Moderna

Mild to moderate dizziness and nausea for three days starting 01/06/2021. Reported it to a advice nurse and a physician on 01/08/2021 . Meclizine and Ondansetron was used immediately. Scopolamine was prescribed by the physician on 01/08/2021, picked and used on 01/09/2021; felt better . Residual dizziness remains after use. P.S. I do have a medical history of BPPV for the last 2-3 years and have been treated for it. Generally speaking my BPPV symptoms resolve themselves quickly after treatment. This current episode has lasted forthree days.

c/o severe headache & generalized body aches; Temp 100.8; dizzy/faint symptoms relieved by Tylenol 1000 mg PO. after lasting from 1/8/21 - 1/9/21

Moderate pain (4 on 1-10 scale) upper R. deltoid, persisted for approx. 36 hours. Not tender to touch. Pain was sensitive to movement and somewhat restricted movement of R. shoulder for a while. Not considered serious by patient. Pain was fully gone 48 hours post injection.

1305: vaccine administered 1312: Client reports facial numbness, feeling faint, short episode of shortness of breath x 1 min that resolved already, O2: 97%, P: 74 1315: Given life savers candy, BP 142/82 LA, Temp 98.1, Lungs CTAB 1317: States that he is no longer feeling faint but still has lip numbness, capri sun given 1325: Client states he is feeling better 1335: Client feels ok to drive. Released from clinic

Vagal response--lightheaded, nausea, queasy, cold sweats, felt like I might pass out--lasted about 10-15 minutes and then

One minute after vaccination, recipient started to gradually feel dizzy. Medic was called right away to respond, vitals were normal. Medical history and medication list was noted. BP: 138/72, HR: 71 BPM. Recipient was instructed to recline his seat back, sip water slowly, and relax. He said that since starting his medication provigil, he has been having dizzy spells. We had the recipient wait another 10 minutes, we checked him out, and clearing him with no signs or symptoms. Nothing follows.

5 hours post vaccination broke out with a hive on my face, felt lightheaded and heavy in the chest but not short of breath. went to bed around 10 that evening and slept well. felt fine the next morning, hive stayed for about 2 days.

DVT in right leg 4 days after injection, severe pain in thigh/calf, difficulty walking Placed on Xarelto 15mg 2X daily for 21 days and then 20mg daily for 9 days. Next Doctor visit is 1/26/2021 at 9:00am Next scheduled Covid 19 vaccine is scheduled for 2/5/2021 at 7:15am

After second Moderna shot, Pt developed nausea, headache, extreme fatique, and bad back and leg cramps/spasms to the point where he couldn't walk. These symptoms lasted for 48 hours and gradually subsided. His wife (me) was so frightened that I will not be getting the Moderna series since it's so dangerous and will caution friends and family as well.

Chills, sweats, fatigue ("horrible"), headache, body aches, slightly dizzy, could not get up and do anything. still with body aches and fatigue 3 days post vax.

Temporary paralysis of left eyelid which was a symptom of Bells Palsy. At the same time I experienced a very disturbing sensation of having no saliva in mouth or throat. I was completely dry and unable to produce saliva. This is my description of the event: I woke up around 3am with rapid heartbeat, lightheadness, and upon opening my eyes I realized my left eyelid was drooping and I was unable to open it. At the same time I experienced extreme dryness in my mouth and throat where i had absolutely no moisture/saliva and was unable to produce any for approximately 20 minutes. I walked to an emergency, which was just 2 blocks away, to get checked out. I told the attending nurse and physician what my symptoms were. Luckily by the time I was admitted to the ER the symptoms began to dissipate. My eyelid was slightly droopy but moving and i was able to produce saliva again. I explained that I've never experienced symptoms like this before in my life and that I believed this was from the vaccine. I had been experiencing symptoms every day since receiving the shot.... from headaches, to fatigue, to tightness in my chest, a cough, pain in my larynx that towards my chest, pain in my upper left abdomen, strange sensations in my legs, brain fogginess, and some swollen lymph nodes.

Bled Out 40% of blood from lower GI; Bloody diarrhea; Lightheaded; Sweating; Malaise; Fever; tachycardia; A spontaneous report was received from a pharmacist who is a 60-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal tract, tachycardia, sweating, lightheaded, malaise and fever. The patient's medical history was not provided. No concomitant product use was reported. On 31 Dec2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection. On 14 Jan 2021, the patient reported 14 days after receiving the vaccine, he developed tachycardia with a heart rate of 120 and did not feel right. The patient stated was sweating and thought he was having a heart attack. On an unknown date, the patient saw his doctor who performed an electrocardiogram (EKG) – results not provided. The patient also stated he had blood pressure issues but did not provide any further information. On an unknown date, the patient reported he was hospitalized with bloody diarrhea. He stated he bled out 40 percent of blood from his lower gastrointestinal track. He reported he had malaise and fever as well. The patient reported he had to have surgery to stop the bleeding. Treatment for the event included surgery. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, bloody diarrhea, bled out 40 percent of blood from lower gastrointestinal track, tachycardia, sweating, lightheaded, malaise and fever, were considered unknown.; Reporter's Comments: This case concerns a 60 year old male patient, who experienced a serious event of gastrointestinal haemorrhage, associated with other non-serious events after receiving first dose of mRNA-1273. Very limited information regarding this event has been provided at this time. Further information has been requested.

Right upper arm became very swollen, hard, and painful to the point that I could not raise my arm or touch the spot. I also had a fever and headache.

Headache, nausea, muscle pain, dizziness, fatigue, cognitive issues, fever/chills I'm taking Tylenol but don't know if it's doing much. Symptoms are ongoing I may go into my doctor's office if symptoms persist.

HE COMPLAINED OF FEELING DIZZY. AND SAID "HE NEVER FELT LIKE THIS BEFORE? AND HE SAID HE DIDN'T FEEL SAFE TO DRIVE. ON SITE EMS RESPONDED. VITALS BELOW. GIVEN WATER AND GRAHAM CRACKERS. HE WAS MONITORED. THEN GOT OUT OF HIS CAR, WALKED AROUND AND FELT WELL ENOUGHT TO GO HOME.

RPh administered the vaccine, and the patient passed out 10 minutes afterwards and hit his head. Patient felt very faint even after sat up with feet up. Patient was given orange juice and he drank it all. Paramedics arrived and checked him out. 45 minutes after him passing out, patient felt fine and went back to work. He had gashed his head open on the fall.

after vaccination, patient felt dizzy. seated patient who stated "im dizzy" patient stated he only had milk in am which is his usual routine. patient also stated he felt weak. patient given cup of water to drink. patient observed for 30 minutes and patient felt better. was observed while standing with no dizziness ad weakness verbalized by patient. instructed to return to his home and rest, eat, drink liquids; also if any further reactions patient to call 911. patient verbalized understanding and left clinic ambulatory with no complaints

less than 12 hours my whole right side went limp, i woke up to get ready for work the day after the shot and my whole right side was limp and numb, as i was trying to get dressed the use of my arm and leg came back around slowly, the whole right side was tingley all day. and it made me sick

Heart palpitations; shortness of breath; dizziness; hands shaken. Events lasted about 3 minutes. Then disappeared. They checked my blood pressure and it was elevated 155/110. High blood pressure remained for 2 days.

Sore arm. Headache. Dizzy 7pm same night. Didn't sleep well. Achy especially in knees and back. 3/7 am slight fever 100. Headache all day. Still sore arm. Body ache, no appetite.

Syncope. Did not fully pass out, but felt a wave of tightness, followed by paleness (tech said color drained), followed by lightheadedness.

Evening after 2nd injection (Friday, March 6, 2021): severe, debilitating pain, specifically in the area of the heart. Went to ER and was given EKG, Chest X-Ray, and blood tests to check for heart attack. Symptoms subsided after a bit. Labs were inconclusive. Sent home. Continued to have lingering aching in the heart region the next day. Throughout the weekend, continued to experience alternating sweats and chills, nausea and increased pain in hip joints causing difficulty to walk. Stayed home from work on Monday, March 8, 2021 with the same symptoms continuing. Tuesday, March 9, 2021 began experiencing excruciating thigh and knee pain to the point of barely being able to stand or walk. Returned to the ER where they administered Torodol and pain subsided. Will be seeing primary care physician Tuesday afternoon.

First two days, typical injection site soreness; third day my left shoulder joint had a tendonitis feel to it and it has progressively worsened such that range of motion is limited and certain movements very painful

At clinic, patient complained of nausea to RN at Obs station #1. She was walking him to bathroom outside Obs station #2. Pt complained of lightheadedness. Supervisor, grabbed chair out of Obs #2 and asked us for help. I came on seen found pt diaphoretic, pale, shaking. Said he was nausea. given trashcan. Asked his history.Said he had a similar rx after having a flu vaccine in the past and Gallium Injections for cardiac condition. Asked meds. Told me he takes Propanlol for Afib and SVT. Has a low heart rate normally. Heart was very week. HR52. Asked supervisor to call 911. BP tried by one nurse and unsuccessful. I tried and got a 90/52. Pt then stated he was SOB and felt difficultly breathing. Attempted pulse ox. Unable to get reading. Place him on o2 at 10l fase mask. Ask to prep benedryl. Pt said he had benedryl in past and it made symptoms worse. He said breathing was improving. Still very cold with chills. BP rechecked 102/60 Hr 68. Wife was standing by. Patient was slowing improving. Color in face improving, reported nausea was gone. Still unable to get a pulse ox. Heart rate at wrist very hard to palpate.Increased O2 to 15L with face mask. No medication was given, only O2. EMS on seen, reported & assisted him to gurney. Gave his wife his apple watch.

Patient reports feeling lightheaded, dizzy. Passed out a couple times. Presents sweating, flushing, and clammy skin. Patient reports having veso vagal previously. EMs preformed EKG and results were normal. Refused EMS transport

Date & Time started: 3/09/2021 2300 Itchy 3/09/2021 2300 dizzy 3/10/2021 0100 headache 3/10/2021 0100 eye pain 3/10/2021 0130 Fast heartbeat 3/10/2021 0130 Difficulty breathing; Shallow breathing 3/10/2021 0130 Severe Chest pain pulsing to left arm 3/10/2021 0130 Tremors 3/10/2021 0130 weakness 3/10/2021 0130 blurred vision right eye 3/10/2021 0130 joint and muscle pain whole body 3/10/2021 0130 cramping 3/10/2021 0130 nausea all continued through the 10th; Dizziness, headache, eye pain, tremors, weakness, blurred vision right eye, joint pain, and nausea continued through the 11th but got better by the evening. Weakness and blurred vision still present on the 12th.

patient reported any allergies to medication or food. patient signed consent for vaccine and vaccine administered per protocol then proceeded to designated wait area. Patients wife called for assistance 10 minutes after vaccine was administered due to patient being faint and light headed. Medic and RN begin to assess vital signs and patient became unresponsive. Patient was given EPI via EPI pen and 911 was called for assistance. Patient vitals continued to be assessed, patient was also given 50mg Benadryl IM, EMS arrived and assessed patient. Patient regained consciousness and was transferred to hospital for further assessment.

Muscle neck and right arm became very tight and knee joints hurt started at 8 pm one day after .. My wife systems much worse fever, breathing Nausea headache. this lasted for two days no energy confusion sweats

08:10 vaccine administered 08:14 dizzy, light headed, room spinning. Sat down 08:25 felt lump in throat, contacted clinic nurse in waiting area. Uncomfortable but never to the point of difficulty breathing. ~08:30, BP 128/99 (I think) Systolic up only a bit. Diastolic very high for me sent to urgent care part of clinic. Monitored BP, oxygen, did EKG (normal), symptoms started easing ~ 09:40. Sent home. Attending PA though it might just be a Vaso-Vagel response, but, after hundreds upon hundred of needles, I've never had such a response, and, my symptoms did not involve a low BP, fainting or nausea, rather I remained conscious, had throat constriction with increased BP and a narrowed pulse pressure range.

Injection was given very high up near shoulder. Experiencing pain in left shoulder and unable to fully extend my arm. Was not able to sleep first 2 nights with pain. Still not able to lift arm without pain in shoulder.

Moderately severe vertigo onset 1 week post vaccination and duration over 1 week (still ongoing but mild 9 days post onset).

THE PATIENT STARTED FEELING WEAK AND FATIGUED, AS WELL AS HAVING NECK PAIN SEVERAL HOURS AFTER RECEIVING THE MODERNA COVID VACCINE. THE NEXT MORNING, HE WAS BARELY ABLE TO GET OUT OF BED AND HAD SEVERE BODY ACHES AND FATIGUE, THE NECK PAIN WAS WORSE, HE HAD DEVELOPED A RASH ON HIS EXTREMETIES AND COULDNT SWALLOW OR SPEAK. HE WAS EVALUATED AND TREATED FOR POSSIBLE MENINGITIS / GUILLAIN-BARRE. PT WAS HOSPITALIZED FROM 2/26 TO 3/6/2021. HE WAS DISCHARGED HOME IN STABLE CONDITION .

pt presented to emergency department on 3/6/21 with change in mental status first noted at 10am; per reports, his employees noticed he was not acting himself, and he went home to rest; ED notes indicate he reported a right sided headache and was confused and had difficulty with word finding, but did say, "I can't remember anything." Pt also had elevated BP in ED; he was able to follow some commands but continued to have difficulty forming words and hand squeeze noted to be weaker on the right side and he could not keep his right leg elevated; pt fell asleep during exams; patient's neice, who is an ED physician, reported that pt had become encephalopathic with severe DKA and AKI in the past; he was started on IVF and insulin drip and transferred from ED to ICU; he went into rapid atrial fibrillation and was then started on diltiazem drip; cardiology was consulted, adjusted medications, and anticoagulation was not recommended as the episode was transient; he started spiking fever with Tmax of 101; blood cultures were drawn and he was started empirically on ceftriaxone, vancomycin, and acyclovir; IR was consulted for LP with results showing WBC 123, RBC 41, 90% neutrophils, glucose 186, protein 100; he was seen by ID and noted that CSF profile was consistent with most likely an early viral infection

Injection was very painful. Patient felt the liquid going in just like a cortisone injection. Injection site was very high it went into the shoulder joint rather than muscle. Shoulder joint is painful and cannot raise left arm.

C/O DIZZINESS,BP 125/83 HR71, O2SAT 97% R20,PO FLUID OFFERED ACCEPTED,RECLINED IN CAR CONTINUES TO BE MONITORED. RE ASSESSED BP134/88 HR 70, STATES HE FEELS BETTER ,DROVE HOME.

Vaccination on Wednesday. Felt normal fatigue and pain Wed/Thu/Fri. Felt completely fine Fri evening and Saturday. Woke up Sunday with severe dizziness and slight ringing in ears. Rest didnt help. Took Benedryl and seemed to get better in the night. Woke up Monday again with dizziness. Slightly better but still not able to work or do activities. Pharmacy referred to Physician - waiting for that appointment.

IMMEDIATELY AFTER DOSE WAS ADMINISTERED PATIENT COMPLAINED OF DIZZINESS WHILE SEATED. IMMUNIZING TECHNICIAN IMMEDIATELY CAME AND NOTIFIED ME, AT WHICH POINT I ENTERRED OUR VACCINATION ROOM AND KNELT DOWN NEXT TO SEATED PATIENT. HE CONFIRMED THAT HE FELT REALLY DIZZY AT WHICH POINT I ENCOURAGED HIM TO SIT BACK IN THE SEAT AND RELAX AND I WOULD STAND BY HIM. WITHIN APROX 5 MINUTES OF VACCINATION PATIENT FAINTED IN THE CHAIR AT WHICH POINT EMS WAS CONTACTED. WITHIN APROX 30 SECONDS PATIENT STARTED TO REGAIN CONCIOUSNESS (NOTED BY EYE, MUSCLE MOVEMENT) OVER THE COURSE OF THE NEXT FEW MINUTES PATIENT SLOWLY BECAME ALERT AND ORIENTED AT WHICH POINT EMS ARRIVED AND TOOK OVER HIS CARE. AFTER APROX 15 MINUTES OF CARE FROM EMS PATIENT OPTED TO GO HOME WITH HIS DRIVER. I CONTACTED THE PATIENT AT APROX 130 TO CHECK IN ON HIM AND HE ADVISED ME HE WAS FEELING NORMAL AND THANKED US FOR HELPING HIM THROUGH HIS FAINTING EPISODE.

Patient woke up in middle of night the following day after the vaccination with shaking, muscle weakness, dizziness, severe muscle soreness, and inability to walk. Patient went to emergency room to rule out more serious complications. All tests came out normal and was told the symptoms were a reaction to the vaccine. The symptoms continued for 2 days, but eased up with time. Patient was feeling normal 5 to 6 days after administration.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Tachycardia-Mild, Additional Details: IRREGULAR HEART BEATS. PATIENT REFUSED TO HAVE US CALL PARAMEDICS. WIFE IS TAKING HIM HOME. WE DID SUGGEST FOR HIM TO GO TO THE HOSPITAL AND PROVIDED THE ADDRESS OF THE CLOSEST HOSPITAL BUT PATIENT REFUSED.

Couldn't lift vaccination arm past shoulder. Low grade fever - 14 hours later, took one Ibuprofen Extreme tiredness Slight headache All symptoms lasted about 1 day

1- On Day one few ours after the 2nd shot, I had my heart flutter and lost by breath few times, next day was gone. 2- Knee joint pain and tendons pain still ongoing was very hard to walk. Improving very slowly. 3-Felt like I had the flue the next day with a headache, flue like symptoms gone within 2 days, however I am on week 3 with a non stop headache. I usually never have a headaches, and now I have it every day and night since the 2nd shot.

From day 2-5 I had symptoms similar to a shoulder rotator cuff injury where I could not raise my arm on its own, had very restricted range of motion, sharp pain when moving the arm. Had two Tylenol (500 Mg) one on the afternoon and one at night day 2, then 1 in the morning,2 at night day 3 and found I got no relief. Then the arm slowly improved on its own. Back to normal after 8-10 days. I believe the injection site may have been too high up on the arm close to the shoulder. The dose was administered.

Severe body, neck and joint pain. Stomach cramps, headache, fever reach 101.8, vertigo, face and lips felt numb, absolute exhaustion. These symptoms lasted for 48 hours although the worst of it was the first 24. Many of the same symptoms we the same I had with Covid in November -December 2020. I did not, however experience sore throat or congestion.

Received 1st covid 19 vaccine Friday the 2nd, Saturday 4/3 he experienced dizziness, weakness, loss of balance, numbness, slurred speech, went to ED Sunday morning, admitted to Med Surg floor 4/4/2021

Vaccine administered at 11:00 am at 11:10 client reported throat and tongue tingling, dizziness and difficulty breathing. Administered 1 mg epinephrine. EMS was called and transported client to the hospital where he was admitted under observation.

9:10 am - After client received his 2nd dose of the Moderna vaccine he began complaining of tingling and itching in his hands and feet, feeling light-headed and dizzy and shaking .Client became red and flushed, he was wheeled to the stretcher were he was advised to lay down. BP-144/83; P-62 ,wife was at his side. 9:45am -Bp-160/102 ;P-57 Client still complaining of feeling dizzy, throat itchy ,client was asked to remain on stretcher a little longer 10:00 am BP checked again 156/104 ;P-61 ,client feeling better no further complaints of dizziness. Client was advised to follow-up with primary care MD if he continued having mild reactions and to call 911 if he began experiencing chest pains ,difficulty breathing or any other severe reactions. Client released with his wife and 2 other family members.

On 2/25/21, two days after receiving this 2nd COVID injection, he developed right leg pain/discomfort (medial thigh and medial posterior calf), which lasted for 10 days, then developed a right foot drop that worsened for one week (worse at about 19 days after the vaccine where he had trouble walking because he could not keep his foot dorsiflexed due to weakness - not pain), then gradually improved. By the time I saw him on 3/23/21 the leg discomfort and foot drop had mostly resolved but was still present. Denies trauma or any other sxs. [ Of note, he had is first COVID vaccine on 1/14/21 and 10 days later was admitted to medical center with hypoxia and DOE, dx with acute hypoxic respiratory failure due to COVID pneumonia and requiring HFNC, discharged after one week.]

Chills and fever started within 4 hours of the shot, followed by a severe migraine headache lasting two days along with soreness and weakness in the arm that was vaccinated. Day 2 had a fever of 102.5 on and off throughout the entire day and night, along with nausea, vomiting, and some diarrhea. Dizzyness and fatigue lasted into the 3rd day.

I recieved the first Moderna Covid 19 Vaccine 1/08/2021 and there were no problems. The second Covid 19 Vaccine on 2/05/2021 went the same but after approximately two weeks I noticed soreness between my miidle and ring finger on my left hand along with soreness but thought nothing of it. the Pain eventually got worse. I went to my doctor on 3/25/2021 and was prescribed Naproxin and Voltaren Gel. The discomfort in my left had continues continues. There is selling above this area and the inside of my hand below those fingers hurts and my hand when I close it feels tight and this I atribute to the swelling. My doctor ran labs and all were negative even for Gout. There is a dense feeling in my left upper arm that comes and goes and some tingling. My left hand will have a burning feeling on the ring finger knuckle and experience pain when I fully open my hand. I have not injured my left hand in any way. I find it very unusual because I am right handed. I would appreciate any assistant if possible. I can send photographs if needed of my hand. Blood Work: URIC ACID 4.5 mg/dL 3.4 - 7.2 mg/dL General information Collected: 03/25/2021 11:39 AM from BLOOD Resulted: 03/25/2021 9:16 PM Result status: Final result

Dizziness. A worsening of my usual problem. Comes in waves and lasts all day/night. Difficulty walking. Intensified spacy, disequilibrium feeling.

Overview of symptoms in order of occurrence: Pain in the arm; Dry eyes; Fatigue; Nausea; Headache; Chills; Joint pain; Muscle aches; Dizziness; Measured Fever; and Arm rash. Symptoms of greatest concern: Nausea, Headache, Chills for 1-2 days; and the ongoing Fatigue is now in its 4th day. Details of symptoms with time of onset, duration and severity are provided below (Note: Injection with 2nd dose of Moderna vaccine took place at 9:24AM on 07APR21): 07APR21, 10:30AM ? Arm Pain: Onset of mild pain in arm that was noticed when not touching the arm; Level of pain was a ?1? out of 10). An annoying level of pain where the pain ramped up to 3 or 4 on a scale of 10 when the arm was moved about began at 7:00PM on 07APR21 and lasted 12 hours until 7:00AM on 08APR21. The pain diminished to a mild ache for another 33 hours until it became insignificant by 4:00PM on 09APR21. 07APR21, 1:00PM ? Dry Eyes: Onset of an intermittent feeling of very dry eyes that lasted approximately 1-2 hours at a time and continued over a period of 9 hours until 10PM on 07APR21. 07APR21, 3:30PM - Fatigue: Onset of mild fatigue that steadily increased until bedtime at 10:00PM on 07APR21; and was significantly more pronounced at 1:00AM on 08APR21 (was difficult to stand and walk 20? to closet to obtain a thermometer; could not walk straight and bumped into hallway on left 4-5 times). Fatigue was rather frightening and severe from 3:00AM to 3:30AM on 08APR21 when I crawled to the bathroom, but could not get off my knees and collapsed on the floor until I could return to bed by crawling on the floor. Was able to stand again at 7:00AM on 08APR21 and walked (slowly) 30? to a sofa. Slept from 10PM on 07APR21 to 1:00AM on 08APR21; 4:00-7:30AM on 08APR21; 8:30-10:30AM on 08APR21; 11:00AM to 3:00PM on 08APR21; 7:00PM on 08APR21 to 3:00AM on 09APR21; 3:30AM to 7:30AM on 09APR21; 9:30PM on 09APR21 to 9:15AM on 10APR21; 6:40PM on 10APR21 to 7:00AM on 11APR21. Ongoing weariness continues as I write this at 11:00AM on 11APR21. 07APR21, 7:10PM - Nausea: Onset of continuous nausea that lasted 13 hours and 20 minutes until 08APR21, 8:30AM. Nausea was particularly bad with intermittent dry heaves for the 7.5 hours lasting from 1:00AM to 8:30AM on 08APR21; Nausea then came in waves for 23 more hours until 09Apr21, 7:30AM when it was finally gone. 07APR21, 7:10PM - Headache: Onset of headache that has lasted 4 days (as of 11APR21, 10:30AM). Finally gave in and took one extended release tablet of 650mg Acetaminophen tablet about 25 hours after the vaccination (i.e., took painkiller at 10:30AM on 08APR21). Took two Ibuprofen at 9:00AM on 11APR21. 07APR21, 7:15PM ? Chills: Onset of chills that increased to intermittent shivering by bedtime at 10PM on 07APR21. Awoke at 1:00AM on 08APR21 and could not get warm. Two hours later, at 3:00AM, I felt completely opposite and could not feel cool. These symptoms gradually subsided and were gone by 7:30AM on 09Apr21. 07APR21, 7:15PM ? Joint Pain and Muscle Aches: Onset of joint pain and muscle aches that occasionally became annoying with twinges of pain. These symptoms subsided by 7:30AM on 09Apr21. 07APR21, 7:15PM ? Dizziness: Onset of mild dizziness that lasted 12 hours until 7:15AM on 08APR21. 08APR21, 1:00AM ? Measured Fever: Decided to measure temperature due to significant chills and shivering and found temperature was 101.0 at 1:00AM on 08APR21. At 3:00PM on 08APR21, my temperature was 100.2 (this was 4.5 hours after taking one extended release tablet of 650mg acetaminophen). At 3:00AM on 09APR21, my temperature measured 98.6 degrees and has remained near there ever since. 09APR21, 4:00PM ? Arm Rash: First noticed presence of a rash measuring about 2? x 3? on upper arm near the area that received the injection. Mild itchiness was present about an hour later and a topical 2% diphenhydramine gel was applied. The rash had dissipated by 5PM on 10APR21.

I was extremely tired on Saturday. My shoulder hurt. About 3 pm, while urinating, I felt very light-headed as if I was about to faint. I stopped urinating and went back to bed. That evening, about 8:30, I tried to eat dinner, but after three bites, I felt extremely tired. I leaned back in my chair, and I passed out. My wife woke me, but it took several minutes. She said my eyes rolled back in my head. She splashed water on my face. She said that I stopped breathing. I woke up, then pushed my plate away and put my head on the table. I could not hold it up. I was sweating profusely. After several minutes, I felt that I was about to have diarrhea. My daughter and wife tried to walk me to the bathroom, but I did not have the energy to get there. I collapsed in the hall and hit my head on the door jamb. After several minute of trying , they pulled me up, and I then got the strength to walk the rest of the way. I had diarrhea, not suddenly, but it was as if my GI system emptied. It was soft, not loose, and there was a lot. I went back to bed, and eventually slept. I felt queasy the next day (Sunday), and I felt lightheaded at times, so I just sat or laid down. But I was feeling better. Today (Monday) I feel much better. A little tired, but much better. I went to the Pharmacy this morning, and they referred me to this website. I did not see the doctor.

mild fever cold sweats severe headaches nausea bad shaking dizziness severe fatigue achy joints severe pain at injection site loss of energy loss of appetite diarrheafelt just like covid 19 symptons lasted approx. 2.5 days

After my second shot had bad shivers 24 hours after the shot 10 days later started to feel severe pain in my left-hand joints, very hard to make a fist. Not nearly as bad on my right hand. its been 3-4 days since I started feeling the pain. Feels I guess what arthritis would feel like, but I don't have that until maybe now??

Slight body aches and headache day of second injection. Moderate body aches and headache the day after injection. Night after second day had severe headache, severe confusion, severe dizziness, severe nausea, unable to walk unassisted.

Within 24 hours developed Fatigue. Then developed benign positional vertigo. Symptoms resolved after 3-4 days. But BPV returned again on 4/15, 6 days after vaccination .

Woke up and walked down stairs 12:30 pm Wednesday with shortness of breath, walked back upstairs 1:00 pm, slept 45 minutes, waled back down stairs, watched TV from sofa in family rm, at 4:00 pm attempted to get up to go to the bathroom and fell. Help from partner to get to bathroom and back to sofa. It was getting more difficult to shift body on sofa, no strength in arms or legs. Spent night on sofa, slept from 2:00 am until 2:00 pm Thursday. Getting up 11:00 am with help to go to bathroom. During the rest of the afternoon and evening slowly regained strength and improved breathing. Went to bed upstairs 2:00 am Friday. Woke up Friday 2:00 pm and felling much better.

stroke; couldn't walk; Breathing was shower; eye sight was been worse; bad headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 245A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMLODIPINE for an unknown indication. The patient's past medical history included No adverse event (No medical history reported. ). On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started AMLODIPINE (unknown route) at an unspecified dose. On 25-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), GAIT DISTURBANCE (couldn't walk), RESPIRATORY RATE DECREASED (Breathing was shower), VISUAL IMPAIRMENT (eye sight was been worse) and HEADACHE (bad headaches). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), GAIT DISTURBANCE (couldn't walk), RESPIRATORY RATE DECREASED (Breathing was shower), VISUAL IMPAIRMENT (eye sight was been worse) and HEADACHE (bad headaches) had not resolved. Not Provided Treatment for the event included clonidine, aspirin (81mg) to try to thin the blood, losartan, atorvastatin and cyclobenzaprine. Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.

In summary this is a 60 year old male who was normal functioning presenting to hospital 4 days following second moderna COVID-19 vaccination with AKI, Rhabdomyolsis, Confusion/Delirium with agitation, multiple acute brain infarcts, DVT, and multilobar pulmonary embolism. 24 hours following vaccination patient began to become slightly confused while driving his wife to her vaccine appointment. Symptoms progressed and included severe fatigue and muscle aches. Patient was taking tizanidine and oxycodone to manage muscle / body aches which had been prescribed for his chronic back pain issues. Patient was noted to be excessively sleeping, and also had fallen twice between vaccination and hospital presentation. 4 days following vaccination he presented to the emergency department with severe lethargy and confusion. He was admitted with presumption of overdose of medication, given activated charcoal. A CT of the head (4/11/2021) was completed which demonstrated No acute intracranial hemorrhage, extra-axial fluid collection or acute territorial infarct. Suggestion of a chronic lacunar infarct involving the left lentiform nucleus. Regions of low attenuation involving the cerebellar hemispheres, right greater than left, which, allowing for image degradation secondary to patient motion artifact, are likely artifactual in nature; follow-up is recommended to assess for stability/resolution.For first several days patient suffered delirium with agitation, he was disoriented to place and time. CK on admission, 4/11/2021, was 17,086, indicating rhabdo. Creatinine on admission was 4.39, indicating new acute renal failure. Liver enzymes were elevated with AST of 477 and ALT of 218. PT was 10.6, INR 0.99. ABG demonstrated metabolic acidosis with pH of 7.22, co2 45, HCO3 18.4. Over several days his mentation improved however was noted to still need light supplemental oxygenation. Because of the delirium a brain MRI was completed on 4/13/2021, which demonstrated acute ischemic infarcts on DWI sequence noting bilateral, right greater than left, acute cerebellar infarcts. Small acute lacunar infarcts at bilateral basal ganglia/genu internal capsule. Due to the infarcts a stroke workup was completed. Carotid duplex was performed and notable for only small bilateral carotid plaque. Renal ultrasound unremarkable. A CTA of the chest was completed on 4/15/2021 for continued hypoxemia, need for nasal cannula to maintain spo2 saturation. Findings included multilobar pulmonary embolism. Venous duplex dopplers of the lower extremities were also completed on 4/15/2021 demonstrated an isolated left popliteal vein DVT. No evidence of right leg DVT. Over several days CK and Cr returned to baseline / normal levels. He remains hospitalized and is still undergoing treatment.

Received vaccine, and hour later felt nauseous and dizzy, went home, laid down and had shallow breathing, next day(3/24/21) couldn't do much, fatigued, legs felt like giving out, midnight on 25th he jumped out of bed to check on animals before he made it to the door he felt really bad and had to sit down, wife checks him and speech was slurred, face was droopy, 40m later went to emergency room, emergency room said he was fine in grants. Hospital said he had a stroke possible bell's palsy. Still not doing well headaches, right side of body weak, blurry vision which is getting worse, one day doing well next moment he's not.

Approximately 1 hour after the vaccination, Patient reported feeling a sudden "pop" in his head. That was followed by loss of balance, weakness, and inability to walk. He collapsed and either passed out or slept for 2-3 hours. Upon awakening he still felt weak and unbalanced. He also had bitten his tongue and lip while unconscious. He slowly recovered over a period of 3-4 days after the vaccination. He has never before had a stroke or a seizure. No one was with him to observe any of his symptoms.

FIRST 24 hrs Fever, headache, dizziness , body pain, joints pain, Increase heart rate 74 beats per minute (14 above normal) After 36 hrs most of the symptoms decrease, but heart rate and dizziness kept high, but irregular heart beats started, I feel a strong beat, then a little time with no beats and recover the rithm. I feel my chest oppressed and feel not fine. These last symptoms are maintained up to now and that worries me

Within an hour or two of the vaccine second dose every area where I have ever had joint problems gave me problems. The worst was the arthritis in my left thumb, which also suffers from Carpal tunnel. My thumb where I do have arthritis became so painful and sensitive to any movement that I could not use it. At one point the pain took me to my knees. I now think that the far above average pain in that joint that I have been having for several weeks may have been from the first dose but the extreme increase in pain right after the vaccine seems very likely to be the vaccine. I also had painful electric like jolts in my back and ankle and have been experiencing higher than normal chest, center of rib cage pain. All these areas are problem spots for me but for all of them to flare up at once right after the vaccine is unprecedented as was the pain in my left wrist/thumb.

Weakness pain in all muscles and joints fever 100.4f dizziness inability to regulate temp (I'm freezing.). If this gets much worse I will go to the hospital. This set of symptoms mirrors exactly what happened when I got Covid last December, but worse and progressing faster.

Developed vomiting 04/20/21 in the evening. This a.m. 04/21/21 he was experiencing weakness and vomiting. He fell while in the bathroom, and states it was because he wad so weak. He seems to be doing better now, but due to the weakness writer opted to report to VAERS. He refused medical treatment.

24 hours after shot, began feeling a little light headed while bike riding. Symptoms worsened around day 8, especially after climbing stairs or walking quickly immediately after sitting or lying down. Felt dizzy, with a headrush and slight jolt of adrenaline afterwards. Lasted a few minutes, then was able to resume normal activity. 21 April, day 9, dizzy spells seemed to occur more easily and frequently. 22 April felt better.

Since Mar 29-Vertigo(Dizziness) fluctuating, more severe in AM-every day since. Tinnitus-pre-existing, now worse. Lethargy. 2 visits to Primary care doc.

I got my first moderna shot on 4/6, numbness on left side of my body include left face and whole head start 4 days later, also strong headache; then dizziness and vertigo start on day 11. Have not gone away yet. I went to see my doctor and waiting for the CT scan and vascular result.

Dizziness or lightheadedness after taking a shower. Was not very severe and I was able to drive to work. The dizziness lasted most of the morning and became less noticeable as the day went on. By 5:00 pm it was hardly noticeable at all. The morning of day 2 there was a slight dizziness still present. As of today I think I am fine, but still feel some dizziness at odd times. The one other event worth noting is that during the vaccination, when extracting the needle from my arm there was a significant amount of blood that came out of the injection site as if the needle had penetrated a blood vessel during administration.

Pt came in for a covid vaccine. He is diabetic and had not eaten lunch before arriving. I gave him his vaccine and upon standing was a little dizzy/light headed. I asked him to sit down and I asked if he had any other symptoms. He did not. He said he felt ok sitting so I asked him if he wanted an orange juice to bump up his sugar level. He agreed and I gave him a bottle. He drank it down, as I continued to monitor him. After about 10 min or so he said he was feeling better, I asked him to stay another 20min or so just to monitor him. After that time was up I went out to him to check him again. He said he felt fine and left. His wife and family was with him.

Extreme fatigue within 14 hrs of shot Body aches (all over) within 14 hrs of shot Sore arm at injection within 4 hrs of shot Light headedness, occasional within 14 hrs of shot

Four hours after the 2nd shot he had a stroke. The ambulance took him to Hospital where he was transferred to another facility. He had to be in the hospital for 7 or 8 days. He is partially paralized on his left side. His symptoms were dizziness and collapse. Sweating profusly. He will have to go undergo extensive physical therapy, occupational therapy, doctors visits, and loss of his ability to work, or maintain any sort of regular daily living without assisstance. For the rest of his life. He was also the primary support of the household.

Sudden onset, fell once, no LOC, right arm felt like "spaghetti" then feeling came back Refused ED, lasted about 2 days. At f/u office visit on 4/20/21 - patient reported residual numbness right arm with difficulty grasping items, new numbness left leg

On 4/9/20 patient developed bilateral numbness and tingling to arms, hands, feet and legs. Went to ED on 4/16/20 Labs and CT head were normal. Had decreased strength and sensitivity in extremities and Babinski's were upward going. Discharged to home without medication and to F/U with PCP in 4-6 days. Saw PCP on 4/20/21. He had S&G hyeresthesia, + Rhomberg, failed tandem walk, and dysdiadochokinesia. Neuropatic pain in shoulders, arms, legs, hands, and feet with weakness in hands and arms and sensory loss in left leg. Was unable to get immediate MRI so patient was admitted directly to hospital. MRI showed concern for transverse myelitis felt to be secondary to Covid 19 vaccine. He will not get second dose. Improved to near baseline with treatment of high dose steroids. He also had an STEMI and was taken to the Cath lab where they found 50% blockage in a coronary artery. They felt STEMI was caused by spasm. Pt was discharged home on 4/26/21 and is having physical therapy to help regain his mobility.

Couple days after 1st shot I started to feel tightness in upper back and then it started to bother my right hand. The pain would wake me up at night a couple of times- I would take extra strength tylenol and use a vibrator on it. Just before the 2nd shot I started to feel a little better. After the 2nd shot it made both my arms hurt but mostly my hands. I also had pain and difficulty raising and lowering my arms. Went to see my doctor; P.A. on 4/29/21 because my right hand was swollen. A blood panel was taken and results were good. Was prescribed Cadista-MethylPrednisolone 4mg.

Approximately 4 days after this second Moderna vaccine I began experiencing severe headaches, dizziness and nausea from the dizziness. This has been ongoing now for 6 days.

"Moderna COVID-19 Vaccine Was relaxing and getting ready to read my book on phone. A few minutes after taking the vaccine, blood pressure fell, dizzy with risk of passing out, weak, very rapid heart beat, nausea. Jumped up and starting moving to create energy to avoid passing out. The dizziness reduced somewhat and did not get worse, but was still present. Heart rate slowed after a significant period of time. Then symptoms resolved. No emotional triggers and no history of any such events at any time in 60 years.

I haven?t had the chills like that in forever! It came in waves. You just lie there, hot, and ache all over, then this wave of chills hits for maybe 5 seconds then dissipates. The 2 mins later, it happens again! And this goes on for an hour or more! I had to pee but was worried I?d be too cold to stand still. So I waited until I could not wait anymore. OMG! Trying to stand up! It?s as if my joints no longer worked! And when I did stand up I was dizzy as hell! The next day, utter exhaustion. I am so weak, it takes effort to move. Even breathing took work! I didn?t sleep all night as every position I lay in was uncomfortable and had twinges of chills. The amount of energy it takes to physically get up and walk to the bathroom is dumbfounding! This morning I am achy, hot and cold, exhausted, and just had a bout of dry heaves. I?m hoping to be able to get some sleep today.

Moderna 2nd shot. Lower, left back pain. Never had any back issues before. Still having pain 17 days later. Pain is between top of hip to spine and about 3-4 inches above top of hip. So painful. Very difficult to move at times. Sleep interrupted by the pain nightly.

Vertigo for 5 days so far about 3 weeks after second shot. First day of vertigo was so bad I threw up twice and had to stay immobile to not throw up. Day 4 I had to take meclizine so I could return to work. Day 5 which is today still dizzy a little bit but not enough to make me sick to my stomach.

Debilitating pain in left arm, exceeding that of a broken limb. 101*F fever, chills, sweat spells, body ache, headache, mental fog, upset stomach. I've never felt more sick in my life. Would have gone to ER however my wife suffered the same vaccination reaction (was vaccinated at the same time/location) and was unable to drive.

chills in extremities, dizziness, headache, rash/swollen skin about 3 inches surrounding injection site

Headache, pain at injection site, headache, fever around 100, and I was very tired. I mostly recovered after a couple of days, but still have some headache. Then yesterday, 6 days after injection, I started experiencing vertigo. It is like my vision is shifting quickly and I lose my balance. It happened yesterday morning when I first woke up, and cleared up in a minute. Then it happened again in the afternoon when we were on a long hike, and I fell into some bushes. Last night it happened 3 more times as I awoke from sleep.

Patient received 1st vaccine on 4/29/2021 (no side effects), 2nd vaccine on 5/27/2021 (patient states he had sore joints). On 6/5 He awoke at 3:00 a.m. in the setting of leg cramps. He got out of bed to walk off the cramps, but then developed substernal chest pain. He describes the pain as ?squeezing? and cramping with radiation towards the left shoulder. He began to feel lightheaded and diaphoretic, and thus began driving himself to the ED. On the way, he felt his symptoms were worsening so he called dispatch he recommended he pull over at a nearby gas station. EMS met him there and transported him the rest of the way to the ED. In the outside ED, he was initially hypertensive to 175/99.

He got his vaccine, had extreme pain in his right arm. He went back to the pharmacy and let her know that it hurt for several days and then went away, and he is still having the tenderness in the arm. It was so painful that he could not sleep on it due to the pain. He then had no problems up until 5/24/21 when he noticed some swelling on his ankle of his right leg. He put it in cold water to see if the swelling would go down and it did not. Then he didn't think about it again until it was stiff, swollen and wanted to turn to the right side and hard for him to drive and taking his anti-inflammatories. It progressively got worse and around 5/25/21 the swelling was severe and doubled in size and getting worse and on 6/3/21 he could not get his pants off due to the swelling and he went to the Dr. The next day. He had pain behind the knee, ankle, pain in the leg. He went to the doctor, and they sent him to the ER for an US which showed DVT of the right leg. He was informed that it was large and that it was in the thigh of his right leg and not returning blood to his heart. He was put on Eliquis 5 mg twice a day and is doing well for him. The swelling is a little better, the ankle is still swollen, and the leg is still swollen, the top of his foot is really bad, front of his leg and thigh. The knee does not seem to be swollen, but the thigh is. He has no problem with the left side. He is to follow up with his doctor on Thursday. He is on Hydrocodone as well for the pain as needed for his neck pain and lower back.

I ended up with a gout flare-up in my left ankle. I could not walk. I was put on medication to help with the pain.

pain left upper arm since injection, can't sleep on that side because of pain. Throbbing. No position helps. Tingles in fingers if picks things up. Can't put hand in hip pocket because it hurts to move arm back that far. Patient states he feels like there's a knot under left shoulder blade. Felt dehydrated when had lab draw 2 weeks ago (1 week after shot). Grip strength right 94.6lb, left 24.6lb, "makes it throb" when grasping.

Severe fatigue and weakness, headache, general muscle ache, fever, lack of appetite Unable to function - 5 days in duration

After first dose of vaccine on 4/23 complained of fatigue and tiredness. After second dose on 5/26 complained of fatigue, dizziness, nausea and body aches. Expired on 5/28.

Patient is a 60-year-old gentleman with a history of tonsillar and skin cancer with mets to the lymph nodes status post chemotherapy and radiation, BPH, hypertension, hyperlipidemia, and CKD stage 4. Patient presented to the emergency department for complaint of dizziness x4-5 days with diarrhea x3 days and syncope today , pt noted hypotensive in ER but per ER physician not orthostatic, Dr spoke with pt oncologist and seems his Blood cell count close to his baseline, but his baseline creat 2.1 so does have acute on CKD and dehydration. pt noted COVID 19 positive and cxr suggestive covid pneumonia, his cxr was better couple of days ago when pt wasin ER as well. pt did recived his covid vacine 1st dose on Saturday. He finished his chemo on May 13th.

Muscle aches, arm soreness, shoulder tightness, lightheadedness (better), decreased appetite. patient taking tylenol and aleve to help alleviate symptoms. Symptoms began 6/23/2021 at 6PM. lightheadedness recovered.

My right arm still hurts and it is hard for me to move it. My range of motion has diminished some. It has been 3 months and the pain still persists. I had the second dose on 4/28/2021 my arm was still sore from the first shot. Seemed like the second shot did not hurt at all compared to the first shot. How long will the the pain continue? Who do I see for this? My pcp said to just keep an eye on the situation.

Patient passed out, fell to floor, got up in sweats, shaking. Patient was given water, orange juice, BP taken, BP rose with second reading, called paramedics, patient was checked out by EMS and was ok after 30 or so minutes. patient was able to go home by himself.

Dizzyness, feeling faint , lasted for 15 to 20 minutes. Feel more sensitive to dizzyness if roll on ground or spin ever since.

Experienced a bad case of vertigo. Urgent Care doctor prescribed Meclizine. Meclizine had no affect so I discontinued use,

I suffered an incident of Vertigo (intense dizzyness and vomiting) lasting approximately 48 hours that required a trip to the ER. Physical Therpay was prescribed and done for a period of one week or until symptoms are no longer present. I feel fine now.

Within 20 minutes of receiving the vaccine, I was experiencing extreme shortness of breath, my entire body hurt and I was dizzy to the point that I could not stand up without holding onto something. Since the injection, I have felt nauseous everyday, I cannot concentrate, I become fatigued just standing up. It's been almost six weeks since the injection & I still do not feel right. I fall asleep whenever I sit down and I've fallen asleep while driving.

Patient complained of pain at injection site of the left arm. He mentioned that he can't move his arm normally and had to do physical therapy. It has been an ongoing pain and affect his normal life.

Had a seizure, 2 other reactions like seizures; Could not breathe, has breathing problems; Was really sick; could not get out of bed for 4 days; shoulder pain; muscle pain; Felt a little nauseated; Is really fatigued, tired; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Had a seizure, 2 other reactions like seizures) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Diverticulitis, Narcolepsy and Vertigo. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-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 SEIZURE (Had a seizure, 2 other reactions like seizures) (seriousness criterion medically significant), DYSPNOEA (Could not breathe, has breathing problems), ILLNESS (Was really sick), MOBILITY DECREASED (could not get out of bed for 4 days), ARTHRALGIA (shoulder pain), MYALGIA (muscle pain), NAUSEA (Felt a little nauseated) and FATIGUE (Is really fatigued, tired). At the time of the report, SEIZURE (Had a seizure, 2 other reactions like seizures), DYSPNOEA (Could not breathe, has breathing problems), ILLNESS (Was really sick), MOBILITY DECREASED (could not get out of bed for 4 days), ARTHRALGIA (shoulder pain), MYALGIA (muscle pain), NAUSEA (Felt a little nauseated) and FATIGUE (Is really fatigued, tired) outcome was unknown. The patient's medical history also included an unknown syndrome (could not understand the name). Concomitant product was not reported. The patient had experienced shoulder pain, muscle pain, fannnnd had elt a little nauseated. Three and a half weeks after having the second shot , he had a seizure, was really sick, could not breathe (started after he got the seizure), and it was horrible. At the time of the report, the patient continued to have muscle pain and everything, predominantly in his upper chest, and has breathing problems; he had never smoked or anything. He also had 2 other seizures like reactions. He was really fatigued and tired. He could not get out of bed for 4 days. He went to doctor but was given no aditional treatment. At some point after he had the seizure, the patient saw his doctor. Treatment was not reported. Very limited information regarding this event (seizure) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of all other events, a causal relationship cannot be excluded. Details regarding diagnostics, doctor's notes from the clinic visit/ treatment are required for further assessment.; Sender's Comments: Very limited information regarding this event (seizure) has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of all other events, a causal relationship cannot be excluded. Details regarding diagnostics, doctor's notes from the clinic visit/ treatment are required for further assessment.

PATIENT HAD EXCESSIVE BLEEDING DUE TO TAKING A BLOOD THINNER. PLACED SOME GAUZE PRESSED FIRMLY TO STOP THE BLEEDING. BANDAGE THE INJECTION SITE . PATIENT FELT DIZZINESS DUE TO LOSS OF BLOOD. HAD PATIENT PUT HEAD BETWEEN LEGS. PATIENT TRIED TO STAND AND LOST HIS BALANCE AND FELL. HELPED PATIENT UP AND SAT BACK ON CHAIR. PLACED A COLD CLOTH ON FORHEAD. LATER PATIENT FELT FINE TO LEAVE

within 24 hours, the patient developed diarrhea, fever, chills, dizziness, headaches, fatigue, muscle cramps, vomiting, aches, and pains throughout the entire body. Symptoms subsided after 48 hours after the shot was administered. Symptoms were most prevalent from 14-30 hours after initial vaccine. Hot showers alleviated pain, and aided vomiting Bed rest when possible. Oral medication to relieve fevers/chills were ineffective due to vomiting.

Chills, body aches, headache, BP increased, pulse increased, lightheadedness, sweats the day after the vaccine. (The evening and the whole night.)

The patient received his vaccine on Thursday, 12/31/20 between 2:00pm and 2:30pm. The patient did not complain of any ADRs or fever immediately following the injection. However, the next day the patient fell in his room and when vitals were collected, he had a temperature of 102 F. Since the patient was febrile, him and his roommate were given rapid COVID tests, both of which were negative. The patient's PCR test has not come back yet. Per nursing report, the patient did not experience fever again over the weekend, it was a 1x occurrence. His temperature returned to normal on Saturday 1/2/21 and remained normal through Monday, 1/4/21. Besides fever, the patient did not complain of any other ADRs.

Next day. 12/31/20 - severe muscle pain myalgia, could not ambulate well 1/1/21 - chills severe shaking chills N/V & diarrhea severe shivering, freezing causing difficulty breathing lasted 1/2 hour

Approximately 18 hrs after vaccination, pt woke up with injection site soreness, Tmax 104, dizziness, myalgias, athralgias.

Reports feeling of chills, debilitating headache, muscle aches. No fever. Tylenol does not help. Unable to get out of bed.

Resident became lethargic, general weakness outside baseline, unable to walk, bumbled speech. Elevated HR and Temp of 105.2F

Beginning on Day 2, nausea on and off sustained now through day 25 Today). Loss of appetite as a result. Extreme muscle pain on day 10 (just day 10). Extreme Fatigue now through day 25, with headache. Dizziness and head pain beginning week 3 after shot. Unable to function properly. Symptoms are not constant, come and go from mild to extreme.

lightheadedness, headache, aches in the legs post-vaccination which improved with rest food and hydration

After 12 + hours I felt a headache (like a sinus headache), In addition I experienced fatigue, light headedness, and mild sense of nausea. It felt like I had Covid again, but to a lesser degree.

patient sent home from work on the morning of 1/21/2021 due to muscle pain, weakness, nausea. Symptoms worsened including decrease in o2 sats 72% (compared to normal mid-90%), patient was unable to ambulate due to muscle weakness/pain, pulse elevated to greater than 100 bpm. Ambulance was called and arrived to the home where patient resides at 8:55 am on 1/22/2021. Home director emailed symptoms to the pharmacy after the patient left for the ER. Pharmacist called home director to get additional info. As of 1:03 pm on 1/22/2021 patient has returned home after ER staff determined his symptoms were an adverse reaction to Moderna. He was advised by the ER staff to rest and drink plenty of liquids. Pharmacy advised home director to contact patient primary provider to report ADR and determine if the 2nd dose of Moderna is advised by the primary provider. The pharmacist will follow-up with the house director status on 1/23/2020 before 3 pm and will have any additional ADR's reported to the pharmacy and the patients primary provider

Dizzy, lightheaded, severe headache, shaking, freezing cold, profuse sweating, muscle aches, joint pain, tachycardia, minor chest pain, nausea, dehydration with constant thirst, metallic taste in mouth. Took 2 tylenol pm pills, drank water and 7-up. Symptoms were gone 20 hours later except for very sore right arm, neck and back muscles which were completely gone and normal by day 3.

2nd shot stung a bit unlike 1st one. around 10:30am head felt woozy/slightly dizzy, left work at 1:30pm dizzyness getting a little worst body started aching. fell asleep for about 30 minutes once home, bed at 9:30pm and started to shake violently like I was freezing but not cold, didn't feel like I had a fever, put on sweatpants and tshirt, turned on elec. blanket, I stopped shaking after about 45 minutes, took acetaminophen and 1 dose of zquil and fell asleep. up at 3:30am in pain, especially my left arm I couldn't lift with pain. called out of work all muscles and joints hurt, less pain with no movement, more acetaminphen every 6 hrs, started feeling better around 4Am Saturday

Patient reports known onset of right foot drop the following day of vaccination (time unknown, reported "Evening time"). Currently being worked up in the clinic, but now patient is day 12 of foot drop without any significant improvement. Unsure if vaccine reaction, reporting out of caution. Patient has no recent trauma or injury to spine. Signs/Symptoms: Weakness in Dorsiflexion/Eversion of right foot, Mild weakness of right hip extension, Decreased sensation to right lateral lower leg, steppage gait

Pain right arm- site of injection- not able to move for almost 3 days, followed by chills, body ache, and headache. Symptoms lasted for 3 days.

* Lightheaded, achy joints and heavyness night of day two *lightheaded (unstable), tingling (electrodes in my brain day three * lightheaded unstable dizzy with head motions - now to present time * motion of head throws off balance, I have to rest to regain lightheadness (never hand this feeling before * on today 2/17/2021 I went to urgent care , EKG, CAT scan, blood work. it's said that all test are normal large amount of fuild was discovered between ear, never had this before, will seek a specialist opinion

Received at approximately 2:30pm. At just after midnight following vaccine, woke up and had what appeared to be Vertigo/dizziness. This has not completely gone away since onset on 1/21/2021. I began having "floaters" in my vision beginning about 8am following vaccine. This has not gone away. I did have a bout of vertigo in January 2020, that had not reoccurred since that time. I have not had "floaters" prior to the 2nd dose of the vaccine.

2/20/21-61 year old male with decreased level of consciousness and hypoxia. I received a call from nursing staff indicating that patient was having low oxygen saturations this AM and required oxygen. He needed only 1.5-2L by NC but was mouth breathing so mask was used and 4L due to mask. This brought his saturations back up. He has been quite drowsy since receiving his second COVID vaccine on 2/17/21 and has not been eating and drinking much. Today he is not responding to nursing staff in a coherent fashion. I met with him in his room along, RN. He did not wake to my voice or touch. On examination he is sleeping and using accessory muscles to breath, especially his abdomen. NC/AT, face symmetric. Lungs are clear to auscultation bilaterally anteriorly with no wheeze heard. No pretibial edema. 61 year old male with decreased level of consciousness. I will send patient to the ER due to his decreased level of consciousness and difficulty with breathing causing accessory muscle use despite normal respiratory rate of 17 but with hypoxia. I do believe his fever of 103 this AM was due to the COVID vaccine. I am concerned that he could be having a COPD exacerbation on top COVID vaccine symptoms and his bladder cancer is dragging him down along with dehydration from poor intake the past few days. I did call and speak with the ER provider and the EMS crew. They reported seeing a lot of this with the second COVID vaccine. 2/21/21-I received a call from nursing staff indicating that patient had worsening hypoxia with need for 8L of oxygen by mask. He was very restless and not making a lot of sense. He had receive Tylenol PR for a fever of 103 that was now only down to 101 and not budging. He was in the ER yesterday and diagnosed with possible Right middle lobe pneumonia on CT. He is already taking Levaquin. Due to his Oxygen need I did call to see about possible direct admission as he had a full work up the day before. The hospitalist was concerned that he might need BiPAP and so I did call and speak with the ER provider and she agreed that due to his new oxygen requirements he should be sent to the ER there and likely would need ICU. She was advised of the work up from yesterday so as not to repeat what wasn't needed. He was sent by ambulance due to his inability to sit up well. I received a call later that night from the intensivist in the ICU indicating that patient was reacting to the COVID vaccine most likely. He felt that there really was not much in the way of a pneumonia diagnosis as that has really not shown up on their imaging and all labs are normal including white count, CMP and blood gases. He is still requiring oxygen and is able to answer in sentences but is very drowsy and may be a bit confused. He has a minimal UTI and they will keep him given his low level of consciousness and hypoxia.

Initially all joints (neck, shoulders, elbows wrists, etc) ached and stiff. Moved to Tendonitis/Arthritis wrists, hands, fingers and Left patellar knee tendon. SLOWLY improved but did not leave, despite treatment with Aleve, until 2nd vaccine 2/5/2021. Then, same symptoms worsened and included BOT patellar tendons, nd plantar tendons. Continues to present and are very painful at night, despite 2 Aleve BID daily, and cannot make fist or extend fingers on both hands and cannot walk on feet without pain at MTP's. Discussed with orthopedic surgeon who assured me that I was having "an immune reaction in tendons to vaccine. It should get better over time". It has not at present.

Moderna COVID 19 vaccine ADR. Approximately 14 hours after receiving the vaccine on 01/29/21 the patient starting experiencing extreme confusion, shaking, and then subsequently fell. EMS was called and was taken by ambulance to Hospital where he was admitted for 6 days. I called up follow up 02/16/21 and he still reports a daily persistent headache that migrates around the circumference of his head.

Started feeling a bit dizzy Monday 22nd in the evening. Woke up Tuesday 23rd room was spinning (patient had labyrinthitis 18 years ago symptoms lasted 2-3 weeks) dizziness lasted throughout the day (Tuesday 23rd, 2021). Vomiting started late afternoon Tuesday. The symptoms were lessening Wednesday and Thursday.

Right side face swelling, right eye sore to the touch, dizziness on the first two days. Next day, sharp cramping in different parts of the body at different times lasted about a day and half and a little dizziness. Today, he's doing ok.

Was find 1st and 2nd day. 3rd day morning dizzy and loss of energy. A little nausea caused me to lay down, stay home from work. Rested. Took Tylenol and slept throughout the day. Got up around 12:30pm, felt better, did decide to go for a jog to get body temperature up. Jogged for 60 minutes, returned, ate and rested again. 4th day, felt much better, no dizzyness, still a little tired but maybe 85% energy level. 5th day back to normal.

Not sure if this was a reaction to vaccine or not? 3/4/2021 when I woke up to get out of bed, upon standing, I got a severe feeling of dizziness or vertigo that resulted in my legs giving out and me falling down. I didn't get hurt but it felt like I almost passed out. I fell backwards against a wall and slid down. I did not report this to my doctor previously listed.

Client phoned; C/o face swelling; trouble breathing; dizziness and weakness. 911 phoned for client home address; client refused medical care/ambulance service.

fever, chills, head ache, light headed, sweats, body hurt. for about 12 hrs. just tired now the second day, a lot better! it was just like it was when i had Covid 19.

Client reported being bothered by 'blurry vision' about 25 minutes after receiving the Moderna vaccine, accompanied by feeling dizzy and lightheaded. Speech was normal, grip strength equal and strong. Blood pressure was low (85/58), HR 94. Client drank 12 oz water over 5 minutes, BP improved to 95/60 w/ HR 86 (11:48). Client still c/o blurry vision and light headedness, but was talkative and making jokes. He started to stand (to test his balance) but was still unsteady. Gave him another bottle of water, explaining re: low BP and hydration. Reassessed after an additional 5 minutes (11:53) with BP further improved to 100/62. Denied improvement in vision or lightheadedness. Client sat for 30 more minutes. I attended to another client at 12:00, with another RN monitoring him. When I returned to check on him, she said he did not exhibit any signs of being in distress and got up to leave voluntarily.

A few minutes after client received the vaccination he felt light headed, dizzy, chest pain, disoriented, throat discomfort, and difficulty breathing. Was transported to Medical Center for further evaluation.

received vaccine friday afternoon saturday started feeling extremely dizzy and weak, difficulty walking sunday unable to walk, blood pressure high, tremors called 911

March 4, 2021 - 1:30 PM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish. The right arm swelled up at the point of the injection for a few hours. Was hot to the touch. March 11, 2021 - 9:40 AM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish. March 17, 2021 - 3:17 AM - Severe stomach pains in the same area. My stomach bloated up. I felt very dizzy and nauseous. I burst out again in a cold sweat. I had diarrhea. I was white, and the color of my face was grayish.

Maderna Covid Vaccine 2nd dose Extreme chills that night, got up to go the bathroom,, had sweats and suddenly felt very dizzy and fainted on the bathroom floor. Felt very weak and couldn't get off the floor. Had a fever of 101.6, Wife had to help me get up after some time on the floor.

fainting, sweating, eyes rolled back, slouched over in chair then perked back up. still complained of dizziness and sweating. called 911 within 1 min of episode and paramedics came to take over. Patient was talking and coherent but sweaty.

Exactly 32 hours after injection, both myself and a 41 year old friend who got the vaccine with me experienced the following: vomiting, incredible amounts of mucus coming from lungs, uncontrollable diarrhea, violent sweating and chills, extreme headache, bed-ridden for two days. Both the pharmacy and the health dept. refused to record our reactions, and the health dept. hung up when we tried to report this incident. The pharmacy would not call us back.

Slight headache and vertigo when getting up after sleeping. Able to walk but have to be careful. Lasts for 15-20 minutes unless I drink coffee -- then it goes away after about 5-10 minutes, with headache last to go. With vertigo: Blood pressure normal. Heart rate normal. Blood O2 normal. Temperature normal. Had a constant three day case of vertigo back in 2003 after flu-like illness. This is much less severe, but now on 11th day.

Seventeen hours after vaccine, woke up at 5:30 am to extreme dizziness, vomiting, nausea, sweat, chills, and headache. These symptoms lasted all day and into the night with some minor relief. Following morning woke up to light-headed, headache, and some dizziness. Throughout out the second day symptoms diminished some what and was able to get up out of bed and walk around. Still feeling light-headed. The following days experience ligh headedness in the morning and serious dizziness when laying down for the night. After about an hour of getting up, feel almost normal but not fully.

Woke from sleep at 12:45 a.m. on 3/19 with severe pain at injection site. Got up to urinate and take Tylenol. While in bathroom, became dizzy, broke into sweats, and felt I was about to faint. I went to my knees holding onto counter. My wife came in to help me in bathroom. She observed I was incoherent but uttering moaning sounds and breathing heavily. She called 911. While on phone I came to and vomited into sink. It appeared I had not digested anything from dinner that night. After vomiting (1x) I felt much better. First responders reported normal vital signs. I did not go to E.R. that night but went to Urgent Care later that morning and all seemed fine.

Started to have chills around 7:00pm Friday night, then around 4:00am Saturday morning, I got up to use the bathroom and pasted out in the bathroom. My wife sad she heard a loud noise and came into the bathroom to see what had happened. She called my daughter and son-in law to come over and get me up I couldn't move at the time, I must have hit my back and neck because they are sore. Then Saturday night I had sweats all night, today I fell a little better except for my back and neck, I have a doctor's app. Friday. I am concerned about the 2nd shot if the 1st shot did this to me.

Extreme fatigue on first day. On the second day I experienced dizziness and vertigo. I have not felt safe to drive although the symptoms are becoming less severe the last 24 hours.

pt states that he developed a headache, sore arm, had fatigue along with body aches and pains. He was dizzy and eyes were very droopy. He woke up next day and his arm is very sore, he is very tired and has a flushed face. Pt feels like his symptoms are improving now.

Foggy headed, sometimes a little dizzy, off balance Fatigue More aches and pains than usual sometimes a feeling of shortness of breath

Injection to L/arm and was very sore an hour later. Now 4 days later the pain is worse, the area is red, and I now have limited mobility in this arm. Significant muscle pain in this arm and can not lift it over my head.

Chills sweating bad headache Throwing up stayed in bed for 36 hours when I stood up very dizzy 45 hours later I am feeling a lot better

On the evening of February 24th after the I received the vaccine, I had severe pain on my left lower back radiating all the way to my left foot with tingling. I didn't sleep for 4 nights and I had difficulty walking. On February 28th I went to Emergency Room and I was given a Toradol shot. On Monday, March 1st I went to my primary doctor and gave Prednisone, Gabapentin and Meloxicam tablets then I was given 9 days off from work. Up to the present, I'm under physical therapy and I still have on and off pain on my left leg.

Severe brain fog for days. Dizziness and off balance. Forgets what he's talking about mid sentence. Pain at injection site. Feels funky still after 4 days.

Severe soreness at injection site. Fatigue Stomach cramps Joint and muscle aches Bad headache Diarrhea High fever chills severe sweating Dizziness

1. Muscle soreness at injection site/arm 2. High Uric Acid Levels as determined through blood teats 3. Gout-type joint pain in the knees and back. The pain limits movement and and causes stiffness of the joints when sitting or after sleep. I still experience the pain. I have altered my diet (Gout symptoms recommended foods) to try and reduce the uric acid levels.

Memory problems, some increase in headaches. Also issues with balance and bumping into walls. Still to not have smell or taste. These symptoms have continued for 3 months after vaccine. Initially after vaccine became acutely ill with high fevers 102-104 f. Also became severely weak with severe muscle aches and severe headaches. This lasted for 7 days with worst at the beginning. Then I have had the memory loss and equilibrium and loss of ability to spell simples words that I had no issues with before. I have had these symptoms for 3 months. I thought it would all get better but it has not. I thought I better let you know these problems. I did not want to but because they have continued I thought I better tell you.

Extreme pain in shoulder after vaccination that lasted 3 days. Injection was given at the top of my shoulder. I did not have the rash or redness at the injection site. I could not move my arm without felling pain and could not sleep well because of it.

Patient was in observation area after vaccine administration. Twelve minutes after vaccination, he fell to the floor and appeared to be having a seizure. Staff protected him from injury, and administered oxygen, and called EMS. He stopped seizing, then had another seizure before EMS came to transport him to the ER.

Lungs filling up with fluid; Cannot move; Uncontrolled diarrhea and uncontrolled bowel movements; Vomiting; A spontaneous report was received from a consumer concerning a 61-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lungs filling up with fluid/pulmonary edema, uncontrolled diarrhea/diarrhea, vomiting, cannot move/mobility decreased, uncontrolled bowel movements/bowel movement irregularity. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 16 Mar 2021, prior to the onset of the events, the patient received their doses of mRNA-1273 (Batch number:unknown) for prophylaxis of COVID-19 infection. On 16 Mar 2021, within 12 hours of vaccination, the patient experienced lungs filling up with fluid, uncontrolled diarrhea, vomiting, cannot move and uncontrolled bowel movements. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of events, lungs filling up with fluid, uncontrolled diarrhea, vomiting, cannot move and uncontrolled bowel movements, were unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Severe vertigo, with cold sweat, extreme nausea-went to ER-given cardiac, blood and CT tests. Symptoms going away. Will follow up with ENT

Numbness, tingling, entire body. Neuropathy, extreme exacerbation. Face, tongue, hands, painful numbness. Very weak, exhausted, and very dizzy. Also, increased blood pressure and increase of heart PVC's. Symptoms ebb and return. It's been 8 days and still dizzy, weak, and neuropathy is so bad that it feels like I'm slightly paralyzed on the left side of my body.

After 5 minutes post vaccine, patient started vomiting and became dizzy. patient symptoms were not resolving so paramedics were called.

member recieved the first covid vaccine dose at 9:20 am . At 9:29 am member complained of feeling dizzy and sweating. Member was still being observed . at 0929 am Overhead page for MD assistance to evaluate member. Found member sitting in chair in covid vaccine area. Member able to answer questions, member oriented times 4 , respirations even and unlabored. his eyes closed and head tilted forward , skin pale and wet . Pt c/o dizziness.First BP reading 59/32 p42 , 02 saturation 100% on room air . This RN rechecked BP 68/33 and pulse 32 via machine ,this RN checked radial pulse 40. At 0933 this RN gave epi auto injector to left thigh . At 0935 911 called and Dr. and this RN assisted member to floor and elevated legs , applied O2 2l n.c. repeat BP 88/47 p-42 lying , then second lying BP 98/56 P 51 . Machine read 156. Member stated he was feeling better, less dizzy and was answering all questions and speaking in full clear sentences. Skin pale and wet. 911 arrived at 0942.

After feeling well and dinner I passed out. I came to after a minute or so. Everything was spinning and I was sweating profusely and had pretty strong chills and shivering. I stood on the floor until I felt better. I was able to go upstairs and I went to bed. I did continue to shiver for about 15 minutes. I have felt ok since then. I am not sure if I will get the second dose after that experience.

Moderna COVID-19 Vaccine EUA 4 degree higher than normal fever, chills, headache and body aches lasting approximately 32 hours Took Tylenol and drank large amount of water to stay hydrated. Stayed in bed because I couldn't hardly move.

two after shot, patient had joint stiffness and pain all over body and rash all over the body. Patient mentioned top layer of the rash (patient said it was like dead skin) would peel off. It is still going on and patient mention its hard to walk. Patient saw PCP on 4/9/21 and got a shot of steroid and also oral steroid to take. Patient was informed to come back next Friday for follow up and blood work.

Fist day,Headache,dizziness, fatigue,soar throat an coughing. Second day Headache,soar throat an coughing.

I woke at 4:30 AM and spent the next SEVEN HOURS explosively vomiting and diarrheic. Muscle pain and tightness spread from my left shoulder, across my back, to my right shoulder. Lying flat gave me dry heaves. Standing up made me dizzy. I?m coughing like there is fluid at the bottom of my lungs. The base of my skull felt like it was in a C-clamp. My temples felt like they were in a vise. I have a rash on my shoulder and arm. I smelled like rotting flesh. (To head off any concerns over lifestyle or hygiene, I have a BA, BFA, MBA, MSL, and completing my PhD.) After two days of exhaustion, vomiting, diarrhea, pain, etc. I took a shower at 11:58 PM Saturday. When I swiped my soapy face towel over my left should, I wiped away a layer of skin, like a burn victim. Be grateful I don?t have power. I would stop the Moderna injections until someone finds out what it is about my genetic makeup that might signal those with similar genetics to stay clear of Moderna.

During daytime of 3/25/2021, began to feel discomfort on the left arm. The discomfort worsened to inability to move the left arm, left hand, or fingers. Admitted to the emergency room, then hospitalized for 3 days. Diagnosed as an Ischemic Stroke.

Lethargic, disoriented, fever 103.7, muscle weakness, joint pain- needed help to walk, weakness, joint pain and fever lasted 2days. Still feeling a little disoriented, balance off a little after 6 days and sore arm,

After 12 hours of being vaccinated was bed ridden, high fever, unable to walk for 12 hours. , skin color turned grayish and very pale for 24hours. Broke out in hives, particularly on back and chest area. Several bumps per sq/in., unbelievably itchy. 5 days later hives seriously affect sleeping habits and can barely sleep at night. Have had mild eczema for years, 95% out breaks occur on hands and forearms, never back. Vaccine cleared up eczema on fingertips and one small spot on forearm. Now 30% of body covered in hives (ie, small itchy bumps). 5 days later still have slight headache, thinking still a little cloudy.

Pt presented to clinic today for his 2nd dose Moderna vaccine at approx 1033. Pt was brought back to conference room and was given his 2nd dose Moderna vaccine at approx 1040. Pt reported no allergies to medications, no severe allergic reaction in the past. Pt states doing fine with the 1st dose of the Moderna vaccine. Pt was waiting his observation time of 15 min and began itching face, arms, and legs. Nurse questioned pt if he was feeling ok? If he is itching? Pt reports that he is itching but he has some anxiety but that he is hanging in there. Nurse offered pt some water. Pt declined. Pt started clearing throat and coughing. Nurse questioned pt if he was still feeling ok and again offered pt some water. Pt declined. Pt reports that he is feeling ok. Pt's timer alarmed and pt got up ready to leave. When asked if he is doing ok, pt reports that he is. Nurse questioned pt if his cough is normal for him and pt reports that he has asthma and proceeded to walk out. Pt was escorted by nurse. Nurse questioned pt again if he is feeling ok. Pt states that he is. Nurse notifies pt that if he not feeling ok then he should come back. Pt states understanding and exits building. Nurse seen pt returning back to clinic from window. Nurse meets pt upon entering building. Pt reports trouble breathing. Nurse observes that pt has voice change, trouble completing sentences, cough is worsening, and itching is intensified. Pt grabs the wall while ambulating. Nurse provided stand by assist. Nurse immediately escorts pt back to exam room and gets assistance from nursing staff and provider presents to exam room immediately. Crash cart arrives. Epi 0.3mg autoinjector administered IM to LT at approx 1100. IV NS ordered. At approx 1104 pt O2 sat of 98% on RA, HR 96. Approx 1105 Duo Neb administered via nebulizer mask as ordered. Approx 1107 IV inserted to RAC with 18g on 2nd attempt. Approx 1108 Diphenhydramine 25mg/0.5ml administered IV as ordered. SoluMedrol 125mg/2ml administered IV as ordered. Pt O2 sat 97% on RA, HR 102. Approx 1110 pt BP 140/85, O2 sat of 93% on RA. Pt has coughing spell. EMS was called. Approx 1113 pt O2 sat 90% on RA. Ongoing coughing spell. Approx 1114 O2 2L administered via mask as orderd by provider. Pt's wife contacted via pt's cell phone. Approx 1116 Epi 0.3mg administered IM to LT as ordered. Pt O2 sat 97% on 2L O2, HR 87. Pt reports itching getting worse. Approx 1121 Diphendydramine 25mg/0.5ml administered IV as ordered. Approx 1123 pt O2 sat 97% on 2L O2, HR 119. Approx 1125 EMS arrived. Approx 1127 BP 183/75. Pt taken by ambulance with EMS to ER at approx 1135. Report called to ER by provider. ER transfer form faxed to ER.

61-year-old white male received his second Moderna COVID-19 vaccine at 0910 and at 0945 he became slightly vertiginous and noticed poor balance and on both sides of his face and both sides of his upper neck became. He felt like there was some swelling of his lips and tongue and he notes some trouble swallowing and states his throat feels "tight". He denies lateralizing neurological signs, specifically denying tingling or numbness or weakness of extremities. He had no trouble with his vision or cognition. He had no trouble with the previous vaccine. Presently the symptoms are resolving. Feeling better with less sensation of neck and facial swelling and numbness as well as decreased vertigo after 1 dose of Benadryl. Time: 11:23

Patient called the pharmacy to report feeling light dizzy spells on Friday, one day after receiving the vaccine. Then he said on Saturday night he was very dizzy for most of the night. After Saturday he has been feeling light headed and intermittently dizzy up until reported day, Monday.

After patient got vaccinated. He was in observation area and complaint of lightheaded, tingling right arm and finger. History of myocardial infarction and stage 4 neck cancer. Patient speech became delayed and did not responded to questions being asked. Paramedics responded. Patient vitals stable. Blood sugar normal. Patient felt better and less dizzy. No shortness of breath. Alert and oriented. No transportation needed.

The individual felt faint / light headed as he walked towards his vehicle following 15 min observation period . He Did not feel that he would be able to safely operate his vehicle . Returned to the observation area Glucose levels were within normal range reading was normal. Blood Pressure reading and pulse were within normal limits. No abnormal respirations. Appeared flushed and slightly diaphoretic after additional 10 min of observation at vaccine site . Decision made at 3:30 PM to transport to the ER. Patient agreed

Vomiting, dehydration, nausea, fever, joint inflammation, muscle weakness, inability to ambulate, pain, soreness and decreased appetite.

Severe dizziness went bending ormoving head and feelings of vertigo head down, 2 days after 2nd vaccination shot No rash, no swelling

Headache, body aches (especially legs), extreme chills with extremities shaking, probable fever, injection site considerably more painful/tender than with first dose, inability to sleep all night, a bit light headed, weak and balance problems while walking, dry mouth After roughly 6 hours, most symptoms gone or greatly improved. Still had some headache and body aches, felt mildly feverish, injection site still painful, fatigue due to lack of sleept

Patient developed vision changes, dizziness, and right sided weakness after receiving 1st dose of vaccine. Patients BP was measured at 230/118, HR: 58, pOx: 99% on RA. Patient determined to be experiencing hypertensive emergency and emergency services were called in order to r/o possible stroke.

Headache, chills, fever,( pain ,tenderness , edema, redness & hot to the touch of injection site), fatigue, dizziness, muscle & joint pain, restlessness. Increased fluid intake & took Tylenol ES every 6 hours, rested as much as possible.

Evening that I received the shot, became extremely light headed and diaphoretic (outcome resolved). The next day, temperature rose to 103 F (treated with acetaminophen, outcome resolved) . The following day had chest pains which continue to persist. Saw Family Physician on 4/26. (ECG, Pulse Ox done, Dx Costochondritis most likely related to the vaccine, outcome not resolved).

after 15 min observation period the patient began to feel tightness in his throat and lightheadedness. Initial vitals- BP- 160/85 HR-65 RR- 20 T-97.3 O2Sat 100% on room air. lungs clear to auscultation. patient in no respiratory distress, postenior pharynx/ Uvula without swelling vital signs prior to being transferred to ER: BP-147/72 P-65 02SAT- 100% on room air RR-20

Vaccine was administered on 3/26/21. On 3/28/21, started experiencing symptoms which included hives, joint pain, and difficulty walking.

Bursitis from vaccine. Poorly administered in wrong location with a needle that was possibly too long. Clinician did not roll up my sleeve and examine my arm before choosing needle size. Cannot lift or use left arm after 1 week.

Fainting; vertigo; spins; dizziness; confusion; fogginess; the craps; heart running; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainting) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history reported. Concomitant products included LOSARTAN, METOPROLOL and HYDROCHLOROTHIAZIDE for an unknown indication. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced VERTIGO (vertigo; spins), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (fogginess), DIARRHOEA (the craps), HEART RATE INCREASED (heart running) and HEADACHE (headache). On an unknown date, the patient experienced SYNCOPE (Fainting) (seriousness criterion medically significant). At the time of the report, SYNCOPE (Fainting), VERTIGO (vertigo; spins), DIZZINESS (dizziness), CONFUSIONAL STATE (confusion), FEELING ABNORMAL (fogginess), DIARRHOEA (the craps), HEART RATE INCREASED (heart running) and HEADACHE (headache) was resolving. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. Treatment in the ER included "methazine." The patient noted that he will not be getting the second planned vaccine dose. Company Comment: This case concerns a 61-year-old male with a serious unexpected event of syncope, and nonserious unexpected vertigo, dizziness, heart rate increased, diarrhea, confusional state, feeling abnormal, and expected headache. Event onset with unknown latency after first dose mRNA-1273. Events resolving. 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 61-year-old male with a serious unexpected event of syncope, and nonserious unexpected vertigo, dizziness, heart rate increased, diarrhea, confusional state, feeling abnormal, and expected headache. Event onset with unknown latency after first dose mRNA-1273. Events resolving. 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.

dizzy spells; swollen feet; frequent urination; vertigo/room was spinning around me; hypokalemia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKALAEMIA (hypokalemia) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], COLECALCIFEROL (VITAMIN D3) and PARACETAMOL (ACETAMINOPHEN) for an unknown indication. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced HYPOKALAEMIA (hypokalemia) (seriousness criterion medically significant) and VERTIGO (vertigo/room was spinning around me). On an unknown date, the patient experienced DIZZINESS (dizzy spells), PERIPHERAL SWELLING (swollen feet) and POLYURIA (frequent urination). At the time of the report, HYPOKALAEMIA (hypokalemia), DIZZINESS (dizzy spells), PERIPHERAL SWELLING (swollen feet), POLYURIA (frequent urination) and VERTIGO (vertigo/room was spinning around me) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Blood potassium: 2.6 (Low) diagnosed with hypokalemia. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event hypokalemia included 2 intravenous bag of potassium chloride. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient stated two weeks after his first dose, he experienced chills, body aches, fatigue, and dizziness. This lasted two days.

Patient became dizzy and started sweating. He was given some water and took a small sip. He then started nodding in and out of consciousness and stating that he did not know where he was and that he just needed to rest and lie down. He repeatedly attempted to stand but was kept sitting. During this, myself and his girlfriend kept trying to engage him in conversation and keep him awake. Shortly after the EMTs came and attempted to talk to him. Blood Pressure and temperature were taken (I am not aware of the readings) and he eventually agreed to go to a hospital. He was taken out of the building on a stretcher.

vertigo; Migraine type headaches; Flu like symptoms; Fever; Blood clot in right upper arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (vertigo) and THROMBOSIS (Blood clot in right upper arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-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) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VERTIGO (vertigo) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot in right upper arm) (seriousness criterion medically significant), MIGRAINE (Migraine type headaches), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). The patient was hospitalized on 28-Feb-2021 due to VERTIGO. At the time of the report, VERTIGO (vertigo), THROMBOSIS (Blood clot in right upper arm), MIGRAINE (Migraine type headaches), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) outcome was unknown. No concomitant medications were reported. No corrective treatment was provided. 28-Feb-2021, he was hospitalized for vertigo for 3 days. 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. Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events have been provided at this time. Further information has been requested.

APPROX 12 HOURS AFTER 2ND SHOT, AT 1 IN THE MORNING, WOKE UP GASPING, THEN WENT FOR APPROX 8 HOURS CONTINUOUSLY GASPING AT EVERY BREATH, SHORT AND QUICK BREATHS. SEEMED LIKE I NEVER FEEL ASLEEP UNTIL GASPING SUBSIDED AT BOUT 7 THE NEXT MORNING. TWO DAYS LATER STILL ACHY AND LIGHT HEADED.

I fell while helping my neighbor move a box into her apartment. When I tried to get back up, I found I had no strength in my left arm.

patient was not concentrating well and asks not to be asked too many questions; it does not let him walk almost; he can walk indoors and he runs out of oxygen, he use oxygen all the time; lot of back pain; sweats a lot, when he is not cold he sweats a lot; arm pain; tired/exhausted; lost consciousness/couldn't even remember the days; woke up all the time, he could not breathe/breathing like panting; woke up very bad; patient had no balance; did not feel well; got very hungry; got very thirsty; sneezing; started to feel silly; running nose/running nose was getting stronger and stronger; patient has been dead for two or three days day and night; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Emphysema and COPD. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced HUNGER (got very hungry), THIRST (got very thirsty), SNEEZING (sneezing), FEELING ABNORMAL (started to feel silly), RHINORRHOEA (running nose/running nose was getting stronger and stronger) and UNEVALUABLE EVENT (patient has been dead for two or three days day and night). On 27-Apr-2021, the patient experienced DYSPNOEA (woke up all the time, he could not breathe/breathing like panting), MOOD ALTERED (woke up very bad), BALANCE DISORDER (patient had no balance) and MALAISE (did not feel well). On 28-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days) (seriousness criterion medically significant). On an unknown date, the patient experienced DISTURBANCE IN ATTENTION (patient was not concentrating well and asks not to be asked too many questions), GAIT DISTURBANCE (it does not let him walk almost), OXYGEN CONSUMPTION DECREASED (he can walk indoors and he runs out of oxygen, he use oxygen all the time), BACK PAIN (lot of back pain), HYPERHIDROSIS (sweats a lot, when he is not cold he sweats a lot), VACCINATION SITE PAIN (arm pain) and FATIGUE (tired/exhausted). At the time of the report, LOSS OF CONSCIOUSNESS (lost consciousness/couldn't even remember the days), HUNGER (got very hungry), THIRST (got very thirsty), SNEEZING (sneezing), FEELING ABNORMAL (started to feel silly), RHINORRHOEA (running nose/running nose was getting stronger and stronger), MOOD ALTERED (woke up very bad), BALANCE DISORDER (patient had no balance), MALAISE (did not feel well), DISTURBANCE IN ATTENTION (patient was not concentrating well and asks not to be asked too many questions), GAIT DISTURBANCE (it does not let him walk almost), OXYGEN CONSUMPTION DECREASED (he can walk indoors and he runs out of oxygen, he use oxygen all the time), BACK PAIN (lot of back pain), UNEVALUABLE EVENT (patient has been dead for two or three days day and night) and VACCINATION SITE PAIN (arm pain) outcome was unknown and DYSPNOEA (woke up all the time, he could not breathe/breathing like panting), HYPERHIDROSIS (sweats a lot, when he is not cold he sweats a lot) and FATIGUE (tired/exhausted) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. Treatment medication included acetaminophen for arm pain and a lot of back pain and other medications included Steroids and oxygen. Concomitant medications included High blood pressure medicines, high blood sugar medicines ("under control"), cholesterol medicines and medicines for his lung disease. 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 felt flushed and light-headed after receiving vaccine. Received Benadryl and Zantac form pharmacist. Remained in vaccination booth with wife for monitoring. After 30 minutes pt felt fine and went home. Instructed to seek medical attention if needed. This PharmD called pt at home 1 hr later to check on him. Pt stated he felt fine and did not need immediate medical attention.

He just told me yesterday that the day after he got his second moderna injection both feet swelled up. Severely ! He complained of not being able to move his toes etc. There is no pain or trauma. just ironically it happened the day after his injection. He will not go see a doctor yet because he thinks it will go away. He started wearing compression stockings the day before last and it has helped. I am worried that he has a blood clot but he thinks that it woudn't be in both feet. Not sure if it matters but he is a 61 year old man . with no known co morbities. Is this a side effect that has been recorded? I am concerned but dealing with a stubborn man.

Aches and chills beginning nine hours after second vaccination, headache and dizziness beginning about 12 hours after vaccination. All this continued for 36 hours. Feeling much better now almost 48 hours after injection, but still only about 75%. I did not take any analgesics.

Started with slurred speech, difficulty with balance, weakness on 5-1-21. Symptoms worsened on 5-2-21 with garbled speech, inability to walk without assistance, weakness. Admitted to hospital and was diagnosed with stroke.

Presents to emergency department with complaints of intermittent chest pain for 4 days. Denies any radiation of his chest pain. He also complains of having leg weakness with trying to stand or ambulate x4 days. States that his legs feel like "gummy". Wife notes that the patient has to hold onto objects to aid in ambulation which is not normal for him. The patient denies any headache or dizziness. He denies any acute vision changes. He denies any numbness or tingling to his lower extremities. Denies any history of stroke.

Immediate chills and fever 101 degree out of work for 2 1/2 weeks morning fatigue and fever both knees/ inflamed could not walk loss of appetite severe insomnia chest pains went to hospital fear of heart attack

Within 3 minutes of vaccination, pt began to feel lightheaded and was assisted to lie down on a cot. He c/o a "scratchy throat" and a little trouble breathing; he developed a rash on his neck. VSS were stable throughout episode with SpO2 95-99%. Pt was administered Benadryl 50mg po x once w/good effect. The reaction resolved and patient left for home after an hour.

Losing breathe; Paralysis of face; Bells Palsy; Guillain-Baire syndrome,; Numbness in hands; Could not swallow; Tingly in hands; Impaired vision; Speech impairment; Could not walk; Paralysis in his head from neck up.; Pneumonia; Totally impaired; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralysis in his head from neck up.), PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Plasmapheresis in April 2021, Feeding tube insertion in April 2021, Tracheostomy tube insertion in April 2021 and Mechanical ventilation in April 2021. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARALYSIS (Paralysis in his head from neck up.) (seriousness criteria hospitalization, disability, medically significant and intervention required), PNEUMONIA (Pneumonia) (seriousness criterion medically significant), DYSPNOEA (Losing breathe) (seriousness criteria hospitalization, medically significant, life threatening and intervention required), FACIAL PARALYSIS (Paralysis of face) (seriousness criterion hospitalization), BELL'S PALSY (Bells Palsy) (seriousness criterion hospitalization), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), HYPOAESTHESIA (Numbness in hands) (seriousness criteria hospitalization and medically significant), DYSPHAGIA (Could not swallow) (seriousness criteria hospitalization and medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired) (seriousness criterion disability), PARAESTHESIA (Tingly in hands) (seriousness criterion hospitalization), VISUAL IMPAIRMENT (Impaired vision) (seriousness criterion hospitalization), SPEECH DISORDER (Speech impairment) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization). At the time of the report, PARALYSIS (Paralysis in his head from neck up.) had not resolved and PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) outcome was unknown. Non-drug therapy included: The patient had 7 plasmapheresis, trachea to breathe, feeding tube and put on a ventilator. 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-2021-141559 (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.

Dizziness, lightheadedness, imbalance, ataxia Nausea, vomiting Hospitalized for extensive work-up, Possible diagnoses Guillain-Barre variant (Miller Fisher)

Patient presented to emergency department around 7:00pm with signs and symptoms consistent with stoke. In the drive to the hospital, patient could not speak, move the right side of his body, and was drooling. Patient was immediately taken for a head CT and was diagnosed with a massive hemorrhagic stroke. The on call neurosurgeon wall called in the perform and emergency craniotomy. Patient underwent craniotomy and neurosurgeon was unable to find source or cause of bleed. Patient was sent to ICU for recovery. Patient was on a ventilator and receiving hypertonic saline for brain swelling. Patient never regained mobility in right side of body or speech. Patient tried rehabilitation, but patient's brain continued to swell with increase neuro-cognitive decline. Neurosurgeon was unable to determine cause of recurring edema and patient was not a candidate for repeat surgery. Patient failed rehab qualifications due to repeat brain swelling and was eventually placed in hospice care to pass.

Major virtego for a few days then dissipated. 4 weeks later I felt I would die. Major virtego. I cannot drive. I can hardly walk. My Doctor doesn't know what to do. It has been 7 days since the Major virtego attack.

Fall due to weakness, severe myalgias, abdominal pain, elevated troponin, burning and pain in the lower legs and feet.

About 2 weeks after my second vaccine, i got very ill; abdominal issues, sever fatigue followed by severe sinus congestion which lasted for about 10 days. This has been followed by ongoing severe fatigue, inflammation of my joins, painful movement and walking, brain fog and inability to concentrate. i am still dealing with the debilitating effects 7 weeks out.

On June 1, I was hospitalized for pancreatitis although I had none of the preexisting conditions for it such as a history of drinking alcohol or anything else that the hospital could find. Next on June 16, I began feeling lightheaded. I went to an internal medicine doctor who referred me to a specialist. After some testing, Doctor informed me that my heart was beating lower than the normal range. I just had a heart stress test done a few years earlier and my heart was more than fine. It is hard for me to understand how my heart health could have such a dramatic reversal so quickly.

The day after the vaccine he started to get an headache, brain fog, and dizziness. He also lost his sense of smell and taste. Went to see his doctor stated they increased his Effexor. They tried giving him Atarax but it didn't work also gave him supplements L-theanine 200 ml, Ashwagandha 200ml and Magnesium Glycinate 300ml said it helped a little.

On January 21st he started to get an headache, brain fog, and dizziness. Went to see his doctor the next morning his doctor didnt know what to do so he set him up for an MRI but the results didn't show anything. Seen a Neurologist on January 23rd but all he did was prescribe him with a stronger Effexor.

I had all the typical previously reported symptoms up to the point when getting first injection as mentioned in print and on the news. Headaches, body aches and some dizziness. They occurred shortly after the injection (within the first 3 days) But, i noticed (just like mentioned in the news now) that about 2 weeks after getting the 1st injection my chest had a odd "pressure" feeling. Like something wasn't right in there. At the time my work was from home that week so it wasn't a problem to just "take it easy" instead of doing anything strenuous. And in a week or so afterwards it went away totally and I felt confident that the 2nd shot would be ok to take. The 2nd shot had less side effects other than some minor dizziness that subsided within the first week totally. The 2nd week did not have the first shots pressure feeling on my chest like my body had adjusted to getting the shot in some way. Since I have gotten both shots though it seems there is the intermittent "dizziness" that doesn't affect my thinking or motor functions in any way. There just seems to be times where I feel "funny" nothing that is adverse or causes driving or walking issues (motor functions). It's just noticeable at times.

Extreme soreness after first injection. After second injection, soreness moved to left shoulder which has been compromised as to motion. Unable to move shoulder as before injections.

Woke up day after vaccine, thought i had broken ribs, this went on for about 72 hours, then a few days of ok and then walking up my 3 stairs to my house, i got dizzy, my eyes went black and white abd squiggly, instantly massive headache, and stomach aches, my bones hurt thruout my torso... ongoing headaches, Tired all the time, my eyes are blurry alot, Very shaky all the time, loss of appitite, brain fog, back aches

rapid heart beat; Palpitations; Shortness of breath; Chest pain; Chest heaviness; Dizziness; Weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (rapid heart beat) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Liver transplant in 2011 and Cardiac ablation on 16-Jun-2021. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (rapid heart beat) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue). At the time of the report, ATRIAL FIBRILLATION (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Heart rate: high. On 15-Jun-2021, SARS-CoV-2 test: negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient had heart Ablation Surgery on 16/Jun/2021 at (Hospital name) as a treatment for atrial fibrillation. The patient had been tested for COVID-19 on 27/Jun.2021. No concomitant medication information was provided. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, very limited information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; 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, very limited information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.

Migraine headaches; Increased anxiety; Muscle stiffness; Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile; Rash in the genital area which comes and goes; Tenderness and swelling of the injection site and underarm glands; Tenderness and swelling of the injection site; Tenderness and swelling of underarm glands; Muscle ache; Joint aches; Vomiting; Nausea; Fatigue(tiredness); Chills; Suicidal thoughts; Loss of smell; Loss of taste; Loss of appetite; 22 pound weight loss; Arm pain; This spontaneous case was reported by a patient and describes the occurrence of SUICIDAL IDEATION (Suicidal thoughts) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bipolar disorder. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUICIDAL IDEATION (Suicidal thoughts) (seriousness criterion medically significant), ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), WEIGHT DECREASED (22 pound weight loss), PAIN IN EXTREMITY (Arm pain), MIGRAINE (Migraine headaches), ANXIETY (Increased anxiety), MUSCULOSKELETAL STIFFNESS (Muscle stiffness ), GAIT DISTURBANCE (Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile), RASH (Rash in the genital area which comes and goes), VACCINATION SITE SWELLING (Tenderness and swelling of the injection site and underarm glands), VACCINATION SITE PAIN (Tenderness and swelling of the injection site), LYMPHADENOPATHY (Tenderness and swelling of underarm glands), MYALGIA (Muscle ache), ARTHRALGIA (Joint aches), VOMITING (Vomiting), NAUSEA (Nausea), FATIGUE (Fatigue(tiredness)) and CHILLS (Chills). At the time of the report, SUICIDAL IDEATION (Suicidal thoughts), WEIGHT DECREASED (22 pound weight loss), ANXIETY (Increased anxiety), MUSCULOSKELETAL STIFFNESS (Muscle stiffness ), GAIT DISTURBANCE (Pre-vaccine walked 4-5 miles daily and now lucky to walk 1/2 mile), RASH (Rash in the genital area which comes and goes), VACCINATION SITE SWELLING (Tenderness and swelling of the injection site and underarm glands), VACCINATION SITE PAIN (Tenderness and swelling of the injection site), LYMPHADENOPATHY (Tenderness and swelling of underarm glands), MYALGIA (Muscle ache), ARTHRALGIA (Joint aches), VOMITING (Vomiting), NAUSEA (Nausea) and CHILLS (Chills) outcome was unknown, ANOSMIA (Loss of smell), AGEUSIA (Loss of taste), DECREASED APPETITE (Loss of appetite), MIGRAINE (Migraine headaches) and FATIGUE (Fatigue(tiredness)) had not resolved and PAIN IN EXTREMITY (Arm pain) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Patient reported that the adverse events started immediately after the first shot. Increased anxiety and suicidal thoughts required increasing the dosage of a benzodiazepine. 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 patient´s medical hystory of bipolas disorder could be a confounder for the events, suicidal ideation and anxiety. Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Added current condition bipolar disorder, added start dates of the 2 doses. Added events suicidal ideation, gait disturbance, rash, anxiety, lymphadenopathy, musculoskeletal stiffness, myalgia, arthralgia, chills, rash, nausea, vomiting, migraine, vaccination site pain, pain in extremity, vaccination site swelling. Verbatim of the events ageusia and anosmia changed to loss of taste and loss of smell respectively. Outcome of the events anosmia, ageusia and decreased appetite changed to not recovered. This case was upgraded from non-serious to serious due to the addition of new event suicidal ideation; 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 hystory of bipolas disorder could be a confounder for the events, suicidal ideation and anxiety.

Developed weakness in legs, needed help with walking, legs got weak like rubber, couldn't hold self up. ambulance to hospital, next day, could walk again. Was sent home after 3 days with home PT, had return of weakness, slid off bed, couldn't stand up. Was sent to Rehab- 2 weeks, 75% back to baseline and is extremely tired, sleeping easily

Diagnosed with AFIB; rapid heart beat; Palpitations; Shortness of breath; chest pain; chest heaviness; Dizziness; weakness; ftigue; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Liver transplant and Cardiac ablation (Patient had heart Ablation Surgery on 16-06-2021) on 16-Jun-2021. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Diagnosed with AFIB) (seriousness criteria hospitalization, disability, medically significant and life threatening), HEART RATE INCREASED (rapid heart beat) (seriousness criteria hospitalization, disability and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization, disability and life threatening), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization, disability and life threatening), CHEST PAIN (chest pain) (seriousness criteria hospitalization, disability and life threatening), CHEST DISCOMFORT (chest heaviness) (seriousness criteria hospitalization, disability and life threatening), DIZZINESS (Dizziness) (seriousness criteria hospitalization, disability and life threatening), ASTHENIA (weakness) (seriousness criteria hospitalization, disability and life threatening) and FATIGUE (ftigue) (seriousness criteria hospitalization, disability and life threatening). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Heart rate: high (High) High. Concomitant medication and Treatment medication use was not provided by reporter. Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-238357 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

1) Within 1 minutes left hand went numb, shot in left arm 2) within 5 minutes all hands and feet went numb 3) within 10 minutes felt dizziness 4) within 30 minutes tongue went numb 5) within 18 hours severe pain left arm, shot site 6) within 18 hours fever and flu like body aches 7) within 18 hours poor sleep 8) within 72 hours rash on right shoulder 9) within 72 hours tinnitus Note, items 2, 8 and 9 remain

Discomfort and soreness at the injection point and left elbow joint about 2 hours after vaccinated. Similar to my 1st vaccine 4 weeks earlier, except this time my elbow joint had some soreness. The soreness and swelling continued to get worse throughout the day and could not sleep well that night. The following day I woke up with a painful and swollen elbow joint, and still had soreness around the injection point. By the afternoon I could not move or extend my left arm with severe pain. The swelling and pain increased and Advil or ice was not effective in reducing these symptoms. The pain and swelling got so severe and I could no longer tolerate the pain and went to Urgent Care. I continue to experience left elbow joint pain, and now experience similar joint swelling and pain in my ankle and knee. It's not as severe and painful as my left elbow joint. I am making this report now because 2 days ago I started to develop the same symptoms in my right elbow joint and leg/hip joint, and now I can barely walk. The joint pain is severe so I will seek medical treatment today.

Uncontrolled muscle spasms radiating up left arm and in hand. Spasms lasted 10 days. Followed by hand shacking and weakness in left arm. Currently left hand is not as steady as it was before vaccine and left arm feels weak.

After eating lunch on 12/29, he felt nauseated and dizzy, vomited within 10 mins and felt dizzy, there was some orthostatic BP changes clinically, he was at work in the hospital on that day, he was taken to ED, kept under observation for 24 hours, cardiac workup was done, non specific EKG abnormality was noted and he got a stress test on the 30th, which showed a normal stress perfusion study and normal cardiac function. He was discharged from observation status. No further dizziness.

whole body muscle aches, chills, fever over 101, light headed/dizzy (fainted), fatique, some nausea. all disapated within 48 hours of getting shot

Arm weakness increased each day by post vaccine day 4 arm weak and unable to raise arm, conduct ADLs, painful interrupting sleep. Unable to initiate movement in arm. Use other arm to help move arm. Went to ED on post vaccine day 4. Wbc 12. Crp 4. CT no abscess. Mri on 1/4 shows bursitis. DX SIRVA. Bursa aspirated. Pending cultures. PO MEDROL DOSEPAK.

Dizziness, Headache, Myalgia, NauseaVomiting, dehydration, could not eat, runny nose, sore throat-employee reported being off work since the day of her injection Narrative:

Significant pain at injection site, worsening overnight. 24+ hours later I am still having difficulty raising my L arm to shoulder level. Significant point tenderness as well. Pain about a 6/10.

1/18/21 6 PM left arm soreness, took tylenol. Patient states that he started having chills, muscle aches, Patient states that he started having fever of 101 degrees Fahrenheit, dizziness, and tachycardia 1/19/21 at 8 am. Pt. states he took tylenol at 8 am and heart rate and tachycardia improved and dizziness improved as well. Pt. states that he feels good now, but feels like his covid symptoms are light with a cough. Pt. states that arm is still sore.

Shot taken on a tuesday 12:45 Pm. starting around 6 mild pain to injection area, Mild nausea, fatigue, dizziness. Disturbed sleep. Joint pain overnight. Took advil during the night and helped immensely. Following day mild dizziness and fatigue, just feeling slightly unwell. Slept 9 hours that night where normally sleep 6-7. Thursday morning back to 85% and by end of day back to normal.

Day 1 - Dizziness aches and pains; increased sense of pain in all normal chronic ache locations Day 2 - severe aches, fever of 101.0

Onset yesterday (1/21/21) after stretching left shoulder. Felt like itching and mild burning in left deltoid. Rapidly increased to mild pain/discomfort/aching. Went for walk. Upon return, muscle tested and stretched arm to see if I had injured arm. Afterwards, there was onset of pain, swelling, redness, increased itching. Redness generalized over left deltoid with pronounced scarlet redness at site of injection, about 3mm diameter. Today (1/22/21, Day 2 of flare-up, about 22 hours after onset of symptoms): increased aching over entire left shoulder/trap/scapula with pronounced redness over slightly greater area on deltoid, itching at deltoid, hardness and swelling of deltoid. Almost a burning sensation over the deltoid, but not quite. Tissue feels irritated and hot. Limited loss of range of motion. Pain increases with use of left arm, pushing arm through ROM movements. Moderate headache at waking, relieved with 25mg Sumatriptan. Still mild headache. Mild lethargy and fatigue.

On 1/16/21 stiffness in the hips. Sharp pains in the lower extremities. Prolonged standing and lying down pain. Joint stiffness, and muscle tenderness. All these pains were on the same side of the injection on left arm.

Pain in upper left arm, approx 2 hrs after injection. Nausea, headache, light-headedness: approx 21.5 hours after injection

pt developed dizziness immediately following vaccine administration. patient gently moved himself to the floor. Pt never lost consciousness, awake alert. BP 145/85 Pulse of 41. (patient is a runner and this is his baseline) No other symptoms. Pt recovered fully within 10 minutes and at 30 minutes was fine. (History of previous vaso-vagal reactions and he warned the vaccine administration staff before receiving injection.

Dizziness started approximately 30 minutes after injection, weakness approximately within two hours along with extremely tiredness. Muscle pain in left leg started approximately 24 hours after injection.

Moderna COVID-19 Vaccine EUA 5-10 minutes after receiving the vaccine the following symptoms were experienced: Dizziness, weakness, brain fog, breathing difficulties, lowered O2 saturation, nausea, elevated BP and elevated / thready pulse. O2 was administered, I was placed in a response room and monitored by staff nurses (RN and LPN's) MD checked on progress. O2 saturation returned to 100% after 15 minutes and an EPI pen was determined to be not required. Walked out of the hospital 2 hours after administration of the vaccine.

3/3: Woke up with headache that got continuous. Took acetaminophen and alternated with ibuprofen every 4 hours. Around 2:00pm, uncontrolled shivering due to chills started. By 3:30, had muscle\joint pain in back and began feeling lightheaded. At 5:30, was unsteady on feet, pounding headache, fever of 101.8F and no appetite for dinner. Fell asleep on couch, woke at 7:30 pm, discontinued ibuprofen and acetaminophen, took 500mg Excedrin, fever of 102.8F and went to bed. Uncontrolled shivering resumed around 8:30pm, woke up several times during the night drenched in sweat and took ibuprofen at 4:30 am. Awoke at 8:30 am on 3/4 drenched in sweat again, took hot shower, had light breakfast and took 500mg Excedrin. Temperature is currently 99.3F

Light Dizziness .BP 130/62,P61,Pulse Ox 96, R20.Took BP meds this AM. PO fluid offered accepted. 13:35 States he feels good will drive home. Instructed to notify his PCP or EMS if symptom returns /severe. Verbalise understanding.

After receiving the vaccine patient stated he felt really hot and felt he was going to pass out. Patient states he thinks it's because he is trying to breathe through to mask and a face shield. Patient also had gloves on and a heavy jacket. Patient started to become diaphoretic and appear to be hyperventilating. Once pt was removed from the area and masked and jacket was removed he immediately started to feel better. Patient breathing improved and skin became dry. Patient did says he was nervous because this is the first public event he has done since before COVID. Patient was observed for 30 minutes and then released.

Approximately 12 hours after injection, had horrible chills off and on for several hours with fever. The following night, the fever spiked to 103.6 and stayed above 103 for several hours. Fever finally broke 3 days post injection. Injection site was very painful and is still somewhat painful after 4 days. Experienced body and muscle aches, nausea and headache. Still experiencing nausea and dizziness 4 days after the injection. Have been taking Tylenol on a regular basis and pushing fluids.

Note: *I did test positive Covid-19 in November 2020, had full recovery and symptom free 90 days before before receiving vaccine.* 1st Dose @ 10:30 am on a Saturday. 45-60 minutes (11:30 am)after dose. Light headed and dizziness. By 4:00pm body & joint aches. @ 7:00pm- Chills started with 99.8 fever. @11pm fever @ 100.6 with bad cold chills. Fever and Cold Chills progressed over next 30 hrs. peaking times @ 101.2. On Monday approximately 4 am fever broke to 99.2, bounced up and down over next 6 hrs. before dropping below 99. By end of day on Monday. 48+ hrs. after 1st dose, No sides effects other than fatigue from experiencing side effects

Vertigo, slurred speech, difficult swallowing, numbness on left side of face/chin area; extreme weakness in both arms and both legs but more pronounced in left arm & left leg; blurred vision, extreme fatigue

The morning after the vaccine, the symptoms started with a stiff neck and headache on the left side including soreness at the injection site. As the symptoms progressed, I felt aching in my lungs on the backside, and flu-like symptoms with no fever, and spasms in my feet and stomach region. Other symptoms have been dizziness, facial puffiness and tingling, with continued aching and tingling in the left arm. The stiff neck and headaches and general malaise has persisted throughout even until now. As a school teacher, I have taken the appropriate precautions and received a Covid19 test: Results negative.

Patient reports feeling a little dizzy, pressure on his head, ringing in his right ear. Felt better after a few minutes. Cleared by EMS

Patient started within 6 hours having joint pain and chills. Chills lasted about 5 hours, but joint pain in all joints on left side of the body never left and is still present currently.

,body aches,shortness of breath,pain and fog in brain, entire bone and joints shooting with pain couldn't sleep for,2 days, dizziness,etc etc

Serious Dizziness / Vertigo when moving from a laying down position to sitting or standing, and when moving from sitting or standing to laying down. Visual "room spinning" and some nausea as well. Symptoms began 3/17/2021. Still ongoing.

major vertigo attack. Dizziness and fog for 6 weeks after. Skipped second dose. Very bad reaction in that I still cant funciton at 100%....still dizzy,

Loss of hearing in L ear, tinnitus in L ear, Fullness in L ear, Episode of Vertigo resulting in an emergency Room visit.

3/25/21 developed chills, muscle aching, diarrhea evening of vaccination--symptoms continued for 48 hours with poor appetite/nausea. lost 4 pounds over the next few days. 3/28/21 c/o dizziness, heart fluttering/irregular. 3/30/21 saw dr, and EKG showed afib. medication changes. 3/31/2021 repeat EKG a flutter. admitted observation to hospital. NOTE: Does have a history of episodic afib/flutter--no episodes for the last few years

Awake 4am, and fell down (down to knees and hands) because I was really dizzy and nauseated. I couldn't walk (well, I could with great difficulty leaning on furniture) and was very dizzy and felt like I would throw-up. I moved to a reclining chair and stayed there 20+ hours (it's 20 now)... I got up to go to the bathroom and not much more. I had a difficult time even making it to the bathroom. Never had a fever (that I know of... I don't have a thermometer but didn't feel feverish or chilled), but I felt dizzy and nauseated all day and could hardly move from the recliner except for extreme need.

About 10 minutes after I received the shot I was sitting in a chair and I started getting very hot, sweaty, and found like I was going to throw up. Started seeing stars, vision narrowing. I laid down on the floor, and it seemed like I was having a hard time breathing. The pharmacist came out and started talking to me. My wife happened to be there and was trying to calm me down. I felt like I was passing out. The pharmacist checked my BP and it was like 80 something. He felt I was having an allergic reaction so gave me a show with an Eppy pen. They called paramedics. I started feeling better but paramedics said I should still go to ER so ambulance took me to ER. They ran blood tests, EKG, and chest Xray. After a few hours they released me. They basically said that it was ok for me to get second shot, but obviously I am now extremely concerned out about getting it

Patient reported feeling lightheaded and his ? heart felt like it was racing? Patient seen by medical team and provided water Patient?s symptoms resolved and refused medical transport and signed AMA form Patient will be driven home by spouse

After receiving the first Moderna vaccination in my Left arm, I started feeling pain in the area of the vaccination site on the evening of 03/22/21. As time progressed I started to realize I was losing all motion in my arm and weakness on my entire left side of my body, but assumed this was a side-effect of the vaccination . I was not concerned until my wife alarmed me in the morning when she looked at me and noticed the left side of my face drooped and had that I had difficulty standing, no balance, little use of my left leg and no use of my left arm and hand. At that point, 7:00am 03/23/21, my wife drove me to the ER. I was admitted and an inpatient for 15 days including PT/OT/ST therapies at the hospital for Stroke.

High fever (104) Severe body aches, dizziness, Severe twitching in hands and legs. After 24 hours, symptoms are beginning to subside

Day 1-body aches. Day 1/2-middle of night- high fever 101-102, extreme chills, labored breathing during night lasting approx 30 min,. Day 2 -High fever102 continued, extreme chills next day, body aches, SOB, cough Day 3 - 9am, fever broke, body aches, cough, headache, dizziness

When I woke up, my entire body felt really bloated and soar. Moderate headache. Dizzy, could not think. Walking very slow. No desire to do anything. Sat in my recliner most of the morning with body aches and sleeping. In the early afternoon, I decided to go lay down in my bed to get more comfortable. Continued drinking water throughout the day. Woke up about 7:00 PM. As I got out of bed, I immediately noticed that I was feeling about 80-90% better. The whole body bloating feeling was gone. Body aches were very reduced. Headache was very minor. I felt like a different person when I woke up (better). Very freaky feeling! I was also able to eat some good at this time.

pt says he felt a warming sensation in his shoulder and his head after taking the vax. He woke up next day he had some dizziness, fatigue, headache, and had intensified the ringing in his ears. He wears a hearing aid to help mask the Tinnitus noise in his right ear. He says the noise has increased since having this 2nd dose. Pt says his Tinnitus normally ranges about a 4 but now it is about a 7 out of 10.

Approximately 36 hours after shot experienced dizziness and nauseousness. After throwing up, experienced tinnitus which has not subsided.

patient felt nauseous, dizzy, light-headed 15 minutes after shot. Patient threw up after a couple more minutes then his symptoms improved. He sat another 10 minutes before going home.

patient reported dizziness, near syncopal episode and body aches. Dizziness still present 6 days after administration.

Sore arm, occasional burning sensation in arm, fever (102.5 °F), stiff joints, teeth sensitivity - 9th and 10th April

No immediate ill effects after this second shot of the Moderna vaccine at 10 am. Worked that day and went home, woke up around 2 am with sweats and nausea and headache which became progressively worse through the day prohibiting any activity. Dry heaves and severe headache with dizziness lasted until 4 pm or so. I did take Ondansetron at 12 noon to limit nausea. Worked the following day with few physical symptoms but very irritable. The next day (Saturday) woke with headache and slight nausea which became worse as the day wore on, limiting activity but I was able to get chores done, though I was very lethargic. The next day was much better. Worked on Monday the 12th of April and felt well. Fell ill again with similar but less severe symptoms, though marked nausea and dry heaving again. Slept until approximately 2pm and started writing this report. 4/13/2021

I received the shot around 9:15 AM. Early afternoon started feeling tired and a general feeling of unwell. Went to bed around 9:00 PM. Woke up at 10:00 PM with real bad chills and headache. Got up at 1:00 AM 4/12/21 very hot and chills. Took my temp and it was 103 degrees. Felt dizzy and weak. Took two Acetaminophen and went back to bed. Got up around 4:00 AM still hot. Took temp and it was 101.6. Took two more Acetaminophen and went back to bed. Continued this type of treatment all day. Drank water and rested. All day had temp, headache, fatigue, and nausea. Went to bed at 7:00 PM after taking 2 Tylenol PM's. Upon getting up (4/14/21), took my temp 99.5 degrees. Still have slight headache and fatigue, but feeling better.

Patient described lightheadedness and left arm tingling approximately 15min after receiving vaccine. Vitals WNL, patient elected to stay additional 15min for monitoring. Patient discharged from clinic at 9:40am.

major stroke; cannot speak; cannot move his arms; declining quickly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (major stroke) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse effect. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (major stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced SPEECH DISORDER (cannot speak), MOVEMENT DISORDER (cannot move his arms) and FEELING ABNORMAL (declining quickly). At the time of the report, CEREBROVASCULAR ACCIDENT (major stroke), SPEECH DISORDER (cannot speak), MOVEMENT DISORDER (cannot move his arms) and FEELING ABNORMAL (declining quickly) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment information were not reported. The patient was now in intensive care at the Hospital of Bay City in Michigan and he was declining quickly. Company comment:Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of cerebrovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of cerebrovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.

Several days prior to the shot, I had been experiencing sore, muscle-related pain in my neck, especially the left side and shoulder area, making it difficult to turn my head to the left. I was still experiencing this pain at the time of the shot. The evening of receiving the shot, I awoke at about 11:30 p.m. with extreme pain in my left shoulder (would describe as 8 on scale of 1 to 10)...not sure I could even get out of bed. Was able to "walk it off" and went back to bed, but had the same pain and difficulty getting out of bed twice more that night. Once prone, the pain would eventually subside. Went to work that morning (the day after receiving the shot) but returned home after an hour as I had a mild fever (100.1) and chills. I took 2 Ibuprofen and slept for about 2 hours. I awoke with temperature down to 99.7 and less pain in the left shoulder/arm area. Throughout the day, my temperature continued to go down and the chills lessened. Two days later, I have no fever and mild pain at injection site.

Had a severe adverse reaction to Moderna Covid vaccine, 2nd shot. Admitted into the hospital due to confusion, fever and loss of cognitive impairment. (unable to walk and speak) speech was out of context) and loss of muscle use and fever.

Within a few days stiffness and swelling in left knee and leg; stiffness and soreness in both shoulders, stiffness in hips, stiffness in hands, particularly left. After about 3 weeks, swelling of right foot.

4/11/21 - extreme vertigo with nausea; Epley maneuver helped but took all day before I could walk. Continued to do Epley daily for both sides and only started to dissipate on late on 4/18/21.

PT EXPERIENCE DIZZINESS AND BLURRED VISIONAPPROXIMATELY 20 MINUTES POST IMMUNIZATION, TOOK PT BLOOD PRESSURE AND GLUCOSE READING. PT REMAINED AT PHARMACY FOR ABOUT 45 MINUTES UNDER OBSERVATION. HE FELT BETTER AND LEFT PHARMACY

Patient complained of dizziness and ringing in his ears 30 minutes after 2nd dose of Moderna. A doctor on site evaluated the patient and he was observed for 30 minutes and discharged when symptoms resolved. Vital signs stable.

Resurgence/worsening of similar symptoms associated with Meniere's disease -- dizziness, light headedness.

Second Dose Side Effects A fast heartbeat Dizziness and weakness Fatigue/tiredness Headache Muscle & Joint pain Chills Fever Nausea Vomitting Diarrhea Abdominal pain Lost OVER 20 lbs from starvation, inability to eat for 5 weeks, this skyrocketed ALT and AST.

62M with complex medical history incl IDDM, CVD, stroke and hx of allergies to oral meds and anaphylaxis to multiple foods (peanuts, monosodium glutamate) requiring evaluation for reaction to first dose of moderna vaccine. Does not carry epi pen with him though he has been prescribed one in past. Vaccine administered 10:02am. Immediately after vaccine patient reported dizziness that persisted for about 60 min. He reports similar if less severe dizziness after flu vaccine one month ago and that he often feels dizzy after taking his morning dose of nortryptiline which he took today. Symptoms evolved to include mild nausea, feeling that abdomen was "shaking", and headache. No SOB or chest pain, feeling of throat closing, or rash. Patient AO x 3 throughout evaluation and talking throughout. Fasting BG 234. Took basalglar 40u this AM and 5 of aspart. Drank 8oz chocolate milk 9:30am which is his typical breakfast. He notes that his home BP this past week was elevated into SBP 170s though typically is in the 120s/70s without antihypertensive medications. Prolonged dizziness and hyperglycemia (454). Regular insulin 5u SQ administered. Patient symptoms after 60 min. Repeat BG essentially unchanged but patient symptomatically back to prevaccine baseline. Discussed with ID on call. Plan for transport to SMMC lab for CH50 and tryptase with instructions to patient to repeat in more than 24 hours (to establish a baseline). Patient given strict ED precautions.

Patient states" In the morning about 30 hours after his vaccine" patient broke out in rash (redish pink circles) mostly on his stomach, one circle in the middle of his back and some on his leg. Slightly itchy and started out smaller circles then bigger. Once it got bigger it actually stopped itching but he also states that he used cortisone cream for itch. He says he may be a little bit dizzy but he sometimes gets dizzy even before the vaccine. He states "no other symptoms" and rash is getting better. He is concerned whether or not he should have the second dose of Moderna Vaccine.

The vaccine was given outside of the system (? county program). Patient's daughter thinks diffuse or migrating arthralgias started about 4 days after the vaccine was given. He visited ED on 3/09 complaining of pain in multiple joints for 3 weeks. No labs were done then. He returned 3/19 with difficulty walking and talking, was sent to SNF after MRI with diagnosis (probably incorrect) of acute cerebral infarct. He returned to the ED on 3/29 less alert, and no longer able to speak. LP showed 10 WBC (mostly lymphs) and protein 70. MRI was repeated, looked similar to previous scan , but reinterpreted as diffuse cerebritis, worst in basal ganglia. By 4/02 he was deeply obtunded ... (cont. on next page)

Client has had a very achy arm since his second injection on April 8th. It was bruised but is healing. Client had a flare up yesterday 04/22/21 of not being able to move left arm well. Client states the injection site is 3 to 3.5 inches below shoulder. Client advised to place heat on arm for 20 mins and complete range of motion exercises.

I was typing in this section when I was timed out due to "inactivity". Pls change your definition of "inactivity". I do not believe that I will be able to duplicate what I previously wrote before being timed out. I will do the best I can. To the best of my recollection and ability. NOTE: Automatic Wrist BP readings (also takes pulse) closely follows manually-taken Stethoscope Sphygmomanometer readings. 4/22/21 Doing active range of motion pre and post injection. 7:45pm Signs & Symptoms (S/S) Mild - arm discomfort w/swelling, fatigue, lightheadedness, and body ache. Ice- alternating periods of 15 minutes on, then off - done several times. Lessen arm discomfort, no redness noted. Slow increase S/S through night. 4/23/21 mid afternoon- marked increase S/S plus start sporadic flush feeling, noted 1 x 1 inch oval red area over site. 8pm- Increased & more constant flushed. Temp 98.9 F. Noted marked increase body ache, first moving across chest, then descending to both toes/feet. 9pm- Temp 100.4 F. Monitoring temp, hoping peaked. 9:30pm 99.9 F- 9:50pm Felt very dizzy, self-palpated pulse- felt weaker than my normal, noted more distended veins on arms. Asked wife to get pulse oximeter- sat/pulse ranging 93-97, depending on finger, hand, how long on each; noted amplitude lower than my normal; 82-86 range pulse. 9:53pm Obtained BP R wrist supine 105/61 Pulse 82. Felt too dizzy for BP to be done in sitting. BP confirmed by second reading. BP wrist supine sys about 30 -35 & diastolic about 10-20 below baseline. 9:56pm Took 1000mg Acetaminophen. 11pm Temp less than 99, marked decrease head to toe pain, more towards my mild lightheadedness at times due to my mild TB baseline. Able to ambulate. 4/23/21 4-5 am Temp low 98 range (more my normal). 7am BP L wrist supine 135/70 Pulse 69. Sat 98 reading obtained very quickly, pulse amplitude more my normal. Feeling better but not to Pre-vax. Repeated BP & Sat readings twice during the rest of date. Don?t recall time of 1st BP 135/70 Pulse 70 & Sat 96/Pulse 69, noted injection site redness. 9:30pm- started having headaches, pain on L side head (near site of my head wound/mild TBI site), slight increase lightheadedness, injection site red area increased in pain & size to covering almost full deltoid area. BP 125/73 Pulse 65 Sat 97/ Pulse 65. Both Sat numbers obtained very quickly, as per my normal. Ice used. Alleviated pain to tolerable. Monitoring size of red area & intensity/duration of lightheadedness. Recall a strong tingling sensation going down my left arm once. Noted change in sensation afterwards. Slight increase lightheadedness felt due to what usually happens in change in weather, like rain coming. Rain occurred. 4/25/21- Basically the peripheral of deltoid showing redness with some scattered redness centrally. At 8pm redness fully covering deltoid area. Will continue to monitor ("Covid arm"). Other than fatigue thought due to vax, NO S/S of markedly reduce platelets. If need be, will contact Teledoc. Have prior training as a respiratory therapist & occupational therapist.

4/18/2021 at 1:00 AM i woke up with extreme dizziness and was very unsteady while walking at 6:00 Am, the dizziness was worse, the unsteadiness was worse and I had vomited. Had a virtual visit with my doctor who said to take Dramamine for the dizziness. I was not feeling less dizzy until Wednesday afternoon (4/20/2021) - I am still slightly dizzy if I move my head too quickly. I have an appointment with my doctor for later this week.

I have anxiety, rapid heart beat especially when waking up unable to sleep, chest pain, higher blood pressure, a little dizziness and weakness.

Severe stabbing pain in the head ,jaws,teeth, dizziness, profuse sweating, feeling like your burning up,pain in the joints, toes,fingers,still having stabbing pain through the temples 10 days after the last vaccination, nausea,severe constipation,never before,pain in the spine, feel fine for 5 minutes then suddenly feel like you've been hit by a truck!feels like you can't think clearly!

Polymyalgia rheumatica; Pain became more consistent; Arm pain/pain is in his arm; Could not lift arm; Inflammatory reaction; Shaking; he could not get out of bed, was shaking, and used a cane to walk; Pain in legs got worse; Bedridden; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pain, Rash, Panic attack (2 episodes) and Anxiety. Previously administered products included for an unreported indication: PREDNISONE (for 6 days). Concomitant products included PREDNISONE for Pain and Rash, METHYLPREDNISOLONE (MEDROL DOSEPAK) for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica) (seriousness criterion medically significant), PAIN (Pain became more consistent), PAIN IN EXTREMITY (Arm pain/pain is in his arm), ARTHRALGIA (Pain in shoulders), HYPOKINESIA (Could not lift arm), ARTHRALGIA (Left hip hurt), INFLAMMATION (Inflammatory reaction), TREMOR (Shaking), GAIT DISTURBANCE (he could not get out of bed, was shaking, and used a cane to walk), ARTHRALGIA (Joint pain) and PAIN IN EXTREMITY (Pain in legs got worse). At the time of the report, POLYMYALGIA RHEUMATICA (Polymyalgia rheumatica), PAIN (Pain became more consistent), PAIN IN EXTREMITY (Arm pain/pain is in his arm), ARTHRALGIA (Pain in shoulders), ARTHRALGIA (Left hip hurt), ARTHRALGIA (Joint pain) and PAIN IN EXTREMITY (Pain in legs got worse) had not resolved and HYPOKINESIA (Could not lift arm), INFLAMMATION (Inflammatory reaction), TREMOR (Shaking) and GAIT DISTURBANCE (he could not get out of bed, was shaking, and used a cane to walk) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Since the patient's first dose of the Moderna vaccine, he had not been on prednisone the whole time but was recently put on a Medrol pack. He was diagnosed with polymyalgia rheumatica as his pain became more consistent after the first dose of the vaccine. His pain is in his arm and shoulders, his left hip hurt and he was not able to lift his arm all the way up. The patient believed that the vaccine may had caused an inflammatory reaction that aggravated his pain that was present before the vaccine. The patient also stated there was a time that he was not able to get out of bed, he was shaking, and had to use a cane to walk. He says he never had joint pain, only stiffness when waking up and soreness in his hip and leg that was painful. After the vaccine, his arm hurt to the extent he could not sleep on it and the pain in his legs had worsened. He makes it very clear he had a lot of pain prior to the vaccine, but the pain he was experiencing now is more consistent. This case was linked to MOD-2021-081568 (E2B Linked Report).; Sender's Comments: MOD-2021-081568:crosslink

It started with pain in my right shoulder then it became my boss shoulders it's similar to having a rheumatism then it'll be after the second shot it became severe pain in my bows shoulder joints and the muscles around them I can't lift my arms above my shoulders I cannot use my hands to do anything for more than 30 seconds then severe pain will start

Pt reported that he was vaccinated around 2:45 pm and at 6:45 pm the same day began to feel nauseous and light headed. He states he was so weak he had trouble getting into bed. He also experienced feeling cold and sweaty. He states he took his temperature and did not have a fever. He states he felt a little better around 8:30 pm and ate crackers and soup. He states he didn't sleep well and was still nauseous and felt like he had heartburn around 5 am. He states he was able to eat at 7 am the next morning (3/13) and took a shower around noon. Pt states he took his blood pressure on the morning of 3/13 and that it was low. He says he took his blood pressure daily until the 22nd, and it took about a week for it to return to normal for him. Pt reports that he saw his primary care provider on 3/18/21 and his EKG was normal but his BMP was elevated. PCP referred him to cardiologist.

On 4-15-21, patient started having breathing problems and shortness of breath. He had a cough that he had productive phlegm. He continued to get worse. On 4-18-21, he fell getting out of the shower and slumped onto the floor, stating that he couldn't breathe. His wife and neighbor took him to the local ER. His condition improved with oxygen. He was admitted on 4-18-21 and then was transported by Air Evac to ICU. He was placed on the ventilator prior to leaving on 4-21-21 and transferred to hospital. His condition continued to deteriorate and he passed away on 4-25-21.

from the second day after vaccination -> itchy, swollen, aching feet and fingers, hard to walk (does not pass). On the third day -> chills, cold as with a fever (has passed).

Extreme muscle and joint pain. For 2 days. First day after shot I couldn?t get out of bed. Same feeling as the COVID toes I had with COVID-19 Shot site soreness for 1 week following the vaccine.

Hospitalized twice 4/18-4/21 and 4/24-28: Flu-like systems for 6 weeks. Nausea, headache, dizziness, muscle ache, inflammatory markers CRP 23.6, ESR 97, Chest pain, shortness of breath, pericardial effusion, pleural effusion, A-Fib. Manually drained right pleural cavity 400 cc. Fluid came back. Was put on prednisone for 10 days. Fluid was reduced.

Symptoms started on day 7 After first vaccination. Symptoms included: headache which continued for 21 days, dizziness, blurred vision, light sensory issues, imbalance, night sweats, and tinnitus. Symptoms mostly resolve themselves In 21 days with the exception of tinnitus

Moderna COVID-19 Vaccine EUA. Following first shot, I had really bad joint and muscle pain around joints. Took hot showers for pain and Tylenol. Pain in right shoulder (where I have something else going on) increased a lot. After the second shot (about 3 days later), joint and muscle pain returned in all joints. Now, May 9th, joint pain is really bad in arms, hips and legs. It is difficult to walk and to raise arms. I haven't slept due to severe pain. I hope this subsides. I will give it a few more days but it's very painful.

Woke up with head-spinning dizziness the first night the symptoms started. Since then I've had regular headaches and an ongoing sense of subtle lightheadedness. The dizziness returns if I move my head too drastically, particularly if I lie down quickly in certain directions. If I am careful through the day I am not dizzy but there's the lightheadedness. Existing tinnitus also seems aggravated.

Patient c/o sudden onset of lightheadedness f/b syncopal episode 15 min pta. Rec'd Moderna COVID-19 vacc yesterday. Has h/o HTN but has been refusing meds and chronic clinics since 2018. C/o SOB and upper back tightness. Responding nurse indicates pt's HR was initally irregular. Peripheral pulses thready. Unable to obtain BP. 18g IVs were placed in bilat ACs w/NS running wide open. EMS was called. On arrival they attempted adenosine 16mg then 8 mg. Then patient was successfully cardioverted and taken to the hospital.

Vaccine was administered at 8:56 AM. Patient began experiencing lightheadedness at 9:11AM, notified Dr. Vitals Taken : Temperature: 97.7 Spo2: 97 % Pulse: 77 BP: 102/64 mmHg. Per Dr. observe patient an additional (30) Minutes. After (30) Minute Observation symptoms resolved. Vital Taken after (30) Minutes; 9:46 AM Temperature : 97.9 Pulse: 82 BP: 120/82 mmHg Spo2: 97% Dr. was notified. Had patient walk in hallway and per Dr. okay to release patient home. Patient advise he may go no nearest emergency room if symptoms return and/or may contact his PCP and/or our office for additional assistance if needed.

Acute pain in arms, shoulders, upper back, groin, hamstrings, lower buttock. Can hardly stand the pain. Does not allow me to lift arms or stretch legs due to crazy pain. Can hardly lift blankets off me in morning. Movement helps and I loosen up by late afternoon, but the evening tightens me up again. Acute pain ranging to 8 or 9 on a scale of 10. Tried Advil 4x per day. Helped me maintain, but never took pain away. Went to Rheumatology Clinic, took many labs and x-rays. Gave me prednisone. Worked day 1, then back to acute pain that continues to keep me sleepless.

dizziness, nausea, light-headed, loss of appetite, general ache, low fever with chills lasting approximately 48 hours.

Severe vertigo with vomiting lasting several hours that occurred on the following dates: Shot was 4/7/21 Attack on 4/13/21 Attack on 4/15/21 Attack on 4/17/21 Attack on 4/24/21 Attack on 5/2/21

Patient was provided with the COVID-19 vaccine outside of the hospital and begain having shortness of breath approximately 15-20 minutes after receiving the vaccination. In route home, the patient could not catch his breath. The patient was found slumped over at home. EMS arrived and the patient received ACLS and ROSC was achieved. Days later, the patient arrested again and passed away on 5/13/21.

Equipment malfunction on first attempt of dose. Administering pharmacist believes greater than half of the dose was lost on external portion of arm/skin between syringe and needle. Vaccine was re-administered with full dose. Patient reported feeling very sick after administration of dose, report included general overall sickness, use of oxygen required, returned to lower home elevation and extreme dizziness.

@1/31/2021 Pain started in left ankle Lasted @10 Days. Swollen joints and pain. Swollen joints continued and pain moved throughout different parts of the body. (Right knee, right ankle, etc..) Pain increased every day until he couldn't stand it anymore so on 2/23/2021 went to emergency room for the first time in his life as the patient. Doctor gave him predniSONE 10 mg Discharge Diagnosis: Inflammatory arthropathy; Left arm pain; Tendinitis. 2/26/21 went to PC doctor Diagnosis New onset Polyarthropathy Prescribed PredniSONE 10 mg for 5 days. 3/2/21 Received 2nd Covid Vaccine shot. 3/8/21 called PC doctor still in extreme pain. Doctor prescribed Diclofenac Sodium 50 mg. 1 tablet every 8 hours. 3/9-3/10 started slurred speech. 3/10/21 Emergency room. Discharged Diagnosis Polyarthralgia (Joint pain) Prescribed methLPREDNIsolone 10 mg for 5 days. 3/11/21 Dr. called telling him to stop taking the Diclofenac Sodium immediately. Continued taking PredniSONE until 3/18/21. 3/22/21 sent to Gastrologist noted to have progressive microcytic anemia without GI bleeding, B12, folate, iron panel, EGD and Colonoscopy ASAP, Joint Swelling, Rheumatology evaluation pending, slurred speech, consider neurology evaluation. 3/31/21 Colonoscopy and Endoscopy performed. 4/1/21 Rheumatologist Appointment - First Appointment with this doctor. 4/5/21 Gasterology doctor diagnosed him having H-Pylori infection. All of his biopsies came back negative."H-Pylori Diagnosis - Amoxicillin 500 MG 2 Capsules twice daily for 14 Days /Omeprazole 20 MG 1 capsule twice daily for 14 days/Clarithromycin 500 MG 1 tablet twice daily for 14 Days. 4/8/21-4/10/21 Hands started shaking. 4/29/21 PC doctor appointment. Still experiencing fatigue and very pale. Can't catch his breath and gets tired very easily. Doctor took him off of his blood pressure medicine. 4/30/2021-5/2/2021 Had a horrible weekend. Pain/Fatigue/Absolutely No Energy 5/3/2021 stopped at PC office to see doctor. Took blood for more tests. Still experiencing pain in his body and swollen joints. "Prescription for Iron Tablets Take 1 pill in the am and 1 pill in the pm for 1 month Ferrous Sulfate 325mg (5gr) 5/7/2021 patient looks horrible today. He looks almost yellow to me and 1 of his eyes is bloodshot He has no energy (ZERO) and is very tired. He has lost over 15 pounds. 5/7/2021 patient called PC Doctor and asked him to look at his lab work. Dr. called and told him he made arrangements for him to go and see Neuropathist ASAP. Patient met Dr that same day. Dr. sent patient over to Hospital. In the ER they took blood, EKG test, CT scan of his lower abdomen and pelvis. They took a Chest X-Ray. He was given 60 mg of Steriods and started on IV fluid. They also scanned his head. Acute renal failure. Transabdominal ultrasound of the kidneys obtained. Ultrasound retroperitoneal kidneys. Findings: The right kidney measures 10.8 x 6.8 X 7.1 cm The left kidney measures 11.8 X 7.3 x 6.2 cm. There is mild bilateral renal cortical atrophy. There is increased renal cortical echogenicity of both kidneys. There is no hydronephrosis or shadowing renal calcui. The bladder is partically distended and unremarkable. Medical renal disease. No hydronophrosis or shadowing renal calculi. Clincial Indication: ARF-Other Acute renal failure. 5/10/21 Kidney Biopsy. Prednisone 20 MG Tablets Take 3 Tablets by Mouth Daily for 10 Days. 5/13/2021 Dr. visit diagnosis Focal Necrotizing and Crescentic Glomerulonephritis, Pauci-Immune Nine 0f 25 (36%) nonglobally sclerotic glomeruli show necrosis and/or cellular/fibrocellular crescent formation. Correlation with ANCA serologies is recommended. 05/17/2021 Prednisone 20mg. Next doctor appointment scheduled Monday, May 24, 2021. I also have 9 different Blood Lab Test Reports if you need to see them. My husband went from running 3 miles a day with nothing wrong with him except reflex condition to not being able to move at all. I'm not sure if it is related to the vaccine or not but I wanted to submit this report just in case. Please let us know if you have any further questions or need any additional information. Thank you.

Stroke; Vertigo; Dizziness; High Blood Pressure; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), VERTIGO (Vertigo), DIZZINESS (Dizziness), HYPERTENSION (High Blood Pressure) and HEADACHE (Headache). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), VERTIGO (Vertigo), DIZZINESS (Dizziness), HYPERTENSION (High Blood Pressure) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products were reported. Treatment information provided included steroids. Patient stated he in now in a walker due to having a stroke. Very limited information regarding these events has been provided at this time. Further information has been requested. However, the patient may deny additional follow-up. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Event fell diagnosed as stroke (Seriousness criteria - medically significant).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. However, the patient may deny additional follow-up.

first dose. Muscle soreness first 2 days joint pain next two days. Dose recieved 4/28/21 Second dose. Upset stomach then loss of appetite the first day. Got better on second day. Very tired on the second day Third day: Hacking cough and sore throat. Could eat, but when drinking caused me to cough. Then started to lose my voice. 6th day. Coughing better but still there voice still weak. Fluids do not make me cough anymore. 2nd vaccine date 5/26/21

6/3 @ about 10:00Am felt warm sensation in my head then 3 bouts of disinyness in succession. I had to sit on the ground for a couple minutes because I felt I was at risk of passing out

I had pain in my arm and it was swollen up. I was really tired. I had a headache (low grade), dizziness, and an hour or 2 later I started getting chills really bad. The next day I felt dizzy and kind of foggy. I did not take my temperature.

Dizziness; Aches; Weak; Fever; Nausea; DIED; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (DIED) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea). The patient died on 18-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that the vaccine was not the cause, he had other medical issues too. This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: New event (death) and narrative was updated.; Sender's Comments: This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death

experienced standard flu like symptoms for both injections. I have currently at three months later ; I have lost muscle strength and range of motion in my left shoulder and left elbow. A Sharp stabbing pain when I raise my arm, in the shoulder joint, loss of the use of my left arm , due to pain when using arm. Feeling fatigue and a desire to be active/ my upper part of my body wants to lay down and go to sleep. the lower half wants to go out dancing ....Pain in shoulder L side ; pain in elbow L side..... loss of range of motion and strength.

after 1st shoot got dizzy. after 5 or 6 days .after .secound shot got so dizzy on the7 day after the shot . I went in to hospital.

1st vaccination had little after effects. 2nd vaccination: terrible leg pain...within 2 hrs. of the 2nd shot left knee swelling and one week later right knee swelling to where I can't hardly walk or bend either. Knee pain persists to today (06/16/2021).

I experienced immediate chest pain, chills, difficulty sleeping, numbness, dizziness when standing. Vomiting. Occasional elbow pain on left arm.

I had the injection on 03/04/2021 I had the first dose on the vaccine on 03/06/2021 four days after that I had lower pain in my back, right glute and right leg. Three more days after that on 03/13/2021 I could not get up from the couch and my right food could not raise up. I was hospitalized at the emergency department. I got there at 8 or 9 o clock at night and was hospitalized until the next day. I was there for around 5 days. It ended up being diagnosed as a infectious disease. I was on Vancomycin IV. I was then put on vancomycin home infusion for six more weeks that along with opiates for the pain.

Tinnitus is both ears. Feeling of blocked ears and pressure in ears, and loss of balance. Left ear worse than right ear. Hearing loss.

I received my first Covid 19 Moderna vaccine (lot 001A21A) on 3/5/2021. I received my second Covid 19 Moderna vaccine dose (lot 017B21A) on 4/2/2021. On 4/11/2021, I awoke to excruciating, bilateral pain in my hips and shoulders. I could walk only with difficulty and I had trouble dressing myself. This pain persisted for days and, after testing to rule out Lupus and Rheumatoid Arthritis, I saw rhematologist Dr. at Health Center on 5/5/2021. She diagnoses me as suffering from PolyMyalgia Rheumatica and prescribes MethylPrednisolone 16mg. Over the course of a few days, the pain subsided and I remain on this dose of MethylPrednisolone today and continue to see Dr. monthly to track the status of my Polymyalgia Rheumatica. She suggested that I post my experience on VAERS because she has seen some other instances of Polymyalgia Rheumatica proximal to the Covid vaccine.

Patient reported feeling dizzy, anxious and sweaty at 2:45pm. Patient given a water and observed for an extra 15 minutes. Reported feeling better and left at 3:06pm.

APPROXIMATELY ONE MINUTE AFTER RECEIVING MODERNA, PT REPORTED FEELING DIZZY AND HOT. I APPLIED ICE PACK TO WRISTS AND A COOL CLOTH TO BACK OF PTS NECK. PT SAID HE COULD HEAR HIS HEART BEAT LOUDLY IN HIS EARS SO I THEN CHECKED PTS BLOOD PRESSURE , PULSE OX, AND PULSE RATE. PTS BLOOD PRESSURE WAS SLIGHTLY ELEVATED BUT PULSE OX AND PULSE RATE WERE NORMAL. APPROXIMATELY 5-10 MINUTES LATER, I RECHECKED PTS BLOOD PRESSURE AND IT NORMAL. PT ASKED FOR AND DRANK A BOTTLE OF COLD WATER. AFTER 35 MINUTES PT SAID HE WAS FEELING BACK TO NORMAL.

Anxiety directly related and due to the vaccine; I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.; his chest hurt so bad; he got sick very bad; He has elevated immunity; More than 35 days after the first dose without receiving the second dose; I felt like I was having a heart attack; my knees were aching; When I woke up the next day, felt like a truck ran me over; lost all appetite; it attacked both my knees so severely I could hardly walk; Couldn't get off my toilet seat; I can't sit in my couch; had all kind of symptoms; 101 fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (his chest hurt so bad), MYOCARDIAL INFARCTION (I felt like I was having a heart attack), ANXIETY (Anxiety directly related and due to the vaccine) and INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Endocervical) at an unspecified dose. On 22-Mar-2021, the patient experienced GENERAL SYMPTOM (had all kind of symptoms), PYREXIA (101 fever) and CHILLS (chills). On 23-Mar-2021, the patient experienced INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.) (seriousness criterion hospitalization), FEELING ABNORMAL (When I woke up the next day, felt like a truck ran me over), DECREASED APPETITE (lost all appetite), GAIT INABILITY (it attacked both my knees so severely I could hardly walk), DYSSTASIA (Couldn't get off my toilet seat), SITTING DISABILITY (I can't sit in my couch) and ARTHRALGIA (my knees were aching). On 06-Apr-2021, the patient experienced CHEST PAIN (his chest hurt so bad) (seriousness criterion hospitalization) and MYOCARDIAL INFARCTION (I felt like I was having a heart attack) (seriousness criterion medically significant). On an unknown date, the patient experienced ANXIETY (Anxiety directly related and due to the vaccine) (seriousness criterion hospitalization), PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose), ILLNESS (he got sick very bad) and IMMUNE SYSTEM DISORDER (He has elevated immunity). The patient was hospitalized from 06-Apr-2021 to 07-Apr-2021 due to CHEST PAIN. At the time of the report, CHEST PAIN (his chest hurt so bad), MYOCARDIAL INFARCTION (I felt like I was having a heart attack), ANXIETY (Anxiety directly related and due to the vaccine), INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.), GENERAL SYMPTOM (had all kind of symptoms), FEELING ABNORMAL (When I woke up the next day, felt like a truck ran me over), DECREASED APPETITE (lost all appetite), GAIT INABILITY (it attacked both my knees so severely I could hardly walk), DYSSTASIA (Couldn't get off my toilet seat), SITTING DISABILITY (I can't sit in my couch), ILLNESS (he got sick very bad), IMMUNE SYSTEM DISORDER (He has elevated immunity), ARTHRALGIA (my knees were aching), PYREXIA (101 fever) and CHILLS (chills) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 101 (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Endocervical) was unknown. Patient reported that he wont get the second one, as he got sick very bad. He had elevated immunity, his antibodies level is off the charts, that was documented in his hospital. Concomitant medications was not reported . Treatment history was 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 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.

Suffered an unwitnessed fall this evening ~ 0130. Prior to this he had been ambulating in the dayroom around midnight without difficulty at his baseline and interacting with staff. He then went to his room. During rounds ~0130, the staff found him in the bathroom face down. He stated he lost his balance but was not able to provide more information. He was assisted up and he had difficulty walking . RN noted three abrasions on his forehead and one on his chin. His vitals were 146/86, 20, 74, 97.2. He had a change in his baseline mentation and ambulatory status at that time. Patient transferred to local ED, where he was seen by two providers. At that time, patient was noted to be using his right arm and left.

It's interesting as a non-medical person, the struggle I'm having, to get one person to just understand the period of time that I've seen different providers. Since my second injection I had suffered from ongoing problems, I have days where I can just hardly stay awake. I have never felt like there was a single medical professional who was trying to even find out what was going on with me. On May 28th I woke up in the morning at 2:30AM with an extreme case of dizziness and nausea. I got up and went to the bathroom and went back to the bed thinking I could go back to sleep. It was as if I had some type of horrible severe hangover or something, but I did not. About an hour later I got up, fell on the floor, then decided I had to go see somebody. I called the ambulance and was taken to the ER, where they ran lots of tests. The diagnosis was that I had severe peripheral vertigo. and prescribed medications for that. So in June 2021 I went to the DR for a stress test and echocardiogram and those came back fine. I get mild nausea and dizziness still but nothing like had happened originally. I had visited PCP, my DR, after my visit to the ER and she is the only one kind enough to me to care. I have had an ongoing effect on my ability to function so when I got the v-safe check in, of course I replied that I have had an event of course. Ondansetron 8MG as needed for nausea Meclizine 25MG as needed for dizziness, these are the medications they gave me at the ER by the way.

Patient was given the vaccine at approximately 11:40 am by technician. The patient was advised to wait for 15 minutes in the waiting area after the vaccination was given. During the 15 minute waiting period the patient fainted in the waiting area of the pharmacy. The patient was immediately assisted. The technicians were told to call 911 and management. Upon encountering the patient, the patient was gently rubbed and asked if he could hear me. The patient was immediately responsive and told me his name and date of birth. The patient was asked if he had any health conditions or prior incidents of fainting after a vaccination and the patient stated "no". The patient was provided water and asked if he could sit up. The patient stated that he could. The patient sat on the floor in an upright position for approximately ten minutes. The patient was then asked if he felt that he could stand to get back into the chair. The patient sat back in the chair and continued to drink water and take deep breaths. The patient stated that he still felt dizzy and nauseous. The patient's emergency contact was contacted to inform of the situation. EMT arrived at approximately 12:15 pm. Patient was asked by EMT's if he wanted to go to the hospital. The patient responded "no". The patient was then asked if they could "check him out" and he agreed. After assessing the patient the patient was taken to the hospital by ambulance.

True vertigo. Room spinning dizziness with perceived movement. Symptoms made worse by changes in head position. Nausea and vomiting with extremes of vertigo symptoms. NO fever, chills, cough, loss of taste or smell. No muscle aches, body aches, myalgias, nasal or sinus congestion.

True vertigo - room spinning dizziness, perceived motion, made worse with changes in head position. Nausea and vomiting at extremes of vertiginous symptoms. Also generalized fatigue noted. No fever, chills, diaeresis, headache, hearing loss, loss of taste or smell, cough, or nasal congestion, muscle aches, body aches or myalgias.

Patient was monitored for 1 hour after receiving his vaccine as requested by his primary care provider due to history of reaction to a previous vaccine. Patient monitored by EMS provider x 1hr, no s/s adverse reaction. Patient started walking out of facility on his own and came back reporting he felt dizzy. He was initially hypertensive with a pulse of 70, respiratory rate 12, systolic BP 188. We had him lay down and about 10 minutes later his blood pressure was 140/70. After another 10 minutes or so we had him sit and drink water but his dizziness, while improved, did not go away and he started to have chills and was visibly shaking so 911 was called as we did not feel he could drive himself home. Patient was monitored in the emergency department at Hospital x 1hr and released with blood pressure WNL.

increase temperature 99.6-103, elevated Blood Pressure 196/128, Heart Rate 115, mild light headedness, no shortness of breath, alert and oriented

Developed chills and fever approximately 12 hours after shot. As I had the Covid 19 in May, (tested negative on the 18th May, positive on 21st May) the symptoms are very similar. Except for no loss of smell or taste. Moderate to extreme fatigue at this point 72 hours later seem to be the only lingering effects with some light headedness.

Moderna COVID-19 Vaccine Extreme dizziness since waking at 5am that persists still. Only goes away when lying down. Nausea with repeated vomiting earlier. Feeling somewhat better this evening, but afraid to eat or drink and get sick again. Extreme fatigue; unable to get out of bed.

Moderna COVID-19 Vaccine Extreme dizziness except when laying down since waking at 5am. Nausea with several episodes of vomiting earlier has subsided, but I'm afraid to eat or drink and get sick again. Severe fatigue and tiredness which are both unusual symptoms for me.

Patient sat down and alerted observation that he was experiencing feeling flushed and felt his pulse was faster than usual. He took off his jacket to cool down. As time progressed, he said he did not feel as dizzy. Patient was in observation for over thirty minutes. EMS arrived at scene to evaluated patient. Patient signed a refusal form to go to the hospital and to receive treatment. Pulse 76, pressure 121/83, oxygen was 96. Patient was instructed to download the app .

On Saturday 01/23/2021 morning when I got out of bed I experienced difficulty maintaining my balance. I had to use a wall to be able to stand. I did not fall. I stumbled into the bathroom, still unsteady. I urinated sitting down, still feeling unsteady, head spinning. I took my blood pressure 130/70, which is normal. Was feeling steadier. Was able to walk down stairs to ground floor of home. Still not felling normal, but steady on my feet. After eating breakfast, no additional symptoms through day. I had not consumed any alcoholic beverages over the past week. When I went to bed Sat night, lying in bed I was light headed. Sunday morning same problems. I performed some vehicle maintenance and would get down on the ground. Head would start spinning, everything would return to normal once standing. At bedtime same feelings when lying down in bed. Monday morning (today) same problems.

Lightheaded and dizzy, and elevated BP 180-100 one hour after injection. Monitored on-site for another 1/2 hour and BP remained high. Transported by ambulance to Hospital for further observation. Head cleared and BP came down to acceptable level about 8:00 PM. Released.

Acute severe vertigo associated with nausea. Approximately 10 events each lasting 1-2 minutes. Treated with OTC meclizine and seems to have resolved. No associated headache. Only other symptoms was moderate pain at the injection site

Day 1: sore arm, fatigue, headache Day 2: headache, fatigue, chills, mild nausea, body aches, joint stiffness Day 3: sore arm, fatigue, lower back pain, chills at night Day 4: sore arm, a period of body aches, a phase of fatigue, sudden lower back, neck, and knee pain Day 5: sore arm, fever, chills, lower back pain, stiff joints, neck pain, headache

Second and now third day have speech trouble, articulating is difficult, stumbling somewhat, typing is very difficult. No fever, cough, or flu-like symptoms.

Got the 2nd dose of Corona Vaccine Moderna at 12:45pm yesterday - at 6p, started to feel weak/dizzy - then this am on 2/22/21 at approx 6:30, pt had a syncopal episode with preceding dizziness, denies cp/fever.

Morning after shot was at church and all of a sudden got nauseous and very hot for a number of minutes, then passed out before leaving church. Had a cut lip, nose and have a stiff(sore) neck last day or so.

Severe chills, shaking and fever lasting 6 hours. Fatigue lightheaded dizziness vomiting next 2 days +

Patient was found on the ground sitting. Reported he was leaving after receiving 1st COVID-19 vaccine and "loss balance". Patient denies hitting head. Laceration to the elbow noted. Patient requested assistance to get up and still felt "dizzy". Patient assisted to wheelchair and recommended to go to ED via ambulance for evaluation. Patient then loss consciousness for 10 seconds. 911 was called. Patient refused all care by EMS. They called by EMS as they deemed patient was not safe to drive due to unsteady gait. It was advised patient to go to ED as instructed by EMS and The provider but refused. They also advised for patient to go to a hotel nearby to rest. Patient refused all recommendations and was escorted by EMS to his car.

Complained of dizziness after the shot. No lightheadedness or difficulty breathing. Patient stated that he was anxious before receiving shot. Hx of lightheadedness after flu shot. VSS. Patient remained seated x 30 minutes. Offered water and patient drank. Started feeling better after sat down and drank. Dizziness resolved. Feeling better, observed steady gait when leaving.

Within the 15 minutes following vaccination client complained of feeling light headed, weak, and nauseated. He appeared very pale and diaphoretic. Reportedly may have loss consciousness for few seconds per monitoring staff. While in his car his seat was inclined. His B.P. was 124/76 Heart Rate 63, O2 level was 93 % initially and increased to 97%. He reported improvement after being in inclined position for few minutes. However after 10 minutes he complained again of feeling light headed and nauseated, appearing pale. Blood Sugar level was 134. MDs assessing client decided that it was best to have him further evaluated in the ER and therefore 911 was activated. With EMT clients Vital Signs were 130/80 HR in the 60's and O2 sats continued to go between 93% and 97%. Client continued to be diaphoretic, pale, also shaky

initially patient had no symptoms with Moderna vaccination, no pain worked out at gym in week after shot, initially felt well then started having throbbing severe pain in right deltoid area of arm where vaccine was placed reports no falls, no accidents to this body region noted as well a rash over the area, itchy, 1 week duration, with red vesicles that are now older pain is worsened with palpation of deltoid muscle, acromioclavicular joint and passive abduction and flexion at shoulder and range of motion was limited incidentally patient also had new-onset hypertensive urgency at that time, possibly secondary to pain

Maderna COVID-19 Vaccine EUA Got injection at 10:49 am Tuesday 3/9/21. At approximately 9:30 pm same day, started having chills and low grade fever of 99.3. Woke up around midnight with chills and body aches. Woke up at 5 am and was extremely fatigued. But fever was gone. Could barely get out of bed. Also had a headache. Able to go to work but left after being there for 45 minutes due to being dizzy, really fatigued, bad headache, and just sore all over. Got home and basically went to bed.

About 15 minutes after the injection approx 10:55am I started felling light headed and slight dizziness, Its now 3:00 pm still a little light headed, flushed and feeling tired. I've not done any treatment for the symptoms

Full body aches, chills, sweats, fatigue and dizziness. Body aches, chills and sweats lasted around 20 hrs. Fatigue and diziness on and off 48rs

During normal activity around 3pm 3/9/21, patient was overcome with nausea, vomited, and required assistance to his car and home. His symptoms persisted throughout the night into the next day (3/10/21), and he went to his primary care physician. He vomited multiple times in transport and at the physician's office. Due to the nature of his symptoms and his concurrent hypertension there was concern for stroke and he was taken to the emergency department at Medical Center for evaluation around 4pm. Stroke was ruled out, and he was sent home with a prescription for meclizine with a presumed diagnosis of vestibular neuritis. 3/11/21 patient did not leave the bed except to use the restroom, however vomiting controlled with meclizine. 3/12/21 symptoms persist and patient has not yet improved.

Patient wife called clinic at 1156 am. Patient lethargic, too weak to stand or walk, dry heaves. Advised to call 911 and take to ER. Called patient 3/17 for details. States on 3/4/21 in the evening, he developed HA, chills, and body aches. 3/5/21 took a shower and became light-headed, near-syncope or syncopal episode reported by patient. Wife gave him a Zofran ODT, which relieved the dry heaves. He rested remainder of day. Felt mostly better by 3/7/21, with remaining fatigue until 3/9/21.

3/17/21 63 y.o. male who presents with sudden onset of chest pain and palpitations, which occurred while patient was exerting himself. Pain is substernal, radiated to the left arm, associated with lightheadedness. Denies diaphoresis or nausea. Per EMS there were short runs of nonsustained ventricular tachycardia 3/18: - remains inpatient admission as of 3/18/21 @ 0900 63 y.o. male with a past medical history of nonsustained ventricular tachycardia. He states he was lifting a couch yesterday and his heart started beating fast. He did not really have any chest pain, but felt a little bit lightheaded. He called an ambulance and they brought into the ER. In the emergency room his EKG did show some frequent PVCs. However, he did not really require any intervention. He was given 3 nitro, but it really did not make any difference in the way he was feeling. The patient denies multiple times that he actually had chest pain. He states he just felt like his heart was beating funny. The patient's most recent stress test was a nuclear stress test in May of 2019. Overnight, the patient has felt very well. He denies any significant chest pain. He denies any further heart palpitations. On the monitor he would occasionally going to bigeminy, which is not abnormal for him. EKG this morning was unremarkable. After speaking with the patient's wife, she told me that he has had a several month history of very limited exertion. She states every time he exerts he becomes extremely dyspneic and has heart palpitations and sometimes almost passes out. She states last night he was extremely diaphoretic and very nearly passed out.

illness onset 1 day post vaccine (headache, fever, chills, aches) Severe body rash and Prurtus appearing over multiply locations on the torso, back, head, legs and arms approximately 2 weeks after second (2nd) Moderna vaccination shot. Other symptoms include headache, fatigue, dizziness, asthenia, Current course of treatment prescribed for rash is Prednisone 20mg. Symptoms as yet NOT resolved.

shoulder became very sore several hours after injection, to the point where I could barely lift my arm, lasted about 48hours. also about 8 hours after injection got chills, slight fever and body aches which lasted about 36 hours

Patient waited his 15 minutes and had no symptoms. Patient walked out the door to leave and than came back in saying he was dizzy. We sat him down and took his vitals. BP 133/74, Pulse 66 O2 Sat 97% than went to 94%. Patient was instructed to sit for another 15 minutes. He got up and walked around the room and sat back down. Patient than stood up to leave and was very unsteady upon standing with vertigo. Response team called and report given to RN and response team. Patient was taken to the ED.

13 DAYS AFTER MY FIRST VACCINE I STARTED TO EXPERIRNCE DIZZINESS - BALNACE ISSUES, DIFFICULTY WALKING WITHOUT HOLDING ON TO SOMETHING. THESE SYMPTOMS ARE STILL GOING ON. SOME DAYS THE SYMPTOMS ARE SO SEVERE THAT THEY ARE ALMOST DEBILITATING.

Severe pain right foot at base of big toe - same as possible gout attack for past two years. Could not walk on foot and very sensitive to touch. Took Mitigare and was nauseous all day. Next morning pain subsided but nausea stayed with me by Saturday morning everything was back to normal

After the first day I developed soreness at the injection site. After about 2 days, the soreness moved to my left shoulder joint. Currently, 8 days after the injection, my left shoulder joint remains sore and any motion to left my left arm laterally from my side is painful; like my joint is inflamed. There is no redness or other visible external signs or discoloration. I can not say for certain it is linked to the Modern vaccine as I've had left shoulder issues infrequently in the past. But timing wise, my current discomfort started shortly after receiving the vaccine.

No immediate reaction. Five hours after injection upset stomach followed by light headedness, and fatigue. No fever. Loss of appetite. Soreness at injection site which spread from shoulder to elbow of left arm. Chills. Poor night's sleep with most symptoms continuing in morning.

Pt received first Moderna COVID-19 vaccine on 3/15/21. Starting 3/27, patient began to have acute onset dizziness, muffled hearing, loss of consciousness and sinus congestion. On 3/28, this dizziness lead to a fall in which he hit his head and was sent to the ED. Pt tested positive for COVID 19 while in the ED, and was admitted.

Started experience what can be described as cold like symptoms 12 hours after vaccination. Next morning had full cold-like symptoms (chills, muscle aches, stuffy head, dizziness). The second day felt better but became nauseous after physical exercise. The third day felt better in the AM but then started experiencing nausea and cold-like symptoms prior to bed. Today, the nausea continues when I eat.

Body aches, headache, severe chills, fever up to 101, light headed/dizzy all started about 12 hours after injection. The most significant side effects subsided within 12 - 15 hours after onset (about 24 - 27 hours after the inection. dull headache and light headed feeling went away about 36 hours after injection. No medical treatment was sought. I took two Advil on Friday morning (injection was 11:15 am Thursday), but did not take more because I read an article that suggested taking Advil and similar medications could negatively affect the anti body production.

Per administering nurse: "Gave benardryl 25mg PO x 1 dose. Feeling flushed, light headed, O2% 97%, HR 88, stayed for 1 hr felt back to baseline after 1 hr, left to go home safely"

Fever, dizziness, vomiting, stomach aches, fainting, all body aches., fast heart beats, injection location soreness and pain. Cannot sleep at night. I thought to call 911.

Vertigo and dizziness. 2d day vertigo was intense when I woke up. I had to sit on edge of the bed for several minutes before I could stand. The room was spinning. Has dissipated over time, but I have experienced vertigo when I lie down to sleep just about every night since 26 Mar. I also have dizziness sometimes when I look down. Mostly resolving in that the room doesn't spin as intensely as at first, but I can tell something is not right. Feels like I have a low grade headache most of the time. I am hesitant to get the second shot.

PATIENT SAID HE WAS FEELING DIZZY ABOUT 10 MINUTES AFTER RECEIVING HIS VACCINE. RPH WAS IN THE PROCESS OF CHECKING HIS BP, WHEN HE FAINTED. 911 WAS CALLED . HE SHORTLEY GAINED BACK CONSCIOUSNESS AFTER EPI PEN WAS ADMINISTERED

Immediate excessive bleeding. Immediate pain compared to previous vaccinations. Arm and shoulder became increasingly more painful through out the next several hours. By evening I was unable to lift arm. Any movement resulting in extremely sharp pain. No movement and the arm and shoulder had high degree of aching. Next day same and stayed in bed for next 3 days due to pain. On 4th day some improvement and could move arm by lifting with other hand. 5the day slight improvement. 6 the day small improvement still can not lift objects or reach out without severe pain

about 14 minutes into 15 minute post vaccination wait time, pt stated he was feeling dizzy and having blurred vision. Gave pt water to drink and observed pt for another 15 mins; he said the dizziness got better but still slightly blurry vision. Suggested he follow up with primary MD if that did not resolve.

After 15 min receiving 2nd dose Moderna vaccine (Covid) left hand, lips, face and chin numbness and tingling. Light headed.

Pt complained of dizziness for 2 weeks prior to hospitalization 4/10/2021, and passed out 6 times in the 2 days prior to admission. Upon admission was found to have acute pulmonary embolism. Physician requested VAERS report.

Started on 4/9/21 (1 day post vaccination) with lower back pain and impaired ability to walk. Progressed to numbness and pain in the lower extremities. Unable to walk. Presented to the Emergency Room on 4/10/21 and was admitted. MRI showed inflammation in spinal cord. Treated with IVIG and IV steroids. Diagnosed as myelitis. Remains hospitalized and scheduled for spinal tap 4/12/21

I have red sore spots on my toes on both legs. They are red and tender and painful to touch and walk. They seem to vary a bit from day to day. I did not visit a doctor. I never had something like this before and nothing changed in my behavior or shoes. Just concerned about what they are and how to treat them.

My left hand was in severe pain for maybe two hours. I took three Aleve to try and stop the pain. I could not close my hand into a fist, nor could I hold anything in my hand. No grip at all. My hand remained like this for most of her night. Today it is a little better, I can close my hand and make a fist, but I am unable to close tightly and grip anything. I feel as though the strength in my left hand is gone for now. No pain today but the muscles in my wrist and in my left hand are still somewhat tight and present what feels like muscle tightness parallel to a pulling of the muscle. I rode my motorcycle to work yesterday, the morning ride was good, on the way home, my hand started with the pain thing. It was severe enough to prevent me from using the clutch lever properly. Presenting a lot of pain squeezing the lever to engage the clutch.

Pt. reports immediately feeling tingling in both hands and some dizziness with mild nausea. Pt. denies ever having similar reaction to vaccines or blood draws. He reported he does have an allergy to "streptomycin mixed with penicillin". Pt's BP initially elevated in treatment room. EKG ordered and reviewed by physician. As time passed pt. reports symptoms "dissipating". Pt. evaluated for 30 minutes and sent home with ER precautions given.

Patient received 2nd dose in series on 4/5/21. On 4/7/21 patient started to experience vertigo type symptoms including dizziness and occasional nausea. On 4/11/21 nausea became particularly worse and he also reported vomiting. Patient had an acute episode of dizziness in which he lowered himself down to the floor and remained there for 2-3 hours until his wife helped him up. On 4/12/21 he presented to the emergency department for ongoing nausea and dizziness. He denied other symptoms including fever, chest pain, shortness of breath, and abdominal pain. Patient reports having an appetite, but is unable to keep food/drink down due to nausea and vomiting. Upon exam patient had left-sided nystagmus, which worsened with head turning.

Headache, fever, nausea, chills, body aches, dizziness, tiredness, and ear ringing. All symptoms subsided accept for dizziness and ear ringing as of 4/18 6pm.

Guillain Barre; Myelitis; could not walk without assistance; had severe leg pain; lower back pain; numbness in his lower extremities; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of BACK PAIN (lower back pain), GAIT DISTURBANCE (could not walk without assistance), HYPOAESTHESIA (numbness in his lower extremities), PAIN IN EXTREMITY (had severe leg pain), GUILLAIN-BARRE SYNDROME (Guillain Barre) and MYELITIS (Myelitis) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Myelitis (admitted in the hospital with Gillian barre or myelitis) since 10-Apr-2021. On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced BACK PAIN (lower back pain) (seriousness criterion hospitalization) and HYPOAESTHESIA (numbness in his lower extremities) (seriousness criterion hospitalization). On 10-Apr-2021, the patient experienced GAIT DISTURBANCE (could not walk without assistance) (seriousness criterion hospitalization) and PAIN IN EXTREMITY (had severe leg pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain Barre) (seriousness criteria hospitalization and medically significant) and MYELITIS (Myelitis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 10-Apr-2021 due to BACK PAIN, GUILLAIN-BARRE SYNDROME and MYELITIS. At the time of the report, BACK PAIN (lower back pain), GAIT DISTURBANCE (could not walk without assistance), HYPOAESTHESIA (numbness in his lower extremities), PAIN IN EXTREMITY (had severe leg pain), GUILLAIN-BARRE SYNDROME (Guillain Barre) and MYELITIS (Myelitis) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 10apr2021, he could not walk without assistance and had severe leg pain then went to the emergency department. Treatment: IV steroids, and IV immunoglobulin. 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.; 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.

later that night patient began to have extreme back pain, legs hurt even to touch (lasted for days), knees rubbery ...patient had pain for 11 days...patient had dizziness and his balance was off...patient had difficulty breathing ...patient stayed in the er all day underwent a battery of tests "all day" ...in the end didnt have answers ....still having problems breathing and coughing ...patient was zapped of all energy and had difficulty even dressing self

Vaccine on 04/10/21.Shortness of breath, dizziness, nausea 04/13/2021. Death on at hospital on 04/14/2021 Autopsy found Bilateral pulmonary thromboemnbolus

Patient received first dose of Moderna COVID-19 vaccine on 3/31/2021. Vaccine given at 0857. Patient complained of dizziness, confusion, fatigue, and mild SOB. He was evaluated by PCP and PA-C. BP 150/100 and glucose 156. EMS evaluated the patient and did not send to ED. Patient was observed for 30 min.

Vertigo when laying down; varies from mild to severe; first appeared 1 week after initial shot. Saw physician about 1 week later and diagnosed as BPV and prescribed physical therapy. After several sessions noted some improvements but after 2nd shot worsened

Anaphylaxis reaction; fast heartbeats; stomach ache; shortness of breath; orthostatic hypotension; sore shoulder; headache; minor nausea which increased the third day; dizziness; body ache; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis reaction) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN (body ache). On 16-Apr-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (minor nausea which increased the third day). On 21-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis reaction) (seriousness criterion medically significant), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), ARTHRALGIA (sore shoulder) and HEADACHE (headache). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis reaction), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), DIZZINESS (dizziness), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), PAIN (body ache), ARTHRALGIA (sore shoulder), NAUSEA (minor nausea which increased the third day) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant meds were reported. No treatment information was provided. Company comment:Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.

Moderna COVID?19 Vaccine. While I was sitting, suddenly I had light-headedness for a second and then chest pain and rapid heart rate. Cold sweat started running over my face and wet my shirt. I went to the Emergency Department at the hospital. While I was waiting in the Emergency Room, all symptoms were gone after 1hr except rapid heart rate. Discharged around 11 pm after signing

1st, after about 2 hours: sore shoulder 2nd, after about 5 hours: whole arm, chest, back and side pain. 3rd, next morning: all of the above, plus dizziness and nauseated, but no vomiting. Fever peaked at 101.4. This lasted all day. 4th, next morning: Fever, dizziness and nausea gone. Pain reduced. Sore arm remains.

First day after the shot the arm was extremely sore; could not lift. Now, 5+ weeks later the arm is burning and the fingers are extremely burning and tingling. Pain is a 9 and 10.

A Week after my first dose ~ I had a rash all over my body 14 hours after my second dose. I awoke to a very painful cramp about an inch below my left rib on my left side that lasted for almost 2 hours. The more I moved, the worse it became. I could not go to the bath room and when I drank water, the cramp intensified. Worse pain that I had ever experienced. I sweated profusely. Felt like I got kicked in the side. I was not nauseous, a little dizzy for a moment. My mouth was dry only because of my heavy breathing. My second episode happened the following Saturday morning, I don't think that it was as intense, but it felt like it was only because my left side was sour from Friday mornings episode. My third and final episode happened again early Sunday morning. This one was not as intense, but still woke me up and made me struggle. I did not experience another episode on the 4 the night from my second dose. At this time, my left side feels bruised internally and I have to change the speed of my walk. It hurts to walk fast

4 days later (5/1/2021) anaphylactic shock after a bee sting. No allergy to bee stings before. Whole body rash with severe itching, swelling in mouth and throat, extreme weakness, close to fainting within minutes. Emergency room visit, EPI pen injection, steroid injection, EKG, chest x-ray, blood work. 4 hours of observation in hospital. Still weak today, voice weak, and can't seem to take in enough oxygen to go on a walk or do simple yoga stretches.

Patient reported soreness after 1st day of vaccination which went away within 24 hours. However, several after weeks after vaccination patient developed soreness at the injection site with a raised bump and redness surrounding the area on 4/28. There was no associated weakness in the arm except due to pain which prevented him from lifting his arm. The patient experienced diarrhea for about a week prior. He did not see a doctor for this and attributed this to a viral illness. The soreness and swelling resolved after 4 days. The patient reported the reaction on 4/28. He was given a prescription for PT, but as it resolved by the time of his appointment, he did not see PT. The patient reports that the injection was high on his shoulder, about 2.5 fingerwidths below the joint. He denies experiencing joint pain.

Muscle and Joint aches, upset stomach, mild loss of balance, temperature 102.4, Pain at injection site. Lasted for 48hrs

10:20am Patient c/o dizziness and was put in the recliner chair with feet elevated. P88 and regular, Respirations 20, B/P 170/82. He was offered water and had no swallowing issue. His skin was cool and dry. He states he has had dizziness in the past. Nurse stat called. ER nurses arrived within a few minutes and he was agreeable to go to ER to be examined. Transferred via wheelchair with ER staff in stable condition.

Hello, Had the 2nd Moderna COVID-19 vaccine at the pharmacy on April 2nd at 6:45 PM. The nurse asked me to stay around the store for 15 minutes for any immediate side effects, and to drink plenty of water when I got home. Did some shopping, and probably left about 30-45 minutes after the shot with no side-effects, and when I arrived home about another 45 minutes later still had no side effects. Upon waking the next morning my right arm where I received the shot was extremely painful, and I could not raise any higher than parallel to the floor without extreme pain for 2-3 days. Then I also started with a slight fever, which of the times checked, reached about 101. Also was getting muscle and joint soreness, and later that started getting extreme cramping in my leg calf muscles while sitting on the couch. I then had to stand up for 5-10 minutes, or walk around a little and then after sitting the extreme cramping would begin again so I would have to stand up again. That went on all day. When laying down that night the cramping would subside enough to sleep a little on and off during the night. The calf muscle cramping started to gradually subside, but took about 17 days to go completely away. The day after the vaccine when my legs were cramping I was extremely worried about possible leg clots since I had never had extreme leg cramping like that my entire life, and I was drinking plenty of water like the nurse recommended. Best regards,

it was convulsive shaking; I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes; chill bumps; I could not stand up; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (it was convulsive shaking) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced SEIZURE (it was convulsive shaking) (seriousness criterion medically significant), TREMOR (I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes), PILOERECTION (chill bumps) and DYSSTASIA (I could not stand up). On 20-Apr-2021, SEIZURE (it was convulsive shaking), TREMOR (I started shaking so bad/I was shaking out of my skin/shaking lasted for 15-20 minutes), PILOERECTION (chill bumps) and DYSSTASIA (I could not stand up) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that, patient was scared to take the 2nd vaccine. Patient almost fell back. 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.

Feb 28, Sunday: went sleep around 12:45am, woke up 7:15 am, fever 100.6 F, dizziness, complete hearing loss in right ear, fatigue, stayed in bed for a few hours, fever continued through the day, 100.2 to 102.1 F Mar 1, Monday: went sleep 12:00 am, fever 100.4F. Woke up 8am, sudden hearing loss (SHL) in right ear continued, no change, and 99.6F in morning, dizziness, fever was gone by afternoon. SHL continued. Mar 2, Tuesday: SHL continued, dizziness, temperature 96.7F, body ache and soreness were less. Went to Otolaryngology for checkup and treatment at 11:40 am. Diagnose results: complete hearing loss in right ear. Received treatment: injection into right ear and prescription of Prednisone 10mg, injectio

Patient did not have any reaction to first dose of Moderna vaccine. After second dose he started to feel dizzy and had tingling effect on eyes, facial area , right arm . Also he lost his balance and fell from chair while waiting in post vaccination area after vaccination. Patient was given Benadryl and monitored for while . He felt better after 30 minutes but not completely. Patient refused to call 911. I also called him in the afternoon and he stated he still has tingling effect but he is getting better. I called doctor's office and spoke with nurse and informed her about adverse reaction.

feel weak; this one really scared me; bone pain; Dizzy; arm is still painful; I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened; Joint pain; Achy, body pain; worst experience, I was in coma for 2 days; hallucinated; was sweating all over; Did not eat in two days; not woke up, just sleep; This spontaneous case was reported by a consumer and describes the occurrence of COMA (worst experience, I was in coma for 2 days) and HALLUCINATION (hallucinated) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: PNEUMOCOCCAL VACCINE and Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine and PNEUMOCOCCAL VACCINE. On 05-May-2021 at 2:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced COMA (worst experience, I was in coma for 2 days) (seriousness criterion medically significant), HALLUCINATION (hallucinated) (seriousness criterion medically significant), HYPERHIDROSIS (was sweating all over), FEEDING DISORDER (Did not eat in two days), HYPERSOMNIA (not woke up, just sleep), BONE PAIN (bone pain), DIZZINESS (Dizzy), PAIN IN EXTREMITY (arm is still painful), CONFUSIONAL STATE (I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened), ARTHRALGIA (Joint pain) and MYALGIA (Achy, body pain). On 07-May-2021, the patient experienced FEAR (this one really scared me) and ASTHENIA (feel weak). On 07-May-2021, COMA (worst experience, I was in coma for 2 days), FEEDING DISORDER (Did not eat in two days), HYPERSOMNIA (not woke up, just sleep) and CONFUSIONAL STATE (I do not know what happened in the last 2 days, I woke up some hours ago did not know where I was, what had happened) had resolved. At the time of the report, HALLUCINATION (hallucinated), HYPERHIDROSIS (was sweating all over), FEAR (this one really scared me), DIZZINESS (Dizzy) and MYALGIA (Achy, body pain) outcome was unknown and BONE PAIN (bone pain), ASTHENIA (feel weak), PAIN IN EXTREMITY (arm is still painful) and ARTHRALGIA (Joint pain) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. The patient did not receive any treatment medication. No concomitant medication was reported. The patient spoke to his doctor about not getting the 2nd shot. 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 felt dizzy, like heart racing - pt had cold water & sat a few minutes longer then stated he was ok to leave. Pt has parkinsons & wife said he gets anxiety.

After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet; sweating; started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013; started walking slow; sleeping a lot; they were leaking out; got real sick; could not drive; what used to be daily life ended; arm hurting; my husband died in the hospita at 4:30 AM"; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (my husband died in the hospita at 4:30 AM") in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart failure since 2013. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet), HYPERHIDROSIS (sweating), ASTHENIA (started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013), GAIT DISTURBANCE (started walking slow), SOMNOLENCE (sleeping a lot), URINARY INCONTINENCE (they were leaking out), VACCINATION COMPLICATION (got real sick), IMPAIRED DRIVING ABILITY (could not drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (what used to be daily life ended) and VACCINATION SITE PAIN (arm hurting). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet), HYPERHIDROSIS (sweating), ASTHENIA (started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013), GAIT DISTURBANCE (started walking slow), SOMNOLENCE (sleeping a lot), URINARY INCONTINENCE (they were leaking out), VACCINATION COMPLICATION (got real sick), IMPAIRED DRIVING ABILITY (could not drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (what used to be daily life ended) and VACCINATION SITE PAIN (arm hurting) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: normal (normal) Normal. In 2021, Endoscopy: normal (normal) Normal. Reporter could not provide the list of concomitant medications or hospital details. 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. Regarding the event death, very limited information has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Regarding the event death, very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death

Dizziness Weakness Face dropped. Right side Breathing labored 30 mins. Benadryl given Happened again that night. Right side face droop and right side motor function affected. Still can't lift right leg correctly

Serious lower left back which I believe was my left kidney. The serious pain problems started the day after receiving the shot and lasted for at least two weeks. As the kidney pain started, my fingers started to feel numb and they have felt numb ever since. Left hand is a little worse then my right hand. Want to get second shot but?? I have walking pneumonia since 1973, since I was 15 years old, and will die if I get Covid 19. I need help to know what happened to me, and maybe monitor me during second shot. I am open research person. I am a 64 year old man that has had walking pneumonia since I was 15 years old in 1973. I know that if I do get Covid-19 I will quickly die. I need vaccination from Covid-19. I received my first Moderna Covid 19 vaccine on Thursday March 18th, 2021 after 3 PM and immediately had problems. I had problems in my left lower back which I believe was my left kidney. The serious pain problems started the day after receiving my first Covid 19 Moderna shot and the pain lasted for at least two weeks. Immediately as the kidney pain started, my fingers started to feel numb and they have felt this way ever since. This lead me to the situation of "I am damned if I do and damned if I do not". I want to get the second Covid-19 vaccine shot because I am truly scared to die if I do get Covid 19. But if I do get the second shot, what will happen to me? I am scared that it may have the kidney pain again, may worsen my numb fingers problem, and/or do other damage to my body. It may already have caused other problems? In summation, whether I get the second Covid-19 vaccination shot or not: Get the second shot: 1. Everything could be OK? 2. I could have Kidney pain again, possibly doing damage or more damage to my body, even my numb fingers could get worse! Not get the second shot: 1. Be lucky and not get Covid-19. 2. Get Covid-19 and die. I want very much to get the second Covid-19 shot, but I am scared and I find nobody cares about what had and has happened to me regarding my kidney pain and my fingers becoming numb, and any future consequences to me if I get the second shot. I do not know what to do. My current and main concern to me, for now, that if I do get the second Covid-19 shot I will get that kidney pain and may do worse damage to my fingers feeling numb or possibly other damage to my body. I am not sure what happened, as a non medical person I can only guess things like maybe I have blood clots that reduce the circulation in my hands. I just recently got on government assistance only because of this Covid-19 problem and I had a very hard time trying to find a job, I had no choice. I have not been on government assistance long enough to get financially stable to afford medical insurance, but I plan to do so as soon as I can. I tried to tell my doctor, but she kept telling me to go to the emergency room. So, I finally went to the Hospital on Friday April 16th. They checked my bloodwork and told me I was OK and OK to get the second shot, but I had really no explanation as to what had happened to me, my kidney, or my still numb fingers, or most of all, what might happen if I get my second shot. I am hoping to get help, for someone to care about me, my health, and my future health. The numbness in my left hand has been a little stronger than my right hand. I had the shot in the left arm and my left kidney had the pain, if any of these matter. The left kidney problem was very painful within 2 days. I could not do anything due to the pain. I could forget about dealing with my feet in any way, such as to tie or untie shoes, put on or remove socks, getting out of bed, and just about anything I did, any movement at all was very painful. What has me very worried is the continuous numbness of my fingers. I want to get back to work and my profession involves computers and keyboards, and my numbness in my fingers bothers me, even having problem feeling the raised bump on the ‘f' and ‘j' keys. The most immediate problem is trying to untie shoestrings, which I cannot feel to do due to my fingers feeling numb. This problem with my fingers affect my life in many ways continuously everyday. I cannot feel zip lock bag openings. I have had a left kidney problem once before over 2 years ago, which I believe was a result of doing Benicar for my blood pressure. I have only had that problem that once and I got off Benicar and have never had the problem since, not until a day after I had my first Moderna Covid 19 vaccine shot March 18th. For both of these times, the left kidney pain I immediately stopped all of my medicines and after a few weeks the pain went away. This time was muc worse than the first time. I have high blood pressure, diabetes, and high cholesterol and take medicines for these. I resumed these medicines after the pains went away. As to the fingers feeling numb, I have never had this problem in my life. My left hand fingers are a little worse than my right hand fingers. They feel as if they are very cold for frozen, or I have burnt my fingers. I have never felt this feeling ever in my life. At the beginning of, January 1st to be exact, when I was 15 years old and in the 10th grade, I came down with pneumonia and was very sick. It was not until the middle of March when my mother took me to the emergency late at night when she got a doctor to see me on the side. The doctor gave me prescriptions of antibiotics, cough syrup, and Guaifenesin (which was a prescription in 1973 and is the main ingredient in Mucinex). For the next 2 weeks I came home from school and laid down on the sofa and filled up about a third to a quarter of a medium size mixing bowl with phlegm from my lungs. After that doctors have told me I ruined my lungs and I will have walking pneumonia for the rest of my life. I have lived with this problem and have had to pay special attention to my lungs my whole life. When I saw on TV a report on the second e-cigarette and what if did to the lungs, I said that looks like what happened to my lungs when I was 15 years old. I recently saw news that someone had a similar problem. However, because of my walking pneumonia I need to get the second shot or vaccinated in whatever way, I want to live. Please help!

The evening of his second shot, he collapsed. He said he became light headed, but I believe he may have lost consciousness briefly. He rand a low fever for 12 hours. Afterwards, he complained that he had "not felt right" since the second shot. He died of a heart attack on May 27, roughly one month after his second shot.

Dizzynies, loss of balance, loss of apitite, chils, redness, swelling, mild fever, altered sense of smell and taste, headache, joint pain, muscle aches and pain, cough, "brain fog", extreem fatigue, body aches, shortness of breath, difficulty concentrating, loss of taste or smell.

Fine until about 4 a.m. on the 20th, day after vaccine. Woke up with uncontrollable shaking, nausea and teeth chattering, cold and could not move my left arm . Same arm as shot. I had a temperature of 101.2 Took tylenol, still sore and chills. Had to call in to work to say I was sick. Took naps mostly throughout the day, fever still persisting around 101. Took Tylenol, 2 hours later fever down to 99.1. Could not stay awake for long. Slept most of the day.

short of breath; Missed dose 2; heart rate dropped below 40; dizziness; "hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive); Pea Sized Nodes/nodes were tender; Sore Muscles; fatigue; fever; sore bones; patient felt like he was "hit by a bus"; This spontaneous case was reported by a consumer and describes the occurrence of BRADYCARDIA (heart rate dropped below 40) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced BONE PAIN (sore bones), MALAISE (patient felt like he was "hit by a bus"), MYALGIA (Sore Muscles), FATIGUE (fatigue) and PYREXIA (fever). On 16-Feb-2021, the patient experienced INJECTION SITE LYMPHADENOPATHY (Pea Sized Nodes/nodes were tender). On 18-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS ("hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive)). On 25-Feb-2021, the patient experienced DIZZINESS (dizziness). On 26-Feb-2021, the patient experienced BRADYCARDIA (heart rate dropped below 40) (seriousness criterion medically significant). On 26-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed dose 2). On an unknown date, the patient experienced DYSPNOEA (short of breath). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and Surgery (Pacemaker) for Bradycardia. On 19-Feb-2021, INJECTION SITE LYMPHADENOPATHY (Pea Sized Nodes/nodes were tender) had resolved. On 21-Feb-2021, INFLUENZA LIKE ILLNESS ("hit by a bus" and had a "bad flu"/Covid-19 like symptoms (not positive)) had resolved. At the time of the report, BRADYCARDIA (heart rate dropped below 40) was resolving and DIZZINESS (dizziness), DYSPNOEA (short of breath), BONE PAIN (sore bones), MALAISE (patient felt like he was "hit by a bus"), PRODUCT DOSE OMISSION ISSUE (Missed dose 2), MYALGIA (Sore Muscles), FATIGUE (fatigue) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: negative (Negative) Negative. On an unknown date, Heart rate: 40 bpm (Low) 40 BPM. It was reported that, in total the patient recorded 3 negative COVID tests. There was no history of cardiovascular disease in patient's family. The patient was advised by his doctor to not receive the second dose of the vaccine. Treatment medication include Advil. Company Comment : This case concerns a 63-year-old male patient who was advised by physician not to receive the second dose (product dose omission) due to adverse events. The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Injection site lymphadenopathy, myalgia, fatigue and fever are consistent with the product known safety profile. Product dose omission is not applicable. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Additional information received and case was upgraded to serious, Height, age, race and Ethnicity updated in patient tab, Suspect product Batch number and route of administration updated in products tab, Updated events and event outcome in events tab.; Sender's Comments: This case concerns a 63-year-old male patient who was advised by physician not to receive the second dose (product dose omission) due to adverse events. The remaining events are temporarily associated with the product use and hence, a causal relationship cannot be excluded. Injection site lymphadenopathy, myalgia, fatigue and fever are consistent with the product known safety profile. Product dose omission is not applicable.

Patient states the vaccine was administered to high on the shoulder and hit a nerve. Patient states they cant move their arm.

I started feeling cold and shaking and very bad headache and discomfort all over. I was bedridden for a couple of days, then it got a little bit better and then it got worse again. Then it got hard to breath. So I lost over 30 pounds in the matter of a month and that is unlike me, I have always been overweight and a food addict and so I called the DR and they told me to get a covid test because the symptoms were similar. I got the test and it was negative. I went to the ER and they said I got pneumonia, which I do not know is related or not but it did happen after the shot and seemed pretty odd. I tend to be the person to just tough things out. At the ER they told me pneumonia in my right light and gave me antibiotics. I called my pulmonologist when home because it was getting worse and he prescribed more antibiotics. I went to see him and he took another x-ray of my lungs. I still had stuff in my lungs so he gave even more antibiotics. He took another x-ray and CT scan recently that I do not have the results of yet. I have vertigo which just started about two weeks ago as well, I read about exercises to do for that and it helped a bit but it came back and now cannot get rid of it. It still is kind of hard to breath as well. I have no appetite which is weird for me and I am cold which is also very strange. I usually could go in a cold place of like 35 degrees and be fine and now I am just always cold. Even when I know I'm hot and know it's hot, I am cold and using a blanket. I shiver and shake so much from being so cold but my bed is soaking wet from sweating, it just doesn't make sense. I have a hard time going to sleep because I am cold and uncomfortable. Even today I am still very tired and now with the vertigo it is hard to do anything today, just talking a lot like right now I am out of breath.

4/15/21 At local Hospital with double vision, neuropathy, Bells Palsy type face with droopy eye, altered gate, swallowing issues. Hospital tested for stroke but could not find evidence ( CT, EEG, Xray Bloodwork) History did not include that he had neurological side effects for the first Moderna vaccination. He was rushed by ambulance to a much larger hospital. I realized the error of not telling the history of the Moderna neurological adverse event from the hospital and called the hospital. The hospital had already sent him on to a larger hospital. I then contected his spouse regarding the adverse event from the first dose of Moderna. 4/15/21 at secondary Hospital, MRI, CT, EEG, Xray, Bloodwork still found no evidence of stroke. Precious time was lost. I called the nurses station to relay the information regarding the neurological adverse event from the first vaccination and told them that he had just taken his second dose. Soon they had their diagnosis and a path to treatment. He was diagnosed with Guillaine-Barre Syndrome with Variant caused by the Moderna Vaccination. Ventilator inserted, causing pneumonia 04/17/21 Feeding tube inserted 4/17/21 Treatment started plasmapheresis plasma exchanges done 4/17, 4/18, 4/20, 4/22. 4/24, 4/26, 4/28 4/20/21 No infection of brain 4/24/21 patient suffered a respiratory arrest when left unattended. Died temporarily. 4/25/21 starting to respond to commands 4/29/21 trach inserted 5/10/21 Patient breathing on own, Trach sealed with red cap 5/16/21 getting physical therapy sessions Released to spouse and sent home. Hospital records may be obtained by going directly to the patient if he has recovered enough to help.

Patient states he developed "seizure symptoms" four days after second dose of Moderna COVID vaccination. Patient described "seizure symptoms" as a headache and chest pain severe enough that he was not able to drive. He took an aspirin for his symptoms and symptoms were completely resolved in two hours. Similar episodes occurred Thursday, Friday, and Saturday. Writer advised patient to seek emergency medical care for symptoms on Saturday for further evaluation. Patient was resistant, and writer stressed importance of evaluation of chest pain. Unable to follow up further.

about 4 days after vaccine administration patient developed rash behind right ear and periauricular area, persistent headache, scalp tender to the touch as if he had sunburn, seen 3/21/21 diagnosed with shingles prescribed valtrex rash resolved in about 3 days. 4/1/21 patient seen again continued headache, diminished hearing on right side, rash resolved. Audiologist referral placed meclizine prescription given. 4/12 seen again, dizziness, ringing in right ear, hearing loss, dizziness is not positional but emanating from the right side. Lightheaded, woozy feeling, numbness/tingling, and sunburn-like feeling around right ear down neck. Chiropractor performed epley maneuver no improvement, meclizine ineffective. Now also describing "feels like water in ear". 4/15/21 Audiogram demonstrated sloping sensorineural hearing loss right ear with STS score of 76% and type A tympanogram, symptoms persisting urgent ENT referral sent. 4/28/21 seen by ENT Right ear with hearing loss and disequilibrium prednisone 60mg once daily in the morning prescribed, repeat audiogram 1 week, MRI with contrast ordered. 5/7/21 ENT completed course of prednisone hearing has significantly improved on right side still describing equilibrium, NOT acute episodic vertigo. Audiogram SDS improved from 76% to 92% and SRT improved 30-10DB. Physical therapy offered. 5/18//21 MRI performed impression: 1-no acute findings, no acute neuroma, no abnormal enhancement temporal bones eitherside. 2-several nonenhancing white matter T2 Flair hyprintensisties bilaterally 3-giant cisterna magna 4- generalized cortical atrophy 6/7/21 follow up with ENT still experiencing disequilibrium MRI does not show any significant pathology to account for hearing loss or disequilibrium. 7/7/21 follow up with PCP patient reports he is not feeling any better, symptoms of loss of balance and tinnitus continue although hearing in right ear largely improved.

Head pressure; Dizziness; Headaches; such imbalance he couldnt stand for an hour; Started losing balance and kept getting worse every day; vertigo; Mini strokes; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head pressure), DIZZINESS (Dizziness), HEADACHE (Headaches), TRANSIENT ISCHAEMIC ATTACK (Mini strokes), BALANCE DISORDER (Started losing balance and kept getting worse every day) and DYSSTASIA (such imbalance he couldnt stand for an hour) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 12-May-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 26-May-2021, the patient experienced BALANCE DISORDER (Started losing balance and kept getting worse every day) (seriousness criterion hospitalization). On an unknown date, the patient experienced HEAD DISCOMFORT (Head pressure) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization), HEADACHE (Headaches) (seriousness criterion hospitalization), TRANSIENT ISCHAEMIC ATTACK (Mini strokes) (seriousness criterion medically significant), DYSSTASIA (such imbalance he couldnt stand for an hour) (seriousness criterion hospitalization) and VERTIGO (vertigo). On 26-May-2021, BALANCE DISORDER (Started losing balance and kept getting worse every day) had resolved. At the time of the report, HEAD DISCOMFORT (Head pressure), DIZZINESS (Dizziness), HEADACHE (Headaches), TRANSIENT ISCHAEMIC ATTACK (Mini strokes) and DYSSTASIA (such imbalance he couldnt stand for an hour) outcome was unknown. Concomitant product use was not provided by the reporter. 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. Very limited information regarding medical history and the events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding medical history and the events has been provided at this time. Further information has been requested.

husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred; can't drive anymore; first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred) and CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Knee replacement and Carpal tunnel syndrome. Concurrent medical conditions included Overweight and High cholesterol. On 10-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) (seriousness criterion medically significant). On 26-Jun-2021, the patient experienced FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred) (seriousness criterion hospitalization). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (can't drive anymore). The patient was hospitalized for 2 days due to FALL. The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at a dose of 325 milligram once a day and ATORVASTATIN CALCIUM (LIPITOR) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred), CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) and IMPAIRED DRIVING ABILITY (can't drive anymore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications 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. The patient's medical history of Hypercholesterolemia and being overweight are possible confounding factors.; 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 medical history of Hypercholesterolemia and being overweight are possible confounding factors.

Pt states that he experienced local reaction at site of Moderna injection which was red and hot- approximately 4"x6", severe body aches, extreme fatigue. He states that he was only able to get out of bed to use the restroom. He was unable to leave his home for 4-5 days following the immunization.

Pain at injection site; much less than flu shot. No treatment. Resolved by Jan 2. Brief bouts of dizziness and nausea; stayed home from work and rested. resolved by Jan 1. Seasonal allergy symptoms- runny nose, including bloody nose from left nostril. Resolved by Jan 2. Allergic reaction to a scented hand cream used by wife- burning eyes, nasopharyngeal tightness, nasal discharge. Wife since removed so I can't tell you brand. Occurred/Resolved Jan 1 when product was removed.

On 12/31/2020, at approximately 00:15, pt developed a fever of 102.9 F and tachycardia with rate of 120. He was treated with acetaminophen. Later in the morning, he complained of nausea, generalized muscle aches, intermittent increase in confusion. At approximately 14:00, he had a fall out of bed and at that time noted to be short of breath, tachypneic. He was taken via ambulance to Emergency Department. From there he was transferred to Hospital for admission with acute respiratory distress, suspected sepsis with lactic acid 7.4 and Bilateral Pulmonary Emboli. He was started on heparin and broad spectrum antibiotics and transitioned to ELIQUIS on 1/3/2021. Infectious etiology of sepsis was unclear. He continued broad spectrum antibiotics with clinical improvement. Abdominal CT scan was obtained due to intermittent nausea, vomiting, abdominal pain, loose stools. His heart rhythm flipped to Atrial Fibrillation with RVR on 1/2 and his rate improved with titration of metoprolol. He was also treated with prednisone for suspected underlying undiagnosed COPD. It is noted in his hospital summary that PEs presumed provoked in the setting of his recent COVID 19 infection. He was discharged from the hospital on 1/8/2021 and readmitted to the Veterans Home. He has been stable.

patient states he felt fine the day he received the vaccine, but at 0500 on 1/15/2021 he was woken out of his sleep having difficulty breathing. He estimates this episode lasted 30 seconds- 1 minute. he drank a sip of water thinking that would help. He then had a second more severe episode that lasted about 2 minutes. "I could not breathe, it felt like I was under water". H stated that after the episodes he felt jittery and very fatigued the rest of the day. He stated that the second episode was the worst he had ever had and thought he was going to pass out. He is a nonsmoker with NKDA. He does have asthma. He is on an inhaler and has a rescue inhaler. He stated that his last episode was 3-4 months ago, but these episodes were different. " It was a bigger fight to breathe". On 1/18/2021 at 2100 He had another episode that lasted 1-2 minutes. He used his inhaler, and improved. He was weak and dizzy after this episode and was unable to go to work.

Patient had an argument about some issues, so he got excited while he was waiting for observation in the post vaccination area. He had a complaint of feeling of light headed and anxious . No SOB, no chest pain, no headache, no dizziness, no visual problems. Vital signs: BP-142/90 HR-84 O2 Sat-99% He had good color, good O2 saturation and was alert and active, Oriented X3 in NAD. I told him to relax ,take deep breaths and was watching him for almost 30 minutes after he reported feeling light headed. Lungs was CTA and heart rate was normal. H/O HTN. Informed patient to relax gave him post vaccination care instructions and told him to drink enough fluids and take Advil or Tylenol PRN for pain relief.

Patient received Covid- 19 vaccine on 1/15/2021 at 5.15pm. On the 1/16/2021 around 8.35pm, he had chills and required assistance for walking and up on nurse assessment his temperature noted to be 101.9 F. nurse administered Tylenol 650mg and fluids were given. Up on follow up assessment of nurse on 1/17/2021 at 1.03am, the repeat temperature was 103.6F per ear probe. Due to high fever the 911 was called and was taken to ER. Normal assessment per ER evaluation and discharged to center with the diagnosis of vaccine reaction without any labs or chest x ray. Up on return to center, his temperature was 101F around 3.45 am on 1/17/2021, he was placed on increased oral fluids and Tylenol given as needed basis for fever. No more spiking of fever noted after that. He was hospitalized for Covid - 19 pneumonia from 11/6/2020 to 11/20/2020 at center, during the hospitalization he had intermittent spiking of temperature [101f-102F]. He had prolonged hospitalization due to intermittent fevers only and did not require ICU care. His work up was negative for infection other than Covid -19 infection and received broad spectrum antibiotics. He lives in facility for developmentally delayed individuals, due to group home setting & high risk of mortality in developmentally delayed [DD] population with Covid -19 infection - it was decided to vaccinate with Covid -19 vaccine after 2 weeks of Covoid -19 infection with they remain asymptomatic after 14 days of isolation with contact & droplet precautions.

Following vaccination, patient experienced lightheadedness, dizziness, headache and nausea. BP elevated. Blood sugar 315. Little improvement following rest in reclining position. Transferred to the hospital via ambulance. Next day, family reported patient was released from the hospital that evening and has resumed activity . No rash or wheezing noted during the episode. Telephone call to patient x2 for more information to complete VAERS but did not return my calls.

Patient received his second dose of COVID vaccine (Moderna) on 1/20/2021. Patient reported his joint stiffness symptoms about 8 hours after the vaccine. However, symptoms exacerbated on 1/24/2021. Patient endorses low grade fever and joint inflammation in the bilateral knees, finger stiffness, and left hip post vaccine. He notes hearing his right knee "pop," while he was walking. Patient was on crutches due to his pain and the popping noise of his knees. He notes symptoms have minimally subsided, however, his right knee continues to worsen. Patient notes his right knee feels like their is fluid in there. He didn't turn in his vaccine card due to not having a smart phone.

Starting at 9:30pm I started having violent shaking and chills, Temperature 100, followed by severe body aches and profuse sweating throughout the night. By the following morning shakes and chills dissipated but body aches and fatigue persist with some light headedness and mild cold sweat.

Patient complained of diaphoresis and light headedness about 5 minutes after receiving 2nd dose of Moderna Covid vaccine. Patient was able to ambulate to cot. Blood pressure, heart rate, and respirations all within normal limits. Patient given water and observed for an additional 30 minutes. All symptoms resolved.

Patient reports feeling slight lightheadedness and dizzy, flushed, (but no sweating) for a few seconds post vaccination. Patient was seen and cleared by EMS (BP 118/81, HR: 72). Instructed patient to call PCP, 911, or go to the nearest emergency room for any further issues.

After receiving Moderna vaccine, client became nauseous and diaphoretic. Laid down and lost consciousness. Came to within seconds. Denied any head injury or headaches. Complained of dizziness. O2 initiated 10L nonrebreather. Declined epinephrine. EMSA called. Client transported to hospital via EMSA for further evaluation.

Vaccine given in clinic per protocol - patient monitored for 15 minutes, no adverse reactions noted at the time. Patient stated he felt fine following 15 minute monitoring time. Patient left facility- it was later reported that pt had a fall at home. Upon review of pt's medical record - Pt's wife had to initiate CPR and call EMS for transportation and life saving measures enroute to the Emergency Room. Pt was intubated as pt was in asystole upon arrival to the ER, ACLS was continued, pt was noted to have a traumatic brain injury from his fall at home, and pt was pronounced dead at 1620.

HE FELT DIZZY AFTER RECEIVING THE VACCINE. HE BROUGHT HIS OWN BLOOD PRESSURE MACHINE. ON SITE EMS RESPONDED VITALS BELOW. HE HAD CRACKERS AND WATER. HE FELT BETTER AND WAS RELEASED TO HOME

Fever of 101, neck muscle pain, leg and back pain, dizziness starting 10 hours after second vaccination and lasting 26 hours (so far)

I started having dizziness two days after I received the 1st shot, it was strong the first 5 days, then it was lightly, mostly lightheaded and some dizziness depending on how I move my head. Today I have been dizzy for a couple of hours in the morning. My concern is that is not going away and I am worry, not knowing what to do. I contacted my PCP and left a message, I haven't talked to her yet.

Pt's right arm and R side of neck where numb and pt. was dizzy, lasted 10min then went away, O2 @2lt was given and vitals where normal, Pt was monitored for 30 min and pt was allowed to leave . Pt was fine when he left

Intense dizziness, hard to walk straight , very troubling. Only been a couple days but have read a forum on last which others reporting lasting for weeks. I am very concerned, I would not like to live like this permanently

First unusual symptom the day after vaccine - felt as though we were experiencing an earthquake. Unsteady balance since then. I had aches common with flu shots, which are now (3/9) gone - these are not a problem. Yesterday my apple watch said my heart beat was below 40 bpm for ten minutes a few times. I tend to have a low heart rate so not a major surprise. But last night when I got up, I lost balance and fell, hitting my head on a chest. No major damage. But feeling of dizziness is still a little present.

Severe shortness of breath. RR 50. Severe chest pain unable to take deep breath severe back pain unable to move.

I left the vaccination feeling nothing at all. I awoke the next morning with a moderate pain/discomfort in my left upper arm at the vaccination site. I went to work because I felt okay. I have five years of recovery. As a result every 8-12 moths I undergo an episode of about three days where my brain forgets how to sleep properly. So the morning after my injection, I was on my second day of irregular sleep. Around 10 am, the side effects started kicking in. I had a slight to moderate pain above my ear on the right side of my head. I probably had a slight fever as I felt warm and sweaty for about four hours. I felt slight to moderate chills during the height of my discomfort for about four hours. I could hardly walk the five blocks to my girlfriend's home because I was very conscious of my breathing. (I have been a heavy cigarette smoker for 4o years and an developing a heightened awareness of my breathing and pulse as I feel that I am overdue for a stroke or heart attack after 40 years of heavy smoking.) Therefore his side effect was largely hypochondriacal. I took off work yesterday even though the side effects had subsided. Today, I feel great. I feel so great that I laughed at the entry below - "Patient Died".

Severe headache...nausea...dizziness..severe joint pain..uncontrollable body temps from cold to hot over and over

On 3/9 - sore arm On 3/10 - fever, body aches, sore arm On 3/12 - woke up dizzy, sweating, pale., very low BP, severe drop in hemoglobin count. Admitted into hospital. ER dr name unknown so provided family dr nane

I was awakened with severe chills,runny nose,hot head,nausea,short of breath,unable to walk because of severe shaking,blurred vision,slight headache,exhaustion

ADVERSE EVENT REPORT: MODERNA VACCINE 1 of 2 Dates: Feb. 17 to March 16, 2021 1. I received the first dose of the Moderna Anti-COVID19 vaccine at the Outpatient Clinic on Feb. 17, 2021 at 1:31PM. I have been suffering from Gulf War Illness (GWI) for over four years. a. My condition is a combination of ME/CFS and Fibromyalgia. Please review these CDC pages for details: https://www.cdc.gov/me-cfs/index.html and https://www.cdc.gov/arthritis/basics/fibromyalgia.htm. b. GWI a neuro-immunologic disease that is still not well understood by the medical community. 2. Feb. 17, 2021. I received the FIRST MODERNA VACCINE SHOT on my right arm on Wednesday, Feb. 17, 2021. The injection site hurt for two days (Feb. 17 & 18, 2021). I had the following side effects on Feb.17, 2021: chills, headache, joint pain (arthralgia), muscle pain (myalgia), fatigue, nausea, and swollen glands. 3. Feb 18, 2021. I had no side effects. 4. Feb. 19, 2021. I had a headache. 5. Feb. 20, 2021. On Saturday, Feb. 20, 2021, I walked one mile in 29 minutes. I felt tired, weak, short of breath, and I had to stop walking on 4 separate occasions. I produced phlegm. The phlegm secretions were white, very thick, and extremely sticky. I started Mucinex 1200MG (guaifenesin) and Neil-Med Saline Solution nose irrigations this day. 6. Feb. 21, 2021. On Monday, Feb. 21, 2021 between 1AM to 7AM, I had itching at the injection site (right arm), chills, headache, arthralgia, myalgia, fatigue, nausea, and swollen neck glands. 7. Feb. 22, 2021. From 8AM to 4PM my side effects were itching at the injection site (right arm), chills, headache, arthralgia, myalgia, fatigue, nausea, swollen neck glands, coughing, and stomachache. At 5PM I had difficulty breathing. It lasted until 8PM. I took albuterol via nebulizer and was observed by my wife and son to ensure that I did not get worse. 8. Feb. 23, 2021. No side effects. 9. Feb. 24, 2021. I had a headache and a runny nose. 10. Feb. 25, 2021. It has been 8 days since I received the first dose of the Moderna COVID19 EUA. The side effects have been chills, cough, shortness of breath (oxygen saturation of 95%), and thick white and sticky phlegm. Today my neck glands and tongue are swollen. My throat, and the inside of my ears hurt. My nose is runny, like if I had a cold, and I sneezing often. My chest congestion has moved from my chest to my nose sinuses. I have no nausea today. I have no fever. My injection site does not hurt. My Rosacea became active today. Today, I wore an N95 mask to ensure that I did get anyone in my family sick. They all wore their N95 masks. At 6:35 PM, I had a Gulf War Illness ?crash? and was bedridden until 9:06 PM. At 9PM both my malaise and nausea were back. 11. Feb 26 to Mar 2, 2021. I had no Moderna vaccine side effects. 12. Mar 3, 2021. I had four explosive vomiting episodes starting at 10AM. Initially, I thought that the vomiting had nothing to do with the Moderna vaccine. However, my son ate the same food that I did and he did not vomit. I vomited so hard that my son wanted to take me to the Emergency Department, but I refused. I vomited four times today Saturday, March 3, 2021. Every time I vomited it sounded horrible to my family members. The vomit had an extraordinarily strong nasty smell. 13. March 4, 2021 to the present. I have not experienced any Moderna vaccine side effects side March 3, 2021. In conclusion, for any questions regarding this Adverse Event Report please email me. Thank you. Very respectfully,

Dizziness started on 3/14/21. Dizziness when standing, lying down and sitting. Leaning back in recliner and getting up.

Bad Dizziness the next morning after the shot. Each day it is getting less but has not gone away. I have not gone to the doctor. I am concerned because I know this shot was the smaller dose of the two and when I get the next shot will the Dizziness be more severe?

MILD ITCHING: OVERALL BODY ITCHING MANIFESTED APPRX. 4 HOURS AFTER INJECTION ESPECIALLY AT FEET, EYES, HANDS AND ARMS. NO RASH. PATIENT TOOK DIPHENHYDRAMINE FOR ITCHING. ITCHING LASTED APPRX. 24 HOURS. AUDITORY SENSITIVITY: MINOR SOUNDS SEEMED AMPLIFIED. TO THE POINT OF IRRITATION TINNITUS: SEVERE TINNITUS 4 TO 10 HOURS AFTER VACCINATION. HAD SOMEWHAT DISAPPEARED BY 8 AM FOLLOWING DAY. PATIENT STILL HAS MINOR TINNITUS. MUSCLE AND JOINT STIFFNESS: MUSCLE AND JOINT STIFFNESS MANIFESTED APPRX. 2 DAYS AFTER INJECTION AND LASTED FOR APPRX. 5 DAYS TOTAL. PATIENT HAD NO INJECTION SITE REDNESS OR SWELLING. PATIENT DID NOT SEEK MEDICAL TREATMENT FOR SYMPTOMS.

Officer reported feeling dizzy, blurred vision, lips were numb and tingling to the left side of his face. Vitals signs were taken and his condition and complaints were reported to NP. An evaluation was done and a granola bar was given since the officer reported he did not eat this morning. Another set of vital signs were taken and then NP consulted with Dr. who recommended that the officer be seen in the ER for further evaluation. Officer was then transported to local ER by wife.

Moderna COVID- 19 Vaccine EUA: patient presents to the emergency department (ED) with shortness of breath, dizziness, abdominal pain, nausea, cough, malaise, and headaches. Symptoms started four days prior to arriving in the ED when shoveling snow. Three days prior to arriving in the ED patient received vaccination and reports fever and persistent shortness of breath ever since. Seen by primary care provider one day before presenting to the ED and prescribed prednisone but did not take it. Initial vital signs showed tachycardia, fever, tachypnea, and decreased oxygen saturations on room air. Physical exam noted faint wheezing. Patient placed on oxygen, received albuterol, ipratropium, and steroids with improvement. Patient discharged to home with steroids, inhalers, and oxygen.

Upon waking on the third day after receiving the second dose of the Moderna vaccine, I've experienced vertigo/disorientation. This side effect has continued a second day causing me to notify my primary care provider and preparing this event report. Other side effects experienced after the second vaccination were soreness at the injection sight, mild fatigue, and slight fever which were all anticipated. These side effects have passed.

On 3/20/2021 I woke up with vertigo (never have had it before). After symptoms persisted all day iwent to Doctor on 3/21/2021. After examination of the ears was normal I was prescribed Meclizine 25 MG tablet (1 tablet 3xs/day by mouth); Ondansetron ODT 4 MG Tablet (1 tablet by mouth prn for nausea every 8 hours); and, Fluticasone Proprionate Nasal Spray USP (2 sprays in each nostril every day at bedtime). Symptoms persisting today and I have made an appointment with my ENT for tomorrow 3/23/2021 at 8 a.m. for evaluation. Saw on website that numerous similar reactions thought by the reporters on that website to be vaccine related so I thought that I should report my situation.

Acute neuropathy pain in their left foot particularly in the lateral aspect; Made walking difficult and running (which they do frequently) impossibl; Two weeks of significant discomfort; A spontaneous report was received from a Physician concerning a 64-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced acute neuropathy pain in their left foot particularly in the lateral aspect/neuropathy peripheral, made walking difficult/gait disturbance and two weeks of significant discomfort/discomfort. The patient's medical history included kidney removed because of cancer. Concomitant medications reported included vitamin d3, calcium carbonate, cyanocobalamin, calcium levomefolate and curcumin. On 9 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 024M20A) in the left arm for prophylaxis of COVID-19 infection. On 21 Feb 2021, the patient experienced medically significant event acute neuropathy pain in their left foot particularly in the lateral aspect, made walking difficult and two weeks of significant discomfort. Treatment details included paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, acute neuropathy pain in their left foot particularly in the lateral aspect was considered resolving (gotten gradually better). The outcome of events, made walking difficult and two weeks of significant discomfort was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Vertigo starting one day after vaccine and resolving spontaneously after 3 days, also had some sweating (did not check for a fever)

Patient was standing from chair in observation area to be checked out and upon standing stated was dizzy. He stated a spinning feeling, like coming from inner ear. I had him sit in chair for 15 more minutes in front of me and he started to feel better. We then moved him to chair in observation chair for 10 minutes and he stated feeling better. He then went home

On 03/26/21 received my shot and about 20 minutes later i started to have side effects. My lower back started to hurt, a bad taste came into my mouth, I started to feel woozy like i was looking through a glass gallon jar. A PA came in and took my blood pressure which was very high for me. I walked around for awhile and felt a little better. Took a trip to to pick up a Discharged patient but had to stop several times because my heart was racing causing me to start sweating. On 03/27/21 around 02;30 am i woke up to a left arm swollen down to my finger tips. Both of my legs had severe muscle cramps in the upper and lower muscles. It took 2 hours to come out of that. My leg strength was almost gone and now I had a severe pain in the ball of my left foot. The site were I had to shot was burning like it had been branded. I had brain fog couldn't remember what i was doing up. Though I had no breathing problems I was sweating like I had a bad fever. I noticed also that my vision became light sensitive! It was hard to watch the tv with the screen light which looked too bright to me. The site on my left arm were I strained the muscle hauling 70 lb sandbags became a very sensitive area. the swelling on my left hand was so bad I had to put lotion on the creases to relieve the stretching pain I felt. The headaches are a constant now even with my ears starting to ache too. Also the my eyebrow hair was very sensitive to touch. Had to go to the bathroom a couple of times but not as much as i thought I would. Both shoulder blades are constantly aching like my left hand fingers.

Extreme dizziness. Felt a bit clouded in the first 24 hours after the second shot of Moderna's Covid vaccine. The morning of the second day I woke up extremely dizzy. Hard to get up. Still experiencing dizziness. By dizziness I mean "Disequilibrium relates to a feeling of unsteadiness or impending fall. " Again, this is after the second shot Lot information above is for second shot Lot # for first shot was 012A21A

Moderna COVID-19 Vaccine EUA Mild headache/eye aches, vertigo, no elevated body temp. Eight days after injection got a large, splotchy rash around injection site. At nine days the rash turned into a 2"x4" hive with various hive around it on my shoulder and neck.

1.) Strong soreness in lower back and gut area. Hard to bend over. I don't typically suffer from back pain and didn't exert or do anything that might have strained muscles. Pain seems muscular in back and deep in lower gut/groin area in front. 2.) More concerning is the tinnitus or ear ringing I am experiencing. Very loud and unrelenting. Feels like ears need to be popped such as when air pressure changes. However, can't swallow hard or chew hard enough to clear ears. It's a bit flummoxing as it is unrelenting. Sounds like cicadas in my head.

2:15 pm. Complained of dizziness, blurred vision and diaphoresis. Stated he has prior fear of needles. 2:20 VS 95/65; p79; Sat 97. R. 14. Offered water, cereal bar. Stated he felt better. Assessed by NP and onsite EMS. Remained in Observation for 30 minutes. Discharged home 2:50 pm. All symptoms resolved.

Pt stated that he began feeling dizzy soon after the vaccine. States he had not had any food this morning or much water. States he took all three BP medications this morning consisting of carvediolol 12.5 mg, propanolol ER 120 mg and chlorthalidine 25 mg. We wheeled pt to private observation area. BP labile ranging from lowest reading of 89/62 with HR of 55. Positive for positive orthostatic BP. Provided pt with multiple small bottles of water, pack of crackers and other snacks. 12-lead EKG performed, which was supportive of his condition of cardiomyopathy/CHF. Other conditions of hep c, HIV, and COPD. Monitored pt from 09:42 to 11:00. Sitting BP of 119/76 with final standing BP of 128/73 with HR of 58; pt denied subjective feelings of dizziness and felt well to drive home. EMS walked with pt to his car and he left in stable condition.

Medical Summary - Friday, April 9, 2021 Patient received 2nd Moderna vaccination at Care Center. (1st Vaccination at Care Center unremarkable.) Approximately five minutes after vaccination, seated in Observation area patient leaned forward with elbows on knees, when asked stated he felt light-headed, put his head between his knees, wanted to lie down. He lowered himself to floor, with help transferred to different chair, sipped water, given lollipop, suddenly unresponsive, eyes glazed and rolled back, teeth clenched on lollipop stick, leaning to left side, incontinent of urine, no abnormal arm or leg movements, duration ~ or under 1 minute. Lollipop removed by staff, vitals: BP 1 Additional information for Item 18: Lollipop removed by staff, vitals: BP 117/72, P68, SpO2 Room Air 96%: now alert and oriented x4, no shortness of breath, no chest discomfort, able to sit in chair without support, was surprised by incontinence. Stated he felt sleepy, tired, and with staff assistance walked to next room for observation where he laid down on carpeted floor. He had no further episode of LOC, remained alert and oriented but continued to feel "tired". No complaints of chest discomfort or shortness of breath. ~ One hour post-incident BP 94/58 with repeat BP 120/82. ~ Two hours post-incident BP 118/80 (his usual he said) sipped water and electrolytes solution. Patient verbalized several times this event much different from previous events associated with blood draws which he described like typical vasovagal reactions with recovery within ~ 15 minutes. Drs. spoke with patient via telephone: PLAN o Can go home today o Do not drive today o Son will pick him up and stay with him for about 24 hours until wife returns from out of town o Appointment scheduled with PA at PMD office for Monday April 12 @ 8:00am – Patient called the office and I listened via speaker, his PMD is out-of-office till later in month, this is first available at the practice o Dr. recommend PMD work-up to also include EEG and CT Scan o R/O vasovagal event v. seizure v. other etiology o Dr. will contact him by phone later today PA-C MD

Received vaccine approx 11:20am, no issues until 10:30pm when I started to feel chilled. I took my temp with a forehead thermometer and it read 98.x. I put the thermometer on my nightstand thinking it prudent to have it handy. In bed under covers I kept feeling cold and started shivering/teeth chattering, within an hour or so my forehead thermometer read 102. My recollection of the time between midnight and 2 to 3am is vague as I was very disoriented, I recall taking my forehead temp several times during those hours - that took a lot of effort, and I saw several readings of 105 and I believe one over 106. I remember thinking I should be in the ER, then thinking how could I get there, then thinking I would call 911 but that I could probably not get my mind/body to be able to physically make a phone call. I believe that during this time span I had brief periods of consciousness when I was somewhat aware that I was having a high fever event, but that there wasn't much I could do about it (I live alone). By 4am I was more aware, forehead temp reading was 102.something - I got up and made my way to the kitchen, I was unsteady on my feet and remember telling myself to be careful and not to fall. Temp gradually dropped throughout Tuesday, mostly back to normal on Wed.

Client became ill approximately one hour after COVID immunization. Symptoms include weakness, light headed, general malaise. Client refused wife's offer for medical assistance.

14 days after 2nd dose severe shortness of breath, fatigue, lightheaded, near syncope. Diagnosed with bilateral DVT and bilateral PE

First dose received 3/17/2021. First two days I had muscle aches. Third day, lack of coordination and fatigue. Fourth day also had chills, sneezing and runny nose. Brain fog, fatigue and lack of coordination improved over the following days. The second dose receive 4/13. First day fatigure, chills, lack of coordination and muscle aches along with a lot of soreness at the site of the injection. Second day also had dizziness, mild abdominal cramps and mild headache. Could not eat until midday. The third day dizziness, brain fog and lack of coordination continue. Close to a point of seeking medical care but probably worth filing a report.

Rheumatoid arthritis; kidney failure /dialysis; could not walk due to severe joint pains; fever; severe joint aches; severe body aches; extreme chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and RENAL FAILURE (kidney failure /dialysis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis (Rheumatoid arthritis). On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (fever), ARTHRALGIA (severe joint aches), MYALGIA (severe body aches) and CHILLS (extreme chills). On 05-Mar-2021, the patient experienced RHEUMATOID ARTHRITIS (Rheumatoid arthritis) (seriousness criteria hospitalization and medically significant) and RENAL FAILURE (kidney failure /dialysis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced GAIT INABILITY (could not walk due to severe joint pains). The patient was hospitalized from 05-Mar-2021 to 15-Mar-2021 due to RENAL FAILURE and RHEUMATOID ARTHRITIS. On 15-Mar-2021, RHEUMATOID ARTHRITIS (Rheumatoid arthritis) and RENAL FAILURE (kidney failure /dialysis) outcome was unknown. At the time of the report, GAIT INABILITY (could not walk due to severe joint pains), PYREXIA (fever), ARTHRALGIA (severe joint aches), MYALGIA (severe body aches) and CHILLS (extreme chills) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Feb-2021, Body temperature: 103 (High) 103 Fahrenheit. In 2021, White blood cell count: high (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Patient was prescribed Mobic at urgent care. In urgent care blood work was performed, white blood cells were elevated and inflammatory rate increased. Two doses of antibiotics ((product name not provided) were prescribed. Based on the information provided, a causal association between the event of renal failure and the administration of mRNA-1273 - is assessed as not related as event was reported as due to treatment with Mobic and more likely pre-existing. Based on temporal association between the other reported events and the product, causal relationship cannot be excluded. Pyrexia, arthralgia, myalgia and chills are consistent with the product known safety profile.; Sender's Comments: Based on the information provided, a causal association between the event of renal failure and the administration of mRNA-1273 - is assessed as not related as event was reported as due to treatment with Mobic and more likely pre-existing. Based on temporal association between the other reported events and the product, causal relationship cannot be excluded. Pyrexia, arthralgia, myalgia and chills are consistent with the product known safety profile.

Patient received 2nd dose of the Moderna series. Explained that he had COPD and a post traumatic event from a hospital but received previous dose with no issue. After receiving the vaccine, patient stated he was hot and dizzy. An another associate gave the patient water. Patient still had complaints of dizziness and I confirmed that the patient was not having an anaphylactic shock (patient was still able to breathe, talk, and no signs of swelling, hives, or itching). Proceeded to place patient to lay down with his feet elevated with feet with pillows and fanned him while store management and 911 was called. Continued to fan patient until ER services came to assist.

Randomly approx 4-5 times over the next 3 weeks, first my left eye, and then my left eye would go black from the outside in, as though I was going to pass out. I would remain still and my vision would come back, first in the right eye and then the left eye. It always happened the same way. My left eye would begin to go black from the outside circumference to the middle, losing site, and then the right eye would start to do the same thing. It hasnt happened again after that first month of reoccurrences, and it never happened before the shots.

PATIENT STATES: WITHIN FIVE MINUTES OF INJECTION MY FACE BEGAN TINGLING ON THE LEFT SIDE STARTING IN MY CHIN AND MOVING UPT O INCLUDE MY ENTIRE MOUTH, LIPS, UNDER MY LEFT EYE AND THE ENTIRE LEFT SIDE OF MY FACE AND HEAD. THE TINGLING BECAME NUMBNESS AND VISION ISSUES IN MY LEFT EYE. I STARTED EXPERIENCING HEART ARRHYTHMIAS DIZZINESS AND VERTIGO. I THINK IT WAS CAUSING ME SOME STRESS, WHICH CAUSED ME TO BE HYPERSENSITIVE TO EVERTHING. I WAS SITTING IN MY CAR FOR THEREQUIRED 15 MINUTES AND AT THAT TIME I WENT INTO THE PHARMACY TO REPORT IT BUT THERE WERE SO BUSY THAT I COULD NOT GET ANYONE'S ATTENTION TO ALERT THEM SO MY WIFE AND I LEFT. WE WENT TO A COFFEE SHOP, I HAD SOME CAFFEINE AND I FELT OK TO DRIVE BACK HOME TO REST.

pale, clammy, sweating, lightheadness, possible absence seizure after 2nd shot. He waited his 15 minutes, and was waiting on his wife's 15 minutes, when he started to feel badly. Ambulance came to make sure he didnt have a seizure and his vitals were okay. patient said he had not eaten before shot and walked to a nearby restaurant to eat.

HEADACHE, STIFF NECK, CHILLS OF SHORT DURATION, LEADING TO IMBALANCE, FINE TREMORS, SEVERE "HEAD FOG", DYSPHAGIA,

Low grade fever, chills, bilateral hip pain/stiffness, left arm pain/stiffness. Symptoms still occurring 16 days after second injection. I usually hiked 5-10 miles/day prior to vaccination. Now I hike 5 minutes and have to rest due to fatigue and hip pain. Have difficulty using left arm due to shoulder pain stiffness.

1st moderna lot number 027A21A given 3/14/21. Pt woke up with right side weakness and aphasia. Still ambulating on his own. At 0800 he went with his wife to get his second Covid-19 vaccination. Symptoms progressed until he was unable to speak or move his right side at all. Family called 911. Pt admitted to hospital with Dx of Left MCA Stroke.

Patient states started feeling light headed and week about 5 minutes after COVID injection. No rash, difficulty breathing. An IV of 0.9% sodium chloride was started. Patient received 25mg of diphenhydramine IVP and 125mg of methylprednisolone IVP . Patient discharged to home without incident.

1st Dose: No reaction 2nd Dose (Booster): Nausea - Dizzy, could not stand for several hours. Severe Headache, Full body muscle pain. 3rd day symptoms cleared up 85%

Patient experienced a small seizure the day after Moderna second dose which resulted in extreme exhaustion and unable to get out of bed for 36 hours. Patient did not follow-up with doctor and continues to take Keppra ER daily. Patient's seizures have been controlled for 3 years until second dose of Moderna.

No effects on day of vaccination, nor into the evening. Morning of 27th woke with headache. Symptoms worsened as the day progressed. Body and muscle aches, extreme fatigue, sleepiness, some difficulty moving around, heart seemed to be pounding harder as I moved, so stayed put in my chair. About 8 o'clock I had a fever of 101. Drank lots of water. Took Tylenol. Fever faded away. In bed by 9pm. Alternately hot, then cold for several hours but did not have chills. Around 1am temperature stabilized and I slept well. Today, the29th, symptoms gone. Arm not even sore.

Mil headache, muscle joint pain and Vertigo like symptoms that have lasted 1 week so far. The dizziness is coupled with nausea depending on my activity. I was unable to do much at all because of the severity of this. I will not take another vaccine no matter what. Being this sick is ridiculous, I will take my chances.

Pt reported slight feeling of lightheadedness 15 min after injection given. Pt denies dizziness. Orange Juice given. Symptoms resolved after finishing juice. Vital signs stable. Pt felt well and was d/c home from vaccine clinic in stable condition.

Dizziness, palpitations and not feeling well followed by confusion/altered mental status, chills and weakness 4 days later. Presented to medical center with bacteremia & hypotension on 4/26 PM. Transferred to same medical center on 4/29 with concerns for myasthenia crisis.

Weakness in upper legs, pain in knees and thighs, typically will occur after sitting or laying down, During nighttime pain will wake me and become severe while attempting to roll over on my side. Sometimes it is difficult to stand from a sitting position and once I do obtain a vertical position, baby steps are required until my legs are loosened up. This pain seams to come and go, one day the pain level will be a 2 and the next a 5 with no reason, I have been minimizing activities to provide rest for it, but it does not seam to be doing any better.

Kidney failure; emergency dialysis; severe body ache unable to walk or move without assistance; bad chills; joint pain; muscle aches; sharp pain at the injection site; severe headache; 100-103 degree temperature; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (Kidney failure) and DIALYSIS (emergency dialysis) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Colitis (Have not been taking medications from 3-4 years). Concurrent medical conditions included Hypertension, Diabetes, Cholesterol high and Drug allergy (Allergic to NSAIDS). Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for Blood pressure high, METFORMIN for Diabetes, ATORVASTATIN for High cholesterol, ACETYLSALICYLIC ACID (BABY ASPIRIN) and MINERALS NOS, VITAMINS NOS (ONE A DAY ADVANCE ADULTS) for an unknown indication. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE PAIN (sharp pain at the injection site), HEADACHE (severe headache), PYREXIA (100-103 degree temperature), ARTHRALGIA (joint pain) and MYALGIA (muscle aches). On 20-Feb-2021, the patient experienced CHILLS (bad chills). On 04-Mar-2021, the patient experienced GAIT DISTURBANCE (severe body ache unable to walk or move without assistance). On 06-Mar-2021, the patient experienced RENAL FAILURE (Kidney failure) (seriousness criterion hospitalization) and DIALYSIS (emergency dialysis) (seriousness criterion hospitalization). The patient was hospitalized from 05-Mar-2021 to 14-Mar-2021 due to DIALYSIS and RENAL FAILURE. On 24-Feb-2021, PYREXIA (100-103 degree temperature) and CHILLS (bad chills) outcome was unknown. At the time of the report, RENAL FAILURE (Kidney failure) and DIALYSIS (emergency dialysis) had resolved, GAIT DISTURBANCE (severe body ache unable to walk or move without assistance) had not resolved and VACCINATION SITE PAIN (sharp pain at the injection site), HEADACHE (severe headache), ARTHRALGIA (joint pain) and MYALGIA (muscle aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Blood test: high (High) WBC high Sedimentation rate elevated. On 22-Feb-2021, SARS-CoV-2 test: negative (Negative) negative. On 27-Feb-2021, SARS-CoV-2 test: negative (Negative) negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 27-Feb-2021, a flu test was performed and results were not provided. On 05-Mar-2021, blood work and CT scan were performed and results were not provided. Treatment: Mobic and Hydrocodone for pain on 22FEB2021 Two Antibiotics and discontinue Mobic on 27FEB2021 Emergency Dialysis on 06MAR2021 IV Antibiotics and Steroids were given at hospital Patient was advised to follow up with Nephrologist and Rheumatologist. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Historical conditions added, Hypertension, Diabetes, High cholesterol, Colitis. Concomitant drugs added Lisinopril/HCTZ, Metformin, Atorvastatin, Baby aspirin and Men's one a day. The outcome of events changed to Recovered. The patient updated new adverse event as severe body aches unable to walk or move without assistance and was admitted to hospital and the outcome of the event is not recovered.; 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.

severe fatigue, mild lightheadedness, nighttime chills followed by sweats, unknown if fever present the day/night following the vaccine nighttime symptoms resolved after one night ,daytime fatigue with lightheadedness continued into third day mild arm pain for three days

I got my first shot actually felt better but the second shot my arm got very sore around the injection site and then I got deathly sick throwing up for around 8 to 12 hours got very week and dizzy headed and also messed my mind up to where I couldn't think right couldn't hardly walk had to hold onto the wall which I have some problems walking already but that made walking much much more difficult and after that started to feel better and so far I'm still feeling better just wanted to let you know how it done me to see if anyone else has or had any of these symptoms

increase shortness of breath and pt tried putting on trilegy machine. He tried doing this two days in a row and didn't relieve his SOB, so pt went to ER and they diagnosed him with influenza B. Pt had increased weakness and had trouble with ambulation.

MYSTERY "STROKE": The patient remembers receiving the MODERNA COVID vaccination and feeling nothing immediately after shot, took off work a few days later and then on following Monday remembered getting up and preparing for day with shave and shower. Remembers blood sugar being in normal range. Went to dress and collapsed. Could not move left side of body or cry out for help. Was found by a neighbor after two days of being face down on floor unable to reach phone drifting in an out of consciousness. Transported by EMT to hospital. MRI brain scan, ultrasound of legs including Doppler velocimetry conducted. Now at healthcare facility. Continued weakness left side.

Four days post vaccine, associate started to get a pulsating headache. Two days later while at work, started to get a pounding headache, by noon started to get chest pain and felt dizzy. Went to the ER, did an EKG and blood work to rule out a stroke. has an appointment with an allergist and a brain scan.

3 weeks after injection: Sudden onset of hearing loss in one ear, feeling of fullness/congestion in ear. Absolutely not a bacterial ear infection - no soreness/pain, redness, or discharge. Visited an ENT Dr. and inner ear issue confirmed. Hearing test showed significant loss or hearing (loudness) and loss of word discrimination. Fri, 2-Apr: 1st COVID shot (Moderna). Slightly sore arm, no other symptoms/side-effects, all clear in 24 hrs. Fri, 23-Apr: Relatively rapid (over an hour or so) onset of hearing loss in left ear. Feeling of fullness in left ear, thought it might be congestion. Sat, 24-Apr: No change/improvement in hearing of feeling of fullness in left ear. Sun, 25-Apr: I started to feel dizzy. I developed vertigo, though I did not get nauseous. Slept it off. Mon, 26-Apr: Awoke with no dizziness or vertigo. No change/improvement in hearing or feeling of fullness in left ear. Dizziness returned after dinner. Vertigo followed, more severe than the previous night. Unable to walk without help. Vomited and the nausea passed. Vertigo abated a bit, though still present. Slept it off. Tue, 27-Apr: Awoke with no dizziness or vertigo. No change/improvement in hearing of feeling of fullness in left ear Wed, 28-Apr: Saw ENT. First hearing test. Test confirmed quite a bit of hearing loss in left ear and some in the right ear. Thu, 29-Apr: 2nd COVID shot (Moderna). No side-effects until evening. Slight body ache, mild headache, maybe a mild fever. Some dizziness after eating. Fri, 30-Apr: Continued mild side-effects from COVID shot. Some dizziness after eating Sat, 1-May: Side-effects from COVID shot completely gone. Left ear noticeably worse. Sounds more attenuated, speech sounded more distorted. Sun, 2-May: No improvement in hearing Mon, 3-May: 2nd hearing test. Test confirmed significantly reduced hearing (volume) and speech recognition in left ear. Agreed to steroid injections to try to clear the suspected fluid retention/swelling. Tue: 4-May: 1st eardrum injection (10 mg dexamethasone) at 11:00 AM. No noticeable effect through bedtime. Wed, 5-May: Woke up with notably improved hearing in left ear (now only 10 or 20% attenuated). However, felt dizzy as soon as I woke up. Dizziness persisted until late afternoon. Thu, 6-May: No dizziness Fri, 7-May: 2nd eardrum injection (10 mg dexamethasone) at 11:30 AM. No noticeable effect through bedtime. Sat, 8-May: No improvement in left ear hearing, mildly dizzy when I woke up, dizziness persisted until late afternoon. Hearing not great in right ear over the course of the day (maybe 20% attenuated) Sun, 9-May: Minimal improvement in left ear hearing, if any. Right ear still partially impaired. A little light headed at times, no real dizziness. Mon, 10-May: Not dizzy when I woke up at 5:30 AM. Made a cup of coffee and ate an oat bran muffin at 6:15. Felt mildly dizzy by 6:30, persisted through the day and started to abate by evening. Tue, 11-May: No dizziness when I woke up. Hearing in left ear marginally improved. 3rd eardrum injection at 4:30 PM. Wed, 12-May: Woke up with improved hearing in left ear, still some attenuation, almost no distortion, still some feeling of fullness in the ear. No dizziness. Thu, 13-May: Woke up with hearing unchanged from Wed (i.e. no back-sliding). No dizziness in AM, though slightly lightheaded. Hearing degraded as the day progressed. Fri: 14-May: Woke up with hearing worse as compared to Thursday. Feeling of congestion/fullness in ears (more on the left than the right). Slightly lightheaded, no dizziness.

Low grade fever 100.6 started at 9pm, moderate low back pain started at 4pm, cold chills started at 10pm, knee joint pain started at 10pm becoming worse through the night. All events occurred same day as vaccine. Woke up at 7:30 am, fever and chills gone, low back pain gone, knee pain subsided somewhat but hard to walk.

Day after vaccine pain and limited range of motion occurred. This progressively got worse to the point of immobility and excruciating pain. After 2nd dose, top of right shoulder developed pus filled circular area and pain

Two weeks after my second shot, I developed dizziness/vertigo, not unlike what I experienced first in my 20s living in the dry climate where I lived. It gets better with attention to hydration and good sleep. Pretty profound initially. It has gotten better over time, as happened in the past.

shot site pain, headache, shivering, diarrhea, fatigue, disyness, bad general body aching all the symptoms were gone in about 24 hours

Symptoms are variable but some combination troubles me every day since March 6, excepting the twelve days I was on the Prednisone prescription. In general, pain increases during sleeping hours, when I grow stiff and less flexible. I wake several times during the night (almost hourly) dry-mouthed. I don't know if pain wakes me or not. I rise with great difficulty and hobble to the bathroom. Mornings are the worst part of the day, but I find if I keep moving, I loosen up and the general inflexibility goes away, and to some degree, so does the pain. It is never entirely gone. I also find that the pain seems to generally occur during movement and not at rest, although the pelvic pain and upper leg pain has and does occur while at rest. The most regularly-occuring pain is hamstring and shoulder (shot locations). Rising from a laying or seated position has always been the most difficult. Lately, pelvic pain has been rare, and knee pain intermittent.

injection in arm became very painful and could not use my arm,within 2 weeks I could barely walk from groin pain and back pain

Less than 24 hours after 2nd shot extreme itching. From then to now left elbow very hard to bend without extreme pain. Have a hard time holding items now.

The symptoms started 3 hours after the 2nd dose of COVID. I felt pain in my left arm ( the same arm where I was injected ), chills and fever across my body, sweating, numbness and electric tingling in head, dizziness and vertigo with sensation of wanting to vomit, a lot of pain in my joints, watery eyes and pain in my eyeballs, lack of equilibrium and orientation, and other symptoms.

Dizzy spells. There have usually been other factors involved (extreme heat, exhaustion, alcohol) so I've not worried about it. However, in the same time frame I have begun to have a constant ringing in the ears. The dizzy spells are getting worse and today lost me a job. I mentioned it to one of the doctors when he was treating me for a sprained wrist that I got when a dizzy spell caused me to fall down. He blamed the ringing on me being exposed to loud noises. He said the dizzy spells were from drinking and smoking. This was the first time I'd ever seen this doctor and he gave me those diagnoses without any examination.

Joint pain and stiffness throughout body. Became prominent and intense at aproximately one week after injection. Continuous and persisting. Had workup by rheumatologist. Blood tests show no RA, but arthritis indicated in all joints x-rayed except left knee (pain in knee is pronounce as all other joints)

Person experienced vertigo, vomiting, double vision, low body temp of 95*. Took him to the ED Hospital. It was determined that he had suffered a small Ischemic Stroke. He was given Asprin and Lipitor (Atorvastatin) and an anti nausea medication. Several tests were done as outlined in Item 19 below.

Severe pain at injection site, muscles of outer upper right arm. Immobility of right arm. By 06/07/2021 , little change. Range of possible motion only 30% of normal. Severe pain and (arm "not working") outside of 30% range of motion.

June 14, 2021 This E-Mail concerns continuing ?side effects? from the second shot of the Moderna vaccine. I received the second shot on May 11. Today is June 14. So, I am writing this report 5 weeks after the last shot, with many of the effects continuing. I am 64 yr. old male. I have a history of high blood pressure, which has been controlled successfully with medication for the past 8 years. I had a hemorrhagic stroke in 2013, successfully recovered. Otherwise no severe disease-type medical risks, I am health and physically fit. I live with serious chronic pain from a multitude of factors. I have severe tendinitis-type problems in my arms and legs; joint stiffness and pain, tight muscle problems. The vaccine ?attacked? and severely worsened these symptoms. The night of the vaccination, I started getting serious pain in a number of painful areas ? knees, ankles, elbows and forearms, like inflammation, all at once. This pain advanced to injuries in prior injured areas, like knees forearms lower legs, and worsened when I would try basic loosening up exercises, to point that I could barely walk for a couple of weeks. After exercising or loosening up, muscles and joints would tighten up severely, exacerbating pain and function. I was barely able to walk or do much for a week or more. I?ve needed extra bodywork and chiropractic sessions to deal with this. The problem with tendinitis areas is less bad than right after the shot but still significantly worse than it had been before the vaccine. When exercising, I am slower and able to do less time at cardio functions and have to lift 10-20 lbs. less weight when using weight machines. I also get joint pain, ala knees when I use exercise bike; knees and shoulders get a certain type of pain (I feel it on the outside of the joint). These are quantifiable factors. The joint problems mirror a type of joint problem I had for a couple of years after my stroke, not what I experience every day. The joint is weaker, and I feel a vague pain like the pain is coming from outside of the joint. So, the vaccine seems to have ?attacked? and exacerbated problem areas of mine which already affect my ability to function adequately, and it is unclear whether or not these will fully resolve. It is not a ?one or two-day? thing as suggested. Additionally, I?ve generally felt drowsiness and ?headachy? during the day since. These symptoms have lessened, but still there to some extent. It is unclear whether or not I will fully recover or if anything else is wrong. I am doubtful that I should take any additional ?booster shots? later if suggested or mandated. Your attention to this matter is very much appreciated.

red,hard knot on it; Rashes and hives all over the body; Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow; He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles; Patient was wondering who he should to go to, so someone can can write "Do not give the second dose; Upper lip was really swollen; Upper lip was really swollen; Puffiness around the eyes; burning sensation on his upper lip on the inside; Felt pressure on his face; Swollen eyes; Feeling exhausted; Swollen face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of the first episode of LIP SWELLING (Upper lip was really swollen), PERIORBITAL SWELLING (Puffiness around the eyes), BURNING SENSATION (burning sensation on his upper lip on the inside), FACIAL DISCOMFORT (Felt pressure on his face), EYE SWELLING (Swollen eyes), MASS (red,hard knot on it), SWELLING FACE (Swollen face), the second episode of LIP SWELLING (Upper lip was really swollen), URTICARIA (Rashes and hives all over the body), RASH (Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow), FATIGUE (Feeling exhausted), GAIT INABILITY (He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles) and PRODUCT DOSE OMISSION ISSUE (Patient was wondering who he should to go to, so someone can can write "Do not give the second dose) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The patient's past medical history included Stroke (he had a mild stroke 2 years ago on August 27th and his right arm, right leg, and right foot were paralyzed.). Previously administered products included for No adverse event: Flu vaccine. Past adverse reactions to the above products included No adverse event with Flu vaccine. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced EYE SWELLING (Swollen eyes), SWELLING FACE (Swollen face) and FATIGUE (Feeling exhausted). On 15-Apr-2021, the patient experienced the first episode of LIP SWELLING (Upper lip was really swollen), PERIORBITAL SWELLING (Puffiness around the eyes), BURNING SENSATION (burning sensation on his upper lip on the inside), FACIAL DISCOMFORT (Felt pressure on his face) and the second episode of LIP SWELLING (Upper lip was really swollen). On an unknown date, the patient experienced MASS (red,hard knot on it), URTICARIA (Rashes and hives all over the body), RASH (Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow), GAIT INABILITY (He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles) and PRODUCT DOSE OMISSION ISSUE (Patient was wondering who he should to go to, so someone can can write "Do not give the second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergy, at an unspecified dose and frequency; CETIRIZINE HYDROCHLORIDE (CETRIZINE) at an unspecified dose and frequency; EPINEPHRINE (EPIPEN) at an unspecified dose and frequency; DIPHENHYDRAMINE at an unspecified dose and frequency; FAMOTIDINE (FAMOTIDINE ACID REDUCER) at an unspecified dose and frequency and METHYLPREDNISOLONE at an unspecified dose and frequency. On 15-Apr-2021, PERIORBITAL SWELLING (Puffiness around the eyes) had resolved. At the time of the report, BURNING SENSATION (burning sensation on his upper lip on the inside), FACIAL DISCOMFORT (Felt pressure on his face), EYE SWELLING (Swollen eyes), MASS (red,hard knot on it), SWELLING FACE (Swollen face), the last episode of LIP SWELLING (Upper lip was really swollen), URTICARIA (Rashes and hives all over the body), RASH (Rashes and hives all over the body ,Rashes under his arms about two inches long and on the left arm inside of the elbow) and FATIGUE (Feeling exhausted) was resolving and GAIT INABILITY (He used to go for 6-10 mile walks but now he can not walk long distance, he can up to walk up to two miles) and PRODUCT DOSE OMISSION ISSUE (Patient was wondering who he should to go to, so someone can can write "Do not give the second dose) outcome was unknown. Not Provided 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. Other non drug treatment include Ice pack to alleviate the Rash. The patient experienced just felt different. The patient rang his HCP who advised him to go to emergency room. The patient was discharged a few hours later.Patient mentioned that he is not allergic to anything and found it strange that he would have severe allergic reactions from the vaccine.During the month of May, there were a couple of times where his face was swollen, upper lip was swollen, rashes and hives on the upper arms and upper thighs. On 07 Jun 2021, his face was swollen again. Patient noticed there were rashes under his arms about two inches long and on the left arm inside of the elbow, there was a very red, hard knot on it. Patient put a cold compression to alleviate the rash. Patient is concerned because he had never been allergic to anything in his life until this incident happened. He received other vaccines like the flu vaccine and he did not experience any side effects from the vaccine. Patient also reported that he has been feeling exhausted everyday.He has not taken any allergy medications since his last allergic reactions. He was currently not experiencing any symptoms.Patient is concerned about exhaustion and the swollen face that he had woken up to three times from 14 Apr 2021- 07 Jun 2021. Healthcare professional advised patient not to take the Second dose. Company comment: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow-up received, Updated events outcome to recovering and Seriousness criteria in events tab,reporter information updated, Historical vaccine in other relevant history updated,Vaccine route of administration updated in events tab and added event (Gait inability) and reporter information.; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded

chronic joint stiffness in the neck, back and hip bone for past two months occurring after the second dose. Attending Physical Therapy to relieve spinal stiffness in neck.

Pt standing in post observation awaiting allotted time in post vaccination. Pt complaining to family members that the "room is spinning ". 1709 RN called and assessed alert man complaining of headache, denies breathing difficulty, lightheadedness, and nausea. EMTS called and arrived at 1710 Pt seated and BP 142/84 HR60 O2sat 97RA. Pt given H20 and resting in chair and monitored my EMTs. Pts symptom of dizziness is resolved and discharged at 1720.

This is an administration error report. This client received the J&J vaccine on 03/29/2021 through his place of work from us at the health department. We went back out to this clients place of employment for a vaccine clinic on 07/07/21 and the place of work sent out a text reminding people who signed up for the vaccine clinic and this client responded to the employers text saying "I think I will get Moderna today." The clients employer or the health department did not catch that the client had J&J vaccine on 03/29/2021 until after we gave the Moderna vaccine first dose on 07/07/2021. This error was caught after administering the first dose of Moderna. Client was having symptoms of headache, dizziness and just not feeling well.

Began having sore left shoulder. Moved to right shoulder,hips, and knee. Pain so bad couldn't lift arms. Trouble walking. Some days had to use a walker to get around. Began steriod treatment for inflammation. Seeing Rheumatologist. Diagnosis unclear but thinking Polymyalgia rheumatica.

On the midnight of April 29, 2021, I got fever at 100.4 degree. On the morning of May 1, the fever was gone; in the afternoon, I suddenly felt back pain. The pain lasted for about a month. During the time, I didn't see doctor and didn't take any medicine. On May 30, 2021, I suddenly got right leg pain which made me couldn't walk for even 20 steps. The whole right leg from the heel to the butt feeling painful. Those pain I felt like muscle pain, tendon pain, ligament pain and nerve pain. It's already the 7th week. Even though now the pain is lighter than before, but it's still painful. I took some medicines to ease the pain, but I didn't go to doctor.

Bell's, Palsy, Treatment with steroid pack and anti viral pills Loss of muscle control left side of face symptoms began 6/16/2021 , no previous history of Bell's palsy

Beginning 1.5 hours after the 2nd Moderna dose, my hands began shaking, and my arm was sore. These symptoms continue today and have not gotten better. Beginning 2 days after the shot, my left foot from my toes to my ankle turned black and green. Beginning 1 week after the shot, my toes turned purple; this has continued on and off since May 5, 2021. Beginning 2 weeks after the shot, the lymph nodes in my neck, roof of my mouth, nose, and ears were swollen and tender. At random times, I would get hot and begin to sweat profusely 2-3 times per day, and my ears would get extremely red. At this time, my temperature would be between 100F and 101F, and my blood pressure was elevated. These symptoms lasted about 4 weeks. Beginning 3 weeks after the shot, I developed a walnut-sized, squishy knot on the inside of the joint of my left elbow. I also began losing the hair in my armpits and have since completely lost all the hair in my armpits and on my legs. Beginning 4 weeks after the shot, I developed a golf-ball-sized, squishy knot on the inside of my right knee, similar to the one that appeared on my elbow. I also developed a walnut-sized, squishy knot on my left knee just below the kneecap. Beginning 5 weeks after the shot, I developed shin splints but had not completed any running or other activities that could explain the tenderness in my shins. Beginning 6 weeks after the shot, I noticed a loss of muscle mass in my arms and legs. Beginning 7 weeks after the shot, I have had severe chest pain three times. Each felt like I was having a heart attack; 2 times were in the middle of the night and 1 time was early in the morning. Beginning 8 weeks after the shot, I began getting lightheaded at random which has caused me to fall multiple times. In addition, I have begun bruising very easily; the bruises take weeks to heal. My left eye is also extremely tender and waters more than normal. Beginning 9 weeks after the shot, I notice that I have begun drooling even though I have never drooled in the past. My gums occasionally feel tender when I brush my teeth.

Symptoms: Fatigue, dizziness, and shortness of breath Diagnosis: small blood clots in right upper lung Treatment: Eliquis

Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.; Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) and GAIT DISTURBANCE (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 028A21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced DYSPNOEA (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) (seriousness criterion medically significant) and GAIT DISTURBANCE (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) (seriousness criterion medically significant). At the time of the report, DYSPNOEA (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) and GAIT DISTURBANCE (Trouble breathing/Hard for me to walk 2 to 3 steps before I am out of breath.) outcome was unknown. No concomitant medications were reported. The patient reports that his doctor prescribed an inhaler for his breathing issues but the medication name is unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up: Date and batch no added for dose 1 and dose 2; 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 WAS NERVOUS RIGHT BEFORE IMMUNIZATION. HE COMPLAINED OF DRY MOUTH AND WANTED GLASS OF WATER. AFTER WATER SAID HE WAS OK FOR SHOT. I DID SHOT AND HE SAID IT WAS GOOD. HE CHOSE TO STAY IN IMMUNIZATION AREA. ABOUT 5 MINUTES LATER, HE TOLD TECHNICIAN HE WAS FEELING LIGHT HEADED AND HE LAYED DOWN. I VISUALLY ASSESSED HIM, HIS FACE WAS RED BUT HE WAS BREATHING NORMALLY. I ASKED IF HE COULD SPEAK AND HE RESPONDED VOCALLY. HE ASKED FOR 911 TO BE CALLED. I CALLED 911 AND STORE MANAGEMENT. STORE MANAGER BROUGHT HIM WATER TO DRINK. AFTER CALL, I CHECKED ON HIM. HE WAS SITTING UP AND FACE COLOR WAS IMPROVED. I ASKED HIM TO SIT COMFORTABLY AND WAIT FOR EMT TO ARRIVE. THEY ARRIVED A 5 MINUTES LATER AND ASSESSED, TOOK BP AND VITALS. AFTER DISCUSSING WITH THEM, PATIENT SAID HE HAD A PANIC ATTACK FROM SHOT. HE DECLINED TO BE TAKEN TO HOSPITAL. EMT SIGNED HIM OFF AND STARTED PACKING UP. PT LEFT UNDER HIS OWN POWER

Lightheaded (in a fog) jitters, difficultly breathing (Asthma attacks) , Anxiety (had several panic attacks), headaches . The side effects lasted several weeks but have tapered off I continue to deal with difficultly breathing and anxiety. I did get a second vaccination (Moderna OU7B21A) on 5/24/21. with the same but more intense side effects, which caused me to visit my general practitioner.

1. Sore arm started several hours later approximately 9 PM 12/29/2020 2. Chills started approximately 12:30 AM on the following day 12/30/2020 3. Severe myalgias and arthralgias with difficulty moving approximately 6 AM 12/30/2020 4. Fever starting approximately 6 AM starting 101.5-1 03 then later in the day 105. 5. Severe headache starting approximately 9 AM 12/30/2020 and persists but much less 6. Nausea starting approximately 9 AM 12/30/2020

Moderna COVID-19 Vaccine EUA Woke up at 1:30 AM to get drink of water, feeling somewhat lightheaded. Vomited and a few minutes later experienced diarrhea. Went back to sleep, woke up at 7:00 AM. Diarrhea again. Experienced slight headache and some lethargy. Can eat and drink but decided to fast for the day and just drink water. Went to work as usual. I believe I am recovered now.

Pain tenderness in the shoulder, fatigue, headache, muscle and joint pain, chills, Dizziness and weakness.

tingling, dizziness, lightheaded, vertigo; seen & cleared by EMS. B/P-193/112, blood glucose- 226. Client declined further evaluation @ emergency room as recommended by EMS.

Patient received the Moderma Shot IM to L arm 0.5m CoVid Vaccine at 11:30am on 012220221 and then was taken to observation room and observed for 15 minutes. At 15 minutes the patient complained of Nausea and dizziness Blood Pressure was taken by 158/90 pulse 64 R 16 T 97.4 She noted no signs and symptoms of Distress Paramedics on the scene transported to ER at 12:00pm Paramedics reported diffuse rash all over body by the time the patient arrived at the hospital

On Friday 1/22/21 9:30 pm patient reports sudden onset of visual changes such as double vision with vertigo. He presented to Hospital to the emergency room. Treatment CT (negative) -blood work then transferred to healthcare facility via ambulance where he had an MRI (negative) and a CTA (negative). He was diagnosed with Lateral Sixth Nerve Palsy. He was intructed to follow with ophthamalogy and neurology and priamry care providers.

Temperature increased to 100.1 F, blood pressure elevated 148/92, dizziness with fall, radial pulse rate increased to 120/min, shortness of breath, rash

acute infarct right basal ganglia after having difficulty walking patient remains in hospital, having physical therapy

Rash and swelling at injections site approximately 36 hours after injection. Headache, lightheaded, and general malaise about 8 hours after injection.

1. One hour after injection severe tinnitus (bilateral) which has persisted 2. FIve hours after injection arm swelling and mod-severe pain at injection site - resolving after 3 days but left with low grade pain 3. Seven hours after injection developed moderate headache, fever to 101 F, and shaking chills that lasted about 4-5 hours, generalized achiness, mod-severe fatigue 4. #1 has persisted, with varying intensity 5. #3 chills stopped after 4-5 hours, took tylenol twice to relieve fever Have persistent low-grade headache 6. I have a photo, injection has given very medially near tendon, remains tender with decreased ROM

With 06:10 pm injection on 02/02/2021 symptoms started the next day (02/03/2021) at 2:00 pm when I became slightly dizzy with a fever of 100 degrees (my normal is 97.2 degrees). Fever, dizziness, tiredness continued 12 hours with fever decreasing to 97.4 degrees at 04:00 am (02/04/2021) and dizziness/tiredness ended aprox 02:00 pm that afternoon.

Numbness and cramps in the fingers of the left hand a few minutes after I have received the vaccine. Pain in the upper left arm close to the humeral grater tubercle almost 8 hours after the vaccine was applied . I think the vaccine was applied higher than expected in the upper part of the muscle near the joint. The pain increase by the hours. Some dizziness and muscle discomfort. Slight and constant headache.

He got the vaccine yesterday, 2/10/21, and at 8:00 PM started getting chills. About 10:30 was getting joint aching with pain. Went to bed at 8:00 due to fatigue. Felt nauseated. Was hurting really bad with the joint pain that lasted until about 2:30 AM. He woke up this morning and is feeling much better. He did not take anything for the pain. It attacked his joints mainly his ankles and knees and was not able to move. His knees felt hot to the touch.

History Chief Complaint Patient presents with ? Elevated Blood Pressure ? Dizziness multiple times a day Patient who presents to the emergency department today for evaluation of hypertension, head pain, blurry vision, and neck pain. He states about 6 months ago he had open heart surgery. Since that time he states that he has been having intermittent episodes of blurry vision usually lasts a few minutes and resolve on their own. Today however, he notes that the blurry vision lasted for greater than 5 minutes and he started to become concerned. During that time he also began to experience some pain in his neck and a headache in the back of his head. He took his blood pressure at that time and noted that his systolic blood pressure was in the 190s. This alarmed him and so they called EMS. When EMS arrived they rechecked his blood pressure again and his systolic blood pressure was over 200. Upon arrival here to the ER he states that he is feeling much better and his blood pressure appears to be better as well. At this time he states he still having some right shoulder pain and a little bit of right-sided neck pain but he does state that he had his Covid vaccine yesterday in his right arm. Currently patient states he still has a little bit of a posterior headache but it is much improved. He denies any fevers, body aches, chills, cough, chest pain, shortness of breath, palpitations, lightheadedness, nausea, vomiting, abdominal pain, diarrhea, constipation, dysuria, hematuria, or swelling of the lower extremities. He has no known drug allergies. ? ED Course: I discussed physical exam finding with patient. Apparently most of his symptoms have already resolved at this time. His blood pressure is back down to 142/98. I still advise since he was having some weird blurry vision I would like to get a CBC, CMP, troponin, EKG, and a chest x-ray. Patient agreeable to this plan of care. We will also continue to monitor his blood pressure to ensure that it does not spike back up. Patient's work-up was unremarkable. His blood pressures down to 123/60 and states he is feeling much better. This point time it sounds like what happened was a hypertensive urgency. I advised him he needs to contact his PCP and schedule close follow-up discuss if anything further needs to be done. At this time though he is safe to be discharged home with strict return precautions. ED Course Procedures Clinical Impressions as of Jan 20 2235 Hypertensive urgency Plan: New Prescriptions No Prescriptions at Discharge. Disposition: Discharge

Minutes after shot felt woozy and light headed. As my fifteens was up , I started getting severe heightened sense of smell and could smell body odors from people all around me. Threw up before exiting building in rest room.Needed to get out of building ASAP fast for fresh air . Breathing-20 degree fresh air maskless helped but still felt weak so wife and medical aids brought me inside to isolated area on a cot to rest and take vitals . When I was sick with COVID-19 in September 2020 I had same issues with heightened smell and taste before I lost them for three months.

I awoke at 3:00 a.m. this morning (Feb 16) with itching in my skin beginning to be felt. By 3:30 am it was widespread and developing a rash over much of my torso and arms. This appears now to have run its course. My nose and lips swelled. My nose became hard and numb. Both now less swollen than early on. My body temperature was 95.4 degrees. I felt dizzy when standing, and there were waves of mild nausea. I had major nasal congestion and could breathe only through my mouth. My CPAP machine (which I use all night every night) was on before the 3 am wakeup, and I donned it again when I returned to bed at around 4 am. Nasal congestion now has improved a lot. On two occasions (maybe around 4 am) I noticed a minor wheeze. On a couple of occasions I coughed lightly, and it was a sore one from the chest. I still have some dizziness, and now an intermittent headache. Before going to bed last night I took two Naproxen Sodium PM tablets for some neck pain.

unconscious, near death experience; extreme headache while at work; felt like he was walking on water; couldn't eat; couldn't sleep; doesn't remember any of it; couldn't talk; speech was garbled; wasn't understanding or comprehending anything; difficulty breathing; fatigue; muscle pain all over his body; joint pain; chills; nausea; vomiting; he couldn't control his bladder; fever that went up really high; dizziness; Weakness; Two spontaneous cases were received on 02Feb2021 concerning a male patient, 65 years of age. The cases are cross-linked. The reporter stated the patient is their nephew. According to one report, the patient experienced the following symptoms: "extreme headache while at work", "felt like he was walking on water", "couldn't eat", "couldn't sleep", "doesn't remember any of it", "unconscious", "near death experience", "he couldn't talk and speech was garbled", "he wasn't understanding or comprehending anything". According to the other report, her nephew experienced symptoms immediately upon receiving the vaccine. She reported the following symptoms not already mentioned by the first reporter; "difficulty breathing", "chronic headache:, "fatigue", "muscle pain all over his body", "joint pain", "chills", "nausea", "some vomiting", "couldn't control his bladder", "fever that went up really high", " lost ability to breathe", "dizziness", "weakness", "Moderna shot is killing him", and "he is dying". The patient's prior medical history include an allergy to Shellfish, previously reported as fish allergy. No other medical history was provided and concomitant product use was not provided by either reports. Prior to the onset of events, the patient received his first of two planned doses of mRNA-1273, (date and batch number not provided), (injection site not provided), for prophylaxis of Covid-19 infection. On ??Jan-2021, shortly after receiving mRNA-1273 immunization, the patient began experiencing the following symptoms: "extreme headache while at work", "felt like he was walking on water", "couldn't eat", "couldn't sleep", "he couldn't talk and speech was garbled", "he wasn't understanding or comprehending anything". At an unknown time later he experienced "difficulty breathing", "lost consciousness" and was admitted to the hospital ICU on 22Jan-2021. Transport to hospital and name of hospital was not reported. According to the reporters the patient remained in the ICU for eleven days. The following symptoms were reported as occurring during his hospitalization either in the ICU or after transfer to a less acute unit on or about 01-Feb-2021: "chronic headache:, "fatigue", "muscle pain all over his body", "joint pain", "chills", "nausea", "some vomiting", "couldn't control his bladder", "fever that went up really high", " lost ability to breathe", "dizziness", "weakness", "dying", unconscious for almost a week". According to the reporters he had CT exams of spine and brain, and heart exams twice on different days while hospitalized but results "didn't find anything". No other significant results or details of his hospital stay were reported. As of the report date 02-Feb-2021 the patient remained hospitalized. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were unknown. Company comment: The reported events, "loss of consciousness", "headache", "feeling abnormal", "weakness" "decreased appetite", "insomnia", "amnesia", " aphasia", "dysarthria", "confusional state", "dyspnea", "fatigue", " myalgia", "arthralgia", "chills", "nausea", "vomiting", " pyrexia", "urinary incontinence", and "dizziness" were possibly related to mRNA-1273.

1) Tinnitus - The principal adverse event was a significant increase in my tinnitus, to levels I hadn't experienced since I originally developed the condition following a viral infection in May 2006. I first noticed mild tinnitus the day after the injection and it gradually became worse over two weeks. [not recovered] 2) Sore arm - I had a hard time lifting my arm the evening of the injection. I recovered in a day. [recovered] 3) "COVID arm" - My right arm became red swollen and itchy for about three days, starting a week after the injection. [recovered]

* loss of balance, general feeling of disorientation. Staggering, accompanied by a flush feeling and diaphoresis. This lasted about 10 minutes, then I returned to the chills, headache, and maliase.

Approximately 16 minutes after receiving the vaccination, I began to get quite dizzy. The staff was notified by my wife; and, a Pharmacist responded immediately to check on me. As minutes passed, I became more dizzy and was experiencing a mild "out of body" type experience as though I was in some sort of a dream. Knowing in advance that many people had experienced adverse reactions from these vaccines, my wife and I had brought along an "eppie pen" in the event I might experience something similar. The problem was that my "pens" had expired in 2015. My condition improved when I lifted my facemask to get more air. While the Pharmacy was obtaining a new "Eppie pen" for me, the Pharmacist told me to take the mask off. This stabilized me until we left after 45 minutes. I did not need to use the new Eppie pen. Still dizzy, my wife helped me to my vehicle. Enroute, being somewhat weak, I clasped against a parked car and to the pavement. During the trip home, my muscles began to ache and my joints stiffen and hurt. A heaviness began to present on my upper chest.

Patient felt dizzness and giddiness . Onsite EMS was called vitals were taken BP 140/96 92% O2 room air HR 90. Patient refused evaluation/care. Left aginst medical advice.

After waiting 15 minutes, I got in my car to return to work. Approximately 25 minutes after receiving the vaccination, I became flush, felt hot and had a red face and neck. I felt lethargic and a little dizzy. The redness diminished throughout the rest of the day and for the next day I felt a little lethargic, dizzy, and weak in the knees. I returned to the facility and EMTs took my vitals. My blood pressure was slightly elevated but, no other negative indications. They released me.

Stroke (blood in the brain); heavy legs; not feeling himself; difficulty walking secondary to stroke; Bad Headache; A spontaneous report was received from a consumer concerning a 65-years-old, male patient who experienced bad headache, stroke (blood in the brain), difficulty walking secondary to stroke, heavy legs, and not feeling himself. The patient's medical history included atrial fibrillation (A-Fib) four years ago. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included blood thinners. On 10 Jan 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient experienced a headache. On 28 Jan 2021, he reported having a bad headache, heavy legs and was not feeling himself. On 29 Jan 2021, the patient was admitted to the hospital and was told he had a stroke (blood in the brain). Patient was discharged on 02 Feb 2021. He now has difficulty walking and is trying to walk with a walker and has to go to rehab. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events bad headache, stroke (blood in the brain), difficulty walking secondary to stroke, heavy legs, not feeling himself and headache were resolved on 02 Feb 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Of note, patient's medical history of atrial fibrillation and concomitant use of blood thinners may have been contributory for hemorrhagic stroke.

Moderna COVID 19 Vaccine EUA Experienced equilibrium issues for two days (during the day) stability issues walking ? at night dizziness ? room spinning. Subsided after two days.

Vaccine - Moderna COVID-19 EUA, dose 1. Patient received the first dose on 2/1 around 6PM PST in his left arm. By 2/2, the patient experienced arm soreness, and by 9PM, he felt pain in his right ear. On the morning of 2/3, the patient woke up with hearing loss in his right ear, slight dizziness and nausea, but was able to work and eat with normal appetite. On 2/4, the patient woke up with general malaise, dizziness, lightheaded feeling, GI discomfort (minor diarrhea and vomiting), sweating, and chills. The patient still experienced hearing loss. The patient was fatigued, and had no appetite; stayed hydrated and slept most of the day. The patient gradually became less fatigued and gained appetite from 2/5-2/8. On 2/8, the patient visited urgent care for his ear. The NP on site observed yellow fluid in the patient's right ear and prescribed amoxicillin and flonase generic. The patient took the amoxicillin for 10 days and flonase generic for 14 days. On 2/22 (D21 post vaccine), the patient saw his PCP, still reported hearing loss, but the doctor did not report any findings. The patient received a referral for the ear specialist. To date, 2/23, the patient has hearing loss in his right ear.

During observation, patient stated he was lightheaded. Denied any other symptoms. No SOB, no oral or facial swelling, no rash or swelling. Vitals stable- BP 100/62, pulse 62, RR 12. Ate breakfast but had not had lunch. Patient was observed for 30 minutes and given water. Symptoms resolved by end of observation period.

Patient stated approximately 24 hours post-vaccination, he was at home in his garage and became extremely light headed and was unable to walk. He crawled into his house and called his wife to help him, and she immediately contacted 911.

Chills, Sweats, Low Grade Fever, Dizziness, Shakes, very bad injection site pain. Blurry vision, trouble sleeping.

Received vaccination at 14:20 2/26/21. Was observed until discharged at 15:15. Discharged per wheel chair to lobby in alert/stable condition, to wait on bus to take him home. At 18:00 his neighbor heard him fall, could not get patient to answer phone, found him unresponsive. Neighbor called 9-1-1, ambulance personnel could not revive patient. Coroner's office ruled his death as Natural Causes due to Hypertension, Cardiac disease, Diabetes, ESRD. There were no indication of anaphylactic reaction noted when I questioned the coroner's office. The Coroner's office/EMS were aware the patient had received the Moderna COVID 19 vaccination that day.

ABOUT 16 HOURS AFTER SHOT I STARTED DEVELOPING A SERIES NECK ACHE WHICH TURNED INTO A VERY STIFF NECK AND AND HEADACHE. IT'S BEEN MORE THAN 48 HOURS NOW SINCE START OF PROBLEM. THINGS SEEM TO BE GETTING BETTER BUT STILL HAVE LIMITED MOBILITY WITHOUT PAIN.

Woke up and the room was spinning, carefully walked to the bathroom for drink of water, had to sit and wait for the room to stop spinning. When I tried to lay down it started spinning again and I found I could not focus on single spot. At 9am The spinning stopped but I feel very weak.

5 days after injection woke up with severe vertig. Dizziness, night sweats, low blood pressure lated for a week. Still feeling occasional dizziness 4 weeks after first shot

Patient started experiencing dizziness, blurred vision, a "rush", increased blood pressure, feeling hot, tingling in arms, and appeared flushed. Occurred approx. 15 minutes after vaccination. Patient was given water and a snack and was told to take deep breaths. Blood pressure was monitored and returned to normal before patient exit. Patient was assisted by wife. No medications were given.

Mild dizziness onset approximately 10 minutes status post vaccine administration. Patient reports history of issues like this after blood draws, but improved due to frequent lab draws. Possibly "slight headache." Mild, intermittent nausea (unchanged from baseline that started this morning). Patient continually stated that he needed to get to a bathroom (not urgently), but it was quite a focus. He is having frequent diarrhea this morning after increasing Miralax dose last night for constipation. Patient with ulcerative colitis. Transferred via wheelchair to reclining chair and reclined to flat position approximately 10 minutes. Vitals stable. Positioning helped. Sat for approximately 20 minutes prior to leaving. Dizziness resolved prior to discharge. No concern about symptoms from patient or caregiver. Patient took diazepam yesterday and Celebrex yesterday (as needed medications).

On February 19th, one week after shot I woke up with severe dizziness and nausea. Room was spinning and would only stop by sitting up. Eventually dizziness subsided but had mild nausea all day. Dizziness returned each morning for following week but not as severe as on the 19th. Went to an urgent care where they gave me rapid and pcr covid tests. Both came back negative. Also checked heart and blood pressure multiple times. Everything was normal. Reported everything to my doctor. On March 6th, woke up at 7am with severe dizziness and nausea again. Dizziness is subsiding and nausea is gone. Seeing doctor on March 10th and will discuss then.

STRONG SPASMS IN LOWER BACK. NOT NORMAL. NEEDED TO TAKE STRONG PAIN KILLER. ALSO, NEXT DAY - DIZZINESS AND NAUSEA.

Began feeling very weak with a constant headache that later led to blurry vision on March, 2, 2021. On the morning of March 4, 2021, I was still experiencing a right sided headache as well as double vision. I was no longer able to drive at that point. I took my blood pressure digitally at the local pharmacy twice where it was 200/104. I went home to call my physician and also have my wife take my blood pressure manually. My blood pressure at that time was 214/106. I went to the hospital where they examined me and then discharged me with a General Headache without a know cause. I contacted my PCP and he advised me to quadruple my Lisinopril until my BP came down to normal range and see him the morning. My visit the next day showed an elevated blood pressure, double vision, and a continuing headache. My meds were adjusted to Lisinopril 10 mg qd and an addition of Norvasc 5 mg qd. Later that day my blood pressure was down, but still not in the normal range. The following day, March 6, 2021, I was still having the same issues despite the changes in medication. I took my blood pressure at 6 pm and it was 199/104. I immediately went to another hospital where I was admitted as a "stroke alert" patient in hypertensive emergency. I am presently being followed as an inpatient in order to get these issues under control.

A little over 12 hours after getting my first Moderna shot I experienced severe joint pain in my left knee that caused my entire left leg to become so painful I could not move it at all, as if I pulled an ACL. I decided to ride it out as each day went by the pain subsided more and more to where after 3 to 4 days later the pain was about 90% gone. I still feel a little bit of soreness on the left side of my left knee cap though. I am mostly back to where I was before the shot. During the first few hours of the worst pain I did experience a cold sweat also. All in all I am feeling pretty good now however, a bit concerned about my second dose scheduled for March 23rd though, especially considering that I have neve had a negative reaction to a any type of vaccine before and I am not allergic. Great thanks to all!

1/5 vaccination 1/8 started with pain lower R back, near waist. I could not turn. extreme sharp pain. I could hardly stand. Went to physiotherapist for 2-3 weeks. Cardiologist for ultra sound. Blood panel. Urine. on and off with symptoms. frequency has subsided.

Symptoms began 3/5/21 and resolved by 3/8/21, included headache, fever, sore throat, fatigue, turning pale, feeling 'woozy', body aches, sweating, nightmares, ear ache and nerve "jumping" bottom lip. Self treated OTC tylenol, ibuprofen, oral fluids.

Severe Vertigo the day after both shots lasting around 4 hrs. Headache all day following second shot.

Neck pain began 4 or 5 hours after the shot in left arm. It has persisted daily and contant since then ans limits range of movement in my neck. I had to previous long term persistent neck pain. I am currently undergoing physical therapy for my neck which is slowly improving the condition. I asked my doctor if I should take the second vaccine. He was indecisive.

On 03/11 I received 1st shot of Moderna COVID-19 Vaccine EUA, after about 8 mins I became very light headed and short of breath after about 10 mins. I felt a rush come over my body followed by rapid heart beat. These symptoms lasted about 2 mins then subsided. I really didn`t want panic everyone or go to the hospital all I wanted was fresh air so I left, admittedly not my smartest move but I knew my doctors office was right across the street. After 24 Hrs. still Light Headed, no breathing issues, heart rate normal sore arm no rash.

woke up 3/10/21 with 101.3° temp; temp was elevated between 99.7°-100.9° during 36-38 hours after injection; two times over the next day (3/10/21) between 12 noon and 6pm I experienced a very short dizzy in spell and felt nauseous ... felt "normal" the next morning (3/11/21) when i woke up

Exactly 4 days after receiving the vaccine I experienced intense stiffness of muscles and joints from neck to ankles. I struggled to get up from sitting and then could barely walk until I was moving for a short while; then it was easier to walk but with the pain of the sore muscle/joint feeling. It felt like I had been beat up, especially in my upper torso front and back. It stayed the same until approximately 3:00 a.m. on the second day. i noticed the pain, stiffness, and difficulty moving was getting better. It gradually continued to get better for the next 24 hours until completely gone. My calf muscles were the last to return to normal.

I was having difficulty breathing, a horrible migraine like headache, my calves were aching, nausea and barely able to stand and walk. All started 2:00 am. Spent next day in bed until 3:00pm Sunday 3/14. Just now starting to feel a little better at 3:30.

felt like he had something in his throat, dizzy and wheezing BG was 54 Provided OJ, Benadryl, Epi pen , albuterol and dexamethasone 4mg Symptoms continued called 911 to sent to ED BG improved to 120

This person experienced heightened MS symptoms including increased impaired mobility in bilateral lower extremities, increased anxiety/stress, and a pounding headache.

While in Recovery c/o dizziness, feeling flushed, full shaky body tingles. Brought to First Aid area. VS taken 152/90, HR 74 Reg, resps 12, SPO2 96%. Left Deltoid site being monitored - LOC - NIV. Water for hydration. Stay for 30 min recheck. Pt stated he feels much better. V-Safe OK'd to exit. S. Reagan RN 3/15/2021 - 3:20pm - Feeling much better.

Dizzy on morning of 9th day upon waking. Lasted about an hour. Stayed in bed until it passed. I have never ever experienced dizziness.

Caller states that her dad is experiencing "alot of pain" in his joints, unable to extend arms and legs, progressively getting worse since it started on 03/05/2021. Caller says her dad is at dr appt now. Has been taking Advil as needed. No other symptoms. Advised that we will follow up tomorrow. states that her father is feeling a little better. Saw PCP yesterday who told him to continue with tylenol/ibuprofen. Call us if needed

Reports shaking episode "like having a seizure but conscious" with spasms in mouth and then unable to move legs. Went to sleep and awoke at 3:30 AM feverish and shaking with temperature of 101..0 F. Headache this morning 03/18/21 at 8:41 AM, feels terrible, and shaky on the inside.

Prior to the vaccine on 2/13/21, He was a healthy 65 year old active college professor. 32 hours after the vaccination on 2/14/21, He had acute pancreatitis, which led to septic shock and respiratory failure, and he was placed on a ventilator at Hospital. On 2/24/21, he was transferred to Hospital and continued to have additional diagnoses, including polyneuropathy critical illness, acute gangrenous cholecystitis, abdominal pain, anemia, impaired mobility, oropharyngeal dysphagia, pulmonary embolism, and assistance with ADL. On 3/19/21, he was transferred from Hospital to Acute Rehab Unit for acute physical, occupational, and speech therapy. He remains there today. We do not know if this sequence of events is related to the vaccine, but because it occurred one day after the vaccine, we thought it should be reported.

Increased intense Asthma events, new inhaler (Albuterol) prescribed and used for 3 days, Some vertigo, occasional body temperature fluctuation & SEVERE CHRONIC BRONCHITIS & intense coughing for over a week! - Tessalon Perles, NettiPot rinse routine 3x's/day, Flonase 3-4X's/day, Salt Solution oral & throat rinse, Tylenol & inhaler as needed. Very stressful & scary/unpleasant. I have very minimal confidence in injection repercussions now.

12 hrs after shot around midnight, Dizzy when eyes open, Body ache , Joint pain , Fatigue, Chills, Sinus pressure , Slight Headache and Thirsty, 5 glasses of water in 5 hours, lasted 24 hours. Off work on Thursday 3-25-21. Friday 3-26-21 at 1am symtoms gone except for back pain. Saturday 3-27-21 1am Night sweats x 3 till 5am. Went to work Saturday

On 3/28 I had Arm pain, Chillis/Shakes/Dizziness , My glucose what from AM reading of 129 (7am) to 200 (7pm), my BP went from 110/70 (7am) to 155/90 (7pm). On 3/29 (7am) my glucose is 126, BP 117/73, arm hurts just alittle

Lightheadedness after vaccine administration. History of same with previous vaccines. Denies cardiac history or DM.

Much energy on first day. Then severe spasms in legs and hands, unable to flex. Breathing labored. I believe it was injected into my left arm muscle.

Patient said he was feeling unwell. Started to feel dizzy and felt like he could possible faint. Had slight trouble breathing. Had patient lay down and elevate legs. Patient started to feel better. Sat back down on chair but started to feel faint. Laid back down until EMS arrived. No loss of conscience. Patient was able to communicate without issue. EMS checked patient out and there was no issues found. Patient called and said he is feeling well.

I?m 65 years old and took 2nd Moderna vaccination on 3/16: ? Had severe dizziness the next day. Fell onto bed after trying to get up ? Have been dizzy for the last 15 days. ? Constant phases of lightheadedness

Severe brain zaps, falling, having to hold onto walls to walk, numbness on my left side (face, arm & side), headache

Slowly progressive tingling, imbalance, and mild weakness, with loss of reflexes, elevated CSF protein, and slightly elevated WBC in CSF. Current diagnosis is probable AIDP/GBS (Guillain Barre Syndrome) beginning about 12 days after vaccination. EXAM: Mild weakness, imbalance, absent reflexes in legs, trace biceps reflexes

Initial pain, tenderness and discomfort at injection site after a couple of minutes. Within 24 hours after injection body aches and flu like symptoms. After 48 hours intermittent dizziness and lightheaded has continued to the present day.

Since leaving the clinic, with use of my left shoulder I have had excruciating pain in and around the shoulder to the point I have considered going to the hospital thinking I?m having another heart attack. I have taken a boat load of Tylenol and it doesn?t touch it. Only thing that helps is to prop my arm on a pillow and not use it.

Pt had second Moderna vaccine around 1100. Because he had dizziness with the last vaccine it was requested that he wait 30 minutes. At the end of the 30 minutes the patient complained of severe dizziness. He also had nausea but stated that this was present prior to the vaccine. The patient was pale and sweaty. He denied any chest pain or difficulties breathing. Attempted to get vital signs. O2 was 96 on room air. HR was 52. Unable to get a blood pressure as the patient would not keep his arm straight. Rapid responders were called to assist and a wheelchair was brought over. When we were going to move the patient to the wheelchair he complained of even more dizziness so we did not move him. He declined any juice due to nausea. He was given a few sips of water and a cold pack was placed on his neck. Urgent triage responded and attempted to get vital signs as well. Manual blood pressure was 80/62, HR 47, O2 97% on room air, respiratory rate 14. Patient denied diabetes or blood sugar issues. He had eaten breakfast and took all of his normal medications. First responders then moved patient to the gurney to take him to ER.

Patient became nauseated and lightheaded after receiving vaccine, symptoms were resolved after 5 minutes with no known re-occurrence at this time

diarrhea, nausea, feeling faint, exhaustion, headache, eventually congestion and cough initial symptoms cleared up by noon the next day, but the congestion and cough began the second day and have continued.

Tremors throughout his body; Weak after the fever; sicker than the first; Dizziness; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TREMOR (Tremors throughout his body) and ASTHENIA (Weak after the fever) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse reaction. Concomitant products included METOPROLOL and ATENOLOL for an unknown indication. On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On an unknown date, the patient experienced TREMOR (Tremors throughout his body) (seriousness criterion medically significant), ASTHENIA (Weak after the fever) (seriousness criterion medically significant), ILLNESS (sicker than the first), DIZZINESS (Dizziness) and PYREXIA (Fever). At the time of the report, TREMOR (Tremors throughout his body), ASTHENIA (Weak after the fever), ILLNESS (sicker than the first), DIZZINESS (Dizziness) and PYREXIA (Fever) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Treatment provided included Tylenol. This case concerns a 65-year-old male with PMH of COVID-19, had serious unexpected events of asthenia and tremor, and nonserious unexpected dizziness, illness, and expected pyrexia. 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 This case was linked to MOD-2021-059569 (Patient Link).; Sender's Comments: This case concerns a 65-year-old male with PMH of COVID-19, had serious unexpected events of asthenia and tremor, and nonserious unexpected dizziness, illness, and expected pyrexia. 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

Approximately 12 hrs after the vaccine injection I experiences mild flu like symptoms. The flu like symptoms went away around 24 hrs after the injection. The following morning around 3:00 AM I woke up with severe lateral movement. I was not able to walk, experienced severe vertigo and nausea. These symptoms began to reduce 24 hrs later. At this point double vertical vision began and lasted for approximately one week. Currently I have mild vertigo 18 days after the injection. I am able to drive safely and the vertigo symptoms are reducing day by day.

On March 18th I received the Moderna Vaccine #2 at approximately 11 am. A few days later I started to feel tired. Then as time progressed, I lost my libido, sex drive, this vaccine made my vertigo worse...I am dizzy...My heart rate went down 10 bpm and I feel like I have a virus in me. The longer I sleep the worse it feels...If I had to go back and do this again, the way I feel, I WOULD NOT. This vaccine messed up my RNA and the Cytosine's are making me feel ill and not 100%.

slipped in ice twice, and after second time, he went to the hospital and underwent surgery; slipped in ice twice, and after second time, he went to the hospital and underwent surgery; difficulty walking/drags the leg while walking; feeling so debilitated; cramps all over the body; body aches; could not get up of the bed not even to get to the restroom, he could not get up straight; had no strength; pain in his back, his lower back; difficult to get up; legs very, very cold, freezing cold; with a walking stick; no strength in legs and hands; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (slipped in ice twice, and after second time, he went to the hospital and underwent surgery) and ACCIDENT (slipped in ice twice, and after second time, he went to the hospital and underwent surgery) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced MUSCULAR WEAKNESS (no strength in legs and hands) and WALKING AID USER (with a walking stick). On 17-Mar-2021, the patient experienced DYSSTASIA (difficult to get up) and PERIPHERAL COLDNESS (legs very, very cold, freezing cold). On 18-Mar-2021, the patient experienced MOVEMENT DISORDER (could not get up of the bed not even to get to the restroom, he could not get up straight), ASTHENIA (had no strength) and BACK PAIN (pain in his back, his lower back). On 19-Mar-2021, the patient experienced FALL (slipped in ice twice, and after second time, he went to the hospital and underwent surgery) (seriousness criterion hospitalization) and ACCIDENT (slipped in ice twice, and after second time, he went to the hospital and underwent surgery) (seriousness criterion hospitalization). On 28-Mar-2021, the patient experienced FEELING ABNORMAL (feeling so debilitated), MUSCLE SPASMS (cramps all over the body) and MYALGIA (body aches). On an unknown date, the patient experienced GAIT DISTURBANCE (difficulty walking/drags the leg while walking). The patient was hospitalized from 19-Mar-2021 to 28-Mar-2021 due to ACCIDENT and FALL. At the time of the report, FALL (slipped in ice twice, and after second time, he went to the hospital and underwent surgery), ACCIDENT (slipped in ice twice, and after second time, he went to the hospital and underwent surgery), MUSCULAR WEAKNESS (no strength in legs and hands), GAIT DISTURBANCE (difficulty walking/drags the leg while walking), WALKING AID USER (with a walking stick), DYSSTASIA (difficult to get up), PERIPHERAL COLDNESS (legs very, very cold, freezing cold), MOVEMENT DISORDER (could not get up of the bed not even to get to the restroom, he could not get up straight), ASTHENIA (had no strength), BACK PAIN (pain in his back, his lower back), FEELING ABNORMAL (feeling so debilitated), MUSCLE SPASMS (cramps all over the body) and MYALGIA (body aches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. There were no concomitant medications reported. No treatment information provided. Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities.; Sender's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities.

Started Hallucinating, couldn't grab or hold anything. Hard time walking or standing. All started on the evening of April 9. Shot was given April 9,at 8:38 am. Symptoms stopped Sunday April 11 around 4:00 pm.

Patient presented to local ED on 4/8 after having symptoms ~0400 with right sided numbness unable to move fingers on right hand. Patient also unable to use right leg properly to walk. Later ~0800 weakness, numbness progressed to left side and patient had worsening paralysis to all extremities, trunk, and to face. Patient was transferred to our facility for concern for guillain-barre syndrome. Once admitted, patient was intubated for airway protection and remains on ventilator receiving plasma exchange sessions for presumed diagnosis.

Approx 10 minutes after receiving vaccine, pt called out for help from his car in the waiting area. Was monitoring the area and went to assess patient. He stated he felt faint. O2 sat 94%, pt diaphoretic, pale, drooling, tongue protruding from mouth, eyes open, but difficult to arouse, unable to respond. Epi administered and EMS contacted. Pt then lost consciousness. Grossly diaphoretic, clammy to touch, in and out of consciousness, pupils small but reactive, BP 84/48, R16, pulse 68. Unable to obtain O2 sat as monitor wouldn't register values. Lost consciousness again. Not responding to sternal rub. Gave 2nd dose of epi and maintained airway with jaw thrust. Pt regained consciousness

I initially had pain in left shoulder, some chills and light headiness. Those dissipated by the second day. But 5 days later I developed a hematoma in my left bicep. It was like someone punched my arm as it was purple and red. Within a few weeks it turned to a brown and yellow and currently no coloring. However, my shoulder is tight and some pain and my bicep is experiencing tightness and pain. The Dr who administered the shot was not wearing gloves and injected the vaccine towards the rear of the shoulder and caused me to bleed. I usually coagulate well. My shoulder has discomfort and when moved side to side has a crackling and clicking. I had Torn labrum surgery approximately 4 years ago.

Extremely bad headaches, severe dizziness, shortness of breath, sharp, shooting pain in the middle of the back of the head

Woke up sweating dizzy, wanting to throw up (2 or 3 times to the point of dry heaving), arm sore Recommendation: Drink fluids/pedialyte to stay hydrated. Flu-like symptoms should resolve in 2-4 days, if longer than 4 days seek your PCP. You can take over the counter pain relievers/anti-fever medication such as ibuprofen, naproxen, or acetaminophen to treat your symptoms.

On 3/8/21 65 y/o M received his first Covid-19 vaccine (Moderna) and states on 4/2/2021 he had a myocardial infarction with 2 stents placed. He discharged to home and was doing very well. Tuesday, 4/6/2021, he received the second Covid vaccine. The following morning, he had pain in his right ankle. It progressed and involved his left foot and ankle. Over the next few days his pain progressed to involve his legs, but stopped at the knees. He had leg weakness and associated diarrhea, fever and chills. He thought his symptoms would pass and tried to wait it out over the weekend. When he awoke on Monday morning, 4/12/21, he could not move his feed. He went to the ER and was diagnosed with Guillain Barre Syndrome.. He received 5 doses of IVIG with very good response. Patient states his leg strength is improving, but is not back to baseline. His arms are unaffected by his Guillain-Barre. He is in Rehabilitation now.

3/18 Initially aches and chills. 3/20-29 Progressed on to more severe pain in muscles, joints, tendons and ligaments. 3/30-4/3 pain became debilitating, difficult to get out of bed without using arms to move legs, sitting and rising from a sitting position required extensive use of arms. 4/4-4-26 pain gradually diminished but was not eliminated. Remaining pain is mainly in shoulders, hamstrings, buttocks and hips. 4/23- some breathing difficultly started, only when taking deep breaths. Appt with PCP tomorrow to diagnose and for potential EKG.

hot flash followed by dizziness then fainting. These events occurred at 7:00 AM and again at 11:00 AM. No recurrence after these two episodes.

On 04/20/21 at approx. 1:30 AM he awoke disoriented, lightheaded, "feeling funny" - knew something was different. States he could not make works come out his mouth, make complete sentences. This lasted for 7 or 8 minutes, then cleared up. He called his PMD that morning and was told to go to ER. He went to Hosp. ER, but was then sent to another Hospital. Hospitalized from 04/20/21 and discharged late afternoon of 04/22/21. Extensive blood work done, CAT scan, MRI, Carotoid ultrasound, Echo cardiogram. No signs of A-fib, cholesteral slightly elevated. DX. with TIA. Referred back to his cardiologist Has been under care of his cardiologist for 7 plus years - Pt is an active runner - Runs approx. 6 days a week for 2 1/2 to 3 miles per day. For the past few months he has switched to interval walk/run. After 1st dose of Moderna 03/03/21 - Reports no issues expect slight injection site discomfort. After his second dose of Moderna 03/31/21 - Reports chills 12 hours after injection, low-grade fever (99.0 - 100.0) started 14 hours after the injection. All symptoms resolved 30 hours after injection date and time. Stated he kept notes of this.

I had a syncope event while trimming tree limbs from a platform 8 feet off the ground. I suffered 3 compression fractured vertebrae when I blacked out getting ready to get off onto a ladder to get down. No advance warning, no dizziness, no vision impairment, nothing except a sore knee when I bent over to kneel on the platform in preparation to get on the ladder. It was like someone turned off a light switch and then turned it back on after I was on the ground. Don't remember even getting down or a fall, but I was down on the ground. When I went to get back on ladder to retrieve my equipment I could not lift my leg due to pain and felt like I had a pulled groin muscle. Laid down and could not get up.

65-year old man with PMH notable for CAD s/p 3v CABG 2015, HFrEF (EF 54% 11/2020), CKD, T2DM (A1c 7.5% 9/2020), and OSA, presenting with 2 days of weakness, malaise, difficulties getting out of bed and walking. The patient was in his normal state of health until he got the 2nd dose of the moderna covid vaccine two days ago; since then he has been somnolent, weak, not eating or drink much, and slid out of his bed and woke up on the floor once. He came to the ED because he was so weak that he couldn't walk. He furthermore endorses suprapubic and generalized right-sided abdominal tenderness that started after two episodes of nonbloody emesis and chills while waiting in the ED. He denies fevers, chest pain, dyspnea, orthopnea, lower extremity swelling, palpitations, brbpr, melena, dysuria, rash, easy brusing/bleeeing, headache, vision changes, and sensory changes.

Patient states that the evening of the vaccine he started having tightness in his left arm and soreness as if he had worked out excessively. As the evening went on the tightness spread across left arm into chest and neck and over to right arm. Felt somewhat better in morning but still sore in both upper extremities. 2 days later (3rd day after shot) he went to use the restroom in his home and could not get himself off the toilet - he describes himself as having lost all strength in his legs and when he went to stand he fell right over. He could not get up and had to be helped to the bedroom. He rested for several hours and used a walker to ambulate around the house for the next several days. Now feels back to normal.

Emergency room visit and subsequent Hospitalization x 3days for severe vertigo, nausea, and vomiting. Transferred to rehab hospital for therapy to treat vertigo.

Date and time adverse event started: 1st dose symptoms occurred approx 1/31/2021 (3-4 days pos-vac). 2nd dose symptoms occurred right away. Date and time of vaccination: (list both if they received both shots): 1st dose 1/29/2021 ~1300-1400. 2nd dose 2/26/2021 ~1300-1400. Pt reported ~3-4 days post-vac of 1st dose, pt experience ache and pain in every joints "joints felt like I was crippled", reports his whole body was in agony only with movement but not at rest. Pt reported that these symptoms did not subsided and the 2nd shot seems to make the symptoms worse per had lots of muscle pain and he could not move, had to have his wife help him in and out of the bed. Pt reported he took extra strength Tylenol on 2/27/2021 after his 2nd shot for a duration of 3-4 days which provided no relief. Pt reported that just approx. a little over a week prior to his scheduled orthopedic surgery (2/18/2021 - for an microscopic surgery for his torn MCL in his left knee), pt was seen by his orthopedic surgeon because his left knee had puffed up on the side, as a result his doctor drained his left knee and gave the pt a cortisone injeciton in his left knee to reduce inflammation. Pt reports that after rcvding cortisone injection he felt great and all his ADEs from the Moderna vaccine subsided. Pt reported that his orthopedic surgeon had adv that his ADEs of joint and muscle pain and achiness may be vaccine related. Pt reported doctor prescribed him Methylprednisolone 6 days dosing regimen approx. 1 month ago, and while taking pt reported he felt great and all symptoms subsided. Then approx 3-4 days post last Methylprednisolone dose was taken pt reports all his symptoms came back again. Pt reached out to his orthopedic surgeon again and got another prescription for Methylprednisolone and just completed his last day of dosing today and reported no pain again while on the treatment. Pt have another follow up appointment with orthopedic surgeon on 5/4/2021. Recommend pt to monitor if any of those symptoms occur again, and if so discuss with doctor and contact MD for further evaluation. 5/5-Patient does not have any pain at this time, he went to see orthopedic surgeon yesterday on 5/4/21 to get another Methylprednisone script just in case of relapse since the steroids significantly helped with pain in left knee. Ortho surgeon did not refill Methylprednisone script. Patient is upset and is at primary provider's office today to get another script.

Joint stiffness progressing to a full flair-up of PMR. Effected knees, hips shoulders, jaw and hands. Treatment until 2 weeks after facing was controlling pain with Tramadol and anti-inflammatory with Dicofenac Sodium. Was not effective in controlling joint stiffness associated with PMR . 12 days after vaccine began regiment of Prednisone beginning at 120mg per day and tapering off to 2 mg per day 5 week period. Effective while taking Prednisone. Stifness returned after completing Prednisone. Had shot of Torodol and another steroid. Effective for a few days. Went back (currently taking) Prednisone beginning with 10mg per day tapering to 2 over a 5 week period.

Site of injection (left shoulder) was slightly sore after about 4 or 5 hours. Shot was administered at 8:05AM. Felt fine until about 6:45PM. Noticed aches and painst beginning in neck, shoulders, and a slight headache which came and went. at 8PM, was very tired and began to feel somewhat lightheaded. Went to bed and felt chills. Awakened six or seven times during the night to urinate. Was a little dizzy each time I rose from the bed. Also felt feverish and took my temperature. It was elevated to 99.3F, which for me is definitely elevated, since it is usually no higher than 98.6 and is often around 97.9F. Felt very tired the next morning and had continued mild aches and pains and occaisional shingles-like stabbing pains in rotator cuff of left arm , mastoid bone behind right and left ears, and occaisional random stabbing pains in earl lobes. The pains were mild to moderate on occaision. Left arm was a little sore during movement, especially near the shoulder. Felt very tired throughout the day and went to bed at 8PM the day after the shot. That evening in to nightime when I would get up to go to the bathroom, I began to feel better and after midnight of the second day, I felt pretty much back to normal. The lightheadedness, aches and pains, and tiredness all went away by the morning . I would also report that I ate normally during these effects and did not suffer any nausea or feel like vomiting at any time.

Extreme fatigue, weakness, dizziness, muscle soreness, profuse sweating-no fever detected, heart seemed to race at times, headaches. Started the morning after vaccine, and is still continuing today, 5th day, 5/18/2021. I had to see my doctor today due to symptoms continuing and not improving. Doctor did a Covid test to make sure I didn't now have Covid. Was advised to rest and drink fluids.

Pt admitted hospital on 5/21/2021 for vaccine reaction, received first moderan vaccine 5/20/21, severe nausea, vomiting, weakness, falls, history of severe COVID-19 infection with pneumonia and resp. failure requiring hospitalization and 02 in October 2020, had been well after, feeling back to normal 5/21/2021 AM, discharged home, follow up in clinic 1 week, Dr followed in hospitalization.

Extreme dizziness, nausea, vomiting that started Saturday May 29th and has not subsided. Trip to the emergency room and appointment with provider.

Woke up the 2nd morning and tried to stand up, I immediately fell back onto bed and the room was uncontrollably spinning very badly. Tried to call out but was unable to due to the dizziness. after about 10 min the dizziness subside enough to call out and get help. was unable to lift my head off bed without uncontrollable dizziness. stayed in bed the entire day with 1 trip to bathroom. The trip to the bathroom I basically crawled since I was unable to stand up. The dizziness lasted for about 5 week. Unable to look up due to dizziness coming back. I lost 7 days of work and was extremely cautious of falling over going to work. Loss of appetite, balance, and a feeling of nervousness lasted for many weeks. Visited by family doctor and said it was nothing and not related to corvid injection. Visited neurologist and said it was not related to corvid injection. N one seemed to know what the problem was except I know it was caused by the injection.

May 28, 2021, about 28 hours after receiving the second Moderna shot, began to feel light headed and almost passing out. Breathing became labored. 911 was called and the EMTS arrived. Blood pressure was very low below normal readings. Also did an EKG on site. Was transported via Ambulance to Hospital. IV fluids administered in the ambulance. More fluids were given by IV in Emergency room. Blood Pressure monitored at 152/82 in Emergency room, about 2 hours after admitted. EKG, Chest and Lung Xray, full blood work. Emergency Dr gave 2 mg of Doxazosin scheduled meds and was released. Blood pressure continued to elevate after released. BP meds were still taken as scheduled.

Inflammatory response, unable to walk without cane after 2cnd shot, could not walk up stairs, diagnosed with spinal stenosis after 2cnd shot

In the arm got the shot, I felt painful. I applied cooling pad to release the pain. Throughout the body, I felt tiredness, muscle pain, chills, and had fevers. I had bed rest for one and half days and drank a lot of water. Side effects were gone in two days after the vaccination.

The patient had a raised area where the vaccine was administered immediately following the injection. A few seconds later the patient reported not feeling well, claiming to be light-headed. He was light-headed for a few minutes and then reported feeling nauseas. A few moments later the patient vomited. He took a few sips of water and reported feeling much better after vomiting.

I have had a lump at the injection point as well as decreased use of my left arm since March 4, 2021 with increasing pain and decreasing use of the left arm

passed out due to pain from the shingles; went blind for two weeks; neuropathy in left eye; Shingles progressive around his eyes/ shingles on his face and on his eye; tooth fracture; haemorrhoids; pain in right arm; calcium deposit build up; injuring neck; injuring back; still has pain above left eye; bad tooth ache; toothache and cavity on left side; teeth have become more brittle; fungal rash; low back pain on the right side; teeth have been a real problem; sleep all day; loosing teeth; constipation; gaining weight; muscle spasm; allergies; big knot over his eye; nerve damage above left eye; someimes breaks out in a rash with red spots; fell; rash on outer right leg that was painful; pain in my hips; tired, worn out , exhausted; fever for at least 2 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out due to pain from the shingles), BLINDNESS TRANSIENT (went blind for two weeks), NEUROPATHY PERIPHERAL (neuropathy in left eye) and OPHTHALMIC HERPES ZOSTER (Shingles progressive around his eyes/ shingles on his face and on his eye) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product RUXOLITINIB PHOSPHATE (JAKAFI) for Polycythemia vera. Concurrent medical conditions included Kidney stones (Kidney stones), Blood uric acid increased, Myeloproliferative disorder, Postherpetic polyneuropathy, CML, Itching, Haemochromatosis and Polycythemia vera. Concomitant products included MEFENAMIC ACID (ADVIL [MEFENAMIC ACID]), ATORVASTATIN CALCIUM (LIPITOR), VALACICLOVIR HYDROCHLORIDE (VALACYCLOVIR [VALACICLOVIR HYDROCHLORIDE]), AMOXICILLIN, LORATADINE (CLARITIN [LORATADINE]), TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), ALLOPURINOL, OXYCODONE, PREGABALIN (LYRICA), ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [VITAMINS NOS], PROBIOTICS NOS, UBIDECARENONE and DOCUSATE SODIUM for an unknown indication. On 27-Mar-2017, the patient started RUXOLITINIB PHOSPHATE (JAKAFI) (Oral) 15 milligram twice a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out due to pain from the shingles) (seriousness criterion medically significant), BLINDNESS TRANSIENT (went blind for two weeks) (seriousness criterion medically significant), NEUROPATHY PERIPHERAL (neuropathy in left eye) (seriousness criterion medically significant), OPHTHALMIC HERPES ZOSTER (Shingles progressive around his eyes/ shingles on his face and on his eye) (seriousness criterion medically significant), TOOTH FRACTURE (tooth fracture), HAEMORRHOIDS (haemorrhoids), PAIN IN EXTREMITY (pain in right arm), CALCINOSIS (calcium deposit build up), NECK INJURY (injuring neck), BACK INJURY (injuring back), POST HERPETIC NEURALGIA (still has pain above left eye), TOOTHACHE (bad tooth ache), DENTAL CARIES (toothache and cavity on left side), TEETH BRITTLE (teeth have become more brittle), FUNGAL SKIN INFECTION (fungal rash), BACK PAIN (low back pain on the right side), TOOTH INFECTION (teeth have been a real problem), SOMNOLENCE (sleep all day), TOOTH LOSS (loosing teeth), CONSTIPATION (constipation), WEIGHT INCREASED (gaining weight), MUSCLE SPASMS (muscle spasm), HYPERSENSITIVITY (allergies), MASS (big knot over his eye), NERVE INJURY (nerve damage above left eye), RASH MACULAR (someimes breaks out in a rash with red spots), FALL (fell), RASH (rash on outer right leg that was painful), ARTHRALGIA (pain in my hips), FATIGUE (tired, worn out , exhausted) and PYREXIA (fever for at least 2 hours). The patient was treated with TERBINAFINE HYDROCHLORIDE (TERFINABINE) for Fungal infection, at a dose of 250 mg. At the time of the report, LOSS OF CONSCIOUSNESS (passed out due to pain from the shingles), BLINDNESS TRANSIENT (went blind for two weeks), BACK PAIN (low back pain on the right side) and PYREXIA (fever for at least 2 hours) had resolved, NEUROPATHY PERIPHERAL (neuropathy in left eye), PAIN IN EXTREMITY (pain in right arm), POST HERPETIC NEURALGIA (still has pain above left eye), TOOTHACHE (bad tooth ache), DENTAL CARIES (toothache and cavity on left side), FUNGAL SKIN INFECTION (fungal rash), SOMNOLENCE (sleep all day), MUSCLE SPASMS (muscle spasm), RASH MACULAR (someimes breaks out in a rash with red spots), RASH (rash on outer right leg that was painful) and ARTHRALGIA (pain in my hips) had not resolved, OPHTHALMIC HERPES ZOSTER (Shingles progressive around his eyes/ shingles on his face and on his eye), TOOTH FRACTURE (tooth fracture), HAEMORRHOIDS (haemorrhoids), CALCINOSIS (calcium deposit build up), BACK INJURY (injuring back), TEETH BRITTLE (teeth have become more brittle), TOOTH INFECTION (teeth have been a real problem), TOOTH LOSS (loosing teeth), WEIGHT INCREASED (gaining weight), HYPERSENSITIVITY (allergies), MASS (big knot over his eye), FALL (fell) and FATIGUE (tired, worn out , exhausted) outcome was unknown and NECK INJURY (injuring neck), CONSTIPATION (constipation) and NERVE INJURY (nerve damage above left eye) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Very limited information regarding the events has been provided at this time. Further information has been request.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been request.

Site: Bruising at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium

Patient became dizzy, weak and woozy/nauseous. He reported that he may have passed out for a quick moment.

Trouble moving or getting out of position; Pain in his arm; Feeling some symptoms including some chill; A little bit of blood after the injection; Pain during injection; When he has the headaches, he cannot even be driving; Headaches and has bad vision during his migraines; Bad vision during his migraines; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED DRIVING ABILITY (When he has the headaches, he cannot even be driving) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis. Concurrent medical conditions included Sleep disorder and Eczema. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 600 mg once a day. On 12-Mar-2021, the patient experienced INJECTION SITE HAEMORRHAGE (A little bit of blood after the injection) and INJECTION SITE PAIN (Pain during injection). On 18-Mar-2021, the patient experienced MOVEMENT DISORDER (Trouble moving or getting out of position), PAIN IN EXTREMITY (Pain in his arm) and CHILLS (Feeling some symptoms including some chill). In 2021, the patient experienced IMPAIRED DRIVING ABILITY (When he has the headaches, he cannot even be driving) (seriousness criterion disability), MIGRAINE (Headaches and has bad vision during his migraines) and VISUAL IMPAIRMENT (Bad vision during his migraines). On 21-Mar-2021, MOVEMENT DISORDER (Trouble moving or getting out of position), PAIN IN EXTREMITY (Pain in his arm) and CHILLS (Feeling some symptoms including some chill) had resolved. At the time of the report, IMPAIRED DRIVING ABILITY (When he has the headaches, he cannot even be driving), MIGRAINE (Headaches and has bad vision during his migraines) and VISUAL IMPAIRMENT (Bad vision during his migraines) had not resolved and INJECTION SITE HAEMORRHAGE (A little bit of blood after the injection) and INJECTION SITE PAIN (Pain during injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter causality was updated from not reported to unassessable. No treatment information 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. however, the concomitant use if DUPILUMAB could be a confounder because visual impairment is an adverse event for this drug. No further information is available for this case because patient denied 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. however, the concomitant use if DUPILUMAB could be a confounder because visual impairment is an adverse event for this drug. No further information is available for this case because patient denied follow-up.

Rapid heart rate (atrial flutter), chest pain with elevated troponin, fever, fatigue, shortness of breath, lightheadedness

The first two weeks after the vaccine I got severe muscle spasms that were pretty much all over my body but they were mostly in my back, I could not even stand up straight. I was 50/60 degrees, could not stand up straight. Also for like 3 days straight I just slept. The back spasms were the worst, they have gradually gotten better but not completely better. It progressively gets better, but is going very slow. I talked to my DR and my Rheumatologist several times throughout this time and I saw my DR at least once every six weeks since this began and Rheumatologist once since this has happened. This started on 2/19/2021 and it is now 7/19/2021. My Internist put me on Prednisone and Valium and muscle relaxer. The Prednisone helped, I was given those medications at different times, about a month apart.

Patient felt dizzy and almost fainted within 5 minutes after receiving 2nd Moderna vaccine. Pt was seated in post-vaccination area but did not faint. Cold compress applied to patient neck, BP taken every 10 minutes and Patient flexed muscles to increase blood flow. Pt was felt well after 25 minutes. Pt got up and walked out of building with no assistance after 30 minutes after shot.

Woke up with extreme pain in my lower back; lesser pain in various joints. I could barely walk. I have had back pain before, this was different. At first I assumed it was coincidence, but later after my wife had me check the 'side-effects' of moderna shots, decided it was more likely the shot (I had no problem except shoulder pain with the first shot). This lasted for several days - fortunately I had the weekend, and then hobbling around at work all I had to do was say that I'd had the second Covid shot and everybody gave me enough flex to do my job slowly and gingerly. It was Thursday or Friday before I was able to get around with a semblance of normalcy, and nearly as many days before I was back to normal. I've had back problems before, including debilitating like this - but this was different - just pain. I went to the chiropracter twice - he immediately recognized that I was walking bent over sideways, and that it was muscle rather than actual vertebra, as I've had in the past. The first visit made things feel better for a few minutes, but I was still walking bent sideways. The second visit was during the time I was getting better, and definiately helped more. Note, I don't know if this is cause (shot 2) & effect (joint & muscle pain). I doubt it was just correlation, but I'll grant the possibility. More likely, my opinion is that the shot caused something, which made things worse than they would've been. Just over a month, hence not required, but included in case the time between shots is significant - doubt it, but included anyway.

extreme nausea, heart palpitations, sweating (first night). Weekly bouts of nausea, reduced appetite, weight loss, difficulty waking up, brain fog.

Moderna COVID-19Vaccine EUA Arm soreness, headaches, nausea, chills, fatigue, dizziness; started the morning after I received the injection and lasted 24 hours. 48 hours later I still have fatigue and headaches. (It is noteworthy that I had COVID in October, recovered at home, in bed for 3 weeks. This was very similar)

Felt heart rate going up 5 minutes after taking the vaccination. Felt for about 3-4 minutes. Then an hour after taking vaccination started feeling dizziness when I stand. Lasted for couple hours. Also, started drinking lot of water. Feel improvement.

On Jan 11, 21 immediately after the vaccine I felt my heart wad high. Then after an hour I felt dizzy for couple hours. At night on the same day, I had chills, temperature 101 F. Had Tylenol. Next day on January 12, 21 felt feverish, body pain, tired and lost some food taste. So slept all day. Same later in the evening started coughing. January 13 and 14, 21 felt tired and dizzy when I stand up. Had cough syrup and today it has improved. However, still feel dizzy but hope to recover gradually. Daughter is listed as my doctor. She is my daughter. She watches me but she is not my official physician.

Lightheaded, high pulse rate of 116 bpm, breathless, fatigue. I sat in the facility for 40 minutes after receiving the injection. Started an hour + after I departed the facility, (an hour and 40 minutes after injection). Laid down and sleep overnight. Pluse dropped to 88. My average resting pulse rate is 68-72. Current resting pulse rate is 88-94. Still feel lightheaded. I feel like my heart is fatigued. My oxigenation is 95-96. Meds Cont: Atorvastatin, Aspirin (81), CoQ10 (200mg), Albuterol, Flovent, Vit C, Vit B-12

very sore arm for 3 days, a bit dizzy 2 hrs after shot, lasted about 5 mins, foggy brain for a few days

Fever, unsteadiness of feet, increase falls. total assist with care resident normally is able to complete all ADL's on own.

Around 8:30PM started to feel bloated and the feeling of something out of the norm. Around 8:45PM-diarrhea. Then, nausea followed quickly. Stood up, felt light-headed, and vomited several times. Went to bed around 9:30PM. Got up 3 times during the night with diarrhea. Got up in the morning and felt fine. No headache or fever. But was feeling chilled when I went to bed.

Severe chills the night of the shot, teeth chattering, couldn't get warm; next afternoon, chills resumed mid afternoon. Decided to get into bed to warm up. Walking up the stairs and holding both rails - left and right - I blacked out, fell forward and hit my mouth on the edge of one stair, and my ribs on the edge of another stair. Lots of blood,, chipped a tooth, lots of swelling in my mouth, deep laceration on my face and very sore ribs. Saw doctor the next day. No stitches required and ribs are bruised only. I will need dental work done to repair my teeth.

lightheadedness and syncopal episode. States "all of the sudden he felt hot and passed out" He was hypotensive with b/p 75/51 HR 65. EKG NSR. sent to the ER for further evaluation.

The joint at the base of my little finger swelled up rapidly, starting at about 2pm. It became extremely painful. Due to swelling and pain, I could not grasp with that hand. That evening, I used ibuprofen and Aleve. The swelling and pain was better in the morning of the next day. Forty-eight hours after onset, the hand was essentially back to normal.

Patient is a 66 y/o male with a PMH of adenocarcinoma of the colon s/p sigmoidectomy and colostomy, currently receiving chemotherapy, CKD3, single R. kidney, R. Hydronephrosis, pulmonary hypertension, presented to the ED from clinic due to weakness x 2weeks. Pt reports feeling weak and dizzy when he stands up, which improves with laying down. Denies any head trauma. Pt reports his BP usually ranges from 120-140 in clinic, but it has been consistently less than 120 for the past couple of weeks. Associated with brown colored urine, sometimes with a small amount of blood when initiating urination, general malaise, nausea, and vomiting a small amount of clear fluid every 2-3 days. Pt does endorse decreased PO intake for the past few months since starting this cycle of chemotherapy but is still able to keep food/water down. Pt denies recent changes in colostomy output, last changed yesterday. Denies fever/chils, urinary frequency/urgency, hematemesis. Assessment/Plan: * Sepsis - WBC 1.54, Hypotensive on admit - Likely 2/2 UTI - 1L IVFs in ED - Lactic Acid: wnl - BNP: wnl - CXR: Calcified granuloma left upper to midlung zone. Small nodular opacities questioned right upper lung zone and right midlung zone. Left subclavian Port-A-Cath again noted. - UA: 1.010, 2+ blood, 3+ leuks, 66 RBCs, >100 WBCs, many WBC clumps, 4 Hyaline casts - No urinary complaints on admit - Received an additional 30cc/kg of fluids - Day 3 of Neupogen - BCx pending - Continue broad spectrum abx (Vanc/ Zosyn), will de-escalate pending cx - Urine gram stain pending Anemia - H/H baseline 11-12 - H/H slowly dropping, today 8.8/26.5 - Denies any hematemesis, no bloody output in colostomy - s/p sigmoidectomy - Not symptomatic - Will continue to monitor - Transfuse if hemoglobin <7 or becomes symptomatic Hypotension due to hypovolemia See Sepsis Acute kidney injury superimposed on CKD - Patient presented with Serum Cr 3.5, with a baseline Serum Cr of 2.7 - Resolved. Serum Cr 2.2 today - Most likely due to sepsis - Gabapentin held at admit due to AKI superimposed on CKD3 1. Challenge with gentle IVF's 2. Maintain UOP at 0.5ml/kg/hr 3. Hold nephrotoxic medications 4. Renally dose current meds if applicable 5. Bladder scan if suspicion of retention, followed by retroperitoneal US to evaluate for hydronephrosis hydronephrosis. Foley if retention. 6. Avoid hypotension 7. Stricts I/O's 8. Monitor renal function closely Neutropenia - WBC on admit: 1.54 - Last chemotherapy 1/25 - ANC 494 today, down from 774 yesterday - Day 3 of Neupogen - See Sepsis NSTEMI (non-ST elevated myocardial infarction) - Troponin mildly elevated on admit: 0.052, repeat plateau will not trend - EKG on admit: NSR, no ST changes or evidence of ischemia present - Likely 2/2 sepsis, low concern for ACS - No CP on admit - Will hold off on initiating ACS protocol - Cardiac monitor Adenocarcinoma of colon metastatic to liver - History of Stage IIC (pT4bN0Mx) poorly differentiated adenocarcinoma of the colon in 2016 with recurrent disease in 2018 and 2020, now p T4b N2 Mx - Followed by CMC Oncology - Last Oncology appt 1/26/2021: Received Irinotecan but leucovorin of Folfiri held - Will continue to monitor Neuropathy VTE Risk Mitigation (From admission, onward) Ordered heparin (porcine) injection 5,000 Units Every 8 hours 02/04/21 2026 IP VTE HIGH RISK PATIENT Once 02/04/21 2026 Place sequential compression device Until discontinued 02/04/21 2026 pt admitted for inpatient stay from ED on 2/4/2021 and discharged to home on 2/8/2021

On the way home from getting the vaccine I started feeling tired and I had to stop a few times on the way home, when I got home I just laid in bed. I took some ibuprofen for the headache and had no appetite. The next day I felt fine.

syncope, c/o itchy throat Narrative: Patient was seen prior to administration of the Moderna COVID-19 vaccination. He has allergies to bees/egg and a h/o anaphylaxis 2/2 receiving an injection of penicillin in the past. Discussed that prior h/o anaphylaxis to PCN injection was not a contraindication to this vaccination, but is a precaution. Discussed risks of receiving the vaccination vs benefits of the vaccine, which patient states "I already had this discussion with Dr.!" He has multiple comorbidities which place him at a higher risk for more severe illness from COVID-19. Again received the risk vs benefit discussion. Patient stated understanding and desire to proceed with the vaccination. He will be monitored for at least 30 minutes in area where staff can directly observe him. Patient received the COVID vaccination at 13:00. At 45 minutes later, staff alerted that he was c/o palpitations. Due to confusion and weakness, we were unable to transport him to an examination room. Oxygen, water, and vitals machine were brought to him. He presented with SOB, confusion, lightheadedness. Exam demonstrated acute distress, speaking in staccato sentences. HR in 80s, with lungs CTAB and no stridor - despite increased RR to 20s. Vitals with HR in 70s, SpO2 remained 97% or greater on RA. BP was initially 140/72. A code blue was called and Drs. presented to the area. Patient c/o itchy throat and still p/w confusion/combativeness, loss of orientation, and SOB. No visible swelling noticed. At around 13:58, patient syncopized. HR and SpO2 remained 70-80s and >98% on room air respectively. Pulse remained palpable. At that time, an epipen was administered. Patient woke up. During the entire episode, he was able to recognize a staff member with whom he was previously familiar. EMS arrived, vitals remained stable. EMS transported patient to the ER for further monitoring and f/u. Concern for immediate allergic reaction 2/2 vaccination. After event, patient in need of referral to allergy provider for evaluation prior to consideration of 2nd dosage.

left arm mobility -could not lift Armand movement limited for 3 days-then got 95% better but then about 1 week later same issue with left arm-limited lifting ability and movement-after 3-4 days called my doctor who told me to take Tylenol, has helped and I am about 96% normal s of ti date 2/15- **question --is it recommended for my second shot 2/22 to be given in left arm?

Second day: sore arm and neck (over by next morning), dizzy spells and nausea (ended by evening), temp 100 (normal by next morning).

Patient had COVID vaccination on 2/3 with no adverse s/s before leaving unit. Upon coming to treatment Friday 2/5 he reported to the RN that he had fallen on thursday 2/4 due to "getting up fast" did not hit head or hurt anything per RN discussion. Began treatment without difficulty. About 3/4 way through treatment was talking with staff and became unresponsive - code was called and pt expired after 30 minute resuscitation efforts.

02/13/21 Headache, fatgue, shortness of breath, pain at injection site 02/14/21 Same 02/15/21 Fatigue, shortness of breath increased and dizziness

Patient became pale and felt faint while sitting in the observation area after receiving the vaccination. He was alert and talking but quickly reported the need to lay on the floor with dizziness and faintness. The patient began feeling better after laying down and wanted to then sit in the chair again. After sitting up a second time the patient fainted in the chair and was guided to the ground where he became alert again and waited until the medics arrived. After some time with the medics the patient began feeling better and declined to be taken for further medical treatment.

Before given vaccine, patient stated he has passed out from vaccines before. He received the dose, stated that I provided good technique but would stay with his wife for the 15 minute period afterwards just in case. He started to feel lightheaded/dizzy and voluntarily laid down on the floor. We provided him water, and he was sitting up, standing up, and able to leave within the next ten minutes.

Rash to face and neck approx. 12 hours after vaccination. Also reported chills, body aches, headache, feeling feverish, dizziness and fatigue after.

Received shot at 6pm thursday. Friday I felt tired, and by late afternoon had temperature of of 100.4. I felt fine when I woke on Saturday, and felt pleased that my immune system was apparently working properly Seeing nothing in the Moderna fact sheet about avoiding alcohol, at dinner I had 3 and a half cocktails. Had no problem walking home and walking the dog, but after getting in bed, I had a much stronger reaction to the alcohol than I ordinarily would - vertigo, and the next day, extreme tiredness. Though I don't ordinarily drink that much, I'm a large man, and it doesn't affect me as much. I'm concerned that the alcohol may have affected the efficacy of the vaccine, and wonder if avoidance of alcohol should be mentioned in the fact shett.

Patient received his injection at 12:20 pm. He was observed for 15 minutes and released. Almost an hour later he was still grocery shopping in the store he stated he very rapidly became dizzy almost like vertigo, began to feel shaky and sought a chair to sit down. He quickly became very nauseous and found a nearby trashcan to vomit but states he could only dry heave 3 or 4 times. He became quite pale and sweaty. He was observed by his wife accompanying him who is an RN. After appoximately 15 minutes the patient began to feel somewhat better. He was given a bottle of water to drink and he could sip it successfully . He was able to stand successfully and walked back to the pharmacy where I checked his blood pressure (136/86) and pulse (68). He refused a 911 call and said he felt about 95/100. Will check on patient again later this afternoon. Patient will check with his doctor before getting the second vaccine.

30 mins after vaccine was shopping at the store that administered the vaccine and had a severe dizzy/vertigo episode. Had to hold shopping cart and sit down. 3 mins into dizziness I became nauseated and had to find a garbage can to vomit into. I had 4 episodes of dry heaving and was diaphoretic and sat for 15 mins and slowly the dizziness subsided. Pharmacist asked me to return to pharmacy the gave me water and took my BP. 136/86 HR68. It is now 3 hours later and I feel much better. I just ate lunch. I'm very healthy with no issues and this literally floored me.

About 60-90 minutes post injection he began to feel bad. Voice became very raspy, felt weak, felt like someone was chocking him. Extremely diaphoretic, felt very hot, had to remove shirt. Felt SOB, Called 911 with EMT response. BP 220/160, declined transport to ED, went home with family. BL more stable by 2100 that day. Day after shot blood sugar elevated at 220, normally 150/180.ALso vomiting clear fluids. Still not feeling well 4 days later, feels like "in another world", feels weak at times. Feels dizzy. Has and "eerie" feeling. Feels "equilibrium is off". Took Benadryl on 2/20. Has some disorientation "forgot what he was doing" at one point. Cramps in bilateral legs, both thighs and calves. Has headaches, migraine like at 3am without an elevated BP. Encouraged to see PCP, has appointment with physician on 3/2

Severe arm pain at area of injection about 9 hours after shot (bedtime). Next morning very severe total arm, head and joint pains, total fatigue, mild fever, no appetite. Unable to get out of bed except once to urinate which was a painful struggle. Next morning most symptoms subsided greatly. Only a mild headache and moderate arm pain remained. As of this writing headache is gone but moderate arm pain at injection site continues.

Onset of chills after 20 hours of injection followed by nausea and lightheadedness as day progressed. Symptoms completely gone after twelve hours.

Very disoriented he was like he was looking into space, shaking, very nervous, panicky, afraid to drive, seeing things, felt like he was having a heart attack. Hosptial did tests for his heart everything was fine with his heart. They said it may be from the shot. For him to go to his primary doctor. The doctor said not to get the second shot. Patient's first shot was 2/12/2021 and he still has the effects it?s going on two weeks .

Extreme dizziness in morning on Day 3 and 4, lost sense of balance. This lasted 2 days. Other than that, light headedness and headaches have been daily since vaccination.

About six hours after receiving the Covid Moderna vaccine I quickly began constant tremors that was strong enough that I could not walk or stand. I did not have a thermometer but I?m certain I had a fever. This lasted throughout the night. The following morning I was bedridden, unable to eat and had flu like symptoms. This is continued for three days now. I am slowly Beginning to gain strength but I?m still bedridden.

Recurrence of intense pain and limitation of movement of left arm 9 days after receiving the vaccine and after 4 days of complete recovery for the same symptoms. Both treated with Tylenol.

right wrist is swollen and un-usable at this time...cannot use for cleaning after bowel movement///am on crutches and very difficult to use left hand left achilles tendon is so painful, i cant bear weight; throbbing having difficulty maintaining equilibrium...I believe I had the virus in march of 2020, though the antibody test i took in may was negative. there may be some question as to the efficacy of the test that was being used at that time

At 12:30 that night I woke and I felt like to throw up and diarrhea at the same time. I had a terrible headache, dizziness, nausea. I had chills. The next day I was still very, very sick and had a fever of a hundred degrees. And I was sick all day Saturday. Unable to hold down any water. Sunday morning it broke and I was starting to come out of it. Today I'm not feeling 100% but much, much better.

about an hour after vaccine I started having dizzy spells, face flushing, the were short in duration but lasted a couple hours overall, then got light headed and tired, right arm got very cold, lasted an hour, Left side of face got numb, that lasted 3 days, upper right side of chest was painfull for two days

Rather severe back ache (lumbar & thoracic) to the point that I could not bend over, twist to either side or even cough without a severe stabbing pain and then general soreness.

Presented to the ER 1 day after receiving the second dose of Moderna vaccine with truncal ataxia, vertigo, and dizziness. Patient later became aphasic in the ER. Patient also noted to be febrile, hypotensive, with elevated lactic acid. Patient discharged on day 3 of admission per neurology clearance.

"Moderna COVID-19 Vaccine EUA temp of 101.6, extreme letheragy, dizzy, weak, cognitive impairment, body aches, chills, loss of appetite

He complained of dizziness the evening of the shot. He went to bed and when he woke up the next morning he was having double vision. Is eye drifted off to the side and he was too dizzy to get up. He was taken to the hospital. They did a CT scan which didn't give a diagnosis, and they were unable to do a MRI scan due to a medical reason, so they could not determine for sure if he had a stroke. They are assuming that he did have a stroke and he has oculomotor nerve paralysis on the right side. The nurse practitioner saw him today and she reports he is doing very well now. He had been staying in a assisted living type facility when this occurred, but he is expected to return home tomorrow.

Patient presented to ED after he became dizzy while shooting pool and felt his defibrillator fire. Patient underwent diagnostic cardiac cath and it was deemed that there would be no intervention at this point. Patient was discharged with plans to follow up with PCP and cardiologist

Extreme pain in the left shoulder and arm at the injection site. Unable to lift arm past height of shoulder or head without further pain. Pushing with the left hand on an object creates pain in the arm and shoulder. Resting on the elbow will also create the same pain. The pain is constant. At night I usually wake up between 1 and 3 am from the throbbing pain. According to the physician, the pain seems to mimic a rotator cuff injury, which I do not have, nor have I had. I have been taking Motrin 2 to 3x per day, and Extra Strength Tylenol during those 1 to 3 am morning wake-ups. Putting the left arm thru a shirt is a painful task. Outside of arm at injection to the touch creates pain.

Moderna Vovid-19 Vaccine EUA Got Vaccine at 10am that morning and by 9pm patience was having chills, fever, balance issues, muscle aches. It felt like a bad case of the FLU. It lasted until the next day about 8pm.

Patient was given Moderna vaccination and was waiting in the post-vaccine area. Patient reported to the associate that he was feeling funny. The pharmacist was called and the patient reported feeling light headed and dizzy. While talking the pharmacist the patients eyes rolled back in his head. The pharmacist held his shoulders and his hand and continued to speak to the patient. He regained consciousness. The patient was able to move to his knees and then to lie on his back on the floor with his feet elevated. The injection site was clear and smooth. He had no fever. After resting 15 minutes his color improved and was conversing well. He was able to sit up and his blood pressure was taken. His blood pressure was within normal range. He sat for another 15 min and drank some juice. He was feeling well enough to go home in the care of his wife.

Rash, dizziness, fever, muscle aches, joint pain, headache, injection site pain, fatigue, and sniffles. Dizziness gone on day 2. Rash gone after 10 days. Fever gone after2 days. Muscle aches, joint pain, headache, fatigue, and sniffles gone on day 3. Injection site pain gone after10 days.

Saturday March 6th ~6:00am - Severe vomiting, sweats, chills lasting the whole day... Sunday March 7th ~ 3:00 - 4:00am - drenching sweat and dizziness preventing him from getting up. This is ongoing at this time. Sunday March 7th @ 1pm. Any movement of the head brings the dizziness back .

Temperature 102-104 F 15 hours after vaccine. No temperature when going to sleep 3 hours earlier. Chills and severe shaking. Fainting when standing to go to bathroom (fell on bed no injuries). Chills and temperature continued for next 12 hours. Stayed in bed the entire next day (3 March). Temperature subsided and was able to work on 4 March.

66-year-old gentleman who received his first COVID injection on Friday. His family member feels that since this time he has had some drooping of the left eyelid and then today while they were making love he had a several minute episode of vertigo. He states that may be lasted 1 to 2 minutes. His wife states he was "unresponsive" when I asked what she meant by that she states his eyes were closed and his eyes were open and he stared. She states this lasted for 4 to 5 seconds. He denies headache, double vision, blurred vision, tinnitus, focal neurologic complaints. He denies neck pain, back pain, chest pain abdominal pain, syncope, near syncope, abdominal pain, extremity pain. He has no history of CVA/TIA. He denies any history of trauma.

Had the vaccine and 5 hours later had vertigo, unsteadiness, headache. Cannot walk stably due to weaving around. Has no reaction to the vaccine site. The vertigo seems to be steady or getting worse, but is very dizzy. He took some Ibuprofen for the headache. He has not called his doctor.

Flu-like symptoms -- chills, achy, tired, loss of appetite. Started 2nd day. Back to 100% normal by start of 3rd day.

Swelling and discomfort in joints and hands, dizziness, extreme fatigue for 24 hours, pain and pressure in center of chest and upper back strait across from chest pain( lasted about 6 or 7 hours.

Just after midnight patient becam very weak, developed severe bilateral leg pain with cramps, his left ankle was weak and would roll. He couldn't stand and felt as though he was going to pass out. He developed low back pain as well. He was covid positive in October of 2020. The symptoms were still present 4 days later after the vaccine.

I had Chills, Felt Nauseated, Light Headedness, and a Slight Fever (100) approximately 24 hours after receiving my shot. It lasted overnight and I felt fine the next morning on 3-13-21. No Medical Treatment Required.

Kidney Stones/pyelonephritis; Severe Pain; Couldn't Stand; Difficulty Breathing; Joint Pain; Severe Fever 102.9; A spontaneous report was received from a consumer who was also a 66-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced with kidney stones or pyelonephritis/ nephrolithiasis, severe fever 102.9/ pyrexia, severe pain/ pain, couldn't stand/ dysstasia, joint pain/ arthralgia and difficulty breathing/ dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12 Feb 2021, approximately one day 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. On 13 Feb 2021, morning at 2-3am patient had a severe fever of 102.9 and joint pain. Later patient developed severe pain and couldn't stand up. On same patient went to emergency room and was diagnosed with pyelonephritis (kidney stones). Patient also reported that patient was having a difficult time breathing. Treatment for the event included receiving oxygen. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

03/15/2021: Presented to the emergency department with general malaise, polydipsia, polyuria, and dizziness. The patient was found to have blood glucoses in the 500s and a hemoglobin A1C of 12. The patient was admitted and improved with metformin, long acting and short acting insulin.

Patient reports that he experienced immediate numbness and tingling to his limbs. He stated that he had a warm sensation to limbs. Heart rate felt a little fast but was not taken. He had general shakiness and felt unsteady for about 24 hours after vaccine.

Fever, chills, headache, diarrhea, shoulder ache, balance issue Tylenol for fever was resolved by 3/17/21 Still weak and diarrhea on 3/19/21

About 9:30 PM on March 17, 2021 (the day that the vaccine was administered), patient began experiencing chills with shivering. Went to bed shortly thereafter. Woke two or three times in the night. Began feeling somewhat warm instead of chilled (except for extremities, which remained cold to the touch). Felt weak and temporarily dizzy each time of getting out of bed. Awoke at one point with a headache, so took one Excedrin migraine tablet. Took a second Excedrin migraine tablet later in the morning of March 18, 2021, since headache persisted. Other than that, took no other prescriptions or supplements until the evening of March 18, 2021. Throughout March 18, 2021, patient felt occasional periods of weakness and took bedrest for it. Probably slept an additional 3 to 4 hours during the day. By evening of March 18, 2021, patient was feeling more normal. On March 19, 2021, patient experienced no adverse effects.

Severe shaking after feeling cold. Nothing like chills, nothing I have ever experienced before. Shaking so bad I had trouble walking. Couldn?t open Tylenol bottle, kept dropping it from shaking. Felt like a seizure. Went back to bed and covered up with blankets. Slowly went away. Episode lasted 20 minutes or so. Shook me up as I live alone. Was ready to dial 911...

Lower legs felt tired and sore., muscle pain. Progressively got worse over the month of February making it nearly impossible to bend, raise and lower myself. Saw my personal doctor on March 1st. He does not think it is vaccine related. Rans some bloodwork tests. Put me on Prednisone for 3 weeks. That did alleviate the muscle soreness/stiffness but that seems to be starting to return now that I am no longer taking it. Have a Dr. appointment with a Rhuematologist on Friday 3/26/2021.

My left arm is in excruciating pain I cannot use nor could I sleep first night. Arm is almost dead in some ways. I cannot life past my mouth as cannot even extend very well. Severe pain, aching also pain down shoulder into right hand. I have tried icing, heat, applied Cold spray. It is slightly painful 2 days later but still lots of pain. I cannot use arm to do chores. Even brushing teeth was hard. Arm was fine till 10 hours later then became worse and worse. Plus have little strength in arm. I cannot use arm to dry myself after shower. Arm continues to be painful, aspirin does nothing to alleviate pain. I regret getting vaccine and have doubts to complete series as I heard second shot worse. I have not sought treatment yet but may go see my PCP this week.

Extreme pain and weakness in the right leg [mid thigh to lower calf]. Unable to walk or climb steps. Unable to stand unsupported. Right leg buckles and gives out. Unable to travel, or see my doctor. The onset of my issues were very sudden and immediate, no lead-up. In a sitting or lying down position, I am able to freely articulate and rotate my right leg without pain. In the nine days since the onset, I have treated myself with Aleive and a heating pad for my neck. The issues have lessened by less than 25%. Background: due to spinal cord injury in 1996, I have permanent damage; sensory issues on my right side [mid chest to foot], and motor issues on my left side.

Pain in joints, body aches, and loss of appetite. Pain at injection site and could not lift left arm for over 24 hours. Fever of 101 started about 13 hours after the first vaccination. Fever went up to 103 and remained at that level for another 22 hours. Total recovery time was about 3 days.

Fever chills and loss of energy. Have never recovered energy. Sever nasal issues with drying of nasal passages , headaches and on going vertigo. All Unresolved

he started with dizziness in early morning after the vaccine. As the day went on, it got worse. He is having nausea and severe dizziness. He will call his dr. tomorrow.

pt states that later that night he had a very sore arm, headache and dizziness that lasted about 24 hours then went away. About 10 later he developed diarrhea and this has lasted 3 days so far. He took Pepto Bismol for 2 days but this did not seem to help. He has an already scheduled appt w/ his Diabetic doctor and will discuss his symptoms with him to see what he suggest he should do about the diarrhea.

Stroke; Itchiness on the back of the head; Bad headache; Lost mobility on one side; Muscles went all mushy; A spontaneous report was received from a consumer regarding a 66 year old, elderly male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had his muscles went all mushy/muscle weakness, lost mobility on one side/mobility decreased , stroke/cerebrovascular accident, itchiness on the back of the head/pruritus and bad headache. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included an unspecified blood pressure medication and clopidogrel busulfate. On 10 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 048A21A) in left non dominant arm for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced Itchiness on the back of the head and bad headache. On 20 Mar 2021, the patient's muscles went all mushy and lost mobility on one side. On 23 Mar 2021, the patient was hospitalized for stroke. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event bad headache was not resolved and outcome of Itchiness on the back of the head, muscles went all mushy, lost mobility on one side and stroke was unknown at the time of this report. .; 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.

Monday 2/29 in the morning felt a little dizzy Tuesday 2/30 in the morning felt something was not right. Felt a little more dizzy Wednesday morning had full blown vertigo. So bad I could hardly stand up. Never in my like had I ever had vertigo. At 3:00 pm Two Doctors adjusted the left ear twice to get the crystals right. No issues with the right ear. The left ear is the one I have ringing in. Had to use a neck brace for 2 days and slept in a chair for two night. No more dizziness. But for 4 weeks was not myself

ended up passing out, seemed to black out; couldn't respond/ not responding to his name; falling; achy; very shaky; eyes were glassed over; couldn't hold his head up straight; breathing was labored; soaking with sweat; slight temperature of 99.5-100.9F; A spontaneous report was received from a spouse concerning a 65-year old, male patient who received Moderna's COVID-19 vaccine(mRNA1273) experienced ended up passing out, seemed to black out/ loss of consciousness, couldn't respond, not responding to his name/ unresponsive to stimuli, fall, achy/ pain, shaky/ tremor, eyes were glassed over/ glassy eyes, couldn't hold his head up straight/ balance disorder, labored breathing/ dyspnea, soaking with sweat/ hyperhidrosis, and slight temperature of 99.5-100.9f/ pyrexia. The patient's medical history was not provided. Concomitant medications included medicine for chlolestrol and blood pressure. On 18 Mar 2021, prior to the onset of the events, the patient received second of two planned doses of mRNA-1273 (lot/batch:047A21A) intramuscularly on left arm for prophylaxis of COVID-19 infection. 19 Mar 2021, the patient complained of being achy and had a slight temperature of 99.5 F that went up to 100.9 F. The patient was very shaky, and ending up passing out, and falling. The patient seemed to black out, his eyes were open and glassed over, but he couldn't respond or hold his head up straight. He did not respond to his name and his breathing was labored. The patient was also sweating. Treatment for the events included aspirin and rest. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events was unknown.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded.

Very sore arm (1 hour after injection. Lasted for more than 24 hours) Fever/chills (overnight following injection) Severe headache (24 hours) Tinnitus (started several hours after injection and still continues more than 24 hours later) Dizziness when standing up (24 hours) Dry mouth

Swollen lip; Rash over their body (it itches bad); Heartbeat fast; Difficulty breathing; Had all of the symptoms of an allergic reaction; Dizziness; Weakness; Swelliness of their face, hand and feet; A spontaneous report was received from a healthcare professional concerning a 66-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events had all of the symptoms of an allergic reaction, rash over their body, it itches bad (hypersensivity), dizziness, weakness (asthemia), swelliness of their face, difficulty breathing (dyspnea), heart beat fast (heartbeats increased), swollen lip, feet and hand swolle up. The patient's medical history was not provided. Concomitant medications reported were metformin, carvedilol, atorvastatin, aspirin, citalopram. On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) via unknown route for prophylaxis of COVID-19 infection. On 5 Feb 2021, the patient experienced the event(s) had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast. On 19 Feb 2021, the patient experienced the event(s) swollen lip, feet and hand swolle up. Treatment details included Benadryl. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), had all of the symptoms of an allergic reaction, rash over their body (it itches bad), dizziness, weakness, swelliness of their face, difficulty breathing, heart beat fast, swollen lip, feet and hand swolle up 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 these events, a causal relationship cannot be excluded

AFTER FIRST VACCINTION: SEVERE SHOULDER PAIN , TOTAL IMMOBILIZATION OF ARM , LEFT LEG SEVERE PAIN FROM HIP TO ANKLE ,CURRENTLY STILL OCCURING. AFTER SECOND VACCINATION: PREVIOUS SYMPTOMS CONTINUING,ALSO RIGHT LOWER BACK SEVERE PAIN , DOWN RIGHT LEG.,CAN NOT WALK ON RT. LEG . BOTH SIDES OF FACE HAVE SWELLED UP IN AREA OF PRIOR FACIAL FILLER INJECTIONS

After first dose I experienced light headed ness After second dose I experienced muffled hearing in both ears five days later

He developed weakness and could not raise his right arm without assistance from his left arm. He has passive rom and was evaluated by Dr. who advised a course of PT.

Three days after the vaccine , I experienced (more than mild)dizziness. Sluggish energy level, enough so,that Icould not go to my part time job. I went back to bed and slept off and on the rest of the day.

weakness; inability to rise; frequent urination; lack of taste for food/loss of sense of taste; inability to produce a bowel movement; inability to walk/inability to reach bathroom; blood sugar higher than normal; blood pressure higher than normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GAIT DISTURBANCE (inability to walk/inability to reach bathroom), ASTHENIA (weakness), DYSSTASIA (inability to rise), POLLAKIURIA (frequent urination), AGEUSIA (lack of taste for food/loss of sense of taste) and CONSTIPATION (inability to produce a bowel movement) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (10 day hospitalization and administration of oxygen therapy) on 01-Nov-2020. Concurrent medical conditions included Hypertension and Diabetes mellitus. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced GAIT DISTURBANCE (inability to walk/inability to reach bathroom) (seriousness criterion hospitalization), ASTHENIA (weakness) (seriousness criterion hospitalization), DYSSTASIA (inability to rise) (seriousness criterion hospitalization), POLLAKIURIA (frequent urination) (seriousness criterion hospitalization), AGEUSIA (lack of taste for food/loss of sense of taste) (seriousness criterion hospitalization) and CONSTIPATION (inability to produce a bowel movement) (seriousness criterion hospitalization). In March 2021, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar higher than normal) and HYPERTENSION (blood pressure higher than normal). The patient was hospitalized from 03-Mar-2021 to 06-Mar-2021 due to AGEUSIA, CONSTIPATION, DYSSTASIA, GAIT DISTURBANCE and POLLAKIURIA, and then from 03-Mar-2021 to 06-Mar-2021 due to ASTHENIA. On 06-Mar-2021, GAIT DISTURBANCE (inability to walk/inability to reach bathroom) and CONSTIPATION (inability to produce a bowel movement) had resolved. On 24-Mar-2021, ASTHENIA (weakness), DYSSTASIA (inability to rise) and AGEUSIA (lack of taste for food/loss of sense of taste) had resolved. At the time of the report, POLLAKIURIA (frequent urination), BLOOD GLUCOSE INCREASED (blood sugar higher than normal) and HYPERTENSION (blood pressure higher than normal) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by the reporter. Treatment History includes ER visit, hospitalization, IV fluids, IV medications, "injections for blood sugar", EKG, scope to check for blood clots, physical therapy. Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Causality for hypertension and blood glucose elevated is confounded the concurrent history of hypertension and diabetes mellitus; Sender's Comments: Based on the current available information, a strong temporal association between the use of the product and the start date of the events, a causal relationship with the events cannot be excluded. Causality for hypertension and blood glucose elevated is confounded the concurrent history of hypertension and diabetes mellitus

Vertigo - Sometimes when changing head position when lying down and when changing body position from sitting to standing or bending over.

Patient reported dizziness and throat swelling. He was given epi 1:1000 0.3mg IM, solumedrol 125mg IV, and NS 500 cc bolus in the urgent care. His symptoms improve after treatment; he was monitored for an additional 2 hours and discharged home.

Suffered stroke like symtems on April 12. Severe headache ,right arm tingly and numb, sissy when I got from chair, vision seem blurry. Took 800mg of ibproferin and things improved. Right hand Remains slightly numb

Note I had Covid June 2020 Vertigo like symptoms 7 days from 2nd vaccine 8th day through 10th day pretty severe 11th day somewhat better Gradually got better day by day Could not drive for 5 days Still experiencing a little dizzyness from time to time when looking up and then down Can not prove related to vaccine but I've never had vertigo like symptoms

On 4-1 2021 My husband started with lightheadedness and unsteady on feet went to AAGH ER in Annapolis MD ruled out a stroke and diagnosed with ataxia and given antivert. Two days later 4-3-2021 he developed right side of face drooping . MRI was re-done with contrast and without and no stroke. Diagnosed with possible Bell Palsy started on prednisone and antiviral drug. Is now 4-14-2021 he feels better but right side of face still drooping. But he feels better. Only reporting as saw Bell Palsy was seen in trials for Moderna.

extreme fatigue (falling asleep in front of a meal for long periods can't arouse himself), severe frontal headache, loss of appetite, didn't eat for over 24 hours. Poor appetite for several days after this. The only symptom remaining was extreme fatigue that seemed sometimes to be improving and then return. Then woke up in middle of the night to go to the bathroom April 5th and couldn't coordinate his legs, they were numb. Equal in strength when checked in bed by me, but had to crawl back from bathroom in early morning. Since then the numbness comes and goes and balance issues come and goes, fatigue is getting worse again to the point where he is sleeping or too exhausted to move for most of the day. S

Patient reported to ED with severe dizziness, emesis and left arm heaviness that started at about noon on 4/1/21. Found to have a cerebral infarct.

Day after and following day-fever, joint and muscle pain. Muscle pain and joint stiffness still effecting me 16 days after shot.

first shot, on and off dizzy, lightheaded, a bit nauseou 2nd shot, heart tightness, fullness, some tingling in fingers,

Not able to leave bed for 3 days after vaccine and very fatigued. Felt mostly back to normal the weekend of 4/3/21 then fatigue returned around 4/6/21 accompanied by generalized weakness, tremor or upper and lower extremities and increased shortness of breathe. Then became dependent on someone else to get up, stand. Was unable to walk due to severity of tremor in upper and lower extremities. Continues to have tremor in rehab facility where he is residing at this time after hospitalization.

States he was mowing his grass on 4/14/2021 and his left leg went numb. States he was unable to walk.

Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient presented to the ER on 3/8/21 after being sick the prior 2 weeks with loose, bloody/tarry stools, frequent falls, and hypotension. Hospital course progressed to worsening encephalopathy secondary to decompensated alcoholic cirrhosis. Developed pneumonia that did not improve with antibiotics and progressed to palliative care with him passing away on 3/24/21. Comorbidities include COPD, alcoholism, Takotsubo cardiomyopathy, HTN, cirrhosis, HLD, former smoker.

Extreme headache, the worst I have ever had. Extreme body ache over my entire body, could barely walk or stand. Headache got better around 7pm same day, one day after vaccine. These symptoms weren't just inconvenient, they were very extreme. Not just a little headache and body discomfort but absolutely extreme. All better today, two days after vaccine.

Almost immediately got 'woozy' and fell off the chair onto the floor. His eyes were glassy and his hands and arms were jerking. He was able to get back up on the chair and said that he was ok, but he looked pale and felt a little clammy. He sat on the chair and drank some water while we were waiting for the EMS. He said that he had breakfast but no lunch. While he was sitting on the chair his eyes glassed over again and he made some grunting sounds. EMS came checked him out and said that his vitals where okay, and he wanted to drive home which was 15 miles away. The EMS gave him a report as to what happened and his vitals incase he needed to seek further medical attention.

Patient received the first dose of Moderna COVID vaccine on 4/22/2021. Upon reporting vaccine to state registry, pharmacist noticed he had previously received Johnson & Johnson COVID vaccine on 03/10/2021 at another facility. This information was not volunteered by the patient at the time his Moderna vaccine was administered, but was confirmed with the patient after the vaccine (Moderna) was administered. The patient will not be receiving the second dose of the Moderna vaccine, due to the fact that he was not indicated to receive both Modera and Johnson & Johnson vaccines. The patient reported low-grade fever, headache, nausea, and dizziness lasting for 1 day beginning the day after vaccine administration of Moderna vaccine. No treatment was necessary, and patient fully recovered from this adverse effects.

Within 3 minutes of getting COVID-19 moderna first shot, he started getting warm and then hot, tingling, knot in the throat, dizziness, and called a safety medic over, they took vitals, then doctors showed up , and a medic gave him 2 Epi?s on the thighs left and right leg, low blood pressure and high pressure, then they transported him in ambulance and he has severe neck pain. They wanted to give a third epi shot in the ambulance but they didn?t do it. They monitored him at the hospital and received an ekg no fluids.

Patient presented to the clinic diaphoretic with slurred speech, altered mental status and significant weakness unable to walk or bear weight. He was sent out 911 for hospital evaluation. He was admitted and was in the hospital for 48 hours. Acute CVA was ruled out. Within 48 hours after presentation of symptoms he was back to baseline.

Watery eyes rentlsly coughing fatigue vomiting diarrhea dizzy shortness of breath weakness in muscles in arms wheezing head ache. Chils fever it was just like I had covid-19 again

on 2/14 he woke up and couldn't move his left side, couldn't walk. Went to ER, numerous tests were run and there was nothing to substantiate. ER suggested to follow up with neurologist, neurologist said possibly Parkinson's. Went to more dr's, they don't think Parkinson's. Started getting better a few days before the second dose, got the second dose on 2/25. After the second things everything was exscaberated, weight started dropping, started losing muscle tone, appetite, and extreme fatigue. Cognitive thinking was gone,almost like a psychosis, was suicidal, couldn't think straight. Went back to the Er, couldn't find anything. They admitted him to observe and could find nothing. We came home and continually

Dizziness and weakness. Difficulty in describing the dizziness. Stated weakness felt like body weighed alot. brought to immediate care for further care. Patient states he is a diabetic and hasnt eaten. initial sugar 200. Due to the severe dizziness and weakness the ICC doctor advised 911 to ER for further care.

Patient sitting in observation room, received first Moderna vaccine at 1010 am. Stated to observation staff that he is feeling dizzy and trouble reading.. Patient stated that he did not eat and that he did not take any medication. VS at 1105am BP 124/66, HR 100 and O2sat 96%. 1108 BP 123/67, HR 98, O2sat 98. VS@ 1111am BP 100/79, HR 94, O2sat 97% encouraged to drink and eat some crackers..VS @1114 BP 109/68,HR 104,O2sat 99%. VS @ 1117 BP 124/62, HR 105, O2sat 99%.Patient continued sitting and stated some head pressure on the top , not sure if HA, but no dizziness. 1125 Patient went to restroom and stated improprovement ,decrease in HA/pressure. VSS BP 124/64, HR 96 and O2sat 97% Patient felt 1145 am.comfortable going home at 1145.

Patient is a 66 y.o. male who presents to the ED for onset of substernal chest pain associated with nausea and weakness. Pain onset around 6 PM. Has been nauseous and weak all day. Relates this to second Covid shot obtained on Monday (5/11/21). Reports feeling fine yesterday. As the morning and afternoon progressed he noted that he was just more and more weak and was really not able to get around which he normally does with a walker. Endorses a past history of both pulmonary embolus and pancreatitis for which his chest pain feels like. Is not currently anticoagulated. Last PE 2 years ago. History of Parkinson's disease. Denies any fever. No other symptoms reported.

Within 2 hours I was throwing up, my chest hurt, my head hurt, and I could hardly get up. This lasted for 3.5 days. Day 4, and I still have a mild headache.

1/22/2021 6:30pm dizziness, fell over, vertigo, suspected stroke at 3am, brain stem stroke, released 2/19 to other facility, limited mobility in eft arm, dysphasia, cognitive skills in tact

Approximately 30 minutes after vaccine resident c/o dizziness, right sided headache, blurry vision, weakness. Resident also talking but making no sense.

patient received second dose on Moderna at approximately 1:45 pm. Around 1:55 patient started feeling nauseous and dizzy. Blood pressure was checked at that time, 107/75. Patient reported hadn't eaten lunch but had breakfast. Gave client some orange juice and continued to monitor. Patient reported feeling some better, rechecked blood pressure at 2:05 pm, 97/65. Reported feeling more dizzy, nauseous, requesting to lay down. Nurse helped patient to wheelchair and wheeled patient next door to Health Department, to Hospital at 2:10 pm. Gave report to clerical staff and pushed patient to ER lobby. 2:20 patient started vomiting. ER nurse came to get patient, gave ER nurse report.

AFib; I cant walk; Heart cant send blood to rest of my body; This is ruining my life; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFib) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ATRIAL FIBRILLATION (AFib) (seriousness criteria hospitalization and medically significant). 17-Feb-2021, the patient experienced POOR PERIPHERAL CIRCULATION (Heart cant send blood to rest of my body) and ANXIETY (This is ruining my life). On an unknown date, the patient experienced GAIT DISTURBANCE (I cant walk). The patient was treated with DIGOXIN at an unspecified dose and frequency and ACHILLEA MILLEFOLIUM, CRATAEGUS MONOGYNA, OLEA EUROPAEA, VALERIANA OFFICINALIS, VISCUM ALBUM (BP (BLOOD PRESSURE)) at an unspecified dose and frequency. On 17-Feb-2021 at 12:00 PM, ATRIAL FIBRILLATION (AFib) had not resolved. At the time of the report, POOR PERIPHERAL CIRCULATION (Heart cant send blood to rest of my body), ANXIETY (This is ruining my life) and GAIT DISTURBANCE (I cant walk) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.; 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.

March 1 to March 11, 2021: Light-headedness, presyncope events progressively worsen for 10 days. Continuous symptoms of Myocarditis such as heart palpitations, arrhythmias, and irregular pulse. Tachycardia and Bradycardia. Some chest discomfort. Occasional blood pressure spikes and drops. Sudden onset Glaucoma in left eye over two months following vaccine. March 11 Admitted to Emergency room, High blood pressure peaks at systolic 205 mm Hg. Pulse irregular and drops to 30 beats per minute in Emergency ward. Cardiac arrhythmias evident. Several episodes of presyncope over few hours.

Outcome: Patient Death CHIEF COMPLAINT in ER: chest pain, SOB History of Present Illness: Patient is a 66 yo with PMH of chronic afib on chronic anticoagulation who presented to the ER with a chief complaint of shortness of breath and increased fatigue over the past several weeks that has progressively become worse. Patient denies orthopnea or PND but does have some palpitations and occasional chest pain associated with increased fatigue with exertion. On evaluation emergency room patient was noted to be tachycardic consistent with chronic atrial fib, also acute renal insufficiency likely secondary to dehydration. Patient is admitted to the medical service for further treatment and evaluation. DEATH SUMMARY Date of Admission: 04/07/2021 Time of Death: 04/10/2021 at 0737 Final Diagnoses: 1. Sudden Cardiac Death 2. Acute Renal Impairment Secondary to Hypovolemia, A TN 3. Chronic Atrial Fibrillation w/ RVR, Resolved 4. Atypical Chest Pain, Resolved 5. Hypokalemia, Resolved 6. Obstructive Sleep Apnea 7. Chronic Diastolic Heart Failure Hospital Course: Patient is a pleasant 66yo admitted for acute renal impairment secondary to significant o hypovolemia resulting in ATN as well as atrial fibrillation w/ RVR after presenting to ER with complaints of chest pain, dyspnea, malaise, and anorexia that began after receiving his second COVID vaccine on 4/01/2021. Please see H&P for full details. Patient reported that on the day after his COVID #2 vaccine, he lost his appetite and was not able to eat or drink. He continued to take his home medications as prescribed including losartan, chlorthalidone, and meloxicam. After experiencing progressive worsening of symptoms for 5 days, patient presented to ER for further evaluation. Upon arrival to ER, patient was noted to be hypotensive and tachycardic. EKG showed atrial fibrillation w/ RVR. Routine labs were obtained and were remarkable for elevated creatinine and mild hypokalemia w/ normal BNP and negative cardiac enzymes. CXR showed enlarged cardiac silhouette, but no evidence of pulmonary edema or other acute abnormalities. Patient was subsequently admitted for further evaluation and medical management. He was staited on aggressive IV hydration for his hypotension and hypovolemia w/ PRN IV metoprolol as needed for HR> l lObpm. He was continued on anticoagulation. Serial cardiac enzymes were obtained and were negative. TIE report from Dr's office that was performed recently was obtained and showed EF of 55-60% with Grade 1 diastolic dysfunction. Patient's wife brought his CPAP from home and patient wore his CPAP while sleeping during his hospital stay. During the course of hospitalization, patient's blood pressure & HR improved, though he remained in atrial fibrillation. His creatinine continued to trend up consistent with ATN, but patient continued to produce adequate urine and he had no signficant electrolyte derangements. IVF were adjusted based on urine output and volume status. Patient had no recurrence in his presenting complaint of chest pain and he overall reported feeling better throughout his course of hospitalization despite reporting that he continued to have little appetite. Patient was monitored closely on telemetry throughout his hospital stay. On the morning of 4/10/2021, lab tech and nurse walked into the patient's room to obtain specimen for AM labs. Patient reportedly tried to get out of the bed independently, grabbed at his chest & pulled off his telemetry, and fell to his knees. Staff called Code 99 and patient was placed back in the bed. He was noted to be in asystole. ACLS was performed and despite maximal efforts, patient subsequently expired at 0737. I personally called the patient's cardiologist & personal friend, to discuss the events leading up to the patient's death. Upon review of the patient's course of hospitalization, it was felt that patient most likely experienced sudden cardiac death. Of note, Dr reports that the patient frequently contacts him via text message with concerns or complaints. He states that the patient did not message him during the hospitalization to report any chest pain or other concerns. Disposition: Patient Expired

Patient had massive heart attack, lost consciousness and hit his head as he fell. Patient had pain in his left arm approximately 5 days before the event. on 6/16/2021 patient lost consciousness again, this time due to low blood pressure. the low blood pressure was said to be due to dehydration.

Stroke; numbness in left hand; Headache; Ataxia left arm,; Motor skill issues/steadiness, unbalance; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042C20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), ATAXIA (Ataxia left arm,), BALANCE DISORDER (Motor skill issues/steadiness, unbalance) and HEADACHE (Headache). On an unknown date, the patient experienced HYPOAESTHESIA (numbness in left hand). The patient was hospitalized from 25-Jan-2021 to 26-Jan-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) had resolved, ATAXIA (Ataxia left arm,) and HYPOAESTHESIA (numbness in left hand) had not resolved and BALANCE DISORDER (Motor skill issues/steadiness, unbalance) and HEADACHE (Headache) 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. It was reported that on an unspecified start date the patient is currently in OT. Treatment information 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. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received by safety 10-Jun-2021 included an ADR added. Reporter address is updated. Patient height, weight, race and ethnicity is captured. Information of first and second vaccination updated. Event information was updated. new events, stroke and ataxia in left arm added and the events led the patient to visit ER.; 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 with no active medical problems other than diet controlled diabetes had his Moderna COVID vaccines 02/16 and 03/16/2021. He presented to the hospital with c/o 2 mo (since around 4/14) of progressive fatigue and weakness which progressed to dizziness and now shortness of breath the past month and was found to have profound pancytopenia. He had no history of alcohol use, b 12 or folate deficiancy, no recent illness, no medications, HIV and hepatitis testing were negative. He does not smoke. He had no prior history of problems with his white blood cell count, red blood cell count or platelet count. He admitted that shortly after his second vaccine he began to feel fatgiued with symptoms progressing afterwards. Upon admission his hemoglobin was 6.7 and he was given 2 units of blood. His D-dimer was elevated at 1224 and a CTA of the chest was negative for PE. His PT/INR PTT were within normal limits EKG showed no acute ischemia and normal sinus rhythm. Fibrinogen was 246. His iron was 238 saturation of 77 TIBC of 309 and ferritin of 941. His hemoglobin A1c was 6.0. He was seen during his hospital stay by Hematology/oncology . vitamin B12 and folate levels were normal. He has no prior history of malignancy. Patient's ultrasound of the abdomen showed no splenomegaly. Again vitamin B12 and folic acid levels were normal. A peripheral blood smear was done which was concerning per oncology for an underlying bone marrow condition. Ultimately his bone marrow biopsy showed Acute myeloid leukemia with blasts and monocyte features.

About a month after 2nd vacine started to get headaches, light headed, dizzyness, with diarrhea. Lated for about 10 minutes. occured several time a day. When getting up from a chair became dizzy and lightheaded. Currently waiting for doctor exam.

Sudden cardiac death; Acute kidney injury; Atrial fibrillation; Cardiac arrest; Cardio-respiratory arrest; Cardiomegaly; Chest pain; Chronic left ventricular failure; Condition aggravated; Decreased appetite; Dehydration; Diastolic dysfunction; Dyspnoea; Fall; Fatigue; Feeding disorder; Fluid intake reduced; Hypokalaemia; Hypotension; Hypovolaemia; Malaise; Palpitations; Renal impairment; Renal tubular necrosis; Sleep apnoea syndrome; Tachycardia; This case was received via DA VAERS (Reference number: 1391483) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN CARDIAC DEATH (Sudden cardiac death), ACUTE KIDNEY INJURY (Acute kidney injury), ATRIAL FIBRILLATION (Atrial fibrillation), CARDIAC ARREST (Cardiac arrest), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), CARDIOMEGALY (Cardiomegaly), CHEST PAIN (Chest pain), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure), CONDITION AGGRAVATED (Condition aggravated), DECREASED APPETITE (Decreased appetite), DEHYDRATION (Dehydration), DIASTOLIC DYSFUNCTION (Diastolic dysfunction), DYSPNOEA (Dyspnoea), FALL (Fall), FATIGUE (Fatigue), FEEDING DISORDER (Feeding disorder), FLUID INTAKE REDUCED (Fluid intake reduced), HYPOKALAEMIA (Hypokalaemia), HYPOTENSION (Hypotension), HYPOVOLAEMIA (Hypovolaemia), MALAISE (Malaise), PALPITATIONS (Palpitations), RENAL IMPAIRMENT (Renal impairment), RENAL TUBULAR NECROSIS (Renal tubular necrosis), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) and TACHYCARDIA (Tachycardia) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included Coronary artery disease, Congestive heart failure, Hypertension, Atrial fibrillation (Chronic Afib), Pulmonary hypertension, Cholecystectomy, Hernia repair, Tonsillectomy and Anticoagulant therapy on 02-Apr-2021. Concomitant products included CHLORTHALIDONE, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ACCORD), MELOXICAM and METOPROLOL SUCCINATE for an unknown indication. On 01-Apr-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 02-Apr-2021, the patient experienced ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization, medically significant and life threatening), ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization, medically significant and life threatening), CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization, medically significant and life threatening), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria hospitalization, medically significant and life threatening), CARDIOMEGALY (Cardiomegaly) (seriousness criteria hospitalization and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure) (seriousness criteria hospitalization and life threatening), CONDITION AGGRAVATED (Condition aggravated) (seriousness criteria hospitalization and life threatening), DECREASED APPETITE (Decreased appetite) (seriousness criteria hospitalization and life threatening), DEHYDRATION (Dehydration) (seriousness criteria hospitalization and life threatening), DIASTOLIC DYSFUNCTION (Diastolic dysfunction) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Dyspnoea) (seriousness criteria hospitalization and life threatening), FALL (Fall) (seriousness criteria hospitalization and life threatening), FATIGUE (Fatigue) (seriousness criteria hospitalization and life threatening), FEEDING DISORDER (Feeding disorder) (seriousness criteria hospitalization and life threatening), FLUID INTAKE REDUCED (Fluid intake reduced) (seriousness criteria hospitalization and life threatening), HYPOKALAEMIA (Hypokalaemia) (seriousness criteria hospitalization, medically significant and life threatening), HYPOTENSION (Hypotension) (seriousness criteria hospitalization and life threatening), HYPOVOLAEMIA (Hypovolaemia) (seriousness criteria hospitalization and life threatening), MALAISE (Malaise) (seriousness criteria hospitalization and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization and life threatening), RENAL IMPAIRMENT (Renal impairment) (seriousness criteria hospitalization, medically significant and life threatening), RENAL TUBULAR NECROSIS (Renal tubular necrosis) (seriousness criteria hospitalization, medically significant and life threatening), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) (seriousness criteria hospitalization and life threatening) and TACHYCARDIA (Tachycardia) (seriousness criteria hospitalization and life threatening). The patient died on 10-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ACUTE KIDNEY INJURY (Acute kidney injury), ATRIAL FIBRILLATION (Atrial fibrillation), CARDIAC ARREST (Cardiac arrest), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), CARDIOMEGALY (Cardiomegaly), CHEST PAIN (Chest pain), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure), CONDITION AGGRAVATED (Condition aggravated), DECREASED APPETITE (Decreased appetite), DEHYDRATION (Dehydration), DIASTOLIC DYSFUNCTION (Diastolic dysfunction), DYSPNOEA (Dyspnoea), FALL (Fall), FATIGUE (Fatigue), FEEDING DISORDER (Feeding disorder), FLUID INTAKE REDUCED (Fluid intake reduced), HYPOKALAEMIA (Hypokalaemia), HYPOTENSION (Hypotension), HYPOVOLAEMIA (Hypovolaemia), MALAISE (Malaise), PALPITATIONS (Palpitations), RENAL IMPAIRMENT (Renal impairment), RENAL TUBULAR NECROSIS (Renal tubular necrosis), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) and TACHYCARDIA (Tachycardia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood creatinine: increased (Inconclusive) increased. On 02-Apr-2021, Chest X-ray: abnormal (abnormal) CXR showed enlarged cardiac silhouette.. On 02-Apr-2021, Echocardiogram: normal (normal) normal. On 02-Apr-2021, Ejection fraction: normal (normal) 55-60% with Grade 1 diastolic dysfunction. On 02-Apr-2021, Electrocardiogram: abnormal (abnormal) atrial fibrillation. On 02-Apr-2021, Myocardial necrosis marker: normal (Negative) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Advanced Cardiovascular Life Support (ACLS) was performed and despite maximal effort, the patient subsequently expired at 0737. Company Comment : This is a case of death in a 66-year-old male patient with medical history of Coronary artery disease, Congestive heart failure, Hypertension, Chronic Atrial fibrillation and Pulmonary hypertension, that occurred 10 days after receiving second dose of vaccine (Lot number unknown). The patient experienced sudden cardiac death during hospitalization for worsening dyspnea in the past weeks prior to hospitalization. No further information is expected.; Sender's Comments: This is a case of death in a 66-year-old male patient with medical history of Coronary artery disease, Congestive heart failure, Hypertension, Chronic Atrial fibrillation and Pulmonary hypertension, that occurred 10 days after receiving second dose of vaccine (Lot number unknown). The patient experienced sudden cardiac death during hospitalization for worsening dyspnea in the past weeks prior to hospitalization. No further information is expected.; Reported Cause(s) of Death: unknown cause of death

Pt was healthy prior. Approx 4-6 weeks after the 2nd vaccine injection the pt was noted to have joint stiffness in the R shoulder which then progressed to knuckles, wrists, and legs with weakness at his artificial knees. Stiffness was initially worse in the am and was without relief with NSAIDS. Pt had trouble with ambulation and getting up and down from chairs/sitting. He became significantly debilitated and f/u with MD ensued. Steroid dose pack helped but after several days post completion the s/s returned. C-RP & ESR were elevated but all other RA and autoimmune markers were neg on his labs. Repeat f/u with MD a Ketorolac Injection was given that didn't touch the s/s. As the s/s continued the pt was then put on Celebrex 200mg bid and instructed to f/u with Rheumatology. The pt gets relief with the Celebrex bid but if the dose is decreased to 200mg x 1 q day > the pt has immediate return of s/s. Repeat C-RP and ESR were again elevated on the second set of labs also. We are in the process of follow up with Rheumatology who after first visit said he didn't know what was wrong with him. We are pending additional labs and xrays this week. The pt has always been very active and healthy with no medical problems other then slight hypertension. His body has gone into a systemic inflammatory response acutely for no reason.

Dizziness and weakness, injection site pain, tenderness, swelling, redness, fatigue, headache, muscle pain, joint pain, severe chills started on Thursday, July 8 early evening and ended on Friday evening around 11:30 p.m. , had a fever that lasted the same amount of time. Side effects started on Tuesday, July 6, 2021. Injection on July 3, 2021 later in the afternoon pain from shot in the left arm, joint pain and redness occurred that night. On Wednesday, July 7, I started taking Ibuprofen 200 mg every 4 hours until Saturday, July 10, 2021. Symptoms seemed to be gone late Saturday night, July 10, 2021.

After getting his 2nd Moderna COVID 19 injection, in his right arm, the patient began experiencing numbness and tingling in his right hand and the bottom of his right foot. It was very strong numbness such as when the hand is asleep and he could not use the hand. He had 3 fingers that stayed awake. This stayed this way for a day or two then his face went numb on the right side and his right arm developed numbness as well, though there was no drooping or disruption of his speech. He was concerned enough he went to the emergency department and they diagnosed him with Paresthesia. The numbness left his face and arm after a few days but has remained in his hand and foot.

heart palpitations, cold sweats at night, 5 days after the vaccine, on February 27, 2021. On the 10th day after the vaccine, I was playing golf around noon, and I started having heart palpitations and felt dizzy again and I stopped playing golf. I went to see my cardiologist. Diagnosed me that I basically had an occasional additional heart beat. It was occurring less than 3 percent of the time. They ruled out Atrial fibrillation. I still have some episodes were I feel heart palpitations, they are not as frequent, they are totally random. It occurs maybe once a week now. It doesn't stop me from exercising.

4 days following dose 1, dizziness similar to orthostatic hypotension began and lasted about 3 weeks. At times it required steadying my self. Most of the time it was mild enough not to require standing still. Follwing dose 2, the dizziness returned and has been persistent for the past five weeks. It is never severe but is definitely persistent, unrelated to activity, amount of sleep, time of day, occasional alcohol use, or diet.