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.

This was dads 2nd vaccine in the Moderna series. He experienced arm soreness and fever up to 100 degrees Fahrenheit for 48 hours including chills, fatigue, and lethargy. Since that time he has experienced confusion, loss of mental acuity,, loss of appetite, confusion, loss of short and long term memory. His ability to provide for his needs on his own have greatly diminished. Prior to the second injection my dad was fully supportive of his own care and mentally sharp. He does seem to be recovering at times, is once again able to take care of his personal needs, but doesn?t eat and is still confused. He doesn?t want to leave his chair..

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.

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.

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

Pt experiencerd soreness in neck area, difficulty swallowing and speaking a few days after 2nd vaccination. Quickly progressed to lymphadenopathy. On Mar 18 Pt complained about extreme pain in heach & neck area x 2 weeks. Unable to schedule appt with MD until 3/22. PET scan and biopsy performed showing possible cancer with metastasis to other areas of body. Pt deteriorating very quickly with additional altered mental status, pronounced lymphadenopathy and inability to communicate. MD as instructed family to expedite admission to hospice. MD had no prior knowledge of potential link of lymphadenopathy associated with Moderna vaccine. Family provided him with published articles.

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.

90-year-old male, who has a history of atrial fibrillation, benign prostatic hypertrophy, congestive heart failure with coronary artery disease and cerebrovascular disease among other comorbidities. Resident of a group home and was brought to ER with one week of decreased appetite and generalized weakness. CXR with PCP showed pneumonia and he was started on antibiotics. Family stated that since then he has not eaten or drank anything. They state he is not acting like himself and is overly tired. He tested positive for COVID upon admission to the hospital.

chest pain; sluggish and limited energy; High amount of mucus; Hard for him to sleep; His wife says he is having breathing problem left side; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Smoker (I haven't smoked in 40 years) and Alcohol use (nor had alcohol in 30). Concurrent medical conditions included Hypertension since 03-Apr-2021. Concomitant products included METOPROLOL SUCCINATE (TOPROL) from 03-Apr-1966 to an unknown date for Hypertension, CAFFEINE, MEPYRAMINE MALEATE, PARACETAMOL, PHENIRAMINE MALEATE, PHENYLPROPANOLAMINE HYDROCHLORIDE (TRIAMINICIN [CAFFEINE;MEPYRAMINE MALEATE;PARACETAMOL;PHENIRAMINE MALEATE;PHENYLPROPANOLAMINE HYDROCHLORIDE]) from 03-Apr-1966 to an unknown date and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced SECRETION DISCHARGE (High amount of mucus), INSOMNIA (Hard for him to sleep) and DYSPNOEA (His wife says he is having breathing problem left side). On 17-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization). The patient was hospitalized from 18-Mar-2021 to 31-Mar-2021 due to CHEST PAIN. At the time of the report, CHEST PAIN (chest pain) had not resolved and SECRETION DISCHARGE (High amount of mucus), INSOMNIA (Hard for him to sleep) and DYSPNOEA (His wife says he is having breathing problem left side) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) Urgent care who took x-rays and confirmed something happening in my lungs.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Cardiologist, who ran tests and said "he saw no sign of a heart attack" that he suspected lung damage. He was admitted to the ER and later began treatment to remove water from my system. 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. Action taken with mRNA-1273 in response to the events was not Applicable. he ruled out cancer. This case was linked to (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient demographics updated. Historical condition, lab data, second dose of moderna vaccine, events chest pain (Hospitalised) and asthenia was added.; 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.

Infection; Confusion; Could not get out of the bed; Very sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (Infection) and CONFUSIONAL STATE (Confusion) in a 90-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 provided. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFECTION (Infection) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confusion) (seriousness criterion hospitalization), BEDRIDDEN (Could not get out of the bed) and MALAISE (Very sick). At the time of the report, INFECTION (Infection), CONFUSIONAL STATE (Confusion), BEDRIDDEN (Could not get out of the bed) and MALAISE (Very sick) had not resolved. Concomitant product use was not provided. Treatment information was not provided. Company Comment: Very limited information regarding the events has been provided at this time. Reporter did not provide permission to follow-up. Reporter did not allow further contact; Sender's Comments: Very limited information regarding the events has been provided at this time. Reporter did not provide permission to follow-up.

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.

Pt received 1st Moderna covid vaccine Wednesday 1/20/21. Pt's daughter reports pt is having hallucinations and hip pain starting 1/23/21. Pt has not been seen by PCP in ~2 years for baseline comparison. Daughter reports pt is doing somewhat better as of 1/25/21. Working to get pt seen for follow-up by provider.

on the 18th he started to hallucinate and has continued for the last 4 days. seeing people sitting on the couch and all over the house

Belligerent; scatter-brained; Erratic; Delusional; A spontaneous report was received on 16FEB2021 from a caregiver concerning a 91-years-old, male patient who received second dose of Moderna's COVID-19 vaccine and became belligerent, delusional, erratic and scatter-brained. The patient's medical history, as reported by the consumer, include Myasthenia gravis (MG). Relevant concomitant medications reported included prednisone 10 mg, nortriptyline HCL 10 mg caps QD, tamsulosin HCL 0.4 mg caps BID, lisinopril 5 mg QD, gabapentin 200 mg QD night, pyridostigmine 90 mg TID, xanax 25 mg as needed, lexapro 5mg QD, levothyroxine 50 mcg QD, amiodarone HCL 200mg QD, carvedilol 6.25 mg BID. He had been on prednisone 20 mg for 6 weeks and they dropped it to 10mg a week before he received his first vaccine. Patient was taking prednisone for Myasthenia Gravis. On 06JAN2021, patient received their first of two planned doses of mRNA-1273(BATCH/LOT # 012L20A) injection intramuscularly for the prophylaxis of COVID-19 infection. On 09FEB2021, patient received their second of two planned doses of mRNA-1273(BATCH/LOT # 007M208) intramuscularly for the prophylaxis of COVID-19 infection. After receiving second dose of vaccine, patient became belligerent, erratic and scatter-brained. He has no history of dementia. On 16FEB2021 at 3:30am, patient called 911 for a foot fungus and paramedics took him to the hospital. The caregiver stated that he was delusional. Treatment for the events were not provided. The outcome of the events, belligerent, delusional, erratic and scatter-brained, 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.

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.

The caregiver on duty tells the nurse in charge that on 5/3/2021 she proceeds to bathe the resident and he was disoriented, so she goes to bed at around 5:00 a.m. The resident expresses that he feels bad, when the caregiver goes to look for things to take vital, when he returns she finds him without vital signs and was presenting respiratory problems.

Open 24 hours of receiving the vaccine, the patient was noted to be fatigued and increasingly confused. Had some response to IV fluids but within 72 hours became progressively hypertensive and transferred to hospital

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.

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.

2/4/21 - awoke from sleep 11 PM with jaw/teeth pain lasting several hours 2/5/21 - extreme weakness, rapid heartbeat, fatigue. Slept on and off all day. 2/ 6 - 2/8/21 - irregular heartbeat, rapid heartbeat, fatigue 2/8/ 21 - appt with primary car, Physician 3:30PM, EKG showed afib, BP 178/100, pulse 140 - sent directly to ER for further testing. Physician in ER: cardiac enzymes normal, chest xray normal, administered metoprolol IV which decreased heartrate from 140 to 84. Prescribed Metoprolol 25MG 2x/day and follow up with cardiologist. 2/8/- 2/12/21 - with metoprolol heart rate remained in 80s, weakness, fatigue 2/12/21 - appt with cardiology; Physician Assistant - EKG showed afib, heartrate 80, BP 142/80 - ordered echocardiogram 2/18/21

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.

My Dad found he could not sleep that night until nearly 6 am. He tossed and turned but only slep a couple of hours. Mind racing, but no restless legs syndrome. The next day, he had no soreness at all, but he woke up constantly all night and couldn?t settle to sleep. That happened for the subsequent 5 nights after the vaccine, he just got short naps. On Tuesday the cardiologist said he could safely take melatonin ( he also tends to low bp) and he took 10mg tap(last 5 mg time released). He woke up frequently but was able to get back to sleep. He has been taking that tablet most nights and sleeping better.

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.

1/30/2021- he was found to be confused by family and taken to the ER where he was found to have bilateral pneumonia, symptoms of decompensated heart failure. he did not improve with interventions and ultimately was placed on comfort care and passed away in the hospital 2/2/2021

The day after the shot my dad became incoherent, was unable to complete a sentence, began talking gibberish, was confused, and seemed to be hallucinating. That evening he fell in the shower, which necessitated a 911 call. He was taken to the local hospital.

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.

pt became confused a few days after receiving the vaccination. he began having hallucinations. family took him to ER on 1/19/21

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

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.

Client had some lumps in his throat. They were bothering him on 2/4/21. He did take some Tylenol and gargled with salt water but lumps were still there. He also complained of some chilling but stated that went away. His daughter took him to his primary care doctor on 2/4/21. He stated the doctor told him to continue taking the Tylenol, gargling, and encouraged him to keep walking. He is supposed to contact his PCP if needed.

Very sleepy all day Saturday, March 13th. Overnight, had hallucinations and sleepwalking, was found at the foot of the bed, confused. Went back to sleep and when he awoke he was fine.

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.

from nursing home for lethargy and altered mental status, onset this evening. Two initial EKGs were negative for ischemia. Troponin came back positive. Evaluated for NSTEMI, continued to monitor and started to see trending down troponin. Continued to monitor over several days and provider discussed with family and no intervention done. Improved over time and discharged to skilled nursing facility

Severe left upper extremity edema and erythema (extended from the shoulder to arm and hand) with small bullae and weeping on forearm. Progressive acute onset over the course of a week. Started on oral clindamycin, however superimposed cellulitis was NOT suspected but oral antibiotics are low risk. Limited to left arm, showed no signs of systemic illness (afebrile). Had no signs of neurovascular compromise, was able to move hand, sensation intact and notable pulse.

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.

Dad woke up on January 29, 2021 with severe stomach pains and vomiting. He was very uncomfortable and ended up going back to bed. He was miserable all day. I called his physician and we decided to keep him comfortable at home and give him the BRAT diet which seemed to be helping with the pain and vomiting. Dad never got out of bed again. On February 4th, Dad was placed on Hospice and died on February 7, 2021.

DEATH Narrative: PRIOR TO DEATH, spoke with pt's daughter and she reported that pt is unable to keep his appt for the second Covid vaccine appt because is sick today. Per daughter, pt has been lethargic, not enough sleep last night because of frequent urination at least every 30 to 45 minutes looks exhausted and with poor appetite. Pt has not been drinking fluids at least 6 to 8 glasses a day and daughjter tries to make sure pt drinks fluids, the best he can. Per daughter, pt's vitals signs are as follows: BP: 93/48mmhg PR: 93/min. Temp: 98.1 F and O2 sat: 95%.

Ppt collapsed at home on 3/27/2021 late morning. Presented to ED on 3/27/21 from home around 11am with altered mental status. Was found to have a hyper acute stroke per CT head (intracranial hemorrhage). Ppt was pronounced on 3/28/2021 at 1:45pm. UNSURE IF DEATH RELATED TO VACCINE.

EXTREME weakness, pain in left arm with reddened welt size of orange. Unable to collect thoughts. States does not feel good all over. Denies headache, dizziness. Previously able to transfer with minimal assist to wheelchair but unable to even help with transfer after reaction. Continues to have reddened itchy welt on arm 3 days later but now able to transfer again and converse normally.

Woke up extremely fatigued, and no appetite. Later developed chills and fever. Temp max was 100.6. Took Tylenol for fever. Slept most of day. States felt like same symptoms on day he was admitted to hospital when he had covid except no shortness of breath. Next day on 1-21-21, he continued with exhaustion, being cold and nausea.