Moderna

Headache, Dizziness, Nausea, Fainted and hit my head on tile floor. Started at 2:30 a.m. on 1/10/2021 and culminated with fainting on same day at 12:30 p.m. Have continued with weakness, tiredness and dizziness. Other reactions have subsided.

9:30 client became lethargic, diaphoretic, pale and taken via w/c to triage area. Oriented x 4 - drowsy. States the symptoms occurred immediately, that he felt too warm, felt clammy and light headed. States he has problems with claustrophobia. Cooled area by opening doors, patient removed layers of shirts. EMT personal at vaccine site in attendance. BP 136/78; HR 79; O2 sat 99% on r/a. 9:32 EMS activated 9:36 EMS cancelled per patient request. 9:50 states he feels much better and wants to leave, ambulated down hall and turned back stating he still felt lightheaded. Sat back in chair. States he last ate last night. provided juice. declined cookies. 10:00 States he feels much better, trial ambulation tolerated will without lightheadedness, gait steady. Left with wife to personal vehicle.

WOKE UP AT 0700 THIS AM WITH BODY ACHES, NAUSEA/VOMITING, CHILLS, DIZZINESS, WEAK, TEMP 102. ADMITTED 1/21/2021 INPATIENT. IV NS @ 100ML/HOUR, ZOFRAN 4MG IV, LOVENOX 40MG, SOLUMEDROL 125MG IV.

approx 2 days after shot got dizzy and has continued a little less each day. Had to call ambulance for a check up but stayed home and continued to sit in chair and took blood pressure. 2nd day pressure was finally at 128/73. dizziness was severe for a day where I couldn't lay in a bed but felt better in a chair. Called Doctor on 1-21-21 and was advised to take lots of liquids and get plenty of rest.

Low grade temperature of 101.2 dealt with by taking aspirins. Overall body ache dealt with by aspirins. Extreme pain in area of left arm/shoulder where the vaccine was given. Arm severely ached for 48 hours in any position, was very tender/painful to touch, and difficult to use or move. I'm pretty tough where pain is concerned with past injuries (broken leg in 17 pieces, severely sprained ankles, broken ribs, broken tail bone from horse accident. This vaccination arm pain was right up there with the worst.

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

1. OK day of innoculation 2. Next day 1/25/21, 7:30 am, Blood Pressure (BP) was 141/76. Temp 98.1, pulse 88. (note my normal temp is 95.5-96.5) 8:30 am BP dropped to 66/46, cold sweat, dizziness. Woozy, passed out, but woke when I hit the deck. 9:26 am, BP up to 85/50, 80 bps, 96.2 degrees. 10:08 am, BP 98/55, 82 pps, temp 96.1. 1:23 pm, BP 88/54, temp 96.1. 6:30 pm, BP 103/60, 82 bps. 8:19 pm, BP 156/72, 80 bps. Temp up to 100.4 degrees. 11:28 pm, BP 125/65, 68 bps, temp 98.4 degrees 1/26/2021: 5:15 am, BP 123/70, 71 bps, temp 99.7 degrees 8:14 am, BP 110/60, 64 bps, temp 97.4 8:02 pm, BP 124/70, 72 bps, temp 97.6 1/27/21: 1:06 am, BP 132/75, 62 bps, temp 97.6. 7:35 am, BP 123/75, 63 bps, temp 95.3 (back to normal range) 1/27/21

Patient stated to feel "light headed". He was brought to cot in back of facility. VS were taken: BP 176/90, R 61, R 20, O2 96%. Patient states to have high blood pressure. He stated to have eaten this morning. Denies diabetes or low blood sugar. Denies any other health conditions. Copy of medications obtained. Juice and crackers given. Patient lied down on cot for 5-10 min, ate crackers and finished juice, stated to feel better. Called wife (who was in parking lot) to pick him up. Patient was stable, walked to vehicle. He was advised to rest today, no strenuous activity. Call 911 or go to nearest hospital if severe symptoms occur such as difficulty breathing, swelling of face or throat, r fast heart rate.

Reported lightheadedness "feeling woozy" that lasted few minutes after vaccination. No further reactions. Reported improvement after few minutes.

I woke in the night on Monday, Feb. 1 to use the bathroom and when I stepped out of bed I felt a sharp pain in the outside ball of my right foot. I thought I had stepped on a needle. I could not step on that side of the foot as I walked without sharp pain. I immediately searched for what might be in my foot and found nothing. The pain continued through the night and into the morning. My shot was in the left shoulder. I have concluded this is a neurological reaction (nerve pain) from the vaccine (Moderna). Never had this pain before.

Patient received first dose of Moderna vaccine at 11:11am. Patient then moved to observation area to be monitored and at 11:26 am he reported feeling dizzy and a slight flush. No redness or hives visible on patient. Continued to monitor patient, breathing was even and unlabored, O2 sat assessed at 98%, HR 61, patient sitting upright in chair. Patient had 3 sweaters on and 2 facemasks. Patient removed the second facemask. Patient refused to remove sweaters to assess BP. Patient reported he played tennis prior to his vaccine appointment and had diet coke and a bag of chips following. Patient given bottled water and monitored for additional 15 minutes. Patient reported feeling better and had a ride home. Patient in no signs/symptoms of distress or anaphylaxis, respirations even and unlabored, denied itching, swelling, shortness of breath. Patient left facility at 11:47, gait steady. Informed to f/u with his PCP and seek emergency medical attention if any signs of anaphylaxis develop.

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

App on phone and smart watch reported resting heart rate had increased 21 bpm on Feb 3. and elevated heart rate at rest of 162 bpm. Started to get up but felt dizzy. Took blood pressure with results less than 100/50 and 90 bpm heart rate. Rested for few hours and heart rate began to decrease and blood pressure started to increase. I was no longer dizzy

Slept all day on 2-5-2021 low grade fever. Very wobbly had to have help getting out of bed and to the bathroom. Was better on 2-6 but still wobbly but not as bad.

On the evening of January 30 I began having chills and shaking. I then went to bed and had difficulty moving in the bed. I went to sleep. When I awoke on the morning of January 31, I was unable to sit up in bed and had been incontinent during the night. My wife called the paramedics to help get me out of bed and to change my clothing. At this time I refused to go to the hospital. The paramedics wheeled me to my lounge chair in the living room. About 1:00 p.m. in the afternoon I asked my wife to help me get out of my chair so that I could take a shower. I was not able to get out of the chair, stand or walk. My wife again called the paramedics and I was transferred . I was in the emergency room until 10:00 p.m. that evening. I was given some fluids IV. The ER staff had me walk to be sure that I was mobile before discharging me. They could not say for certain if this was a reaction to the Moderna vaccination, but thought it could be. Within a few days I spoke with my primary care physician, who concluded that I did in fact have a reaction to the vaccine. She has recommended that I not get the second shot at this time.

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

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

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

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

Pt reported dizziness and disorientation the evening after vaccine. States he "got lost in my bathroom" and "felt like I was going to die". He did have body aches and headache

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

Only one incidence of severe dizziness for 10 minutes or so. Very tired for that day and following day.

caller stated he developed neurological issues a week after receiving the covid vax. Pt became weak, confused, unable walk, hallucinating. He fell 3 times in that week. Symptoms got worse to the point that 911 was called and he was admitted to the Hospital. He had a MRI and CT of brain. MRI on spine. Both had abnormal results w/ no bleeding. Blood Work was normal. He was treated and will be released on Hospice 2/25/2021.

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

Initially night of the vaccine 3/2/2021 body felt hot, felt sweaty but temp was 98.0, unable to sleep through the night. just felt uncomfortable. Morning of 3/3/2021 woke up with extreme pain in injection sight, sweaty, but cold, dizzy and weak, no fever., Could not stand up. Was sat down on sofa for maybe 2 mins. all of a sudden shoulders drooped, head fell forward, I asked "dad are you ok" there was not a response, I walked closer to him and his head flew back, his eyes were slit open, and he started gasping for air 3 times then slumped forward and passed out. 911 was called paramedics checked all vitals including blood sugar, oxygen, heart rate etc everything registered as normal.

2/21 Patient presented after slip and fall on the ice, admitted for hypertensive crisis. hospitalizations are to be reported irrespective of attribution to the vaccine. This hospitalization does not appear to be related to the vaccine.

Feeling cold weak fatigue very slow gate tired sleepy beginning 5 days after vaccination with moderate improvement in next two weeks with above symptoms, but repeated drops in blood pressure starting around day 8 and persisting to present with episodes of a fib episodes 2 days later and brief leading to present prolonged episodes of irregular beats and prolonged a fib.

Severe onset of autoimmune vasculitis and renal failure. Loss of movement & sensation (paralysis) of left arm and leg. Mild cognitive deficit and confusion. Fell due to loss of use of L leg. Hospitalized x 5 days, now in rehab facility slowly regaining function of L arm and leg, and relearning how to walk. Sudden renal failure (stage 4 renal disease) onset suddenly as well with this reaction.

Vertigo started while watching a video on 3/3/21. General feeling of vertigo continues at this date but is not disabling.

patient reported generalized weakness and fall at home which started shortly after receiving vaccine. progressed to the point of severe weakness causing him to fall and not be able to pick himself up from ground. reports that around 2 AM on Friday, 3/5 patient had gotten up to go to the bathroom, he felt very weak, was unable to successfully ambulate to and from the bathroom and had a fall without injury on his way back to the bed. His wife was able to assist him back into bed and he rested later in the morning he got up a second time to go to the bathroom he essentially crawled to the bathroom. he was unable to get back to bed his wife was able to help him to sofa in the living room which was nearby; states that he basically leaned against the sofa until this morning when family arrived and helped bring him to the hospital for evaluation. Patient denies shortness of breath but the patient is breathing approximately 34 times a minute on my physical examination. He denies pain. He has had no nausea or vomiting since his vaccination.

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

Moderna COVID-19 Vaccine EUA 0300 on the 10th, flu-like symptoms, headache, 100.8 fever, complete body ache, dizzy spells complete bed rest, hydrate, soup, TYLENOL 0900 on the 11th, fever has returned to normal, some body ache remains, dizzyness has subsided

Started 5 days after vaccine with dizzyness, nausea, sever headache, stabbing pain in left thigh, and continued soreness left arm at injection site. Has doctors appointment on 03/15/2021

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

On 2/13/21 at 4 AM, experienced vertigo/dizziness and a second episode, lasting 2-4 minutes, on 2/22/21 At 5 AM. After the second vaccination (on 3/6), frequent episodes started on 3/17 and every day after that.

Symptoms: about 20 minutes after eating a headache in back of head and blood pressure drops. Some light-headiness also. After about 45 minutes the blood pressure stabilizes. Had routine Dr. appt. on 3/22 and Dr. suggested it could be an adverse effect from second dose of vaccine. Heart check was fine. It hasn't been quite as severe the last several days. Dr. said to report this to you.

At about four weeks after my second (Moderna) Covid vaccine I started having dizziness and light-headedness on and off which has persisted. It causes balance issues which I have never had before. I am a retired Nurse Practitioner.

A few hours after the second dose, the patient was so fatigued that he could not walk. He fell down trying to walk. He said his entire body hurt to the point that he could not move.

hard to understand when speaking; hiccups; sore throat; diagnosed with stroke; dizziness, dizziness continued to get worse, not spinning, but quickly moving from side to side; feeling cold; A spontaneous report was received from a consumer concerning a 76 year old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced a stroke (Cerebrovascular accident),, dizziness, dizziness continued to get worse, not spinning, but quickly moving from side to side/ Dizziness , hard to understand when speaking/ Speech disorder, hiccups, sore throat (Oropharyngeal pain) and feeling cold (Feeling cold). The patient's past medical history not provided. Concomitant product use was not provided by the reporter. On 06 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) via intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 07 Mar 2021, the patient experienced feeling cold which lasted for 48 hours. On 08 Mar 2021, the patient started experiencing dizziness, the dizziness continued to get worse until 13 Mar 2021 when it was described as not spinning, but quickly moving from side to side, and patient was taken to the emergency room. On 14 Mar 2021, the patient was diagnosed with a stroke, was extremely hard to understand when speaking, had hiccups and sore throat. The patient had been in the hospital since 14 Mar 2021. The action taken with mRNA-1273 in response to the events was unknown. The outcome of feeling cold was recovered on 09 Mar 2021. The outcome of stroke, hiccups and sore throat, hard to understand when speaking, dizziness was unknown at the time of this report.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

7-8 hours after injection slight soreness at shot location; 20 hours after injection sudden wave nausea & possible need to vomit, defecate, urinate, & dizziness; sat on toilet & collapsed forward onto floor into stack of towels remaining semi-conscious for a several minutes trying to determine location; worked way upright, got to bedroom, and tried to sleep but severe chills; chills subsided and slept 6 hours; felt feverish and in period of 2 hours had temperatures of: 99.6; 100; 100.4; 101.5; 101.8; 98.8 & went back to bed for night; awoke feeling relatively normal 03/13/2021; thereafter to the present time of 04/04/2021 days of feeling relatively normal, but often waves of feeling light-headed; blood pressure my blood pressure taken at home on Omron wrist device has been highly variable from 136/74/58 down to 101/64/72 with prior normal being about 115/65 to 130/70 at home and as taken at the eye doctor's office on 03/01/2021 the week prior to cataract surgery on 03/08/2021 it was 128/70, but is commonly higher at doctors office exams likely due to stress of driving to the doctor's office and on day of surgery was up to 158/80; on those days of being light-headed the blood pressure was commonly in the 101/64/72 to 114/65/61 range; my body temperatures remained in normal ranges of 97-98; beginning on 03/30/2021 there was some feeling of some throat or esophagus constriction and harder to swallow; this has continued & included acid reflux on 04/03/2021 and feeling very tired and went to bed about 05:00pm & slept to 08:00pm followed by going to bed at 11:00pm and unable to sleep the rest of night due to acid reflux in throat all night; but better on awakening this morning; it remains that there is the feeling of being light headed; a few times during this period after getting the Moderna vaccination the area of the injection has had a minor soreness, and/or itchiness. I have not yet seen a doctor about this reaction, but I did indicate to my eye doctor prior to the cataract surgery on 03/08/2021 that I would be getting my second Moderna vaccination 3 days after. He felt it should be okay. Similarly at the time of my first Moderna vaccination, I told the nurse practitioner that I would be having cataract surgery 3 days prior to the scheduled second vaccination. She also felt it should be okay, as well as having had a reaction to Amoxicillin for the first time about 11 months earlier. That reaction was hives all over the body that kept recurring for 3 weeks and thereafter at places on the body for another month. I am otherwise in excellent health for my age and the only medication taken is Timolol for glaucoma. I am active and frequently walk several or more miles several days per week. My reaction seems unusual. I have only now ceased taking the last of the cataract surgery eye medications, that being Prednisolone eye drops. If the symptoms persist after seeing my eye doctor tomorrow, and after elimination of the eye drop medication as of today, I will be scheduling an appointment with my regular doctor for a checkup.

Light headed, assed out in hallway, wife called ambulance Still light headed, fatigued, loss of appetite

couldn't stand on feet; has a large swollen area/swollen twice the normal size/hardness belowhis elbow; has a knot in his arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (has a large swollen area/swollen twice the normal size/hardness belowhis elbow) and DYSSTASIA (couldn't stand on feet) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030C20A) 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 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced MUSCLE MASS (has a knot in his arm). On 02-Feb-2021, the patient experienced PERIPHERAL SWELLING (has a large swollen area/swollen twice the normal size/hardness belowhis elbow) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSSTASIA (couldn't stand on feet) (seriousness criterion hospitalization). The patient was hospitalized for 10 days due to DYSSTASIA and PERIPHERAL SWELLING. At the time of the report, PERIPHERAL SWELLING (has a large swollen area/swollen twice the normal size/hardness belowhis elbow), DYSSTASIA (couldn't stand on feet) and MUSCLE MASS (has a knot in his arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case concerns a 76-year-old male was hospitalized with serious unexpected events of dysstasia and peripheral swelling, and nonserious unexpected muscle mass. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Email address of primary reporter was added, peripheral swelling was updated as serious due to hospitalization, new event "couldn't stand on feet" and duration of hospitalization was updated.; Sender's Comments: This case concerns a 76-year-old male was hospitalized with serious unexpected events of dysstasia and peripheral swelling, and nonserious unexpected muscle mass. 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.

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

PATIENT WAS TIRED AND SORE AT SIGHT OF SHOT A COUPLE OF DAYS AFTER SHOT HE WAS DEHYDRATED AND HAD LOW BLOOD PRESSURE SO WEAK HE COULDN'T STAND NOT LIKE HIM AT ALL HE USUALLY IS VERY OUTGOING. CALLED 911 RUSHED TO HOSPITAL. ALL TESTS WERE TAKEN EVERYTHING IS NEGATIVE. SENT TO A REHAB FACILITY AT ADMISSIONS HAD TROULE BREATHING CALLED 911 BACK TO HOSPITAL. ADMITTED INTO ICU SAID HE HAS SWELLING ON THE BRAIN RAN EVERY TEST POSSIBLE NEGATIVE FOR EVERYTHING. DOCTOR HAS TREATED HIM FOR ANYTHING HE THINKS COULD BE WRONG. DISCHARGED TO A LONG TERM ACUTE CARE TO SEE IF ANY IMPROVEMENT FOR 25 DAYS. NO DIAGNOSIS OF WHY THIS IS HAPPENING. ONLY THING THAT MAKES SENSE IS THAT EFFECTS OF VACCINE.

Moderna COVID?19 Vaccine EUA After getting the 2nd Moderna COVID shot, the patient was ok for about 10-11 days. Then, suddenly on March 25, he started showing high levels of dizziness and increasing blood pressure. We didn't think much of it and thought it was fatigue and asked him to rest. But, by April 2nd, his blod pressure was around 200/110. We rushed to ER. They conducted all the necessary tests and released him with his blood pressure holding around 170/100 asking him to go to a general practitioner. Then, on Monday we visited Dr. who recommended we wait for 2 weeks to see if the effects will dissipate to determine if it is neurological or if it is vaccine effect. It has been a very very slow dissipation of the side effects. He still has to walk very carefully and feels dizzy all the time. The impact has diminished about 20-25% in about 10 days but 6 weeks after his vaccine, he is still in trouble and is worried.

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

Persistent pain in left upper arm over three months after first injection. Worse at night. For the first month, some loss of function in left arm/shoulder but that has resolved now. Dull pain persists.

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

Woke up at approximately 4:00 am with headache and severe dizziness. It was so bad it forced me to go to Emergency Room at the Medical Center 3/7/21. They checked my eyes that were bouncing back and forth, gave me IV, did an EKG. Prescribed Meclizine 25 mg for the dizziness, three times a day. Absolutely no help. Went to Primary Care Physician, and he thought it might be an inner ear infection and gave me a prescription for progressive Steroid Treatment. No help. Got appointment for 4/9/21 with Ear, Nose and Throat specialist. At the same appointment was sent to see, an Audiologist in the same building. The two doctors determined it was not an inner ear problem. I was then advised to get a Cat Scan of my Brain and see my cardiologist. I am now in my 6th week of major dizziness which has affected all aspects of my life.

Vertigo in various intensities has now lasted 28 days. I have had a 4-5 chiropractic adjustment and one acupuncture treatment. With more of each scheduled.

stroke; trouble walking; Difficulty getting out of bed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant). On 19-Feb-2021, the patient experienced MOVEMENT DISORDER (Difficulty getting out of bed). On an unknown date, the patient experienced GAIT DISTURBANCE (trouble walking). The patient was hospitalized for 3 days due to CEREBROVASCULAR ACCIDENT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident; Rehabilitation therapy for Movement disorder and Rehabilitation therapy for Gait disturbance. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), MOVEMENT DISORDER (Difficulty getting out of bed) and GAIT DISTURBANCE (trouble walking) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: unknown unknown. In 2021, Magnetic resonance imaging: abnormal Abnormal. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The patient got worse so was sent for MRI was done and showed something. The patient stated the stroke has affected his right side and has trouble walking. He was in the hospital for 3 days. He then went back for rehab hospital and there for about a week. He is now home and doing out patient rehab. No concomitant medications were reported. Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded

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

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

Patient, 10/31/44 was admitted Sunday night for confusion, weakness, and a fall at home. Patient had his Covid-19 vaccine here on 4/9 through the clinic. Per patient?s step-grandson (which is the most involved family member) patient had his first vaccine on March 4th at our clinic. On March 6th patient became extremely weak and step-grandson went to check on him and was unable to get into the house because patient was too weak to get off the couch. A window AC unit had to be removed for step-grandson to get access to patient. They did not seek medical attention at that time and patient improved within a few days back to baseline. Family was unaware that he was getting the second covid shot on 4/9. Patient was seen in grocery store the evening of 4/9 but family was unable to get ahold of patient on Saturday 4/10 and on Sunday (4/11) step-grandson went to his home and found patient on the floor. Patient has been a poor historian but states that he became weak and fell out of a chair. We think he may have been laying on his right side for about 36 hours at home. Patient was found to have blisters on his right forearm and right chest, liver enzymes were elevated on labs and he had dehydration. Patient has also had hallucinations and confusion but everything seems to be slowly improving with supportive care. He is still incontinent which is very unusual for him per family. He was negative for rhabdomyolysis, stroke, C-spine injury, negative for hepatitis, urine drug screen was negative. We are continuing to provide wound care for his blisters and PT/OT. Just a strange case.

I have had neurological problems since December of 2019. I had problems after an episode of water in my ear. I have had lightheadedness and near fainting episodes since then. Since I got the first dose of the vaccine my problems have gotten worse. My episodes of Dizziness and near fainting have become more severe. It had seemed to improve before I got the vaccine. I am lightheaded every day and I see a doctor every week. Vestibular Rehab Training, Neurology, Physical Therapist and other professional. Dose 2 # 007M20A

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

Patient had 2nd met during a vaccine on 05/15/2021. That same evening into the next day noticed profound weakness with difficulty walking without assistance. Needed to be helped to bed last night. This morning woke up at baseline and feels completely normal with no weakness or fatigue. Never had any fevers, chills, nausea, vomiting, diarrhea. No dysphagia, aphasia, facial drooping noted.

I COULD NOT GET AND KEEP MY BALANCE. I FELT LIKE I WAS REALLY DRUNK. I WAS TAKEN TO ARH BY AMBULANCE.

7-8 hours after injection slight soreness at shot location; 20 hours after injection sudden wave nausea & possible need to vomit, defecate, urinate, & dizziness; sat on toilet & collapsed forward onto floor into stack of towels remaining semi-conscious for a several minutes trying to determine location; worked way upright, got to bedroom, and tried to sleep but severe chills; chills subsided and slept 6 hours; felt feverish and in period of 2 hours had temperatures of: 99.6; 100; 100.4; 101.5; 101.8; 98.8 & went back to bed for night; awoke feeling relatively normal 03/13/2021; thereafter to the present time of 04/04/2021 days of feeling relatively normal, but often waves of feeling light-headed; blood pressure

Received the first and second doses at Pharmacy. Second vaccine shot was on Friday, May 14, 2021, in the left arm. On Saturday, May 15, 2021, I wasn't feeling well. Then later in the evening I developed a bulge under the left arm. The lympth node increased in size; my left arm would ache, especially if I would stretch to reach for something. I have been applying cold packs. This situation has now continued for two weeks.

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

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

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

In case it was pneumonia; Not feeling good since the vaccine; severe dizziness; vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (In case it was pneumonia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. no medical history was reported by reporter. Concomitant products included OMEPRAZOLE, METOPROLOL TARTRATE, LOVASTATIN, CLOPIDOGREL, FINASTERIDE, HYDROCHLOROTHIAZIDE (THIAZIDE), MONTELUKAST, FUROSEMIDE, FELODIPINE, BUSPIRONE, SPIRONOLACTONE, DOXAZOSIN MESYLATE, LABETALOL, ASA and IRON for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DIZZINESS (severe dizziness) and VERTIGO (vertigo). On an unknown date, the patient experienced PNEUMONIA (In case it was pneumonia) (seriousness criterion medically significant) and FEELING ABNORMAL (Not feeling good since the vaccine). At the time of the report, PNEUMONIA (In case it was pneumonia), DIZZINESS (severe dizziness), VERTIGO (vertigo) and FEELING ABNORMAL (Not feeling good since the vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, X-ray: inconclusive not able to determine if he had pneumonia. On an unknown date, SARS-CoV-2 test: negative tested twice for Covid-19 with Negative results both times. On 23-APR-2021 with in one hour of vaccination the patient began to experience severe dizziness and vertigo. The patient did not receive any treatment medications for the reported events. The patient reported that he had not been feeling very good since the vaccine, stating "I don't think this is a coincidence me getting sick after I got the vaccine". He was evaluated at the Emergency Room this past Sunday on 5/23/2021, because he still wasn't feeling very good. He states he had an X-ray done and was they were not able to determine if he had pneumonia, however they treated him with IV antibiotics in case it was pneumonia. He reports feeling "a little better" since the IV antibiotics. Action taken with mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR: AE details. Case upgraded to serious. additional adverse events were updated and narrative information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 032M20A) for COVID-19 vaccination. No Medical History information was reported. Concomitant products included METFORMIN for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced DIZZINESS (Dizziness) (seriousness criteria hospitalization and medically significant). The patient was treated with CARVEDILOL ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, DIZZINESS (Dizziness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 220/140 (High) Blood pressure was recorded as 200/140 in emergency. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. 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.

patient reported dizziness immediately after shot. reported he had not ate or drank that day. patient was given water and orange juice and sat down for 15-20 minutes. he denied any other symptoms, and chose to leave the pharmacy against medical advice to stay a bit longer. denied any further help.

On the 9th, my father suddenly froze while standing up by thekitchen sink and stopped talking. He looked as if he was losing consciousness and couldn't talk and wouldn't drink. He suddenly collapsed into my arms after i ran to get a chair so he wouldn't fall on the floor. He could barely Sir in the chair himself. He got up and tried to walk but collapsed into the chair that i had dragged over to his new spot. He say and suddenly began to faint and seemed to be dying. I called 911 and the paramedics arrived and took his vitals and said he was fine now. By the time they'd arrived, he was up and alert and able to walk and talk. This was extremely scary as i truly though my father was dying. He had the first dose in May and also had a reaction. His lips blew up to a very large size. I didn't agree that he should have taken the 1st nor 2nd dose.

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

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

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

7-8 hours after injection slight soreness at shot location; 20 hours after injection sudden wave nausea & possible need to vomit, defecate, urinate, & dizziness; sat on toilet & collapsed forward onto floor into stack of towels remaining semi-conscious for a several minutes trying to determine location; worked way upright, got to bedroom, and tried to sleep but severe chills; chills subsided and slept 6 hours; felt feverish and in period of 2 hours had temperatures of: 99.6; 100; 100.4; 101.5; 101.8; 98.8 & went back to bed for night; awoke feeling relatively normal 03/13/2021; thereafter to the present time of 04/04/2021 days of feeling relatively normal, but often waves of feeling light-headed; blood pressure Continuing description of events after second Moderna vaccination: my blood pressure taken at home on Omron wrist device has been highly variable from 136/74/58 down to 101/64/72 with prior normal being about 115/65 to 130/70 at home and as taken at the eye doctor's office on 03/01/2021 the week prior to cataract surgery on 03/08/2021 it was 128/70, but is commonly higher at doctors office exams likely due to stress of driving to the doctor's office and on day of surgery was up to 158/80; on those days of being light-headed the blood pressure was commonly in the 101/64/72 to 114/65/61 range; my body temperatures remained in normal ranges of 97-98; beginning on 03/30/2021 there was some feeling of some throat or esophagus constriction and harder to swallow; this has continued & included acid reflux on 04/03/2021 and feeling very tired and went to bed about 05:00pm & slept to 08:00pm followed by going to bed at 11:00pm and unable to sleep the rest of night due to acid reflux in throat all night; but better on awakening this morning; it remains that there is the feeling of being light headed; a few times during this period after getting the Moderna vaccination the area of the injection has had a minor soreness, and/or itchiness. I have not yet seen a doctor about this reaction, but I did indicate to my eye doctor prior to the cataract surgery on 03/08/2021 that I would be getting my second Moderna vaccination 3 days after. He felt it should be okay. Similarly at the time of my first Moderna vaccination, I told the nurse practitioner that I would be having cataract surgery 3 days prior to the scheduled second vaccination. She also felt it should be okay, as well as having had a reaction to Amoxicillin for the first time about 11 months earlier. That reaction was hives all over the body that kept recurring for 3 weeks and thereafter at places on the body for another month. I am otherwise in excellent health for my age and the only medication taken is Timolol for glaucoma. I am active and frequently walk several or more miles several days per week. My reaction seems unusual. I have only now ceased taking the last of the cataract surgery eye medications, that being Prednisolone eye drops. If the symptoms persist after seeing my eye doctor tomorrow, and after elimination of the eye drop medication as of today, I will be scheduling an appointment with my regular doctor for a checkup. Additional information as of May 24, 2021: I had an examination by Dr., Care Center on April 14, 2021. After discussing the reaction and symptoms that occurred thereafter an EKG indicated a slight heart beat abnormality. Combined with the continuing lightheaded symptoms that periodically recurred he considered the potential that the Timolol that I have used since my late 30s to reduce eye pressure from glaucoma could potentially have reacted with the Moderna shot. As such he later called my opthalmologist, Dr., at Eye Clinic in to discuss this possibility. Dr. also scheduled for me to have an echocardiagram to determine if there has been a resulting heart problem from the Moderna shot. Subsequently after discussing this with Dr. I discontinued taking Timolol for about 3 weeks with a subsequent eye exam to determine the pressure in my right eye to see if a new prescription may be necessary or other alternatives. This was on May 19, 2021. I had been taking my blood pressure daily, sometimes multiple times during the day since the collapse after the Moderna shot. Toward the end of the 3-week period of not using Timilol drops in my right eye the feeling of being lightheaded had become less frequent and blood pressure had become more consistently above 110/65. The feeling of being lightheaded had seemed to often correlate with blood pressure below that, but often my blood pressure was erratic going as low as 100/60 and upward to more normal areas of 120/68-130/75. However, it was not clear to me, or to Dr. if this was a result of having discontinued Timolol or if it was the needed period of time for the Moderna aftereffects to subside. He has me now using only 1-drop of Timolol per day, rather than 2-drops per day in my right eye as my eye pressure is just over borderline of concern for glaucoma in that eye. The cataract surgery on March 8, 2021, 3 days before the 2nd Moderna shot, had eliminated the need for taking Timolol in my left eye. As it stands, I continue to feel relatively normal. I had a second checkup with nurse practitioner at Unity Care Center on May 12, 2021 and she agreed that I should have the echocardiagram as scheduled on May 28, 2021 which is in 4 more days. Additional information as of June 25, 2021: I had an echocardiagram on May 28, 2021 and was provided the evaluation of the results on Jun 9, 2021 by nurse practitioner at Care Center. 1) overall results were good; 2) my ejection factor was 65% and normal; 3) the only abnormality is a mild resistance to ventricle heart relaxing when it is filling up with blood (she further indicated that in positions of some stress is when this was primarily occurring and could result in lower blood outflow and lower blood pressure potentially related to the feeling of being lightheaded and could possible pass out); 4) my heart valves look OK; 5) keep well hydrated to maintain a healthy blood pressure. At the time there was a period of several weeks of having felt relatively normal most of the time with few episodes of feeling lightheaded. However, during a period from June 11 to June 19 there reoccurred daily feeling of being lightheaded and at times the systolic blood pressure dropping to as little as 104 and often no more than 115. However, since that time the blood pressure has returned to the more normal range of 115-130 and feeling more normal. It remains unknown what part the second Moderna shot had to do with this, but there had not been these prior periods of feeling on the verge of passing out combined with lack of energy during these periods. However, the periods of feeling lightheaded seem to be shortening and the periods of feeling normal longer and whatever the causes are gradually subsiding.

Achy and felt tired, so went to bed early. When patient stepped out of bed, he fainted twice within a short period of time. He was found on the floor by wife at one point and had passed out. He then fell down and passed out on the way back to bed. Patient took some Tylenol before bed. When patient awoke the next morning, no other issues occurred.

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

Developed Guillian Barre Syndrome. Lost mobility in legs and unable to walk, shortness of breath, heartburn, severe burning in the chest.

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

THE FOLLOWING SYMPTONS BEGAN ON 5/19/2021 AND COME AND GO PERIODICALLY: GENERAL MALAISE, HEADACHE, FATIGUE, NUMBNESS IN LEFT ARM AND FACE, DIZZINESS, LOSS OF BALANCE. ON THE MORNING OF 6/8/2021 I WENT TO MY FAMILY PHYSICIAN AND THEY SENT ME TO THE ER FOR THE POSSIBILITY OF A STROKE. I WAS ADMITTED TO THE HOSPITAL AND AFTER NUMEROUS TESTS, A STROKE WAS RULED OUT. I WAS DISCHARGED THE EVENING OF 6/9/2021 WITH NO DIAGNOSIS. ALSO I WAS GIVEN A HEART MONITOR THAT I HAD TO WEAR FOR TWO WEEKS AND RESULTS WERE NEGATIVE.

Stomach Bleed; Flu symptoms; From that week on I've had no energy/ Ive felt weak; Dizzy; Short of breath / anything I do I feel out of breath.; Fever for a week.; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA (Flu symptoms), ASTHENIA (From that week on I've had no energy/ Ive felt weak), DIZZINESS (Dizzy), DYSPNOEA (Short of breath / anything I do I feel out of breath.) and PYREXIA (Fever for a week.). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed) (seriousness criterion medically significant). On 11-Mar-2021, INFLUENZA (Flu symptoms) and PYREXIA (Fever for a week.) had resolved. At the time of the report, GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed), ASTHENIA (From that week on I've had no energy/ Ive felt weak), DIZZINESS (Dizzy) and DYSPNOEA (Short of breath / anything I do I feel out of breath.) had resolved. No concomitant medication was reported. The patient stated that per his doctor, his chest, heart and veins were all tested (type of tests were not specified) and all tests were negative. No treatment medication was reported. Patient reported that later found out it was a stomach bleed but said not related to vaccine. Is all fine now and does not want to be contacted for follow up. 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. Further information to clarify causality for the event gastrointestinal bleeding is not expected due to patients denial to be contacted. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up added. Added event and upgraded case to serious. Outcome of case updated to recovered.; 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 to clarify causality for the event gastrointestinal bleeding is not expected due to patients denial to be contacted.

The first week he started getting sore, affected hand and arm, can't raise right arm completely, soreness and brown spot at injection site

Patient was seen in the Emergency Department on 07/28/21 for frequent falls. He was swabbed for COVID-19 in anticipation for possible hospital admission. Pt tested positive for COVID-19. With no upper respiratory or GI symptoms. He did not want to stay in the hospital and was discharged home. Pt previously tested positive for COVID-19 on 05/07/21.

Arm was sore starting approximately 4 hours. after the shot. I usually set thermostat to 68, but got so cold last night i pushed it up to 74 and added a blanket. Around 4:00 I woke up to go to the bathroom. Problems similar to Cirpro. Did not have control over direction I was walking.. Had to rock back and forth to sit up so I could get out of bed. I estimate this was a 3-5 minute ordeal. Drank some Powerade and went back to bed. I had gone to bed just before midnight. Slept till 10:30 because maid was coming at 11. I was totally unstable. When she saw me she immediately made me sit in a recliner. Said my face was pale and my eyes were blood shot. I would have fainted within seconds.

Within 30 sec post injection, patient moved his head back and closed his eyes as the NP was putting syringe into sharps. Another RN also witnessed this as well as his wife who said "he does this". NP rubbed his arm and called out his name twice while the RN got the EMS from another room. As EMS arrived (2:36?), pt opened his eyes, was oriented to PPT, had vitals at 159/102, and was offered to be taken to hospital to be further evaluated but declined. Pt was talking and walking with cane into the observation wait area within 10 min. He waited for at least 45' where EMS monitored him and retook vitals before being sent home with wife and driver. Wife and Pt stated he had a visit with a new PCP Monday 1/11/21 thus was instructed to follow-up about this event of possible Petite Mal seizure at that visit.

Patient complained of Nausea and dizziness on following evening and and vomited few times after that and symptoms were relieved after that. on January 19th , about 80 hours after the vaccination patient complained of being very weak and lost strength to move which lasted for about 30 minutes and family called ambulance. They checked vitals. They were okay. After that patient felt better and went to rest.

Right after receiving the vaccine had a headache in the front of the head which lasted for about 6 hours. About 24 hours later noticeable amount of dizziness making it difficulty walking. Has not decreased since first appearing. Left arm is sore. If it does not clear up in the next few days will seek medical attention.

1/17/21 midnight-fever as high as 103.8, chills, sweats, mental confusing, imbalance, weakenss, COVID like symptoms (PT tested positive for COVID 11/21/20, patinet had to take 2 asprinin to help with side effects. Present-sweating, chills, fever, ibuprofen/tylenol rotated as needed

1/17/21 midnight-fever as high as 103.8, chills, sweats, mental confusing, imbalance, weakness, COVID like symptoms (PT tested positive for COVID 11/21/20, patient had to take 2 aspirin to help with side effects. Present-sweating, chills, fever, ibuprofen/Tylenol rotated as needed

Passed out cold around 8 a.m. when heading to bathroom. He doesn't remember anything; woke up at some point half in and half out of his closet; injured elbow. Other symptoms beginning during the night were dizziness, weakness, headache, nausea, fever of 101, chills, extreme fatigue.

Severe pain in arm. Limited movement. Difficulty raising sideways after 3 days. Greenish streaks down arm (veins?).

On 1/23/2021, one day after receiving the mentioned vaccination, I was working as a volunteer and at about 11;30 am I became very dizzy and nearly passed out. a passerby helped me to a seat, a coworker brought me water, and called security for assistance, An EMT came and checked my vitals, gave me a small package of raw honey, and checked my blood sugar. Everything checked out ok, except my blood sugar was slightly low. I quickly soon felt better, and resumed my volunteer shift. I don't know if the vaccine was related to this incident, but felt it best to report it to you.

Went to the ER at the Hospital the day after receiving the vaccination because I had zero energy, no strength in any limbs and could not get out of bed. Dehydrated and high fever were detected.

The morning of Jan 20, 2021, Patient was disoriented, could not communicate well, and fell when he tried to get out of bed. He was taken to The Hospital by ambulance about 11:30 am. He is still hospitalized. Emerging symptoms include: passing a blood clot from his mouth, slight pneumonia, high white count, low kidney values, high fever, all of which fluctuated. A blood transfusion was given because of blood in the urine. He has been confused and disoriented until this morning.

Pt complained of dizziness within 15 minutes of receiving Moderna COVID vaccine. Vitals were taken, pulse was in the 40's, pt alert and oriented, soda given to see if blood sugar dropped. Continued to monitor, pulse remained low and pt continued to complain of feeling dizzy. 911 was notified and EMS arrived by 12:35pm. EKG strip performed, along with vials from the EMT in the health department. Positive orthostatic hypotension found by paramedic. EMS notified ER doctor on call for recommendations. ER doctor said vitals were consistent with dehydration and could be admitted for IV fluids or return home and encouraged to increase fluids. Wife and pt declined ambulance ride and request to return home.

EXTREMELY DIZZY, SWEATING, LACK OF APATITE. I HAD TO HOLD ONTO THING WHEN WALKING. TODAY 1/ 28/2121 I AM BACK TO NORMAL. NO SIDE EFFECTS. JUST ONE DAY OF COMPILATIONS

Feeling normal before the vaccine, with exception of slight cough that Dr said was due to allergies. But then a fever, chills and aches the day after vaccine. Two days after, still febrile and feeling worse and experiencing shortness of breath and lightheadedness. Fatigue, fever and lightheadedness continue for three more days. On the 6th day post-vaccine, taken to ER and admitted to hospital with a pneumonia and blood counts dangerously low. Received 3 blood transfusions and is receiving 2 different IV antibiotics to treat pneumonia. Still in hospital and waiting to see how blood counts go. I can?t say the vaccine CAUSED this, but it all happened rapidly, immediately following the vaccine.

WEAKNESS UNABLE TO WALK WITH OUR HELP CHILLS AND EXTREME HEADACHE...SECOND DAY ONLY INDICATION IS MY RED ARE SAME AAT THE FIRST INJECTION.

I woke up in the middle of the night, with a pain in my left shoulder. This is the injection sight of the vaccine. When I looked at the area around the sight it was extremely red an noticeably swollen. This approximately 10 hours after I received the injection I was unable to left the arm above elbow level without incurring additional pain. I took an Aleve and just rested the remainder of the day. Things returned to normal about 1500 hours on the 28th.

Post Covid vaccination patient appeared to be starting to fall from chair. He appeared lethargic and unable to speak or hold himself upright. Vitals where taken and 2 liters Via mask administered. Increased to 4 liters after no improvement in pulse o2. wife who stated he was released from the ED yesterday and stated he needed a stent. Patient nodded that he was having substernal chest pain without radiation. four 81mg Asa given and nitro administered after verbally ordered. EMS arrived and transported patient.

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

On 1/07/2021 approximately 11:30 am patient started experiencing weakness; by 1:30 p.m. patient couldn't get out of a chair or walk without assistance of cane and person. Patient became increasingly weak and by 4 pm could not walk nor understood how to walk without caregiver telling him. Patient's doctor was called and at 5:30 pm patient was told to go to the hospital. Doctor thought patient could have had a mini stroke. Patient arrived at hospital at approximately 6:30 pm and underwent stroke test, COVID test, blood work; chest xrays and brain scans. All were negative.

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

TODAY (7/10/2021 - VERY DIZZY FOR ALL DAYS AFTER SHOT, URINE BLOCKAGE, BEING SEEN ALSO BY DR , C FOR BLADDER CANCER, TREATMENT, CYTOLOGY, NURSE WEEKLY, CATHETER TREATMENT 9 WEEKS. TODAY 7/10/2021 AFTERNOON BECAME VERY DEPRESSED, SCARY, DRY MOUTH, SOME KIND OF 'HIGH SPEED HUMMING IN MY HEAD AFTER VACC, BALANCE PROBLEMS BUT A LITTLE UPLIFTED AFTER 2ND VACC, INSOMNIA, EVEN WITH OTC SLEEP AIDS, SUDDENLY, AROUND 7:00 PM PACIFIC, DEPRESSION 'FELL OFF' THANK GOD. VERY SELF-RELIANT, STRONG INDIVIDUA, NON-RELIGIOUS, EDUCATED, BA LITURATURE, AA COMPUTERS - PROFESSION NOW RETIRED

Moderna COVID- 19 Vaccine EUA: soon after vaccination patient reported feeling warm and naseated. Symptoms resolved within one day. Six days after vaccination patient developed an itchy rash on the face that is warm to the touch, stomach cramping, dizziness, and chest discomfort. Physical exam remarkable only for rash: patient presented alert and oriented, well-appearing. Patient prescribed hydrocortisone cream.

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

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

became light headed, then had to go to bathroom Hand, arms and legs began to itch I could barely get him up to walk to bathroom had to lay him on floor - he was staring off into space and not really reacting to me. Called 911 due to his extreme reaction. by time ambulance got there, had gotten him up and to toilet, and back into a chair. he went on to hospital and was released several hours later

pt states that he developed a pain in his abdomen. He woke light headed, nauseated, had diarrhea and gastro intestinal issues but does not have fever. PCP called the VA today and was told to call us to make report and FU w/ them tomorrow if he isnt feeling any better.

Chills, headache, body aches, oral mucous membrane burning, runny and stuffy nose, feet "hot", cough, chest pain, difficulty breathing, crampy abdominal pain, rash - Henoch-Schonlien purpura purpura and petechiae, edema, proteinuria, hematuria, decreased appetite, dizziness

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

8 days following the first vaccine, extreme chills came on rapidly. Vomit. Unable to sit alone in bed. Paramedics called and to ER. Treatment included EKG, CTscan, antibiotics, etc. Sent home at 1:00am. Still too weak to stand and walk independently. 4:00am rolled off of bed onto floor; collapsed. Unable to raise his body. Paramedics called again. Hospital said being treated for vaccine reaction. Sent home again at 4:00 by ambulance. Continues to feel extremely fatigued and upset stomach. He is ambulatory. We are being told for him to get his next Covid Vac this Friday, the 2/19. Worried

Patient felt dizzy after receiving the vaccine - monitored, and stabilized. BP 114/65, pulse 81. Standing BP 155/68.

marked weakness and inability to walk without assistance. Very unstable. Has fallen several times. These symptoms are much more pronounced than before the vaccine was given.

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

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

Increased weakness, fell twice at home. Unable to get back into bed. Admitted to observation status at hospital for weakness for until 2/23 when transferred to skilled care. On day of admission, patient was 2 assist when normally he was independent. IV fluids D51/2 normal at 75/hr

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

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

Reported via Nurse Triage / PCP: Fainted earlier, eyes rolled back, mouth was drooping. Nausea, weakness, and chills. BP was 107/75, HR in the 70s. Currently alert and resting. States that patient had his 2nd covid vaccine yesterday AM and then develop chills and clammy skin last night. Symptoms worsened today and patient became weak and fainted. Was unconscious for about 5 minutes and while unconscious, mouth was open and drooling and became incontinent and eyes rolled back in head. Is awake and alert now, but still weak and only able to take 1 or 2 steps. No chest pain or breathing difficulty and no fever. Feeling very nauseous. Caller requesting prescription for zofran. Yesterday AM 2nd vaccine. Last night chills. This AM feeling weak. Today at 11am he felt weak with ambulation. He fainted. Was unconscious for 5 min. Had drooping of the face. He was unresponsive during this time. Had incontinence of urine. Then became awake but very weak still. Only able to walk a few steps. He is communicating. No chest pain. No current fever. No shortness of breath. BP 107/75 with HR 70. He has been very nauseated. He is drinking only small sips of water. Does not seem like a usually COVID-19 vaccine reaction. Given the LOC with urinary incontinence and sustained weakness, I advised ER evaluation to rule out neurological issues. Pt's daughter in agreement. They will go to ER. From Emergency Department: Patient presenting with chief complaint of syncopal episode which was witnessed by his wife. He reported the got dizzy and lightheaded and then passed out while seated. The reported duration of his loss of consciousness was somewhat inconsistent, unclear how long he passed out for, there was however no postictal state. He was not noted have any shaking or seizure activity, he did have an episode of urinary incontinence. He has not been feeling well ever since receiving his 2nd COVID-19 vaccine. By the time of my exam patient states that he is completely asymptomatic, he states he is feeling much better after receiving IV fluids. His lab work is remarkable for a slightly low sodium, compared to his previous levels which were many months ago. Unclear of the acuity of this, although upon further discussion with the patient he has been drinking large amounts of water since his vaccine trying to stay hydrated. I advised him to substitute to some electrolyte balanced fluids and to have his sodium rechecked by his PCP to ensure that this is transient. With negative testing and resolution of his symptoms he is stable for discharge home. Close return precautions were given.

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

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

Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Medium, Systemic: Headache-Mild, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe

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

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

Slightly elevated temperature, chills, felt like I was getting a cold. Resolved on its own without intervention.

Severe dizziness, 4 weeks after first shot on 02/02/2021 and continues after second shot on 03/03/2021. Must use walking cane to remain upright. Cannot drive or work. Weakness

<10 degrees movement in flexion and abduction with left arm. Pain and aching at injection site. Site was not warm or red but firm. Possible flare of RA.

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

On or about 06 March I began to experience slight dizziness, and noticed that SOME things I was seeing were apparently moving. A neighbor is experiencing very SIMILAR symptoms. He is also 77 years old, and had his MODERNA booster shot about a week or so before I had mine, and we chatted this morning, so I concluded that our symptoms APPEAR to be related to the MODERNA booster.

Pt was in the bathroom in the mall and felt dizzy, lightheaded, and fell. Pt hit his head, no LOC, no pain, no trauma noted. Pt denies not nausea, vomiting or chest pain. Pt got his first COVID vac yesterday per pt. Pt had hx of valve replacement and HTN.

Neurological, including trigeminal neuralgia and one Bell's Palsy symptoms. Tried to complete online at library on 2/24/2021 but timed out at 20 minutes. Item #18: CDC asked to report any Bell's Palsy symptoms (also trigeminal neuralgia is related to BP). 48 hrs post vax, mid-afternoon Sat, Feb 6th: Suddenly unable to comprehend book I was reading; and there was a physical sensation of irritation just inside my skull, wrapping around my brain (meninges?) - it did not intrude into brain. Felt lack of 'presence' in room. Slightly unstable on my feet. Believed these were related to vaccine, would soon abate, but, also, that this would be no way to go through life! These lasted 2-3 hours. (I neither drink alcohol or take recreational drugs.) About that time, a 'twinging' precursor to trigeminal neuralgia began – uncertain whether it was TN? Recurred every 3 hrs. But then awakened at 6:30 a.m. by two painful TN jabs, repeated more strongly at 9:40 a,m. At about 12:30 pm, return of light 'twinging' sensation, then nothing – no recurrence. 3rd TN episode in 3 years, the briefest, the only one not requiring oxcarbazepine. Checked for Bell's Palsy symptoms (which I've never had): The left side of my mouth wasn't producing any saliva at all – none. This improved very slowly, continuing for 5 or 6 days; by far the longest lasting symptom. About Monday, the 8th, experienced an expanded time warp driving to library – took forever to reach two roundabouts. Lucid, alert, vision & reactions normal. Speed was a mile or two above limit. No euphoria or nystagmus. At library, conversation and work seemed normal. Around the same time I had about an 18 hour complete memory loss with regard to medications. Two dose periods in succession. On Monday, Feb 8th, I called our 4 day a week neurologist. He said the symptoms were an immune response to the vaccine but that he's never seen them together before. It was scary. I'm not going to take the second dose at this time. And will depend upon PCP. Filling out this form because you've asked about any adverse reaction related to Bell's Palsy (which TN is closely related to). I wonder how many others have experienced trigeminal neuralgia symptoms following vaccination? It's a cumulative disease and devastating in advanced forms. :-(

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

Patient awoke the morning of March 5th feeling weak, fatigued, and unsteady. He went to his primary care provider 5 days later on the 10th of March, as his symptoms were not improving. He told his PCP there that the past few days he was suffering from unsteady gait, walking around like hes "drunk", and bouncing off walls. It was thought his symptoms were caused by a low serum potassium value, so he was given a rx for potassium. 3 days later the patient presented to the emergency room where his problems persisted. He was still having trouble keeping balance when he walked around. One of the providers treating him reached out to neurology, who recommended that the patient be started on high dose steroids followed by a prednisone taper for tranverse myelitis, The patient was then admitted and treated at Hospital.

Symptoms began the day after the patient received the second shot. He was very tired and weak. By the afternoon, he was so weak he could not lift himself out of the chair. Even with the help of another person, he was too weak to stand. I called for emergency help. He had a fever of 101, was vomiting, very disorientated, confused, could not understand what people were saying to him. At the hospital he continued to feel disorientated, had nausea, dizzyness, a headache, a fever of 104, was dehydrated. He was admitted to hospital and spent one night. Once home, he has begun to regain strength and other symptoms have diminished. Four days after coming home he is feeling stronger and more back to normal.

Hallucinations; Dizziness; Fatigue; Nausea; Vomiting; A spontaneous report was received from a consumer, concerning her husband, a 77-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucinations, dizziness, fatigue, nausea and vomiting. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) via unknown route for prophylaxis of COVID-19 infection. On 01 Mar 2021, approximately three days prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 03 Mar 2021, after second dose of vaccine, the patient experienced nausea and vomiting, fatigue, dizziness, and hallucinations. The event hallucinations were considered to be medically significant. The patient was also not been out bed for seven days. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable. The outcome of the events, hallucinations, dizziness, fatigue, nausea and vomiting were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events (dizziness, fatigue, nausea, and vomiting), a causal relationship cannot be excluded. Very limited information regarding these event (hallucination) has been provided at this time. Medical history and concomitant medications are required for assessment. However, further information has been requested. However, fatigue, nausea, and vomiting are expected for mRNA1273.

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

Immediately after the injection I felt dizzy for approx. one hour. Experienced severe itching and mild pain at injection site one week after injection. I had a red area about the size of an apple. Telephone conversation on 3/16/2021 with family physicians' office resulted in treatment to use TRIAMCINOLONE ACETONIDE CREAM, .1% twice a day. Cream reduced itching for approximately 4 to 5 hours after each application.

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

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

Patient became diaphoretic and felt like "I want to pass out" immediately after receiving vaccine and reports history of syncopal event. Patient unable to recall events that lead up to the previous syncopal event.

Infarct; Double vision; Dizziness; A spontaneous report (United States) was received from a consumer concerning a 77-years-old, patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an infarct that effected the left thalamus of his brain (Thalamic infarction), double vision (Diplopia) and dizzinesss (Dizziness). The patient's medical history was not provided. Concomitant medication included amlodipine for unknown indication. On 02 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number004M20A) intramuscularly in the left ( non-dominant) arm and on 02 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number- 001A21A) intramuscularly on the left (non-dominant) arm for prophylaxis of COVID-19 infection. On 17Feb2021, patient states that he had an infarct that effected the left thalamus of his brain. On the same day around 8pm he was driving not far from his house and developed double vision and dizziness. Once reached home he went to bed, upon waking up in the morning symptoms were still present, at this time he went to the emergency room. Patient was hospitalized for 2 nights and 2 days. While hospitalized he had several blood test done and a CAT scan done and also had an MRI on 24Feb2021, report details were not reported. Treatment for the event included are plavix, Catapres, rosuvastatin and doxazosin. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable The events double vision and dizziness were as recovered on 19-feb-2021. The outcome of the event, Infarct 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.

Hospitalized for 8 to 9 hours; Could not walk; Whole body shutdown; Swollen arm; nostalgic; A spontaneous report was received from a consumer concerning a 77 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nostalgia, could not walk, swollen arm and whole body shut down, and hospitalized for 8 to 9 hours. The patient's medical history included allergies to bee stings. Products known to have been used by the patient within two weeks prior to the event include: unspecified cholesterol medication, aspirin and unspecified hernia meds. On 08 March 2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 036a21a) intramuscularly for prophylaxis of COVID-19 infection. On 08 Mar 2021, the patient experienced nostalgia, could not walk, swollen arm, whole body shutdown and was hospitalized for 8 to 9 hours. Laboratory details were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. At the time of the report, the outcome of the events, nostalgic, could not walk, swollen arm, whole body shutdown and hospitalized for 8 to 9 hours, were unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

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

104 degree fever, disoriented, delirius (couldn't talk coherently, didn't know where was or what he was doing), achiness, couldn't walk, tired/fatigued. made an emergency room trip

Patient came to pharmacy to report adverse events following 2nd Moderna COVID19 dose. Unable to determine if this was related to vaccine or not, but reporting as patient perceived event. The day after vaccine administration, patient felt weak and fell to floor when getting out of bed. He stated he was so weak that he could not lift his body up until someone came to help lift him. He said he felt shaky and could not control his bladder/was urinating uncontrollably. Pt reports that he only has 1 kidney and doesn't know if this may be relevant. Counseled patient and recommended consulting his physician/nephrologist and would report to VAERS.

Patient came to office for complaints of body aches, chills, hot flashes, sweating and lightheaded. Nausea and loss of appetite.

Patient began to develop progressive weakness on the night he received his first vaccine dose. This continued to progress over the course of two days and included left sided numbness and left sided deficit, including facial droop. Patient presented to the emergency department and was admitted for an acute ischemic CVA.

Patient complained of intense abdominal burning sensation across abdomen followed by intense flushing redness of face and lightheadedness. Symptoms resolved within 5 minutes, cool wash cloth to face. Patient on home oxygen canula. BP 142/84. HR 64 and regular. Resp 20-22. Patient observed for 45 minutes after vaccination without further complaints or symptoms

Patient became light headed and blacked out, did not know where he was. Indicated his right eye was red and swollen.

Gastro intestinal hemorrhage associated with chronic gastritis; Chronic gastritis; Nurse reports patient has fallen twice since being home; Abdominal pain; Acute Kidney Injury (found during hospital workup); Seven weeks and 3 days between shots; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (Gastro intestinal hemorrhage associated with chronic gastritis), CHRONIC GASTRITIS (Chronic gastritis), FALL (Nurse reports patient has fallen twice since being home), ABDOMINAL PAIN (Abdominal pain) and ACUTE KIDNEY INJURY (Acute Kidney Injury (found during hospital workup)) in a 77-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 No adverse event (No medical history was provided). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Seven weeks and 3 days between shots). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (Gastro intestinal hemorrhage associated with chronic gastritis) (seriousness criteria hospitalization and medically significant), CHRONIC GASTRITIS (Chronic gastritis) (seriousness criterion hospitalization), FALL (Nurse reports patient has fallen twice since being home) (seriousness criterion hospitalization), ABDOMINAL PAIN (Abdominal pain) (seriousness criterion hospitalization) and ACUTE KIDNEY INJURY (Acute Kidney Injury (found during hospital workup)) (seriousness criterion medically significant). The patient was hospitalized from 23-Mar-2021 to 02-Apr-2021 due to ABDOMINAL PAIN, CHRONIC GASTRITIS, FALL and GASTROINTESTINAL HAEMORRHAGE. On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Seven weeks and 3 days between shots) had resolved. At the time of the report, GASTROINTESTINAL HAEMORRHAGE (Gastro intestinal hemorrhage associated with chronic gastritis), CHRONIC GASTRITIS (Chronic gastritis), FALL (Nurse reports patient has fallen twice since being home), ABDOMINAL PAIN (Abdominal pain) and ACUTE KIDNEY INJURY (Acute Kidney Injury (found during hospital workup)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Nurse reported history of fall, non-compliant with cane use. Supra-therapeutic INR, watchman procedure was scheduled on 15-Apr-2021. Nurse reports patient had fallen twice since being home. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.

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

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

Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)

Approx. 6 weeks after 2nd shot, experienced shortness of breath, fatigue, chest tightness, sinus/head pressure. Cannot exercise for more than 10 minutes without resting. Heart monitor and stress test results show no abnormalities.

45 minutes after administration patient developed signs of a stroke: inability to speak, facial paralysis, inability to move

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

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

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

The patient is a 77-year-old male with history of coronary artery disease, hyperlipidemia and hypothyroidism was hospitalized with confusion, fever, and generalized rash after receiving the first dose of the mRNA-1273 vaccine. Fever started one day after vaccine administration and was episodic, lasting for minutes to hours and recurring throughout the day. Over the next 48 hours, the patient developed a generalized body rash, starting from the trunk and spreading to the extremities. Thereafter, he began to experience headache, dizziness, and double vision, that later progressed gradually to severe encephalopathy in the course of 5 days. On dermatological examination, he was noted to have deep red, non-scaly, edematous papules coalescing into plaques on the abdomen, upper chest, proximal upper extremities, bilateral upper flanks and back, with scattered non-follicular pustules. On neurological exam, he had intermittent and irregular orofacial movements and bilateral upper extremity myoclonus. No other cranial nerve, motor or sensory deficits were noted on exam. Deep tendon reflexes were 2+ throughout, without signs of an upper motor neuron lesion. No nuchal rigidity was evident. The patient presented with leukocytosis and neutrophilia, elevation of creatine kinase, C-reactive protein and ferritin. Cerebrospinal fluid (CSF) analysis revealed 120 cu/mm leukocytes (77% lymphocytes), no erythrocytes, normal glucose (65 mg/dL, concomitant serum glucose of 106 mg/dL) and increased proteins (124 mg/dL). All CSF cultures were negative, and the CSF meningo-encephalitis panel did not detect any infectious agent through RT-PCR analysis. Blood and urine cultures, as well as an infectious respiratory panel were all unremarkable. RT-PCR of SARS-CoV-2 was negative. Antinuclear antibodies (ANA) (1:160) and rheumatoid factor (RF) (1:2) were positive. Further autoimmune testing demonstrated normal complement C3 and C4 levels as well as negative anti-double stranded DNA, ribonuclear protein, Smith, Ro, La and anticardiolipin antibodies. Brain and cervical spine MRI with and without contrast did not show any remarkable findings. Continuous video electro encephalogram (vEEG) monitoring revealed a generalized slow background in the theta range, with state changes and reactivity but no sleep features. The facial and upper limb movements were captured on video recording without an epileptiform correlate on EEG. Skin biopsy demonstrated intracorneal micro abscesses, edematous papillary dermis and a band-like infiltrate of predominantly neutrophils and histiocytoid cells with nuclear debris in the superficial dermis without vasculitic changes and rare eosinophils, consistent with a neutrophilic dermatosis. Evaluation for malignancy was unrevealing including serum protein electrophoresis, peripheral blood smear, peripheral blood flow cytometry, and computed tomography of chest, abdomen and pelvis. The patient initially received empiric broad spectrum antibiotics and antiviral coverage for suspected sepsis and meningitis, including vancomycin, cefepime (later switched to ceftriaxone), ampicillin, doxycycline and acyclovir (for 9 days) without any improvement. As no infectious etiology was found, antimicrobial therapy was deescalated. Given concerns that the clinical picture might be related to an inflammatory reaction to recent vaccination, we started a four-day course of 1 gram methylprednisolone once a day. After the first day of treatment, the patient had marked improvement in his neurological exam, and went from mumbling incomprehensible words, to formulating full sentences and regaining orientation to self and place. He was able to follow simple commands consistently. Myoclonus also quickly resolved as well as the orofacial movements. The patient progressively improved, achieving his baseline before the fourth dose of methylprednisolone. Moreover, the cutaneous findings significantly improved, with near complete resolution of the pustules within 36 hours of administration of steroids. At this time, he met both major and all 4 minor criteria for the diagnosis of Sweet syndrome. The patient was switched to prednisone 60 mg/daily with a plan to taper over the course of three weeks. He was discharged two days afterwards with no evidence of neurologic symptoms and normalization of initially altered laboratory evaluations.

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

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

He then felt dizzines and a headache the following day. On 6/2/2021(4 days after vaccination) he had slurred speech which prompted his family to bring him to ER. CT brain negative for acute CVA. Pt was placed on DAPT (Plavix and ASA). On 6/25/2021-- pt was hospitalized again for severe mixed aphasia and dysarthria--- second stroke with hemorrhagic conversion.

Pt c/o lightheadedness 15 mins after receiving his 2nd dose of the vaccine, he had no reaction to 1st dose at site but reported that he felt a little weak a day later. He has Hx of HTN and hyperlipidemia. His last meal was 2hrs ago. He was assessed and monitored by NP, EMT, and paramedic. BP - 129/64, HR - 75, O2 sat 98% on RA. He was offered H2O and something to eat but refused. He was kept until he reported that he felt better and had no other complaints. He was given the Vaccination information sheet, reinforced instructions on ADRs/SEs to call 911, follow up with her PCP and to register with V-safe. He verbalized understanding and willingness to comply. He left site with wife in no acute distress or any other complaints, awake, alert, oriented to person, place, time and situation.

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

I got lightheaded on the drive home. Since I got home I had cramps, gas and diarrhea. I've recovered some but not 100%. Ate no dinner last night. Its been 5 days with these symptoms.

About 10 min after 1st dose Moderna Covid-19 vaccine, patient notes he felt "woozy." denies nausea, lightheadedness or diaphoresis. Offered water, engaged in conversation. After about 2 min, patient notes he feels back to normal. Left with caregiver.

Dizziness and Nausea starting 01/17/2021 thru today 1/22. Some days stronger than others, with today being very minor and hopefully over. I am prone to motion sickness and these symptoms are very similiar, even to the point of looking up to see the horizon and getting some relief. Took some Meclizine with mixed results.

Arm hurt badly right after injection, swelling after a couple hours, then in the night got sick vomiting, then incontinence in the morning due to weakness not being able to get to bathroom in time, then had shakes and chills and fever for the rest of the night and into the day for at least 6 hours. Very weak and shaky for another 24 hours.

Severe chills, extreme dizziness, faint, felt like the worst days of my Covid infection. Outcome, other than fatigue, fine within 24 hours. For your information, I have never had an adverse reaction to vaccines, including pneumonia, shingles,etc. I am filing this primarily because I know there isn't a great deal of information about adverse reactions of previously infected Covid patients.

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

At 5:00 AM Sunday morning, extreme pain, achy all over, headache, aching all the way down legs, back, neck. Almost like having the COVID virus. Rolled out of bed, could not stand up or hardly walk to the bathroom. Felt very faint, had to hold onto wall. Was very sweaty, running temperature, cold sweats. Just kept getting worse and thought about going to the ER and then decided to put it off until talking to somebody. Called 2-1-1 and the lady told her that it was part of the side-effects to it. She told her to call her doctor, and they were not in on the weekend. This morning, the doctor called and asked if she had Corona, his other doctor retired and got this one the first of January. Took 3 months to recover from the COVID and was on antibiotics, and told her because he have antibodies. Feeling better, still having some achiness.

The patient's right arm is all bruise- It is purple in color. He cannot raise his arm beyond his shoulder.

SOB, Fatigue, weakness Narrative: F: Telephone call: Pt's wife called and said that patient is in the hospital- He went into hospital on 1/24/21. He had the Covid injection here at facility on 1/22/21@0945. He was feeling fine till approximately 1800 that night. His symptoms included the following: chills- fever of 102- he took Motrin 11PM on 1/22. On 1/23- @0200 fever was 99 on 1/23- he was fatigued feverish was back @ 101 degrees. He had no appetite all day. He was tired- weak- trouble breathing with SOB- Call was made to to this facility at 0230 but there was no answer. On 1/24/21- 0230AM patient could not breath and 911 was called. The EMT came- Sao2 was 65 %- couldn't walk- very short of breath. He was taken to hospital where he has been since. He was Dx with Pneu and placed on IV/ABT. Covid test was done and was negative at hospital. He has been on Oxygen since. His wife was very tearful. Family says that he may need O2 at home and a HHA.

1/31/21 - Light Headed all day. Nausea at 7:00 pm. Slight temperature rise at 8:00 pm. Arm sore at vaccination site. 2/1/21 - Light headed all day til now. Arm sore at vaccination site.

Change in gait followed by seizure like bilateral movements. Transported to hospital and admitted. 2 days of testing and consults. Symptoms gradually decreased and released 2 days later.

Patient presented to hospital with 1 day of extreme lethargy 2 days after receiving the Moderna COVId-19 vaccine. Patient had Mohs surgery on a L forearm lesion with cryotherapy to scalp on 27 Jan. He went to daycare problem on 28 Jan, in normal state of health. upon return, patient felt warm and had difficulty standing out of car. Wife let him rest on a chair in the kitchen and found him on the floor in the morning, for a unknown amount of time, unwitnessed descent to floor.

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

Suspected delayed vasovagal reaction. Patient was post 15 minute observation period. He had left vaccine clinic accompanied by family. Family went to get car while leaving patient in lobby of the clinic. Patient became light headed and dizzy and fell, did hit his head. He has a history of vasovagal reactions and reports this has happened to him before.

Nausea, vomiting, dizziness, distorted vision, sore arm, fever, injection site swelling, ambulatory deficiency. Admitted to Hospital

Got up to go to the bathroom in the middle of the night, was dizzy. Wife walked with him because of the dizziness. On way back to bed he passed out and I tried to help ease him down. Came back almost immediately. Got on hands and knees and crawled to bed. Ran a fever of 100.3 all Wednesday and stayed in bed because of dizziness. By Thursday he was fine again and started doing his normal activities.

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

Extreme pain at the injection site and unable to lift my arm. Believe shot was not administered properly - into bursa sac and not the muscle

Hallucinating; Urinary incontinence; Lack of awareness / became unaware and didn't know where he was; Lethargic; Couldn't find the bathroom; Couldn't get off the end of the couch; Temp of 102-103; A spontaneous report was received from a consumer concerning a 78-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced temperature of 102-103, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. The patient's medical history was not provided. No concomitant medications were reported. On 20 Jan 2021, before the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient developed temperature of 102-103 degree fahrenheit, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. The reporter stated that these side effects began approximately a day to two days prior to the vaccine. The treatment information included paracetamol. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, temperature of 102-103 degree fahrenheit, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch were unknown.; Reporter's Comments: This report concerns a 78--year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and experienced temperature of 102-103, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. Very limited information regarding these events has been provided at this time. Further information has been requested.

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

Client's wife contacted RN to inform RN that she had taken client to the emergency room the evening of 2/24/21 . She reported that on that day he had "no use of his body" and was unable to really move his arms or legs on his own. She reported while in the lobby while waiting to see the doctor that he had started regaining some of the ability to move his legs and this had increased by the time he seen the physician. She stated the doctor had completed evaluation/ workup and suggested that the client could have had reaction to Covid-19 vaccine. She stated at the time of the call that client was doing some better and did continue to appear to be improving. RN encouraged her to contact clinic with any future concerns and updates and to call 911/ return to ER as needed. She verbalized understanding.

An in-home fall, dizziness, slurred speech, blurry vision, felt very ill. Did not lose consciousness. Was able to sleep. Day after event was okay. Two days after event, dizziness and loss of balance re-occurred twice during the day -- but did not precipitate a fall.

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

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

Around 6 pm last night he had 100.3 fever and it went up to 100.7 by 3 am. He had a lot of fatigue and his balance was off. I found him bent over a chair in the bedroom @ 3 am and he couldn't straighten himself out. He needed help to go to the bathroom. He was very off balance. He hit his head into a cabinet that is above the toilet. I had to hold him up as he used the toilet. He also had a problem getting back into the bed twice.

March 3, 2021 SUBJECT: Moderna COVID-19 Vaccine, Side Effects This letter/email is addressed to a number of individuals with a request that you seriously evaluate the below discussion, take action to alert medical staff of your respective agencies of these side effects, and work with the manufacturer, Moderna, to address them. As the recipient of them it has thus far been debilitating and interfered with my daily activities. It is my hope that the medical community can find ways to prevent or treat them such that daily activity can be unimpeded. I will first provide a chronology of my medical history and my Moderna vaccine experience. Then I will discuss my observations. My medical history: Age: 78 Gender: Male Pre-existing Conditions: Medications Hypertension: Blood pressure medication, 50 mg of Metoprolol Succinate ER daily Cholesterol: Atorvastatin, 40 mg daily Medical History 2018: Triple By-Pass Surgery 2019: Passed out, Hit head on falling, Brain bleed: Subdural Hematoma, Hospitalized: No surgery required and released. Subsequently, pacemaker installed. 2021: Moderna COVID-19 Vaccine administered. First Dose: Lot Number: 011J20A, Date: 01/08/2021, Clinic Site: Pharmacy Second Dose: Lot Number: 032L20A, Date: 02/05/2021, Clinic Site: Pharmacy Side Effects to Moderna Vaccine administration First Dose: Administration Site: Swelling, Site Redness and Fever. All dissipated within week after administration Second Dose: Fever and Chills day following administration. Lethargic for several days following administration. These symptoms disappeared. Observations February 24, 2021: Began to experience dizziness, symptoms progressed to mild vertigo. Based on history of presentation of these symptoms, assumed I had an inter-ear problem and began taking Zyrtec D, half a tablet. Experience with Zyrtec D has been that ear dries out and symptoms of dizziness and disorientation disappear. In this case the symptoms of vertigo progressed to the point of difficulty in walking and loss of balance. Stopped taking Zyrtec D on Friday, February 26th. February 26, 2021: Had more severe vomiting, walking difficulty and lose of balance. Used walker to stabilize walking. At approximately 7 to 7:30 PM, following consultation with wife and daughter, decided to go the emergency room of the Medical Center (MC). Was quickly seen by emergency room staff. Following questions on medical history, the ER doctor, based on head bleed history, I believe, had a CT conducted. I do not recall any questions about COVID-19, but do think we told them that both myself and my wife had been vaccinated for COVID-19. I specifically recall that prior to my transport, a nurse came in to do a nasal swab for COVID-19. I informed her that I had been vaccinated, but she said this was a requirement for admission to the location where I was being transported. Following the CT scan, the ER physician determined he believed there was a possibility of a small new brain bleed. At approximately 2 to 2:30 AM I was transported by ambulance to Health Center at approximately 5:00 AM. I am not certain about the exact times here. February 27, 2021: Health Center administered a number of tests including CT scan, EKG, and an echocardiogram. While there, physical therapists came to see me twice and exercised me to improve my balance and walking ability. The last one recommended exercises to help reset my vestibular system. Based on the administered CT scan there, the physicians saw no evidence of a new brain bleed and were prepared to release me. At the time of that discussion in my room, the attending nurse pointed out to the physician there that my blood pressure was elevated. He ordered a new EKG and deferred on releasing me until a cardiologist reviewed the results. Their concern was that I was experiencing episodes of atrial fibrillation (AFib). Subsequently, the cardiologist reviewed the new EKG and concluded the episodes were within the normal range, my understanding, but did note that my heart rate was elevated. At no time did the medical staff raise or question the possibility of COVID-19 side effects as being a possible explanation for my disorientation or heart rate problem. I was released later that day. February 28, 2021: While speaking to her sister, my wife shared with her my experience of dizziness and disorientation. Her sister related that her husband had and was experiencing a similar event. Further, her husband?s sister had experienced a similar event. Additionally, the husband?s sister had experienced vertigo. On further discussion it was determined all three of us had received the Moderna Vaccine, and approximately three to four weeks post second dose administration, developed these symptoms of vertigo. This prompted me to go to the internet for information on vaccine side effects. The Food and Drug Administration Fact Sheet, revised 12/2020 in the Section Titled: What are the risks of the Moderna COVID-19 vaccine? speaks of severe allergic reactions including: a fast heartbeat and dizziness and weakness. I believe that I have suffered these two reactions. March 1, 2021: Called both hospitals to alert them to inform their respective staffs of the need to question the possibility of these side effects should other patients present in their emergency rooms. In my case, it may have helped to alleviate my concerns had I been informed of these possible side effects. At MC I left a voice mail for the Chief Medical Officer and at Health Center I spoke to the Nursing Supervisor. The nursing supervisor advised me to report my side effects and directed me to call the entity who had administered the vaccine doses. I called the Pharmacist and spoke to her. She said she would report my concerns through her reporting system. Further she informed me that there was a medication my primary care provider could prescribe. I called my primary care provider, and he has prescribed Meclizine, 25 mg tablets. I am currently taking ½ tablet, three times per day. A whole tablet made me drowsy. As of today, March 3, 2021, I am still experiencing disorientation. Hopefully this will subside and disappear. The above discussion is provided to assist medical professionals to further assess the side effects of the Moderna COVID-19 Vaccine. I am glad that I received it. I have no complaint about the care I received at the two medical facilities referenced. In fact, I think it was excellent. However, it would have helped me to have raised by either or both of them that my symptoms may have been COVID-19 Vaccine related. Further, it may have changed how they proceeded in assessing my situation. As an industrial hygienist with statistical training, it seems to me somewhat unusual to have three members of my extended family experiencing similar dizziness and weakness side effects, and for us all to have similar time periods following the administration of the second dose. Perhaps, if related to the vaccine, this cluster would suggest that this side effect may be more common than a ?remote chance.? Should any of you have further questions or wish to speak to me, please do not hesitate to call. Since I get a lot of calls from numbers I do not recognize, I do not always answer, but a voice mail left with a return call number normally results in a return call. Today, I received a return call from the Chief Medical Director of MC and told her she would receive a copy of this document. Thank you for your attention to this matter.

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

While eating breakfast the next morning after my shot, I got dizzy/light-headed and fainted, falling to the floor. I was "out" for ~2 minutes, according to my MD wife. After 2-3 minutes ,I felt fine and went and played tennis 15 Minutes later. I don't think that I have never fainted in my life time. I take no prescriptions for anything. I do still have a sore shoulder from the fall, since I was sitting in a "Bar stood" at a counter at the time of the fall.

pt states on 2/27/2021 after he got the vax he had a high fever. On 2/28/2021 he was weak and was getting out of the shower when he fell. He was to weak to get up. He stayed on the floor for four hours before he was able to get to a phone to call 911. Paramedics took him to Medical Center he was directly admitted. His temp was 103. He stayed for four days before he was stabilized enough to be able to go home. They ran numerous test, CT, EKG, Labs, Covid (negative). He has a nurse and PT coming to his house 2 times weekly. He states he now how control over his bowels and bladder and can take short walks w/ walker. He has a FU apt w/his PCP on 3/29/2021. He is scheduled for his 2nd Covid dose on 3/25/2021.

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

Patient felt generally unwell, tired and unable to walk well. Said his feet felt numb. He could not get up and slid to the floor. He did not have the core strength to even help him sit up. Sometime after he was assisted back on the couch around 4:30 am he must of got back up and attempted to go to restroom because he was found on the floor with his arm and face resting on the love seat which looked as if he was trying to pull himself up. His wife found him in the morning around 11:00 am and he had been died for some time according to EMS. His death was unexpected. Even when contacting his doctors they were confused as to why he had passed away. No autopsy was done but as of this moment he has not been cremated yet and is at Funeral Home.

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

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

Day 1 totally exhausted and slept for 24 hrs. Day 2 totally exhausted. Day 3 felt better but tired. Day 4 woke up dizzy and exhausted. Day 5 dizzy and exhausted. Day 6 dizzy and exhausted. Day 7 dizzy and exhausted. Day 8 still dizzy and tired, but beginning to feel better. Slightly dizzy for days 9, 10, and 11. This affected my work where I couldn't work. I will not get the second shot.

Dizziness blood pressure increased, shot injection area swelled and was red the size of an orange. Light headed, stomach cramps, overall fatigue, not able to sleep.

Got the vaccine, and he got home and his whole body was like he was freezing with chills, could not walk, could not talk, had a headache, could not eat, felt like he was dying. Really bad. The arm is swollen up like a balloon, black and blue from the injection. Took aspirin, and still having the chills and he can hardly move his arm.

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

1/15/21 (1st dose of Moderna COVID vaccine) about 10 min after taking the Moderna Covid-19 vaccine, patient noted that he felt "woozy", denied nausea, lightheadedness or diaphoresis. He was offered water and engaged in conversation. After about 2 mins later, patient noted he felt back to normal. He then left with caregiver.

Patient complained of feeling dizzy. Patient states he is Diabetic. Spouse states he didn't eat this morning, just had coffee with his morning meds. EMS called to car. Juice, piece of cheese, and a sandwhich was given. Patient was cleared by EMS. Before leaving patient denied any symptoms saying he felt much better. Patient was instructed to seek medical attention if symptoms re appear. Verbalized understanding. Spouse present at time and verbalized understanding also.

headache, fever, ad confusion since getting vaccine; worsening generalized weakness over the next 2-3 days causing inability to perform ADLs or ambulate

Patient reports chills, fatigue, aches, diarrhea, and dizziness/imbalance approximately 24 hours after vaccination. Patient advised to see primary care physician given his balance issues/concerns. Given that patient was referred to make an appointment to see PCP, I am submitting a VAERS report on that basis.

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

Moderna COVID-19 Vaccine EUA. DAY 0 (03/01/2021): REDNESS & TENDERNESS AT INJECTION SITE. INCREASING ACHE DISCOMFORT UPPER ARM. DAY 1: CONSTANT ACHE-TYPE PAIN, ENHANCED TENDERNESS UPPER LEFT ARM. UNABLE TO RAISE ELBOW ABOVE HORIZONTAL WITHOUT EXPERIENCING INTENSE ACHE/SORENESS-TYPE PAIN. UPPER ARM FELT AS IF PATIENT HAD RECEIVED A SERIOUS NUCKLE-PUNCH ADJACENT TO BICEPS. REDNESS AT INJECTION SITE. NO SLEEP-TIME INTERRUPTION. UNABLE TO LAY ON LEFT SIDE WITHOUT SERIOUS ARM DISCOMFORT. DAY 2: DIMINISHED CONSTANT ACHE-TYPE PAIN & TENDERNESS AT INJECTION SITE. ABLE TO RAISE LEFT ARM ABOVE HORIZONTAL WITH MILD DISCOMFORT. ABLE TO LAY ON LEFT SIDE WITH MILD CONSTANT ACHE IN ARM. SEE CONTINUATION PAGE.

?Can?t get a full breath? Nauseated, Dizzy, balance was off. ?Thought I was having a heart attack. Couldn?t walk without a cane because of pain and weakness.?

This was second dose, exactly one month after first. Both at Pharmacy. Evening of 3/26 restless, little or no sleep. Morning of 27th seemed normal until about 11am when daughter tells me I was stumbling, sluring words which quickly got worse. Family tells me it got progressively worse and became like a daylong, staggering drunk completely unable to walk without assistance, showing some belligerance until finally asleep around midnight. This am (3/28) woke about 10am feeling normal except a bit weak and uncertain balance. After eating grew stronger with recovered balance.

Five days after shot I had rapid pulse (120) and felt weak. Ten days after shot I felt very weak in morning and couldn't stand long enough to shave. Rapid pulse again (120).

I experienced this rather immediate unexpected gradually increasing dizziness with impaired balance while walking at accustomed pace over approximately 12-15 minute time period. I was compelled to leave the track and lay down on an exercise mat where fortunately my wife came by t Within half hour of this attack i coiuld not stand and walk independently without support. My first time to a hospital ER in my 78 years of life. Recommended for observation and additional tests I stay overnight in observation unit. Diagnosis appeared to be perplexing for physicians. My wife came by to assist me in standing , walking to the car and driving me to nearby ER. What happened to me was a frightening, anxiety-producing and dangerous situation. I could have easily fallen with substantial head or other bodily injury. Being in excellent health and with nothing else unusual having occurred recently to affect my general health (no changes, no illnesses), I cannot help conclude this episode was a serious adverse reaction to my 2nd Moderna vaccination. I now consider what happened on 3/28/21 a "Vestibular Attack". I think possibly my body for some reason related to the vaccine might have been attacking itself, if that makes sense to scientists. I hope this doesn't happen to others. I am not anti-vaccination. But individuals should be warned about this possible dangerous reaction or adverse side effect, which in my case did not occur immediately after the 2nd Moderna dose. I've complained to the hospital that possibility of severe dizziness with extreme loss of balance being related to recent Moderna 2nd vaccination was NOT discussed or commented.

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

worse with the second shot.; worsening tremors; weak and dizzy; weak and dizzy; extremely nervous; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak and dizzy), DIZZINESS (weak and dizzy), NERVOUSNESS (extremely nervous) and FEELING ABNORMAL (worse with the second shot.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced ASTHENIA (weak and dizzy) (seriousness criterion intervention required), DIZZINESS (weak and dizzy) (seriousness criterion intervention required), NERVOUSNESS (extremely nervous) (seriousness criterion intervention required) and TREMOR (worsening tremors). On 03-Feb-2021, the patient experienced FEELING ABNORMAL (worse with the second shot.) (seriousness criterion intervention required). At the time of the report, ASTHENIA (weak and dizzy), DIZZINESS (weak and dizzy), NERVOUSNESS (extremely nervous), FEELING ABNORMAL (worse with the second shot.) and TREMOR (worsening tremors) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case concerns a 78-year-old male with medically significant serious unexpected events of asthenia, feeling abnormal, dizziness, nervousness and nonserious unexpected tremor. Event onset 5 days after first dose. 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-2021-049775 (Linked Report). Reporter did not allow further contact; Sender's Comments: This case concerns a 78-year-old male with medically significant serious unexpected events of asthenia, feeling abnormal, dizziness, nervousness and nonserious unexpected tremor. Event onset 5 days after first dose. 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. MOD-2021-049775:

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

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

Paitent had a stroke for no identifiable reason. They saw little bloodclots in his brain. Because he has heart stints, the doctors at the hospital said everything that prevents strokes was already being done for him. They had a heart monitor placed in his chest and today the cardiologist read the results. There is nothing in his heart that would cause the clots. Blood clots are not part of his family health history. The only thing "different" during the time previous to the stroke was the covid shots. Just reporting in case it is part of a trend. He hd mobility issues and had to be in physical therapy for a few weeks. His balance is still weak.

the next day, dizzy , 2 days later sore throat pain, chest pain short lived ( not like when he has had heart attacks in past ) , fever 99.2, coughing Advised may want to talk to PMD about breathing treatments, if chest pain seek medical attention. Placed follow up call on 4/16/2021 at 11:17: Pt reported that he is feeling much better today. Pt reported that the ADEs he had occurred within couple of days of rcvding his 1st Moderna vaccine, by the 3rd day all the symptoms had cleared up, and on day 4 he reported still had some running nose (which he contribute to his allergies). Pt reported for his symptoms he did not try anything to help alleviate his symptoms, he stated he is already taking Tylenol daily.

weak and dizzy; Worsening tremors; Extremely nervous; weak and dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weak and dizzy), TREMOR (Worsening tremors), NERVOUSNESS (Extremely nervous) and DIZZINESS (weak and dizzy) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced ASTHENIA (weak and dizzy) (seriousness criterion medically significant), TREMOR (Worsening tremors) (seriousness criteria disability and medically significant), NERVOUSNESS (Extremely nervous) (seriousness criterion medically significant) and DIZZINESS (weak and dizzy) (seriousness criterion medically significant). At the time of the report, ASTHENIA (weak and dizzy), TREMOR (Worsening tremors), NERVOUSNESS (Extremely nervous) and DIZZINESS (weak and dizzy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was unknown. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-049791 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-049791:

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

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

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

Patient on 4/18/21 experienced "chicken wire" vision (never before an issue), after vision issues patient said he lost vision on and off for the next 24 hours, accompanied with mental confusion, and was unable to get out of bed on the morning of 4/19/21. Next two days a continued decline in in ability to ambulate and demonstrated neurological deficits on 4/20/21 of impaired vision, cognition and experienced difficulty in moving limbs. Patient was in a car accident on 4/21/21, is now hospitalized, unable to ambulate, and has further neurological deficits with impaired speech, cognition, and movement as well as pneumonia.

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

on April 30,2021 I woke up thinking I was having a CVA, the room was spinning and I felt nauseous . I went to the ER at the regional Hospital. When admitted the check my vital signs, chest x-ray, CT brain scan . CVA negative, chest clear, heart rate elevated to 155bpm

Sensorineural hearing loss (sudden hearing loss in right ear) concurrent with labyrinthitis. Late evening preparing for bed on March 3, 2021 experienced a ringing in right ear. Awoke at 3:30 am on March 4 with severe vertigo, no hearing in right ear. Required ED visit to stabilize, MRI and scans ruled out stroke or other brain issues, thus dx as labyrinthitis. Sent home with Meclizine and instruction to visit with primary care as soon as possible. Started 10 trial of oral Prednisone at 60 mg daily on March 12. Signs of vertigo, mostly unsteadiness and having to walk with cane, and some vision impairment and inability to focus continued at least seven weeks, just recently having finally cleared. However, following three intratympanic injections of Prednisone, I still have total hearing loss in the right ear.

HPI/Subjective: 78 yo with above PMH who presents for new patient evaluation. He was admitted to hospital on 4/3-4/5 for acute episode of dizzines jaw pain found to be hypertensive with elevated troponin. Troponin peaked at 10K. Echo showed no WMAs. Angiogram showed mild distal PLA disease but no other obstructive disease. Cardiac MRI showed a focal area of mid wall LGE consistent with myocarditis. Supportive treatment. Additionally during this admission was found to have small acute L occipital infarcts and tiny infarcts vs artifact in the left thalamus and medulla. Lipid panel and HbA1c unrevealing. ECHO unrevealing. CTA was unrevealing. Patient will D/C with zio patch. Long term blood pressure goal is <130/80. Today, reports feeling OK. No recurrence of the dizziness or jaw pain that brought him into the hospital. No chest pain or pressure or syncope or dyspnea on exertion. No orthopnea, PND or LE edema. Walking 2 miles fast pace without any symptoms. Blood pressures are 130-200s (pre increase in Lisinopril) lower in the morning and worse in the afternoon/evening. Former smoker (quit in '85). Family history - Mom had a AVR in 70s

Sudden inability to move and delirious and hallucinating. Hospital ran numerous tests to find problem without being able to determine.

Patient received his second dose of the Moderna vaccine on 5/21/21. On the morning of 5/22/21, patient started having issues with mobility, heavy sweats, body aches, and headache, although he had no fever and maintained his sense of smell and taste. Patient was later hospitalized and tested positive for COVID on Thursday, May 27, 2021. Patient passed away on Friday, May 28, 2021.

Jab 5pm; 11pm brief dizziness, slight headache (rare for me); 5am diarrhea for 3 hours; very tired for two days, on/off headache; next four days woke before dawn to very strong heart palpitations... jumping heart... each time soon following with strong headache; I could at strongest beats see the beats through 'flashes' in my eyes; standing or walking to bathroom felt faint, sometimes wondering if will pass out; always begins while lying down; sleeping on both sides, on back the same; sitting in chair seemed to eventually help; once up and eventually more active palpitations have settled down to a few 'reminders' during the day and evening. Fear going to bed now., eleven days after 2nd Moderna.

states had no symptoms for first 24 hours, then developed expected side effects including headache, body aches, fatigue. then on day 4 or day 5, states he developed problems with his equilibrium(falling into walls) but catches self and has not actually fallen to floor/ground. states no really "dizziness, just problems with balance". has not seen doctor or had any follow up. states afraid of vaccine and will not receive dose 2.

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

After first vaccine administration pt developed slurred speech that has not improved. After second vaccine administration patient developed difficulty with balance.

Diagnosed with Transverse myelitis; Numbness; Paresthesia; Progressed to a point that the patient can no longer walk and no is on wheel chair; Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness; This spontaneous case was reported by a health care professional and describes the occurrence of MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in January 2021. Concomitant products included ROSUVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], UBIDECARENONE (COQ10 [UBIDECARENONE]) and PANTOPRAZOLE for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis) (seriousness criterion medically significant), HYPOAESTHESIA (Numbness), PARAESTHESIA (Paresthesia), GAIT INABILITY (Progressed to a point that the patient can no longer walk and no is on wheel chair) and ASTHENIA (Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness). The patient was treated with METHYLPREDNISOLONE at an unspecified dose and frequency. At the time of the report, MYELITIS TRANSVERSE (Diagnosed with Transverse myelitis), HYPOAESTHESIA (Numbness), PARAESTHESIA (Paresthesia), GAIT INABILITY (Progressed to a point that the patient can no longer walk and no is on wheel chair) and ASTHENIA (Progressive weakness in lower extremities and worked its way up to mid torso/ Weakness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Magnetic resonance imaging: abnormal (abnormal) Diagnosed with Transverse Myelitis. 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) (Unknown) was not applicable. Company comment: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Further details regarding medical history and treatment for assessment. Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021 contains Non-Significant information.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Further details regarding medical history and treatment for assessment.

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

Slight dizziness upon awakening in the morning around 7:00 AM. dizziness faded through the day, but mild headache developed around 1;00PM. Symptoms not severe or incapacitating. Patient took two Tylenol caplets.

a history of Parkinson's who presented with generalized weakness as well as urinary frequency. Patient had a history of prior COVID 19 infection in 10/2020, was hospitalized. He had the first dose of COVID vaccine 1/19 and after that, he developed fever, increasing weakness and was unable to get out of a chair and therefore presented to the ED.

Chills 6 hours Headache I4 hours Fever 100.8 4 hours Dizzyness 6 hours High Pulse 101 High blood pressure 164-89 6 hours

falling out of his wheelchair and having altered levels of consciousness every since receiving his COVID vaccine 2 days ago. Admitted with multiple pelvic fractures from fall and NSTEMI with elevated trop

My L4-L5 stenosis was completely healed after my Nero surgery in 2018. After the Vaccine I took on 1/12/2020 - my right leg pain has suddenly returned on 1/20/2020. It is worse. I will be seeing my primary care doctor on 1/25/2020. I have difficulty walking. The pain is severe. Is it due to COVID vaccine I took?

7 hours after the vaccine tiredness and mild nausea started. Approximately 26 hours after the vaccination extreme dizziness occurred and he lost consciousness for a few seconds. He was clay and completely lost his coloring . His son is a retired HCP and we took vitals and within 30 minutes after drinking electrolytes he was back to normal. We believe he was dehyrated. He has had vertigo in the past and has a pacemaker. His blood pressure was taken in 3 positions and within less than 30 minutes after having him hydrate all symptoms subsided. I emailed these symptoms to his Medical Doctor. We also had him use his pacemaker monitoring system to send a report to his healthcare specialist.

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

Patient rec'd vaccine on 1-25-2021. Patient woke up on 1-26-2021 feeling so bad with joint stiffness and trouble breathing, he called 911. He was taken to Hospital where he was admitted. He says by 1-27-2021 he was feeling much better with each passing hour. He was discharged on 1-27-2021. Then on 1-28-2021 he noticed a red and very itching rash at the injection site and all across his back.

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

Lightheadedness and rapid more shallow breathing 10 minutes after injection. Lasted about 10 minutes, began to subside and were gone in about 30 more minutes.

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

5 days after vaccine given , patients started having chills for very short time twice, some chest pain, extreme fatigue , loss of equilibrium

Patient's wife reported the symptoms of dizziness started on 2/4/2021 and lasted for 3 days. She denied any other symptoms like fever, body aches or chills.

Had chills/shakes night of1/31st, on 2/1st, had fever that day plus dizziness and off balance. Next day was better but still kind of dizziy and off balance. The third day,2/2nd seem better.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: slurred speech, confusion, possible seizure, minimal right side of body function-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Seizure-Severe

Patient became dizzy 15 minutes after vaccination. Emergency services was called. Patient went into a sleep state for about 15 seconds but with stimulation was responsive and was able to speak to me immediately. Patient then became nauseated and approximately 10 minutes from start of event vomited. After this the patient began to feel better. Paramedics arrived and evaluated patient. Blood pressure, pulse, oxygen level, glucose level were all normal. Patient was convinced to go to Emergency Room with paramedics to be evaluated.

Currently waiting for dental work (crown removal and replacement to treat cavity). 2/18/21 Started to experience toothache (R) which got worse as the day progressed. Tylenol didn't help. Took one tab of Percocet (5-325) to allow me to sleep. 2/19/21 Contacted dentist and was prescribed Penicillin VK 500 mg. Started Penicillin around 3 pm. 2/19/21 ~6 pm onset shakes, chills, sweating, low grade fever (~100.2), nausea, headache, weakness, difficulty in standing. Took more tylenol, lay down, fell asleep for approximately 3 hours. Woke briefly took my nighttime meds (atrovastatin, metoprolol, ranolazine, baby aspirin.) Additional information for Item 18: 2/20/21 Felt better when I woke up. Temp normal. Ate breakfast. Mild stomach ache. Around 3 pm onset of sweating and chills, shakes. Low grade temp (~100) 2/22/21 Fully recovered. No lingering issues. Not sure whether what I experienced is related to the Moderna vaccine or a reaction to the Percocet I took to alleviate the severe pain associated with my toothache.

Pt received COVID injection at doctors office. Approximately 1 hour later while sitting in recliner, wife noticed patient pale and unarousable. Paramedics were called and found patient with agonal respirations in asystole. Pt was intubated, received epinephrine, amiodarone and atropine per ALS care. Pt wife stated patient complained of dizziness and headache, but no chest pain or shortness of breath. Pt transported to ER. Following testing and treatment in ER, pt transferred to ICU.

Patient experienced generalized weakness and inability to ambulate. He presented to the ER on 2/24/21 and was found to be hypoxic 88% on room air and was stated on O2. He presented with a rash at site of vaccination on left arm over deltoid muscle. He had a red petechial rash on anterior chest and upper abdominal wall.

sudden onset sever vertigo with severe nausea and vomiting, diagnosed by ENT doctor as vestibular neuronitis. Treatment was physical therapy and symptoms 95% resolved in 5 weeks

Patient was given injection on 3/3/21, symptoms started in AM on 3/4/21 with dizziness and headache. Patient was given meclizine by one of our providers from our clinic to help with the dizziness since patient experienced this with the first vaccine. Patient will follow up with a clinic visit if symptoms do not improve.

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

Arm was a little sore after shot, but the next morning pt. wasn't able to walk when he tried to get out of bed. He fell on the floor and was unable to get up. His face was very flushed and he broke out in a sweat several times. We had to have fire dept come and pick him up off the floor. He was able to get around a little bit with a walker, but spent most of the day in bed and was transported to bathroom by wheelchair. He was also a bit confused. He had very little appetite and was unable to eat very much. At dinner time, he ate a little bit of soup and when he stood up at the table, fell again onto wood floor. We had to call fire dept to pick him up from floor and EMT's/ambulance to come out and check him over. VItals were all normal. He was just a little bit better on the next several days. We made an appointment for him to see Dr. on 3/3. Doctor did blood work which came back normal. Pt. is still not back to normal.

3/6 at 8 AM collapsed to the floor with generalized weakness, headache (5/10), severe nausea with dry heaves, copious sweating & minor nosebleed. No loss of consciousness. Was able to get to sofa about 8:30 AM and vomited scant amount of whitish fluid. Temp at 5:30 PM 98.1. Slept all day and all night. On 3/7 felt fine and resumed all normal activities. On 3/8 felt extremely fatigued from awakening at 7:30 AM until 11:00 AM. Fatigue resolved midday on.

By 3:00 he had a whole body chill. He was then incoherent, lost all control of all body muscles and was incontinent both bladder and bowel. He continued as such when Dr. said to give him Prednisone along with the Benadryl he was receiving every six hours starting at 3:30 p.m. 3/8/2021. He was given a Prednisone at 4:00 p.m. 3/9/2021 and again at 8:00 p.m. on 3/9/2021 along with his Benadryl. He was unable to ambulate or even turn his body over in bed. He was able sip water and sports drink but ate nothing since noon on 3/8/2021. It wasn't until early Sunday morning that he was able to move his legs and get to a walker and use the toilet. He slow, very slowly has improved since then. Late Sunday he was able to get up, and sit in a chair. Later he was able to take a sit down shower and shampoo and be an to feel "nearly human" again. He has slowly progressed since then and Monday morning was able to navigate by himself and to descend and ascend a 13 stair step to the basement. In discussing the 24 hours he spent in bed he was unaware of any of the things going on such as not being able to move, but knew he was in pain if he moved his legs. He also had a temperature of 102.3 which rose to 102.9 and then with cold compress on his forehead and time his fever dropped to 95.4 and the back up to a normal of 97.5. These are similar symptoms he had after the first injection of the Covid 19 Moderna vaccine and he had had a similar reaction in 2017 from the first flu shot he ever had in his life. He felt he needed to take this vaccine in order to be able to "have a life" even though we assumed he would have such a bad reaction. He is slowly improving and if it is like the first injection it will take him nearly two weeks before he can ambulate at the level he was before the vaccination. Still, he is grateful to Center for being so proactive as to have available the vaccine and it being more convenient for cancer patients than waiting in line at a mass inoculation center. He would appreciate an acknowledgement that this information has been received and could possibly passed along to help others in his situation. Thanks.

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

Fall occurred, patient had trembling of both legs and arms, garbled speech for about an hour; couldn't walk without assistance for about 6 hours ,extreme fatigue for the next 48 hours and tiredness for the remainder of the week (3 days)

He woke up the next day after the vaccine he did not know where he was and was confused. He did not take his medications, did not remember to take it. He came out to his wife and she heard some noise and he looked over to the dog dish to refill it and didn't refill it as he usually does. Just a lot of forgetful things that he did. He had dizziness and was hanging on the door frame and went to bed, and told his wife that he did not know anything and did not know what he was doing. They took him to the doctor and was seen by the doctor who checked his VS and said that he was okay, and told them that he was having a reaction to the vaccine, and was starting to come around and remembering things while he was in the doctors office. They were advised to take him home and let him rest, and he did and didn't eat until last evening. He had the same reaction that he had when he had the COVID virus. He knew everything this morning and back to his baseline.

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

blurred vision: unable to focus dizziness: blood pressure spike: gradually rising. 185/110 after 90 minues

Patient is an 79 year old male who had his 2nd Moderna vaccination in his dominant right arm Thursday afternoon. Upon awakening Friday morning, he had difficulty walking. His legs were strong enough to hold him, but he was unstable. He also had some numbness on the palmar surfaces of some index and middle fingers of his left hand. His speech was somewhat garbled, but when his wife would encourage him to repeat himself, he could enunciate more clearly. He had some nonspecific difficulty swallowing. He attributed this all to adverse reaction to the vaccination, which would pass... Friday mid day his wife took him to the barber, and on return home he was briefly nauseated and vomited. Later in the day on Friday they went for car ride, and on return home he was briefly nauseated and vomited. He had no other episodes of nausea. He had no fevers or chills. He had no visual disturbances. He had no other numbness or paresthesias. He was aware of no clear weakness. Finally today, the gait instability persisted and the numbness in the left hand, so he came to the ER for evaluation. Patient is currently recovering in the hospital

Wife called clinic on 3/3/21. Said he had a serious reaction requiring EMS to be called twice. Was seen by PCP on 3/3/21. Chief complaint of recent falls, no appetite, and cognitive issues since 2/26/21. HPI Per PCP Note: 79 yo male with Celiac, mild type 2 DM and prostate cancer on Leuprolide and Xtandi here for f/u Diabetes and to get advice following adverse reation to first COVID vaccine received 2/25/21. He has chronic RUE tremor. He was diagnosed with a TIA from an endocardial lesion many years ago. No cardiovascular disease history. He experienced increased generalized weakness and poor balance following the vaccine. He felt restless for 4-5 hours. He fell to the floor twice and next morning and afternoon and EMS evaluated both times. Glucoses 140-150. No hypotension or tachycardia. No arrhythmia. No focal hemiplegia or slurred speech. Did have sluggish cognition but not obtunded and could communicate wishes to remain at home. Spouse feels he was 80% better on Saturday and is 95% better today (Tuesday). No low glucoses. Hydration and rest the first 48 hours seemed to help but he doesn't feel completely normal yet (still has fatigue and no appetite). He can walk but is not confident of his strength. He was anxious about getting the vaccine. No prior hx of COVID but spouse did have it in August. Spouse had localized reaction only. Patient weaning off Gabapentin taken for tremor and neuropathy.

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

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

Got the vaccine, and yesterday 3/24/21 somewhere around 3:30 he started feeling weak, tried to walk and had weakness. By 6:30 he could not get up. He was on the floor as he slid off the bed and could not push himself up on his arms, and got worse and worse. He went up to bed, and his son had to come over and help him into bed as he was not even able to lift his legs to get into bed. Then at 3:00 AM this morning he could start walking again. Now this morning he is a little wobbly and otherwise getting better. He did take 2 Tylenol. No soreness around the injection site, just the extreme weakness.

started with chills and slight fever. Went to bed; however, wears a CPAP. At around 2am spouse awoke and heard strange gurgling sounds. Husband sleeps on back due to CPAP. Upon turning on light discovered he had thrown up and had regurgitated the vomit into his mask and back down throat. Very high fever, body hot all over, in state of confusion and slid off bed; tongue swollen and hard to understand him. Called paramedics and they took him to hospital immediately saying "he was in bad shape". Admitted to Hospital at around 6am after being in emergency room and treated with antibiotics and steroid. Stayed in hospital 4 days. Diagnosis: aspirated pneumonia. Home but with health care.

Severe Pain in left arm fro injection site down the forearm. Severe Pain radiating through the left chest and the left shoulder blade. Inability to sleep unable to find a comfortable position for my arm due to tingling, numbness and lack of ability to use my arm in greater than 70 % movement.

Acute intertribal hemorrhage; Stroke; Starting getting confused; Had a fall; Brain bleeding, brain hemorrhage; Induced coma; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Acute intertribal hemorrhage), CEREBROVASCULAR ACCIDENT (Stroke), CONFUSIONAL STATE (Starting getting confused), FALL (Had a fall), HAEMORRHAGE (Brain bleeding, brain hemorrhage) and COMA (Induced coma) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) Dosage form. On 24-Mar-2021, the patient experienced COMA (Induced coma) (seriousness criterion medically significant). On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Acute intertribal hemorrhage) (seriousness criterion death), CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), CONFUSIONAL STATE (Starting getting confused) (seriousness criterion medically significant), FALL (Had a fall) (seriousness criterion medically significant) and HAEMORRHAGE (Brain bleeding, brain hemorrhage) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was intra cerebral hemorrhage. At the time of death, CEREBROVASCULAR ACCIDENT (Stroke), CONFUSIONAL STATE (Starting getting confused), FALL (Had a fall), HAEMORRHAGE (Brain bleeding, brain hemorrhage) and COMA (Induced coma) outcome was unknown. Not Provided Concomitant medication not provided. No treatment information/hospitalization information provided. This case concerns death of a 79-year-old male patient who expired from acute intertribal hemorrhage after receiving mRNA-1273 vaccine. three days after vaccine administration, the patient developed confusion and fell with subsequent events ensuing. Based on the available information causal association between the event if confusion leading to fall and product use cannot be excluded. The other events are assessed as directly related to the fall and unlikely due to product use.; Sender's Comments: This case concerns death of a 79-year-old male patient who expired from acute intertribal hemorrhage after receiving mRNA-1273 vaccine. three days after vaccine administration, the patient developed confusion and fell with subsequent events ensuing. Based on the available information causal association between the event if confusion leading to fall and product use cannot be excluded. The other events are assessed as directly related to the fall and unlikely due to product use.; Reported Cause(s) of Death: intra cerebral hemorrhage

chest pain; Shaking legs/ Tremors in hands; legs buckled; anxiety; Weight loss; fell to ground; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain), TREMOR (Shaking legs/ Tremors in hands) and LIMB DISCOMFORT (legs buckled) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced FALL (fell to ground) and WEIGHT DECREASED (Weight loss). On an unknown date, the patient experienced TREMOR (Shaking legs/ Tremors in hands) (seriousness criterion disability), LIMB DISCOMFORT (legs buckled) (seriousness criterion disability) and ANXIETY (anxiety). On 04-Apr-2021, CHEST PAIN (chest pain) had resolved. At the time of the report, TREMOR (Shaking legs/ Tremors in hands), LIMB DISCOMFORT (legs buckled), FALL (fell to ground), ANXIETY (anxiety) and WEIGHT DECREASED (Weight loss) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) Normal. In March 2021, Computerised tomogram: normal (normal) Normal. In March 2021, Weight: 148 (Inconclusive) Inconclusive. On 06-Apr-2021, Weight: 125 (Inconclusive) Inconclusive. On an unknown date, Blood pressure measurement: elevated (High) BP Elevated. On an unknown date, Heart rate: elevated (High) Elevated. The patient underwent CAT scan of the stomach, complete gastro work-up and complete blood work up. All tests were result normal. On 3 Apr 2021 he experienced severe chest pain and was transported to the hospital they concluded it was not heart related but he was hospitalized overnight. His BP and heart rate were also elevated. Concomitant product use was not provided.Treatment information was unknown. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Patients significant other states that patient had been in the bed since the vaccine on 4/8/21. He was told that he was positive for COVID. She advised the patient not to come in for vaccine. She reports that he had dizziness, chills, fever, and nausea along with lethargy. He was told by a physician that he was dehydrated. He has been resting since the last vaccine and drinking fluids. As of today, she states that the patient is out of the bed and improving.

Patient admitted after syncopal episode and fall. At time of admission, no respiratory needs, however did require supplemental O2 during current hospitalization. Positive COVID-19 result with admission, >14 days post vaccine completion.

79-year-old male with history of Parkinson's disease who has become extremely weak since his second Covid vaccination 2 days prior to admission. He has chronic gait instability from his Parkinson's and he had difficulties walking over the last couple days. He slid from the couch onto the floor and was brought into the ECC for further evaluation. He could have been down about 48 hours per his wife and daughter. He injured his buttocks. He has chronic peripheral edema and is not using his compression stockings because they are too difficult. In the ECC, his temperature was 99.2. He did fall to 89% on room air but improved with nasal cannula. Patient was treated for 4 days an

Patient came for vaccination in the morning, then went out to breakfast. During breakfast, the patient slumped forward in his seat and was unresponsive for about a minute. There was no incontinence or seizure activity. On regaining consciousness, patient seemed to quickly get back to his usual level of mentation. He was diaphoretic and nauseous. He denies any preceding lightheadedness, nausea, visual changes, chest pain or palpitations. He presented to the emergency room, also had nosebleed and UTI. Was admitted for observation overnight and discharged the next day.

I have a sore left arm in area of where the shot was taken. Arm accidentally bumped which made the soreness apparent on 5/4. On 5/5 still very sore. I cannot raise my arm past shoulder height.

1/19 vaccination 1/24 Woke up, I was so dizzy, nauseated, vomiting I couldn't stand. I crawled to the bathroom. My wife came home and helped me. Vestibular Neuritis Symptoms diminished that evening as I was able to walk around. I mildly continued if I turned quickly for 2-3 weeks. Didn't keep me from regular activities but I was unstable during this duration. *recommended PT and still currently doing even though discharged at this point

Almost immediated weakness within 3 or four hours, collapsed the next day, repeated falls, taken to Emergency Room on Thursday, March 25, 2021--admitted to Heart Hospital with heart failure, lung failure ( no history of lung problems), and severe sepsis, placed on ventilator until Saturday, March 27, 2021. Died on March 28, 2021.

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

Patient has a history of simple Prostatectomy and Kidney Stone. He had the first Moderna Covid 19 vaccine on 2/3/2021 and the second dose 3/8/2021. 5 days ago He started with severe dizziness and next day he was admitted to hospital for severe Urosepsis.

The next day after my second vaccination, my left arm was immobile and very sore. I couldn't move it -- it just hung by my side. After three day of the same, I started range-of-motion stretches. At first just moving it inches, then working up to full motion -- the progression was very slow, over a period of days. But throughout this ordeal the pain never stopped, it is worse on some days. This has been continuing for 97 days and nights with no end in sight. I was able to see my doctor (new to me) after about a month. He offered physical therapy, but I declined because of time and distance -- it would have been 145 mi round trip for 3 days a week. I have been working out at home daily. I have a background in athletics and have equipment at home. I have no strength or endurance because of this and suspect it is an injury for life. I do not trust Moderna anymore.

Tested prior to hospital admission. Started with a cough on 7/17/21 and fell at home. Was brought to ER for evaluation. Per nurse on the floor, he was admitted for fall and COVID, and has no issues from fall so continued admission is due to COVID treatment. Currently receiving plasma treatment and oxygen.

Soon after 1sr injection, experienced dizziness, fatigue. Within hours of 2nd shot, experienced loss of appetite; Fatigue; Confusion; Nausea; he fell several times; lack of grooming was noted.

Really bad headache first 3 days Horrible Chills still ongoing Disoriented and almost like hallucinations Most interesting randomly talking to himself. I mean like a full conversation with someone that isn?t there. He also sometimes feels like when holding something he doesn?t see it or feel it and drops it or vice versa ?.. thinks holding something and isn?t Balance is off Shortness of breath No fever thank goodness and taste and smell are normal

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

Pt got home at 3pm. Pt passed out and fell down. Pt did not hit head, but did bite his tongue. Pt reported to feeling nauseated and tired the rest of the evening.

Weak; Collapsed; Delirium; Night sweats; Chills; Discomfort; Did not sleep at all that night; A spontaneous report was received from a physician, who was also an 80-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, chills, discomfort, night sweats, did not sleep at all, delirium, collapsed, and felt weak. The patient's medical history, as provided by the reporter, included type II diabetes, diabetic neuropathy, heart failure, acid reflux, and urinary retention. Concomitant medications included metformin, gabapentin, furosemide, spironolactone, omeprazole, and tamsulosin. On 06 Jan 2021, hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On the evening of 06 Jan 2021, hours after vaccination, the patient began feeling chills and discomfort. Overnight he began to experience night sweats and did not sleep at all. During the night on 07 Jan 2021, the patient experienced night sweats and had delirium. When he tried to get out of bed, he collapsed. No treatment information was provided. On 11 Jan 2021 and 12 Jan 2021, the patient began to feel better. He no longer had night sweats or delirium. He returned to his exercise routine at about 50 percent of what he normally did although he continued to feel weak. Action taken with mRNA-1273 in response to the events was not provided, although the patient reported he was not sure if he would take the second dose. The outcome for the events, night sweats and delirium, was considered resolved. The outcome for the events, chills, discomfort, did not sleep at all, and collapsed, was considered resolving. The event, weak, was considered not resolved. The reporter assessed the events, chills, discomfort, night sweats, did not sleep at all, delirium, collapsed, and weak, as related to Moderna's COVID-19 vaccine due to feeling well before the vaccine and feeling more or less disabled after receiving it.; Reporter's Comments: This case concerns a 80-year-old, male subject with medical history of type II diabetes and diabetic neuropathy, who experienced a serious unexpected event of delirium and non-serious unexpected event of asthenia, discomfort, insomnia, fall, and night sweats, and non-serious expected event of chills. The event of discomfort, insomnia, chills and night sweats occurred 1 day; the event of delirium, and fall occurred 2 days and asthenia occurred 6 days after mRNA-1273 administration. The subject was on metformin for diabetes ty II and gabapentin for diabetic neuropathy, Lasix and spironolactone for heart failure, omeprazole for acid reflux and Flomax for urinary retention. Treatment details not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Began feeling dizzy shortly after receiving the vaccine. I notified the workers. They took my blood pressure and found it was hig. They took it several times and when it was 210/110 they called an ambulance to take me to the emergency room.

wife called this morning at ~ 9:00 a.m. to report that he woke up with a fever of 101, has been throwing up, is dizzy and disoriented since he woke up this morning. I advised that he remain seated or lying down, to give Tylenol per dosage on pkg/bottle. To call 911 if symptoms worsen. Wife stated that did have COVID infection in Sept. 2020. He walks with walker. I called wife back at 1:50 pm. States took Tylenol, fever went down to 99, and he has been able to keep small amt of fluid down. He has remained seated to avoid risk of falling. Wife has him urinating in bucket. Re-emphasized calling PCP to consult, or 911 if symptoms worsen. To continue Tylenol per pkg instructions. Wife voiced understanding.

extremely dizzy when first got out of bed. Difficult to walk. Mostly abated in a few minutes. Very sore at location of shot

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

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

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

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

Was vacinnated with first shot on 01/17/2021 at 1:30 PM and had no side effects until the next morning and had some fatigue which passed after the first day. Had second shot on 02/14/20121 about 12:30 PM. No side effects the afternoon, and during the night. The next morning had fatigue and headache so rested and eventually by end of day went away, 1 day passed all OK but on 02/17/2021 had severe headache and loss of all balance, equilibrium, and was very dizzy and lasted all day. Standiing up I would have to prop myself or hold onto furniture, By next day, began to regain balance and by end of day, was able to walk balancing with cane. With the dizziness came halicunations at times, especially if laying down.

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

Patient developed fever and severe weakness about 24 hours after second COVID-19 vaccine. Spouse called ambulance and taken to the ED. Patient unable to get out of bed by self due to weakness. Patient admitted to observation unit due to fever and fatique for PT and strengthening.

Patient was observed after 15 minutes of vaccination, appeared to be well. 5 minutes after observation person, patient was in the waiting room and stated he was feeling dizzy and lightheaded

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

Since I was not with my husband I can only tell you what was told to me. He walked out of the store toward our car. Someone watched him, concerned, because he was walking very slowly (normally has a slow gait because of leg braces and toe amputations so I don't know if it was unusually slow). The woman saw him fall and she ran to help-administered CPR immediately-and told me he died instantly. Medics tried to resuscitate and failed to bring a pulse. (My husband left our home around 11:15 to drop a package off at store. The store is one mile from our home. At around 12:30 a deputy came to my door and when I saw him my knees buckled. I knew something horrible happened.

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

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

Next day confusion, problems with balance and inability to walk, mumbling speech, scattered thought, unable to follow or understand speech which lasted 24 hours and resolved spontaneously without medical intervention.

Weakness; 80% blockage of the carotid artery; Could not walk; chills; A spontaneous report was received from a consumer regarding her spouse, a 70-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced 80% blockage of the carotid artery/carotid artery occlusion, could not walk/gait disturbance. Weakness/asthenia and chills. The patient's medical history was not included. Products known to have been used by the patient were not provided. On 20 January 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 29 January 2021, approximately ten days after the mRNA-1273 vaccine was given, the patient experienced 80% blockage of the carotid artery, he could not walk, weakness and chills. He was taken to the emergency room, where he was admitted for two weeks. During this time, he had carotid artery surgery. His primary care doctor could not confirm whether he had a TIA. The consulting neurologist thought the symptoms might be related to the vaccine. Action taken with mRNA-1273 was not reported. The outcome of the events, 80% blockage of the carotid artery, he could not walk, weakness and chills, were considered unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

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

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

Chills and violent shaking at 7:30pm temp 99.0. Gave 2 Tylenol. At 10:00 temp 101.6 then went to 101.7 and gave Ibuprofen 400mg. At 11:00 pm temp down to 99.7 and fell asleep. 9:00 a temp 97.5. Had no appetite all day 2/26 injection site red, swollen and bad pain. When fever went high had no mobility and could not sit up to take meds. Next day tired and listless.

During post vaccination observation period c/o dizziness,, feeling weak, requesting to lay down. C/o mild acute headache. History of chronic Atrial fibrillation on Coumadin, allergic to IV dye. Transported to ED, EKG in atrial fibrillation, lab work within normal limits, Given Benadryl and Pepcid, symptoms resolved and discharged to home.

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

Approximately 15 minutes after injection, patient developed a severe headache, dizziness and swelling of the face with red rash across cheeks and nose. Profound fatigue - needed to lay down rather than sit up. Was admitted to the Emergency Room for observation and benadryl IV was administered. Patient experienced the profound fatigue for seven days after the vaccine.

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

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

1. Inability to sleep after doses of Xyrem. 2. Loss of Consciousness ×3. 3. Falls x3--injuries to RIGHT arm, and lower back. 4. Confusion 5. Loss of Time Awareness 6. Reduced breathing, alamingly, during sleep 7. Clamminess; cold extremities 8. Shortness of Breath Lasted approximately 12 hours into March 21, 2021.

4 days after second dose patient has noted a feeling of heaviness and unsteadiness when walking. He also feels sweaty in the morning

Patient called the office stating that his arm is red and hot and his arm is swollen all the way around. He has been feeling dizzy and nausea and has fallen. He was having a fever of 100.0. Patient was also having arm pain. Patient was advised to go into UC.

Patient became lethargic, increasingly suffered from delirium & hallucinations, leading to inability to walk. ER visit resulted in no explanation. Took him off meds, patient returned to normal, added them back one at a time. After adding Metformin, delirium began again so took him off medication again & he again returned to normal. Doctors didn't prescribe new meds for diabetes, so Metformin was again re-added to control blood sugar, & again delirium and hallucinations began. Patient had no issue with medication prior to 2nd dose of vaccine. This occurred between 2/9/21 to currently. He was recently in hospital after a car accident and was mistakenly given Metformin again, symptoms resumed and he's still recovering.

You got the vaccine, had no reaction initially. Arm never got sore, nothing at all. Approximately 8 days later he was watching TV, woke up, got up to use the restroom and walked about 40' to get to the bathroom and was breathing so hard that he had to sit down. He went to go back to the couch and was exhausted, got light headed and fell on the floor. He got his wife up, got her dressed and he went to the ER . They said he had a pulmonary embolism and kept him in ICU for 5 days. He has since been okay, been on Eliquis since he has been discharged. Admitted on 2/18/21 and discharged on 2/22/21.

0200/02/26/2021 awakened by being EXTREMELY cold as if laying in snow - nude, Attempted to crawl to bathroom. Was not strong enough. Pulled my way up to a standing position and slowly and unsteadily got to bathroom for water, then to a mountaineering clothes storage closet and put on warmest down trousers and jacket. Stumbled back into bed and fell immediately asleep. Slept12 hours during daylight on 02/27/2021 0215/02/27/2021 Awakened by being EXTREMELY HOT and soaked in sweat. I was wearing normal bed clothes. Able to walk to bathroom for two glasses of water then returned back to bed, I could not get into bed, falling once even with wife assisting. Fell immediately asleep once comfortable in bed. Wife had changed sheet. It did not occur to us to take my blood pressure (we have a battery operated BP device) nor my temperature. Upon waking I was just a little weak and able to continue normal activities fully recovered.

Patient received Moderna vaccine initial dose at clinic on 4/2/21. Patient presented to the Emergency Department on 4/14/21 with complaints of dizziness and mild nausea. CT angio chest w& wout contrast identified pulmonary embolus within the intermediate pulmonary arteries bilaterally. Treatment started 4/14/21 with Eliquis (apixaban) patient admitted for observation overnight and discharged in stable condition on 4/15/21.

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

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

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

breaking hip; Consumer put pressure on the leg and it collapsed; right leg feel asleep; Patient missed his second dose because he had to get a surgery; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HIP FRACTURE (breaking hip) in an 81-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 Diabetic and Overweight. On 05-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 HIP FRACTURE (breaking hip) (seriousness criteria hospitalization and medically significant), FALL (Consumer put pressure on the leg and it collapsed), HYPOAESTHESIA (right leg feel asleep) and PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose because he had to get a surgery). The patient was treated with Surgery for Hip fracture. At the time of the report, HIP FRACTURE (breaking hip) had not resolved, FALL (Consumer put pressure on the leg and it collapsed) and PRODUCT DOSE OMISSION ISSUE (Patient missed his second dose because he had to get a surgery) had resolved and HYPOAESTHESIA (right leg feel asleep) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The treatment reported was surgery for breaking his hip. No concomitant medication information was provided. Caregiver states the fall was not related to vaccine. Caregiver did not provided information whether consumer was hospitalized and what kind of care he got afterwards. He did not have much information since he was calling with a medical inquiry. 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 he could not walk in the morning and this lasted for about 12 hours after the second dose of Moderna.

On 05/07/2021, patient's wife, called the nurse who administered the vaccine in the home, to report the following: - On Wednesday, 05/05/21, patient awoke from a full night's sleep, he reported to his wife, he was not able to move his legs. The wife reported she was able to get dressed and assisted him to a power chair he uses regularly. - She reported that at 9:00 am or so she left her husband alone to get blood work and returned home within 20-30 minutes to find her husband half in and half out of the chair. She believed he "slipped out of the chair." - She reported she could not get him up, he was still unable to use his legs. She contacted 911, EMS arrived within minutes and transported patient to Hospital. - Patient remained in the hospital until 05/09/21 when he was transferred to other facility for rehab. - Patients' wife reported to me on Saturday, 05/08 that prior to the Moderna 2nd dose vaccine, patient was able to walk

Sudden Onset Atypical Parkinson's diagnosed by neurologist. Symptoms began in early to mid March and progressively got worse. Posture & Balance, Mental Confusion, Thinking difficulty, Dexterity, Speech changes, Writing changes, Tremor, Emotional changes, Swallowing problems, Fatigue.

This is an 81-year-old male with a history of dementia also a history non traumatic SAH over the right cerebral convexity in 7/17 thought due to amyloid angiopathy , stroke and TIA who is brought by his wife for evaluation of changes that she noted last night around 9:00. She stated around 9 when she was getting ready for bed she thought his speech was a little bit thick but thought she had worn about since they were outside doing a lot of walking and had been to a picnic. The morning of the admission he has been more tired his tongue has been thick his speech is been a little bit slurred and his gait was slow with a shuffling gait. In the afternoon when visiting her son he recommended she bring him in immediately for evaluation.head CT showed small amount of bilateral subarachnoid hemorrhage Neurosurgery at Medical Center was consulted and no surgical intervention was recommended. He was transferred to Hospital for further evaluation treatment . repeat ct head was stable. He was discharged on 5/20/2021 and his aspirin was stopped. He also tested positive for covid 19 despite being fully vaccinated. ddimer was 1787- venous doppler was not done. he did not require oxygen. He was placed on quarantine on dc. Called wife on 5/22 and she reports he is complaining of fatigue but no cough or sob. He also has a history of covid 19 on 12/20 and was hospitalized and discharged on 1/6/21 and tested negative on 1/7/21. during that admission he was treated with remdesivir and decadron. He did not require oxygen. His hospital stay was protracted due to deconditioning and confusion but he was ultimately discharged home . the baby aspirin was added on dc. mri during that admission was normal with no acute abnl seen.

Fall down completely to the floor; Felt extremely dizzy; Bad stomachache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Fall down completely to the floor) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LISINOPRIL DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]), HYDROCODONE, SIMVASTATINE and CYCLOBENZAPRINE for an unknown indication. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Fall down completely to the floor) (seriousness criterion medically significant), DIZZINESS (Felt extremely dizzy) and ABDOMINAL PAIN UPPER (Bad stomachache). On 29-Apr-2021, LOSS OF CONSCIOUSNESS (Fall down completely to the floor) had resolved. On 05-May-2021, DIZZINESS (Felt extremely dizzy) and ABDOMINAL PAIN UPPER (Bad stomachache) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable. Treatment for the events included antacid. 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 US-MODERNATX, INC.-MOD-2021-128874 (E2B Linked Report). This case was linked to MOD-2021-128772 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-128874:Husband 2nd dose

Pt had covid 19 infection in dec 2020 and recovered and was sent to rehab facility on 1/6/21 and ultimately discharged home with his family. He received his 1st and 2nd covid 19 vaccines on 2/10 and 3/12/21 and was admitted on 5/18 and shipped to another hospital after coming to the er with a non traumatic subarachnoid hemorrhage. He was discharged home on 5/20 and his daily aspirin was discontined. He returned back to the ER on 6/1/21 with the family c/o the pt not thriving , difficulty ambulating and progressive decline. Head CT and chest x ray were negative. cbc was normal, tsh normal. covid 19 negative. urinalysis was negative, cmp was normal, cbc was at his baseline. He was ultimately discharged to a nursing home on 6/4/21.

Shingles; Weakness; Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance; Ringing in ears; inner ear infection; sleeping most of the day; blank look in his eyes; Headache; Seeing things; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION, VISUAL (Seeing things) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 037B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Surgery (Patient mole removed from his back and when after having the stitches removed, the incision opened.). On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-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 HALLUCINATION, VISUAL (Seeing things) (seriousness criterion medically significant), HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache). At the time of the report, HALLUCINATION, VISUAL (Seeing things) had resolved and HERPES ZOSTER (Shingles), ASTHENIA (Weakness), BALANCE DISORDER (Fallen multiple times/unstable to walk well on his own / legs just give out, looses his balance), TINNITUS (Ringing in ears), LABYRINTHITIS (inner ear infection), SOMNOLENCE (sleeping most of the day), EYE DISORDER (blank look in his eyes) and HEADACHE (Headache) outcome was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Follow-up received on 21-Jun-2021 contains non significant information; 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.

Tested prior to hospital admission. Started with a cough on 7/17/21 and fell at home. Was brought to ER for evaluation. Per nurse on the floor, he was admitted for fall and COVID, and has no issues from fall so continued admission is due to COVID treatment. Currently receiving plasma treatment and oxygen.

Per records submitted by the hospital: Symptoms began 7/16, went to urgent care 7/19 with fever and cough, treated with albuterol and doxycycline. Hospital ED 7/22 after vertigo and a fall, hypoxic, placed on bipap. Diagnosed with CHF and pneumonia. Intubated 7/24/2021 and in ICU. Client had CABG 5/23/2021 and had post op complications with a-fib, AKI, hypervolemia and had 3 thoracentesis. Submitter does not have access to full medical record.

Starting on 1/2/2021 patient started experiencing intermittent tremors of upper /lower extremities that have been impacting on his mobility including transfers, ADLs and eating. Staff has now given the resident cups with lids to decrease spilling with meals. Provider was updated on resident's condition on 1/5/2021. On interview on 1/6/2021 resident stated he was feeling better, less tremor. Still felt unstable with transfers. Was able to eat and drink normally 1/6 and 1/7/2021. On exam on 1/6/2021 no tremor seen with rest or movement. In update from nursing staff 1/7/2021 no tremor noted, back to baseline. Had been on Losartan K 25 mg daily which was d/c'd 1/6/2021

Serious weakness, inability to get up from sofa, very shivery, had to get assistance from facility nurse to get to bed. Temp was 102, talked to doctor by phone and took Tylenol. Slept for 4 hours. Was able to navigate again.

Light headedness,Loss of balance, vomiting, sick feeling on 2nd day @ 12:00 pm recovered after laying down for 3 hrs.

Patient with unwitnessed fall after vaccine administration. Found down with small forehead laceration in front of post-vaccine observation area. Sent to ED. On review of hospital admission note, patient left vaccine observation area prior to 15 min observation period to assist his wife. Went to bathroom unassisted, had BM without issue. Upon leaving bathroom syncopized with head strike.

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

Patient came in to receive his first COVID-19 vaccination at 2:00pm on 1/25/2021. Patient received his vaccine at 2:08pm intramuscularly in his left arm. Patient was asked to remain in the waiting area to be observed. At around 2:34pm, patient started feeling light headed and started yawning. Patient's wife noticed the yawning and said that he does that before experiencing a seizure. After a couple minutes of slow steady breathing, patient started having a seizure and his eyes started rolling back. Patients pulse was steady at the time and soon came out of the seizure. About 45 seconds-1 minute later he started experiencing a second similar seizure that lasted roughly 15 seconds. EMS was called and they came to help him. Patient experienced 1 more quick seizure in the time it took the EMT to get to the store. Patient started having a stronger pulse, breathing better, and looked a lot better. Patient also is a diabetic at the time and his blood sugar was slightly low. EMT assisted patient the rest of the way and they patient and wife left the store to go home.

Muscle twitching, lost balance and fell in the bathroom and couldn't get up for 15 minutes, extremely dry mouth, stated he kept feeling like his body was "pulling to the right".

(1) Noted vertigo approx 200AM - 1-9-21, & nausea, dizziness and weakness. Continued with improving after Day 7. Initial No pain or redness & injection site - (2) Noted -

01/12/2021 (8:00 A.M.) Felt dizzy. (8:15 A.M.) Severe fatigue. Went to sleep in recliner. Slept for 13 hrs. (only waking up to go to the bathroom or to eat lunch and dinner). Went to bed at 9:00 P.M. Slept for an additional 8 hrs. Woke up at 5 A.M. and felt fine. 01/19/2021 Began itching at the injection site. Spots all over body appeared shortly thereafter (with exception of neck, face, head and feet). Resembled chicken pox. Severe itching for 4 days. Itching subsided slowly. Got better each day until no itching ~ 01/24/2021. Spots mostly gone by ~ 01/29/2021.

The morning on 2-4-2021 he was walking across the yard and started to feel light headed and dizzy. He fell injuring his right knee. He is unable to bear any weight with significant swelling that is visibly enlarging. He has decreased passive and active ROM and pain with any attempt at movement.

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

Patient started feeling very dizzy, sick like, and weak starting about 24 hours after getting the vaccine. He was taken by ambulance to the local hospital and treated with fluids I believe. After regaining strength, he went home and was given meclizine for nausea and dizziness. He was told to keep up fluids and rest.

total loss of strength. could not crawl on the floor, only roll at about 10:30pm on day of vaccination via ambulance to Hosp. ER

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

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

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

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

Very cold, had chills and shakes, weak, dizzy, bad head ache trouble with balance, trouble walking and in bed Monday after noon all day Tuesday. Still weak today but doing better

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

Starting the next day after his vaccine he started having issues with dizziness. It happened several times on the day after the vaccine, and today as well. He said that today he was so dizzy that he actually lost his balance and fell down. He is still occasionally dizzy, not constant, but worried about driving and being alone

Blood pressure went down until he died; Couldn't hear his heartbeat; neck was sweating; He was cold; Couldn't get up; Death; Sick; immediately very tired; he was tired; Hands were shaking; Slept for too long; A spontaneous report was received on 18 Feb 2021 from a consumer concerning a 81-years-old, male patient who received Moderna's COVID-19 vaccine and developed immediately very tired, hands were shaking, neck was sweating, was cold, sick, couldn't get up, couldn't hear his heartbeat and blood pressure went down until he died. Patients' medical history, as provided by patient's spouse, was emergency room(ER) admission in November 2020 because he had a congested chest (he had fluid around his heart). At that time, they gave him pills for kidney function. Other concomitant medication reported was Coumadin, blood thinner. Two weeks before receiving the vaccine, patient's EKG was normal. On 11 Feb 2021, in the morning, patient received their first of two planned doses of mRNA-1273(BATCH/LOT # 007M20A) probably in the right arm for the prophylaxis of COVID-19 infection. On 11 Feb 2021, approximately after 15 minutes of receiving vaccine, they left and patient was immediately very tired, his hands were shaking. So, patient's spouse made them down sleep for too long. On Friday, 12 Feb 2021 she tried to pick him up, but he was tired, exhausted, and sick. On Saturday, 13 Feb 2021, she brought him a coffee and he couldn't hold it because his hands were shaking, so she gave him the coffee and then made him pee on the bed because he couldn't get up. At lunch time she made him eat something and he fell sleep again. His wife was hanging around him all day and around 7:30pm she realized that he was cold, and his neck was sweating, she couldn't hear his heartbeat. So, she called emergency services and when they arrived, her husband's blood pressure went down until he died. Treatment for the events were not provided. Action taken with mRNA-1273 was not applicable. Patient was pronounced dead on 13 Feb 2021 20:00. The cause of death was not provided. The plans for an autopsy were not provided. The events of blood pressure went down until he died and couldn't hear his heartbeat were fatal. The outcome for the remaining events were unknown.; Reporter's Comments: This case concerns an 81 year old, male patient, who experienced a serious event of death among others, 2 days after receiving mRNA- 1273 (Lot# 007M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

1st day severe headache, diarrhea, weak 2nd day " " " " needed help to get up. Then collasped 02/23/2021 in hallway couldn't move at all, heaving sweating, Temp 100 degrees shakes, irregular heart beat B.P. 101/84 before got him up, weak for several days

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

At 9:30 am Saturday morning client got light headed, dizziness, bright lights became bothersome, and experienced weakness all over body which lasted approximately 30 minutes. Client then became nauseous and threw up within 30 minutes of other symptoms. Once client got home he slept for approximatley 4-5 hours, woke up feeling 100 % better.

3/6/2021 9:30 AM: Client experienced dizziness, lightheadedness, all over body weakness, light sensitivity, nausea, and vomiting. Episode lasted for about 30 minutes, client was in a parked car at time of incident. Once client returned home he slept for 4-5 hours and woke up feeling "100% better."

Patient went down in the parking lot while walking back to his vehicle with his wife. Pt was using a walker. When this nurse responded, the patient was on his side and responsive. Pt denied pain or injury. Upon assessment patient was responsive but had a left-sided facial droop, which his wife said was new. Checked grasps and left side was significantly weaker than the right. Unable to check the lower extremities as legs were under a vehicle. Blood sugar checked, which was 168. Pt is diabetic. 911 was called and patient was taken to hospital via ambulance. Pt was markedly improved at the time of transport but was still pale and ashen.

arm could hardly be raised in evening and had large lump at injection site, woke up around midnight with bad chills, felt feverish and dizzy. Stayed in bed and slept pretty much until 2:30 when was woken up by wife. around 11:00am on 03/05/2021 face looked swollen and still feverish and dizzy. Wife called the hospital and spoke to a nurse who wanted him to be woken up to check facial swelling and advised going to a walk in clinic or emergency room. face looked better so did not go, he went back to bed around 7:00 p.m and the next morning on 03/06 still felt light headed and not normal. Today 03/10/2021 still doesn't feel right still some light headedness, just not normal at all.

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

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

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

death Narrative: Patient received 1st dose of Moderna COVID-19 vaccine on 03/08/2021. Patient died 03/09/2021. Medical examiner received report that patient was alert before a fall on the night of 03/08/2021. Death certificate will report death likely due to arrhythmia due to underlying CHF. Contributing factors include diabetes.

my grandfather suffered a stroke affecting his left side. it took us over a day to conceive him to see a Dr. he was finally taken by ambulance to our local hospital and transferred to another hospital about an hour away. they did multiple tests to make sure he wasn't in further danger and released him to the care of my mother. it didn't damage his ability to think. he struggles to speak, swallow, and walk, and can't move his arm at all.

Shortness of breath, chest tightening, nausea, lightheadedness. Chest pain while in the ER. Intubated after cardiac arrest. Transferred to ICU. Life support removed 3/22/21. Pt expected to expire today.

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

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

Passed out on driveway; Arm Pain; Tremors in hand; Could not get up; Headache; Nausea; Vomiting; A spontaneous report was received from a consumer concerning an 81-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain/ pain in extremity, headache, nausea, vomiting, passing out on the driveway/ loss of consciousness, could not get up/ hypokinesia and tremors in hand/ tremor. 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 xylometazoline hydrochloride, simvastatin, cyanocobalamin, folic acid, metformin, lisinopril, propanol, hydrochlorothiazide and levothyroxine. On 01 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly on right upper arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly on left upper arm for prophylaxis of COVID-19 infection. On 02 Mar 2021, the patient experienced arm pain, headache, nausea, vomiting, medically significant event of passing out on the driveway, could not get up and tremors in hand. Treatment for the event included nausea medication. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events, arm pain, headache, nausea, vomiting, passing out on the driveway, could not get up and tremors in hand was resolved on 06 Mar 2021.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events, a causal relationship with the events cannot be excluded. Fever, nausea and vomiting are consistent with the product safety profile.

He had covid in November 2020 and was hospitalized and went to rehab to start walking again, after treatment walked out of rehab. After receiving the vaccine the next day couldn't get out of bed and was very weak and could not walk. Went to the hospital and was there 4-5 days and sent home for physical therapy at home and still cannot walk more than 4-5 feet with out a walker. All of this after 1st dose of Moderna, he can no longer walk.

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

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

He received the vaccine on 3/4/2021 and by Monday morning 3/15/2021 he was running a fever and not feeling well. Fever continued until Friday March 19 when he went to the dr. Dr did a lung xray and said he had cloudiness on his lungs so she started antibotics. On March 22 he was brought to the ER because he was too weak to walk and wasnt feeling well still had the fever. The switched his antibotics and he went home. On March 24 he was rushed back to the hospital via the ambulance and they admitted him. He stayed in the hospital until March 30 when they finally let him leave to a care center. He had finally not had a fever. Had confusion and weakness. The confusion comes and goes from day to day sometimes min to min.

Daughter said patient was hospitalized after both shots of Moderna vaccines. According to her he wasn't able to move his body and had fever.

PATIENT'S DAUGHTER REPORTED THAT HE WAS NOT ABLE TO MOVE HIS BODY AND HAD FEVER. SHE SAID HE WAS HOSPITALIZED .

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

Persistent encephalopathy beginning 2 days after vaccine, with multiple hospital admissions, some clinical improvement after CSF drainage from VP shunt, then recurrence of encephalopathy with falls, lethargy. Treatment included intubation, CSF neg for infection, clinically diagnosed with autoimmune encephalitis, brisk response to steroids.

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

Patient experienced dizziness and fell the day after receiving vaccine. The patient's wife said that she took him to the ER and that the patient had a sprain.

passed out 4 times; Withering away and is dying/wont live long enough; lost 20 pounds; He is still experiencing dizziness and too weak to get out of bed; Weak; Nausea; dry heaving 3-4 times/day; Swollen arm; Stopped eating; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 4 times) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), RETCHING (dry heaving 3-4 times/day) and NAUSEA (Nausea). On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 4 times) (seriousness criteria hospitalization and medically significant), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed) and ASTHENIA (Weak). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough) and WEIGHT DECREASED (lost 20 pounds). The patient was hospitalized until 23-Apr-2021 due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (passed out 4 times), GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough), WEIGHT DECREASED (lost 20 pounds), PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed), RETCHING (dry heaving 3-4 times/day), ASTHENIA (Weak) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment with Reglan and magnesium oxide pertained to the events experienced. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

A few weeks after vaccination , blurry vision, , not feeling well,increased shortness of breath, ringing in ears, dizziness

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

12/28/2020, Pharmacy staff administered Moderna COVID Vaccine. 12/29/2020, he had not eaten breakfast or lunch but did consume fluids and take his medications. BP =150/70, Temp. = 101.6, Pulse= 102, Respirations= 18 and Oxygen saturation= 97%. Tylenol 650 mg given. It was difficult for him to swallow. Also had no use of right upper extremity and unable to move lower extremity, mouth was drooping and was drooling. Physician in attendance and ordered to send to ER. 1/1/2021, received information from nurse at hospital that patient received a Peg Tube this afternoon and Clinical indication of a stroke.

The day following vaccination, 12/31/2020 at 1230, the patient had an acute onset of shortness of breath, tachypnea (rate 34)wheezing, tachycardia (rate 130s and irregular), oxygen desaturation (89 to 91% on room air), and clear rhinorrhea, non-productive cough. Earlier in the day he complained of not feeling well, but non-specific. He was assessed and given an albuterol nebulizer treatment. In the coming hour, his wheezing resolved, work of breathing improved, heart rate and respirations decreased. He was ambulating around without signs of activity intolerance. It was felt that he was stable and back to baseline, so he was monitored by the nursing staff. A chest x-ray was ordered but not completed. On 1/1/2021 at approximately 0925, a nursing assistant described loss of consciousness for 20-25 seconds. It appeared that he was not breathing, slumped over in the chair at the breakfast table eating cream of wheat, eyes rolled back in his head. He regained consciousness, breathing normally after coughing. He did not appear to be choking. His heart rate was recorded as irregular, rate 32 by the nursing staff. He was transported to the Emergency Department at Hospital for evaluation. No concerning findings.

MODERNA COVID-19 VACCINE EUA Patient reports approximately 24 hours after receiving vaccine , he came in from a doctor's appointment and remembers opening the door and then woke up in the floor and there was blood on the floor. Patient had no other adverse reactions other than soreness in his arm. No follow-up treatment required per patient.

weakness, dizziness, and one day of diarrhea, onset 2 days after receiving covid vaccine, resulting in ER visit. (ER evaluatiion done, included labs, chest xray and EKG, reportedly normal)

Pt uses a walker, upon moving to observation area, patient fell trying to sit down. Pt states he simply missed the chair. He has very thin skin and suffered several skin tears. We applied pressure and bandaged wounds and observed pt for 30 minutes. He did not hit his head. Followed up with pt's wife next day and she reported that his arm was sore, but no other complaints. I recommended they see a Dr. for his skin tears.

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

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

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

patient stated he began having trouble walking. had 2 cat scans infection not confirmed but started on antibiotics anyway. patient arrived for second vaccination in a w/c. he did not need a w/c before first vaccination. family doctor recommended that he wait for a week. will reschedule 2nd vaccination w/ approval of PCP

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

Extremely SOB around 1AM...tremors in arms & legs. Did not respond to any options available, oxycodone, Ventolin, Nebulizer, for approximately 2 hrs. Couldn?t get air in or out. Did not call 911 because he didn?t want to die in hospital. Gave Boost drink & sipped on drink for dehydration. Breathing finally calmed a bit. Oxygen now at 84-92. Extreme weakness, arm has big red blotch. Next day still extremely weak & SOB. Must use walker & assistance getting to bathroom. No appetite. Can?t dress, cook, or anything. 6 days later, still weak, low appetite, has to double up on Nebulizer.

Day after vaccination: sore arm, tingling all day in arm and fingers, light headedness and occasional dizziness. Second day after vaccination: sore left arm.

EXTREMELY extremely WEAK. - he had to use wheelchair to move, and fell off chair. nausea, insomnia. I could not move him and had to call fire deparment. They said his extreme weakness was concerning and took him by ambulance to hospital.

2/13 0800 Post second vaccine. Weak, dizzy, unable to walk per self as usually does. SBP 80 when getting up to use commode with diarrhea. Syncope lasting approx 15 seconds. Came to et was oriented X3 at that time but having times of confusion. Staff reports pt felt weak and same way after first Covid vaccine. Encouraged hydration, bed rest, use of stand aide for use of BR. Gave Claritin 24 hour tablet. Held lisinopril. 2/14 @ 10 am. Feeling some better, mostly oriented with episodes of intermittent confusion. Drank lots of fluids over past 24 hrs. SBP 99. Continued with some diarrhea. Held lisinopril et gave another Claritin 24 hr. Tablet and encouraged hydration. Monday 2/15. SBP. 114/51. Gave Claritin 24 hour tablet and held lisinopril. Encouraged fluids. Feeling some better. Not as weak. Denies dizziness. Able to walk some per self. In evening used stand aid. 2/16 dayshift. BP 123/47 et heart rate 78. lisinopril held. Able to ambulated in room with supervision. Mentation at baseline. 2/17 dayshift.: lisinopril held. Ambulation per self in room and hall with supervision. BP 114/59 with heart rate of 57. No confusion. Mentation at baseline.

Patient was not feeling well with symptoms starting on 2/8 after receiving 1st Moderna dose on 1/23/21. On 2/10 the patient's wife had him taken to the hospital for repeated ?falls? and once he was in the hospital, he tested positive for covid-19. The patient's wife remarked he had tested positive back in December as well while in the hospital.

A fast heartbeat; Dizziness and weakness. Went to ED - "Patient is an 82yo male with a history of chronic Afib on Eliquis, HTN, and bradykinesia (thought to be PD) who presented to the ED with a CC of weakness after receiving 2nd dose of COVID-19 vaccine. He also had low-grade fever and difficulties ambulating. In the ED he was febrile at 38.5C and HR 159bpm. EKG revealed Afib RVR. BP was stable. He was given Cardizem 10mg IV x1. Basic labs were unremarkable. COVID negative. CXR negative. He was given Tylenol for fever and admitted under observation. He remained afebrile and heart rate remained controlled with home Cardizem dosing. Cardiology was consulted who will refer him to their clinic to establish routine care with their service. PT/OT recommended home with home PT/OT. The patient overall felt much improved compared to admission and felt ready for discharge. He was discharged home in stable condition.

Excessive sleeping, hand shakes and had trouble holding spoon and fork. Use walker and could not balance (very groggy). Kept wanting to fall. Had to have wife help to get into bed on Friday night. Saturday was better, but still needed help. Sunday better and today Monday doing better. If Moderna second shot is known to be much worse for side effects, should it be taken?

2/17 first occurrence: symptoms = confused speech, memory impairment diagnosis = TIA 2/20 second occurrence: symptoms = confused speech, memory impairment 2/21: symptoms = confused speech, memory impairment, cognitive difficulty understanding others 2/23: unusual behavior (perhaps due to confusion), difficulty driving (almost hit a parked vehicle and a mailbox; and ran off the right side of the road), agitation (upset, because he considered it a waste of time to visit the ER and have more tests run on 2/23; and also upset that people were "questioning his driving")

Moderna COVID- 19 Vaccine EUA: one day after vaccination patient reported increasing fatigue after flying on an airplane to a high altitude destination. Two days after vaccination patient fell out of bed overnight and awoke confused with a temperature of 104 degrees Fahrenheit. Patient was transferred to another hospital by ambulance, admitted, received antibiotics, but developed acute hypoxemic respiratory failure. Eight days after vaccination patient transferred to intensive care unit at current hospital with acute respiratory distress syndome and bilateral pulmonary infiltrates requiring intubation and mechanical ventillation three days after arrival. Patient remains in the intensive care unit receiving antimicrobials and steroids.

Patient is an 82-year-old male with past medical history of dementia, CVA 2017, with right-sided weakness and expressive aphasia, gastroesophageal reflux disease, CABG, CAD, HLD, HTN, history of MI. Patient presenting to emergency department for further evaluation of generalized pain and balance problems. Caregiver at bedside reports symptoms began this morning. Last known well was the night before he went to bed. Caregiver reports patient having difficulty with walking, noticed his gait was abnormal which is not his baseline. She also stated patient is currently at his mental baseline, also states pain he was experiencing is resolved.

Pt co lightheadedness after covid vaccine. Has waited over 15 minutes. Reports "floaters". Declines water. States" I just don't feel right". BP 120/62, Pulse 67. Denies difficulty breathing or diziness. Pt taken to ER via wheelchair with wife.

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

On Monday, 3 days after, just felt weak, like a zombie, but didn't have swelling or hurting at injection site or headache. But in the days following, felt whoozy, dizzy, and had low blood pressure, once took a nitro for my heart and then blood pressure went down to 68/36, another time 75/45, another time 90/55,

Patient reported feeling dizzy 12 minutes following vaccine. Patient sitting in chair. Vital signs assessed: 0915 - BP 106/72, HR 90, O2 sat 96%. 0921 - BP 112/61, HR 85,O2 sat 97%. 0927 BP 107/62, HR 87, O2 sat 98%. Patient assessed by his PCP who works onsite. MD had patient taken back to an exam room to lie down and be monitored.

On January 26, patient lost his balance and fell, no injury. On January 28, patient, fell, no injury. In both cases falls were observed and were not to the head. On January 29 patient could not maintain his balance. Taken to hospital. MRI revealed large subdural hematoma. Craniotomy on January 30, by Dr. Approximately 10 days later, Hbg, was down to 7, unexplained internal bleeding.

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

Client is elderly and has reduced mobility status. Client was ushered up into the bleacher seating at the vaccination site following the dose administration, and upon sitting down was experiencing shortness of breath (reported by the client to be from walking up the stairs). Client pulled out personal inhaler (albuterol) and self-administered a dose. Responder noted pallor and increased difficulty with speaking for the client, but client's breathing returned to a regular rate and rhythm in the minutes following albuterol administration. Client's pallor resolved. The client refused emergency medical services twice, and refused having his vitals taken. The client was monitored visually by responder until deemed appropriate for discharge from the observation area. When the client ambulated down the stairs, Responder noted unsteadiness in gait. Once the client was safely at the bottom of the stairs, a wheelchair was retrieved for the client so that the client could safely exit the facility. Client accepted the wheelchair at this time. Client refused a vitals check a second time at the checkout station, per responder.

confused, not walking well, fever, fatigue. Went to ER by ambulance and was given IV fluids which helped improve pt's status and was discharge home in stable condition. Was diagnoses with dehydration and fatigue. All symptoms were resolved on 3-15-21

Death Narrative: Patient received dose 1 of COVID vaccine on 1/27/21. Was observed x15 minutes, no reactions noted. Later that day patient's spouse reports patient has been acting out (reports behaviors the night before) and that she cannot care for him any longer. Patient falls sometime in the 48 hours after vaccine and is admitted to the hospital with an unknown diagnosis. Not certain of patient's history after this hospitalization until 2/9 when patient is admitted again to the hospital with hepatic encephalopathy. Patient is switched to hospice status by 2/12, and passes on 2/21/21.

45 minutes after the vaccine, daughter and pt. stopped at a restraint for breakfast. Pt. stated that he had to go to the bathroom and he felt limp and needed assistance with ambulation to the bathroom. Went home and sat in the recliner and said he felt like a limp noodle and was incontinent of urine. Pt. states that he had a fever (did not check it), brain fog and weakness.

High fever 104, Balance hard to stand. deep red rash on lower legs and blotchy condition on rest on body. Went to Torrance Memorial Emergency 03/07/2021 for day and half -- every test they could run with Xray, EKG, and covid test

He woke up the morning after the vaccine and was so achy he couldn't get out of bed, then he noticed his R ear had lost all hearing and left lost some. Has seen an audiologist and is requiring steroid injections and oral prednisone to reduce the inflammation they think caused it. Audiologist hopes it will return but unsure if will be permanent.

Approximately four hours after administration of Moderna vaccine the patient had a sudden syncopal event without warning. He suffered a scalp contusion. His equilibrium, hearing and vision were diminished for 7-10 days thereafter, gradually returning to normal.

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

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

My Dad complained about dizziness, feeling unbearably cold and weak. There was also shaking of the extremities.

PATIENT RECEIVED INJECTION AND WAS WAITING FOR THE 15 MINUTES AFTER INJECTION. PATIETN HAD BEEN TALKING TO OTHER PATIENTS IN ROOM WHEN PATIENT APPEARED TO BE MOVING IN CHAIR AND THEN FELL. PATIENT WAS UNRESPONSIVE AND SHOWING SIGNS OF RIGHT SIDED NEGLECT. PATIENT WAS UNABLE TO COMMUNICATE OR SPEAK. PATIENT WAS IMMEDIATELY TAKEN TO THE EMERGENCY ROOM WHERE HE WAS EXAMINED AND WAS THEN TRANSFERED TO A HIGHER LEVEL OF CARE DUE TO STROKE.

very confused and didn't remember the first day, diarrhea, and nausea, couldn't move or walk; this was similar to when he had covid, chills, nausea and fever also. I was so weak I couldn't get into bed. I still have foggy thinking and blurry vision.

After taking the vax the patients blood pressure went from 130/60 up to 170/70. His heart rate was around 60 and went to 80 and 90. Patient was having difficulty sleeping. He was exhausted and fell when trying to walk. He went to the hospital on 3/8 or 3/9. He had an X-Ray of his left hand/thumb. Nothing was broken. Blood pressure and heart rate is better but still not back to normal. His seems to be sleeping more now and feels some better.

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

Developing flushing of face within 15 minutes of vaccination, upon getting home, noted full body rash - itchy bumps. Headache and lightheaded with a slight little cough and able to taste something in mouth immediate. then one week later, 1/18/21 developed stabbing chest pain, medivac'ed 1/19/ 21 to tertiary facility hospital. had 2 stents placed on 1/20/21. Received second dose of Moderna on 2/09/21, again having flushing, headache, taste, smell of medicine, rash, less severe than first dose. Took a nap following. Hurt all over all night 2/10/21. 2/11/21 felt somewhat better. one week later, again experienced shooting chest pain on 2/16/21 (pain 'down my breast bone'). Has not followed up with medical care. Has been 'living with it' due to expense of Medivac. Finally does have a follow up appointment with Dr. on June 7th.

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

Dad had been feeling dizzy and tired much of the time when he first knew something was not right and went to his primary doctor and his heart doctor. From the date of 02/13/2021,the first COVID-19 vaccine shot, Dad?s condition worsened but once he was administered the second dose of the COVID-19 vaccine it quickly accelerated. One month and one day after the second vaccination shot he was dead from internal bleeding, an excellerated decrease in hemoglobin, red blood cells, platelets, and the complications this caused after surgery which removed a portion of his colon to stop the bleeding. Following is a chronological list of occurrences to the best of my recollection: 1) 2/25/2021 NP, received lab results which she had ordered earlier. Red blood cells 2.21 MIL/uL, hemoglobin 6.7 GM/DL, platelets 92 THOUS/uL. 2) 2/28/2021 admitted to the hospital to receive 3 units of blood and a bone marrow biopsy. Discharged 3/2/2021. 3) 3/3/2021 diagnosis: anemia, unspecified Melena, and ocult blood in stools. 4) 3/5/2021 Dr. with lab results: red blood cells 2.7 MIL/uL, hemoglobin 8.6 GM/DL, platelets 56 THOUS/uL. 5) 3/10/2021 Video Capsule Endoscopy. 6) 3/12/2021 Outpatient blood transfusion. 7) 3/15/2021 Dr. with bone marrow report. Diagnosed with Myelodysplastic Syndromes. Received first shot of ARANESP with orders to receive the ARANESP shot every two weeks and see a specialist at Hospital. 8) 3/16/21 transported to ER by ambulance with GI bleed. Received blood transfusions and admitted. Received several more tests and blood transfusions. Diagnosis: Arteriouvenous Malformation in descending colon. Treatment: 4 clamps in bleeding veins. Discharged: 3/19/2021. 9) 3/29/2021 Dr. office visit, labs, and second ARANESP shot. Ordered transfusion, no blood match. 10) 3/29/2021 Taken from Dr. office to ER and admitted to Hospital. Transfusions and additional tests performed. Test showed additional bleeding in colon. A colonoscopy was performed and several areas in the colon were sealed. 11) 4/2/2021 Discharged 12) 4/4/2021 Hemorrhaging from colon. Transported by ambulance to Hsopital. More transfusions and tests. 13) 4/5/2021 Performed surgery to remove part of colon. My dad continued to worsen over the next 9 days. 14) 4/14/2021 My dad died.

My husband was living at home and able to perform normal daily activities until the morning of May 13th when he woke up in his bed at home. He got out of bed to go to bathroom and ended up on floor due to no use of left side. I called emergency services and they took him to hospital ER where he was diagnosed with a stroke. His left side is still not functioning and he was sent to rehab facility for after stroke rehab to relearn use of his left side. The stroke occurred within 20 days of his second dose of the Moderna vaccine.

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

rash,bllsters,skin peeling In large sheets, swelling, redness, lips swollen, arms, hands,legs and feet swollen, peeling, inflamed fo2 weeks. Went to ER. Admitted to hospital for 3days, then sent home with no diagnosis or help. After another week, went to Dermatologist, got biopsy, determined itwas AGEPI Then put on Prednisone for 2weeks, off for a week, then back on for undetermined amount of time. Still can hardly walk due to pain In feet (bottoms) and toenalls and fingernails are all coming off! Hands also still difficult to usel

CONFUSION, DIZZINESS, BODY ACHES, FEVER, AND HEADACHE STARTED ABOUT 7-8 HOURS AFTER VACCINE. HEADACHE, AND HTN, UP TO 250/113, SINCE VACCINE AND STILL ONGOING. PT HAS BEEN TO DOCTOR NUMEROUS TIMES. TRIED GABAPENTIN 400MG AND AMLODIPINE, AND THEY DIDN'T HELP. HE STARTED ON LOSARTAN 50MG 6/29.2021 AND REPORTS HIS BP IS BACK TO NORMAL, BUT HEADACHE, DIZZINESS, AND PROBLEMS WITH BALANCE IS STILL PRESENT.

Congestive heart failure, he had 32% of his heart; Patient asked caller to "help him with suicide"; escape from house, Confused; Super sick; medication having opposite effect on him; his kidney levels were also not where they needed to be; died after receiving the Moderna vaccine; Nails were blue; Very cold; Fidgety; Vomiting; Wasn't breathing right/abdomen breathing; Continued to deteriorate; Went outside and could barely make it up the steps; Neck veins distended; Had not slept the night before; Didn't feel good; right arm was swelling; Pale in the face; Right arm red; Chills; Nausea; This spontaneous case was reported by an other caregiver and describes the occurrence of DEATH (died after receiving the Moderna vaccine), CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) and SUICIDAL IDEATION (Patient asked caller to "help him with suicide") in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced PALLOR (Pale in the face), ERYTHEMA (Right arm red), PERIPHERAL SWELLING (right arm was swelling), CHILLS (Chills) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INSOMNIA (Had not slept the night before) and FEELING ABNORMAL (Didn't feel good). On 13-Apr-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps) and VASODILATATION (Neck veins distended). On 25-May-2021, the patient experienced VOMITING (Vomiting). On 26-May-2021, the patient experienced DEATH (died after receiving the Moderna vaccine) (seriousness criteria death and medically significant), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold) and RESTLESSNESS (Fidgety). On an unknown date, the patient experienced SUICIDAL IDEATION (Patient asked caller to "help him with suicide") (seriousness criterion medically significant), CONFUSIONAL STATE (escape from house, Confused), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him) and RENAL IMPAIRMENT (his kidney levels were also not where they needed to be). The patient was treated with HALOPERIDOL (HALDOL [HALOPERIDOL]) at a dose of 1 dosage form and DIAZEPAM at a dose of 1 dosage form. The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart), SUICIDAL IDEATION (Patient asked caller to "help him with suicide"), PALLOR (Pale in the face), ERYTHEMA (Right arm red), INSOMNIA (Had not slept the night before), FEELING ABNORMAL (Didn't feel good), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps), VASODILATATION (Neck veins distended), CONFUSIONAL STATE (escape from house, Confused), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold), RESTLESSNESS (Fidgety), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him), PERIPHERAL SWELLING (right arm was swelling), RENAL IMPAIRMENT (his kidney levels were also not where they needed to be), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Renal function test: abnormal (abnormal) Kidney levels were also not where they needed to be. No concomitant product 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. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request. This case was linked to MOD-2021-248336 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information added in laboratory data, treatment drug and events.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; Reported Cause(s) of Death: unknown cause of death

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

Two days following the dose I felt light headed and was lying in bed most of the time for 2 days, since then I am ok.

Pt had the Moderna vaccine on 1/16/2021. called into the nurseline around 2000 on 1/17/2021 stating the pt had dizziness and shaking for about 15 mins around noon today and in the last 30 mins has vomited 3 times.

Sore arm, 2nd day tongue swelled huge went to ER got shot of Benadryl and steroid tired and some dizzy

Reddening of cheeks, mildly light headed 1.5 hours following injection. Took 2 benadryl - sxs remediated in 3 hours time

3 days after getting first Moderna vaccine, he experienced dizziness and falling. He fell at least 3 or 4 times and is now using a walker to prevent falls. He had not used a walker before. He had not seen his doctor,but was encouraged to make an appointment to see if he has fluid in his ears, etc. He reports no nausea or broken bones. I will foolw-up with him at the end of this week to check progress. He states some improvement.

1406: After receiving COVID vaccine, pt c/o sudden lightheadedness, LE weakness, bilat ear pressure, tingling sensation to nose, HA pressure 1410: BP 118/78 HR 52 RR 16 SpO2 99% Add. RN called; head of car seat lowered; pt denied CP or SOB. 1417: HR 60 SpO2 98% Missed heart beats noted on auscultation by NP; pt denies cardiac hx; dizziness persisting 1430: HR 62 SpO2 97% Pt requested to stand; 3 RNs on standby to assist 1432: BP 117/70 HR 58 RR 16 SpO2 97% Pt states, "I feel totally normal." O2 1 L N/C 1450: O2 weaned; no missed beats noted; sxs resolved 1455: Emergency precautions given; pt verbalized understanding; released home

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

Narrative: Patient is 82 years old with cardiovascular disease and fell when bending over to pick something up. Therefore, it is not clear if fall was caused by these risk factors or by the vaccine. However, he had complained of weakness prior to this episode.

At 5:30, started getting woozy in a fog. Could not remember what happened. For the next 2 days patient was in bed. The following morning patient went to bathroom, urine is red, which hasn't happened in years. Patient may think dizziness is from blood loss. The following days it slowly cleared. Patient contacted doctor. A few days after MD appointment patient was back to normal.

Patient received 2nd dose of Moderna. He was placed in the WR. After about 5 minutes he starting complaining of throbbing headache and would drift off and about to fall out of chair. NP was called and she assessed patient. Glucose was obtained it was 107. He is diabetic. Per , an ambulance was called. When ambulance techs arrived, patient refused to leave in/with the ambulance. After about 30 minutes he left with (lives with her). Instructed to call or seek medical attention should anything change.

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

22 hours after injection; extreme weakness. Inability to stand, walk, rise from chair. Fell to floor of home, lay there. Wife called 911. In ER: some fever and high B.P. discovered. IV. Chest x-ray. After 2-3 hours felt improved. Discharged after about 5 hours. Diagnosis: "Vaccine reaction. Fatigue." Slept normally. Feel well, normal now (10:00 a.m. 2/12/21)

Stroke. I do not know if the vaccine was related or not, but the patient had a stroke and falls on 2/17/2021 and 2/18/2021 and was found to have two strokes. He does have atrial fibrillation, but with the proximity to the second vaccine, I cannot tell if they are just related temporally or if there is a true risk. Another patient at this facility had a stroke within same time frame post second Moderna vaccine, but not my patient, so I do not know if that was reported. Due to new nature of this vaccine, I felt it important to report this event for further investigation. Again, I am not sure if it is a true adverse reaction of the vaccine or not.

He became very weak and kiss all strength and mobility in his legs. Increased confusion and inability to concentrate. This also happened after the first vaccine and went away the following day.

Patient was admitted at Hospital from 2/11/2021 to 2/17/2021 after a fall with presyncope. Patient sustained head trauma with scalp laceration and staple were placed. Patient has longstanding history of atrial fibrillation and has been taking Eliquis. He was initially seen in the office complaining of fatigue blaming it on the Eliquis that was started. Patient had a Covid vaccination on 2/8/2011. Patient denies any respiratory symptoms. No cough no chills no fever. Complain of exertional shortness of breath. He was seen in the emergency room at and tested positive for COVID-19.

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

Patient states he was called a few minutes prior to 1000 today to remind him about his vaccine appointment; he relays he didn't know about his appointment and therefore he did not eat breakfast. Patient states he was observed for 15 minutes following the vaccine administration and was advised he could then go home. He states while driving home, he began to feel dyspneic, nauseous, and lightheaded. Patient also states he felt as if his voice changed. He states he then started to drive back to the hospital. When he arrived back to clinic, he was unable to park properly as he felt he was going to vomit.

Profound weakness that occurred 14 hours after his 1st met during COVID vaccination. He had marked weakness and was not even able to stand or crawl on the floor. He does spend the night on the floor. He was better during the day. The following night, he had similar episodes when he got up in the middle the night. Again had to sleep on the floor but was able to get back to bed. Vaccine was 5 days ago. This happened over the 1st 2 nights. For the last 3 nights he has been find any feels back to his baseline. CPK, 3/2/21 was 427

weakness Pt states that he became so weak that he was unable to move and het OOB. When he did, he fell and hurt his head. Went to ER following day from Injection and has been in Rehab since.

Daughter calling to ask about side effects of COVID vaccine? She said her 83 yr old dad got the COVID- 19 yesterday and overnight he became confused, had severe weakness, couldn't get out of bed, and became feverish. She said mom said they both got first dose of COVID vaccine yesterday around noon- then last night he started to feel unwell. Around 2am- her mom said her dad- became very weak, couldn't get out of bed, confused, started coughing, he had chills, felt feverish. She said so concerning by 4am her mom called EMS who came and took him to the Medical Center. She said he had pretty severe case of COVID in December that he need hospitalized for-she said he as really weak, foggy headed at that time, kind of out of his mind- she said was told that is how he was acting last night. After being seen in ED and getting put on some fluids and then antibiotics he now seems to be acting more like himself. They hydrated- have some concerns about possible pneumonia dx so they started him on antibiotics- was told this might be due to his rxn post + COVID vaccine - which is what prompted her to call today. He is supposed to follow up with his PCP doctor. He seemed better when he got home this morning- she said just left him a little bit ago after eating early lunch with him. She is not sure if getting him hydrated & sent home with antibiotics is what helped or just time since now about 24 hours post vaccination dose. Confirmed he has had no prior rxn to any other vaccines in the past.

Lightheaded, chest started to hurt. Patient fell down in line for vaccine. BP 132/67 (pulse 86), 99% O2 sat. Discharged from hospital on 3/7/21 (stayed ~ 2 weeks).

Patient's wife stated on 3/12 patient became extremely confused, weak and fell 3 times. She stated that they were having difficulty getting him up and her daughter called EMS. Patient was taken to hospital and admitted. Patient is still in hospital, she stated he is more lucid. Patient has history of Parkinson's

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

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

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

After the patient received the 2nd vaccine dose on 03/17, he became weak and unable to walk. He also experienced headache, nausea, and diarrhea. On 03/18, he was sent to the emergency department where we received a diagnosis of acute on chronic hypoxia related to the 2nd dose of COVID-19 vaccine. He required up to 2 L of O2 during the night time. He was given his regular home medications and Lovenox 40 mg SQ QD for DVT prophylaxis. On 03/21 he was discharged as his SpO2 improved. His hypoxia returned to his baseline level upon discharge.

Stroke; Passed out; Was flailing like a fish; Could not walk; lost motor skills and had to be fed; Could not speak; Did not understand where he was; was in La La land; A spontaneous report was received from a consumer concerning his father a 83– years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke, passed out, was flailing like a fish, was in la la land for many day, could not walk, he lost his motor skills and had to be fed, he could not speak, did not understand where he was and he was wheelchair bound. The patient's medical history, as provided by the reporter, included blindness in one and lost some hearing. Concomitant medications reported included diazepam, bisacodyl and oxycodone. On 12 Feb 2021, approximately three days prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (batch 013m20a) via unknown route for prophylaxis of COVID-19 infection. On 15 Feb 2021, the patient experienced stroke, passed out, was flailing like a fish, was in la la land for many days, could not walk, he lost his motor skills and had to be fed, he could not speak, did not understand where he was and he was wheelchair bound. No tests were done, and it was previously agreed that he would not go to the hospital if anything should happen to him. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, he lost his motor skills and had to be fed, was considered resolving. The outcome of the events, stroke, passed out, was flailing like a fish, was in la la land for many days, could not walk, he could not speak, did not understand where he was and he was wheelchair bound were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Lethargy and "achy" the first day after the second injection. increase in symptoms through that day and overnight. The following day unable to get up out of chair/walk. Confused and disoriented. Wheezing and SOB. Had to call an ambulance for transport to ER. Admitted. Became completely unresponsive. Testing revealed Ammonia level of 104. Liver function studies/scans negative for liver problems. MICU for 10 days, rehab for 3 weeks.

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

Cannot control himself; Face feels hot; loss of control of legs/cannot control himself/gait inability; shaking with chills; A spontaneous report was received from a consumer concerning a 83-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of cannot control himself (loss of control of legs), hard to walk (gait inability), shaking with chills (chills), face feels hot (hot flush). The patient's medical history and concomitant medications was not provided. On 17Feb2021, the day before the onset of the events, the patient received first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 18Feb2021, the patient experienced not controlling himself. He reported it was hard to walk, he was shaking with chills, had three coats on and his face felt hot. Additionally he reported he was on the floor because he was nervous he was going to fall. The patient's granddaughter came to his house and he tried to call his physician but was unsuccessful as his physician was not available. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, were considered as unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Cerebellum Stroke, dizziness, vomiting, erratic blood pressure, low platelet count, increased AFIB activity, high BUN, increased creatinine levels, excessive and easy bruising, slurred speech, total body weakness (right side weaker), recovering.

death Narrative: Patient received COVID vaccine #1 on 1/13/2021. On 1/19/2021, notes from primary care indicate advancing dementia and a urinalysis suggestive of a UTI, he was ordered a course of cefdinir and PCP at that time suggested long term care. On 2/1/2021, he was admitted to a facility for acute kidney failure and was also noted to have frequent falls at home, no scanned records from that hospitalization are available. On 2/7/2021, he discharged from that facility with home hospice. On 2/11/2021 at 0140, Patient passed away at home. No autopsy results available.

death Narrative: Patient received Moderna Covid vaccine #1 on 2/12/21. On 2/17/21, his son contacted the clinic social worker to inquire about home health services as he thought Patient had had a stroke (no longer able to walk and slurred speech). Patient refused to go to the hospital and son agreed to not have him admitted for fear that he would die alone in a hospital. Patient receives primary care from a provider and social worker suggested that he contact his PCP regarding home hospice services. No further notes of what occurred after that conversation and his date of death is reported as 3/21/21. No autopsy results available. 37 days from date vaccine to date of death.

March 30, Weakness, light headed , no energy, upset stomach. March 31 slept 24 hours could not wake up, April 1, weak, could not sit up, wanted food, too weak to eat. My brother , retired fire caption medic, called 911 to ha e my father transported to ER

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

Healthcare facility administered the vaccine. I do not have the lot number or vaccine site. He has also had the #2 vaccine given just over 7 weeks ago. Given his history of atrial fibrillation, it is entirely possible the CVA was a result of this, however he has been anticoagulated with Eliquis for a few years without recurrent stroke. He is still hospitalized with intention of transfer to rehab facility as mobility is impaired.

Day one: Minor pain in upper arm; Day after for a week or two, loss of strength and unable to lift or exert use of arm above the shoulder. April: do not remember the first time for pain in upper arm. The pain usually would hurt at night at varies times. Pain continue to get worse day to day. April 30, 2921: Gone to bed @ 11:00 pm, At 1:30 am woke up with very severe pain in upper left arm, continued for 30-40 minutes. Took 1000 mg Acetaminophen, 100 Antihistamine, Minor pain continues through 3:00 am

Vertigo ,severe dizziness, Can not walk straight, fell 4 times . Had MRI MRA. visited ENT <Neualogist They found nothing to cause dizziness . Also blurred vision , headache. At witts end. Citizens should know of this adverse reaction

He has had vertigo non stop shortly after first dose vaccine and he's been on Meclizine with Sudafed to control the spins, he falls if doesn't take the meds. After second dose, 3/29/21 he still had the spins, but he was healthy. His wife became ill a week a go and after mothers day around 12/13 she died in her sleep on the 19/20th at night. She had been sick and did not go to the hospital. Two days later my dad came through with breakthrough covid on Saturday 5/22/2021 after receiving both vaccines. He was admitted into the hospital after testing positive for Covid. on the 26th he was moved to a skilled nursing unit for covid patients.

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

I took the First dose of the vaccine on 01/28/2021 and the lot number is 007M20A. And I took the second dose of the vaccine on 02/25/2021 and the lot number is 002A21A. on 02/02/2021 i started to get very dizzy and I was hospitalized for 4 days. The hospital referred me to a physical therapist, the physical therapist referred me to a eye doctor that stated the prism in my eyes keeps changing. I can no longer drive because I am too dizzy. How am I supposed to go to the doctors office or take care of myself or my wife.

I was given my first moderna vaccination on April 26,2021 . on April 28 my hands were shaking making it very difficult to eat . I had difficulty walking . I became very weak . My hands stopped shaking in about one week . I am still very weak . I still use a cane or walker . I did my receive a second moderna vaccination . The second vaccination made no difference .

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

No immediate reaction to Moderna COVID-19 Vacination 01/15/2021. Swelling, tenderness, at vaccination site started on 01/21/2021. Increasing discomfort over few days included swelling, tenderness,and increasing bruising / hematoma on upper arm extending past elbow. Ultrasound of neck to wrist ordered by on Monday, 01/25/2021, revealed no venous blood clots. Swelling, tenderness, discomfort, range of motion limitation, though somewhat less intense, continuing through today (01/31/2021).

Weakness started at night and got progressively worse until I slid off the bed and could not get up without assistance. The problem continued thruout the day but diminishing in intensity until the following morning that I was able to get up but feeling very tired.

Blurred vision, off balance, low blood pressure. Sent to ER and was admitted to hospital. Tested negative for Covid19 on 1/25/2021 at hospital. Returned to community 1/26/2021 and was sent to the ER within hours of being back from hospital. He remains at the hospital and will be returning on hospice.

Vaccine was given approximately at 1130. Patient was sitting in the waiting are for the 15 minute waiting period. At 1145 he stated he was getting up to leave and was putting on his jacket and "tripped" over it. He fell to his knees. Writer did not witness fall but he states that he did not hit his head and bystanders confirmed this. He was able to get up with assistance. He reported dizziness that started a few minutes after the vaccine. His heart rate was 97. Blood pressure was 152/88 at 11:50 AM and 148/80 at 12 PM. He states he had not yet eaten that day. At 12 PM he states he was feeling better. Denied dizziness, pain, nausea, palpitations, weakness. Hand strength equal. No facial drooping, clear speech. He was able to stand with no dizziness. He was able to put his coat on without assistance. I monitored him walking the length of the facility and out to his vehicle where he was able to get in with no assistance. He was advised to follow up with his doctor regarding elevated blood pressure and fall.

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

Dizziness, nausa, headache, weakness, tired. slept all afternoon. Some better in eve. today, 2-21-21, after sleeping 11 hrs, Much better.

At 4:30 p.m. became dizzy, had to hold on to walls to guide me to the bathroom. Could not control my bowels, regurgitated, no headache, ugly situation for about 20 minute, washed myself, wrapped myself in towels and slept on top of my bed from 5:45 to 8: pm. Felt better. Next day i continued to be somewhat groggy.

Resident came up to staff and approximately 1400 and said, "I have a fever" - temperature was assessed and was 98.4 resident came back several minutes later and stated again, "I have a fever" - temperature assessed again and was 98.2 - staff asked if resident had his window open, he stated no - staff suggested maybe he open up his window because it is quite warm in the building at this time. Resident said ok - went back into room - staff told writer he had c/o "I have a fever" while staff was in change of shift report and they assessed fever and it was 97.1. Around 1525, Resident noted to have sudden SOB. PRN albuterol neb given. RR before neb was 40 and did not improve. BP 136/66, pulse 158, temp 101.7 tympanic, and O2 sats 76% RA. Placed on supplemental O2 and sat came up to 86% on 3 L. Resident then started to complain of chest pain. Resident was weak and unsteady and insisted on standing but was guided to his chair to sit down. Resident said he wished to go to ER and daughter in agreement. 911 called. Writer assisting with transferring resident out to hospital. While waiting for ambulance, patient restless and visibly short of breath. Lips with blue discoloration, pale appearance, and breathing with accessory muscles. Changing positions frequently from lying to sitting and standing due to being uncomfortable. Temp 103.2 in left hear and 102.5 in right ear. Respirations 36. Blood pressure unable to be checked due to restlessness and moving around. Pulse 167. O2 92% with nasal cannula on 3L. Asked him to point to the pain and he pointed to his upper abdomen, but describes it as chest pain. Per EMTs he is being sent to clinic instead of the other clinic due to abnormal EKG readings. Received update from EMT around 1700 that patient arrived to ER and heart attack was confirmed so patient was being sent to cath lab for angioplasty procedure.

February 11, 2021 – Arm pain – He starts taking Tylenol as prescribed on day of Vaccination. February 13, 2021 – Stabbing pain on the left side of the head (above his ear) – Poor sleep the next 2 days February 14, 2021 – Spoke to Dr – He ordered a CT Scan and recommended for him to take Tylenol Extra Strength. The headache continues to escalate. February 15, 2021 – He is taken to ER (Hospital) February 16, 2021 – He is released with pain/insomnia medication February 20, 2021 – He is confused, disoriented, repeats things, forgets things, has difficulty functioning normally and sleeping February 21, 2021 – He has difficulty standing, he falls, he has difficulty swallowing. He is taken to ER (Hospital) February 21-26 - He is still at the Hospital. Was diagnosed with Viral Meningitis/Shingles

Severe Vertigo lasting 12 hours requiring confinement to bed. Called ambulance and taken to Emergency Room. Treated with fluids and meclazine. Vertigo attributed to Vestibular Neuritis/labyrinthitis. This condition is often caused by a virus, however patient did not have any known virus prior to onset of symptoms.

Pt called for Dose 2 appointment. Contracted COVID right after Dose 1 Moderna Vaccine. Hospitalized 2/08/2021. Discharged 2/10/2021. Admitted with nausea, diarrhea, lightheadedness, and weakness. Pt treated for Covid-19 Infection with GI symptoms, Acute Kidney Injury, Leukocytosis

loss of hearing/hearing completely gone in right ear; Ringing in left ear; probably vertigo; Extreme dizziness; blood pressure was 214/113; vomitng; Weakness; nasal drip; dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee; diminished hearing in left ear/sounds like listening through a drum; pressure in temples like a hammer on each side of head; headache in back of head; A spontaneous report was received from a consumer who was also an 84-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme dizziness, nausea ,vomiting, nasal drip, weakness, loss of hearing/hearing completely gone in right ear (deafness unilateral), diminished hearing in left ear/sounds like listening through a drum (hypoacusis), blood pressure was 214/113 (blood pressure increased), pressure in temples like a hammer on each side of head (head pressure), headache in back of head, and dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee. The patient's medical history was not provided. Concomitant product use was not provided. On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 020L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. The patient reported he felt fine for about one week after the vaccination. Then, in the early morning of 05 Feb 2021, right after midnight, he experienced extreme dizziness, vomiting, weakness, nasal drip, and loss of hearing including ringing in his left ear and no sound in his right ear. He also started to notice a dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee. The patient was taken by ambulance to the hospital. In the ambulance, he vomited and his blood pressure was 214/113. He was placed the COVID-19 wing of the emergency room (ER) and given tests including a COVID-19 test, sonogram, "echogram", MRI, and EKG (results not provided). The patient reported he was admitted to the hospital. He was told he probably had vertigo. After his ER visit, the patient had appointments with his general practitioner, an ear nose and throat specialist, and a hearing specialist. He was told his hearing was completely gone in his right ear and diminished in his left ear. The patient could still somewhat hear out of his left ear but it sounds like listening through a drum. He states he has to have his television up very loud to be able to hear it. At the time of this report, the patient continued to feel extremely weak, dizzy, and he had pressure in temples like a hammer on each side of his head, a headache in back of his head, and the hearing changes. Treatment for the events included unspecified medications in the ER. Action taken with mRNA-1273 in response to the events was not reported. The events of dizziness, weakness, loss of hearing/hearing completely gone in right ear, vertigo, weakness, diminished hearing in left ear/sounds like listening through a drum, pressure in temples like a hammer on each side of head, and headache in back of head were not resolved at the time of this report. The outcome of the events of blood pressure was 214/113, nausea, nasal drip, vomiting, and dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee was unknown.; Reporter's Comments: This case concerns an 84 year old, male patient, who experienced a serious unexpected event of Deafness (unilateral) among others, 9 days after receiving 1st dose of mRNA- 1273 (Lot# 020L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.

I was doing light yard work in the sun, them in the 70s, became dizzy and could not stand, fell backward to the ground, tried to get up and became nauseated, had the dry heaves so I laid down on my side. Every time I opened my eyes the area began spinning again. I had a fever and sweated heavily for about 1 hour. I took two aspirin with a glass of water. I had a short nap, lying on the ground, when I woke up the fever was gone and I started having chills. After about 30 min, my dizziness was less, but I still could not walk. I started sitting up and scooting backward into the house, which took about 30 min to get into the house. I laid on the floor, was still having chills, so covered up with many blankets. About 8pm, 5 hours after first getting dizzy, the chills were gone and I was able to get up and get in bed. About 10 pm I took 2 asprins and went to sleep.I had to get up

Pt. homecare person came up and stated that he was sleepy and was not able to get out of bed. Was responding and eating and drinking well. Was told to go to the ER. To let us know. Finally reached pt. today. Said he was in and out of hospital for 3 weeks. Not feeling well since the shot. Is trying to get to a long term center

Fever, chills, nausea the morning After vaccine. Took out the trash and had a cardiac arrest and fell. 911 called went to hospital 3 1/2 days no change. 2 Dr.s said no improvement brain dead. Had a living will disconnected after 48 hrs. Disconnected at 7:00 pm died 8:17 pm. 2/7/21

02/21/2021 Patient was found on the floor of his room at 0800am hitting the right temple resulting in a laceration of the area. Patient complaining of Right arm pain within the location of vaccination site. 02/21/2021 1215 pm Patient fell forward out of his wheelchair hitting his right temple resulting in bruising and hematoma arm. 02/23/2021 1300 patient with increased agitation, combativeness, and change in mental status. Patient sent to emergency room for evaluation to rule out intercranial bleeding. Patient has fallen 3 times since the vaccine striking his head twice and now with changes in mentation.

Friday the 12th I had flu-like systems all day. Saturday the 13th at 6 am I woke to go the bathroom. Upon stepping out of bed I collapsed to the tile floor, cutting my arm and head. My legs and arms would not function. I squirmed on the floor for about fifteen minutes but was unable to stand up. Finally, I did and was able to slowly make my way to the bathroom.

dramataic change in neurologcial status within 24 hours of 2nd vaccine in an already compromised alzheimers individual. Progressive difficulty following directions and or ability to get out of be or chair, finally requiring a wheelchair. Progressive getting frozen when still able to walk with a walker, required 2 person assist into bed and to change night clothes. Required assistance with feeding last evening meal.

Received his 2nd covid 19 vaccination on 3/19 and the following day was walking to the dining room of his facility and became weak and slumped to the floor with inability to get up. he presented to the ER with malaise, body aches, fever 101.4 and inability to ambulate and was admitted to the hospital with new leukopenia and thrombocytopenia

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

Dizziness; A spontaneous report was received from a consumer (patient), concerning himself, an 84-years-old male patient, unknown race and ethnicity, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dizziness. The patient's medical history included major brain surgery one year ago due to a major fall off a ladder, a blood clot in his head, seizure and a pacemaker placement several years ago. Current condition included needs cane or walker. Concomitant medications reported were levetiracetam, pantoprazole, allopurinol, apixaban, carvedilol and rosuvastatin. On 02 Feb 2021, prior to the onset of the event, the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A), intramuscular for prophylaxis of COVID-19 infection. On 08 Feb 2021, the patient experienced dizziness that was pretty severe and needs cane and walker when standing. Patient stated that he was feeling better today on 10 Feb 2021, than past two days. Reportedly, patient was inquiring about his second dose scheduled on 02 Mar 2021. Treatment details were not provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of event, dizziness was recovering.; 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.

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

About 12 hours after first dose of vaccine, patient described extreme weakness and had an episode where he had to lower himself to the ground and could not get up, was very dizzy as well, and had been experiencing diarrhea for about 12 hours as well. Was back to normal after the 12 hours and was instructed to report is this occurs again after second dose.

Patient reported feeling dizzy and weak. Patient had observation time increased from 15 min to 30 minutes. vitals take at start of event and q 15min. BS 123, taken at time of event. After 30 minutes patient reported "feeling fine" and had relief of all complaints. Ambulated out of clinic with steady gait.

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

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

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

Patient presented to the emergency department on the morning of 5/25/21 with decreased ability to walk and increasing confusion (has mild dementia at baseline), as well as nausea, burping, stomach pains. The patient received 2nd dose of Moderna vaccine at 5PM the evening prior (5/24/21). Also noted to be febrile. Patient's son reports after receiving the second vaccine dose the patient started to take very short steps and took a long time to get anywhere. Had to be held up by his son. Normally he uses a walker to ambulate and get around most places. Also the patient's son reports that he was poor to respond when given directions and will instead stare straight ahead. Son also reported frequent belching with the patient occurring overnight. No vomiting or diarrhea. Patient did have AKI on admission (creatinine 1.7, baseline ~ 1.1) and had been on gabapentin 900mg TID outpatient (this was reduced inpatient) which could have contributed to confusion. The patient did not have any reaction to the first vaccine. Attending physicians attributed acute metabolic encephalopathy, gait abnormality, and fever to Moderna vaccine. Acute encephalopathy was noted to be resolved on 5/27/21. Patient discharge home with home health 6/1/21.

No appetite, dizzy, rash around chest and very tired for 4 weeks. No treatment, Advised to consult with his primary care provider.

hospitalized overnight because of problem related to heart.; blood pressure was high in hospital; feeling crappy.; fatigue.; feels dizzy; feels weak / doesn't have lot of strength; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CARDIAC DISCOMFORT (hospitalized overnight because of problem related to heart.) and BLOOD PRESSURE INCREASED (blood pressure was high in hospital) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (feels dizzy) and ASTHENIA (feels weak / doesn't have lot of strength). On 04-Mar-2021, the patient experienced FEELING ABNORMAL (feeling crappy.) and FATIGUE (fatigue.). On 12-Apr-2021, the patient experienced CARDIAC DISCOMFORT (hospitalized overnight because of problem related to heart.) (seriousness criterion hospitalization) and BLOOD PRESSURE INCREASED (blood pressure was high in hospital) (seriousness criterion hospitalization). The patient was hospitalized on 12-Apr-2021 due to BLOOD PRESSURE INCREASED and CARDIAC DISCOMFORT. At the time of the report, CARDIAC DISCOMFORT (hospitalized overnight because of problem related to heart.), BLOOD PRESSURE INCREASED (blood pressure was high in hospital), DIZZINESS (feels dizzy), ASTHENIA (feels weak / doesn't have lot of strength), FEELING ABNORMAL (feeling crappy.) and FATIGUE (fatigue.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood pressure measurement: high (High) Blood pressure increased. Concomitant medication included Blood pressure medicine. Treatment included Blood pressure medication. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Blurred Vision; Falling down; Speech; Motor skills/dropping fork; Lesions on spine; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of VISION BLURRED (Blurred Vision), FALL (Falling down), SPEECH DISORDER (Speech), MOTOR DYSFUNCTION (Motor skills/dropping fork) and SPINAL DISORDER (Lesions on spine) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-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 10-Jun-2021, the patient experienced VISION BLURRED (Blurred Vision) (seriousness criterion hospitalization), FALL (Falling down) (seriousness criterion hospitalization), SPEECH DISORDER (Speech) (seriousness criterion hospitalization), MOTOR DYSFUNCTION (Motor skills/dropping fork) (seriousness criterion hospitalization) and SPINAL DISORDER (Lesions on spine) (seriousness criterion hospitalization). At the time of the report, VISION BLURRED (Blurred Vision), FALL (Falling down), SPEECH DISORDER (Speech), MOTOR DYSFUNCTION (Motor skills/dropping fork) and SPINAL DISORDER (Lesions on spine) had not resolved. Concomitant product use was not provided by the reporter. No treatment information was provided. On 28-Apr-2021 patient received his second dose of vaccine and after 13 days he started to felt the symptoms. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

he fell flat on his back facing the ceiling and didn't know where he was at that moment,He fell down 3 times; Vaccine nearly killed; He fell down 3 times going to use the bathroom and when he tried to stand up he couldn't feel if his leg is there/numbness in his leg bilaterally; Confused/messed up in the head; Unstable/Feels like he does not have much longer to live/feels like he is in a nightmare; Disoriented; Memory worsen; Fallen between the bed and table/fell multiple times in the hallway; Weakness; Felt unstable on his feet/off balance; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (he fell flat on his back facing the ceiling and didn't know where he was at that moment,He fell down 3 times) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History was Reported. Concomitant products included ASA for an unknown indication. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-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 LOSS OF CONSCIOUSNESS (he fell flat on his back facing the ceiling and didn't know where he was at that moment,He fell down 3 times) (seriousness criterion medically significant), VACCINATION COMPLICATION (Vaccine nearly killed), HYPOAESTHESIA (He fell down 3 times going to use the bathroom and when he tried to stand up he couldn't feel if his leg is there/numbness in his leg bilaterally), CONFUSIONAL STATE (Confused/messed up in the head), FEELING ABNORMAL (Unstable/Feels like he does not have much longer to live/feels like he is in a nightmare), DISORIENTATION (Disoriented), MEMORY IMPAIRMENT (Memory worsen), FALL (Fallen between the bed and table/fell multiple times in the hallway), ASTHENIA (Weakness) and BALANCE DISORDER (Felt unstable on his feet/off balance). At the time of the report, LOSS OF CONSCIOUSNESS (he fell flat on his back facing the ceiling and didn't know where he was at that moment,He fell down 3 times), VACCINATION COMPLICATION (Vaccine nearly killed), HYPOAESTHESIA (He fell down 3 times going to use the bathroom and when he tried to stand up he couldn't feel if his leg is there/numbness in his leg bilaterally), CONFUSIONAL STATE (Confused/messed up in the head), FEELING ABNORMAL (Unstable/Feels like he does not have much longer to live/feels like he is in a nightmare), DISORIENTATION (Disoriented), MEMORY IMPAIRMENT (Memory worsen), FALL (Fallen between the bed and table/fell multiple times in the hallway), ASTHENIA (Weakness) and BALANCE DISORDER (Felt unstable on his feet/off balance) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. This case concerns an 84-year-old male with a serious unexpected event of loss of consciousness, and nonserious vaccination complication, hypoaesthesia, confusional state, feeling abnormal, disorientation, memory impairment, fall, asthenia, and balance disorder. Event onset with unknown latency after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Added Vaccine Dose dates, New events Feeling abnormal ,Disorientation, Confusional State, Fall, Asthenia, Balance disorder added.; Sender's Comments: This case concerns an 84-year-old male with a serious unexpected event of loss of consciousness, and nonserious vaccination complication, hypoaesthesia, confusional state, feeling abnormal, disorientation, memory impairment, fall, asthenia, and balance disorder. Event onset with unknown latency after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Dizzy during observation period immediately after vaccine administration during occupational vaccine drive. Then the patient still decided to go back to work. Upon going back to work was noted to be flushed in the face. And was noted to have high blood pressure. Ultimately was sent to on-site ER for evaluation. Upon questioning, unclear if patient ate or drank prior to administration.

Pt received Moderna COVID 19 vaccination at approximately 1145am 1/23/21. Patient complained of labored breathing and dizziness approximately 10 minutes after receiving vaccine. No medication/intervention given on site in vaccine clinic. Pt taken to 1st floor urgent care for evaluation.

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

Inflammatory initially with neurological symptoms after 12-14 hrs. Unable to stand, walk, sit up or roll over in bed even with assistance

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

Date and time of vaccination: (list both if they received both shots): 1/5/21, 2/2/21 Facility name where the vaccine was given: Dizziness occurred 6 days after the 2nd vaccine

On Tuesday after receiving the vaccine Lowell fell out of bed and was unable to get up. I called 911 and the EMTs helped him up into his wheelchair. Since he has Parkinson's and has balance problems he is unable to stand on his own for very long. All day Tuesday he was incoherent and fell twice in the bathroom where on the floor he was incontinent of his bowels. Later in the day he was incontinent of urine while sitting in his chair and was unaware of it. Two days later he says he doesn't recall any of that but his cognition seems to be better now. I think this should be a warning for Parkinson's patients.

A few days after getting the vaccine, we had bad wind storm come in and I was without power for about a week. I was unable to shower and could not see my arm good. Around the 22nd I went over to my granddaughter's home to shower and noticed that my bicep was black, over the next week it spread to the left breast, collarbone to the elbow. The where the shot there is about a mark on the muscle where I got the shot. On 28th of January, I went to see my doctor, my shoulder was swollen and I could not raise my arm to about my shoulder level. When I try to move I could feel a pain up there. Doctor put ice on it and told me to take Aleve. Since the swelling has went down I am no longer putting ice on it, I am not using heat. I tried to put my arm in a sling but it is painful. The other pain I feel no pain in my arm is I sit on the couch and put my arm straight out and do not move. The black area on the bicep is almost gone, the darkened area up by my collarbone went away, most of the darkened area is on my left breast. If I rotate my arm counter clockwise or clockwise there is pain there and it feels like it is stretching the muscle. I have also seen Doctor on the 2nd or 4th of this month. I am thinking of going to see him again this week. My doctor thinks that the person who gave me the vaccine, hit a blood vessel and that is what caused the blackness on my arm. The pain is mainly in the collarbone area and in the bicep. Before this started, about the first of January I came home and went to put my keys up and went to reach up and had some pain in my arm, but the pain and mobility issues both went away before receiving the vaccine.

Aprox. 5 minutes post vaccination patient complained of dizziness. When interviewed he stated he had not had any water only coffee today. Patient was provided a bottle of water to sip on while he finshed waiting in the vechile for observation for 15 min. About 5 mins later, checked on patient and patient reported to be doing fine, no complaints and dizziness had resolved. 5 minutes later patients wife called over observation staff reporting patient was having chest pain. Patient appeard altered, but with history of dementia. 911 was called and patient was transported via ambulance. Complaining of 5/10 dull pain in his left upper chest improved when given nitroglycerin en route ED department. No SOB and patient denies ever having pain like this in the past. Observed in the ED for approx 6 hours. Patient then discharged home. Per ED provider "85 y/o male who presents w/ CP s/p COVID vaccine inj. Low clinical suspicion for acute cardo pul pathology give atypical hx, neg ED workup. No recurrence of sx while being observed in ED. Dc w/ con sx care, f/u PCP

I am a four-year resident of facility and have never experienced a serious illness or traumatic injury in all of my adult life (I turn 86 this year). So on January 23rd I received my initial shot of the Moderna vaccine, for which I experienced no reaction, whatsoever. One month later I returned to hospital for my Moderna Booster shot on Saturday, February 20. I felt a few chills that evening, with nothing to speak about, but awoke on Sunday morning feeling so ill that I could barely sit up in bed. I borrowed my wife?s walker and managed to make it to and from the bathroom, and got back to bed again, whereupon I called my son, an emergency-room physician, who told me to take two Advil tablets (or its equivalent), and welcomed me to the club. I stayed in bed through the rest of Sunday and continued to sleep and rest throughout Monday morning, only feeling well enough to get out of bed without assistance by noon on Monday, thereby missing the February meeting of the monthly meeting that had been scheduled for that morning (and for which I had regularly been a member of and had attended every meeting for over three years). My personal takeaway from all this was that ?the cure was worse than the disease.?

My husband started having a reaction 12 hours later, he said he didn't feel good, he didn't want to move, cold and felt weak, and couldn't get out of his chair, he was unstable.

Patient experienced sweats, fevers, and extreme weakness with difficulty ambulating the afternoon after second COVID vaccine. Patient was admitted to the hospital overnight for observation and was given tylenol to help with fevers, was discharged the following day.

presents to the emergency department status post mechanical fall this afternoon with a scalp abrasion. Patient states he had surgery performed 6 weeks ago to correct spinal stenosis for L3-L5, and had a recent fall with no LOC. Patient found to have a subdural hematoma. Currently admitted.

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

On 3/11/2021 the patient presented to the ED with diarrhea x 4 days, weakness, lightheadedness. The patient was found to have metabolic acidosis secondary to diarrhea. There are also liver lesions suggestive of metastatic disease.

Immediately after injection, I developed a headache and slight dizzyness. I returned home in 45-60 minutes and found that I had a significant increase in my blood pressure. Normally, 115 -120 mm Hg systolic and 75 - 80 mm Hg diastolic; when I returned home, my blood pressure was 150 mm Hg systolic and 90 mm Hg diastolic. The blood pressure has gradually returned to normal over 3 days. Tachycardia has also been present (110 bpm), but has returned to normal of 70 - 75 bpm.

Altered mental state/semi-conscious. Awake but unable to respond to questions., unable to rise from seated position. Lasted approximately 5 hours. Has no memory of this time period. Headache, weakness, fatigue persisted beyond 5 hours. Was fatigued for approximately 48 hours. Typically, he has excellent cognition, and is alert and oriented. His wife spoke to Dr., but didn?t have office visit.

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

Frequent falling down, dizziness, inability to walk normally, confusion, inability to breathe , heavy chest

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

Per discussion with wife, patient experienced worsening shortness of breath after each Moderna vaccine. The patient has history of inhalers used for COPD, but the patient's wife stated that he has had difficulty moving from room to room without becoming short of breath, which did not happen before the vaccines.

Patient presented to the ED and was subsequently hospitalized several times within 6 weeks of receiving COVID vaccination. Dates include: 2/24/21, 3/2/21, 4/17/21. Patient presented to the ED on 4/29/21 with NSTEMI and 5/7/21 with dizziness.

he crippled; not able to move; he has extreme pain/stabbing pain; he has overactive immune system; he can hardly walk; he can not do anything by himself/can not go to bathroom; can not get out of bed; he can not come down to eat so I need to bring food; when he is trying to lie down I need to lift up his feet,; he can barely feels his feet, its numb; This spontaneous case was reported by a consumer and describes the occurrence of DISABILITY (he crippled) and IMMOBILE (not able to move) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Polymyalgia. Concomitant products included PREDNISONE for Polymyalgia. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced DISABILITY (he crippled) (seriousness criterion medically significant), IMMOBILE (not able to move) (seriousness criterion medically significant), PAIN (he has extreme pain/stabbing pain), IMMUNE SYSTEM DISORDER (he has overactive immune system), GAIT DISTURBANCE (he can hardly walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he can not do anything by himself/can not go to bathroom), BEDRIDDEN (can not get out of bed), MOBILITY DECREASED (he can not come down to eat so I need to bring food), HYPOKINESIA (when he is trying to lie down I need to lift up his feet,) and HYPOAESTHESIA (he can barely feels his feet, its numb). At the time of the report, DISABILITY (he crippled), IMMOBILE (not able to move), PAIN (he has extreme pain/stabbing pain), IMMUNE SYSTEM DISORDER (he has overactive immune system), GAIT DISTURBANCE (he can hardly walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he can not do anything by himself/can not go to bathroom), BEDRIDDEN (can not get out of bed), MOBILITY DECREASED (he can not come down to eat so I need to bring food), HYPOKINESIA (when he is trying to lie down I need to lift up his feet,) and HYPOAESTHESIA (he can barely feels his feet, its numb) had not resolved. Not Provided Additional concomitant medications included blood pressure medication (not otherwise specified). Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. Though the events reported are expected due to the patient's medical history of polymyalgia, 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-2021-114778 (Patient Link).; Sender's Comments: Though the events reported are expected due to the patient's medical history of polymyalgia, 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.

Blood clots; felt he was having a heart attack; He lost control of his ability to walk; Became Worse; He lives a sad limited life; Angry; Purple like having a blood clot; Pain; Completely ill/sick; Weaker Heart; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) and MYOCARDIAL INFARCTION (felt he was having a heart attack) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cancer (Was on Chemotherapy and radiation treatment), Handicap, Penicillin allergy, Sulfonamide allergy (Sulfa) and Drug allergy (Morphine). Concomitant products included APIXABAN, FUROSEMIDE and METOPROLOL TARTRATE for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced THROMBOSIS (Blood clots) (seriousness criteria hospitalization and medically significant), MYOCARDIAL INFARCTION (felt he was having a heart attack) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (Weaker Heart), VACCINATION COMPLICATION (Completely ill/sick) and VACCINATION SITE PAIN (Pain). On an unknown date, the patient experienced GAIT DISTURBANCE (He lost control of his ability to walk), CONDITION AGGRAVATED (Became Worse), DEPRESSED MOOD (He lives a sad limited life), ANGER (Angry) and VACCINATION SITE ERYTHEMA (Purple like having a blood clot). The patient was hospitalized from 17-Feb-2021 to 26-Feb-2021 due to MYOCARDIAL INFARCTION and THROMBOSIS. At the time of the report, THROMBOSIS (Blood clots), MYOCARDIAL INFARCTION (felt he was having a heart attack), CARDIAC DISORDER (Weaker Heart), GAIT DISTURBANCE (He lost control of his ability to walk), CONDITION AGGRAVATED (Became Worse), VACCINATION COMPLICATION (Completely ill/sick), DEPRESSED MOOD (He lives a sad limited life), ANGER (Angry), VACCINATION SITE ERYTHEMA (Purple like having a blood clot) and VACCINATION SITE PAIN (Pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The first dose of Moderna vaccine reportedly given on 08 Jan 2021. The patient's wife reported that he would not take the second shot. However, it was reported that patient's events started 10 Feb 2021, 2 days after vaccination. Therefore, the date of first dose and whether patient received second dose (and if he did, on what date) are unclear. Patient has received home therapy. Patient stated that on 22 Jun 2021 his health was failing daily and he had radiation from his cancer treatments in his body when the shot was given. It was felt the shot had taken his health to a point of no return - "bad call on the people who set him up for the shot and did not screen his health ". 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-Jun-2021: Patient details, medical history, and suspect product details were updated. Events and concomitant medications were added. Case upgraded to serious.; 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.

Myasthenia Gravis; Death; Hallucinations; confusion; shortness of breath; dizziness; stroke like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), MYASTHENIA GRAVIS (Myasthenia Gravis) and HALLUCINATION (Hallucinations) in an 85-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 Heart attack (20 years ago). On 25-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 MYASTHENIA GRAVIS (Myasthenia Gravis) (seriousness criteria death, hospitalization prolonged and medically significant), HALLUCINATION (Hallucinations) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms). The patient died on 12-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HALLUCINATION (Hallucinations), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms) outcome was unknown. Patient started experiencing side effects 2 weeks after taking the vaccine. He was taken to the hospital for stroke like symptoms but it was ruled out by X-ray. He went to the hospital as symptoms persisted & got admitted on 13March2021. He died 24 hour later after being diagnosed with Myasthenia Gravis and thymus removal refusal. Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death

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

Patient received vaccine on 1/4/2021. He was in Hospice for CHF and renal failure, but was able to get up in his wheelchair and eat and take medications and talk. On 1/5/2021 am, he was noted to be very lethargic an could only mumble, could not swallow. No localizing neurologic findings. He was too lethargic to get up in chair.

Pt received Moderna covid vaccine on 1/11/21. Began experiencing "violent shaking" and decreased appetite yesterday morning, throughout the day yesterday became delirious and unable to recognize people, understand speech, control his bladder or walk without falling.

Patient woke on 1/12 with violent shaking, nausea, fatigue and decreased appetite. Throughout the day on 1/12 pt became delirious, no longer recognizing people, not able to understand speech, incontinence of bladder and is unable to walk without falling.

I experienced a vertigo phenomenon on 1/21/2021, especially in the morning when I turn my head either left or right. It is still going on. I also experience an itching rash since 1/25/2021. It develops into a redish itching patch.

He tried to get up from the couch to go lay down, but couldn't as he kept getting dizzy. It lasted for at least 30 mins. He eventually made it to his bed and laid down.

[Casirivimab/indevimab] treatment under Emergency Use Authorization(EUA): Infusion started at 9:45 and was stopped at 11:00. At 11:30 Patient developed SOB and drop in Sat from >96% to 88%. Patient had a large cough and expectorated a quarter size of brown phlegm. Code blue was activated, patient placed on NRB 180/81, 72, 24, 91%. Patient was AAOx3 and talking during this time. Patient transferred to the ER gurney and transported to ER for further evaluation. From H&P: tested positive for COVID-19 outside facility on 1/22 w/onset of covid sxs on 1/18 after returning from hunting trip with son on 1/17. Patient s/p Moderna vaccine #1 on 1/14/2021. Initially symptoms were just fatigue, cough, and chills and then spiked low grade fever on 1/20. Patient began to experience weakness and difficulty walking on 1/24 and fell from standing on 1/25 and possibly hit his head but without LOC. Patient presented to ED complaining of SOB that began after receiving monolconal antibodies about an hour PTA. Patient states that prior to the infusion, he was not feeling overly short of breath. After the transfusion, a code blue was called in the parking lot due to the patient becoming light-headed and short of breath - he never lost pulses. Upon arrival to the ED, he was in obvious respiratory distress and O2 sats were 92% on 15L NRB and patient switched to BIPAP. Patient given dose of epinephrine injection,after which he states he began feeling better.

Patient was up at 6 AM on morning following injection. Temp 101.7. Difficulty mobilizing. Could straight leg raise. O2 sat was 94. B/P 170/70. Through out day has had some improvement. Incontinent (rare for Him) Achy. Sensorium unchanged.

When doing regular upper body exercise routine,(abdominal crunch, lateral pulldown & chest press), (normally 60lbs, 25 reps), had to reduce to 50 lbs, 15 reps. Could not do the 60 pounds. I've been doing these exercises weekly for at least past 5 years.

ON 2/10/2021- Resident with wife and he felt like he was going to pass out, became silent and arms began to shake and then his dead went back and he began snoring. He was unresponsive for two minutes. While nurse was there to follow up he felt like he was going to pass out. He became silent again, but nurse kept talking to him. His legs began shaking uncontrollably. He remained alert with this episode.

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

Pt reported feeling light headed shortly after his injection. Pt evaluated by EMS, BP 160/80. Pt reported he was feeling very hungry and can often get light headed when hungry. Pt signed refusal for EMS transport. Pt was given ED precautions. Pt reported feeling better when he left after eating a snack and drinking water.

pt stated that after he took the vax he woke up cold with fever and chills. Next morning he woke up feeling better with some light headiness. Pt says he his symptoms are better now with just a little light headiness. Pt has not contacted his PCP at this time.

Right arm swelling and pain(not arm injected), difficulty walking, very weak, some dyspnea, elevated blood sugars, total body aches, subjective fever, patient report fever 102 deg F. S/S lasting >4 days. Sent by nurse to PCP for covid-19 rule out. Tested at clinic for covid 19, then sent into hospital for CXR and labs that were all "normal" No other treatment reported. Patient not admitted, sent home and remains a little better but still weak.

Atrial fibrillation; Cold body temperature especially in the feet; fast heart rate; dizziness; A spontaneous report was received from a consumer regarding her husband, an 86-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced fast heart rate/heart rate increased, cold body temperature/coldness, dizziness and atrial fibrillation. The patient's medical history was not included. Concomitant medications were not reported. On 27 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06 Feb 2021, approximately 10 days after the patient received the vaccine, he experienced a fast heart rate, dizziness, cold body temperature, and atrial fibrillation. (The wife reports that they purchased an EKG machine, and this is what the machine showed them. Unaware if he had this before the vaccine or not.) Treatment information was not provided. Action taken with mRNA-1273 was unknown. The outcome of the events, fast heart rate, cold body temperature, dizziness and atrial fibrillation, was unknown.; Reporter's Comments: Although a temporal association exist, the event occurred 9 days after vaccine administration and very limited information regarding this patient's medical history concomitant medications were event is also confounded by the patient's advanced age. Further information has been requested.

Fell out of bed, couldn't walk, talk and had severe heath palpitations sleep on floor. Later crawled to bathroom and could get on toilet. Wife helped me up.spent the rest of the night on floor. Next day the same situation got on bed slept all day. Third day made it to the living room and slept all day. Drowsy and confused for 3 days. I did not remember much of this my wife helped me.

The patient reported that he had severe weakness following the shot, stating that he actually fell down at home on his way back from the bathroom and couldn't move for over an hour.

he could not move his hands easily, felt like paralyzed; he could not stand up; A spontaneous report was received from a consumer concerning a 86-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and he could not stand up, he could not move his hands easily and felt like paralyzed. The patient's medical history was not provided by the reporter. Concomitant medications reported included lisinopril and brimonidine tartrate/timolol maleate. On 02 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection. On 03 Mar 2021, he could not stand up, he could not move his hands easily and felt like paralyzed. Treatment for the events was not provided. Action taken with mRNA-1273 in response to the events was unknown/not reported. The outcome of the events, could not stand up, could not move his hands easily and felt like paralyzed, was considered recovering/resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

VASOVAGAL SYNCOPE (PER NOTE) Narrative: Patient received vaccine, became dizzy, and cold without sweats. Albuterol was administered though patient does have breathing problems. O2 stats dropped and patient heart elevated. Patient was observed and once o2 was given via NC, O2 increased to 95-96% in minutes and HR returned to baseline of in the 70s. Patient was provided a warm blanket to offset feeling cold.

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

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

S/S began Saturday, 3/6/21. Patient was unable to walk or stand. He had to crawl. He also lost his vision, and was only able to see frame of television. He couldn't see anything else in the room. Approximately, 2200 or 2300, his vision returned. He also was able to get up out of chair. He did not seek medical care or report to a health professional until the following Monday, 3/8/21. He saw a urologist (didn't remember name) who instructed him not to get the second dose. He is now reporting the episode to the Pharmacy today.

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

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

Noticeable decline after 2nd Moderna vaccine, patient could no longer get out of bed, stopped eating and was unable to communicate verbally

reed blodd cells/hemoglobin down; white blood cells down; possible lymphoma; platelets down; Spleen enlarged; liver enlarged; Not feeling well overall; Dizziness; Throwing up bile; shortness of breath; Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), GENERAL PHYSICAL HEALTH DETERIORATION (Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly), HEPATOMEGALY (liver enlarged), ANAEMIA (reed blodd cells/hemoglobin down), LYMPHOPENIA (white blood cells down), LYMPHOMA (possible lymphoma), THROMBOCYTOPENIA (platelets down), SPLENOMEGALY (Spleen enlarged), MALAISE (Not feeling well overall), DIZZINESS (Dizziness) and VOMITING (Throwing up bile) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. The patient's past medical history included Blood transfusion (Patient has had 4 blood transfusions, has been hospitalized). Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), COLECALCIFEROL (VITAMIN D3), IRON, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), MACROGOL 3350 (MIRALAX), DOCUSATE SODIUM (COLACE), WARFARIN SODIUM (COUMADIN), ASPIRIN [ACETYLSALICYLIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced MALAISE (Not feeling well overall) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization) and VOMITING (Throwing up bile) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), GENERAL PHYSICAL HEALTH DETERIORATION (Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly) (seriousness criterion hospitalization), HEPATOMEGALY (liver enlarged) (seriousness criteria hospitalization and medically significant), ANAEMIA (reed blodd cells/hemoglobin down) (seriousness criterion hospitalization), LYMPHOPENIA (white blood cells down) (seriousness criterion hospitalization), LYMPHOMA (possible lymphoma) (seriousness criteria hospitalization and medically significant), THROMBOCYTOPENIA (platelets down) (seriousness criteria hospitalization and medically significant) and SPLENOMEGALY (Spleen enlarged) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 7 days due to DYSPNOEA and GENERAL PHYSICAL HEALTH DETERIORATION. The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) at an unspecified dose and frequency; CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) at an unspecified dose and frequency and IRON at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), GENERAL PHYSICAL HEALTH DETERIORATION (Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly), HEPATOMEGALY (liver enlarged), ANAEMIA (reed blodd cells/hemoglobin down), LYMPHOPENIA (white blood cells down), LYMPHOMA (possible lymphoma), THROMBOCYTOPENIA (platelets down), SPLENOMEGALY (Spleen enlarged), MALAISE (Not feeling well overall), DIZZINESS (Dizziness) and VOMITING (Throwing up bile) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy bone marrow: unknown (Inconclusive) Inconclusive. In 2021, Biopsy liver: unknown (Inconclusive) Inconclusive. In 2021, Blood smear test: unknown (Inconclusive) Inconclusive. In 2021, Haemoglobin: low (Low) Low. In 2021, Platelet count: low (Low) Low. In 2021, Red blood cell count: low (Low) Low. In 2021, White blood cell count: low (Low) Low. Concomitant medications also include an inhaler (unspecified). Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Resident had body aches, a low O2 sat and had chills starting on 12/30/20. He had stated that they had slightly improved. On 1/1/21 he sustained a fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat dropped again. He later went unresponsive and passed away.

Weakness and some dizziness started about 1 1/2 hrs after shot was given. It lasted the rest of the day the shot was given and continued on the next day, 01/12. The feeling was far from normal for me. Better this AM, 13th. Called Moderna on 1/12 and they said this was not unusual.

Patient felt light headed for 30 minutes. No associated symptoms. Thinks just nervous. Patient monitored for 45 minutes with resolution.

The day after vaccine 01/14/2021, he had no strength once so ever in his body. We had to have help from a man and a women to help get him on the toilet, off the toilet, to sit him up on the couch, getting in and out of bed. He could not function on his own. It effected him mentally. Right now he couldn't even that this happened. On the 15th he seemed normal. But now like a week later his memory and strength was bad. Today he is not that bad. It seems to be coming and going with the problem mentally. I took him to the doctor today.

Moderna COVID19 vaccine EUA given at Cheyenne Wy 2/6/2021 1:45 p.m. can't sleep, harder to breathe, anxiety, light headed - dizziness, loss of appetite, no energy

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

The morning after the vaccination I was extremely dizzy from the time I got up at 7 Am until about 12 Pm. After Noon, I did not have any other adverse reactions.

Was given vaccine around 1:30Pm on 2-11-2021. He and his wife waited in the building for 15 minutes and then left. he denied complaint. (He was waiting to have both Covid shots before he went to cardiologist Re: CAD.) He had an alarm going off in his house, was going to basement to check it out. Police officer heard alarm, came into house, & heard a thud when Doc fell. He was in PEA (Pulseless Electrical Activity) when brought into ER. Given 5 "rounds of Epinephrine with no response.

Narrative: Patient and wife contacted telephone triage nurse today requesting advice. States patient did fine with the first covid vaccine, but after he got his second covid vaccine on 2/20/2021 he became ill, has not recovered yet. Patient is c/o nausea/vomiting, "he looks jaundiced" per wife. Some mild SOB, + epigastric discomfort, chills, increasing weakness. No diarrhea, "some constipation." + Dark urine. This nurse asked wife to check V/S. [B/P: 116/65, pulse 75]. Pt still able to getup and walk around to use restroom, etc. - some lightheadedness with ambulation. No leg swelling. Patient has been vomiting several times daily since 2/20/2021. Emesis x 4 since last evening. Recommended local ER. Wife states she will take him to ER now. Please follow up, thank you.

In one week fell and was in Icu. now in rehabilitation. can't walk. very weak, even voice sounded different. All test were negative. Don't really know what happened.

Felt unwell; Coudn't walk; Couldn't talk; A spontaneous report (United States) was received from a consumer concerning a 87 year old male patient, who experienced feeling unwell (malaise), couldn't walk (gait disturbance), and couldn't talk (speech disorder). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received the first dose of mRNA-1273 (lot number 029L201A) on 14 Jan 2021. On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number 030M20A) intramuscularly in the right arm for COVID-19 infection prophylaxis. On 14 Feb 2021, the patient felt unwell for a few days, and couldn't walk or talk. On 16 Feb 2021, the patient was admitted to the ICU for 7 days. Then, moved to rehabilitation and remains there. Wife stated that she wants Moderna to reach out to them with regards to compensation or whatever can be done. She is OK for safety follow-up. The patient received both scheduled doses of mRNA-1273 prior to the events. Therefore, action taken with the drug in response to the events is not applicable. The outcome for the events of feeling unwell (malaise), couldn't walk (gait disturbance), and couldn't talk (speech disorder) was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.

Pt is an 87 yo M, hypothyroid and peripheral neuropathy who presented to the ED with weakness. Pt reports that he was outside loading a trailer when he suddenly felt lightheaded and like he was going to pass out. Pt also enorses nausea, denies vision changes. Pt lowered himself to the ground and called his son to help him and take him to the hospital to be assessed. Pt reports that he frequently has episodes of lightheadedness in the mornings for the past 5 years, but they have been increasing in frequency and this episode was the worst he has ever had. On arrival to the ED he continues to have generalized weakness and is unable to sit up and feels unsteady on his feet.

10 min after patient received vaccine patient bent over and felt dizzy. After taking vitals patient reported that he felt as if he was going to vomit. Patient was assessed by provider, after several minutes patient felt better.

Patient came to the receptionist's desk shortly after recieving his vaccination stating his abdomen felt "tight." With further questioning by provider, he also endorsed feeling slightly lightheaded and dizzy. He was moved to an exam room for examiniation and monitoring. Patient found to be bradycardic but otherwise normal vitals (108/70, HR 56, T 97.5, O2 98%). Patient slightly pale. Patient given water and offered a snack which he declined. Patient later reported he had experienced this same abdominal sensation earlier in the day prior to vaccination. Described as "tight" and "like something's in there that needs to come out." Denied history of constipation or recent GI illness including nausea, vomiting, and diarrhea. During his vasovagal response, he was unclear if he felt nauseated; at one time he thought he might feel a bit nauseated but then later denied nausea. No emesis occurred. Patient was monitored for ~30 minutes and released to go home with his spouse when he was feeling better (resolution of lightheadedness/dizziness). He was given ER precautions and instructed to call his PCP in the morning if his abdomen still felt tight. A clinic nurse was asked to follow the patient home to ensure he arrived without incidence, and no adverse event occurred between the clinic and his house. Patient was called the following morning and reported he felt better with resolution of his abdominal tightness.

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

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

Swollen hand starting on 3/26/2021, his hand and fingers were swollen with decreased ROM to extremity. 4/8/2021 presented with persistant elbow pain/swelling with continued limited ROM and ADLs.

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

2nd dose appointment for 21Mar2021 but could not attend; Fractured his femur; Fell down; This spontaneous case was reported by a consumer and describes the occurrence of FEMUR FRACTURE (Fractured his femur) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced FEMUR FRACTURE (Fractured his femur) (seriousness criterion medically significant) and FALL (Fell down). On 21-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose appointment for 21Mar2021 but could not attend). At the time of the report, FEMUR FRACTURE (Fractured his femur), FALL (Fell down) and PRODUCT DOSE OMISSION ISSUE (2nd dose appointment for 21Mar2021 but could not attend) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was taking an unspecified blood pressure medication concomitantly. Patient needed surgery for the fracture. No other treatment information was provided. Company Comment - This report refers to a case of Product dose omission issue for mRNA-1273, lot #unknown with no associated AEs.; Sender's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot #unknown with no associated AEs.

Called patient to check on the reason he has not returned for his 2nd Moderna injection. Patient stated he has had issues moving his left arm and pain in arm since he has received his first shot. He called his PCP who advised him to go to ER for signs of stroke. Patient did not go to ER and has not been seen for his left arm pain and limited ROM. This nurse consulted with our medical director who stated that there has been cases of Neuropathy type issues in injection arm after COVID vaccine that he has came across in his practice. He suggested patient see PCP for assessment and possible treatment with steroid dose pack and anti-inflammatories. This nurse instructed patient to contact PCP for further treatment and evaluation. Patient refuses second dose of Moderna at this time.

legs became paralyzed; Within an hour of discharge I was walking wobbling outside,; sometimes brain fog; more like a sinus condition in my head; effecting my sleeping; nauseous; still tired; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MONOPLEGIA (legs became paralyzed) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced MONOPLEGIA (legs became paralyzed) (seriousness criteria hospitalization, disability and medically significant), GAIT DISTURBANCE (Within an hour of discharge I was walking wobbling outside,), FEELING ABNORMAL (sometimes brain fog), SINUS HEADACHE (more like a sinus condition in my head), SLEEP DISORDER (effecting my sleeping), NAUSEA (nauseous) and FATIGUE (still tired). The patient was treated with Physical therapy (to gain strength) for Gait disturbance. At the time of the report, MONOPLEGIA (legs became paralyzed), GAIT DISTURBANCE (Within an hour of discharge I was walking wobbling outside,), FEELING ABNORMAL (sometimes brain fog), SINUS HEADACHE (more like a sinus condition in my head), SLEEP DISORDER (effecting my sleeping), NAUSEA (nauseous) and FATIGUE (still tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Scan brain: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. The patient took his second dose of the Moderna COVID-19 vaccine (Right Dominant Upper Arm) on 25-Mar-2021. About 1.5 hours after his second dose while he was eating lunch, his legs became paralyzed. He went to urgent care and they took an EKG which found nothing. They suggested he spend the night in the hospital which he did. 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. It is of note that date in RA report is not consistent with the narrative date of second dose (suspect dose), 25 March 2021, after which events took place. Age of subject can be a confounding factor in the event. No further information is expected.; 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. It is of note that date in RA report is not consistent with the narrative date of second dose (suspect dose), 25 March 2021, after which events took place. Age of subject can be a confounding factor in the event. No further information is expected.

1-9-2021 @ 1:45 AM Chills temp 98.4f. 4AM "I can't getup" helped to BR sat on commode while I prepared a cath and then assisted to cath while sitting. warm to touch temp 102.4f. " I need something to eat". I brought a glass of milk and his monitor BS 113 drank 1/2 cup of milk and helped back to bed. complained of nausea-no emesis. 4:35 temp 99.4f " I think I can sleep now" 8:36AM 98.8 T sleeping. 9:45AM ate 1/2 bowl cereal 10 U insulin, 1/2 cup coffee 1 glass water with medications. 10:15 resting in chair 98 t. 10:51PM 97.8 BS 228 28 u long acting Woosey most of day ate poorly "not hungry" 2 glasses of water during day. no other problem

Got COVID 19 shot on 01/11/2021. Then on 01/22/2021 when I got up at 5:00 am I was extremely dizzy. I could hardly balance myself. I am now about 90% back to pre vaccine shot. So I had about a 24 hour extreme dizzy spell My second vaccine is due on 02/09/2021

on 1/13/2021 at 3:40am Cliff called for assistance. He lost his balance and had fallen. Cliff refused vitals, refused emergency department, denied hitting his head. As the day progressed patient developed a headache, diarrhea, and vomiting. He again declined the offer for the emergency room. At supper time wife and staff found Cliff unresponsive, 911 was called and he was taken to the emergency department. The ER did a CT scan and found an acute subdural hematoma. Patient was placed on comfort cares and expired at 3pm on 01/14/2021. Cliff did not have a history of falls.

Felt dizzy - BP 126/71 (supine), 110/70 (sitting), HR 90, O2 sat 98%. Patient rested then felt better.

felt delirious; felt lightheaded; had a terrible dream; felt nauseous; A spontaneous report was received from a consumer reporting on himself, an 88-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt delirious/MedDRA PT: delirious, felt nauseous/MedDRA PT: nausea, felt lightheaded/MedDRA PT: lightheadedness, and had a terrible dream/MedDRA PT: terrifying dreams. The patient's medical history was not provided. Concomitant medication use was not provided. On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. The patient reported that during the night, he felt lightheaded, had a terrible dream, felt nauseous and delirious. The patient felt better the following day and his primary care physician was aware of the side effects. Treatment for the events included paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events of felt delirious, felt nauseous, felt lightheaded and had a terrible dream were considered recovering/resolving.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the event to be unlikely related to company product.

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

I came home and found my father on the floor in his bedroom just after 8am. He was disoriented and unable to get up. I had to lift him up and he was still off balanced. I asked him if he had fallen and how long he was on the floor. He couldn't give me a clear answer and I don't know how long he was on the floor. I noticed he seemed very weak and I asked him when was the last time he had something to eat and he wasn't sure. He said maybe 1 or 2 days. I asked if he didn't have an appetite and he couldn't answer me or give me a reason.

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

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

Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Had nausea and diarrhea, not feeling as well as he was before the vaccine, weaker, poorer memory.

Gemeralized weakness; Lightheadedness; Dehydration (hospital diagnosis at time of emergency treatment) Sudden complete loss of bowel contol (day after vaccination (02/26/2021) Dizziness, loss of balance (02/27/2021) Confusion, low energy, constipation, diarhea, limited ability to use computer (02/28-03/14/2021)

pt had a headache and some dizziness. Next day he had gargled speech and unsteady on his feet so 911 was called. He was transported by EMT to ER . They started TPA protocol upon arrival in the ER. He had CT, MRI, Doppler study of heart and carotid, blood work. He was diagnosed w/ a stroke and then admitted to ICU where he was kept overnight. He saw a cardiologist, Internist, and Neuro doctors. He speech was clear by 3/21/2021 and was released to FU w/ his physicians.

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

Debilitating chills, shakes, dizziness, slight fever for about 8 hours. Also, another set of similar symptoms on March 29, much less severe. Still feeling a loss of energy.

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

About 15 min after the pt received the 2nd Moderna covid vacdine, he started complaining of dizziness. BP 118/66, HR 64, SpO2 98% RA. About 15 min later he is dizzy, eyes watering, with blurry vision. Pt waited about 30 min more BP 138/82, HR 58, SpO2 99% RA. Pt said vision still blurry but getting better. Dizziness resolved.

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

Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug adverse 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 was admitted on 2/27/21 with acute encephalopathy and suffering progressively worsening mental status. He was admitted for over a month through 3/31/21 where he was eventually discharged on hospice before passing on 4/5/21. His hospital course consisted of treating community acquired pneumonia/bacteremia from hemodialysis catheter placement. Patient continued to have positive cultures despite antibiotics due to a found vegetation on the aortic valve. He experienced functional and cognitive decline over his admission. Comorbidities include vascular dementia, h/o stroke, ESRD on HD, HTN, DM2, HLD

Fell flat on my stomach, face first; After about 30 minutes I felt the surface descending and my walk pace increased; Finally I fell forward on my face; Suddenly felt like I was walking down a hill, I was descending. The street was flat.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Fell flat on my stomach, face first), GAIT DISTURBANCE (After about 30 minutes I felt the surface descending and my walk pace increased) and FALL (Finally I fell forward on my face) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Prostate cancer since 01-Jul-1996 and Cane user. Concomitant products included LEUPRORELIN ACETATE (LUPRON) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Fell flat on my stomach, face first) (seriousness criterion hospitalization), GAIT DISTURBANCE (After about 30 minutes I felt the surface descending and my walk pace increased) (seriousness criterion hospitalization), FALL (Finally I fell forward on my face) (seriousness criterion hospitalization) and FEELING ABNORMAL (Suddenly felt like I was walking down a hill, I was descending. The street was flat.). The patient was hospitalized from 07-Apr-2020 to 08-Apr-2020 due to FALL. The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 2 UNK. At the time of the report, MUSCULAR WEAKNESS (Fell flat on my stomach, face first), GAIT DISTURBANCE (After about 30 minutes I felt the surface descending and my walk pace increased), FALL (Finally I fell forward on my face) and FEELING ABNORMAL (Suddenly felt like I was walking down a hill, I was descending. The street was flat.) outcome was unknown. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received medical history, concomitant medications and events were added and reporter information was updated and 1st dose details were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.

Dizzyness-Unsteady 2/4 doctor visit (cardiology) ecg set up 2/10 doctor visit (gp) brain scan set up reduced tamsulosin, changed metoprolol succinate to tartrate

After receiving Moderna vaccine, pt became increasingly tired, withdrawn, and confused, refusing to walk at home. He has begun to have mild memory changes after suspected COVID illness (covid testing negative) in November, but daughter of patient, with whom he lives, states that his memory and orientation now significantly changed- he seems to have forgotten the last "3 years" of memory. Presented to ER 1/16/21 as she checked his O2 and found him to be hypoxic in 60s. He is being treated for possible CAP with underlying perviously undiagnosed ILD vs post-covid lung changes (per pulmonology), and his energy and ability to walk have returned but memory is significantly impaired, confabulating and oriented only to self despite good oxygenation on 5L O2 by NC.

diaphoresis Narrative: Patient was clammy and pale and vomited after receiving Moderna Covid-19 vaccine. Patient BP dropped to 70/40 and HR 120. Patient felt dizzy. 2L of oxygen by nasal cannula given. 911 was called and patient taken to hospital and seen in ER. Patient was discharged from hospital. Patient previously tested positive for COVID-19

MEDICATION REACTION (Pt got his covid shot and immediately had a reaction to it. Diaphoretic, nauseous, dizzy. Was given 4 of zofran in route.). Comes to the emergency department today after getting his 1st Monday and a COVID-19 vaccine at 7:30 p.m. and about 5 minutes after while sitting down developing significant diaphoresis, nausea, dizziness and feeling very warm. The symptoms lasted for about 15 minutes and then resolved. Since then the patient has felt a little off in his stomach but has not had any difficulty breathing, difficulty swallowing, difficulty speaking, chest pain, diarrhea, rash or itchiness. With this episode the patient did not have any changes to his vision or feel like he was going to pass out. Patient will be given 25 of Benadryl, 125 of Solu-Medrol, 20 of famotidine of concern for possible allergic reaction. Additionally the patient will be given a small bolus of normal saline. Given the patient's reassuring vitals and reassuring physical exam he will simply be monitored here were sure. I do not feel any lab workup is necessary this point this is resolved episode seems either like a mild allergic reaction or a vasovagal episode.

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

I did have and still have soreness of shoulder where I got the injection. That I can expect to stay. When I woke up at 1:00 am my lips and my tongue were in lots of trouble. Its hard to describe, somewhere between numbness and whatever. They sent an ambulance, they looked at it and had me move my tongue and said the area wasn't swollen so they said it would be ok sooner or later. The second day that was a little bit improved but even until now my lips are not normal. By the second day i was having a swallowing problem, the back of my throat feels like the top of my throat. Even when I swallow saliva its not good. But i am still able to eat. So lips and throat are still a problem. When I went to get the shot I was quite able to walk but not long distance. By the second day i began to have a problem in my back, I assume just muscular unless something is wrong in the vertebrate. I can barely walk now, I just shuffle one foot ahead of the other. At any moment if I move I just collapse. I'm always using a cane and always have something to hold on to because I don't know the next minute I'm going to go down, it is very bad.

Per granddaughter's report, pt became very weak within hours of receiving the first dose of the Moderna COVID-19 vaccine and could not get out of bed the next morning without assistance, reported difficulty seeing, and did not recognize some family members. By Sunday, 1/31, pt was unable to be awakened, would not eat, and had low urinary output. Granddaughter reports that the morning of 2/1 he was awake and ate a small amount and seemed to be improving although still weak and unable to get out of bed. Granddaughter reported he died 2/1 around 10am in the morning.

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

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

Awakened drenched in sweat and muscles useless. EMTs got me to an emergency room. Battery of scans and tests eliminated usual suspects. Muscle use returned by midafternoon.

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

woke up not feeling well, injection site red & swellon, as day progrssed became sicker with flu like symptons, tired, achy,. developed low fever of 101. about 2pm, took 2 tylenol, at about 5 pm went to use bathroom started feeling dizzy, then fainted. after about 5 min bp 107/53 pulse83. wen to bed, got up the next am felt much better, as day progressed felt fine

Started having confusion at 3#0 a.m. Sunday morning. Unstable gait and hypoxia at home. More congested than usual. Had 2nd COVID vaccine 4 weeks ago. Had visual hallucinations with seeing "bugs" Admitted with positive COVID and Influenza B diagnosis.

No adverse event resuting from vaccine administration noted. patient reported that he fell off his chair while attempting to adjust his sitting position. Patient was evaluated and assisted off the floor on to his chair. No injuries noted. He denied pain. V/S - bp134/76, RR16, HR 88,PLSOX 98%RA, T98.4

3/11/21 orthostatic hypotension, Fall and N-Stemi dx at a hospital -3/12 transferred to another hospital - 3/16 discharged to Swing bed at another hospital HPI: History of Present Illness: Patient is an 89-year-old Caucasian male with a medical history significant for atrial fibrillation on anticoagulation due to prior GI bleed, HTN, HLD, T2 dm, BPH who initially presented to outside facility following a fall. Fall was mechanical in nature and occurred whenever he slipped on water while walking with his cane out the front door. Primary point of impact was on his left leg in hip as well as possible head trauma. Preceding this event, patient denies any presyncope, syncope, chest pain, shortness of air, palpitations. An extensive workup was performed outside facility including CT scan of the left hip without contrast, CT scan of the head without contrast, lumbar x-ray, CT scan of the left knee without contrast all of which showed no acute fracture or abnormality. EKG showed normal sinus rhythm heart rate of 75 with incomplete RBBB. Labs are included below. Vital signs normal. Patient was getting ready to be discharged from facility and whenever they sat him up, he had an episode where he stared ahead and got diaphoretic as well as dizzy. Patient has recollection of this incident. Outside ER decided to get troponin at that time and came back elevated at 0.163. Patient continues to deny any chest pain. Denies other associated symptoms including fever, fatigue, chills, shortness of air, palpitations, abdominal pain, nausea, vomiting, diarrhea. CBC: WBC 9.2, HGB 13.4, HCT 39.3, PLT 223 BMP: Na 141, K 3.7, Cl 104, HC03 31, BUN 22, CRT 0.94, GLU 124. PT 10.5, PTT 24.7, PLT 1.07. Due to lack of Cardiology coverage at outside facility, patient transfer was requested for further troponin trending and possible cardiology evaluation should be deemed warranted. hpi 3/16 The patient is a 89 y.o. male with a past medical history notable for atrial fibrillation, CAD, diabetes, BPH, hyperlipidemia. The patient presents for evaluation of worsening issues of weakness status post recent hospitalization were patient was fainted and was found to have orthostasis. Patient had a cardiac workup which was negative for any significant cardiac disease. Patient's plan is to hopefully get stronger return home to more independent living. Patient was seen today in his room. Patient notes that he has done very well with therapy after his fall. Patient is hoping to get stronger. Patient has no issues with any bowel or bladder function. Patient denies any shortness of breath. Patient has had good intake. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed.

Patient reports that he lose the use of his legs about 18 hours after receiving the vaccine. He was unable to move them but had feeling in them. He also reports having a fever of 102F. Patient also reports that this happened when he had COVID, but no records from the hospital note this.

liver level was up 1000 times what it normally is; pain in arm; a little bruising on that arm; pulled a muscle in the back of my thigh; calves and ankles are all swollen; hardly walk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIVER INJURY (liver level was up 1000 times what it normally is) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (pain in arm) and VACCINATION SITE BRUISING (a little bruising on that arm). On an unknown date, the patient experienced LIVER INJURY (liver level was up 1000 times what it normally is) (seriousness criterion medically significant), MUSCLE STRAIN (pulled a muscle in the back of my thigh), JOINT SWELLING (calves and ankles are all swollen) and GAIT INABILITY (hardly walk). At the time of the report, LIVER INJURY (liver level was up 1000 times what it normally is), VACCINATION SITE PAIN (pain in arm), VACCINATION SITE BRUISING (a little bruising on that arm), MUSCLE STRAIN (pulled a muscle in the back of my thigh), JOINT SWELLING (calves and ankles are all swollen) and GAIT INABILITY (hardly walk) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information included one dose of acetaminophen 500mg and heating pad. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Arm swelling and visible bruising all up the right arm on 2/15/2021. Bruising all along the armpit down to waist started three days prior to the second shot on 3/9/2021. Contacted his cardiologist who stated it was a spontaneous bleed and not related to the vaccine. Received 2nd vaccine on 3/12/2021 in the left arm this time. The swelling and bruising on the left arm started the next day. Called ems on the 17th after a fall and was unable to get up.

Ministroke; not able to get up on his own; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Ministroke) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 18-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 TRANSIENT ISCHAEMIC ATTACK (Ministroke) (seriousness criterion hospitalization) and HYPOKINESIA (not able to get up on his own). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Ministroke) and HYPOKINESIA (not able to get up on his own) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

Patient felt tired and weak after vaccine. He also fell down 3 times due to reaction and got CT scan. Everything ok now.

Family called to report patient passed away within 24 hours upon receipt of first vaccination. Patient was ambulating to the bathroom when they heard him fall. Upon going to check on him he was already deceased.

Tested positive for COVID on 5/24 after exposure to family member. Presented to ER with increased weakness, confusion, fevers and fall at home. Patient admitted to hospital for suspected superimposed bacterial pneumonia and treated with IV antibiotics then subsequently discharged on oral cefprozil to complete 7 days.

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