Moderna

Starting on Thursday, Dec. 31, patient began having shoulder and neck tightness. That night patient began having chills, and noticed redness at the vaccine sight and then the redness started streaking. Also complaints of itching at the vaccine sight. Started taking Tylenol for the two days following the vaccine, states feels like it is improving. Referred to PCP for evaluation. Has appt. Monday, January 4th

Five days after shot I ran a temp of 99.8 degrees for four hours with aches in my neck and shoulders.

Developed a severe headache within 2-3 hours of receiving vaccine. Took 2 Tylenol. Headache abated but did not resolve. Within the next 2-3 hours felt tingling in my left upper lip. It grew worse and headache worsened. Lip felt like it was swelling but no change was seen. Then left side of face began to ache. Took 2 more Tylenol. Texted my primary care physician who recommended Benadryl in case it was an allergic reaction. Took Benadryl about 4:30 or 5:00. Left work and went home. Had severe headache. Took my blood pressure. It was 185/68. Had some old Propanolol 10 mg from 2 years earlier and took one and a Prednisone 10mg. By 9:00 pm still felt bad with facial pain and tingling. BP decreased to 148/89. Took another Benadryl and went to bed. Face ant lip better in the morning. Arm sore for 2 days. Developed body and joint aches for the past 2-3 days. Slowly resolving.

She reported that she began experiencing chills, muscle aches and respiratory symptoms last night. She went to see her physician today and was given a Covid test. Her results will probably not be in until next week

Felt fatigued and weak while taking routine daily walk (cold, clear, sunny weather). Had to stop once to rest (almost never happens). Then nearing end of 2-mile walk, knees buckled and fell down on sidewalk. (Did not trip). Hurt arm, scraped face. Went home, put ice on face, laid down, rested.

Fever TMax 102 F, chills, myalgia, R arm intense pain, but no acute inflammation in area of injection

Moderna COVID-19 Vaccine EUA administered at 10:59 am on 1/16/21. Felt ok for the remainder of the day. Awoke at 1:25 am ith severe pain in left arm injection site, headache, nausea, fatigue, muscle and joint pain throughout body, chills and low grade fever. these symptoms persisted until mid-afternoon on 1/17/21 and gradually subsided i took ibruprofen and drank water. Finally ate a slice of toast at 5 pm and noticed the pain at injection site was improving. 12 hours later, feeling ok but still fatigued.

severe pain in neck and shoulder area, slight fever, swollen glands, affected vision for over five days

Fever, sore muscles, sore joints, headache, fatique, nausea & chills. I had a positive Covid 19 test on September 9th. The symptoms I've had from the shot are pretty much the same as when I was sick. I was fortunate not to have any respiratory symptoms either time as confirmed by my oximeter. I had two Antibody tests. One on Nov. 23rd, which was positive for both IgG and IgM. I had my second anti-body test on 1/17/2021, the day of my injection which was positive for IgG and negative for IgM. I have not contacted my doctor concerning this and I am taking Advil for the fever and ached and pains. Today i feel better than yesterday.

One week after receiving the vaccine shot, my left upper arm from should down began to itch. Slight red, under the skin 'rash' could barely be seen. The individual spots did not seem to be the specific irritant. The arm around the shoulder was somewhat achy and tight feeling. I was able to sleep through the night after rubbing on Sarno-anti itch lotion. Could not get comfortable on my left side, with the shoulder area hurting.

Arm went stiff for two or three days and it was very painful and ache , bruise at injection site for weeks no rash.

I had no side effects after the injection except for very slight arm discomfort for a day or two. Then, the evening of Day 6 (Jan. 20) I felt a little itchy around the injection site. Morning of Day 7 (Jan. 21) I was very itchy and my upper right arm was very itchy, red and inflamed. I called my dermatologist, and she told me to use a prescription cream I had from an irritation on my thumb last year, called Triamcinolone Acetonide Cream 0.1%. I also called my primary doctor, to let her know what was happening. Day 8 (Jan. 22) my upper arm was still very inflamed and seemed to be spreading wider across my arm, maybe 4"x3". Day 9 (Jan. 23) a little better. Day 10 (Jan. 24) much better. Almost gone. Little bit of red left. Still using cream until it goes away..

Received the second dose of Moderna on Friday afternoon at 3 p.m., Awakened in the middle of the night with significant muscle pain. Unable to sleep. Was unable to stay awake on Saturday. Slept almost all day. I took no medication. Did not seek medical care. Used my Series E Apple watch to monitor my heart rate: 80 bpm average. Side effects were gone by the next day, Sunday.

Appx 24 hours after injection I presented with a sharp lower left back pain. This lasted about 34 hours. Another strange anomaly was that my dog bit me twice 12 hours after injection. He is 7 years old and has never done that. Wonder if he smelled something strange

Very lethargic leading to flu type symptoms including achy muscles and joints, vomiting and very sleepy and tired

Pt states she got her second Moderna COVID19 vaccine in her LUE yesterday 1/26/21. She developed a low grade fever and nausea last night. Today, 1/27/21, around 0800, pt states that she fainted, fell on her left side and injured her L elbow. She states that her husband found her and said it appeared as if she was having a "mini seizure". Husband states pts fainting/seizure episode lasted for 15-20 seconds. Pt states that her L elbow pain was 7/10, but is currently 2/10 and she is now experiencing some tingling in her L third and fourth fingers. Pt denies any hx of a seizure and is currently able to get up and walk around. Pt speaking in full and coherent sentences while on call. Pt advised by triage RN and PCP to go to ER for an evaluation

Redness in upper left arm, slight muscular pain, moderate itchiness. Pain and redness basically gone but itchiness continues constantly

Patient came out of a sleep feeling numb all over and head felt empty. Thrashed about on floor with muscle spasms in both legs. Kept trying to hold onto head and not swallow the tongue. The attempt to swallow the tongue went on for one hour, if the patient was reclining on a bed. If standing, the tongue felt sore. The patient was still shaken, the next morning.

Got vaccine on Wed, fatigue started on Sat at first then headaches off and on and by Sun had muscle aches that got progressively worse. Mon I worked for 4 hours at desk job and by the end my ribs and back hurt so bad I caught myself holding my breath when breathing. Went home and laid sown the rest of day. Tues slept till 4:30 in the afternoon and then laid down rest of day. Slept till 11am on Wed and rested rest of the day. Headache and muscle pain not as bad. Called doctors office Wed and doctor wasn't in. Nurse will talk to him tomorrow and call if he advises anything mofre then what she had said which was rest. drink plenty of fluids and take tylenol. She advised to sign up for v-safe to VAERS.

1/28/21 vaccine received; couple mins after receiving numbing, tingling in arms, flush feeling, stabbing pain in chest area/back for about an hour, arm sore, lightheaded. PT has had to take Tylenol as needed

9 DAYS AFTER VACCINATION ITCHING, HIVES ON BACK AND ARMS; ARM HEAVY; TONGUE HEAVY; DIZZY, HEART POUNDING; CHEST TIGHTNESS ED visit 01/21 --given Decadron and Benadryl IV for allergic reaction Urgent Care visit 01/25 for chest tightness

Chills, shortness of breath (mild) joint and muscle pain, fatigue Essentially similar symptoms to when I had covid, towards the end of my illness. So like immune system symptoms. I had covid 3/15/20-4/30/20. I?m a long COVID sufferer, I still have resp pbs, arrhythmia, fatigue. I would like to get the second shot but am concerned about my over reactive immune response

Lower back pain radiating around to the rib cage. Went to ER and had ultrasound, cat scan, blood work, urine culture. All scans negative awaiting results of urine and blood work. Possible uti but not sure. Prescribed Keflex

Headache, chills, fever, muscle pain, joint pain, nausea, vomiting, diarrhea, extreme fatigue, brain fog

Moderna COVID- 19 Vaccine EUA: one day after receiving vaccination patient presented to the emergency department with epigastric pain for three hours. Patient denies sweating, shortness of breath, nausea, vomiting, and diarrhea. Stated that soon after receiving vaccination experienced fever, chills, and myalgias. Initial vitals within normal ranges except for blood pressure of 158/77 mmHg. Patient administered antacids and lidocaine with symptom improvement. Repeat vital signs within normal ranges and patient discharged to home stable.

Patient had vaccine given at her senior living apartment by staff. She reported to her PCP today that she has upper back and neck pain, left arm pain, and headache. This started one week after the vaccination. She has had to use biofreeze, ice packs, and Tylenol to treat the discomfort. She did state that it is slowly letting up.

Muscle ache, right arm, 3first days; vomited dinner day 2 and occasional nausea 2 more days; joint pains off and on for first few days; "Covid Arm" day 8, ongoing: baseball sized 6" diameter hot red rash around injection site, and swollen finger joint opposite (left) hand. Ongoing, but pain and redness in arm is subsiding; finger joint remains swollen, stiff, and painful. Probably not related, 2 wks duration tendinitis left retro heel.

Sore arm for 2 days which I think is normal. On day 2, I started having back pain running down my left side and around the side to my left breast.

Client stated on 1/30/21 she started to have pain in her left arm. Pain continued and on 2/2/21 she visited the Emergency Room. At the ER she was given a splint for her left arm and instructed to take ibuprofen. She stated she is feeling better today and her left arm is still a "little weak (2/3/21)..

Fever, chills., muscle achyness in my back at base of lungs (hurts when I walk) area, knee joint pain

SWELLING OF INJECTION SITE (~6 INCHES DIAMETER) & TEMPERATURE 106F SORENESS (MODERATE) MUSCLE ACHES THROUGHOUT BODY & JOINT ACHES FATIGUE FEVER (99 - 100.6F (BEGINNING ON DAY 2 AFTER SHOT @ 5:00 A.M.).

Moderna COVID-19 Vaccine EUA 3 am - Was awakened with severe headache, which passed after several minutes of being up out of bed. No medication required. For 2 days had tolerable discomfort in left upper arm, especially when raised arm outward and upward.

Swelling the size of an apple which lasted for 11 days Strong joint pain left wrist and both knees still present 3 weeks after the injection Throbbing pain in all past scars from surgeries including my skull (40 years ago) abdominal sutures ( 6 years ago ) and right thigh ( 4years ago). The pain started within hours after the injection in scars which never hurt once they healed after the surgeries but now the pain is hard to bear. The strangest pain is the site of vein ablation in the right thigh where the tissue looked normal before but now it looks hollow and throbbing.

7 days out from first vaccine I had extreme pain in my neck, shoulders and upper back. Could not turn my head left or right because the 6 Scalene Muscles in the neck were so tight. The pain also went up the right side of my face & skull affecting my TMJ and eating. The Scalene Muscles are on the side and front of a person's neck so I looked on the web as to how to release them. I gently used my knuckles, fingers and a tennis ball for 4 days on these 6 muscles while someone used a large 2 ball massager on my spine from my bra line and up my neck, and I laid on a heating pad but the stiffness and pain remained. Pain last 2 weeks, first week the worst. Extreme fatigue for a week . I believe I might have some arthritis in my neck and I frequently have minor aches and pain in my upper back, shoulders, & neck. So this area is venerable so maybe that's why it happened. I hope my 2nd shot won't be worse.

I woke up with severe Number 10 pain in my right knee, front , back and side. It was red, tender and swollen. The pain moved down to my right ankle and foot with severe muscle spasms pulling my right foot inwards toward my left foot. I could not walk to bathroom without screeming. Then it moved to my right hip area with muscle spasms across my lower back. I am still experiencing pain and muscle spasms (not as severe) today at this writing. It seems to be attacking my body where I have old injuries.

I still have redness, bruising and the area is warm to the touch at the injection site. I am having pain in the underarm and going into the chest area. Have not been treated ... I did tell the people who are doing the texting about the results of the shot. I have not seen anyone about the problem. Since I had not received any text referencing the problem I assumed it was standard.

About about an hour after shot, (given in left arm) I had what felt like a jab pain the area inside my left wrist. It was a sharp pain like being stung. Thus happened for two days, woke me up at night. I took a picture of my left wrist on Feb 11 and my right, both in the same minute. The structure and size of vein enlarged on the left side, as well as the color of skin. The right side was normal. As of today, the difference in the veins is still there, yet the jabbing pain has stopped.

Started feeling pain in right side (opposite side of shot) about 2 am on 2/9/21. Got worse during day and no sleep at all 2/9/21. Called Dr. 2/10/21 for appt next day. Severe pain on right side under armpit, shoulder and neck. Very painful to lay down (would get spasms), could not lift right arm at all and extremely painful to bend over. At 2/11/21 appt, was prescribed 10 mg Zyrtec twice daily, Aleve every 10 hours and Hydrocodone 5-325 mg at bedtime. Was able to get a little sleep 2/11/21 but pain back with a vengeance 2/12/21. On the morning of 2/13/21, the pain was less on right side but now also on left side in same areas.

Sick Large red hard spot at injection sight Pain in neck and headache Repeat of large hard red spot a weed later

Per Client received COVID 19 Vaccine in left arm on 02/9/2021 at 4:00 PM and by 2/11/2021 at 2:00 PM started having symptoms: Right arm painful, sore and left sided trapezius musle sore, achy and tender to touch. Per Client taking over the counter Aleve by mouth, applying ice and heat to site. per Client symptoms are still present in areas listed above and Client has already placed a telephone call to PCP for further follow up.

About 12 hours after vaccine I woke up with muscle aches across shoulder going up back of neck. The next morning same thing muscles ached in back...no fever, this lasted until I went toned that might. Next morning got up and was really tired and sleepy for about 5 hours, and then no more side effects.

NO fever at all during this time or shortness of breath. Pain in the arm at injection site up into neck and top of head. (48 hours) Tylenol for pain. About 3pm Saturday 2/6: Concerning spike of blood pressure 154/92-resulted in urgent care visit. Covid test taken as precaution by MD. Mom not "feeling well" 0630 Sunday 2/7: BP spike to 166/109, Blurry vision, dizziness. EMS called to assess at home. followed up by ER visit. all tests resulted negative. BP dropped to 120/72. On discharge BP up to 162/92. Lisinopril prescribed for HBP. 1 dose given. Monday 2/8: Vomiting and diarrhea, lightheaded. EMS called for assessment, BP drop 100/70. Hydration, rest. Moderate/Severe fatigue and aches (6-7 days) Mild lethargy. (24-36 hrs)

Started to get achy later that night after shot. Achiness got worse as all joints and bones hurt. Got up next morning with a temp of 101* and still achy all over. Slept most of the day with same symptoms. Got up next morning (Feb 17) fever was gone, aches were gone, but very very tired all day. A little unsettled stomach. Everything improved as the day went on. There is a report # 269542 from the first shot reported by telephone.

Injection site: pain, tenderness and swelling General side effects: fatigue, muscle pain, joint pain, nausea

Pain, swelling, tenderness at injection site. Muscle pain in body, headache and nausea started several hours after injection and lasted about 24 hours. Fatigue lasted into second day. Fever and chills started about 12 hours later for about 6 hours. (Some of symptoms at injection site may have been a result of the administration of the injection. There was some blood at the site and I still have a black and blue mark)

I received the Moderna vaccine on Saturday February 13th, 2021. I had no adverse event on that day. The next day when I woke up around 6:00 am I felt muscular pain in my upper left arm (arm of vaccine) when I moved my arm, and I could not raise my arm. Later that day I took an Ibuprofen and went out to eat Indian food at night. The pain went away. The following day the pain was almost all gone, and after that it went away completely.

Developed fever up to 99, severe aching in all joints, headache, chills, loss of taste, injection site in arm sore. Felt fine evening of 2/2/21 (date of injection) and awoke 0500 2/03/21 with symptoms listed here. Fever broke about midnight of 2/3/21 and only mild headache and feeling of fatigue next 2 days and then all symptoms completely disappeared.

Stomach pain , back pain, nausea, confusion, headache.. Started around 2pm in 02/20/2021. Ambulance was called, stated she felt like she was dying and was having severe pain

Pain to neck, shoulder joint, front snd back of arm. Severely limited range of motion and unable to Lift arm.

Headache, joint pain in shoulders, fingers, legs and back; stomach pain and diarrhea. Loss of appetite. All these symptoms lasted 8 hours and diarrhea continues for 48 hours. Took Tylenol and rested for first 12 hours, then continued normal daily routine. I had a severe bought of COVID 19 in March 2020, resulting in 3 weeks hospitalization. Exhaustion and pain in finger joints continue today.

When I woke on the 19th I was trying read my bible and I couldn't concentrate and I was really cold. I went to back to bed and slept most of the day. I was really cold and fatigued and didn't have an appetite. I took some Tylenol. I woke up about 3:30 AM Saturday and my back, arms and my head were all hurting and I took some Tylenol and went back to bed. I woke up about 6AM and was covered in sweat. I didn't want to do anything Saturday, I rested most of Saturday and Sunday. Today the 22nd I am back to my normal self.

Extreme ache, pain and stiffness in left arm, from elbow up into neck and shoulder area. This began on Day 8 after receiving vaccine and has continued through today - 10 days after vaccine 2 Arthritis Tylenol 650 mg

LEFT ANKLE APPROX 10 DAYS AFTER INJECTION: BUMPY RED RASH, ITCHING, BURNING EVENUALLYSPREAD TO COVER APPROX 4.5" IN DIAMETER . NOW NO MORE ITCHING OR PAIN BUT LIGHTER RED ANDDRY FLAKY SKIN. BASE OF LEFT THUMB AND RIGHT THUMB" APPROX 14 DAYS AFTER INJECTION. SAME SYMPTOMS AND CURRENT STATUS. SITE OF INJECTION ON UPPER RIGHT ARM:

I got extremely hot. I undressed quickly and got into my bed. My head moved from side to side with out my control. I was swallowing rapidly. I was awake and knew what was happening. I don?t know how long it lasted. When the episode was over, I went to sleep. I awakened in about 3 hours, went to the rest room, and returned to bed. I was uneasy and thought I might fall. I slept another three hours and went to the bathroom again. I felt a little better. I got up in about two more hours and felt a little better. Didn?t feel good all day and my arm was really sore.

I had a sudden onset of diarrhea immediately after getting the vaccine. a couple hours later I had another onset of diarrhea. that evening I had chills so bad that I could not get warm. Left arm is sore and swollen but mobile.

Chest pain, fever, chills, headache all these lasted a day and a half. Took lots of Tylenol After the second day pain around chest and neck have subsided. 3rd day still have headache.

Have a soreness in the armpit of my left arm as well as a small lump at the base of my neck on the left side. I had the same type of reaction 40 years ago to a Tetanus vaccination.

Immediately after the injection and got a pounding headache behind her eyes. Then about 7:30 PM she started to ache all over and very tired. She went to bed around 8:00 PM and then she couldn't sleep all night. She kept trying to drink liquid, running fever, hot and opened a window with temp being 30 outside. She could hardly walk to the bathroom due to the muscle weakness and fear of falling. She tossed and turned all night long. She got up and her temp was 99.8, and she was told not to go to PT this morning. She is being treated for a frozen shoulder. She feels dehydrated and is drinking water, and going to drink Ginger ale and crackers due to the nausea.

Moderna Covid-19 Vaccine EUA Patient had low grade fever (101.1 degrees) as well as muscle aches and pain

Sudden onset shaking chills , headache , body aches , joints pains , weakness. Chills relieved 30 minute after taking 500 mg Tylenal . No relief of headache , body aches and joint pains . IN pain , weak and losing balance at 7 am , temp 99 , mild nausea . Took 5/325 hydrocodone , paetial relief joint pains , headache persists .

02/25/21: Slightly accelerated heart rate; sore arm, tender nodule above left clavicle. 12/26/21: severe chills, heart face and head, stiff neck, general weakness, sore arm. Severe symptoms lasted approximately four hours but continue to a lesser degree for several more hours. Throughout the day, weakness, feeling cold, sore arm and nodule is still there and still tender.

Began walking on treadmill at 5:30 a.m. and left foot felt heavy and dragging, L hand tingling, and facial/neck numbness. Arrived at hospital at 8:15. Vitals, EKG, CT scan, and MRI conducted. MRI showed an acute mild stroke on R side of brain. Over-night stay was recommended. Echocardiogram was performed the following day and nothing was abnormal. I am now on a heart monitor for 30 days. Upon departure of hospital the symptoms in L leg and arm have nearly resolved but face is still numb/decreased sensation. Plan to contact PCP tomorrow.

The same night after receiving the vaccine, my arm starting swelling, itching. The next morning I woke up and the rash was there, and spread over the different areas of body. I was sweating bad, muscle pain, joint pain, and nauseated for about 3 days. I had knots in my arms. I went to the doctor last week, and she gave me a shot in the hip, it helped with the swelling. Then I called her back and she called in a cream for me. The other symptom remaining is the rash at the injection site, I have been putting the cream on it twice a day, taking Benadryl and Tylenol for pain

February 23 large left axillary lymph node. February 24 rash to left deltoid area at site of vaccination. February 26 supra clavicular and anterior cervical lymph node. February 23 through February 28 left posterior shoulder and scapular pain.

Chills, no fever, headache, body aches, loss of appetite, some heart palpitations, fatigue, muscle aches, shortness of breath. Unable to do daily tasks for five days. Swelling, redness and severe pain at injection site.

2-3 days after 2nd Moderna vaccination a 10 inch area around injection site swelled and became hot, painful and hard, and a large bright red rash appeared . It persists without improvement today. I also had pain in the joints in my feet and ankles, hands. Some fatigue. No fever, no chills. I had NO reaction after 1st vaccination, although injection site was hot and very tender for days. Used left arm both times. I saw an online photo of "COVID arm" hypersensitivity reaction and looks exactly like mine. Really quite uncomfortable.

First: Vaccine was not given at Center. It was a drive-up at Drive Thru. Adverse general side effects that lasted from 3:00 a.m. 02/27/2021 through 03/01/2021: fatigue, headache, muscle pain, joint pain, chills, nausea, heart palpitations, loss of appetite. Considerably more pain than with Fibromyalgia, shaking chills even though wrapped in a quilt, more heart palpitations than usual.

Chills. Low grade fever, severe headache, shooting joint pain. Took Tylenol. No treatment necessary. Symptoms gone in less than 24 hours.

18 days post injection I had severe pain in right shoulder and under scapular. pain level 9. This continued for a few days. Made appointment with my MD. Day 4 of pain a large painful rash appeared on my R upper back, under the arm and upper chest. ( Quite sure it was shingles. Started on Famciclovir 500mg. and tramadol 50mg. Had severe case of shingles with fatigue and excruiciating pain. My MD stated he has seen a number of patients post vaccine with shingles. Was scheduled for second vaccine on February 16th. The pharmacist at the vaccine center would not approve booster, stating my immune system is already stressed. My primary also recommeded no booster at this time.

Received 2nd dose and had extreme muscle weakness that caused collapse twice. Unable to stand for over 6 hours. Did not lose consciousness. As a result of the collapses, injured knee and arm.

Moderna COVID-19 Vaccine EUA 02/18/21 - achy back and neck (beyond ?normal? for me) - left arm sore 3/10 - pink rash near injection site - temp: 100.3 (normal 98 or below); Tylenol was not strong enough to relieve discomfort - took Aleve; improved on Friday 02/19/21; much better on Saturday 02/20/21; back to my ?normal? Sunday 02/21/21

On the 9th day (Fri., 2/19) after my shot I developed a very intense rash all over my stomach, and on the underside of my breasts. It was very itchy. I considered the possibility that it was the seafood soup I had eaten, but all day I also had very bad pains in my lower back, left hip, and left knee. I had knee surgery in August, but this pain was much worse than I'd had in months. The pain and rash continued thru the next day Sat., 2/20. Then on Sunday the pain was completely gone, and the rash started to subside. Then the following weekend (2/27 and 2/28) the rash had a mild flare-up, and there's mild itching off and on since them.

Patient presented to ED with altered mental status and leg weakness at home causing fall. Ammonia 89, being treated with lactulose for hepatic encephalopathy. Patient currently admitted.

Moderna COVID-19 Vaccine EUA Interrupted sleep the first night with shakes. The next day I had chills, shakes, and muscle weakness. I had no appetite, slept most of the day, and had a full night's sleep. I felt better about 9:00 PM and am fine today Friday, the 5th

Three days after second vaccination developed red, itchy rash covering large portion of outer upper arm,. Was swollen. Also, diarrhea that day. Later in day of shot was fatigued, during night chills and severe muscle aches. Aches and low fever the next day.

6 days after first dose, developed pain behind R ear, down R neck, into R upper chest, elevated BP at 4:05 pm on 03/01/21. Admitted to ER for workup. Remained in Hospital for 25 hours. All coronary tests negative. Tested positive for Covid-19 in ER

2 am (13 hrs after shot) the following day, i awoke with intermittent shooting type pain down my arm into my finger tips and a sore upper arm at injection site. 1:30 pm (24 hrs after shot) i had a bad headache and queasy stomach, approximately 1/2 hr later had the chills and a fever of 99.8. I slept for approximately 3 1/2 hrs. Upon awakening I still had chills but no fever 98.8 and all my joints ached. 6 pm I took 2 Ibuprofen and by 7:30pm I had warmed up but was extremely tired. 10 pm I took 2 more Ibuprofen and went to bed. I slept until 7 am and feel wonderful. My arm is a little tender yet but no trouble using it.

Blurred vision, eyes crossed, Face swelled, Face broke out with rash, Headache, Nauseous, All happened within 30 minutes. Next day backaches and feeling tired. Dr. gave me Pepcid and Xyzal. Most all thru Sunday, Still not 100%.

FELT COMPLETELY FINE THE DAY OF THE SHOT. WOKE UP THE NEXT MORNING AND COULD BARELY WALK. MY BUTTOCK AREA WAS EXTREMELY TENSE AND HURT TO STAND OR WALK. THE PAIN WENT DOWN BOTH OF MY LEGS, MORE PROMINENT ON THE LEFT SIDE. I HAD BEEN FEELING THAT PAIN FOR A FEW WEEKS, BUT IT WAS A DULL ACHE, NOTHING DEBILITATING. I HAVE BACK PAIN, BUT THIS WAS INTENSE AND NOT A PAIN I'VE FELT BEFORE. AS THE DAY WENT ON, IT EVENTUALLY GOT A LITTLE BETTER. WHEN I AWOKE THE NEXT DAY, I COULD BARELY GET OUT OF BED. MY DAUGHTER HAD TO TAKE ME TO THE ER BECAUSE THE PAIN WAS SO INTENSE.

1. Injection site pain, tenderness, on February 2-4 2. Fever (never exceeding 101.3), chills, muscle and joint pain, fatigue, headache, cough 3. Productive cough with greenish colored sputum first occurred on February 4 reported to personal pulmonary physician; oral antibiotic prescribed

Sudden significant nausea 7 hours after vaccine. Lasted an hour. Suddenly went away. Muscle and body aches and headaches, beginning about 5 hours after vaccine, lasting for 60 hours. Swollen lymph glands in neck and under jaw on both sides, 26 hours after vaccine. Significant fatigue, beginning about 6 hours after vaccine, ongoing at hour 52. LARGE RED HARD BLOTCH on vaccinated arm, one inch+ UNDER the vaccine site (which still has bandage on it), TENDER, ITCHY, ABOUT 32 HOURS AFTER VACCINE. ONGOING, although the hardness is decreasing, and the redness isn't as angry at hour 52.

Initial redness and discomfort in arm. Two days afterward, runny nose and temperature to 100.3. Extremely red rash on arm, measuring approximately 4 and 1/2 x 5 inches. Had eye surgery today and the nurses strongly encouraged me to report the rash.

Have noticed now several weeks after vaccination that several of the hand joints are extremely enlarged where they were never like that before, especially on thumb and first finger. Also, overall very painful joints. Also, joints in hands locking when using.

Fatigue, headache, joint pain, chills, fever, slight nausea. Started Saturday day after vaccination with fatigue to the point couldn't stay awake and weak. Sunday woke with bad ache all over and harder to move along with fatigue. Small headache along with slight nausea in afternoon. Woke about 5 am Monday with total sweat, then chills and couldn't warm up. still had fatigue but not as much pain. Called Hospital Covid Hotline as directed by my Dr.s office (never talked to my Dr.) Nurse with Hotline discussed it with me and we determined it was probably side effects. Since I am aware of allergic reactions, I didn't feel threatened, only messed up. The fatigue and some aches lasted throughout the weak, and I am still fatigued and weak compared to normal.Aches seem better.

On March 9, I noticed some discomfort in my left arm. Upon examination, I observed swelling in my left arm around the injection site. There was also redness around the site measuring 4 1/2? long and 3 1/2? wide. It was warm to the touch. I applied ice to the area and took a Benadryl capsule. The ice brought down the swelling and the redness did lighten some. Today I still feel some discomfort in the shoulder, the swelling is gone, and the redness, although lighter, has increased in size to 5 1/2? long.

Sore arm, fatigue, headache, muscle pain, joint pain, chills, fever all starting during the night. all next day no appetite, very tired, slept most of the afternoon and evening. Went to bed slept that night, fever gone. Just very tired the day after. Two days after almost back to normal. If booster needed in the future or another shot, I would try another brand.

2/27 Muscle aches,headache,nausea, lasting 2 weeks 3/6 Covid arm lasting 1 week 3/9 Jitteriness,dry heaves

tiredness,headache,musle pain, join pain,injection site swelling,injection site redness,feeling unwell,swollen,throat swelling,lost appetite.

"Moderna Covid-19 EUA" Admitted inpatient after ground level fall when she fell after attempting to get out of bed. right hip pain, headache Lab worrk showed stable eectrolytes, but significantly elevated myoglobin, CK, and CKMB and troponin, WBC elevated, admitted for rehydration PT/OT evaluation and pain management

March 11, at about an early 9 pm bedtime, heaviness in left shoulder, soon into both shoulders, and mild, intermittent ache in other limbs. Thereafter, through the night, a feeling of fever, back & forth: skin hot, then normal feeling. Some chills. Took my temperature several times and would only get a normal reading. Puzzled, because I thought I must have a fever.....the STRANGENESS of this was that my skin felt like it was BURNING UNDERNEATH my skin....not like any fever I might have ever had. Still normal temp readings. The next day...mostly in bed, tired, no appetite, continued fever feeling, but no fever temp reading. The second day, up and around, eating.

Fell; Severe Stiffening and Cramping up of all muscles for hours; Worse Severe Unbearable pain in body ever felt; Stiffening of muscles; Worse pain in neck and head ever. Went to the ER twice and finally got an appt at primary care, now seeking another primary care Dr.

pt stated that she had bad pain in her left arm, shoulder, and breast. This pain lasted about 3-4 days. Pt stated she developed a burning, sore rash over a week after taking the vax. The rash is underneath her left arm pit, back, and chest. She says her muscles feel very sore. Pt has only taken Tylenol, Ibuprofen, and using an allergy cream. Pt will call PCP regarding her symptoms.

Swollen upper arm, redness, very warm to the touch , itching, sore arm muscles (difficulty holding anything using left arm. Pain extends to the wrist.

Patient c/o extreme fatigue, pain and swelling to right neckline onset 3/4/21. She states the pain and swelling increased over the next 4 days, swollen area was now the size of a golf ball. She was seen and evaluated on 3/9 by her PCP, DR. CMP, Thyroid Profile and Lipid Panel were completed, all results were within normal limits. Pain began to ease up on 3/11/21. On 3/17/21 she is still c/o extreme fatigue, no change in the swelling to her neck. She is calling her PCP to schedule another appointment for next Friday 3/26.

Tinnitus -had it after 1st shot, but was not sure of cause- definitely stronger soon after 2nd vaccine; extreme chills for hours so hard to sleep, because whole body shaking; arm sore to raise and lower, all joints ache, especially knees and neck; fatigue and little energy; runny nose. Feeling better next day, but tinnitus noise still strong, left arm and joints hurt, and low energy.

soreness of arm, fatigue, loss of taste, loss of appetite, chills, pain in the back of head and neck, nausea and vomiting, right arm numb and tingling

Migraine type headache, dry mouth, achy arms (both arms not just at injection site), heaviness in lower extremities (inability to get out of bed for several hours).

Headache 10 mins after shot, muscle spasm in left arm & left shoulder 15 mins after shot, pain lower back, weakness in both legs, aching all over, tired, started about 20 mins after shot, large raised area, red, itch, slight soreness shortly after shot

Symptoms began Saturday afternoon: fatigue, nausea, headache, chills, muscles ache. Diarrhea began on Sunday around 3pm

Moderna COVID-19 Vaccine EUA - In the night I wokeup feeling like all my muscles were being torn from my bones. Never had such pain. I took 2 tylonia around 3am. I finally after hours took 2 Aleve and by dinner time I did feel better. Layed around the rest of Saturday. Got a slow start on Sunday but felt okay. No fever, or headache

About 21 hours after receiving the vaccine, she developed a temp of 101.8, fatigue, headache, muscle aches and pain, chills and nausea, did not vomit. Back to normal today.

Pt. received her first dose of Moderna vaccine in her left arm on 3/11/21 and began having symptoms on 3/13/21. She noticed a heaviness feeling in her right shoulder extending to her elbow with her right arm feeling limp and her right hand cold. She spoke with her doctor's office on 3/17/21. Her symptoms have continued.

The evening of the first shot on February 5, I had a strong headache, muscle aches and was extremely tired for the next two days. I had brain fog for the next 2 weeks. Tylenol and Advil mostly relieved physical discomfort. I had the second shot March 16. The next day I had a severe headache, no energy, achy body, chills and fever and on the second day after the shot my temperature was 101.4 - 101.8. Tylenol and Advil relieved the symptoms. Today, one week after the second shot I developed a pungent chemical taste in my mouth and a similar sense of smell. The tip of my tongue is tingling, and while I can breathe in deeply, my chest feels heavy, like I'm not getting enough oxygen.

Temp 101.1 and muscle aches so badly couldn't get out of bed for over 24 hrs. Took over two days to recover. I am reporting this as suggested by worker at County and just found the site to do so. It may have been nothing but just making sure! Thanks

Arms, legs and body was paralyzed; Nerve pain that travel from her head to the back; Excruciating pain,Pain is still remaining; Not being able to get up from bed; Lightning pain in the back; A spontaneous report was received from a 76 year old female patient concerning herself, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced excruciating pain and the feeling of not being able to get up from bed, because her arms, legs and body was paralyzed, nerve pain that travel from her head to the back and patient had lightning pain in the back. The patient's medical history was not provided. Concomitant medications were not reported. On 26 Feb 2021, the patient received the first of two planned doses of mRNA-1273 intramuscularly on left arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, after receiving the first dose of the mRNA-1273, the patient experienced excruciating pain, feeling of not being able to get up from bed, because her arms, legs and body was paralyzed (Other Important Medically Significant). This pain was still remained, kind of nerve pain that travel from her head to the back and also the patient had lightning pain in the back. Laboratory investigation details was not provided. Treatment details included Tylenol for pain. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, excruciating pain, feeling of not being able to get up from bed, because her arms, legs and body was paralyzed, nerve pain that travel from her head to the back and lightning pain in the back was not recovered/not resolved at the time of reporting.; 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.

Exhaustion (still sleep several hours during the day), low grade fever, chills, involuntary body jerks, headache, irregular heart beat, joint pain, muscle pain, itchy area under the shot, swelling of upper arm, red rash under shot-4"X6", continued "brain fog"

Got the vaccine, had no reactions. Then on 3/8/21 woke up with a stiff neck, muscle cramps and then broke out into a rash. She went to her PCP, and it had just come out and was right where you would wear a necklace and diagnosed her with an allergy, but did not take the medicine he prescribed as she felt his diagnosis was wrong. A couple of days later it was hurting and bother her and went to a dermatologist who diagnosed her with shingles which came out on her neck and her shoulder, and typical shingles reactions with stinging, hurting, itching, etc. Her dermatologist put you on Acyclovir, which is helping a lot, fading reaction, and help with the pain. She does still have some sensitivity around her neck but the rash is fading. She also had pains in her ears at the same time.

Fevers to 103 degrees, lethargy, weakness, myalgia in neck and shoulders severe. Poor exercise tolerance. Oxygen desaturation with walking. Symptoms of severe neck and shoulder pain persisted greater than 3 weeks. PT required. Still ongoing. Then 2nd vaccine on March 12th. Symptoms of high fevers, weakness, myalgia this time in low back and hips.

Giant cell arteritis. Symptoms started 2 days after COVID with upper back and neck pain, lymph node enlargement and tenderness, TMJ pain/trimus. After second dose of Moderna vaccine, worsening sympotms with intermittent sharp lancing pain behind right ear, right >left frontal headache, lancing pain on forehead that radiated to back of head, scalp tenderness, no vision changes or temporal artery tenderness. Labs, exams, CT head and MRI/MRA head done. Video, telephone, office visit, ER visits. Prednisone started. Temporal artery ultrasound negative. Temporal artery biopsy consistent with temporal arteritis. Symptoms improved with prednisone.

shaking chills -severe X 15 hours, then intermittantly- day 1; Rt side crushing chest pain, Lt side extreme squeezing & twisting sensation of heart; intense bone pain in areas that were injured 15 years prior- neck, posterior thorax, sacral area- all on right side only- day 2; awoke day 3 drenched, extreme diaphoreses- loss of 4 lbs; others less intense- loss appetite & thirst, Rt side only parietal and also occipital headache; tired & weak. Ended in 7 days.

The day after the vaccine I started to feel nauseated, Chest pain, lower abdominal pain and back pain. My blood pressure was a little high. The following day I was feeling a little better, but the chest pain was worrisome. I went to Urgent care and they said my EKG was not normal. I was taken to the hospital which was also the vaccine site. I was treated in the ER and they ruled out a heart issue with a complete workup. I was admitted for an unexplained bowel obstruction and remained in the hospital for four days. I got the second dose of the vaccine and I did not have any significant problems. I may have Covid-19 in the spring of 2020.

passed out; she fell down; bruised her lower back; her back is killing her; she felt cold inside; really hot while in bed; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (passed out) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 006A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Mar-2021, the patient experienced SYNCOPE (passed out) (seriousness criterion medically significant), FALL (she fell down), CONTUSION (bruised her lower back), BACK PAIN (her back is killing her), FEELING COLD (she felt cold inside) and FEELING HOT (really hot while in bed). On 26-Mar-2021, SYNCOPE (passed out), FALL (she fell down), FEELING COLD (she felt cold inside) and FEELING HOT (really hot while in bed) had resolved. At the time of the report, CONTUSION (bruised her lower back) and BACK PAIN (her back is killing her) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: positive. Concomitant medications taken by the patient were not provided. Treatment activities was done with paracetamol, ibuprofen, a shot and pill. This case was linked to MOD21-064155 (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

Patient's husband alerted pharmacy staff that patient was having difficulty breathing with bright red pallor roughly 5 minutes following her second dose. She was slightly hyperventilating, had pain radiating from her neck superior to her ears and anterior down her back. She described the pain as "shooting" and moving downward. She was able to take deep breaths and converse with no issues so epinephrine was not administered. Paramedics were called to the scene to assess her condition. She was able to stand, showed no signs of dizziness or change in mental status, and her pallor began returning to baseline. EMS took her BP and oxygenation, she declined transport to a hospital and remained at the pharmacy for an extra 30 minutes.

Pain coming from around the liver area but it radiated under my right and left breasts; Pain coming from around the liver area but it radiated under my right and left breasts; Lost my appetite; Urine was gold; Lost 10 lbs; Could not get a deep breath; Temperature reached 101F; vomiting; Nauseous; A spontaneous report was received from a consumer who is 76 year female who experienced a reaction to the vaccine, experienced pain coming from around the liver area radiating under right and left breast, loss of appetite, difficulty breathing, vomiting and nausea. The patient's medical history included fibromyalgia, ulcerative colitis, and obesity. Concomitant product use included:levothyroxine 150 mg, verapamil 120 mg (blood pressure), losartan 100 mg (blood pressure), Asacol 800 mg three times a day, Eliquis 5 mg, alprazolam (Xanax) 0.5 mg up to three a day, Centrum silver once a day, iron pill once a day, B12 500 mcg once a day, GNC probiotic 50 billion CFU, vitamin D 1000 mg, Citracal max Plus D3 once a day, magnesium glycinate, diphenydrinate. On 15-FEB-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number015M20A.). On 16Mar2021,approximately 1 day prior to the onset of the symptoms, the patient received their first/second of two planned doses of mRNA-1273 (Batch number: 001B21A.) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 17Mar2021 about 10 am, the patient woke up screaming with pain coming from around the liver area radiating under the right and left breasts. The patient states that taking deep breaths lead to excessive vomiting resulting in the ultimate loss of 10lbs. After the initial episode of vomiting, there was only nausea. An ambulance transported her to the hospital, as she continued to scream, resulting in being medicated to calm her down. The medication used is unknown. In the hospital, received morphine for three days In the hospital, she was told her temperature reached 101F. Upon returning home on 19Mar2021 afternoon, her temperature ranged from 99.4 to 99.8, one day peaking 101F. Today (29Mar2021) it is back to a more normal temperature: 98F. In the hospital, ultrasounds, CAT scan, and blood and urine tests was performed, results were not provided. Patient reports currently she is still in pain, that has reduced from a 10 to a 2. The outcome of the events, pain coming from around the liver area radiating under right and left breast, loss of appetite, difficulty breathing, vomiting and nausea is unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities.

Chest and back pain, legs weak since COVID shot 10 days prior; Feet feel like "pins and needles". Lower extremity weakness and paresthesia's and low back pain which now extend to her hands. Unsteady gait. No urinary or vowel incontinence. No similar reports from other vaccinations

3/18/21 admitted via ER for Transient cerebral ischemia (left sided weakness/paralysis primarily left arm)- discharged 3/19/21 3/19/21 Acute Stroke (progression of symptoms, involving left arm and leg/foot drop)- transported via ambulance to ER and admitted again, then transferred to inpatient rehab ~3/23/21 and discharged to home 3/31/21

complete body pain, fever, legs were killing her, back and neck, headache, thighs, and lower legs, when going to lay down it felt like pins and needles in legs, feet and ankles were swollen, ear ache, itching near vaccine site,

Issues with her heart pushing fluid; Cellulitis collecting fluid; Missed 2nd Dose due to hospitalization; Did not feeling well; Extreme pain because she is in need of reverse shoulder replacement bad knee and back; Extreme pain because she is in need of reverse shoulder replacement bad knee and back; Nausea; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis collecting fluid) and CARDIAC FAILURE (Issues with her heart pushing fluid) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cardiac catheterization. Concurrent medical conditions included Cellulitis. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced CELLULITIS (Cellulitis collecting fluid) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CARDIAC FAILURE (Issues with her heart pushing fluid) (seriousness criteria hospitalization and medically significant), PRODUCT DOSE OMISSION ISSUE (Missed 2nd Dose due to hospitalization), MALAISE (Did not feeling well), BACK PAIN (Extreme pain because she is in need of reverse shoulder replacement bad knee and back), ARTHRALGIA (Extreme pain because she is in need of reverse shoulder replacement bad knee and back) and NAUSEA (Nausea). The patient was hospitalized on 23-Mar-2021 due to CARDIAC FAILURE and CELLULITIS. At the time of the report, CELLULITIS (Cellulitis collecting fluid), CARDIAC FAILURE (Issues with her heart pushing fluid), MALAISE (Did not feeling well), BACK PAIN (Extreme pain because she is in need of reverse shoulder replacement bad knee and back), ARTHRALGIA (Extreme pain because she is in need of reverse shoulder replacement bad knee and back) and NAUSEA (Nausea) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed 2nd Dose due to hospitalization) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. patient missed second dose of vaccination due to hospitalization. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter stated that hospitalization has nothing to do with the vaccine. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter stated that hospitalization has nothing to do with the vaccine. Very limited information regarding the events has been provided at this time. Further information has been requested.

1st day slight feeling in shoulder. April 6 approx 10 AM my shoulder started to hurt. Over that day and the next week, sight began to swell, get hard, feel warm. The size of the swelling was between a baseball and a softball that was cut in half. It became itchy and turned red. These symptoms continue to this day. Tho the swelling is less and the warmth is diminishing as is the red. My temp was taken during this time. It was and remains normal

Stiffness and increasing pain in shoulder, arm. Inability to sleep due to pain. Unable to rollover at night, and loss of use of arm. Saw 2 doctors, neither of which could identify the source of the pain. Inability to rise from bed or couch without assistance. Both doctors recommended physical therapy. I waited to visit a doctor for a week, then another week to see a specialist. I started physical about 3 weeks after the vaccine was admiistered.

Chart notes written on 4/16/2021: Patientis presenting for having muscle aches and back pain since she received the 1st Moderna vaccine on 03/26/2021. The patient states that her arm started hurting right after she got the vaccine but just over the past couple weeks it has gotten worse. It is red under her arm and not by the injection site. Her whole body has been achy since the injection. On Monday of this week she developed 3 areas of red itching round patches. She denies any other causes for the hives. She has been taking some tylenol for the muscle aches and this seems to help a little.

Traverse myelitis. Extremely painful neck and back in joints which moved outwards to arms and legs. Started on about day 4. Could no walk to toilet. Pain moved out from joints to muscles in arms and legs. It is improving but after 30 days! Also my tinnitis got worse. I have never had a vaccine or a flu shot in my 76 yr life.

Continued, nonstop nausea/diarrhea, headache, joint pain (back, hips, knees), circulation issues (in mornings hands don't open and close well)

Patient rec'd Moderna COVID vaccines 1/30/21 and 2/27/21. On 4/3 she presented to the emergency department following a syncopal episode. Prior to syncopal episode she had a 2 week history of dry, nonproductive cough, left side rib pain (Pain rating 8/10). She was admitted and treated for PE and possible pneumonia. She was discharged 4/5 on warfarin anticoagulation. She had follow up appointments with PCP and hematology and will likely be on anticoagulation for unprovoked PE x 6 months.

1st dose...only right arm (shot spot) sore and it's still sore today, but no other side effects at all 2nd dose...arm not sore, BUT I was so out of it the next day 1. Major headache...no relief with acetaminophen & didn't try anything else 2. Minor temperature...99.8 most of the day 3. Every muscle, every joint and every bone in my body ached...perhaps my skin & hair also :-) 4. Nausea...without vomiting 5. Dizziness upon standing and intermittent lying down 6. Lethargic...probably due to all the above Stayed prone all day and night except to get water and go to the bathroom Drank lots of water and hot tea with saltines Day 2: 1. Headache...gone 2. Temperature...back to normal 3. Aching...subsided, but not totally gone 4. Nausea...gone 5. Dizziness...subsided but not totally gone 6. Lethargy...hung in there, but not nearly as profound Made myself get up, eat and do minor household chores to gain better equilibrium and feel more productive plus work out the muscle tightness from being inactive

Two weeks after second shot, I experienced all over body myalgia, chills, extremely fatigue and weakness. It lasted for ten days. Extra strength Tylenol, 2 every 8 hours helped. Then the symptoms would return. This lasted off and on for weeks. Gradually feeling better but still taking some Tylenol now and then. Had blood work and my sed rate which is usually 5 was 67 and showed positive antibodies for Covid. I have not had Covid 19.

shoulder blades with pain number 2 and head number 6; jaw pain; chest pain, chest was hurting; very bad feeling in the head, back of the throat and lips.; it has been over 42 days since she receive the first dose; very bad feeling in the head, back of the throat and lips.; shoulder blades with pain number 2 and head number 6; headache; very fatigue; felt drained; funny feeling that she doesn't know how to describe it in her lips; shortness of breath; lips were swollen; feeling like anxiety; barley walk; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain, chest was hurting) in a 77-year-old female 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. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ORAL DISCOMFORT (funny feeling that she doesn't know how to describe it in her lips), DYSPNOEA (shortness of breath), LIP SWELLING (lips were swollen), ANXIETY (feeling like anxiety), GAIT DISTURBANCE (barley walk), FEELING ABNORMAL (felt drained), FATIGUE (very fatigue) and HEADACHE (headache). On an unknown date, the patient experienced CHEST PAIN (chest pain, chest was hurting) (seriousness criterion life threatening), OROPHARYNGEAL DISCOMFORT (very bad feeling in the head, back of the throat and lips.), ARTHRALGIA (shoulder blades with pain number 2 and head number 6), PAIN IN JAW (jaw pain), INTENTIONAL PRODUCT USE ISSUE (it has been over 42 days since she receive the first dose), HEAD DISCOMFORT (very bad feeling in the head, back of the throat and lips.) and HEADACHE (shoulder blades with pain number 2 and head number 6). On 22-Feb-2021, CHEST PAIN (chest pain, chest was hurting), ORAL DISCOMFORT (funny feeling that she doesn't know how to describe it in her lips), LIP SWELLING (lips were swollen), ANXIETY (feeling like anxiety), GAIT DISTURBANCE (barley walk), FEELING ABNORMAL (felt drained) and HEADACHE (headache) had resolved. At the time of the report, OROPHARYNGEAL DISCOMFORT (very bad feeling in the head, back of the throat and lips.), ARTHRALGIA (shoulder blades with pain number 2 and head number 6), PAIN IN JAW (jaw pain), DYSPNOEA (shortness of breath), INTENTIONAL PRODUCT USE ISSUE (it has been over 42 days since she receive the first dose), HEAD DISCOMFORT (very bad feeling in the head, back of the throat and lips.), FATIGUE (very fatigue) and HEADACHE (shoulder blades with pain number 2 and head number 6) 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. Treatment include Benadryl and Tylenol.. Event Start date and stop date updated. 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 28-Apr-2021: Event start date and stop date updated for events On 28-Apr-2021: Significant follow up; 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.

First I had two bumps size of half a dollar on my upper left arm and, like, a mass or swelling about the size of a silver dollar on my left arm right above my right wrist on the upper side. The two bumps on my upper arm have gone away, but the mass or swelling above my wrist is still there.

O2 levels where they'd be mid 90s and would walk a little and go down to 79%; weakness; shaking; shortness of breath; unable to get out bed; heart rate would go into the 100s with minimal exertion; myalgia in neck and shoulder; chills; 103F fever; This spontaneous case was reported by a physician and describes the occurrence of HYPOXIA (O2 levels where they'd be mid 90s and would walk a little and go down to 79%) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (had COVID19 at the end of October) in October 2020, Fever (beginning of November 2020 where she presented fever, myalgia, loss of appetite that lasted about 2 weeks then she was back to normal.) in November 2020, Myalgia (beginning of November 2020 where she presented fever, myalgia, loss of appetite that lasted about 2 weeks then she was back to normal.) in November 2020 and Appetite lost (beginning of November 2020 where she presented fever, myalgia, loss of appetite that lasted about 2 weeks then she was back to normal.) in November 2020.Concurrent medical conditions included Hypertension (for which she takes a small dose of an antihypertensive medication). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced HYPOXIA (O2 levels where they'd be mid 90s and would walk a little and go down to 79%) (seriousness criterion medically significant), ASTHENIA (weakness), TREMOR (shaking), DYSPNOEA (shortness of breath), HYPOKINESIA (unable to get out bed), HEART RATE INCREASED (heart rate would go into the 100s with minimal exertion), MYALGIA (myalgia in neck and shoulder), CHILLS (chills) and PYREXIA (103F fever). At the time of the report, HYPOXIA (O2 levels where they'd be mid 90s and would walk a little and go down to 79%), ASTHENIA (weakness), TREMOR (shaking), DYSPNOEA (shortness of breath), HYPOKINESIA (unable to get out bed), HEART RATE INCREASED (heart rate would go into the 100s with minimal exertion), MYALGIA (myalgia in neck and shoulder), CHILLS (chills) and PYREXIA (103F fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Angiogram: negative (Negative) Negative. In 2021, COVID-19: negative (Negative) Negative. In 2021, Cardiac stress test: negative (Negative) Negative. In 2021, Electrocardiogram ambulatory: negative (Negative) Negative.NThe action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant products included ANTIHYPERTENSIVES for Hypertension.BHer neck and shoulder pain persisted so she used Lidoderm topical and muscle relaxers which seemed to help as well as resting. Her doctor also advised she go to physical therapy to help.NBased 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.NThis case was linked to MOD-2021-103020 (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,s a causal relationship cannot be excluded.

Experienced intense pain in joints and muscles on 1/27. During the next 2-3 weeks, pain moved to other joints and muscles. Intensity varied. Applied ice to back of knees and legs when movement was affected. As the weeks progressed, fatigue, weakness and pain became more intense. It became difficult to stand from a sit position, walk, turnover in a lying position, bend-over and sit-down. PCP ordered labs on 3/08, which resulted in ESR and CRP showing elevated, inflamed condition. Referred to rheumatology. Diagnosed on 4/21 with polymyalgia rheumatica. Prescribed prednisone 15mg/day. Symptoms relieved and strength returned. Gradual tapering off of prednisone is planned.

Soreness started in fingers and elbow joints and then to hip, knee and foot joints about one month after second shot - I walk 2 miles every day and play golf - was unable to walk or play golf for 4 weeks - slowly getting better - joint pain mostly subsided and have started a slow walk and up to over 1/2 mile ? just reporting for data purposes.

This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia Rheumatica) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dairy intolerance, Drug allergy (allergic to Compazine), Hay fever since 1976, Osteopenia since 2000, Tinnitus since 2016 and Osteoarthritis since 1990. Concomitant products included MACROGOL 400 (BLINK TEARS) for Dry eye, VITAMINS NOS (MULTIPLE VITAMIN) for Multi-vitamin maintenance, VITAMIN D3, PROBIOTICS NOS, FISH OIL and HOMOCYSTEINE THIOLACTONE HYDROCHLORIDE for Routine health maintenance, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 01-Jan-2020 to an unknown date and MOMETASONE FUROATE (FLONASE [MOMETASONE FUROATE]) for Sinusitis, MAGNESIUM CITRATE for an unknown indication, GLUCOSAMINE & CHONDORITIN. On 22-Jan-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced ARTHRALGIA (severe leg pain (both)/Pain seemed to concentrate in back of legs/intense pain in joints and muscles of the legs). On 21-Apr-2021, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia Rheumatica) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST DISCOMFORT (tightness in the chest). At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia Rheumatica) and ARTHRALGIA (severe leg pain (both)/Pain seemed to concentrate in back of legs/intense pain in joints and muscles of the legs) had not resolved and CHEST DISCOMFORT (tightness in the chest) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Additional concomitant medication taken at the start of the events included OsteoThera 4 times per day. On 27-Jan-2021, the patient experienced intense pain in the joints and muscles of the legs. She applied ice as treatment. Over the next 2-3 weeks pain moved to other joints and muscles with varied intensity; fatigue and weakness noted. Overtime it became very difficult for the patient to stand up from a seated position, walk, turn over when lying down, or bend over to sit down. On 09-Feb-2021 additional daily supplements were started: Pea Protein, Calcium D-Glucarate, Digestive Enzymes (Digest Gold), GI Motility Complex, Glutagenics Powder, Sun Fiber. The patient sought medical attention from her Primary Care Provider (PCP). The patient's ESR and CRP were elevated, indicative of an inflammatory condition. The patient was referred to Rheumatology. While she waited 5 weeks for the appointment, she experienced tightness in the chest and continued loss of function. She eventually went to the Emergency Room (ER) and 1 lab result was slightly elevated, indicative of Lyme disease. The ER doctor administered ketorolac and iodixanol and the patient started treatment with doxycycline. On 21-Apr-2021, doxycycline was stopped as additional lab tests for Lyme disease were normal. The patient was diagnosed with Polymyalgia Rheumatica and started treatment with Prednisone 15 mg daily (gradual tapering off was planned), heat, light stretching, and exercise to regain leg movement. 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. Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Additional initial received on 12-May-2021. Concomitant medication added; event added.; 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.

COVID-19 Chills Body aches Fatigue, unspecified type Lyme disease Nausea and vomiting, intractability of vomiting not specified, unspecified vomiting type Acute nonintractable headache, unspecified headache type Dyspnea on exertion Acute midline low back pain without sciatica Diarrhea, unspecified type BMI 28.0-28.9,adult Close exposure to COVID-19 virus Fever, unspecified fever cause Care Coordination Progress Note RN (Registered Nurse) COVID 19 MAB Infusion Navigator Post Infusion Outreach #1 Infusion Date: 05/19/21 ED Course as of May 23 1036 Sun May 23, 2021 1025 EKG shows normal sinus rhythm rate 84 axis of 61. There is no acute ST or T wave changes noted. No signs of ST elevation. [RS] 1032 Patient was given meclizine and Zofran and saline. I reevaluated her. She says she is feeling much better. She is able to stand and walk without any difficulty. I discussed keeping her for MRI as we cannot completely rule out stroke. She verbalizes understanding of this. She still wishes to go home. She will get outpatient follow-up with her family doctor and return for worsening symptoms. We will give her a prescription for meclizine. Medication ? bamlanivimab/etesevimab ? casirivimab ? bamlanivimab

When I woke up I felt my legs wouldn't hold me up. I passed out in the bathroom. Finally managed to get up and walk with the aid of a walker. I have no more memory of that day. Except for meals and bathroom use I remained lying down all day. I was very nauseous and severely weak, light-headed, and had brain fog, Except for the nausea I felt that way for 10 days. On the 10th day I felt able to stand long enough to take a shower.

Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom; Left foot was broken; Had fallen on her foot, fell; Mild aches; Bed was soaked with diarrhea after second dose; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031M21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (Bed was soaked with diarrhea after second dose). 02-Apr-2021, the patient experienced MYALGIA (Mild aches). On 19-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom) (seriousness criterion medically significant) and FOOT FRACTURE (Left foot was broken). 19-Apr-2021, the patient experienced FALL (Had fallen on her foot, fell). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) for Ache, at an unspecified dose and frequency. At the time of the report, LOSS OF CONSCIOUSNESS (Has no memory of this but on 19Apr2021 she woke up on the floor in the bathroom), FOOT FRACTURE (Left foot was broken), DIARRHOEA (Bed was soaked with diarrhea after second dose), FALL (Had fallen on her foot, fell) and MYALGIA (Mild aches) outcome was unknown. Concomitant product use was unknown. The patient reported that the day after her second shot, she woke up and her bed was soaked with diarrhea. She has no memory of this, but on 19Apr2021, she woke up on the floor in the bathroom. She stated that she had fallen on her foot, and her left foot was broken. She also reported she had mild aches on 02Apr2021. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-162182 (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.

Fever ,chills,headache,unable to sleep 2 wks due to tartness of both leg muscles,lose of balance & leg strength, extremely tired loss of energy.

Severe nerve muscle attack almost paralyzed; considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders; considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders; considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders; arms Pain; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUS SYSTEM DISORDER (Severe nerve muscle attack almost paralyzed), PAIN IN EXTREMITY (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders), NECK PAIN (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders), ARTHRALGIA (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders) and MYALGIA (arms Pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No medical history information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (Severe nerve muscle attack almost paralyzed) (seriousness criterion disability). an unknown date, the patient experienced PAIN IN EXTREMITY (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders) (seriousness criterion disability), NECK PAIN (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders) (seriousness criterion disability), ARTHRALGIA (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders) (seriousness criterion disability) and MYALGIA (arms Pain) (seriousness criterion disability). The patient was treated with GABAPENTIN ongoing since an unknown date at a dose of 300 mg three times a day; PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form and IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, NERVOUS SYSTEM DISORDER (Severe nerve muscle attack almost paralyzed), PAIN IN EXTREMITY (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders), NECK PAIN (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders), ARTHRALGIA (considerable pain , started in my leg gradually progressed up to the arms and neck and shoulders) and MYALGIA (arms Pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Inflammation scan: extremely high (High) extremely high. In 2021, White blood cell count: extremely high (High) extremely high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. As reported primary healthcare provider, increased the Gabapentin to 200 mg for a couple of week since pain is not going away. Currently patient is on 300 mg of Gabapentin 3x a day. Velocity test from another Dr., result shows it was not Guillain Barre Syndrome. Onset of events began exactly two weeks after the shot. Concomitant medications were not reported. Second dose was given on 18Feb2021 administered on same arm. No adverse reactions were noted (Lot number: 041L70A) 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. No further information is expected at this time.; 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. No further information is expected at this time

Attempted to get out of bed to go potty and slid to floor unable to stand on legs, daughter and grandson had to help put me back to bed, went to emergency room and they couldn't figure out what was wrong but with assistance from nursing was able to walk. I came home and pretty much slept all day. The next day was weak, sore all over and had a headache

Pt stated that she had her Moderna covid vaccine on Thursday and woke up the next morning extremely weak. She said her legs were so weak she couldn't stand and had to be helped back to bed. She was also very tired. This lasted for 2 days, until Sunday. She was feeling better by Monday. She contacted the doctor and is to call them again in a few days with an update.

Patient received the second moderna covid-19 vaccine on 4/1/21. 2 days later she developed a painful itchy rash at injection site that traveled down her whole arm to her hand. Over the next few days she began to feel dizzy and weak. She had an episode where she was parked in her driveway and felt she could not get out of the car due to feeling dizzy, weak, and faint. She was able to get out of her car and to her bed were she remained for the next 8 hours. She felt she could not get our of bed due to feeling so weak and faint and she feared she would fall. She woke up the next morning able to get out of bed. She then began to develop pain and weakness in both shoulders, both arms, both hands, both knees, and both ankles. We ordered blood test on 5/11/21 including a CBC, CMP, CRP, urinalysis, ESR Wes+Fer, Rheumatoid arthritis factor, and ANA all blood test came back within normal limits. Patient was seen in the office on 5/24/21 for a physical exam and was found to have loss of range on motion in both shoulders and arms, pain and swelling at both elbows, both hands, and both knees. Patient also complained of general weakness, fatigue and a fullness or swelling in both ankles. She has been doing physical therapy, is taking tylenol for the pain, and has been on 2 rounds of steroid medrol dose packs. Patients continues to suffer with weakness, fatigue, muscle, joint pain in whole body. We have also contacted the moderna company and was told they could not help us and hand no treatment or other advise for us. We have referred our patient to a Rheumatologist.

PT WITH ALLERGIC REACTIONS. SORE THROAT. IRRITATIONS. SKIN IRRITATIONS. RASH . MUSCLE ACHES. NASAL IRRITATION, LOOSE STOOL FOR 3 DAYS. FATIGUE . AT FIRST, ITCHING NOW AFTER 1 MONTH . AT TIMES., WITH IMPROVED SKIN IRRITATIONS. HAIR THINING PER PT.

Day 2..and 3, headache base of skull Day day 2 to present time. Soooo sleepy. Sleep 12 hours a night, nap in day. June 2 start of stomach or gut hurt, constipated, until June 9, June 2, beginning of all leg, ankle, knee, hip lower spine pain could barely walk. Lasted until June 10. June 15,soreness and roughness inside cheeks, June 16, Terrible pain in left knee ,the leg with varicose veins. Feels like nerve knee, up to hip. Leg swelling. Can only walk for a little. Still happening. Also, drinking water goes right through me, comes out almost clear.

This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of POLYMYALGIA RHEUMATICA (Diagnosed Polymyalgia Rheumatica) and GAIT DISTURBANCE (Difficulty walking. By May 1st could not climb steps. Had to use hiking poles for walking.) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 04-Nov-2020. Concurrent medical conditions included Hypertension since 2014 and Walker user. Concomitant products included LISINOPRIL for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021 at 1:45 PM, the patient experienced GAIT DISTURBANCE (Difficulty walking. By May 1st could not climb steps. Had to use hiking poles for walking.) (seriousness criterion medically significant), ASTHENIA (Weakness), SCIATICA (bilateral hip pain began, unrelated to any injury, gradual onset. sciatic distribution/sciatic pain), INSOMNIA (Difficulty sleeping turning in bed), DECREASED APPETITE (Lack of appetite), ARTHRALGIA (Bilateral hip pain/severe hip pain/hip pain was worse after inactivity), PYREXIA (Fever 103) and MYALGIA (Myalgias). On 20-May-2021, the patient experienced POLYMYALGIA RHEUMATICA (Diagnosed Polymyalgia Rheumatica) (seriousness criterion medically significant). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at a dose of 220 mg twice a day; PREDNISONE ongoing since an unknown date at a dose of 15 mg once a day; PREDNISONE at a dose of 12 mg once a day; PREDNISONE at a dose of 10 mg once a day; MELOXICAM ongoing since an unknown date at a dose of 15 mg once a day and IBUPROFEN at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (Diagnosed Polymyalgia Rheumatica), GAIT DISTURBANCE (Difficulty walking. By May 1st could not climb steps. Had to use hiking poles for walking.), ASTHENIA (Weakness), SCIATICA (bilateral hip pain began, unrelated to any injury, gradual onset. sciatic distribution/sciatic pain), DECREASED APPETITE (Lack of appetite), ARTHRALGIA (Bilateral hip pain/severe hip pain/hip pain was worse after inactivity), PYREXIA (Fever 103) and MYALGIA (Myalgias) outcome was unknown and INSOMNIA (Difficulty sleeping turning in bed) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Haemoglobin: 11.5 (Low) Decreased and 13.5 (Low) Decreased. On an unknown date, Rheumatoid factor: normal (normal) rheumatoid arthritis profile normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication included small dose of unspecified of antihypertensive medication The patient had initial improvement in neck pain, and later bilateral hip pain began which was unrelated to any injury. There was a gradual onset of sciatic distribution which got worsened after inactivity. Also, the patient had difficulty in sleeping, sitting and walking which kept increasing over time. The patient had seen her physician on 30 Mar 2021 and was prescribed Aleve 220 mg, bid at its maximum dose for three days which helped with some improvement in symptoms which stopped after ten days and had rebound of symptoms within one week. The patient's rheumatoid arthritis profile was normal. Ten days after using Aleve, the symptoms soared. The patient also used Ibuprofen and had to return to use Aleve. On 01 May 2021, the patient could not climb steps. On 03 May 2021, the patient started prednisone and meloxicam. The symptoms improved within one day. The patient saw nurse practioner with rheumatologist on 20 May 2021. Later, prednisone was decreased to 12 mg, daily. The patent was diagnosed polymyalgia rheumatica. The patient saw rheumatologist on 03 Jun 2021, and prednisone was tapered beginning with 10 mg, daily. Later, it was tapered by 1 mg on a monthly basis for the next 10 months and also meloxicam was discontinued. 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. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow up received on on 09 Jun 2021: Patient demographics, reporter, relevant medical history, concomitant drug, events, event outcome and case seriousness 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. Further information has been requested.

Within 15 mins after the vaccine, I felt weakness and weak in the knees and chills; it didn't feel flu-like though. and within the first few hours I had "Moderna arm" - right near the injection site - big red splotch and the arm was sore. The redness in the arm lasted a good week. It was a red blotch but not itchy or swollen. I didn't feel well for a few days after the vaccine. The symptoms came and went as far as how I felt - chills, weak, not feeling terrific for those first few days or so. A month after the second shot, I had a rash on my neck. It came and went - a little itchy and then not itchy. (This happened for a month.) And then at the same time, I felt the same original symptoms - chills and not feeling good. It lasted about three days - the chills and weakness. And then it went away. Even since, April, I get this periodically - I feel weak in the knees, I get the chills and I have to take a Tylenol or something. The middle of May, I was taking off my makeup and I felt a burning on my face (same stuff I've been using for 20 years on my face) red splotch from top of nose and all around and on cheekbones and down the face - it was puffy, swollen, red and caused bags under my eyes and redness under my eyes- and it still is. He gave me a cortisone lotion (my dermatologist) - It's not as red as it was but if I press on it the redness comes back. I have not changed anything with make-up; lotion or food. I have photos of it that I can send of my face. It's still here - maybe not as bright - and I'm not sure that I notice difference using the cortisone cream. It's been a good six weeks since it started on the face.

My right leg, hip and groin all hurt all the time, it is very bad pain all the way down that leg. This has been going on since May 23rd, 2021 and is till happening. My dr is having me go to PT soon. Also about three weeks ago I am now having hot flashes.

On 7/8/21, patient contacted the pharmacy to report that she experienced chills and swelling, itchiness, and muscle pain in both legs starting on 7/6/21, Tuesday night. She took Tylenol around 8pm, which helped. The next day the chills resolved, but she is still experiencing itchy and swollen legs. She tried Cortizone 10 cream and Bactine Max spray, but neither helped. She received her 2nd COVID-19 vaccine on 6/28/21, and she has experienced an allergic reaction when taking Tylenol previously.

After 2nd Moderna shot, severe pain developed in left shoulder, and range of motion was totally limited for arm movement forward, sideways, up or back. It became painful to do any routine function. Finally went to ortho doc on 4/7and they took X-ray. Showing no bone issues. Injected steroid into shoulder. Did PT exercises. Little relief by visit on 5/14 . 6/9 returned to NSO, was given Ascent shot...some improvement. MRI conducted on 6/17 showed extreme inflammation in joint.

March 26 first vax, no prob except tired and no energy. a week and 2 days later she went to hospital could not even change clothes , went to Dr. , then ER. they did MRI, and found out she had a stroke on right side of brain. but right side was showing weakness. Week and half later weakness in right hand. 2nd MRI left side stroke on brain, inflammation on spinal cord, short term rehab. They found UTI after going back to ER. Son got call from The 2nd ER doctor and said she was diagnosed with neuromyelitis optica very rare disease. They said she had transverse myelitis (May, 14 2021) Returned to rehab then found out she had high white blood cell count , On May 16, 2021 readmitted to hospital and did not return to Rehab until June 18 2021 . Then returned and is still in on July 2, 2021. (Inflammation of gallbladder, 4th diagnose of Shower strokes, diabetes, On July 12, 2021 in hospital was diagnosed with Covid 19 and is still in hospital

hot, red, itchy and felt like bees stinging me 2nd day severe Vertigo and vomiting 3-4 days severe diarrhea (with nausea) 9 days later arm swelled and got very red and sore for over a week Still hurts 6 months later

waited 15 minutes after shot and went Home, next morning got out of bed, legs VERY week from knee to foot , both legs, I always had strong legs.

In july 2021 I got the shingles, the pain felt like a short on the right and along the back of neck and on my shoulder like I got a shot on my right arm. It start on my back on the right and rubs and breast . I went to the urgent care twice

Starting same day sore arm, by Tuesday late/Wednesday sore shoulder and knife like pains under left shoulder blade. Pain bad enough Wednesday night/Thursday early morning to contact Dr. Thursday. He determined my pain was muscle pain. Suggested Aleve (as Tylenol and Advil weren't working) and heating pad (which I had used on Wednesday during day). Aleve helped a lot. Pain by today (Sunday) is minimal but still some minimal discomfort.

12 hours after receiving vaccination, became "delirious" temp rose to 103.+ with chills malaise, joint pain, "head hurt worse than did during active Covid + HA lasted 2 days". Temp gradually decreased to 100 over 2 days. Injection site had "fever" for 3 days still sore 5 days later PCP ordered prednisone and z-pak for symptoms

pts daughter states she has severe confusion with slow speech with difficulty speaking and slow movement Also has extreme muscle pain and double vision. Pt had urge to urinate but could not. Pts daughter states she is still having some symptoms but is improving and will see her doctor next week for a regular scheduled appt. Pt started the medicine Cymbalta in November 2020 for her Fibromyalgia but had developed confusion from it so the doctor took her off of it on January 11th 2021 and was doing well until the day of the vaccination.

1 week after vaccine the patient experienced a 5-6 inch red area extending down her arm. She reports arm feeling funny, almost numb, she also noticed a rash. I seen the rash today ( 1/25/2021) it is almost resolved.

Symptoms started to show after 6 hours from having vaccine administered. Patient had stiffness (unable to sit back down from standing position), blank stare, depressed breathing and fever. Transferred to ER, seizures were witnessed. IV Keppra was initiated. Patient was discharged after 2 days and followed up with primary care provider in clinic. Primary provider documented that cellulitis is noted in right arm and antibiotic has been initiated.

Very high fever 6 hours after vaccine. Up to 104.3, chills, difficulty breathing, lower back sore. Lasted approx 2-3 hours with shivering

Back pain from left to right along waist, difficult to start from sitting position and pain when bending and sitting

On day of shot, after I got home, I had tingling in my mouth, dizziness, and slight tightness in my chest. The next day (1/27) I woke with chills and fever ranging from 99 to 102.4 degrees. And a severe headache., also very tired....Stayed in bed most of the day. On 1/28 I broke out in hives on my chest and stomach. Also have very sore muscles, especially in my legs, and shortness of breath.

pt developed fever, chills and backache after the vax . Pt had a tele visit w/ her PCP today 1/29/2021 - pt tested positive for COVID. Pt will FU w/ PCP.

24 hours s/p receiving a vaccination in the R deltoid, the patient noted R distal ulnar redness, swelling and discomfort. The next morning the swelling got worse and she also noted similar swelling around her Left Hallux Longus (similar to a pseudogout reaction). No intraoral swelling. Speaking clearly in full sentences. She has never had similar reactions such as this nor has a h/o pseudogout or polyarthritis.

Within 2 hours of receiving vaccine I began feeling achy and cold; within the next two hours was experiencing hard chills, fever of 101.7; muscle aches and pain. This lasted 33 hours; chills stopped, aches lessened and fever began dropping. By 40 hours after shot temp was normal, no chills or body aches. At 44 hours after event, am back to normal.

Moderna Covid-19 Vaccine EUA. 2:00 am 1/28/2021- woke up feeling queasy, joints in legs were achy. My left knee replacement felt like it was in a vise, This was a short lived event with some residual feeling in the knee in the morning. 3 days after injection 10:00 pm 1/30/2021- I noticed a small rash on my left abdomen near the navel, this rash moved quickly to the left and soon covered entire left abdomen, moving to the groin area then down left inner thigh. I took a Benazepril and went to bed. During the night I woke up several time with a strong pressure in left bowel area. Changing position seemed to help and went back to sleep. woke up about 5 am and checked the rash which was mostly gone except for the original spot where it began. The rash and pressure seemed to be restricted to front left side below waist area. It is now 11:00 am 1/31/2021 and I am feeling fine, very little residual rash at initial site. I had not read anything about delayed reactions as late as 3 1/2 days after the injection so wanted to report this event.

pain at injection site (beginning 4 hours after injection) sickness beginning at 3am (15 hours after injection and continues as this is being completed 9.5 hours later) fatigue, headache, muscle pain, pain in legs, chills, nausea and periodic vomiting, fever (100.6)

Sudden onset in the evening of Feb 1 (17 days after initial dose)--chills, fever, headache, muscle ache, discomfort in upper chest and jaw. Temperature 100.1 which is about three degrees above my normal temp. Night sweats. Following day, malaise, headache, and discomfort when inhaling a full breath. Night sweats again. Today, much better. Able to breath fully without discomfort, not muscle aches or headache, but tired feeling.

Fatigue Muscle aches over back, arms, legs Red area on arm Day6. Jan 28-Hip pain and difficulty walking: ongoing feb 2 given cortisone I hip for bursitis of hip. By feb 2 fatigue and generalized muscle pain and arm redness gone. Feb 3 arm redness recurs, swollen, red, itchy and scaly. 3 and 1/2 inches by 4 inches

started hurting same day of shot. i cried. i cant lift my arm at all. i cant dress or bath or anything. my shoulder is swollen. I can only lift it with my other arm. pain goes up my shoulder to the back of my neck and up my head. The shot was given in the muscle and joint. It was am immediate pain.

Moderna COVID?19 Vaccine EUA On Jan 19, 2021 I received my first dose of the Moderna vaccine. I had minor pain at the injection site for 3 days. On Jan 28, 2021 I noticed stiffness and pain in both of my knees. My Right knee was replaced in 2015 and my Left knee was replaced Oct 5, 2020. I thought it was strange to have pain in the Right knee. The stiffness has increased in both knees since Jan 28. I otherwise feel fine but am having difficulty bending both knees and I have pain when I am weight bearing. I am wondering if the vaccine is attracted to artificial joints? I am scheduled to get my second dose on Feb 17. Please advise if this is a common reaction.

Patient received second dose of Moderna COVID vaccine on 2/4/21 at 9:00am. Patient took blood sugar on 2/5/21 at 9:00am and blood sugar was elevated at 219. Patient reports normal blood sugar is around 110. Patient reports having a headache, chills, and muscle aches that night of administration. Patient continued to have a headache 24 hours after vaccine so she took her blood sugar and it was elevated. Client reports taking normal dose of glipuride (1mg) and farxgia to lower blood sugar. Patient retook blood sugar 3.5 hours later, 181. Patient retook blood sugar 4 hours after that and it was 161. Client reports her blood sugar is still currently evaluated and is taking her additional dose of glipuride.

Extreme headache on left side, numbness and swelling of face, neck and jaw pain on left side and soreness of whole left side of body. Body aches and tiredness

I took the first shot of Moderna?s COVID-19 vaccine the middle of January. Two and a half weeks later, I developed a two inch rash above my right breast even though it didn?t itch or burn, if pressed, it hurt. I treated it with antibiotic ointment and calamine lotion. During that time, I experienced tiredness, exhaustion, sluggishness as well as aches around the right shoulder. I went to get a mammogram where they told me my lymph nodes were swollen on the right side under my arm. They had seen adults who had taken the shot develop swollen lymp nodes which made it necessary to retake the mammogram. I also went to the dermatologist to see what the inch rash was, he took a biopsy, and it turned out it was shingles even though I had had the shingles shots a year before.

I developed on my arm under the injection site a lump the size of a half-dollar. I became dizzy and weak. then my back started to hurt. I got a very fast heartbeat. I slept for a long while. I also had chest pain.

I was sleeping, then woke up and my whole body felt numb. I got up to go to the bathroom and fainted. I fell on the floor and got a bloody nose, cut lip and cut and bump on my head. I had stiff neck for a week afterward.

Head ache Fatigue Joint ache: neck, lower back, knees Muscle ache: calves Loss of appetite Night sweats/fever Deep chills Redness and swelling at shot site

weak arm/pain/couldn't move, chills, fever, headache, lips swollen, face pain when touching, huge pouch under eyes/cheeks sore, hoarse

Pain in left shoulder, then pain moved to include muscle from shoulder to near the base of my neck. As of this date, the pain is somewhat less but still is painful enough that I am taking Ibuprofen several times each day.

patient complains of severe shoulder pain 1 day after receiving vaccine. she said she is not able to move arm (reported to us on 12/13/21 at 1:30 pm )

"tightening" of the right side starting with face on down to leg; lasts for a few seconds; started 2 days after shot; continuing off & on throughout day for last 2 weeks.

High fever muscle pain ad sore red itchy arm. Today only arm symptom remains. This was my first shot. My fever broke overnight on the 11th to 12 th of February.

1st of the series of the vaccine no problem...... adverse events due to 2nd shot...... felt fine all day friday following shot, but by evening, soreness was more intense...... did my pt exercises around 9pm that same evening and felt pain in both right/left groin..... took two tylenols before bed around 10:30 pm and had the chills....... by around 4am could feel intense pain/throbbing in both right/left groin areas..... hard to get up ..... woke husband up around 7:30am and asked for 2 tylenols...... relief for a few hours...... took two more tylenols mid afternoon..... spent all day saturday in bed...... by evening, pain had subsided..... do not know whether pain is related to the shot or just coincidental with my pt exercise and femoral nerve damage (left leg)..... i do have consistent slight pain in my right groin area and my left leg still has nerve damage ------ but at least, i can walk now!!!!!!! sunday am better, but slight tiredness...... monday am fine and now back to 'normal' activities....

Starting about 2 days after the vaccine I have had painful muscle and joint pain. It is painful whether I am stationary or moving...it doesn't seem to make a difference. I take aleve to help with the pain. I am questioning whether to go for the second dose in under3 weeks since the pain does not seem to be lessening after ten days.

2/15: Red rash, swelling, firm, itchy, warm to touch. Approximately 3 inches in diameter; 2/16: red rash spreads, doubling in size, still itchy. no medication taken; 2/17: no significant change. Late afternoon, experience left shoulder ache, headache. 9:00pm 1 tablet 500mg Tylenol taken; 2/18: red rash spread; itchy along edges. 2:00pm 1 tablet Benadryl taken; Headache 10:00pm 1 tablet Tylenol taken; 10:30 pm 1 tablet Benadryl taken 2/!9: swelling, red rash diminished by 60%. Slight itching. Still not resolved.

"brain Fog", anterograde amnesia to the events of the day. lost track of what she was doing and where she was for brief moments. Noted leg weakness on the right.

Three hours (9:00pm) after receiving the shot in Left Deltoid muscle pain started. Getting progressively worse it radiated from neck under Left ear to end of fingers in Left hand Pain was so extreme that I took 2 - 500mg tylenol at 10:30pm. Pain evident without even moving. At 3:30am (2/17) I took 2 - 200mg Ibuprophin. Unable to sleep. At 9:30am took 2 - 500mg tylenol. Called pharmacist explained to him the pain. He said he probably hit a nerve upon injection. Take tylenol and ice it 20 min on and off. Today Friday 2/19 I am still in pain even with meds. Not as severe but still have limited motion. Scale of 1-10 with out motion about 2-3, on motion 9-10. Is there anything else I can do?

11:00pm, Monday, 2/8/2021 began 3 hours of chills (no fever). Next day I stayed in bed entire day with extremely sore joints (ankles, knees, wrists, fingers, shoulders), sore muscles (everywhere), headache (all day and into Tuesday night ), extreme fatigue. Mostly in and out of sleep. Third day, Wednesday, symptoms mostly gone except for fatigue and headache which lasted for a couple of days longer. No fever or nausea at all. No treatment. Took Advil for headache Wednesday morning.

red rash back of the neck, back of the left shoulder, then the front of the right shoulder. Muscles in these areas are sore. Now in the second week of the rash. Rash starts as a small red spot, enlarges to the size of a silver dollar. Seems to form a granulated surface.

2/19/2021 - 8:50AM - severe PAIN IN Back OF NECK AND ACROSS SHOLDERS, SHORTNeSS of BREATH.CHCKED B/P - 85/67. DRANK COLD WATER + LAID on COUCH - subsided in about 10min. 9:00AM - SEVeRe PAIN + MUSCLE CRAMPS, BOTH Legs, fROM knees to toes, couldn't stand up, crying with pain, leaned on walls to get to where husband was, He massaged it with Theraworx ~ 15min, got to wALK then. Exhausted NOW, Drinking a lot of fluids. 8:00am earlier syMPTOMS = Headache, PAiN IN LefT ARM, SLuggish

She developed arm pain, redness & swelling at injection site which lasted for 5 days. 5 inches across area. Pain intense. It reoccurred again at day 10 with more redness, swelling & pain for 4 more days. Went away after about 3 days. Reoccurred with soreness on 22nd day, but this time with some soreness also in right inner wrist. No fever, headaches, or chills. Synopsis- arm pain soreness, redness & swelling off & on for over 3 weeks post vaccination

fever: 102.8, chills, muscles aches, "fuzzy" head, took 2 advil, fever broke after few hours, aches remained for 42 hours, repeated advil twice during that time. much better now (vaccination was working)

I had usual aches and pains, I had extreme neck pain and I felt like someone kicked me in the back of the head. My head and neck and mouth and face were in excruciating pain.

Acute nontraumatic pain in neck, left side, and upper left extemity(shoulder). Acute left cervical lymphadenitis. Still have discomfort in shoulder blade, some swelling yet of lymph node. Tingling in two fingers on left arm, had swelling over same two knuckles but that has receded just have like my hand is asleep, more at night time. Fullness feeling inside of arm at bend, vein area. Injection site is high - about 1 1/2 fingers down. Have had no x-rays or tests. Went to Urgent Care - prescribed Predisone for 5 days - no help. Nec k, now, has less swelling. Mom

Emergency Dept visit on 2/17/2021 at Hospital, with complaints of wrist pain. Diagnosed with possible gout from recent Lasix initiation or reactive arthritis from COVID vaccine received at pharmacy. Admitted to Hospital on 2/23/2021 with diffuse body aches, joint pains, weakness and episode of afib/RVR. Remains hospitalized on 2/24/2021

Patient had swollen injection arm, red rash and chills for 7 days following administration. Also had pain in calves and ankles

At aproximately 15 minutes after patient had the 1st Vaccine she complained of upper and lower lips feeling tingly. A couple of minutes later she said she had some difficulty swallowing saliva and the sensation of her throat feeling tight. She then reported resolve of her lips tingling but reoccurrence of same. She was given water and juice to drink w/o difficulty. She continued complaining of throat swelling sensation becoming worse and denied SOB. Patient stated she does smoke tobacco. VS 142/88 P 90 P/Ox 86% on RA Appears anxious w/o distress Heart RRR Lungs Some very mild diffuse wheezing A/P At approximately 45-55 minutes patient monitored with improvement in P/Ox to 91% on RA but continued complaining of sensation of throat closing. 911 called, IV started, paramedics administered Benadryl and patient was transported to ED without need of O2.

Pt received dose #2 Moderna COVID vaccine 2/1/21 @ clinic. 2/4/21 @ 1645 presents to ED for workup of hypotension, headache. Also reporting back pain, fatigue, shortness of breath. Given IVF and able to discharge home without escalation of care

Pt received dose #2 Moderna COVID vaccine 2/2/21 Vaccine Clinic. 2/3/21 at 1815 presented to ED for workup. Reported myalgias, nausea, vomiting, arm soreness, fever, diarrhea. Taking OTC Tylenol. Given IVF, Zofran, Toradol with improvement of symptoms. Dx with immunization reaction. Able to discharge home without excalation of care.

Fatigue for about a month, weight loss, no treatment, symptoms resolved before second dose (less than a month)

11 hours after the vaccination I felt achy all over, my legs felt limp and lump on my arm was sore. Temperature measured 98.6. I took two Tylenol and went to bed. I got up two times during the night to go to bathroom. I felt more achy all over and unsteady on my feet. Did not want to get out of bed next day, so slept until noon. At noon my temperature was 100.4. I took 2 Tylenol every 6 hours. Had a very achy, miserable day and just rested. Was somewhat better by bedtime and had a better next night of sleep. Next day am still achy but much better.

Very Sore arm, Bad headache, Muscle Soreness, especially in right hip and right shoulder. Arm better in the morning after, but headache lingers. Muscle pain a little less by 11:00 a.m.

No effects until 8 hours later. Then swelling of shoulder muscle, and pain, that has lasted 3 days. Does not appear to be an injury, feels more like an adverse reaction or infection.

Started out with waking the next day a fullness in her head, but kind of a headache, and very tired. Then a couple of hours later she got a severe case of the chills. She laid down and slept on and off for about 5 hours. When she got up she took her temperature and it was 101. She also had body aches in her back and her legs felt very heavy. She then noticed a rash on her body from a line that went underneath her breast, and redness on the left side of her breast to her belly button, all red around the belly button. When she realized she had a fever she took Tylenol. The rash by Saturday was fading and she also had diarrhea on Saturday, persistent diarrhea. She felt almost normal except that she was tired. Today, 3/1/21 she has the returned diarrhea, doesn't k now if it was related to the vaccine. She spoke to a nurse yesterday, and she told that she had a typical side effect from the vaccine. She was not sure if the diarrhea was from the vaccine.

Moderna COVID- 19 Vaccine EUA: Six days after receiving vaccine patient reported tongue and lip swelling starting soon after vaccination. Patient did not take diphenhydramine. During clinic visit seven days after vaccination patient reported chest burning, alternating hot/cold sensation, fever, facial erythema, and sensitivity to smell. No swelling or erythema noted on physical exam: findings include malaise/fatigue, tinnitus, constipation, back pain, nervousness, and insomnia. Vital signs all within normal ranges. Patient discharged home from clinic stable with prescription for hydroxyzine.

I felt like I was hit by a ton of bricks. I got feverish, the chills, and muscle aches and pains to the point that all I wanted to do was sleep. So I went to bed, but just as I would be close to falling asleep I'd have to get up to empty my bladder. This was happening almost every 15 minutes for a few hours. I knew I probably should hydrate, but I chose not to because I wanted to get some uninterrupted sleep which I finally did at about 4:00am which only lasted a couple of hours. Then up at about 6:30am when I took some acetaminophin and went back to sleep. I was in bed all day, sleeping most of the time. When I'd wake up I'd take my temperature and most of the time I'd hydrate. I haven't had anything to eat because I wasn't feeling strong enough to even heat water for soup. My normal temperature is about 97.6 give or take. The highest temperature I had was 100 when I took another dose of acetaminophin. But one time it was 94.3!!! I started feeling better at about 8:30pm (3/1/21) and was able to make myself some chicken noodle soup and had some cereal and cottage cheese with it. I finally felt "normal" on Tuesday morning (3/2/21) after getting a good night's sleep.

muscle aches, headache, loss of appetite, swollen lymph nodes, chills, tired. symptoms disappeared excepto for swollen lymph nodes after 2 days

soarness of arm and discoloration at injection site, pain radiating through back of shoulder/neck to elbow. Self care at home

Pain tenderness swelling Left ankle(fasciitis) Unable to walk for one month bec of pain on stretching ankle. Other :muscle aches , joint pains for 48 hours

Symtoms are fever/chills, weakness, headache, muscle and joint pain, nauseous, loss of appetite, light headed/dizzy, lasting four days. I am still not 100 per cent recovered.

Shivers, Weak Legs, increased heart rate and blood pressure, fever (103). After 30-45 minutes of getting vaccinated, patient got reaction, had to call 911 and transferred to urgent care

6 hours (3 pm) after getting the second dose, my left arm was very sore, even though I had been applying ice, so I took 200 mg of Advil. At 9:15 pm, I had chills and fever for 3 hours and during that time, my right forearm, wrist and hand became very, very sore. I couldn't even flex my fingers the pain was so bad. Pain throughout my body continued during the night, including stomach cramps, back and leg pain and then I took another 200 mg of Advil at 9:15 am on 3/4. I feel I am 20% improved 25 hours after my second shot.

On 3/1/21 at 11:00 AM I received my second dose of the vaccine Moderna. I was fine all throughout the rest of the day. Upon awakening early on the morning of the second, I had moderate aching in all joints, headache, weakness and fatigue. I stayed quiet for day. Upon getting ready to shower on the morning of the 3rd I found I was covered with an angry bright red rash from my neck down to my knees both front and back. Because I did not shower on the 2nd of March I have no idea when it began. On Thursday my head still felt pressure but felt a little stronger and that evening I again showered and the rash looked less angry and bright. Waking this morning on Friday the 5th the rash is gone and I am feeling much better except for soreness in the armpit of the right arm that received the injection.

Approximately 10 minutes after second dose injection client experienced weakness in both arms and light headed in the 30 minute monitoring lot. The EMT on site was summoned to car: B/P 189/86, HR 80, SPo2 100%. Client reported to EMT, tingling hands, and chest pressure. No respiratory symptoms reported. Client was transferred to local hospital to monitor for symptom. No medications were administered in ambulance nor at the hospital ER per client report

Extremely tired, disoriented to place, time, and family, loss of appetite, cold, left shoulder and neck pain, intermittent diarrhea that lasted for approximately 8 days before seeing improvement. Symptoms are now intermittently, states this has been the best days. continuation of medications Metoprolol, Digoxin, Diltiazem, Losartan Potassium, Chlorthalidone, Hydroxyzine, Benadryl and Tylenol as needed

After 1st dose on 1/29/21, pain at shot site, some redness & swelling. Tired for 2 days. After 2nd dose on 2/25/21, pain at shot site, redness & swelling. On 2/26/21, heavy chills, short of breath, face flushed, temp 98. Pain in low back & right upper arm (torn ligaments). Pain more severe than previously. 2/27/21 Shot site sore, itchy, red, swollen, short of breath, headache. Heavy chills towards evening. 2/28/21, Light pain at shot site, site swollen, warm to touch, labored breathing. Shakey, anxious, doom & gloom, food seems tasteless. Evening feeling better, swelling down, flashes if left eye. 3/1/21 arm itchy, no swelling, arm aches slightly. Pain in low back severe, right arm pain. There was only 26 days between the two doses. The pain in back may be from scoliosis. Pain in right arm, torn ligaments. But after receiving vaccine, these pains increased tremendously, as well as the shortness of breath and extreme groin pain (maybe from fibroids?).

Severe fatigue, joint pains, muscle aches lasting 2 1/2 weeks from date of receiving first dose of vaccine

Moderna COVID-19 vaccine EUA headache, chills, joint pain, nausea, body aches during the early morning of March 4 and throughout the rest of the day. Then symptoms eased and gradually went away throughout night of March 4 but then just tired for two more days.

A red spot appeared on my back. I thought it might be ring worm but it was gone in a week. Also my shoulder was sore for about a week. After my second shot a lump formed in my arm pit that was extremely sore. It was gone in two weeks

lightheadedness/presyncope, palpitations, racing heart, premature ventricular contractions with bigeminy, atrial tachycardia, fever 101, chills, myalgias, arthralgias, headache, right arm pain

High fever of 102, dizziness, headache, pain in left side of jaw, neck , chest. Nausea, weakness, seizure.,( Never seized before) left eye burning high blood pressure. Symptoms started in bed while asleep 12 hrs after 2 nd vacccine

I am starting this report with the current status of my, nearly, 6-week ordeal of agonizing pain, doctor appts. debilitation, pain meds, a blood test and the final MRI — this past Saturday, 3/6. Finally, an MRI has confirmed physician's recent suspicion that my second Moderna vaccination was improperly administered. In fact, it tore a tendon in my right shoulder. I knew something was wrong when I saw how high the needle was injected into my arm/shoulder. I just didn't know what the ramifications would be. I have been referred to a surgeon, and my appt. is 3/16). Summary of Events: On 2/1/21, I received my second dose of the Moderna vaccine and had 2 days of moderate pain and soreness. But about 3 days later, 2/4, I awoke to excruciating shoulder/arm pain that had me sobbing out loud. I took Tylenol and waited. Nothing. I took more Tylenol and slowly the pain diminished. For an hour or so. All I could do was lie on the couch, literally, groaning and unable to lift my arm By evening, the only relief I could get was from an old (hip surgery) Oxycodone pill. I took 1/4 piece and slept the night. Friday and Saturday I was totally debilitated. I couldn't lift my arm, care for my dog or do anything but lie on the couch, still sobbing, until small pieces of the Oxy set in again. It was the weekend, and I didn't want to bother anyone but I never felt such pain for such an extended time or survived so long on meds. Monday morning, 2/8/21, I called my Doctor. I was very concerned and really wanted to make sure this pain was still from the vaccine and not some "weird" condition that might have hit me. The office told me the pain was probably from the vaccine and advised me to keep taking Tylenol. So it continued, on and off, relief and agony. I was sure it would stop. It didn't. Thursday, 2/11, I saw the Doctor, in person. Physician did not have an answer for the pain but gave me a prescription for Celebrex and did a blood test to see if there was a bacteria infection that might have invaded the area. We would wait for results. Another weekend of pain but lessened a bit. Around 2/13, a neighbor called me with an article he found about the SAME situation MANY people were suffering (thousands) and LAWSUITS pending!! I didn't know what was happening to me but the Gov't did. The article was found on internet, 2/12, and printed an article from news paper, 2/12 No other reports appeared anywhere. The pertinent findings of the article: thousands of vaccinated people (Covid and flu) have reported similar pain and debilitation. The previous gov't has introduced a law prohibiting lawsuits (l think against the pharmas but not the administering agencies. Not sure.) that was to go into effect, 2/23. Again, not sure of details. But no one knows about this - people NEED to know. I immediately notified my family and close friend about my situation. While the cause is not certain, it is suspected that improper injection technique/training/experience is to blame. To get the word out, I posted on social media, wrote representatives, etc. And now I found you. The information must be made available; not to stop vaccinations but to alert the public if they occur.

First 6 hours post injection: localized redness RT. deltoid. Next 25 hours: febrile 101.2 to 102.6, joint pain knees & hips, muscle pain, extreme fatigued. On Day 2: same symptoms for next 10 hours. Very similar to full-blown flu symptomatology. This event was followed 18 hours later by a sore throat & signs/symptoms of a head-cold & sinusitis, thought to be viral (clear mucous from nasopharyngeal area. Weakness & significant fatigue continues; saw my physician?s Nurse-Practitioner: mow on Ampicillin/ clavulanate 825/125 mg.

chills, fever, headache, joint pain all over, red swollen arm with severe pain starting morning after injection and continuing for 2 day. Arm still red swolen, sor to the touch and hot to the touch

Ache in back of left leg. Thought it was a muscle strain from working in yard. Did not go away so went to Clinic February 2nd, 2021. They asked me my symptoms and then sent me for a Sonagram and discovered a DVT and later a Pulmonary Embolism in my right lower lung. I am now on Eliquis.

received shot at ll:45 am was fine went home. about 4:00 started to get cold. developed flu like symptoms, headache, fatigue little bit of fever, pain up back of neck and to my ears. was in bed all night on 3/12/21, stayed in bed all day 3/13/21. Had some oatmeal, gatorade, juice. Could not taste anything back to bed. Sunday got up thought I was good. But dizzy and lightheaded, little itching on my legs and a little nausea. Had tuna sandwich could not taste it, thought it was awful. Back to bed all day. Monday I am up but still dizzy when standing trying to stay up but just sitting. Taste has come back.

Day 1 sore injection site moved to shoulder and upper back, dizziness Day 2 exhaustion, dizziness, headache Day 3 exhaustion dizziness, headache Day 4 continuing headache, joint aches Day 5 back pain, pain in back of head, joint aches Day 6 back pain more severe, pain in back of head, joint aches Day 7 lessening back pain, spasms,, joint aches

Email to COVID CARE - referred to PCP "I'm having side effects after the second shot. I'm having vomiting, diarrhea, can barely talk, balance problems, dizziness, and back pain. I'm very tired. I had a brain bleed six years ago."

Site: Pain at Injection Site-Severe, Systemic: Joint Pain-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)

Developed red itchy smooth feverish rash on legs and arms starting after 7 days and still have rash to this date . Joints ached. Took antihistamine tablet and also acetaminophen but that did not help so quit taking anything.

A-fib; difficulty breathing; sleeping on and off; dry heaving, feeling nauseated, not hungry; weak; chills; mild headache; Tired/fatigue; muscle pain on the arm; joint pain; Feeling nauseated; A spontaneous report was received from a consumer concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain. The patient's medical history, as provided by the reporter, included prior COVID-19 infection. It is not clear if the patient had prior A-Fib. No relevant concomitant medications were reported. On 25-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 25-Jan-2021, patient was feeling fine right after first dose of the Moderna vaccine. On 26-Jan-2021, the patient felt difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain. Lab details was not provided by the reporter. Treatment for the events included rubbing gel. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tired, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

2-3 WEEKs after receiving vaccine...pain in right foot (rheumatoid arthritis) sore and weak all over, tired-lethargic on 3/19- woke up, sat at edge of bed to text daughter, got up walking to bathroom, got dizzy and collapsed = passed out. Got up and again collapsed passed out =don't remember it happening .... Went to ER for fall and analysis as to what , why, etc. I would be having this acute autoimmune reaction... blood work etc. you can contact the LWRM and Dr for details.

Treatment: Tylenol Symptoms: chills, joint pain, muscle soreness, nausea, headache, extreme fatigue, fatigue lasting 5 days

3/24/21 ER: 77 y.o. female who presents with suprapubic abdominal discomfort. Patient reports a 2 day history of increasing cramping and pressure in the suprapubic area. Patient reports she felt this way when she had urinary tract infections. However, patient denies any current urinary frequency, dysuria, hematuria, or urgency. Patient does report some minor dribbling which she states is common for her. Patient denies any fevers but does report an occasional chill. Patient does report pain across her low back. Patient denies any nausea, vomiting, constipation, diarrhea, melena, hematochezia. Patient does have an extensive abdominal surgical history including colon resection, cholecystectomy, appendectomy, and hysterectomy

Within 8 hours of receiving the Moderna vaccination (dose 1), I could not raise my left arm parallel to the floor, extend my arm or lie on my left arm/shoulder. It has been 6 days, and it is somewhat better, but still quite limiting in what I can do. I sure wish I was told that this could happen. I have osteoarthritis, and i rely on my left arm/shoulder when I take the stairs and do daily activities. I am in a lot of discomfort and my activities have had to be quite limited.

Sore muscles began soon after vaccination. In the night woke up dizzy. Then had intense chills and became nauseated. After several bouts of chills finally fell asleep again. Next morning woke up with fever of 101 F (usually body temp is around 97.5) and headache. Stayed in bed all day with fever and headache. In evening symptoms began to disappear.

Chills, 100.4 Fever, Slight Headache, SEVERE attack of Rheumatoid Arthritis One tablet of Tylenol Chills. fever, cured -- Headache persisted for a couple more days --RA persisted for 6-8 days

Red, itchy raised area below injection site; pain in joints and muscles all over body (arms, legs, back, knee joints, elbows, wrists, ankles, calves), short of breath, weakness. Severest late Saturday and through night of March 27th and March 28th. Still feeling restrictions in back, lung area on Monday, March 29th.

severe pain in right scapular radiating to left scapular, right shoulder and right arm. still have pain never dissipated. Constant had x-ray of only right shoulder by orthopedic doctor, negative results. Pain now chronic constant. Never had this prior to vaccine, could it be related. ,over four weeks still have his pain. I would appreciate a reply. Thank you

1st day after: fatigued. 2nd day after: nausea upon eating breakfast, tightness in neck, shoulders & headache. Take Tylenol. Symptoms lessen by mid-afternoon or dinner time. No symptoms first thing next day. The issue has happened for 5 days in a row. Eating oatmeal with no milk or sugar and hot tea. How long can this last???

I am submitting this report not based upon adverse events I experienced after both vaccinations including headache, eye pain, somnolence, dizziness, joint and muscle pain, low-grade fever, loss of appetite. These symptoms resolved two days after first vaccination and four days after second vaccination. No medical advice was sought and acetaminophen was taken on an as-needed basis. What I found to be unusual after both vaccinations was profound changes to the color of my urine two days after the vaccinations. I use the PureWick external catheter and urine collection system due to my NMO-related incapacitation. This system facilitates the assessment of urine output and characterisitics. After my first

first shot a month earlier - sore arm, gland swollen in armpit, very cold & headache. 2nd shot - sore arm, sore back of neck from headache (muscles seemed frozen for days), really cold from 8pm to 4am with debilitating headache. left side of body was without coordination, hip, knee, ankle didn't work. Went sideways with all joints when walking. 03/18/2021 - passed out in bathroom due to pain. Hit door frame and had large lump on forehead. Bowel mess to clean up. 03/21/2021 - didn't dress, still wobbly stomache upset, neck sore, dizzyness, ate squash and beans. 04/01/2021 - still have stomache upset and though day temperature is over 70 degrees, am very cold, tired as soon as do just one thing. continues

iST INJECTION WEAK NAUSEA RIDE CIRCLE UNDER INJECTION SITE LASTED ABOUT 4 DAYS TOOK WATER & TYLENOL 2ND INJECTION WEAK NAUSEA DRY HEAVES EXTREME PAIN IN ALL JOINTS CHILLS CIRCLE BELOW INJECTION SITE UNABLE TO FUNCTION ON MY OWN FOR 5 DAYS WEAK AND NSUSEA LASTED 4 DAYS MORE TOOK tYLENOL AS SUGGESTED BY STAFF WHEN RECEIVING INJECTION

She got the vaccine, was fine and went to bed. She sleeps in a fetal position with her legs curled and when she woke up she was not able to get up and was stuck in the fetal position. She was in excruciating pain, and had a dog to let out as she lives by herself. This went on for about 3 days. Then she went back to work and worked 2 days and then she woke up the next morning 3/28/21 and every joint in her body including her toes was throbbing and aching like she had arthritis. Since then she has continued with these symptoms, and aching all the time in her feet, shoulders and other areas. She saw her stomach doctor who she told him about her side effects and he advised her not to take the 2nd vaccine. She took her normal pills and Tylenol arthritis. She did notify her regular provider of her reaction as well. She went and got x-rays of her knees and legs at healthcare facility that said that they did not find anything other than some arthritis. It also affected her arms, legs and feet and had x-rays again and showed nothing but some arthritis in her hips. She still continues with the same symptoms. It will ease up, she will go about her business and then will wake up with throbbing pains.

Patient states history of fibromyalgia. The day after getting the vaccine, she experienced increasing joint pain. Within a couple days, the joint/body pain increased to the point she was not able to walk and was using a wheelchair. She has been evaluated by her PCP who then referred to an orthopedic specialist for further evaluation and treatment. Now two weeks after the vaccine, her mobility and joint pain have improved to the point she is only needing a walker to move around. However, she states she is still not back to her pre-vaccine mobility/pain status. There may be another VAERS report from her PCP

Body aches night of injection. Extreme bloody nose with clots on 3rd day after injection. Swollen and very itchy right wrist 3rd day after injection. Was able to stop bloody nose after 1 hour, did not need medical help. Have not experienced a bloody nose in over 50 years so this was quite unusual.

swelling of ankles and feet; Difficulty breathing , Lethargic. has continued 3 weeks after 2nd shot.

Approx 10 days after shot - severe pain in muscle part of arm, neck gland protruding , swelled, neck pain going all way to ear- previous to this time could not lift arm above waist- not concerned at first but kept getting worse and extending to neck, shoulder, upper arm. Some swelling in hand as well numbness - fullness feeling in inside of arm especially at bend and hard lump in muscle of arm. I had this w first shot, filled report, met w 3 doctors, each prescribed different rememdoes. First time went to UC - prescription for steroids & ice. Family dr back from seminar visit - said should never have prescribed steroids -- prescribed heat, topical cream. 2nd shot effects mush later showing - this time dr prescribed xtra strength Tylenol, ot ibuprofen. Do not want to talk meds, want to know why this is happening. Since last major surgery, 2019, after 2 others in 6 years, only take low dose aspirin & vitamins pills.

The patient's husband stated she woke up after receiving her second dose of the Moderna shot & she couldn't move her fingers on left hand. Also, she says her arm was very weak, She called her doctor which preceded to tell her to go to the hospital. The patient arrived at hospital & was admitted for 2 days. Upon her discharge the doctors told her they believe she had a minor stroke. She starts rehab next week. I tried to reach out to patient several times about retrieving her current medication list but there was no answer.

27 hours after the vaccination I suffered an episode of total body muscle weakness including my bowels. I was too weak to stand. When my husband arrived home he helped me into the tub and to bed. I was fine the next morning except for some lingering fatigue that has continued.

Sore arm after initial shot on 3/15. Pain in groins started 3/17 making walking painful and slow. Getting on and off commode I sometimes need help. Pains in muscle area of arms has subsided. Called PCP to document how I felt on 3/19. They returned call on 3/22 - said to take B12,Zinc,and Vit. C because I had questions about 2nd. shot. Got 2nd. shot on 4/12 - seems like I'm back to square 1. Taking Tylenol - 2 tabs every 6 hours. Helps but I need to get back to normal.

Within four days after receiving second Moderna injection, my right hip, leg and left hip began aching. This would start early evening and progress into and through the night. I met with my doctor in his office, had an x-ray of the areas involved. Nothing noteworthy appeared on the x-ray. His suggestion was to take ibuprofen and acetaminophen throughout the day and evening. The pain in my hips and right leg is still considerable. I will be seeing my doctor again about this problem.

1st dose pain in right side near small intestine 4 days after vaccine, doctor did blood work, ct scan 2nd dose sharp pain in left lower back morning after, chills same day as vaccine - ER gave muscle relaxers, did blood work, urine test taking advil have continued warm/inflammatory feeling in abdomen 4 days after 2nd shot

Received 2nd moderna vaccine 2/12/21. Left arm a bit sore that night at injection site. Woke up 2am with chills, whole arm and left shoulder blade very painful, fatigue. Sunday felt a bit better. Monday improved. Now use arm to hold the phone. Would just hang at the side, very painful. Laryngitis started yesterday, has chronic PND and allergies. Still have some chills, fatigue overall improved. Took tylenol, mindful of transaminitis

March 8th thru March 29 swollen ankle and left calf. Treated by patient with compression socks. Seemed to relive swelling April 13th Emergency Room at hospital, after extreme shortness of breath + coughing up blood at home. Admitted to hospital

arrhythmia nervosa; Ankles swollen; Areas on both legs that were bright red/swollen/tender; Areas on both legs that were bright red/swollen/tender; Areas on both legs that were bright red/swollen/tender; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (arrhythmia nervosa) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Mar-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. On 10-Apr-2021, the patient experienced ARRHYTHMIA (arrhythmia nervosa) (seriousness criterion medically significant), JOINT SWELLING (Ankles swollen), ERYTHEMA (Areas on both legs that were bright red/swollen/tender), PERIPHERAL SWELLING (Areas on both legs that were bright red/swollen/tender) and TENDERNESS (Areas on both legs that were bright red/swollen/tender). At the time of the report, ARRHYTHMIA (arrhythmia nervosa), JOINT SWELLING (Ankles swollen), ERYTHEMA (Areas on both legs that were bright red/swollen/tender), PERIPHERAL SWELLING (Areas on both legs that were bright red/swollen/tender) and TENDERNESS (Areas on both legs that were bright red/swollen/tender) had not resolved. No concomitant medications provided. Treatment included doxycycline and prednisone. 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.

Client received 1st dose of Moderna vaccine at 1:30 pm and at approximately 7:00 pm she experienced loss of muscle strength/weakness of her left arm along with edema from the left elbow down to the left wrist. No pain was associated with the event. The swelling and weakness resolved itself the next day, within 24 hours of the onset of symptoms.

I fully support efforts to end this COVID-19 pandemic. That is why I took these vaccinations Over the last twenty years I have taken a number of vaccination including an annual seasonal flu shot. I have learned during these years that when I take such a vaccination I need to do it when my schedule is clear to allow for several days of down time. I usually need several days to recover from such a vaccination. I also take only one vaccination at a time to lessen any problems I may have with it. Sometimes I have had a large red spot on my vaccination arm, up to four inches wide, near or around the injection site. Continued:

Foggy brain, dizziness, fatigue, weakness, loss of appetite, depression, nosebleeds. diarrhea, groin pain (left & right), Sciatica (left & right) headaches, head pain,

day four severe pain in muscle in left leg where leg meets trunk muscle in waist above navel to left hip

05/07/2021 from 12:30 am - 6:30 am experienced painful crushing viselike pressure on left torso area behind left breast down to left waist in front and back lasting for several hours making it impossible to sleep. 0/5/15/2021 from 3:30 am - 6:30 am again experienced this pain but not as crushing making it impossible to sleep. Pain also occurred in right upper arm and shoulder area at that time. Due to uncertain origin of this pain, I am seeing cardiologist and having Left Diagnostic Breast Mammogram and ultrasound on 05/17/2021, followed by Covid Test on 05/19/2021 and Stress Test on 05/21/2021.

heart cath; Fluid on the lungs; short of breath; Did not get second shot due to illness; sore arm; not being able to stand up and being weak; Aching all over every joint; not being able to stand up and being weak; This spontaneous case was reported by a consumer and describes the occurrence of CATHETERISATION CARDIAC (heart cath) and PULMONARY OEDEMA (Fluid on the lungs) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO), LEVOTHYROXINE, METOPROLOL, FUROSEMIDE, POTASSIUM, WARFARIN, GABAPENTIN and METOLAZONE for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CATHETERISATION CARDIAC (heart cath) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY OEDEMA (Fluid on the lungs) (seriousness criterion medically significant), DYSPNOEA (short of breath), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second shot due to illness), PAIN IN EXTREMITY (sore arm), ASTHENIA (not being able to stand up and being weak), ARTHRALGIA (Aching all over every joint) and DYSSTASIA (not being able to stand up and being weak). On 17-Mar-2021, CATHETERISATION CARDIAC (heart cath) outcome was unknown. At the time of the report, PULMONARY OEDEMA (Fluid on the lungs), DYSPNOEA (short of breath), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not get second shot due to illness), PAIN IN EXTREMITY (sore arm), ASTHENIA (not being able to stand up and being weak), ARTHRALGIA (Aching all over every joint) and DYSSTASIA (not being able to stand up and being weak) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Cardiac catheterization on 17-Mar-2021. Based on the current available information and temporal association between the use of the product and the start date of the events( cardiac catheterization, dyspnea, pulmonary oedema, dysstasia, asthenia, pain in extremity and arthralgia) a causal relationship cannot be excluded. However for the event of inappropriate schedule of Product administration for mRNA-1273, causality is assessed as not applicable; 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( cardiac catheterization, dyspnea, pulmonary oedema, dysstasia, asthenia, pain in extremity and arthralgia) a causal relationship cannot be excluded. However for the event of inappropriate schedule of Product administration for mRNA-1273, causality is assessed as not applicable

Pain in area of where the lower buttocks meet the upper leg. Pain radiating down and across upper leg. I wouldn't have even thought about this being related to the vaccine, but 2 other acquaintences have mentioned the same problems coming up since the last vaccine. There has been no injury or event to explain this pain.

Onset urticaria 3/12/21. ED visit 3/14/21. Syncopal episode in context of rash 3/17/21 leading to hospitalization 3/17-8/21. Benadryl, loratadine, famotidine, cephalexin for UTI. 2nd Moderna shot 3/27/21. 4/2 Office visit dizzy, weak, headaches, nausea, loss of appetite since 2nd vaccine Na 127. 4/16 Office visit for Headache, neck pain. 4/25 ED visit for dizziness. MRI head NL, labs mild hyponatremia. Given meclizine. 4/27-8 Hospitalization for dizziness, orthostasis, URI symptoms. OC43 Coronavirus, orthostasis. Alb 2.7 Globulin 5. New cervical and axillary Lymph adenopathy. 5/8/21 admitted to hospital w/ new diagnosis of lymphoma (pathologic diagnosis Nodal peripheral T cell lymphoma w/ follicular helper phenotype. Large axillary lymphadenopathy, thrombocytopenia, elevated total protein, acute kidney injury, anemia. 5/15/21 patient passed away from acute hypoxic respiratory failure in the setting of new lymphoma diagnosis.

She got her vaccine, her left arm hurt as it does with her regular flu shot and normally goes away after a week. The next day she read what to do, but she moved her arm slowly around to exercise it to get rid of the soreness. On the 2nd day the pain went away. By the 3rd day it was back with a vengeance, and stayed there and never got better. Her joint and everything started to hurt. It felt like she had to have rotator cuff surgery again, and it still feels that way. She went to her doctor who gave her a steroid shot which helped but then it came back again. Within a week she could move her arm, but in a certain position it hurts her extremely badly. If she raises her arm it "bites" her and the pain does not cease. Her groin area also she is having pain there as well that radiates to her knee. The front top side is burning and sore all of the time, and does not want to quit. She takes baby aspirin and was given Norco but she did not like how it made her feel and doesn't take that. The 800 of Ibuprofen did not help with the pain, neither does Tylenol or Advil. She states that the medicines make her muscles sting and burn and feel worse. She feels that the vaccine got to her vulnerable places of pain from before that have healed and feels that it has reactivated that pain and the pain won't go away. Her arm did not hurt her for years, and her leg pain had been gone for a long time, but since the vaccine she has had nothing but pain. She got her 2nd vaccine on 3/25/21, she did not have any adverse reaction, just the reaction from the 1st one did not go away and it did not go away after the 2nd one and still has the same pain. It did not bother the bladder where she had surgery, just the joints of her body where she had previous problems. Her back has been out of place and could not walk for a year and a half, but this has not bothered her back.

Diverticulitis; cannot lift anything up or drive; painful arm between the elbow and shoulder; muscle spasms; stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of DIVERTICULITIS (Diverticulitis) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced MUSCLE SPASMS (muscle spasms) and ABDOMINAL PAIN UPPER (stomach pain). On an unknown date, the patient experienced DIVERTICULITIS (Diverticulitis) (seriousness criterion medically significant), MUSCULAR WEAKNESS (cannot lift anything up or drive) and MYALGIA (painful arm between the elbow and shoulder). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency and IBUPROFEN (ADVIL 12 HOUR) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIVERTICULITIS (Diverticulitis) had resolved, MUSCLE SPASMS (muscle spasms), ABDOMINAL PAIN UPPER (stomach pain) and MUSCULAR WEAKNESS (cannot lift anything up or drive) outcome was unknown and MYALGIA (painful arm between the elbow and shoulder) had not resolved. No concomitant medication were provided Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Action taken with mRNA-1273 Moderna vaccine was Not applicable Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Significant follow up was accepted on 27-May-2021 On 26-May-2021: Non significant follow up; 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.

Symptoms began 12-13 hours after shot was given. 2-4 a.m., strong chill with whole body shaking and knife-like sharp pains in legs 5- 7 days heavy nasal mucus discharge painful muscles and joints; fatigue, unstable balance, sensitivity to light lasted 3-4 days 3rd day sore upper left arm with rash from injection site to elbow lasted 3-4 days Symptoms generally cleared up by June 16. Treatment: bed rest, fluids and 1000 mg Tylenol every 6 hrs over 4 days

cannot use my left arm where i had first shot. severe pain at all times. cannot lift arm. shoulder pain is such that i cannot tell you how disdisabling this is.

Received Moderna vaccine against COVID on 2/15/2021 and 1/28/21 (lot number 037k20a). Vaccinated at a site but immunization in state database. Presented with shortness of breath and weakness in lower extremities. No requirement for supplemental oxygen. Treated with PT/OT. Shortness of breath resolved.

I never considered it as an adverse effect. I did wonder if by stimulating my immune system if it stimulated the shingles. I had pain in my shoulder and going up the side of my bed. It wrapped around my head and behind my eye. I had had shingles before and it felt like shingles pain. I noticed I was breaking out on my shoulder and starting up the side of my neck. I went to the urgent care and they diagnosed me with shingles. They gave me some medicine and it went away 2 weeks later. It didn't affect my eye itself, but it did affect my eyelid and around my eye. I saw my regular doctor later on. I just had a prescheduled appointment with her. I did tell her about it. She looked at the area and said I was healing up nicely. She suggested I get the shingles vaccine.

Within the first 24 hours the patient manifested symptoms of headache, persisting fatigue and pain in the joints of the arms and legs noting the elbows and wrists as particularly irritating. Within one day of appearance the symptoms of headache and fatigue resolved, but joint pain remains and patient has developed a 3-inch radius rash without elevation centered at the site of injection which the patient reports to be painful.

Fainted; Diarrhoea; Feels weak; bone pain from falling; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Fainted) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No reported medical history. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Fainted) (seriousness criterion medically significant), DIARRHOEA (Diarrhoea), ASTHENIA (Feels weak), BONE PAIN (bone pain from falling) and VOMITING (Vomiting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 19-Mar-2021, LOSS OF CONSCIOUSNESS (Fainted), DIARRHOEA (Diarrhoea), ASTHENIA (Feels weak), BONE PAIN (bone pain from falling) and VOMITING (Vomiting) had resolved. Concomitant product use was not provided by the reporter. Action taken with mRNA-1273 was not applicable. Company Comment: This case concerns a 77-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected diarrhoea, asthenia, bone pain and expected vomiting. Event latency 2 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 77-year-old female with a serious unexpected event of loss of consciousness, and nonserious unexpected diarrhoea, asthenia, bone pain and expected vomiting. Event latency 2 days after second dose mRNA-1273. 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.

5/23/chest discomfort. Hiked pain going uphill. went to Clinic care. They did ekg -negaitve. Dx me as Costa Chondritis and rx prednisone 6 -1st day to 1- 6th day Pain abated somewhat at first by 6th day could not sleep from the pain. Admitted into hospital 5/31 for stress test 5/31. Negative discharged. Returned 6/4 admitted second time in hospital. Placed on iv antbiotics . 5/7 83 cc removed from cardiac sack and 6/6 6oocc removed from left lung sack. Pain abated. all lab tests negative no cause found for this strange event. I am a daily workout person. I do hike and yoga and taichi.

2 days after first injection I could not turn my head, neck pain, shoulder and arm pain. went to urgent care, symptoms got progressively worse, numbness in my arm and severe spasms in my back, after 2nd injection I could not function or go to work. I have seen 8 doctors, 2 trips the ER 2 MRI and CT scan. 3 cortisone injections and i still have pain in my shoulder and numbness in my arm and hand. Pins and needles if I try to use my arm. I am still out of work and very painful. A surgeon has been recommended to relieve the nerve pain I am experiencing.

I developed a rash from my shoulder to my elbow. I had a fever for 24 hours, weakness in the legs, nauseated, went into AFIB. Went to hospital.

Patient was a 77 year old, resident, past medical history of dementia, hypertension, schizophrenia, hyperlipidemia, Parkinson's disease. Patient presented to the ED with altered mental status and a potential seizure. In the morning of 3/24, patient reportedly had an episode of seizure that lasted 30 seconds, generalized tonic/clonic. It is unknown if she fell or hit her head. Per manager, patient is following Neurology, recent work up for possible syncopal month ago. Patient received her 2nd dose of Moderna Vaccine recently on 3/19. At baseline patient is independent, ambulates by her self. Patient has been ill after receiving a COVID vaccine last week. Patient has progressive weakness of the bilateral lower extremities and progressive difficulties with talking , had had multiple falls.

Possible myocarditis. Patient experiencing profound non-ischemic cardiomyopathy and acute CHF, without obvious other cause on preliminary investigation. Sx of fatigue, dyspnea, exercise intolerance, myalgia began 24 hours after vaccination. Myalgias resolved but CHF progressed until Dx 6/29/21. Previously an active runner.

Shortness of breath; loose bowels, cannot eat fiber; Bled a bit; Spasm in Neck; Temperature of 100.3; Chills very severe; Headache; Severe joint pain for her rotator cuffs and neck, tendons in arm, ribs, and all bones; Injection really hurt; Nausea; Knocked out from going up stairs and getting up chair now; Pain in tendons in her arm/ sore arm; Pain in ribs; Pain in all her bones; Rapid heartbeat/Palpitation Continues; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Knocked out from going up stairs and getting up chair now) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis (Patient had arthritis attack prior to vaccination.). On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Knocked out from going up stairs and getting up chair now) (seriousness criterion medically significant), TENDON PAIN (Pain in tendons in her arm/ sore arm), MUSCULOSKELETAL CHEST PAIN (Pain in ribs), BONE PAIN (Pain in all her bones), PALPITATIONS (Rapid heartbeat/Palpitation Continues), VACCINATION SITE HAEMORRHAGE (Bled a bit), PYREXIA (Temperature of 100.3), CHILLS (Chills very severe), HEADACHE (Headache), ARTHRALGIA (Severe joint pain for her rotator cuffs and neck, tendons in arm, ribs, and all bones) and VACCINATION SITE PAIN (Injection really hurt). 03-Apr-2021, the patient experienced MUSCLE SPASMS (Spasm in Neck) and NAUSEA (Nausea). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath). an unknown date, the patient experienced DIARRHOEA (loose bowels, cannot eat fiber). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Fever and Headache, at an unspecified dose and frequency and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) ongoing since an unknown date for Allergic reaction, at an unspecified dose and frequency. On 05-Apr-2021, CHILLS (Chills very severe) had resolved. On 25-Apr-2021, TENDON PAIN (Pain in tendons in her arm/ sore arm), MUSCLE SPASMS (Spasm in Neck), PYREXIA (Temperature of 100.3) and NAUSEA (Nausea) had resolved. At the time of the report, LOSS OF CONSCIOUSNESS (Knocked out from going up stairs and getting up chair now), MUSCULOSKELETAL CHEST PAIN (Pain in ribs), BONE PAIN (Pain in all her bones), DYSPNOEA (Shortness of breath), VACCINATION SITE HAEMORRHAGE (Bled a bit), HEADACHE (Headache), ARTHRALGIA (Severe joint pain for her rotator cuffs and neck, tendons in arm, ribs, and all bones) and VACCINATION SITE PAIN (Injection really hurt) outcome was unknown and PALPITATIONS (Rapid heartbeat/Palpitation Continues) and DIARRHOEA (loose bowels, cannot eat fiber) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, Body temperature: 100.3 (High) Temperature 100.3 Degree. On 01-Jun-2021, Cardiac monitoring: inconculsive (Inconclusive) Patient Wears a heart monitor.. On 16-Jun-2021, Antibody test: negative (Negative) Patient was reported to have no antibodies at all. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient's Date of Birth was reported to be 1944. Chills were reported to be very severe and she could not get warm even with a heater on. Patient was reported to have had a cardiogram done after consultation with physician. No concomitant medications were reported. Patient also reported that she could not eat fiber. Patient still has heart palpitation and wears Heart monitor. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) 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. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow up was received on 17-JUN-2021. Lab data- antibody test was added. Additional event- diarrhea was added.. Event- Loss of consciousness was updated. Case was upgraded to serious- medically significant. Outcome of events- arthralgia, palpitations were updated. On 21-Jun-2021: Secondary reporter information was added. Added medical history Arthritis.Lab data-Cardiac monitoring was added. Added newevents spasm in neck and Nausea. Added stop date for sore arm/pain in tendon in her arm event.; 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.

left knee warmth; left knee swelling; woke up/collapsed after trying to get out of bed; felt fluish; felt weak/got weaken as day went on; fall; could not walk; joint infection; This spontaneous case was reported by a physician and describes the occurrence of SYNCOPE (woke up/collapsed after trying to get out of bed), GAIT INABILITY (could not walk), INFLUENZA LIKE ILLNESS (felt fluish), JOINT WARMTH (left knee warmth), JOINT SWELLING (left knee swelling), ASTHENIA (felt weak/got weaken as day went on), FALL (fall) and ARTHRITIS INFECTIVE (joint infection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030LZ0A) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. The patient's past medical history included Knee replacement (LEFT) in 2013. Previously administered products included for Hives: Amoxicillin. Past adverse reactions to the above products included Rash with Amoxicillin. Concurrent medical conditions included Tobacco user (30 TO 40 CIGARETTE STICKS A DAY) since 1962, Drug allergy (AMOXICILLIN-RASH AND HIVES), Abstains from alcohol, Diabetes, Blood pressure high, High cholesterol, Water retention and Rheumatoid arthritis. Concomitant products included LISINOPRIL for Blood pressure high, INSULIN GLARGINE (LANTUS) and INSULIN ASPART (NOVOLOG) for Diabetes, SIMVASTATIN for High cholesterol, HYDROCHLOROTHIAZIDE for Water retention and Blood pressure high, AMOXICILLIN for an unknown indication. In September 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg. On 10-May-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg. In February 2021, the patient experienced FALL (fall) (seriousness criteria hospitalization and medically significant). On 22-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt fluish) (seriousness criteria hospitalization and medically significant) and ASTHENIA (felt weak/got weaken as day went on) (seriousness criteria hospitalization and medically significant). On 23-Feb-2021, the patient experienced SYNCOPE (woke up/collapsed after trying to get out of bed) (seriousness criteria hospitalization and medically significant) and GAIT INABILITY (could not walk) (seriousness criteria hospitalization and medically significant). On 25-Feb-2021, the patient experienced JOINT WARMTH (left knee warmth) (seriousness criteria hospitalization and medically significant) and JOINT SWELLING (left knee swelling) (seriousness criteria hospitalization and medically significant). On 17-Mar-2021, the patient experienced ARTHRITIS INFECTIVE (joint infection) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 23-Feb-2021 to 25-Feb-2021 due to GAIT INABILITY. The patient was treated with AMOXICILLIN SODIUM, CLAVULANATE POTASSIUM (AUGMENTIN [AMOXICILLIN SODIUM;CLAVULANATE POTASSIUM]) at a dose of 1 dosage form. In February 2021, SYNCOPE (woke up/collapsed after trying to get out of bed), JOINT WARMTH (left knee warmth) and FALL (fall) had resolved. In April 2021, GAIT INABILITY (could not walk) and JOINT SWELLING (left knee swelling) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (felt fluish) had not resolved and ASTHENIA (felt weak/got weaken as day went on) and ARTHRITIS INFECTIVE (joint infection) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Laboratory test: left knee infection (abnormal) Left Knee Infection. On an unknown date, Culture: unspecified (Inconclusive) unspecified. On an unknown date, Laboratory test: showed no stroke (normal) Showed no stroke and unrecalled results (Inconclusive) Unrecalled results. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the events included un-specified intravenous fluids and unspecified intravenous medications during her hospital stay. Patient stated that On 23 Mar 2021, she had a Left knee replacement surgery due to the infection of the Stryker knee. Laboratory test include fluid sample test which results in Left Knee Infection on 17-mar-2021. Patient stated that her metal knee was replaced with a plastic knee patient went to rehabilitation on 02-apr-2021 and was discharged from rehabilitation care on 16-apr-2021. Patient stated that she was admitted for three days on 23 Feb 2021.On 02 Apr 2021, she was discharged from hospital. It was reported that the patient had a culture test and unspecified laboratory test on an unknown date; results were not 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. However, patient's medical condition and co-administered drugs may be considered as a alternative explanation for the reported events. This case was linked to MOD-2021-234196 (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. However, patient's medical condition and co-administered drugs may be considered as a alternative explanation for the reported events.

Swelling of L knee; infection of the stryker knee/ left kneee replacement surgery; Joint infection; joint warmth; Orthostatic collapse; weak; Flu-like symptoms; fall; unable to walk; This spontaneous case was reported by a physician and describes the occurrence of ARTHRITIS INFECTIVE (infection of the stryker knee/ left kneee replacement surgery), SYNCOPE (Orthostatic collapse), ARTHRITIS INFECTIVE (Joint infection), ASTHENIA (weak), GAIT INABILITY (unable to walk), INFLUENZA LIKE ILLNESS (Flu-like symptoms), JOINT WARMTH (joint warmth), JOINT SWELLING (Swelling of L knee) and FALL (fall) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A2114) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis. The patient's past medical history included Knee replacement (left knee replacement.) in 2013. Concurrent medical conditions included Tobacco user (TOBACCO USER:30 TO 40 CIGARETTE STICKS A DAY) since 1962, Allergy to antibiotic (AMOXICILLIN DRUG ALLERGY MANIFESTED BY RASHES/HIVES), Abstains from alcohol, Diabetes, High cholesterol, Water retention and Blood pressure high. Concomitant products included INSULIN GLARGINE (LANTUS) and INSULIN ASPART (NOVOLOG) for Diabetes, SIMVASTATIN for High cholesterol, HYDROCHLOROTHIAZIDE for Hypertension and Water retention. In September 2017, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg once a week. On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg once a week. On 10-May-2021, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 40 mg once a week. In February 2021, the patient experienced FALL (fall) (seriousness criterion hospitalization). On 22-Feb-2021, the patient experienced ASTHENIA (weak) (seriousness criterion hospitalization) and INFLUENZA LIKE ILLNESS (Flu-like symptoms) (seriousness criterion hospitalization). On 23-Feb-2021, the patient experienced SYNCOPE (Orthostatic collapse) (seriousness criteria hospitalization and medically significant) and GAIT INABILITY (unable to walk) (seriousness criterion hospitalization). On 25-Feb-2021, the patient experienced JOINT WARMTH (joint warmth) (seriousness criterion hospitalization). On 17-Mar-2021, the patient experienced ARTHRITIS INFECTIVE (infection of the stryker knee/ left kneee replacement surgery) (seriousness criteria hospitalization and medically significant) and ARTHRITIS INFECTIVE (Joint infection) (seriousness criteria hospitalization and medically significant). On 25-Apr-2021, the patient experienced JOINT SWELLING (Swelling of L knee) (seriousness criterion hospitalization). The patient was hospitalized from 23-Feb-2021 to 25-Feb-2021 due to GAIT INABILITY. The patient was treated with AMOXICILLIN, CLAVULANIC ACID (AUGMENTINE [AMOXICILLIN;CLAVULANIC ACID]) at an unspecified dose and frequency. In February 2021, SYNCOPE (Orthostatic collapse), JOINT WARMTH (joint warmth) and FALL (fall) had resolved. In April 2021, GAIT INABILITY (unable to walk) and JOINT SWELLING (Swelling of L knee) had resolved. At the time of the report, ARTHRITIS INFECTIVE (infection of the stryker knee/ left kneee replacement surgery), ARTHRITIS INFECTIVE (Joint infection) and ASTHENIA (weak) was resolving and INFLUENZA LIKE ILLNESS (Flu-like symptoms) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Body fluid analysis: left knee infection (abnormal) Left Knee Infection. On an unknown date, Laboratory test: showed no stroke (normal) Showed no stroke. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the events included un-specified intravenous fluids and unspecified intravenous medications during her hospital stay. Patient stated that On 23 Mar 2021, she had a Left knee replacement surgery due to the infection of the Stryker knee. Laboratory test include fluid sample test which results in Left Knee Infection on 17-mar-2021. patient stated that her metal knee was replaced with a plastic knee patient went to rehabilitation on 02-apr-2021 and was discharged from rehabilitation care on 16-apr-2021.Patient stated that She was admitted for three days on 23 Feb 2021.On 02 Apr 2021, she was discharged from hospital. On an unknown date, it was reported that the patient had an unspecified laboratory test; results were not provided. 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. However, multiple underlying co-morbidities may remain as confounding factors. This case was linked to MOD-2021-234158 (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.However, multiple underlying co-morbidities may remain as confounding factors.

Neuropathy in her feet (like pins and needles) and in her muscles from the waist down; Floppy ankles; she could not complete "stair climber" exercises up until a month ago; Can wiggle toes, but even though functioning they are numb; still suffering from long term effects (neuropathy); Caller stated her balance is off as well.; still feels exhausted.; Neck pain; Couldn't sleep; Headache; Chills; Fever; Muscle Achiness; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (still suffering from long term effects (neuropathy)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced MYALGIA (Muscle Achiness). On 22-Mar-2021, the patient experienced NECK PAIN (Neck pain), INSOMNIA (Couldn't sleep), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (still suffering from long term effects (neuropathy)) (seriousness criterion medically significant), BALANCE DISORDER (Caller stated her balance is off as well.), PARAESTHESIA (Neuropathy in her feet (like pins and needles) and in her muscles from the waist down), HYPOTONIA (Floppy ankles), EXERCISE TOLERANCE DECREASED (she could not complete "stair climber" exercises up until a month ago), HYPOAESTHESIA (Can wiggle toes, but even though functioning they are numb) and FATIGUE (still feels exhausted.). On 25-Mar-2021, NECK PAIN (Neck pain), INSOMNIA (Couldn't sleep), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown. At the time of the report, NEUROPATHY PERIPHERAL (still suffering from long term effects (neuropathy)), BALANCE DISORDER (Caller stated her balance is off as well.), PARAESTHESIA (Neuropathy in her feet (like pins and needles) and in her muscles from the waist down), HYPOTONIA (Floppy ankles), EXERCISE TOLERANCE DECREASED (she could not complete "stair climber" exercises up until a month ago), HYPOAESTHESIA (Can wiggle toes, but even though functioning they are numb), MYALGIA (Muscle Achiness) and FATIGUE (still feels exhausted.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No adverse events reported after first dose on 20 January 2021. No concomitant medications reported. Patient reported she had a COVID test on 27 March 2021 but no results were provided. Patient reported elevated blood pressure and heart rate that persisted for weeks but has since resolved. Patient reported an electrocardiogram was performed on an unknown date with a normal result. No treatment information was provided by the reporter. 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.

After the second Moderna dose, a day later I exhibited severe neck pain - this lasted for 2 one-half weeks before it subsided. I did not go to the doctor but was very worried about it. I am 5'2" tall, weigh 100 lbs. and in excellent health. I am very active, ride my bike, go to water aerobics, and walk - this reaction was very debilitating; I am concerned about taking a booster shot and feel that the dosage should be adjusted based on weight as I had the same dosage a much heavier person would receive. Please consider this issue in the future if a booster is needed. Thank you.

Nine days after receiving first Moderna shot I broke out with rash on injection site. That evening I experienced extreme abdominal, back, underarm pain and bloating. It was enough to double over and almost pass out. Pain has continued on still. I called my gastroenterologist a few days after. We had a telehealth call. I?ve had ultrasounds, endoscopys, mris, ct scans, blood work. No diagnosis as yet. I have malnutrition and extreme weight loss.

She has symptoms of bilateral adhesive capsulitis. She is using NSAIDs, intraarticular shoulder injections, and physical therapy.

didn't get the second dose; Blood pressure High; Heart beat raised up to 110 bpm; Throat raspy; Throat dry; Knees swollen,knuckles swollen; Knees red, knuckles red, face red; Knees hot, knuckles hot; A little bit of fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood pressure High), TACHYCARDIA (Heart beat raised up to 110 bpm), OROPHARYNGEAL DISCOMFORT (Throat raspy), DRY THROAT (Throat dry), JOINT SWELLING (Knees swollen,knuckles swollen), ERYTHEMA (Knees red, knuckles red, face red), FEELING HOT (Knees hot, knuckles hot), PYREXIA (A little bit of fever) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced HYPERTENSION (Blood pressure High) (seriousness criterion medically significant), TACHYCARDIA (Heart beat raised up to 110 bpm) (seriousness criterion medically significant), OROPHARYNGEAL DISCOMFORT (Throat raspy) (seriousness criterion medically significant), DRY THROAT (Throat dry) (seriousness criterion medically significant), JOINT SWELLING (Knees swollen,knuckles swollen) (seriousness criterion medically significant), ERYTHEMA (Knees red, knuckles red, face red) (seriousness criterion medically significant), FEELING HOT (Knees hot, knuckles hot) (seriousness criterion medically significant), PYREXIA (A little bit of fever) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (didn't get the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form; ALPRAZOLAM (XANAX) for Adverse event, at a dose of 1 dosage form and AMLODIPINE for Adverse event, at a dose of 1 dosage form. At the time of the report, HYPERTENSION (Blood pressure High), TACHYCARDIA (Heart beat raised up to 110 bpm), OROPHARYNGEAL DISCOMFORT (Throat raspy), DRY THROAT (Throat dry), JOINT SWELLING (Knees swollen,knuckles swollen), ERYTHEMA (Knees red, knuckles red, face red), FEELING HOT (Knees hot, knuckles hot), PYREXIA (A little bit of fever) and HEADACHE (Headache) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (didn't get the second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Blood pressure measurement: 210/110 mmhg (High) Blood pressure went up very high. On 04-Feb-2021, Heart rate: 110 bpm (High) Heart beat was raised all day. 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 relevant concomitant medications were reported. Patient went to the Emergency Room and diagnosed for allergic reaction. 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

2 days after vaccination: Muscle pain in both thighs - difficult to sit, squat, get out of a chair, difficulty climbing stairs Hip, pelvis, and butt pain in the muscles, hip bones as well Right arm, shoulder, back, neck pain Swollen joints in hands, stiffness especially in the morning Prescribed Prednisone for pain, 30 MG gradually weaned over 5 months. Still extreme pain and difficulty performing daily tasks - weaned due to it being only a short term solution. Overall arthritis-like symptoms in joints that never experienced arthritis before, either from age or injury.

Her ALT was 101,JUL2021 her ALT (83); AST was 70,and AST (66) rose again; she has no memory of falling asleep soon after turning on her tv and sitting on the couch, or even taking her ear piece off; she has been having is a backache on her right side above her waist possibly by her kidney; had an unusual need of staying alert and trying not to fall asleep while texting because her texts; unusual need of staying alert and trying not to fall asleep while texting; On 30APR2021, she experienced the shaking again from her hips to her shoulders; it was my body shaking,her body was shaking again at night but not as violently as the1st time.; had an occasion to be awakened at night,the following night, I had an awakening again; tremor; passed out after turning on television; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out after turning on television) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history is provided by the reporter. Concomitant products included Vitamin B, Vitamin C, COLECALCIFEROL (VITAMIN D3), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and ATORVASTATIN CALCIUM (AVASTIN [ATORVASTATIN CALCIUM]) for an unknown indication. 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) (unknown route) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out after turning on television) (seriousness criterion medically significant). On 27-Apr-2021, the patient experienced TREMOR (tremor). On 28-Apr-2021, the patient experienced SLEEP DISORDER (had an occasion to be awakened at night,the following night, I had an awakening again). On 29-Apr-2021, the patient experienced TREMOR (it was my body shaking,her body was shaking again at night but not as violently as the1st time.). On 30-Apr-2021, the patient experienced TREMOR (On 30APR2021, she experienced the shaking again from her hips to her shoulders). On an unknown date, the patient experienced ALANINE AMINOTRANSFERASE INCREASED (Her ALT was 101,JUL2021 her ALT (83)), ASPARTATE AMINOTRANSFERASE INCREASED (AST was 70,and AST (66) rose again), MEMORY IMPAIRMENT (she has no memory of falling asleep soon after turning on her tv and sitting on the couch, or even taking her ear piece off), BACK PAIN (she has been having is a backache on her right side above her waist possibly by her kidney), SOMNOLENCE (had an unusual need of staying alert and trying not to fall asleep while texting because her texts) and FEELING ABNORMAL (unusual need of staying alert and trying not to fall asleep while texting). At the time of the report, LOSS OF CONSCIOUSNESS (passed out after turning on television), SLEEP DISORDER (had an occasion to be awakened at night,the following night, I had an awakening again), ALANINE AMINOTRANSFERASE INCREASED (Her ALT was 101,JUL2021 her ALT (83)), ASPARTATE AMINOTRANSFERASE INCREASED (AST was 70,and AST (66) rose again), MEMORY IMPAIRMENT (she has no memory of falling asleep soon after turning on her tv and sitting on the couch, or even taking her ear piece off), BACK PAIN (she has been having is a backache on her right side above her waist possibly by her kidney), SOMNOLENCE (had an unusual need of staying alert and trying not to fall asleep while texting because her texts), FEELING ABNORMAL (unusual need of staying alert and trying not to fall asleep while texting), TREMOR (tremor), TREMOR (it was my body shaking,her body was shaking again at night but not as violently as the1st time.) and TREMOR (On 30APR2021, she experienced the shaking again from her hips to her shoulders) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment drug was provided by the reporter. On 28APR2021, she was able to sleep well through the night. 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-2021-262809 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Significant follow Up appended. On 22-Jul-2021: non-significant follow up; 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.

My arm started feeling sore the evening of the injection day. I di not sleep well that night as slight chills and general achiness began. When I got of bed the following morning I felt so weak, woozy and light headed that I was afraid I would fall. I slept all day but by that evening I began feeling better and by the following day (day 2 after the shot) I felt normal except that my arm was still sore. It is now day 3 and my arm is still slightly sore but not limiting my use and is steadily getting better.

On 1/8/2021 patient called stating her right knee was swollen and painful, an 8/10 on pain scale, she iced it and took Tylenol now 5/10 pain scale. Patient received 1st dose of Moderna on 1/7/2021.Patient stated that she thought she remembered joint pain was a side effect of vaccine. Provider spoke with patient and stated more than likely knee pain due to far driving distance and walking more than usual. Continue topical and OTC treatment.

Arm was a little swollen. About 26 hours after injection, had weakness in her legs. Had a little sniffle. This morning woke up about 4:30 a.m., has some nausea but did not vomit. Had some lightheadedness. Has had vertigo in the past.

Patient complains of left rib pain that started 3 hours after getting her first COVID 19 vaccine on 1/4/2021. Patient did have a chest xray that showed lower left penumonia and was started on antibiotics. Patient returned to PCP on 1/8/21 with continued complaint of left rib pain that had not gotten better. Chest Xray clear on 1/8/21.

fatigued and tired, sore arm within a day. On day 8-9 very large red area and swelling from below injection site to elbow, itching and very uncomfortable.

10:30 IN BED FELT CHILLED THOUGHT SHE HAD A SLIGHT FEVER. GOT BLANKETS TO GET WARM AND FELL TO SLEEP. WOKE UP EARLY MORNING UNSURE OF TIME HAD TO GO TO BATHROOM. PT REPORTS EXTREME MUSCLE WEAKNESS IN ALL EXTREMITIES AND COULD NOT MOVE. HAD TO SLIDE OFF BED AND CRAWL TO GET TO BATHROOM. WHEN SHE GOT TO BATHROOM, SHE DOES HAVE LIMITED RANGE OF MOTION IN L SHOULDER BUT WHEN SHE ATTEMPTED TO GRAB BAR IN BATHROOM HER R ARM WAS LIMP AND COULD NOT GRAB BAR TO LIFT SELF UP TO TOILET. WAS FOUND BY FAMILY IN BATHROOM SOILED. DID NOT APPEAR TO HAVE ANY INJURIES FROM FALL PER PTS DAUGHTER AND PT REPORTED SHE DID NOT HAVE A HARD FALL OR HEAD INJURY.

Very bad back and stomach pain beginning 7:30 pm to 7:00 am the next morning when I called advice nurse, told to take Tylenol. pain got much better. Continued to take Tylenol every 6 hours, kept pain bearable, slept 12 hours the next night. Had a slight fever 100.5 the next day, still having some pain in my abdomen. Thursday night, pain in abdomen was bad again, but not as bad as the first night. Talked to my doctor on Friday about these effects. Friday night pain in my abdomen is much better but still there. No fever on Friday or today, Saturday

Moderna COVID-19 Vaccine EUA chills, shortness of breath, fatigue, body and muscles sore to the touch headache with funny feeling, sluggish, flushed, no taste. sore throat, nausea (not vomiting), severe leg cramps, droopy, eyes won't focus and want to close, lumpy throat that is sore to the touch

Arm: prolonged pain, tenderness, swelling and redness (for about 5 days) Other: headache, muscle and joint pain, chills, nausea, dizziness (for about 18 hours) oxygen level: averaged 96 but dropped to 93 one time (but that might have been equipment error)

Wicked lower back pain for two days. Moderated to a 10 in two more days. Still some twinges to this date. Never had such reaction to flu, shingles, pneumonia, vax.

Deep muscle pain and joint pain on hips, knees and ankles. No joint pain above the waist. No pain in a sitting or standing position. the pain happens at night when lying down often followed by cramping and "charlie horse" symptoms. This has lessened somewhat after 2 weeks, but it does still happens. Really considering declining the second vaccine as that is reported to be much more likely to have side effects.

Patient had small localized reaction for 2 days after injection that cleared. At approximately 7 days post injection she began to have another localized reaction that included reddness, swelling, pain, heat, and a dry skin tecture that progressed to cover the lateral aspect of upper left arm from shoulder to elbow. At time of examination by RN, the patient reports that size and intensity have been increasing for about 7 days. Patient finds relief in hot shower. No other treatments attempted at time of exam. Patient reported area may be improving, but she is unsure. Area was outlined with marker by RN and patient was advised to see PCP for treatment if area increased in size and was not continuing to improve. Counseled on using OTC benadryl cream if there was itching.

fatigue, headache, muscle pain, joint pain nausea. Slept most of the day. No appetite, very little food consumed.

Upon going to bed, within a matter of a few minutes, I started to get the chills real bad. Then my muscles and joints started to hurt. I could not even turn over in bed without my whole body hurting. I don?t know if I had a fever or not. I was so tired, but shaking with chills and body hurting I couldn?t go to sleep. Put more blankets on and took 2 Tylenol. I was able to eventually go to sleep. I felt better in the morning but was very tired during the day. It felt like I had covid again. I had the same symptoms then. I tested positive for covid November 27 at a rehab/nursing home where I was sent after foot surgery.

The first day felt fine, the next day when she got up in the morning she didn't feel well, but felt well enough to put a roast in the crockpot. Felt then headache, aching in all joints and muscles with achiness. Felt it in her heart, short of breath. The following day felt worse, just wanted to sleep, freezing cold and her temp was low, she could not get warm, and went back to bed and stayed there. She could not eat much, drank water. The following day after that felt a little bit better. She feels about the same she did yesterday, heaviness of her legs especially her knees, weakness and fatigue. Had a pressure like headache in the top of her head and back of her head, right side of her face. The 2nd day the pain was up her neck on the right side, it hurt bad. All her joints are hurting, she does have arthritis. Also having back pain. The 2nd day took Tylenol a couple of days, and took 1/2 pill of Hydrocodone, which causes liver/stomach pain. Not in the pain in the muscles now just a heaviness in her legs and shaky. Called her doctor who did not have much information and informed to call us.

Approx 8 hours after receiving injection headache began, went to bed. Woke up at 3 am aching muscles and head. Fell going to the bathroom. Able to get up and go to bed. Got up at 6 am, went to bathroom and fell in bathroom hitting doorframe causing black and blue bruise on right shoulder. Feeling very weak, sweaty, and shaky. Laid on floor x 15 min until able to get up and scooted over to sink and pulled self up and vomited x 1. Got back to bed. Felt weak, shaky and sweaty for the whole day. Feeling better after taking Tylenol for the achiness by the end of day. Felt weak and tired the following day but better.

Large red swelling at injection site, 4" x 2 1/2", tender to the touch, hot to the touch, whole right shoulder, right trapezius, right pectoral and right side of neck painful, ichy at site of injection. Onset of symptomatic side effects - seven-plus days following injection.

1. Tendonitis of the left achilles. Began 29 hours after injection -- 5pm on Saturday, January 30th. 2. Nausea and vomiting: Began 40 hours after injection -- 3am on Sunday, January 31st.

After administration of the Covid-19 vaccine I had 2-3 days of chills, muscle aches, fatigue, sore arm. Symptoms gradually went away. Then about the 7th day I started experiencing an itchy arm and a 6 inch circle of intense red at the injection site, with a wide band of white surrounding it, that itched unbelievably, was hot and swollen. That lasted for several days, then began to subside and now is only slightly red, itches some and is no longer swollen or hot. My question is: Is it safe for me to get the 2nd dose, after experiencing this kind of reaction?

Pneumonia in left lung; Pain in neck; Acute serious pain under her ribs, all the way around her body; A spontaneous report was received from a consumer concerning a 78 year old female who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed acute serious pain under her ribs, all the way around her upper body, pneumonia in her left lung and neck pain. The patient's medical history was not provided. Concomitant medications included non specified medication for blood pressure, calming down, dementia and thyroid. On 04 Jan 2021, approximately 2.5 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 04 Jan 2021, the patient developed acute serious pain under her ribs, all the way around her upper body that lasted ten days. The patient also experienced neck pain. On an unknown date, she was treated in the emergency room for pneumonia in her left lung and given antibiotics. She later followed up with her primary care doctor and additional x-rays were taken and she was treated with prednisone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, acute pain under her ribs, all the way around her upper body, was considered resolved on 14 Jan 2021. The outcome of the event, pain neck was resolved on 19 Jan 2021. The outcome of the event, pneumonia in left lung, was unknown.; Reporter's Comments: Company Comment: This case concerns a 78-year-old female patient who experienced unexpected serious event of pneumonia and non-serious event of acute serious pain under her ribs, all the way around her upper body and neck pain. The event developed on the same day after the first dose and only dose of the vaccine mRNA-1273 vaccine (lot # unknown, expiration date-unknown). Although a temporal association exist between the event of pneumonia and the administration of the vaccine, in the absence of clinical details including diagnostic test, a definite diagnosis was not established. The events of acute serious pain under her ribs, all the way around her upper body and neck pain are also temporarily associated with vaccine administration and a causal association cannot be excluded. Main field defaults to ‘possibly related' for all events.

severe numbness and tingling of both lower limbs extending from the buttocks to the toes on 02/02/2021 to 02/3/2021 associated with lower limbs weakness. resolved with some residual right thigh muscle tenderness and sensitivity. chills low grade fever headache and severe nausea resolved by 02/03/2021

Got the vaccine, had sore arm immediately. Thought she was fine. Husband had the same vaccine, and had the splotch and soreness, but then around 1/23/21. The shoulder started to hurt after about 3 days, and put a heating pad on it, and finally the pain and discomfort gradually subsided. She is not having any problems now.

I have extreme join and muscle pain, (shoulders, arms, hands, back, hips, knees, legs) so bad that I cannot sit or walk. I have a slight fever and headache.

12/28 Vaccination Later that evening, muscle aches and HA. 12/29 Joint pain, HA, and mild cough 12/31 Severe cough, lost voice, unable to sleep 1/2021 Urgent care; COVID test; Positive Bamlanivimab; treatment/infusion; 3 hours 15 days isolation 1/18/2021

I did not feel particularly lightheaded or dizzy, but I passed out in my kitchen while preparing breakfast at approximately 7:30 AM on the morning following my vaccination

per pt. on Monday afternoon apx 2pm started feeling feverish and tongue swelling. Stated had a stiff neck for a couple of hours that evening, unable to eat Tuesday, Wednesday, feverish, and shaking. Slowly recovering through week. As of today per pt. "feels perfectly line"

Extreme weakness, chills, mild fever, body & joint aches, headache, coughing, one episode of chest pain! Trying to recover by resting and staying in. I will be contacting the my doctor, just as soon as I finish this inquiry!

low grade fever, fatigue, headache, muscle aches, chills, pain at injection site these symptoms started around 9:00am 24 hours after injection of second dose.

The patient was administered the Moderna Covid-19 vaccine on 1/14/2021. The patient reported experiencing arm pain around the injection site during the 2 days following the vaccination. The patient reported experiencing hip pain and trouble with her legs on 1/21/2021. On 1/22/2021 the patient reported not being able to stand without bracing. The patient visited a doctor on 1/25/2021 and there was suspicion for inflammation of the spinal cord leading to the patient being prescribed prednisone for 6 days. The patient visited the doctor again on 2/2/21 and another course of prednisone was initiated. The patient reports that she can stand from a sitting position without help getting up about half the time and that she had no such trouble standing prior to the vaccination. The patient returned to the second vaccination clinic on 2/11/2021, which was 4 weeks after receiving the first dose, to report her symptoms. The patient was not administered the second dose of the Moderna Covid-19 vaccine.

extreme temperature drop; extreme fatigue; headache; joint pain; right side of face and ear painful; Next day - drenched, trouble controlling temperature, headache & joint pain and nausea

I received the vaccine on 2/9 and started having an adverse reaction. Chills, extreme fatigue, muscle and body aches, bone and jaw pain, no appetite, nausea and diarrhea?all starting on the same day and rather severe by the next day.

Redness, slight swelling, achy muscle, This occured immediately after vaccine, went away on its own. Reoccurred 10 days later with itching off and on

I had Soreness on the arm the same day of vaccination, redness, achy in the muscle area on my arm. I think the injection was administrated to high in my arm. The within the next 24-48 hours I had a headache and was tired. About the 4th-5th day I had tingling, prickly feeling across right shoulder, down both arms down to my fingers and down my legs down to my toes. This lasted about 5-10 minutes. Then on the 16th it happened again but this time it was my whole body the torso area and my limbs. I also had weakness, I felt like I needed to hold onto to someone to be able to stand. I had an unstable feeling while standing. The headache has occurred on and off since time of vaccination about 4-5 times. I went doctor on Tuesday 2/16/2021, I did not see my doctor this time I see a different it was a lady doctor. She wasn't aware of this being one of the side effects and just to monitor myself and return if the symptoms worsen. She thought it was safe to get the 2nd dose. I have a virtual visit scheduled with Dr. on 2/23/2023

Experienced severe acid reflux with white, coated tongue for 3 days 4th and 5th days nausea, headache, chills aching joints from neck to feet on 2/19 left arm sore (it was not sore except for day after injection) and itchy

Sharp pain in knees and elbow, nausea ... took pain pill and pain was gone in am. Have been feeling bad (like I was hit by a Mack truck all day. (Flu like aches) nausea on and off but cant throw up. Feeling weak.

injection site started aching almost immediately but within 6-7 hours upper arm painful and hard, back of head so painful had to go to bed. Body became like a lead weight, couldn't raise my arms, couldn't turn over, couldn't reach my phone 8 inches away. Had shaking chills for 8-9 hours even though temp. was only 99.8. This was 10 times worse than when I had Covid. Thank goodness the severe reaction only lasted a day and a half then slowly got better over the next 2 days.Took week for arm tenderness to go away.

Rash at injection site started late in day of injection. Rash red, warm to touch, itching and pain. Rash continued to spread, around and under arm. Has not started to improve even at 9+ days later. Also on and off pain at back and both sides of neck ("stiff neck".)

moderna COVID-19 Vaccine EUA rash occured on Feb. 18th on neck sides of face forhead very red very itchy also about a couple of inches on the front of my chest directly under my neck I had a similar reaction after a shingtrex second dose shot which was given January 19th 2021ad a teledoc appt. on Feb. 19th was prescribed to take an antihistamine(claritan or zyrtex and use a cream, triamcinolone acetate for the rash and if needed a benedryl tabblet at bed time but only if necessary due to severe itching the cream gave enough relief in that regard so no benedryl was necessary I also had a very light head ache and a bit of stiffness in my neck during this time also, although I don't know if this is relevant to the vaccine I am a carrier of Kennedy disease and occasionally have vessiculations I have not seen any doctor about this but I hbit of that the day after my shotad a slight

02/02- Shivering chills, 6 hrs.; muscle & joint pain, 4 days; excessive fatigue and cold, 2 1/2 weeks; fatigue continues; 02/10- injection sight red, feverish. appt. at urgent care 02/11. entire back of right arm infected, cellulitis. RX antibiotic. End of 10 days, cellulitis appears gone.

After Dose #2 Muscle swelled and red mark just below vaccination site same day. Next day fatigue, chills, sweats, diarrhea, low grade fever, burping Next day pain above stomach below breast bone, nauseau, vomiting, indigestion, burping. Next day arm still swollen, red spot much larger, itchy, hot.

Bone on left wrist turned red & was swollen for 2-3 days. In addition joint on index finger on right hand turned red & bruised.

Evening of 1/28 I started feeling fatigue, muscle aching, stomach upset and headache which lasted till next day around noon. Then was fine for 7 days. On 2/5/2021, I went to get my B12 shot and asked the doctor to check left arm where Moderna shot was given as it was itching and a bit sore at the same time. He told me I was having reaction. By evening, a third of my arm around injected area was swollen an had red rash. Then same symptoms of fatigue, etc. came back and I was in and out of bed for the next three days....then at end had a bout of diarrhea.

Four days after injection right foot became inflamed and hugely swollen. Top of foot and all along the outside side of it both on top and at bottom of foot all very painful. Ankle and leg very swollen and painful. Can't walk on foot. As of 2/26/2021 swelling is not as bad and not so discolored but still some swelling and redness burning and very painful and still cannot use the foot. Also have noticed places where I have had surgery or injuries is hurting and being stiff. Am questioning whether or not I should get the 2nd shot. Concerned it will make situation even worse.

Upper arm became somewhat sore by later afternoon, became excruciatingly painful by later evening. Did not feel well by bedtime, and a bit fuzzy-headed. Next day, I was fuzzy-headed, body stiff and achy, very tired, upper arm excruciatingly painful. All symptoms began to clear significantly by evening, and back to normal by the following morning (2/10).

Severe muscle and body aches throughout my body and fatigue. Tylenol relieved the symptoms but they lasted for 2 days.

The patient developed back pain one month after the first injection on February 24 she was diagnosed with pericardial effusion?s and 750 mL was drained from the pericardium. The work up is on going but it seems to be Pericarditis which occurred after the vaccination

At 24 hours after 2nd dose of vaccine; Severe back pain, all joints hurt, felt terrible like she had the flu, spent all day in bed. At 48 hours felt better but not well. At 72 hours, felt tired but better. at 84 hours felt much better (almost back to normal) . Her husband, myself, also had 2nd dose of vaccine. Felt fine until 36 hours, then both shoulders ached for another 24 hours. No other symptoms for husband.

THE PATIENT NOTED THE TYPICAL DELTOID MUSCLE SORENESS 2/25-2/27. ON SUNDAY 2/28 SHE NOTED PRURITIS OF HER LEFT UPPER ARM. SHE STATES SHE TRIED NOT TO SCRATCH IT. SHE NOTED YESTERDAY ONSET OF RASH ON HER LATERAL UPPER ARM. TODAY THE UPPER ARM PLAQUE WAS STARTING TO FADE AND WAS SLIGHTLY WARM. THE DISTAL UPPER ARM PLAQUES (MEASURING 10 X 12 CM OVERALL) WERE RED, WARM AND SLIGHTLY THICKENED SKIN CONSISTENT WITH CELLULITIS.

2 days after receiving first dose of vaccine, patient called to report worsening shortness of breath, back pain, fatigue and a cough. She was sent to the emergency room for evaluation. At that time, she was given a 7 day course of antibiotics. Patient then presented to the ED on 02/25/2021, with worsening symptoms, and was found to be COVID positive.

Triggered arthritic flareup. . It caused inflamed right hip enough to jam the nerves in the right leg. Taking 2 anti-inflamatory drugs and treating for pain.

pt stated that both arms and legs started tingling and aching. She stated she would would drop anything she tried to pick up or hold. Pt states her hands are still weak uncontrollable but no longer tingling and her legs are still aching but no longer tingling. Pt has not contacted her PCP at this time.

Mild nausea, mild headache on Feb. 24 plus extreme joint and whole-body muscular aches that continue a week and two days after the 2nd injection

Aching and pain in every bone in my body for several hours. Started at 10 p.m and lasted until 4 a.m. Today I am fine.

Pt. called clinic today at 8:22am to report overnight fever and chills, as well as neck, left shoulder and left arm stiffness and pain at the injection site (left deltoid). Pt. advised that she may alternate acetaminophen with ibuprofen for fever/pain relief as well as heat/ice to help with muscle stiffness and pain. Clinic will call patient on Monday to re-evaluate the condition of the patient.

Within two to three hours, I reacted with chills, fever, weakness, fatigue, soreness at vaccination site, waves of nausea, joint soreness. I can only remember a couple of times in my life ever feeling so sick. Within 24 hours my side effects subsided. Ten days later I developed itching and burning on hands, arms, chest and neck which, when scratched, turned bright red. The rash lasted about three of days.

48 hours after receiving the vaccine, I had a hive reaction (redness, slight swelling) over a roughly 7?x5? section of both of my upper arms. This is a typical allergic reaction I have to ibuprofen, Benadryl and occasionally to something I?ve eaten (source unknown). This is a stronger reaction than I usually have. 24 hours after the shot, I had headache, muscle ache, chills, and fatigue. Those symptoms had pretty much abated about 36 hours after the shot. I did not notice the hive reaction earlier than 48 hours after the shot.

About 4-5 hours after receiving vaccine: Severe Chills- Arms shaking, freezing, hands like ice, Temp 99.6; Tylenol, to bed sleep 4-5 hrs, Temp 100.??; sleep; awoke middle of night Temp 107.2, legs very warm to touch; into shower; Temp came down to 99.??; sleep, Temp OK. Later in day Temp 100.4. Some muscle pain but not too bad. Didn't feel good rest of day/night. Next day felt OK. All lasted about 36 hours. After 1st vaccine, I felt somewhat same as above - except Temp 104 and lower; Very sever muscle pain initially- hard to get out of bed and walk. Started 4-5 hours after injection and lasted about 36 hours. severe chills but not freezing. Taste and smell were not affected either time.

Began with feeling exhausted and sleepy within a few hours. Progressed to aching throughout body, painful L arm and stiff neck. By 9pm unable to elevate L arm, unable to turn head and blazing headache. Symptoms continued for 24 hours. Began to decrease and bu the 36th hour was nearly normal. It has now been 4 days since vaccination and I?ve resumed normal lifestyle......but have residual ?fatigue? in late afternoon.

With the first shot, I experienced chills for a day and a half. Absolutely could not get warm. With the second shot, I experienced chills; was clammy at the same time as the chills; very fatigued and could not stay awake; my muscles, joints and my whole body ached; headache; sinus infection (for which I am currently on an antibiotic); nausea; loss of appetite (lost 5 pounds); loss of taste and smell for 2-3 days. Too weak to make it to the bathroom by myself. I felt like I was in a delirium but my husband said that I was not incoherent. Appetite is still not normal. Mouth was so dry that I was not able to feel any moisture at all which I feel led to my sinus infection.

On day 3 there was slight swelling, tenderness and heat at injection site. On the fourth and subsequent days there has been a red rash. It is about 2+ inches wide and 3+inches long. Still quite red and tender to touch. Muscle underneath the injection site is still tender. It has been eight days since the injection. I also experienced some lethargy for the first two or three days.

After a few days, I woke up with my left middle finger joint near fingernail in pain and won't bend! Is it a coincidence that I now have arthritic-like pain in my left fingers at the nail first joint? I am unable to use those fingers for even support of a small dinner plate. Advise if you can.

Fever, extreme back pain, nausea, lightheaded, headache, chills, redness, bruising and swollen arm where injection was given.

First dose was on 01/12/2021 at 9:30 am. No reaction until Feb.7. 2021, when left leg began to swell, but not seriously. Feb.8, 2021 leg was continuing to swell. went to doctor's office where he prescribed an ultrasound. Was told there was a clot behind my left knee and in some of the smaller veins. I had the chills, joint pains all over, which lasted about the three weeks, but was slightly different every day. When I began the 20 mg dose of Xarelto, every symptom cleared up and I felt great. I am continuing on the 20 mg Xarelto.

2/22 right hip spasm 2/25 right shoulder blade pain 2/30 right hip socket very painful 3/1-3/15 pain in right knee 3/15 pain now in left knee 3/16 extreme pain at 3AM in BOTH knees, thought might go to Emergency

3/12/2021 Patient got her first Covid vaccination on March 4. She was told by her rheumatologist to stop taking methotrexate for 14 days after she had the vaccine. Yesterday afternoon the patient began experiencing left groin pain. It progressively got worse. During the evening it was 10 out of 10 in severity. Patient took 100 mg of prednisone and also went ahead and took her methotrexate but got no pain relief from this. She localizes the pain to her left groin region. She said the exact same thing happened 5 years ago right before she was diagnosed with rheumatoid arthritis. The pain was localized to the same exact area. Over the course of her admission, the patient improved after the methotrexate and the prednisone she took the today prior to arrival, and also started on as needed Percocet.

weakness in legs, collapsed onto floor, unable to control bladder, headache, Legs continued to give out while walking, fatigue

3 days after vaccine experienced fever, extreme muscle pain, extreme bone pain, head ache, chills. 13 days after vaccine experienced extreme swelling in glad under left ear and down the neck under chin. Ear ache in both ears but worse in the left ear. Visited physician next day and was prescribed an antibiotic. Was better in 14 days.

Patient was awakened at 0400 on 3/18/2021, with shortness of breath and her entire right side hurting. Pain was in the lower right chest, right upper abdominal quadrant and right flank pain. Presented to the ED. CT of chest /abdomen showed pulmonary embolus in the right lower lung. Patient is being treated with Eliquis and was sent home from the ED on 3/18.

Fever 102, chills, muscle/bone aches, extreme fatigue, headache. Slept most of March 13/14. March 15 awoke totally symptom free

Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.), Additional Details: Pharamcist that had administered first shot on 2/16/21 punctured the patients skin twice with the same needle. The reason for this is unclear. After the injection a rust colored liquid came out immediately according to the patient. She feels that she may not have received all of the first dose of the vaccine. She later reported brusing and pain. The pain is still present to this day. She has received the second shot and did not experience any problems.

6 hours after having shot it triggered PTSD because she couldn't lift her feet (like heavy rocks) staggering to lay down, diarrhea, nausea, poor appetite, headache, fatigue throughout body, aching bones/joints

joint ache, nausea, fatigue, no appetite, no taste, very weak, difficult swallowing, memory problems,. Start evening of 2/25 to present - 3/22/21 Emergency room treatment: blood profile, X-rays, Cat Scan, urine analysis, etc. All OK.

3ays after shot massive depressive episode, suicidal. 4 days after, exhaustion, muscle weakness (I normally walk 2 - 4 miles daily)- this continued for almost two weeks. Along with weakness, extraordinary "brain fog", vertigo, loud tinnitus (buzzing). 2 1/2 weeks in I found an elliptical itching rash at the vaccine site. almost a month later I'm still suffering from dizziness, brain fog, and exhaustion. 2nd dose due 26th March and I'm scared to proceed.

3/10/21 5:00 p.m. extreme body/abdominal pain; 3/11/21 a.m. pain & abdominal and back (kidney area spasms) p.m. Fever of 101.2; . itchy rash started in arm pits 3/12-3/15 extreme body and internal back pain and itchy rash continue 3/16 p.m. doctor prescribed Simethicone 125 mg. (I added Acidophilus & Bifidus) one capsule each after each meal 3/25 Itchy rash gone; extreme pain gone, continued stomach tenderness and low inner back pain.

The arm was sore for 2 days. I have diverticulitis and it flared up a few days letter. my legs feel a little heavy. I don't think that a vaccine should be attacking my weaknesses or current health conditions. I eat very bland and I don't have issues but now I have terrible issues since the vaccine.

Last night around 10 pm she achey, muscle and joint pain, and then a headache and then chills, lips bluish, but not SOB, blood pressure 185/78 usually it's lower like 120 or 130, pulse ox 85 low. Suggested to go to ER or call 911 She called her DR.

Noted change of consciousness in evening following vaccination. She had a tonic gaze to the right when EMS 1st arrived at the scene. She was not having any overt epileptic activity. She is normally very debilitated and moderately demented but conversational and jovial according to the daughter. She is normally able to be fed, taken to the toilet, and has no trouble with day-to-day living. She was brought to this hospital day after vaccination. She was alert at the time of the vaccination. She had COVID in August of this last year. In ED, she was given a very small dose of Ativan. She had immediate effect from this with resolution of the tonic gaze, developed a voluntary gaze and had minimal but clear-cut purposeful conversation. She was also able to move her extremities after the Ativan. Prior to that she was fairly rigid in her extremities. She did not have any obvious seizure activity however. She was transferred to another hospital for higher level of care and continued management.

SEVERE CHILLS - TYLENOL EFFECTIVE (STARTED 8 HOURS AFTER) LOW GRADE FEVER - TYLENOL EFFECTIVE (STARTED 8 HOURS AFTER) NAUSEA - NO TREATMENT BETTER (STARTED 8 HOURS AFTER AND LASTED 12 HOURS) PAIN IN ARM AND BELOW LEFT RIB CAGE - TYLENOL EFFECTIVE (STARTED 8 HOURS AFTER) RED RASH AT INJECTION SITE - NO TREATMENT BUT NO PAIN (STARTED NEXT DAYS 4/10/21 STILL GOING AS OF 4/12/21 11:00AM CST) COLD SWEATS - NO TREATMENT (STARTED NEXT DAY 4/10/21 STILL GOING AS OF 4/12/21 11:00 AM CST) STIFFNESS IN NECK AND SHOULDERS - NO TREATMENT (STARTED NEXT DAY 4/10/21 AND ENDED 4/11/21 IN THE EVENING)

is not in rythm (think it's in A-FIB); Skipping of beats; the chest moved not in the right way; could not walk; dizzy; Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long; headache; nausea but did not throw up; have never ache and hurt as bad as they started hurting; sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Arthritis and Cardioversion (Had 2 cardioversions). Concurrent medical conditions included Atrial fibrillation. On 27-Jan-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. On 27-Jan-2021, the patient experienced PAIN (have never ache and hurt as bad as they started hurting), ILLNESS (sick), GAIT DISTURBANCE (could not walk), DIZZINESS (dizzy), ARTHRALGIA (Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long), HEADACHE (headache) and NAUSEA (nausea but did not throw up). On 29-Jan-2021, the patient experienced ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)) (seriousness criterion medically significant), EXTRASYSTOLES (Skipping of beats) and CHEST DISCOMFORT (the chest moved not in the right way). On 28-Jan-2021, PAIN (have never ache and hurt as bad as they started hurting), ILLNESS (sick), GAIT DISTURBANCE (could not walk), DIZZINESS (dizzy), ARTHRALGIA (Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long) and NAUSEA (nausea but did not throw up) had resolved. On 29-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)), EXTRASYSTOLES (Skipping of beats) and CHEST DISCOMFORT (the chest moved not in the right way) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Heart rate: 80 (High) 80. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment included paracetamol. 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 received her second dose of the Moderna COVID vaccine in 3/2021 (unknown which specific date) and presents on 4/10/21 with feeling ill, shortness of breath, myalgias, and loss of appetite. Patient has h/o asthma, DM, HTN, COPD, CHF with pEF, severe OA b/l knees/r hip, and neurogenic bladder

Tiredness in leg; in a wheelchair after second dose of vaccine; Swelling; Heart racing; Out of breath; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Tiredness in leg) and GAIT DISTURBANCE (in a wheelchair after second dose of vaccine) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse reaction (no reported medical history). On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Tiredness in leg) (seriousness criterion disability), GAIT DISTURBANCE (in a wheelchair after second dose of vaccine) (seriousness criterion disability), SWELLING (Swelling), PALPITATIONS (Heart racing) and DYSPNOEA (Out of breath). At the time of the report, MUSCULAR WEAKNESS (Tiredness in leg), GAIT DISTURBANCE (in a wheelchair after second dose of vaccine), SWELLING (Swelling), PALPITATIONS (Heart racing) and DYSPNOEA (Out of breath) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. No relevant concomitant medications were reported. The patient was treated with prednisone and Percocet (oxycodone/paracetamol).; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded.

Came to see PCP on 4/8/21: Left Shoulder pain- she had a steroid injection in this shoulder years ago for pain, but the pain returned after she received her first COVID vaccine in that arm. Referred to Physical Therapy. Patient also c/o "hot flashes in her back" She was rx Lyrica.

About 10 p.m. on 2-22, sore arm. About 2 a.m. on 2-23, very dizzy During the day on 2-23, headaches, muscle aches, fatigue About 7:30 p.m. on 2-23, chills and fever

Diagnosed with rhabdomyolysis; Found on floor with knee in an awkward position; Strength has not come back in legs and now needs a walker; Did not have strength to lift legs to go to bed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHABDOMYOLYSIS (Diagnosed with rhabdomyolysis) and JOINT DISLOCATION (Found on floor with knee in an awkward position) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cholesterol. Concomitant products included LEVOTHYROXINE and ROSUVASTATIN for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Did not have strength to lift legs to go to bed). On 12-Mar-2021, the patient experienced RHABDOMYOLYSIS (Diagnosed with rhabdomyolysis) (seriousness criteria hospitalization and medically significant), JOINT DISLOCATION (Found on floor with knee in an awkward position) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Strength has not come back in legs and now needs a walker). The patient was hospitalized from 12-Mar-2021 to 18-Mar-2021 due to JOINT DISLOCATION and RHABDOMYOLYSIS. At the time of the report, RHABDOMYOLYSIS (Diagnosed with rhabdomyolysis), JOINT DISLOCATION (Found on floor with knee in an awkward position) and ASTHENIA (Did not have strength to lift legs to go to bed) outcome was unknown and GAIT DISTURBANCE (Strength has not come back in legs and now needs a walker) had not resolved. Treatment for events included fluids and shots in knee. 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.; 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 12 hours elevated temperature,extreme fatigue, flulike feelings lasting 2 days. On 03/24/2021 back discomfort worsening every day. To Emergency Room on 03/31/2021 confirming diagnosis of Shingles

Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: pain in left shoulder blade-Medium

Five minutes after vaccine was given the patient experienced a tightness in her jaw. Her mouth was very dry and also she experienced an unpleasant taste. This was immediately reported to the head nurse. She was given 25 mg of Benadryl po which she swallowed without difficulty. Her VS were monitored. her BP was 154/48 , P was 86 and O2 sat 95%. She was monitored for 20 minutes and she her symptoms resolved 10 min after taking the Benadryl. Her Bp was 154/74, P was 86 and O2 Sat 94%. Patient was also on her own oxygen via nasal cannula at 3 liters. She did not feel sleepy and stated she felt comfortable to drive home. Her symptoms were resolved and she was in no distress. she was discharged after 20 min.

I had the normal chills and tiredness after the second dose. But ln late March, I began tr have muscle and joint pain that got so bad I had to go to ER. I couldn't walk or get in and out of bed. I was diagnosed with Polymyslgia Rheumatica, an immune disorder which I exp[erienced in 2013.

Admitted with generalized weakness, lethargy, and muscle aches for a couple weeks (since receiving vaccine). Planned to rule out atypical PNA. Blood cultures positive for bacteroides, likely abdominal source. Abdominal CT scan showed portal vein thrombosis, confirmed on MRI.

Intense Pain in upper back muscles, both upper arm muscles, both thighs and buttocks. This pain is worse at night in morning. It is there randomly during the day and subsides randomly. Physical therapy 2x?s weekly, Acupuncture 1x weekly and Chiropractor initially weekly, now 1x weekly. Waiting to see Rheumatologist June 1.

Pt states about 2 weeks after taking the vax she had back pain, pain in her left arm and stabbing chest pain. On 4/23/21 she went to ER. They did multiple test but could not find anything wrong. Pt developed red blotches on her left breast. She had a FU apt w/ Cardiologist Dr. on 4/28/21. She was diagnosed w/ Shingles. He referred her to see a Primary Care doctor but she does not have one at this time. She will visit an Urgent Care since she is still in pain and has a severe rash.

Low grade fever, nausea, extreme pain in all joints, hands swollen and stiff, headache. diaherra for 2 days,, sleep on and off for 3 days. Just starting to feel a little better. It was hell. 10 days.

Arm was sore after the shot and I was a little light-headed, but went away--on the 12th I noticed the area of the arm was slightly red and felt slightly stiff. Talked to my Drugist and he said to let you know. Today, 15th, not as red nor as stiff.

Pt c/o headache, muscle weakness, anxiety, flushing/sweating. Pt indicates that they have a hx of adverse rxn reported w/ first vaccine dose but no VAERS was submitted by clinic staff at that time. Clinical review cleared patient for second dose. Pt assisted to bed. Abnormal vitals. BP 251/91 (133), HR 82, RR 21 -- > 237/84 (120), 70, 17. Pt denies hx of HTN, NKA. Physician advised patient to go to urgent care d/t elevated BP; pt verbalized understanding. After 5 mins pt denies and HA, verbalizes feeling calm, muscle weakness resolved. Pt ambulating w/o c/o dizziness. Patient taken to Urgent Care/ER by private car.

Felt lightheaded; Neurologic event; left cheek, arm and leg on the left side felt numb; can't stand on the left leg; falling; fell in the bathroom and cut eye and got black and blue, knocked head; pain; fever of 99 and something, which is high for her, usually her temperature is around 97; aches; sleeping a lot; weak, could not get up, right hand is weak, progressive weakness; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weak, could not get up, right hand is weak, progressive weakness), HYPOAESTHESIA (left cheek, arm and leg on the left side felt numb), DYSSTASIA (can't stand on the left leg), FALL (falling) and INJURY (fell in the bathroom and cut eye and got black and blue, knocked head) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020621A and 003AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes, Hypertension and COPD. Concomitant products included GLIPIZIDE and METFORMIN for Diabetes, SERTRALINE for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced ASTHENIA (weak, could not get up, right hand is weak, progressive weakness) (seriousness criteria medically significant and intervention required), HYPERSOMNIA (sleeping a lot), PAIN (pain), PYREXIA (fever of 99 and something, which is high for her, usually her temperature is around 97) and MYALGIA (aches). On 29-Apr-2021, the patient experienced HYPOAESTHESIA (left cheek, arm and leg on the left side felt numb) (seriousness criteria medically significant and intervention required), DYSSTASIA (can't stand on the left leg) (seriousness criteria medically significant and intervention required), FALL (falling) (seriousness criteria medically significant and intervention required) and INJURY (fell in the bathroom and cut eye and got black and blue, knocked head) (seriousness criteria medically significant and intervention required). On 30-Apr-2021, the patient experienced NERVOUS SYSTEM DISORDER (Neurologic event) and DIZZINESS (Felt lightheaded). The patient was treated with Rehabilitation therapy for Asthenia; Rehabilitation therapy for Hypoaesthesia; Rehabilitation therapy for Dysstasia; Rehabilitation therapy for Fall; Rehabilitation therapy for Injury; Rehabilitation therapy for Nervous system disorder and Rehabilitation therapy for Hypersomnia. At the time of the report, ASTHENIA (weak, could not get up, right hand is weak, progressive weakness) and NERVOUS SYSTEM DISORDER (Neurologic event) had not resolved and HYPOAESTHESIA (left cheek, arm and leg on the left side felt numb), DYSSTASIA (can't stand on the left leg), FALL (falling), INJURY (fell in the bathroom and cut eye and got black and blue, knocked head), HYPERSOMNIA (sleeping a lot), DIZZINESS (Felt lightheaded), PAIN (pain), PYREXIA (fever of 99 and something, which is high for her, usually her temperature is around 97) and MYALGIA (aches) outcome was unknown. Events began after second dose of vaccine. Treatment included ibuprofen. Patient was taken to an emergency room on 30-Apr-2021. CT scan (computed tomography) and blood tests performed. Patient was not admitted to the hospital, but was transferred to a rehabilitation center. Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: No specific follow-up information recorded.; 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.

Patient called requesting form be filled out. Reported she was not very "tech savvy". She reported left ankle swelling beginning yesterday afternoon (5-25-21). Swelling decreased overnight and is swollen again today. This is new and has not occurred before. Denied other side effects or reactions. Instructed to follow up with physician to rule out other causes as well.

I started having hip pain where I couldn't put weight on my left leg and the pain went from place to place on my body but it stopped, but the hip pain has been continuous and I'm going to physical therapy. It felt like maybe advance stages of arthritis but I've not had arthritis.

Severe weakness in both legs. I couldn?t walk. Dizziness and mental confusion. I was taken to the ER. Blood and urine samples taken, chest X-ray, ECG, and was told I had a UTI and was prescribed a course of antibiotics for 10 days and discharged.

I had just woken up and I was making my coffee and I passed out and I found myself sitting in my kitchen floor which is granite, which is very hard, I really hurt myself so I called my primary care and she said to go to the ER and I waited for a couple of days until I finally went. On the ER they only did the CT scans. I have been to many doctors after that and they did a bunch of CTs, MRI, x-rays, echocardiogram, EKG. The diagnosis was that I fractured my sacrum and had acute strains of the muscles in the pelvis. I am still being treated for the muscle sprains.

very sore left arm for 4 days. No energy, shivers, muscle aches, mild ear ache with ringing in ears, light headed for 13 days

When I got the injection, I took two Tylenols. I noticed after my arm got hot and swelled a little. About 2-3 days later I had a bad rash spread from around the injection site. I went to see my doctor after a week of having that and they told me to take Benadryl. I also was taking cortisone cream. I went back to the doctor because it would not go away. My doctor prescribed me two different pills, the rash and swelling went away a little. I had to back to the doctor and he prescribed a different pill, and the itching and swelling went away.

Muscle joint aches, terrible headache, 106 fever and slept for 36 hours. I had hives spots again and i grabbed the leftover predinione and took them. I went to the doctor and she gave me another prescription of predinisone.

Polymyalgia rheumatica; Pain interfered with sleep; Pain in buttocks 2nd dose; pain in trapezius muscle 2nd dose; This spontaneous case was reported by a health care professional and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cervical spinal stenosis (The stenosis was treated) in November 2020, Arthritis of neck (The Arthritis neck was treated.) in November 2020 and Parathyroidectomy. Concurrent medical conditions included Latex allergy and Hypothyroidism since 07-Mar-2003. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 26-Jan-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021 at 5:15 PM, 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 ARTHRALGIA (Pain in buttocks 2nd dose) and MYALGIA (pain in trapezius muscle 2nd dose). On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant). an unknown date, the patient experienced INSOMNIA (Pain interfered with sleep). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 200 milligram and PREDNISONE for Polymyalgia rheumatica, at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica), INSOMNIA (Pain interfered with sleep), ARTHRALGIA (Pain in buttocks 2nd dose) and MYALGIA (pain in trapezius muscle 2nd dose) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Basophil count: 0.05 (Inconclusive) The value was 0.05 10E3/uL (reference range: 0.01 to 0.08 10E3/uL). and 0.4 (normal) The value was 0.4 percent (reference range: 0.0 to 1.0 percent).. On 16-Apr-2021, Blood alkaline phosphatase: 127 (High) The value was 127 (high).. On 16-Apr-2021, C-reactive protein: 28.60 (High) The value was 28.60 (units was not mentioned).. On 16-Apr-2021, Eosinophil count: 0.15 (normal) The value was 0.15 10E3/uL (reference number: 0.03 to 0.51 10E3/uL). and 1.3 % (normal) The value was 1.3 percent (reference range: 1.0 to 9.0 percent).. On 16-Apr-2021, Haematocrit: 38.3 % (normal) The value was 38.3 percent (Reference range: 34.1 to 44.7 percent).. On 16-Apr-2021, Haemoglobin: 12.2 (normal) The value was 12.2 g/dL.. On 16-Apr-2021, Lymphocyte count: 11.4 (Low) The value was 11.4 percent (reference range: 18.0 to 51.0 percent). and 1.30 (Inconclusive) The value was 1.30 10E3/uL (reference range: 1.02 to 3.25 10E3/uL).. On 16-Apr-2021, Mean cell haemoglobin: 28.6 (normal) The value was 28.6 picogram (reference range: 23.5 to 32.6 picogram).. On 16-Apr-2021, Mean cell haemoglobin concentration: 31.9 (normal) The value was 31.9 g/dL (reference range: 31.4 to 35.2 g/dL).. On 16-Apr-2021, Mean cell volume: 90 (normal) The value was 90 fL (reference range: 76 to 98 fL).. On 16-Apr-2021, Monocyte count: 0.77 (Inconclusive) The value was 0.77 10E3/uL (Reference range: 0.23 to 0.70 10E3/uL). and 6.7 (normal) The value was 6.7 percent (reference range: 4.0 to 12.0 percent).. On 16-Apr-2021, Neutrophil count: 79.9 (High) The value was 79.9 percent (reference range: 37.0 to 73.0 percent). and 9.14 (High) The value was 9.14 10E3/uL (high) ( Reference range: 1.43 to 6.19 10E3/uL).. On 16-Apr-2021, Platelet count: 315 (normal) The value was 315 10E3/uL (Reference range was 158 to 384 10E3/uL).. On 16-Apr-2021, Red blood cell count: 4.27 (normal) The value was 4.27 10E6/uL (reference range: 3.67 to 5.15 10E6/uL).. On 16-Apr-2021, White blood cell count: 11.5 (High) The value of white blood cell count was 11.5 10E3/uL (Reference range: 3.3 to 9.4 10E3/uL).. On 12-May-2021, Albumin globulin ratio: 0.88 (Low) The value was 0.88 (low).. On 12-May-2021, Anion gap: 2 (Low) The value of Anion gap was 2mmol/L .. On 12-May-2021, C-reactive protein: 9.4 (High) The C-reactive protein value was 9.4 mg/L (reference range: 0.0 to 9.0 mg/L).. On 12-May-2021, Light chain analysis: 2.56 (High) The value was 2.56 mg/dL (Reference range: 0.33 to 1.94 mg/dL)., 1.74 (High) The value was 1.74 (high). and 1.47 (normal) The value was 1.47 mg/dL( Reference range: 0.57 to 2.63 mg/dL).. On 12-May-2021, Protein urine: 5.0 (Low) The value was 5.0 mg/dL.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Other relevant concomitant medication included multiviamins. Treatment information included Acupuncture. On 12-May-2021, the patient was referred to a rheumatologist with various x-rays and blood work. On an unknown date, the patient was diagnosed with polymyalgia rheumatica. The pain interfered with patient's sleep. On 15-May-2021, the patient underwent the following laboratory tests with no result. The laboratory tests were as follows: foot complete bilateral, hand bilateral, chest two view, wrist complete bilateral, glomerular filtration rate, creatinine comment, ana screen with reflex, component four complement, component three complement, comprehensive metabolic panel, c-reactive protein, creatine kinase, sedimentation rate and hepatitis C antibody. 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 25-May-2021: Non significant follow up appended On 08-Jul-2021: Additional significant Follow-up was received on 08-Jul-2021: Patient details, suspect product details, medical history, event details and lab tests 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.

Vomiting, not feeling good, malaise, muscle pain, +fever, vomiting 99-100-99; incr BP 184/79, 136/76, 157/82 feeling better after 24 hours. Given Tylenol. Had refused medications while feeling ill after vaccination, medications taken next day with no problem.

Sore throat, pain across shoulders and down arms and earaches , all of which came on suddenly while walking outside some 7 hrs after vaccination

I had very tender injection site, with stiff ness in the injection shoulder. The next day I had a steroid injection in both knees , the day after the steroid, my injection site and shoulder were fine. Also I had the hot flashes and flushes. Possibly from steroid, or the vaccine, is the steroid masking the reaction to the vaccine? Will the steroid negate the effects of the vaccine on my immune system?

started that night at 9 senativity in right knee cap Left foot the started burning really bad . next day more sensitive in knee cap but 11:30 am could not walk on right leg.

12 hours after injection had chills Temp of 100, severe body and joint pain, headache, fatigue for 12 hours Headache lasted for 48 hours I did have the virus in April. Took 7 months to fully recover

Eleven hours after receiving COVID vaccine, client started experiencing stroke-like symptoms legs/arm weakness, couldn't speak, shortness of breath, and throat swelling. Hospital ruled out acute stroke but could not entirely exclude a cerebellar stroke due to her dizziness with vertigo and nystagmus (per hospital report). Client was in hospital 2.5 days, per hospitalist. note-all work up including MRI and tte were negative for acute findings- symptoms have resolved. Hospitalist noted symptoms may be worse following second shot. Spoke with client 1/19/21 and she reported feeling weak and tired only.

6:13 pm - 9 pm Extreme shooting pain, right shoulder, clavicle and neck causing my arm to jerk and sometimes my body spasmed. Pain was intermittent, coming and going but taking my breath away. I called CVS about aspirin and took 5 Baby Bayer aspirins. Pain went away at around 9 pm. Never returned. NO other adverse effects Surprising result is diminished pain in knees! When it gets cold, rainy, my knees have been extremely painful so I'd have to lift myself up from sitting but since then the pain is at 1 to 2 on the scale rather than 10 ! It sounds strange but it has happened and that's why I felt I needed to report this. Rainy days this week with no debilitating pain and I waited to report this for a week since the pain usually began days before.

Did not have an immediate reaction to injection. 8 days after injection. started to have discomfort, swelling, temperature went up to 100.3 that lasted for a couple of hrs and then went away. slept real good and woke up and not long after waking up my arm started feel very uncomfortable and swelling, turning red and a little itchy. and took a little Acedimidafin and now its back to normal.

SYMPTOMS: SEVERE, SORE/STIFF LEFT ARM - COULD NOT RAISE MY ARM TO TAKE MY SHIRT OFF AT NIGHT - HAD NO MOBILITY. SUBSIDED OVER A PERIOD OF 72+ HOURS. 1 WEEK LATER THE SEVERE SORE/STIFF SITUATION REAPPEARED, COULD NOT TAKE MY NIGHTGOWN OFF THE NEXT MORNING AND COULD NOT PUT A SEATBELT ON OR DRIVE, DRY MYSELF AFTER A SHOWER, ETC.... THIS CONDITION, WHILE IT HAS DIMINISHED TO A POINT, BUT NOT COMPLETELY HAS BEEN PRESENT FOR 3 WEEKS. 1/25/21 I RECEIVED MY SECOND VACCINE IN MY RIGHT ARM. WITHIN 3-5 MINUTES I HAD A BURNING SENSATION AT THE SITE OF THE LEFT INJECTION, I AM WRITING TO YOU ALMOST A WEEK AFTER THE SHOT AND THE SORENESS STILL PERSISTS. THE RIGHT ARM WAS SORE AT THE INJECTION SITE ONLY LIMITED AFFECT ON MY ARM MOVEMENT. THAT HAS SUBSIDED A BIT. BUT MY LEFT ARM IS STILL A PROBLEM. I HAVE BEEN IN TOUCH WITH BOTH MY DOCTOR AND MODERNA. IN EACH CASE THEY BOTH RECOMMENDED ADVIL AND THAT I SHARE MY REACTION WITH ALL OF YOU. THIS HAS BEEN A VERY LONG A DIFFICULT REACTION TO THESE 2 VACCINES. I RECOGNIZE THAT ANY REACTION IS BETTER THAN COVID BUT THIS SERIOUS REACTION IS UNEXPECTED. THE DOCTOR'S ASSESSMENT BOTH TELEPHONE AND IN-PERSON VISIT, ASSURED ME THAT IT WAS NOT HEART, ROTATOR CUFF OR BURSITIS RELATED. THE DOCTOR SUGGESTED IT WAS MOST LIKELY A VACCINE RELATED EVENT.

Next night vomited, fever, chills, back pain, extreme fatigue, inability to eat, lack of coordination in legs, confusion ...lasted for 4 days now. Worse symptoms when temperature is high.

Jan 24 - shortness in breathe, back and lungs hurt with deep breathe and pressure in chest lasted 2 1/2 days. Jan 28- large red rash on arm itchy , sill red . Also having light headiness and pressure in chest and short of breath at time

Severe chills nausea severe stomach pain and lower back pain , diarrhea. At times felt like throat closing but kept clearing throat and okay, then drinking water Lasted Over 48 hours

Immediately had visual disturbance: couldn't focus clearly. And felt tingly-sensation all across chest, deep inside, very uncomfortable and scary, and couldn't get a deep breath. Visual problem lasted about 1 hr.; chest/lung feeling lasted about 5-8 mins., tightness in chest lasted about 10-15 mins. Later in afternoon had pain/edema at injection site, left shoulder joint pain. As of today, 2/3, it's minimal.

pain in side and front of left elbow (same arm as I had the vaccine in). and down to the wrist. Difficulty stretching or raising my arm.

Stroke like symptoms; Couldn't speak; Shortness of breath; Legs and arm weakness; Dizziness with Nystagmus; Throat swelling; Dizziness with vertigo; Dizziness with vertigo; A spontaneous report was received from a nurse concerning a 79-year-old, white, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke like symptoms, dizziness with nystagmus, legs and arm weakness, couldn't speak, shortness of breath, throat swelling and dizziness with vertigo. The patient's medical history, as provided by the reporter included anemia, overactive bladder, fibroid cystic disease, allergy to fluoroquinolone, ciprofloxacin, povidone iodine, morphine and adhesive tape. The concomitant medications reported included atorvastatin, calcium, colecalciferol, metoprolol succinate, pramipexole hcl and prasugrel hcl for unspecified indications. On 07 Jan 2021, 11 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient experienced stroke like symptoms, couldn't speak, shortness of breath and throat swelling. It was reported that the patient was hospitalized for acute stroke. On an unknown date, while still being hospitalized, the patient developed, dizziness with nystagmus and dizziness with vertigo. The lab findings included, magnetic resonance imaging (MRI) and computed tomography (CT) scans as negative for acute findings, electrocardiography (EKG), complete blood count (CBC), X-ray and chemistries were reported as within normal limits. The patient remained hospitalized for 2.5 days while the symptoms improved. On 09 Jan 2021, the patient was discharged. On 20 Jan 2021, the reporter stated that the patient felt weak and tired without other symptoms. It was also noted that the patient's discharge summary stated the patient's symptoms may be worse following a second dose of mRNA-1273 vaccine. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, stroke like symptoms, dizziness with nystagmus, legs and arm weakness, couldn't speak, shortness of breath, throat swelling and dizziness with vertigo. were considered as resolved on an unknown date.; Reporter's Comments: This case concerns a 79-year-old, white, female patient with medical history of anemia, overactive bladder, fibroid cystic disease, who experienced the serious, unexpected event of stroke, Aphasia, dyspnea and non-serious, unexpected events of , dizziness, vertigo, pharyngeal swelling, nystagmus and muscular weakness. The events of stroke, Aphasia, Dyspnea and pharyngeal swelling occurred 11 hours after the first dose of mRNA-1273 (Lot number: 025J20-2A) administration and the events of dizziness, vertigo, pharyngeal swelling, nystagmus and muscular weakness occurred on an unknown date while the patient was still hospitalized. 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.

Rec'd vaccine at 1:30 pm on 02/03/21. Next morning, diarrhea, fever, and was unable to stand up, even with aid of a walker and my husband's help. Muscle weakness, which lasted about 24 hours. . After 24 hours, took 2 Tylenol, Next day problem was gone. And no further problem with muscle weakness. Did read CDC recommendations, not to take 2nd dose if there were problems. And I will not be t aking the second one on 03-03021. Did call Health Dept and reported it but not sure what staff member I visited with, but it was not the nurse who gave injection nor the Administrator.

after I received the vaccine I had a dizzy spell. I went home and was fine but the next morning I couldnt walk. I had excruciating pain in my right leg down to my foot. the strongest pain was coming from my hip. It took about a day for my leg to stop hurting and then my right arm started hurting. I had pain in my right shoulder, over and down in to the front of my arm. I could not lift my arm. the pain resolved by the end of the next day.

Patient given vaccination at pharmacy around 11am Thursday 2/4/21. No problems at time of administration or 15 minutes following. Spouse reports patient experienced generalized weakness and joint pain at around 3am 2/5/21. She could "hardly get out of bed." They brought her to the ED and she was admitted to the hospital for observation. She was discharged on Sat 2/6/21 and sent home with Rx for prednisone.

Patient observed for a total of 30 minutes. Stated headache and some chest discomfort, back aches as well. stated pain 1/10. BP 151/86, HR 71 and 98% on room air. after 30 minutes stated feels achy and slight headache. Denied chest discomfort. Able to be released to home.

Pt received dose #2 Moderna COVID vaccine 1/26/21 @ Vaccine Clinic. Pt presented to PVH ED 1/29/21 @ 0732 for workup. "Patient states that she got her Covid vaccine 3 days ago, had 1 day of myalgias, flulike symptoms, yesterday she felt much better however she felt that her heart was beating irregularly and she was feeling anxious. This persisted through the night. She denies any chest pain, shortness of breath. Patient is scheduled for follow-up with her cardiologist later next week." Afib, tachycardia, palpitations. Rhythm self converted. Given NS bolus and discharged home without further escalation of care. Entered by PSS for tracking.

Monday Eve.: Typical flu-like symptoms: Dizziness, Nausea, Headache, Bone Pain, sore arm Tuesday: Arm hard, warm, very sore --continued Wednesday: Black and Blue around injection site Thursday: Red rash that extended to elbow. Checked with NP who said could be cellulitis or inflammatory reaction --put topical Hydrocortisone on it and watch. It did shrink some, but still present through this evening.

Starting on Sunday her left arm where she got the shot was hot. The right was unusually cool. She got up and had trouble walking. She has pain in the bend of her left knee that radiates down through the calf of her leg. When she gets up from sitting it hurts, and having to use two canes to walk and it still hurts. The pain has not gone away from the day of vaccine, but the persistence has continued since Sunday. The arm is okay, but the leg that is on the same side. She did not have any problems with walking prior to the vaccine.

Moderna COVID-19 Vaccine EUA On Jan. 28th my knees and hips began to hurt. I have osteoarthritis in my left knee and right hip as well as a left hip replacement and right knee replacement I thought perhaps the pain I experienced was weather related as I had not experience pain in these joints like this before. I went to bed that night about 9 p.m. and was experiencing more pain in my legs. The pain kept me awake most of the night and I got up about 4:30 a.m. By then I could barely walk. The pain was not only in my joints but felt like it was in my bones as well. My skin on the lower leg felt tight, almost like my legs were swollen, but they did not appear to be. My right leg hurt the worst. I still have a discolored spot on my arm where I had the shot. It is about a 1/2" diameter. It does not hurt.

Awoke on 1/10/2021 with severe arm pain in left arm. Unable to lift arm. Thought odd that it hurt in arm opposite injection site. on 1/12/2021 pain extended to right arm, next, down towards elbows. Acitivities of daily living difficult. Pain severe in morning, better throughout day, but still painful. Unable to lift arms, pick up items. Hips begain hurting within a week. Started prednisone 2/2/2021 with very significant relief of pain. Weaned every 3 days until 20 mg - continue to take 20 mg until seen by rhuematologist. Continues to have morning bilateral arm and shoulder pain, improving throughout day, although not always complete relief. In addition, vertigo started on 1/8/2021 and continues.

NAUSEA, FEVER (100.3), CHILLS, HEADACHE, MUSCLE ACHES FOR 24 HOURS. EXTREME FATIGUE CONTINUEING FOR 3 DAYS.

A few hours later, my head and bones and muscled started hurting. I was hurting really badly when I woke up this morning. I had a little nausea and my hips felt like they were going to collapse. I started coughing and developed a fever. The muscle pain is very bad. my chest area is very uncomfortable. ( its not over my heart, its higher up) I took Tylenol that seems to be helping the muscle pain a little.

COVID-19 Vaccine EUA-FDA/CDC Vaccine Adverse Event; Onset: 3:30 pm Headache, fatigue, dizziness, joint pain, muscle pain, chills, rapid heart, some GI distress. Duration: 28 hrs. Tylenol 500 mg. kept it under control.

Rc'd apx 12noon on 2nd, following am 2/3 expected sore arm, but shoulder also painful which progressed and more intense , left side neck pain , between shoulders, and left shoulder. appx 2/6 pain more intense, weakness unable to raise arm fully saw Dr. 2/11 which he dx as Roto Cuff injury, and injected shoulder. 3 days later pain started to lessen. Pain now with certain movements but still unabe to raise arm fully

with first injection muscle was toxic for 36 hours, T t 100, diffuse myalgias, arthritis, felt miserable, slept 36 hours as couldn't lift head even to drink water. Second injection was toxic for 36 hours , T t 100, diffuse myalgias, arthritis, felt miserable, slept 36 hours,also temp of 100.4. When I could drink I took a tylenol. questionaire did not ask, but I had covid in mid August

laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain); horrible pain on left side (side of the injection); awful pain on left leg; could not raise leg; congestion in head, like a sinus infection; tiredness/fatigue; Headache; Chills; A spontaneous report was received from a consumer, a 79-year-old female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain), horrible pain on left side (side of the injection), headache, chills, tiredness/fatigue, awful pain in leg, could not raise leg, and congestion in head, like a sinus infection. The patient's medical history was not provided. Her allergies included sulfa, mycin, meloxicam and glycopyrrolate. Concomitant medications included blood pressure medication (name not reported). On 28 Jan 2021, approximately one day prior to the onset of events, the patient received her first of two planned doses of mRNA-1273 (Batch number: 028L20A) on the left side (anatomical location not reported) for prophylaxis of COVID-19 infection. On 28 Jan 2021, on the night of the vaccination, the patient woke up with a horrible pain one her left side (side of the injection), headache, chills, fatigue/tiredness, an awful pain on her leg, and congestion in her head, like a sinus infection. She got up thinking that walking would make the pain on her leg go away, but it did not. When the patient tried to go back to bed, she could not raise her leg so she laid on the floor and she did not know if she passed out on the floor or fell asleep (she thought she could not have fallen asleep with such pain). When the patient woke up, she could move her leg normally. Treatment information was not provided. Action taken in response to the events was unknown. The events, laid on the floor and does not know if passed out on the floor or fell asleep (thinks could not have fallen asleep with such a pain), horrible pain on left side (side of the injection), headache, chills, awful pain in leg, could not raise leg, and congestion in head, like a sinus infection were considered resolved on 29 Jan 2021. The event, fatigue/tiredness was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 79 year old female subject, who experienced a serious unexpected event of loss of consciousness after first dose of mRNA1273 (Lot# 028L20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

On the 19th by about 4 pm pain in both arms not just the pain in a left arm muscle which was expected Pins and needles and pain in both hands Neck and shoulder pain Later that night chills Stomach ache and constipation followed by loose bowel later These were milder versions of my reaction when I had Covid-19 in November except the pins and needles in hands. That came on after I got over Covid. These pains went away after a couple of courses of Tylenol extra strength. Except the chills and stomach ache recurred and my stomach is still a little achy

Acute sneezing x 10 Min followed by shacking chills, temp 102, severe muscle aches, headache, sore throat lasting 16 hours

Symptoms: large red itchy spot on arm, chills, fatigue, slight nausea, mild general headache that became piercing,painful and intermittent for several hours Symptoms lasted for approximately 36 hours ,arm remains red and slighty itchy 4 days later, slight headache Treatment:tylenol,liquids,rest

On Feb 21, fever of 101 discomfort in arm, extreme tiredness. Difficulty sleeping. On February 22, fever of 99.1 , increased redness, heat, and swelling at site (about the size of my palm). Iced site for about an hour and took citirezine antihistamine. Feb 23, today AM temp 98.6, perhaps size of swelling has decreased. Still painful to raise arm there. Can do all household activities.

pt reported that 10 days after vaccine she had a delayed reaction of itching, swelling, a knot, and feeling warm in where the injection was given. She also reported neck pain.

Got the shakes at 11PM on sat. night and at 2Am in the morning i am throwing up. I have a fever my head hurts and my neck. I am still sick. I do not feel good. I am not getting the 2 shot.

Really tired on Monday the 22nd and I felt fatigued. I began to get nauseated and then I began to vomit. I vomited 5-6 times even though I had not eaten anything. I also had diarrhea. I had chills. Some point during the night I spiked a fever, I woke up and drenched. Yesterday the 23rd I had a fever, my stomach still does not feel settled. I have not ate much since Sunday but have been trying to stay hydrated with lots of water. I also developed a cough yesterday. Tuesday night my temperature 100.6 and I think it got higher because I woke up once again drenched in sweat. This morning my temperature was 99. I am achy today with muscle and joint pain, my stomach feels better but I still leery of eating. I did eat some Ginger ale and eat some saltine crackers. I also feel horse. I called my doctor yesterday and still have not heard back. I will call again today. It feels like I feel better in the morning but as the day goes on I get worse and start feeling worse. I have been resting a lot in bed.

2 episodes in which she wanted to pass out; Ache; Flu like symptoms; Fever; A spontaneous report was received from a consumer, concerning herself, a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, aches, flu like symptoms and 2 episodes in which she wanted to pass out. The patient's medical history was not provided. Concomitant product use was not provided. On 08 Feb 2021, the patient received their first of two planned doses of mRNA-1273 ([LOT# 007M20A]) intramuscularly for prophylaxis of COVID-19 infection. On 08-Feb-2021, the patient reported that about 1 to 2 hours after receiving the vaccine, the patient reported that she "wanted to pass out" when she went grocery shopping. The patient also had fever, aches and flu-like symptoms. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events of fever, aches, flu like symptoms and "2 episodes in which she wanted to pass out", were considered resolved on an unspecified date in 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.

Intense upper arm and shoulder pain, gradually diminished over a three week period. Numbness and tingling in right forearm , hand, and fingers, impinging on use of right hand, has gradually abated over athethree-week period since the injection but is still present.

Feb. 26 - dizzy spell & weakness in legs lasting less than 2 hours Feb. 28 - hot red rash at site of injection, also swelling of upper arm

"Moderna COVID-19 Vaccine EUA" Immediately felt routine pains in right arm at shot sight and just out of sorts. By 6 PM I felt nauceous , headache, pains in every joint of my old body , cough, chills, virgo, weakness , low grade fever, unsteady on my feet. Unable to sleep finally took Tylenol . This lasted 48 hours!

Nausea, vomiting, weakness, confusion, headache, body and joint pain, fever, tiredness, arm soreness,chills. started within 15 hours of injection. Uncontrolled vomiting and weakness necessitated going to emergency room. She had had severe covid 19 in 2020 and was hospitalized for 5 days. Received remesdivir and dexamethasone

2 days later began with headache, dizziness, weakness, on 1/25/21 was admitted to hospital with severe leg weakness, inability to walk, urinary incontinence

Initial tissue reaction with erythema to us change, swelling, and pain on injected site and place, left arm has not subsided even in 6 weeks duration. Second shot on the rt. arm didn?t cause any problem. No warm sensation on injection site. She feels heavy on lifting her left arm and pain on motion of left arm above injection site. She has used arm sling to support lt. arm and took Advil occasionally, but no help. No fever elicited. I am very curious . Not sure what specialty dr to take her for further assessment. Similar repoRt?

patient had sore shoulders for a few days after the vaccine. woke up 3/3/2021 with left shoulder pain and unable to lift left arm. left arm was the vaccine site. concern for SIRVA.

CLIENT AWOKE 3/2 WITH SORENESS TO THE INJECTION SITE THAT EXTENDED ACROSS HER BACK AND SHOULDERS ACCOMPANIED BY INTERMITTENT NAUSEA. THIS MORNING (3/5) SHE WOKE UP TO THE LEFT HALF OF HER FACE SWOLLEN.

Following the vaccine she noticed the same day fatigue. She was so tired that she didn't understand it. Then had headaches off and on, as well as muscle and joint pain everywhere, weakness all over her body. She also had a low grade fever Saturday and Sunday. She did have the Corona Virus in July of 2020. She is feeling better today as far as the weakness, just a little bit of muscle and joint pain. She did have a trace of nausea this morning, but took her medication and it subsided. The weakness was something like she had never had before. She took Tylenol for her symptoms. She did not call her doctor. Just has a small amount of symptoms, but still not feeling herself yet.

Passed out; Things were going downhill; Dizzy; Injection site was painful; Fatigued; Muscle pain; Joint pain; Nausea without vomiting; Low grade fever; A bit of an ache in injection arm; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following: things were going downhill, injection site was painful, fatigued, muscle pain, joint pain, nausea without vomiting, low grade fever, dizzy, passed out, and a bit of an ache in her injection arm. The patient's medical history was not provided. No concomitant medications were reported. On 19-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 032L20a) intramuscularly for prophylaxis of COVID-19 infection. On 19-Feb-2021, the patient received the vaccine around noon and by the evening she could tell things were going downhill. She went to bed early, and throughout the night the injection site was painful, she was fatigued, she had muscle pain, joint pain, nausea without vomiting, and a low grade fever. The patient got up at night to go to the bathroom and got dizzy and passed out. She said she was passed our for barely a minute and when she came too she laid there for a bit before she went back to bed with her husband's help. All day on Saturday 20-Feb-2021 the patient was in bed but by that evening she was able to get up and walk out of the bedroom. On Sunday night 21-Feb-2021, she was able walk up stairs without huffing and puffing and felt much better. The patient states they have recovered from it all except sometimes when doing yoga, they can feel a bit of an ache in the injection arm. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The outcome of the events things were going downhill, injection site was painful, fatigued, muscle pain, joint pain, nausea without vomiting, low grade fever, dizzy, and passed out, were considered recovered/resolved. The outcome of the event, ache in injection arm, was unknown.; Reporter's Comments: This case concerns a 79 Y/O F with a serious unexpected event of loss of consciousness along with NS unexpected dizziness, feeling abnormal, pain in extremity, and NS expected fever, fatigue, myalgia, arthralgia, nausea, vaccination site pain. Event onset the same day as second dose mRNA-1273. Events resolved except arm pain. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Extreme pain in knee opposite injection site. Had hip pain first day. Knee second day. Now it is the fifth day after vaccination and she has trouble standing. Slid off be trying to stand up and required EMS assistance to get her to stand.

Was napping the day after receiving the vaccine and woke up about 3:00 pm to severe chest pain on the right side radiating deep into the shoulder blade. It would last about 5 - 10 min., stop for the same amount of time, then start up again.... on & off until close to 11:00 pm. Since someone else I know had the same thing happen the day after her shot, I assumed I had the same symptom, tho' it was very frightening. A week later after going to bed on Friday night, I woke at 2:00 a.m. to the same pain only this time on my left side. Thinking I could be having a heart attack, I went to the hospital where I was admitted after having a series of tests. I was there for 2 days during which time I also began to have un-controllable diarrhea. Altho' they could find nothing wrong with my heart, after scans, x-rays, a stress test, numerous blood tests etc., they cannot say positively whether or not it was from the Covid vaccine. I tho't it best to report this in case others have similar events. I had the MODERNA vaccine

fever and chills, headache, nausea muscle aches, fatigue treated with tylenol felt fine after 24 hours

Pt developed throbbing, pulsing pain down her entire Right lateral Ribcage, by day 5 Post Covid vaccination. Vx admin to R side. + Mild pleurisy also.

after first vaccineSymptoms were on left side and I awoke to my neck painful, this pain moved from there to upper arm , elbow, lower arm, wrist, leg , and ended in my foot as it traveled from one are to the next the last area improved. it lasted in total about 10 days with no after effects. after second vaccine right side was affected painful neck and swelling and pain in entire arm was very painful and swollen and very difficult to move. this improved slowly from the neck down took about 7 days to go away. I know I had considerable swelling as it was obvious my wrist and hand.

On 3/2/21 had arm discomfort into next day, felt tired, on 3/11/21 started with body rash on back, stomach, groin area, base of skull, and chest. Dr. said to take Zyrtec or Benadryl, neither had any effect. I was then prescribed Methyl PREDNISolone tablets 4 mg.

Chief Complaint Pt had fall last night due to "shakiness." Pt was unable to get up by self. Pt found at 0800 this AM by caregiver. Denies injury from fall, on Eliquis History of Present Illness Patient is a 79 year old of Dr who is well known to the Hospitalist program. Patient was originally dx with pelvic fracture 12/29/20 with direct admission to hospital until 1/11/21. Readmission to acute care setting 2/22/21 from HCP and then back to hospital 2/25-3/11/21 when she was dc home with home health. Patient states she was doing well until yesterday with "my legs started shaking" while she was up ambulating with her walker and caregiver. She did not fall and had an uneventful day until around 10PM when went to the bathroom and then went to the kitchen. She was using her walker. When she attempted to get back into her bed "my legs just went out" with general weakness to both legs. She gently slide to the floor, no injury with exception to left ankle but not sure of the nature of the injury. She was unable to get up and could not get her phone. She was found at 8AM by caregiver and brought to the ED. Her daughter is at the bedside with her. Her only new pain at this time is to her left ankle, feeling well otherwise, no recent Rx changes, generally poor intake per daughter. No other new concerns today. No change in chronic lower back pain. Addendum; COVID screen + which could account for her weakness in her legs past 24 hours. Has had multiple previous negative screening studies, most recently 3/2/21. Discussed with ID and patient could have contracted since home from hospital. Will make COVID infectious disease team aware. Left ankle XR was negative for fracture. RICE.

Moderna COVID-19 Vaccine EUA About 1-1/2 wks after the first vaccination, every muscle/joint in my body started aching. It is now over 2 weeks after the second shot, and it only gets worse. I have a hard time getting out of a chair without assistance, much less off the toilet.

The patient stated that she gets paralyzed after getting vaccines. I asked her if she had someone in the pharmacy to help her. She said she came alone. I told her I would have her wait 30mins after dose to make sure there were no issues. After I gave her the shot, she looked at me and said that didn't hurt at all. Then she looked and said my neck hurts. So I had her take deep breaths with me to get her to calm down as she appeared anxious. She was doing great then she went limp. I held her head up and asked her is she was ok. She said she was, but then her breathing become shallow. She was un responsive at this time with her tongue pushing her mask off her mouth. So I lowered her mask and her tongue appeared to be enlarged. I had my technician call 911 and I gave her a dose of epinephrine 0.3 mg. She was unresponsive, but breathing on her own. The paramedics came and got her vitals, placed her on stretcher, and put in a medicine line to give her medications if need be. She left somewhat unresponsive. They said she should be fine and took her to ER.

Temperature elevation, chills, headache, joint pain nausea, dry heaves...I had COVID IN NOVEMBER, DIAGNOSED Nov.19, had double pneumonia , released from hospital Dec. 6....I waited over 90 days to have vaccine...adverse effects lasted around 48 hours, I?m still fatigued, no temperature elevation, but the whole episode was like my first stages of Covid. I do not want to get my second shot in April and go through this again..what are studies showing about vaccine given after having had Covid...have you learned anything from them yet? Will I be certified as being vaccinated with only the one shot?

Every part of body hurt one day after the injection, didn't eat, Second day everything ran out of me until I pooped yellow liquid. Third day started to eat and be up more and moving around. Felt like flu. Day 4 checked weight and lost

1st day all joints stiff 2nd day chills head ache body pain coughing third day neck stiff backache and stomach pain fourth day coughing and generally body ACHES

Approx. hour after injection started with a nagging headache for over a week, chills, muscle aches, joint pains, fatigue, tireness, and nausea all lasting for over a week. On 1/16/2021 vomited all day - no stomach cramps or any other indication of that being a "stomach virus". Continued nauseated feeling resulted in cancelling a dental appt on Tuesday after injection.

I felt very bad that evening. I couldn't eat. I felt a little nauseated. my arm was sore across my shoulders and down my left arm. I had fatigue, headache (I felt like my head was going to explode) , muscle pain and general pain all over. My heart rate was 96 and my BP was 62/36. I felt Dizzy, weak. 03/16/21 I went to the ER Still feel hazy and foggy. I feel like my limbs are disconnected and dont respond as easily as they should.

swelling of left arm and shoulder from shoulder to below elbow, extreme itching and rash, fatigue, headache, loss of appetite, low-grade fever. This has continued for two weeks.

Arm pain started the next evening after the shot; but pain went away after 3 days; but the pain returned more severely 7 days later. The pain both times was so severe that the arm was immobilized. And the second bout of pain involved the hand, arm, neck, and ear ache. The pain slightly subsided yesterday, but came back more intense today. raises concern about incorrect injection technique causing severe shoulder pain (SIRVA)

Patient states that later in the evening (approximately 6 hours) after getting immunization on March 24th she started feeling muscle aches and itching. Thursday March 25th, in the morning, she was having trouble standing and could not walk, plus confusion understanding husband when he talked to her about her problems. They went to hospital and she was admitted. Do not know what tests or treatment patient got at hospital, but she was released to go home on Saturday March 27, 2021.

Second day after the vaccine in March, I had fatigue, aches, AND CHILLS IN MY LOWER EXTREMITIES. These symptoms carried over until noon on the third day. THEN I developed weak muscles in my legs and sprained my R knee. I continue to have weak muscles and the knee (R) was swollen. I have alleviated the swelling but continue to practice stretching to strengthen the leg. The leg is still not as strong as it was before the vaccine in March.

STARTING TWO DAYS AFTER VACCINATION, TENDERNESS AT INJECTION SITE. AFTER A COUPLE OF DAYS, THE PAIN RADIATED FROM SHOULDERS DOWN TO MIDDLE OF THE LEFT HAND AND EXTENDED THROUGH THE PECTORAL AREA AS WELL AS THE BACK. UNABLE TO LIFT ARM ABOVE THE SHOULDER/HEAD REGION. DESCRIBED AS AN INTENSE BURNING SENSATION.

Per client states she had pain and was unable to move her left arm after receiving the vaccine. She need to go to the Chiropractor for an adjustment. Client still having some pain in left shoulder.

can't sleep; muscle aches ("I can't walk , I can't sleep, it hurts so bad"); crippling; A spontaneous report was received from a 79-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events muscle aches (i can't walk , i can't sleep, it hurts so bad), insomnia, and crippling. The patient's medical history was not provided. No relevant concomitant medications were reported. On 16 Feb 2021, prior to the onset of the events the consumer received first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly for prophylaxis of COVID-19 infection. On 26 Feb 2021, ten days after the vaccination, the patient experienced the events muscle aches (i can't walk , i can't sleep, it hurts so bad) and crippling. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, muscle aches (i can't walk, i can't sleep, it hurts so bad), insomnia, and crippling was not recovered / 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 events, a causal relationship cannot be excluded.

Swollen left elbow that decreased over time. Was still somewhat swollen 4 hours later. Pt reports she experiences no pain at the swollen site

fever, generalized muscle ache, diarrhea, loss of appetite, weakness - lasted for three days - took 1 1/2 week to fully recover

Five days following vaccine #2, pt presented to the emergency department on 3/2/21 with complaint of severe generalized arthralgias and fatigue. Completely different from her chronic osteoarthritis. Complete work-up including labs were negative. Normal CBC; normal electrolytes; normal inflammatory markers (ESR and CRP); rheumatoid factor was normal; urinalysis was normal; chest x-ray was normal. She was discharged home on no medication. She was seen by primary care on 3/29/21 and reported her symptoms, although not completely resolved, were markedly improved. Because of her autoimmune liver disease, she did not take Tylenol or Ibuprofen for her discomfort.

Severe left leg, hip, joint/muscle pain, can barely walk, leg gives way. Taking Tylenol every 4 hours, is not helping very much! Have not called doctor yet. 4/6/2021.

Unable to get second dose; physiologic arthritic flare; Physiologic arthritic flare; High Temperature; Small patches of pneumonia (pleuritis); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Small patches of pneumonia (pleuritis)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D1DM20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis. Concomitant products included PREDNISONE for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PNEUMONIA (Small patches of pneumonia (pleuritis)) (seriousness criterion medically significant), ARTHRITIS (physiologic arthritic flare), ARTHRALGIA (Physiologic arthritic flare) and PYREXIA (High Temperature). On 10-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Unable to get second dose). On 10-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Unable to get second dose) had resolved. At the time of the report, PNEUMONIA (Small patches of pneumonia (pleuritis)), ARTHRITIS (physiologic arthritic flare), ARTHRALGIA (Physiologic arthritic flare) and PYREXIA (High Temperature) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided by the reporter. Based on the current available information and the Temporal association between the use of the product and start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the Temporal association between the use of the product and start date of the events a causal relationship cannot be excluded.

One week after the first Moderna shot on 1.28.21, I experienced severe upper body pains, aches on shoulders, arms, fingers, continuing to date: 4.13.21. My concern is that the Moderna vaccine stimulated an underlying & unknown arthritic condition, diagnosed via xray on 4.8.21. The disabling pain continues, even after the 2nd shot, 3.4.21, which I listed in item 4, so that I could include the first shot as happening one month prior in item 22.

Reporting side effects for Moderna COVID-19:first injection March 2. No effects. Second injection Tuesday, March 30: Wednesday- fatigue, muscle weakness and tender injection site; Thursday: cancelled appointments due to serious muscle weakness with pain and recurring strong headache; Friday: fatigue with weakness, hard, hot, painful, reddened area at injection site, occasional headache, episodes of nausea; Saturday: itching reddened injection site ( approx. 3"x2"), leg muscles very weak, general malaise; Sunday: itching light reddened injection site (all day), extreme muscle weakness with significant pain, swelling of lips and glands under jaw bone (11 pm), Monday, April 5: all effects subsiding; Tuesday (today): beginning to feel more like myself.

3/21 admit HPI: 80-year-old white female with a past medical history for oxygen-dependent COPD who presents to the emergency room today due to falls and possible confusion. According to the family member, he does not think her oxygen was set at the right level. He thinks it was set up higher because she tends to get confused and fall when this happens. The patient really has fallen twice of late. She said she aches all over. She also cites dizziness when she stands up. Because of the symptomatology, she came to the emergency room for evaluation. Workup, including chest x-ray imaging, was fairly unremarkable. The patient did not, however, feel safe going directly home. At the present again, she just feels achy. There is no chest pain or shortness of breath. No abdominal pain or urinary symptoms. No rash. 3/26/21 admitted 80 y.o. female with a PMH notable for COPD, atrial fibrillation, hypertension, diabetes and obesity who presented on 3/26/2021 for evaluation of physical deconditioning. Patient presents to our facility yesterday after hospital stay from hospital from 03/21 through 3/26/2021. Hospital course - The patient is an 80-year-old white female with a past medical history for oxygen-dependent COPD who presents to the emergency room today due to falls and possible confusion. According to the family member, he does not think her oxygen was set at the right level. He thinks it was set up higher because she tends to get confused and fall when this happens. The patient really has fallen twice of late. She said she aches all over. She also states dizziness when she stands up. Because of the symptomatology, she came to the emergency room for evaluation. Workup, including chest x-ray imaging, was fairly unremarkable. The patient did not, however, feel safe going directly home. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the machine. Since admit, patient admitted to pain in her back. CT spine showed L1 compression fracture which appeared new. PT worked with patient and felt she should go to rehab for continued therapies.Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor. Patient is then to follow-up with neuro surgery and 3-4 weeks. 4/17 ER: 80 y.o. female who presents with increased somnolence and lethargy. Patient was discharged from the hospital 2 days ago after having a stay on swing bed. She has multiple medical problems and was admitted following a hospitalization at Hospital. She has generalized debilitation and advanced COPD with CO2 retention. Patient has been instructed to utilize a BiPAP machine. According to her family, she has been none a compliant with this and did not utilize it last night. Patient noted this morning that she was somnolent and lethargic. Prior to that she had been doing well since discharge. Other than the lethargy and somnolence there are no other complaints. 4/18/21 ER to admit: dx sepsis 80 y/o F with PMHx COPD with chronic CO2 retention and respiratory failure on 2L NC, OSA, non-compliant with CPAP, myoclonic jerks, essential tremor, type 2 DM, HTN, paroxysmal a.fib on eliquis, essential tremor and recurrent falls with recent L1 compression fracture s/p brace placement, presented to ED on 4/18/2021 for shaking and AMS.

severe joint and muscular pain segueing into what appears to be severe sciatica. Could be coincidence but I don?t think so. I didn?t have the sciatica previous to the vaccine.

Area of burning moved to upper arm, shoulder, neck, and scapula; Burning at the injection site; Area was hot to the touch; painful; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SKIN BURNING SENSATION (Area of burning moved to upper arm, shoulder, neck, and scapula) and VACCINATION SITE PAIN (Burning at the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No historical condition reported.). On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN BURNING SENSATION (Area of burning moved to upper arm, shoulder, neck, and scapula) (seriousness criterion hospitalization prolonged), VACCINATION SITE PAIN (Burning at the injection site) (seriousness criterion hospitalization prolonged), SENSITIVE SKIN (Area was hot to the touch) and MYALGIA (painful). At the time of the report, SKIN BURNING SENSATION (Area of burning moved to upper arm, shoulder, neck, and scapula), VACCINATION SITE PAIN (Burning at the injection site), SENSITIVE SKIN (Area was hot to the touch) and MYALGIA (painful) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. 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.; 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.

After 4 hours of the vaccine dose, but within 6 hours; the patient experienced: patient reported lethargy, "blood spots" in the hand (possibly petechiae), itchiness all over body; bruises on arms; fever and chills; headache; muscle pain. Received the 1st dose vaccine on 3/1/21. Then, on 3/3/21, patient reported fainting, and hospitalized (duration of hospital stay was about 12 hours). After hospital discharge; patient reported that felt all symptoms were resolving.

Extreme fatigue, chills, muscle pain in back, slight headache, fever, lack of appetite - for 3 days; then Diarrhea & bloating for 24 hrs; then prior symptoms gone but very weak & tired - for 4 days (the first day had low blood pressure); then general malaise for 1 week

3 HOURS LATER AFTER VACCINE PATIENT EXPERIENCED: DIZZINESS, BACK AND CHEST PAIN, SHORTNESS OF BREATH, LEG AND STOMACH HIVES, INSOMNIA, AND VOMITING. CONTINUED FOR 3 DAYS. TODAY (ALMOST 2 WEEKS LATER SHE IS FULLY RECOVERED)

Presyncope directly after injection. SIRVA directly after injection and prolonged. Fatigue, Chills, Muscle Aches in chest and back set in 4/30/21 at 12:00 pm.

Severe arthritis flare, severe soft tissue pain whole body, unable to get out of bed or chair by myself lasting 3 weeks untill able to get on Prednisone

Patient presented to PCP worsening fatigue and spells of shortness of breath, chest discomfort, felt like something was stuck in her throat and not feeling right for the past one week had the chills; legs weak, EKG showed ST segment elevation. Patient was transferred to hospital ED and admitted

very tired, slept all day; slept all day; She had trouble breathing; pain in back of right shoulder; found two blood clots on lungs and two in legs; found two blood clots on lungs and two in legs; there was damaged to his wife's heart too; weighed165 pounds initially and then went down to 145; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She had trouble breathing), ARTHRALGIA (pain in back of right shoulder), FATIGUE (very tired, slept all day), HYPERSOMNIA (slept all day), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs) and CARDIAC DISORDER (there was damaged to his wife's heart too) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A2 or 078A2 and 028A2 or 078A2) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (She had trouble breathing) (seriousness criterion hospitalization), ARTHRALGIA (pain in back of right shoulder) (seriousness criteria medically significant and life threatening), FATIGUE (very tired, slept all day) (seriousness criteria hospitalization, medically significant and life threatening), HYPERSOMNIA (slept all day) (seriousness criteria hospitalization, medically significant and life threatening), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs) (seriousness criteria hospitalization and medically significant), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (there was damaged to his wife's heart too) (seriousness criterion hospitalization) and WEIGHT DECREASED (weighed165 pounds initially and then went down to 145). At the time of the report, DYSPNOEA (She had trouble breathing), ARTHRALGIA (pain in back of right shoulder), FATIGUE (very tired, slept all day), HYPERSOMNIA (slept all day), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs), CARDIAC DISORDER (there was damaged to his wife's heart too) and WEIGHT DECREASED (weighed165 pounds initially and then went down to 145) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: two blood clots on lungs and two (abnormal) two blood clots on lungs and two in legs. On an unknown date, Weight: 145 (Low) weighed 165 pounds initially and then went down to 145. The patient was hospitalized for around four days. The patient size of clots as 10 cm and 9cm in the lungs. The reporter stated that Heparin was used in the hospital and after the discharge the patient was put on Eliquis for the next 6 months. The reporter reported that the patient weighed165 pounds initially and then went down to 145 afterwards. Action taken with the mRNA-1273 is considered as not applicable. Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded.

Suddenly had muscle "screaming" at top of both legs when standing from a sitting position, and when bending over to retrieve something from the floor. Lasted 2 months, then just as suddenly disappeared. Doctor sees no other explanation.

14 day after the vaccine had worsening of arthritis, before patient could walk and performed daily activities of living. Now patient needs walker and cannot shower on her own. Increase join pain in hands not able to knit anymore.

"Moderna COVID-19 Vaccine EUA" A week after the first shot, an itchy red area appeared on the inside of that arm. It went away in about a week. Approximately two weeks after the second shot, a small, red sore spot appeared on my left shoulder close to the joint of the collar bone with the arm bone. Redness began to appear, first forming a streak downward. By the end of the week, the redness continued to spread and pain developed in my bones on that shoulder. On May 19, I was referred to Urgent Care by my normal healthcare provider. There I was prescribed prednisone. The course of treatment was 3 pills per day for four days, 2 pills per day for four days and 1 pill per day for three days. I have not yet finished those pills. The pain in the bones has decreased but the redness continues to spread. Where it was at first just a streak that developed, it started over my shoulder and now has crossed the middle of my chest. I had been told that I could stop taking the prednisone if the pain went away. Earlier this week, I thought it was gone, so I didn't take the pills that day. However, the next morning, the pain was back and I resumed the prednisone.

Left side of her face seemed frozen; Gland and cheeks were swollen; Super tired; Carotid artery was hurting; Sinus was hurting; Could taste the medicine; Little lump on her neck by her ear; Bacterial infection at the injection site; Black scab and a lot of pus at the injection site; Black scab and a lot of pus at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FACIAL PARALYSIS (Left side of her face seemed frozen) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis (Left shoulder). Concomitant products included ESTRADIOL (ESTROGEN), PROGESTERONE, LORATADINE (CLARITIN [LORATADINE]) and COLLAGEN for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced NECK PAIN (Carotid artery was hurting), SINUS PAIN (Sinus was hurting), DYSGEUSIA (Could taste the medicine), NECK MASS (Little lump on her neck by her ear) and FATIGUE (Super tired). On 06-Apr-2021, the patient experienced FACIAL PARALYSIS (Left side of her face seemed frozen) (seriousness criterion medically significant) and LYMPHADENOPATHY (Gland and cheeks were swollen). In April 2021, the patient experienced INJECTION SITE INFECTION (Bacterial infection at the injection site), INJECTION SITE SCAB (Black scab and a lot of pus at the injection site) and INJECTION SITE PUSTULE (Black scab and a lot of pus at the injection site). On 29-Apr-2021, INJECTION SITE SCAB (Black scab and a lot of pus at the injection site) and INJECTION SITE PUSTULE (Black scab and a lot of pus at the injection site) had resolved. At the time of the report, FACIAL PARALYSIS (Left side of her face seemed frozen), NECK PAIN (Carotid artery was hurting), SINUS PAIN (Sinus was hurting), DYSGEUSIA (Could taste the medicine), NECK MASS (Little lump on her neck by her ear), INJECTION SITE INFECTION (Bacterial infection at the injection site) and FATIGUE (Super tired) outcome was unknown and LYMPHADENOPATHY (Gland and cheeks were swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Other concomitant medication included: high blood pressure medicine (unspecified), "calfix 10 mg, and "a whole lot of holistic medicine for arthritis." The patient's 2nd dose of the Moderna COVID--19 vaccine was supposed to be on 07-May-2021 but the pharmacy denied her the second dose due to their reaction she had to the first dose given in her left non-dominant arm. The doctor advised that the patient had a bacterial infection at the injection site. The patient was still swollen as of 07-May-2021 and was unsure when all the symptoms began and resolved. The vaccine provider advised the patient that she would be unable to get the second dose unless she went to the hospital. 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 MOD21-091284, US-MODERNATX, INC.-MOD-2021-138847 (E2B Linked Report).; 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. MOD21-091284:crosslinked US-MODERNATX, INC.-MOD-2021-138847:Daughter's case

By May 3 onset of fatigue, generalized aching in all muscles, soreness in shoulders, wrists, fingers, back, knees. By week of May 10 felt as though I had the flu. Saw rheumatologist on May 14 who drew labs and prescribed Prednisone for diagnosis of Polymyalgia Rheumatica

Atelectasis; Back pain; Cardiomegaly; Dizziness postural; Essential tremor; Fall; Lethargy; Mental status changes; Myoclonus; Pain; Sepsis; Somnolence; Spinal compression fracture; Tremor; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for an unknown indication. The patient's past medical history included COPD, Atrial fibrillation, Hypertension, Diabetes, Obesity and Respiratory failure. Concurrent medical conditions included Allergy to allopathic drugs (Jardiance Lyrica) and Allergy to allopathic drugs. Concomitant products included CHOLECALCIFEROL and APIXABAN (ELIQUIS) for an unknown indication. On 11-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ATELECTASIS (Atelectasis) (seriousness criterion hospitalization), BACK PAIN (Back pain) (seriousness criterion hospitalization), CARDIOMEGALY (Cardiomegaly) (seriousness criterion hospitalization), DIZZINESS POSTURAL (Dizziness postural) (seriousness criterion hospitalization), ESSENTIAL TREMOR (Essential tremor) (seriousness criterion hospitalization), FALL (Fall) (seriousness criterion hospitalization), LETHARGY (Lethargy) (seriousness criterion hospitalization), MENTAL STATUS CHANGES (Mental status changes) (seriousness criterion hospitalization), MYOCLONUS (Myoclonus) (seriousness criterion hospitalization), PAIN (Pain) (seriousness criterion hospitalization), SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), SOMNOLENCE (Somnolence) (seriousness criterion hospitalization), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) (seriousness criteria hospitalization and medically significant) and TREMOR (Tremor) (seriousness criterion hospitalization). At the time of the report, ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood gases abnormal: abnormal (abnormal) patient's ABG showed significant CO2 retention.. On 21-Mar-2021, Chest X-ray: abnormal (abnormal) shows new cardiomegaly. Mild bibasilar volume loss is again seen. Remaining lungs are clear. No pleural effusion is noted.. On 21-Mar-2021, Computerised tomogram: abnormal (abnormal) CT spine showed L1 compression fracture which appeared new. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Because of the symptoms, patient came to the emergency room for evaluation. Chest x-ray imaging, was fairly unremarkable. She just feels achy. There were no chest pain, shortness of breath, abdominal pain, urinary symptoms or rash. On 26-Mar-2021, patient presented for evaluation of physical deconditioning. Patient presents to our facility yesterday after hospital stay from hospital . Patient tends to get confused and fall and has fallen twice. Patient has aches all over, dizziness when she stands up. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the m. Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor. Patient is then to follow-up with neuro surgery and 3-4 weeks. On 17-Apr-2021, patient presented to the emergency room with increased somnolence and lethargy. Patient was discharged from the hospital 2 days ago after having a stay on swing bed. She has multiple medical problems and was admitted following a hospitalization at Hospital. She has generalized debilitation and advanced COPD with CO2 retention. Patient has been instructed to utilize a BiPAP machine. According to her family, she has been none a compliant with this and did not utilize it last night. Patient noted this morning that she was somnolent and lethargic. Prior to that she had been doing well since discharge. Other than the lethargy and somnolence there are no other complaints. On 18-Apr-2021 she was diagnosed with sepsis. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) 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 event, a causal relationship cannot be excluded. However, multiple underlying co-morbidities may re; 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. However, multiple underlying co-morbidities may remain as confounding factors.

Stiff legs (not walking well), hands paralyzed below 2nd knuckle, voice raspy, cannot complete sentences, going to physical therapy, occupational therapy, and speech therapy.

After the shot ended up in the hospital with kidney failure...a week later ended back in the hospital after falling, little use of right hand, has become very weak

Diagnosed with breast cancer; Flu like symptoms; Body Ache; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (Diagnosed with breast cancer) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LOSARTAN, METFORMIN, EZETIMIBE (ZETIA), CALCITRIOL and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BREAST CANCER (Diagnosed with breast cancer) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body Ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). The patient was treated with Surgery (Double Mastectomy) for Breast cancer. At the time of the report, BREAST CANCER (Diagnosed with breast cancer), INFLUENZA LIKE ILLNESS (Flu like symptoms), MYALGIA (Body Ache), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information in response to events 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 of influenza like symptoms, myalgia, pyrexia, chills and headache, a causal relationship cannot be excluded. Although a temporal association exists, based on the current available information , the mechanism of action of mRNA-1237 vaccine, and the pathogenesis of breast cancer, the event of breast cancer is assessed as unlikely related. Since breast cancer occurred after the second dose, it should be captured in the linked case only. This case was linked to MOD-2021-227876 (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 of influenza like symptoms, myalgia, pyrexia, chills and headache, a causal relationship cannot be excluded. Although a temporal association exists, based on the current available information , the mechanism of action of mRNA-1237 vaccine, and the pathogenesis of breast cancer, the event of breast cancer is assessed as unlikely related. Since breast cancer occurred after the second dose, it should be captured in the linked case only.

Patient has serpiginous choroiditis of unclear etiology, diagnosed 2017 with about 6 total lifetime flares with unclear triggers. She had COVID-19 infection 12/2020, with no significant symptoms. She was treated with monoclonal Ab infusion (bamlanivinab) which she received 12/24/20. After the infusion she developed fatigue, headache, nausea lasting for 1 day that were self limited. Subsequently, her arthritis has significantly worsened since 1/2021 and continues to be very poorly controlled with significant arthralgia. She received her first dose of Moderna COVID-19 vaccine on 3/26/21, ~90 days after her infection. On 3/28/21, she developed blurred vision in left eye, no other symptoms. Specifically no rashes, no respiratory symptoms, no GI symptoms. She went to her Ophthalmologist on 3/30/21 who noted she has a flare of Serpiginous choroiditis in left eye. She had prior Utiq infusion 1/12/21 still active in left eye. Given flare, her methotrexate dose was increased from 4 tabs to 6 tabs and she was given 4mg intravitreal dexamethasone in left eye on 3/30/21. She was seen by Rheumatology on 4/5/21 who noted her arthralgia could be from viral infection, but did note the source of her current choroiditis flare is unclear and could not advise on whether or not she should receive the second COVID-19 vaccine. She returned to ophthalmology on 4/7/21 when she received a second dose of intravitreal dexamethasone 4mg in left eye. She again returned to Ophthalmology on 4/21/21 where she received a 3rd dose of intravitreal dexamethasone 4mg given persistent inflammation. Her vision has continued to be slightly blurred in left eye, but no worsening since receiving dexamethasone. She was due to receive the second dose of the COVID-19 vaccine on 4/27/21, and she was referred by her ophthalmologist to allergy/immunology clinic 5/3/21 to determine the safety of receiving her second dose of moderna vaccine. Our team performed a literature review that revealed that vaccines (though not specifically the COVID-19 vaccine) can be associated with serpiginous choroiditis flares, therefore we recommended she not receive her second dose of the Moderna vaccine series given risk of recurrent flare. Based on chart review completed today, she continues to struggle with this flare and continues to require intravitreal steroid injections.

Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family

I had a slight headache immediately after vaccine, I had a tennis ball sized red area where I received the vaccination. My joints started to really bother me about 2-3 weeks after vaccination. It started in my knees and went to my wrists and hips. It was extremely painful, I couldn't walk and couldn't sleep.

stiffness in her both shoulders ,hip, neck,hand; Pain in hand; stiffness in her both shoulders ,hip, neck,hand; Pain in neck; 1-2 week after 1st dose, she started with pain in both shoulders,pain in hip; Doctor diagnosed her with polymyalgia Rheumatica; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Doctor diagnosed her with polymyalgia Rheumatica) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included FAMOTIDINE (PEPCID AC), LOSARTAN, CALCIUM, ERGOCALCIFEROL (CALCIUM 600+VIT D), COLECALCIFEROL (VITAMIN D3), PANCREATIN (CREON), IPRATROPIUM BROMIDE, LOPERAMIDE HYDROCHLORIDE (IMODIUM) and CETIRIZINE HYDROCHLORIDE (ZYRTEC R) for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2021, the patient experienced POLYMYALGIA RHEUMATICA (Doctor diagnosed her with polymyalgia Rheumatica) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), PAIN IN EXTREMITY (Pain in hand), JOINT STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), NECK PAIN (Pain in neck) and ARTHRALGIA (1-2 week after 1st dose, she started with pain in both shoulders,pain in hip). The patient was treated with IBUPROFEN at a dose of UNK dosage form; PARACETAMOL (TYLENOL) at a dose of UNK dosage form; MELOXICAM at a dose of UNK dosage form; CELECOXIB (CELEBREX) at a dose of UNK dosage form and METHYLPREDNISOLONE at a dose of UNK dosage form. At the time of the report, POLYMYALGIA RHEUMATICA (Doctor diagnosed her with polymyalgia Rheumatica), MUSCULOSKELETAL STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), PAIN IN EXTREMITY (Pain in hand), JOINT STIFFNESS (stiffness in her both shoulders ,hip, neck,hand), NECK PAIN (Pain in neck) and ARTHRALGIA (1-2 week after 1st dose, she started with pain in both shoulders,pain in hip) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No laboratory was given. 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.

After April 7th shot, the arm was so for a few weeks. Received the second shot on May 5th. The pain lasted a long time - 3 or 4 weeks. Reports starting to lose her appetite and she was losing weight during the middle of June. This continued on. The weekend of July 4th, she reports knowing something was wrong. On July 8th, she reports not being able to sleep and her right arm started to bother her a great deal. On July 9th, July 10th and July 11th, the pain in the right arm was unbearable according to individual. There is also swelling in the arm. On July 12th, she went to the Walk-in center. Doctor felt lymph nodes under the right arm that were swollen. Individual had an ultrasound which showed swollen lymph nodes and fluid in that area. She was given a prescription for Keflex and Naprosyn.

interstitial cystitis; feeling very sick in the morning; After not much sleep; projectile vomiting; shaking and teeth chattering; impossible to eat w/out vomiting / She couldn't eat or; she had all over excruciating pain; UTI; extreme back pain; weak legs and unsteady/ very unsteady; arm was sore at the site; aching head to feet, body that had ever been in pain was more painful; rigor chills, teeth chattering; Nauseated; cytokine reaction; headache; sick to her stomach; dizziness/; This spontaneous case was reported by a consumer and describes the occurrence of CYTOKINE STORM (cytokine reaction) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cystitis interstitial from 1996 to 1999. On 05-Mar-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) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced CYTOKINE STORM (cytokine reaction) (seriousness criterion medically significant), ABDOMINAL DISCOMFORT (sick to her stomach), DIZZINESS (dizziness/), HEADACHE (headache) and NAUSEA (Nauseated). On an unknown date, the patient experienced CYSTITIS INTERSTITIAL (interstitial cystitis), MALAISE (feeling very sick in the morning), INSOMNIA (After not much sleep), VOMITING PROJECTILE (projectile vomiting), TREMOR (shaking and teeth chattering), FEEDING DISORDER (impossible to eat w/out vomiting / She couldn't eat or), PAIN (she had all over excruciating pain), URINARY TRACT INFECTION (UTI), BACK PAIN (extreme back pain), MUSCULAR WEAKNESS (weak legs and unsteady/ very unsteady), VACCINATION SITE PAIN (arm was sore at the site), MYALGIA (aching head to feet, body that had ever been in pain was more painful) and CHILLS (rigor chills, teeth chattering). At the time of the report, CYTOKINE STORM (cytokine reaction), CYSTITIS INTERSTITIAL (interstitial cystitis), MALAISE (feeling very sick in the morning), INSOMNIA (After not much sleep), VOMITING PROJECTILE (projectile vomiting), TREMOR (shaking and teeth chattering), FEEDING DISORDER (impossible to eat w/out vomiting / She couldn't eat or), ABDOMINAL DISCOMFORT (sick to her stomach), DIZZINESS (dizziness/), PAIN (she had all over excruciating pain), URINARY TRACT INFECTION (UTI), BACK PAIN (extreme back pain), MUSCULAR WEAKNESS (weak legs and unsteady/ very unsteady), VACCINATION SITE PAIN (arm was sore at the site), HEADACHE (headache), MYALGIA (aching head to feet, body that had ever been in pain was more painful), CHILLS (rigor chills, teeth chattering) and NAUSEA (Nauseated) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.6 degree Celsius (High) 100.6 and 99.1 degree Celsius (High) 99.1. Relevant concomitant medications were not reported. Treatment information was not provided. Patient visited her cardiologist and primary care doctors and they reported good strong immune response. Patient also visited oncologist; he reported cytokine reaction. Patient also had a medical history of interstitial cystitis for 3 years but again she developed interstitial cystitis after the 2nd dose. 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 11-Jul-2021: Additional information received on 10-JUL-2021 regarding the 2nd Dose events and lab data. On 12-Jul-2021: Follow-up information received on 12-JUL-2021 contains updated event onset date.; 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.

Fever of 101 degress, took tylenol, 3 times throughout the day. Fever broke during the night Fatigue - lasted from early morning throughout the day through the evening. Did not continue the next day Chills- Intense chills appreared around 11:00 a.m. and continued until about 1:00 p.m. After that the chills were moderate and stopped around 4:00 p.m. Headache - tylenol take for fever and headache. Headache lasted through the evening and early night. Was gone by morning. Muscle ache - extreme, sharp muscle pain in both thighs. Appeared intermittently thoughout the day. Subsided by evening, but returned briefly the next morning.

Patient presented to urgent care clinic approximately 24 hours after receiving the Moderna Covid-19 vaccine with complaints of fever and myalgia. She had mild confusion with the fever which resolved after acetaminophen. However, due to the confusion, she received an extensive work-up in clinic for other causes of altered mental status.

at approximately 4:30 am she woke up and could not move her entire body. She stated that her husband called the paramedics approximately 6:30 am ( event lasted from 4:30am -8:30 am). She stated that she was evaluated by the paramedics and decided to stay home because she began to regain feeling in her arms and hands. However, she reported that her legs and feet were weak. She was advised to report her reactions and follow instructions, if s/s returns to call the hospital or dial 911 for immediate care.

The patient reported dizziness and neck pain (pt reported similar feels of having a stroke), went to the ED on 1/16/2021

Starting the following evening around 6 pm, upon waking up from a nap, spiked a fever of 103 degrees. Experienced significant muscle weakness with gross motor coordination compromised. Could not sit up. Had to rock back and forth to try to sit up. Difficulty walking. Difficulty speaking and altered mental status. Speech not clear. Took Tylenol on advice of GP administered by husband. Temperature fell to 101, then 99 degrees by 10 pm. By 4 am Sunday morning, temperature was 99 degrees, speech had returned to normal. Sunday 8 am, sleeping normally. Sunday during the day, felt shaky and weak, still slight fever of 99 degrees but normal mental status and speech. Continued taking Tylenol periodically. By Sunday evening, felt mostly back to normal, but have continued to feel somewhat weak/shaky for the last week.

Starting around 6 pm the following day, awoke with fever of 103 degrees. Significantly compromised muscle weakness and gross motor coordination. Had difficulty sitting up and walking. Compromised speech and altered mental status. Took Tylenol at advice of GP administered by husband. By 10 pm fever down to about 99 degrees. Speech and mental status recovering. By the next day, still felt quite weak and shaky, but fever 99, speech and mental status basically recovered. A week later, still feel slightly weak and shaky

middle of the night awakened by terrible shakes, uncontrollable, feeling very cold. fever of 101.2, brain fog, severe body aches, every joint unable to eat forced myself to drink fluids; anxious and depressed, felt weak and unable to assist my husband who was having adverse effects as well(mobility issues: he fell on the floor and was unable to get up. I had to call fire department to get him back to be. Later on he could not reposition himself in bed and I had to do my best to help him. hydration, Tylenol x2 q6 hours, bed rest

left shoulder painful, overnite and into morning some. painful upon lifting up still into afternoon (3pm). pain in rib area. Some pain in right shoulder. (reverse replacement March 6,2020). Upon waking in morning of 27 achy in knees and ankles. that gone after supplements.

late Saturday, headache, buzzing in head, doctor Monday steroid shot, Thursday night buzzing in head again soreness of shoulder

pt stated when she woke up the day after receiving the vax she had a sharp pain on her right side around rib area. Pt said the pain has since subsided.

swelling from elbow to chest and upper shoulder. hurts to touch it. skin hurts all over. Sore neck. feels like she is drunk. thursday and friday had staggering. Took conafec for pain in arm. poor appetite, not wanting to cook

hours after vaccination arm soreness, stiffness in hands, two days after vaccination fatigue, breathing difficulty-feeling of tightness around rib cage, heart felt tight, headache, body aches, sinus trouble

12 days after vaccine, red, hot swollen area on arm where shot administered. Area continues to spread downward towards elbow area. Started out about size of 50 cent piece, now @ 6 inches long and@ 3 inches wide

on Feb 1,2021 my rt arm stated itching and felt a llittle heavy.. Feb2 still itching I noted redness in area of vaccine injection it measured 3 x3.5 inches.

Experiencing muscle weakness in legs and arms. Feel as if I have over-stressed those muscles, and they resist by being weak and feeling as if they sort of tremble. I usually walk one mile a day and as I was walking the day after my injection my calf in my left leg shortly after I started began to tighten up. At first I thought I would press on through but the muscle tensed more something like a "Charlie Horse." I quit walking came in an rested. I have not attempted my mile walk since then because my leg muscle is still sore from the cramp. When I raise my arms they feel heavy and seem to quiver and my legs do the same as I'm doing my stretching exercises. I have been waiting to contact anyone to see if time would take care of this problem I am having. I am seeking guidance as to whether or not I should proceed with my second injection on 18 Feb 2021. I am waiting for my doctor's office to respond regarding my call about this. I did speak with a nurse at the local HD who said I should file this side effect event report with you. I have never had a reaction to any of my flu shots and I have had one each year for a number of years. One thing I do want to mention is that my mother took the flu shot the first year it was offered and she was one who experienced muscle loss due to it and never completely recovered muscle strength.

RIGHT ARM PAIN FROM SHOULDER TO WRIST, NOW TO ELBOW SOME NECK PAIN. LUMP/THICKNESS AT THE SITE OF INJECTION

20 mins after vaccine became nauseated, light headed and chest pain, tightness in central to epigastric area. VS found she was Orthostatic - BP dropped to 99/55 while standing. Diabetic. Chest pain persisted. Sent to ED

After second Moderna dose: First night: insomnia, agitation during the night, flashes in brain like electrical discharges between ears and sharp pain in joints.. In morning chills, sharp pain in joints that made walking difficult, fever of 100.1. Felt miserable all day. Second night: slept well and felt much better in morning and almost myself again. Still some muscle pain in injection arm. No adverse effect after first dose on January 10.

I developed headache, chills , 99.3 temperature, very tired with pain all over my joints particularly my back , shoulders, right arm at the site of the inyection and these symptoms lasted for 24 hrs . I feel fine and normal after one day of feeling these symptoms.

Extreme Fatigue, headache, stomach ache, swollen tongue, ankle swollen, constipation, limited cognition, unsteady gate, loss of appetite. Weird feeling in head to the point of losing focus and almost passing out. Severe symptoms lasted for five days until 2/6/21. Currently limited fatigue, slight cough.

area of injection on upper left arm (ovoid rash about 6 inches by 3 inches) red and sore and warm (began a few hours after injection and continues now) Headache, body aches, chills and discomfort began a few hours after injection and lasted about one and a half days (totally gone now)

General aches and pains began 36 hours after injection and lasted approximately 24 hours. It felt as though every arthritic joint was inflamed. I used heating pad to relieve pain and felt normal the next day.

shooting pain's in back at waist like someone is putting knife in back. Was sore in back next 2 days. Not sure how long it lasted was there for over 45 min.

Severe pain ln neck, back, up the back of the head and behind the ears. Some rash around the waist. Chills for several hours one night. Pain lasted about 9 days. Yesterday and today, 15 and 16 February, no energy.

Day 1: sore arm. Day 2: severe bladder pain with chemical smell to urine ( 6 hours), mild headache resolved with APAP, fatigue, mild stiffness. Day 3: bladder pain gone but mild chemical smell to urine, increasing stiffness and joint pain, mild muscle pain. Day 4: chemical smell in urine slight but still present, severe joint pain and swelling requiring narcotics, mild muscle pain, moderate stiffness, moderate fatigue. Day 5: chemical smell gone, severe joint pain and swelling requiring narcotics, drenching sweats, significant stiffness, fatigue with 12-14 hours sleep, inability to manage ADL w/o help; Days6-8 same as Day 5; Day 9-10 mod fatigue, less jt pain, no narcotics, able to do ADL's w/o help;

pt stated that her left leg around the groin area in the muscles started to hurt. She had severe pain in the left lower back. She also had muscle spasms in the top part of her back then got nausea and vomited. No fever. Pt will call her PCP for medical advice.

Suddenly this morning, 13 days after receiving the first Covid Moderna vaccine - my arm is red and feverish at injection site. In the meantime starting Sunday, Feb. 14th, I had pain in right chest and right upper back, that I contributed to making a wrong move and straining muscles. The back pain is better, but I still have it when I reach high , move wrong, or take a deep breath.

BOTH SHOULDERS HURT. HEAD AND BODY FELT HEAVY COULD NOT GET UP. LEFT ARM SWOLLEN, RED AND PAINFUL FOR 5 DAYS

the first 3 days sore muscle near shoulder when lifting it up, warm at injection site , swollen at injection site. third day back hurts and a little fatigued.

Sore Arm Temperature of 99.8 degrees all day Fatigue all day Difficulty in walking more than 15 mins without sitting down Legs felt very tired all day Lack of energy by 5:00 PM

Cannot walk, cannot speak, slow response time physically, cannot hold items with hands, leaning to far right. Slow response to audible commands

Pain all over the body back pain more severe and hard to breath in the beginning for 17 days now after the second doze Hard to straighten up to walk

Severe grade 3 Headache, high fever, chills, grade 3lymphadenopathy, pain and swelling, high fever (grade 3) persisting several days, fatigue, lethargy, myalgia, arthralgia, grade 3 chills.

Beginning about 4 hours after receiving shot, muscle aches in arm, from elbow radiating up the arm, over the shoulder thru collarbone & up the side of the neck to the ear. By 6 hours after the shot, pain was excruciating and I was in literal Agony for the next 8 hours. It felt like a hot poker was being pushed along that pathway. Tylenol & ibuprofen had no effect. I could not sleep & could barely move the arm at all. (I am Not a pain Wimp) I would say this was the longest lasting without relief/strongest pain I have ever experienced and I have had one child;+ hip & shoulder surgery which required almost no after surgery medication at all. By 5 a.m. I was able to sleep a bit & most of the extreme pain was gone by 8 a.m. I had some headache the following day and was barely able to function (I live alone) just from all over tiredness. About 36 hours after injection, I was back to normal.

extreme pain in joints particularly left arm, elbow, hand, shoulder . Pain throughout rest of body, so debilitating that I could hardly walk. Need to use walker ever since

Started with chills, Dizziness. weakness, mild headache, injection site soreness & stiffness, nausea, vomiting, dry heaves,, fever 101.3. and fatigue. Was transported to Emergency Department via ambulance. At ER given saline IV, ran chest xrays, blood test and observation. Transported around 11:00-11:30, discharged 4:45 pm.

Post-second Moderna vaccine: initial heaviness of arm, for first 12 hours, a little soreness, some muscle fatigue - felt like I couldn't stand up straight = too much effort. Went to bed, with 2 @400 mg. Tylenol boosted during the night with Tramadol 50 mg. Was able to drive & swim in the morning (21 hours) post. 24 hours post: extreme fatigue (kept falling asleep), then felt like I'd been run over by a rototiller. Aches in joints, body, and skin. 2 @ 400 mg Tylenol alleviated symptoms enough to sleep for 2 hours. Arose at 3:30 pm feeling better. Not great, but better ! Better enough to feed animals and prepare dinner for myself.

For about 12 hours I was spiking fevers of 101 degrees. I had shaking chills and couldn't get warm even though my body felt like I was burning up. The arthritic joints in my hands became so inflamed that I could hardly use them and over all I felt like I had a terrible case of the flu.

Heavy legs, numbness in arms, reported swelling of face, tingling of tongue. Hypertensive. Hx of anxiety, HTN on Zanax. Only took 1/2 dose this morning. Patient taken to emergency room.

2 weeks after Moderna vaccine for COVID. Low fever 99.7, Chills, headache, Joint/muscle body Aches, Fatigue, no appetite, and abdominal pain. Duration was 24 hours. Took Tylenol.

Fever for 36 hours, head, muscle, joint pain, weakness (unable to walk without support for 30 hours, fatigue lasting three days. Temp=100?

I woke up the next morning with pain on the balls of my feet and the pads of my hands. I thought nothing of it and got my 2nd shot,on 2/5/2021,but the pain increased every day and I finally called my rheumatologist, who ordered CRP and sed rate. The lab tests were elevated and he told me to increase the prednisone to 10 mg, which did very little. The pain now was also in my shoulders and neck. I eventually went to 20 mg of prednisone, but that still does not relieve all the pain. I use excedrin during the night to help tide me over. I will be seeing my rheumatologist in April for follow up, but the pain is worse than it was when it started.

I had all symptoms ofcovid except arm pain and diarreha fever. I had Extreme fatigue, nausea, headache, balance was off, muscle and nerve and back pain. Just took covid test and just got results--Negative. (3-19-21) The symptoms subsided March 12. Still vaguely experiencing all of them. Should I take the 2nd shot. Feel those results would return at an even heightend level. Pharmacist said I was probably 85 % covered now with these effects from the 1st shot and should not take the 2nd. My Dr. said the 2nd shot was my call to make and that I should report it to CDC.

- Started with weakness and ?feeling bad? 03/16/2021 at 4pm. Stated she developed nausea but no vomiting and severe, jerking chills overnight. C/o leg weakness that caused her to need assistance of cane to ambulate that night and next day. 3/19 patient saw her PCP and the PCP suggested she report her symptoms to the HCHD. Patient stated the weakness to her legs is slightly better, but not 100% resolved.

Chills, extreme soreness on left arm where I got the 2nd vaccine. Hurt from my wrist, all the way up to my left shoulder across shoulder and up side of left neck, headaches, body aches, no appetite. Extreme fatique. was up all night

Patient started experiencing shallow breathing and had a hard time breathing two days after vaccination. She said her ankles were swollen and hurting and she could not sleep for three days after these symptoms started. She did not seek medical attention and the symptoms resolved on their own without treatment.

Moderna COVID-19 Vaccine EUA Mod. severe muscle pain, esp across back/shoulders, incr, weakness, headache, pain at injection site, fatigue, nausea and dizziness. Retired early and got up during night with GI distress. Before getting back to bed passed out hitting my head and lower back on a metal door frame. I did not recall this but found myself back in bed partially dressed. Husband found a hallway Persian rug (heavy) displaced in AM. Slept until 3PM following day and awoke with lg. bump on head and pain in sacral area. Self treated with ice to painful areas plus Tylenol 500 mg. After 6 days with no relief saw orthopedist who took x-rays and diagnosed bruise to sacrum and post-concussive syndrome. Offered visit to neurologist which was declined as cognitive ability seemed intact, Treated with ice to sacrum 20 min. x 5 daily, Tylenol 1000 mg. and Aleve 1 q 12h x 5 days. Sx continued for 8 days requiring Tylenol, Aleve, iceand/or heat. Feeling less pain by Day 20 post vaccine.

After 2nd shot, sore arm and achy joints for about 2-3 days. Then, about 5 weeks, developed headaches, ear aches and achiness in neck and lower skull. Then about 6 weeks later (3/29/21) got dizzy and felt no energy, still had headaches, slight ear aches and achiness in neck and lower skull. Lasted about 3 days but seems to be better (took Meclazine starting on 3/30. This all concerned me until I saw my chiropractor today (3/31) and he told me 2 of his patients had dizziness too. They took Benedryl and that helped immensely. They told him that they looked it up and dizziness can be a an adverse reaction to the Covid vaccs. I looked it up on FB and saw that dizziness can be a reaction although the timeline for it to happen varied greatly - from immediately after to 3 weeks after. In my case it's about 6 weeks after. Felt ok in between the vacc #2 and first reaction of sore arm. 5 weeks after til next reaction of achy neck, skull and earaches. 6 weeks after Vacc # 2 til dizziness.

Head ache, fever, chills, tired, muscle ache lasted 5 days, less severe on day 4 and 5. Treated with rest and lots of water.

Low temperature; Fatigue; Headache; Joint pain; nausea; Body aches; R arm of injection rash of 6-7 inches from high arm down to elbow; R arm of injection soreness; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Low temperature) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Chronic bronchitis since 2020 and Allergy. Concomitant products included MONTELUKAST, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), VITAMIN C [ASCORBIC ACID], OMEPRAZOLE, MULTIVITAMIN [VITAMINS NOS], ATORVASTATIN, ATORVASTATIN CALCIUM (LIPITOR), FISH OIL (OMEGA 3 [FISH OIL]), CALCIUM, COLECALCIFEROL (CALCIUM+VITAMIN D), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and POTASSIUM for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOTHERMIA (Low temperature) (seriousness criterion medically significant), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (nausea), MYALGIA (Body aches), VACCINATION SITE RASH (R arm of injection rash of 6-7 inches from high arm down to elbow) and VACCINATION SITE PAIN (R arm of injection soreness). At the time of the report, HYPOTHERMIA (Low temperature), FATIGUE (Fatigue), HEADACHE (Headache), ARTHRALGIA (Joint pain), NAUSEA (nausea), MYALGIA (Body aches), VACCINATION SITE RASH (R arm of injection rash of 6-7 inches from high arm down to elbow) and VACCINATION SITE PAIN (R arm of injection soreness) outcome was unknown. Concomitant medication includes joint pain medicine and eye medicine. The patient has allergies. The patient robbed cream on knees and muscle left heart to relief. 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.

No memory; Passed out; Hallucination; lost feeling in her legs; incontinent of urine and feces; Had a terrible fall; Never able to walk, she crawled; Bruises all over body; urinary tract infection; Severely dehydrated; Legs felt weak; emotionally distraught; A Spontaneous report received from a physician concerning a 80-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced weakness in legs/muscular weakness , legs felt weak / hypoaesthasia , fall , never able to walk so she scrawled /gait inability , hallucination ,passed out / loss of consciousness , bruising / contusion ,urinary tract infection , dehydration , emotionally distraught/emotional distress, memory loss /amnesia. The patient's medical history was not provided. concomitant product used not provided by reporter. On 14-feb-2021, the patient received their first of two planned doses of mRNA-1273 (batch no: 031L21A) via unknown route for prophylaxis of COVID-19 infection. On 01-mar-2021, the patient experienced muscular weakness (legs felt weak). On 03-mar-2021, the patient experienced fall (had a terrible fall), gait inability (never able to walk, she crawled) and contusion (bruises all over body). On 05-mar-2021, the patient experienced loss of consciousness (passed out) (seriousness criteria hospitalization and medically significant) and hallucination (hallucination) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced urinary tract infection (urinary tract infection), dehydration (severely dehydrated), amnesia (no memory) and hypoaesthesia (lost feeling in her legs). The patient was hospitalized on 05-Mar-2021 due to hallucination and loss of consciousness. No treatment information was provided. The outcome for the events, loss of consciousness (passed out), hallucination (hallucination), fall (had a terrible fall), gait inability (never able to walk, she crawled), contusion (bruises all over body), urinary tract infection (urinary tract infection), dehydration (severely dehydrated), emotionally distraught/emotional distress, amnesia (no memory) and hypoaesthesia (lost feeling in her legs) was not reported. The action taken with mRNA-1273 in response to the event was not reported.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities

Soreness started at injection site about 2 PM and migraded down my arm into fingers sending sharp pains. By 6 PM my shoulder was very sore and couldn't lift my arm. I woke and 12:14 and my left side was sore and stiff, including ribs and collar bone. My left breast felt like it was in a vice. I woke at 6:18 and my ribs were better but the pain in the shoulder and arm is still very painful. I am very tired.

She got the vaccine on the left arm, it was okay, and acted like the 1st vaccine, and about 7-8 days later she noticed a lump on her neck near her collar bone. It feels like a round ball, not real big around the size of a dine, it is still there on 4/16/21, but not as big as it was. She did not have any other symptoms. On Monday she had a knot on her right leg which is still present. She does notice that her left wrist swells up which has been present since the knot appeared on her neck. She did call her doctor and she went to see him and he ordered X-rays and was sent to a throat doctor who said he did not see anything wrong, but no other treatment. She has not run any fever, and has not taken anything for the symptoms.

every afternoon she gets chills; blood pressure extremely low; pelvic fracture; Fell in her bedroom; legs felt very weak, like they were giving out; she was in lot of pain; sick with fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PELVIC FRACTURE (pelvic fracture) and FALL (Fell in her bedroom) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) 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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced PYREXIA (sick with fever). On 27-Feb-2021, the patient experienced FALL (Fell in her bedroom) (seriousness criterion medically significant), MUSCULAR WEAKNESS (legs felt very weak, like they were giving out) and PAIN (she was in lot of pain). On 10-Mar-2021, the patient experienced PELVIC FRACTURE (pelvic fracture) (seriousness criterion medically significant). On 09-Apr-2021, the patient experienced HYPOTENSION (blood pressure extremely low). On an unknown date, the patient experienced CHILLS (every afternoon she gets chills). At the time of the report, PELVIC FRACTURE (pelvic fracture), FALL (Fell in her bedroom), MUSCULAR WEAKNESS (legs felt very weak, like they were giving out), HYPOTENSION (blood pressure extremely low), PAIN (she was in lot of pain), PYREXIA (sick with fever) and CHILLS (every afternoon she gets chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, X-ray: normal (normal) normal. On 10-Mar-2021, X-ray: abnormal (abnormal) pelvic fracture. On 09-Apr-2021, Blood pressure measurement: extremely low (Low) Extremely low. No relevant concomitant medications were reported. On 28-FEB-2021, patient went to emergency room and x-rays were normal. On 10-MAR-2021, she went to her orthopedist, and repeat x-rays showed pelvic fracture. Action taken with mRNA-1273 in response to events was not applicable. No treatment information was provided. This case concerns an 80-year-old female with serious unexpected events of pelvic fracture and fall, and nonserious unexpected hypotension, muscle weakness, pain, and expected pyrexia, chills. 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 80-year-old female with serious unexpected events of pelvic fracture and fall, and nonserious unexpected hypotension, muscle weakness, pain, and expected pyrexia, chills. 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.

States she had the shot in the morning, states in the evening she had a stiff neck that radiated down into her R side (the side she got her shot on). States she went to bed and woke up at about 3 a.m. and she was so sick vomiting/dry heaves (2-3) and having diarrhea (approx 3). She also had chills. States she could hardly use her R hand. States her wrist is just now getting better. She notes she was able to walk but she was very careful. She did not try to speak. She does not have residual symptoms other than some residual stiffness. She had to use her rescue inhaler the morning prior to the vaccine, and again in the evening after the vaccine.

Loss of control of bladder; Patient got her second dose after 35 days of first dose; fever; Convulsions; terrible contractions of muscles; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SEIZURE (Convulsions) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 010A21A) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Apr-2021, the patient experienced SEIZURE (Convulsions) (seriousness criterion medically significant), MUSCLE CONTRACTIONS INVOLUNTARY (terrible contractions of muscles), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her second dose after 35 days of first dose) and PYREXIA (fever). On 09-Apr-2021, the patient experienced URINARY INCONTINENCE (Loss of control of bladder). On 08-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient got her second dose after 35 days of first dose) had resolved. At the time of the report, SEIZURE (Convulsions), MUSCLE CONTRACTIONS INVOLUNTARY (terrible contractions of muscles), URINARY INCONTINENCE (Loss of control of bladder) and PYREXIA (fever) had resolved. No relevant concomitant medications were provided. No treatment information was provided.; 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.

Tightness in neck muscles. Then lips swelled. Then inside of nostrils swelled. All fairly slightly. Was all over by 3:15pm same day

Day 1-3 Left upper shoulder pain from injection. Day 4-8 Headache, tiredness, fatique, nausea, vomit (1), knees joint pain. Day 4 to present - some tiredness, continued severe knee joint pain (left and right)

3-4 hr onset fatigue. for 3 days confined to bed from fatigue. Has slowly remitted. - Now - 8 weeks after second shot still daily fatigue, pedal edema with activity. Nap required daily. Occasional episodes of sleep disruption. 2-4 days severe arthritis flare with rheumatoid joints swelling as well as mild swelling in OA joints: fingers, wrists, elbows, neck, back, hips, knees and ankles. deformity of dips, not previously present. Now, 8 weeks later, swelling resolved but arthritis still worse than prior to 2nd immunization. Severe bruising in R upper arm. 8 weeks later still have brown discoloration over6 inch area - INR increased to 5.4 3-4 hour mild headache lasted 2 days reoccurred 2 or 3 times over the week

Both knees became swollen and painful and she could not walk for 2 days. Also had some groin pain which she has had in the past but this was a lot more intense pain.

March 2 - second Moderna March 3 - spontaneous bruising appears March 4 - visit with primary care doctor, blood work shows significant drop in platelets March 9 - first visit with oncologist/haematologist & hospitalized March 9-19 - hospitalized for tests, treatment to increase platelets, & many blood panels. No official diagnosis, treat as ITP. Follow up visits with oncologist/haematologist to keep an eye on platelets as they increase. March 30-Apr 4 - ER visit due to swelling of ankles, feet, and left arm. Tests show superficial blood clot, fluid on lungs, and pneumonia. Oncologist said that "we have no official diagnosis", that she's being treated for ITP. April 6-14 - follow up visit to oncologist/haematologist show elevated kidney enzymes, then later liver enzymes, low sodium. April 14 - decision to move to short term rehab for regular PT and OT. Continued swelling (fluid in third spaces.) April 21 - visit to cardiologist to perform cardioversion, successful (during first week of hospital stay, heart rhythm med had to stop). April 23 - facility nurse discovered significantly low Hemoglobin and a blood transfusion was ordered. April 24 - returned to short term rehab facility. April 25 - discovered my mother on O2 and state of health was different, extremely weak and not moving, arm hurting badly. I insisted that her oncologist is contacted. Transported to ER. Discovered her blood work abnormal. After stabilizing her, rushed to the hospital ICU. April 26 - Discussed with her ICU doctor the history of what you have read above. He explained that the covid-19 vaccination has a tendency to affect three proteins specifically that clot and thin blood. I begged him to "get it out of her system." Her bleeding was significant and platelets dropped, again. Still has her mental facilities. Responding well to aggressive treatment: albumin transfusion, plateletpheresis, and CRRT. Pleural catheter to remove fluid from the lungs. Mention of Sepsis. April 27 - Lifted her head up today, opened her eyes, making doctors very happy. Her cardiologist and the ICU doctor both said they were "confused" and everything happening to my mom was "a mystery." Though going in to the evening, her nurse expressed to me that she's worried. The ICU oncologist called me at home in the evening. He asked me if she had been having a fever on a regular basis. He said he thought it could be TTP or a rare disease called HTH, but both results wouldn't be back for one week. He planned to consult with a doctor. He explained to me that the blood was attacking itself and "confused," and that her organs were shutting down. He indicated that the blood work wasn't indicating significant infection. He referenced how the vaccination has made her auto immune system "go crazy." April 28 - I get a call very early from the nurse that she has been fighting with my mother's blood pressure all night, trying to keep it elevated. She told me to come to the hospital, because she had taken a turn for the worse. I arrive to find my mother's eyes wide open, breathing shallow, and blood pressure steady, but drops without assistance from medication. She continues to have her mental facilities. She passed away, organs shutting down, and blood pressure dropped.

Had a Bad Headache for 2 Days took Tylenol. Muscle Aches had to take tramadol. Weak Legs blood pressure was high

I had the vaccine on 01/16/2021 and then at the end of the month my husband got Covid and we both had the vaccine already. Of course he gave it to me, so the 02/01/2021 he tested positive and then he had the antibody infusions and a couple of days later I tested positive and I had the infusions on 02/05/2021. About 2 weeks later I got very sick, back ache and chest pains so I went to the ER so I ended up with blood cots in my lungs. They did scans and tons of blood tests, heart scan, lung scans. I have been on blood thinners since them. After Covid and everything I had me second dose this past Friday. So far I am doing okay, I am feeling a little bit dizzy.

Dose 1 caused arthritic and neuropathy pain in hands. Dose 2 increased the symptoms in 2 days. Was told by the administrator at the pharmacy that it could bring back rheumatoid arthritis. PCP office confirmed patients are reporting neuropathy.

As far as I know, I was sitting after dinner reading and I was aware that I could not see well out of my right out, it was very blurry and at the very same time though I had a very sharp pain in the left occipital region. So I was most worried about my eye because I know something was wrong. First thing in the morning I called my eye DR and she told me that I had a right side occlusion in my right eye. So then what she had me do was wait a couple weeks to see if it would go away spontaneously and it didn't. So I went to a retinal specialist and they gave me shots in that eye because I could still not see out of my eye. It has not completely cleared but it is much better. I also had a severe pain in my neck and brain. I went to the ER and the DR that evaluated me there didn't know what my diagnosis was at the time but he put me on some medications that he thought would help with the inflammation. So he put me on cortisone and gave me a prescription for valacyclovir, because I have a history of herpes infections all over my body. SO that was on the Sunday that I went to the ER. Then by Wednesday the pain was so severe that I went to the ER at the hospital because I was so uncomfortable and worried. At the end of five weeks it just went away. I did see a neurologist but it was over by then, he said the diagnosis was occipital issues.

Two days after second injection we noticed swelling in ankles, which has not happened before. We cut back her fluid intake but the swelling persisted for two weeks. She was brought to see doctor (NP) on 17th of March which lead to no resolution. She was brought to ER on the 18th and admitted. After inpatient treatment she was released two days later and has had no subsequent issues.

The patient reported that after receiving the second Moderna Covid-19 vaccination that she had a headache for 3 days. Additionally, she has been experiencing a stiff neck, has been passing out, her toes have been turning blood red, and she feels like she has not been able to function during the past 3 months. She reported that she went to the hospital to have multiple tests ran, and no unusual lab values were noted. The patient went to the hospital due to the adverse effects she experienced from the vaccine. Upon speaking to the patient it was not noted how long the patient remained in the hospital.

chest tightness; loss of appetite; irregular heart rate/palpitations; irregular heart rate/palpitations; extreme PMS; Diarrhea; Fatigue; sleeping on and off all day; shakes; trouble moving and walking; terrible cramping like menstruation; bloated; had a painful stomach; pain moved to the chest area; body aches; chest pain; body pain; lung congestion; so much muscle pain - Muscle pain throughout the body was intense; sick; Muscle pain; fever; Nausea; Headache; chills; Fatigue/ extreme fatigue; shortness of breath; Weakness in her body, muscle and legs; Intense pain; Sore throat; Shaking; Diarrhea; Dizziness; severe stomach cramps - PMS type; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (lung congestion) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) 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, Bronchitis, Hives since an unknown date, Hypersensitivity reaction since an unknown date, Irritable bowel syndrome in 2000 and Reflux esophagitis. Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Irritable bowel syndrome, Penicillin allergy (penicillin allergy), Drug allergy (arestin), Allergy to antibiotic (allergy to macrolides) and Allergy to antibiotic (ketolides used for red rashes). Concomitant products included ERYTHROMYCIN, DENOSUMAB (PROLIA), ARTHROBENE PLUS, VITAMIN D3 and DOXYCYCLINE HYCLATE for an unknown indication. On 07-Mar-2021 at 12:25 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced DYSPNOEA (shortness of breath), ASTHENIA (Weakness in her body, muscle and legs), PAIN (Intense pain), OROPHARYNGEAL PAIN (Sore throat), TREMOR (Shaking), the first episode of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), ABDOMINAL PAIN UPPER (severe stomach cramps - PMS type), CHILLS (chills), FATIGUE (Fatigue/ extreme fatigue), MYALGIA (Muscle pain), PYREXIA (fever), NAUSEA (Nausea) and HEADACHE (Headache). On 28-Mar-2021, the patient experienced ILLNESS (sick) and MYALGIA (so much muscle pain - Muscle pain throughout the body was intense). On 12-May-2021, the patient experienced PULMONARY CONGESTION (lung congestion) (seriousness criterion medically significant). On 24-May-2021, the patient experienced CHEST PAIN (chest pain) and PAIN (body pain). On 08-Jun-2021, the patient experienced MUSCLE SPASMS (terrible cramping like menstruation), ABDOMINAL DISTENSION (bloated), ABDOMINAL PAIN UPPER (had a painful stomach), CHEST PAIN (pain moved to the chest area), TREMOR (shakes), HYPOKINESIA (trouble moving and walking) and MYALGIA (body aches). On 09-Jun-2021, the patient experienced HYPERSOMNIA (sleeping on and off all day), the second episode of DIARRHOEA (Diarrhea) and FATIGUE (Fatigue). On an unknown date, the patient experienced CHEST DISCOMFORT (chest tightness), PREMENSTRUAL PAIN (extreme PMS), DECREASED APPETITE (loss of appetite), PALPITATIONS (irregular heart rate/palpitations) and HEART RATE IRREGULAR (irregular heart rate/palpitations). The patient was treated with PARACETAMOL (TYLENOL) on 28-Mar-2021 at an unspecified dose and frequency; PARACETAMOL (TYLENOL) on 08-Jun-2021 at a dose of 500 mg; ARNICA MONTANA (ARNICA 30C) at a dose of 2 Tablets; MAGNESIUM at a dose of 500 mg four times per day; LOPERAMIDE HYDROCHLORIDE (IMODIUM) ongoing from 09-Jun-2021 for Diarrhea, at a dose of 2 mg as required and CHLORPHENAMINE MALEATE, PHENYLPROPANOLAMINE HYDROCHLORIDE (ALLERGY RELIEF MEDICINE) ongoing since an unknown date at a dose of 180 mg once a day. On 18-Mar-2021, DYSPNOEA (shortness of breath), ASTHENIA (Weakness in her body, muscle and legs), PAIN (Intense pain), OROPHARYNGEAL PAIN (Sore throat), TREMOR (Shaking), DIZZINESS (Dizziness), CHILLS (chills), FATIGUE (Fatigue/ extreme fatigue), MYALGIA (Muscle pain), PYREXIA (fever), NAUSEA (Nausea) and HEADACHE (Headache) had resolved, ABDOMINAL PAIN UPPER (severe stomach cramps - PMS type) had not resolved. At the time of the report, PULMONARY CONGESTION (lung congestion), ILLNESS (sick), ABDOMINAL DISTENSION (bloated), CHEST PAIN (pain moved to the chest area), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest tightness), TREMOR (shakes), HYPOKINESIA (trouble moving and walking), HYPERSOMNIA (sleeping on and off all day), PAIN (body pain), PREMENSTRUAL PAIN (extreme PMS), DECREASED APPETITE (loss of appetite), PALPITATIONS (irregular heart rate/palpitations), HEART RATE IRREGULAR (irregular heart rate/palpitations), FATIGUE (Fatigue), MYALGIA (body aches) and MYALGIA (so much muscle pain - Muscle pain throughout the body was intense) outcome was unknown and MUSCLE SPASMS (terrible cramping like menstruation), ABDOMINAL PAIN UPPER (had a painful stomach) and the last episode of DIARRHOEA (Diarrhea) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, Blood pressure measurement: 193/75 mmhg (High) 193/75 mmHg. On 17-Mar-2021, Body temperature: 98.8 degree celsius (Inconclusive) 98.8 degree Celsius. On 17-Mar-2021, Heart rate: 60 breaths per minute (Low) 60 breaths per minute. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient took 2 papaya chewable tabs for stomach. The patient is taking allergy 10 -plus, refresh lubricant eye drops, refresh optive advanced eyedrops every 2-3 hours as needed for both eyes, trace mineral drops -8 drops(3-4 water bottles per day). Company Comment: Very limited information regarding this events has been provided at this time. Noting the history of reflux esophagitis, IBS and treatment with Prolia may remain as risk factors. However, notes from HCP evaluation, details regarding tests/diagnostics, diagnosis and treatment are required for further assessment. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 30-Mar-2021: Concomitant medication Prolia, Treatment medication Arnica tablets were added. New events severe stomach cramps - PMS type, extreme fatigue, too sick, so much muscle pain - Muscle pain throughout the body was intense were added. On 10-May-2021: Reporter's FAX number was added. On 10-Jun-2021: Treatment medication Imodium and Magnesium were added. New events were added. On 23-Jun-2021: Outcome, FAX number updated On 01-Jul-2021: event added, lab data, medical history, con-med added; Sender's Comments: Very limited information regarding this events has been provided at this time. Noting the history of reflux esophagitis, IBS and treatment with Prolia may remain as risk factors. However, notes from HCP evaluation, details regarding tests/diagnostics, diagnosis and treatment are required for further assessment. Further information has been requested.

Extreme muscular pain starting in both arms and moving to both legs after 7 weeks. After being very active before vaccine, now pain is so bad I can barely walk.

Heart damage; Irreversible lung damage; She gets out of breath from walking across the floor/could not breathe; When she wakes up in the morning she has to force herself to function; She is always in pain; Pain in arm; Hard to lift arm off pillow; Weakness; Blurred vision; Pain behind eyes; Irregular heartbeat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEART INJURY (Heart damage) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy NOS (The patient stated she has a lot of allergies). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced HEART INJURY (Heart damage) (seriousness criterion medically significant), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache). At the time of the report, HEART INJURY (Heart damage), LUNG DISORDER (Irreversible lung damage), DYSPNOEA (She gets out of breath from walking across the floor/could not breathe), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (When she wakes up in the morning she has to force herself to function), PAIN (She is always in pain), PAIN IN EXTREMITY (Pain in arm), LIMB DISCOMFORT (Hard to lift arm off pillow), ASTHENIA (Weakness), VISION BLURRED (Blurred vision), EYE PAIN (Pain behind eyes), HEART RATE IRREGULAR (Irregular heartbeat) and HEADACHE (Headache) outcome was unknown. No concomitant medication information was mentioned by reporter No treatment medication information was mentioned by reporter 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, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested. This case was linked to MOD-2021-035954 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications. Information regading the events is vague. Further information has been requested.

2-3 days following second vaccination I woke in night with hands swollen and painful trying to use them even to pull up sheets in bed. Pain not changed by Tylenol. Ordered Paraffin and used baths on hands with only temporary relief. Symptoms seemed to constantly change over following days and weeks. Individual joints in hands would be inflamed and tender to touch. This varied from day to day as to which joint was inflamed. Shooting pains in lower arms and hands in April and May,. Sometimes extended to all joints. Pain when interlacing fingers. Pains shooting through fingers when just sitting. Sensations of pin pricks or bugs crawling on my skin when nothing touching me.

Found on floor by CNA at 6 am. On assessment by charge nurse, VS: 99.6-94-16 212/105 manual. Noted increased confusion. Temp. 99.6 FBS 114. Resident had been provided tylenol just prior in shift for general discomfort (sore muscles) and low grade temp. On call for Dr notified of all and received order to send to ER.

Swollen to 1 and a half times normal, not red; "like a big pad on top", severe pain in left arm. Nausea but it passed; feels weak and slept 6 extra hours today. Joint pain in shoulders and legs. No fever.

Patient came in today for initial dose of COVID-19 Vaccination. Patient has denied exposure to COVID-19 and denies any sign and symptoms of COVID-19 (loss of smell, taste, cough, fever, fatigue and body aches) in last 14 days. After administration of injection patient reported" tightness in the neck area, compromised breathing, numbness and tingling on the face, and high Blood Pressure of 180/100, and Pulse of 110 bpms. Patient reported allergic reaction has occurred within first 10 minutes of the post vaccination during the observation period. She denies any known allergies to food, drugs, and prior vaccination. Attending Physician and Vaccination Coordinator called the Paramedics (911) immediately. Paramedics has arrived within first 5 minutes at the vaccination site. As per Paramedics the Patient Blood pressure was high (180/110), Oxygen Saturation was dropping fast from 99% to 92%. Paramedics notified Patient that they will be administrating BENADRYL (IV) in route to the hospital. The Follow up call has been made to the Patient Husband name and as per Husband she is doing well and has been discharged from the Hospital. Patient Husband has been advised to make follow up appointment with their personal PCP and discuss precaution to take second shot.

Fever of101.0 for approximately 24 hours with muscle and joint discomfort no temperature on 1/24/2021 feeling better today

Had Covid in December, the day after receiving the vaccine around 11AM I developed chills and my shoulder/arm was sore and achy this morning made it up to my neck I started experiencing chills.

The patient developed left wrist swelling, pain, warmth one week after getting the Moderna COVID vaccine. It is in the same arm in which she got the vaccine. She tried tylenol but it didn't help. I applied Voltaren gel to the wrist and that helped the pain. I advised if it worsens for her to return. She will monitor the wrist for signs of infection however at this time we will treat for arthritis flare.

pt started feeling weak, deep dry cough 6 hours after vaccination, pt took robitussin dm to help, fever low grade, increased fluid intake, muscle/joint aches , cough worsened, pt tried Mucinex to try and break up mucus if there was any, sweats, next day mucus was beginning to loosen, fever low grade, pt also had to take Aleve twice daily to help with symptoms, body aches, flu like symptoms

Woke up Friday with terrific headache, darts shooting through head, sore neck, sore back, sore arm, pretty much sore all over, had temp of 101 in afternoon, felt weak and very, very bad, did not visit dr. felt really bad for 1 day and 1 night, am a bit afraid to take second dose, was much better on Saturday

Painful neck and shoulders, right arm, followed by chills. Also lightheadedness and slight dizziness. Temp 90.1 degrees (at highest). Total lack of energy and appetite. Next day, lethargy and some diarrhea (not bad). side effects lasted from Feb. 7 evening to Feb. 8 evening. On Feb. 9, just some lightheadedness.

pt stated that she has had difficulty breathing at night, congestion, thickness in her throat, chills, nausea, constant dizziness, has a rash around her neck, has fatigue and weakness. Pt also has had pain in her right knee the night of the vax. Pt just feels bad, raised blood pressure, has numbness in both hands and is very uncomfortable. Pt called her PCP and was told to her to take an extra HBP pill. Since pt is still having most of these symptoms she will call her PCP back for more medical advice.

Jaw bone popping and sometimes out of place, lower back pain . Reporting for your side effect information only. No need for medical attention ar this time

1-TRANSIENT ISCHEMIC ATTACK: PARESTHESIAS OF FACE, MORE MARKED AROUND CHEEKS AND MOUTH, FELT EYES DEVIATING TO RIGHT SIDE, BLURRED VISION, DIZZINESS, FEELING OF MAJOR DISTRESS 2-, MUSCLE SORENESS STARTED TO INCREASE AFTER ONE WEEK AND HAS CONTINUED TO INCREASE OVER TIME, BECOMING WORSE AT 4 WEEKS, AND LIMITING EXERCISE: CANNOT RAISE ARM, OR DO ANY MOVEMENT THAT REQUIRES MUSCLE FLEXION OR EXTENSION.

On Sunday, Feb. 14, I awoke to find my left arm paralyzed. I was unable to move my fingers or thumb. Could not hold anything. Towards the end of the day, I got feeling back in my thumb, first and middle fingers. the outside of my hand, the ring finger and little finger were still numb and I had no control over them. Could not keep them straight. Since Monday was a holiday, the clinic was closed so I sent an email to Dr. explaining the situation. He told me to report to the CDC and that he would refer me to a neurologist. My two fingers and the outside of my hand are still numb. I have seen Dr. and have been referred to a hand therapist.

Nearly 1 week after, I developed a rash, redness, and swelling at injection site. I also experienced a low grade fever ( 99.7) with chills, muscle and joint aches.

Patient presented with three weeks of progressive back pain and bilateral lower extremity radiculopathy, associated with night sweats (no fevers, no leukocytosis), found to have extensive T9-S1 spinal epidural abscess due to MSSA. Symptoms started at around the time the patient received her first COVID-19 vaccination on 1/26/2021. No other obvious source of infection (she does have an ear wound but this did not appear infected). She was admitted to the Hospital on 2/17/2021. Adverse event reported on 2/23/2021. She remains hospitalized as of this report.

on the 11th I woke up around 4 or 5 am both legs were locked below my knees through the feet and it was very painful. i rubbed theraworx relief and finally 20 to 30 mins later it quit.

pt stated after she received the vax she got a strange taste in her mouth. At 1 AM pt woke up with a heavy feeling in her left arm. Her left arm, hand and fingers started to swell. At 3 AM her head felt warm and the entire left side of her face was swollen, including lips, gums, nose and eyelids. Her teeth felt strange. At 5AM she could feel a sensation going down the left inside of her body moving from her neck to her toe. Then the right side of her face started to swell from the neck to the top of her head. Pt woke up at 7 AM next day and the swelling was starting to go down on the right side. On 2/26/2021 she is noticing the swelling is going down out of her left side. She never really had any pain or discomfort just swelling. Pt. has not contacted her PCP at this time.

81 y/o otherwise healthy female on no prescription medications Received Moderna Covid 19 vaccine on 2/25/2021 at 11:30 am -- > no problems following administration of vaccine About 15 hours later, on 2/26/2021 at around 2:30 am, pt went into the shower and suddenly felt acutely weak in lower extremities; unable to bear weight, so sat down on floor; no fall or injury; no focal neurologic sx at that time. Patient was able to crawl out of bathtub and call family member - total time down about 3 hours. Patient denied any associated fever, chest pain or upper body weakness. Due to extreme lower extremity weakness, pt taken to ER -- > dx: nontraumatic rhabdomylolysis She was treated with IVF, Tylenol and discharged home. Since discharge, she has been steadily improving. Three days after ER, pt is able to bear weight, ambulate but still with mild bilateral upper thigh pain and weakness (unable to get up from low seated position or squat).

Aggravated my Neuropothy for approximately 3 weeks. Also affected muscles in Right Foot. Every night Right Foot would get "BURNING HOT" & would have to soak foot in cold water. For last 10 days of problems, Right Foot, Middle of Leg, and Total Knee TOTALLY SWELLED UP AND STAYED THAT WAY FOR THAT LAST 10 DAYS! Burning foot is no longer and swelling is almost gone.

slow onset of fever, aches, chills, stiffness and pain in lower extremities and back (entire), pain in center of chest, neck, head no trouble breathing, greast weakness, difficulty rising and standing -- best lying in bed under warm covers- Like the worst cases of flu or virus I've ever had.. Very thirsty

approximately 8 hours after the injection a sudden case of chattering chills come on - temperature checked soon after was 103 - followed approx. an your later by vomiting and then restless night of sleep due to body aches and stiffness in trying to get out of bed. Following day improved but no appetite or energy and mild headache. Well by 32+ hours after incident

The day after the shot she developed fever for 2 days as high as 101. She developed a pruritic burning rash to posterior right leg extending down the lateral lower leg. She had fatigue and myalgias. Diagnosed with shingles on 2/23. and informed to not receive the 2nd vaccine. She presented to the Emergency room on 2/27 with fatigue, numbness right side of the face, no reports of shortness of breath or chest pain. Ambulated in to ER. After her work up she was discharged home - she present back to the ER within 30 minutes. PTA arrival at the ER for the 2nd time - she complained of left neck and arm pain - then went unconscious. She arrived to the ER in full arrest - pronounced deceased after resuscitation efforts were not effective

Shaking,teeth chattering chills, splitting headache, fever of 102, ,bone and muscle aches, vomiting from 7:15 p.m. until 2:00 a.m. It all started and stopped at about the same time. Now it is just extreme fatigue.

3:am on Friday I woke up with severe generalized pain , headache and temp of 102 . My left I took 2 Tylenol. It didnt help. The next morning the pain level was about 5 and fever was down to 100. By the 3rd day my temp was normal and I just had mild muscle aches

Weakness in both arms started around 2:40 Thursday afternoon. The weakness in right arm subsided but continued in left arm until Monday evening. There has been swelling and redness in the upper left arm since Sunday still persists until now. There is also itching and redness around the upper left arm, injection sight.

Her doctor said she may have possible leukemia; Soreness; Redness the size of a quarter, Redness was 2 inches round, Redness is 4.5 inches in length and 3.5 inches in width; Pain at the injection site, couldn't sleep, every time I turned, it was painful; Rash; Pain at the injection site, couldn't sleep, every time I turned, it was painful; Terrible pain on her arm; A spontaneous report was received from a consumer who was also a 81-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced soreness, pain at the injection site, couldn't sleep, vaccination site pain, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width. Patient's doctor suspecting leukemia. The patient's medical history included COVID 19 infection on 13 Oct 2020. Products known to have been used by the patient, within two weeks prior to the event, included hydroxyurea nonspecific. On 13 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031M20A) intramuscularly in the Left Deltoid for prophylaxis of COVID-19 infection. On 13 Feb 2021 at night 11pm, patient began to feel pain at the injection site. Patient reported that patient couldn't sleep all of Saturday night, every time patient turned, it was painful. By Monday, the pain turned into just soreness, however, patient developed redness the size of a quarter at the injection site. Two days before reporting, the redness was 2 inches round and currently the redness is 4.5 inches in length and 3.5 inches in width, which indicates that it was spreading. Patient reached out to patient's doctor. Patient also reported some itching at the injection site last night. The patient also reported Rash, terrible pain on arm, and COVID-arm reaction. Patient's also reported that her doctor is suspecting a leukemia. Treatment for the event included ice on the area 3 times a day, 15 minutes at a time. Action taken with mRNA-1273 in response to the events was not provided. The events, soreness, pain at the injection site, couldn't sleep, every time turned, it was painful, COVID arm reaction, terrible pain on her arm, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width, rash, were considered recovered on an unspecified date and The outcome of the event leukemia is unknown. Addition information Additional information received on 01 Mar 2021 included outcome of the events , pain at the injection site, couldn't sleep, every time turned, it was painful, COVID arm reaction, terrible pain on her arm, redness the size of a quarter, redness was 2 inches round and redness is 4.5 inches in length and 3.5 inches in width, rash and reported patient was suspecting leukemia.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Within a week of 1st shot, I began to have joint pain... shoulders/neck, hips/top of legs, & knees. Called Dr. after 2 weeks. He said common complaint. Wait Took 2nd dose of Moderna. 2/3/21. Pain continued. By March 1st Dr. setup lab work. Diagnosis: PMR - polymialgia rheumatica My symptoms were fatigue-physical & mental, loss of appetite & weight, aching muscles, and stiffness. Rx: 15mg prednisone which will be reduced gradually. Also worked with physical therapist for 4 sessions to gain strength & flexibility. Still tired, but gradually becoming more active. In

I had a painful stiff neck, the back of my head hurt and there was a slight headache and the stiff neck was the most painful I've ever head. It lasted several days.

On the date of first occurance March 10, felt fatigue and muscle ache in groin and legs, on first night felt restless, and sleepless with pain occuring in more joints. Next morning March 11, could not get up out of bed without assistance. Excruitiating joint and muscle pain . Sleeping 10-12 hours during day. Could barely walk pain persisting. Foggy brain, unable to consentrate. Feeling depressed. This last through weekend, subsiding some on Sunday March 14. Visited family physician, Dr. on Monday. Diagnosed with Serum Sickness. It has been a gradual decrease in joint pain, but still persists in my hips and legs as I write this on March 22.

Moderna COVID-19 Vaccine EUA: Fever, large swelling at injection site, dizziness and weakness, shortness of breath, headache, body ache (joint and muscle pain), chills

I got the "Covid arm" twice, after first and second injection. First did not come on until day #11 after vaccination, second only after 3 days. Besides this were chills, extreme tiredness, a sort of "brain fog," general aches and pains with the second shot and knees weak and feeling like a rag doll which lasted a couple days. Several episodes of urgent diarrhea with the first dose. First "Covid arm" lasted 8 days, the second just 4. With both, there was an almost constant feeling of queasiness.

Not to receive second dose in series until she recovers; "couldn't get out of bed"; doing a little better now; Practically immobile; could barely walk; achiness became worse and worse; "achy"; sore left arm; A spontaneous report was received from a consumer, concerning herself a female patient of age 81years, who had received her first dose on (17-feb-2021) Moderna's COVID-19 experienced sore left arm , achy , achiness became worse , Difficulty in walking , immobile , Bedridden. The patient's medical history include hypertension, COPD, hypothyroidism, and Fibromyalgia with pain, concomitant medication includes Levothroid, hydralazine, Bystolic, Savella, lisinopril, Ventolin Inhaler, Advair Inhaler and Oxygen at night was provided by reporter. On 17-feb-2021 patient received her first dose of two planned doses of mRNA-1273 (lot number:028L20A) via intramuscular route for COVID-19 infection prophylaxis. On same day she experienced soreness of left arm, 20Feb2021 she developed "achy" and stated that the achiness became worse and worse on 17Mar2021, she was "practically immobile" and "couldn't get out Of bed". On 18 mar 2021 Patient consulted HCP and took ibuprofen (every 6th hourly) as treatment and her HCP advised her not to take second dose which was scheduled on 21 mar 2021. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event was resolving at the time of this reporting.; Reporter's Comments: This case concerns an 81 Y/O F with a serious unexpected event of immobile along with nonserious unexpected bedridden, gait disturbance, pre-existing condition improved, treatment noncompliance and expected vaccination site pain, myalgia. Event onset on Day 4 after first dose mRNA-1273. Treated with ibuprofen. Events resolving. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Rheumatoid flare-up that started in her hands and moved to her feet; Swollen joints/joints are swollen; Red and swollen joints; A spontaneous report was received from a consumer, concerning an 81-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed rheumatoid flare-up, red/erythema and swollen joints/ joint swelling. The patient's medical history included rheumatoid arthritis. Products known to have been used by the patient, within two weeks prior to the event were not provided. On 16 Feb 2021, the patient received first dose of mRNA-1273 (batch number: unknown) for prophylaxis of COVID-19 infection. On 13 Mar 2021, prior to the onset of the events, the patient received their second dose of mRNA-1273 (batch number: unknown) on right arm for prophylaxis of COVID-19 infection. On 14 Mar 2021, one day after vaccination, the patient experienced rheumatoid flare-up which started in her hands and moved to her feet which was considered as serious (medically significant). On 20 Mar 2021, the patient's joints were swollen and red. Treatment for the event is not provided. Action taken with mrna-1273 in response to the events was not provided The outcome of the events were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Elderly age and medical history of rheumatoid arthritis are considered confounders.

Developed acute pain in right hip and muscles in anterior lateral half or thigh and posterior lateral portion of thigh down to knee. Acute pain lasted 2 1/2 days and continued pain for week, but lessened a little, pain increasingly lessened, but lasted 1 month.

Couldn't think; Tickle In Her Throat; coughing ( persistent cough); Mouth is currently dry; Achy body that started five to six days after receiving the first dose of the vaccine; Vomting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENTAL IMPAIRMENT (Couldn't think) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Osteoporosis. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VOMITING (Vomting). On 30-Jan-2021, the patient experienced MENTAL IMPAIRMENT (Couldn't think) (seriousness criterion medically significant), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine). At the time of the report, MENTAL IMPAIRMENT (Couldn't think), THROAT IRRITATION (Tickle In Her Throat), COUGH (coughing ( persistent cough)), DRY MOUTH (Mouth is currently dry), VOMITING (Vomting) and MYALGIA (Achy body that started five to six days after receiving the first dose of the vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications provided. No treatment was 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. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

PAIN FROM THE SITE OF THE SHOT TO MY NECK. 14 DAYS AND STILL PAINFUL..........MAYBE HIT A NERVE. WENT TO DR. AND TO EMERGENCY ROOM. ON MEDICATION AND ANTIBIOTICS...........

Upper back and right flank pain. Herpes Zoster with out complication - right thoracic dermatome braline, T5 area).

I woke up the next morning with bad muscle and joint pain, chills, nausea, threw up and had fever. This was worse than when I had covid.

patient hospitalized secondary to fever, generalized weakness and myalgias and had a fall. she was hospitalized for 2 days.

Patient is a 81-year-old woman who last Tuesday received her second vaccination shot in her left arm. Several hours after the procedure she developed pain and discomfort in her left arm. The left arm discomfort gradually increased over the past 3 to 4 days and she began to experience symptoms of claudication in her left forearm and hand. She had a difficult time performing her daily tasks. The pain significantly worsened today to the point that she had constant pain in her hand and developed numbness in her fingers. She presented to the urgent care clinic and was subsequently transferred to the emergency room where CT angiogram demonstrates thrombus in her left brachial artery. She denies a history of heart palpitations. She has no history of hypercoagulable state. She has no history of blood clots or easy bleeding. She has no history of infection and denies fevers chills or night sweats. She has no significant history of peripheral vascular disease and can walk over a mile without difficulty. She denies symptoms of transient ischemic attacks. Left brachial ulnar and radial artery thrombectomy due to inflammation of the brachial artery and thrombus in the brachial artery extending into the origin of the radial and ulnar arteries done on 3/22/2021. Discharged on aspirin 81 mg daily and Lovenox. Has transitioned to Eliquis now. Complication of left arm wound dehiscence. Debrided by wound clinic on 4/9/2021. Taken for washout/wound closure on 4/13/2021. Continues to f/u in our clinic.

Pain in right hip; quite severe at times. Usually when I stand up from a lying or sitting position. Moving does not always alleviate it. Took Tylenol and seemed to be improving, but pain started getting worse a few days later and had muscle spasms occasionally. Dr suggested using Motrin instead of Tylenol during the day and 1/2 10 mg Baclofen tablet nightly. Appears to be getting better at the moment, but that happened earlier before I went to the DR.

Moderna Covid-19 Vaccine --Approximately 4 days after the second dose was administered on 3/1/21, I woke up with a totally weak left leg. I would have fallen down getting out of bed except I usually first grab a cane because that is also the same leg that I had TKR in about 2 years prior. I wonder of the vaccine somehow affected the artificial knee--but the whole leg was not able to bare my weight--as if the muscles and tendons were gone. I used a walker to slowly bring back the leg support over about 5 hours. I told my knee doctor about this on 3/9/21 and he said one other patient of his who also had TKR 2 years ago (same as mine) told him about the same thing happening to him. Now I am having a "tight knee" in that same leg and am very worried.

MODERNA COVID-19 VACCINE EUA Extremely painful joints, especially hips--hardly able to move for 2 days Not only tired, but seemed to be passing out Neck ache--third day Fever/sweating for 4 days and nights Swollen, painful, numb and itchy left inside arm from pit to elbow Previous one--numb and swollen through 5 days

Patient called office on 5/19/2021 to report that after her 2nd shot of Moderna she was sick in bed for several days with nausea, no appetite, pain in her legs and R knee swelling. The R knee swelling has become progressively worse and it is now (5/19) double in size. She acknowledged that she has osteoarthritis and her primary provider has recommended an X-ray.

Pt called and stated she received her vaccine on 05/18/2021, started having arm and neck pain, nausea, lightheadedness, stomach cramping, on 05/19/2021 in the afternoon. She sat up to get some saltine crackers to help her feel better, and she started to get dizzy. She then remembers trying to hold herself up, and then the next thing she recalls is laying on her back on her kitchen floor. It was then she felt dizzy again and then sat herself up enough so she could vomit 3 times. She also reported having profuse sweating and dry heaves. Her husband found her about 30 minutes later when he returned home from picking up lunch for them. She refused to go in the hospital to get checked out until she called her PCP on 05/21/2021 because she still was not feeling well. They recommended that she go into the ER. She had a CT scan, UA, troponin levels checked, and other blood work. Was treated with IV lactated ringers in the ER, and given meclizine for the dizziness. UA showed positive E. coli, indicative of a UTI. Pt chose to be discharged home instead of staying overnight because she stated she would get plenty of rest at home. Spoke with pt 05/25/2021 after she had called to let us know what happened. Pt has scheduled additional CT scan on 06/08/2021 and follow-up with a neurologist 06/10/2021.

4/29/21: HAD BLURRED VISION (ALL DAY UNTIL MORNING OF NEXT DAY) + PRESSURE IN HEAD (ALL DAY INTO EVENING OF NEXT DAY) ABOUT 40 MINUTES AFTER RECEIVING VACCINE. 4/29/21: EVER SINCE VACCINATION, EXPERIENCING EXCESSIVE THIRST. ONGOING 5/1/21: PATIENT DESCRIBED SYMPTOM AS SKULL BONE PAIN (TENDER SCALP WHEN TOUCHED) UNTIL 5/5/21 5/3/21: ONGLING BLADDER IRRITATION. NO BLOOD IN URINE, BUT SOME SPOTTING (~2TSP) ON PADDING 5/17/21 . NO BLOOD PRESENT SINCE 5/4/21 MORNING: LYMPH NODE SWOLLEN UNDER THE LEFT ARM (INJECTION WAS IN RIGHT ARM). SIZE OF A TENNIS BALL, VERY PAINFUL, AND PAIN RADIATED TO AROUND THE LEFT BREAST AREA. PAIN LASTED UNTIL THE AFTERNOON OF 5/6/21. 5/9/21: BLOOD CLOT IN LEFT LEG REACTIVATED IN THE MORNING, ACCOMPANIED BY EXTREME PAIN, SWELLING, WARM TO THE TOUCH. PAIN AND SWELLING HAS BEEN MINIMAL BEGINNING 5/24/21, AND HAS NOT BEEN AS WARM TO THE TOUCH AS IT HAS BEEN. TREATMENTS: TOOK IBUPROFEN AND TYLENOL AS NEEDED FOR PAIN. USED ARNICA GEL ON THE ARM AT THE INJECTION SITE + MASSAGE+ CONSTANT MOVEMENT FOR PAIN/STIFFNESS. USED ARNICA GEL ALSO ON LYMPH NODE UNDER LEFT ARM ELEVATED CLOTTED LEG AND STAYED ACTIVE TO OPTIMIZE BLOOD FLOW, USED LIGHTLY HEATED PAD TO EASE THE LEG PAIN

Herpes on lip, all joints aching, temperature, hot and cold shivering, headache, moaning in pain. Took Excedrin. 24 hours

The patient recieved the second dose of Moderna vaccine on 5/10/2021, she called us today 6/3/2021, and reported that on third day after the shot , she had slight fever then she felt severe side effects: she lost smell and taste, headache, pain and swelling in joints and dizziness. The symtoms still last till now and we advised her to see her doctor right away.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Unilateral pitting edema/swelling of calf+ankle & bruising-Medium, Additional Details: Referred to closest urgent care

stated a little of everything going on, not feeling good, UTI and sinus infection, had last covid vaccine on March 4, was on 4 different kinds of HTN meds that were being adjusted, woke up Thursday AM 6/03 with dizziness, went to ER, Stated concern about symptoms after taking covid injection 5 wks after second dose, had second dose March 4 of Moderna injection for covid, received in left arm, soreness in muscle very little that lasted one day, stated on April 18 LLE cellulitis and went to urgent care, rash to chest 3 days after taking tetracycline, was told she had statis dermatitis by doctor, stated went away after 1-2 days of using hydrocortisone and compression stocking, HTN meds changed one week before rash

I began feeling dizzy, nauseous, weak in legs, blurred vision in early May which continued throughout the month. On June 3 I experienced an event like no other. My legs felt like rubber and tried but could not speak. My husband carried me to the sofa, when I sat down I felt disoriented, and saw a circle in front of my eyes. I felt as if I was about to pass out. I saw my cardiologist a week later. He is concerned that the neurological symptoms are new. He suspects I had a mini stroke despite being on blood thinner for my CHF and referred me to a neurologist. He suggested I report this sudden change to VAERS.

pt says she developed a rash and has progressively gotten worse since then. The rash is red, with little pea shaped pimples that are burning and spreading all over her body. The skin is prickly and very sensitive. She still cannot think clearly and still has fatigue. Her legs are bothering her know as well. She saw PCP Dr on 2/19/21 and told to take Claritin which did not help. On 2/26/21 she saw Dermatologist PA. She was given a skin biopsy. She was diagnosed w/ spongiotic and interfaced dermatitis w/ rare eosinophils. She was prescribed triamcinolone. She has since developed nose bleeds that would come every couple of days then started happening daily. She has had blood test which white blood count cells were up, the doctor thinks the steroid cream may have caused this so she is no longer using it. She has been to the doctors several times due to the skin rash and nose bleeds and nothing the doctors have done for her has helped with her symptoms thus far. She goes back to the doctors in a couple of weeks for another biopsy. These has had these symptoms for months.

This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 031B2114) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Crohn's disease. The patient's past medical history included Pain in hip since 2019, Osteopenia, Stenosis, Femur fracture and Back surgery. Concurrent medical conditions included Alcohol use (occasionally) since 1959. Concomitant products included BUDESONIDE (ENTOCORT) for Crohn's disease, COBAMAMIDE (VITAMIN B12 [COBAMAMIDE]) for an unknown indication. In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) UNK,1 in 2 Weeks. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2020, the patient experienced CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome). In February 2021, the patient experienced SWELLING (Swelling). On 12-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant). In April 2021, the patient experienced FATIGUE (Tiredness). In 2021, the patient experienced PAIN IN EXTREMITY (Hand pain). On an unknown date, the patient experienced HAEMORRHOIDS (Hemorrhoids), PAIN (Pain), OSTEOARTHRITIS (Osteoarthritis), ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea). The patient was treated with COLESTIPOL at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), HAEMORRHOIDS (Hemorrhoids), SWELLING (Swelling), PAIN (Pain), PAIN IN EXTREMITY (Hand pain), OSTEOARTHRITIS (Osteoarthritis), ABDOMINAL PAIN UPPER (Stomach cramps) and DIARRHOEA (Diarrhea) outcome was unknown, CARPAL TUNNEL SYNDROME (Carpal tunnel syndrome) had not resolved and FATIGUE (Tiredness) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding the events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-219975 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Death 4/18/2021 Causes of death listed on patient's death certificate: 1) Sequelae of SARS-Coronavirus 2019 Other: Rheumatoid Arthritis, Insulin Dependent Diabetes, Chronic Hypoxic Respiratory Failure, Morbid Obesity

Flashing light hallucinations; Pain in joints; Numbing of toes both sides; Toes tingling/ Fingers tingling/ Occasionally numbing and tingling fingers both hands; Insomnia / Slept for 6 to 7 hrs knocked out completely / Cant sleep at night; Pain in hips and legs up to knees/ Pain in legs feet and fingers; Bone pain; Sleep seven hours in raw; "could not drive"; Body pain/ Constant pain in body; Tiredness/ Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, VISUAL (Flashing light hallucinations) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included Drug allergy (Macrobid allergy), Fibromyalgia (Fibromyalgia was under control. Unbearable now.), Arthritis (Arthritis was under control. Unbearable now.) and Myalgia. Concomitant products included DOXYCYCLINE, VITAMIN A [RETINOL], VITAMIN B NOS, VITAMIN D NOS and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 06-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced BONE PAIN (Bone pain), MYALGIA (Body pain/ Constant pain in body) and FATIGUE (Tiredness/ Fatigue). 06-Mar-2021, the patient experienced HYPERSOMNIA (Sleep seven hours in raw) and IMPAIRED DRIVING ABILITY ("could not drive"). On 22-Mar-2021, the patient experienced HYPOAESTHESIA (Numbing of toes both sides), PARAESTHESIA (Toes tingling/ Fingers tingling/ Occasionally numbing and tingling fingers both hands), INSOMNIA (Insomnia / Slept for 6 to 7 hrs knocked out completely / Cant sleep at night) and PAIN IN EXTREMITY (Pain in hips and legs up to knees/ Pain in legs feet and fingers). On an unknown date, the patient experienced HALLUCINATION, VISUAL (Flashing light hallucinations) (seriousness criterion medically significant) and ARTHRALGIA (Pain in joints). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Myalgia, at a dose of 2 dosage form. On 08-Mar-2021, HYPERSOMNIA (Sleep seven hours in raw) and IMPAIRED DRIVING ABILITY ("could not drive") had resolved. At the time of the report, HALLUCINATION, VISUAL (Flashing light hallucinations) and ARTHRALGIA (Pain in joints) outcome was unknown and HYPOAESTHESIA (Numbing of toes both sides), PARAESTHESIA (Toes tingling/ Fingers tingling/ Occasionally numbing and tingling fingers both hands), INSOMNIA (Insomnia / Slept for 6 to 7 hrs knocked out completely / Cant sleep at night), PAIN IN EXTREMITY (Pain in hips and legs up to knees/ Pain in legs feet and fingers), BONE PAIN (Bone pain), MYALGIA (Body pain/ Constant pain in body) and FATIGUE (Tiredness/ Fatigue) had not resolved. The patient had implant dental work near 2 weeks ago around 10-Apr-2021 and received Doxycycline. The patient reported that the doctor won't return the call. 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 20-Jun-2021: Additional information received included patient demographics race, relevant history details including Macrobid allergy, current condition fibromyalgia and arthritis; new concomitant medications added; Treatment medicines were added . Added New adverse event Flashing light hallucinations.; 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.

covid; cough; aches all over; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Chemotherapy. Concurrent medical conditions included Cancer (seven and half years ago). On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced COUGH (cough), MYALGIA (aches all over), PYREXIA (fever) and HEADACHE (headache). On an unknown date, the patient experienced COVID-19 (covid) (seriousness criterion hospitalization). The patient was hospitalized for 24 days due to COVID-19. The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, COVID-19 (covid), COUGH (cough), MYALGIA (aches all over), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, Body temperature: 100.3 °F (High) 100.3°F. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. Concomitant products included blood pressure medicine (unspecified). Reportedly, the patient had COVID five days after the first shot of vaccine. The patient had to stay three and a half weeks in hospital that destroyed her immune system and she said that it was coming back after medications. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: 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 21-Jun-2021: Case upgraded to serious, includes- serious event of covid-19 (hospitalization) and historical condition of cancer and had chemotherapy.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the rest of the events: 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.

Death 5/31/2021 Causes of death listed on death certificate: 1. Autoimmune cold-agglutinin hemolytic anemia 2. COVID 19 3. rheumatoid arthritis, chronic immunosuppression

On 4/7/21, she received the second dose of the Moderna COVID-19 vaccine. Then, around 5/1/21, she developed fevers to 102 with associated fatigue and poor appetite, but no other clear localizing symptoms, including no sore throat, cough, chest pain, SOB, abdominal pain, N/V/D, joint swelling/pain, rashes, or dysuria. She presented to an outside hospital ED where she had an infectious workup that included a CXR concerning for LLL pneumonia. She was prescribed doxycycline for 7 days with resolution of her fevers and subjective improvement. In early June 2021, the patient redeveloped fevers and chills, worst at nighttime, without localizing symptoms. Her appetite and energy level remained very poor despite several changes to antidepressants as an outpatient. She was treated with nitrofurantoin x 5 days for presumed UTI, but fevers persisted, still without associated cough, CP, or SOB. With going fevers, fatigue, and poor appetite resulting in ~18lb unintentional weight loss, she was admitted to Hospital on 6/22/21 for further evaluation. While at Hospital, she continued to have fevers to 102+ without localizing symptoms despite empiric doxycycline. A broad infectious workup returned negative. CT chest and CTAP were also unrevealing for a cause of fevers. She was found to have an elevated ferritin, LDH, and triglycerides, as well as a low fibrinogen, concerning for HLH (high H-score). She received high-dose dexamethasone. Bone marrow biopsy was performed that was negative for malignancy. However, peripheral flow cytometry returned with a clonal B-cell population, her soluble IL-2 was elevated, and she was found to have splenic enhancement on PET-CT, all concerning for occult lymphoma as the potential driver of her HLH. She remains admitted and is critically ill with complications of DIC and bleeding that preclude a splenic biopsy to confirm the suspected diagnosis of lymphoma. Since her fevers, malaise, and fatigue started less than 1 month after her second dose of the Moderna vaccine, and the patient was insistent that she "hadn't felt right" since she received that second dose of the vaccine, we decided to report this event in the VAERS system.

minor stroke/a small stroke in the left parietal region of the brain, tiny but visible; Have to use a cane or a walker; right leg gave up; patient fell on the floor; difficulty with balance because of their right leg; difficulty with walking because of their right leg; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (minor stroke/a small stroke in the left parietal region of the brain, tiny but visible) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Fall (Patient had a fall in November 2020 and broke their shoulder) in November 2020 and Broken hand (Patient had a fall in November 2020 and broke their shoulder) in November 2020. Concomitant products included FISH OIL, MAGNESIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), FISH OIL (OMEGA XL), LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]), DILTIAZEM, LISINOPRIL and ROSUVASTATIN for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (minor stroke/a small stroke in the left parietal region of the brain, tiny but visible) (seriousness criteria hospitalization and medically significant), MUSCULAR WEAKNESS (right leg gave up), FALL (patient fell on the floor), BALANCE DISORDER (difficulty with balance because of their right leg) and GAIT DISTURBANCE (difficulty with walking because of their right leg). On an unknown date, the patient experienced WALKING AID USER (Have to use a cane or a walker). The patient was hospitalized from 28-Jan-2021 to 29-Jan-2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) for Adverse event, at a dose of UNK, qd. At the time of the report, CEREBROVASCULAR ACCIDENT (minor stroke/a small stroke in the left parietal region of the brain, tiny but visible), MUSCULAR WEAKNESS (right leg gave up) and FALL (patient fell on the floor) outcome was unknown and BALANCE DISORDER (difficulty with balance because of their right leg), GAIT DISTURBANCE (difficulty with walking because of their right leg) and WALKING AID USER (Have to use a cane or a walker) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: small stroke in the left parietal region of the br (abnormal) Small stroke in the left parietal region of the brain, tiny but visible. Additional concomitant medications included vit-asid for macular degeneration. Company comment: This case concerns an 81-year-old female hospitalized with a serious unexpected event of cerebrovascular accident, and nonserious muscular weakness, fall, balance disorder, gait disturbance, and walking aid user. Event latency 18 days after second dose mRNA-1273. 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-year-old female hospitalized with a serious unexpected event of cerebrovascular accident, and nonserious muscular weakness, fall, balance disorder, gait disturbance, and walking aid user. Event latency 18 days after second dose mRNA-1273. 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.

Severe headaches, eye pain, ear pain, jaw pain on the left side, extreme stiffness in neck. Sent to hospital. Outpatient surgery on both temples. Biopsy. Diagnosed with Greater Cell Arteritis. Inflamation of the temporal arteries. On medication- pregnezone 50 mg daily, fosamax 70 mg weekly. Also dealing with a side effect of the prenezone- elevated blood pressure and on medication 5ml amlodipine daily.

Feels weak from waste down, Left arm is weak; Feels very weak; Went home paralyzed from waste down; This spontaneous case was reported by a consumer and describes the occurrence of DIPLEGIA (Went home paralyzed from waste down) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A and 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIPLEGIA (Went home paralyzed from waste down) (seriousness criterion medically significant). On an unknown date, the patient experienced MUSCULAR WEAKNESS (Feels weak from waste down, Left arm is weak) and ASTHENIA (Feels very weak). On 20-May-2021, DIPLEGIA (Went home paralyzed from waste down) had resolved. At the time of the report, MUSCULAR WEAKNESS (Feels weak from waste down, Left arm is weak) and ASTHENIA (Feels very weak) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had cold before her second dose. Patient reported to agent that mostly her legs were affected. Patient also called EMS and they did not transport her to hospital. Patient states that she has not taken any medications to help subside the possible adverse events. No concomitant medications were mentioned. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-263043 (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.

Severe lower back pain, seems like muscle spasms. Cannot rise from sitting position without severe back pain. Standing, sitting, lying down is pain free unless I try to change position.

Seizure like episode on 1/12/21, one week after vaccine, last 1.5 hours, consisting of both eyes twitching and clenching/spasm of right hand and arm. EMS called. BP normal. Continuing weakness of right arm and right leg, which was side weakened by stroke. Could no longer stand or walk on right leg. Some slurring of speech. Some confusion. Went to hospital 1/14. No evidence of stroke or current seizure. Considered problem to be mild UTI, started antiobiotics, rapid improvement. Discharged 1/17. Woke up 1/18 with aphasia. Went to urgent care, sent immediately to hospital. Doctors found no evidence of stroke or seizure. Consider problem to be due to inflammation, caused by mild UTI (which was cleared by antibiotics) or perhaps due to inflammation caused by Covid vaccination. The inflammation reinitiated the symptoms of her stroke, although she never had expressive aphasia prior to this, only word-finding problems, which had been resolved.

Pain upper rt. Lateral back, side, chest- unable to sleep because of pain-tender to touch-reflux with no relief from antacids

mild fever (101-102), chills, intermittent chest pain (she said it was likely related to muscle contractions due to chills), pulse ox 91-92, pulse 110, finger bone ache. the following morning, vomited water, diarrhea symptoms resolved over the next 2-3 days.

Chills, fever, severe muscle pain, nausea, sudden onset BM, Weakness, shakey, Pretty much all the adverse sympton reaction listed on the information paper given me at the Clinic

Presented to ED with complaints of Fever, chills, and myalgia. Symptoms transitioned into lethargy and weakness. Treatments: Physical Therapy for strengthening, lab work, fever reducing medications!

Confusion, brain fog, loss of appetite, extreme muscle weakness with inability to stand by herself and walk, intermittent dry cough, decreased oxygen level

Shoulder pain within 10 min. after shot. Rash started the next day. Waited till Saturday, the 29th to see a doctor., and she diagnosed that I had Shingles. She gave me two medicines to get from my druggist. One was valacyclovir and the other was HYDORcodone. These helped to relieve the pain. I was limited to 5 of the HYDROcodone, so when I was finished with those tablets, my nighttime pain in my shoulder was very uncomfortable.

First day after injection all of these events came at one time: Muscle soreness in thighs & lower back, headache, stiffness both sides of neck, temperature: 101, exhaustion (much like covid), vomiting, severe chills (first day) , burning bottom of feet and palms of hands. Redness and swelling vaccination site. Day 2: muscle and joint soreness, no temperature, no appetite, continued fatique, vaccination site redness, hard. Site is currently only reaction left..still quite sore and heated, red , swollen and hard.

Moderna COVID-19 Vaccine EUA. Muscle aches, joint aches. Personal physician contact on 2nd day of symptoms and recommended 2 Bufferin tablets every 6 hours. Symptoms began diminishing after first ingestion of Bufferin.

Arm started hurting, chills, back ache, extremely smelly diarrhea, lots of gas, headache, back ache, joint aches, weakness, and a 100.1 fever that lasted 24 hours only.

muscle soreness, mild headache, no appetite, slept more than 18 hours during the next 24 hours. All symptoms gone by ten AM 2,13/21.

Patient is stating they are having pain behind left knee that caused limping. Has gotten better but still hurts going up and down stairs. On a scale of 1 to 10 where 1 is no pain and 10 is the worst pain, patient stated it was a 10 originally but now is a 5 as of 2/15. Patient stated they did nothing to hurt it outside of getting the vaccine on the 10th.

Received vaccine on 2/3, On 2/5 developed pain in upper back and bilat axillae soft tissue. Feels like painful muscles. No rash. Started to feel better after 10 days. Advil PRN only treatment remedy tried.

The night after my second vaccine, I started experiencing burning pain in my left hip area. I had a total left hip replacement on June 1st and had no pain in that hip prior to the second vaccine.

Vaccine #1 had no issues. Vaccine # 2 had the following: Site of shot was hot, large, inflamed 4 days/ started to imrove on day 5 Day #1 Woke up at midnight with severe shooting pain in neck and went straght up head/followed by inability to move legs/eased off and the next morning could use legs and pain gone, but arm had started to swell at site of shot Day #2 Very sick, flu like symptoms, sleepy, no headache, chills Day #3 same as day 2 Day #4 Same as day 2 and arm easing off Days 5-9 severe fatigue , abnormally tired and unable to function normally Day nine severe dizziness started and has continued to day 13. Cannot drive, wobbly

The vaccine was given on Friday and on the next Tuesday evening she experienced excruciating pain in her joints, knees, arms and elbows. She developed difficulty walking without pain or holding on to something. She also experienced dizziness and headache with balance issues.

Patient received second dose of COVID vaccine on 02/19/21. That evening, she experienced weakness in her legs and her legs wouldn't support her. She fell down and ended up sleeping on the floor all night. She was able to stand this morning, 02/20/21 and feels fine.

new muscle pain and increased old pain. neck pain. flu-like systems. fever chills, tired for two days.

Muscle and joint aches, no fever, general tiredness. Went to bed, slept all night, felt pretty good when I woke up, felt fine by noon that day.

Patient reported that during the first hour after vaccine she felt pain in her shoulders and back, and "intense chest tightening". She took a children's tylenol tab and put heat on her back and then rested and fell asleep for a period of time. SHe woke up to "pins and needles" feeling in her head and face that felt "intense" to her maybe 4-5 hours after vaccination. She continued to feel "discomfort, tightness in chest/back" for 2-3 days. SHe then stated around day 10 she had abdominal tightening, overwhelming nausea, and pressure in her stomach, but no diarrhea for about 6-7 days. She also states she had "bad reflux". Around Feb 14th-16th she started feeling a rash on both arms/neck/chest and then hives that were red/blotchy a few were raised and hard on thighs/hip/arms. She went to physician and was given Benadryl and Steroid cream. She then reports that on Feb 20th she had swollen lymph nodes under arm.

WITHIN THREE HOURS AFTER VAX, FACE BECAME REALLY FLUSHED, WOKE UP AT 2AM WITH SEVERE CHILLS, BODY & JOINT ACHES AND STIFF NECK ALONG WITH POUNDING HEADACHE.

RASH ON ARM AND ACROSS CHEST; GLANDS SWELLED A LITTLE; BURNING, ITCHING AND STINGING ARMS AND LEGS; CONTINUED FOR 5 WEEKS AND STILL CONTINUES ALTHOUGH SUBSIDING. STOMACH MUSCLES HURT BUT NO NAUSEA. EXPECTED FATIGUE, DIZZINESS AND WEAKNESS BUT NOT CONCERNED ABOUT THAT. RAISED BLOOD PRESSURE AND PULSE RATE ON 2/3/2021. STILL EXPERIENCING VARIATIONS IN HEAT/COLD FEELINGS..MAY OR MAY NOT BE RELATED.

5:00am 2/21/21 thru 5:00am 02/22/21 (24 hrs) chills, fever (99.7), headache, nausea, muscle/joint pain; For reainder of 2/22/21 thru 2/2/24/21 experienced Fatigue, lack of energy and did have swelling, soreness, redness/heat Upper Right Arm where had injection.

On the first evening I had a fever and joint pains which resolves by the next morning, On 02/03/2021 I had diarrhea on awakening and about two hours later, after doing morning chores including carrying and lifting 4 gallons of water, I fainted,which included having another episode of diarrhea while I was out. I was seen by emergency medical personnel, had an EKG, and then my children, with whom I live, took me to see my primary care provider who ordered some basic blood tests: a CBC and panel. All blood tests were normal as well as the EKG, I assume. We think the faint was perhaps triggered by the diarrhea and exertion of chores in addition to the vaccine's effect . Since then I have had fatigue.

Daughter provided the information for her elderly mother who, at this time, was being evaluated in the ED at Medical Center . 3/5/21 - approximately 16.5 hrs after her mother's second dose of Covid 19 vaccination, she woke up very weak and felt very tired. 3/6/21 Patient noticed rash (not raised) but reddened in the left upper arm where the injection was given. She stated it was oval in appearance and covered most of the upper arm. She noted a lump in her underarm of the left axilla also. Denied any fever or other symptoms and otherwise felt fine. On 3/9/21 she noticed a lump in the groin area and noticed that walking was a little more difficult than usual since both of her knees bothered her. 3/12/21Pt went to orthopedic surgeon and had a "cortisone injection" in the right knee. This afternoon, the patient's daughter suggested that she go a local Urgent Care because the patient stated that the lump (previously in groin area) "was moving." She waited in there for over one hour and then a nurse came out and told her to go to the ED for evaluation of her left upper arm for the redness and swelling. She went directly to the ED and is being evaluation and having bloodwork done. Daughter said if the lab results are normal, her mother will be discharged with an oral antibiotic and benadryl

Several days after receiving the 2nd Moderna vaccine for COVID 19, I began have pain in all the joints in my hands, shoulder. Unable to use my hands due to excruciating pain. The pain began 3-4 days after the 2nd shot, starting in 2 of my fingers and progressively moved to all the joints in all of my fingers, wrists and my shoulders. In addition there is swelling. I have very little use of my hands, requiring assistance to care for myself. I have never had joint pain in my hands before. The pain has continued for 2 weeks non-stop. At the doctors recommendation I have been taking Tylenol for Arthritis, however this does not alleviate the pain, only reduces some of the discomfort.

Patient called to report that her face got red and swollen within 45 minutes of vaccine and she had a rash on her face and she had a little bit of throat swelling and was speaking like a frog and it was hard to swallow. She said within 3 days her legs started to go numb and especially her thigh muscles and her veins in her left foot were engorged. She said she went to the ER and they rxed 40mg prednisone for 4 days and her papers from the ER read "allergy." When I spoke to her for the second time and advised her she does not qualify for a second moderna vaccine, patient said that when she went to the ER she went for abdominal swelling, leg swelling, leg numbness, and swelling of the left ankle and foot. I confirmed with her that her symptoms have all improved and she said "yes, tremendously." She said she spoke to her PCP and at least one additional doctor yesterday.

After injection a little itching . The next day I had what is called 'Covid Arm'. Rash and itching on the arm. Had fever, muscle pain, tired and chills

left shoulder warm to touch, tenderness, swelling about 2 inches, bruising. Used ice compress to alleviate symptoms with no relief. Recommended to see primary provider if symptoms worsen.

Severe auto immune flare--terrible unrelenting muscle aching all over body--profound weakness and fatigue necessitating bedrest for hours at a time. This has continued for 4 WEEKS and is just beginning to slightly let up. My immune system has been in the worst flare I have ever experienced in all the 20 years I have had auto- immune flares--it just cannot seem to down regulate itself and I have crippled up badly as a result. Every movement hurts--even my chest hurts every time I take a breath!

The patient received her FIRST dose of Moderna COVID vaccine on 1/26/21 and SECOND dose on 2/23/21. On 3/8, she first started to experience shortness of breath, which was attributable to cardiac etiology and diastolic heart failure at the time, but which in retrospect may have been her earliest symptom of new onset myasthenia gravis, which is the AE I am wanting to report. She was hospitalized from 3/8-3/13, and underwent extensive cardiac workup that was negative. She again developed shortness of breath on 3/17/21 and was re-admitted to the hospital on 3/18/21 for diuresis for presumed diastolic heart failure exacerbation, received diuresis from 3/18-3/22/21 but then developed new onset diplopia, at which pint I evaluated her in neurological consultation on 3/22. Her brain MRI disclosed an UNrelated incidental small left cerebellar infract, but her neurological exam showed a new R lateral rectus palsy and new moderate to severe left eyelid ptosis, suspicious for myasthenia gravis. Anti-acetylcholineseterase antibodies--- binding, blocking, and modulating, were all sent off and came back all strongly positive on 3/26-27/21. The patient then called stating she had developed recurrent shortness of breath, new onset dysphagia, and worsening double vision. I urgently re-evaluated her in outpatient follow-up in my office on 4/2/21 and sent her immediately to the hospital to be readmitted, where she remains as of this reporting date and she has been receiving IVIG with improvement in her symptoms. She did NOT have any previous known history of eyelid ptosis, dysphagia, diplopia, or muscle weakness. In retrospect, the patient states that her current symptomatology began around 3/7/21 with the benefit of hindsight. I am reporting this event because it is very unusual for an 82 year old WOMAN to develop new onset of myasthenia gravis, and it is a known autoimmune disease, and a vaccine would be a plausible trigger for its development, or trigger for its first symptomatic manifestation. I was also especially concerned because my fellow neurologist, ALSO had a patient develop myasthenia gravis about 2 weeks or so following their second dose of the Pfizer COVID vaccine. It would be an EXTRAORDINARY coincidence for two instances of new onset myasthenia gravis to occur 2 weeks post- vaccination at essentially the same time in an institution of our size, so we both felt obliged to report both cases ASAP to the VAERS. I was not able to reach the patient in her hospital room today to get additional specifics about where she got the vaccine, its lot number etc., however she is a retired and has indicated her willingness to provide you with any and all additional information you need, and I am also personally very willing to provide any additional information about her eventual outcome.

I was in the kitchen fixing food when I started having pain in my back, it went up into my shoulders. It was an intense pain. I became extremely weak, I started vomiting, my blood pressure was 196/117 BP, and I was sweating. My grandson called 911 and I was taken to the hospital Cardiologist said heart was fine. I did NOT have a heart attack. He thinks it is due to the vaccine. Advised that I take the second shot.

hit her head and blacked out; feeling awful; not felt well ever since; don't feel like eating; feeling the same symptoms as she did when she had covid; taste not the same; headache; Fatigue; mucsle aches; slight nausea; problem with a lymph node in that arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (hit her head and blacked out) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (also treated with 5 days of Remdesivir) in January 2021 and Lumpectomy. Concomitant products included NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMIN-B COMPLEX), ASCORBIC ACID (VITAMIN-C), VITAMIN D [VITAMIN D NOS], ZINC, APIXABAN (ELIQUIS), CARVEDILOL, ATORVASTATIN and LETROZOLE for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (hit her head and blacked out) (seriousness criterion medically significant), FEELING ABNORMAL (feeling awful), MALAISE (not felt well ever since), DECREASED APPETITE (don't feel like eating), COVID-19 (feeling the same symptoms as she did when she had covid), TASTE DISORDER (taste not the same), HEADACHE (headache), FATIGUE (Fatigue), MYALGIA (mucsle aches), NAUSEA (slight nausea) and INJECTION SITE LYMPHADENOPATHY (problem with a lymph node in that arm). At the time of the report, LOSS OF CONSCIOUSNESS (hit her head and blacked out), FEELING ABNORMAL (feeling awful), MALAISE (not felt well ever since), DECREASED APPETITE (don't feel like eating), COVID-19 (feeling the same symptoms as she did when she had covid), TASTE DISORDER (taste not the same), HEADACHE (headache), FATIGUE (Fatigue), MYALGIA (mucsle aches), NAUSEA (slight nausea) and INJECTION SITE LYMPHADENOPATHY (problem with a lymph node in that arm) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Mammogram: sensitive (Inconclusive) Sensitive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included was acetaminophen for headache. The patient was hospitalized with coivd in January and had 5 days of Remdesivir. The patient also had problem with a lymph node in that arm. She had a Lumpectomy. They took at a lymph node in the left side of that armpit to see if it had spread. It was sensitive when she had a breast exam and was sent to get a mammogram. Got the breast exam last week in February. Based on the current available information a temporal association between the use of the product and the onset date of the event, a causal relationship with the events cannot be excluded. Headache, fatigue, myalgia, nausea and injection site lymphadenopathy are consistent with the product safety profile.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the event, a causal relationship with the events cannot be excluded. Headache, fatigue, myalgia, nausea and injection site lymphadenopathy are consistent with the product safety profile.

Within a couple of hours of the first vaccine, after a long walk, my R hip/leg became weak and unreliable to the extent that I was limping and it has continued to be a problem. I'd had no problem at all with that since recovering from the surgery done in April 2019. I delayed the second vaccine until 5 weeks, and after some gradual improvement, it did get somewhat better during that fifth week -- though still not normal. Prior to the first vaccination, I was accustomed to walking 1 to 2 miles almost every day with no difficulty at all. The initial reaction to the second dose was less than with the first. (I didn't walk for two days after that one.) However, it worsened over the next couple of weeks so that again I could barely walk 1/4 mile without making things worse again. Now it's about 3 1/2 weeks since dose #2 and it does seem to be starting to improve, but slowly. (And I took ibuprofen for 5 days last week, 400 mg 2x/day, which helped.) The only other reaction I had to either dose was the usual sore arm. Neither affected the L hip which still has severe arthritis. I have kept a day-by-day journal with details.

Started having joint soreness. Hurts to sit, soreness in neck, hurt to move neck, unable to extend arms completely. Weak. Upper thigh muscle soreness.

Second day after first vaccine received slight rash on feet and legs. This happened once more. After second vaccine, next day horrific red rash this last a few days and goes away. This has happened several time since 2nd vaccine. Today it's back with a vengeance, rash is redder and spots larger. Doesnt itch and not sore. A couple weeks ago severe joint pain started. This too comes and goes. I had absolutely NONE of these symptoms before the vaccine!

onset of severe L back pain, L arm pain and L chest pain very similar to previously experienced brachial plexopathy

Pt. presented to ED. Was currently being treated for UTI. Husband states that she has had low oxygen saturations for the past week with any movement, statins she will do as low as the 60's% accompanied with SOB. Husband reports noticing more confusion than normal and reports being very anxious and delirious, poor appetite and lethargic. In ED pt. was found to have O2 saturation of 74% on RA. Weight was also noted to be up. Pt. usual weight in the 190 range and currently pt. is 207 range. Pt. was admitted from ED with diagnosis of Community acquired pneumonia, hypoxia requiring high flow O2 via Airflo, elevated d-dimer.

Patient presented to the outside hospital on 4/27/21 with lower extremity weakness which progressed to paralysis and back pain (which had been intermittent since Dec. 2020), but had started to become persistent and rapidly worsen starting around 4/24/21. Patient subsequently transferred to HCF on 4/28/21 for concerns of Guillain-Barré syndrome with recent COVID-19 vaccination (Moderna: first dose on 4/14/21) with lower extremity paraplegia lack of deep tendon reflexes. Unable to perform MRI due to type of pacemaker that patient has. Lumbar puncture done 5/1/21 was consistent with Guillain-Barré with elevated protein. However, patient had minimal improvement in symptoms despite full 5-day course of IVIG. During her hospitalization, concern emerged for central compression and after further imaging patient was subsequently found to have a T8 compression fracture, spinal mass, and severe spinal canal stenosis at the level of the compression fracture. Spinal biopsy completed suggestive of DLBCL. Hematology/Oncology were consulted, and chemotherapy initiated. Bone marrow biopsy done on 5/7/21 with results pending as of 5/11/21.

Guillain Barre syndrome. Presented with rapid onset L >R leg weakness, numbness and radicular pain. Symptoms came on overnight. 3 days later developing hand symptoms.

Bleeding internally; Internal intestinal bleeding; Kidney function changed; Arm bothered her after receiving the vaccine; Very tired; Slight low-grade fever/Felt warm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INTERNAL HAEMORRHAGE (Bleeding internally), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding) and RENAL IMPAIRMENT (Kidney function changed) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B2119) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Gastrointestinal bleeding, Kidney function abnormal and Aortic aneurysm. Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]) for Blood pressure management, SUCRALFATE, PANTOPRAZOLE, POTASSIUM CITRATE, SIMVASTATIN, METOPROLOL, IRBESARTAN and VITAMINS NOS for an unknown indication. 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 LIMB DISCOMFORT (Arm bothered her after receiving the vaccine), FATIGUE (Very tired) and PYREXIA (Slight low-grade fever/Felt warm). On 07-May-2021, the patient experienced INTERNAL HAEMORRHAGE (Bleeding internally) (seriousness criterion medically significant), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding) (seriousness criterion medically significant) and RENAL IMPAIRMENT (Kidney function changed) (seriousness criterion medically significant). At the time of the report, INTERNAL HAEMORRHAGE (Bleeding internally), GASTROINTESTINAL HAEMORRHAGE (Internal intestinal bleeding), RENAL IMPAIRMENT (Kidney function changed), LIMB DISCOMFORT (Arm bothered her after receiving the vaccine), FATIGUE (Very tired) and PYREXIA (Slight low-grade fever/Felt warm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event included acetaminophen. Company Comment There is not enough information to ass the event of renal impairment as the exact condition was not describe. However, based on temporal association, a causal relationship between the product use and the remaining events cannot be excluded; Sender's Comments: There is not enough information to ass the event of renal impairment as the exact condition was not describe. However, based on temporal association, a causal relationship between the product use and the remaining events cannot be excluded

lyme disease type symptoms; blood sugar decreased; right arm pain at injection site; fatigue; generalized body ache; chills; runny nose; cough; left arm pain-no injection; left eye twitch; This spontaneous case was reported by a nurse and describes the occurrence of LYME DISEASE (lyme disease type symptoms) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 014MZ01) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Rheumatoid arthritis, Arm injury (left arm cannot raise arm) in 2012, Dislocation of vertebra (3 vertebrae out of place), Radiofrequency ablation (ablation in neck), Low back pain (bilateral), HLA-B*27 positive, Kidney stones, Reiter's syndrome, Salmonella infection, unspecified (dating back to 1981) and Knee replacement (two knee replacements). Concurrent medical conditions included Diabetes, Asthma, Lyme disease and Fibromyalgia (fibromyalgia with neck and shoulder pain). Concomitant products included FORMOTEROL FUMARATE, MOMETASONE FUROATE (DULERA) for Asthma, INSULIN GLARGINE (LANTUS) for Diabetes, MINOCYCLINE, DAPSONE, ATOVAQUONE, PROGUANIL HYDROCHLORIDE (MALARONE) and LEUCOVORIN [FOLINIC ACID] for Lyme disease, CODEINE PHOSPHATE (CODINE), PARACETAMOL (TYLENOL) and DIAZEPAM (VALIUM) for Pain. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced BLEPHAROSPASM (left eye twitch). On 15-Mar-2021, the patient experienced RHINORRHOEA (runny nose), COUGH (cough) and PAIN IN EXTREMITY (left arm pain-no injection). On 12-Apr-2021, the patient experienced LYME DISEASE (lyme disease type symptoms) (seriousness criterion medically significant), BLOOD GLUCOSE DECREASED (blood sugar decreased), VACCINATION COMPLICATION (right arm pain at injection site), FATIGUE (fatigue), MYALGIA (generalized body ache) and CHILLS (chills). On 20-Mar-2021, BLEPHAROSPASM (left eye twitch), RHINORRHOEA (runny nose) and COUGH (cough) had resolved. At the time of the report, LYME DISEASE (lyme disease type symptoms), PAIN IN EXTREMITY (left arm pain-no injection), VACCINATION COMPLICATION (right arm pain at injection site), FATIGUE (fatigue), MYALGIA (generalized body ache) and CHILLS (chills) outcome was unknown and BLOOD GLUCOSE DECREASED (blood sugar decreased) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Blood glucose: abnormal (abnormal) abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was 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. 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.

started running temp and had pain in the left side of her neck and head. Next day left jaw and lips were numb so could barely talk. Pt saw her PCP Dr. and was told it was a side effect from the vax. Left eye started swelling so went to eye Dr. on 4/14/21. She was prescribed eye drops but continued to use her regular eye drops. At times her eye continues to feel hard and that the vision has been impaired and jaws feels funny.

Developed body aches, headaches which worsened over the course of a week or more progressing to arthralgia and severe fatigue. Treated with prednisone. Symptoms have currently resolved after treatment. Follow up testing planned for July 2021.

Hemorrhoids; Stomach cramps; Osteoarthritis; Pain; Diarrhea; Tiredness; Rheumatoid arthritis; Swelling; Hand pain; CARPAL TUNNEL OF BOTH HANDS; This spontaneous case was reported by a health care professional and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease. The patient's past medical history included Hip discomfort in 2019 and Alcohol use in 1959. Concomitant products included BUDESONIDE (ENTOCORT) for Crohn's disease, VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication. In December 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2020, the patient experienced CARPAL TUNNEL SYNDROME (CARPAL TUNNEL OF BOTH HANDS). In February 2021, the patient experienced SWELLING (Swelling). On 12-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criterion medically significant). In April 2021, the patient experienced FATIGUE (Tiredness). In 2021, the patient experienced PAIN IN EXTREMITY (Hand pain). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), HAEMORRHOIDS (Hemorrhoids), ABDOMINAL PAIN UPPER (Stomach cramps), OSTEOARTHRITIS (Osteoarthritis) and PAIN (Pain). The patient was treated with COLESTIPOL at an unspecified dose and frequency. At the time of the report, RHEUMATOID ARTHRITIS (Rheumatoid arthritis), CARPAL TUNNEL SYNDROME (CARPAL TUNNEL OF BOTH HANDS), ABDOMINAL PAIN UPPER (Stomach cramps), SWELLING (Swelling), PAIN IN EXTREMITY (Hand pain) and FATIGUE (Tiredness) had not resolved, DIARRHOEA (Diarrhea) and HAEMORRHOIDS (Hemorrhoids) was resolving and OSTEOARTHRITIS (Osteoarthritis) and PAIN (Pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the event swelling was prior to 1st dose of vaccine administration and it is unlikely related to vaccine. Humira may remain as risk factor.; 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. However, the event swelling was prior to 1st dose of vaccine administration and it is unlikely related to vaccine. Humira may remain as risk factor.

Within 1 week of injection, patient reported pain in deltoid tendon region--required PT, multiple doctor visits including ortho, steroid injection and she is now WORSE with increased pain/decreased ROM more like adhesive capsulitis. I will check no disability/permanent damage box, but it is really too soon to say as she has not recovered after months. Has limited use of arm--difficulty especially with grooming.

Began to feel pain in both legs, used heating pads but did not work. Mostly in the upper thigh and knee area constantly. Was prescribed prednisone - did not work. Referred to an orthopedic.

Shortly after getting the vaccine arm started to itch. Within a few days full body rash with bumps that could be felt under the skin. Hands and feet are hot and burning. Feels like they are being placed in steam. Has been constant and ongoing since second dose.

Started feeling weakness at the back of her neck; red blotches; itchy; disorder sleep; Phone monitoring device and it stated it might be afib and something else (she cannot remember the term); Heart palpitations; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lupus erythematosus, Polymyalgia rheumatica, Sjogren's syndrome, Raynaud's syndrome and Hypothyroidism. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)) (seriousness criterion medically significant), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Started feeling weakness at the back of her neck), RASH MACULAR (red blotches), PRURITUS (itchy) and SLEEP DISORDER (disorder sleep). At the time of the report, ARRHYTHMIA (Phone monitoring device and it stated it might be afib and something else (she cannot remember the term)), PALPITATIONS (Heart palpitations), MUSCULAR WEAKNESS (Started feeling weakness at the back of her neck), RASH MACULAR (red blotches), PRURITUS (itchy) and SLEEP DISORDER (disorder sleep) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment medication included an unspecified cream for an unknown indication. A week after the 1st dose (??-Mar-2021), patient reportedly had red blotches on her arms, face, back, thigh and chest areas. She consulted with two doctors and was prescribed with an unspecified cream which did not help. The red blotches are still present - they are itchy and she cannot sleep. She also says that she has to explain to everyone she meets that they are not contagious. She has an appointment with her rheumatologist on the last week of September. 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-2021-248016 (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.

Patient had arm soreness for a few days following vaccine and mild redness for 1-2 days. On 1/4, she developed an area of redness at injection site, about 2.5", warm to touch. She did not have a fever or pain. She was referred to urgent care for evaluation as unable to be seen by primary care office that day.

The injection did sting, but didn't think anything about it. For the first 30 minutes I did seem to be fine, so I was released, but my shoulder was not looked at. It was itching some. About an hour later I started getting a headache, some nasal congestion and a sore throat. I took a couple of Tylenol and went to bed early. Day 2 I felt sluggish and achy and my stomach was bothering me some. Day three my chilling was worse, but after Tylenol I began feeling better around 6:00 pm. The rest of the week I felt sleepy and achy. My shoulder was feeling sore. I am the type of person that tries to push through when I feel bad because I live a very busy life. On day 5 I finally looked at my left. It had a large red area beginning at the injection site. I got a tape measure and found it was 10 inches long and 3 inches wide. Today is day 6. I have finally admitted I feel bad and will rest a few days. I am wondering if I should skip taking the 2nd vaccination? . I am also taking some 60mgjAllegra on ce a day.

The patient passed away today, 1/13/2021. She was a hospice patient. She showed no adverse effects after receiving the vaccine on 1/12/2021. This morning she woke up as normal and during her morning shower she had a bowel movement, went limp and was non-responsive. The patient passed away at 7:45 am.

brieflysevere muscle pain approx 15 hrs later; following day[day #1] severe headache, nausea, chills, low grade fever, fatigue; #2-intermittent headache, loose stools x3, nausea, fatigue; #3- nausea, loose stool x2; fatigue; slight intermittent headache; #4- nausea , weakness; #4- better with some hives at injection site and upper arm

day #1- 4;15 AM w severe muscle pain for brief period. Day #1- severe headache; nausea; intermittent chills; very tired [slept most of day]; #2- intermittent headache [scale 5-6] nausea; loss of appetite; loose stools x3; fatigue; weakness; #3-better- still nausea, weakness' loose stool x2; loss of appetite; vague headache; #4- better w mild hives and itching at injection site and upper arm below site. lasted for two days.#5- no further symptoms

Friday night between 6 or 6:30 lost apatite, began to feel like had the flu, body aches. fatigue. pain in knee worsened, very tired. had to take half of a perkaset. and did not help. could not sleep because of the pain. the next day. felt really horrible, bad body aches. Could not stay awake. no apatite, eating made stomach upset Went to bed early about 9:00 and slept all night and all that day. just felt like fighting the flu. Had no energy. Felt better on the third day.

Few hrs after getting shot at mid day, lower back started aching. By 10:00 p.m. my lower back, sides were in pain and abdominal muscles and stomach were like frozen in place. Couldn't move anything and the area seemed to be swollen. Had lost appetite in late afternoon so had not eaten dinner, only liquids since figured I needed something. Couldn't sleep, aspirin didn't help. Next day around noon my abdominal area was better and pain decreasing on sides. Still no desire to eat. Trouble sleeping, 2nd day after shot, still lower back pain, feel bloated, no desire to eat. Very little side pain. Had slight headache This third night after shot I could finally sleep. This fourth day I felt back to normal. During all this time, the arm that had the shot never really bothered me

After 16 hours very tender at site of injection followed by shoulder pain when the left arm is lifted and left-side neck pain (not sharp, but an ache) when the head is turned to the left. Less so, but still achy when head is turned to the right..

6 days following the vaccine (1/22), extreme itching and redness around the injection site. Next day, it got (1/23) it got redder and itchier. It looked like there were 2 giant hives on my my arm (bigger than a nickel). Took 1 Benedryl (25mg), which didn't help. Hardly slept due to itching, and soreness to the touch. I can't wear a blouse with a sleeve. Today (Sunday 1/24), the redness came together into 1 big red blotch, measuring 2"x3.5". Hot to the touch, and very sensitive. I feel pain into my shoulder blade area and where my arm meets my body in the front. Also, pain going towards my elbow. Ice / cold packs make it feel better. I will call for Dr. appointment tomorrow (Monday morning).

Pain in right leg from hip area such that I was unable to put weight on right leg and had to walk with support and cane. This lasted for 3 days along with random muscle aches and dizziness at times. The pain gradually wore off and I can walk normally. I took Tylenol for the pain but it did not seem to help.

Patients states within 12 hours of vaccine administration she had urinary incontinence and butterfly rash developing into full facial rash and ear flushing. Incontinence resolved after 10 hours and facial flushing continues to improve 2 days later. Other more common symptoms included myalgias and fatigue. NO oral swelling/symptoms or difficulty swallowing

fever, muscle aches, headache, shortness of breath, loss of appetite, fatigue sleep, Tylenol, cpap with oxygen, aspirin (Bufferin) 2.5 days I am up and dressed on 2/3 (third day), but very tired and sleepy.

My mother, received the 1st vaccine for COVID 19 last week on Tuesday, Jan 26th. On Friday, Jan 29th, she started having diarrhea and continues to experience the same. She feels bad all over, can't get up and move around. When she stands and walks, she said she feels pain in the back of her neck and head. She is out of breath and generally laid in bed all day today. She is not eating much on a daily basis, today just some cheese and crackers and orange juice.

Patient states Right neck pain, middle and down Right arm, not sharp, in the evening after shot. Afib evening of 1-19-21, patient took nitro pill and called Dr.

Warm places on skin. Seems to be various places with pressure on them ie. chair, another body part, socks. There is no pain, no fever. It's just weird. Feels like sitting on the heated seats in my car.

Started with intense abdominal pain and need to evacuate/nearly fainted Started to run a fever accompanied bu aching in joints, muscles, head. The fever has continued for two days (low grade 100.8 plus or minus No appetite for two days so far

1/28/21 5:35 p.m. extreme fatigue (useless), 1/29/21 Muscle pain in both upper arms all day, 1/30/21Intense joint pain in left hip continued 1/31 and 2/1 plus painful to walk, sit down and get up again, Unable to lead with (before vaccine) good left leg to go up stairs and now am unable to walk on my own because of the hip joint pain and must use a walker or furniture to get around. Muscle pain in upper left arm has continued and frequently in the upper right arm. I am scheduled for the second dose of Moderna Covid-19 vaccine and am concerned about having same.

1/11 I had an EKG that was normal. after receiving the vaccine, my chest started hurting, both arms started hurting really bad. 30 hours later the arms stopped hurting but the chest was still hurting. back started hurting but went away but the chest still hurt. I went to Dr. 3 days after i started hurting and he did an EKG 1/25 and that evening the DR called and said "GO TO THE HOSPITAL YOU ARE HAVING A HEART ATTACK. CALL AN AMBULANCE." I took an ambulance to the hospital and had surgery and had 3 stints put in.

BILATERAL REDDENED RASH ON BOTH ARMS BEGINNING 2 DAYS AFTER VACCINATION ALONG WITH CONSTANT NECK PAIN. RASH STILL PRESENT, HOWEVER IMPROVED AS OF TODAY, SEEMS TO DISAPPEAR AND REAPPEAR. NECK PAIN CONTINUES AND IS CONSTANT

First, pain in arm before bed. Took Tylenol so I could sleep. Next day toward late afternoon, had soreness somewhat at upper center between shoulders. Tired and listless.

Upper arm pain from elbow to shoulder and throbbing. Some swelling in lower arm near wrist. Considering Urgent Care Visit

Patient complained of severe chest pain radiating to back within 5 minutes of vaccination. Significant language barrier but patient grimacing and clutching chest. Pain described as burning by family member. Evaluation by EMS, vital signs stable, Oxygen given and transported to Hospital ED - disposition unknown.

S.ymptoms: fever 2/14, 2/15 Muscle back pain severe 2/15, Diarrhea 2/14,2/15. Weakness, tired 2/14, 2/15, 2/16, 2/17

Patient developed severe gout in L foot 3 days post vaccine. Seen in office and treated. Hadn't had episode for 30 years. Was not on chronic gout medication. No other precipitating events. No change in foods or meds.

One hour after second injection on 2/17, felt a little 'out of it', then redness at injection site. 3" by 4" area of redness, warmth, stiffness and soreness at shoulder.

Five days ago, patient received her 2nd COVID vaccination. Following that she had myalgias and some sedation/confusion. She apparently stumbled and struck her head. She did not lose consciousness. She did recover from her symptoms by the next day. She has some soreness on her scalp in the scratch but no significant hematoma. However, she then developed some swelling and redness beneath her eyes. She is here to evaluate that. She she is back to her normal self. Comments: Patient has ecchymosis in swelling beneath both eyes and the bridge of her nose. It is nontender. Scalp-minor area of tenderness in the right vertex. There is a slight abrasion on the skin. No signs of hematoma. Assessment / Plan: 1. Contusion of scalp, initial encounter Contusion right scalp-I suspect patient's lungs are delicate skin informed a small hematoma. The swelling and bruising and 5th settle down into her eye sockets. I reassured patient that this will resolve the next 1-2 weeks. I believe patient had some severe myalgias and fatigue after a COVID shot. I do not think this is a longstanding problem. Expect her to get back to her normal self. Patient did have COVID-19 approximately 3 and half months ago. I told her that people have more significant reaction to the COVID vaccine after having had the illness. At this point, I do not agree need further workup.

Red circle about 3" round at the base of my neck with red line going from circle to each side of my neckIt did nt hurt unless touched but when touched felt like a burning sensation. Was still very red the next day but did not hurt anymore when touched . It is now two days later and redness is still their but much lighter. Called my doctor was told to watch it & come in if it got worse.l

Got the vaccine and was feeling tired, and her arm hurt, an all she wanted to do was lay in bed with her heating pad. The following day she woke up with a headache, some nausea but nothing came up. She also had diarrhea and her arm was sore. She felt weak, and since she had COVID she has had shortness of breath. She stayed in the bed all day unless she had to as her arm felt like it was made of metal and was extremely tired. She was moving around upstairs and somewhere around 8:00 PM she went to the bathroom, was sweating profusely and wiping herself with tissue, and apparently turned out the light and apparently passed out as she woke up on the floor in the hallway and could not get up right away. She could not use the left arm, was able to get herself up with the help of the door to stand on her feet. She walked into her room and sat on the bed, and did not lay back down and greatful that she did not fall down the steps. She went back to bed, but in the morning she was terrified and her family heard her talking to the doctor on call who told her to go to the ER. In the ER they told her that she had syncope, seen by Dr. at Health Care. She was admitted at 11:11 AM on 2/27/21. She was given IV, had a CAT scan of her head, told her that it did not reveal any blood. After several hours they discharged her. She called her doctor and she has an appointment tomorrow morning. She is feeling tired, not sleeping well.

Per MD/PA report: Received 2nd vaccine on 3/5/21. That evening, began to have diffuse myalgias, became too weak to get up from being seated and could not walk. Was admitted to the hospital for rhabdomyolysis. Hydrated.

Hours after receiving the 1st Moderna Vaccine patient realized left arm would not move at all and left leg was weak and dragging. Called ambulance and was transported to Hospital. No other signs of a stroke, other than paralyzed left arm and weak leg. Initial scans did not show a stroke. Patient could talk fine, smile, etc. Ran tests in ER, then admitted patient. Treated with muscle relaxers given arm was bent and stiff and would not move. After admitted, the next day an MRI was performed and indicated a stroke in the part of the brain which affects the left side. Began treatment for stroke with blood thinners, etc. Patient moved to Rehab after 4 days in hospital. Remained in Rehab until Monday, March 15th then discharged with weakness in arm and leg remaining.

Moderna COVID-19 Vaccine EUA injection side pain, swelling and redness, fatigue, muscle and joint pain, chills, nausea. also some dizziness, and weakness, no energy. This is still ongoing on 3/12/2021, 10:00AM MST

knocked her out; uncontrollable shaking; terrible neck pain; terrible neck stiffness; pain down spine; sternum hurt; toes hurt; fingers hurt; overwhelming fatigue; chills; nausea; joint pain; body pain; A spontaneous report was received from a consumer concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, and joint pain. The patient's medical history was not provided. Concomitant medications reported were Paxil, melatonin, red yeast rice supplement, fish oil, Hydrochlorothiazide for drug use for unknown indication. On 28 Jan 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. On an unknown date, the patient experienced the events overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain. Treatment details included Tylenol and ibuprofen Action taken with mRNA-1273 in response to the events was not reported. At the time of reporting, the outcome of events include, overwhelming fatigue, chills, uncontrollable shaking, terrible neck pain, terrible neck stiffness, pain down spine, sternum hurt, nausea, toes hurt, fingers hurt, knocked her out, joint pain was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

right arm extensive erythematous, papular rash with crusting lasting more than 10 days, radiating from right lateral upper arm to right wrist. some pain and mild itching.

Soreness, lethargy/fatigue, and sneezing for approximately 3-4 days. Patient now feels completely fine.

faints when she gets up; Yesterday started to get itch and rash around the injection site; Yesterday started to get itch and rash around the injection site; Was sick for days; joint pains; fatigue; headache; muscle pain; chills; sore arm; A spontaneous report was received from a consumer who was an 82-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm, was sick for days, fatigue, headache, muscle pain, joint pains, chills, itch and rash around the injection site and faints when I get up. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03-Mar-2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 013A21A) intramuscularly for prophylaxis of COVID-19 infection. On 03-Mar-2021, the patient experienced the events sore arm. She reported that she was sick for days, suffered fatigue, headache, muscle and joint pain and chills. On 06-Mar-2021, she stated that her vaccination site started to itch and a rash developed around it and that she felt tired all day. On 07-Mar-2021, she reported that the redness and itchiness at the injection site was gone and that she felt better but still like when she had Covid in the past. Additionally, patient reported that she fainted when she got up (date unknown). Treatment included paracetamol 2 tablets on 06-Mar-2021 in the evening. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, itch and rash around the injection site, was considered recovered/resolved. The outcome of the events, sore arm, was sick for days, fatigue, headache, muscle pain, joint pains, chills and faints when I get up, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Immediately following the second vaccination, the individual's arm felt heavy and she had pain at the injection site. Around 10-11 hours later that evening, the individual started feeling dizzy, experienced fever and chills, had shooting pain in her arm at the injection site, severe fatigue, appetite loss, headache and experienced diplopia. These symptoms lasted about a day and a half. The first 24 hours were the worst.

Day 2 severe pain in upper arms and shoulders (both). Same pain as I experience after a nuclear stress. test. Vaccine site was badly inflamed and itchy for next 4-5 days.. Also noticed a scale-y patch at the injection site. Use Cortizone on it and it made the pain in my left arm and shoulder really hurt. Severe diarrhea all day the 18th. No known reason for it. 19th very tired. 20th unable to go to sleep all night. Body aches travelled up and down my body. 3/21, up at 1:30, took shower and started to fix breakfast. Suddenly felt like I was going to vomit. Very sweaty and dizzy on the way to the bathroom. Threw up, no diarrhea. Vomit was yellow, foamy liquid. 3/22 left shoulder much pain at bedtime. Took tramadol and applied heat pad to shoulder. Shoulder still has issues.

Right arm full of blood; Fell while walking, over the right arm; Has to crawl, drag herself to the phone; Joints still swollen; Muscles, legs, hip, and knees were steel; Arm sore; Elbow sore; A spontaneous report was received from a consumer who was an 83-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right arm full of blood/ hemorrhage, fell while walking/ fall, has to crawl/ mobility decreased, joints swollen, muscles, legs, hip, and knees were steel/ musculoskeletal stiffness, arm sore/ pain in extremity, and elbow sore/ arthralgia. The patient's medical history included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included unspecified blood thinners, blood pressure medications, and vitamins. On 4 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch: Not provided) Intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 4 Mar 2021, the patient could not get up from bed. She stated her muscles, legs, hip and knees were steel. The patient stated she fell while walking, over her right arm- which resulted in the right arm sore and full of blood. The patient stated she had to crawl, drag herself and her joints still swollen, and elbow sore. No treatment information was provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable. The outcomes of events were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Body aches and pains, severe headache, lack of appetite, lack of energy, started Tuesday at 3:00 AM. Lasted about 24 hours! Wednesday 3/24/2021 7: OO AM A LARGE red and swollen area appeared on left upper are! Redder are around injection site. Arm sore and heavy feeling. Rash was hive like. Mild itchiness! Rash present still on Thursday 03/25/2021. Beginning to feel better.

leg was hurting and had a hard time to get out of the chair; Tried to sit in the kitchen chair which is hard, and also had hard time walking; can hardly bend the leg and that didn't hurt when was laying in bed; goes from the groin area to the toes; A spontaneous report was received from a 83-years-old female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events leg was hurting and had a hard time to get out of the chair, tried to sit in the kitchen chair which is hard, and also had hard time walking, swelling goes from the groin area to the toes and can hardly bend the leg and that didn't hurt when was lying in bed. The consumer's medical history was not provided. The consumer's current condition included congestive heart failure (CHF). No relevant concomitant medications were reported. On 23-FEB-2021, prior to the onset of the events the consumer received second of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly for prophylaxis of COVID-19 infection. On 20-JAN-2021, prior to the onset of the events the consumer received first of two planned doses of mRNA-1273 (lot/batch: 013M20A) intramuscularly for prophylaxis of COVID-19 infection. On 03-MAR-2021, after the second dose the consumer experienced events leg was hurting and had a hard time to get out of the chair, tried to sit in the kitchen chair which is hard, and also had hard time walking, swelling goes from the groin area to the toes and can hardly bend the leg and that didn't hurt when was lying in bed. No treatment information for the events was provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome for the events was unknown. The assessment was not provided for the events.; Reporter's Comments: This case concerns an 83-year-old female with PMH of CHF who had serious unexpected events of pain in extremity and gait disturbance along with nonserious unexpected limb discomfort and peripheral swelling. Event onset occurred 9 days after the first dose of mRNA-1273. Treatment not reported. 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.

Fever of 102, nausea, flu symptoms i.e. muscle aches, headace. Lasted about 8 hours, felt normal after symptoms abated

The morning after her shot she felt unwell and did not get up for any meals. She said she couldn't lift her legs and she could not tell when she had to go to the bathroom. Prior to this shot she was able to walk with a walker ; she knew when she had to go to the bathroom and she got up by herself in the morning and knew what her routine was. Now she is unable to walk and is totally incontinent. She does not know her routine anymore and is waiting for directions from her caretakers on when to get up, when to go to the bathroom and sits in bed all day or is moved to a chair by caretakers. She needs pillows propped around her in order to sit upright.

tarry black diarrhea; swollen foot; vomiting; possible gout attack; possible cellulitis; shceduled to receive the second dose after 58 days; Runny nose; hard area at injection site; tender to touch the injection site; left arm swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GOUT (possible gout attack), CELLULITIS (possible cellulitis), FAECES DISCOLOURED (tarry black diarrhea), PERIPHERAL SWELLING (swollen foot) and VOMITING (vomiting) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) 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). Concomitant products included CITALOPRAM, RIVASTIGMINE (EXELON [RIVASTIGMINE]), FAMOTIDINE, ASPIRIN [ACETYLSALICYLIC ACID], ZOLPIDEM TARTRATE (AMBIEN), XANTOFYL (LUTEIN OPT), KRILL OIL, CALCIUM, VITAMIN B3, VITAMIN C [ASCORBIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]), TOCOPHEROL (VITAMIN E [TOCOPHEROL]), CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) and EVOLOCUMAB (REPATHA) for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced RHINORRHOEA (Runny nose), VACCINATION SITE INDURATION (hard area at injection site), VACCINATION SITE PAIN (tender to touch the injection site) and VACCINATION SITE SWELLING (left arm swelling). On 15-Feb-2021, the patient experienced FAECES DISCOLOURED (tarry black diarrhea) (seriousness criterion hospitalization), PERIPHERAL SWELLING (swollen foot) (seriousness criterion hospitalization) and VOMITING (vomiting) (seriousness criterion hospitalization). On an unknown date, the patient experienced GOUT (possible gout attack) (seriousness criterion hospitalization), CELLULITIS (possible cellulitis) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shceduled to receive the second dose after 58 days). The patient was hospitalized for 8 days due to CELLULITIS, FAECES DISCOLOURED, GOUT, PERIPHERAL SWELLING and VOMITING. On 03-Feb-2021, RHINORRHOEA (Runny nose), VACCINATION SITE INDURATION (hard area at injection site), VACCINATION SITE PAIN (tender to touch the injection site) and VACCINATION SITE SWELLING (left arm swelling) had resolved. At the time of the report, GOUT (possible gout attack), CELLULITIS (possible cellulitis), FAECES DISCOLOURED (tarry black diarrhea), PERIPHERAL SWELLING (swollen foot) and VOMITING (vomiting) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (shceduled to receive the second dose after 58 days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was started on antibiotics and prednisone treatment for possible gout attack or cellulitis. No treatment information regarding other events was available.; Sender's Comments: This case of an 83-year-old female patient who experienced inappropriate schedule of vaccine administered after first dose of mRNA-1273 (58 days). Based on temporal association between mRNA-1273 use and onset of the events of runny nose, vaccination site induration, pain and swelling, a causal relationship cannot be excluded. There is not enough information to assess the other events due to lack of critical details in patient's medical history. Additional information is being requested.

Today April 9 returned from getting 2nd dose. By 5pm exhaustion and sleepy. Slept for a few hours. Around 8pm broke out in sweats, 9pm chills, backache