 1 over night stay) Outcomes - continued pain in his neck, ?fuzzy? head, and dizzy 11 days after vaccine

Dizziness the morning after vaccination (lasted 1 hour), chills the morning after vaccination ( lasted 3 hours), sore shoulder around vaccination injection (lasted 2-3 days)

Severe shoulder joint pain(level 9) first night following injection, unable to sleep. Second night some sleep with pain medication. Third night(last night ) some sleep without pain medication. Pain located deep in arm/shoulder joint. Getting better each day, still painful lifting arm straioght up or swing out. WHERE SHOULD I GET MY SECOND INJECTION?

Pain between shoulders in shoulder blades, frequent urination, dizziness/unsteadiness beginning evening 1/26/21 Followed on 1/27/2021 by increased dizziness/unsteadiness, more frequent urination and very frequent diahrea - lasting through the day/evening. On 1/28/2021 - pain between shoulders is slightly subsiding, unsteadiness remains along with frequent urination and diahrea

constant dizziness and headache; pain and stiffness in arms, shoulders, and neck; occasional numbness in both arms; tightness in the chest, brain fog

minor muscle soreness during late afternoon - no treatment light Injection-site pain since late afternoon for 2...3 days - no treatment

NAUSEA VOMITTING DIARRHEA CHILLS MUSCLE JOINT PAIN GENERAL MALAISE LIKE HAVING A HEAVY FLU NO FEVER SLEEPY STAYED IN BED UNTIL 02/12/2021 SLOWLY RECOVERING

Patient states that 5 days after getting the vaccine he developed severe diarrhea which has persisted. He has not been able to eat much as every time he eats he has diarrhea, sometimes to the point he can't make it to the toilet. He has not sought medical attention. Upon arrival for 2nd vaccine dose today he asked to speak with someone and it was noted he had lost 30 lbs in the last 4 weeks. He was advised to contact his regular physician immediately for complete evaluation and told this may or may not be vaccine related. Second dose was held today as precaution and once cleared by regular physician he can call us to get the 2nd dose. Patient did admit to history of "bacterial infection" causing diarrhea many years ago from drinking well water but doesn't drink well water currently. He also had body aches, headache after vaccine but these resolved and also complained of his hands swelling up like arthritis.

Caller states he received Moderna vaccine last Wednesday. Since receiving the vaccine has notice an exacerbation of a condition he has of leg weakness and now with falls. Instructed to contact PCP for an evaluation of his condition.

fatigue - muscle pain - chills - diarrhea Felling better the second day after the second injection. No problems existed after the first injection.

slight pain at injection site, extreme fatigue, muscle and joint pain in areas where arthritis had caused discomfort, abdominal pain, one incident of vomiting, and most concerning, I felt "foggy" till March 1.

At 9:00 PM on 02-13-21 experienced extreme pain in the bones of the neck from head down to the shoulder blades and half way to both elbows. Could not tolerate the pain, called Ambulance and went to Health Center.

Passed Out; Felt really bad and weak; Achy in his shoulders and neck; Chills; Temperature started at 99.6 then 100-101F; Burn really bad when he urinated; Traces of blood in urine; Threw up really bad; Fatigue; Joint Pain; Nausea; A spontaneous report received from a Consumer concerning, 82-year-old male patient who received first dose of the Moderna COVID-19 vaccine and experienced a lot of incidences. /MedDRA PT: [Incidences] The patient's medical history included Type 2 Diabetic. Patient's concomitant included Metformin 500mg daily. On 13FEB2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in right arm (Batch #: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. Patient friend stated he got the Moderna vaccine on 13FEB2021 at 2:30pm in the right arm. He urinated fine at church the next day on 14FEB2021. At 2:30pm, Patient friend stated he started feeling bad and weak and could barely unlace his shoes. Patient friend stated that he had achy in his shoulders and neck, and chills. Patient friend stated he is a type 2 diabetic and he thought his blood sugar was very high and took a 500mg metformin (usually takes it once a day). Patient checked blood sugar which was 99 (low for him). Patient friend stated that she gave him apple juice to bring it back to normal. Patient friend stated his temperature started at 99.6F and an hour later it was 100-101F. Patient was told by HCP to take Tylenol. Patient friend stated that he had burning and traces of blood in his urine. Patient friend stated that the second time he urinated; it was less burning. Patient friend stated that he had severe vomiting and passed out. Patient went to bed at 7PM and then at 8:45PM, without the Tylenol, temperature went back to 99.6F. Patient friend stated that he feels completely fine now. Patient friend stated that she only gave him only two 500mg Tylenols for the whole 24 hours of the reactions. Patient friend stated that he had other symptoms including fatigue, muscle pain, joint pain, chills, nausea, vomiting, and fever but no headache. Patient friend would like to know if the Moderna COVID-19 do something to his kidney or bladder? Patient friend would like to know if he should get the second Moderna COVID-19 vaccine. However, the patient still would like to get the second vaccine to be protected from COVID-19. Patient was treated with 1 500mg Metformin and 2 500mg Tylenols. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: This case concerns an 82-year-old male who experienced a serious unexpected event of Loss of consciousness along with NS unexpected feeling abnormal, dysuria, blood in urine, and NS expected fever, chills, myalgia, arthralgia, nausea, vomiting, fatigue. Event onset 1 day after the first dose of mRNA-1273. Treated with Tylenol. 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.

at midnight client got up to go to the bathroom. His legs became weak and he fell and hit his head on the wall. He called for his wife and said he didn't feel right. He denied any pain. She called EMSA and he stopped breathing while she was waiting on them. She gave him CPR with instructions from the dispatcher. He was pronounced dead at 1:30am. She has tried to call the clinic 3 times and left messages and no one has called her back, Her PCP told her this needed to be reported .

On 3/8/2021, the patient presented to the ED after mechanical fall from ground-level and developed right hip pain. The patient was diagnosed with a closed right public fracture. Per EUA, all hospitalizations must be reported after receiving a vaccine. This hospitalization does not appear to be related to the vaccine.

NERVE TINGLING IN HANDS AND ARMS FOR SEVERAL DAYS, WEAKNESS IN LEGS, SEVERE DEBILITATING JOINT PAIN , SHOULDERS, ELBOWS, BACK, HIP, KNEES, THIGHS ,CALVES AND GROIN. CHILLS, SLIGHT HEADACHES AND SLEEP DISTURBANCE

Excrutiating leg pain from knee to groin began on day after first shot 1/28/2021 then after 2nd dose was given on 2/24//2021 a massive stroke occured within 8 hours.

"Moderna Arm", muscle swelling, pink itchy rash occurring 12 days after first injection, has not gone away after four days. Am using anti itch cream externally.

LEG WEAKNESS, CHILLS, SHORTNESS OF BREATH Narrative: Patient reported after taking his second dose of Moderna vaccine on 2/25/2021 he developed extreme leg weakness, shortness of breath, fever, chills and elevated blood pressure. States the fever and chills lasted for 5 days and the chills were so bad he "shook all over". Patient states the leg weakness and SOB are not completely resolved yet. He completed a chest xray this week and the results are: streaky opacities at the lung bases, likely atelectasis and/or scarring. Patient to complete PFT soon. States his BP has been running 167/88 until 3/15. However patient reports he doesn't take his metoprolol all the time. Legs are still weak 3/15, but began using an exercise machine yesterday for his legs and "feels that may help". Patient also reports he had purchased a "so clean" device to keep his cpap machine clean. He received a letter from the Clinic stating those devices have been linked to asthma and lung problems so he stopped it.

3/24/21 ER C/o high blood pressure. States he got up to use the restroom this morning and "felt like my legs wouldn't hold me up & then I checked my blood pressure & it was high". Ambulates from waiting area to room without difficulty. Pt denies dizziness, shortness of breath or pain.

82 year old male with history of hypertension, hyperlipidemia, mild dementia presented with progressive worsening weakness over the past 2-3 weeks. Patient reported that he has noticed whole body weakness that has progressively worsened over the past few days. Reported that he has noticed feeling weak, fatigue and requiring more energy to do his daily activities over the past few weeks. He went to his PCP's office yesterday and had laboratory tests for further evaluation. Initially his PCP thought he might have PMR since he had bilateral UE soreness. However, the labs returned reassuring and does not seem to suggest the diagnosis of PMR. Since yesterday, he has noticed worsening of his weakness. Reported that last week, he was still able to play golf. Today, he was unable to get out of his car or get up from a sitting position without help. Associated with unsteady and poor gait. And reported that he has numbness in both hands and feels like his grip is weak. Denied fever, chills, nausea, vomiting, diarrhea, constipation, chest pain, shortness of breath, headache, vision changes, no urinary/fecal retention or urinary/fecal incontinence. Primary Discharge Diagnoses 1. Guillain Barr syndrome., 03/16/2021 Secondary Diagnoses: Guillain Barre Syndrome (AIDP) Hypofibrinogenemia Thrombocytopenia and Anemia, have been fairly stable for more than a week Hypokalemia Hyperlipidemia Hypertension, BPs controlled Mild dementia

Inflamation at site and progressively down the arm over three days with simptons of swelling and itching as well as some pain and stiffness. Took some pain killer - one ibuprofen per night. And when itching severe enough used Sarna lotion sometimes twice over the night

Lump and itchiness at vaccination site on day 1, took 10 mg Cetirizine Hydrochloride tablet Flu symptom like muscle and joint aches, tiredness, headache, no appetite. on day 2, took 500 mg acetaminophen (2) caplets Severe vertigo, nausea, tiredness, and no appetite on day 3, took 12.5 mg of Meclizine caplet

soreness at the site for about 2 days gout at the right toe, swelling, redness, burning, tenderness, pain. took (1) motrin every 4 hours four times. pain subsided by 75% in 2days.

Spinal infarct @ T 10-12, resulting in paraplegia. Symptoms began 4 days after receiving vaccine. Leg numbness and flaccidity, loss of bowel and bladder function.

Two weeks after receiving the vaccine my left shoulder, left thumb and lower back started hurting. It felt like a flare of arthritis though I've never had arthritis in these areas before. Pain is only with movement. At the beginning I would rate the pain as 7 out of 10. I have only used topical pain control. My back stopped hurting after about 1 month but my shoulder and thumb still ache. Pain is now 3 out of 10

SEVERE PAIN THROUGHOUT BODY - JOINTS- ESPECIALLY SHOULDER AREAS - ROTATOR CUFF AREAS - UNABLE TO RAISE BOTH ARMS AND LATER LIMITED MOVEMENT OF LEGS AND HIPS . THESE SYMPTOMS WORSENED AFTER 24 HOURS AND CONTINUED WITH MUCH LIMITATION OF BODY MOVEMENTS FOR THE NEXT WEEK. CONTACTED PHYSICIAN AND WAS PLACED ON PRESCRIPTION OF PREDNISONE (10 MG) - AS OF THIS DATE IMPROVEMENTS WITH BODY MOVEMENTS BUT STILL WITH SEVERE PAIN BOTH SHOULDERS ESPECIALLY LEFT ONE . APPOINTMENT WITH ORTHOPEDIC ON APRIL 27TH WHO GAVE A CORTISOID SHOT. HAVE APPT WITH PHYSICIANS FOR RHEUMATOLOGHY EVALUATION.

Death Acute Kidney Failure E87.5 - Hyperkalemia M54.9, G89.29 - Chronic back pain N17.9, N18.9 - Acute on chronic renal failure VOMITING DIARRHEA BACK PAIN DIZZINESS LEG SWELLING

Patient had COVID-19 infection in October 2020, then received 2 doses of COVID vaccines. On 6/1, COVID-19 tested positive, but patient denies any COVID related symptoms. Subsequence COVID tests on 6/2 and 6/3 all showed negative. On 6/1, patient presented initially to his PCP for evaluation of groin swelling. The patient had noticed a left groin swelling since last fall and had not previously bothered him over the last 2 days he noticed the swelling had increased in size and was uncomfortable with walking. Then he was instructed to ED and CT showed left inguinal hernia, so admitted at hospital for left inguinal hernia repair.

Early morning day following 2nd shot. EXTREME/VIOLENT shaking/chills for 2 hours....very concerning---upset stomach =slight temperature. General sickness. Extremely sore arm/shoulder at injection location. 2nd day was bet ter. 3rd day most symptoms gone gone with exception of shoulder pain. In the last few weeks pror to this date the pain in the shoulder has increased SUBSTANTIALLY and migrated in the the lower area of the shoulder. It is now difficult to LIFT my arm and have use of it do the the pain and decreased ability to use it. Having had major joint surgeries in the past I know what pain and lack of function can be. This is something different and becoming worse quickly.

The first thing was I had no feeling in my arm, shoulder, and hand. Still have no feeling in my arm. Tremendous pain in my back, upper and lower back. Went to the hospital and thought I had a stroke. Went to see another doctor for it. Could not get rid of the pain and was given steroids' to help. The pain left after two weeks, but occasionally still appears. Still cannot use hand, arm, or shoulder.

Patient contacted the office 3/31/21 with complaints of arm/shoulder/axillary pains since receiving the vaccines, treated in office 4/5/21 for lump at injection site and continued axillary pain, treated 5/25/21 for shingles outbreak on chest, contacted office again 5/28/21 with elevated bp, heart rate and confusion- possible med reaction, contacted office 6/9/2021 with low blood pressure, dizziness, confusion, increased edema, treated 6/15/21 for urinary tract infection. Treated with oncology - notes from 4/13/21 notes patient is doing well, but with 'knot' on arm and axillary tenderness following COVID vaccine, then notes from oncology 6/24/21 notes patient found to have new retroperitoneal and pelvic lyphadenopathy, along with new splenic lesions with sudden rapid change in mental status and new diagnosed pulmonary hypertension. Patient placed on hospice and deceased as of 7/7/2021

Patient is a surgeon, developed pain and swelling right palm and 5th finger with swelling, gradual development of pain and decreased ROM right shoulder and neck. He believes this is a manifestation of post vaccination arthropathy with tenosynovitis as reported.

A feeling of significant lassitude, pain at injection site and also the site opposite in the right shoulder. I could not sleep after 3 am, awake until 7:30 am. January 13: in the morning, body aches, requiring bed rest. After 12 pm, relief came with normal feeling.

These symptoms lasted 3-4 days: Extreme sleepiness; inability to open eyes; tremors; delusions/hallucinations; non-ambulatory; required assistance to sit, in and out of bed, in and out of chair, in and out of bathroom; tremors; anorexia; difficulty swallowing; slurred/difficult speech; hypotension; aches on right side hip, waist, leg, back; Required 24-hour supervision/caregiving. Marked improvement on Day 5; by Day 6, at 80% improvement. FOR ITEM 20 BELOW, we are indicating "unknown" as the patient is still not 100%. FOR ITEM 21 BELOW, we had a conference call with the primary physician, but not an in-person office visit.

1st five days i was fine then wed morning felt like i was hot by a truck. I have dizziness, cant walk straight, headache, muscles pain and joint pains

Ischemic stroke 2 days following vaccine administration resulting in hospitalization. Symptoms began with left lower extremity weakness. The patient also reported a low-grade fever as well as fatigue and generalized weakness following vaccine.

83 year old male was here at our clinic to receive his first COVID vaccine. After leaving the building he was getting into his car, fell and hit his head on the adjacent car. His wife came into the office asking for help, he could not get up himself . Clinician and three providers went out to the parking lot to assist and evaluate the patient. Patient was alert and talking. He was complaining of pain in his r ankle. He was assisted on to the wheelchair, brought back into the office and the ambulance was called. While he was waiting for the ambulance he had a loss of consciousness for 90 sec. Heart rate and pulse ok. EMS arrived and patient was taken to hospital for further evaluation. Pt required ORIF of the right ankle.

VAMS ID 100781798. On the day following vaccine administration, the wife of named individual called to report non-allergic symptoms that occurred approximately 7 hours after vaccine administration. Wife reports that after husband awoke from a nap that lasted about 2 hours she observed him to have bilateral "whole body" muscle stiffness including "legs crossed and could not uncross them" and stiff jaw like a "lock jaw". Lasted 20 minutes and then he was well the following day and beyond. He has a known but unspecified, well controlled seizure disorder but symptoms did not resemble usual seizure activity. Reporter notified usual health care office, and patient was seen by Dr. on 2/8/21. I spoke with his wife who reported symptoms to our office. Wife advised that per Dr. he classified it as a post-vaccination "adverse neurological event". Wife further advised that per Dr., patient can proceed with getting his second dose of Moderna COVID-19 vaccine.

Patient was admitted for pleuritic chest pain. It was determined during his hospitalization, that his pain was likely musculoskeletal in nature and was advised to follow up with PCP

Patient reported swelling in his legs, knee trouble (making walking difficult), dizziness, headaches, temporary memory loss and tired. These were all experienced for about 2 1/2 weeks post 2nd dose of Moderna vaccine.

Renal failure; Horrible Headaches; Body ache; A spontaneous report was received from a consumer concerning an 83-year-old male patient, who was administered Moderna's COVID-19 vaccine and one week later, he had horrible headaches, body ache and hospitalized for kidney problem (Renal failure). The patient's medical history included diabetes and high blood pressure. Products known to have been used by patient, with in two weeks prior to the event, included apixaban, sitagliptin, carvedilol, furosemide, glipizide. Patient became COVID positive on 14-DEC-2020 while in the hospital and survived. On 02-Feb-2021 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09-Feb-2021, approximately one week later, patient had horrible headache and body ache. Patient is better now but he is in the hospital because he has kidney problems (Renal failure) started on 14-Feb-2021. Patient's wife mentioned in call that this has never happened in past and she already asked MD not to give him the second dose. No treatment information was provided. Action taken with the second dose of mRNA-1273 in response to the event was discontinued. The outcome of the events, he had horrible headaches, body ache, were considered resolved. The outcome of the event hospitalized for kidney problem (Renal failure) was considered 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 reported events, a causal relationship cannot be excluded. Patient's elderly age and medical history of diabetes and high blood pressure may have been contributory for the event of renal failure.

Shoulder area around injection site was swollen, inflamed, itchy and very warm to touch. My doctor looked at it and prescribed Z-pac antibiotic as he thought it might be infected. While the symptoms subsided a bit, they did not go away until after the antibiotic was used up. Since then I have had much loss of strength in both arms while trying to use them reaching above my head. I have to push my left arm up with my right hand to get dishes off the second shelf in the cupboard. The doctor then took blood samples and did a urine analysis but found nothing. He sent me to the ER to have a CT scan of the abdomin and IV fluids. While there they took more blood samples and found nothing. I am also having lower back pains

Slight fever, cold chills that lasted for hours. Soreness in joints, soreness muscles, aching all over body. Complete loss of appetite

10 days after my shot both of my shoulders became extremely sore, I could not use my arms with out feeling extreme pain. After about four hours the pain was reduced enough so that I could continue my daily routine , however the shoulder pain continues. About a week ago my hips began to hurt when I walk sat and stood up. The pain in hips is about half of what is in shoulder.I have taken Ibuprofen and Extra Strength Tylenol but have no felt any relief.

tightening in his throat muscle; unable to move much; unstable blood pressure; unstable oxygen; bled due to blood thinner; weak in terms of walking; coughing; every joint and muscle from neck to toe in pain; every joint and muscle from neck to toe in pain; cold; entire body in excruciating pain; A bit off; Bruising in arm; A spontaneous report was received from a consumer concerning a 83-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following events: bruising in arm (contusion), a bit off (feeling abnormal), entire body in excruciating pain (pain), every joint and muscle from neck to toe in pain (arthralgia/myalgia), tightening in his throat muscle (throat tightness), unable to move much (hypokinesia), unstable blood pressure (blood pressure abnormal), unstable oxygen (oxygen saturation abnormal), bled due to blood thinner (haemorrhage), cold (feeling cold), weak in terms of walking (muscular weakness), and coughing (cough), The patient's medical history included small cancer treated last year with 38 radiation treatments. No concomitant medications were reported. On 11 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031620A) intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient experienced little bruising in the arm. On 12 Feb 2021, the patient was a bit off. On Sunday, 28 Feb 2021, in the evening, the patient got cold, and within minutes his entire whole body was in excruciating pain, every joint and muscle from neck to toe were in pain. It felt like it was invaded with COVID. He went to hospital and got tested for COVID, Strep throat and Flu, and all three test results were negative. On an unknown date, the patient experienced tightening in his throat muscle and he went to the hospital where he was admitted. While there, they did every possible test, chest MRI, Neck MRI, all possible viral tests, and rapid and full COVID test. The rapid and full COVID tests came back negative. Results for chest MRI, neck MRI and viral tests were not provided. The hospital also performed a blood culture for bacteria. Results were not provided. The patient was unable to move much, his blood pressure and oxygen were a little unstable. On 06 Mar 2021, the hospital did a major blood test which came back negative and the patient was released from a hospital. He stated that he was still weak in terms of walking and coughing. He stated that he recently bled due to taking blood thinner. Treatment included major antibiotic treatments and steroids for pain during the hospital stay. The patient was still taking prednisone at a tapering dose. Action taken with mRNA-1273 in response to the events was unknown. The events of weak in terms of walking, coughing were unresolved, while the outcome of the events of tightening in his throat muscle, unable to move much, unstable blood pressure, unstable oxygen, bled due to blood thinner, Bruising in arm, cold, entire body in excruciating pain, every joint and muscle from neck to toe in pain, every joint and muscle from neck to toe in pain was unknown.; Reporter's Comments: Based on a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Myalgia and arthralgia are consistent with the known safety profile of the vaccine

about 7 hours after injection of sedond Moderna Covid-19 vaccine, the left arm became very sore and by the next morning was noticeable red and slightly swollen; very tender to the touch (skin hurt); this symptom lasted for about 4 days. A low fever 99F was observed in midafternoon for 3 or 4 days but subsided by suppertime. Chills seemed to occur in midevening and into bedtime, requiring hot drinks to comfort him, and extra blankets on top while watching TV or retiring for bed. Tired easily; would drift off to sleep sitting in chair about 10 or 11 AM; trouble focusing on reading or doing computer games. Took 3 and 4 hours naps in the afternoon but still felt like going to bed earlier than normal. Day 7 or 8 felt significantly nauseous and queeezy on and off for three days, and didnt eat very much. Sudden headache in upper forehead area lasted about 3 hours on two consecutive days. Constipated days 8-14 so took a stool softener days 12 and 13 and ate more fruit. Joints hurt, especially the right hip, to the point of not being able to dress himself days 6-13; could not do normal activities (stopped his daily exercise and walks, avoided getting up off couch or chair and asked me to bring things to him, used a cane when walking inside the house due to balance issues that got worse. Tylenol and Tylenol PM were taken to manage pain and for sleep. Took additional vitamin C and ate mandarin oranges for healing.

Patient called today to report that his arm muscle that he received his second vaccine dose in began hurting on 2/21/2021. 9 days after vaccination. He also says it has now began hurting in his "joint." Referred to his PCP.

Extreme soreness, stiffness in right side of body, hip, leg. Same side of injection. Pain relented slightly after a few days, has now returned, making walking or lying difficult.

Need to be able to attach photos of patient's arms and hands. Left arm became inflamed, colored, pustules, swollen, blackened fingers, swollen knuckles, five days after vaccine. Three weeks later, right arm did same thing. Patient continues to live with this condition, without pain, some minor itching, but much discomfort and embarrassment for people to see arms. He has seen multiple doctors, including primary care, dermatologist, urologist, cardiac specialist, oncology doctor, been in a rehab facility for two weeks after fall and L-1 fracture, and no one knows what it is, or what caused it. Very frustrating. Suspicious of Covid vaccination. Pt stopped taking amiodarone a couple of months ago, with no change.

Seems like Arthritis in both hands, fingers, wrist as well as both shoulders. No such symptoms before this vaccine

Within three days of shot started with blurred vision, swerving while driving, progressing rapidly to unable to hold fork, falling down. Hospitalized since. Lost all motor skills, unable to walk, stand, feed self, control urine, slurring speech. No stroke. MRI found "lesions" in brain, spine/neck area, lung and stomach. Four Neurologists examined. They still are perplexed. One said she has not seen anything like this in her 20 years. Spent week in hospital, now in rehab center Minor improvement in ability to feed self (still can not hold fork), Receiving physical therapy.

Gets cold very easy; Out of breath; Strep through body; Swelled all over body/left foot still swollen; Weak; Paralyzed for over two weeks; Possible A-fib; Arthritis aggravated; Face was swollen; Hands were swollen; Not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARALYSIS (Paralyzed for over two weeks), FEELING COLD (Gets cold very easy), DYSPNOEA (Out of breath), STREPTOCOCCAL INFECTION (Strep through body), SWELLING (Swelled all over body/left foot still swollen), ASTHENIA (Weak) and ATRIAL FIBRILLATION (Possible A-fib) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis and Cane user. Concomitant products included HYDROCHLOROTHIAZIDE, FINASTERIDE, OLMESARTAN, SIMVASTATIN, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and PARACETAMOL (TYLENOL) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced MALAISE (Not feeling well). On 04-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRITIS (Arthritis aggravated), SWELLING FACE (Face was swollen) and PERIPHERAL SWELLING (Hands were swollen). On an unknown date, the patient experienced PARALYSIS (Paralyzed for over two weeks) (seriousness criteria hospitalization and medically significant), FEELING COLD (Gets cold very easy) (seriousness criterion hospitalization), DYSPNOEA (Out of breath) (seriousness criterion hospitalization), STREPTOCOCCAL INFECTION (Strep through body) (seriousness criterion hospitalization), SWELLING (Swelled all over body/left foot still swollen) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization) and ATRIAL FIBRILLATION (Possible A-fib) (seriousness criterion medically significant). The patient was hospitalized for 34 days due to PARALYSIS, then for 36 days due to ASTHENIA, DYSPNOEA, FEELING COLD, STREPTOCOCCAL INFECTION and SWELLING. The patient was treated with MORPHINE in April 2021 at an unspecified dose and frequency and Physical therapy for Paralysis. At the time of the report, PARALYSIS (Paralyzed for over two weeks) had resolved and FEELING COLD (Gets cold very easy), DYSPNOEA (Out of breath), STREPTOCOCCAL INFECTION (Strep through body), SWELLING (Swelled all over body/left foot still swollen), ASTHENIA (Weak), ATRIAL FIBRILLATION (Possible A-fib), ARTHRITIS (Arthritis aggravated), MALAISE (Not feeling well), SWELLING FACE (Face was swollen) and PERIPHERAL SWELLING (Hands were swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Hepatic enzyme: elevated (High) Patient experienced elevated liver enzymes.. In 2021, Heart rate: high (High) Heart rate- increased possible a Fib. Concomitant medication also includes an unspecified blood thinner. Patient was prescribed with Tramadol which was provided at discharge. 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. However, patient's hx of arthritis and being a cane user are confounding factors that may play a possible contributory role providing an alternative explanation. FU1 received additional serious AEs after second dose does not change company comment. Further information has been requested. This case was linked to US-MODERNATX, INC.-MOD-2021-067304, US-MODERNATX, INC.-MOD-2021-067204 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-JUN-2021, upgraded case to serious with the addition of event paralysis and hospitalization.; 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, patient's hx of arthritis and being a cane user are confounding factors that may play a possible contributory role providing an alternative explanation. FU1 received additional serious AEs after second dose does not change company comment. Further information has been requested. US-MODERNATX, INC.-MOD-2021-067304:First dose case US-MODERNATX, INC.-MOD-2021-067204:Crosslinked (family member)

Admission Note: ? Weakness - Generalized Patient reports feeling weak prior to dialysis, but demanded clinic to perform dialysis. Had full tx done and brought to ER. Reports still feels weak after dialysis. 84 year old male comes in today after completing dialysis for evaluation of generalized weakness x 5 days. He has also lost his voice. He tells me he received his COVID vaccine yesterday, but he is concerned he may have COVID. He denies any fevers, cough, sore throat, NVD, abd pain. Transfer Note: HOSPITAL COURSE: Patient is a 84 y.o. male who presented with shaking chills and was found to have Gram-negative rods in the blood. The source of infection was unclear. Initially it was thought that it could possibly be cholecystitis but imaging was negative for that. There was concern that it could be UTI but the patient is on dialysis and is an uric and therefore no urinalysis could be got. Early this morning when I saw the patient the patient did have significant pain and tenderness in the right knee and is not able to put weight on that. I.e. Consulted Dr. Today with per lumbar from Orthopedics who said that it would be in the best interest of the patient for him to be transferred to hospital where he could decide on aspiration and or washout of the right knee. Transfer center has been called and we are trying to finalize a transfer of the patient hospital at this point of time Please see problem list listed below. REASON FOR ADMISSION/ ADMISSION DIAGNOSES Sepsis cause unclear

Muscle pull; A spontaneous report was received from a physician, concerning an 84-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle pull. The patient's medical history was not provided. Concomitant medications included blood thinners. On 31 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 31 Dec 2020, on the same day of vaccine administration, the patient experienced severe pain in the arm, shoulder, and front of his chest into his back. He was taken to the emergency room (ER) where he was diagnosed with a muscle pull and was admitted to the hospital for one night. Treatment for the event included 500mg paracetamol. At the time of the report, the patient was still experiencing symptoms. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event, muscle pull, was considered not resolved.; Reporter's Comments: Company comment: This case concerns an 84-year-old male patient, who experienced unexpected serious event of muscle pull. The event occurred 1 days after the administration of the first and only dose of the Moderna's COVID-19 vaccine (mRNA-1273). Based on the known cause for muscle pull which is mostly due to an overstretched or torn muscle, the event is assessed as unlikely related to mRNA-1273 administration.

At 4am this morning woke up with headache, chills, nausea, slight fever, joint pain, muscle pain. Had COVID and bacteria pneumonia back in October Spoke with doctor this morning and said the symptoms were not unexpected. Doctor encouraged to file VAERS report.

Heart beat 100-103, Headache, Temperature 102.3, Muscle aches, extremely weak, needed help walking, fell down and needed help getting up

Few hours after receiving treatment his arm became very sore which is normal, but the next day he had a severe reaction in his back resulting in an unbearable pain. Each day the pain has gotten worse and now a week later he is in the worst shape so far. The primary care Physician has associated the symptoms with the vaccine and on the 25th he saw a cardiologist who again blamed it on the vaccine

Rash on upper arm that has spread to both arms, legs, back of the neck and cheeks. Itchiness, redness, swelling. Joints swollen - particularly left elbow. No other symptoms (no difficulty breathing or other issues).

patient developed progressive diffuse muscle weakness, altered mental status including excessive drowsiness, decreased oral intake starting on 1/31/2021. Symptoms continued to worsen overnight and he was evaluated in the emergency room on 2/2/2021 and admitted with dehydration and altered mental status. He was aggressively hydrated overnight, but showed persistent diffuse muscle weakness, altered mental status with decreased responsiveness progressing, but no focal neurological findings noted. CT scan of the head on 3/3/2021 showed no findings other than age-related diffuse cerebral atrophy. The patient did spike a fever to 103 on the morning of 2/3/2021. CBC, CMP, procalcitonin and lactic acid levels remained normal. He remains hospitalized in stable condition as of 2/3/2021 @1300.

states that since his vaccine, his muscles are weak and he has a HA. Claims chills, fatigue and dry cough Temp 100.4, BP 151/68 HR 84 EKG indicated atrial flutter and low QRS voltage in the prechordial leads.

ITCHING, RASH, SWELLING, PAIN ALONG DELTOID TO INSIDE OF ELBOW. STARTED ~2 DAYS AFTER ADMINISTRATION. AS OF 2/10/21- STILL RED "LIKE SUBNURN TURNING TO SUNTAN" NO LONGER SWOLLEN, OCCASIONAL MUSCLE PAIN "IF [HE] BENDS IT THE WRONG WAY"

Nausea, Night sweats, Joint Pain in legs and lower back, Headache, fever (99.3 to 100.9), fatigue. Treated with Tylenol , Naproxen , Lidocaine patch, fluids, heating pad and rest. Reduced fever, reduced joint pain, headache persisted. Time course: 24 hour period

Very sore arm with hard area at injection site, hematoma at injection site (day1), Headache, muscle pain, joint pain, fatigue (day 2), rash on left arm upper and lower (day 3 and 4 - current day).

Swelling of upper left arm to the elbow patient said it is red, doesn't really hurt but is very itchy. The redness started after the injection on 2/10/2021. Instructed patient to use ice pack on the upper arm arm and to take benadryl and use a topical anti itch cream.

my husband has been suffering with being light headed and a mild headache. he does not complain and has no history of headaches. he also has very weak legs .he is complaining of his legs feeling like rubber.

soreness at injection site; 5 days later extremely sore left shoulder/neck, 2 days later extremely sore right shoulder neck

My grandpa got his second covid vaccine on Thursday. Saturday he complained of stiff neck. Sunday he had low grade fever, nausea and vomiting, chills, and mild headache. He was feeling bad enough to call squad at 3 pm. The paramedics did evaluation and thought he was just experiencing normal side effects from vaccine and felt no need to transport to hospital so my grandpa decided to stay home and just rest. At 2 am that same night he went into cardiac arrest and was not able to be brought back

Upon attempting to get out of bed about 9:15 AM on Saturday, February 27, pain in my right knee was so severe I collapsed back onto the bed. Pain in my left knee was strong but less severe than the right. I did not seek treatment, but limited walking, aided by two canes, to necessary movement. By evening the pain seemed to be lessening and through Sunday and Monday continued to diminish. By Tuesday I was able to walk without noticeable pain.

Death Narrative: 83 y.o. male with pmh of heart failure admitted on 3/9 for shortness of breath and weight gain. Had Vfib arrest on 3/12 and was intubated/xfer to ICU. Continued to require increasing levels of pressors. He suffered VF arrest in the setting of metabolic, septic and cardiogenic shock. He had end stage heart failure and required 4 pressors. Was made CMO and passed away. Noted to have not received 2nd does of Moderna likely due to hospitalization at the time that the second dose would have been due. Patients history of adverse drug reactions included: lisinopril, dabigatran, and penicillin.

Polymyalgia Romatica - joint aches on both sides ( hips, shoulders arms, wrists. Successfully treated with Prednisone over a long period.

Dizziness, weakness, elevated troponin, otitis media, COVID-19 infection Patient presented with elevated troponin likely secondary to rhabdomyolysis. CT suggestive of mass lesion rectosigmoid area. Brain MRI/MRA unremarkable for metastasis or acute CVA ECHO unremarkable for regional wall motion abnormalities

Patient apparently was in the bathroom, shaving. Patient's wife was in the kitchen. He does not recall exactly what happened other than he fell backwards. His wife heard a "thud." She went into the bathroom and the patient was not responding. Eyes were open but he was not focusing. He did have generalized shaking of his extremities. Nine-one-one was called at this time. Patient does complain of some mild back pain. He denies any significant headache. There has been no nausea or vomiting. He was diagnosed with syncope event and new onset bells palsy.

My Father was ill for approx 3-4 days after first vaccine with fatigue and some minor chest pressure, this start approx 3 days after injection and had made a complete recover, he then recieved his 2nd vaccine shot and again 3-4 days later he again stated began having severe fatigue and mobility issues, ( he stated his legs felt like jello ) , no chest pains and no breathing issues were associated. 3 days later he was still feeling the same with symptoms and on the 4 day he was found deceased in his home.

Adverse events: Weakness in legs (had a fall), feeling of pins and needles in legs, feet and hands, loss of normal leg activity and strength, numbness in fingers, loss control of walking abilities Diagnosis: Guillain Barre Syndrome Treatment: 5 days of intravenous immunoglobulin Outcome: Don continues to slowly progress at home with therapy

2/22/21 - achy/weak, nausea/vomiting with clear vomit taste like blood, no fever 2/23/21 to 2/25/21 - continues with weakness and developed joint pain and red rash on arm that had injection - rash lasted 4 days 3/12/21 - developed pain behind left knee and down to left foot 3/15/21 - knee/leg pain contiues and goes to urgent care - diagnosed with DVT 3/22/21 - developed chest pain, goes to ER, diagnosed with kidney stones

Patient admitted on 2/17 after noncardiac syncopal episode. He had recently gotten his first dose of Moderna on 2/15. He is normally ambulatory independently. He had mild rhabdo and was admitted from 2/17-2/19. DC'ed in stable condition.

NAUSEA, FATIGUE, MUSCLE ACHE, CHILLS, FEVER, LOSS OF APPETITE, UNABLE TO GET OUT OF BED WITHOUT HELP, UNABLE TO WALK WITHOUT HELP. THIS LASTED FROM THURSDAY UNTIL SUNDAY MORNING.

84 y.o. male who presents with chills, weakness and low back pain that had onset approximately an hour and a half ago. Upon presentation, the patient's temperature was noted to be 102°. Patient's states that he had a similar set of symptoms several years ago was found to have sepsis of unknown origin. He denies anorexia malaise generalized body aches headache cough dyspnea chest pain nausea vomiting abdominal pain diarrhea or urinary tract symptoms. The patient has been covered vaccinated and reports no known exposures. Of note, the patient has been on cephalexin for the past week due to a postoperative infection related to his recent carpal tunnel release. Transferred to a different hospital for Severe Septic shock, on dopamine drip; remains inpatient as of 5/17/21

2/17, admitted 2 days after covid vaccine with syncope/rhabdo. Patient admitted for mild rhabdomyolysis after a noncardiac syncopal episode that was thought to be related to recent Covid-19 vaccination. Troponin is elevated 0.25, lactate is elevated at 5.5. BMP shows elevation in glucose and BUN. PT/INR is elevated. VBG is unremarkable. CBC shows a macrocytic hyperchromic anemia. Patient's CK came back significant elevated likely indicating rhabdomyolysis. Admitted for cardiology consult. Patient was treated aggressively with IV fluids. Patient had multiple reevaluations given his history of congestive heart failure. After evaluation- not sure what caused the patient to collapse, but the etiology does not appear to have been cardiac. The patient thinks it may have been due to a reaction to the COVID vaccine.

Pt showed up to the ER via EMS on 6/5/2021 with low back pain and weakness, bilateral leg swelling, shortness of breath. On 6/6/2021-developed bilateral upper and lower weakness that progressed to dysphagia and dysphonia. Transferred to ER on 6/8/2021 for Gillian Barre Syndrome On 6/11 had bilateral DVTS He was placed on palliative care and passed away on 6/19/2021

swelling in my neck threatening ability to breathe as well as in ankle and face the threat to breathing most alarming to me and with all my allergies I have not gone back for second shot

Sore muscles; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L02A) for COVID-19 vaccination. Concomitant products included APIXABAN (ELIQUIS) for Drug therapy, METOPROLOL SUCCINATE and DOXYCYCLINE for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced MYALGIA (Sore muscles) (seriousness criterion medically significant) and ARTHRALGIA (Joint pain) (seriousness criterion medically significant). At the time of the report, MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications reported. 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-2021-256561 (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 event, a causal relationship cannot be excluded.

Noted left arm soreness without swelling or redness. Shoulder was sorer the next day. Upon arising noted BL facial swelling/tightness similar to past reaction with lisinopril. 0 lip/tongue swelling. Swallow and breathing is normal.

Upon awakening at 07:00 began an uncomfortable feeding in chest. Over the next few hours, the feeling became painful. The pain was radiating from the center of my middle chest outward. It became more painful to breath deeply. At about Noon I began feeling worse all over my body. Joint aches, sensitive skin and just feeling not well. It is now 1:48 and I feel no better, but no worse. A nurse from the facility, is going to give me and my wife a Covid-19 test momentarily.

I woke up at 10:30 pm Wed. night with severe chills, headache, aching joints & a big lump in my right lymph node in the neck. I took 2 Tylenol 650 mg. & it helped with the joint pain & headache. I still have a big lump on my right side neck where the lymph node is at. Other than that I feel fine.

bilateral neck pain, low back pain, Left arm pain. Pt reports he "passed out" at ER. Pt states he went to the ER at 6:00 due to symptoms- Pt reported all testing in ER came back normal

1/24/21 0445- patient presents to the ED with complaints of neck pain, chest pain, and back pain for about a week. States also feels SOB, intermittent fever with temperature 100.3 on arrival. Patient was worked up for his cardiac type symptoms, found to have elevated WBC and CRP with no explanation. D-Dimer was elevated with CT showing no sign of PE. Patient was sent home from the ED with instructions to follow up with primary care and/or return if s/s worsen. 1/24/21 1705- patient is returned to the ED via ambulance after becoming unresponsive and some seizure like activity. Patient was intubated. Head CT showed large brain bleed that was irreparable and not compatible with life. Patient was also found with positive blood cultures x2 with gram positive cocci in clusters growing after 9 hours.

Pt. woke up on 1/13/21 throwing up, this continued throughout the day about 5 episodes total. Pt. had no appetite that day and drank or ate very little. During the night on 1/13/21, he woke up and when his caregiver tried to help him to the bathroom, he had weakness on the right side of his body. Caregiver called on 1/14/21 letting us know the pt. has increased weakness. Caregiver encouraged to take pt. to Er. Pt. refused. Pt. seen in clinic on 1/15/21 and examination found pt. to have right hemiparesis including foot drip, right arm weakness, loss of motor control on the right upper and lower extremities. Facial droop on the right with disarticulation of speech and control of the tongue.

Patient presents today with his wife and son. He was recently hospitalized having developed a fever the day after his Covid vaccine 1 with associated confusion and some ataxia. He was admitted to the hospital overnight where an MRI scan suggested no acute change showing only moderate cerebral atrophy and some small vessel occlusive changes. He tested positive for Covid by PCR in the emergency department on 1/22. His oxygen saturation was stable. He did have a fever and describes falling off the toilet because of some generalized leg weakness and uncoordination. He has had some chronic left greater than right upper extremity sensory loss following prior cervical spine stenosis requiring urgent surgery in 3/2019. He has had some chronic left foot drop as well. He reports being somewhat deconditioned having spent some time in bed to the above episode but is now ambulating with a cane at home and has occupational and physical therapy in place. He has been mildly dyspneic on exertion above baseline but attributes this to some deconditioning. He did have an episode of lower dental pain with ambulation in the office that was more than usual though denies associated chest pain or pressure and has had no jaw or shoulder pain with exertion. Review of systems is negative for headache.

Patient states he was not able to get his sleeve up far enough but the person that gave the injection went ahead and gave the injection in the bottom part of his arm. The patient began having pain and burning in his arm and it went into his back and neck area. The pain and burning continued until the patient sought medical care at an ER and was referred to Neurology Clinic.

Received 2nd dose of Moderna on 1/26/21. Went to the hospital and admitted 2/21/21-2/22/21 for UTI, weakness, and neck pain.

Lethargy, Brain fog, night sweats, huge increase in Arthritis pain all for three days, still lingering

States the day after, he was weak with muscle aches. He states that this has continues every other day for 18 days.

UTI; weakness; neck pain; A spontaneous report was received from a healthcare professional concerning an 85-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced UTI (urinary tract infection), weakness (asthenia) and neck pain. The patient's medical history was not provided. Concomitant medications were not reported. On 26-Jan-2021, the patient received the second of two planned doses of mRNA-1273 (LOT/BATCH: 029K20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 21-Feb-2021, the patient went to the hospital and was admitted for two days for UTI, weakness, and neck pain. 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 of the events, UTI, weakness and neck pain, 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.

On the evening of 3/05 I experienced a sore arm and a slight temperature (98.8--about 1+degree from my normal). The next morning I began a bike ride and within a few blocks was having sore arms and extreme fatigue. I went home, took my BP and it was 101/59. On 3/07 I used a stationary bike at the gym, came home very fatigued and BP was 92/63. On 3/08 it was 111/61 after I spent 2 hrs or so flying airplanes, my other hobby. Today I tried a bike ride again, quickly got shoulder, arm and back pain and extreme fatigue--came home and BP was 90/59. I ate lunch, drank a Coke for caffeine, tried to ride again and it was 104/61 after a short ride.

PATIENT REPORTS ARM STILL HURTS 28 DAYS AFTER VACCINATION. PAIN RADIATES FROM NECK TO FOREARM. ARM IS OFTEN COLD.

Around mid-day the day after vaccination the patient started to experience chills, muscle aches, and flu-like symptoms. Throughout the day, he developed edema in his legs and feet. The following day, he noticed a rash on his feet, which resolved after about 24 hours. He had severe pain through the right side of his body, and some tenderness at the vaccination site.

Limp; Paralyzed (pain was so bad he couldn't move it); Low grade fever; Severe left hip pain; A spontaneous report was received from a consumer who was also a 85-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced left hip became paralyzed (pain was so bad he couldn't move it) (paralysis), low grade fever (pyrexia), limp (gait disturbance), and severe left hip pain (arthralgia). The patient's medical history was not provided. No relevant concomitant medications were reported. On 09 Jan 2021, approximately 10 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09 Jan 2021, the patient woke up at 10:00 pm with severe left hip pain. His left hip became paralyzed (pain was so bad he couldn't move it), and he took 2 ibuprofens then went to bed. On 10 Jan 2021, he was still in pain with a low grade fever of 98.8 which is 1 to 2 degrees higher than normal for him. He reported using his wife's walker to ambulate and took 4 ibuprofens which helped his hip. On 11 Jan 2021, the patient was still in pain, had a limp, and ran a low fever until the afternoon. Treatment for the events included ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, low grade fever, was considered resolved on 11 Jan 2021. The outcome of the events, left hip became paralyzed (pain was so bad he couldn't move it), low grade fever and limp, was unknown.; Reporter's Comments: Based on the information provided, the events of low grade fever, gait disturbance and severe left hip pain are temporally associated with the administration of mRNA-1273 and a causal association cannot be excluded. Fever and arthralgia are consistent with the known safety profile of the product. The event of paralysis is considered unlikely pending additional information.

2 days after receiving the second moderna vaccine my father experienced a stroke. He was transported to the emergency room medical center where he went thru a procedure to remove a clot in his left side brain. Prior to this vaccine my father was in good health and was very active and still works and owns and operates a restaurant. He has never had any problems like this before the vaccine. One day after the vaccine he was complaining about a pain on the left side of his neck area. He was doing paperwork at approx 7:40pm when he experienced the stroke. I had to call 911. My father is currently at the medical center recovering from the incident.

symptoms started 1/23/2021 Hard Chills, temp spike 103, nausea, frontal headache, and muscular aches, recurrent chills and fever, most of my difficulty came after midnight, I'm not sure exactly when I went to the Dr maybe 6 days later and admitted me to the hospital, I was fine until two weeks ago I had chills fever and a little nausea and abdominal pain, lab results largely returned to normal and showed the same problem, liver enzymes, 785 amylase. My physician did not want me to get second dose.

Fainted; Left rib cage injured; Aches in the bones; Ill; Fell face first into the floor, fell on my hands; Bruised his hand; Face injured; Left hip and knee is injured; Nausea; Aches in the joints; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted) and CHEST INJURY (Left rib cage injured) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042821A and 003821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Patient spent 50 days in the hospital) from October 2020 to 04-Dec-2020. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), CHEST INJURY (Left rib cage injured) (seriousness criterion medically significant), BONE PAIN (Aches in the bones), ILLNESS (Ill), FALL (Fell face first into the floor, fell on my hands), CONTUSION (Bruised his hand), FACE INJURY (Face injured), JOINT INJURY (Left hip and knee is injured), NAUSEA (Nausea) and ARTHRALGIA (Aches in the joints). At the time of the report, SYNCOPE (Fainted), CHEST INJURY (Left rib cage injured), BONE PAIN (Aches in the bones), ILLNESS (Ill), FALL (Fell face first into the floor, fell on my hands), CONTUSION (Bruised his hand), FACE INJURY (Face injured), JOINT INJURY (Left hip and knee is injured), NAUSEA (Nausea) and ARTHRALGIA (Aches in the joints) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Cardiac function test: normal (normal) normal (heart was ok). No relevant concomitant medications were provided. On 22 Apr 2021, patient experienced aches in his joints and bones, he was becoming ill and had nausea which triggered emergency and needing to go to bathroom. He was heading to the bathroom, he fainted and fell face first into the floor. He injured his face, fell on his hands. He had bruised his hand. His left rib cage and left hip and knee was injured. He went to the Emergency Department where he was told his heart was ok, he was not delirious and consciousness was ok. He stated, it has now been a week and the bruising is still there and the stiches will be coming off tomorrow. No treatment information was provided. Action taken with mRNA in respect 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 events, a causal relationship cannot be excluded. However, the events face injury, contusion, fall, chest injury and joint injury is unlikely related to m-RNA 1273.; 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, the events face injury, contusion, fall, chest injury and joint injury is unlikely related to m-RNA 1273.

On 2/16/2021 in the morning I found that I was fatigue for about 4 - 5 days and at 85 it knocked me ion a ditch., with fatigue and a bad back it exploded a bit. I felt a little winded and did deep breathing exercises. I did not see a doctor, as I expected some symptoms. I spoke to my doctor about my back and I went to see a chiropractor and he gave me some adjustments and I felt real good after that

Pain in my toes. Thigh pain. Lower back pain. Hip & groin pain. Diagnosed with spinal stenosis & perhaps arthritis. My condition is improving with medication, but I still have not fully recovered.

Rash on chest that went to his stomach; Went to hospital for fast heart rate; Trouble breathing; Felt like he had the flu; Sore muscles; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Went to hospital for fast heart rate), DYSPNOEA (Trouble breathing) and RASH (Rash on chest that went to his stomach) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, METOPROLOL SUCCINATE and DOXYCYCLINE for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 25-Feb-2021, the patient experienced MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain). In May 2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt like he had the flu). On 30-May-2021, the patient experienced TACHYCARDIA (Went to hospital for fast heart rate) (seriousness criterion medically significant) and DYSPNOEA (Trouble breathing) (seriousness criterion medically significant). On 01-Jul-2021, the patient experienced RASH (Rash on chest that went to his stomach) (seriousness criterion medically significant). At the time of the report, TACHYCARDIA (Went to hospital for fast heart rate), DYSPNOEA (Trouble breathing), RASH (Rash on chest that went to his stomach), INFLUENZA LIKE ILLNESS (Felt like he had the flu), MYALGIA (Sore muscles) and ARTHRALGIA (Joint pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-May-2021, Heart rate: fast (High) Fast. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. 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. This case was linked to MOD-2021-256548 (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.

Drop attack. No loss of consciousness, dizzyness, or loss of balance. No associated symptoms except abrupt fall to the ground, falling to the left on two separate occasions.

Three men in their mid-80s, of whom I am one, developed rheumatoid arthritis within 2 months of getting the second vaccination. We live in different parts of the country, but all got the arthritis within the same kind of time period.

No injection site pain. Cephalgia, intermittent and primarily occipital and suboccipital in location with worse pain 01/12/2021. Rated at 5-6 over 10. General arthralgia

Patient awoke at 1:00 AM on 2/10/2021, five days after his Moderna COVID-19 booster, with chest pain radiating to the back and worse with deep inspiration. Patient arrived in our office on 2/10/2021 at 9:30 AM for an evaluation. Patient was noted to have new EKG changes with new concave-up ST elevation across the precordium. Bedside echocardiogram showed no pericardial effusion and no pericardial friction rub was appreciated. Due to ongoing chest pain, patient was transported to Emergency Department by medics for further workup and evaluation for possible pericarditis. Formal echocardiogram in ED was normal. Acute myocardial infarction ruled out. ST changes improved. Patient now being discharged in stable condition 2/11/2021.

2 weeks ago 1st dose; two days later pain in LT hip, progressively worse, moved over to middle of back

24 hours after vaccine patient was very fatigued, weak-knees, dizzy, headache, collapsed against wall.

Tremendous pain in neck; I was so weak that I could not pick my head up; Headache; A spontaneous report was received from a consumer who was also a 86 years old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced tremendous neck pain, severe headache and weakness. The patient's medical history and products known to have been used by the patient were not reported. The patient received their first of two planned doses of mRNA-1273 (Batch number: 030L20A) on 22 Jan 2021. On 22 Feb 2021, approximately two hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 006M20A) intramuscularly in the left shoulder for prophylaxis of COVID-19 infection. On an unspecified date, the patient start to experience tremendous neck pain, severe headache and weakness, later he was admitted to a hospital. No treatment information was provided. No relevant laboratory details were included. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events were not applicable. The events, were considered recovering/resolving.; 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.

Temp @ 10:30AM - 97.3; 4:30 PM - Rt. arm red, hot , muscle hard and sore @ inj. site; temp 99.8, took 10 gr ASA; 10:30 PM, temp 101.3, N&V, fever and chills, terrible body aching; took 15 gr ASA, applied cold cloth to head and neck. This lasted with fever, aching and flu like symptoms for 3 days and general fatigue and malaise with temp running 99, taking ASA. Did not return to normal until 5th day, but arm was still slightly wqrm, sore and itching. No problems after day 6. Only able to hold down soup and gingerale for first 3 days.

Patient reported low HR 1/27/21 (one day after vaccine) and went to ER. Patient reports no interventions at hospital and he was not admitted. Patient slept for 5 days after vaccination. He experienced joint/muscle pain and occasional dizziness which has continued at 8 weeks post vaccination. Patient also reports neuropathy which started in half of foot and progressed to leg (below the knee). He uses acetaminophen and DMSO for pain.

Headache, very fatigued, muscle aches, dizziness, light headed, cold type symptoms, runny nose, stuffy sinuses, sore arm Lethargic Started Sat 3/27 morning. Not really improved until this morning 3/31

Client reports got really sick with pain in elbows, feet, hands, and knees right after vaccination on 04-16-21. He didn't think he could drive home, felt like he needed to stop at a friend's home, but did not make it home. Could barely walk and had a hard time getting out of bed the next day. Reported he did get sick to stomach and had diarrhea on Saturday, did not have a fever. Reports Sunday through Monday he felt better but still painful in his joints. He wanted to go to ER but his daughter told him to wait it out.

On or about April 17 he began having shortness of breath with exertion. On or about May 1 he began having severe right flank pain. May 3 he went to the ER a Bilateral pulmonary embolism diagnosed.

Prior to the vaccine patient was active, Driving car, tutoring kids math as volunteer. Started with sever upper back pain between shoulder blades. Used diclofenac gel, Advil ones a day - pain went away in this area within two weeks. Debilitating pain transferred to lower back pain and it continues for over two month. Tried to apply heat, any possible over the counter remedies for lower back pain such as lidocaine patches, Bungay cream, heat patches. Tired physical therapy. Got cortisone and Novocain shut in facet joins in lumbar area. Still conditions did not improve. Now patient has to walk with walker, lost 20 pounds and in the addition patient has swollen legs.

received the first dose of the vaccine on April 8. He presented to the emergency room on April 27 with generalized weakness and inability to ambulate. He had an episode of blurred vision, pain and weakness in his left leg. A stroke was ruled out. His family refused the second dose of the Covid vaccine.

Patient experiences weakness in the lower extremities causing daily activity to be difficult. Patient pushed through and continuously worked out the weak body parts until normal feeling was regained.

Shoulder was sore after shot. Hands were cold (freezing) within a day, Joints at hands are swollen and can barely use; joints at shoulders ache; Hips and knee joints ache; oxycotin prescribed for pain but patient did not like side effects

reaction to the nitrofurantoin mono-mcr; brain fog (which came and went); weight loss (lost 20 lbs); very little energy; bleeding from the bladder/bleeding from his bladder lasted for a couple of weeks sporadically/ passed a blood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY BLADDER HAEMORRHAGE (bleeding from the bladder/bleeding from his bladder lasted for a couple of weeks sporadically/ passed a blood clot) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Gluten intolerance and Allergy to antibiotic (nitrofurantoin mono-mcr). On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-May-2021, the patient experienced FEELING ABNORMAL (brain fog (which came and went)), WEIGHT DECREASED (weight loss (lost 20 lbs)) and ASTHENIA (very little energy). In May 2021, the patient experienced URINARY BLADDER HAEMORRHAGE (bleeding from the bladder/bleeding from his bladder lasted for a couple of weeks sporadically/ passed a blood clot) (seriousness criterion medically significant). On an unknown date, the patient experienced ADVERSE DRUG REACTION (reaction to the nitrofurantoin mono-mcr). The patient was treated with ACETAMINOPHEN at a dose of UNK dosage form and NITROFURANTOIN at a dose of 100 mg, 1 dose. In June 2021, URINARY BLADDER HAEMORRHAGE (bleeding from the bladder/bleeding from his bladder lasted for a couple of weeks sporadically/ passed a blood clot) had resolved. At the time of the report, FEELING ABNORMAL (brain fog (which came and went)), WEIGHT DECREASED (weight loss (lost 20 lbs)), ASTHENIA (very little energy) and ADVERSE DRUG REACTION (reaction to the nitrofurantoin mono-mcr) outcome was unknown. No relevant concomitant medications were provided. Patient experienced the events within a week after receiving the second dose of the vaccine. Patient had visited the emergency room (ER) multiple times for the bleeding from the bladder and tests were done. It is stated that within a week, the patient experienced bleeding from the bladder, brain fog (which came and went), weight loss, which started shortly after second shot (lost 20 lbs), from start had very little energy (which was sporadic but had improved). This was not on 14-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. Further information has been requested. This case was linked to MOD-2021-220964 (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.

Noticed that my urine was cloudy the night after the vaccination, then turned red with blood in urine, and very dark, also achy in shoulder joint.

Intense Pain in both knees - 2 hours plus lesser pain continuing Weakness in legs and in general - still a little Sweating - no fever - has stopped

1/31/2021 03:56 Nursing Note Note Text: Pt. c/o R Abd pain at the waist line. Pt. stated it felt like a muscle being pulled. Not constipated, bowel sounds active. Took VS and they are charted. Writer called on call and spoke to NP and she stated to give him Tylenol and check the above. Bowel sounds and such. So writer did give him Tylenol at 3:45am. 1/31/2021 12:53 Admit/Discharge/Transfer Note Note Text: at 1030 pt stated that he had been having RLQ pain for the past hour. VS retaken. Described pain as constant but "increases suddenly" to an 8 on a 10 point pain scale. worsens with movement, alleviates with rest. RLQ pain radiates to R shoulder and around to his R lower back. bowel sounds x4, tender abd in right lower quadrant and upper right quadrant. follow-up assessment at 1220 found rebound pain. pt states last bm was yesterday and it was brown, formed, easy to pass. Lower posterior R lung sounds diminished and lower posterior L lung fields contain crackles. at 742: temp 98F, 140/68, 02 saturation 96%, respiration 16. denies n&v. ate pancakes, sausage, and fruit for breakfast. gave morning pantoprazole, held morning am medications. Called on call triage nurse and NP. on call NP suggested sending pt to hospital. transferred to hospital via ambulance and paramedics at 1240.

Patient described feeling nervous, anxious the next morning (Wednesday) after the vaccine. He later fell in the bathroom after using the restroom, his legs gave out (his words) and consequently was on the ground for 23 hours before being transported to the hospital. That was Thursday afternoon. He was diagnosed with COVID-19 on Saturday night and died the following Friday morning.

Extemely sore left fore-arm muscles for a few hours, followed by fatigue and chills the next morning for about six hours

patient reports that roughly 72 hours after first dose of MODERNA COVID-19 vaccine, he developed pain, redness, and swelling in his left ankle (with notable history of prior ORIF with hard ware in this ankle). It was initially treated as potential gout through the Emergency Room with low dose prednisone burst. Symptoms did not improve and was later given Keflex 500mg PO Q6hr for possible cellulitis in setting of tinea pedis. First dose of vaccine was 29Jan2021. Patient had second dose of MODERNA COVID-19 vaccine on 26Feb2021. About 48 hours after vaccination, he reported worsened swelling and redness at his left ankle (in setting of improvement since starting antibiotics). The recurrence of redness and swelling started to improve about 6 days later, where he came back to Internal medicine clinic for repeat evaluation.

Extreme chills. Uncontrolled violent shaking in my entire body for four hours during the night. Some slight nausea, no vomiting. March 5, extreme chills. No violent shaking. Wearing sweat pants, 3 sweat shirts --- I put a heavy blanket in the clothes dryer to get hot and wrapped it over my head and around my body. Extreme fatigue. No desire to do anything. Muscle pain in my shoulders, back and stomach until Monday, March 8. Diminish the incidence of crime --- THREATEN THE CRIMINAL-WANNA-BE with these effects instead of prison.

pt had no problems the day of the vax but next day he started having itching on his back, arm, and leg. Later that day his gums hurt like he had a toothache for 3 days. (pt has dentures) On 3/7/2021 pt becomes lightheaded. On 3/8/2021 pt started having pains in both fingers moving up to the arms and to the chest. On 3/10/2021 early am he woke up with severe pain from his fingertips to his shoulders and then across his chest and he thought he was going to die. He took Tylenol. The meds helped but pain came back about 2 hours later (around 8 AM) so took more Tylenol. Fever of 99.7. BP 145/80. pulse 65. Pt states that the pain he has had is not all at one time but happens like one thing at a time. Pt called medical office and was instructed to continue taking Tylenol and if he had anymore episodes where he felt he was dying to go to the ER. Pt is feeling some better now with just some pain in the shoulders and will contact his

Patient reports he has had a sore arm starting 2 days after receiving 1st dose of covid vaccine. Patient describes it as soreness and the muscle being strained especially when moving the arm a certain direction. Patient still has a sore arm 28 days later when he came in for his second dose. Patient says he was gardening and using his arms heavily for gardening after receiving the first dose of the vaccine and soreness could be due to that.

Per patient experienced pain in arm and neck after receiving injection. Per patient has difficulty moving his head to the side, feels stiffness and has to take an analgesic

Severe lower back pain Severe thigh muscle pain both legs Strong neck pain Nausea for two days Dizziness when standing or walking Upper arm pain, both arms

Got the vaccine, had no problems at all. He woke up the next morning on 3/24/21 with extreme pain in his legs, buttocks area, arms, and all muscles for some reason he got quite a bit of pain in his right hand and wrist. He was spared any pain or discomfort in his left hand which is his dominant hand. All of his limbs are very sore, and has a difficult time and having the feeling that he could not use a lot of his muscles. He enjoys walking a couple of miles, bike riding, and push ups and he's not able to do that anymore and very limited in his mobility since his vaccine. He now he cannot get in a car due to having difficulty lifting his legs, he has to use his hands to get his legs in the car now. Getting up and down from a sitting position is also more difficult since the vaccine. He found that bedrest is not what he needs and has to exercise as much as he can, and waking up in the morning is the worst part of the pain that he has, and a little bit better by moving around, and then it returns to the same in the morning. He is not able to walk fast or as far as he used to before. He went to the doctor for his physical and he checked him out and the blood tests which showed no inflammation but otherwise were normal other than some anemia, which they felt came from the vaccine. Now this has caused depression for himself and his wife as they are not able to do the things that they used to be able to do, camping, vacationing and doing yard work as they used to be able to do before the vaccine.

BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 4/22/2021; Discharge Date: 4/23/2021 Active Hospital Problems - Admitted for bilateral PE ? Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type (HCC) 04/22/2021 DETAILS OF HOSPITAL STAY: Patient is a 87 y.o. male with psoriatic arthritis, essential hypertension who presents today with right-sided chest pain. He reports onset starting yesterday. The pain radiated around to his back into the center of his chest. Thought he had pulled a muscle was having heartburn. Taking a deep breath made the pain worse. He tried Tums but no significant relief. It was not associated with shortness breath. Denied any, lower extremity swelling or calf pain. Today the pain was acutely worse so presented to the emergency department for evaluation. No prior DVT, PE, no FH of DVT/PE. No weight loss. No recent prolonged trip. On arrival to the emergency department his pulse was noted to be elevated to 120 but otherwise vitals unremarkable. CT angiogram thorax had significant findings of multiple bilateral pulmonary emboli involving segmental and subsegmental vessels. There was no evidence of right heart strain. He was started on heparin drip and transferred to another facility for ongoing care. He was switched to Eliquis 10 mg bid for 7 days, then 5 mg bid for 3 months. He has not sign of any malignancy, no weigh loss. He received Moderna COVID-19 vaccine on 3/4/21 and 4/1/21. It is conceivable that this PE could be complication of COVID-19 vaccine. He should follow up with PCP in 1 week. CTA also showed partial visualization of gas fluid collection within the right upper quadrant, likely reflecting a duodenal diverticulum which was present on 8/20/2012 CT abdomen, incompletely assessed. There is a small hiatal hernia. PCP to follow. Discussed with wife, and with daughter over the phone. Patient discharged home.

Patient has two admissions post vaccine, history of pancreatic cancer: 5/5 with worsening abdominal pain and jaundice which warranted ERCP. Patient treated and discharged. Second admission on 5/13 for ischemic stroke. Patient awoke with lower extremity weakness on standing and dizziness on standing; tingling sensation right leg, arm and face.

Patient presented to the emergency department on 6/15/2021 with weight gain, peripheral edema, and worsening dyspnea. Patient has a history of CHF. Upon admission screening, he was found to be COVID-19 positive. He was treated for COVID-19 infection as well as CHF exacerbation. He is currently admitted at time of writing.

2 days after the vaccine pt developed a stomach ache radiating to the back ,after several tests and seven weeks later pt. was diagnosis with multiple myeloma went blind and passed away,

Pain in upper back: L-R --centered; up down--below shoulder ; above shoulder blades. Persistent , 3-4 on scale of 10; tennis ball diameter . Wife had same but seemed much worse. She called clinic - recommended advil/tylenol regime. An hour ago I started with advil--seems to help.

Day after Vaccination: Chills, Muscle aches. Warmth and rest solved in 1 day. 4th day after Vaccination: Soreness at injection site, itching and rash extended from about 1 inch above injection site down to elbow mostly on inside of arm. 23rd day after vaccination: Still have very slight itching and rash in same area, hardly noticeable.

Hypoxia, Decreased responsiveness, Narrative: 86yo male with PMHx HTN, Afib not on AC after head trauma, CVA, and colon cancer who was brought to the ED by his family on 2/17. Per documentation the pt was in his usual state of health until 2/16. Received Moderna covid vaccine #2 on 2/16/21 at 0900, and was monitored for 15 minutes following immunization no noted issues. Later that night, had myalgias and took Tylenol. Per the family he slipped on the ice and fell on his butt. Overnight, had several dark stools and vomitus. was brought to the ED by his family because he was being less responsive. Pt arrived to the emergency department in extremis. No pulse identified. CPR immediately initiated for several rounds lasting about 25-30 minutes. ROSC unable to be achieved. Patient expired on 2/17 at 1941. Of note, per previous documentation had waxing and waning mental status at baseline. No symptoms noted with 1st dose of Moderna vaccine, which was administered on 1/16/21.

Having the feeling of a need to urinate, but inability to. A lot of pain in the groin area. High blood pressure. Diarhea all night.

Patient started feeling weak/fatigue on 3/4 and progressive get worse. He became very weak, had unsteady gait and s/p fall which resulted scalp laceration. He came to the emergency at noon on 3/5 and was sent home. He had another fall and came back to ER in evening. He had another fall while in the ED. He continues to have generalized weakness and myalgia. He was seen by PT and recommended to d/c with his walker

Patient states it started the day of shot with shoulder, arms, hip stiffness and so bad it was very difficult to get around. Presented to ER on 2/21/21 stating he hadn't felt good all week. C/o weakness, dizziness and shortness of breath and pain on right side ribs from coughing. Diagnosis: Pneumonitis, Hypoxia

Got his vaccine, had no problems. Went taking a walk on a flat road over a period of a few seconds felt that he was walking down a descending road. He had his cane, tried to use it to stop him as he felt that he was walking faster walking down a road. He finally could not go any further and fell over on his face, didn't trip. He was not knocked out and had no pain at that time. People were around him walking and saw him fall over and somebody called 9-1-1. He was taken to the hospital as his ribs were hurting and had CAT scan done that said he was okay. He told them kiddingly that he had the vaccine, and while he was talking to them said that. He was discharged within a couple of hours. He thought about it and realized that maybe there was some coincidence that he fell after receiving the vaccine. He is still having pain in his ribs and just felt that it was weird that he felt like he was walking downhill when he was not.

Severe dizziness about 3 weeks after the injection causing patient to fall. No nausea reported. Only severe dizziness and some weekness in legs. The severe dizziness lasted approximately 2 full weeks before it began to subside. The prescribed medicine for vertigo did not help. The second shot was due to be administered on 4/6 and per the doctor's instructions patient received the 2nd shot. By the 3rd day patient had completely relapsed back to severe dizziness,however, by the 4th patient was already feeling better.

blood clots in his right leg and left leg; Emergency Room at 4am because he had trouble breathing and walking; found blood on both his lungs; chills especially at night that lasted 2 nights; He states he is still in misery; Patient was supposed to get second dose on 04-Mar-2021, but he is not going to get it; shoulder pain/hip pain; Pain in arms, leg; trouble walking due to his pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots in his right leg and left leg), DYSPNOEA (Emergency Room at 4am because he had trouble breathing and walking), HAEMOPTYSIS (found blood on both his lungs) and CHILLS (chills especially at night that lasted 2 nights) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Asthma since an unknown date. Concomitant products included MONTELUKAST and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced THROMBOSIS (blood clots in his right leg and left leg) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Emergency Room at 4am because he had trouble breathing and walking) (seriousness criterion hospitalization), HAEMOPTYSIS (found blood on both his lungs) (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (Pain in arms, leg), GAIT DISTURBANCE (trouble walking due to his pain) and ARTHRALGIA (shoulder pain/hip pain). On 04-Mar-2021, the patient experienced INTENTIONAL DOSE OMISSION (Patient was supposed to get second dose on 04-Mar-2021, but he is not going to get it). On an unknown date, the patient experienced CHILLS (chills especially at night that lasted 2 nights) (seriousness criterion hospitalization) and FEELING ABNORMAL (He states he is still in misery). The patient was hospitalized on 20-Feb-2021 due to DYSPNOEA, HAEMOPTYSIS and THROMBOSIS, and then for 2 days due to CHILLS. At the time of the report, THROMBOSIS (blood clots in his right leg and left leg), DYSPNOEA (Emergency Room at 4am because he had trouble breathing and walking), HAEMOPTYSIS (found blood on both his lungs), PAIN IN EXTREMITY (Pain in arms, leg), GAIT DISTURBANCE (trouble walking due to his pain), FEELING ABNORMAL (He states he is still in misery) and ARTHRALGIA (shoulder pain/hip pain) had not resolved and CHILLS (chills especially at night that lasted 2 nights) and INTENTIONAL DOSE OMISSION (Patient was supposed to get second dose on 04-Mar-2021, but he is not going to get it) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: (abnormal) Found blood on both of his lungs. On an unknown date, SARS-CoV-2 test: (Negative) Negative. On an unknown date, Ultrasound scan: (abnormal) Found blood clots in his right leg and left leg. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was taken to the ER (Emergency Room) on 20-Feb-2021 at 4 AM. Several tests including Chest X-Ray, MRI, Blood work, Ultrasound (groin and legs) were performed. Only few tests results were reported. Received treatment including Oxygen, Eliquis and Antibiotics. Patient has been on oxygen full time until 7Apr2021 Company comment: Based on the current available information and temporal association between the use of the product and the start date of these event, 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 these event, a causal relationship cannot be excluded. Further information has been requested.

My father died, 20 days after his 2nd vaccination. Not sure if it is related to the vaccine, but a sister reported Arthritis pain, 3 times as bad, after the 2nd vaccination and recommended I report this. My father started having severe back pain, 3 days after the second immunization. I took him for an XRay and the hospital said he had Compression Fractures of the vertebrae, but they could not tell if they were new or old, so needed to do an MRI. Said it also looked like he had a Bowel Obstruction, but I told them he had been having normal BM's up to the previous day. He lived until the 17th of April and never had another BM. They said bring him to the ER. The ER decided to do a CAT Scan, but Dad was not interested in any further treatment. He just wanted to go, so we put him on palliative care and he passed away, 20 days after the 2nd vaccination.

Fell flat on my stomach, face first; After about 30 minutes I felt the surface descending and my walk pace increased; Finally I fell forward on my face; Suddenly felt like I was walking down a hill, I was descending. The street was flat.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Fell flat on my stomach, face first), GAIT DISTURBANCE (After about 30 minutes I felt the surface descending and my walk pace increased) and FALL (Finally I fell forward on my face) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Prostate cancer since 01-Jul-1996 and Cane user. Concomitant products included LEUPRORELIN ACETATE (LUPRON) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Fell flat on my stomach, face first) (seriousness criterion hospitalization), GAIT DISTURBANCE (After about 30 minutes I felt the surface descending and my walk pace increased) (seriousness criterion hospitalization), FALL (Finally I fell forward on my face) (seriousness criterion hospitalization) and FEELING ABNORMAL (Suddenly felt like I was walking down a hill, I was descending. The street was flat.). The patient was hospitalized from 07-Apr-2020 to 08-Apr-2020 due to FALL. The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 2 UNK. At the time of the report, MUSCULAR WEAKNESS (Fell flat on my stomach, face first), GAIT DISTURBANCE (After about 30 minutes I felt the surface descending and my walk pace increased), FALL (Finally I fell forward on my face) and FEELING ABNORMAL (Suddenly felt like I was walking down a hill, I was descending. The street was flat.) outcome 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. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received medical history, concomitant medications and events were added and reporter information was updated and 1st dose details were updated.; 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.

Moderna COVID-19 Vaccine EUA About 8-10 hours after my wife and I first noticed that my left (vaccinated) arm was sore. Within a few hours, my left hand began to tingle and my right leg felt stiff. I experienced a loss of balance that made walking difficult. For the next 24 hours I became very fatigued. But two days after the vaccination, I have begun to regain my strength.

Second day after receiving vaccine, felt fatigue and slept most of day. Had some muscle and joint pain and loss of appetite. Never had a fever. Only symptoms to this date are fatigue and appetite loss. ON Thursday January 21 tested positive for Covid 19. No real bad problems never had a fever.

On 0126/2021-After 4 hours, left arm, became stiff in muscle down to wrist plus pain and ache upon movement plus itching from left armpit to stomach; subsided by 4pm; then next 4 days, patient awakened about 1:30 am to 2:30 am with constant pain in arm; took 2 Tylenol, lessened by 6 am. Then at 1:30 am 01/31/2021, flat in bed, awakened by a severe pain in both shoulders, arms, sides with movement of crushing sensation and weird feeling going down left side to belt line, crossing over and meeting at right side belt line; with crushing, paralyzed effect for about 30 minutes. i felt like about ready to die. Tried arms and legs to work with some exercise, helped little. Got up,for toilet to urinate, took 2 tylenol,

I received a Moderna vaccine injection on January 19, 2021 at approximately 3:15 p.m. Later that evening at about 7:40 p.m, I was suddenly hit with pain in my back like someone had hit me with a board. The pain continued to surround the midsection in a swath of about 15 inches. I felt like my muscles were failing me. I made it to my bed where I started shivering and shaking uncontrollably feeling like I was having a seizure. The shaking was sporadic, lasting about an hour. I was covered with a blanket and continued with liquids for dehydration and was given an Xanax to calm nerves. Later that night while attempting to sleep, I was perspiring and my heart was beating 90 to 100 beats hindering sleep. Through the night I attempted to go to the bathroom but with absolutely no control over my arms and legs I was unable to stand. Rolling off the bed and unable to pull myself back, I lay on the floor and pulled a cover over me. At about 4:30 a.m. (Wednesday morning.) I was covered with another blanket and a pillow was put under my head. I slept until awakened at about 11 a.m My heart rate and oxygen level was chedked and appeared to be within normal range. I was greatly fatigued, and light-headed. Continuing a regimen of liquids, I was fed a small amount of soup and some fruit. I ate nothing the rest of the day. I slept most of the day. In the evening, I was fatigued and nauseated and spent 2-3 hours through the night on my knees in the bathroom attempting to vomit. Thursday morning I was awakened around 11.a.m. and was barely able to lift my head. I slept more until needing to use the bathroom and receiving more liquids. Two hours later I was able to eat only a half a piece of toast ? the first and only thing I was able to eat that day. Early evening having no control of my legs, I attempted to walk. It was difficult getting legs out of the covers, but I got up and walked a few feet with the help of a walker. However, an hour later (about 8:30) I went to the bathroom and was unable to pull myself up from the toilet and fell to the floor and crawl flat on my stomach to my bed. I had no strength in my legs and arms and needed assistance from two people to put me on my bed. Periodic rapid heartbeat and fatigue caused restless sleep. Some strength began to return on Friday and with caution over the weekend, and support from a loving family, I appear to be making a slow recovery. Checking with several family medical people working in hospitals, my experience with the serum seemed more extreme than most. Therefore, it was felt that I should report some information on how the Moderna injection affected me that it may be of help to others. (Some of the above information was related to me as I was not always cognizant of conditions at particular times.) I am still puzzled, as members of my family are, as to what happened to me. We would be grateful for any information that might be helpful for us to understand my situation as it relates to others that may have had similar experiences with the Moderna serum.

Weakness in legs. This occurred during the 1st and 2nd dose to the point of unable to stand. Symptoms disappeared within 24 hours. Please be advised that patient had previously tested positive for Covid.

acute pain in hip area, began suddenly and woke me up following morning after second shot has persisted for the last 6 days(and is still painful when walking though not quite as badly as it was.

Pt received second Moderna Vaccination on 2/21/21 at 1:00 pm at Pharmacy. Pt present on 2/22/21 to ER via ambulance at 1940. Upon presentation C/C hypotension Post COVID vaccine. Nurse notes states that Home Health nurse sent patient to ER secondary to hypotension and hyperglycemia. Pt states back ached and was holding his head. Nurse noted pt had random petechiae over body and bruising to abdomen following injections received during recent hospitalization. (unknown hospitalization). Patient was treated with IVF bolus in addition to initiating Dopamine for hypotension, patient became agonal and daughter at bedside presented Adv. Directive, pt was DNR. Pt pronounced time of death was 2110pm. (Pt only reported a sore shoulder secondary to vaccine).

Aches, Extreme chills(Chattering Teeth), no strength in legs.Could not stand up.EMS took him to hospital at 6:30 PM 2/20/2021. Extremely dehydrated. He was discharged the next afternoon at4 PM. Diagnosis: Elevated lactic acid level and fever after COVID -19 vaccination.

on 2/27 patient's wife called and stated that he had fatigue, body aches, low grade fever, and poor appetite. on 3/4, patient's wife called and stated he had some shortness of breath and extreme fatigue. on the evening of 3/4, he experienced sharp back pain and shortness of breath and was taken by ambulance to the hospital, where he was diagnosed with CHF exacerbation and NSTEMI and worsening CKD. he developed cardiogenic shock and renal failure. on 3/10 he was started on milrinone, then on 3/11 he went into pulseless VT and expired.

liver level was up 1000 times what it normally is; pain in arm; a little bruising on that arm; pulled a muscle in the back of my thigh; calves and ankles are all swollen; hardly walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIVER INJURY (liver level was up 1000 times what it normally is) in an 89-year-old male 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. The patient's past medical history included No adverse event. On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in arm) and VACCINATION SITE BRUISING (a little bruising on that arm). On an unknown date, the patient experienced LIVER INJURY (liver level was up 1000 times what it normally is) (seriousness criterion medically significant), MUSCLE STRAIN (pulled a muscle in the back of my thigh), JOINT SWELLING (calves and ankles are all swollen) and GAIT INABILITY (hardly walk). At the time of the report, LIVER INJURY (liver level was up 1000 times what it normally is), VACCINATION SITE PAIN (pain in arm), VACCINATION SITE BRUISING (a little bruising on that arm), MUSCLE STRAIN (pulled a muscle in the back of my thigh), JOINT SWELLING (calves and ankles are all swollen) and GAIT INABILITY (hardly walk) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information included one dose of acetaminophen 500mg and heating pad. 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

walked a mile a day and has always taken care of himself. He ran marathons. He never was bothered by walking the daily miles. Nothing happened while he walked even though he has a sarcoma. One night, after he got into bed, his hip and leg started hurting and have continuously hurt since then. His pain is debilitating and his leg is very heavy. He can not lift his leg to get into bed. His wife has to lift it with two hands. He cannot lift his leg to get into a car. He has been given Gabapentin, Norco, Tramadol, and Tylenol for pain. He needs ice packs during the day and night. He cannot sleep in his bed all night. He has gotten up to sleep in a recliner.

The resident noted slurring his speech and unable to answer her questions. Upon examination by the charge nurse and RN supervisor, the Resident showing stroke-like symptoms. The left side of the face is drooping, slurred speech, and unequal grips with L<R. 911 Notified of need for transfer, and family notified of CIC. The report called to ER. Noted in patient records upon return. - Resident to ER related to stroke-like symptoms and elevated blood pressure. Available records reviewed and indicate neurology consult via telemedicine. Ruled out for tPA related to time frame. CT head showed no evidence of acute intracranial process. Appears to have been treated in ER. Given Rx for Levaquin 500mg po daily x5 days related to pneumonia, and discharged back to Village. The resident reports that they were wanting to transfer him; however, he and his daughter declined the transfer. Indicates he stayed in ER. Reports that he feels fine today. Denies shortness of breath and phlegm production. Indicates an occasional cough. Denies pain. History of C

Client reports having "every thing he can think of." Specifically reports SOB, rash from waist up and itching. He has not seen a doctor for this condition. This writer encouraged client to call and make an appointment with his doctor. He agrees. In the last few weeks, client had severe pain in his right hip. He saw a orthopedic physician that did an x-ray and determined it was arthritis.

Progressively worse muscle and body aches, shortness of breath upon exertion, aggressive behavior, insomnia, confusion,

Crticial illness; He couldn't dress himself; The elbow on his left arm was killing him; he had a lot of pain in his left arm; Warmth of hands; swelling, pain, and the heat in his hands; Couldn't move his right arm; Both of his hands and fingers swelled; Pain in elbow; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Crticial illness), MOBILITY DECREASED (Couldn't move his right arm), PERIPHERAL SWELLING (Both of his hands and fingers swelled), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He couldn't dress himself), PAIN IN EXTREMITY (The elbow on his left arm was killing him; he had a lot of pain in his left arm), ERYTHEMA (swelling, pain, and the heat in his hands), FEELING HOT (Warmth of hands) and ARTHRALGIA (Pain in elbow) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K0A) for COVID-19 vaccination. The patient's past medical history included Lyme's disease (4 years ago) and Paralysis (Both legs and one arm). On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MOBILITY DECREASED (Couldn't move his right arm) (seriousness criterion medically significant), PERIPHERAL SWELLING (Both of his hands and fingers swelled) (seriousness criterion medically significant) and ARTHRALGIA (Pain in elbow) (seriousness criterion medically significant). On 17-Jan-2021, the patient experienced ERYTHEMA (swelling, pain, and the heat in his hands) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced ILLNESS (Crticial illness) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He couldn't dress himself) (seriousness criterion medically significant), PAIN IN EXTREMITY (The elbow on his left arm was killing him; he had a lot of pain in his left arm) (seriousness criterion medically significant) and FEELING HOT (Warmth of hands) (seriousness criterion medically significant). The patient was hospitalized on sometime in 2021 due to ILLNESS. The patient died on 04-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MOBILITY DECREASED (Couldn't move his right arm), PERIPHERAL SWELLING (Both of his hands and fingers swelled), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He couldn't dress himself), PAIN IN EXTREMITY (The elbow on his left arm was killing him; he had a lot of pain in his left arm), ERYTHEMA (swelling, pain, and the heat in his hands), FEELING HOT (Warmth of hands) and ARTHRALGIA (Pain in elbow) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. on 17-Jan-2021. There the patient underwent bloodwork, ultrasound, and x-rays to rule out blood clots or anything else. Treatment included a steroid shot, antibiotic shot, and medication, steroids and antibiotics and 4 pain pills on 17Jan2021. No concomitant medications was provided by the reporter. Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Added reporter's email address. On 06-Jul-2021: F/U-1 : Case upgraded to serious: Patient has died on 04-Jun-2021.; 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: Unknown cause of death