Moderna

On 1/12/20 resident woke up and was not able to stand in the E-Z stand. E-Z lift was needed. In addition he needed assistance with eating. At that time VS were stable, equal hand grasp noted, and no further concerns. Around 3pm resident became flaccid on the left side of his face and speech became mumbled. Hand grasp was equal at that time and VS were stable, but B/P was elevated compared to previous recordings earlier in the day. Family did not want him sent to the hospital and asked for comfort cares. Hospice referral obtained and he will be admitted to hospice in the near future. Resident's left side of face has improved within the last 48 hours. He remains total assist with all cares.

Patient reported fever, dizziness and lightheadedness, as well as low blood pressure to this nurse by phone. This nurse requested patient to be seen by provider as soon as possible. Patient agreed and came to clinic soon after phone call. Dr notified this nurse that patient was advised to be seen by provider in ER for possible IV fluids and lab work due to symptoms. Pt refused and went home.

About 45 minutes after vaccine resident reported feeling light headed. Pulse was elevated at 120. Administered PRN Benadryl per protocol. Resident drank Gatorade and ate some food. Reported chest pain 15 minutes later. Administered PRN nitro which relieved his chest pain significantly.

Gentleman received his 1st Moderna dose on Thu. 2/11 at 0849. Vaccination protocol was completed. Pt reported feeling fine, no fever, and that he had no allergies which would prevent him from getting the vaccine. Pt played cards with friends later that day 2/11, but left at 1930 (normally plays late into evening) telling his companions he didn't feel well and his neck hurt. A welfare call was completed on Sat. 2/13, and the patient was found deceased in the bathroom by his son. It appears patient fell off toilet and hit his head on the tub. Pressure ulcer present under injection site. The presumed time of death was Thur. evening.

Patient, who wears a hearing aid, claim that his hearing was affected. He said sound had diminished and was slightly dizzy.

Significant fatigue - Notable in 91 year old lady, with associated fall - Began day following injection and persisting at least three weeks later

Fall - 7 AM Fall in Dining Room Community Center 1 PM Ambulance to Hospital ER 1:30 PM Tests - Blood, CT scan of head and brain, X-ray of Chest Release from hospital - 5 PM Arrive by car to home 5:30 PM fall from car to grass Call for Security and Nurse to get him up and into the house - vital signs taken Fall again in the house at 6 PM Seemed to back to normal +/- 7 PM

Patient seen by physician for weakness, tired, increase SOB, falls, increase confusion and then subsequently hospitalized . Patient then expired on 3/7/21.

He came home, laid down and went to sleep and slept all day long. He had incontinence or urine, and could not put any weight on his legs, could not stand on his own and confused about what was going on. His wife was able to get him up after pulling and tugging on him, and mentally confused. He was able to go to the bathroom, and got him back to bed. He had a urinary accident and slept until the evening. She could tell he was better and walked with a walker. She said the symptoms resembled a stroke, but he got better. He did not take anything, did not want anything for the symptoms. She does not think that he ate anything that night. He says that he's fine now.

The day following his Moderna vaccination, the pt became profoundly week with difficulty standing on his own and frequent falls. He also experienced sever malaise

I took a .5mg Lorazepam at 11pm the night of the injection and about 4am I was very cold and the room temp. was 78 degrees. I got up to go to the bathroom and I was so cold and shaking so bad I could not walk and about fell. After getting back in bed my wife covered me with two heavy blankets. I got up at 9am after not sleeping all night and I felt bad. I went out side for a minute in 54 degrees and when I got in the house I was cold and shaking. I stayed in the house all day and at 11pm i tool a lorazepam and sleep all night to 8am. Today I feel better and not cold.

pt states he has been off balance ever since he took the 1st dose covid vax 1/8/21. He waited a half hour after getting the vax to leave but as soon as he walks he feels off balance. If he is sitting he is fine but as soon he gets on his feet he has a feeling of being unbalanced. He got his 2nd dose on 2/2/2021 Lot # 012M20A with no changes. Today 3/25/2021 he is still experiencing a balance issue. Pt will contact his PCP regarding these symptoms.

Patient started feeling chills about 3 hours after injection. Uncontrollable shakes that lasted into the evening. He said he could not walk because his legs kept collapsing on him. It lasted until the next morning. He did not report it to anyone. He said he didn't think he ran a fever.

Patient developed confusion, weakness, and had multiple falls resulting in admission to the hospital for generalized weakness and loss of balance.

Urinary incontinence, weakness, loss of speech, loss of mobility (couldn't walk), fever for almost 12 hours. Still has loss of cognitive function from before the second shot almost 2 months after. Alzheimer's worsened. Needs more help around the house.

Patients' wife states that at 2:00 am on 3/5/2021 Patient woke up not able to move his upper/lower extremities and couldn't talk. So he started to shake/rock back and forth until he could move around and talk, which took him about 2-3 hours. He then called his wife at 6 am. She told him to push his Alert to get help, but patient declined and proceeded to his car and he drove himself to the ED. His wife felt they arrived about the same time because they were in separate cars around 7:00 am. He was seen at ED, where he was evaluated/treated for stoke symptoms. Patient's CT of head was normal, and all other testing was normal as reported by patient?s wife. Patient was feeling normal and like his normal self once he arrived at the ED and after his d/c. He was advised to F/U with his PCP at Medical Group. He was seen either the 3/8 or 3/9 by Dr., who felt that he possibly had a reaction to the COVID Moderna vaccine as to the reason wife called to report the reaction.

Extreme weakness, can't stand up, low-grade fever, restlessness, dementia symptoms increased, confusion, anxiety, inability to find words or speak what's on his mind.

pt says his right arm became very heavy the day he got his vax. He says it was so heavy he had to take his other arm to move it. He has had some shortness of breath and very fatigued. He has fever, dizziness, body aches and pains, chills, and joint pain. He says these symptoms come and go but has them almost ever day. He had a seizure one night while sleeping but was better next day. He will get cold and have to go to bed to sleep before warming up. He had an episode where his feet became very heavy and he couldn't walk. He has become extremely weak and has trouble doing daily task. He has cramping in his back muscles that moves up and down his back. He has never had any other these symptoms before getting vaccinated and has only had a couple of days where he felt normal.

Patient reported feeling dizzy 10 minutes after receiving the vaccination. His vital signs were taken at 1100: BP 11760, HR 49, 02Sat 94%, T 98.6 which is consistent with his baseline. Patient wife stated "he has a vascular problem in his brain and he gets dizzy spells like this at home." Veteran was instructed to remain seated for a few more minutes. Patient reported feeling shaky and was given 4oz of orange juice. His vital signs were retaken at 1125: BP 138/63, HR 54, 02Sat 96%, Blood glucose 164. Provider consulted. After symptoms resolve and pt. history reviews, patient was sent home at 1130.

Patient admitted to Inpatient on 1/13/2021 after receiving vaccine on 1/6/2021. Diarrhea and dizziness. Since Sunday, corona vaccination last week. No headache, abdominal pain, nausea or vomiting, loss of taste or smell, muscle aches or general malaise. Patient was hypoxic at clinic visit, 84% on room air, transferred to ED for evaluation.

Pt developed COVID-19 infection, symptoms starting 7 days after first dose was given. Patient was admitted to hospital on 1/21 after falling (secondary to weakness) and striking head on toilet. Patient expired due to respiratory complications of COVID on 1/25.

Sore armpit region, right shoulder where vaccine was administered. Cannot raise right arm past horizontal.

Headache, fever, uncontrollable shaking, heart rate 104, bp 140/86 called 911, ambulance ride to above Hospital. IV on route, Kept over night in hospital. Shake stopped in about 2 hours , continued rapid heart for awhile and fever, Hospital gave him tylenol. after about 4 hours his bp fell to 89 over 64 ... thus keeping him in hospital. They did multi tests. found an unknown infection in his blood. Patient has had an elevated WBC but in hospital it was 50,000. two weeks ago at his primary Dr. it was 40,000. He walks with a walker and cane, however he has lost his balance and fallen 3 time since vaccine and one of those was today.

Patient presented to Medical Center on 02/23/2021 for weakness and fall. Patient had received his 1st Moderna COVID-19 vaccine on 02/22/2021. Was weak unable to rise out of the chair the next day. Patient has a history of COVID-19 in November of 2020. Patient was admitted to the hospital on 02/23/2021. Patient was ultimately diagnosed with generalized weak, right knee pain status post fall and elevated troponin level. Patient was managed conservatively and recovered over 24 hours. Patient was discharged on 02/24/2021 to follow-up.

mechanical fall during transfer from chair to wheel chair with family assist post vaccine monitoring. Blood noted to right ear . Family states frail skin. EMS assisted. No further follow up required per EMS and family

My birthfather had an adverse reaction after he got his 1st Moderna COVID vaccine. He lives alone and was doing well with some underlying conditions. The day of the shot was fine. The next AM, he had vision changes and sudden numbness in his R arm/leg and fell after getting up. ?The numbness went away pretty quickly, but the visual changes remained. He refused to go to the ER/Dr. The next week and a half, he was weak, tired, and couldn?t think as clearly. ?He was brought to the ER? on Wed, 3/3/21 at Hospital. He was found to have a low oxygen level, possible a-fib, fluid retention, emphysema, and aortic stenosis, in addition to his other health issues. ?The Dr said his symptoms the day after the vaccine were a mini-stroke.. He was released from the hospital on Friday, 3/5/21. On Saturday, Hospice came to see him, since nothing can be done for his medical conditions; however, they decided not to sign him up yet, since he I was told they didn't feel he needed to, at this time. One of my sisters is staying with him during the day until he builds his strength back up. Do you think his Mini stroke and health changes had anything to do with the vaccine? He will not be getting the second COVID shot. ?We?re all caught between a rock and a hard place as far as what to do, esp for older folks.

Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors (PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did no 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 90 yo and admitted on 2/10/21 for SOB and a fall resulting in a femur fracture. Patient was on Eliquis and has h/o CABG x5, dementia, bradycardia s/p pacemaker. Patient was discharged to a rehab facility where his condition declined ultimately resulting in transfer to inpatient hospice. He eventually required care in ICU where he eventually deceased.

Had swelling in left foot, unable to wear shoe. Had severe pain, like walking on nails. Lasted approximately 4 days and then abated. My dad thought he?d have to give up walking.

Dad woke up one morning in February with a a pain in his groin so severe he could not swing the leg forward to walk. He used a walk-behind walker to get around for several weeks. Eventually he could walk without support, but only if careful. The pain would also radiate down the thigh of the same leg. After the groin/thigh issue started to improve the pain changed to the buttock and thigh of the same leg. He had to use the walker again to safely walk. He also had difficulty lifting the leg up to get out of a recliner. He had to use his fists on either side of the bad leg and lift himself with his arms because of too much pain if he tried to push up with his leg. He has discovered that if he swings the bad leg behind him before he starts to try to walk, movement of the leg is less painful. He is using the walker to maintain balance because of the problems with his leg. It just recently occurred to us that these problems coincide with the Covid vaccine doses and decided to report this.

Pt was unable to stand, move his hands, or talk for days. He was a zombie. Months later he could walk again--but now he needs to use a walker.

Starting the day after the vaccine, severe left shoulder pain and left leg pain. The left knee joint was especially painful. The night of January 21, 2021, the patient could hardly walk the pain was so bad. January 22, 2021 the pain subsided considerably in the shoulder. The leg pain is improved and the knee joint pain has subsided, although the knee joint still hurts more than the shoulder or leg. This was all reported to the patient's primary care physician.

weakness in legs, difficult to get out of chair, fell and could not get up. fever loose stool Went into AFIB and it snowballed from there. Was taken to Emergency.

Patient received dose 1 moderna 12/29/20, and dose 2 moderna 1/25/21. Admitted to hospital for fall, altered mental status, hyperglycemia on 2/4/21.

Four hours after the vaccine had no strength and could not walk at all. in addition all the pains he had before escalated so he needed very strong pain relievers. Also lack of comprehension when we got the ER.

Resident yelling for assistance in apartment. Nursing personnel found resident on floor at 6:10 AM on 2/18/2021. Resident was transported to Hospital on 2/18/2021. Status update on 2/18/2021 from son, resident CT & X-rays were done all normal. Labs done and WBC count was elevated and awaiting results. Resident stable and admitted to hospital for observation. Resident passed away on 2.21.2021.

bad headache that lasted for a few hours the day after; I took aspirin for the pain. I also experienced being very tired a couple hours after receiving the shot and later that evening. I feel more tired than usual the next day. Left arm is quite sore, maybe swollen. Slightly more light-headedness than usual.

92 y/o M, hx of HTN, otherwise healthy and well here for second dose with no reported adverse rxn from first dose. VR was driving from the vaccination area and got app 250 meters away when he became lightheaded. He got out of the vehicle and had a syncopal episode, had an unwitnessed fall backwards and struck his head on the roadway causing a full thickness 5cm stellate laceration. Vitals: BP 215/98, HR 50 and regular, O2 93% on outdoor air. Reports taking BP meds this am. Pt was amnestic to the event but denies LOC. Had one episode of N without V. No midline C spine tenderness. Reports no blood thinners. EMS was summoned and transported him to a nearby hospital for further evaluation and treatment.

Patient felt dizzy and very weak about 30 minutes after vaccination. He was coherent but very weak. needed to be taken by ambulance

The second dose of vaccine was administered, in error, on the 22nd day (given too soon) following the first dose. The second dose should have been administered on March 17th but was given on March 10th. In the morning following the vaccination, caregiver noted individual to be very weak, fatigued and complained of body aches, requiring assistance to get out of bed and required more assistance with mobility than what is usually needed for a period of 2 days following the vaccine.

Fell; Felt like he was dying; couldn't taste, and had a terrible taste in his mouth; Could not smell; Stomach hurt; A spontaneous report was received from a consumer concerning a 92-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced could not taste and had terrible taste in his mouth (ageusia), could not smell (anosmia), his stomach hurt (abdominal pain upper), felt like he was dying (feeling abnormal) and he fell (fall). The patient's medical history included hospitalization due to COVID-19. No relevant concomitant medications were reported. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) an unspecified date. On 22 Feb 2021, two hours prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. Two hours after the vaccination, the patient could not taste, and had a terrible taste in his mouth The patient could not smell and his stomach hurt. The patient felt like he was dying. On 23 Feb 2021, the patient fell. 911 was called and the patient was hospitalized. Treatment for the event included electrolytes. The patient had an abnormal electrocardiogram (EKG 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 of the events, could not taste and had a terrible taste in his mouth (ageusia), could not smell (anosmia), his stomach hurt (abdominal pain upper), felt like he was dying (feeling abnormal) and he fell (fall), were unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time. Noting advance age is a risk factor. Noting the history of advance age and previous COVID infection may remain as risk factors. Further information has been requested.

PATIENT COLLAPSED IN PARKING LOT AFTER WAITING HIS 15 MINUTES. HAD SHORTNESS OF BREATH AND LABORED BREATHING. HEART RATE WAS VERY FAINT AND PATIENT WAS SWEATING. WIFE STATED PATIENT DID NOT EAT YET TODAY

Feb 8th 2nd vaccination. Next day lost consciousness, fell no injuries. Following day Feb 10th weak and could not stand, BP low, Dr sent him via ambulance. EMS identified him having a heart attack that started Feb 9th. He had no cardiac history He was hospitalized for a sudden blockage, had a vtach episode, did not lose consciousness, one stent placement, had a 2nd vtach episode and did lose consciousness. Placed on blood thinner, within a few days had uncontrolled urinary bleeding, catheter to irrigate, changed blood thinners and did not stop. Continued weakness and decline. Then developed pneumonia the following week. Placed on antibiotics, oxygen 2-7 L/nc. Went to rehab, back and forth to hospital. Came home twice, once Feb 14th for 24 hours, then 2nd time March 9 (his birthday) for his final 2 weeks t home where I cared for him until he passed March 21st. On 4L/NC, did not have catheter, bleeding had stopped.

Patient received the Moderna Vaccine 1/2/21 at his VA Clinic. He received the vaccine that morning and by the evening he was not feeling well. He developed cough, weakness and fever and now is unable to ambulate. He has since been hospitalized and has tested positive for COVID-19.

2 hrs after vaccination, not feeling well, pt requested to be taken to ER. Per Spouse pt grabbing constantly to R side arm underneath armpit, pain. Pt discharged, next 2 days pt consistently sleeping only 1 meal. Extreme tiredness and pain in R side underneath armpit continues. Per Spouse pt is "no where near alert as he used to be". Per Spouse pt fell to floor 1/19/2021 couldn't stand or walk, did not hit head or injury self. Spouse took pt to bed, pt has been in bed sleeping consistenly since then.

Patient complaint of dizziness. BP 132/78, P 66, R 16, O2 95%. Head to assessment completed. Patient monitored for 15 minutes. Patient felt better after 15 minutes and left clinic.

Low grade temp, weakness, minor muscle aches Weakness resulted in a fall. 2 Tylenol, rest Temp down to 98.8 after three hours Weak the following day but able to function independently

Presented to the ED with profound weakness including inability to ambulate (at baseline goes on moderate distance walks daily without assistive devices). Patient admitted to hospital on observation due to inability for him or his family to take care of himself due to the profound weakness.

Family, daughter, reports that patient felt "a little sick" on 2/24/21 and "sick" on 2/25/21. She reports that approximately 1 week later her father had weakness and and frequent falls, was evaluated in the E.D. and ultimately admitted to hospital (3/4-3/15) Patient was discharged to nursing home where he died on 3/16/21.

case in from long term care facility 2 days after receiving his second covid vaccine for nausea, vomiting, weakness, decreased ambulation. he also had 2 falls. he was started on Rocephin for possible pneumonia and new focal consolidation in l base.

Hi, my name is, I'm a RN and am submitting this report about my grandpa. I took him into the VA to get his second covid vaccine on 2/17/21. At that time my grandp lived semi-independently in a house between my parents and my uncle . He didn't get out very much but with some help of grocery shopping and organizing his medication he was still able to live alone and function well independently. My mother reported to me on 2/18/21 that my grandpa was confused, weak and tired. My grandpa has never had any signs of dementia. At this time he developed a delerium that waxed and waned. He complained of headache, no appetite and extreme weakness. On 2/23/21 he fell down in his house and we decided to move him into my uncles spare bedroom to keep better eyes on him. The delerium persisted and on 3/5 he was taken to Hospital for a workup for his delerium and weakness. There he saw Dr. an internal medicine doctor at hospital. The workup showed an elevated BNP (probably baseline but I'd have to look at previous lab results) but nothing further. We opted not to do further imaging and instead take him home. It became obvious to me that this was the end of his life and so I requested a hospice referral from Dr. My grandpa died on 3/24/21.

Chest pain; Gallbladder with stones; Unable to walk on walker; admitted to the rehab facility to get therapy for upper and lower extremities as LLT upper extremity disfunction; He was so weak from laying there at the hospital for 4 days; The time the facility has it in stock it will be two months after the first dose; The time the facility has it in stock it will be two months after the first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain), CHOLELITHIASIS (Gallbladder with stones), GAIT INABILITY (Unable to walk on walker) and MUSCULOSKELETAL DISORDER (admitted to the rehab facility to get therapy for upper and lower extremities as LLT upper extremity disfunction) in a 93-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 Dementia and Walker user. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT AVAILABILITY ISSUE (The time the facility has it in stock it will be two months after the first dose). On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization), CHOLELITHIASIS (Gallbladder with stones) (seriousness criterion hospitalization), GAIT INABILITY (Unable to walk on walker) (seriousness criterion disability), MUSCULOSKELETAL DISORDER (admitted to the rehab facility to get therapy for upper and lower extremities as LLT upper extremity disfunction) (seriousness criterion disability), ASTHENIA (He was so weak from laying there at the hospital for 4 days) and PRODUCT DOSE OMISSION ISSUE (The time the facility has it in stock it will be two months after the first dose). The patient was hospitalized for 4 days due to CHEST PAIN and CHOLELITHIASIS. At the time of the report, CHEST PAIN (Chest pain), CHOLELITHIASIS (Gallbladder with stones), GAIT INABILITY (Unable to walk on walker), MUSCULOSKELETAL DISORDER (admitted to the rehab facility to get therapy for upper and lower extremities as LLT upper extremity disfunction) and ASTHENIA (He was so weak from laying there at the hospital for 4 days) outcome was unknown and PRODUCT AVAILABILITY ISSUE (The time the facility has it in stock it will be two months after the first dose) and PRODUCT DOSE OMISSION ISSUE (The time the facility has it in stock it will be two months after the first dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: abnormal (abnormal) Gallbladder with stones was found. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. Treatment information mentioned therapy for upper and lower extremities. Patient's PCP mentioned that there may be a reoccurrence of gallbladder stones in the future. 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. More information about the events 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. More information about the events has been requested.

Days 1-3 - fatigue, lightheadedness, shoulder pain. Day 7: redness, mild swelling, mild tenderness at injection site (no infection)

weakness; Unable to move; So weak he fell over on the carpet; Trembling,tremor; teeth chattering, chills; A spontaneous report was received from a consumer concerning a 94-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced asthenia, disability, muscular weekness, trembling, tremor and chills. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 023L20A) intramuscularly in the upper left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, at 21:00, patient experienced chills, trembling, weakness, tremor, teeth chattering ,so weak he fell over the carpet and unable to move.At 03:00 am the patient was hospitalized. The reporter also added that the patient usually is a very active for a 94 year old man person .The reporter was worried when the patient was unable to move. On 17 Feb 2021 the patient was discharged from hospital. The events weakness and unable to move were considered as serious. No laboratory details provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were 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 events, a causal relationship cannot be excluded. However, patient's advanced age may have been contributory for the event of asthenia.

Pt started feeling weak within hours of vaccine progressive weakness ensued and pt began to have falls and Rapid decline in general status and Died 3- -2021

After pt received first dose of Moderna on January 27, 2021, he experieced continuous increased decline in his health , with symptoms of increased difficulty swallowing, increased coughing, at least one episode of choking with expulsion of food; increased difficulty walking with walker, increased shortness of breath. On Wednesday, Feb. 24, at 7:50 a.m. , Pt was in wheelchair exiting home, on way to detached garage, being pushed by his daughter, when he slumped over, stated that he couldn't breathe, and went unconscious. Pt. did not have a detectable pulse . EMT was called and upon arrival performed CPR and obtained a pulse. Pt was transported to local hospital, where, again he lost pulse and was resuscitated again with mechanical CPR. Pt was supported with blood pressure medicine and ventilator until 7:53 p.m. when his heart stopped again. Pt. passed at that time.

Received Moderna dose series through the department, with patient's daughter stating series was completed on 2/10/21. No record to verify this date. Patient presented to ED after a fall for a fracture of superior pubic rami on 3/24/21. Was found to be positive for COVID-19 during prescreening prior to transfer to medical floor. Reported no symptoms of COVID-19 infection during hospital admission.

A 95-year-old gentleman with significant Medical history for dementia/hypertension/hyperlipidemia, who presents from nursing home after being found on the ground, unable to get up; the patient was evaluated in the ED, patient is hard of hearing, does not have a hearing aid, is alert, able to communicate. Patient subsequently tested positive for COVID on 4/10/2021 and placed on 5L nasal cannula. Patient was previously diagnosed with COVID on 12/07/2021, so this could represent a persistent positive.

After second dose, individual became weaker and needed to use of cane to walk around. Became progressively weaker over course of a few weeks, then on May 14th had chest pressure, nausea, and dizziness. This continued, Wednesday May 19th complained of trouble breathing, shortness of breath, but felt better Friday, May 21st, until Saturday May 22nd at 6:00 AM individual complained of more severe chest pressure. Taken to hospital, determined heart attack and kidney failure.

2/23/2021 - patient found in room w/ left groin pain & right sided numbness - upon admission to hospital he has no movement in right leg & minimal movement in right arm.

First shot uneventful. Second shot, patient had a fall the next morning, where his knees weakened and gave out. He had been active prior to this, without similar events. He also had extreme brain fog, and has had long-lasting fatigue, weakness and decreased appetite since then. This writer saw him 4/5/2021. He has now developed thrush without any evident cause. He did lose his sense of taste but that is returning.

complain of feeling light headed directly after vaccine. Vital signs normal. no other symptoms. resolved after a while.

weakness and fallsNarrative: 95 yo male w/ a PMH significant for Afib, legal blindness, Hx of CVA, cognitive impairment, GERD, HTN, pseudogout, BPH, chronic knee infection, and DJD who received his first dose of the Moderna COVID-19 vaccine on 01/08/21. The pt's COVID-19 screening questionnaire prior to receiving the vaccine was negative. The pt presented to the ED on 01/13/21 for weakness and m PCR test on ultiple recent falls (since receiving his first dose of the COVID-19 vaccine). The pt's COVID-19 01/13/20 was positive and he was admitted. He was started on treatment with remdesivir + dexamethasone on 1/14. The pt initially required supplemental oxygen via low-flow NC, however his oxygen requirements increased to 100% NRB. On 01/16/21 his MPOA elected for hospice care. The pt passed on 01/17/21. Unclear if the COVID-19 vaccine attributed to the patient's hospitalization and eventual death, or whether these events occurred from COVID-19 itself, however this case is being reported the FDA since this vaccine is under an emergency use authorization (EUA).

Patient states that he woke at 01:00AM on 03/02/2021 to go to the bathroom. He reports that he was unable to move his arms or legs and had to call out to his daughter to assist him. His daughter had to physically assist him with sitting up on the edge of his bed. Symptoms lasted approximately 15 minutes. When he regained use of his arms and legs he was unable to void or have a bowel movement. Patient states that his symptoms have resolved and that he currently reports feeling fatigued.

weakness Narrative: 96 y/o male received 2nd COVID 19 (Moderna) shot on 03/11/21 @1700. Tolerated first COVID 19 vaccine shot with no issues. History of afib, CKD, basal cell carcinoma of neck and ear, squamous cell carcinoma, valvular heart disease, coronary arteriosclerosis, pacemaker, hypertension, aortic valve stenosis s/p aortic valve replacement. No prior ADR to vaccine or severe allergy to medications. Brought in by ambulance to outside hospital after being found on the floor by neighbor on 03/13/21; may have been down for up to 24 hours. Patient reported feeling woozy the day prior and very weak. Currently being treated for pneumonia. Had elevated troponin likely secondary to prolonged downtime and thabdomyolysis, but cannot r/0 NSTEMI. Currently still hospitalized today 03/15/21.

Patient received 2nd Moderna Covid-19 vaccine on 3/4/21. Patient was admitted to hospital on 3/14/21 with a stroke. The patient fell the night before and laid on the floor until family found him and then was taken to the ER. Prior to falling he experienced left arm weakness.

Lethargic, pale, glassy and pinpoint eyes to unresponsive, limp and falling to the right side. Client laid on ground due to unresponsiveness and unable to obtain vitals, client gasped when laid flat then reported nausea, rolled to side client started vomiting. EMS called, EKG ran, client refused services. Walked out of clinic.

Patient reports his left arm/shoulder hurts and has been sore for over a month since his shot. He says it only hurts when he tries to raise his arms up. He says he has been taking Tylenol, but it hasn't been helping. He reported his reaction to his primary care provider Dr. but Doctor, told patient to ask pharmacy for advice instead. Patient says he will try to reach a orthopedic doctor for a second consultation.

Musculoskeletal discomfort; pain started in chest, moves to sides and back. Painful to cough, and painful to bend over, and twist; getting in and out of a chair difficult. Peripheral edema; swelling in ankles and feet. Coughing up phlegm/muscus All tests came back normal; regiment of ibuprofen and acetaminophen recommended for the pain. All symptoms persisted.

Friday his legs gave out and he couldn't walk or anything and my son had to pick him up and carry him back to bed, and Saturday he was having joint pain, muscle, and body aches. And then his right hand is swollen.

Moderna COVID-19 Vaccine EUA - lost ability to walk, feed self - this from someone with Alzheimer's disease and who was frail and an extreme fall risk. However, the severe downturn exactly one week after the shot made us wonder if it caused this significant decline.

He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got; He could hardly walk; Lightheaded and dizzy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got) in a 97-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 25-Feb-2021, the patient experienced DIZZINESS (Lightheaded and dizzy) and FATIGUE (Fatigue). On 22-Mar-2021, the patient experienced ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got) (seriousness criterion hospitalization) and GAIT DISTURBANCE (He could hardly walk). The patient was hospitalized from 22-Mar-2021 to 27-Mar-2021 due to ANAEMIA. At the time of the report, ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got), GAIT DISTURBANCE (He could hardly walk), DIZZINESS (Lightheaded and dizzy) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included blood transfusions. Concomitant product use was not provided by the reporter. 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.

Death Narrative: Patient was not previously COVID positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 97 and admitted to Hospital on around 2/20/2021 due to a fall at home. He later passed away on 3/5/21.

Patient is a 99-year-old man with prostate cancer and sprouting eyes. No signs of dementia; awake, alert, and oriented by 3 (person, place, time). The patient needs a walker and a person assisting so he can move. He visited the pharmacy and came with two family members. After I evaluated the patient, I administered the vaccine. Just after the administration of his first dose of the Covid-19 Vaccine he felt very dizzy and with severe headaches after standing up. Family members told me the patient occasionally suffers from dizziness when he changes from the sitting position to the standing position. I sat him again and he keep telling everyone he did not felt fine. He was semi unconscious; his eyes were almost wide shut and his family members besides me told me he felt cold and never had dizziness like this. Just after that, I asked him if he could breathe, and he nodded yes with his head. I was ready for applying CPR or oxygen depending on the scenario. But I was very worried for him because of his age and decided to call the ambulance. The paramedics came in half an hour, but he started to feel better after a while. The paramedics got his blood pressure and was low and his glucose levels were high. They recommended the patient to go to the hospital, but he refused. He talked with his family members and instead decided to go home.

- Felt weak and light headed after receiving vaccine, continued to feel weak up until 07/12/21. ( Least of problems ) - Feb. 22 begin to lose hearing in my right ear ( Went to see an ENT ) found to be deaf - Recovered some hearing 2-3 days later - Started bleeding from lower GI tract 03/2021 went to hospital 03/06/21 lost 1/3 of blood, spent 4 days in hospital - I Assumed the bleeding was trigged by the vaccination

Patient reports that he felt "woozy" or dizzy a little bit after getting the injection. This was short lived and no further side effects.