Moderna

Systemic: Headache, Systemic: Eyes dilated and difficulty remembering information; symptoms lasted 2 days

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".

Temperature of 100.3 degrees Fahrenheit noted on 1/18/2021 at 5:40pm. Acetaminophen 650mg administered. Temperature at 7:02pm on 1/18/2021 was 98.3 degrees Fahrenheit. No other adverse reactions noted.

soreness, stomach problems, constipated took prune juice, milkamagnesia, next day felt, bad chills, has not gotten out of bad, no energy, weak feeling in her legs, 3rd day hand were very hot, have no energy at night lots of chills, pain between shoulder blades, no apatite, pain in legs and still weak today.

Thursday - day of shot after dinner she began to not feel good. Her stomach was upset & vomiting, increased mucus, and a slight headache we gave her Compazine suppository and she went to bed. Said she rested well that night. Friday all day her stomach was upset but was able keep down tea/toast and have some broth. Friday Night/Saturday Early AM she became mentally unstable, confused and knew she was confused, felt like she was going to die, had a hard time breathing, her chest was tight and had shortness of breath. Later that morning she was weak, shaking, vomiting. After a good bowel movement and a 4-hour nap she started to feel better. 1/28/21 PCP Televisit - reaction do not take 2nd sho

Patient was showing signs of weakness, lethargy, change in LOC, and complaints of pain. She experienced a fall. Sent to the ER for evaluation.

Pt. received vaccine in AM. Reported feeling 'tired' and 'having trouble breathing'. Brought to ED by ambulance @ 1805hrs.. Per ED report, had mild tachypnea upon initial evaluation, HR 80, RR26, B/P 137/105, O2 sat 99% on room air.

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.

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.

I began to feel very tired and weak the same day slept through the night and all day the next day And all night the second night till 10 o?clock in the morning on the 13th. Within 12 hours my kidneys were working overtime I was running to the bathroom constantly. Couldn?t hold It at all. Made me incontinent for at least 24 hours up three or four times to go to the bathroom. Lack of appetite. Arm is aching at site of injection and a little red.

Nausea, vomiting, diarrhea, chills and fever, fatigue, PO2 dropped into high 80's. Diarrhea lasted about 24 hours, N/V about 48 hours. Chills ("teeth clattering") lasted 36 hour and fever (subjective, temp not taken by patient) lasted about 48+ hours. At 5 days post vaccine, PO2 is back up to 97 and she has only fatigue.

Shortly after receiving the Moderna COVID-19 vaccine, patient complained of chest and stomach pain, then became very sleepy and fainted. RN was unable to obtain a manual BP; Apical pulse 36. Pulse Ox in the 70s. She was placed in bed and eventually regained consciousness. Her pulse ox improved to the 90s. BP 92/55. Her only complaint was that her hands were cold. Medical Director believes it was vasovagal syncopy due to receiving the vaccine. Patient died on 1/28/2021, due to progressive dementia.

Fall on 1/21/2021 following first vaccination and fall on 2/18/2021 following 2nd vaccination. No falls since admit in 3/2020. Falls causing increase pain with head strike on 1/21/2021. Is recovering slowly from pain of events

arrhythmias; rapid heartbeat; slight nausea; slight headache; light bothered vision for some days; mild chills; A spontaneous report was received from a retired nurse concerning herself who is 90 year old received Moderna COVID-19 vaccine and have experienced arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills. The patient has prior history of irregular heart beat . Her relevant concomitant medications were cholesterol medication, Crestor and medication for irregular heartbeat. No information on allergies. On 28-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of COVID-19 vaccine intramuscularly for the prophylaxis of COVID-19 infection. On 30-JAN-2021, 2 days after her vaccination, she developed arrhythmias, rapid heartbeat, slight nausea, slight headache, some visual problems (light bothered her for some days) and mild chills. After one week she felt like no more symptoms ongoing and felt good again. She visited her physician for arrhythmias, and he said, she should keep an eye on it, but no medication yet. She is concerned about her second shot. Action taken with 2nd dose of Moderna COVID-19 vaccine was not reported. The outcome of the events, arrhythmias, rapid heartbeat, slight nausea, slight headache, visual problems and chills were resolved at the time of report.; 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 and prior history of irregular heart beat are considered risk factors for arrhythmias.

Patient says she felt well after getting the vaccine, but shortly before midnight the same day started feeling fatigue, body pain all over. Next day pain was improved; only remaining jaw pain and fatigue; then the day after pain resolved but persistent fatigue and SOB since then (for 13 days now). Severe dyspnea on exertion; baseline able to walk more than 5 minutes before getting tired; over last 13 days unable to walk from one room to another without severe SOB> Had a ride today so came to urgent care for evaluation. Patient found to be in atrial fibrillation with rapid ventricular rate at 140

Achy, fatigue, dizziness which subsided. Rash appeared at injection site 4 days after injection. Sprayed benadryl.

nausea next day on second day 3 pm shaking, shot of breath then - had chill then fever, 3 day another chill and fever - lose of appitite

030- C/O DIZZINESS A LITLE LA FRONTL; DENIES CP OR PRESSURE, NO BLURRED VISION. HEADACH:CONSTANT, NON THROBBING, LOCALIZED TO FRONTAL REGION PTS DAUGHTER ADVISED TO PROVID HTN MEDS AND FOOD/HYDRATION ONCE BP LOWERS, PATIENT SENT HOME

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.

Ten days, 03-13-2021)) after receiving vaccine I woke up up at l:00 A.M. with pain, itching, redness and heat at site of vaccination with hard, raised area. I had an hive measuring l7"x5". Applied ice pack 20min on and off. I still have heat and itching at site 33 hours later. Slight pressure at back (right side) of head.

Patient is a 90 y.o. female who presented to ER complaining of generalized shivering which began late last evening (3/3/21). Patient states she received her 2nd dose of her Moderna COVID 19 vaccine yesterday (3/3/21). She states she went to bed, woke up in generalized shaking which has yet to stop that she came to the ER (on 3/4/21). In ER patient's initial blood work was unremarkable which include CMP and CBC. CT brain was done to rule out any underlying neurological deficits or acute CVA which was unremarkable. She denies any numbness tingling no blurry vision no headache no sensory motor deficits. She denies any recent falls.

On Saturday morning, Mar 6th had erratic racing heart beat and high to very low blood pressure, 168/ , low 88/51, afib, unsteady, lightheaded, hot and chilled, headache, very weak. On 8:10am Sunday, heart beat ranged from 50 to 125 bpm, blood pressure dropped to 90/64. Doctor took me off all meds except Xarelto, said stay in bed, drink lots of fluids. I did not connect the symtoms to the vaccine at the time because problems happened after the 1st few hours, and I was too sick to think clearly. It was only when I read the side effects after 1-3 days, that I realized it could be from the vaccine. I worry about being deathly sick after the second vaccine shot, so I'm reporting this.

Dyspnea, chest pressure, fatigue. Sought care at the hospital/ED -- found to have acute pulmonary emboli (by CT) with hypoxic respiratory failure. Treated with hospitalization, Xarelto, nasal canula oxygen. She improved to be stable on room air with improvement of her symptoms and went home after 3 days.

Started in her back and goes across her back, shoots down the middle of her back and both sides. Front in the ribs and around the breast - chest pains. Exhausted - energy is gone. Can't do normal activities that she was able to do prior to vaccine. Sharp pains. When I breath or cough/sneeze or laugh it hurts. Had some relief from heat and cold packs. Left knee has hurt a lot since this happened, too.

pt states she has chills that goes from her her arms to her legs. She says the chills will start in her upper body and then will move down into the lower body. She does not have any fever. She says it feels very weird. she has had these symptoms since taking the second dose.

One week after second Moderna shot, patient began low-grade fever, loss of appetite, foggy thinking, fatigue, general malaise. She was treated with three different meds for a possible UTI. All symptoms except fever continued for 10 days, and on March 25, she suffered a TIA. She went to the ER and stayed in the hospital for 36 hours. MRI showed no lasting damage. She is improving but is still fatigued.

Extreme fatigue, headache, brain fog, weakness, lasting one month. Extreme in beginning, fading over-time.

4/30/21 weakness and tremors in all 4 extremities, febrile 39.8*C, observation hospitalization 4/30/5/1/2021

her right lung has pulmonary fibrosis,and her left lung has 80% pulmonary fibrosis; feeling very lethargic; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY FIBROSIS (her right lung has pulmonary fibrosis,and her left lung has 80% pulmonary fibrosis) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced PULMONARY FIBROSIS (her right lung has pulmonary fibrosis,and her left lung has 80% pulmonary fibrosis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced LETHARGY (feeling very lethargic). At the time of the report, PULMONARY FIBROSIS (her right lung has pulmonary fibrosis,and her left lung has 80% pulmonary fibrosis) and LETHARGY (feeling very lethargic) outcome was unknown. Patient was put on ventilator and in hospice care. No concomitant medication was reported. 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.

one week after 1st vaccine shot, mom started to feel sick around lunch. Took mom to hospital she had a heart attack. They dissolved the blood clot and found out she also had pneumonia with no symptoms. She died 2 weeks later. She had dementia but health was fine until she received the covid 19 vaccine.

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.

Weaknesses. Dizziness. Headaches. Blurry vision both eyes. Sleepiness. Strokes. Hospitalization. Death

Pt developed GI upset and weakness on 6/2, followed by chills and emesis 6/3. Was found deceased on the toilet on the morning of 6/4/21.

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.

Noted increased weakness on R side compared to L side - appears drowsier than baseline. HEMIPLEGIA, UNSPECIFIED AFFECTING RIGHT DOMINANT SIDE

Caused extreme dehydration. 3 days after shot her Kinsey?s went into failure and she never recovered despite all the efforts of the doctors / staff. She was never advised not to get shot if she had kidney issues. She diesels eight days after getting shot

Resident became lethargic and reports of blood coming from resident's nose and mouth on the morning of 1/13/21. Resident went out to ER for eval, and came back to facility with dx of pneumonia and recommendations for resident to be placed on hospice. Resident deceased on 1/14/21. Unknown if vaccine related, but with timeline of events I was advised to report this per medical director of facility, as well as Pharmacy who administered the vaccine.

Other meds; potassium chloride, VitD3, super B complex, Cal-mag-zinc. Increased neuropathy with increased pain, stiffness, myalgia, arthralgia, prickly skin feeling all over, sensitive. Criteria for reporting: states saw Dr. 1-18-21, prescribed steroids. Took prescribed pain meds and prevented her daily activity; Grade 3 for pain and fatigue, myalgia, arthralgia.

Resident reported soreness to left arm and began having diarrhea and chills at approx. 0900 the day after receiving the vaccine. No treatment at this time.

Woke up skaking all over body-very violent. Could not control. Arms, legs everywhere. Continued for all day but did decrease a little bit toward evening. Doctor said nothing to do. Called 911, they checked. Blood pressure, heart etc seemed normal. Did not go to hospital because of virus cases being there. Vomited 1 time about 3 hours after I woke up. Second day was much better but extremely tired.Third day was back to normal but body very tired. Back to normal now. Will I have this with second shot???

4 days after injection, I experienced chills, slight fever (99.1), drop in oxygen level (96), aches all over, intestinal distress, extreme fatigue, lasted over 12 hours. Temperature and oxygen level back to normal, but am still shaky this morning, so I'm returning to bed.

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

The patient came to the Emergency Room at approx 3:30 am on 02/03/2021 with pain in right arm (same arm the COVID vaccine had been administered in approx 12 hours earlier) and feeling generally unwell. Patient was concerned about possibility of gout flare or that something was wrong with her arm. Elevated blood pressure was noted; this was attributed to anxiety. She was evaluated, given 500 mg Tylenol, and discharged since the pain was decreasing and blood pressure was stabilized. Patient instructed to follow-up with physician. The next day, on 02/04/2021, the patient arrived at the Emergency Room by ambulance; cardiac arrest was the chief complaint. The patient's daughter stated the patient had been "feeling generally poor and then suddenly collapsed." Daughter described "gurgling respirations" and being unresponsive. 911 was called, police arrived within 5 minutes and initiated CPR. Epinephrine, atropine, lidocaine and bicarb administered after arrival to Emergency Room. Shockable rhythm never demonstrated. Patient never recovered spontaneous respiration or movement. The death was called at 23:04. Coronary artery disease with cardiac arrest is the cause from the ER records; the coroner is putting COVID-19 vaccination in Part 1 of the death certificate.

vaccine given at 1532, symptoms started about 1545, client started coughing, said she felt funny, felt faint, pale, skin to touch was very cold, she said she was cold, BP 182/94, Resp 28, O2 99% on room air, HR 64, she was short of breath, was not tracking, would stare off looking at the ceiling, at 1552 0.5mg Epinephrine was given IM, EMS was called at 1553, EMS arrived at 1558, no relief in with the Epi, left via ambulance at 1605

Dizziness/vertigo, nausea, vomiting, chills started at about 7:30 am on 2/20/2021. This was the day after I received the vaccine. Nausea and vomiting subsided around noon. Chills were ongoing through out the day. On and off vertigo episodes continued through 2/23/2021. All symptoms subsided by 2/23/2021. Also had a very sore left arm.

91 YEAR OLD FEMALE COMPLAINED OF BEING TIRED AFTER RECIEVEING VACCINE. ON SITE EMS RESPONDED. VITALS BELOW. SHE REFUSED FURTHER EVALUATION AND CARE AND WENT HOM

Sore throat ,body aches to point of believing dieing, severe fatigue, headache on 1st dose ,2nd dose severe body aches and fatigue no fevers

Patient's daughter called to report that patient had received vaccine Friday morning, by Friday night was in bed with tired, achy and flu like symptoms, stayed in bed all Saturday and woke up feeling better on Sunday. Sunday night arm began to itch at injection site. Has continued to itch and has become red and swollen. Reddened are extends from just below injection site to elbow. She stated it begins at the back of the arm and wraps around the front.

She found passed out on the floor by a friend. The ambulance was called. She was hospitalized for 24 hours and treated for dehydration. She had fever and diarrhea.

Administered 0.5 ml of Moderna Covid EUA vaccine IM to patient's left arm. Patient went out to waiting room after told to wait 15 minutes before leaving store. Approximately 2 minutes later caregiver and patient approached register and stated patient wasn't feeling well. Brought patient back into consultation room. Patient was slouching and not responding to questions. "Are you okay" & "Can you sit up" Patient continued to slouch. Administered EpiPen 0.3mg to patients left thigh and called 911. Patient then began to respond to questions. Paramedics showed up and assessed patient. Paramedics took patient to emergency room after their evaluation of patient.

Woke up at 8 am drank some orange juice and immediately threw up several times and began having hot flashes for a couple hours. By 10 am , she seemed to settle enough to try and drink some slim fast. She feels weak and tired.

24 hours after-headache- sinus type 48-hours -after- headache and body aches particularly left buttock 72- hours after- all of above plus 100.2 fever, extreme body aches, chills and could barely walk 96 hours after- symptoms going away, 120 hours after- only headache remained and red spot on left arm developed One week later all symptoms gone

VIIS ID: 7827510; Moderna COVID-19 Vaccine Vaccine Lot Number: 025B21A second dose. Vax clinic. Pt received vaccine in vehicle-unable to walk inside-family member stated that about 10mins after vaccine she began nodding off and was difficult to wake. 16:10: 123/80 POX 80% CPR not indicated. EMS On-site. S/S hypoxia, altered mental consciousness, unresponsive then alert. Family stated that she has been exhibiting similar symptoms recently-today is a 'bad day'. Son stated that it has been a difficult day for her. She has had to stop to "catch her breath' numerous times. "nods off' frequently. Assessment completed by EMS; transported to Hospital (doctors).

Lethargic/ felt extremely weak lethargic/m body shut down; sleepy; lost appetite; couldn't use bathroom, open her eyes, or eat; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Lethargic/ felt extremely weak lethargic/m body shut down), SOMNOLENCE (sleepy), DECREASED APPETITE (lost appetite) and FEELING ABNORMAL (couldn't use bathroom, open her eyes, or eat) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No relevant medical history provided). On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced FATIGUE (Lethargic/ felt extremely weak lethargic/m body shut down) (seriousness criteria hospitalization, disability and medically significant), SOMNOLENCE (sleepy) (seriousness criterion hospitalization), DECREASED APPETITE (lost appetite) (seriousness criterion hospitalization) and FEELING ABNORMAL (couldn't use bathroom, open her eyes, or eat) (seriousness criterion hospitalization). The patient was hospitalized on 09-Mar-2021 due to DECREASED APPETITE, FATIGUE, FEELING ABNORMAL and SOMNOLENCE. At the time of the report, FATIGUE (Lethargic/ felt extremely weak lethargic/m body shut down), SOMNOLENCE (sleepy), DECREASED APPETITE (lost appetite) and FEELING ABNORMAL (couldn't use bathroom, open her eyes, or eat) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Reporter did not allow further contact; Sender's Comments: This case concerns a 91-year-old female hospitalized with serious unexpected events of fatigue, somnolence, decrease appetite, and feeling abnormal. Event onset Day 1 after first dose mRNA-1273. Event outcomes 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.

extreme muscle fatigue confusion/disorientation patient fell out of bed and daughter was unable to help her get up; paramedics were summoned; patient transported to ER; next day patient had absolutely no memory of anything that happened; she was totally confused as to why she was in the hospital or how she got there; two days later she is absolutely fine except for being very tired

About 16 hours after the shot, she had a fever of 100.0, she felt very sick, nauseous, feverish, didn't eat breakfast like normal, didn't sleep last night as well. The fever broke and she's starting to feel better but it's making everyone concerned about the second shot.

Extreme fatigue from 10AM, April 17 through April 18 and continuing presently. Slept most of the time.

48 days post first vaccine and has not received the second dose; Weak; Underweight; Nausea; Dry Heaving; Upper Respiratory Infection; Fainted; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant) and CHILLS (Chills). On 16-Mar-2021, the patient experienced UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection), DYSPNOEA (Dry Heaving) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days post first vaccine and has not received the second dose), ASTHENIA (Weak) and UNDERWEIGHT (Underweight). On 23-Feb-2021, SYNCOPE (Fainted) had resolved. On 28-Feb-2021, CHILLS (Chills) had resolved. On 06-Apr-2021, UPPER RESPIRATORY TRACT INFECTION (Upper Respiratory Infection) had resolved. On 12-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (48 days post first vaccine and has not received the second dose) had resolved. At the time of the report, DYSPNOEA (Dry Heaving), ASTHENIA (Weak), UNDERWEIGHT (Underweight) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. She reported that she Fainted, and had chills, after the first vaccine. About 2-3 weeks after Vaccination she had an Upper Respiratory Infection with Negative COVID Test. She had Nausea, and Dry heaving since then. She feels Weak and Underweight. Today 12APR2021 and 48 days post first vaccine, She has not recovered from her upper respiratory infection. MD and Cardiologist told her to get the second vaccine. She wants to receive the second vaccine but she would like to delay it more, until she feels 100% well. Patient had a pneumonia shot and Flu shot SEP2020.; Sender's Comments: This case concerns a 92-year-old female with a serious unexpected event of syncope, and nonserious unexpected upper respiratory tract infection, dyspnea, asthenia, underweight, inappropriate schedule of product administration and expected chills, nausea. Event onset the same day as first dose mRNA-1273. Events resolved. 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.

cellulitis was developed belowher injection site which is 3-5 inches in size; Fever 99.7 F; mild headache; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CELLULITIS (cellulitis was developed belowher injection site which is 3-5 inches in size) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced CELLULITIS (cellulitis was developed belowher injection site which is 3-5 inches in size) (seriousness criterion medically significant). In April 2021, the patient experienced PYREXIA (Fever 99.7 F) and HEADACHE (mild headache). At the time of the report, CELLULITIS (cellulitis was developed belowher injection site which is 3-5 inches in size) was resolving and PYREXIA (Fever 99.7 F) and HEADACHE (mild headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 99.7. The patient was taking unspecified concomitant medication. The patient visited her Doctor's office and started treatment which her MD prescribed sulfamethoxazole oral antibiotic, and mupirocin 2% Ointment. Action taken with mRNA-1273 in response to events was not applicable. Treatment included Sulfamethoxaz and topical ointment. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Reporter details, event (fever 99.7) and treatment medications were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

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.

after first dose of the Moderna vaccine she became very ill and was hospitalized on 3/13 - 3/23. After 2nd dose of the vaccine she seemed to be doing ok but gradually declining and less and less to be able to do for herself, it slowed down greatly after the vaccine. There was a gradual decline, but on May 2 she woke up and was semi conscious and said she thought she was dyeing and was in pain and discomfort and was taken into the ER and she was DC'd and started hospice and two days before she passed she got the hospice care. My mother was in a semi coma and could not communicate properly. Many test were done at the hospital during her stay even though they never identified what the cause was. At the last ER visit they diagnosed her with pneumonia

Reports about 3 days after the shot she developed a headache, was cold, felt like a "dishrag", tired. She went to her family physician. He sent her to the hospital as she said he told her that her heart was hardly beating. At the hospital she had to have a pacemaker placed. She had no history of any heart issues. She reports being healthy before the vaccine.

Patient is a 91 year old female who presented with a chief complaint of aphasia. Patient with increasing frequency in confusion episodes over the past few months. Patient presented in no acute distress, normal neurologic exam. Vitals stable, afebrile. Asymptomatic. CT Head without acute findings, but chronic microvascular disease consistent with age which may explain patient's symptoms. TIAs cannot be ruled out however at this time. Recommend patient be evaluated by neurology. Discussed with patient who is in agreement with plan. Incidentally, patient with CXR findings consistent with pneumonia. Patient treated with antibiotics for CAP in case this is contributing to symptoms. COVID is positive but patient states that she tested positive in March and has received both vaccines. SpO2 94% on RA.

5/10/2021 Patient died. 5/3/2021 Patient is a 91 y.o. female with a history of afib, PE/DVT, hypothyroidism, GERD, htn, colon resection 206 and HTN who presented to the ED with AMS and difficulty breathing. Patient unresponsive in the ED and was intubated for airway protection. CTA chest with extensive acute pulmonary embolism with findings of right heart strain. Patient intubated and sedated, information is obtained from her son, medical staff and medical records. Patient was hospitalized with Covid 2 weeks ago, following discharge she seemed to slowly be improving until Saturday prior to admission Per son was more tired but she had worked with physical therapy and HH on Friday. Sunday she was having difficulty breathing and was brought to the hospital. 4/17/2021 Altered mental status, unspecified altered mental status type; Pneumonia of left lower lobe due to infectious organism; Atrial fibrillation with rapid ventricular response (HCC); Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type (HCC); Acute hypoxemic respiratory failure (HCC); Chronic respiratory failure with hypoxia (HCC); Pressure injury of sacral region, stage 3 (HCC); SOB (shortness of breath); Palliative care encounter; Shock (HCC); Chronic atrial fibrillation (HCC); Acute respiratory failure with hypoxia and hypercapnia (HCC)

Skilled nursing facility reported that patient was hospitalized on 7/27/2021. Patient received a chest x-ray on 7/25/2021 which indicated right lower lobe pneumonia. Began antibiotics but signs/symptoms worsened. Sent to hospital on 7/27/2021 and received a positive Covid-19 PCR test upon admission. Facility reported the patient had a fever of 100.4 degrees and shortness of breath.

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

Resident present with new onset fever, cough, and muscle aches. Assessment performed with V/S: T- 100.5, BP- 152/80, 78, 20, 96% RA,. Primary care provider notified. Ordered to give PRN acetaminophen 500 mg. No complications noted. Medication effective. Will continue to monitor

the following day 1/14/21 was extremely fatigued and had the big red mark and itch in the area of the injection. It went away and 8 days later 1/21/21, 2" diameter big red area that was itchy came out. No pain in the arm unless touched, hard to touch. Still has red hard area, warm to touch.

Feeling tired, nauseated, vomiting. She fell and had to have assistance getting up, Afterwards, had some weakness in legs. She did have COVID in July. Still having some weakness. No pain.

11:00 pm on day of vaccine had fever, chills, headache, dizziness Next morning had temperature of 102

2 days after receiving the vaccine started having a headache and odd visual changes - lights in sparkly patterns, seeing something move in periphery of vision that wasn't there. No fever, no aches, arm didn't hurt, no nausea, was able to continue working so no change in mental status. Lasted until 1/23/2021 and stopped completely. Is asymptomatic now.

Resident became chilled, unable to get warm, shivering, unable to get up, oxygen saturation dropped to 50% with heart rate of 133. Tachypnea

Client received vaccine on Monday January 25 in the am Phone call from daughter client started fever and weakness late on Wednesday afternoon. coughing but had been coughing prior to vaccine Daughter called MD started client on her standard dose of Predinisone No respiratory distress experienced at this time. Family will continue to monitor client for any changes MD aware of status at this time . MD not sure related to Covid 19 vaccine but felt it needed to be reported.

Patient had complaints of joint and body aches and pains, generalized complaints of not feeling well and fatigue.

developed joint and body aches and pains, generalized complaints of not feeling well and weakness. She fell as a result of weakness. Physician ordered her to be sent to the ER

On Saturday the 30th well I started off I didn't feel good. I noticed that I had a temperature of around 99.6 and I normally don't get a fever. As it got later I aching, a bad cough and diarrhea. During the night I temperature of around 101. The next morning I called my son and he came over and he called an urgent care who advised him that is was probably a reaction to the vaccine and to give me Tylenol. I got better and my temperature went down yesterday (Monday). I still didn't feel good on Monday and slept all day. I still feel a little washed out today.

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

Symptoms hit suddenly around 2pm on 2/112021( approx. 25 hours after vaccination) Soreness in right arm, Stomach cramping, Severe Chills, Low grade temp 99.8, Nausea. Pt was given Tylenol at 530pm and again at 2 a.m. on 2/12/2021. Symptoms subsided by the morning of 2/12/2021 but patient remained fatigued and "drained." She did not seek medical attention for this

Reaction to second dose of moderna (no reaction to first dose; Ten hours later, had sharp pains in lest side of my head (thought I was having a stroke). Before I called 911, I got extreme shakes. after that, no pain - nothing. Shakes lasted 5-10 minutes.

Chills, fever (101); arm sore all night; could not sleep; took Tylenol to bring temp down; nose was running; did not feel like eating; feeling much better today; no fever, chills, temp normal

Chills; headache; extreme fatigue; gas or chest pain that was thought to be gas and went away Died 4 days later

pt states she started having pain in the right arm. Her arm has limited movement. Pt has extreme fatigue and has slept the majority of the time after getting home from receiving the vax. Pt still has these symptoms.

Received the vaccine had no reaction, no temp, no headache. She felt a little funny, and possibly a week later she started getting reaction in her body, burning sensation in her chest, possibly thought related to acid reflux. She then had sensation down her leg nerve pains. Sometimes she also gets some hot flashes but they go away. She woke up early in the morning yesterday and had a pressure like sensation in her head, she still has that today. She still has burning sensation in her chest, and her legs and ankles are hurting still. She has taken some Tylenol for the aches and pains. Also has itchiness of her arm from the vaccine, as well as soreness.

She started feeling poorly the day after vaccination. She had flu symptoms with body aches, headaches and joint pain and thought I had the Covid-19. Called ambulance and they did a test but it was negative but did not go to the Hospital. I felt fine the next day,

Patient c/o feeling flushed, color pale pink, warm, dry. Radial pulse strong, steady. Breathing unlabored.Patient given bottle of cold water to drink, no swelling to face or lips. Patient stated she did eat breakfast that morning. Patient states water helping, then has some coughing after a drink. Patient states she often coughs after drinking things, denies difficulty breathing or swallowing. Patient c/o head throbbing after drinking. C/o nausea and has dry heaves x 1 but no emesis. Patient states has some chronic breathing problems and heart problems. Family member at side. BP 146/90 left arm sitting automated cuff, pulse 84. Respirations even and unlabored, O2 sat 88% on RA, Patient remains alert and talking, nausea subsides. Patient assisted to stand and ambulate with walker to be dismissed at 1053, but is dizzy so sat back down and dizziness subsides. Patient remains sitting and alert, talking to volunteer medical staff member. BP decreases to 132/86 and pounding in head decreases. Patient reports feeling okay to leave and at 1107 ambulates out with her walker and stand by assist from volunteer member and patient's family member.

Extreme chills then 101 fever, started about 11 pm. Woke in morning still had the fever, then took Tylenol and by 5 pm felt better, fever gone.

On the morning of 3/31/2021 patient had chills, she seemed to develop a cold, she was achy and not wanting to eat. She was very sleepy and by 6:00 P.M. she passed away.

She got the vaccine and started out with nausea below the vomiting point, and she could not eat much and had stomach upset. She did not feel well. She went to bed for a whole day and then slept the following day. It is still going on but not quite as bad, very tired. The arm was a little sore the night of the vaccine, but when she started using the arm the feeling left. Did have some soreness for a couple of nights. She can still hardly eat, but her stomach feels better. She has the bad feeling where she cannot eat but a few bites as she gets nauseated then. She has not taken anything for her symptoms. She is just not feeling well at all as if you don't want to be out of bed. It's a big struggle for her to get up and get her something to eat. Something that she doesn't have to cook.

Patient was not tested for COVID prior to the vaccine; one month after being fully vaccinated, the patient was admitted for pneumonia, altered mental status and reduction in ability to do ADLs. Upon admission, the patient was tested using the Abbott-ID NOW rapid COVID test and patient tested positive on 04/04/2021. Patient clinical presentation consistent with COVID per lung changes on chest x-ray and symptoms, positive for UTI.

Swelling in mouth, bottom lip, and tongue, sore throat Itching on entire body and head Rash on entire body --looks like sunburn PCP prescribed-- Prednisone 10mg tab--12 day course on 04/5/21 Betamethasone valerate 0.1% ointment on 03/25/21 Patient claims to be recovering

Admitted with increased SOB, acute respiratory failure secondary pneumonia. Previous COVID-19 infection in December 2020. Positive COVID-19 test on admission 4/16/2021.

Patient went to hospital with complaints of tachycardia and tachypnea, also complained of lethargy and chills. Patient does have baseline shortness of breath and atrial fibrillation.

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

"Patient received her second dose of Moderna vaccination on 6/11. She was sent to the ER on 6/12 with SOB, respiratory distress. Diagnosed with CHF. VS: POX 72% and placed on O2, BP 168/106, HR 120, Resident was diaphoretic. DNR, DNH but family wanted her sent out. Doctor notified, ordered Lasix 20 mg and Coreg 3.125mg given immediately and 911 called. Went to hospital, diagnosed with CHF. Returned and family requested hospice and that was initiated. Resident is back to her baseline?up, participating in Bingo and other activities, eating in the dining room. Did not have fever."

The history is notable for 92F well known to dept p/w generalized malaise, fatigue, weakness--received 2nd COVID vaccine day prior. Has been trying to eat/drink normally, but admits to me probably less than normal. No focal weakness, pain, rash.. Exam is notable for On my eval after initial interventions by PA, pt is ambulatory, tolerating PO, well appearing, normal complexion, normal/stable VS.. Patient at risk for Vaccine reaction, dehydration, ACS, AKI. Our plan is Workup unrevealing of acute pathology. Pt feeling well after tylenol and IVF, ambulating well. Discussed by phone with her son, agreeable to bringing her back home if she's up and moving about okay. Understanding about her symptoms mos

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.

7.11.21: Patient presents to the ED with fatigue, dyspnea, cough, and malaise. found to be COVID-19 positive. has a history of receiving both doses of Moderna COVID-19 vaccine. diagnosed with Pneumonia. Found unresponsive during CTA of chest. Then coded in the ED. transferred to the ICU. 7.12.21: rapid response called for respiratory distress. intubated. started remdesivir. received 1 dose of tocilizumab. 7.16.21: patient still admitted as of today - the day of report submission. still intubated. completed 5 day course of remdesivir.

Mom was feeling fine before she had the Moderna vaccines. A few weeks later, she became extremely ill. She died on May 14, 2021.

dementia flared up; Friend got worse / dementia flared up; Feel lousy; Starting to forget more and more after the shot/friend got worse and is starting to not remember things; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA (dementia flared up) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetic. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEMENTIA (dementia flared up) (seriousness criterion medically significant), CONDITION AGGRAVATED (Friend got worse / dementia flared up), MALAISE (Feel lousy) and MEMORY IMPAIRMENT (Starting to forget more and more after the shot/friend got worse and is starting to not remember things). At the time of the report, DEMENTIA (dementia flared up), CONDITION AGGRAVATED (Friend got worse / dementia flared up), MALAISE (Feel lousy) and MEMORY IMPAIRMENT (Starting to forget more and more after the shot/friend got worse and is starting to not remember things) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medication information was provided. No Treatment drug information was provided. Company Comment An alternative explanation is that the event Dementia was more consistent with the advanced age and the event Malaise was more consistent with the underlying comorbidities. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received on 14 Jul 2021 wherein events were added and case was upgraded to serious.; Sender's Comments: An alternative explanation is that the event Dementia was more consistent with the advanced age and the event Malaise was more consistent with the underlying comorbidities.

On 1/14/2021 resident began having a loose nonproductive cough. Lungs clear. Increased shortness of breath, Afebrile. Complaints of Left sided rib pain. Resident currently on hospice. Started Duonebs every 6 hrs. Resident also began having loose stools as well.

Does not have lot number. About an hour after getting the vaccine started with fast heart beat, felt like my heart was like "boom boom boom" and was really loud, sweating, weakness, runny nose. Symptoms since then have been on and off and steady for 5 hours today. Today it feels like my heart is in down in my lungs.

About an hour after receiving the vaccine my heart starting beating really hard and loud. You sweating, weakness and runny nose. The symptoms have been on and off since then. But the last 5 hours they have been steady. It feels like my heart is in my lungs. I do have a pacemaker and my Doctor just prescribed Lasix for swelling in my legs. I have not received it in the mail yet. Does not have the lot number.

pt stated within 10 minutes after receiving vax she became flushed, had chills, cold sweats and palpitations. Pt stated her vitals were taken and her BP was 215/104. After about and hour it came down to 160/?. Pt stated that 2 weeks after the vax she developed a 6" red, warm, swollen, itchy area around injection site. Pt stated her symptoms have subsided but she has contacted her PCP about getting second dose and was advised not to take it.

Patient stated she had a headache and felt like her blood pressure was high. Vital signs: BP 160/102, P 88, R 14, O2 96%. Head to toe assessment completed. Advised patient to stay for 15 minutes for monitoring. Patient did not want to stay for monitoring and left AMA.

1/31/2021 12:50 Nursing Note Note Text: Res had low BP, low O2 sats, 30 breaths per minute, eyes open wide, making confused utterances. Started supplemental oxygen via NC, 2L, then 3L. Sats went up to 93% for a while, Sprvsr called. Unable to auscultate Left lung sounds. Called to update Res daughter. Called to page NP, writer went back to assess Res and O2 sats were 88%, turned O2 to 4LPM, called 911 for transport to Hospital ED. Left around 1030. NP called back afterwards, was updated. Family updated that Res was sent to Hospital ED. Note Text: Received phone call from daughter as well as information from hospital. Resident has pneumonia with septic shock. She is on abx and had thoracentesis performed for large pleural effusion. [linked]

In the morning following the shot, she could not get out of the bed without assistance. She was very weak and could not stand by herself. She did not want to eat very much. Then by lunchtime, she was running a fever of 102.5 fever for many hours. We put her to bed. On Sunday morning she was much better with a better appetite and no fever. She also had normal amount of energy. She had a rash on her arm that received the shot and it ran from her spot of injection to her elbow. It was hot with the rash for about 5 days.

Patient's daughter reported at 2/20/21 (next day after her shot) that her mother was experiencing chills, fatigue, sore arm and fever (peak 101F). The patient's daughter gave her a Tylenol when she found out she had a fever and this resolved the fever and the patient was feeling back to normal around midnight that same night.

Mom has mild cognitive impairment. She is well above average for a 93 year old. I live with her and she is highly functioning. The day of her vaccine, she seemed very tired. The next day, she was exhausted. She had a hard time doing her normal activities. No fever. It was much more challenging for her to walk. She just couldn't get moving. It seemed to stay the same. I noticed she was having a harder time doing everything. Suddenly, her comprehension seemed to change. Within a week, she went from mild cognitive deficits to full blown cognitive impairment: not knowing how to take her pills, how to wash hands, how to use her watch/fitness tracker, to not removing her bottle cap to drink water, to having a hard time communicating. I called the Pharmacist where she had the vaccine, and they told me that this was not uncommon after the vaccine. They had been getting lots of similar calls. They haven't given out any second shots yet, and were not looking forward to it after everything they've been hearing. This is very frightening.!!!! Our Mom cannot be left alone now. How long will this last????!!!!

pt has CTCL and has developed more intense itching than usual. Pt has dementia but has had more severe episodes of aggression, confusion and delirium. Her upper left arm is red and has developed more defined lesions around the injections site and on her lower back. Her arm pain and back pain seemed to be heightened more than usual and she also has some fatigue. Pt saw her cancer Dr. on 3/24/21. Dr. made notation in her chart about her symptoms and was instructed to continue the using the cream that she was currently using. Pts PCP is aware of the increased episodes of confusion and being argumentative since taking the vax. Pts daughter is her full time care giver and is dealing w/ her increased intensity of the patients symptoms.

The patient recieved her second dose of Moderna and was sitting in observation when staff told us that the pt was falling asleep and was near syncopal. The patient was assessed by and the patients Power of Attorney was called to ask if they wanted the pt transported. who makes decisions for the patient did not want the patient transported and we advised him that it was against our medical advise and he still refused transport. He stated that he wanted staff to observe the patient.

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.

4/3-was feeling unwell and didn't eat much 4/4-could not get out of bed without assistance in the am; vomited mucus and could not eat; refused Easter dinner. 4/5-woke up and had trouble breathing; ambulance called "she had no pulse, and had trouble breathing" Throughout had no fever or chills.

Patient was alert and verbally responsive in usual state of health on 1/11/2021 received Moderna vaccination dose 1. Patient seemed stable until 2/6/21. Then on 2/6/21, patient was noted with slight elevated temp of 99.2, pulse 100, spo2 94%RA at 2:15am. By 5:20am, patient was pronounced dead.

Total disorientation, fatigue and not moving, used bathroom in bed peed and pooped on herself, chills, slight fever, extremely nausea, vomiting and 24 hours later diarrhea.

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.

resident was hospice she was afebrile day of vaccine on 4/20. on am of 4/21/21 0600 nurse stated no c/o of pain or discomfort. Resp were even and unlabored. That morning at 1145 charge nurse stated she was extremely hard to rouse. Vs were ok. SHe had some weakness in right side. they notified hospice. She had labs done. She was diagnosed with PNA and started on Abt. That night she was unresponsive to verbal commands and couldn't get po med. she received gentamicin im. on 4/22/21 charted she was vommiting small amount. She expired late that night. MD doesn't believe the vaccine caused the death, but thinks it has the potential.

93 y.o. Nursing home resident with comorbidities. On 2/4/21 resident complained of dyspnea and not feeling well. Resident and family refused transfer to Emergency Room. Supplemental oxygen consistently worn x5 days for symptom management. On 2/8/21, PA noted resident had transient hypoxia with elevated troponin suggesting a possible MI. Resident/Family continue to refuse transfer to ER. On, 2/16/21, resident had Syncopal episode and resident/family continue to refuse transfer to ER.

Vaccinated at about 9:50am Five minutes after vaccination, complained of itchy or "dry" throat. Gave water. 10 minutes after vaccination complained of throat beginning to close up. 10:01am given 0.3mg Epinephrine into right thigh. 911 called. 10:03 given 25mg Diphenhydramine oral tablet. 10:06am pulse 90 BPM. 10:09 pulse 96 BPM. She started to feel better by the time EMS arrived. 10:16am EMS took her to Hospital. She was returned home in the afternoon. Unknown if any further complications.

Patient reported not feeling well. Staff at the facility checked her blood pressure and it was high. 911 was called and paramedics determined patient was fine. She was not taken to the hospital.

Nausea, vomiting, headache, fatigue, diarrhea that started about 24 hours after the vaccine and lasted about 3 days

*extreme* fatigue. could not awaken for more than few seconds. When briefly awake she was coherent and not confused. slept deeply from 4pm and could not wake to eat or drink. No fever, bp normal, blood oxygen ok. Blood sugar at 11pm was 230. Gave her 15u lantus at 11pm (normally 25u). Was sleeping at 2:30am but had died at next check at 3:30am.

When she woke up around 7:00 AM, she was so called. Around 9:00 AM she was very weak, hurting all over, had diarrhea. She did not take anything for it. Had fatigue, muscle pain, chills, nausea and vomiting. Today, 2/15/21 she is feeling better and is back to normal. Tried calling her doctor but could not get through to them.

On 2/11/21 bruising possibly related to anticoagulant use. D'C's med. 2/21/21 recieved vaccine, dose #2. on 2/14/21 resident expereinced a temp of 100.4°F. C/O "pain all over". MD visited resident in the facility on 2/14. Spoke with family, comfort measures only. Due to history of ESBL treating empirically with ABT. As of 2/19 no improvement in condition. On comfort care.

Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: pt was not responding well, urinated on self and felt nauseas. Pt is on hospice and felt dizzy even before the vaccine.-Mild, Systemic: Nausea-Mild, Additional Details: Pt was dizzy and fell 02/21/21 at the site; paramedics called; refused to be hospitalized. Pt vaccinated 02/22/21, was dizzy and urinated on self, paramedics called, refused to be hospitalized. Staff told vaccinators then that pt was hospice and own guardian, so nothing could be done.

Awakened 12 hours after injection with chills and shivering. Got out of bed 18.5 hours after injection with temperature of 101.7 degreees F. By 24 hours after injection, temperature dropped to 100.0 degrees F. No other symptoms at all.

Family states patient had been coughing and was weak after the vaccine. Patient walked to the bathroom and then fell striking her head found in PEA with agonal breathing. Despite aggressive CPR medications patient remained in asystole. Unknow if Moderna or Phifzer

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.

Hypoxia on 3/12/21 in afternoon around 3pm. New Right lower lobe Infiltrate on Chest Xray 3/12/21. Cough 3/13/21. Worsening generalized weakness 3/12/21 7am, Nausea 3/12/21 7am, No appetite 3/12/21 7am. Malaise 3/12/21 7am. Encouraged fluids. Placed on oxygen via nasal canula. Started Levaquin antibiotic. Started on Guaifenisin cough syrup. Patient is still on Oxygen and antibiotic as of this report. Incentive spirometer ordered 3/15/21

Withing 24 hours of vaccine admin developed nausea, chills, aches, dyspnea, elevated heart rate. Saw PCP on 2/15 and was sent to ER and then admitted to hospital for 5 days-continued extreme nausea and atrial fibrillation after diuresis for CHF. HR 120s had to be put on multiple meds to bring ratedown. Discharged on 2/19. Cont worsening nauaea/chills/aches. Passed away on 2/23

Patient was a resident on a LTC wing. Received Covid-19 vaccine on 1/13/21 & 2/10/21. Pt stated she felt phlegm in her throat 3/14/21. On 3/15/21 patient started having trouble swallowing, and started needing supplemental oxygen for low oxygen saturation and needing suctioned for c/o being unable to swallow.. ST eval showed no gag reflex and inability to swallow effectively or safely. Pt needed 5L/O2 and unable to hold saturations above 90%. Patient became ?comfort care?, and passed away 3/18/21.

pneumonia; urinary tract infection (UTI); talking nonsense and not being clear; The reason the patient did not have the second dose one month from the first dose is because she got ill; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia), URINARY TRACT INFECTION (urinary tract infection (UTI)) and COMMUNICATION DISORDER (talking nonsense and not being clear) in a 94-year-old female 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 No adverse event (No medication history was provided). Concomitant products included ASCORBIC ACID, BETACAROTENE, COPPER, TOCOFERSOLAN, ZINC (OCUVITE [ASCORBIC ACID;BETACAROTENE;COPPER;TOCOFERSOLAN;ZINC]), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), METOPROLOL TARTRATE (METOPROLOL TARTRATE ACCORD), CLOPIDOGREL and DULOXETINE for an unknown indication, ACETYLSALICYLIC ACID (ASPIRIN 81). On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion hospitalization), URINARY TRACT INFECTION (urinary tract infection (UTI)) (seriousness criterion hospitalization), COMMUNICATION DISORDER (talking nonsense and not being clear) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The reason the patient did not have the second dose one month from the first dose is because she got ill). At the time of the report, PNEUMONIA (pneumonia), URINARY TRACT INFECTION (urinary tract infection (UTI)), COMMUNICATION DISORDER (talking nonsense and not being clear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The reason the patient did not have the second dose one month from the first dose is because she got ill) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. While hospitalized she was diagnosed and treated for a UTI, with intravenous fluids and antibiotics. Patient was discharged from the hospital with Foley's catheter and rehabilitation was advised. While hospitalized she was due for her second dose but she got pneumonia, so she was not given the second dose. The reporter assumes the pneumonia was bacterial, because the patient was treated with antibiotics. Very limited information regarding the events has been provided. Further information was requested.; Sender's Comments: Very limited information regarding the events has been provided. Further information was requested.

Resident began coughing then complained of abdominal pain and was taken to the Hospital. He began to vomit and breathed in. Had a heart attack

Extreme pain in the back, hips and legs upon waking up lasting 3+ weeks. Unable to sit to go to the toilet. Weakness in legs causing a fall. Pain and weakness lessened as day went on only to reappear next morning. Also extreme fatigue lasting weeks.

Was informed by local Medical Examiner that on 04/10/2021, 4 days after receiving second Covid-19 vaccine, that the pt slipped on a rug and hit her chin very hard and that she died. The family informed Medical Examiner that she was not feeling very well after receiving her vaccine and felt more fatigued than usual. Family raised concerned that the cause of her fall was due to vaccination. Medical Examiner ruled cause of death as a closed-head injury or cardiac arrhythmia, with significant other conditions at time of death being "mild symptoms following covid-19 vaccination"

Systemic: Chills-Medium, Systemic: Generalized Body Aches -Severe, Systemic: Joint Pain-Severe, Systemic: Diarrhea-Severe, Systemic: Fainting-Severe

nausea, vomiting, insomnia, runny nose--started 1:00 AM 21. /Left arm sore at injection site. Still have runny nose

death. Per son pt was not feeling well after the vaccination "like her legs were weak." Son found the mom in her bed 1am on 2/12/2021 unresponsive.

The vaccine was administered at the patient's residence in an assisted living facility. The morning following the vaccination staff report that she was very agitated and stated she did not feel well. They called an ambulance and she was transported to a local ER, staff report that it was not at the hospital that the patient is usually seen by when when she has issues and they were concerned that the facility did not have her medical history to treat her properly. The patient's grandson reported back to the assisted living director that the patient was diagnosed with asymptomatic pneumonia, was transferred to the ICU and passed away in the night.

patient complained stomach pain, responsive but lethargy and slightly clammy. Vital Signs: BP 112/45; pulse 41; O2 Sat 99 - 100%. Bradycardia patient put on gurney, heart monitor, started IV lock. transferred to ED for further evaluation.

5 days after injection, had sudden onset of severe back pain, tingling and burning in hands and down legs into feet. Jerking extremities and seizure like activity. Facility staff called for ambulance to transport to ER. No treatment, observed overnight, prescription for Tramadol. Transferred back to facility. Extreme fatigue. Pain manageable with Tramadol. 4 weeks later: extreme fatigue continues.

fever 100.4 (2 days duration), diarrhea ( on day 4), extreme fatigue ( durated 2 days commenced on day 4), erythema and swelling of right arm where injection administer( commenced day 1 , fading but not gone on day 8).

Pt received 2nd dose of Moderna too early. On 03/12/2021 when health dept nurse learned of the error, the patient was called to assess for any problems and to determine if the doses were given too early. RN said the patient was hard to understand and a poor historian. Pt could not give names of caregivers. RN had EMS go by to provide a welfare check. EMS reported pt was at baseline health status. EMS staff spoke with nephew who reported pt has only had one vaccine. On 03/15/2021, RN received calls from step daughter-in-law and Nephew, both advising pt did get both vaccines. Per family, the patient?s vaccine appointments were not communicated well between the family caregivers. One caretaker thought the 2/24/2021 trip to health dept was just to register and the second trip on 03/05/2021 was when the actual vaccine was to be given. Registration forms were completed at each visit, with both showing no previous vaccine administered. Pt and family report no side effects after the 1st vaccine, the nephew did report noticing that the patient was lethargic and weak 3 d after the 2nd vaccine. Family was advised the patient does not need another dose of COVID vaccine at this time, 2 dose series complete.

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.

Pt has continued to experience injection site reaction 2+ weeks post vaccination. Area of arm is red and feverish and itching. The itching has lessened at this point however. Patient has been self-treating with diphenhydramine and ibuprofen per recommendation from home pharmacy.

irritated her heart condition; Clot blood; weakness in legs, couldnt walk with legs; Coma; couldn't breathe; stroke/massive stroke in left side of her brain; Irritated her heart condition, rapid heart beat; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke/massive stroke in left side of her brain), CARDIAC DISORDER (irritated her heart condition), DYSPNOEA (couldn't breathe), THROMBOSIS (Clot blood), COMA (Coma) and MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Covid-19 Vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart disease, unspecified, Hypertension and AFib. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) for Hypertension, METOPROLOL for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tiredness). On 12-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs) (seriousness criterion hospitalization). On 13-Mar-2021, the patient experienced CARDIAC DISORDER (irritated her heart condition) (seriousness criterion hospitalization), THROMBOSIS (Clot blood) (seriousness criterion hospitalization) and HEART RATE INCREASED (Irritated her heart condition, rapid heart beat). On 15-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke/massive stroke in left side of her brain) (seriousness criteria death and medically significant). On 16-Mar-2021, the patient experienced DYSPNOEA (couldn't breathe) (seriousness criterion hospitalization prolonged) and COMA (Coma) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 13-Mar-2021 due to CARDIAC DISORDER, COMA, DYSPNOEA, MUSCULAR WEAKNESS and THROMBOSIS. The patient died on 17-Mar-2021. The reported cause of death was massive stroke in left side of her brain. It is unknown if an autopsy was performed. At the time of death, CARDIAC DISORDER (irritated her heart condition), DYSPNOEA (couldn't breathe), THROMBOSIS (Clot blood), COMA (Coma), MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs), HEART RATE INCREASED (Irritated her heart condition, rapid heart beat), HEADACHE (Headache) and FATIGUE (Tiredness) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. This case concerns an 95 year old female patient, with medical history of A Fib, Heart disease, Hypertension who experienced a serious unexpected event of Death 8 days after receiving 1st dose of mRNA- 1273 . Very limited information regarding these events has been provided at this time. However, the patient's advance age, multiple co-morbidities, may remain as risk factors. Further information is requested. This case was linked to MOD-2021-074814 (Patient Link).; Sender's Comments: This case concerns an 95 year old female patient, with medical history of A Fib, Heart disease, Hypertension who experienced a serious unexpected event of Death 8 days after receiving 1st dose of mRNA- 1273 . Very limited information regarding these events has been provided at this time. However, the patient's advance age, multiple co-morbidities, may remain as risk factors. Further information is requested.; Reported Cause(s) of Death: massive stroke in left side of her brain

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.

Pt call hospital call center 5/14/2021. Pt c/o difficulty breathing, swelling throat, palpitation, itching whole body, tiredness, body aches whole body since pt got 2nd covid vaccine 5/12/2021. Pt recommended pt to call 911 or go to nearest ED d/t emergency covid vaccine side effects shown. Pt refused to call 911. The writer offered to call 911 on behalf of pt. Pt agreed the writer to call 911 on behalf of pt. Called 911 and connected with pt in conference phone connection.

On the evening of 10JAN2021, patient experienced a low grade fever, decreased oxygen saturation of 38%, heart rate of 124, confusion. Patient received oxygen via face mask, morphine and ativan. By 11JAN2021, patient was no longer verbal, able to eat or communicate and was kept on comfort measure only. On the morning of 17JAN2021, the patient passed away.

Four days side effect free. On the fifth day, woke with very bad headache which continues (1/27-1/30, so far). Acedaminophen (sp?) helps. Rarely have headaches. Two friends, one 105 and one 65+, developed severe backaches 4-5 days after covid vaccine.

Resident reports that she is not feeling well this morning. Reports cold chills, nausea. Stated that she vomited around 4am.

Res not feeling well this shift, very weak and tired. Res having minimal output and has been to the bathroom x1 today.

Pt receieved her first dose of the Moderna COVID-19 on 12/29/2020. Lot number, route, and site not specified in medical record. No record of 2nd dose was found on medical record review. Pt was admitted to reporting hospital 2/2/2021 with an admitting diagnosis of failure to thrive/poor oral intake. Pt was reported in ER to have a sore throat, cough, shortness of breath, and general recent decline. Reported that pt and others in family had GI like illness about a week ago. Admission test for COVID was positive per PCR NP swab on 2/2/2021. Pt still currently admitted.

Fever of 104.5 at 330am. Reduced to 101.5 by 500am with Tylenol. Collasped at 830am on the floor unable to verbalize or move, 02sat =72. EMTs were called, checked vitals and transported to the ER.

According to patient's caregiver, patient presented with symptoms of fever (101.6 F) and purple blotches all over the body within an hour. Since patient was in hospice , caregiver called Hospice and a pharmacy and was told to give patient Benadryl and Tylenol. Patient was given both medications and the fever subsided in a few days but the purple blotches never went away. Patient passed away at the facility a week later.

Individual developed severe body aches, severe shoulder discomfort, high fevers (documented max temp. 103.7 F). Daughter reported that she became non-responsive with high fevers, and when the fevers decreased she was more lucid. Her condition rapidly progressed to nausea vomiting, diarrhea and patient died on 2/9/2021.

Pneumonia; Unresponsive at times; Weak; Diarrhea; Feeling Punky; Body aches/muscle aches; Fever; Chills; Nausea; Vomiting; Sore arm at site of injection; A spontaneous report, was received from a nurse (caregiver), regarding a 96 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced pneumonia, unresponsive at times (unresponsive to stimuli), weak (asthenia), diarrhea, feeling punky (malaise), body aches/muscle aches (myalgia), fever (pyrexia), chills, nausea, vomiting, sore arm at site of injection (vaccination site pain), and vomiting. The patient's medical history was not reported. Historical vaccine reported was flu shot. Concomitant medications included insulin, unspecified medication for pulmonary hypertension and heart failure. On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscular for the prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient experienced the sore arm. On 07 Feb 2021, the patient experienced body aches, sore arms, felt punky, weak, fevers with a body temperature of 103.7 (unknown units), chills, nausea, vomiting, diarrhea and muscle aches. Treatment medication included acetaminophen. On 08 Feb 2021, the patient continued with high fever, unresponsive at times, and all other symptoms. On 09 Feb 2021, the patient's fever was control, very weak and passed away on the same day at 04 45 pm. The death occurred and death certificate stated that pneumonia was the cause of death. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the event, pneumonia was considered as fatal, and that of other events unresponsive at times, weak, diarrhea, feeling punky, body aches/muscle aches, fever, chills, nausea, vomiting, sore arm at site of injection, and vomiting were considered as unknown. The patient died on 09 Feb 2021. Plans for an autopsy was unknown. The cause of death was reported as pneumonia.; Reporter's Comments: This case concerns a 96 year old, female patient, who experienced a serious unexpected event of Pneumonia (fatal) among others, 5 days after receiving 1st dose of mRNA- 1273 (Lot# 013M20A). Very limited information regarding these events has been provided at this time. The subject's con meds included insulin, unknown medications for pulmonary HTN and heart failure. The cause of death was determined to be pneumonia. Advanced age and co-morbidities may remain as risk factors.; Reported Cause(s) of Death: Pneumonia

Pt c/o of left arm pain after injection and for several days after. Pt was in bed for 2 days after injection c/o generalized malaise and weakness. Pt c/o of feeling of funny heart rhythms and feeling of constant anxious feeling. Pt started having episodes of SOB and was very labored doing simple tasks such as using the toilet. Pt started using o2 for the first time and had to recover for any activity for several minutes. Different medications were tried to help control symptoms such as Morphine for SOB and ativan for anxious feelings. Symptoms were never well managed after vaccine. Pt eventually died from worsening symptoms on 3/20

Flu symptoms, but most notably the loss of muscle strength in her legs. She collapsed and was unable to walk.

Became lethargic. Wasn't answering simple question. Did not have trouble breathing. Looked as if she was falling asleep. Son was with her and said this was very unusual for her.

Arm turned bright rosy pink/red in a 2? area, then extreme pain, throbbing, heat, fever, and then area extended down and around arm. At this time it was lighter: spreading out. Began to itch. Still hurting somewhat at varied times but not nearly as bad.

Patient's home healthcare worker tested positive for COVID19 and Filomena had some mild symptoms, so was tested 2/4/21. She had dry cough and tiredness. She received antibody treatment 2/5/21 outpatient. After infusion she had rash/ hives.

Resident became unresponsive after bath. unable to get O2 stats P76 B/P 116/70. Very lethargic all am did not get out of bed all day continued to be very lethargic all day.

Extreme fatigue, shortness of breath. Stopped eating within 2 days, stopped fluid intake 3 days later. Family notified on March 3. ery little fluid intake until Sun, when fluid intake stopped as well. Death occured on mon, Feb 8 2021.

Hallucinating; Occasional rapid heart beat; Hadache; A spontaneous report was received from a caregiver concerning reporter's mother a 97-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced hallucinating/ hallucination, occasional rapid heartbeat/ heart rate irregular and headache. The patient's current conditions included chronic urinary tract infection. Products known to have been used by the patient, within two weeks prior to the event, included antibiotics for chronic urinary tract infection. On 26-Feb-2021, prior to the onset of the symptoms, the patient received their unspecified dose of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route and site for prophylaxis of COVID-19 infection. On 27-Feb-2021 the patient had headache for 2 days, was hallucinating and had occasional rapid heartbeat. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The Outcome of the events, hallucinating, occasional Rapid Heartbeat, and headache was unknown. Company Comment: The reported events, hallucinations, heart rate irregular, and headache, were considered possibly related to mRNA-1273.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported event and excluding any other etiology, a causal relationship with the event cannot be excluded. Headache is consistent with the vaccine profile

03/15/2021: Presented to the emergency department with shortness of breath and not feeling well. The patient was admitted with pulmonary vascular congestion on imaging and UTI. The patient is currently still admitted.

We were told by the administering healthcare worker that approximately 20% experienced symptoms, and someone of her advanced age would probably only experience a sore arm. Nearly everyone in the retirement home was extremely ill after the second dose; most of the administrative staff went home sick; skeleton crew pulled double shifts caring for residents with extreme "blow-out" diarrhea and debilitating nausea. One patient reported temporary paralysis. Men complained of sore arms but women couldn't get out of bed. We were prepared with prophylactic anti-emetic meds and avoided diarrhea. However, patient had headaches and nausea for a week; refusal to eat/drink put patient at risk for dehydration and kidney issues; fasting exacerbated confusion and put patient at risk of harm (wandering, falling, etc.) Patient is still lethargic and confused, has started eating again but only minimally, a few bites. Strongly regret vaccinating.

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

Possible Covid Spots; just wants to sleep all the time; "getting very tired"/more progressively tired"/"not wanting to do anything."; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Possible Covid Spots) and FATIGUE ("getting very tired"/more progressively tired"/"not wanting to do anything.") in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced FATIGUE ("getting very tired"/more progressively tired"/"not wanting to do anything.") (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced SOMNOLENCE (just wants to sleep all the time). On an unknown date, the patient experienced COVID-19 (Possible Covid Spots) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Possible Covid Spots), FATIGUE ("getting very tired"/more progressively tired"/"not wanting to do anything.") and SOMNOLENCE (just wants to sleep all the time) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was hospitalized and prescribed antibiotics. Multiple test were done including head CT and chest x-rays done that showed "possible COVID spots." Patient was discharged to hospice.; Sender's Comments: Although a temporal association exist, based on the natural history of COVID-19, and the established information about the mRNA-1273 vaccine, a causal association between the fatal event of Covid-19 and the product use is assessed as unlikely. Fatigue and somnolence are also assess as symptoms of Covid-19. However, based on temporality, causality with the product use cannot be excluded.

COVID-19; confusion; weakness; cough; fever; body aches; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) in a 97-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization), CONFUSIONAL STATE (confusion) (seriousness criterion hospitalization prolonged), ASTHENIA (weakness) (seriousness criterion hospitalization prolonged), COUGH (cough) (seriousness criterion hospitalization prolonged), PYREXIA (fever) (seriousness criterion hospitalization prolonged) and MYALGIA (body aches) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 14-Mar-2021 due to ASTHENIA, CONFUSIONAL STATE, COUGH, COVID-19, MYALGIA and PYREXIA. At the time of the report, COVID-19 (COVID-19), CONFUSIONAL STATE (confusion), ASTHENIA (weakness), COUGH (cough), PYREXIA (fever) and MYALGIA (body aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not provided. Patient was hospitalized due to worsening condition. Company Comment: This case concerns a 97-year-old female hospitalized with serious unexpected events of COVID-19 with confusional state, asthenia, cough, pyrexia and myalgia. Latency 6 days after first dose mRNA-1273. 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: This case concerns a 97-year-old female hospitalized with serious unexpected events of COVID-19 with confusional state, asthenia, cough, pyrexia and myalgia. Latency 6 days after first dose mRNA-1273. 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 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.

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

Moderna COVID-19 Vaccine EUA In addition to chills, patient was pale and extremely weak, experiencing difficulty standing from a seated position and great difficulty walking. She stayed hunched over after standing and was unable to walk unassisted. With assistance it took her several minutes to walk about 15 feet. The weakness persisted for 6-8 hours after which her previous strength and mobility were restored.

in and out of consciousness; blood pressure was 170/112; severe chills; UTI; A spontaneous report was received from a consumer, concerning a 98-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe chills/ chills, blood pressure was 170/112/ hypertension, was in and out of consciousness/ consciousness fluctuating, chronic heart failure/ cardiac failure chronic and urinary tract infection (UTI). The patient's medical history included were chronic heart failure and urinary tract infection. Concomitant medication included was apixaban. On 18 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 18 Feb 2021, same day of receiving vaccine, the patient experienced severe chills, blood pressure was 170/112, and was in and out of consciousness. She was hospitalized and remained at the hospital. 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, were considered as unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. However, advanced age, history of chronic heart failure and concurrent underlying urinary tract infection may remain as risk factors. Further information has been requested.

She kinda knew she wasn't with it but not really /really don't know what to do. She didn't know what she wanted for breakfast; She seemed a little confused; She seemed a little off; Fever of 99.8; You could tell something was off; A spontaneous report was received from Consumer and Healthcare Professional concerning a patient 98 years old , female and who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced a little confusion, she seemed a little off, you could tell something was off, memory impairment and fever. It is a serious case; Seriousness criteria: Hospitalization The patient's medical history was not provided. The patient's lab data was provided- did a CAT scan, chest x-ray, urine sample (which was negative). Everything was clear. Concomitant products were not provided. On 12 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number unknown) via unknown route on left arm for prophylaxis of COVID-19 infection. The patient waited 15 min after shot. (it was Friday at 1:00) she was fine Friday and Saturday and Sunday morning. She seemed a little confused and didn't know how the remote(to her recliner) worked. She seemed a little off. She really don't know what to do. She didn't know what she wanted for breakfast. She didn't know how to use her nose drops (caller states her mother had difficulty expressing this). The consumer stated that "This woman is very sharp." I put her thru some memory test. she couldn't tell me (her birthday), you could tell something was off. She didn't know how to use the phone, TV remote, remote for recliner, she wasn't really talking from Sunday. Took her to ER at hospital they did a CAT scan, chest x-ray, she had a fever 99.8, urine sample (which was negative). everything was clear. They kept her for observation overnight. Thursday her doctor (through her insurance) wanted to come check her out. He gave her a memory test. She was coming into herself again and she remembered the 3 words. We then handed her the phone (which she was able to use). Within half an hour of him arriving she was completely fine (last Thursday) and has continued to be. Caller states regrading her mother she "kinda knew she wasn't with it but not really." They called the patients neurologist and they said it should clear up in 10days regarding her side effects. Treatment provided was unknown. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events she seemed a little confused, She seemed a little off, you could tell something was off, she kinda knew she wasn't with it but not really were Not Resolved / Not recovered and for fever were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

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

in and out of consciousness; blood pressure was 170/112; severe chills; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (in and out of consciousness) and HYPERTENSION (blood pressure was 170/112) in a 98-year-old female 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 UTI and Chronic heart failure. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (in and out of consciousness) (seriousness criteria hospitalization prolonged and medically significant), HYPERTENSION (blood pressure was 170/112) (seriousness criterion hospitalization prolonged) and CHILLS (severe chills). At the time of the report, LOSS OF CONSCIOUSNESS (in and out of consciousness), HYPERTENSION (blood pressure was 170/112) and CHILLS (severe chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 170/112 (High) Increased. No treatment information was 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. Patients underlying chronic heart failure and advanced age are confounders. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up information was received on 27-Apr-2021 contains information regarding follow-up consent (follow-up and consent was denied for follow-up).; 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. Patients underlying chronic heart failure and advanced age are confounders.

Starting the afternoon of 1/14/21 patient stated the injection site started to feel itchy. When she looked in the mirror, there was an area of bright pink surrounding injection site. She reports the site felt swollen and she could not tell if it was warmer than her other shoulder. Early on the morning of 1/15/21, patient reports the area around injection site was bright pink and remained swollen. At this time it is less itchy, but remains lightly itchy intermittently. At 9am on 1/15/21, RN visited patient and was informed of her reaction. RN observed her L upper arm and she has an oval-shaped light pink area with injection site at the center. Oval measures 8.8 cm x 6.1 cm. The site is warm, slightly swollen, and feels indurated from the swelling. Patient is afebrile at 97.4 orally. Patient reports the light pink coloring at this time is less bright than it was earlier in the morning. Report is being made at 10 am 1/15 so outcome of reaction unknown at this time.

Patient became lethargic, extremely tired, unable to care well for self. Patient had no appetite, refused most food and spent many hours simply sitting in her chair. She felt that she was having a heart attack and called 911 using her emergency response button on 2/21/2021. Doctors indicated that the patient's life was in serious danger, but because of age they were hesitant to try to remove the clot pressing on her heart. She was only allowed to go back home because we utilized Hospice. When asked about her life expectancy, we were told she could die any minute or might live a few more months, but that she was not expected to live much longer. SHE WAS IN GOOD HEALTH PRIOR TO THE IMMUNIZATION!

developed stroke (unresponsive, unable to express herself or her needs, lethargic, unable to swallow)

A little delirious; Very tired; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (A little delirious) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history provided.). On 30-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced DELIRIUM (A little delirious) (seriousness criterion medically significant), FATIGUE (Very tired) and VOMITING (Vomiting). At the time of the report, DELIRIUM (A little delirious), FATIGUE (Very tired) and VOMITING (Vomiting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

Generalized decline in status: increased lethargy, increased weakness, decreased oral intake of food and liquids, alert but decreased socialization all of which have progressively gotten worse but was first noted the early morning of 6/18/21 which was about 12 hours after administration of the vaccine. Currently, resident is not exhibiting s/sx of generalized pain. Zoloft was d/c'd on 6/25 to see if the start of this medication induced residents symptoms. Since d/c of medication, residents status continues to decline with only new item in regimen being the second administration of the MODERNA vaccine.

Vomiting the night of the vaccine. Low oxygen and high fever next morning. Has been on palliative care Was hospitalized, but section 21 will not let me fill the info. Hospital Admitting Dx: Sepsis, likely biliary cause; Acute on chronic encephalopathy likely sepsis related Returned 1/12 on hospice

Chills, nausea and vomiting on days 1 and 2 post vaccine. Days 2 and 3 post vaccine developed burning sensation in esophagus and dehydration. Given GI cocktail (Maalox and viscous lidocaine), IV protonix, and 500mL fluid bolus in ER on evening of 1/23 and discharged home feeling significantly better.

Onset of event approximately 12:30 pm on 3/4/2021 with duration through approximately 4:pm on 3/5/2021. Patient described extreme fatigue and weakness, disorientation/lethargy, vomiting x 1.

These side effects lasted about 24 hours: fever-101, chills, pain ,swelling and redness at injection site, swelling/ knot the size of orange, throwing up, very tired. The pain and swelling of injection site/ arm lasted about a week. My mom tested positive for covid=19 on 1/15/2021. She had a negative covid test on 1/22/2021. She received the 1st Moderna vaccine on 2/24/2021 in which she had the above side effects. the 2nd vaccine is supposed to be given on 3/24/2021.