Moderna

Caretaker at Facility contacted me to tell me that this morning, patients left arm is red and raised all the way to the elbow and very painful. Patient gets scheduled ibuprofen for arthritis which is helping. She has had no other problems with other vaccinations including flu shot Fall 2020. Denies SOB, swollen tongue or throat, or rash/red areas anywhere else on body. Wondering if getting vaccine 3-1/2 months after getting COVID may be reason she is reacting. Caretaker anticipates she will recover just fine but is concerned about giving 2nd shot of series.

10:10 am received Moderna vaccine; observation time 30 min due to previous allergies stated (shrimp-throat closure); 10:37 am RN was observing/talking to pt & mid-sentence pt. reported "I'm feeling funny." Resident's eyes appeared glazed over and she reported "feeing out of it. Like I'm in another world." Resident unable to provide any further specific descriptions of how she felt. Resident's radial pulse felt regular. No loss of consciousness. Resident remained in seated position. 10:39 am Resident reported no improvement & stated, "I feel week". Rn paged for assistance. 10:45 am another staff member arrived with bp cuff. L upper arm blood pressure was 136/72. Heart rate remains regular. Lungs sounded clear. Resident was able to drink a 1/2 glass of orange juice. 10:49 Resident reported feeling " a little better." 10:51 am We noted resident's face appeared flush. No baseline observation of what her cheeks looked like prior to vaccination due to mask, but questionable mild facial swelling present. 10:53 asked resident if she was able to swallow normally. Resident wasn't sure, so RN asked if she felt like she had a lump in her throat or like she needed to clear her throat, but couldn't and she confirmed that her throat felt different than normal. 10:55 am Epi pen administered to L outer thigh by RN. Call placed to EMS. Discussed expected side effects of Epi administration. 10:57 am Resident started to feel anxious and visible shaking present. 11:05 am Resident reported felling slightly better, perked up a bit. 11:08am EMS arrived. 11:10 Ambulance crew arrived. Resident was able to walk to stretcher with assist of 1. 11:17 am Ambulance left with resident. Resident was still reporting "feeling weak".

left arm pain and Malaise immediately after, followed by sweling in both feet and purple discoloration in feet that resolved spontaenously over the next 4 days. Erythema and swelling to bilateral upper arms with associated skin tenderness, Malaise / intense fatigue both not yet resolved at time of this writing on 2/3/2021.

Redness and swelling noted underneath upper right arm from elbow to armpit. Light pink in color. Denies any pain and occasional itching noted.

Day 12 post-vaccine - both arms red and swollen, swelling in extremities, irritation in vagina. Swelling worse in Right arm. Both legs had rashes, particularly the knees, feet red to the end of the toes. Top of legs were extremely dark. The symptoms are still present as of 2/9/2021

left arm swollen, red, itchy and "feverish. Patient went to the clinic initially provided "bactrim" - helpful with cellulitis. Patient then went to the Emergency Department 2/6/21 - for fever and body aches. Chest xray/labs/UA done with negative results. Recommended to stop bactrim and sent home.

Pt exam 2/25/2021 found swelling to left hand from wrist to fingers with discomfort in left arm which began 2/13/2021. No erythema noted. No clubbing, cyanosis. Treatment - Patient advised not to get 2nd vaccine.

sepsis; UTI; shingles; severe headaches; A spontaneous report was received from a 90-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced UTI, sepsis, shingles, and headaches. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient began experiencing severe headaches. On 11 Feb 2021, the patient developed a severe urinary tract infection and had to be hospitalized. The patient broke out with shingles and now has sepsis. The patient is reported as being conscious, but not responding. No treatment information was provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcomes of the events, UTI, sepsis, shingles, and headaches, were not provided.; 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.

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

Patient developed a rash and angioedema at some point later in the day after receiving the vaccine. Patient reported taking Benadryl routinely for several days after the development of symptoms. This was self reported to hospital at time of scheduling the second dose. It is believed patient had some follow up with PCP, possibly per phone or office visit.

Measles like red itchy rash over all body but especially areas of sun contact such as tops of hands, arms and chest after 7 days of anti histamine pill still itchy and now face swollen and red

The morning following vaccination, patient stated her right ankle was swollen. Over the next few days the rest of her right foot swelled, which is the current state. She described it as "pulling" feeling when asked to describe how it felt. (It looked slightly swollen compared to her left foot). Recommended she see her doctor, which she agreed to.

Daughter reports vaccination was received on 5/21. On the morning of 5/22, patient began to develop fever (>100.0), bilateral leg swelling, and palpitations. She reports an episode of tachycardia up to HR 140's, but states she was most likely febrile but was unsure. She reports that at baseline she is confused but reports she was more disoriented than usual. She states that the patient was experiencing more DOE. Of note, she has hx of COPD and is on 2L NC at baseline. Per daughter, leg swelling and palpitations began to resolve after fever resolved -- now improved but still has more DOE. Also reports some mild suprapubic discomfort. No N/V/D.

Pt had her 2nd Moderna vaccine on 3/18/21. She was brought to the ER on 5/25/21 c/o nausea and vomiting and abdominal pain and not feeling well. work up at the time was negative. she was thought to possibly have a UTI and sent home on antibiotics. urine culture from that visit was ultimately negative for infection/growth. She retuned to the ER on 6/1/21 c/o weakness, confusion and new shortness of breath. Her temp was 99.5, chest x ray showed extensive bilateral patchy opacities. head CT was neg. Her wbc was 14.4 with left neutrophilic shift, lactic acidosis of 2.1 and dehydration. She was admitted with sepsis and possible pneumonia. She was started on ivf and antibiotics and admitted. She was also started on oxygen for new hypoxia of 81%. CT chest showed interstitial pulmonary edema, interstitial pneumonia. echo showed normal LVEF and grade 2 diastolic dysfunction with severely dilated left atrium. Her wbc returned to normal and her shortness of breath improved. She was started on lasix 10mg qod. Previous chest x rays showed no interstitial disease. Covid 19 testing negative.

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

Started with slight itchy rash on Feb 27 on right side of face. Became more itchy and spread on Feb 28. Face swollen to almost eye shut by Mar 1, very itchy and weepy. Rash also visible on neck and front of torso. Visited doctors office on Mar 1 at 1:00pm. Received prescription for Prednizone 20mg, to be taken over 10 days. Seems to be working, swelling is down and not as severely itching. Still very visable and dry crust forming on face.

large area of erythema and mild swelling measuring 26 cm x 28 cm affecting the left upper arm which is where the injection was located (left deltoid is where the injection occurred). Itching noted. No pain, no induration. No systemic symptoms, angioedema, or shortness of breath. I advised use of a non-sedating antihistamine and gave her a prescription for topical triamcinolone.

Swelling and confusion advised to the ed call 911 Sister calls for 91 year old sister that caretaker called and stated patient more confused today and is swollen face arms legs abdomen. advised to call 911. sister had little info , list given of information needed to complete adverse event chart Taken to Hospital, diagnosed with a UTI, on antibiotics. Feeling much better an symptoms resolving per sister. Taken to Hospital, diagnosed with a UTI, on antibiotics. Feeling much better an symptoms resolving per sister.

Itching and swelling of right hand. Erythema. Began about 30 minutes after injection and lasted through the night, decreasing in intensity but still itching through the next night.

extreme pain in her chest and abdomen on the R side of her body (around the heart); had very high blood pressure; The vaccine worsened her constipation problems; legs, feet, and ankles are swollen and sore; legs, feet, and ankles are swollen and sore; legs, feet, and ankles are swollen and sore; legs, feet, and ankles are swollen and sore; Dehydration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED (had very high blood pressure) and CHEST PAIN (extreme pain in her chest and abdomen on the R side of her body (around the heart)) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypertension. Concurrent medical conditions included Constipation. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Mar-2021, the patient experienced BLOOD PRESSURE INCREASED (had very high blood pressure) (seriousness criterion hospitalization prolonged) and DEHYDRATION (Dehydration). On 29-Mar-2021, the patient experienced CHEST PAIN (extreme pain in her chest and abdomen on the R side of her body (around the heart)) (seriousness criterion hospitalization). On 20-Apr-2021, the patient experienced JOINT SWELLING (legs, feet, and ankles are swollen and sore), PERIPHERAL SWELLING (legs, feet, and ankles are swollen and sore), PAIN IN EXTREMITY (legs, feet, and ankles are swollen and sore) and ARTHRALGIA (legs, feet, and ankles are swollen and sore). On an unknown date, the patient experienced CONSTIPATION (The vaccine worsened her constipation problems). The patient was hospitalized on 29-Mar-2021 due to BLOOD PRESSURE INCREASED and CHEST PAIN. At the time of the report, BLOOD PRESSURE INCREASED (had very high blood pressure), CHEST PAIN (extreme pain in her chest and abdomen on the R side of her body (around the heart)) and DEHYDRATION (Dehydration) had resolved and JOINT SWELLING (legs, feet, and ankles are swollen and sore), PERIPHERAL SWELLING (legs, feet, and ankles are swollen and sore), PAIN IN EXTREMITY (legs, feet, and ankles are swollen and sore), CONSTIPATION (The vaccine worsened her constipation problems) and ARTHRALGIA (legs, feet, and ankles are swollen and sore) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Blood pressure measurement: 217/157 (High) 217/157. Concomitant medications include Vault to treat constipation. Treatment included amlodipine tablets. 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.

April 1, 2021 a rash occurred on both legs from above her knees down to her toes. Legs began swelling, experiencing nerve pain. Received one shot of prednisone in the shoulder. June 28, 2021 legs are still swollen.

Afib; edema; Muscle Spasm; Burning Sensation from upper extremity to lower extremity; Swelling below her knee; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) and OEDEMA (edema) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. 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 PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criteria hospitalization and medically significant), OEDEMA (edema) (seriousness criterion hospitalization), MUSCLE SPASMS (Muscle Spasm), BURNING SENSATION (Burning Sensation from upper extremity to lower extremity) and PERIPHERAL SWELLING (Swelling below her knee). At the time of the report, ATRIAL FIBRILLATION (Afib), OEDEMA (edema), MUSCLE SPASMS (Muscle Spasm), BURNING SENSATION (Burning Sensation from upper extremity to lower extremity), PERIPHERAL SWELLING (Swelling below her knee) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Concomitant medication information was not provided. Treatment medication information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Patient reported that she was in hospital due to edema and A-fib. 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. Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Case upgraded to serious, new events added, corrected email updated; 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.

12/30/2020 07:02 AM Resident noted to have some redness in face and respiration were fast. Resident vital signs were abnormal except blood pressure. Temp at the time was 102.0 F taken temporal. Resident respirations were 22 labored at times. Pulse is 105 and pulse ox 94% on room air. Resident is made comfortable in bed. Notified triage of change in condition also made triage aware of resident receiving Covid vaccination yesterday morning. Resident appetite and fluid consumption has been poor for few days. 12/30/2020 07:32 AM Received order from agency to administer Acetaminophen 650mg suppos rectally due to resident not wanting to swallow anything including fluids, medications and food. This writer administered medication as NP ordered. Will monitor for effectiveness and adverse effects if any. 12/30/2020 08:41 AM Received new orders to obtain Flu swab, obtain CBC and BMP, and Chest Xray all to be obtained today. Notified family of resident having temperature and vital signs excluding b/p that was abnormal. Family was thankful for call and inierated to nurse that family does not want resident sent to hospital. Did educate family on benefits of Hospice services, but family persistant on continued daily care provided by nursing staff. Requests visits if decline continues. Family assured if resident continues to decline, facility will accomandate resident family to be able to be at bedside when time comes to do so. NP ordered IVF and IV Levaquin on 12/31/20. Family chose at that time to sign for Hospice services and not have resident provided with IVF or IV Antibiotics

She developed erythema, swelling and a rash to Left deltoid area. She also developed increase swelling to BLE with rash and itching.

Moderna COVID-19 Vaccine EUA - Pain on left lymph node (same side where injection was given) at 7am the following day. Pain subsided within 6 hours.

Present to ED for chest pain, nausea, chest heaviness, mild headache and slight SOB with lower extremity swelling, Hospitalized starting today 2/5. EKG shows Afib with RVR (new oneset). Still in hospital at this time

SWELLING AND PAIN IN HAND AND WRIST IN RIGHT ARM (WHICH IS THE ARM THAT WAS VACCINATED). PAIN AND HEAT AT SITE OF VACCINATION. INTENSE ITCHING, SORENESS AND REDNESS WHICH BEGAN 2 TO 3 DAYS AFTER VACCINATION OVER INJECTION SITE. THE PINK/RED, ITCHY, RASHY AREA HAS NOW DESCENDED TO HER ELBOW, IS SLIGHTLY SWOLLEN, 3 INCHES BY 5 INCHES (NO LONGER OVER INJECTION SITE)

pt developed golf ball size swelling on left arm immediately following covid vaccine dose 1 administration. pt had minor bleeding after needle removed from pt, then blood pooled in the surrounding area to a golf ball sized lump. applied pressure to stop the bleeding, monitored swelling and provided pt with ice pack to reduce swelling. swelling decreased significantly during 30 minutes post administration. followed up with pt via telephone 2 hours post administration - pt said that swelling continues to reduce. no pain.

5/18/21 9:20pm - c/o general aches & soreness right arm 5/19/21 6:10pm - c/o general aches, sleepiness, soreness to right arm temp 99.8 5/20/21 11:21pm - redness adminstration site, redness & puffiness to eyes & face, arm very sore 5/21/21 11:02am - c/o pain at injection site, red, warm, swollen, afebrile 5/21/21 10:03p - arm red, warm, swollen at injection site, afebrile, states feels better today 5/25/21 4:27am - lethargic, tremoring, nausea, diarrhea, temp 103.4 pulse 128, SPO2 82%, sent to hospital

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

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

Received 2nd vaccine 3/9 one week after vaccine developed. Multiple kanker sores in right side inner oral mucosa and right side facial swelling temp 98.4 improving today facial swelling and lesions are decreasing. We contacted dentist and primary care physician by phone sent pictures of mouth to dentist. Received advice for treatment.

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

pt says her throat started burning immediately after taking the vax and she had some difficulty swallowing. her PCP came and checked her vitals. She was observed for about 30 minutes and was able to leave. About 4 or 5 days later she noticed her vision declining. She already has poor vision but seemed to be getting worse. She has a varicose vein on her right leg and her upper right leg is swollen. She will contact her doctors.

Pt presented for routine primary care visit 3/30 and reported swelling of right lower leg starting 2 weeks prior. Ultrasound positive for DVT.

Patient was awakened by itchiness on left arm from elbow to wrist. Increased in severity to feeling as though on fire and being bitten by a thousand mosquitoes. Spread to other arm, both becoming bright red and blotchy. Some areas became raised. The itchy red began to creep up to injection site. Next day, February 21, legs began to ache, swell, and itch. Developed bright red, splotchy hives similar to arms spreading from knees to ankles before creeping up thighs. Large, hard, itchy area behind both ankles, and navel also became inflamed and itchy. Today (March 1) arms and legs are still red, though it has faded in some areas, and the itchiness is persistent but has subsided.

Swelling, redness and resultant pain of both ankles, and lower legs worse at the end of the day, improved in the morning. Awakening with swelling of hands (moderate) and face (mild) resolving as the day goes on.

On 3/10/2021 the patient presented to the ED with fatigue and diarrhea. The patient had been constipated and then started taking magnesium citrate and Colace. Since starting the laxatives the patient had been experiencing diarrhea. Once at the hospital, the patient was routinely tested for COVID-19. She had one COVID antigen that was positive and one negative, and the COVID PCR negative. Chest xray shows no pneumonia and he WBC was 11,000. Reason for admission: diarrhea and weakness.

My mom received her first Moderna Vaccine on 1/22/21. Late on 1/23 her face began to swell so the staff called the ambulance to come take her to the hospital for what they thought was an abscessed tooth. ER doctor said there was an infection and that she needed to be seen by an oral surgeon. On 1/25/21 I took my mom to Dr., her oral surgeon and after the examination he advised that there was no abscess but an allergic reaction to the Moderna vaccine. He suggested Benadryl. I gave her benadryl and the swelling started subsiding. From this point on her gums and teeth hurt. Her eating habits started to decline. She received her 2nd Moderna vaccine on 2/19/21 and from that point on she could no longer chew or brush her teeth because the pain was so severe. She passed on 3/19/21.

Clinic appointment for RUQ abdominal pain and emesis. Admitted to unspecified hospital, treated with IV protonix and IV fluids with K+.

Large unusual swelling with non puss pinnacle and black subdermal discoloration. Very dark yellow urine. Itchy non painful swelling on top of left shoulder. Never had anything like this before.

About an hour after receiving her 2nd dose, she went to a restaurant and ordered her favorite shredded beef burrito. After only a few bites, she experienced non-stop "burping" and swallowing any liquid became impossible. We were at a useless ER hospital from 2-6 pm when they finally saw her and said they did NOT have any means of looking down her throat. Long story short -- the next day I drove her to another Hospital. We were there from 2-8 p.m. The Dr. removed a bolus at 7:15 p.m. - 7:45 p.m. and he said "everything looks good". HOWEVER -- my mom continued having "esophagus" issues from that time on. And ALSO, on April 4, she told me, "I don't feel good" and she proceeded to fall asleep on her couch and did NOT WAKE UP for about 6 weeks except to use the bathroom, take her morning and evening pills and eat a tiny bit of soft foods. I can't think of any other reason for this bizarre "sleeping" except for that 2nd Covid shot. I've taken her tour GP 2 times since then and all blood work comes back normal. And a few visits to the ER within the last 3 months only showed she's had another UTI within 6 weeks and her swollen lower legs/feet can only be cured with lack of gravity. Weeks ago I took her to her annual checkup with her heart doctor and he said her blood pressure was on track. So as of today, I am waiting a call-back from hospice to see if I can get someone to help me with her bathing, etc. at home. Just wanted to tell somebody that since her second dose of Moderna Covid vaccine, it's been downhill for her and it's hard for me to believe the cause can be anything other than that 2nd vaccine.

The day of vaccine she had no problems. The following wee her arm was red, swollen and hot at the top. That reaction slowly went down and it's just above her elbow, she's 95 and it is kind of filled up with a hard mass in that area. Her arm looks like a sunburn with two different shades of skin, on the back side of her arm where it is red. She still has it on her arms today, 2/11/21. She has not taken anything for it or put anything on it. Her doctor told her to call us to see what we said she should do. There is no pain, but it just looks bad and she is concerned.

Delirious; Diarrhea; Flu-like symptoms; Weak; Swollen; Fatigue; Joint achy; Fever; A spontaneous report was received from a consumer concerning a 95-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced flu-like symptoms/influenza like illness, fever/pyrexia, diarrhea, delirious/delirium, weak/asthenia, joint achy/ arthralgia, swollen/swelling and fatigue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 11 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 0D1B21A) intramuscularly for prophylaxis of COVID-19 infection. On 12 Mar 2021, the patient experienced flu-like symptoms, fever, diarrhea, delirious, weak, joint achy, swelling and fatigue. The event delirium was considered medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, flu-like symptoms, fever, diarrhea, delirious, weak, joint achy, swelling and fatigue, were considered as unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

On 1/24/2021 the patient was discharged from the hospital due to swelling in the body, when they proceeded to infuse medications. She herself had passed away.

Patient developed COVID-19 with complaints of increased cough on 4/6. Was found to be COVID positive on 4/12. Recieved combo Bamlanivimab/etesevimab treatment for infusion on 4/14. Patient had initial recovery to baseline period on 4/22. Rapidly declined shortly after and died 4/25.

Resident complained of feeling "hot" at supper time. Had emesis an hour or so later. Became hypoxic and was transferred to the hospital emergency room. Her evaluation in the ED revealed continued presence of UTI, leukocytosis (19.8), and renal insufficiency (BUN 22 Cr. 1.3) BP 99/63; P 74; Temp 98.1; RR 16; and O2 sat of 95% with 2 LPNC (she is typically on RA). CXR reported changes most consistent with CHF with cardiomegaly and bilateral pulmonary vascular prominence. Bibasilar pleural effusions greater on the right than left with pulmonary edema. Large hiatal hernia and likely old chronic wedge defromities involving the mid thoracic vertebral body. She was admitted for IV antibiotics. She expired 2/6/2021

Started with pain at injection site 2 days later felt itching all over then found redness and swelling and redness the size of a surgical gauze radiating from her shoulder to the crook of her arm. It was warm to touch.

Pt. had hx of SOB prior to vaccination and Dx with hear failure Woke up day after vaccination with being very tired. Admitted to hospital with UTI, Sepsis

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

3 days ago patient was started on Cipro for a UTI. Patient received the ModernaCOVID vaccine 2 days ago. The past 48 hours patient has had increased confusion, decreased p.o. intake. Patient was sent to emergency room for evaluation. Patient was found to have a low sodium, 112, high potassium 6.9 with corresponding EKG changes. Patient was bradycardic with a rate between 30 and 40. Patient was also found to be in acute renal failure with a creatinine of 5.6. In ER pt was confused, unable to tolerate PO fluids. Due to severity of illness patient's family has elected to avoid aggressive medical care. Patient has poor prognosis. Patient was returned to nursing home for comfort care only.

Swollen arm, lymph nodes, neck, sinuses, and chest on left side; redness and pain in arm; difficulty breathing and heaviness in left side of chest; chills; loss of appetite; fever (her normal is 96.5 and she had 101 degrees); lethargy; aching all over

Looked like she had a stroke; Muscle pain; Disabled; Brain does not work with her body; She cannot use her legs; Swelling of hands and feet; Nausea; Felt Sick (After First Vaccine); Slurring words; Throwing up; Fever 100.3 F (After First Vaccine); Loss of Taste (After First Vaccine); Pain in arm; Redness in arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), MALAISE (Felt Sick (After First Vaccine)), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs) and NAUSEA (Nausea) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills). On 04-Feb-2021, the patient experienced AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)). On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Looked like she had a stroke) (seriousness criteria hospitalization and life threatening), MALAISE (Felt Sick (After First Vaccine)) (seriousness criterion medically significant), DYSARTHRIA (Slurring words) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Throwing up). On 04-Mar-2021, the patient experienced LOSS OF CONTROL OF LEGS (She cannot use her legs) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling of hands and feet). On 14-Apr-2021, the patient experienced CEREBRAL DISORDER (Brain does not work with her body) (seriousness criterion medically significant). On an unknown date, the patient experienced DISABILITY (Disabled) (seriousness criterion disability) and MYALGIA (Muscle pain). On 16-Feb-2021, VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills) had resolved. On 25-Feb-2021, AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)) had resolved. On 14-Apr-2021, PERIPHERAL SWELLING (Swelling of hands and feet) had resolved. At the time of the report, DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs), NAUSEA (Nausea), MYALGIA (Muscle pain) and VOMITING (Throwing up) outcome was unknown and MALAISE (Felt Sick (After First Vaccine)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-076475 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: stroke, on hospice. On 22-Apr-2021: Additional info; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-076475:CROSS LINKED WITH DOSE 2

Swelling to right side of neck and lymph nodes- hospice practitioner notified. No new orders received.

17 days after shot resident presented with Cellulitis to right arm. Red, swollen, warm to touch. No pain reported or assessed. Arm is completely cleared.

Edema in arm and especially hand. Very swollen like a balloon, non-pitting, still, one month since second dose of vaccine. Pain in lymph nodes under left arm..