Moderna

Patient was showing signs of weakness, lethargy, change in LOC, and complaints of pain. She experienced a fall. Sent to the ER for evaluation.

On 1/17/2021 patient woke and began her day as usual, was found down by family member 1 hour later conscious but unable to speak and unable to move her R side. She was admitted to the hospital - Initial NIHSS was 26 and CT imaging showed no acute hemorrhage but mild hypodensity of greater than 1/3 of the MCA territory (TPA not recommended). CTA did show distal L M1/M2 occulsion and she was transferred to larger facility for thrombectomy. Unfortunately the patient had persistent severe neurological deficits after thrombectomy. Was discharged home on hospice care and expired on 1/23/21.

Client had pressed her call pendant this morning (2/18/2021) at 0750, LPN found client in her bed unable to stand. Client reported she had to use the restroom, upon standing client, LPN noticed blood on client's pillow. After assisting with ambulation to her bathroom, LPN noticed blood covering the floor near her shower. After further assessment, blood appeared to me coming from the back of client's head. Vital signs assessed while she sits on the toilet. BP: 128/92 O2: 89% on RA RR: 18 HR: 69 T: 99.1 Client reported significant dizziness, lightheadedness, and nausea. She reported unsteadiness when standing. Quarter sized lump with dried blood noted on the back of client's head. She does report left arm soreness, likely from where vaccine was administered. Ambulance was contacted while LPN assisted dressing client. Client was unable to recall the incident that occurred overnight, she did not utilize her call pendant during initial fall. Time of fall/incident unknown.

Patient became incoherent for a few seconds while sitting in a chair in the observation area. Pharmacy manager went to observe patient and ask how she was feeling. Patient's head started to droop to the side for a few second and her shoulders made shrugging movements for a few seconds. During this time I called 911, while individual waited with the patient seated in the chair. Patient became more coherent in a few seconds and could speak and smile normally. Ambulance came and patient went with paramedics.

Fall on 1/21/2021 following first vaccination and fall on 2/18/2021 following 2nd vaccination. No falls since admit in 3/2020. Falls causing increase pain with head strike on 1/21/2021. Is recovering slowly from pain of events

Patient says she felt well after getting the vaccine, but shortly before midnight the same day started feeling fatigue, body pain all over. Next day pain was improved; only remaining jaw pain and fatigue; then the day after pain resolved but persistent fatigue and SOB since then (for 13 days now). Severe dyspnea on exertion; baseline able to walk more than 5 minutes before getting tired; over last 13 days unable to walk from one room to another without severe SOB> Had a ride today so came to urgent care for evaluation. Patient found to be in atrial fibrillation with rapid ventricular rate at 140

Achy, fatigue, dizziness which subsided. Rash appeared at injection site 4 days after injection. Sprayed benadryl.

extreme weakness, shaking extremities, diarrhea, loss of bowel/bladder control, mental disorientation, unable to walk

Sudden extreme muscle weakness. Fell to the floor. Could not use arms or legs to get up. Was on the floor for several hours until someone came home and called for ambulance.

While sitting in waiting room, patient stated she felt a little lightheaded. Patient stated the lightheadedness is not completely abnormal. Vitals checked: B/P: 120/58 Right arm, Heart Rate: 58 bpm, SpO2: 98% Room air

On Saturday morning, Mar 6th had erratic racing heart beat and high to very low blood pressure, 168/ , low 88/51, afib, unsteady, lightheaded, hot and chilled, headache, very weak. On 8:10am Sunday, heart beat ranged from 50 to 125 bpm, blood pressure dropped to 90/64. Doctor took me off all meds except Xarelto, said stay in bed, drink lots of fluids. I did not connect the symtoms to the vaccine at the time because problems happened after the 1st few hours, and I was too sick to think clearly. It was only when I read the side effects after 1-3 days, that I realized it could be from the vaccine. I worry about being deathly sick after the second vaccine shot, so I'm reporting this.

TIA diagnosis at hospital; Conscious after fall; Dizzy/ lightheadedness; Head bump (temple area and ear caused by hit sink during fall); A spontaneous report was received from a consumer who was also a 90-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced transient ischemic attack, fall, dizzy lightheadedness, and a head bump. The patient's medical history, as provided by the reporter, included transient ischemic attack; the patient experienced 3 events in 2020. No relevant concomitant medications were reported. On 23 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 25 Jan 2021, the patient experienced dizzy lightheadedness and a fall, resulting in a head bump in her temple and ear caused by hitting the sink as she fell. The patient was hospitalized following the fall and diagnosed with transient ischemic attack. On 26 Jan 2021, the patient received magnetic resonance imaging and a laboratory test. On 27 Jan 2021, the lightheadedness and head bump had resolved. Action taken with mRNA-1273 in response to the event(s) was not reported. The outcome of the events, transient ischemic attack and fall, was considered resolved on 25 Jan 2021. The outcome of the events, lightheadedness and head bump, was considered resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a 90-years-old female patient with a relevant medical history of three TIA within last year, who experienced a serious unexpected event of Dizziness and Transient ischaemic attack and non-serious unexpected events of Fall and Head injury. The events of occurred approximately 2 days after first dose of mRNA-1273, lot # 030L20A. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded. However, patient's advanced age and prior history of TIA are considered significant confounders.

Within a couple days of second shot, legs became very weak, one was swollen and the other was atrophied. She can barely walk as a result. Can't keep eyes open, can't smile and trouble speaking. Back pain and all over pain.

Broken leg; missed second dose of vaccination; Fell down; A spontaneous report was received from a daughter, concerning her 90- year-old, female mother who received Moderna's COVID-19 vaccine (mRNA-1273) experienced fell down, broken leg/ limb fracture and missed second dose of vaccination. The patient's medical history was not reported. Concomitant product use was not provided by the reporter. On 25 Jan 2021, patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via unknown route for prophylaxis of COVID-19 infection. Approximately on 15 Feb 2021 or after 3 weeks of receiving mRNA-1273, the patient fell down; broken leg was reported and patient was in the hospital and rehab now. Daughter wanted to learn if it is late for her to have the second dose of vaccine (missed second dose of vaccination). No Treatment information was provided. Action taken with mRNA-1273 in response to events were not reported. The outcome of the events of fall, broken leg and missed second dose of vaccination was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Weaknesses. Dizziness. Headaches. Blurry vision both eyes. Sleepiness. Strokes. Hospitalization. Death

Month after vaccine she would occasionally she would have dizziness and she would take a tylenol but the feeling still comes and goes

1-2-2021 10:30 PM Complained Right arm/back hurt - took Tylenol 1-3-2021 Complained Right arm hurt, dizzy 1-4-2021 Felt better - did laundry, daughter found her deceased at 3:30 pm. Dr. at hospital said it was "cardiac event" according to death certificate.

Memory care resident complaints of feeling "woozy". After much questioning, it was determined that she was dizzy. This occurred an hour after administration of vaccination and continues. Appetite has been good. Refuses to lie down. Denies headache, body aches, nausea, stiffness, visual disturbance, or injection site pain. Monitoring vital signs for the next 24 hours; every 2 hours while awake and once during the night per instruction of County Public Health Nurse.

She became so dizzy that she could not stand. Also experienced nausea. Took to ER. Administered numerous tests and determined reaction was likely to vaccine. Took several days to recover.

VACCINATION WAS RECEVIED THE MORNING OF 1/5/2021- IN THE EVENING OF THAT DAY RESIDENT SUSTAINED A FALL AND WAS TRASNPORTED TO FACILITY FOR TREATMENT. IT IS NOT UNUSUAL THAT RESIDENT WAS SELF TRANSFERRING AND HAS A HISTORY OF FALLS.

FIRST THING WHEN GETTING UP IN THE MORNING, FELT DIZZY, NAUSEA AND VOMITED 3-4 TIMES, Increase in Blood Pressure; Treated with Phenergan for N & V; and rest, fluids. Lasted just this day, but wasn't back to normal for 2 days.

Started 8 p.m.-ish last Sat. Injection arm (right) very swollen, painful, tingly to fingertips. Fever 101. Unable to move arm or sleep for pain. Symptoms bad through Wed. a.m., when fever broke, swelling/pain started to subside. It's now Thurs.: She's still symptomatic but slowly getting better. Tried inserting Julia's current meds/supplements in Continuation Page but wouldn't accept copy so putting here: Aspirin 81 mg/day; clopidegrel 75 mg every other day; hydrochlorothiaziada 12.5 mg/day; amlopidine besylate 5 mg/2x day; losartan potassium 50 mg/2x day; rosuvastatin calcium 41 mg/day; nexium/2 per day; esomeprazole magnesium 20 mg/2x day; vitamin d3 1000 iu/day; calcium carbonate 1200 mg/day; multivitamin Centrum

Diarrhea, nausea with dry heaves which resulted in light headedness. Resolved with fluids and rest later on in the day.

vaccine given at 1532, symptoms started about 1545, client started coughing, said she felt funny, felt faint, pale, skin to touch was very cold, she said she was cold, BP 182/94, Resp 28, O2 99% on room air, HR 64, she was short of breath, was not tracking, would stare off looking at the ceiling, at 1552 0.5mg Epinephrine was given IM, EMS was called at 1553, EMS arrived at 1558, no relief in with the Epi, left via ambulance at 1605

Dizziness/vertigo, nausea, vomiting, chills started at about 7:30 am on 2/20/2021. This was the day after I received the vaccine. Nausea and vomiting subsided around noon. Chills were ongoing through out the day. On and off vertigo episodes continued through 2/23/2021. All symptoms subsided by 2/23/2021. Also had a very sore left arm.

Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Shakiness-Severe, Additional Details: Pt experienced lower back pain, difficulty breathing, dizziness, light headed, shaking more than normal, cold, felt like she was fainting

As reported by son and by DON of Medical Center: 02.06.2021 Son reports that patient had spoken with her daughter the morning of 02.06 via phone and that patient sounded fine. Patient's son tried to call her around 3:30 or 4 and there was no answer. Son called the facility where patient resided and staff went to check on her, where they found patient on the floor, conscious. Patient was communicating fine when they found her. It is unclear if she bumped her head when she fell, but patient deteriorated and was taken to ER where a CT was done and it was determined patient had a brain bleed as well as a UTI. Patient was admitted to hospital. Patient subsequently had a stroke while in hospital. Patient was discharged to rehab facility on 02.23.2021 and while she has regained the ability to walk with a walker and some use of her right hand, she remains unable to speak.

Administered 0.5 ml of Moderna Covid EUA vaccine IM to patient's left arm. Patient went out to waiting room after told to wait 15 minutes before leaving store. Approximately 2 minutes later caregiver and patient approached register and stated patient wasn't feeling well. Brought patient back into consultation room. Patient was slouching and not responding to questions. "Are you okay" & "Can you sit up" Patient continued to slouch. Administered EpiPen 0.3mg to patients left thigh and called 911. Patient then began to respond to questions. Paramedics showed up and assessed patient. Paramedics took patient to emergency room after their evaluation of patient.

24 hours after-headache- sinus type 48-hours -after- headache and body aches particularly left buttock 72- hours after- all of above plus 100.2 fever, extreme body aches, chills and could barely walk 96 hours after- symptoms going away, 120 hours after- only headache remained and red spot on left arm developed One week later all symptoms gone

VIIS ID: 7827510; Moderna COVID-19 Vaccine Vaccine Lot Number: 025B21A second dose. Vax clinic. Pt received vaccine in vehicle-unable to walk inside-family member stated that about 10mins after vaccine she began nodding off and was difficult to wake. 16:10: 123/80 POX 80% CPR not indicated. EMS On-site. S/S hypoxia, altered mental consciousness, unresponsive then alert. Family stated that she has been exhibiting similar symptoms recently-today is a 'bad day'. Son stated that it has been a difficult day for her. She has had to stop to "catch her breath' numerous times. "nods off' frequently. Assessment completed by EMS; transported to Hospital (doctors).

Balance disorder; Fall; hurt her arm; Bleeding; Blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history was not reported On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Apr-2021, the patient experienced blurry vision, lost her balance and fell very hard and was bleeding everywhere and hurt her arm. The patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant), VISION BLURRED (Blurry vision), FALL (Fall) and PAIN IN EXTREMITY (hurt her arm). On an unknown date, the patient experienced BALANCE DISORDER (Balance disorder). At the time of the report, HAEMORRHAGE (Bleeding), VISION BLURRED (Blurry vision), BALANCE DISORDER (Balance disorder), FALL (Fall) and PAIN IN EXTREMITY (hurt her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant were given No lab details was provided. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-068245 (E2B Linked Report).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-068245:Husband case

I got my 2nd vaccine shot April 2 . I felt OK the next morning, but later, when I got up from a chair & tried to walk, I couldn't. I kept trying, but my knees kept buckling & I sank to the floor. I had to go to the bathroom, so I hitched along on my butt, but when I got there, I couldn't haul myself up onto the toilet. Bad news.Was mostly OK the next day, just didn't have my normal strength back. Am sending this note as I understand that you want to hear about vaccine effects./

extreme muscle fatigue confusion/disorientation patient fell out of bed and daughter was unable to help her get up; paramedics were summoned; patient transported to ER; next day patient had absolutely no memory of anything that happened; she was totally confused as to why she was in the hospital or how she got there; two days later she is absolutely fine except for being very tired

Significant decrease in ability to function physically and mentally. Increased confusion. Unsteadiness resulting in two falls. Weakness of muscles. Facial numbness which lasted for several hours. These symptoms showed up within a few days of the second dose of the Moderna vaccine. The effects lasted for about one month. Since then, the person is back to normal functioning with no weakness, or confusion. She is doing well now but for one month following the Moderna vaccine was very debilitated and unable to function in normal activities of daily living.

Feeling tired, nauseated, vomiting. She fell and had to have assistance getting up, Afterwards, had some weakness in legs. She did have COVID in July. Still having some weakness. No pain.

11:00 pm on day of vaccine had fever, chills, headache, dizziness Next morning had temperature of 102

Resident became chilled, unable to get warm, shivering, unable to get up, oxygen saturation dropped to 50% with heart rate of 133. Tachypnea

developed joint and body aches and pains, generalized complaints of not feeling well and weakness. She fell as a result of weakness. Physician ordered her to be sent to the ER

Felt nauseated afteR Receiving vaccination. Did not eat or drink afteRwards. Stated had small emesis. Found on flooR in Bathroom with walker on top of heR 1230 AM 2/14/2021. Stated had lost consciousness. Side effects are as described to attending nurse.

Pt received moderna vaccine #2 at 1:30pm. No s/s of adverse reactions. Ate dinner at 4pm. She was in her room at 430pm and she slid out of her chair and was laying on her Right side. She reported she slid out of her chair because she needed to go urinate per staff. She denied pain. At 630p complained of right hip pain. mobile xray was ordered. At 825pm resident was sleeping x 30 mins in her bed when she was found to have no pulse or respirations. She ceased to breathe. Mobile xray did not make it on time.

Joint affected in left groin/hip area. Cannot put weight on left foot. Difficulty walking or standing. Using cane to take pressure off left foot.

pt states she started having pain in the right arm. Her arm has limited movement. Pt has extreme fatigue and has slept the majority of the time after getting home from receiving the vax. Pt still has these symptoms.

A customer came with questions regarding dizziness they have been having since receiving the second dose of the Moderna vaccine. She states that any time she takes a step down (not up), she feels very dizzy. She has started using a cane because of this which she is dissatisfied with. This started after she got the second dose on the 10th of March, and has been continual for her since then. She is not our patient and we do not have any real information about her except that she received both of her doses from the Health Department.

Approximately 4 hours after receiving the Moderna COVID-19 vaccine (left-arm), my mother began to have moderate pain in her left arm, particularly in the left shoulder area. The pain continued to increase throughout the afternoon, until it became so severe (10 on a 10-point pain scale) by 8:30 pm on 3/10/21 , that she could no longer lift her arm. She took 500 mg of Tylenol to attempt to relive the pain and went to bed early. At 2:45 am on 3/11/21, she needed to go to the restroom, and I (daughter) had to assist her to get out of bed, as she had no use of her left arm due to severe pain in that arm. While seated on the toilet, she indicated that her arm was extremely painful and she felt that she was going to pass out and felt nauseated. Within a minute, she lost consciousness and I called emergency services. EMT arrived within 5 minutes and stated that her blood pressure was extremely low and she needed to be placed on the floor. They placed her on a gurney and took her to the ambulance, where they started an IV and took her to her local hospital. I followed shortly thereafter, where she was taken to the ER. She was admitted to the hospital for observation and given Ativan (she refused any opioids) She was ultimately diagnosed with vasovagal syncope due to the pain in her left arm. Two days later, the pain has subsided.

Severe Dizzy, Nausea, vomited x5, elevated HR and Elevated BP . No short of breath, no fever. Day 4 still dizzy, nausea but vitals stable

Patient presented to emergency department on 3/27/21 with weakness, lightheadedness, decreased appetite and vomiting. Patient tested positive for COVID-19. Chest xray was negative for acute process. Patient was saturating 92% on room air. Patient received remdesivir and steroids. Oxygen was weaned off prior to discharge. Patient was discharged to a rehab facility.

Pt. stated she was light headed and hadn't ate any lunch or had any water. She also reported being anxious. BP 180/100 P78. Pt given a bottle of water and banana and observed for 30 mintues. Dizziness resolved and BP down to 150/80 at discharge.

Slipped down; Left broken femur above the knee; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Slipped down) and FEMUR FRACTURE (Left broken femur above the knee) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The patient's past medical history included Bone operation in April 2021. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced FALL (Slipped down) (seriousness criterion hospitalization) and FEMUR FRACTURE (Left broken femur above the knee) (seriousness criterion hospitalization). The patient was hospitalized from 01-Apr-2021 to 07-Apr-2021 due to FALL and FEMUR FRACTURE. At the time of the report, FALL (Slipped down) and FEMUR FRACTURE (Left broken femur above the knee) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was at nursing home at the time of reporting. Concomitant product use was not provided by the reporter. No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

2/18---dizziness/weakness (CMP, CBC, troponin, TSH, urine, EKG, chest xray)?ED visit. 2/24 traumatic hematoma (possibly from blood draw on 2/18)---xray, Doppler done 6/12 Nausea/vomiting hemocult + blood, maroon/coffee ground consistency, RUQ pain, diarrhea, colorectal enteritis, heparin given as prophylaxis against DVT. Hemoglobin trending down (14.1 to 11.5), type and screen done in case blood transfusion is needed (when hgb <7), endoscopy; CT scan showed the following: 1. Multiple regions of small bowel wall thickening and to a lesser extent large bowel wall thickening concerning for a coloenteritis. Differential includes infectious, inflammatory, or ischemic coloenteritis. Recommend correlation with lactic acid levels. No pneumatosis or free air. 2. Small volume ascites. Mesenteric edema. 3. Advanced atherosclerotic change of the abdominal aorta and side branches.

Rash and itching developed over arms, legs, neck, trunk, stomach, crotch, scalp. Persisted for weeks and would not abate with several prednisone treatments. Blisters arose at each point of irritation along with red splotches. Begins with burning, then itching, followed by visual eruption. Inflamed sites are hot and swollen. About 15-25% of body affected at any given time, mostly upper body and arms. Rashes moved over time to various locations. Patient began to feel badly around June 15 2021, with symptoms including: extreme weariness, novel tinnitus, severe itching an burning at night, novel severe brain fog and confusion, inability to drive or accomplish household tasks, novel ocular migraines/loss of vision, headache, loss of appetite.

On 1/14/2021 @ 0659, patient was noted to be weaker, arms were flaccid R>L. Unable to answer questions speech gargled. Unable to grasp hands. Pupils reactive, but sluggish. Probable CVA. Dr. and family were notified. Family wished to keep patient at hospital and provide comfort care rather than send to the hospital. MD was in agreement. APNP, assessed patient. Her tongue was red and swollen. Bite marks noted on right side of tongue likely d/t event. ST evaluation done to evaluate patient's ability to chew and swallow safely due to swelling of tongue. Hospice services were initiated. (Unsure if event was caused by vaccine administration)

Sudden pain in left ankle joint about 8 days after vaccine, unable to stand or put weight on that leg for 3 days. Then sudden pain in big toe (inflamed) on left foot still continuing now. Elevating leg gave some relief also took Tylenol.

Pt received Moderna COVID vaccine at 0850. RN responded when pt c/o dizziness at 0905 while sitting in observation area. Pt pink, warm and dry. RR easy and regular. Radial pulse 100, BP 174/108. Pt stated she took her morning meds including antihypertensives this am at 0800 on an empty stomach and then did not eat breakfast. Pt given water to hydrate and crackers. At 0910 pt denied dizziness. At 0910 BP 200/76 and pt stated I feel better. Both nurses remained with pt at all times. At 0918 BP 208/88. Pt encouraged to go to ER or her PCP for further evaluation. Pt's niece was in attendance and made an appt with pt to go to her PCP at 1215 today. At 0930 pt stood and ambulated and stated she felt fine to go to her doctor. Pt escorted by wheelchair to her car per volunteer staff. Pt discharged with her niece in attendance.

Patient felt dizzy, lightheaded and fell. She reported that she could have "passed out" she lives alone. She remembers getting up off the floor.

94 yo Female patient reported dizziness and stomach pain 7 minutes post vaccination. v/s taken BP 156/76, HR 101, SPO2 97%, RR-21. T 98. Patient stated no PO intake. Water given for rehydration + tolerated. Patient observed and RRT responded and took over. Patient taken to ER for further evaluation with s/o Pt v/s retaken BP 142/72 HR 86 SpO2 98% on room air. RR 21 T 98

In the morning following the shot, she could not get out of the bed without assistance. She was very weak and could not stand by herself. She did not want to eat very much. Then by lunchtime, she was running a fever of 102.5 fever for many hours. We put her to bed. On Sunday morning she was much better with a better appetite and no fever. She also had normal amount of energy. She had a rash on her arm that received the shot and it ran from her spot of injection to her elbow. It was hot with the rash for about 5 days.

Felt as if drunk, off balance, had to hold furniture to walk, lasted into 2nd day. No fever or soreness.

Patient had sudden death 1 week after 2nd COVID vaccine. Had complained of dizziness throughout the week leading up to it.

Mom has mild cognitive impairment. She is well above average for a 93 year old. I live with her and she is highly functioning. The day of her vaccine, she seemed very tired. The next day, she was exhausted. She had a hard time doing her normal activities. No fever. It was much more challenging for her to walk. She just couldn't get moving. It seemed to stay the same. I noticed she was having a harder time doing everything. Suddenly, her comprehension seemed to change. Within a week, she went from mild cognitive deficits to full blown cognitive impairment: not knowing how to take her pills, how to wash hands, how to use her watch/fitness tracker, to not removing her bottle cap to drink water, to having a hard time communicating. I called the Pharmacist where she had the vaccine, and they told me that this was not uncommon after the vaccine. They had been getting lots of similar calls. They haven't given out any second shots yet, and were not looking forward to it after everything they've been hearing. This is very frightening.!!!! Our Mom cannot be left alone now. How long will this last????!!!!

Moderna COVID-19 Vaccine - Pt reported dizziness, nausea, chills and red and swollen arm after receiving her first dose of the moderna covid-19 vaccine. Pt stated that she rested and stayed hydrated and symptoms went away after a couple of days. She decided to forgo her second dose until she has talked to her doctor.

Fall; fracture; A spontaneous report was received from a pharmacist concerning a 93-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a fall and a fracture. The patient's medical history was not provided. Concomitant product use was not provided. On 03 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (batch no. 012M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On an unknown date after the first vaccination, the patient experienced a fall and sustained a fracture and was hospitalized. The pharmacist stated that the patient has crossed 42 days to received the second injection due to hospitalization (the day of this report was day 42). The patient was in a nursing home at the time of this report. The action taken with mRNA-1273 COVID-19 Vaccine) was unknown. The outcomes of the events of fall and fracture were unknown. The reporter did not provide causality assessment.; 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.; Sender's Comments: MOD21-056578:Cross linked case for patient 2

4/3-was feeling unwell and didn't eat much 4/4-could not get out of bed without assistance in the am; vomited mucus and could not eat; refused Easter dinner. 4/5-woke up and had trouble breathing; ambulance called "she had no pulse, and had trouble breathing" Throughout had no fever or chills.

4/16 515am Itchy at vaccine area, nausea, used Sarna itching lotion, tylenol 230pm more itching lotion 315pm redness the size of baseball, hot to the touch, went to urgent care, icing 4/17 physical aches throughout, continued icing and tylenol 4/21 4am nausea and aching all throughout the limbs, couldn't walk due to pain in thighs, short of breath, tried to rest. the pain continued for over an hour till fell asleep.

Reports she has pain mainly in her left side. Her legs. She could not bend over as it hurt too bad in the lower back to bend. Could not walk, left side. As of yesterday started on the right side. Now in the ER and cannot raise her right foot up. Slowly worsening.

Patients dementia symptoms got worse after getting vaccine. Patient became nonverbal, would not eat, and started having falls. Patient was hospitalized and eventually went home with hospice.

Admitted 6/10/21 w/current covid illness. Partial vaccination noted. 6/17/21 urine culture w/no growth. Progressed to release from Covid unit to general population in recovery status on 6/22/21. Seen/Assessed by NP/MD /IDNP during stay. 6/26/21 urine culture w/no growth. 6/27/21 seen by MD d/t increased falls and confusion. Fall on 6/29/21 w/increased confusion and immediate transport to ER for increased confusion, decreased oxygen saturation and fall w/possible head injury r/t unwitnessed fall and increased confusion. She expired at the hospital 7/3/21 w/respiratory failure.

Nurse: the resident received her vaccine at 09:25 am and immediately began to feel cold. This nurse was notified at 0945 at which time the resident complained of nausea and dizziness. The resident was also emotional, confused and experiencing high blood pressure (170/78) .

Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: pt was not responding well, urinated on self and felt nauseas. Pt is on hospice and felt dizzy even before the vaccine.-Mild, Systemic: Nausea-Mild, Additional Details: Pt was dizzy and fell 02/21/21 at the site; paramedics called; refused to be hospitalized. Pt vaccinated 02/22/21, was dizzy and urinated on self, paramedics called, refused to be hospitalized. Staff told vaccinators then that pt was hospice and own guardian, so nothing could be done.

Family states patient had been coughing and was weak after the vaccine. Patient walked to the bathroom and then fell striking her head found in PEA with agonal breathing. Despite aggressive CPR medications patient remained in asystole. Unknow if Moderna or Phifzer

Red pruritic rash at the injection site Two days following vaccination, she had an episode of syncope with fall, head trauma, rhabdomyolysis that resulted in hospitalization

03/14/2021: Presented to the emergency department post fall on right hip. The patient underwent a surgical repair of a right hip femoral neck fracture. Patient remains admitted, but no complications/adverse events noted.

client had Right side severe joint and muscle pain. barely able to move. large bruise on leg; lasted 7-10 days; saw her provider who thought she should not take the 2nd dose of the vaccine

Mechanical fall; Cut her wrist pretty bad and had to get stitches; A spontaneous report was received from a consumer concerning a 94-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced mechanical fall/ fall and very bad cut on the wrist /skin lacerations. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 23 Feb 2021, prior to the onset of the symptoms, the patient received the first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On 20 Mar 2021, the patient experienced a life threatening and medically significant event of mechanical fall and cut on her wrist which was pretty bad and had to get stitches. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events, mechanical fall and cut her wrist pretty bad and had to get stitches was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested

Resident had acute onset of confusion with difficulty following directions, severe decrease in safety awareness, and significant weakness x2 days leading so several falls.

Extreme pain in the back, hips and legs upon waking up lasting 3+ weeks. Unable to sit to go to the toilet. Weakness in legs causing a fall. Pain and weakness lessened as day went on only to reappear next morning. Also extreme fatigue lasting weeks.

Patients caregiver states that patientcan't move her arm. Said it not just a sore arm but can't move it. Caregiver said went to hospital but did not mention vaccine adverse effect. I advised caregiver to seek healthcare, hospital or primary care, since she can't mover her arm.

Was informed by local Medical Examiner that on 04/10/2021, 4 days after receiving second Covid-19 vaccine, that the pt slipped on a rug and hit her chin very hard and that she died. The family informed Medical Examiner that she was not feeling very well after receiving her vaccine and felt more fatigued than usual. Family raised concerned that the cause of her fall was due to vaccination. Medical Examiner ruled cause of death as a closed-head injury or cardiac arrhythmia, with significant other conditions at time of death being "mild symptoms following covid-19 vaccination"

administered vaccine left arm at 12:08pm about 5 minutes later, 12:13pm patient reported feeling mild dizziness, denied any other symptoms including breathing difficulties. patient was observed for 20 minutes from time the vaccine was administered. blood pressure was normal at 140/70, pulse was normal at 65 and pulse rate was regular. patient's color remained normal during observation. symptoms never worsened and patient wanted to go home. she then left the clinic accompanied by her son.

Patient daughter reported that patient was admitted to Neurology with a stroke. She has cognitive and speech impairment as well as motor impairment. She was admitted either 2-2-21 or 2-3-21. She is still in the hospital.

Approximately 10 minutes after vaccination, pt began complaining that she was lightheaded. Pt is A/Ox4, speaking clearly in complete sentences without increase in respiratory rate or effort, lungs clear and equal bilaterally, spo2 98% RA, bood sugar 189. Radial pulse strong and regular, skin PWD, BP hypertensive at 169/61. 12 lead shows paced rhythm at a rate in the 60s. Pt denies CP, SOB, abdominal pain, nausea, itchiness, difficulty speaking. Pt has no neurological deficits or visual disturbances. Orthostatics negative. Lightheadedness resolves on its own within 15 minutes and does not return. Blood pressures taken every five minutes remains about the same. After resolution of symptoms, pt demonstrates the ability to rise from seated position on her own and walk with steady gait. Her daughter states that she will stay with her for the remainder of the day and will seek medical attention if symptoms return or new ones arise.

Both arms hurt, but left arm became so painful and numb to wrist, cannot move it without extreme pain. Sleeping is very uncomfortable . Making feeding herself is very diffuicult. Pain is impossible to control. Using Voltairen cream and Tylenol all day with little to no help

Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out; Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out; This spontaneous case was reported by a consumer and describes the occurrence of PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) in a 95-year-old female 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 (No medical history was reported). On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) (seriousness criterion medically significant) and DIZZINESS (Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out). At the time of the report, PRESYNCOPE (Almost blacks out/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) and DIZZINESS (Dizziness/when the patient bends down to tie their shoe their dizziness get to the point where the patient almost blacks out) outcome was unknown. The action taken with mRNA-1273 in response to the events 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.

Pt. received first dose of Moderna without incident. Received second dose on 6/8 and experienced extensive weakness. Son describes significant decline in cognitive function over the next ten days, as pt. became increasingly altered. She also switched from using a mix of language to communicate to only being able to use one. Pt. also became incontinent of stool and urine during this period. Pt. proceeded to have significant fall on 6/10. She was ultimately BIBA to the ED on 6/19 with concerns for altered mental status and failure to thrive. She was found to have a significant saccular aneurysm of the descending thoracic aorta. Ultimate outcome of aneurysm is still pending, as this is a life-threatening disorder.

Weakness and dizziness. Not fully coherent to take evening blood pressure pill at 7:30 pm. Right hand motor skills not good. Could not hold water bottle to take pill.

Patient reported feeling dizzy after vaccination. Patient's blood pressure was taken and trended high - it was 140s-150/80. It was high 10 minutes after vaccination. Patient was instructed to stay seated and wait under supervision for 15 more minutes. Patient was given water and BP remained high, ~140/80s. Over the entire course of observation, the patient's pulse was normal (80 BPM).

Flu symptoms, but most notably the loss of muscle strength in her legs. She collapsed and was unable to walk.

My mother fainted on the night she was vaccinated, early in the morning. She had gone to the kitchen to get a heating pad and felt faint while standing She didn't make it to a chair, but fell and broke her hip. While this could have been due to another health problem, my mother had never had a fall or a near-fall. it is concerning that very old adults are not warned to have someone with them after receiving the vaccine (for instance, overnight), I realize that the vaccine has not been studied specifically in geriatric populations, but it is realistic to assume that there are substantial numbers of very old people living on their own, particularly in cities where there is no need to drive, and where food and other necessities can be delivered. There should be a warning to people that they should not be alone after receiving the vaccine.

The patient fell the day after receiving the Moderna COVID-19 vaccine. She broke her hip in this fall. During surgery to correct the broken hip, she went in to sudden and unexpected cardiac arrest. The anesthetist did not notice any ST changes or A fib; dysrhythmia was very unexpected. The patient had a DNR. She died at 13:00 on 02/07/2021. Causes of death are listed as 1. Cardiac Arrest 2. Recent hip fracture with hip placement 3. History of Breast Cancer 4. Hypothyroid and 5. Dementia

Pt's daughter reports that after the patient received her second dose of the Moderna vaccine on Friday, April 23, 2021, on Saturday, April 24, 2021 around 3:00pm the patient started having trouble lifting her foot, she was also having trouble standing; the pt's daughter evaluated her on Sunday and thought she was having a neurodeficit. The patient was taken to the hospital on Monday evening (4/26/21) and a CT scan revealed the pt had a stroke. The pt is anticipated to recover.

Patient was well 5/13/21 vaccinated 05/14/2021 with second Moderna COVID Vaccine and according to son pt rapidly declined with recurrent falls 5/15-seen in er 5/16 and sent home and cont to have worsening profound weakness presenting to the ER again 5/18 and admitted with Sepsis secondary to right lower lobe pneumonia, right 8th, 9th and 10th rib fractures, syncope/ rhabdomylosis and NSTEMI, profound weakness and new anemia with GIB needing 2 units prbcs. Pt was living independently alone pta with help from his son and was at his baseline up until getting his second vaccine. he was ultimately discharged to nursing home on 5/21/21. he was still too weak to walk or get out of bed at the time of discharge.

On 1/15/21, resident fell during the night while getting up without assistance and hit her head. She did not have any neurological impairment after fall and remained at facility to be monitored. 1/26/21, resident had sudden loss of consciousness with hypotension and tachycardia. This resolved slowly after resident was put in trendelenberg position. She has not had similar events in the past. She was sent to ED without a distinct underlying cause of the event identified, differential included cardiac arrhythmia, ? orthostatic hypotension, vasovagal syncope, stroke She had a similar event occur on 1/27 after she had returned to the facility from the ED. The family elected not to pursue further evaluation for second event and she was placed on hospice as she had been experiencing some gradual decline before these events occurred.

Moderna COVID-19 Vaccine EUA In addition to chills, patient was pale and extremely weak, experiencing difficulty standing from a seated position and great difficulty walking. She stayed hunched over after standing and was unable to walk unassisted. With assistance it took her several minutes to walk about 15 feet. The weakness persisted for 6-8 hours after which her previous strength and mobility were restored.

Could not stand or walk Shooting Ppin in right arm Achiness Confusion High Blood Pressure High Heart Rate - 116 Trouble speaking No appetite

On 2/26/21 patient had tingling and numbness in legs. Legs wouldn't move. Patient fell. provider not contacted 3/27/21 called 911, patient had maybe had seizure couldn't talk. Patient had EEG,MRI and CAT scan- all came back negative for stroke or seizure.

This 98 year old female received the Covid shot on 2/13/21 and went to the ED and admitted on 4/30/21 with the diagnoses listed below and died on 5/9/21. J44.9 - COPD (chronic obstructive pulmonary disease) S72.002A - Left displaced femoral neck fracture W19.XXXA - Fall, initial encounter S09.90XA - Head injury, initial encounter

Patient developed lightheadedness and extreme shaking in the extremities such as the hands. It slowly progressed worse over a period of 20 minutes. Patient had no nausea or vomiting.

Patient complained of tingling in her arms and extremities. She said it continued to get worse and she was unable to lift her arms. She was able to squeeze my hands. She said she was having trouble swallowing, but did not have any issues with breathing. I gave her 2 diphenhydramine 25mg and her symptoms seemed to get better. She said she felt a little pressure in back of her neck.

Pt. received her 1st Moderna Covid vaccine on 1/28/2021 with lot number of 010M20-A at 0906 am. Family reports since the first vaccine pt. has had weakness and has fallen. Pt. received her 2nd Moderna vaccine on 2/24/2021; see information above for lot, etc. Pt. was brought into ER with c/o falls, weakness and confusion. Pt. had fallen on 2/27 and 2/28. With one of the falls pt. fx. her right radius and ulna. PCP due to altered mental status, right sided weakness and aphasia at times is r/o stroke.

102 female who is a COVID survivor.. had a mild case of COVID in May 2020. Received first dose of Moderna at assisted living facility on approximately January 20th and suffered no ill effects. Had second Moderna vaccination late afternoon of February 8th. Later that evening or in the early morning of February 9th tried to go to the bathroom and either fainted or fell onto the bathroom floor on her face. Lay on the bathroom floor face down until assisted living facility staff found her in the morning when they were passing out medications. Taken to ER at hospital on 2/9/2021. Was not admitted to hospital- all CT scans and x-rays and blood work were normal. Taken back to assisted living facility where she exhibited dramatic change in behavior- uncooperative, refusing to eat or take meds, refusing to get OOB. Mentally a decline in cognition. Transferred to different facility with higher level of care on February 15th and is improving somewhat.

On 02/16/2021 at approximately 6 PM, patient, who usually uses a walker, fell while returning to her chair. Although she reports that she is not in any pain, since then she has been unable to walk more than 1-2 steps. She has also lost her appetite.