Moderna

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

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..

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

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.

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

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.

Woke with severe Body Aches , chills and fatigue Two days later shoulder pain, rash at swollen site.

2/23 5am diarrhea in bed with some blood; 24th diarrhea, 2 bouts in a.m. at 7 pm stomach pain, gas, nauseus sweating chills, 25th woke up feeling better, but in the night again complained of stomach pain and nausea; on 26th again some liquid diarrhea in bed (Blood?) Since 28th no problems

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

Received Moderna Vaccine 1st dose on 2/24/2021. Went for a cystoscopy and biopsy on 3/8/2021. On 3/9/2021 was sent to the ER and admitted for acute renal failure, UTI, and dehydration.

On 2/18/2021 the resident spiked a fever of 101.7 and had decrease oxygen saturation down to 86% with a cough. The resident was transferred to the ER for evaluation. Per Advanced Directives resident was not treated with antibiotics and returned to the Nursing Home on 2/19/2021. The resident had several episodes of emesis and was placed on comfort measures. He dised on 2/25/2021.

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.

Acute renal failure; Dehydration; Urinary tract infection; A spontaneous report was received from a nurse concerning a 90-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed acute renal failure/acute kidney injury, urinary tract infection, dehydration and vaccine administered intramuscularly in the right thigh. Medical history or concomitant medications were not reported. On 24 Feb 2021, the patient received his first planned dose of mRNA-1273 (batch number: 029K20A) intramuscularly in the right thigh for prophylaxis of COVID-19 infection. On 08 Mar 2021, he went for cystoscopy and bioscopy with unknown results. On 09 Mar 21, he was sent to the ER for acute renal failure, dehydration and Urinary tract infection (UTI). He was admitted to the hospital. The events acute renal failure and urinary tract infection were considered to be medically significant. The action taken with mRNA-1273 in response to the acute renal failure, dehydration and Urinary tract infection was unknown. The outcome of the events acute renal failure, dehydration and Urinary tract infection was not provided. The outcome of the event, vaccine administered intramuscularly in the right thigh, was considered resolved on 24 Feb 2021. The reporter did not provide any causal relationship between mRNA-1273 and the events acute renal failure, dehydration and Urinary tract infection.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient 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.

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.

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.

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.

Heart had stopped for 4 minutes; Some coronary incident; went to emergency room because wasn't feeling well; Fractured ribs; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of CARDIAC ARREST (Heart had stopped for 4 minutes), CORONARY ARTERY DISEASE (Some coronary incident), MALAISE (went to emergency room because wasn't feeling well) and RIB FRACTURE (Fractured ribs) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The patient's past medical history included Multiple myeloma (Had multiple myeloma treatments in past 13 years and I'm in remission. Had multiple chemotherapies for them throughout since the year 2008.) in 2008. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced CARDIAC ARREST (Heart had stopped for 4 minutes) (seriousness criteria hospitalization, medically significant and life threatening), CORONARY ARTERY DISEASE (Some coronary incident) (seriousness criteria hospitalization, medically significant and life threatening), MALAISE (went to emergency room because wasn't feeling well) (seriousness criteria hospitalization, medically significant and life threatening) and RIB FRACTURE (Fractured ribs) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized on 24-Apr-2021 due to CARDIAC ARREST, CORONARY ARTERY DISEASE, MALAISE and RIB FRACTURE. The patient was treated with Manual therapy (CPR) for Cardiac arrest and Rehabilitation therapy for Rib fracture. At the time of the report, CARDIAC ARREST (Heart had stopped for 4 minutes), CORONARY ARTERY DISEASE (Some coronary incident), MALAISE (went to emergency room because wasn't feeling well) and RIB FRACTURE (Fractured ribs) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were provided. The patient went to emergency room because he wasn't feeling well. The patient was treated (details not provided) for 6-7 hours and assigned him the room. According to the patient, he did not remember anything after that. He woke up next day with all the tubes in him. Reportedly, his heart had stopped for 4 minutes and he had some coronary incident. The patient was given CPR to bring him back and due to that, he had fractured ribs. He was discharged after 5 days to a rehabilitation facility. No other information provided. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant information not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.

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.

pt rep states patient was hospitalized after receiving first dose of moderna vaccine. he became severely ill and was diagnosed as having 20 bleeding ulcers

Possible Kidney Infection; Possible Pneumonia; Passed away; Low Iron Levels; Lack of appetite continued after first shot; Nauseous; Felt Cold (Chills); This spontaneous case was reported by an other caregiver and describes the occurrence of KIDNEY INFECTION (Possible Kidney Infection), PNEUMONIA (Possible Pneumonia) and DEATH (Passed away) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Aspiration pneumonia (Had Aspiration Pneumonia prior to vaccination and was hospitalized.), Stent placement (Received a heart stent 7 years ago.), Heart valve replacement on 12-Jan-2021 and Intubation. Concomitant products included AMIODARONE and HYDROCHLOROTHIAZIDE (DIURETIC [HYDROCHLOROTHIAZIDE]) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Felt Cold (Chills)). On 14-Mar-2021, the patient experienced KIDNEY INFECTION (Possible Kidney Infection) (seriousness criteria death, hospitalization, medically significant and life threatening), PNEUMONIA (Possible Pneumonia) (seriousness criteria death, hospitalization, medically significant and life threatening), DECREASED APPETITE (Lack of appetite continued after first shot), NAUSEA (Nauseous) and BLOOD IRON DECREASED (Low Iron Levels). On 23-Mar-2021, DECREASED APPETITE (Lack of appetite continued after first shot) and BLOOD IRON DECREASED (Low Iron Levels) outcome was unknown and CHILLS (Felt Cold (Chills)) and NAUSEA (Nauseous) had resolved. The patient died on 23-Mar-2021. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Blood iron: (Low) Had very low Iron levels.. On an unknown date, Polymerase chain reaction: (Negative) Had several Negative PCR tests every time he was hospitalized. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter states that her Husband passed away on 23MAR2021 but his death was not vaccine related. Had damaged his esophagus while intubating him. He was not doing great but he was functional prior to vaccination. On 14MAR2021 he was hospitalized. Doctors did not know what was wrong with him. His doctor stated that he had Kidney infection or pneumonia but all tests were normal. Reporter stated that the Doctors do not know what was happening to him but it was not vaccine related. Concomitant medications included Defibrillator along with above mentioned medications.; Sender's Comments: This fatal case concerns a 90-year-old male hospitalized with serious unexpected events of kidney infection, pneumonia, death and nonserious decreased appetite, blood iron decreased, chills and nausea. Event latency 11 days after first 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.; Reported Cause(s) of Death: Possible Kidney Infection; Possible Pneumonia; Passed away

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.

90 y.o. Nursing home resident with comorbidities including oxygen dependent CHF with gradual declining course prior to 1st dose of COVID 19 Moderna vaccine died 12 days after receiving 2nd dose. Resident experienced increased dyspnea and hypoxia 5 days after receiving 2nd dose.

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

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.

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.

Inflamed area noted to left arm that is warm to touch, tender, and lumpy; Inflamed area noted to left arm that is warm to touch, tender, and lumpy; Inflamed area noted to left arm that is warm to touch, tender, and lumpy; Inflamed area noted to left arm that is warm to touch, tender, and lumpy; 100.0 temp; Possible cellulitis; It appears that the injection was given too low that muscle may have been missed; May not have received the full dose of the Moderna vaccine; A spontaneous report was received from a nurse, concerning a 91-year-old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced inflamed area noted to left arm that is warm to touch, tender, and lumpy, 100.0 temp, may not have received the full dose of the Moderna vaccine, it appears that the injection was given too low that muscle may have been missed, and possible cellulitis. The patient's medical history was not provided. Concomitant medications were not reported. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K208) intramuscularly in the left arm for the prophylaxis of COVID-19 infection. On 26 Jan 2021, at the time of the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly in the left deltoid for the prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient may not have received the full dose of the Moderna vaccine as it appeared that the injection was given too low that muscle may have been missed. On 28 Jan 2021, the patient experienced an inflamed area to the left arm, that was warm to touch, tender, and lumpy. The patient also had fever of 100.0 Fahrenheit (F). He was being evaluated for concerns of possible cellulitis Treatment for the events included paracetamol and diphenhydramine. 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 events, inflamed area noted to left arm that is warm to touch, tender, and lumpy, 100.0 temp, may not have received the full dose of the Moderna vaccine, and possible cellulitis, were considered unknown. The events, it appears that the injection was given too low that muscle may have been missed and may not have received the full dose of the Moderna vaccine, were considered resolved on 26 Jan 2021.; Reporter's Comments: This case concerns a 91-year-old, White, male, who experienced a Product administration error, Incorrect dose administered, and non-serious unexpected event of injection site cellulitis, injection site warmth, and non-serious expected events of injection site swelling, injection site pain, and pyrexia. There were no reported AEs associated with this case of a Product administration error and incorrect dose administered. The events occurred 2 days after mRNA-1273 (Lot# 039k208). Treatment included Tylenol and Benadryl. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.

Patient was admitted to hospital on 2-9-21 for urinary tract infection and tested positive for Covid. Developed pneumonia and expired on 2-12-21.

Resident went out of facility to the Fairgrounds on 2/25/21 for an appointment at 11:30 to receive second dose of Moderna vaccine. Someone from the local Fire Department came to the facility and administered another dose to the patient on 2/25/21 at 3:30pm but actually administered to the wrong patient. on 2/25/21 at 6:20pm, the patient experienced respiratory distress. Pulse oximetry was 85%. BP 175/86. Pulse was 102. Temperature was 102.2. Nurse manager at the facility was notified and when she and the nurse spoke to each other, the patient stated he had two vaccines today. This was when the double dose was discovered. The patient was sent out to the hospital emergency department and was admitted. The patient was on a bipap overnight. Condition has improved this morning.

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.

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.

Not an adverse event. Pt has tested positive for Covid after being fully immunized. Pt has dry cough and feels a little run down but otherwise feels well overall. No fevers, no dyspnea. Exposure to daughter and son in law who are Covid positive. Is not hospitalized. Seems to be recovering well.

On 1/6/21, 91 yo M amb to ER with c/c of allergic reaction to COVID x 1 day. Pt receive COVID vaccine Moderna Jan 3, 2021. Pt c/o fever, n/v, lower back pain, SOB, dark colored urine. Jaundice noted to bilat sclera and generalized skin. Patient hospitalized and discharged on 1/17/21. Admitting diagnosis was pneumonia, hepatitis, acute repiratory failure with hypoxia and acture renal failure. Patient was treated for sepsis due to acute cholangitis and completed 10 day course of IV zosyn

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

Chills, fever, thready pulse, decreased BP leading to transport via ambulance on 12/18/2020 to hospital and admission from ER to hospital for sepsis, hospitalization and discharge on 12/22/2020.

About 1 and 1/2 month later on 4/4/2021, I got a rash on my head and came down on my right side and chest and back. It was very itchy, red and very painful. I went to the dermatologist right away and was diagnosed with Shingles infection. The doctor gave me an injection (don't remember name) and prescribed Valtrex and Pepcid. The medication did not help resolve the shingles and it got worse. I went to the hospital 4/6/2021 and I was admitted to the hospital for 7 days. I was admitted because I was dehydrated and had an allergic reaction to the shot the dermatologist gave me. I also pneumonia and septic. They ran every test they could run and gave me antibiotics for the pneumonia and infection. I was discharged to follow up PCP.

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

The resident resides in an independent living facility/apartment. The reporter at the center was informed by his daughter he was not feeling well on 1/1/2021 (specific symptoms could not be ascertained). He reportedly went to be COVID tested on 1/1/2020 and observed to be deceased in his apartment on 1/2/2020. I do not have confirmation of his COVID results, although the reporter indicates his daughter reports his test was positive.

Received vaccine on 1/26/2021 at 10:30am and at 2134 was observed to be having difficulty with breathing and cyanotic when staff entered his room. He was coughing and sounded congested. He was repositioner and SPO2 78% on room air so O2 applied at 2L which increased SPO2 88% so O2 increased to 4L and SPO2 increased to 95%. Temp 103.1, B/P 188/110, resp 28, pulse 128. 911 called and sent to Community Hospital ER at 2145. Received call from hospital reporting diagnosis of right sided pneumonia. He had received his 1st dose on 12/29/2020. On 1/8/2021 he was on droplet isolation due to possible exposure of Covid 19 and receiving duoneb treatments for chronic nonproductive cough.

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

Woke up morning after vaccine injection with fever of 102° Did not immediately respond to Tylenol within first hour. By 12 noon, fever subsided Normal body temperature by 1pm.

Narrative: Developed "penny sized" erythematous rash around injection area that he noticed on the same day of the initial vaccination, which persisted for about a week before resolving. Associated with pruritus and fatigue, but no warmth to touch, induration, swelling or sloughing. He denied any other adverse effects. No therapies tried or applied.

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

right sided pneumonia; having difficulty breathing; cyanotic; coughing; sounded congested; A spontaneous report was received from a nurse concerning a 92-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right sided pneumonia, difficulty breathing, cyanotic, cough and sounded congested. The patient's medical history, as provided by the reporter included Alzheimer's, hypertension, arteriosclerotic heart disease, hyperlipidemia, benign prostatic hyperplasia, prostate cancer, covid-19, allergy to aricept and exelon. The concomitant medications reported included atorvastatin, tamsulosin hydrochloride, paracetamol, macrogol 3350, furosemide and ipratropium bromide/salbutamol sulfate for unspecified indications. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 039k208) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient was on droplet isolation due to possible exposure of Covid 19 and received duoneb treatments for chronic nonproductive cough. The patient also received honey consistency fluids. On 19 Jan 2021, the patient's droplet precautions were discontinued. On 26 Jan 2021, after receiving the vaccine, the patient experienced difficulty breathing, cyanotic, cough and sounded congested following which the patient was repositioned. The lab findings included oxygen saturation at 78 percent on room air, so oxygen was applied at 2L which increased oxygen saturation at 88 percent, so oxygen was increased to 4L and oxygen saturation increased to 95percent, body temperature at 103.1 degree Fahrenheit, blood pressure 188/110 mmHg, respiratory rate at 28 breaths per minute, pulse rate at 128 heartbeat per minute. The patient was then sent to the Hospital emergency room (ER) where he was diagnosed with right sided pneumonia. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, right sided pneumonia, difficulty breathing, cyanotic, cough and sounded congested was unknown.; Reporter's Comments: This case concerns a 92-year-old, male patient. The patient's medical history od Alzheimer's, hypertension, arteriosclerotic heart disease, prostate cancer, covid-19, on duoneb treatments for chronic nonproductive cough remains as contributing factors. Very limited information regarding this event has been provided at this time. Further information has been requested.

He had rigors starting 6 pm the day after the vaccination. He was treated with one 500 mg tylenol. He had increased wheezing but did not complain of SOB. At 0400 the next morning, he died.

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.

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.

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.

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

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.

He received Moderna Vaccine on 02/16/2021 and 03/16/2021. No reactions developed after two vaccinations. 7.7.21: Patient developed difficulties of breathing one week and presented to ER on 7/7/2021 and has been hospitalized since 07/07/2021. Presented with cough, chest pain, and shortness of breath. Diagnosed with pneumonia 7.11.21: discharged home.

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.

Resident expired on 2/5/21 at 03:35pm, about 25 hours after second dose of vaccine. At breakfast, resident was spitting a lot of secretions, coughing up liquids from nose and phlegm, facial swelling, which were all symptoms that he was struggling with prior to both doses of COVID vaccine, but had increased more than prior incidences on 2/5/21. Gurgling noted in upper airways, hyscolamine given, bath given to loosen secretions, morphine given. Family notified and came into facility for compassionate care visit around 1300. 1400 HR was 3 and RR was 2, but increased back to 60 and 12 within 20 minutes. Then resident expired at 1535.

Dad reports that he is exhausted, achy, and has an upset stomach and food does not taste or sound good. He said he?s feeling a little better right now but he feels he got a second setback from the vaccine

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.

Very harsh dysrhythmia; Parkinson's symptoms got worse with joint contractions, stiffening, and confusion; Napping more; Blood pressure has been haywire, sometimes going high and sometimes low; A spontaneous report was received from a consumer, who was also the daughter of a 93-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a very harsh dysrhythmia (arrhythmia), Parkinson's symptoms got worse with joint contractions, stiffening, and confusion (Parkinson's disease); he has been napping more than before (somnolence), and blood pressure has been haywire, sometimes going high and sometimes low (hypertension, hypotension). Medical history, as provided by the reporter, included COVID in July 2020 from which he fully recovered, slight dysrhythmia, Parkinson's (tremors only), and slightly elevated blood pressure. The reported stated the patient's baseline health had been pretty good and he was usually mobile, active, cognitive, and had speech. Concomitant medications included carbidopa monohydrate (+) levodopa, losartan, beta blocker (unspecified), and liquid morphine. On 20 Jan 2021, one day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 028L20A) intramuscularly in his right (dominant) arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, around 2 pm, the patient had "a very harsh" dysrhythmia and his Parkinson's symptoms worsened with joint contractions, stiffening, and confusion. He had also been napping more than before. Since getting the vaccine, his blood pressure "has been haywire", sometimes going high and sometimes low. Treatment information was not provided. The action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, a very harsh dysrhythmia, Parkinson's symptoms got worse with joint contractions, stiffening, and confusion; napping more than before, and blood pressure has been haywire, sometimes going high and sometimes low, were considered not recovered/not resolved at the time of this report.; 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.

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.

COVID symptoms started within 8-9 days of vaccination. No fever, general not feeling, chills. Turned into very difficult breathing, low oxygen levels and pneumonia. Tested positive for COVID at Hospital ER on Wednesday, January 27. Died in the hospital Saturday morning, January 30, 2021.

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.

Temperature of 103.3, hypotensive requiring vasopressors. Family did not want to continue, patient was switched to comfort care and admitted to hospital. Patient rapidly improved after 24 hours and continued to improve. Hypotension resolved. Patient was discharged to home.

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

Dad became very sleepy the day after. He quickly declined and died on Feb. 7 th. I feel the vaccine may have had something to do with his death.

Tested positive for COVID-19 on 4/16/21. Symptoms worsened at home and home care nurse sent patient to emergency department. On 4/20/21 he presented to ED with shortness of breath and fatigue. He was then admitted for further management.

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.

hospice care; Coughing up mucus; Couldn't swallow food because of mucus build up; lost a lot of weight; Went from very active to very inactive and rapid decline; tired/ asthenia; This spontaneous case was reported by a consumer and describes the occurrence of HOSPICE CARE (hospice care) 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. The patient's past medical history included Hospice care since an unknown date. Concurrent medical conditions included Smoker and COPD (Patient was diagnosed with Chronic Obstructive Pulmonary Disease although his oxygen level is at 99). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HOSPICE CARE (hospice care) (seriousness criterion disability), PRODUCTIVE COUGH (Coughing up mucus), DYSPHAGIA (Couldn't swallow food because of mucus build up), ABNORMAL LOSS OF WEIGHT (lost a lot of weight), LETHARGY (Went from very active to very inactive and rapid decline) and FATIGUE (tired/ asthenia). At the time of the report, HOSPICE CARE (hospice care), PRODUCTIVE COUGH (Coughing up mucus), DYSPHAGIA (Couldn't swallow food because of mucus build up), ABNORMAL LOSS OF WEIGHT (lost a lot of weight), LETHARGY (Went from very active to very inactive and rapid decline) and FATIGUE (tired/ asthenia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 99 (Inconclusive) Inconclusive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medication were reported No treatment information was provided Reporter was not sure if it was the Moderna 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. This case was linked to MOD-2021-236538 (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.

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

Extreme fatigue, been in bed for 2 days, from top of head to the middle of chest extreme pain, can't move neck,

Has developed rash around injection site about 5 inches in diameter and it is red at the injections site. Patient reports not feeling well in general. Sent picture to his provider and left message with provider.

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.

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.

2/14 Emergency room HPI Patient is a 94 y.o. male who presents with complaint of cough that started about a week ago, and was seen by primary care provider on the 9th February 2021. Patient was started on Augmentin and has taken it for about 5 days but said the cough is worse and productive of clear sputum. Patient in ER to get checked for pneumonia. Patient denies a fever or chills, shortness of breath, chest pain, nausea vomiting and no headache or dizziness. Transferred to another facility h&pHistory of Present Illness: 94-year-old former smoker with a history of paroxysmal atrial fibrillation not currently on anticoagulation, coronary artery disease, insulin-dependent diabetes, CKD 4, prostate cancer on surveillance, TAVR 2/17, with a son who is a doctor and a caregiver who is a Radiology NP by his report, who presents in transfer from previous Hospital due to a large right pleural effusion. He has had a cough for some time now, but thinks it may have worsened, at least per his caregiver, over the last 4-5 days. He was seen by his PCP on February 9th and placed on Augmentin, but nothing changed. He himself denies being short of breath, having any chest pain, fevers, chills, sweats, change in appetite, abdominal pain, nausea, vomiting, dysuria, diarrhea. Of note, on a chest x-ray in June he had bilateral pleural effusions, and on an MRI in July to investigate a renal mass, he was noted to have a small right-sided pleural effusion. On arrival to facility this morning, he was afebrile, normotensive, had a normal heart rate, sometimes mildly bradycardic, normal respiratory rate and saturations of 97% on room air. Labs demonstrated chronic anemia and thrombocytopenia, stable stage 4 kidney disease creatinine of 2.6, BUN 64, glucose 187. Chest x-ray demonstrated a moderate right pleural effusion, noting that underlying consolidation cannot be excluded. He was also felt to have bibasilar atelectasis. CT of the chest without contrast showed a large right pleural effusion with most of the right lower lobe being collapsed. Superimposed infection could not be excluded. He had a small left pleural effusion with adjacent atelectasis and a small pericardial effusion as well. EKG and procalcitonin were not performed. He was sent to our facility for thoracentesis. On arrival here, vitals remained stable. His bedside RN informed me that upon returning from the bathroom, he appeared to be a bit dyspneic, but the patient himself denies any shortness of breath or ?huffing and puffing?. 2/25 admEd to hospital admission

Several days after vaccination his left arm turned red. He was taken to the hospital where he was evaluated and admitted with a diagnosis of left axillary vein thrombosis. A chest X-ray was taken and he presented bibasilar atelectasis and pneumonia with pleural effusions.

Pneumonia; coughing with bubble spit; STOPPED EATING AND WOULD NOT SWALLOW PILLS; PAIN IN ARM; NOT FEELING WELL; A spontaneous report was received from a consumer concerning a male patient of 94 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced pain in arm,felt unwell, coughing with bubble spit,stopped eating, would not swallow pills and pneumonia. The patients medical history was not provided.No relevant Concomitant medications were reported. On 08 Feb 2021,prior to the onset of events, the Patient received their second of two planned dose of mRNA-1273(Lot number: 031L20A) vaccine for prophylaxis of COVID-19 infection. On 09 feb 2021,patient experienced pain in arm and felt unwell. On 13 Feb 2021,patient experienced coughing with bubble spit,stopped eating and would not swallow pills. On 15 feb 2021,patient went to the hospital and was diagnosed with pneumonia and patient was hospitalized and received a negative covid test in the hospital. Treatment information for the event included IV and oxygen. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the event pain in arm and felt unwell were considered resolved on 10 feb 2021. The outcome for the event coughing with bubble spit were considered resolved on 14 feb 2021. The outcome for the event stopped eating and would not swallow pills were considered resolved on 15 feb 2021.The outcome for the event pneumonia was not provided.; Reporter's Comments: This case concerns a 94-year-old male who was hospitalized with a serious unexpected event of pneumonia along with NS unexpected malaise, cough, aversion to food and NS expected vaccination site pain. COVID-19 test negative. Event onset 30 days after the first dose of mRNA-1273. Treated with O2 and IV. Pneumonia outcome unknown. 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.

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.

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

2 days after vaccination patient experienced a severe generalized pruritic rash from the shoulders to the feet. He also felt terrible for the next 10 days with severe general malaise. He continues to have a residual rash over his back and abdomen with persistent itching. The patient felt so terrible that he is reluctant to get the second dose.

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.

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.

Death Narrative: 4/12 patient had fatigue/dyspnea -Per NP visit/note: -" reviewed with office/clinic team MD on phone, clinically does not appear to have fluid overload, has chronic LE edema which is no worse than usual, could be pneumonia possible aspiration related to dyaphagia. patient does not want to go to hospital for evaluation and treatment. Spoke with patient's daughter, confirms DNR and LST wishes, no hospitalization, no cpr/ventilation/feeding tubes. She is agreeable to treating with low dose diuretic and antibiotic in effort to help symptoms. She is agreeable to hospice consult. -cipro 250 mg po bid x 7 days, furosemide 10 mg qday and kcl 10 meq x7 days called into pharmacy. caregiver to pick up today. reviewed s/e and precautions with meds in addition to indications - caregiver encouraged to keep patient upright in chair or bed for easier breathing. "

The patient presented to the Emergency Department with lethargy and shortness of breath. Upon presentation to the ED, the patient tested positive for COVID-19 (04/26/21). The patient is currently receiving triple therapy with remdesivir, dexamethasone, and convalescent plasma.

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

Onset of fever, myalgias, headache, fatigue 1-2 days after 2nd dose of COVID vaccine then with onset of erythematous rash on bilateral legs 3 days after vaccine. Of note patient also taking Keflex which he started on the same day as the vaccine. Symptoms resolved by 4 days post vaccine.

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

My grandpa was very lethargic after his 2nd vaccine. The following day he started acting more awake, he had a better appetite but seemed to be breathing a little funny. He was labored a bit. He went to sleep on 2/24/21 and at 230 am was dead.

Cellulitis on chest; Swollen; Tender; Red; Chills; Fever; A spontaneous report was received from a consumer concerning a 96 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, fever, chills and injection site swelling, tenderness, and redness. The patient's medical history included serving as an employee, episodes of days with fever, feeding tube, Pulmonary issues and cellulitis on arm.. Concomitant medication included triamcinolone acetonide cream 0.1%, Tessalon and Robitussin. On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030M20A) in his left arm for prophylaxis of COVID-19 infection. On an undisclosed date, the patient experienced injection site swelling, tenderness, and redness. On 24 Feb 2021, the patient experienced chills. Vital signs included a temperature of 103.9 degrees Fahrenheit. Also, his sputum had some blood in it. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was unknown.; Reporter's Comments: Based on the current available information, a temporal association between the use of the product and the start date of the event and excluding all other etiologies, a causal relationship with the events cannot be excluded. Fever, chills injection site swelling, tenderness and redness are consistent with the known safety profile of the mRNA-1273 vaccine.

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.

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.

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

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

Presented to ED with shortness of breath. Tested + for COVID-19 at nursing home 1 day prior to presentation. Reports complaints of increasing fatigue, body aches, and respiratory difficulties. Was hypoxic on arrival to ER and required high flow nasal cannula at 45L 60% FiO2 initially. Admitted to floor for oxygen/dexamethasone treatment. Patient's oxygen was titrated as needed. The day following admission patient developed apnea/cyanosis with large amounts of thick sputum. Patients respiratory status declined rapidly and patient expired.

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 could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got; He could hardly walk; Lightheaded and dizzy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got) in a 97-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (Lightheaded and dizzy) and FATIGUE (Fatigue). On 22-Mar-2021, the patient experienced ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got) (seriousness criterion hospitalization) and GAIT DISTURBANCE (He could hardly walk). The patient was hospitalized from 22-Mar-2021 to 27-Mar-2021 due to ANAEMIA. At the time of the report, ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got), GAIT DISTURBANCE (He could hardly walk), DIZZINESS (Lightheaded and dizzy) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included blood transfusions. Concomitant product use was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient sparked a high fever shortly after receiving vaccine, was treated with Tylenol suppositories and Morphine. Patient was on 1.5 liters of Oxygen. Hospice refused any additional treatment including IV fluids or doctor visit requested. Patient stopped eating and drinking and lapsed into unconsciousness. He died on June 29. 2021 after Hospice nurse recommended removing Oxygen. At home nurse insisted on maintaining oxygen until his death a few hours later.

pts daughter stated ear lobes were red, he had low grade fever and left arm was warm to touch about 3" below injection site the day after the vaccine. Next day after the arm was increasingly turning more red. On 1/12/2021 the pt went to the ER clinic and was diagnosed w/ cellulitis on left arm. Pt is now recovered from this after being treated w/ antibiotics.

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%.

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.

Resident started have chest pain on 3/02 and on 03/03 he was lethargic and wasn't eating or drinking Resident was on Hospice

Patient reported symptom onset on 4/2 with severe chills where his whole body shook. The symptoms came on all of a sudden. Patient's wife called the EMTs about two hours later and patient had a fever of 102.5. The fever did not last long. Patient reported shortness of breath and congestion but says that he always has those symptoms and that he had them long before COVID. He also vomited on the gurney. They were told that he aspirated and that was how he developed pneumonia. Patient reported having a CT scan but was unsure if they did a chest x-ray. Patient was on oxygen but not a ventilator. Patient was not admitted to the ICU but was on the COVID wing at the hospital.

Patient tested positive for COVID-19 on 5/20/2021, started showing symptoms around 3:30pm. "He drastically decreased in O2sats from WNL to 79% in about an hour?s time. His BP elevated, 152/90, and then dropped to 101/65. His HR increased 132-156 bpm. He had SOB." 99.5 fever while in hospital, on 2 liters oxygen

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.