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.

resident had a pressure ulcer to RT hip, was getting treatment on. Was scheduled to have wound debrided and wound vac applied on 1-19-2021. Appetite was poor, not wanting to get out of bed, and decline in alertness. Passed away on 1-16-2021

01/05/21 resident received first step covid vaccine. 1/12/21: presented with increased lethargy, weakness, poor appetite and loose stools. Weight lose noted, recent adjustments made with prescribed diuretic medication. Symptoms have since improved, MD followed during change in status.

Patient left the pharmacy and was at his table eating. He dropped his bowl and appeared to be shaking and his eyes rolled back. He was unresponsive so his wife called 911 and an ambulance came and transported him to the Hospital. Concern at the time was either a seizure or stroke.

syncopal episode approximately 7 minute after initial COVID 19 vaccine, Moderna Lot number 030L20A Exp: 7/16/202. Patient became unresponsive, gasping for air. Wearing KN95 mask, removed mask, called for assistance, applied 3L Oxygen via non rebreather face mask. Once oxygen was applied patient was able to respond to commands. Blood pressure was checked at 1545, 110/70. EMS was called at 1545, arrived on seen at 1546. Patient was assessed by EMS, vitals stable, transferred to Hospital at 1600.

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 reported following his immunization he became short of breath, tired, weak, joint pain, headache, recommended go to emergency room, resulting Hospitalization 1/20-22/2021 dx Acute Hypoxic Respiratory Failure secondary to Acute on Chronic Diastolic Heart Failure exacerbation, currently patient remains on home oxygen

Three days so far of cold sweat...fatigue....aches....pains.....headaches.........Into day four and cold sweat still.....aches and pains about gone..

Syncope; Shaking; Struggling to breathe; A spontaneous report was received from a consumer concerning a 90-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed syncope, shaking, and struggling to breathe. The patient's medical history was not provided. Concomitant medications reported included warfarin, ezetimibe, bupropion, finasteride, tamsulosin, furosemide, potassium chloride, rosuvastatin, and nitrofurantoin. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, after vaccine administration, the patient stayed at the vaccination site for fifteen minutes to watch for any reaction, he had none, so he left. Later that night the patient began shaking and struggling to breathe, so 911 was called. At the hospital, the patient was diagnosed with syncope. He spent overnight in the hospital and had an echocardiogram the following day. No results were provided for the echo, but the patient was cleared to go home after a sixteen-hour hospital stay. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events, syncope, shaking, and struggling to breathe, was resolved.; Reporter's Comments: This case concerns a 90 year-old, male patient, who experienced events of syncope, shaking, and struggling to breathe. The events occurred the same night after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.

Following day after receiving COVID 19 vaccine patient experience strong abdominal pain and weakness requiring ER visit.

Hypoxic failure secondary to acute on chronic diastolic heart failure; Shortness of breath; Weak; Tired; A spontaneous report was received from a healthcare professional concerning a 90-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypoxic failure secondary to acute on chronic diastolic heart failure, shortness of breath, tired, and weak. The patient's medical history, as provided by the reporter, included chronic diastolic heart failure. Concomitant product use was not provided. On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A), intramuscularly for prophylaxis of COVD-19 infection. On 16 Jan 2021, the patient had shortness of breath, was tired and weak. He was taken to the hospital and diagnosed with hypoxic failure secondary to acute on chronic diastolic heart failure. Treatment for the events included intravenous (IV) bumetanide. The patient was discharged home with oxygen on an unknown date. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, hypoxic failure secondary to acute on chronic diastolic heart failure, shortness of breath, tired, and weak, was unknown.; Reporter's Comments: Based on the diagnosis of hypoxic failure secondary to acute on chronic diastolic heart failure provided by the hospital, the event is assessed as unlikely related to mRNA-1273. Further information has been requested.

Subsequent morning after vaccination, client was too weak to get out of bed (per wife). He stayed in bed for 3 to 4 days , then wife called PCP. Client stayed in bed for a total of 3 weeks , and had 3 home visits from PCP. Was admitted for rehabilitation on 2-13-2021. for a diagnosis of failure to thrive. Client is still at this facility as of this date.

Pt awoke the following day with weakness, presented to the emergency room for evaluation. Admitted to hospital on 2-19-21. Required 2L of oxygen by nasal cannula on 2-21-21. Discharged on 2-22-21 to home with home health to cont. and PT and OT.

Patient not talking, Chills, trembling hands and upper body, eyes staring upward, fever up to 101, fever decreased to normal in one hour after giving 325 gr. Tylenol

30 hours after the first Covid vaccination, the resident was lethargic, non responsive with shortness of breathe.

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

Patient developed tearing of the right eye on 2/24/21 followed by progressive right side facial weakness that resulted in an ED visit on 2/27/21.

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

Fever, chills, nausea and vomiting, weakness and soreness at injection site. Acute respiratory distress.

Systemic: lips numbness-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: patient had lip numbness after taking 2nd dose of COVID Vaccine

Asthenia; Nausea; Vomiting; A spontaneous report was received from a Pharmaceutical Company concerning a 90 Years-old male patient who received Moderna' s COVID-19 vaccine (mRNA-1273) and experienced nausea, vomiting, generalized weakness with a fatal outcome. The patient's medical history is aortic aneurysm, aortic stenosis, coronary artery disease, hypertension, cardiac heart failure, atrial fibrillation, HLD, ischemic heart failure, pacemaker, ventricular fibrillation, peripheral vascular shunt, palpitations, hypotension, and small bowel obstruction. No concomitant medications were provided. On 06 FEB 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. On 11 FEB 2021, the patient experienced the events, nausea, vomiting, generalized weakness. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 12 FEB 2021. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

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 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 called several hours after vaccine stating he has pain and weakness in leg. He was not sure if it was from covid shot or if he hurt it somehow

Bells Palsy, Paralysis of face, Prednisone for 7 days,. Hospital emergency room on the 18th of March to diagnosis.

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.

Patient has a lump under the skin at the injection site. This has led to some discomfort and unusual amount of pain that has him attempting to be seen by his primary provider. He has been urged to seek attention from an urgent care facility, but his response was, "I don't want to be a wimp about this, I'll hold out until I can see my primary doctor." This started almost immediately after his second dose. He received the first dose in the other arm 4 weeks prior without any reaction at all.

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.

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.

Per family member "his arm has been sore since he got the shot" Denied redness, swelling, warmth, etc.

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.

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.

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.

Within hours of receiving the second Moderna vaccine, the patient began experiencing excruciating pain in his lower back and sciatica. Consensus among the health professionals he saw is that the second vaccine triggered an inflammatory response. The pain did not respond to medication physical therapies.

Patient presented to ER on 5/22/21 complaining of left eye swelling and vision being blurred. Physician diagnosed as a corneal abrasion and left periorbital cellulitis. Patient came back to the ER on 5/24/21 complaining of left side of face drooping. Patient stated he noticed this the day prior. Patient was having difficulty closing his left eye. Today 5/24 he is drooping on the left side of his face and difficulty drinking water without running out of his mouth. No chest pain. According to physician, exam was most consistent with Bell's palsy but given patient's HTN, age and bounce back status, a CT was done. Everything was negative. Physician treated patient for Bell's Palsy with Valtrex and prednisone. This all happened within two weeks of receiving the 2nd dose of the Moderna Vaccine.

Patient with initial right arm pain and hand pain in the arm vaccine was given. He also had stiffness and loss of dexterity in the hand. He later developed arm swelling from elbow down to fingertips. That swelling resolved in about 1 month. The stiffness and dexterity of hand has improved but not back to normal 4 months later. Interestingly, patient developed same symptoms on his left arm after he had his second Moderna Covid vaccine on 3/4/21 in the left arm. That swelling is just now resolving.

Within 4-6 weeks of the second vaccine, patient started showing signs of shortness of breathe, swollen feet, cough, weak muscles, tired and no energy. patient had been walking with walker up to that point 5 times a week for 15-20 minutes. Since these symptoms began, he was not been able to walk more than a few feet without resting and being out of breath. He had been put on a diuretic and inhaler which didn't seem to be doing much. He saw his primary and heart Dr since the beginning of June. On June 24th he was admitted into the Hospital with Congestive Heart Failure. After blood tests, he was also diagnosed with Leukemia. A week later, on July 1, 2021, patient passed away.

Staff walked into resident's room around 10:00am and noted resident's left side of his face was flaccid. Nurse was called and upon assessment resident noted to have an unequal hand grasp with left worse. He was able to talk but was mumbled and hard to understand. Physician, hospice, and family were notified. Resident had a stroke at 10:06 am on 1/8/2020. He lost all ability to use his left side. Resident passed away on 1/11/2020.

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.

The following temperature log was kept on Resident: 13.25: 99.7; 18:45: 100.3; 120:01: 101.5; 21:45: 99; 23:00: 100. Resident began to run a fever of 99.7, by 18:45 it was 100.3, and then he was administered tylenol and nausea medications since he was vomiting. He vomited both of these up and retemp check was done and it was up still, but then went up as high as 101.5. Tylenol was given again and this time he was able to keep it on his stomach. Fever was finally reduced and has not returned to that extreme. He was weak and a fall rick, so a sitter was placed in the room with him to keep him safe from falling. He would not wear his normal CPAP machine during sleep time. Feeling much better today.

Received Moderna vaccine on 1/26/2021 in left deltoid. On 1/28/2021 an inflamed area noted to left arm that is warm to touch, tender, and lumpy. 100.0 temp noted and tylenol administered. 1/28/2021 APN and Doctor saw patient here at the facility for concerns of possible cellulitis and new orders received to circle area and notify doctor of increase in redness or any changes in condition, ice to left arm every 4 hours, and one time dose of benadryl allergy liquid. Concerned that patient may not have received the full dose of the Moderna vaccine as it appears that the injection was given too low that muscle may have been missed. Tylenol every 4 hours as needed is also ordered for discomfort . Awaiting to hear back on guidance as to if another dose needs to be given. Continuing to monitor at this time.

Patient was seen at 0710 he was sleeping but at normal cognitive behavior Patient was again assessed at 0720 where he was noted to be unresponsive, BP 180/100s, HR 230s, he was a DNR therefore not CPR was administered. EMS arrived at facility patient was noted to be in full cardiac and respiratory arrest. Time of death 0735

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.

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.

Died Narrative: Pt has a diagnosis of: Parkinson's Disease, severe AS, heart failure Symptoms include: dyphagia, aphagia, excessive secretions. Agency patient has been referred to: Hospice Code Status:DNR/DNI 90M with PMH notable for Afib, chronic aspiration, and dysarthria, severe aortic stenosis who presents3/5 with 2 weeks of generalized weakness and in ED noted to be in AFib w/ RVR to 130s, CT findings suggestive of volume overload with exam supporting this at time of admission, and also noting nonspecific generalized weakness. DC Home 3/9 Hospice

Resident ate a few small bites of pudding then refused. Resident then began with white, foul smelling emesis. Resident noted to be hunched over and clutching chest, unable to verbalize discomfort. BP 155/118 (manual) P 87 T 98.1 R 20. Out via 911 immediately.

First shot 1-20-2021 Immediate flushing with hot ears upon injection. Lasted all day. Sore arm at injection site lasted two days. Leg and back pains in three days which disappeared within the day. February 4, 2021 entire body got cold. 15 minutes later cold chills and shivers for an hour. Went to hospital emergency where treated for blood infection with intravenous antibiotics for 6 days. Then home treated with intravenous antibiotics with home health care until February 22, 2921. Experienced many long period cold spells of entire body both in hospital and home. Still get them until this date on occasion. I am very sensitive to cold.

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.

Leg and hip weakness, Swelling of leg and feet. Acking legs, cramping legs and feet. Shortness of breath, eyes not focusing

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.

No treatment - Very sore arm - red streak below injection 2 in" wide and 4 in" long Spent next day (Friday) after shot in bed most of the day. Didn't eat all day - wasn't hungry. Felt all washed out, no energy - much like COVIT that I contacted 1st week of August 2020 - but not as bad The next day (Saturday)I felt much better with some energy. Ate a good breakfast

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.

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

Patient with severe muscle weakness with tremulousness 3 days post-vaccination, and subsequently patient developed new onset seizure like activity on 2/20/2021 around 3:30 pm requiring admission to the hospital for further evaluation and monitoring. All events occurred within the 14-day period post vaccination.

AFib; Jaw and tooth pain; Jaw and tooth pain; Rapid heartbeat/Rapid pulse; Extreme weakness; Irregular heartbeat; blood pressure was 142/80; A spontaneous report was received from a consumer concerning a 92-years-old, male patient who experienced AFib (atrial fibrillation), rapid heartbeat/rapid pulse, extreme weakness, irregular heartbeat, blood pressure was 142/80, jaw and tooth pain. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included levothyroxine sodium, metoprolol tartrate, pravastatin, fexofenadine, vitamin D, acetylsalicylic acid, fluticasone propionate and latanoprost. On 04 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 004M20A] intramuscularly in the for prophylaxis of COVID-19 infection. On 04 Feb 2021, the patient woke up that night with jaw and tooth pain. He later experienced rapid heartbeat, extreme weakness, irregular heartbeat, rapid pulse and AFib (atrial fibrillation) which was confirmed by his primary care physician (PCP) on 06 Feb 2021. On 08 Feb 2021, patient repoted his blood pressure was 142/80. Treatment for the event included metoprolol IV. Action taken with mRNA-1273 in response to the events was not provided. The events rapid heartbeat/rapid pulse and extreme weakness were considered recovered/resolved or on 08 Feb 2021 and the outcome of the events AFib (atrial fibrillation), irregular heartbeat, blood pressure was 142/80, jaw and tooth pain were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

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.

In the early morning hours of Saturday 2/27, Dad woke with severe pain in his right arm, shoulder and shoulder blade. He realized the right side of his neck was swollen and his throat was swollen as well. He was having trouble swallowing, talking and his breathing felt obstructed. He tried to awaken my Mother but she couldn't understand what he was saying. He finally managed to get up with on walker and make his way to get a drink of water. After that his throat seemed to loosen up some and by later in the morning the swelling had subsided. He did not inform me until I called later in that morning to check on them and he did not feel he needed to see a doctor.

Patient admitted 2/12 for COVID pneumonia. Started to feel unwell approximately 2-3 days after receiving the vaccine. Presented to ED with cough and weakness. Patient treated with remdesivir/dexamethasone, improved and was discharged 2/14. Readmitted 2/19 for further pneumonia. Improved but requiring 5L of O2. Discharged to rehab 3/1.

Hospitalized February 28, 2021 with acute cerebrovascular accident with left hemiparesis, 4 days after vaccine

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

On the morning of 2/22/21 Patient was found by care staff to have signs of stroke as evidence by left sided facial drooping. EMS were called and he was taken to a local hospital where he was admitted. He then was discharge to a skilled nursing facility for rehabilitation. He is still there as of today, 3/11/2021.

48 hours diarrhea and weakness, unable to keep fluids down, admitted to hospital through ED for diarrhea, stool culture, IV fluids. Discharged after 4 days diagnosis gastroenteritis/norovirus, dehydration and hypokalemia

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.

ice cold body; shivering-chills; leg pain; back pain; head pain; injection site soreness; shoulder pain; flushing; cramping neck pain; red hot ears; A spontaneous report was received from a 92-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flushing with red hot ears (ear discomfort), mild soreness at the injection site (vaccination site pain), right-sided cramping neck pain (muscle spasms) accompanied by shoulder pain (arthralgia )radiating to the head (headache), leg pain (pain in extremity), back pain, body became ice cold, chills and shivering (chills). The patient's medical history, as provided by the reporter, included pulmonary fibrosis, sleep apnea, acid reflux and prostatitis. Concomitant medications reported included aciphex and ativan. On 20 Jan 2021, approximately two weeks prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient experienced immediate flushing with red hot ears which persisted throughout the day and mild soreness at the injection site lasting approximately 24 to 48 hours. He experienced two instances of right-sided cramping neck pain accompanied by shoulder pain radiating to the head, lasting 5 to 10 minutes per episode between 20 Jan 2021 and 04 Feb2 021. These episodes were brief and have not returned and awaking to both legs and his back "filled with pains" on 23 Jan 2021. The leg pains subsided upon standing; back pain lasted all day 23 Jan2 021. The patient felt normal from 24 Jan 2021 until 04 Feb 2021. On 04 Feb 2021, the patient's whole body became ice cold at approximately 3PM. By 3:15PM he was experiencing chills and shivering that lasted approximately one hour. Patient called his physician, and was directed to the Emergency Room (ER) immediately. There he received blood tests and prophylactic broad spectrum antimicrobial therapy immediately upon admission. Patient reports that Infectious Disease confirmed there were two strains of bacteria present in his bloodstream. From the patient additional samples were collected for culture to tailor antimicrobial therapy accordingly. He also said he was hospitalized for six days and discharged on 10 Feb 2021 with at home Iintravenous (IV) infusion device to administer continuous (24 hour) antibiotic therapy for a full 14 days. He was released from the hospital to his daughter's care. He had no history of significant adverse events or allergic reactions post vaccine administration. He is concerned about the origin of the infection, as no source could be confirmed per Infectious Disease. The patient is concerned the infection could have stemmed from the vaccine or it's administration. He attests that his physician wants him to proceed with his second dose of Moderna. Action taken with mRNA-1273 in response to the events is unknown. The events, flushing with red hot ears, mild soreness at the injection site, right-sided cramping neck pain accompanied by shoulder pain radiating to the head, leg pain, back pain, body became ice cold, chills and shivering were considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Narrative: Per law enforcement report, patient's death appears to be natural causes. Wife found 91 yo patient on the floor having seizures. Patient was treated for seizure disorder and had recent Primary Care visit with updated labs. Seizure medication lab monitoring was monitored with no concerns.

Stroke; Heart Attack; loss of appetite; weak in the legs; felt achy; felt yucky; felt queasy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and MYOCARDIAL INFARCTION (Heart Attack) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included PANTOPRAZOLE for an unknown indication. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced DECREASED APPETITE (loss of appetite), MUSCULAR WEAKNESS (weak in the legs), PAIN (felt achy), DISCOMFORT (felt yucky) and NAUSEA (felt queasy). On 12-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization, medically significant and life threatening) and MYOCARDIAL INFARCTION (Heart Attack) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized on 12-May-2021 due to CEREBROVASCULAR ACCIDENT and MYOCARDIAL INFARCTION. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), MYOCARDIAL INFARCTION (Heart Attack), DECREASED APPETITE (loss of appetite), MUSCULAR WEAKNESS (weak in the legs), PAIN (felt achy), DISCOMFORT (felt yucky) and NAUSEA (felt queasy) outcome was unknown. Treatment information was not provided. The reporter reported that the patient did not have any medical conditions to cause the events. This case was linked to MOD-2021-132255 (Patient Link).; Sender's Comments: This case concerns a 92-year-old male with serious unexpected events of cerebrovascular accident and myocardial infarction, and nonserious unexpected decreased appetite, muscular weakness, pain, discomfort and nausea. Latency 1 day after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

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.

The day after receiving second shot of Moderna vaccine I felt very weak, had chills and felt generally malaise. On the next day I felt much better with some very less side effects. I only had a slightly sore arm sore arm, which didn't bother me. The first shot gave me no side effects.

Massive ischemic stroke with aspiration, unable to arouse on the morning of 1/21/2021 and placed on Hospice with death 1/24/2021

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

Another customer in the store called over to the technician and pharmacist on duty stating the patient looked sick. He had dropped his timer that was counting down his 15 min post dose wait time. Pharmacist approached patient and asked him how he was doing. He was initially non-responsive, eyes were slightly glazed over. I repeatedly asked him his name and how he was doing. He began to respond after prompting, saying he felt very hot and sweaty. He stated he was thirsty and he hadn't eaten anything before his dose. Technician obtained a glass of water and a granola bar for the patient. Patient began to improve just minutes after food and water. He stated he thought he had stood for too long while waiting for his shot and hadn't eaten that morning so he began to feel sick. Patient recovered enough to call his daughter to pick him up from the store. His daughter arrived to pick him up and patient was able to walk out of the store without issue.

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.

The evening after vaccine she had trouble speaking and fatigue 3/2020. She went to lay down and outx 24 hours, on 3/21 friends were not able to wake her and went to the hospital where she was admitted. Had BP at the time of 220/100s. She was treated for PRES with seizure started on Keppra. She was discharged from the hospital 3/27

Patient is a 93 y.o. male patient who originally presented to the hospital on 4/6/2021 due to generalized weakness. Patient found to have COVID infection as well as UTI. Patient was started on remdesivir and IV antibiotics. Patient did not requiring oxygen. Patient did have decreased appetite which did slightly improve upon discharge. Patient did not require oxygen throughout hospitalization. Clinically stable for discharge home. Will discharge on oral antibiotics to complete course of therapy. Advised to follow up with PCP as outpatient in 1-2 weeks.

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.

started having generalized weakness on 1/21/21, fatigued., nausea/vomiting. went to doctor on 1/25/21 with complaint of sore throat, cough, and felt congested. Went to ER on 1/25/21 with complaints of increased shortness of breath, worsening nausea and vomiting. started on oxygen for sats of 87%. admitted on 1/25/21. On 1/26/21 needed intubated, CXR showed worsening consolidative change right lung at right hilar level. Echocardiogram showed ejection fraction 35-40%, left atrium is moderately dilated.

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.

low grade UTI; collapse; been kind of weak; A spontaneous report was received from a consumer, who was the caregiver of a 94-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection (UTI), collapse (syncope), and weak (asthenia). The patient's medical history was provided. Concomitant product use was not provided. On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number 029L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. The patient was hospitalized for a UTI from 10 Feb 2021 to 12 Feb 2021. The reporter stated, "after that, he's been kind of weak and everything". The reporter indicated it was a "low grade" UTI and the patient didn't show any symptoms but then stated "it actually had him collapse and he did that in between the two vaccines and spent two days in the hospital." On 17 Feb 2021, the patient received his second of two planned doses of mRNA-1273 (batch number 012M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. The patient received both planned doses of mRNA-1273; therefore, the action with mRNA-1273 in response to the events was not applicable. Treatment for the UTI included nitrofluorine. 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 start date of these events, a causal relationship cannot be excluded

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 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.

mini-strokes which have increased in frequency; placed on low-dose seizure medicine Aptiom 200 and Aspirin 325 to prevent further seizures; Wheezing; Shortness of breath; Headaches; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (mini-strokes which have increased in frequency) and SEIZURE (placed on low-dose seizure medicine Aptiom 200 and Aspirin 325 to prevent further seizures) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013l20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included ACETYLCYSTEINE, CALCIUM LEVOMEFOLATE, MECOBALAMIN (CEREFOLIN NAC [ACETYLCYSTEINE;CALCIUM LEVOMEFOLATE;MECOBALAMIN]), COLECALCIFEROL (VITAMIN D3) and AMOXICILLIN SODIUM (AMOXICILLIN [AMOXICILLIN SODIUM]) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (mini-strokes which have increased in frequency) (seriousness criterion medically significant), SEIZURE (placed on low-dose seizure medicine Aptiom 200 and Aspirin 325 to prevent further seizures) (seriousness criterion medically significant), WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), HEADACHE (Headaches) and MYALGIA (Soreness in arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date for Seizure prophylaxis, at a dose of 325 dosage form and ESLICARBAZEPINE ACETATE (APTIOM) ongoing since an unknown date for Seizure prophylaxis, at a dose of 200 milligram. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (mini-strokes which have increased in frequency) had not resolved and SEIZURE (placed on low-dose seizure medicine Aptiom 200 and Aspirin 325 to prevent further seizures), WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), HEADACHE (Headaches) and MYALGIA (Soreness in arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Magnetic resonance imaging: mini-strokes (abnormal) mini-strokes were confirmed via MRI. The patient's caregiver reported the patient stopped taking amoxicillin 875-125 prior to receiving the second dose of the vaccine. After receiving the second vaccine, he began to experience a repeat of symptoms similar to those after the first dose which were described as a number of mini-strokes which increased in frequency. The patient was treated and released in an emergency room (less than 24-hour stay). It was reported the mini-strokes occurred within 24 to 72 hours post-vaccination. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-207709 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Completed 2 dose vaccination series on 1/30/21 w/ Moderna Vaccine. Admitted 7/28/21 to Medical Center w/ complaints of weakness, body aches, dry cough. COVID PCR+ on 7/28. Also patient in atrial fibrillation. So far treated w/ dexamethasone, remdesivir x 1, vitamin D, zinc, vitamin C; O2 has improved from 3L NC to room air (sat 92-94%).

ON 1/21/2020 RESIDENT WAS EXPERINCING CHILLS AND LOOSE STOOLS. FOLLOWING THIS EPISODE BECAME UNRESPONSIVE, PALE, DIAPHORETIC AND BRADYCARDIC. PALLIATIVE CARE WAS PROVIDED. RESIDENT PASSED AWAY APPROX. 10 HOURS LATER.

Patient developed shortness of breath and weakness the morning after he received the COVID vaccine. He also reported diarrhea and fatigue. Per the patient he went to 2 urgent cares before being referred a day or 2 later to the emergency department. The patient was diagnosed with NSTEMI and later transferred hospital.

He vaccine on 2/5/2021 I went to see my husband the next day he was shaking and his mouth was open shaking, and he had fever of 105, they gave him Tylenol suppositories and he passed away 2 hours later. They should not have given him should not have given him the vaccine that is on hospice, it was not the right decision. I am worried about the elderly and those very sick.

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.

Stroke / right CVA (Cerebrovascular accident); Left side instability when walking; Cognitive memory a little unsure; left side face affected; Rash was itchy / Knees were very itchy; Rash was red; Feet drooping on left side / Feet more slurred than usual; Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)) (seriousness criterion medically significant), ATAXIA (Left side instability when walking), COGNITIVE DISORDER (Cognitive memory a little unsure), FACIAL DISCOMFORT (left side face affected), PRURITUS (Rash was itchy / Knees were very itchy), ERYTHEMA (Rash was red), PERONEAL NERVE PALSY (Feet drooping on left side / Feet more slurred than usual) and RASH (Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)), ATAXIA (Left side instability when walking), COGNITIVE DISORDER (Cognitive memory a little unsure), FACIAL DISCOMFORT (left side face affected), PRURITUS (Rash was itchy / Knees were very itchy), ERYTHEMA (Rash was red), PERONEAL NERVE PALSY (Feet drooping on left side / Feet more slurred than usual) and RASH (Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information mentioned. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Patient had presented these reactions a month after their second dose of the vaccine. 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.

Right arm weakness, right hand numbness, leg weakness, fatigue, blurred speech, small eschemic stroke right side

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).

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 his second dose of the COVID-19 vaccine on February 17, 2021. Per family, he complained of feeling chilly and cold. He was found deceased in the early morning on February 18, 2021.

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.

2/9/2021 3:29 pm RESIDENT HAVING CHILLS, NAUSEA, VOMITING POST COVID VACCINE. 2/10/2021 07:45 am- Resident noted sitting up in W/C in room with head down. Required increased assist with standing. While eating breakfast he took longer than usual to finish due to dozing off multiple times. BP 178/76. Was experiencing N/V and low grade temp on yesterday Order received to send to ER for eval.

He suffered a seizure. Shaking (entire body) Labored Breathing, Not responding. Called 911. Taken to Emergency Room.

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.

march 13th -first covid vaccine (moderna) march 3/25: abdnormal movements noted Right arm followed by right leg...hospitalized from 3/25 to 3/29. Neuroimaging negative for acute changes (records requested for review but not received by me yet) Seen by me in telemedicine 4/1; he exhibited choreatheoid movements of right upper extremity and to a lesser extent, his right leg. These seemed lower in amplitude than typical hemibalismus movements. He was unable to control these movements (they were involuntary in my assessment) and followed commands with left side without problem. Neurology consult was requested at the 4/1 visit but has not been completed as of today (4/15). On follow up (4/15) patient and daughter inform me that these abnormal movments gradually decreased and had grossly resolved as of april 9th 2021

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.

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.

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.

- 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

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.

Patient had received second dose of the Moderna COVID vaccine. Within less than 5 minutes of his observation period, patient began having uncontrolled movements of his arms and legs. Patient was A/Ox4 and denied any pain, shortness of breath, chest pain and any other medical complaints. 911 was contacted and EMS was notified. Patient has not experienced this in the past and has no known history of neurological disease according to family member on scene. Patient had no adverse reaction after his first dose of the Moderna vaccine. Patient reports no unusual change to daily routine or medication regime. Patient had no abnormal breathing, radial pulse was within normal limits and skin was warm and dry. Patient was unable to safely sit in chair and was moved to reclining chair where he was left in the semi fowlers position. Patient continued having uncontrolled movements approx. once every 10-20 seconds. Patient was able to talk the entire time and had no change in mental status. EMS arrived on scene and patient care was transferred.