Moderna

3:45 AM awoke with dizziness and loss of balance. 4:57AM awoke again with more intense dizziness and loss of balance; stubbled, fell in bathroom. Symptoms have persisted of state of drunkenness' when walking and head is feeling "weird".

Client's care giver stated she was not as talkative following vaccination, was dizzy and lethargic (Client was in a wheelchair in her van in the 15 minute waiting area from the drive thru event) VSS and not recorded. No LOC for client. Due to extensive list of allergies, client was transported by EMS to ER.

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.

Day 1-3: Sore arm, fatigue Day 4-6: Normal Day 7-present: Injection site is red, swollen and hot, fatigue, dizziness, vertigo, weakness

Day 1-3: Fatigue, sore arm Day 4-6: None Day 7-9: Injection site red, swollen and hot, fatigue, vertigo, dizziness, weakness, facial swelling---experiencing now.

Approximately 5 minutes post-vaccination patient called for staff saying she felt lightheaded. Staff arrived and moved patient to floor, head supported by patient's jacket. We placed her feet above head (in a chair). Upon questioning patient about her history with vaccines, patient stated she had had a similar reaction with blood draws, but not with a vaccine. Patient also stated she is borderline diabetic and had only eaten a small bowl of cereal this morning and not had lunch yet. Patient stated she was feeling better, we sat her up and she drank a bottle of orange juice. Patient monitored for another 15 minutes, felt well and was escorted to her to her apartment and she claimed she felt well. Patient instructed to call her PCP, 911, or go to the nearest emergency emergency room for any additional issues.

Patient said she felt the meds going into her system after the vaccine was given and she became dizzy. Her vital signs were taken over a course of 30 minutes and her blood pressure kept getting higher and higher to 210/140/ Pulse 55 and O2 sat was 99%. Dr. was called and she recommended pt be taken to the ER by the ambulance. The ambulance was called but the pt ended up leaving in the car with her son. I called both Medical Center and Hospital but pt had not been admitted to the ER this afternoon.

Five minutes after the vaccine was injected, I became dizzy, my eyes teared and face swelled up and throat tightened. The EMT's came, checked my lungs, etc. and talked me through the episode which lasted about 15 minutes. Then the swelling subsided. I suspect it had, because I had dermal fillers approximately a year ago. I had no other adverse affects, except for tiredness that evening. People should be warned about this because it is a frightening event. I have never had an adverse reaction to a vaccine before.

Immediate burning sensation in arm and lightheadedness, lasting 10 minutes. Felt weak for another 1/2 hour. Red blotch on arm lasted 5 days, went away but came back a couple days later. This time was very itchy, swollen and hot. Size was about 3 inches down my arm from the injection site.. Lasted about 4 days. Two weeks from shot, arm once again was itchy, with red dots near injection shot and down the arm.

On 1/13/21 throat suddenly seized, had to work hard to expell or inhale air Turned slightly got dizzy then almost passed out but held on to handle of cart and then it passed and was able to breathe freely whole episode took about 20 seconds on the following night (1//14/21) about the same time was overwhelmed with nausea and strong abdominal cramps . Thought I was coming down with the stomach flu. Reaction disappeared after about an hour.

strong headache , brain fog, chills, nausea, heavy chest, heart palpitations,dizziness hot red spot 3 inches on arm

shot 2:30 pm slept woke up got coffee, sat down felt dizzy sweating weak nausea high blood pressure 172/113

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

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.

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

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

The morning after receiving the vaccine, I could barely use my arms and had no use of my legs. My husband called an ambulance and I was taken to emergency room. I did not regain use of my legs until approximately 3:00 A.M., MONDAY 18. Around 4:00 P.M., I was released to go home with PT through an in-home health provider. While in the hospital MRI, x-rays, numerous blood work, etc. we?re performed. No reason could be found. It was speculated that I still had antibodies from having COVID in December and the vaccine was too much.

I slept for more than24 hours, getting up only 3 times to use the restroom and take Tylenal. I had headaches, body aches, dizziness and nausea. I will call my doctor tomorrow. I did not die.

My arm wasn't sore right away but I think I laid on it and the next morning it was sore. It felt like a bee sting I took some medicine and it went away. On the 27th I had bad gas. I did try a new cereal and thought it was cereal. On the 28th I still gas and upset stomach like flu like symptoms and felt light headed but not bad. On the 29th still an upset stomach and had diarrhea, I was still light headed and really shaky. I was really weak. I was shaking a lot at arms (hands) and legs were both shaking and made it hard to walk. On the 30th I still really light headed and my legs and hands were still shaky, still having difficulty walking, still had an upset stomach and still felt weak. On the 31st my stomach was a lot better, I was still shaky and light headed, and I had a weak feeling. My head felt like when you feel like you have a head cold (pressure in my head). Today my stomach is better, I am still lightheaded and still shaky but not as bad. I still feel pressure in my head, but no runny nose or any other cold symptoms. These were symptoms I had in March when I was sick for 3 weeks. I was negative for COVID but didn't get back to my normal self until the June. Doctor was a private practice and recently closed so I do not see my new doctor till the 24th.

DIZZY 5/10 1000 BLOOD PRESSURE 105/70, HEART RATE 50, OXYGEN SATURATION 97. PATIENT COMPLAINS OF DIZZINESS PATIENT IS SPANISH SPEAKING ONLY. DAUGHTER IN LAW IN CAR WITH PATIENT. PAIENT IS ALERT AND ORIENTED X3. GAVE PATIENT AN ORANGE AND BOTTLE OF GATORADE. PATIENT DENIES ANY DIFFICULTY SWALLOWING OR SHORTNESS OF BREATH. SAT WITH PATIENT FOR 10 MINUTES. 1015 PATIENT WAITED 15 MINUTES. PATIENT STATES SHE IS GOOD TO GO HOME. DAUGHTER IN LAW IS DRIVING AND IS TAKING PATIENT HOME TO EAT.

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.

Patient reported being flushed, dizzy, and having blurred vision. We gave her water and kept monitoring her to evaluate for 30 minutes to see if she needed to get checked out in the adjacent urgent care. She felt better after waiting for 30 minutes and did not need to seek treatment.

Patient had already been observed for 15 minutes and left the facility. Patient stated while on her way home her and her husband were discussing side effects when she started to feel SOB, dizziness, and slight chest pain so they returned to the clinic. Full set of vitals was taken. Doctor evaluated patient. Patient started feeling better after drinking some water. Second set of vitals taken and patient discharged to go home with husband 1215pm.

Tuesday after my injection I started getting nauseous, my right arm was very red and swollen along the injection site and overflowed into my upper arm. These symptoms lasted 7 days. When I went to bed on Tuesday night, I woke up early in the morning with palpitations, very nauseated, and light headed. The palpitations lasted about 2 hours, light headedness about 30 minutes. I had no further palpitations or light headedness after this.

Patient states two hours following vaccine injection, she experienced dizziness, feeling faint and an erratic heart (40-83 beats per minute) Breathing was fine, oxygen saturation was at 98. These symptoms lasted for about 2 hours.

Extreme pain and bruising in the left arm which lasted for 4 days, decreasing pain each day. I couldn't sleep lying on my left side. Very restless the first night with little sleep. Small bruise is still showing 7 days later. Mild headache, nausea, and dizziness for 4 days.

Evening of vaccine patient felt chills that lasted through out the night. Patient got up Sunday morning and passed out, fell to floor. Patient reports that once she woke up it was about 15 mins before she could get off the floor. All day Sunday felt very fatigued and rested. Then felt "foggy" on Monday.

About 3:00 p.m. of day of injection, head felt "fuzzy" and I felt somewhat unsteady upon standing and walking. Today, next day, I feel a little better.

At 10:58 am patient stated "I feel like I'm going to pass out". EMS called. At 11:02 am patient stated "I feel faint" & c/o nausea and a "humming sensation" at bilateral ears. Applied cool compresses and monitored until EMS arrived at 11:14 am. Patient transported to local ER by EMS. Vital signs stable.

When injected in the shoulder it was very painful. Went home and laid down. When I got up I could not move my arm without severe pain. I believe the shot was injected too high on my shoulder. Pain was severe for 3 days and I took maximum Tylenol. The arm is usuable now, pain is less, still have trouble raising the arm up or back. I have had no other ill effects from the vaccine.

Red rash at injection site approximately 3-4 inches circle-fading for 5 days. On and off itch-5 days. On and off slight dizziness-5 days. Headache-first evening of rash.

Emergency Medical Technician was on-site during clinic performing medical observation of vaccine recipients. Patient complained of feeling light-headed and general uneasiness. BP taken by EMT was 170/90 and pulse 72. Patient was aware and able to walk on her own. Patient walked to her vehicle, assisted by EMT, but she returned to the building because she still wasn't feeling well. EMT contacted emergency services for transport of the patient to Hospital ED.

Approximately 9:00 PM, experienced severe chills, after having zero side effects all day. She went to bed, and could not get warm. She was unable to use body muscles, could not stand without help, and was conscious, but was unaware of her surroundings. She started regaining muscle control about 12:30 AM, but still no awareness of things around her. Next morning, she was fine, with no remaining side effects. It should be noted that she had a small glass of red wine about 30 minutes before experiencing chills.

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.

Patient stated she felt a little "woozy" for a few seconds but stated the feeling had subsided by the time of staff arrival. Patient stated she only had a headache. Patient advised to call PCP, 911, or go to the nearest emergency room if she has any further symptoms.

less than 24 hours after shot was given, started to feel "crummy" and got worse as the day progressed. Right arm got very sore, to the point of not being able to move it for a day; fever of 101.2, chills, sweats, stayed in bed most of Tuesday (the day after the shot was given), and then symptoms subsided Wednesday, but was weak and fatigued enough to stay in bed all day. Thursday, tried a little physical activity, and after 30 minutes playing croquet, had to stop and sit down. Went hon=me and napped again. Friday, napped most of day, as on Saturday, and yesterday, Sunday. Today is one week after the shot and I'm still feeling weak - not my normal self.

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)

Initially was fine but a few hours later arm hurt. Was unable to move arm the next day and felt tired but on day two, felt so much better. Noticed that now her arm w as itchy and had a small round circle. Notice that the red circle was getting bigger and felt hot.

Fever for 24 hours Chills Lightheaded Nausea Extreme fatigue Pain at site of shot Chest pains New left axillary Adenopsthy -CT scan 2/11/21

Headache, nausea, chills, dizziness, exhaustion, body aches, thought process diminished, excessive urination....for over a week

2:00 A.M. 2/18/2021 I awoke with muscle pain in left arm and left side of body. I arose to use the bathroom and when standing at the sink experienced the room beginning to spin and darken. I steadied myself at the sink; the dizziness passed; I returned to bed after taking two Tylenol tablets to relieve the pain. My husband, who also received the Covid Moderna vaccine yesterday 2/17/2021 at 10:55 a.m. , was also awakened at 2:00 a.m. 2/18/20121 with the same muscle pains. 6:30 a.m. 2/18/2021 we were both feeling much better and able to carry on usual life activities (such as they are...) [note 1: I walked 3 miles yesterday afternoon after receiving the vaccine and feeling perfectly fine.] [note 2: we both are enormously grateful for the vaccine!]

Vaccine Clinic: Patient (10/29/44) received her 2nd dose of the Moderna Vaccine today. She and her son waited in the observation area for 15 minutes and when they getting ready to leave, Patient stood up and felt weak and dizzy. Son sat her back down in the chair and the nursing student called out for my attention. I went over and assessed the patient. MA went and got a manual BP cuff. Patient reported weakness and dizziness. I asked a team member to get Dr. and he quickly came over and assessed the patient. He advised that the patient stay in observation another 20-30 minutes and report any changes. I offered water and a snack, but patient refused. We had the patient and son stay as instructed. About 25 minutes later, the patient was more alert and reported feeling better. I offered to wheel her out in a wheelchair and she refused. Son also stated that she is doing better. Patient and son, were escorted out the vaccine clinic. No other issues reported.

Pt was found sitting on a chair by the exit door. Pt felt dizzy and lightheaded. Said she is a dm2 and skipped breakfast. Was fine when she arrived to have the Covid vaccination today. Pt had the the vaccine for the very first time today. Pt was moved to the medical room for observation. Pt wanted to sit in wheelchair and not lie on stretcher. Pt rested fro 15 min and had her vs checked. Pt vs were normal and felt better. Pt Bsl were checked via finger stick and was 93. Pt had some water and crackers and felt good. Pt was released to observation area and checked out.

About 22 hours after the vaccination I became very weak, could not get up from the floor, was very fatigued, disoriented, and could not walk without being held up. I went home, and slept most of the rest of the day. The following day I was listless with very little energy. I took several naps. Late in the day, the second day after vaccination, I ate food and am feeling a little better.

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

light headedness, nausea, headache, fever 100, chills, extreme fatigue lasted 12 hours at least recovered after 24 hours

Reported that experienced the onset of dizziness, "full feeling in head" at 30 minute discharge time- stated that these symptoms had started @ 2 minutes after Covid-19 vaccine was administered but was not reported until discharge ( did have multiple check-ins in waiting area) "hoping it would go away" no SOB, no urticaria, no facial swelling

I woke up Friday 2/12 morning very dizzy. The dizziness subsided. Later Friday afternoon, I had severe dizziness and was vomiting when I got up. I went to Clinic Saturday 2/13, for being unbalanced and weak, but not so dizzy. Sunday 2/14 I was extremely weak with low blood pressure and fast heart rate. Monday 2/15, in the morning, my left arm started hurting, swelling, was feverish, red, itchy and I had a rash at the injection site. I went to my doctor on 2/19 and he stated that maybe I should not get the 2nd vaccine shot. He stated that he was not certain that everything that happened was a result of the vaccine, but that he couldn't say that it wasn't.

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.

On the evening of the first vaccination, my sister experienced chills and fever. The next morning she experienced a kind of paralysis, could not sit up or stand up, was falling out of bed and out of her chair, had to be carried to the bathroom, although she usually can walk by herself. This lasted about a day. I took her to the ER where they excluded other possible causes of her condition and simiply attributed it to the vaccine. No treatment was prescribed.

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 .

24 hours after vaccination felt instant dizziness and nausea and fell against the wall. Crawled to the bed and collapsed. Stayed in bed with head flat for 2 days. Had to be helped to the bathroom. No walking capabilities. Gradually started coming out of it on the third day, still not able to have head up while trying to eat and drink. 4th day better in the morning with head up and walking. Seemingly gone by evening. Horrible episode.

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.

Periodic pressure and tightness across chest and diaphragm especially on day of vaccination and following 2 days. Rapid heart beat followed by afib that was not terminated with normal medications. Dizziness and shortness of breath. Hospitalized with atrial fibrillation with rapid ventricular response. It resolved after getting two injections of a medication called diltiazem in the emergency department, after which I was monitored overnight in the hospital. Underwent stress test and echocardiogram - results normal. On the day I write this (March 1) continue to have shorter periods of rise in blood pressure and heart rate, diaphragm tightness, insomnia and lethargy.

Tiredness that night and the next morning i felt like i had not slept and continued over 5 days. i was so sleepy. legs were very shaky and i was very nervous inside. I had shortness of breath and i still have it. I road a bike 4 to 6 miles every day and now i cant. i had chills and body pain, i feel like i had the flu. dizziness, just just random spouts of sleepiness and it would last for about an 1 hr and half. My muscle in my chest just tightens and is hard as a rock. and then it goes away.

Dizzy, difficulty walking due to loss of balance. Husband drove me to clinic where my blood pressure was above 214. Dr advised immediate trip to ER possible TIA. At ER in Hospital I was greeted by a nurse at the curb with a wheelchair. .

Patient stated that she had throat tightness and dizziness with in 15 minutes of receiving the vaccine. She report this to me on 03/04/2021. She stated that the sensation lasted about 1hour and 30minutes. She did not seek medical attention.

Pt. got lightheaded, and felt tingly all over about 10 minutes after shot (12:10). About 10 minutes (12:20) letter started feeling "Chest tightening". She denied not shortness of breath, and no other symptoms. About 2 minutes after that all symptoms were resolved. She denied BP check, & EMS. Reports when she got home felt yucky & whoozy but was still able to do chores. Around 9:00 pm started feeling short of breath and real tight chest. She put vicks vapor rub on chest and in nose and about 20-30 minutes felt a little better. She was able to sleep her normal amount. She reports she is back to her baseline this morning.

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.

Instantly felt shot material go through veins on L side of chest, 15 minutes later extremely light headed, 10 min later L side of face become numb, headache, 30 min later L arm swelled to side of 1/2 of baseball, lymph nodes under L arm and on L collar bone became enlarged. Arm swelling lasted 4 weeks, Lymph nodes have not gone down and it has been 5 wks, Advised by Nurse Practioner at Pharmacy advised me not to get 2nd shot. I am extremely healthy and work 5 days/wk, workout at gym 3x /wk Weights and Total Body Lift classes. Sided effects were a major surprise!

The day after the vaccination, I started having a very bad dizziness, and vertigo, and they are ongoing up to today. I went to the doctor and she prescribed some pills called LOSARTAN 25 mg. but they have not done anything, and on the contrary they gave me very bad leg cramps, and a bad pain on my right leg.

Dizziness for month following Burning eyes for month following Skin rash below injection site - 7 days later; lasted week

Left arm swollen from injection to below elbow...itching - red ...having difficulty using my fingers

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.

I lost control of muscles in my arms, legs, bladder, and mouth. I could not sit up, stand up or even grasp a bottle of water. I had trouble speaking and lost complete control of my bladder. My husband called 911 and the end stayed with me and took vitals. I was in this state for about 7 hours. After this I continued to be very tired for about 5 days.

Pt. reports Sat. night developed chills, was dizzy and vision was "bad, like my eyes were tired and had trouble focusing them and just wanted to go to bed", Reports woke up with same symptoms and also had some confusion and had red swollen hard area on L arm were vaccine was given and it is still red and swollen today.

sx APPROXIMATELY 20-30MINS AFTER: Facility nurse reported feeling light headed, heart rate was 44 bpm, feeling cloudy, fatigued

Total weakness. Could not get out of bed without being lifted. After getting up was able to walk with assistance. No appetite or thirst. Could not stay awake. Slept most of a 36 hour period. No treatment given. After that was tired for another 2 days but able to maintain a schedule.

Same day vaccine second dose given March 4. Between 15 minutes reaction was dizziness, difficulty breathing. Went into adverse reaction. Did not wake up - moved to ER

"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

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.

Had severe headache, chills with body shakes, fever, body aches, dizziness, fatigue, and painful arm at injection site that lasted for 24 hours after second vaccine on the 13nth of March, 2021.

Symptoms started suddenly without warning: weakness/fatigue- hard could get out of vehicle , needed assistance. chills shortness of breath excessive thirst

Second Covid Response to Moderna I had a very severe reaction to she second Moderna shot (3/4/2. I went grocery shopping the afternoon after I had my shot at about 11am. Everything seemed normal, but after 20 minutes I was in an episode of the Twilight Zone . I bought the wrong products, I also bought several of the same thing. I bought products I never would have bought and had never purchased before. Then I got home and was feeling still like I was in the Twilight Zone. (nothing seemed real). Soon after I fell on the floor and could not get up. My leg and back would not work. Then I started to urinate and could not stop. Buckets came out and every time I tried to get up, I fell completely flat again. The urination lasted from early afternoon till about 6:30 pm. Then I went to bed and stayed there till morning when I could get up and walk. Meantime I had to wash my bedding, 3 pairs of pajamas and seven pairs of under pants. One of the times I fell, my foot (which was recovering from a burn across my toes) and I jammed it between the wall and the bed, causing a break. Also the first night I took the shot, I could not get to sleep until 4am (my cat and I were stuck watching Robo Cop till it ended at 4am. I?m now in a boot-cast, and will get an x ray tomorrow. I should let you know I take Sartaline HC, 100 mg once a day and Clonazepan, 1 mg 3 times a day.

Patient had her BP increased and light headed after vaccine 158/70 HR:86. Patient stated that she had her kitchen stove had caught fire this morning and she was upset about it. Nurse ask if patient about history of anxiety and she stated yes. So she stayed another 15 minutes in the observation area to make sure everything was ok. Nurse rechecked BP 156/75 HR:80. Patient felt better after 5 minutes of first symptoms. Nurse advice patient to seek medical attention if symptoms gets worst. Patient had no pain or general discomfort or dizziness or light headedness increased HR.

My blood pressure fell to 60/40, could not stand, light headed but did not pass out. It took all day for my g blood pressure to return slowly to normal. slight fever between 100 and 101, not over 100.7

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

Fell on the floor while leaving the building, denies hitting her head, and states she has no pain, and refused hospital treatment.

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).

She received vaccine at 1140 am. At 1200pm, she c/o dizziness upon standing and intermittent chest pain. She stated that she had not eaten today. Crackers and water given. Chest pain worsened. Dr evaluated pt. 911 called. EKG done;no acute changes noted. She was taken to the ER by fire department.

Woke up about 12 hours later, teeth chattering, dizziness, nausea, arm extremely sore, chills and feeling really cold and couldn't get warm. She had diarrhea, lightheadedness, couldn't keep anything down. She tried drinking ginger ale. Lasted for about 20 hours. She started feeling better afterwards. Later she had no taste for food which lasted about 2 weeks. After 5 weeks, she has no taste for wine.

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.

02/25 I had my first dose- within the 15 minutes after I felt dizzy and lightheaded. it subsided enough for me to drive home. I was tired for a few days. injection was very high up in my shoulder and about 3 weeks after I had tenderness in my elbow. My physical therapist said it was due to the injection being too high. 03/25- halfway home I had a significant headache. It diminished but I then got very very sleepy. I napped and then made dinner. 03/26 I was doing normal things and I felt cold, then my hands were very cold. I ate lunch but was very sleepy just before lunch. I then had a fever, My temp is 101.1. I have had a little drainage from one side of my nose.

I am allergic shellfish, the nurse ask me if I was allergic and I told her shellfish only. She gave me the shot anyway, that night I had chills, fever, and diarrhea. The next day I was ok but the following day I noticed my memory started to decline. It got worse where I develop a speech problem and my blood pressure was high. I also noticed that I had an unexpected limp. I went to urgent care and they performed a CT scan of my brain to see if I had a stroke. The results were negative. I wasn't getting better so they wanted me to go straight to the hospital to get an MRI. The hospital performed the MRI with contrast dye to get images of my brain (stroke). Results are neg,

Patient reports tingling and numbness down whole arm after receiving vaccine; could feel and move hands after 20 minutes but could not lift arm without assistance. Refused EMS transport; mother of patient opted to take her mother to urgent care.

The next morning, severe headache, vomiting, chills, sweating, passed out hit my head and now have a black eye and cheek bone swallon. extemely tired, light headed nausea .

Pt is a previously healthy 76 year old woman who received her covid vaccine 2 wks ago. She received Moderna vaccine on 3/8/21. On 3/16/21 She developed symptoms of fatigue, chills, body aches, decreased exercise tolerance. 3/19/21 exercised at YMCA as she does regularly. She was not able to do her usual level of activity and was only able to exercise low level for 10 minutes. Yesterday was very sob and after washing 2 windows had to lay down and rest. In my office the nurse rooming the pt noted the pt to be very winded and sob just ambulating from waiting room to the exam room. Pox was down to 89% and took a while to come up to 94%. Transferred to Hospital ED. DiagnosedDiagnosis: Acute hypoxic respiratory failure secondary to massive Pulmonary Emboli, DVT without known precipitating factors. pt without previous history of clotting disorder, no known neoplasm, no recent travel or sedentary period. unprovoked DVT with MASSIVE PE. patient did not have previous pulmonary disease. Additional information for Item 19: studies: PO Chest Final Result Stable chest. No new opacities are identified in this patient with known extensive bilateral pulmonary embolus. US Venous Duplex Lower Extremity Bilateral Final Result 1. Acute DVT involving the right popliteal and posterior tibial veins. 2. No acute DVT involving the left lower extremity. CT PE Protocol WITHOUT legs Final Result 1. Positive exam: Large-volume central pulmonary emboli seen in both main pulmonary arteries with extension bilaterally into all lobes. Dilated right heart chambers suggesting acute right heart strain. 2. Peripheral groundglass opacities in the right upper lobe may represent small area of pulmonary hemorrhage or developing infarct. Red Level 1 findings were entered into the system. | Actionable Findings system for documentation and communications on 3/22/2021 4:31 PM, Message ID 191499. 3. Pulmonary nodules in the right lower lobe measure up to 4 mm maximally. See below consensus guidelines. TTE - INTERPRETATION SUMMARY: Left ventricle is normal in size. There is normal left ventricular systolic function. The quantitative LVEF based on modified Simpson's method is 62%. There is asymmetric septal hypertrophy with maximal wall thickness of 1.3 cm. There is mild (grade I) diastolic dysfunction with normal left atrial pressure. Right ventricle is normal in size. There is normal right ventricular systolic function. No previous echocardiogram in Froedtert Health system for comparison.

Presented like a stroke approximately 22 hours later - slouched, leaning sideways, breathing, but unresponsive. Called EMTs who transported her to ER where tests showed slight fever and minor dehydration

The next day, I felt light headed and very tired. I felt that way for about three weeks. I had loose stool for those three weeks - it wasn't diarrhea but loose stool. And then 11 days after vaccine, I had a rash on my thighs and my lower torso. And that rash lasted for four days and it went away. Rash looked like measles or chicken pox - red dots. I went to the dermatologist as I have never had a rash in my life. Dermatologist did a Biopsy. The rash lasted for four days and cleared up.

Heart fluttering and weakness; Weakness; Eyes glazed over; Her eyes are bothering her, still feel weak; Head in a fog; Light headed; A spontaneous report was received from consumer concerning a 76 years old female who experienced heart fluttering (cardiac flutter) and weakness(asthenia), eyes glazed over (eye disorder), her eyes are bothering her, still feel weak (ocular discomfort), head in a fog (feeling abnormal), and light headed (dizziness). The consumer's medical history was not provided. No relevant concomitant medications were reported. On 02 FEB 2021, prior to the onset of the events, the patient received first of two planned doses of mRNA-1273 (lot/batch: 013m20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported that on 03 FEB 2021 her eyes seemed glazed over, her head felt like it was in fog, and she had feelings of experienced heart fluttering and weakness. She stated that weakness was also associated with the heart fluttering. The symptoms resolved in about a week, other than her eyes which still feel weak, and bothering her enough. Treatment information included Tylenol. Action taken with mRNA-1273 in response to the events was unknown. The outcome for the events of eyes glazed over (eye disorder), her eyes are bothering her, still feel weak (ocular discomfort) was considered as not recovered. The events of heart fluttering (cardiac flutter) and weakness(asthenia), head in a fog (feeling abnormal), and light headed (dizziness) were considered 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. Further information has been requested.

Woke up in middle of night to use bathroom. Experienced severe dizziness, felt like brain was sloshing around inside my skull. Had trouble keeping balance. Returned to bed, slept, experienced same dizziness in the morning when I woke up. Felt better after having breakfast but very tired throughout day. I took it easy and dizziness cleared up about mid day. fortunately my husband was here to help. I would have gone to clinic if symptoms had continued. It is now 4/3/21 and I am not experiencing anything but slightly sore arm where vaccination was.

feeling shaky, dizzy and not right; Blood pressure was 172/101 at 6am, now is improving at 159/94, but heir normal blood pressure; body aches; feeling shaky; fever; headaches; oxygen was not as good as usual, at 95% (usually between 97-99%); elevated heart rate of 110ppm and climbing, for 3 days; A spontaneous report was received from a Healthcare Professional and a consumer concerning a 76 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Heart rate increased, Hypoxia, Dizziness, Blood pressure increased, Pyrexia, Pain and Headache. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 30 Jan 2021, the patient experienced elevated heart rate of 110ppm and climbing for 3 days, felt they were having a heart attack, oxygen was not as good as usual, at 95 percent (usually between 97 to 99). On 4 Feb 2021, the patient experienced the events feeling shaky, dizzy and not right, blood pressure was 172,101, now was improving at 159, 94, headache, fever and body aches. The Hypoxia was considered medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 2 Feb 2021 the outcome of elevated heart rate was resolved and for blood pressure was recovering. On an unknown date the outcome of other event was unknown.; Reporter's Comments: This case concerns a 76 Y/O F with PMH of COVID-19 who had a serious unexpected event of hypoxia and nonserious unexpected blood pressure increased, heart rate increased, dizziness, nervousness, and expected pyrexia, headache. Event onset on Day 4 after first dose mRNA-1273. Main event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

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

Awakened 5:30 AM with vomit in my throat. I could move my arms and legs but could not move my body and my bed was spinning wildly. I vomited continually. When I was able I called an ambulance from my bedside phone at around 7:30 AM. Vomited all the way to hospital. In hospital I was diagnosed with Vertigo.

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

Fever (went up to 102), aches, sore arm, diarehea, throwing up, tired, headache, dizziness (all lasted for several days). Felt like a very bad case of the flu. I also receive a flu shot each year and have almost the same reactions.

Vestibular neuritis. Was dizzy for 5 days. Went to doc on 5th day. Condition improved in about 2 weeks. Still having some dizziness. Never had any ear problems/dizziness.

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.

Fall occurred 2/24/2021 (while getting out of the booth at restaurant, no prodrome). Received Moderna COVID shot #2 (day of fall preceeding the episode).

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.

On March 5, 2021 I went to an emergency room because I fell and fractured my arm and I was in a Bigeminal Heart Rhythm. I followed up with my Cardiologist in which they did an echocardiagram and placed a holter monitor on me to monitor my heart rate and rhythm. They are currently trying to get this rhythm back to normal with medications. I have NEVER been in a rhythm like this until after I received the vaccine.

My entire body from my head to my toes was so painful that I couldn't even walk. My knees, my ankles, my feet and my neck and shoulders and fingers- a squeezing sensation and pain in my entire body and it was that way for the entire day and the next day it was gone. I never had this pain any other time. I went to my physical therapist that next day after the vaccine because I thought I had done something to my body - he stretched out my back, knees and so with his help maybe it resolved faster than it would have.

Patient had the second COVID vaccine and the next day she was not able to lift or move her arms. She has been having body aches and is barely able to move her neck. She reports she is feeling better today than yesterday. The red area and tenderness have decreased in her arm.

On 5/6, the patient reports she was hospitalized on 4/14 after experiencing myocardial infarction, syncope, and fall resulting in the patient hitting her head

Recieved second dose at 52 days after first one; Broken hip; Fall; This spontaneous case was reported by a consumer and describes the occurrence of HIP FRACTURE (Broken hip) 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. No Medical History information was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced HIP FRACTURE (Broken hip) (seriousness criterion medically significant) and FALL (Fall). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (Recieved second dose at 52 days after first one). At the time of the report, HIP FRACTURE (Broken hip) and FALL (Fall) outcome was unknown and INTENTIONAL PRODUCT USE ISSUE (Recieved second dose at 52 days after first one) had resolved. No concomitant medications were reported. Treatment details was not provided. Company comment:This case concerns a 76-year-old female with a serious unexpected event of hip fracture, and non serious unexpected fall and product use issue (received second dose at 52 days after first one). Latency 28 days after first 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. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: As per the follow-up document received on 30 Apr 2021 the second dose of vaccine was administered.; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of hip fracture, and nonserious unexpected fall and product use issue (received second dose at 52 days after first one). Latency 28 days after first 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.

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.

I had my first vaccine in February and got along fine. My second shot was in March and the first thing I noticed was the shot hurt so bad, and I am not a whiner. The second day my arm hurt so bad i couldn't even lift it and could not use it for almost a week. The second day after the vaccine, I had a massive headache. The third day was Sunday and I was so sick with body aches, fatigue, the arm, and headache I couldn't go to church. For days and days I would wake up thinking I was better but by noon.I was a mess. A church friend mentioned she thought I had Covid bc my symptoms were so much like hers when she had the virus. Both my daughter and stepdaughter noticed how I was struggling with my speech, which has

A week after getting my second Moderna vaccine, upon waking up on April 15, I had vertigo to the point of throwing up. Tried Epley maneuver a few times. Couldn't get in with ear doctor until May 6 and by then it had finally improved. Once side-to-side vertigo abated, I got it when I looked up a certain way or moved too quickly. By the time I was able to get to doctor, I had been free of dizziness for four days. However, i still get a funny sensation a few times a day - it's like time stops for a second and then goes on -- like freeze frame. Don't know how else to describe it.

I could not get out of bed for 3 days terrible chills weakness whole body aches crushing fatigue very bad headache . Worst symptoms abated but I still do not feel good have crippling fatigue unusual headaches & unexplained leg pains & unprededictable cold sweats & odd temperature sensitivity

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.

A few days before she had trouble breathing, wheezing and then she got the vaccine and it got worse. Also had pains in her legs and chest. She gets weak and would have to lay down a walk and when she goes up and down the steps had to huff and puff, which she had not have this type of trouble in the past. She went to her cardiologist who took blood work, and he also did a chest x-ray. She then went to her PCP last week, who said he would check with her cardiologist and see the results of his tests. She is also a little light headed, but the breathing and wheezing is what is most bothersome.

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.

To begin, I cannot sit or rise easily because I do not seem to have the use of my legs. I have to push myself up with my arm when I am trying to stand. When I am standing and walking, I cannot straighten up completely and I seem to loose my balance. This problem seems to only be below the waist. The tops of my legs attaching to my buttocks are a constant soreness. Below my knee on the left side of my left leg, there is constant soreness. My legs are continually throbbing down to the ankles. Just now as I writing this sitting at the computer, my legs are throbbing. When I am lying in bed, there is constant throbbing and soreness. This morning when I awoke, it seemed as if there were needles pushing into my left heel while lying in bed. I have been taking a 500mg Tylenol in the a.m. and before going to bed but it doesn't give relief. This doesn't appear to be a problem with my joints but rather a stinging sensation in both legs. When I am driving, my right leg will begin to have a severe cramp which is very painful until I can stretch. I can bend over but with great difficulty. I cannot step up on a curb without great difficulty. I have a general overall feeling of weakness and instability. I did cease using pravastatin. I have been feeling these issues for about 1 month and they seem to worsen. My first Covid vaccine was January 25th. My second Covid vaccine was last Thursday, February 18th. Thank you for brainstorming this for me. I am a very active person so this is a puzzle for me.

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.

Unstable dizziness; Constant swishing noise in left ear; Wite blood cell at 10.8 and should be 10.2.; head aches.

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.

After second Moderna vaccine I could not walk; the pain is excruciating on my ankles and heels. I have not walked since March 5, 2021.

Fatigue, feeling dizzy, not having good vision, leg cramping/hurting, HA, and SOB. She was diagnosed with myocardial Infarction in the ER with SOB adverse effect of the vaccine. She has no prior cardiac history

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.

I felt an immediate "anaphylaxis-like" reaction right away. I had swelling of my mouth, face, eyes and nausea. I felt dizzy and light headed and had fever of 101F, headache, body aches and I could not get out of bed. I had trouble sleeping. I had trouble concentrating, decrease cognitive abilities and extreme fatigue. I did take an antihistamine (Xyzal) prior to the vaccine. I took Tylenol and Zofran for nausea. The swelling subsided after 2 days, and the acute-flu like symptoms lasted about a week. I usually see my doctor every week for weekly injection for my RA . I still have nausea and he prescribed Zofran for that. I have small-medium lost my appetite and my taste and smell have change and also itchy eye. But I have noticed increased saliva excretion.

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

Patient experienced dizziness for 7days a week after 1st dose. She doesn't know if it's due to an ear infection. Patient had received an a prescription to treat an ear infection during the same duration. She feels better now.

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.

On 04/01/21 patient presented to Emergency Department with altered mental status and fever. Husband stated that at baseline patient has no dementia and speaks and interacts normally. He stated they had their Covid vaccine on 03/31/21 in the morning (location of vaccine administration was not specified). He said beginning 04/01 in the morning she was not acting like normal self. She was not speaking as much as she normally does. He stated she did fall on 03/31, but does not believe she struck her head. He said her behavior was normal yesterday. She does not walk since a seizure 3 months ago. No shortness of breath or cough was reported. He stated her chest seemed red earlier but that has resolved. The patient was unable to give history and not responding to questions. Patient was admitted to hospital to monitor closely. On 04/02 patient was back to baseline and was discharged from the hospital.

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.

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.

Tingling in feet and hands, numbness in feet, loss of balance 2-3 weeks prior to ER visit on 6/12, was admitted to hospital Guillame Barre Syndrome was diagnosis MRI of brain and lumbar Lumbar puncture to confirm high protein IVIG infusion for 5 days

Hospital Course: In summary this is a 76-year-old female with past medical history significant for hypertension, CKD stage III, chronic dizziness, and glaucoma, who presented to the emergency department on 3/11/2021 due to generalized weakness, slurred speech, and confusion. Patient lives alone and there is no last known well time. Of note patient had reportedly received the Madera COVID-19 vaccine in the days leading up to her presentation. History was limited due to the patient's altered mental status. I was later informed by the patient's son via phone that she just recently received her first Covid vaccination here at Hospital earlier this week. Additional information for Item 18: Due to concern for stroke stroke alert was activated and CT imaging of the head was ordered. However due to patient's agitation this is not able to be performed despite giving a total of 4 mg of IV Ativan. As of this point the decision was made to intubate the patient in the emergency department for imaging and further work-up of her encephalopathy could be performed. Patient was subsequently extubated on 3/12/2021 at which point she was able to report her symptoms started as numbness in her feet and the inability to walk followed by no further recollection until being in the ICU. She reports similar episode on a trip for which no cause was identified. The results of her testing remain inconclusive and did not identify any acute cause for her presentation and therefore working diagnosis was possible TIA versus conversion disorder. Patient was subsequently transferred to the general medical floor on 3/13/2021. Patient seen by me on: 3/11/2021 Assessment: 76-year-old female with a history of hypertension and CKD 3 presents to the ED with altered mental status, apparent time of onset approximately 7:15 PM, unable to answer questions or follow commands Differential diagnosis: CVA, TIA, ACS, electrolyte abnormality, occult infection, metabolic encephalopathy Encephalopaty requiring intubation and intensive care.

Stages violent fever, chills, aches (2 days) next nausea , abdominal cramping, diarrhea, more new aches, weakness, exhaustion, loss of balance, another round of fever/chills and repeat again of abdominal distress. This has continued until today (Day 14 since the vaccination.)

I woke up feeling nauseous, dizziness and challenging to walk and a lot of coughing. I went to the dr and he gave me prednisone.

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.

feels terribly weak; hurt really bad; her arms don't work and hands don't work; hands are tingly and don't work; Inappropriate schedule of vaccine administered; Arm on the injection site was hard; Arm on the injection site was red; Arm on the injection site was swelling; Arm on the injection site hurts and feels like it was hit by a baseball; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feels terribly weak), PAIN (hurt really bad), HYPOKINESIA (her arms don't work and hands don't work) and PARAESTHESIA (hands are tingly and don't work) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 038B21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Arm on the injection site was hard), VACCINATION SITE ERYTHEMA (Arm on the injection site was red), VACCINATION SITE SWELLING (Arm on the injection site was swelling) and VACCINATION SITE PAIN (Arm on the injection site hurts and feels like it was hit by a baseball). On 19-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced ASTHENIA (feels terribly weak) (seriousness criterion hospitalization), PAIN (hurt really bad) (seriousness criterion hospitalization), HYPOKINESIA (her arms don't work and hands don't work) (seriousness criterion hospitalization) and PARAESTHESIA (hands are tingly and don't work) (seriousness criterion hospitalization). The patient was hospitalized from 24-Jun-2021 to 28-Jun-2021 due to ASTHENIA, HYPOKINESIA, PAIN and PARAESTHESIA. The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. On 19-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, ASTHENIA (feels terribly weak), PAIN (hurt really bad), HYPOKINESIA (her arms don't work and hands don't work), PARAESTHESIA (hands are tingly and don't work), VACCINATION SITE INDURATION (Arm on the injection site was hard), VACCINATION SITE ERYTHEMA (Arm on the injection site was red), VACCINATION SITE SWELLING (Arm on the injection site was swelling) and VACCINATION SITE PAIN (Arm on the injection site hurts and feels like it was hit by a baseball) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. During the hospitalization the patient had a MRI, CAT scans, X-rays and sonograms, results were not provided. Patient was discharge to rest at home without an official diagnosis. No concomitant products reported. No treatment medications were reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Significant follow up appended to AER; document contains new events, hospitalization dates, and lot numbers for suspect product.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

on 1/22 left arm hurt really bad . Went to doctor because she could not use arm . Had to hold arm in place. Had surgery April 2nd .

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

Within about 10 minutes experienced heart thumping and light headedness. Felt overall as though I was hyperventilating, but breathing was normal. By that evening, I was feeling "not right". By the next morning, started chilling, temp was elevated, over all "sick" feeling. Experienced that until the next afternoon. Arm was very sore (still is, but better). Please note that I had Covid starting November 8, was very ill 2 weeks and continued feeling extreme weakness and fatigue for several weeks after.

Dizziness/light headed (almost passed out) Vomiting Diarrhea Exhaustion (slept for 5 hrs) High blood sugar (300)

Tachycardia (160 to 180 beats per minute), shortness of breath, lightheadedness. Onset 2.5 hours after vaccine. Treated with diltiazem CR 120 mg. Resolved 6 hours after onset.

Chills, shaking so badly could not stand up to drive home from office, headache, ache over entire body. In bed for 2 days.

Lightheaded nausea swelling headache chills itching. Swelling continues spreading around injection site and is hard as a tick. Sensation of stinging

Dizziness starting early AM and progressing to virtigo and nausea with vomiting around 3 pm in the afternoon. Bed rest until 1/21. and able to get out of bed around 8 AM. Ate a small breakfast and returned to bed rest until later in the morning. Vertigo is still evident but not as severe. Vertigo is still present at 4 pm on 1/21 but able to move around slowly with assistance. Vertigo continues at the time of this report.

on the 18th i was in the Dr office and went to take my blood pressure i got up to get my weight and went to walk to the scale IN front of me and instead i was walking backwards instead of forward. i stopped myself but i couldn't make myself forward only going backward. my brain wasn't telling me to walk back but my feet were moving backward. Finally stopped and was able to make myself move forward. i was fully aware of what was happening but just couldn't stop it.

Pt received dose #1 Moderna COVID vaccine 12/28/20 @ Clinic. About 3 hours after had 30 minutes of rapid heart rate, and fluttering. Laid down, went to sleep, and it resolved. She didn't seek emergency care. Did not have chest pain or shortness of breath. Continued to have palpitations occasionally, fatigue, tachycardia. Presented to PCP on 1/7/21 for symptoms and was transferred to ED for additional cardiac workup and treatment after capturing SVT on EKG. Also diaphoretic, dizzy, nauseous, SOB with palpitations. Given IV metoprolol in ED with conversion to NSR. Per ED "Suspect that the vaccine may have been her trigger." Able to discharge without escalation of care. Entered for tracking.

On 8th day after receiving the Moderna COVID vaccine, I awoke and noted that site of inoculation on left upper arm was very itchy with a 2x3 inch raised, red hive. I felt woozy, unsteady, a bit short of breath, a small headache, a bit of nausea,& fatigued. These symptoms subsided gradually over the next 4 days.

On 8th day after after the Moderna COVIDvaccine, I awoke and noted that site of inoculation on left upper arm was very itchy with a 2x3 inch raised, red hive. I felt woozy, unsteady, a bit short of breath, a small headache, a bit of nausea,& fatigued. These symptoms subsided gradually over the next 4 days.

Next morning 1/23 woke up with acute vertigo, dry heaves and chills. Next day only dizziness when raising or lowering head.

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

Patient had onset of LEFT arm nodule over her subacromial bursa, associated w/ tenderness, w/ limited active range of motion. This is the contralateral arm to her vaccine administration site.

After i had my injection about 7 hours later about 4-5 o'clock I was sitting in a chair and I got up and my balance was completely off and I almost fell into glass table. I felt very foggy and my head wasn't right. I had to hold on to things and I sat down and I kept saying I just didn't feel right. I called my daughter and my arm was hurting and I figure that's what happens, I was getting so tired and really bad headaches. My daughter asked somebody and they told me to take extra strength Tylenol (500 mg ) 2 at a time 6 hour intervals. Which i did i got up the next morning and i had to go back to bed i had no energy. I felt horrible. When i did get up in the afternoon all of a sudden i had horrible chills and that day in Florida it was 82 degrees and i put the heat on 84 and i was extremely shaky and cold. I went back to bed and later i did have a fever, not highs, it only went to 100.8 but during the evening it did break because my sheets were almost saturated. Yesterday morning 1/27 Wednesday i felt better, fever had gone down, pain was still there in my arm and swelling. I thought that was natural. In the afternoon i decided to take a shower and i noticed my left arm around the injection site was a red rash about 7inches long and 4-5 inches wide which i had to seen before i called my primary doctor just to make sure this was normal around injection site and talked to the nurse and she thought it was normal. But if there was no changes to call her back on Friday. Last night not able to sleep i saw an article that said COVID arm rash seen after Moderna vaccine, annoying but harmless it was a large article and it made me feel better but there were only 14 examples but they believe there were more because they were younger people with the health dept. that received this vaccine. It said in 1week it should go away. I still have it, its still red and sometimes itchy and i am happy to say now that i know it will be a week i feel better. it should be on the list of side effects for all.

I received my injection on 1/25/2021 I had my second COVID shot, everything went well, I just had a little pain and swelling and was fine. About 7 hours later i got up from chair and i was dizzy and my balance was off and i almost fell into table. I didn't feel right. I went and sat back down and i was very tired and i started getting headache. I called my daughter and a nurse she knows told me to take extra strength Tylenol 500 mg take 2 every 6 hours. I started at 730 and went until 130. I slept on and off and got up Tuesday and my arm was still hurting. I was very tired and had no energy. When i got up later in the afternoon i had extreme chills. It was 83 degrees in Florida nd i turned heat up to 84 and i was still shaking. I got under covers and had a fever it was 100.8. Went to sleep that night and fever broke. Got up Wednesday and felt a little better, still had headache and tired. Decided to take a shower. I noticed my left arm where the injection was was all red. 6-7 inches long and about 5 inches wide which i never saw before. after shower I called my PCP I contacted the nurse said she thought it was normal and if there was no change to call her back on Friday. my arm is still red and warm i went to sleep but couldn't sleep. I saw an article about COVID arm rash seen after Modern vaccine and now i know that's what I had. I feel better after I read it in the magazine today and it said it will only last a week. This should be listed as a side effect so nobody else wonders what it is. I drank so much water because it said to drink plenty of water and i tried to use arm as much as possible.

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 reported feeling like she was going to pass out at around 10pm on 1/26/21 and lowered herself to the floor in her bathroom. Was discovered on the floor around noon, 14 hours later, by staff after noticing her food tray was untouched . Arrived in ED via EMS. Pt was febrile with rectal temp 100.7 c/o weakness. Pt had a WBC count of 11.2, absolute neutrophil 9.9, and creatine kinase 3214. Pt was alert and oriented and reported having been hospitalized for a few weeks in November 2020 with Covid-19 and having received her first dose of covid vaccine at approximately 11:30 on 1/26/21. Hospitalist voiced concerns that this may be a reaction to covid vaccination.

Patient felt weak, dizzy, and faint. EMS was contacted. EMS transported patient in stable condition to the ED for further evaluation and treatment. No airway or other life threats were identified.

Pt. C/o pain onset in Left arm, about an hour after receiving shot. Said pain was severe and requested pain medication. No redness or warmth noted, pt. unable to complete ROM with left arm and pain radiated from shoulder to elbow. Pain persisted through night and the next few days after disrupting her sleep and ranged from mild to severe. Continued to tx with Tylenol and ice packs. Res. does not want second dose.

Itchy and rash where vaccine was ministered. My husband age 80 who got the vaccine same time as I in left arm and has the same rash , No other symptoms

Moderna COVID-19 Vaccine EUA. At home, about an hour after getting the vaccine had extreme blood pressure spike, dizziness, heart palpations, ear ringing, dry mouth, weakness and trembly, visual aura with eyes closed of red ball in field of vision, some pain at temple as if migraine tho I only have had migraines in first trimesters of pregnancy, adolescence and at time of diagnosis of hyperthyroidism. Have had blood pressure brief spikes in past (possible tyramine sensitivity) but this persisted rather than momentary. Live alone and was at home so called Ambulance. Took over 12 minutes for ER to come after called when symptoms did not quickly resolve. Was still having symptoms though blood pressure had dropped to

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.

phone call from patient on 2/5/2021 who states that her arm is swollen and very and unable to lift arm.

flushing, lightheadedness, increased confusion, significant increase in weakness resulting in a fall twice.

Pt received 1st dose of moderna covid vaccine at 0942. At 0953, pt reported feeling hot and eyes feeling funny. Moved to exam room. BP185/82, pulse 70, o2 94% on 4l/nc (pt on home o2 at same flowrate). Reported "spots" in eyes. Spots and hot feeling resolved by 1008. Pt reported jaw stiffness at 1008, states feels similar to when she sits for a long time. Dr notified and benadryl given per order. Continued to monitor patient. At 1047, pt reported that jaw felt "tired", no other c/o. 1101-Dr updated on pt condition, Dr stated that patient may be discharged to home with husband and may receive 2nd dose of vaccine, but should take benadryl prior to appointment. Vital signs remained stable, bp 173/73, pulse 71, SpO2 91% on 4l/nc at discharge.

Within approx 12-15 minutes of injection, I began to feel slightly light-headed. I didn't say anything at the time, because it was so slight, and I attributed it to being a little nervous. It continued, for perhaps hours 3 or so hours, getting slightly worse before subsiding. I had eaten my usual breakfast in the am before I went for my injection.

Woke up feeling poorly. Started with weakness, progressed to dizziness and nausea. Got worse as the day progressed. Has lasted all day at the time of this writing.

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.

2/9/21 Day of injection feeling fine all day. That evening began to feel weak and a little dizzy. 2/10/21 feeling dizzy and weak. I was holding onto furniture and walls in order to move around. Some cramping in belly. 2/11/21 No longer dizzy but still feeling weak. No more cramping; 2/12/21 No longer dizzy. Moving around without feeling so weak. No cramping.

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

48 hours later dizziness for 5 days, less for 2-3 more. I'm never dizzy except on ships/boats. Rash - larger welts on lower back upper legs, some on arms & back. Its my usual reaction to wat too much sugar. This too lasted 5 days

c/o dizziness Patient disoriented to name and year for about 3min when medical and EMS arrived. Mental status back to normal after 3min. Reports anxiety, denies chest pain, SOB, palpitation, dizziness, headache. BP: 117/65 ( sitting), 147/71 ( standing) HR: 94 Sp02: 98% No acute distress, seen and cleared by EMS

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 )

This event , because so many elderly people have the fillers in their knees should be widely publicized! We have fillers that help so much to be able to walk without pain, but this vaccine has caused me to have extreme pain and burning and not be able to walk without pain for 4 days now. NO ONE has said anything about how this Moderna vaccine would affect us because of the Hyaronolic Acid injections to our knees. We should have been allowed to get Pfizer!!!! I am so upset about this and extremely disappointed in our government's lack of disclosure.

severe dizziness early next morning with nausea and slight headache. took medicine for dizziness and nausea but symptoms continued for two days still feel dizziness now and again

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....

Feb 3 afternoon developed headache, began shaking all over, sleepy. During night vomiting 3 times. began to feel very weak. Fell in floor and had great difficulty getting up due to weakness. Slept all day Feb 4. Could not eat. Slept all day Feb 5. Could not eat. Very weak. Feb 6 mouth broke out with sores. Still shaking and headache. Began to feel better Feb 7. Felt fine Feb 8 except for mouth sores.

02/11/21: Left TMJ pain 02/12/21: Left TMJ pain; erythema, edema, itch Left upper arm at injection site 02/13/21: increasing left TMJ pain; increasing erythema, edema, itch left upper arm 02/14/21: decreased range of motion mouth, unable to eat, pain TMJ; left upper arm problems resolving 02/15/21: to dentist - no diagnosis, source of TMJ problems. Prescribed Flexeril, Medrol dose pak, but did not take as symptoms began to resolve. 02/16/21: no TMJ pain, normal ROM, just sore. Not sure if related to vaccine, but thought I should report.

I received the vaccine, and I don?t remember passing out, but I fell and hit my face and nose and its sore and bruised. I felt dizzy and felt like I had covid, my O2 level was at 80 and it?s usually at 92, I also threw up. Now I stay dizzy and shaky. I had covid in November and was in the hospital for 17 days.

The following day she was sitting on her loveseat and she just slid down to the floor, and could not get up. She had no strength at all in any of her extremities which lasted all day, from 10:00 AM to 6:00 PM. Her daughter called and she informed her that she could not get up, and wiggled herself through the house and pulled herself up by the hand of her granddaughter to help her. It then resolved and she has not had any other problems. Her arm did hurt for about a week and sore to the touch, but wanted to report that she had the extreme weakness. She did not consult her doctor, cannot get through to them, been trying for 3 days.

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?

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

I had Covid on 25 Nov. 2020. I had extreme fatigue, shortness of breath, aching, headaches and abdominal pain. I have IBS which flared up during this time. It took me December and January to finally get over the fatigue part. When I received my vaccination on Feb. 12, 2021 (Moderna) by that evening I began to run a temp. of 102-103. I had chills, headache, abdominal pain (worse than in Nov.), fatigue, some dizziness, and short of breath. I felt like I had Covid all over again! I was down for 5 days. On Sunday afternoon, Feb 14 I went to the Clinic to see the doctor on call. I was told they could not test me since I had Covid November 25 and it hadn't been 90 days and I would still have the antibodies.

bilateral lower leg edema started 24 hours after vaccine, associated with dizziness, leg spasm/tremors, unable to walk, resolved in 4 days. no prior history, no other new medications taken

A 77 year old female who presents with patient states went to see PCP today for six-month labs and was noted to have elevated BP. Patient's has never been diagnosed with hypertension. She states after going home she got a headache and dizzy since she recheck her blood pressure and noted that it was 190/106. Patient denies any chest pain or shortness of breath and says that her headache is resolved. 2039 BP 145/78, PT FEELS FINE. EXPLAINED TO PT WILL CHECK A SECOND TROPONIN WITH ABNORMAL EKG AND ELEVATED BP. PT VERBALIZED UNDERSTANDING. SECOND TROPONIN NEGATIVE WILL START PT ON ATENOLOL 25 MG DAILY AND DISCHARGE TO FOLLOW UP WITH PCP.

Patient reported dizziness and unsteady gait after receiving vaccine. BP 121/57 (pulse 69), O2 sat 98%. Followup: 129/68 (pulse 64), 98% O2 sat.

Dizziness, feeling palpitation, cold. BP 172/80 (HR 100). Thirty minutes later, BP 132/71 (pulse 63). Water given.

Fever (102+), chills, faintness, redness on arm the size of softball. Felt as if had flu. Could not eat. Lasted all day 2/20/2021. Redness on arm visible 7 days in large area. Still have visible signs. With first shot I had a metallic taste in mouth and nose about 30 minutes after, a wave of nausea the next day and felt bad the 3rd day. Then just sore arm for 2 weeks.

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.

Client reported feeling faint and fatigued. EMS took vitals and daughter gave client food to eat. Client felt better after 40 minutes. EMS assessed and gave client banana for low blood sugar.

Patient developed sudden SOB 1 week after she received #1 COVID vaccine on 1/28/2021 w/o associated chest pain/palpitation/cough. Her SOB was significant enough for her to seek Urgent evaluation on 2/8 then ED evaluation on 2/11 then again on 2/20/2021. she continues to have SOB/DOE even now. She also has dizziness intermittently. she had chills initially but no fever until she had transient fever for less than 12 hours 2.5 weeks later likely associated w/ unrelated problem( UTI). so far no causes found regarding her SOB after numerous tests( see below for tests).

Vomited approximately 10 hours after the vaccine Diarrhea approximately 10 hours after the vaccine Malaise Cough Fatigued for 7+ days Headache for 4 days Slight Fever (around 99.0 for 2 days) Chills (extreme) Arm Sore Loss of appetite for 3+ days Confused Dizzy/equilibrium issues for 2+ days

Vomited approximately 10 hours after vaccine, but no memory of it Diarrhea approximately 10 hours after vaccine, but no memory of it Malaise for 3-4 days Fatigued for 3-4 days Headache for ~2 days Chills (extreme) Arm sore for ~3 days Loss of appetite for ~3 days Confused Dizzy/equilibrium issues for ~2 days

Patient complained of dizziness. BP @ 5:35 154/81, 5:45 172/76, @ 5:50 198/75. Patient was sent to Urgent Care for further medical evaluation

Chills, 2 degrees of fever, sore arm, whole body ache, disoriented when walking & (collapsing pain in left leg when trying to stand the next morning), slept for 30 hours except for necessaries, didn't eat for 1 1/2 days, all in all body felt like a bad case of the flu.

Severe nausea, vomited, extreme fatigue, dizziness/lightheaded disoriented. Yesterday and today. Stomach pains moderate

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.

Patient presented to ED after ground-level fall. Patient appears to have not lost consciousness or pulses. PT/OT attributed fall to generalized weakness and ambulation due to chronic deconditioning. Patient to follow up with neurology for further management of severe dementia. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

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

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

Dizziness. BP 156/74 (pulse 90), 99% O2 sat. Given orange juice. F/u BP 145/75, pulse 92, O2 sat 98%. Patient stabilized

Early evening post injection sore arm. 9 pm onset of chills, fever, continuing through night and following day. Accompanied by severe fatigue, loss of appetite. Treated with acetaminophen. Fever and chills gone morning of 3/4, but severe fatigue persisted. Morning of 3/5 feeling better, but lightheaded. Improved throughout day and 3/5 evening pretty much back to normal. No medical attention required.

Moderna COVID-19 Vaccine EUA Freezing cold, headache, arm swollen & hurt, fever, dizzy, Memory loss, chest pain, fatigue. No treatment. These symptoms lasted 4 days. (not all at once)

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

Lightheaded Vitals: B/P: 165/85 HR: 87 O2Sat: 98 Skin Signs: Cool and Dry Circulation: 5 Cap refill <2sec Resp: Wheezing (Chronic) Treatment: Supine position, water, 1 Nutter Butter Repeat Assessment at 11:40 am Vitals: B/P: 150/90 HR: 91 Resp.: 30 O2Sat: 97 Skin Signs: Warm and dry Circulation: 5 Cap refill <2sec Resp.: Wheezing (chronic) Treatment: sitting up in wheelchair, continued water, 1 Nutter Butter Disposition: Home at 11:57 am

scratchy feeling on the outside of her throat, dizzy and light headed. She carries an EPI pen for allergic reactions.

red hurting itch rash on L arm of vaccination site, changed to triangle shape day and 2 weeks after, still having pain and lost range of motion in that arm, ongoing 1 week red hurting itchy rash on R butt cheek, then on both butt cheeks 2 weeks after, took Zyrtec 3 day and tar cream RX by Dermatologist, clearing up

Reaction started 6:30 PM on 2/23/21. SXS include feeling very cold, swollen, painful left arm, HA, fever 99.9 F, memory loss, dizziness, could not get out of bed, chest pain, fatigue, dog wouldn't stop licking her hand; started feeling better Saturday 2/27/21; used blankets--to get warm; 2/25/21 still had HA, took ibuprofen 200 mg (doesn't remember if she took 1 or 2 capsules); HA resolved, chest pain felt like she had to burp; took antacid (type unknown) didn't help, drank Root Beer, burped and it resolved chest pain. As of 3/8/21 still dizzy getting in and out of bed, still some fatigue; can't do usual ADLs without sitting and resting.

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

Patient received Moderna Vaccine 1/21/2021. 2 days prior to vaccine administration patient had vertigo and sinus allergies that resolved. Patient canceled her 2nd dose appointment on 2/18/2021 reporting she had been sick. She rescheduled 2 times on 3/4/2021 and 3/11/2021 but canceled those appts as well reporting still not feeling well. She called 3/10/2021 and informed nurse of persistent symptoms that started 2 weeks after receiving her 1st dose of Moderna Vaccine. The symptoms reported throat burning, metallic taste in mouth, metallic smell in urine, body weakness, warm sensation over body, ear pressure and nausea. She reports she has been to an ENT doctor 2 times, her PCP 1 time and the ER 1 time. She and her doctor's are unsure if her symptoms are related to her first injection.

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.

Sudden dizziness with some nausea and cold drenching sweat - no fever - extremely weak and fatigued and could barely stand and then severe headache came on about 10 minutes into episode. Dizziness lasted approximately 2 hours until I could safely move and then began to subside. I noticed my eyes did not want to focus well and was seeing spots when I tried writing down what happened. Chills began and I felt extremely cold, my head felt "foggy" and tight, ringing in ears started and headache moved to migraine level. Slight fever 99.8. Main dizziness did pass after about 2 hours but other things continue to linger on an off. I just feel "off". I have actually heard other seniors mention some of these very symptoms so am not super alarmed, however, I did not have any of these side effects before the vaccine for Covid-19. I did experience extreme fatigue and bad headaches since I received the first dose on January 27, 2021. I have not called my doctor regarding these side effects since I have heard many seniors complain of very similar reactions. I have rested as much as possible, tried to stay hydrated, and taken Tylenol when needed. For the dizziness I tried to stay as still as possible and put my head between my knees until it finally passed.

I was extremely tired the day after, and continued to be tired with gradual improvement over a few days. But I have not recovered my previous level of energy, which was already very, very low because of longstanding chronic fatigue syndrome. My persistent vertigo (since 1989) is also worse than it was, and continues so after 2 weeks from date of first shot.

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.

Trouble lifting her arm; Nausea that came and went; Felt tired and fatigued; Vaccination site pain; Vaccine too high on her shoulder; A spontaneous report was received from a nurse concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine too high on her shoulder/product administered at inappropriate site, trouble lifting her arm/ movement disorder, nausea, fatigue and vaccination site pain. The patient's medical history and concomitant medications were not reported by the reporter. On 02 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012M20A ) in the left shoulder for prophylaxis of COVID-19 infection. On 02 Feb 2021, patient believed the vaccine was given too high on her shoulder, and had nausea, fatigue and pain at the injection site (shoulder and arm) which increased with movements, radiating to the upper limb and had trouble sleeping, treated with Tylenol. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

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."

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

C/o dizzy, lightheaded, shaky. Assess: - LOC, - NIV. VS 132/86, HR 96 Reg, + SOB, Resp 22 reg nonlabored. Within 5 min PT state I feel much better. Only had a muffin earlier. Encourage hydration & nutrition. Resp came down to 16 reg non labored. Daughter with her provided encouragement. Anxious about getting vaccine. Refused to wait 30 min. OK'd to exit. RN

1 - redness, hot feeling, mild swelling about 3" diameter surrounding injection site, starting 1 day after shot, continuing until present time, with severe tenderness for 4 days 2 - headache starting 6 hours after shot, continuing for 4 days without stop nausea, starting 1 day after shot, continuing for 4 days without stop 3 - fever between 101.6 and 102 degrees Fahrenheit, starting 1 day after shot, continuing for 3 days, dropping to 101 for 4th day before returning to normal on 5th day 4 - chills, accompanied by uncontrollable shivering accompanying fever 5 - dizziness off and on during time of fever 6 - extreme sleepiness from 1 day after shot for 5 days No treatment, other than drinking coke in effort to prevent dehydration while being able to keep it down.

Patient states that she experienced pain in her left arm within hours of the injection; she went to bed that evening with increased arm pain and generalized body aches; patient denies taking any pain meds or any type of treatment for the pain. Patient states she slept well but 'knew her arm was in pain. The morning of 02/23/2021 patient awoke as usual but said she was still in extreme pain and felt her vertigo beginning. She did not take any of her vertigo medication. The last memory she has at home that morning was walking into the bathroom. her next memory was being in a helicopter. Patient reports that when she lost consciousness in the bathroom, she fell and sustained a head trauma. her husband called an ambulance that transported her to Medical Center; she was then air lifted to Hospital. Patient states she spent 10 days in ICU to treat an intracranial bleed. She is now in a rehab facility and expects to be there for 2 weeks before being discharged to home.

I had quite an adverse reaction to the second MODERNA vaccine. That afternoon and evening I developed symptoms. I was experiencing chills, fever, body aches, headache, sore throat, shaking and nausea. As the week went on, my reaction became worse. I was sweating profusely and had shortness of breath accompanied with burning pain on the top of my hands and feet and a rash. On Friday morning, 5 days after the vaccine, I collapsed and had a stroke. I was rushed to hospital and was admitted. It was confirmed that I had a stroke. through a Cat Scan and MRI. On Saturday, I had another stroke. This time I was transferred to hospital. I had a huge blood clot on the left side of my brain which has effected my speech and walking. My entire life has been effected and changed. I had a plethora of tests done, MRI, CAT SCAN, EKG, BLOOD WORK etc. I also have to have speech therapy, physical therapy and occupation therapy. I spent about weeks in the hospital. The doctors think it is a possibility that the 2 Moderna vaccine caused my two strokes. What can be done about this? I will have problems for the rest of my life.

13 min post vaccine pt became unresponsive to verbal and uncomfortable stimuli. Pt slumping in chair with right side facial drooping . Pt began to respond in approx 3 minutes with confusion and not recalling events of prior 3 min. Pt with max assist placed in wheelchair and paramedics called. RR. Low teens B/P 150/88 Per family pt had same episode yesterday

Urinary tract infection that was septic; Renal failure; Positive for covid; Confused; Losing her balance; Had no control of her bladder and urinated on the bed; Wasn't feeling well; Tired and didn't want to get up; 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 vaccination related malaise, urinary incontinence, fatigue, confusion, loss of balance, renal failure, severe urinary tract infection that was septic, and Covid 19. The patient's medical history, as provided by the reporter, stated she was sneezing and coughing few days before receiving her first dose vaccine. Concomitant medications reported included iron, metolazone, nicardipine, simvastatin, torsemide, levothyroxine, glimepiride, apixaban, potassium chloride, acetyl salicylic acid, and donepezil 5mg. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 032L20A) for prophylaxis of COVID-19 infection. The route of administration was not provided. On an unspecified date in Jan 2021 after receiving the first dose vaccine, the patient experienced not feeling well, urinary incontinence, tiredness, and didn't want to get up. On 25 Jan 2021, the patient was losing her balance and confused. She was hospitalized and diagnosed with renal failure, as well as, severe urinary tract infection that was septic. On an unknown date post hospitalization, the patient tested positive for Covid-19. Treatment drug administered included Tylenol, Azithromycin, Promethazine, 325mg aspirin, and Vitamin D. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, like not feeling well, urinary incontinence, tiredness, confusion, loss of balance, renal failure, severe urinary tract infection that was septic, and Covid-19 positive test 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 except for the event of COVID-19. The event of COVID-19 is unlikely related to mRNA-1273 since the vaccine does not contain virus capable of causing infection.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-033912:

03/13/2021: The patient was admitted after she suffered fracture of the right lower leg as a result of fall attributed to an episode of vertigo. The patient required surgical intervention for her right lower leg. Multiple thyroid nodules with associated calcification reported in CT imaging studies of the brain and cervical spine during this hospitalization. Review of the patient's record confirms that the nodules were previously reported in thyroid ultrasound studies in 10/2013 and 05/2011.

Patient received second vaccine on 3/15/2021. Today she feels dizzy ( but stated she has history of Vertigo) and feels like she has the flu. She denies any other symptoms.

day of injection: sore arm and lightheadedness. Next day: Swollen arm with pain and redness...intestinal tract upset slight nausea and diarrhea. Next day...arm better, lightheadedness better, very tired and slept a lot. Next day: not bad during day. in evening had shooting pains in calves, and sweated a lot at night. Arm much better. Today: arm almost painless, still a bit lightheaded, intestinal tract still "busy". no pains in legs.

After receiving her second vaccine shot, while in the observation area approximately 20 minutes after recieving the shot, patient became light headed and dizzy. Firefighter / EMT assessed vitals and reported that pt had high blood pressure and a rapid pulse. Chief / Paramedic spoke with pt also. Based upon her continued symptoms and no resolution of the dizzy feeling, an ambulance was summoned and pt was moved to a less crowded location for further observation. She walked with assistance to the kitchen in the fire station due to her dizziness. Lt. completed patient assessment while FF gathered vitals. EMS personnel recorded that pt had no medical history, no medications, and was allergic to penicillin. Patient continued to feel cold and light headed. Ambulance arrived and patient care was transferred to the medics. Medics then transported the female to hospital.

Vaccine hit me so hard; Couldnt move any part of my body; Brain fog; This spontaneous report from was received from a 77 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine hit me so hard/vaccination complication, couldn't move any part of my body/ hypokinesia and brain fog/feeling abnormal. The patient's medical history and concomitant medications were not reported. On 28 Feb 2021 the patient received her second dose of mRNA-1273 (Lot number: 012A21A) solution for injection intramuscularly prophylaxis of COVID-19 infection. On 28 Feb 2021, the patient experienced a strong reaction and couldn't move any parts of body. She said the vaccine hit so hard. She had brain fog. She's never experienced anything like that. She got stuck on the garage floor for so long until her daughter and son in law came to rescue her. She was taken to the emergency room Sunday evening (28 Feb 2021). On the night of 03 Mar 2021, the patient was released from the hospital. As of 04 Mar 2021, the patient felt better. The hospital performed CT scans and she was hydrated with IV fluids. The outcome of all events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

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.

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.

2/22/21- Resident began falling multiple time and reporting loss of feeling in her Rt leg. Sent to ER. Diagnosis with multiple acute CVA and Rt sided hemiplegia

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.

Extreme dizziness the day after, weakness, fatigue. Symptoms of rapid heartbeat, fatigue and weakness have continued - this is day 15 of the effects. Some days better than others.

Hit with extreme fatigue four days after 2nd shot. Legs felt rubbery. And I am a walker doing about 5000 steps a day. Then four days after the fatigue, I was hit with dizziness, and still experiencing both but not to the degree I was at first. Also have a red, scaly rash on the backs of both hands. Been rubbing Neutragena gel on them which has helped.

fractured hip; fallen; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who fell/fall and fractured hip/hip fracture. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. The patient fell and fractured her hip on an unknown date. Treatment for the event included rehabilitation. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events, fall and hip fracture were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Vaccinated at 1pm 10minutes post vaccine epigastric tightness & lightheadedness that improved with getting up and walking. Declined ED when encouraged during post vaccination observation. She left the clinic on her own after 30 minutes . She did go to ED at 1435 EKG with normal sinus rhythm, hypertensive, admitted for observation r/t hypertension, oral medication change and discharged to home the next day..

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

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

I have Vertigo and the second week after my shot began having mini dizzy spells throughout the day. This had been happening for a few days. I usually do not have many episodes for months at a time .

Approx 2 weeks after 2nd shot, I developed severe body aches and felt like I had the flu and a week or so after that I had vertigo, tinnitus and extreme exhaustion. That lasted for 2-3 days and then dizziness to present, but lessening

Pt presented to observation post 2nd Moderna vaccine- had been advised to remain in observation for 30 minutes. @6:00 PM pt walked up to observation RN to express "something is not right, I dont feel right and my teeth are chattering and my hands are tremoring" Pt was able to walk back to sit in a chair Initial BP was 225/205 and pt began to c/o feeling "I feel faint, very tired all of a sudden" RN advised CNA to alert staff for help Pt then began to wheeze and cough. Per adverse drug reaction kit IM Epinephrine 0.3 mg administered @ 6:05 pm 911 called. Within 2 minutes pt expressed "I feel better now" teeth chattering, fatigue and cough resolved. EMS arrived, son arrived Pt w/s/s similar to arrival at time of transport but lessened, pt left via stretcher to Hospital@6 bp recheck at time of discharge 169/64 Staff RN

Following the vaccine, my day progressed normally. Started feeling a bit tired and dizzy in the evening. Next morning, upon rising became very dizzy. Sat in my chair and promptly passed out. Eyes rolled to back of head. Husband could not rouse me for several minutes. Following that experience, became very tired. Returned to bed. Was dizzy, fever of 100.2, headache for a few days. Minor arm pain.

I have been experiencing symptoms for over a month now. Extreme fatigue, sometimes nausea and light headedness. The symptoms are better some days than others but never completely go away. Most of the shaking and shivering have gone away but still do not feel well.

Pain at injection site ongoing. Unable to move arm in normal manner. Have not seem MD regarding problem

5 th day after the second dose, I was awaken at midnight with severe vertigo, cold sweat, nausea and loose stools. I had no serious side effects after the first dose. Did not go to the emergency room. Today I feel better if I do not make sudden moves.

Within hours patient began studdering, slurring and became unable to form a sentence. She had difficulty doing regular tasks such as drive a car., she was tired and went to bed early. The next morning she complained of a headache, pain in her right arm at the insertion site, and could not walk without holding on to walls, speaking was difficult the same as above. She went to the ER by 1 pm where they found that she was having a double brain bleed. With a cat scan with contrast. They send her to a near by hospital with a Neurosurgeon on staff, Medical Center. They administer Vitamin K and Platelets and monitored her. At the first Hospital. She is presently being admitted to a Rehabilitation unit. She continued with difficulty with speaking, difficulty with simple tasks such as using the phone and the nurse reported that she is weaker today than yesterday.

explosive loose bowel movements with burning anus for two weeks (burning elemenations continue still); head ache on top of head - several days; puffy face; Brief Chest pain on 4/4/21 with fatigue following for several hours and balance problems. pain in left plantar fascia and discomfort in right Siatic nerve area and upper thigh 4/13 Cough - productive; patient is mostly recovered from adverse reactions with exception of burning bowel movements

dizziness and concern for elevated blood pressure reading. This afternoon at around 12:00, the patient received her second dose of the Moderna COVID-19 vaccine at the clinic. She had no apparent complications with her first dose of the COVID vaccine. However, about 10 minutes post second vaccination, she suddenly began to feel dizzy, described as lightheadedness, with associated nausea, all of which were rated a 4/10 in severity. Staff there took her blood pressure, which was noted to be elevated, reportedly at 220/104. EMS was activated, and en route to the ED, the patient was given Zofran by paramedics. Currently the patient no longer has nausea and has not had any vomiting. She does have chills, but no measured fever.

She was having difficulty moving her arms and legs; She did have a bump on the side of her head; fallen off her bed another time; she kept saying "I think I'm gonna die"; She felt delirious; did have pain with the second injection; She did have a bump on the side of her head; she experienced fever; strange behavior; chills; This spontaneous case was reported by a patient and describes the occurrence of DELIRIUM (She felt delirious) 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. The patient's past medical history included No adverse event (No reported medical history). On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced ABNORMAL BEHAVIOUR (strange behavior), CHILLS (chills) and PYREXIA (she experienced fever). On an unknown date, the patient experienced DELIRIUM (She felt delirious) (seriousness criterion medically significant), HYPOKINESIA (She was having difficulty moving her arms and legs), the first episode of HEAD INJURY (She did have a bump on the side of her head), FALL (fallen off her bed another time), FEELING ABNORMAL (she kept saying "I think I'm gonna die"), VACCINATION SITE PAIN (did have pain with the second injection) and the second episode of HEAD INJURY (She did have a bump on the side of her head). At the time of the report, DELIRIUM (She felt delirious), ABNORMAL BEHAVIOUR (strange behavior), HYPOKINESIA (She was having difficulty moving her arms and legs), FALL (fallen off her bed another time), FEELING ABNORMAL (she kept saying "I think I'm gonna die"), CHILLS (chills), VACCINATION SITE PAIN (did have pain with the second injection), PYREXIA (she experienced fever) and the last episode of HEAD INJURY (She did have a bump on the side of her head) outcome was unknown. No relevant concomitant medications were reported. No treatment information 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.; 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 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

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.

Morning after injection, I sat down at the breakfast table and said to my husband" I can see you, but everything else out the windows (there is a bank of windows surrounding table) is completely grey....I can't see trees or house next door." The next I knew he was peeling me off the floor after I completely fainted and fell off my chair. No injury other than small bruises and head bump. He got me back to bed and doctor was not needed.

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.

Patient states that she started having trouble feeling tired, having difficulty concentrating/making decisions, vision problems, and dizziness/lightheadedness after the first vaccine dose on 1/26/21. She was not very clear on timeframe of onset of individual symptoms. She received her second dose on 2/26/21. She was diagnosed with A-fib during the time between her 2 doses. She did not notify pharmacy where vaccine was administered of her suspected side effects until 4/20/21. Patient states she has seen several of her healthcare providers to see if they could find any reason for her to be experiencing these things other than the vaccine but she says they haven't found anything.

balance was weird; left side of head, above my ear felt like something inside my head popped and liquid drained; felt really terrible; she thought that maybe she was hallucinating; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (she thought that maybe she was hallucinating) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Dyslexia and Thyroid associated orbitopathy (Unspecified Allergies). On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced BALANCE DISORDER (balance was weird), HEAD DISCOMFORT (left side of head, above my ear felt like something inside my head popped and liquid drained) and FEELING ABNORMAL (felt really terrible). On an unknown date, the patient experienced HALLUCINATION (she thought that maybe she was hallucinating) (seriousness criterion medically significant). On 12-Feb-2021, HALLUCINATION (she thought that maybe she was hallucinating), BALANCE DISORDER (balance was weird), HEAD DISCOMFORT (left side of head, above my ear felt like something inside my head popped and liquid drained) and FEELING ABNORMAL (felt really terrible) had resolved. No treatment medications were provided. Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.

Client started to c/o symptoms approximately 10 minutes after vaccination. She c/o numbness in her fingers, feet, and lips. Stated that she had heaviness in her chest and a pain that shot from her chest to her back lasting only a few seconds. She c/o dizziness. Client reported her BS was 140 this AM, B/P was 136/82, pulse regular and steady. EMS called to evaluate the client at 0930. EMS checked her BS which was 324, and her B/P was increasing. Client was transported to the hospital for further evaluation.

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.

Had second COVID vaccine 03/26/2021. States that she had no itching or severe symptoms after 2nd vaccine. She had some shaking. She did fall on the following day. She went to sit on a desk chair which rolled out from under her and she fell to floor.

Urinary tract infection; sciatic nerve; stressed; can't walk; Cancelled 2nd dose because sick in hospital; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse reaction. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization). On an unknown date, the patient experienced PERIPHERAL NERVE LESION (sciatic nerve), STRESS (stressed), GAIT DISTURBANCE (can't walk) and INTENTIONAL DOSE OMISSION (Cancelled 2nd dose because sick in hospital). The patient was hospitalized on 17-Apr-2021 due to URINARY TRACT INFECTION. At the time of the report, URINARY TRACT INFECTION (Urinary tract infection), PERIPHERAL NERVE LESION (sciatic nerve), STRESS (stressed) and GAIT DISTURBANCE (can't walk) outcome was unknown and INTENTIONAL DOSE OMISSION (Cancelled 2nd dose because sick in hospital) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route), the reporter did not provide any causality assessments. Concomitant product is not provided. treatment includes IV Antibiotics Bactrim Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded

Afib; Lightheaded/dizzy; nervous; Dehydrated; Problems with vision; Tachycardia; Problems concentrations; Fatigued/Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 098K20A) 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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 ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), VISUAL IMPAIRMENT (Problems with vision), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired). At the time of the report, ATRIAL FIBRILLATION (Afib), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired) outcome was unknown and VISUAL IMPAIRMENT (Problems with vision) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Treatment included metoprolol, digoxin and diltiazem. No concomitant medication was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, The patient's advance age may remain a risk factor for the event Atrial fibrillation. Further information has been requested.

Case noted with increasing difficulty walking and writing. Once case noted with difficulty speaking s/o transported to hospital. Hospital dx CVA. Case now resides at LTC permanently.

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

30 minutes of rapid heart rate and fluttering; shortness of breath; supraventricular tachycardia; Dizzy; diaphoretic; Palpitations; Fatigue; nauseous; This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of CARDIAC FLUTTER (30 minutes of rapid heart rate and fluttering) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Dec-2020, the patient experienced CARDIAC FLUTTER (30 minutes of rapid heart rate and fluttering) (seriousness criterion medically significant), DYSPNOEA (shortness of breath), SUPRAVENTRICULAR TACHYCARDIA (supraventricular tachycardia), DIZZINESS (Dizzy), HYPERHIDROSIS (diaphoretic), PALPITATIONS (Palpitations), FATIGUE (Fatigue) and NAUSEA (nauseous). On 21-Dec-2020, CARDIAC FLUTTER (30 minutes of rapid heart rate and fluttering) had resolved. At the time of the report, DYSPNOEA (shortness of breath), SUPRAVENTRICULAR TACHYCARDIA (supraventricular tachycardia), DIZZINESS (Dizzy), HYPERHIDROSIS (diaphoretic), PALPITATIONS (Palpitations), FATIGUE (Fatigue) and NAUSEA (nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, Electrocardiogram: abnormal (abnormal) supraventricular tachycardia. On 21-Dec-2020, Heart rate: increased (High) increased. 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 provided. About 3 hours after receiving vaccine, patient had 30 minutes of rapid heart rate, and fluttering. She laid down, went to sleep, and it resolved. She didn't seek emergency care. Did not have chest pain or shortness of breath. Continued to have palpitations occasionally, fatigue, tachycardia. She presented to primary care professional on 07 Jan 2021 for symptoms and was transferred to for additional cardiac workup and treatment after capturing supraventricular tachycardia (SVT) on electrocardiogram (EKG). Also diaphoretic, dizzy, nauseous, shortness of breath with palpitations. She was given IV metoprolol in ED with conversion to normal sinus rhythm (NSR). They suspect that the vaccine may have been her trigger. She was able to discharge without escalation of care. 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.

palpitations; irregular heartbeat; light headed; Upon receiving at first I felt weird; felt like my heart was skipping beats; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (palpitations) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Contrast media allergy and Drug allergy. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX), ROPINIROLE, ALENDRONATE SODIUM (ALENDRONATE), ATORVASTATIN CALCIUM (ATORVASTIN), FAMOTIDINE, LORATADINE and PANTOPRAZOLE MAGNESIUM (PANTOPRAX) for an unknown indication. On 04-Feb-2021 at 9:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PALPITATIONS (palpitations) (seriousness criterion hospitalization), DIZZINESS (light headed), FEELING ABNORMAL (Upon receiving at first I felt weird) and EXTRASYSTOLES (felt like my heart was skipping beats). On 13-Feb-2021, the patient experienced HEART RATE IRREGULAR (irregular heartbeat). The patient was hospitalized on 19-Feb-2021 due to PALPITATIONS. At the time of the report, PALPITATIONS (palpitations), HEART RATE IRREGULAR (irregular heartbeat), FEELING ABNORMAL (Upon receiving at first I felt weird) and EXTRASYSTOLES (felt like my heart was skipping beats) outcome was unknown and DIZZINESS (light headed) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Feb-2021, Electrocardiogram: unknown (Inconclusive) Unknown. On 13-Feb-2021, Heart rate: irregular (abnormal) Irregular. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. About 9 days later she experienced irregular heartbeat. She was seen by a physician and treated with Metoprolol. Upon receiving at first she felt weird, light headed and that night she starting heart palpitations. It felt like her heart was skipping beats. She called doctor and had an electrocardiogram (EKG), and then she went home. The heart palpitations continued to get worse and she went back to doctor and was admitted in the hospital on 19-Feb-2021. She was continually working with her doctor. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: added patient contact details (address, email ID, phone number), patient demographics (height, weight, race), added patient's allergies, concomitant drugs and events (palpitation, weird feeling, dizziness, heartbeats skipped); 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.

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

1020: Patient was complaining of dizziness. When transporting patient to stretcher she was having weakness and shaking. Onsite NP and EMT assessed patient immediately. First BG reading read low, second reading read 29. Patient was immediately given a breakfast bar. Vitals were taken. BP 171/96, HR 116, 02 98%. EKG showed sinus tach. Patient stated she had not eaten this morning and she is a diabetic. Fire rescue was called. 1035: Second set of vitals were taken BG 89, BP 177/96, HR 120, O2 98%. 1045: Fire rescue arrived, assessed patient. BG was 179. Patient refused to be transported to the hospital. 1100:, Patient agreed to no further medical intervention on our end.

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

severe muscle spasms in back and shoulder on right side, severe pain in right arm, shooting pain and numbness in right arm finger pins and needles numb. Unable to stand without pain and spasms. symptoms started 2 days after first shot, went to urgent care since have seen 8 doctors, 2 trips to the ER, 2 MRI, CT scan and back and neck xrays.. Presently seeing a spine specialist and received a cortizone shot. Still can not stand witout pain and numb arm and hand.

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.

On March 6, 2021, three days after second Moderna vaccine, I had sudden onset deafness in my right ear and progressing dis equilibrium. Within a couple of hours I could barely walk. Extreme dizziness/vertigo, nausea. Went to ER next day, 3/7 and was transferred after about 5 hours to Medical Center. Was eventually diagnosed with Idiopathic Labyrinthitis. ER wanted to admit me at 11:30pm but I hadn't eaten or had any fluids and they don't feed people in the ER so I went home. Conditions worsened with walking like a very drunk person and brain fog, dizziness, vertigo. Went back to ER where they completed all kinds of tests and scans.

Starting one day after vaccine patient began to feel funny in her legs, that progressed to not being able to walk well. She stayed a few days in hospital and by discharge had improved but not recovered to baseline.

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.

can't sleep; she is angry, been crying, is depressed and is taking an antidepressant; headache; couldn't hear anything out of one of her ears temporarily; brain is ringing/debilitating/ringing in head; received vaccine and has been sick; stuttering words; body shaking; trouble walking; This spontaneous case was reported by a consumer and describes the occurrence of SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily) (seriousness criterion medically significant), TINNITUS (brain is ringing/debilitating/ringing in head), MALAISE (received vaccine and has been sick), DYSPHEMIA (stuttering words), TREMOR (body shaking) and GAIT DISTURBANCE (trouble walking). On an unknown date, the patient experienced SLEEP DISORDER (can't sleep), DEPRESSED MOOD (she is angry, been crying, is depressed and is taking an antidepressant) and HEADACHE (headache). At the time of the report, SUDDEN HEARING LOSS (couldn't hear anything out of one of her ears temporarily), MALAISE (received vaccine and has been sick), DYSPHEMIA (stuttering words), TREMOR (body shaking) and GAIT DISTURBANCE (trouble walking) outcome was unknown and TINNITUS (brain is ringing/debilitating/ringing in head), SLEEP DISORDER (can't sleep), DEPRESSED MOOD (she is angry, been crying, is depressed and is taking an antidepressant) and HEADACHE (headache) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that, the patient was taking antidepressants for being angry, been crying, was depressed . The patient also stated that she bought silencil an over the counter medication that she bought on the internet but it didn't help. She wanted to know if she could get a tetanus shot. 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. The patient's age and concomitant use of antidepressants are confounding factors that may play possible contributory roles. No further information is expected at this time. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Added 1 new serious and 3 non-serious events. This case is upgraded per addition of serious 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. The patient's age and concomitant use of antidepressants are confounding factors that may play possible contributory roles. No further information is expected at this time.

Patient became lethargic, weak and generally debilitated with tremors and inability to complete ADLs without assistance, beginning on 4/7/21 (date of second dose of vaccine). She was taken to see a neurologist on 4/12/21. She showed some improvement by 5/5/21 but then had a recurrence of generalized decline and on 5/28/21 she became weak and fell while ambulating. On 5/29/21, she had another event with weakness and fall and was taken to the hospital and admitted.

On 06/15/2021 pt. presents to ED with c/o weakness, SOB, cough, increased sputum production, pleuritic pain, and leg edema. Pt. cont. to smoke. Pt. reports having difficulty getting out of her chair at home to go use the restroom. Pt. states that she collapsed in the hallway, a soft fall and was unable to get up. Pt. was able to activate her life-line button for assistance. Pt. was found to have an O2 saturation on RA of 84%. Pt. had IV placed, received an Albuterol HHN UD breathing treatment, a dose of Levofloxacin 500 mg, lab work, EKG and CXR. Pt. was transferred to higher level of care.

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.

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.

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.

1205p back to clinic c/o "whoozie" and hands tingling, water given, cool cloth to forehead, BP 147/84 P 73 R 18 SpO2 95% RA, 12:16p pt reports "better" denies any s/s, BP 135/78 P69 R 18 SpO2 96% RA, ambulated with RN to valet parking

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.

weakness, fatigue, had a bad taste in her mouth as soon as she got the vax, shortness of breath, chills, was losing her balance, headaches, temporal artery on right side of her head is bothering her, diagnosed with gastroparesis, right arm/near breast is sore, developed tremors

Approximately April 16 (2 weeks after second shot) Left leg went out from under me unexpectledly. Few days later happened again but continued to be weaker and Blood pressure increased to 207/140 while I was out shopping. Drove myself to hospital ER and they admitted me. from 04/26 to 04/29. On 04/29 they did MRI brain scan and determined that I had suffered a right quadron brain bleed which left me left side leg weakness and balance issues. Sent me home on 04/29 and told me see primary Dr. right away.. They ordered in home therapy for a few weeks and in 2 weeks I start outpatient therapy . Since this 3 of my Dr's agreed to have a Heart loop monitor inserted in my chest which I agreed to. Staples come out next week.

Got out of bed, took 3-4 steps, got very dizzy or passed out. Family member stopped by, found me on floor, and called 911. Paramedics transported me to the hospital where I remained until 4-03-2021. Many tests, transferred to specialist hospital.

Fully vaccinated patient tested positive for COVID upon admission to hospital for unrelated event. Patient admitted through ED on 07/01/21 for orthopedic needs after a fall. No s/s COVID throughout stay. Patient also with positive COVID test in 04/2021.

Patient stated that about 6 hours after getting her 2nd dose of her Moderna vaccine, she started to feel a tingling, shaking feeling in the arm where she received her vaccine, then her arm goes numb for about 2-3 minutes. Patient also stated that her legs start to shake, she will get dizzy. Patient has been to doctor to for Adverse Event and wasn't prescribed any medication. Patient stated that this happens at least 6-8 times a day, she's only had 2 days since she was vaccinated that this hasn't happened.

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.

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.

12/31/20-pm upset stomach; 1/1 /21 woke up with diarrhea and mild headache thru the day. Around 7 pm felt like a dizzy spell loosing ability to move with like fog in my head and uncontrolled strong shaking and vomiting. 1/2/21 woke up with no symptoms and feeling fine.

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.

15 minutes after Moderna COVID vaccine patient experienced dizziness, slight chest tightness, and numbness to her lower lip. She was given benadryl 25 mg. Her dizziness, chest tightness, and lip numbness resolved. She did have elevated blood pressure reading at 1200 was 130/90 1230 was 180/82 it took 2 hours of resting to get her blood pressure down to 152/82

6:00PM R arm very sore, soreness progressed to R side of body, began to feel very weak, unable to lift leg to bed, malaise 24-36 hrs, exhaustion, wanting to sleep all the time, extremely weak next day

I got the shot on Monday 1/11/2021, had a slight fever on the 12th and couldn't raise my arm higher then my shoulder. On the 13th my arm was fine. Then I didn't worry about till the 01/18/2021 in the evening and it felt warm and it was a big patch of red (looked like a rash) about 3 inches long and 2 inches wide like a oval shape. On Tuesday 01/19/2021 I called my doctor, spoke with nurse what was going on. Doctor told her to put cold compresses on the site 15 minutes on and then 15 minutes off and take Tylenol as needed. The area is still warm and the redness area is still there. Did go to local grocery store and spoke with pharmacist who advised her to contact VAERS.

PATIENT COMPLAINED OF PALPITATIONS AND SOME DIZZINESS THAT STARTED ABOUT 10MINS AFTER ARRIVING TO OBSERVATION AREA. NO OTHER SYMPTOMS REPORTED AT THAT TIME . PATENT DID REPORT A HISTORY OF HYPERTENSION. INITIAL BLOOD PRESSURE WAS 178/103, PULSE 68, O2 SAT 97%. PATIENT GIVEN WATER AND DRANK THE ENTIRE BOTTLE. AFTER ABOUT 5 MINS REPORTED THAT PALPITATIONS HAD RESOLVED. BLOOD PRESSURE REMAINED SLIGHTY ELEVATED 166/99, PULSE=67. PATIENT REPORTED THAT SHE RUNS O N THE HIGH SIDE TOWARDS THE AFTERNOON. FINAL BP WAS 170/110. PATIENT REPORTING THAT SHE FEELS WELL ENOUGH TO GO HOME AND WILL FOLLOW UP WITH HER PHYSICIAN AFTER SHE RECHECKS BP AT HOME. PATIENT ESCORTED HOME ACCOMPANIED BY HER SISTER IN LAW.

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.

extreme exhaustion at 10 Wed. night. Upon awakening around 7 AM Thurs. morning, severe vertigo. Had to crawl because of room spinning. This continued all day and abated around 6 PM. Left me feeling tired, and still tired on Fri. AM

Client called to report reaction to vaccine. After she had vaccine on 1/11/21 she had soreness in the injection site which improved after a couple days. On 1/18/21 injection site had a sharp pain and a red spot that itches and continues to grow in size. She states its the site of a softball. She also developed dizziness on 1/22/21 and vertigo on 1/23/21. She had an allergy shot in the same arm 3 days after the COVID vaccine. She has an appt with her primary care this afternoon.

pt received the moderna COVID-19 vaccine. Approximately 10 minutes later she experienced dizziness and lightheadness and weakness. She was evaluated in urgent care, found to have severe hypertension 230/120 (no h/o htn). Hypertension remained present for 2 hours and troponin returned indeterminate. She was transferred to ED for further evaluation and management. See note for details of care.

The morning after receiving the vaccine, I woke up and was pretty dizzy which made me nauseous. I had to try a few times to get out the bed. It went off and on on Sunday then it went away. (felt like I was suffering from vertigo) I do not think I have suffered from it since then.

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)

Patient developed cold like s/s on the 11/12 of January 2021. By the 15th of January patient became weak with mild shortness of breath and was sent to the ER. ER sent patient home. Patient was sent back to ER on January 18th as she remained weak with shortness of breath and was unable to get out of bed. On the 19 of January the patient was sent to a SNF for rehab services in which she remains as of today. According to the patient's son the patient is doing better but still requires assist with mobility. Patient is not on oxygen.

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.

head ache 3-4 hours day of vaccination, lips tingly 3-4 hours day of vaccination, shortness of breath 2-3 hours (2 different times) next day after vaccination, increased vertigo symptoms since vaccination & still remains, but other symptoms are improved. Note: just wondering if interaction of the steroid injections every two weeks with the covid vaccination???? (in answer to be if recovered...all except the increase of vertigo)

C/O OF DIZZINESS A MINUTE AFTER RECIEVING VACCINE. UPPER EXTREMETIES COLD TO TOUCH, AWAKE AND ALERT X4 TOLERATED ORANGE JUICE SYMPTOMS IMPROVED.

February 1 2021 6:30am Severe Vertigo Called 911 Was then transported to hospital for further testing. Was kept overnight for Observation and then released.

Pt reported dizziness and was observed coughing and continuing to c/o of SOB. Pt reported chest tightness and throat tightness.

pt states that after vax she had fatigue and loss of appetite. The next day pt woke up w/ no appetite, dizzy, weak and felt like she needed to faint. She was experiencing angina type symptoms w/ short frequent episodes of AFIB. She went to bed and woke up around 11 PM on 1/31/2021 sweating and had a temp of 103. She took extra strength Tylenol and went back to bed. Next morning her temp 101.5. but had returned to normal during the day but had gone back up to 99 later that night. On 2/2/2021 states there was no temp but her arm is swollen, itchy and red with pain. She was able to eat and get hydrated. Pt is still dizzy and light headed at this point. On 2/3/2021 patient woke up feeling some better and able to focus but still has itchy, painful and pink arm that is hot to touch. She is going to call her PCP and Cardiologist today on 2/3/2021.

Patient complained of headache, lightheadedness and anxiety. Observation awake, alert and anxious. No wheezing. Initial blood pressure was 190/100 pulse 92 . Lungs clear. After 5 minutes of observation symptoms unchanged. 170/90 pulse 90 . Extra systoles on pulse palpation. Administered 12.5 mgs Benadryl p.o.. No change in symptoms, no further improvement in blood pressure and pulse. Patient remained anxious, lives alone, transported patient to emergency room.

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.

On the 4th hour I was sleepy and fatigue, 3pm, went to bed at 11pm, woke up at 2am extremely dizzy and the room was fiercely spinning and couldn?t get up. I tried going back to sleep and when trying to move the room spined drastically slowly sat up and went to the bathroom and laid back down and it started again, each duration lasted 10 seconds and it caused me to have 3 BMs in the next3 hours, couldn?t sleep but I have a tightness around my head and sleepiness and last event was 7am, when got up I had diarrhea and and had dry heaves that lasted 5 minutes and now fatigued and hot feeling around my eyes. My stomach feels stressed and tired and weak

24 hours following vaccine arm very sore and red. Beginning 24 hours later arm continued to swell to size of tangerine, very red, hot to touch. Unable to sleep or lay on side. No lymph node swelling. Unable to use. arm. Took Tylenol first day only. Took Ibuprofen for arthritis but not for arm. Did find some relief from the over the counter meds. Seen by private doctor who diagnosed cellulitis. Told to take second dose but in different arm.

Pt called 02/08/2021 at 12:00 PM detailing possible adverse reaction to vaccine. Pt received COVID-19 Dose #1 on 02/05/2021 at 4:20 PM through the Health Department. Around 10:50 AM 02/06/2021, pt stated she began to feel lightheaded, and jittery. Pt is a Type II diabetic. Pt took her blood glucose level which was initially 193. Pt waited 10 minutes and retook her blood glucose which was 230. Pt waited 30 minutes and retook her blood glucose which was 174. At 2:40 PM blood glucose was 157. At 5:00 PM blood glucose was 120.

Pt experienced dizziness and became pale, blood pressure was found to be elevated to 175/84 @1340. Previous dose of COVID vaccine had created a similar response but she had just adjusted medications and attributed it to that. In this case she had taken all her medications. Took rx medication for high BP while being monitored but BP increased to 201/104. Her PCP was notified and she took a second dose of her BP medication. By 1500 her BP had improved to 155/89 and she was no longer dizzy. Taken home with instructions to follow up with PCP if symptoms return or worsen.

SHE EXPERIENCE TIGHTNESS IN HER CHEST AND LIGHTHEADEDNESS 10 MINUTES AFTER VACCINATION. OUR ONSITE EMS WAS REQUESTED. NO VITALS PATIENT REFUSED SAID SHE WAS FEELING BETTER. STATED SHE TOOK HER MEDICATION THIS MORNNG AND DID NOT EAT BREAKFAST BEFORE HAND. PATIENT HAD A B-12 INJECTION 3 DAYS PRIOR TO VACCINE AND FLU VACCINE APPROXIMATLY 2 WEEKS BEFORE. NO RECORD OF FLU VACCINE IN MICR. HER SYPTOMS RESOLVED AND PATIENT WAS RELEASED TO GO HOME.

pt stated within 30 minutes after taking the vax she had leg pain starting in the calf and moved all the way up to the thigh. This pain last for 2 days. On 2/12/2021 she woke up she was dizzy and nauseated. Pt has not contacted her PCP regarding her symptoms at this time.

I started having a headache and felt listless and tired. body aches. lack of appetite. fever of 100. took a tylenol. I woke up at 5am the 10th and I was shaking and having chills and I was hot and cold... I was dizzy and my eyes hurt. My arm was hurting. I took another tylenol. at 6am I called my NP daughter for advice and she told her it was a reaction of the vaccine. my fever was 102.5. I was advised to take more tylenol and to rest. the fever broke later that morning but I was still experiencing those side effects. 3 days later I'm still not 100%.

Hour after vaccine shot started with Slightly swollen lips & numbness in the lips red color of cheeks. . Took Benadryl and 16 ounces of water around 1hour 15 minutes after shot Two hours after shot experience slight sore throat lightheadedness head cold symptoms Symptoms lasted another six hours took a second then a drill. Rank another three bottles of water Symptoms became lighter with a little bit of a headache After 20 hours everything went away except tiredness and light headaches

Severe leg cramps. It felt like many muscles in my legs and toes were cramping at once. Legs were painfully bending and twisting Could barely walk. Very difficult to try to relieve them as motion to relieve one cramp made others worse. Lasted about 45 minutes. After about 15 minutes I took a cyclobenziprene I'd had for a back spasm about a year ago. After seeing a report of a woman with severe seizure-like leg spasms I decided to report my experience. I am concerned about taking dose #2 scheduled for March 4.

Day after injection-Chills, headache, nausea, body aches, diarrhea, dizziness, fainting, temperature. 2nd - 3rd day- headache, fatigue, slight temperature, tightness in chest

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.

Dizzy, seeing white, world disappears, feel faint, broke out into sweat, face is ghostly white. Episode lasted about 10 to 15 minutes. Went to bed, slept, This happened at 2pm on February 1. Felt all right after sleeping. Talked with my doctor on Feb. 2 and started taking electrolytes. Have been okay.

I had my first dose on 1/11 I had dizziness and rapid heartbeat and light Flu-like symptoms On2/8 I had my second dose and the injection site got very sore. I experienced flu like symptoms of achiness, fever, chills. I also had diarrhea and I felt like my intestines were on fire. my arm turned red and was incredibly itchy

I had a room spinning dizzy spell on the 3rd day after the shot but didn't think too much of it after it passed. The 4th day I remember thinking I felt dizzy again, and the next thing I knew I was on the floor and hit my head really hard. I think I must have passed out for a nano second. (The first time in my life!) On the 8th day, Feb. 14th, I got a rash on the injection site. It was red, swollen, hot and shaped like a square about 2 inches diameter. I haven't had an event since.

Lost muscle control, could not raise up out of bed, could not walk, lost bladder control, slept 24 hours, no appetite, weakness, headache, fatigue

8-10 hrs post injection (this was the second dose) nausea, fever, chills, diarrhea, headache, weakness, dizziness, could not get out of bed or stand.

2/9/12-1st lightheaded, metallic taste in mouth, dizzyness, high systolic BP x3, q5 min: 186/80, 180/80, 153/83, normal systolic 120, HR WNL. Ct feels reaction r/t anxiousness prior to vaccination, 'I don't like shots' , Ref to PCP, appt w/ ENT on 03/02/21.

Pt began to complain of feeling dizzy. Initial BP was 130/80. Pt then began to complain of double vision and her head feeling "tight". BP at that time was 160/77. EMS called due to increasing BP, double vision and headache. BP when EMS arrived was systolic BP of 180. Pt also complained of nausea. EMS did not transport patient to ED per daughters request to wait at clinic under observation for 30 min in the quiet and then will go home. Pt observed for 30 min and all symptoms resolved within 30 min. Pt taken home by private care.

Chills, muscle aches throughout body, headache and pain in left arm that made it too painful to move or use it. All symptoms except arm pain resolved within 24 hours. Pain in arm lessened to tenderness on touch and slight pain on movement within 48 hours. All arm pain symptoms were gone by 6th day after injection.

Nausea, Vertigo, mild headache. Vomiting for one and half days. Soreness at site of injection for one day

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.

Arm pain and fatigue from the first shot Arm pain, fatigue, burning breast shortly after receiving second shot and arm was painful and weak and unable to be lifted one week after second shot

Shortly after I received the vaccine, and stood up, I felt a bit light-headed so I continued to walk around the store for a few minutes. Later in the afternoon, my right arm where I had the vaccine was very painful, reducing the ability to raise my arm, which continued through the following day. On Day 3, it was still a bit sore, but improving. On Day 4, I was totally fine.

Bad headache, dizziness, achy, vomiting (3x) Lasted until about midnight, Monday, Feb.22. Felt totally recovered by 9AM Tuesday.

After vaccine I was fine went home and took a nap, when I woke up at 2pm I was a little dizzy. By 7pm I was dizzy and nauseated, and it got worse, I got chills and shook and shook and shook, I had a fever and the next day I tried to get out of bed, and I fell to the floor and couldn?t stand up, I had no energy or appetite. I had covid in August 2020 and the wasn?t made aware of the possible side effects if you had covid. They didn?t ask if I had covid in the past and the pharmacist told me later that people who has had covid has reported having bad side effects. I had gone a couple weeks ago to see if I had the covid antibodies and I was positive for antibodies and the injection works against the antibiotics. This part of the procedure was overlooked. I have no one else to help me and going through this alone, it would have been better to have been made aware of this ahead of time.

1:45 pm January 5, next day I was pretty good but started running a fever. 99.5 and stayed at that temp until 12th - went up to 101.3 and I was very dizzy. Dizziness was just for 24 hours. January 14th - at 6:00 pm - my temperature 100.9 and it started going down after that. It fluctuated to 99.5 to normal up and down - evening when temperature would come back up. I took 1 acetaminophen (phone call to dr told me to take it) to get temperature down when it was 101 but all the rest of the time I just counted on the aspirin that I take at night to help. Have to call the doctor to get the Lot numbers for the dose. Feb2 - was when I was took second dose and I was recovered from 1st dose.

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.

After the second shot, I expected mild side effects and experienced some: mild headache, sore left arm around injection site, fatigue, brain fog. I was walking to my garage with a small package of papers when suddenly my lower back spasmed sharply. The pain was intense. I thought it would subside so I managed, with difficulty, to make it into my car. When I was seated in the car, the spasms subsided. I considered not driving to my two errands but decided that I felt well enough seated in the car to drive and deliver the papers to my tax preparer and the carful of donations to Goodwill. At the tax office, I called an assistant to come to the parking lot to pick up the papers, which she did. At Goodwill, one of the attendants emptied my car. When I got home at about 10:50, I had to call my husband to help me into the house. I spent the next several hours in agony (11 on a scale of 1-10) with spasms, punctuated by absolutly not moving. The spasms were so bad I could not breathe. My doc prescribed a muscle relaxer, then the next day prednisone, which has helped. Today I will have an mri to determine if the spasms herniated a disc.

Patient felt lightheaded and dizzy immediately post vaccination. Observed patient for 30 minutes after which she felt better and left on her own.

Moderna rec'd last Thursday, the injection was pushed in deep and by the evening the pain at the injection site was unbearable, she injected pretty high in my arm and it started to sting. After 4 hours the pain was unbearable and my range of motion was limited and the it feels very hot. I cant sleep because of the pain and have to take Motrin to even function.

The first night she had the chills real bad. She got up to go to the bathroom and was so could she didn't think she was going to get back to bed. She took 2 Tylenol, and went back and laid down. She then awoke the next day starting to have some chills but not as bad as the night before. She covered up with an electric blanket in a chair and finally passed over. She noticed Saturday that she had nausea and dizziness. She then had tenderness in her mouth, used warm salty water which seems to be helping. She cannot eat any hard food on it due to the discomfort. She has continued nausea in the evenings. No problems with the arm where she got the vaccine. She feels it it getting some better, but the dizziness and nausea is the worst issue. She did call her doctor and they told her that they could not give her anything for the rash in her mouth, and the chills. They told her that it had to run it's course.

After 2 days pt experienced difficulty of breathing, dizziness, coughing, racing heart, palpitation, has a pacemaker, headache, was treated with Prednisone tablets

chills & fever (101.7), nausea, dizziness, aches & pains, I felt out of reach with reality for about 24-36 hours. It never occurred to me to try to eat, drink or even to take my daily meds. I have never experienced that feeling before,

When I got the vaccine it hurt so much that I jumped. It felt like it burned for like 3min. The next day I had shortness of breath & I fainted the next thing I seen when I woke up was the paramedics taking me in to the ambulance to do an EKG. Everything was good except my blood pressure dropped. I was not taken to the hospital.

12 hours after injection had tremors in extremities, especially arms and hands, lasted 45 minutes then went away. 1/2 hour later tremors got worse but only in arms and hands - went to bed and woke up fine. Today, 3/5, very dizzy, went to bed that way and still can't walk without feeing I am going to fall down.

About 9 days after my 1st dose of Moderna vaccine, I began to have itching on my right upper arm in the area of the injection. That continues today. Two days after I noticed the itching, the upper arm was hot to the touch, red, and swollen. The area is about 6" in diameter. I did not have an elevated temperature, but I felt slightly nauseous and light-headed on March 5. I had no reaction to the shot until a week and a half to two weeks after the injection. I still have a red, itchy area on my right arm. It seems to be slowly improving.

Dizziness and lightheadedness starting 3/3/21. Some nausea. No vomiting. Tiredness. Saw doctor 3/4/21. Physical examination and lab tests done. Will take Prometazine 12.5 mg , 1/2 to 1 tablet every 6 hours as needed for feeling of being lightheaded. No further dizziness after 3/6/21.

I had the predicted fever 99.9 and chills and headache and sore throat the next day after injection. Recovered as expected after 24 hours, then the day after was very tired and the day after that. My question is, could the symptoms have triggered a chronic fatigue episode? I?m still very tired so that I can?t exercise to rehabilitate my left rotator cuff.

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.

Day after vaccine, I was very sick as though I had the flu. Had a severe headache above both eyes, was nauseous and vomited, slightly off-balance, and tired.

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.

Patient stated that 3 hours (7:40 pm)after receiving her vaccine she experience symptoms of: low grade temp of 93.6 (3 digital thermometers and 2 mercury thermometers) light headedness felt unsteady but blood pressure was ok per patient throat started to feel tight -these symptoms lasted for approx. 1/2 hour (8:10 pm) after giving herself an epi-pen injection, which she carries for bee stings -patient stated the next day on 02/19/2021, she took 2 tablets each 25 mg. of benadryl and never experienced the symptoms again from the previous day.

fell/passed out (unknown) at home, taken by ambulance to local hospital, small bleed noted on CT scan, transferred to tertiary care center, f/u scan after 6 hours unchanged. Sent home. next morning unresponsive, transported back to tertiary care center. required ventilation en route.. massive cerebral hemorrhage noted on CT scan in different area. due to advanced dementia and unresponsiveness life support removed around 9pm that night. passed away at 9am on 3/1.

The following day she was at the clinic (she said to make sure you knew she was a cancer patient) and experienced uncontrollable cold & shaking, they took her temperature at clinic which registered 101 degrees, and she was disoriented and unable to move to get out of her vehicle. She then reported the day after the side effects she woke up and was fine.

Increased vertigo attacks...Dr has been giving me ear injections every week now instead of the every two weeks that he has given since September 2020.

Hospice nurse reported patient started experiencing fatigue, nausea, dizziness, decreased appetite and shortness of breath immediately following vaccination. Hospice medications were ordered and patient began receiving morphine and nebulizer treatments. She then started having dysphasia. She then died on 3/5/21 from presumed respiratory failure.

Didn't feel well around 4:45 p.m. Laid down to rest, went to bed early. The next morning I was dizzy didn't do much. Late afternoon I decided to go out and get my mail. Reached down to pick up a solar light on the ground and just went face down in an icy snowdrift. A neighbor came to my rescue the police and fire came, eventually I went by ambulance to the hospital to be examined.

Nausea, diarrhea, slight headache, lightheadedness and discomfort at injection site. no muscle or joint pain but slight fatigue.

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

Injection hit blood vessel, bleeding, dark blue bruise. Intense Swelling down arm to elbow, deep redness and itching Friday 3-12-21 to today?s date 3-15-21 continues. 3-13-21 fainted after shower, 3-14-21 some dizziness during day. No dizziness as of 3-15-21. Swelling down some, Itching continues.

couldn't move her body at all; lay there unable to move or crawl or even pull herself up for 6-7 hours before she was discovered; no recollection of this episode of what happened to her or what she was doing at the time it occurred; she fell to her garage floor; speech was gargled; brain fog and difficulty; residual confusion; local reaction limited arm movement; local reactions such as pain; 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 local reactions such as pain and limited arm movement (vaccination site movement impairment/vaccination site pain), fell to garage floor (fall), couldn't move body at all (paralysis), lay there unable to move or crawl or even pull self up for 6-7 hours before discovered and taken to hospital (paralysis), brain fog and difficulty (feeling abnormal), no recollection of this episode of what happened or what she was doing at the time it occurred (amnesia), speech was gargled (dysarthria), and brain fog is improved now but still has some residual confusion (delirium). The patient's medical history was not provided. Relevant concomitant medications were not reported. On 27 FEB 2021, prior to the onset of events, the patient received their second dose of mRNA-1273 (lot/batch: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 27 FEB 2021, the patient experienced vaccination site movement impairment and vaccination site pain. On 28 FEB 2021, the patient experienced paralysis, amnesia, fall, dysarthria, and feeling abnormal and due to these events hospitalization was required. On 04 MAR 2021, the patient experienced Delirium. Laboratory details was provided as CT Scan on 28 FEB 2021 and the result was normal. Treatment information was not 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. At the time of this report, the outcome of the event's, local reactions such as pain and limited arm movement,fell to garage floor, couldn't move body at all , lay there unable to move or crawl or even pull self up for 6-7 hours before discovered and taken to hospital, brain fog and difficulty, no recollection of this episode of what happened or what she was doing at the time it occurred, speech was gargled, and brain fog is improved now but still has some residual confusion, 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 events, a causal relationship cannot be excluded.

Admitted to hospital 3/13 with encephalopathy for monitoring. Discharged 3/14. At the beginning of ED visit, Patient did not know her daughter's name. She was unable to lift her legs at home when daughter tried to help patient to dress. At ED patient was given Tylenol and fluid. Patient now recognizes her daughter and was able to get up to the bathroom with only minor assistance. During encounter, patient is awake and able to follow directions. Patient is not oriented to time, though she know she is in the hospital. Patient states that she had COVID this morning and that is the reason why she was in the hospital. Daughter at bedside helped history. Patient received 2nd Moderna COVID 19 vaccination yesterday. Daughter called but patient did not respond at noon. daughter went over to see the patient. Patient could not finish the sentence to questions. Patient could not get her dressed up by herself. Patient went to bathroom for urination but she wiped the toilet, and folded the towel. But she did not do what she was there for. Also she could not life her legs to get helped to get dressed to come to the hospital. Now patient is able to shuffle to the toilet. Now she is able to answer her name and birthday. But still patient looks confused and not her baseline. Patient has difficulty remembering her medications. Patient does remember her children's name and home address. Patient lives alone at home and daughter wishes patient to be monitored as she has not recovered completely. Hospital Course/Treatment Rendered 78/F, CC : altered mental status PMHx Endometrioid adenocarcinoma stage IA, grade 2, status post hysterectomy and BSO on 04/06/2015. Diabetes type 2. HTN. HLD. Altered mental status, Encephalopathy, metabolic, likely related to COVID 19 vaccination. Neuro status as well as hemodynamics been monitored. Fall precaution. PT/OT was consulted for home safety evaluation as patient lives alone. Neurology, Dr. was consulted. Patient refused lumber puncture in ED. CT chest - no pneumonia or Pulmonary embolism. UA - ketone positive and dehydrated but no UTI. In the morning of 3/14/2021, patient has improved and mental status back to baseline. PT deemed patient able to go home safe. Uncontrolled hypertension at ED. Gentle hydration as patient has dehydration(urine specific gravity 1.026) and continue antihypertensives such as losartan. SBP 145-165mmHg, Asymptomatic. Will continue home medication. High D-dimer. CTA chest - excluded DVT. Venous duplex US of Both Lower extremity in AM done and no evidence of DVT. Type 2 Diabetes Mellitus. continue to monitor blood glucose and continue glipizide. controlled with blood glucose 188-135.

Got the vaccine and was fine, on the 2nd day 3/12/21 she got so weak, was freezing, her legs and feet were cold. She turned the AC off and the temp in the house was 82 and she was still cold, had a headache and felt so bad. She took her temperature and it was 101.6, she felt nauseous. She had eaten a protein bar at 11:00 AM on then at 1:00 PM had the above symptoms. She continued to drink water and kept it down, took her temp about 2 hours later and it was 100.4. About 4 hours later she continued drinking water, and her temp had dropped to 99._. She was so weak that she could hardly get off the bed to go to the bathroom and urinated on herself trying to get up out of the bed. After her fever went down she was able to get up. Her husband was almost total care and she was not able to take care of him. She went to sleep and woke up at 3:00 AM and felt so much better, and ate some crackers and took some Tylenol for the headache and felt like she was OK. She did not eat anything on Friday and on Saturday ate lightly. The vaccine area is warm to touch, sore and swollen but not much.

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

She had her second Dose of COVID-19 vaccine in the afternoon. The next morning, she was confused, had tremors in all 4 extremities, was weak, unable to bear weight, and unable to walk. She remained in this state and bedbound for 3 days. Her husband considered taking her to the ER but was concerned that she would be alone and unable to advocate for herself due to severe confusion. She gradually regained strength and tremors resolved after 1-2 weeks.

About 36 hours after the injection, I became lightheaded, along with diarrhea, general feeling of being out of whack. It lasted about 20 hours.

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.

77 yr old caller got her vaccine on Tuesday march 16th her first vaccine at 230, moderna lot # 044 A GA or AUA woke up Wednesday with dizziness history corona virus in sept of 2020, asthma later on Wednesday she vomited one time feels fine today

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

Headache and loss of balance within 1 .5 hrs. after vaccine, recurring, at 8:30 pm. Recurring next day at noon and then at 12:00 am. My lips became numb( like I had a nova cane shot) upon standing I had difficulty with balance and walking and my head felt foggy until 3 A.M. I almost called 911. I took Tylenol, Claritin and Pepsid and finally felt better. On Sunday my head felt foggy and my balance was not good. Then again on Tuesday, I had intermitent episodes.

Additional side affect on Saturday night episode where my lips became numb, my balance was unsteady, and I had difficulty walking, my head was foggy-- and additionally I felt shaky inside. Just as if you have the shivers. This is in addition to my events with the headaches. I am very worried about the second shot in the vaccine.

diarrea, vomiting, cant walk, dizzy, chills, fever SICK SICK SICK SICK SSICK SICK SICK SICK HOW DO YOU EXPECT A SICK PERESON TO FILL OUT THIS long form????????????????????????? I AM STILL ALIVE BUT THE CHECK MARK WON'T LETY ME CHECK SOMETHING ELSE.

complaints of generalized weakness. Patient states she was sitting at home when she developed sudden weakness throughout her body. She states she walked to the bathroom and felt as though she was going to fall down. She reports feeling sweaty as if she was having a hot flash. She states her symptoms lasted approximately 45 minutes and resolved after arriving to the ER. She denies feeling dizzy, lightheaded, no visual disturbances, paresthesia or headache. She denies any chest pain or shortness of breath. No recent fever, cough or chills.

Hives. Pt c/o one hive on L jawline below ear and "head feels funny". Describes feeling "lightheaded". Recommeded to be medicated with Benadryl 25 mg po, pt refused. Pt is scheduled for annual PE with Dr at 1000 BP: 120/73, P; 62, RR: 16 non-labored, SaO2: 95% on RA. Pt waited 30 minutes and left the vaccine clinic stating she would wait in main hospital lobby until her MD appt at 1000.

itching on her back, hands and wrists (severe), and behind her ear by her hairline; delayed types of reactions; dizzy whenever she lays down; rash going up her arm.; exhausted, fatigue, and couldn't get out of bed.; pulmonary fibrosis was also exacerbated.; A spontaneous report was received from a consumer, concerning a 78 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pulmonary fibrosis was also exacerbated(Pulmonary Fibrosis), exhausted, fatigue, and couldn't get out of bed( Fatigue), itching on her back, hands and wrists (severe), and behind her ear by her hairline(Pruritus), rash going up her arm(vaccination site rash),dizzy whenever she lays down(Dizziness), delayed types of reactions(Skin Reactions). The patient's medical history had pulmonary fibrosis.No relevant concomitant medications were reported. On 21 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly in the Left arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient experience exhausted, fatigue, and couldn't get out of bed, pulmonary fibrosis was also exacerbated and On 03 Feb 2021 ,the patient experience itching on her back, hands and wrists (severe), and behind her ear by her hairline,rash going up her arm, dizzy whenever she lays down,delayed types of reactions. The patient was treated with lidocaine for itchiness on her hands and wrists. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, pulmonary fibrosis was also exacerbated(Pulmonary Fibrosis), exhausted, fatigue, and couldn't get out of bed( Fatigue), itching on her back, hands and wrists (severe), and behind her ear by her hairline(Pruritus), rash going up her arm(vaccination site rash),dizzy whenever she lays down(Dizziness), delayed types of reactions(Skin Reactions) were considered as unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The pulmonary fibrosis and dizziness events are probably related to the patient's comorbidities. Based on the current available information and temporal association between the use of the product and the start date of the events vaccination site rashes and fatigue, a causal relationship cannot be excluded.

29 days after patient's second Moderna dose, she had sudden onset significant pain where she couldn't stand or walk, her left leg became swollen twice it's size, and blue. She went to the ER with no treatment. About 5-6 hours after discharged she returned with her leg turning purple and uncontrollable pain. She was diagnosed with venous thromboembolis and transferred to a larger facility where she underwent lytic therapy and venous angioplasty. She is having to go for venous stenting in the next two weeks. She continues to have pain in her leg, chronic fatigue and weakness, as well as being lightheaded with a stable BP (no orthostasis). She has been diagnosed with anemia since vaccination and is being worked up for that.

Dizziness; Weakness; Swollen lymph nodes; Barely walk; Fatigue; Larger patch of hives; Arm pain; large hives as well as small patches of hives; Chills; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of ANGIOEDEMA (Larger patch of hives) in a 78-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. The patient's past medical history included No adverse event. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ANGIOEDEMA (Larger patch of hives) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm pain), URTICARIA (large hives as well as small patches of hives) and CHILLS (Chills). On 27-Feb-2021, the patient experienced GAIT INABILITY (Barely walk), DIZZINESS (Dizziness), ASTHENIA (Weakness), LYMPHADENOPATHY (Swollen lymph nodes) and FATIGUE (Fatigue). At the time of the report, ANGIOEDEMA (Larger patch of hives), GAIT INABILITY (Barely walk), PAIN IN EXTREMITY (Arm pain), URTICARIA (large hives as well as small patches of hives), DIZZINESS (Dizziness), ASTHENIA (Weakness), LYMPHADENOPATHY (Swollen lymph nodes), CHILLS (Chills) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. This case concerns a 78 Y/O M with a serious unexpected event of angioedema and non-serious unexpected dizziness, asthenia, pain in extremity, gait disturbance, and expected chills, fatigue, lymphadenopathy. Event onset the same day as first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 78 Y/O M with a serious unexpected event of angioedema and nonserious unexpected dizziness, asthenia, pain in extremity, gait disturbance, and expected chills, fatigue, lymphadenopathy. Event onset the same day as first dose mRNA-1273. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Friday, April 2nd, in the late afternoon, I began to feel very weak . I had difficulty breathing throughout the night. Saturday, April 3rd, from the moment I woke, I had difficulty focusing due to severe dizziness and extreme weakness, unable to function normally. Shortness of breath continued and I remained in bed throughout the day. Today, April 4th, I am stronger, but unable to physically do more than necessary because of tiring easily with the weakness.

Guest sat down in the observation area for her 30 minute wait and about 5 minutes later she complained of feeling lightheaded and was asked to lie down on the cot. EMS was called. Vital signs were recorded; all within normal range. Guest was offered juice but she refused this. She did accept water. She was helped to a chair. Guest was coherent and cooperative. After about 20 minutes, guest continued to report feeling lightheaded; no improvement in symptoms. EMS decided to send guest to the ED.

Pt stated she was unable to walk and had dizziness. She had to be assisted to chair. BP was 170/60 and a pulse was 60 bpm. Pt stated that she was breathing but felt unable to take a deep breath. Pt stated that she had problems opening eyes and leaving them open. also reported headache . Pt reported chilling and was having tremors possibly related to being cold.

Date:3/13/21 820am Patient c/o feeling nauseous, vomited x1 small amount of yellow color emesis. Patient stated that she feels dizzy and lightheaded. VS 97.3,20,81,176/86 O2 sat @ 96% on Room air. Patient stated that she ate breakfast and took blood pressure medication this morning. Son stated that patient was nauseous while en route to get vaccination. patient awake, alert and verbally responsive. Resting in w/c. Close monitoring in progress. 835am Patient states that she feels a little better VS 97.6,18,70, 134/79. patient stated that she usually gets nervous when getting vaccinations. Encouraged to rest for 15 more minutes. 8:50 am patient stable. VS 97.5, 18, 131/80,72. Patient verbalize relief. left facility with son at side.

High blood pressure 170s-200 approximately one week after receiving the vaccine; Dizziness; Difficulty speaking; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERTENSIVE CRISIS (high blood pressure 170s-200 approximately one week after receiving the vaccine) in a 78-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 (Medical history was not provided). On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced HYPERTENSIVE CRISIS (high blood pressure 170s-200 approximately one week after receiving the vaccine) (seriousness criteria hospitalization and medically significant), DIZZINESS (dizziness) and APHASIA (difficulty speaking). The patient was hospitalized from sometime in February 2021 to sometime in February 2021 due to HYPERTENSIVE CRISIS. At the time of the report, HYPERTENSIVE CRISIS (high blood pressure 170s-200 approximately one week after receiving the vaccine), DIZZINESS (dizziness) and APHASIA (difficulty speaking) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided The patient's wife began experiencing dizziness, high blood pressure that ranged from 170s to 200, and difficulty speaking approximately one week after receiving the vaccine. Treatment for the events, 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. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

Relaxing on couch-normal day. Suddenly felt very sweaty-hair wet - decided to wash face - went into bathroom- Quick reaction - Instant diarrhea and vomiting in bucket. Very scary - asked husband for more toilet paper. After cleaning up, I was extremely COLD. Put on extra clothes sweatshirt - got 3 blankets, by now it is 1:30 A.M. Slept in recliner. Next morning - felt weak, unsteady - afraid to eat anything but did drink lots of water. Today is Sunday April 11th, still very cautious about eating and still taking it easy. Seem to have a little discomfort in sternum area (thinking this could be my "years ago diagnosed hiatal hernia ??

She got her vaccine, and within a couple of hours had fever, cold chills, achy body, fatigue. The following week she lost her taste, and ever since she has cold chills constantly, is weak, cannot do anything. She is light headed, her vision is sometimes blurred and will not go away. She has been taking Tylenol for fever. She went to the ER because it was so bad, and they did a CT scan, EKG, chest x-ray for pneumonia, and did blood work. They could not find anything wrong with her. She has also been to her doctor who checked her over and could not find anything wrong either.

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.

pt had 2nd dose of covid vaccine on 03/16 went home got something to eat laid down- does not remember anything else for 2 days was found on the floor by her bed must have fell off of the bed has lost urine neighbor found her- call paramedics declined to go to hosp thinks she passed out for 1.5-2 days daughter came to take care of her had to drink from straw couldn't eat brain fog feeling better now

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.

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

lightheaded, slightly dizzy immediately. had hard time breathing and my inhaler did not help. this lasted until about 7:00 p.m. the following night. By 3rd day I felt much better.

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.

Shortness of breath and whizzing; Not receiving the 2nd dose; Tiredness; Dizziness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath and whizzing) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath and whizzing) (seriousness criterion hospitalization). On 07-Apr-2021, the patient experienced DIZZINESS (Dizziness) and FATIGUE (Tiredness ). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not receiving the 2nd dose). The patient was hospitalized from 28-Mar-2021 to 06-Apr-2021 due to DYSPNOEA. At the time of the report, DYSPNOEA (Shortness of breath and whizzing), DIZZINESS (Dizziness) and FATIGUE (Tiredness ) had not resolved and PRODUCT DOSE OMISSION ISSUE (Not receiving the 2nd dose) 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 were provided. Patient received a lot of medications at hospital Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Was given shot very high up right below my shoulder. Am still in a lot of pain. Am now able to use that hand but unable to sleep in bed. And unable to lift my arm above shoulder height without experiencing extreme pain. This is 2 weeks after receiving the shot.

Right leg became wobbly (like overcooked spaghetti); unable to realized if I was lifting it to walk without concentrating on the act of walking.

Unable to move. Falling on the floor. Lying on back on floor and vomiting clear liquid for aprox. 3 hours . finally able to move after four hours.

After first shot, only side effect was a very sore arm, could hardly raise it for a few days. Did not affect life. Same after second shot until 5 weeks later. Woke to being VERY dizzy! This did, and has continued to, affect my life. I am walking with a cane, using a grabber, can't bend over to anything below table height. I didn't drive for 2 weeks, now afraid to leave town. on my own. Since I am prone to these episodes, I wasn't too concerned, because they do pass, BUT I am still having the issue, daily. I understand that so many unknowns are with the Covid-19 vaccination. My hope is that this DOES pass and I don't have to live with it the rest of my life! Thank you for taking my symptoms.

Hearing loss; Vertigo; Tinnitus; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEAFNESS (Hearing loss) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. no medical history was provided by the reporter. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced DEAFNESS (Hearing loss) (seriousness criteria disability and medically significant), VERTIGO (Vertigo) and TINNITUS (Tinnitus). At the time of the report, DEAFNESS (Hearing loss), VERTIGO (Vertigo) and TINNITUS (Tinnitus) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Patient went to audiologist and was given a hearing aide. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Late afternoon of 2/18/21 developed high fever, chills, nausea, headache, severe dizziness. I was literally unable to think or move. I was totally bedridden until the next day when I started to feel some better.

She got her vaccine, she had a different person than the first one and didn't even feel anything and was fine. With this one she felt when she was stuck with the needle. She got a flush of heat that went down to her elbow. She stayed there for the allotted time period and went home. She got up the next morning, the first she realized that she could hardly stand up due to the pain and aching everywhere. She then started getting chills, and went in to eat and not able to eat, but no appetite. She laid around all day and started taking her temperature and the last time she took it it was 100, then didn't take it after that. She had a massive headache, in fact that evening she put an ice pack on her head as was told not to take Tylenol. She states that this lasted all day, she went to bed early and the next day had exhaustion, unable to do anything, took it easy. She did have her appetite back, and was able to eat. By the 3rd day she was back to her normal self. She did call the paramedics to ask questions as they are around the corner, and they told her to wait 24 hours and see if it resolved, which she did.

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.

Patient's Chief is a continuous pain to the upper left arm , affecting mobility of her extremity. No evident redness, swelling or induration was noted on exam by primary provider on 5/07/2021. Limited ROM due to pain was noted Please note patient was seen for an unrelated reason 5/07/2021 and made mention of her arm pain to the provider.

If she walks little bit then she felt she passed out; After 2 weeks, she had shortness of breath; Dizziness; Vomiting; Chills; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) in a 78-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 to antibiotic (all cillins), Drug allergy (ibuprofen (MOTRIN)), Sulfonamide allergy (trimethoprim/sulfamethoxazole (BACTRIM)), Allergic to cats and Asthma. Concomitant products included DILTIAZEM, LISINOPRIL and ISOSORBIDE MONONITRATE (IMDUR) for an unknown indication. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021 at 3:00 AM, the patient experienced DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache). On 03-May-2021, the patient experienced LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) (seriousness criterion medically significant) and DYSPNOEA (After 2 weeks, she had shortness of breath). At the time of the report, LOSS OF CONSCIOUSNESS (If she walks little bit then she felt she passed out) had resolved and DYSPNOEA (After 2 weeks, she had shortness of breath), DIZZINESS (Dizziness), VOMITING (Vomiting), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: normal (normal) Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient received her first dose of Moderna COVID-19 vaccine on 20-APR-2021. After two weeks, she had shortness of breath and "if she walks little bit then she felt she passed out." The patient's health care provider did some test (unspecified) and everything came out normal, her lungs are clear and her oxygen level is normal. Treatment information was not reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

hallucinating; Couln't walk; Can barely move; feels awful; chills; fever; This spontaneous case was reported by an other caregiver and describes the occurrence of HALLUCINATION (hallucinating) in a 78-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 Chronic lymphocytic leukemia. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced HALLUCINATION (hallucinating) (seriousness criterion medically significant), GAIT INABILITY (Couln't walk), HYPOKINESIA (Can barely move), VACCINATION COMPLICATION (feels awful), CHILLS (chills) and PYREXIA (fever). At the time of the report, HALLUCINATION (hallucinating), GAIT INABILITY (Couln't walk), HYPOKINESIA (Can barely move), VACCINATION COMPLICATION (feels awful), CHILLS (chills) and PYREXIA (fever) outcome was unknown. Concomitant medication was not reported. Treatment of these events were not reported. 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. The past medical history of Chronic lymphocytic leukemia is a likely confounder the events described This case was linked to MOD-2021-104070 (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. The past medical history of Chronic lymphocytic leukemia is a likely confounder the events described

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.

She got her vaccine, and felt fine. She came home and did what she had to do and when she went to bed she felt fine. When she woke up yesterday she sat on the edge of the bed for a minute and then passed out and woke up on the floor. She called the manager of the apartments and asked if she would come and help her get up. She helped her and felt that she should call the paramedics, which she did, and they came out and checked her out and she was okay. Later in the day the dizziness hit her again and she passed out again. She finally managed to get to her phone again, she was not able to get up, and she called 9-1-1 and they came out and got her in the chair, but did not take her to the hospital. She has not passed out anymore but she feels very dizzy and woozy and does not move fast. She also had some nausea, but that is pretty much gone. She has not called her doctor as it was over the weekend.

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.

GI bleeding; Walking with a walker; Not Able to Walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (GI bleeding) in a 78-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 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced GASTROINTESTINAL HAEMORRHAGE (GI bleeding) (seriousness criteria hospitalization prolonged and medically significant). On 05-Apr-2021, the patient experienced GAIT INABILITY (Not Able to Walk). On 06-May-2021, the patient experienced WALKING AID USER (Walking with a walker). The patient was hospitalized from 15-Mar-2021 to 05-Apr-2021 due to GASTROINTESTINAL HAEMORRHAGE. The patient was treated with Rehabilitation therapy for Gait inability. At the time of the report, GASTROINTESTINAL HAEMORRHAGE (GI bleeding) outcome was unknown and GAIT INABILITY (Not Able to Walk) and WALKING AID USER (Walking with a walker) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. On 14 Apr 2021, the patient was moved to Rehab, and after 3 weeks in rehab, she is now walking with a walker. It was reported that the patient has not received the second vaccine yet. Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Pt admitted to hospital from 5/21 to 5/22 discharged home, dehydration, atrial fibrillation, malaise, had second moderna covid vaccine 5/21, became ill 5/22 woke up with low grade fever, generalized weakness, malaise, no appetite, lightheaded, fall to ground stricking righ cheek, no LOC, baselilne memory losse, confusion improved, better on 5/22 morning, no need for follow up clinic visit. Can't get to fill in hospital information to unshade to fill in

Fell and ended up in the hospital; it is more than 42 days after receiving 1st dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Fell and ended up in the hospital) in a 78-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 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced FALL (Fell and ended up in the hospital) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (it is more than 42 days after receiving 1st dose). At the time of the report, FALL (Fell and ended up in the hospital) and PRODUCT DOSE OMISSION ISSUE (it is more than 42 days after receiving 1st dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient fell down and ended up in the hospital on the way to get their 2nd dose. Now it has been more than 42 days since receiving their first dose. Company Comment: This case concerns a 78-year-old female patient who did not receive second dose due to a fall on the way to receiving second dose and yet to receive the 2nd dose after more than 42 days from receiving 1st dose (missed dose). There is not enough information to assess the relatedness of fall to product use The event of missed dose is assessed as not applicable.; Sender's Comments: This case concerns a 78-year-old female patient who did not receive second dose due to a fall on the way to receiving second dose and yet to receive the 2nd dose after more than 42 days from receiving 1st dose (missed dose). There is not enough information to assess the relatedness of fall to product use The event of missed dose is assessed as not applicable.

Patient presented to the ED on 5/5/2021 for dizziness and double vision. Patient was subsequently hospitalized with vertebrobasilar insufficiency. These visits are within 6 weeks of receiving COVID vaccination.

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.

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

broken foot; Fall; Unevaluable event; Atrial fibrillation; Fall; Cerebral bleeding; Stroke; This spontaneous case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation), CEREBRAL HAEMORRHAGE (Cerebral bleeding), CEREBROVASCULAR ACCIDENT (Stroke), the first episode of FALL (Fall), FOOT FRACTURE (broken foot), the second episode of FALL (Fall) and UNEVALUABLE EVENT (Unevaluable event) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 023M20A) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Depression, Bladder disorder, Cholesterol, Abstains from alcohol and Non-smoker. Concomitant products included OXYBUTYNIN HYDROCHLORIDE (DITROPAN) for Bladder disorder, ATORVASTATIN for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, METOPROLOL for Heart disorder, MIRTAZAPINE (REMERON) for Unevaluable reaction. In 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced the first episode of FALL (Fall) (seriousness criteria hospitalization and disability). In February 2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral bleeding) (seriousness criteria hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 10-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization and medically significant) and UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion hospitalization). On 08-Jun-2021, the patient experienced FOOT FRACTURE (broken foot) (seriousness criteria hospitalization and disability) and the second episode of FALL (Fall) (seriousness criteria hospitalization and disability). The patient was hospitalized from 15-Feb-2021 to 18-Feb-2021 due to ATRIAL FIBRILLATION, CEREBRAL HAEMORRHAGE, CEREBROVASCULAR ACCIDENT and FALL. On 08-Jun-2021, last episode of FALL (Fall) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), CEREBRAL HAEMORRHAGE (Cerebral bleeding), CEREBROVASCULAR ACCIDENT (Stroke), FOOT FRACTURE (broken foot) and UNEVALUABLE EVENT (Unevaluable event) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Magnetic resonance imaging head: confirmed brain is bleeding (abnormal) Confirmed brain is bleeding. On 10-Mar-2021, Electrocardiogram: confirmed atrial fibrillation (abnormal) Confirmed Atrial fibrillation. On 08-Jun-2021, X-ray limb: confirmed broken foot (abnormal) Confirmed broken foot. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was sent to urgent care because the patient fell again and it was determined that her left foot was broken where a boot cast was put on her left leg and was advised to have bed rest and had the left leg elevated. The patient was waiting for brain bleeding to heal. 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.

nerve on top of her left foot was disturbed; swollen feet and veins on legs (between knees and ankles; painful veins on her legs (between knees and ankles); nerve on top of left foot was disturbed which gives constant pain; Cannot walk as much as she needs to; Swollen veins; stomach issues and discomfort; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed) (seriousness criterion medically significant), PERIPHERAL SWELLING (swollen feet and veins on legs (between knees and ankles), VASCULAR PAIN (painful veins on her legs (between knees and ankles)), NEURALGIA (nerve on top of left foot was disturbed which gives constant pain), GAIT DISTURBANCE (Cannot walk as much as she needs to), PERIPHERAL VENOUS DISEASE (Swollen veins) and ABDOMINAL DISCOMFORT (stomach issues and discomfort). At the time of the report, NEUROPATHY PERIPHERAL (nerve on top of her left foot was disturbed), PERIPHERAL SWELLING (swollen feet and veins on legs (between knees and ankles), VASCULAR PAIN (painful veins on her legs (between knees and ankles)), NEURALGIA (nerve on top of left foot was disturbed which gives constant pain), GAIT DISTURBANCE (Cannot walk as much as she needs to), PERIPHERAL VENOUS DISEASE (Swollen veins) and ABDOMINAL DISCOMFORT (stomach issues and discomfort) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. Company comment: Very limited information regarding this events has been provided at this time. Further information has been requested; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested

Severe heart issues resulting in fall, loss of consciousness and a laceration to head. Brain hematoma which is effecting eye function. HIGH blood pressure, pulmonary concerns, thyroid module. Tests and treatment plans still in development. Patient did have a pacemaker inserted. Multiple CAT scans, blood draws, x-rays have been preformed and 1 biopsy on the calendar.

She got her vaccine, she was fine, drove herself home 5-10 minutes, felt fine until her arm started to feel hot and a rash broke out. There was lump at the injection site. Then she felt like she had a lightening strike through her body, and felt like she had the flu the next day. She could not move and it lasted only a day and she stayed in the bed, and it went away. She had a low grade temp of 100, normal temp 97. She then woke up on Wednesday with a rash at the injection site to the elbow but used hydrocortisone cream which did not release the pain and used a cold compress to remove the heat from her arm. The cortisone cream did not work and she called the doctor who prescribed Benadryl cream and Benadryl to take (allergic to). Cream worked, Benadryl made her sick so now lists that as an allergy. She then took Claritin and it worked, but the rash remained. She got a rash then on the back of her right thigh, and she had hives on both knees (one on each knee and on the elbows). The rash on her arm was there and had to use cold compresses and eventually by Friday of that week it subsided . Annoying due to the itching, but not painful. The rash on the thigh went away the next day. Also had rash on her buttocks, which went away the next day as well. Has been fine since the Friday after the vaccine. She saw her doctor who told her to take the shot, her son is a Dr. and they told her to take it. All of her family members and friends had no reactions.

The patient sat in the privacy vaccination area in front of the pharmacy for over 15 minutes (9:30-9:50AM) following the administration of the vaccine. She then walked to the front of the store pushing her buggy. In the "check-out" line, the patient begin feeling "dizzy". A couple of customers helped her sit on the floor so she did not fall. An associate immediately called for a code white and then helped patient to sit in chair. The patient was observed and then offered a snack and/or water which she refused. Her son was contacted so that he could take her home. When son arrived, approximately 30 minutes later, the patient refused a wheelchair and walked out of the store. He spoke with me and believed that the vaccine was not the cause of the "dizzy" spell and stated that she has those occasionally. I recommended not to leave her alone for a few hours and make certain that she rested today. I also advised patient son that someone needed to be with her so that she could be driven home after the 2nd dose in 28 days.

Increased problems with speech, finding words, and confusion. Cannot answer the phone anymore. She seems to be more needy, shuffles (new onset), and incontinence problem has returned. Did not have an office visit as a result of adverse event.

On the second day, I had to drive to get the car serviced. When I got home I was very dizzy, got out of the car took 12 steps backward I was so dizzy it did not end in a fall.. I went into my house and tried to eat and it turned my stomach just to look at food. I lay down and slept until 10 am the next day. Now when I get up in the morning I am too dizzy to walk to the bathroom. I must wait 5 minutes before getting on my feet.

Two days after her shot, she was sitting down working on her computer paying bills. She became nauseas and dizzy and then fainted. She hit the tile floor.

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.

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.

About 20 hours after receiving the COVID vaccine she was tired and lay down to nap. Shortly thereafter she became very dizzy even while lying down. As time went on she started burping loudly and developed nausea. She also has developed a headache and has a low fever of 101.5. This all continues until now, 48 hours after the injection and she is still dizzy in bed with the above symptoms.

Day of injection arm a little sore. Next day (Friday) felt perfectly fine and spent the day at home doing usual house cleaning and laundry. Felt fine in the evening and Saturday morning was extremely fatigued, loss of equilibrium, and elevated blood pressure. This condition remained for a few days and on Tuesday my pressure was somewhat down and I saw my doctor. He suggested that since I was doing a little better had NO other symptoms such as fever or chills or muscle aches I would be better in time. It was a rough week feeling so unlike my self but I pushed through. I see the doctor again on Tuesday the 26th. I have never had any reaction to any other vaccine such as flu or shingles vaccine at any time. I am an active woman who exercises and walks to the beach near my home frequently every week. I am anxious about the second dose of the vaccine. I have an appointment on Thursday, February 4th. Hopefully all my strength will have returned by then. I feel like I'm still only 80% back to normal. I have spoken to a young woman who called me back. I would like very much to speak with a medical person who can give me some feedback on my response to the vaccine. That would be reassuring that I am not alone with these side effects. Thank you.

Passed out; Felt weak; Sweaty; Could not walk; Arm still sore at the left arm injection site; A spontaneous report was received from a consumer, who was an 80-year-old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and passed out, felt weak, sweaty, couldn't walk, and arm still sore at the left arm injection site. The patient's medical history was not provided. Concomitant product use was not reported. On 05 Jan 2021, 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 05 Jan 2021, the patient woke up real sweaty at 3 am. She got up and went to the bathroom and passed out. The patient reported that she fell on the commode then got to the floor because she felt weak and could not walk. Once she regained her strength, she returned to bed. On 07 Jan 2021, the patient reported that her arm was still sore at the injection site and continued to feel weak. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events, passed out, sweaty, and couldn't walk were considered resolved on 06 Jan 2021. The outcome of the events, felt weak and arm still sore at the left arm injection site, were considered not resolved.; Reporter's Comments: This case concerns an 80-year-old female patient with unknown medical history, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted event of Loss of consciousness, the non-serious listed event of Injection site pain, and the non-serious unlisted events of Asthenia, Hyperhidrosis, and Gait disturbance. Based on the current available information and temporal association between the use of the product and the onset of the events on the day after vaccination, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.

Patient felt faint around 10 minutes after vaccination, checked blood pressure went up 147/92. Patient 25 minutes post vaccination is feeling fine and good to go home.

After 1.5-2 hours after injection, patient blacked out on stairwell and fell down stairs. Patient struck head and received a concussion, broken nose, brain bleed, tear in the lip and damage to 6th cranial nerve in right eye. Patient has double vision now.

Large red, itchy area around injection site--continues to spread down the arm. In addition, dizzy spells.

At 3:00 am on 1-27-21 I awoke unable to control my mouth. Face, arms, Legs and whole body. My entire body was shaking violently. Finally able to get to my feet and stumbled trying to notify 911. Stumbled to room closest the front door. Husband opened front door for EMS. For about 1 hour I sat and my whole body trembled. Finally the thrashing about slowed down and stopped. Today I am very tired and achey.

Severe pain which continues to get worse after 1 week and radiates into L clavicle, Limited ROM, swelling and redness. She is to F-U with dr in 5 days. Given pain meds.

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.

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

Delayed localized swelling, erythema, warmth to the injection site Increased dizziness from baseline Increased head pressure

pt was leaving after 15 min waiting period and began to feel dizzy so she returned to the nurse station. assessed pt, medical hx, took vital signs, gave juice, offered snack. observed pt for 15 min, she stated that she felt better and was ready to go home. took vital signs second time before leaving with her husband.

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.

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.

(1) fatigue beginning at 7pm, (2) from 2am until about 2pm the next day: headache, body aches (arms, legs, back, neck), chills, fever 101°, heavy fatigue, sleeplessness, (3) high blood glucose levels all the next day. (4) At this time injection arm still sore, somewhat lightheaded,.

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.

guy put the needle in and the man pushed when he put the needle in and i think he hit the bone and i cant lift my arm today., I don't have fever but i have chills, and body aches, i have tightness in my chest.

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.

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.

Blacked out; fell down the stairs; concussion; damaged or severed 6th cranial nerve to right eye; brain bleed; split lip; A spontaneous report was received from a consumer concerning a 79-years-old, female patient who received Moderna's COVID-19 Vaccine, and who blacked out, fell down the stairs, brain bleed, concussion, damaged or severed 6th cranial nerve to right eye and split lip. The patient's medical history included diabetes, two unspecified high blood pressure medications and naproxen sodium. Products known to have been used by the patient, within two weeks prior to the event, included Sitagliptin and blood pressure medication. On 21 Jan 2021, approximately one and half hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 027L20A) intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient "blacked out" while walking downstairs after one in and half hours of receiving vaccination. Patient was hospitalized from 21 Jan 2021 until 22 Jan 2021. Patient has a brain bleed and a concussion, damaged 6th cranial nerve to right eye, and split her lip which need stitches. Treatment for the event included Tylenol as needed. Action taken with mRNA-1273 in response to the events was withdrawn. The events blacked out and fell down the stairs was resolved on 21 Jan 2021. The outcome of the events brain bleed, concussion, damaged or severed 6th cranial nerve to right eye and split lip was unknown.; Reporter's Comments: This case concerns a 79 year old female patient with medical history of diabetes, two unspecified high blood pressure medications and naproxen sodium, who experienced serious unexpected events of fall, cerebral hemorrhage, loss of consciousness, concussion, damaged or severed 6th cranial nerve to right eye and split lip. The event occurred approximately one and half hours after first dose of the study medication administration. Treatment included Tylenol as needed. 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. Noting the subject's underlying medical condition could remain a confounder.

Laid down to take nap four hours after shot, woke suddenly with two different severe cases of vertigo. I have history of vertigo but haven't had it in over a year. After I sat up and was shaking and had chills. Have had no other reoccurrences and have felt fine.

I had a moderate reaction. I was slightly dizzy. I was weak. I had a low grade fever for a few days. I had a headache for a few days. I had "covid arm". It was red, sore, it had some swelling, and intense itching. I am still tired. I have diarrhea as well.

Up to 72 hours after the shot: * Headache * Pain in the injection site (described as sharp pain) * Her face would get very bright, red and flushed; it would remain this way for about an hour, and then go back to normal. Then the cycle would repeat about 2 hours later. * Patient reports alternating between feeling "feverish" or "really hot" alternating with feeling "really cold" * Dizziness, and very unbalanced on her feet * She fell twice the first two days while trying to walk to the bathroom * Extreme fatigue - she slept most of the first 48 hours * Extreme confusion (more than what was presenting with the Alzheimer's prior to the shot) - she could not remember where she was Ever since the shot/still experiencing: * Persistent nausea * Constant "achy" feeling in her arms, legs and feet * Panic and anxiety (again, more than is common with her daily routine) * Severely decreased appetite - unable to finish more than half a meal or not being able to eat at all due to nausea/a feeling like she is going to vomit * Her arms and legs are visibly shaky * She is too weak often to lift herself out of her recliner (she was able to do this prior to the shot)

Extreme weakness leading to patient falling and unable to get up. Nausea, headache, large itchy welt on arm lasting 7 days.

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

Day 1 Rapid heart rate, Fatigue, chills, slight temp, Slept off and on 24 hrs thru Day 2 Day 3 Red rash over both arm pitts, below breasts, upper thighs, Rapid heart pulse, irregular pulse, called and visited Cardiology Clinic for Ekg confirmed PVCs Day 4 Light headed, dizziness affecting gait, forced lying down , general brain fog, rash continued, shortness of breath, rapid heart rate, went to ER, saw nurse for Ekg, blood work, blood pressure, Tylenol 100mg 3x a day Day 5

Woke up with severe dizziness, nausea/vomiting and increased while at work(denies palpitations). In ER 1/2/2021-CT of head(WNL), MRI (saw lesion and physician thought she had a stroke). Neurologist consult on 1/3 and felt it was not a stroke and unsure the reason of dizziness.. 1/3 no arm or leg weakness. Order to see a cardiologist d/t residual dizziness and advised against 2nd moderna covid 19 vaccine.

Patient received her Covid 19 Vaccination on 2-11-21. I counselled her about side effects and asked her to wait 15 minutes. She waited and as she was leaving she fell to the floor and hit her head. The other patients around her said it looked like she slipped, but when speaking to her it seemed that she had become dizzy and fell. I spoke with her after she fell, she did not loose conscienceness, but was disoriented. She did know what day it was, who she was and where she was. She said her head hurt and she could move all her limbs. I asked the store director, to call for an ambulance. I sit with her for a few minutes and talked to her, then asked store director to stay with her until the ambulance arrived. They arrived and spoke with her and decided to transport her to the hospital. Later that day, her sister in law came by and said she was doing fine and had been released. The doctors indicated they thought she because dizzy due to dehydration

First dose 4 weeks ago, second dose February 17th, 2021. Time 1000 Redness around injection site. She couldn't move her arm and it was sore when trying to move arm above mid chest. "Looks like someone sprayed red paint over her". These sx resolved today however she is still experiencing unbearable itchiness. Caller did mention that she has been having chronic itchiness for what she was taking daily Antihistamines (LORATADINE 5mg) but had d/c it prior to vaccine as she was told that taking antihistamines was not recommended. PCC Recommended to go ahead and take an antihistamine as it is not contraindicated. She usually takes Loratadine and was going to take a 10mg tablet. PCC will fu.

vasculitis; coughing up blood; really bad head cold; dizzy; Started gettting sick; A spontaneous report received from a Consumer concerning, 79-year-old, female patient who received dose of Moderna COVID-19 vaccine experienced Vasculitis. The patient's medical history included Afib. Patient's concomitant included Eliquis. On 04FEB2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in left arm (Batch #: unknown) intramuscularly for prophylaxis of COVID-19 infection. Patient daughter reports her mother who is 79-year-old female with no underlining health issues other than Afib, which she takes blood thinners for has been in ICU since 10FEB2021. Patient daughter stated that she was told her mother has vasculitis as a result of the Moderna Covid-19 vaccine. Patient daughter stated that her mother started getting sick on 06Feb2021. She stated her mother started coughing up blood on Sunday 07FEB2021. She stated her mother also had a bad head cold and was dizzy. Patient daughter stated that her mother has some genetic predisposition and the Moderna COVID-19 vaccine triggered it. Patient daughter stated that her mother doctor advised her not to receive the 2nd dose of the Moderna COVID-19 vaccine. Patient treatment included Chemotherapy Infusion (Rituxan) and Blood Transfusion. Action taken with mRNA-1273 in response to the event was withdrawn. The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient received vaccine and proceeded to waiting area. She began to feel "off" and reported. She did not improve and staff assisted her to rise and she collapsed and was eased to floor and legs elevated and 911 was called. She did not lose consciousness. She was clammy and then color improved; low pulse; normal BP. No problems breathing and no rash. EMS arrived and transported her to hospital. We later learned she was being transported back and doing fine

Seizure on 02/19/2021 Narrative: Patient had a Seizure last Friday 02/19/2021. This is new-onset seizure activity started on Keppra. PMH of a Hemorrhagic stroke October 2020. Patient received the Moderna vaccine on 2/13 developed dizziness, headache and nausea all day on Monday then 4 days later had a seizure and ended up hospitalized so per hospital report may have been a combination of a weakened immune system and old stroke that included the seizure.

Swollen, red, hard and feverish knot at injection site. Severe headache and slept for over 24 hours. Was unable to leave bed for 24 hours except for necessities and experienced dizziness and disorientation when trying to get up. Fever over 100 degrees and no appetite and no food taken. Still no appetite on 02/27/21.

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!

Patient became weak and lightheaded after receiving vaccination. Pt states she ahs had some problems with low blood pressure lately. Observed patient for 30 minutes after which she felt better and left on her own.

After awakening at 11p.m., 1a.m. , and 3:00a.m. , I was off balance and found myself on the bathroom floor. I must have passed out but don't remember how. I had no injuries that I could see. I lay there for a while. I carefully got up and crawled back into my bed. I lay there until about 6:00 a.m. I again carefully arose, and I felt OK.

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

Severe Headache on February 5th and nausea, headache, and the feeling that I would faint if I stood on the 6th. I checked my BP and it was 128/70. My blood sugar was 80. The symptoms passed by the 7th of February (my 80th birthday).

Dizziness and trembling following shot. Slight sinus inflammation. Steroids prescribed. Dizziness and head disorientation continued after prescription over. Took blood. Everything including thyroid and electrolytes were normal. Dizziness and unsteadiness left after 19 days.

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.

Patient received second dose of Moderna Covid vaccine at 0930 on 3/4/21 and presented to ED at 1800 on 3/4/2021 with complaint of weakness and not being able to get out of recliner. Patient was admitted to hospital under observation stay. The following meds were started: pantoprazole 40 mg IVP once and normal saline at 100 mL/hr (ran for 7.5 hours = 750 mL). Patient returned back to her baseline by approximately 1400 on 3/4/21.

During post vaccination observation period c/o lightheadedness and "tingling flushed sensation" BP 165/79. Transported to ED, vital signs and lab work within normal limits. Symptoms had resolved by the time she arrived in ED, discharged to home

First 2-3 days felt normal discomfort at injection sit. It got progressively worse and began to feel like a torn rotator cuff. A lot of pain (7-8) unable to sleep on that side and unable to lift more than two pounds or drive or reach above my shoulder without pain of about a 10 on scale of 1-10. Saw orthapedic physician assistant on 03/26 who gave me a steroid shot in that shoulder with 75% relief by the next day. Still some minor residual discomfort at this writing. Also ran a fever with nausea and headache exactly two weeks after first shot.

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.

Couldn't get up; Couldn't breathe; Lost voice; Felt very tired; A spontaneous report was received from a consumer concerning a 79 years old, female patient who received Moderna (mRNA-1273) vaccine and experienced couldn't get up/mobility decreased, couldn't breathe/dyspnoea , lost voice/aphonia and felt very tired/fatigue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Feb 2021, approximately three days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 022M20A) in the left arm for prophylaxis of COVID-19 infection. 15 Feb 2021, the patient couldn't breathe, felt very tired, lost her voice, couldn't get up, and was hospitalized following a visit to urgent care. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, Dyspnoea, Fatigue, Aphonia, Movement disorder and Hospitalization was unknown.; Reporter's Comments: This case concerns a 79-year-old female who was hospitalized with serious unexpected events of dyspnea, mobility decreased, and aphonia and a serious expected event of fatigue. The events occurred 3 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.

Dizziness. BP 179/97 (pulse 83), 175/96 (pulse 81). O2 sats 98%. Offered water and snack, but patient refused.

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.

I notice mild weasing after about 10 minutes but used my Albuterol Sulfate HFA Inhaler. Weasing went away. I did feel fine until I got severe chills about 6 PM. Chills remained for several hours. Went to bed with heavy covers. Woke up about 2 AM with stomach not feeling well. Was dizzy walking into kitchen getting a Sprite. Set in recliner with heavy covers. Took my blood pressure at 5AM & it had dropped to 104 /44 which was apparently why I was so dizzy. I then took a Tylenol and felt fine after 9AM. I still feel fine but wanted to report my extremely low blood pressure which usually is 135/65 in mornings. I' m thankful for the vaccine.

2/26/21 History & Physical- History of present illness: "Pleasant 79 years old female who started to develop recurrent episodes of nausea and vomiting of nonbilious none bloody material 1 week ago then started to have frequent watery bowel movements with the last bowel movement was associated with rectal bleeding, she started to develop generalized weakness and fatigue, she had 3 falls in the last week without hitting her head, she did not have loss of consciousness, over the last 2 days she has been complaining of numbness and tingling to the hands and feet, she was not able to walk due to generalized weakness. She denied fever or chills she had no chest pain or shortness of breath. 2 weeks ago she got her second dose of COVID-19 vaccine. There was no change to her medications according to her, she denies sick contacts." Intubated and ICU transfer 2/28/21 for "Possible Guillain-Barré syndrome and impending respiratory failure" extubated 3/10/21.

Elevated BP, shortness of breath, tightness of the chest/chest pain, palpations, dizziness 11 days after the vaccine. Continued daily for four consecutive days onset.

received vaccine at health department on 02/25/2021 and presented to this reporters facility ED on 03/07 with dizziness and generalized edema. Seen and treated in ED for CHF and UTI.

I became progressively more sleepy the afternoon after the vaccination, as expected. I did get up and make dinner, then went to bed at 9:15 p.m. on March 8th and slept until 9:15 a.m. March 9th. I felt unstable walking into the bathroom to urinate, and even more unstable waking into the kitchen to take my meds. I passed out and woke up on the floor. I was weak but managed to pull myself up holding on to the kitchen range. I headed for the living room sofa and passed out again, waking up on the floor by the sofa. I'm guessing I was unconscious about 2 minutes each time, but don't really know. I lay down on the sofa and called a neighbor. He thought I should call 911, and they came and drove me to ER . They did an EKG, chest x-ray, and CAT scan of my brain, and drew blood. All results were normal. I returned home that same day (March 9) and had little energy, and ate lightly. When I was getting in bed about 10:30 p.m. I let my head drop on the pillow and the room started to whirl around me for about six seconds. Sometimes when I roll over in bed during the night there is a pause before it feels like the room gives one spin. My scalp is very tender in the large area where I hit it twice when passing out. I'm taking it easy again today, but do feel a little stronger. I am normally exceptionally healthy for my age, and work , traveling to destinations to research and photograph my articles. Both the travel and article take stamina, and I thrive on the work.

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.

5 days later reports extreme dizziness/fatigue. No other symptoms noted. Reviewed severe side effects and what to do including calling 911, call doctor.

I immediately could 'taste' the shot in my mouth. Then, tongue began to feel prickly, and then lips felt the same way. Slight dizziness. After 15 minutes, I left the pharmacy, could drive my car and felt only slight dizziness. However, the tongue and lips continued to feel burning/prickly for the rest of the day. I did not report this to the pharmacy. If the 2nd shot does this again, I will report it to them.

Patient had chills and low fever (99.4) 8 hours after vaccine. Patient went to bed early (8 PM). Patient awoke about 2 AM on 03/09/2021, walked through a dark hallway, and fell down a flight of steps. Injuries include 17 fractures (5 vertebrae, 9 ribs, 1 clavicle, 1 area of lower rear skull, and nose), collapsed lung, brain bleed, and cognition issues. This may be a sleep walking or hallucination issue. Patient has no previous history of sleep walking or hallucinations.

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

Pt received 1st Covid Shot Saturday 10:30am. Felt some abdominal cramping that evening, and when she woke up on Sunday, had abdominal pain, nausea, vomiting, and a small amount of diarrhea. She continued to vomit all day, and became weak/dizzy. Went to ER, where she was found to have Diverticulitis and Dehydration. She was given IV fluids and anti-nausea medicine and hasn't had any further vomiting over Sunday Night. Patient will continue oral antibiotic treatment for Diverticulitis at home.

Heart rate affected - going from 57 to 118 with little or no activity, O2 levels ranging from 77 - 98 (after a few minutes of long slow deep breaths when level is low), BP 3 days after injection was 90/60 - had 2 nurses advise not to take cardevilol that evening. (in fact that same day -Sunday- at 4 am, my cat woke me up doing hard chest "paws", realized horrible headache, checked O2 level was 80 . Can tell when O2 level drops - feel lightheaded, sometimes to the point of touching walls, touching backs of chairs when walking to feel secure, Have kept a record for most of the time for first week after 2nd injection, last few days only occasionaly written down information. 319/2021 approx 4:45 pm O2 was 92 HR was 118. On 3/20/21 felt lightheaded, O2 level 73 HR 52 approx 4;25 had walked approx 150 steps to mailbox and back, at 6:09 pm O2 was 93, HR 58, 3/21/2021 8:30 am O2 97, HR 100;. 3/22/2021 12:58 O2 74, HR 52. Today at 8:41 am O2 95, HR 103.

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.

Stroke; Dizziness; Blurred Vision; Slurred speech; Felt numbness; Tiredness; A sponatenous report was received from a consumer concerning a 79 years old female patient who experienced dizziness, tiredness, slurred speech, numbness, blurred vision, stroke, very very lethargic and had tingling in face and fingers, lost speech, lost eyesight. The patient's medical history as reported by the reporter includes hypertensive, diabetic and had circulation problems. Concomitant medications taken by the patient was not provided. On 25 Feb2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025A21A) through intramuscular route at unspecified site for prophylaxis of COVID-19 infection. On an unknown date, patient had dizziness, tiredness (which is very unusual for patient), slurred speech numbness and blurred vision and then patient was taken to the ER and diagnosed with having stroke. She was admitted and discharged when her condition improved. As per the follow up report received, the reporter reported that patient ended up in having a stroke which was a medically significant event and she was very very lethargic and had dizziness, felt numbness and tingling in face and fingers. Patient had also lost speech, lost eyesight which was a medically significant event. Patient went to the hospital where she was diagnosed. Patient was feeling better at the time of reporting and mostly recovered but feeling weak. Patient went to hospital and treatment activities for events was unknown. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, experienced dizziness, tiredness, slurred speech, numbness, blurred vision, stroke, very very lethargic and had tingling in face and fingers was recovering/resoving and lost speech, lost eyesight was unknown.; Reporter's Comments: There is not enough information to assess the causal association between the reported events and the administration of the mRNA-1273 vaccine. Critical details such as the onset date of the event is lacking. Event is also confounded by the patient's advanced age and underlying medical conditions of hypertensive, diabetic and had circulation problems.

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.

Severe vomiting, blood pressure spiked at172/157 pulse rate 148, then severe hot flushing sensation ending in being soaking wet and clammy feeling, dizziness and feeling like I was passing out. Sat down on toilet, called my daughter and all I could say was help, I think I'm passing out. She found me passed out on the toilet , got me to wake up but not coherent. She called 911 and I was checked and taken to emergency room with diagnosis of dehydration caused by the vomiting.

Symptoms began 15 Hrs. after receiving my 2nd Moderna vaccine. Chills, Frozen joints (couldn't walk) lasted for 3 Hrs. Then profuse sweating with a fever that lasted for 3 Hrs. I was back to my normal self 24 Hrs. later. This 2nd vaccine was given 4 wks. 5 days after I received the 1st. vaccine. I reported my reaction to the 1st. vaccine on 02/28/2021 Temporary that I developed Covid Arm (Red Rash around the injection site) four days later ...Benadryl taken for 4 days with Mometasone cream and it cleared up.

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.

Slight feeling of light headedness. By 9:30 pm pounding heart beat, a few skipped beats with an irregular pattern. I could feel my heart beat at the tips of my fingers when I touched something. This lasted for slightly over two hours.

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.

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.

Patient felt weak and dizzy, which started after receiving the shot and persisted a few weeks. Pt also reported pain swallowing or could not swallow. Patients have reached out to her provider.

This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.), DIARRHOEA (Diarrhea), COUGH (Cough), FATIGUE (Tired), PAIN (Body aches), HEADACHE (Headache), DECREASED APPETITE (Wasn't hungry), OROPHARYNGEAL PAIN (Sore throat from vomiting often) and VOMITING (Vomiting) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013a21a) for COVID-19 vaccination. The patient's past medical history included COVID-19 in November 2020. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), COUGH (Cough) (seriousness criterion hospitalization), FATIGUE (Tired) (seriousness criterion hospitalization), PAIN (Body aches) (seriousness criterion hospitalization), HEADACHE (Headache) (seriousness criterion hospitalization), DECREASED APPETITE (Wasn't hungry) (seriousness criterion hospitalization), OROPHARYNGEAL PAIN (Sore throat from vomiting often) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). The patient was hospitalized for 2 days due to COUGH, DECREASED APPETITE, DIARRHOEA, FATIGUE, GAIT DISTURBANCE, HEADACHE, OROPHARYNGEAL PAIN, PAIN and VOMITING. At the time of the report, GAIT DISTURBANCE (Felt her legs start to wobble and needed her cane to walk.), DIARRHOEA (Diarrhea), COUGH (Cough), FATIGUE (Tired), PAIN (Body aches), HEADACHE (Headache), DECREASED APPETITE (Wasn't hungry) and VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events a causal relationship cannot be excluded. Noting the history of COVID infection (Nov 2020) may remain as risk factor. Further information has been requested.

Patient received the above Friday p.m., woke up Saturday with 101.7 temp. Had all day, finally broke during the night. Sunday & Monday still feel out of sorts. Temp normal but blood pressure on lower side. Reports today still feel unwell; injection site slightly warm, feeling light-headed, slightly nauseous, headache, again lower BP. Took 2 Tylenol @ 4pm.

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.

3/21/2021 Husband , reported that wife attended the Covid clinic 2/13/2021 and received #1 covid vaccine about 11:30 AM Soon after she complained of Discomfort at site on right arm with area from shoulder to elbow swollen extremely tight, red, and had rash by evening. Generalized side effects of nausea and weakness with the inability to ambulate unassisted. She did have Covid #2 3/13/2021 with somewhat similar response but not as severe.

My left arm hurts when I move it in certain positions. It is around the injection site. There is no visible signs around the site. My range of motion is limited in the left arm. I had an injection in my back March 17, 2021 and the pain when away. It started hurting again in about two weeks. It is not as bad now but I do not have full range of movement. I have been applying different pain lotions and exercising it on a regular basis but I still am having trouble with it.

Aside from aching vaccination site I felt OK until 9:00 am. Then I was struck with violent vertigo, which lasted about an hour. I practiced controlled breathing for about 10 minutes and the vertigo gradually subsided. Then for the rest of the day I had chills and a low fever. I also noticed that my thyroid was very swollen and remains so today, approximately 3 weeks later. However, I have no pain in the thyroid.

The morning after I woke up and got out of bed and I was extremely dizzy to the point that I went downstairs on my seat (bottom) so I could go down. I then stayed on the couch and called for help. My tongue swelled up and filled my mouth. My neck glands were swelling and my hands itched and they were red (no welts) like crazy. I took Benadryl and it eased up and I went back to bed. The next morning that was gone. I have had another allergic reaction since then and this time I thought I was getting shingles - my throat got very very red, ears itched and my hands itched and I had ropey welts where my bra sat. My whole stomach area was very itchy. I called the doctor (after hours phone call - on the 31st) - and she assured me that I wasn't getting shingles as I already have had them twice. I took Benadryl and then the doctor prescribed a non-drowsy antihistamine - Claritin - and I am taking that every day. I am not someone that has allergic stuff occur. These took it down and I haven't had it again.

head injury/head trauma; eye infection; syncope/passed out; felling bad; has no balance; felt dizzied; irritated; This spontaneous case was reported by a consumer and describes the occurrence of HEAD INJURY (head injury/head trauma) and SYNCOPE (syncope/passed out) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Glaucoma. Concomitant products included CLONAZEPAM (KLONOPIN) for Glaucoma. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced HEAD INJURY (head injury/head trauma) (seriousness criterion hospitalization), SYNCOPE (syncope/passed out) (seriousness criterion medically significant), FEELING ABNORMAL (felling bad), BALANCE DISORDER (has no balance), DIZZINESS (felt dizzied) and IRRITABILITY (irritated). On 25-Mar-2021, the patient experienced EYE INFECTION (eye infection). The patient was hospitalized from 09-Mar-2021 to 11-Mar-2021 due to HEAD INJURY. At the time of the report, HEAD INJURY (head injury/head trauma), SYNCOPE (syncope/passed out), FEELING ABNORMAL (felling bad), BALANCE DISORDER (has no balance), DIZZINESS (felt dizzied), IRRITABILITY (irritated) and EYE INFECTION (eye infection) outcome was unknown. No treatment medication was included. 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 US-MODERNATX, INC.-MOD-2021-071179 (E2B Linked Report). This case was linked to MOD-2021-071179 (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. US-MODERNATX, INC.-MOD-2021-071179:Case for first dose

Patient presented to ER after a syncopal episode at home. She reports feeling lightheaded and fell to the floor, she is uncertain how long she was unconscious, but when she came to, she called 9-1-1.

pt says she had a rash develop on her neck with was very painful and she could barely move her head. The rash spread on her arms, right knee, her back, right side of her leg, and her chest. She went to her PCP 3/12/21 she was prescribed prednisone which did not help. Her rash was not getting better so she went to UC on 3/15/21. Dr. prescribed triamcinolone medicine and another cream to mix together which did not help. On 3/16/2021 she went to another Dr. She was prescribed the medicine for shingles which didnt help. She called them back to let them know she wasnt any better and they referred her to a dermatologist. She saw Dr. on 3/26/21 he gave her Clobetasol cream. He took a biopsy and sent her for blood test. She went back have the stitches out was told her results were ok and that she had an allergic reaction to the vax. She says her symptoms are getting better

Fatigue; dizziness, light-headedness; repeated episodes of atrial fibrillation and heart rate ranging between 37 and 180; nausea; repeated sensation that I might pass out. These symptoms began on 2/23/21, 5 days after receiving the 2nd Moderna vaccine. Symptoms were similar to but more intense than symptoms experienced after my 1st Moderna vaccine. I was taken to the ER during the night of 02/24/2021 beause of intensification of symptoms. Symptoms continued intermittently until 03/23/202 when a cardiac ablation was performed at a Cardiovascular Center. I also experienced some post-op Afib in first 2 weeks following the procedure.

Fatigue; dizziness; light-headedness; repeated episodes of atrial fibrillation and vascillation between low and high heart rates (ranging between 42 and 130 BPM) These symptoms began 2 days after I received the 1st Moderna vaccine and lasted approx. 7 days. Though I was diagnosed with Afib 10 years ago, my prior experience with Affib was limited to 3-4 isolated episodes per year, lasting only 1-3 hours each. My past Afib experiences were never as long or as intense as this experience. It is not clear whether this worsening Afib experience simply coincided with my Covid vaccination or whether there may have been a causal relationship.

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.

Day after the shot on Tuesday morning woke up a little fatigue she did a little cooking and her chest started really getting tight she was sweating really bad went to bed slept all day tried walking on Wednesday put a heating pad on her legs with muscle spasms called me at 5 AM to get her to the ER she couldn?t walk her leg swelled up really bad

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)

patient felt chest pressure, heart raising, intense heat from toe to head in waves, dizziness (walking on clouds), red and swollen hands

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

Whenever I move my head I get very dizzy. I had a very negative response to the second Moderna shot and ran a fever and was unable to get out of bed the next day. This continued for about 24 hours. I am still experiencing intervals of dissiness to this day. I have been taking over the counter motion pill to alleviate the problem. They help somewhat.

Cleared pharmacist verification with no red flags. Administered in the shot booth in chair and informed patient to wait the designated 15 minutes. Patient seemed fine with no distress. Color normal. I came back into the pharmacy and seen patient doing well. Patient then a couple minutes later stood up and took a couple steps which put her out of my view. technician the asked if she was ok and the I could see the shot booth going sideways. Then I could see her fall. I then ran out the pharmacy to check and she landed in the chair sitting up right. she was still semi-conscious and I talked to her. I got a pulse and told the technician to call an ambulance. while trying to keep the lady awake she drifted unconscious but was breathing ok. Pulse was low but didn't lose. Had the help of a nurse at this time and ambulance arrived. Patient was awake by this point with drowziness and could talk.

orthostatic dizziness began one week after vaccine. eventually progressed into 2nd degree type 2 heart block. Had v Tach. Got a pacemaker.

Patient Summary: Patient is a 79-year-old female with a past medical history significant for hypertension, hyperlipidemia, type 2 diabetes mellitus, GERD, hypothyroidism and previous stroke versus TIA in 2016 who presented to the emergency department at Hospital on April 27 after receiving her second Covid vaccination and developing altered mental status. She was evaluated in the emergency department by the neurology service and there was no evidence of stroke on imaging. She was admitted to family medicine for continued monitoring and evaluation for infection. Extensive work-up including echocardiogram, chest x-ray, MRI of the brain, blood cultures and all of her labs were nonrevealing. Her cognition returned to baseline but she was noted to have weakness and unsteadiness. Physical and Occupational Therapy evaluated the patient and recommended postacute rehabilitation in a skilled nursing facility.

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.

She got her vaccine, she felt very weak, woozy, tired, lethargic. Her blood pressure went up to 196/116 several days later. She was sick for 5 weeks. Her arm was a little achy, which was normal to her as she gets allergy shots which she has the same reaction to. She called her doctor who was out on leave and they told her to go to UC. She went to UC twice and the ER twice due to her BP and her weakness and dizziness. She was not able to drive due to these symptoms. They did increase her BP medication and he said that if it did not help then go to the ER. She went to the ER and was still feeling very weak, and they told her that it was from the vaccine as they have seen other people with the same reactions, and it can last up to 6 weeks. She said nobody knew what happened, she had CT scan of the head, EKG, blood work, chest x-ray and other tests. She went to the cardiologist who believed that she had the COVID virus, and he ordered an echocardiogram that was normal. She also had a LEXI-scan that was normal as well. The symptoms finally went away and is back to normal now and said that it was exactly 5 weeks later that she finally felt better and was not dizzy or woozy any longer. She felt as though she was going to die as she was so weak. She feels that it needs to be explained further that it is not FDA approved and that the elderly do not understand what EUA means.

On 5/28/2021 pt started feeling light-headed, dizzy, chest heaviness, chills and her arm and legs were burning. Her husband eventually called 911 and they told him it "sounded like a reaction to COVID vaccine" and "if she got worse they would send someone out". Pt stated these feelings lasted until about 0300 on 5/29/21 and after she fell asleep most things resolved expect the light-headedness. Pt reports she is still fatigued and has bouts of dizziness and lightheadedness and she has no energy. Pt was encouraged to call and report her symptoms to her primary provider and seek their guidance on when to receive her second injection.

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

Hearing loss; Vestibulocochlear-neuritis; Tinnitus; Traumatic situation; Vertigo; Dizziness; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (Hearing loss) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced DEAFNESS (Hearing loss) (seriousness criterion medically significant), VESTIBULAR NEURONITIS (Vestibulocochlear-neuritis), TINNITUS (Tinnitus), INJURY (Traumatic situation), VERTIGO (Vertigo), DIZZINESS (Dizziness), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was treated with MECLIZINE [MECLOZINE] at a dose of 1 dosage form; ONDANSETRON (ZOFRAN [ONDANSETRON]) at a dose of 1 dosage form; LORAZEPAM (ATIVAN) at a dose of 1 dosage form; PREDNISONE at a dose of 40 mg once a day; PROMETHAZINE (PHENERGAN [PROMETHAZINE]) at a dose of 1 dosage form and METOCLOPRAMIDE (REGLAN [METOCLOPRAMIDE]) at a dose of 1 dosage form. At the time of the report, DEAFNESS (Hearing loss), VESTIBULAR NEURONITIS (Vestibulocochlear-neuritis), TINNITUS (Tinnitus), INJURY (Traumatic situation), VERTIGO (Vertigo), DIZZINESS (Dizziness), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant product use was not provided by the reporter. Patient has through three emergency room visits and two hospitalizations because of her symptoms Patient has been going to balance therapy once a week. Lab details 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. This case was linked to MOD-2021-219233 (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.

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

Severe swelling in limbs that severely limits my range of motion even causing me to walk with a walker, developed love handles on my sides

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.

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.

Fatigue after the 1st dose. Extreme fatigue and development of vertigo soon after the 2nd shot. Went to the doctor several times, had therapy for the vertigo several times with little improvement. Wasn't able to walk stable until late May. Doctor ordered MRI and MRA (scans done 6 years prior completely clear)

nausea, dizzy, loss of balance ,small amount of vomiting: for most of the day (approximately 12 hours) no treatment: subsided the following day, 1/13/2021

PT became dizzy, short of breath, and nervous . IV started at site. PT transported to facility and given IV diphenhydramine and solumedrol.

It has been 6 days - I am still nauseus; lite headed; throat feels tight; lack of energy. I'm this way off and on thru out the day. I have been using Mucinex to relieve the mucus in my throat and Benadrl to relieve other side effects. I have not been ill nor have I experienced any pain. I have an allergy to bee stings but have never been on medication for it.

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

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.

Morning after receiving vaccine (01/14/2021), woke up and was having chills, weakness, "head felt like it did when having covid, dizziness, light-headed". Urinary incontinence and memory loss, and hallucinations on 01/14/2021. Blue color to left deltoid started 01/13/2021 in PM and on 01/14/2021 when waking up, left upper arm was blue and redness noted down to elbow. "I have laid on the couch and that's basically all I've done since getting the shot."

Left deltoid began turning blue evening of 01/13/2021. After awakening on 01/14/2021, left upper arm was blue and red to elbow. Voices that "head felt like it did when I had covid, light-headed, dizziness", hallucinations, urinary incontinence, weakness, memory loss.

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

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.

Redness swelling extreme pain at vaccination site -48 hours following vaccination Nausea, diarrhea, fever, light headed -48 hours following vaccinations

High fever 103 degrees; Arm totally immobile with severe pain; Lethargy; Headache; Chills; Same symptoms as when I had Covid in March 2020

Pt received her Moderna COVID-19 Vaccine at 2:50 pm on 1/25/2021. Pt tolerated administration well and was monitored for 15 minutes inside the agency. She was accompanied by her son. When exiting the building at approximately 3:15pm, pt continued walking off of the side walk into the flower bed. She then was noticed by son to have confused and jumbled speech. Staff from The Agency and EMS was on the scene immediately after this was observed and 911 was called for EMS. Son reports this is not her baseline.

Felt fine at first then everything started spinning and I started vomiting that lasted 2 hours, I was dizzy and my daughter call the ambulance and they gave me meds for nausea and started IV and at hospital they did the same and gave me something for nausea which helped.

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

1/26/2021 - sore arm to the point I wanted to put it in a sling to avoid ANY movement 1,18/2021 - weakness in knees and legs, diminished sense and ability of walk and balance, somewhat feeling of ?out of it? ALL SYMPTOMS GONE ON 1/29/2021

Sore arm Midnight 01 30 am 100 Fever early am 01 31 20 Chills same Lite headed same Took one tylenol 325 aT midnight 01 30 am 2cd Tylenol at 5 am 100. 9 temperature. Took 3rd tylenol 800am Temperature steady. Slept.

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

Moderna Vaccine Lot 029K20A Patient received second dose of vaccine on 2/2/21. Within 30 minutes patient had a near syncopal episode. She felt lightheaded and shortly after had episode of nonbloody vomiting. Hypotensive 81/69 and started on levophed. Alert and orientated. Lungs clear, abdomen benign on admission. Patient had no reaction when received first dose of the vaccine. Patient developed worsening shortness of breath, tachypnea, Afib with RVR, hypotension and required intubation and multiple pressors.

An hour after vaccine I felt lightheadedness, some fogginess, a slow wave of weakness flowed from my face down to the neck, shoulders, arms, torso, thighs, knees, legs, feet. Although my entire body experienced weakness, I tried & was able to stand and walk cautiously, ate a little bit of chicken, had tea but I had to sit. The weakness remained for about an hour. After which my strength was returning slowly. It took 30min more for the strength in my legs & feet to fully return.

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.

Extreme fatigue, had trouble getting out of bed and needed help. Slept most of the 24 hours after the adverse even started. Diarrhea upon getting up and lasted approximately 6 hours. Soreness in left arm.

Mild stroke about 9am. Fell on floor, needed help to stand up and walk, garbled speech, headache, temp. 98.0, 98.2, 98/3; not swallowing food, couldn't handle food. Could not hold cracker, bread or find mouth with hand. needed help to go to bathroom, couldn't answer telephone, was dizzy, couldn't balance herself, she fell 3 times on Feb. 3, I took the top off a water bottle and handed it to her she kept trying to unscrew the lid even after I showed her I had the lid in my hand. Feb. 4 she had the dry heaves all morning, she slept all afternoon. I called the doctors office @ 8:00am and again later @ 8:30am. He said he wanted her to have a CAT scan Medical Center. He said they would call

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.

Three days after first dose, I awoke in the early morning hours to go to bathroom. I lost all strength in my body and fell injuring my rib, arms, head and shoulder I have been hospitialized for two days now.

Six to Seven days of moderate to severe body aches: back shoulders hips with heavy fatigue; loss of appetite and total exhaustion inhibiting ability to perform ADLs (generally very high functioning). Ibuprofen for several days and in bed for nearly a week and after that time symptoms improved. delayed response. only sore arm until about 72 hours. now, 14 days later near resolution of all symptoms.

Pt awoke early the morning following vaccine with overall shaking, dizziness, and increased confusion and somnolence. Evaluated in ER; Back to baseline at end of ER visit.

Immediate reaction was the headache at the time of the vaccine, and has had headaches on and off but nothing like the initial one. Started to get dizzy and felt weird on the ride home from the vaccine. The headache lasted a fairly long time and got tired by the evening and the next morning. The headache has still continued a little off and on until now, 2/17/21. The dizziness has gone away, the feeling "out of it" feeling has gone away, does not feel well about the concentration. The tiredness and fatigue started the day after the vaccine and has gotten worse, has to drag herself through the day and by 1:00 PM is done through the day due to the fatigue. Some days can go to 4:00 but most days only lasts until 1:00. She gets up at 7:30 and today at 10:37 has the feeling of tiredness. The gland under her arm a couple of weeks ago was swollen, which is still sensitive but not as bad as it was. The fatigue is the main thing that continues to bother her. She has not taken anything for these reactions. She has seen her doctor, and is supposed to get some blood tests today, 2/17/21.

Patient reported not feeling well at 3:50pm. Stated she was lightheaded and nauseous. Informed patient to stay for further evaluation and monitoring. At 4:15pm, patient vomited x1 with continued nausea and feeling lightheaded. RRT was called at this time. RRT arrived at 4:20pm to assess patient when patient stated she was no longer lightheaded or nauseous. At 4:35pm patient was taken to ER for further evaluation. Vital signs at 3:50pm: BP 107/59, HR 74, SPO2 96%. Vital signs at 4:05pm: BP 110/52, HR 72, SPO2 96%. Vital signs at 4:20pm: BP 131/82, HR 82, SPO2 95%. Patient was discharged same day on 02/17/21. Follow up today 02/18/21: Patient stated she was feeling better as time goes by. States her only symptom now is an upset stomach. No other side effects noted.

Got shot at 8:15am and got reaction at 9:45pm with violent chills-got into hot shower & got temp up to 95 degrees; went to bed with several blankets; temp went up to 100 degrees about 11pm with stomach ache, horrible headache, & loose stool; lasted all night all next day; day 3 Saturday 4am got up to pee dizzy & faint & fell into glass closet doors then into wooden door then to floor & broke nose & bruised several other areas besides face. Now 11am still dizzy & sick to stomach & loose stool so called CDC but no help so took meds on hand. Zofran 4mg & Loperamide 2mg.

10:30 pm same day/night -- extreme cold; dizziness; 4 fainting spells; head rush-inflamation extreme the next day and Saturday. I found myself looking up at the ceiling 4 times during the night after fainting dead away. Frightening as that has never happened to me before. It was the weekend; I was unable to reach any doctor for advice. Plus with a major snow storm we were snowed in and I couldn't get out. This was the sickest I've ever been in my life!

Pt. felt extremely week and her legs gave out. She fell, the daughter put her in bed and she slept. She woke up around midnight to urinate and she felt better, still week but better.

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

approx 1am I woke up and I was shivering so hard the bed was shaking and I could not get up out of bed safely. I have never experienced a chill like this before. 3-4am I was shivering and shaking and so very cold again. this lasted until at least 4-5pm. I was shaky and my voice was shaky. no appetite.

Dr. called (pt's PCP) to report reaction that was reported to her by pt's sitter and husband. States pt would not eat and was lethargic the night after receiving the vaccine. The next morning pt was extremely fatigued and "not acting like herself." By Tuesday night, pt was experiencing rapid breathing, sweating, and was very agitated. PCP states sitter reported that she heard "rattling" in pt's chest. Pt short of breath this morning with heart rate of 123. Pt will not eat or drink and is very weak. Pt has not been communicating with them like she normally does. Can only walk a few steps before having to rest. Pt was on her way to ED when PCP called to report this.

after 11 days i couldn't move my hand and painful . the redness and hardness and itchiness. started to spread for the last four four days

No side effects from shot #1 on 1/24. Second shot on 2/22 = approx. 14 hours after shot I started with chills for 2 hours, then had about 18 hours of a low grade (100.3) temp., dizziness & slight headache - then had sweats when it broke, then I was fit as a fiddle.

Irregular heartbeat for approximately 5-8 minutes. Light-headed during this time. Resolved on its own eventually.

Patient was dizzy and warm 15 minutes after receiving vaccines. EMS was called was examined and was told to go home with observation from family.

Woke up at 2:30 am and was incoherant, difficulty walking and was assisted to bathroom, chills, headache. Next morning had soaked through pajamas with sweating.

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

02/18/21- 12 hrs after 2nd dose, chills, went to bed, during night got up to go to BR, dizzy, then woke up flat on back-no memory of falling , had to get up 2 more times in night, same thing happened, lost consciousness waking up flat on back both times as well. Slept the next day, headache similar to sinusitis, lost her appetite and swollen glands for 2 days. Today 2/26 appetite returning, scheduling MRI next week per primary care

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

After 20 hours of receiving vaccine, I had chills, fever, sweats, dizziness, & nausea feeling. Returned to bed; slept 4 hours; & then ate & began to feel better.

My mom was difficult to awaken and took 35 minutes for her to respond. Increased confusion (did not know me, nor did she know her own name). Extremely unsteady on feet. She had slept from 5pm to 9am. After breakfast and an hour she regained her knowledge of her name and mine and could correctly recite her DOB. She continues to have difficulty ambulating complaining her legs ache. She is also extremely tired.

Patient complained of lightheadedness, dizziness, and fatigue the next morning. That afternoon she experienced Afib.

the adverse event started on 2/12 around 5pm and i got cold down to the bone and it lasted and I never got warm all night. 2/13 my arm was sore and slightly swollen arm was warm and i got really tired, then the headaches started went across the head and got worse and worse. on 2/14 - 2/28 I had diarrhea headache and bone chills, loss of taste and smell, 2/16 dizzy, sore throat, runny nose, cough and fever, 24th brain fog started, 25 vomiting started, on 3/1 I had just headaches, I'm still tired but I can stay away today

By afternoon I felt a little chilly and achy and took Tylenol. I woke at 2:00am the following morning to go to the restroom and my dog needed to go out. I felt light headed as soon as she was back in the house. I felt things going dark and I passed out in the hallway. I don't know how long I was out but when I came to, I felt like I couldn't move. I laid there for a while and finally crawled back to my bed. I was able to get back in bed. By then it was 3:00am. The next night I woke in the night and had an irregular heartbeat. I could not get back to sleep until it finally went away. For several days after the vaccination, I had very little energy.

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.

Low fever, fatigue, headache, chills, imbalance, and weakness that lasted from early A.M. 3/9/21 to P.M. 3/10/21.

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

While in the observation room after receiving Moderna vaccination, member complained of chest tightness; she denied difficulty breathing/shortness of breath, was alert and oriented and did not appear to be in respiratory distress (also no itching, hives, rashes, or other complaints at the time); manager on duty was also present. Blood pressure, heart rate, and oxygen saturation were 250/87, 76, and 100% (room air), respectively (4:55 pm). 911 was called (4:55 pm). Blood pressure was repeated at 5:00 pm (230/77) and 5:03 pm (221/159); oxygen saturation remained at 100%. At 5:04 pm, member started to complain of lightheadedness and EMS arrived at that time. Member was placed on the stretcher and transferred member to the Hospital. Note: Member has hypertension and stated she did not take her medication today.

Diagnosed with c-diff; Feeling dizzy; A spontaneous report was received from a consumer concerning a 80-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and diagnosed with c-diff(Clostridium difficile infection) and feeling dizzy. The patient's medical history was not provided. No relevant concomitant medications were reported. On 29 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) via unknown route for prophylaxis of COVID-19 infection. On 29 Jan 2021, the patient experienced feeling dizzy. On an unknown date, the patient was diagnosed with c-diff(Clostridium difficile infection) and considered medically significant event. No treatment information was provided for the event feeling dizzy.Treatment for the event c-diff(Clostridium difficile infection) included high dose of antibiotic. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events c-diff (Clostridium difficile infection) and feeling dizzy was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

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.

Loss of mobility in right leg, unable to walk, 12 hours; went to family practice, on recommendation of doctor, went to ER for imaging, mri came out negative for stroke. Regained mobility after 12 hours

Out of the blue, I got nausea and diarrhea the most severe in my whole life. I was vomiting and periodically having diarrhea for four hours. I felt faint. Had a hard time standing. I have never had anything like that in my whole life and I have had food poisoning in the past. This was worse, much worse. Afterwards, for days, I was weak and now three days later still have some nausea although I am not throwing up. I do have loose bowels though.

The administration of the vaccine was extremely painful. Began to feel hot flashes about a half hour after the vaccine was administered, nausea and feverish symptoms. The site of injection began to swell to the size of a half dollar; the next day she could not move her arm. Describes pain from the site of injection all the way down to her wrist. The symptoms have persisted for two weeks, headache, exhaustion, and aching at the site of injection.

Severe headaches, nausea, unsteady, restricted diet (crackers, potatoes, farina, oatmeal, bananas), fatigue

Pt received her 2nd Moderna covid 19 vaccination on 3/10/2021 and the following day woke up severely weak with chills, fever, vomiting and diarrhea and headache and was found on the floor by family at 2:30 pm. She reported she was so weak she lowered herself to the floor around 7:30and lie there till she was found in the afternoon. She was given IVF and admitted to the hospital for further work up and physical therapy.

102.5 temp., off balance and brain fog. Fine two days, then down again with same symptoms and 99 temp. Have had no temp since, but brain fog and off balance like having gotten off a boat and sea legs, occasional nausea. All lab tests fine.

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.

Red, itchy area about 6x4 left arm; severe cold and sleepy started next day and lasted about 8 hours then went away. Had no fever. Later about 10 pm I got up to go to bathroom and my legs just gave out. I could not move my legs or feet at all. Called paramedics who got me up and walked me for at least 30 minutes. I was very weak and unsteady. I did improve slowly. By morning I could walk cautiously. Seem to be ok now.

The patient felt fine on 2/25 and 2/26. On the morning of the 27th, she woke up and was very light-headed and worsened throughout the day. She checked her blood pressure which is normally around 110-130/60's and it was 170/68. She continued to check her blood pressure for the several days and it remained high for 3 days and she continued to feel light headed for 2.5 more days. Then the symptoms and the high blood pressure went away. She continued to take her regularly scheduled Lisinopril 10mg daily on each of these days as she normally did.

pt states that 1 day after vaccine, she couldn't move her legs and couldn't get out of bed. swelling in legs, mostly right side. doctor gave her diuretics, and natural medicines. she is taking advil. she got some sort of electric shock? treatment. she is walking and talking to me today

The morning after the 2nd dose, I got up to make coffee. I had just started and felt a bit light-headed. I was going to go sit down, but I passed out and fell onto the kitchen floor for a few seconds. I have never passed out before or felt such light-headedness. I went to lay down. I vomited a bit of liquid. I lay down and several hours later my husband drove me to the emergency room. After many tests they said I had suffered a Syncope and had a slight concussion.

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.

Per Fire EMS client reported dizziness during observation after COVID vaccine administered. Vital signs and 12 lead EKG performed. Observed for approximately 30 minutes, no other treatment documented.

3/31/21 To er for eval of dizziness. States she was at the hairdresser when she became very dizzy and had to lay In the floor, was nauseated but no vomiting. Incident happened approximately 10am.

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.

PT IS COMPLAINING OF DIZZINESS BEGINNING 5 DAYS AFTER RECIEVING VACCINE AND DIZZINESS IS STILL PRESENT, DR HAS PT USING EAR WAX SOFTENER

Vertigo, nausea, dizzyness, vomitting, hearing loss. All symptoms lasted 48 hours. Went to Urgent care and was givenMeclizine 12.5mg and Ondansetron 4mg. Dizziness and nausea lessened over the next 3 days. Went to ENT doctor - Hearing test on 3/29/21 revealed total loss of hearing in right ear. Hearing in left ear was diminished before vaccination and that was about the same after the vaccination. ENT injected steriod into right ear on 3/31/21. Second steriod injection on 4/2/21. No improvement in hearing so far. Dizziness continues off and on. Still unstable and needs to use a walker.

Pt was exiting the building and became light headed and dizzy. Pt then passed out and was slowly released to the ground. Pt did not hit her head and had no hx of fainting/dizziness spells. EMS were contacted and arrived on scene approximately 5 minutes later.

18 days after vaccination in which I only had soreness at the injection site. Anxiousness, followed by dizziness and later nausea.

I develop a red erythema rash, hot to the touch that developed in to large blister on my arm. The use of arm was compromised and the blister grew bigger and bigger. When to Urgent Care and the Emergency Room and blister was drained. The pain and swelling last for several days. Give IV Motrin in ER. Blisters continued to form for 4 more days and required medical attention. After a week, the skin was dead and black. The skin fell off and the derma and subcutaneous tissue was exposed. (Area looked like a burn).

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

patient called stating her mouth was dry and tongue was dry and she felt dizzy upon walking--after further talking with patient, she had only eaten a banana all day. I told patient she probably not eaten enough today nor drank enough liquids.

EKG showed minor heart Block; Dizzy; Cannot walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIOVENTRICULAR BLOCK (EKG showed minor heart Block) 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. The patient's past medical history included Hip replacement. Concurrent medical conditions included Diabetes. Concomitant products included CALCIUM CARBONATE (FORTIFY) 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 06-Mar-2021, the patient experienced ATRIOVENTRICULAR BLOCK (EKG showed minor heart Block) (seriousness criterion medically significant), DIZZINESS (Dizzy) and GAIT INABILITY (Cannot walk). At the time of the report, ATRIOVENTRICULAR BLOCK (EKG showed minor heart Block) had not resolved and DIZZINESS (Dizzy) and GAIT INABILITY (Cannot walk) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Blood glucose: 140 140. On 06-Mar-2021, Electrocardiogram: abnormal showed minor Heart block.. On 06-Mar-2021, Heart rate: 42 42. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was temporarily withheld on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Based on the current available information and temporal association between the use of the product and 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 events a causal relationship cannot be excluded.

Dizzy, couldn?t do normal housework, breathless after little exertions, terrible headaches . After 10 Days went to Yavapai Regional Medical Center ER and was admitted with high blood pressure 225/97.

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.

Morning on 3/11 awoke with fever and body aches, breathing became difficult over the next several days, along with light headedness. ED visit on 3/14 diagnosed with COPD flare advised to follow up with PCP. 3/22 follow up with PCP, discovered blood in stool sent to ED. Admitted on 3/22 with low hemoglobin and blood in stool. Endoscopy on 3/23 and coloscopy on 3/24. Source of bleed undetermined. Released on 3/23. 4/1 returned to ED as symptoms continued. D-dime blood test and CAT found blood clots in lower right lung. Prescribed Eloquis and released. Returned to ED on 4/5 admitted with low hemoglobin (7.1) bleeding, breathing difficulty. Endoscopy repeated on 4/6 not bleeding found. Released on 4/9.

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.

Started to ache everywhere, headache across eyes, pressure in ears, cold, fever, upset stomach. @ 2 AM had severe pain in left arm, could not move it. Experienced light-headedness, all over body ache. Arm pain was so bad i didn't want to move. couldn't sleep all night. tried to eat breakfast but got dizzy, cold and clammy, couldnt eat. Stayed in bed until around 5 PM because of arm pain and general malaise Was finally able to eat and took a tylenol and fell asleep as light-headedness abated and arm pain was better. Next day was better but couldn't lift arm well until 15th still some pain to this day

Next day pain to right tempel. 3 short violent stabs of pain. Couldnt move, scared I get to the phone to call for help. Then it was gone.

autoimmune hemolytic anemia; Evans Syndrome; Jaundice (presumed from hemolysis) weakness light-headedness Patient received first COVID-19 Moderna vaccination ~10-14 days prior to onset of hospitalization. Presented with weakness, malaise, jaundice. Lab tests revealed severe anemia that did not respond to transfusions (presumed due to ongoing hemolysis). Began treatment with corticosteroids (IV Solu-Medrol) and IV immunoglobulin to attempt to treat immune-mediated hemolysis.

At 1:30am on 4/2/21, my mother had fallen at home and was transported to the hospital. She was not injured from the fall however by 4/4/21, she was showing signs of end stage dementia. Her symptoms literally came on as if switching on a light. Through testing ruled out stroke, cancer, seizure as well as a lumbar puncture was negative for infection. She remains hospitalized and is transitioning to a specialized care facility that will provide 24/7 care.

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.

Patient felt lightheaded after the vaccine. She was asked to stay seated for about 15 minutes and then sent home. Once home she progressively had more symptoms including lightheadedness, confusion, fatigue, unconsciousness, expressive aphasia, loss of bladder and bowel control, elevated temperature, increased pulse, increased respirations, increased blood pressure, dehydration, stroke like symptoms with no evidence of stroke, loss of motor coordination

within 2 days of the vaccine. Patient fell a couple times and lost the ability to walk or use her hands. She was admitted on 3/6 for a 2 week course. She has yet to regain full function of her hands and feet. She was unable to move the other day so they referred her to a neurologist after and MRI. She has had mild confusion at times. The neurologist wanted to do a DAT scan to look for possible Parkinson. She is having Parkinson disease type symptoms post vaccine. Today she is being transferred 911 to the hospital again because she is unable to get out of bed and use her arms or legs. Baseline before she was completely self sufficient living at home my herself.

Patient came to the pharmacy to inform us that she had side effects following the administration of her COVID vaccine. She stated she was clammy, her body was hot and cold. She experienced nausea and vomiting. She took a a shower to cool off. She was dizzy and had the sore arm.

Patient received Moderna COVID-19 vaccine #1 on 02/09/2021. Patient received Moderna COVID-19 vaccine #2 on 03/09/2021. Patient admitted to hospital 03/10/2021 through 03/11/2021 due to syncope on 3/110/2021. Patient had gotten up out of bed to go to the bathroom, called out to her husband then had syncopal episode and fell to the floor. According to husband, she had loss of consciousness for 5 minutes. Per husband and EMS, she then had another syncopal episode after taking a few steps and then collapsed. No urinary incontinence. Syncope occurred day after receiving 2nd dose of COVID-19 vaccination. CT brain as well as CT cervical spine negative for acute abnormality or cervical fracture. Hemodynamically stable. Cardiac enzyme negative x 2. EKG negative for acute abnormality or arrhythmia but with baseline abnormalities. Suspicion was that symptom was due to vasovagal reaction to 2nd dose of COVID19 vaccine. Notably husband also reported that on 02/23/2021 patient was showering, and he then heard her calling out. He found her undressed and wet in the living room area confused. She did not know where she was. Patient also with history of TIA in 05/2020. patient with history of mild dementia.

Patient stated to PCP that she developed significant weakness 2-5 days post second COVID vaccine. Pt also developed significant SOB. Pt is now unable to walk short distances and is unable to lift her legs, gets lethargic easily, and uses a wheelchair.

The morning after the second vaccine, my pulse was over 150, I was short of breath, light headed and experienced nausea. This has persisted since with pulse more often in the 105 to 120 range, although it will go to the 150's at times. The feeling lasts anywhere to about five minutes to the entire day.

pt says she developed fever, was shivering, and was very weak and tired. She went to bed. She woke up to use the restroom. Next thing she remembered was waking up on the bathroom floor. She didnt know where she was or what had happened. She was finally able to reach her son to come help her get up and get back into bed. She was extremely weak for a couple of days. She contacted her PCP and was told to file a VAERS report. She no longer has any symptoms.

Fell on left shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Fell on left shoulder) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The patient's past medical history included Arthritis. Concurrent medical conditions included Borderline diabetes, Cholesterol high and Blood pressure high. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced FALL (Fell on left shoulder) (seriousness criterion medically significant). At the time of the report, FALL (Fell on left shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication includes medication for diabetes, cholesterol and blood pressure. Treatment medication includes ice packs, took Tylenol and put her left arm in a sling. 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.

Received her second dose of Moderna Covid vaccine yesterday (5/23), subsequently this morning (5/24) noted to feel lethargic, dizzy, and had elevated temperature. She sought medical attention and in the ER was found to have temperature of 104°F, tachycardia, and elevated lactic acid. The patient has had no headache, change in vision, photophobia, neck stiffness, abdominal pain, cough. There is no report of sick contacts the patient resides with daughter-in-law and son. She received Rocephin empirically in the emergency room along with 30 mL/kg IV fluid bolus.

The day after the shot, patient developed low-grade fever which lasted 3 days. For 3 days, the patient was lethargic and had no energy to perform normal household duties. On the 3rd day after the shot, patient developed tachycardia for several minutes, became feverish with a clammy sweat and had vertigo saying the room was spinning and said she felt like fainting. She could not recognize her son, asking him, "Who are you?" Patient lost site in her eyes which was recovered several minutes later. Patient felt better starting the 4th day.

Overlapping symptoms and treatment, so reports were combined. Dose 1 - The following Tuesday, I was hospitalized with very bad dizzy spells. They did a CT Scan and couldn't find anything. They also performed a chest x-ray. I was there for two days and I was fine up until the second dose. Dose 2 - 03/11/21 - The following Wednesday, I started having the dizzy spells again. They wanted me to go in the following Tuesday, but had me to come in on Friday instead due to the severity of the spells. They told me to go to an ear specialist. On 3/30, I was given a hearing test and also tested to see if there were crystals in my head, which there were none. They suggested that I see a neurologist and I met with him on 4/27. On 5/27, he performed an EEG and some type of ear test where they put ear muffs on you and play high pitched sounds. On 6/3, I received my results and both were negative. After that, I was fine until 6/7. I woke up really dizzy and I had a severe headache, which I never have. I went to the ER and also discovered that my BP was elevated. They gave me the choice of staying there and seeing the neurologist the next day or going home and making an appt. I chose to go home. I was given Meclizine 25mg to take 3 times a day for dizziness. I saw the neurologist yesterday (6/10) and he suggested therapy to help with the dizziness. I was told to cut the meds in half and wait on my therapy, which begin on 6/22. I've also had a regular eye and dental appt and both said neither of those areas are the issue.

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.

Blood Pressure over 200/My blood pressure was over 200; I became light headed; I had a reaction to my second shot of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (Blood Pressure over 200/My blood pressure was over 200), DIZZINESS (I became light headed) and VACCINATION COMPLICATION (I had a reaction to my second shot of Moderna) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPERTENSION (Blood Pressure over 200/My blood pressure was over 200) (seriousness criteria hospitalization prolonged and life threatening), DIZZINESS (I became light headed) (seriousness criterion hospitalization prolonged) and VACCINATION COMPLICATION (I had a reaction to my second shot of Moderna) (seriousness criterion hospitalization prolonged). At the time of the report, HYPERTENSION (Blood Pressure over 200/My blood pressure was over 200), DIZZINESS (I became light headed) and VACCINATION COMPLICATION (I had a reaction to my second shot of Moderna) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Blood pressure measurement: increased (High) Blood pressure was over 200. No concomitant product information was provided. No treatment information was provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable. Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Live follow up received contains new events light headed and vaccination complication.; Sender's Comments: Very limited information regarding these events has been provided at this time and a causal relationship cannot be excluded

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.

Patient stated that she developed Virtigo around 06/15/21, 3 months after receiving her 2nd dose of Moderna vaccine. Patient stated that she has not seen a doctor for Adverse Reaction. Patient stated that her sister and brother-in-law received their vaccine on the same day, and they also have developed the same Adverse Event, at the same time.

really high blood pressure; could not get up; a reaction to the vaccine at the site of injection with a rash; Nauseous; Passed out; Light Headed/dizzy; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included LEVOTHYROXINE for Thyroid disorder NOS, PRAMIPEXOLE HCL for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced DIZZINESS (Light Headed/dizzy). On 28-Jan-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant), HYPERTENSION (really high blood pressure), MOBILITY DECREASED (could not get up), VACCINATION SITE RASH (a reaction to the vaccine at the site of injection with a rash) and NAUSEA (Nauseous). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), DIZZINESS (Light Headed/dizzy), HYPERTENSION (really high blood pressure), MOBILITY DECREASED (could not get up), VACCINATION SITE RASH (a reaction to the vaccine at the site of injection with a rash) and NAUSEA (Nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was reported Treatment information was not provided Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-248557 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information received; 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.

could not get out of bed; she felt like passed out; having episodic of blood pressure really; dizziness; Pneumonia; nausea; had a temperature; sick for five days; vomited for 3 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder, PRAMIPEXOLE for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), VACCINATION COMPLICATION (sick for five days), MOBILITY DECREASED (could not get out of bed), PRESYNCOPE (she felt like passed out), HYPERTENSION (having episodic of blood pressure really), DIZZINESS (dizziness), VOMITING (vomited for 3 days), NAUSEA (nausea) and PYREXIA (had a temperature). At the time of the report, PNEUMONIA (Pneumonia), MOBILITY DECREASED (could not get out of bed), PRESYNCOPE (she felt like passed out), HYPERTENSION (having episodic of blood pressure really), DIZZINESS (dizziness), NAUSEA (nausea) and PYREXIA (had a temperature) outcome was unknown and VACCINATION COMPLICATION (sick for five days) and VOMITING (vomited for 3 days) had resolved. It was reported that the blood pressure intervals were high mainly during the day time. The patient stated that prior to getting the vaccine, she was healthy and was baby sitting for 10 hours. The patient said she had to do stop doing that because she felt like she may drop her grandson since she felt like passed out. Treatment information was not reported. 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-2021-023313 (Patient Link).

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.

Ischemic Stroke, Hospitalization, Ambulance, arterial blood clot, loss of balance, atrial fibrillation , emergency room

Syncope within 48 hr of vaccination and persisting lightheadedness, palpitations, then hypertensive urgency

Patient had vaccine on 01/06/2021 and reported she woke up early in the am on 01/07/2021. She wanted to go to the bathroom but had severe dizziness and needed help from her husband to get back in bed. She also experienced nausea and vomited 3 times. Also had extreme soreness. Was followed up in office on 01/08/2021 when she continued to report severe pain in L arm where she had the injection. No nausea or vomiting for past 24 hours.

Patient was in 15 minutes observation after COVID vaccination when she started experiencing SOB at 4:18 pm. Started with O2 treatment at 3 ml flow rate, notified site lead immediately. Under site lead supervision, attempted to take VS : HR 90 irregular, RR 40 irregular, unable to take BP due to equipment malfunction. No T due to no thermometer in observation room. Patient is diaphoretic states SOB, dizziness. Denies Chest pain. No N/V. At around 4:20 pm, one dose ( 0.3 ml) of epi-pen adult was administered left lateral thigh and called Emergency service ambulance per protocol. At 4:30 pm, EMS ambulance and police were arrived. Detailed patient care information was provided and handed over the care to the team. At 4:40 pm, patient left with emergency ambulance team.

My shot was Saturday at 2 PM. Monday night I developed a VERY tender, sore achilles tendon. I could barely walk Tuesday. I kept working it up and down and I do not excercise, so it's certainly NOT from overuse. I have never had this problem before I can remember at one time taking some meds that the warnings said they could cause problems with tendons. . so , I'm wondering if this could be because of my shot on Monday. Hence, the report.

1/27/21 - Woke up at 5 am, and felt awful, it was dark outside. Symptoms included; Difficulty walking Felt Shaky Feverish and hot Very confused, could not tell if it was day or night Did not take any medication that day Slept all day, and woke up several times At 5 pm, ate sandwich (but was not hungry) drank water Went back to bed and slept until the next day 1/28/21 Woke up 1/28/21 and felt fine

Client called to report that she had the COVID vaccine yesterday morning, that she felt a little dizzy after, but she was okay and able to drive home. She stated that around 1pm yesterday that she got really dizzy so she took some medication that she had for dizziness, she had it for a previous fall d/t dizziness. She stated that the medication helped, but around 8pm yesterday her head felt like it was going to explode and her heart was racing, so she called her daughter and her daughter called the ambulance and she was taken to the ER. She said they ran a bunch of tests at the ER, including a CT scan, she is doing okay now, and is at home. She stated that she is calling because she does not want to get the 2nd dose of COVID vaccine because she does not want to go through that again. Client stated that she lives alone but her daughter checks on her frequently.

Day 1: 01/07/21 Moderna Vaccine Dose #1 was given in left arm. No side effects noticed. Day 2: 01/08/21 No side effects noticed. Day 3: 01/09/21 Left arm slightly sore (no action taken). Days 4-9: 01/10/21 to 01/15/21 No side effects noted. Day 10: 01/16/21 (T:98.0) Woke up to a large welt, hot to the touch, no pain on upper left arm - below injection site. Began 25mg Benadryl (25 mg) 2 doses taken. Day 11: 01/17/21 (T:98.2) Welt increasing, hot to the touch, slight burning on back of neck also. Took Benadryl (25mg) twice during the day and Tylenol (650 mg) twice during the day. Day 12: 01/18/21 (T:98.0) Rash seems to be flattening out spreading a little, neck rash seems slightly worse. Burns. Day 13: 01/19/21 (T:98.6) No change in symptoms Took Benadryl (25mg) twice Day 14: 01/20/21 (T:98.3) Rash seems to be spreading into the armpit area. Neck area is larger and burning. Took three Benadryl (25mg) during the day-Tylenol 2 tabs (650 mg) at bedtime. Day 15: 01/21/21 (T:98.3) feeling tired. Rash is spreading under both armpits and neck. Back seems to be itching a lot too. Took Benadryl (25mg) three times. Day 16: 01/22/21 (T:98.6) Rash is really bad! Area of original welt is slightly larger. Took Benadryl (25mg) 6 am, 12pm, 6pm 10, pm and 3am. Will call MD on Monday. Used Shea Butter lotion (little help). Day 17: 01/23/21 (T:98.0) Rash is worse, both arms and larger neck areas hot to the touch burning sensation. Benadryl (25mg) 6:30 am. (37.5mg)10:30sm, (37.5 mg) 3:30 pm, (25mg.) 8:30 pm. 2 Tylenol (650 mg.) 9:00 pm. Day 18: 01/24/21 (T:98.8) Rash is still worse and spreading (will call MD tomorrow). Benadryl (25 mg) 6:30 am and 11: 45 am, 2 tabs of Tylenol (650 mg) noon and 4:00 pm. Shea butter lotion not helping. Applied ice, seemed to ease burning sensation but still miserable. Day 19: 01/25/21 (T:98.4) Saw Dr. who prescribed RX: Prednisone 60 mg daily for 5 days, Benadryl 25-50 mg for itching, oatmeal baths, cortisone 1% cream or lotion, I picked up my RX and a new package of Benadryl/Banophen. Went home and took Benadryl (50 mg) 2 tablets at 9:30 am,1:30 pm and 5:15 pm, mistakenly believing they were 25mg tabs because of packaging change and miniscule text on bottle and difficult to find directions. Also Prednisone 60 mg, 10:00 am. Took 2 Tylenol (650 mg) 12:45pm and5:20 pm. I did not realize that the Benadryl dosage was different! Actually double! So I took 300 mgs of Benadryl. Took an oatmeal bath at 5:30 pm. Around 6:30pm I felt a little dizzy. So I went to bed because I did not feel right. I was not making any sense. When my daughter FaceTime?d me and realized I was slurring my words. She phoned her sister to do a wellness check. 2021 Covid Vaccine They found me still incoherent and unsteady. I did not realize that the bottle of Benadryl was a different dosage! Dr. office and spoke to doctor on call. They suspected steroid psychosis. We had not yet puzzled out the exceeded dose of Benadryl/Banophen. Used oximeter during night to monitor breathing, which was normal. Day 20: 01/26/21 (T:98.2) Prednisone dosage was decreased to 40 mg daily (due to question of psychosis). No cortisone cream or lotion. The dosage of Benadryl was discovered and resolved. Rash is still spreading over body. Now on lower stomach. Benadryl (25 mg), one tablet at 9:30am, Benadryl (12.5mg) at 2:00 pm, 9:30 pm. 2 Tylenol (650 mg) at 1:20 am, Pepcid AC (new addition at 10:00 am, Prednisone (40 mg) noon. Trying aloe and calamine. Day 21: 01/27/21 (T:98.4) Rash on neck and underarms spreading, also back is now raw. Feeling less fidgety. Pain slightly better. Benadryl (25mg) 7:30 am, 3:30 pm, 10:00 pm, Prednisone (40 mg.) 9:00 am, Pepcid AC, 2:00 pm. Day 22: 01/28/21 Feeling slightly better, Benadryl (25 mg) 6:50 am,1:00 pm, 7:30 pm. Prednisone (40 mg.) 6:15 am. Pepcid AC, 1:00 pm. Day 23: 01/29/21 (T:98.6) Rash is still spreading. Benadryl (25mg.) 3:30 am, 9:00 am, 2:30 pm, 8 ;38 pm, Prednisone 7:30 am, Pepcid AC 2:00 pm. Day 24: 01/30/ 21 really itching, neck burning, Benadryl (25mg) 2:05 am,8:00 am, 2:30 pm, 8:30 pm, 1:30 am. Prednisone (30 mg) 8:00 am, Pepcid AC 3:30 pm Day 25: 01/31/21 Oatmeal bath at 1:30 am. Benadryl (25 mg) 7:35 am,1:45 pm, 7:10 pm, Prednisone (20 mg.) 7:30 am & 1:00 pm total 40 mg. Pepcid AC 5:00 pm. 2 Tylenol (650 mg) 6:00 pm. Neck bright red again and rash worse on forearms and hands. Wearing gloves in effort not to scratch. Misery continues. 2021 Covid Vaccine Day 26: 02/01/21 (T:98.6) Benadryl (25 mg.) 2:30 am, 7:50am, very itchy, did not use ice for last 12 hours. Rash is now in the groin area. 20mg prednisone at 9:55am. 2 Tylenol (650mg) 11:45am. 12:10pm Pepcid AC. Saw new dermatologist who prescribed Rx strength steroid cream.

patient said on 2.7.21 around 12 pm she got light headed and black out/fainted for a few minutes and blood pressure dropped to 93/56, she felt like it could be vaccine related, no treatment, patient feeling better

1. Extreme Dizziness and Vertigo, 25 hours after inoculation. I experience these symptoms often because of other medications and vestibular disorder. Vertigo lasted approx 36 hours. I fell twice. Once forward on my face and lower body. No damage, other then bruise on leg and sore hands from trying to break the fall. I was able to get myself up and assess no severe damage The other time when lowering myself onto the toilet. 2. Sore arm at injection sight; I exercised arm to alleviate discomfort. Lasted 36 hours.

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.

the patient complained of dizziness 25 minutes after receiving the Moderna vaccine. She had no other symptoms. Her vital signs were recorded and stable. The doctor was informed and he asked that we continue monitoring the patient. After an additional 20 minutes of observation, the patient stated she was still experiencing dizziness. This was discussed with the doctor who asked to have the patient scheduled with him for further evaluation. The patient was discharged home after her doctor's visit.

Patient assessed and monitored by EMS on 2/4/2021 post vaccination: Chief Complaint: Difficulty breathing; tremors Secondary Complaint: Dizziness; full body weakness History of Present Illness: Patient was receiving COVID 19 vaccine. After injection, patient began experiencing labored breathing, full body tremors, and became extremely weak. Patient requested to be checked out. Medical History: Obtained From: Not Recorded Current Medications: None - Reported By Patient Allergies: Albuterol Lidocaine Sulfur Neurological Exam Level of Consciousness: Alert Loss of Consciousness: No Chemically Paralyzed: No Stroke Scale: Cincinnati Negative Mental Present: Oriented-Time, Oriented-Event, Oriented-Place, Oriented-Person, Normal Baseline for Patient Pupils Left, Right Size: Normal, Normal React: Reactive, Reactive Motor, Sensory LA: Normal, Normal RA: Normal, Normal LL: Normal, Normal RL: Normal, Normal Airway Status: Patent Performed By: Patient Outcome: Unchanged Respiratory Effort: Normal Sounds: L: Clear R: Clear Sounds: breath sounds clear all fields Cardiovascular JVD: Not Appreciated Cap. Refill: Less than 2 Seconds Edema: Not Appreciated Pulses Left, Right Carotid: Not Checked, Not Checked Radial: Strong, Strong Femoral: Not Checked, Not Checked Injury Details Reason for Encounter: Injury/Trauma Drugs/Alcohol?: None Initial Physical Findings Assessment Skin: Capillary Nail Bed Refill less than 2 seconds, Dry, Normal, Warm Skin Findings: Skin CTC normal, warm, dry, pink Left Shoulder Findings: Injection site of vaccine; no swelling noted Mental Status: Normal Baseline for Patient, Oriented-Event, Oriented-Person, Oriented-Place, Oriented-Time Impression / Diagnosis Symptoms: Breathing Problem, Tremor, unspecified, Weakness, Tachypnea, not elsewhere classified Impression: Dizziness, Weakness Initial Patient Acuity: Emergent (Yellow) Activity 15:40: HR=98, BP= 106/70, Alert, RA SpO2=99, Resp.= 22 Labored Crew was requested over to RN vaccine station to assess female patient presenting with labored breathing, slight tachypnea, full body tremors, and general body weakness. Patient had just received first dose of Moderna COVID-19 vaccine. Patient is AAOx4, (-)LOC, (-) signs of anaphylaxis. Patient is assisted onto stretcher, secured with straps x3 and side rails raised and brought over to ems triage area. Patient denies any pain, complains of uncontrolled full body tremors. 15:47: HR=78, BP=134/90, Alert, RA SpO2=98, Resp.=20 Labored, Cincinnati Negative Crew assesses, patient shows no signs of anaphylaxis, lung sounds clear in all fields. Patient feels light headed and is lowered to supine position. Patient states she has had an episode similar to present in doctors office a few years ago when administered albuterol, and event had subsided approx. 30 minutes later. 16:01: HR=78, BP=136/p, Alert, Resp.= 18 Labored, Cincinnati Negative Vitals reassessed. Still above normal baseline for patient. 16:10: HR=80, BP=120/p, Alert, RA SpO2=98, Resp.=18 Labored, Cincinnati Negative Vitals reassessed, patient now showing full body involuntary tremors and complains of extreme weakness when moved to fowlers. Patient Cincinnati negative, no signs of anaphylaxis. Patient moved back to supine position. 16:18: HR=76, BP=122/68, Alert, RA SpO2=97, Resp.=18 Normal Vitals reassessed, breathing no longer labored, patient states she feels better and wishes to go to bathroom. Patient is assisted to bathroom with assistance from RN. 16:35: HR=74, BP=126/68, Alert, RA SpO2=97, Resp.=18 Normal Vitals reassessed, patient wishes to walk around and see how they feel, crew monitors. No tremors are noted for several minutes, patient now sitting fowlers on stretcher. Patient is advised that at any time they can call 911 if they feel they don't feel right or are unsure of condition. Patient is always made aware that ems crew does not diagnose and does not have the ability to see and diagnose underlying conditions that a hospital would have the capabilities to do so. After several more minutes of walking and discussion of patient condition, patient wishes to sign RMA , and go home with husband, daughter was waiting at residence. patient signs RMS, AMA, RN signs as witness. Patient care diminished. 2/5/2021 at 11:08am: Public health nurse called patient at for follow-up. Patient stated she was ?not steady on feet for a while? on prior night. Patient stated she started to feel ?back to normal? today. The only symptom patient is reporting today is feeling tired. Received verbal consent from patient to update her HCP, Dr. , about her reaction post vaccine. , RN

Felt like I had the flu. All I wonted to do was sleep For 3 days. The first day I felt a little sick , then mostly Felt real bad.

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.

I just noticed when I took a step it hurt and the more I walked the more it hurt. The pain is in the back of the thigh/backside. I am unable to walk on it, but it hurts.

Patient reported feeling, dizzy, hot and nauseated at beginning at 3:04pm , patient was given an ice pack to cool off and remove several layers of clothing to help with cooling off. Pt requested water asked to remove face mask to help with adequate breathing. Patient was asked questions regarding medical history and medications as well as given time to rest. Patient reported feeling better after 20 minutes and requested to go home. Patient had an assistant who reported she would drive her home. RN spoke with daughter on the phone who reported patient to stay at daughter's home, however patient refused and requested to go home. Pt reported feeling much better was adamant about going home.

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.

L arm/deltoid pain persisting for 3 weeks after vaccination, decreased ROM of L arm due to pain. no redness or bruising at vaccine site. Unable to abduct arm past 40 degrees due to pain.

A few hours after the vaccine, came home and got a headache, then she got nausea. She went to bed, and all night and into the next day had fever/chills. She got up during the night to get some water she collapsed and could not get up as she was so weak. Her husband found her and helped her back to bed. Today, 2/22/21 she is better today and feels almost to normal. She took Pepto-Bismol for the nausea. Tylenol/Ibuprofen did not take the headache, but it did finally go away. The headache was on the top of her head.

DELAYED LOCAL REACTION AT INJECTION SITE, WITH MUSCULAR INVOLVEMENT, STILL PRESENT FIVE (5) WEEKS.AFTER INJECTION 1- SEVERE PAIN IN LEFT ARM, INCREASING OVER TIME, LIMITING MOVEMENT; 2-SWELLING IN THE AREA AROUND INJECTION SITE; 3- AREA WARM TO THE TOUCH; 4-RUBOR IN THE AREA. SYMPTOMS SUGGESTED DEEP VENOUS THROMBOSIS, BUT ULTRASOUND FOUND NO CLOTS.. ANOTHER POSSIBILITY COULD BE BICEPS TENDONITIS, BUT ETIOLOGY NOT CLEAR. MEDROL GIVEN FOR 5 DAYS DECREASED SYMPTOMS, BUT SWELLING, RUBOR, AND PAIN PERSIST FIVE WEEKS AFTER INJECTION. SEVERE LOCAL REACTION TO INJECTION, AFFECTING MUSCLE?

Patient c/o feeling dizzy/lightheaded and her face was warm. Reported feeling anxious. Facial flushing noted. Patient taken to private room for further observation via w/c. Patient reports SOB and chest pressure 9/10 BP 204/85 hr 71 spo2 99%. Nitroglycerin 0.4 mg SL given. Pt continues to appear flushed, and c/o h/a and chest pressureEKG completed and handed to doctor at bedside. FM replaced with O2 2LNC. Patient's facial flushing, redness to upper extremities and tremors, has subsided notably and pt is reports feeling better. Continues to deny chest pain. Pt's affect improving and she is able to smile when she answers questions. BP 144/53 HR 88 Spo2 100%. Pt discharged via w/c with family in stable condition as per doctor. Patient aware allergy department will be following up on her reaction and she will be provided with further instructions regarding second dose of moderna covid vaccine.

Upon getting up next day felt like I was having vertigo It became full blown on the 19th (two days later). Was unable to get out of bed that day. But got medicine to help with dizzy ness and nausea. No fever. Just headache and dizziness

About 12 days after the first dose on Jan. 13, I experienced Vertigo which resolved after 2 days but was left with lingering dizziness for three more days. THEN, after the second doxe on Feb 10, about 12 days later, I once again experienced vertigo which lasted 4 days and experienced dizziness for days afterwards including today as I write this report. The dizziness does decrease daily but is worse in the morning and diminishes as the day proceeds.

Received vaccine on 2/23. On 2/24 arm became swollen and red and spread beyond injection site to approx 4 inches in diameter. There was slight itching, and pain. On 2/28 became nauseated in shower and felt extreme weakness requiring assistance to get to bed to lie down. Thought she would pass out. Lasted 3 hours and then was recovered.

She got the vaccine, got dizzy, laid down in the bathroom floor and laid there for a while and when she tried to get back up she was not able to move. She does have life alert and the fire department broke into the house and she was taken to the ER. In the ER they gave her IV fluids, checked her vital signs. They did not do anything unusual to her. She was then released after 4-5 hours. She is feeling much better, still a little weak but otherwise fine.

Dizziness, lightheadedness, wheezing, chills, headache, body aches, sore arm - 6 to 8 hours Arm swelling, hard lump, redness near injection site - began on day February 15. Hardness lasted five days, redness lasted 13 days Sleep disturbances - difficulty getting to sleep, waking in middle of night with feeling of disorientation - began on February 15 and lasted for four nights. Eye pain with feeling of object in eye and red, itchy eyelids. Began February 17 and recurred intermittently for six days.

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

early next morning got up to use bathroom, and collapsed on bathroom floor, went in and out of consciousness and was too weak/had no energy to pull herself up from the floor. Severe diarrhea all over floor and self. Was not found until Saturday afternoon, and was transported to the ER by ambulance. Remained in hospital Saturday evening until Monday afternoon. As of today, the following Friday the 12th, she is still weak and unsteady at times, where she was previously ambulating fine with adequate energy. Still feels like she has no strength.

11 hours after the injection I developed sever, uncontrollable shaking. Walking was very difficult. It was almost impossible to do anything with my hands. The shaking lasted 1 hour.

Dizziness, difficulty breathing, swelling of face, rash on thighs and low back, slight tightness of chest. Symptoms continued to get worse. After 45 minutes went to ER Vital signs taken + EKG, observation. After approximately 3 hours breathing, dizziness, swelling of face improved. Some rash remains.

pt states that she developed headache, chills, and could not move. She stayed in bed in 48 hours. Headache and chills subsided in 24 hours and fatigue that for 48 hours. She says had the coronavirus in Sept 2020. She says she still has fatigue that comes and goes since getting the vax. Pt will contact PCP regarding getting the 2nd dose.

Patient reported tongue tingling. Then advised that she was feeling light headed. Patient then began slurring words and stuttering. Patient was given 25 mg of Benadryl IM. Then transported via ambulance to the local ER.

1/13/21 Evening of vaccination pt experienced body aches. States she feels like she had the flu. Reports feeling better Friday, Sat and Sunday. Cough productive of green phlegm. Weakness and dizziness that kept her from getting off toilet. Fell or passed out upon return to bed.

I felt really funny after the vaccine. I picked up my girls and we went to eat. They told me I was very quiet. When we were going home they told me I was swerving, all over the road and they told me to stop, they would drive, I said no, i don't trust anyone with my car. We got home, I remember changing into my nightgown and was texting someone and I suddenly I stopped. After that I was unresponsive. I would not answer anyone, they said I looked pale and stared into the air. They called my children and they came and emergency personnel was called. I was taken to a hospital and they transferred me to another hospital. I stayed there for 3-4 days. After going home it took me some days to be able to walk without assistance. I wanted to say I had covid in May (1st time) and September (2nd time) . I still do not have taste or smell back from the covid. I can only eat 3 or 4 bites and then I am done.

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

passed out; Fall; knee got banged up pretty bad; Got dizzy; weak; A spontaneous report was received from a consumer who was also an 81-year-old, female patient that received Moderna's COVID-19 Vaccine (mRNA-1273) and passed out/ loss of consciousness, fall, knee got banged up pretty bad/ joint injury, dizzy/ dizziness, and weak/ asthenia. The patient's medical history included knee replacement, COVID-19 in Nov 2020, and pneumonia. Concomitant product use was not provided by the reporter. On 01 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013h21a or 013E21a) intramuscularly for prophylaxis of COVID-19 infection. On 01 Mar 2021, the patient got dizzy. The patient was weak and passed out. She was sitting on toilet cover and was getting ready for a shower but the next thing she knew was that, she found herself laying in the shower stall. The patient did not know for how long she was passed out for. Treatment for the events included 2 Tylenol. Action taken with mRNA-1273 in response to the events was unknown. The outcomes of events, loss of consciousness, fall, joint injury, dizziness, and asthenia, were considered as unknown.; Reporter's Comments: Very limited information regarding these even/s has been provided at this time. Further information has been requested.

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.

2/1/2021 4" bright red splotch on shot arm, no pain, no fever faded away in two days 2/20 12:20PM #2 shot 1PM Tylenol 2 pm Fatigue+ feeling strange Restless night 2/21 tired + a bit unsteady 2/22 Redness starting on shot arm 02/25 Redness faded away. Rock-hard bowel movement. 03/1 shot arm almost itchy, almost burning tiredness linger

Increase ringing in right ear. Ringing started in left ear. Headaches & Dizziness. Cold like symptoms--some coughing, sneezing, runny nose. Shortness of breath.

4:00a.m., next morning,chills (couldn't get warm), fever ( temp 102.8) , difficult to stand, no appetite, very sleepy all day. Had to hold onto walls just to walk felt dizzy, weak, aching and confused. Right shoulder swollen, not red. No desire to eat,and forced myself to take fluids. Lasted 4 days.

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

tenderness, warm to touch at injection site (left arm) Patient has taken Tylenol and applied ice packs to relieve symptoms with some effect 4/13-Spoke with pt today and she said that she is feeling much better only having a slight headache that goes away with Tylenol. She also complains that her arm is itchy now. She has a doctor's appt this Thurs and would like if we call back on Friday. 4/16- PharmD Rcvd follow up called on 4/16/2021 at 2:06pm: Pt reports that she is feeling much better today, and all the symptoms she reported having on the follow up call on 4/13/2021 has resolved. Pt reports feeling fatigue, lightheadedness, and a headache that comes and goes. Pt stated that she took Tylenol on 4/15/2021 for the headache. ***NOTE*** Recommend pt to monitor her symptoms of lightheadedness and headache. Recommend to continue to stay hydrated and consume adequate meal, and take Tylenol PRN. Also rec pt to get up from sitting and bending position slowly, and to see if the lightheadedness occurs during resting positions. If her symptoms has not gotten better over the weekend, rec for pt to contact MD.

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.

Patient was very ill and homebound. Her son has to physically carry her to move her from one place to another and she is considered homebound.

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

Per nursing notes: patient received Moderna vaccine #1 on 2/1/21. There is no mention of skin issues or rashes in notes until 2/25/21. Then there is an alert note indicating she has red spots all over skin. Skin intact on 2/28/21. Lotion was applied. No itching. On 3/8/21, she received Moderna #2. Hydrocortisone cream started on 3/8 for itchy skin. Eucerin and hydrocortisone used daily. On 3/27, Nystatin topical was added. On 3/30, per primary request, patient went to see Dermatologist. Triamcinolone cream started. On 4/2, reddish raised rash on neck and shoulders noted. On 4/15, she had a fall, hit head and transported to ER. Suffered a brain bleed and vertebra fracture. Upon readmission, itching rashes remained upper/lower extremities, back/front of body, with skin intact. Mention neurodermatitis in notes. On 4/26 ration noted all over hand and body with left hand swelling. Triamcinolone cream applied. On 4/27 rash on body worsening and clear fluid filled blisters noted on left hand, therefore Change in condition noted. 4/28 visit dermatologist. 4/28 blisters with clear fluid open and drained. Bacitracin applied. Red raised rash on her body slightly improved. 5/2 rashes on upper and lower body more raised, itching started. Several small blisters on leg, neck, right hand. Dermatologist appointment on 5/5 noted. 5/4 multiple blisters with clear fluid on upper and lower body, different sized. 5/6 prednisone oral taper started. Triamcinolone and mupirocin topical started. New diagnosis of bullies pemphigoid noted. Treatment in process.

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.

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.

Patient admitted to Hospital for blood clot in lung after falling twice approximately 24 hours after 2nd COVID immunization

Within 24 hours, my mom's arms swelled up from shoulder to fingertips and she had never had swelling in her arms prior. She also was hanging her head as if she had fallen asleep, but actually was unable to lift her head. 4 days following the vaccine she started having breathing issues and was intubated, we had the ventilator removed (she was actually a DNR and was not supposed to be intubated). On January 19, 2021 she died. She went into this facility for rehab regarding an infection she had in her leg.

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.

Pt reports 2 days after vaccination she had a dizzy spell of approximately 2 minutes that came and went intermittently for the next few days. Last dizzy spell 6/17/21. Now resolved as of 7/1/21.

Moderna vaccine was administered at 7 hours past the recommended 12-hr BUD after first puncture. Bottle was kept at room temperature for a total of 20 hrs. Pt reported no significant symptoms the following day after administration, only some lightheadedness the night prior.

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.

After first dose of Moderna COVID-19 vaccine, patient started to experience dizziness and lightheadedness. Patient was given water/juice and observed. Patient was discharged to home in stable condition.

After her 15 min observation she appeared ataxic. Patient stated she felt dizzy, had some water and rested while under observation until dizziness subsided and she walked without losing her balance

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.

After about 10 mins i started to get headache, dizzy,. Got pale. Was put on cot. had heart palpitation felt cold and shaky. After about an hr and half i started to get back to normal. When i got up i started to walk funny. I was able to drive home. took Tylenol when i got home. ate a little soup. laid down and fell asleep. when i woke up a couple hrs later i still had a headache. took another tylenol.

Patient recieved vaccine 1 of covid 19 i 1/19/2021. She felt poorly on 1/20/2021. She felt dizzy and fell at 3 AM on 1/23/2021. She felt poorly and did not know her son's name which was not normal. She went to ER on 1/24. She was assessed as not having fractures. She was going to be transferred to a skilled nursing facility. She was not having respiratory complaints. She was awaiting transfer when her O2 levels started dropping substantially. She declined aggressive intervention and she died within a few hours.

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

passed out without warning around 10pm. woke up on floor. couldn't move right leg. slept on floor all night.

The following symptoms began the day after the shot: headache, dizziness, tiredness, fever, complete loss of hearing in right ear, partial loss of hearing in left ear, Hearing loss lasted 6 hours before beginning to improve. Most symptoms were gone by end of 4th day. Tiredness remains along with occasional dizziness.

Severe headache 3 days, nausea 3 days, weakness 5 days, pain upper part of body 5 days, unable to walk w/o assistance 2 days, red feverish arm, on 6th day could be up but only 20-30 min at a time. 9th day back to normal.

She got home after having the vaccination about 11:00, went to the bathroom, tried to get up but couldn't get up, felt paralyzed. Sat about an hour before she got some help to get up. She crawled into the bedroom, rolled onto a mat and slept there because she could not move. It's getting better but is more in her hips.

3 d post vaccine hospitalized with orthostatic hypotension and vertigo 5 d post vaccine developed R face Bells Palsey

Date and time of vaccination: (list both if they received both shots): 1/5/21 1st, 2/2/21 second Facility name where the vaccine was given. dizziness 3 days after the 2nd shot, resolving .

Left shoulder injury. Unable to reach behind back with left arm. Started approximately 2/4/21. Still have pain & hard to reach behind back on 2/14/21. Noticed small dime-sized red spot on left shoulder on 2/11/21. On 2/14/21 red spot had grown to approximately 3 1/2? long & 2 1/2? wide. Is warm to the touch, but doesn?t seem to be swollen & not painful. Intermittent problem finishing a sentence without taking an additional breath. Started about 2/5/21. Not sure if heart murmur is related.

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.

Patient received first dose of vaccine and felt dizzy about 15 minutes after administration. She felt like she was going to "pass out." She did not lose consciousness and her vital signs remained stable.

Patient had a reaction 4 days after the 2nd Covid vaccination. She began to experience vomiting that lasted 24 hours, accompanied by extreme fatigue and dizziness. Fatigue and dizziness are still peristing in a mild manner.

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

Two weeks after the shot, the patient has become very sick. She is feeling dizzy, very weak, and can't eat. She also has a rash on certain areas of her body (knees and groin area).