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".

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 family had been noticing onset confusion for a few weeks prior to vaccine and event. Patient was taken to ED when found unconscious and died of a subdural hemorrhage a few days after vaccine clinic at retirement home.

Patient awoke on 2/12/21 with altered mental status, confusion, respiratory distress, was taken to hospital by ambulance. Per ED notes from ED attending Pt presented with hypotension and respiratory distress. DNR status, patient given comfort measures and passed away in ED at 11:24 am on 2/12/21.

Patient became incoherent for a few seconds while sitting in a chair in the observation area. Pharmacy manager went to observe patient and ask how she was feeling. Patient's head started to droop to the side for a few second and her shoulders made shrugging movements for a few seconds. During this time I called 911, while individual waited with the patient seated in the chair. Patient became more coherent in a few seconds and could speak and smile normally. Ambulance came and patient went with paramedics.

Hallucinating, seeing things; Was in overdrive; Couldn't sleep, she was awake for 24 hours; A spontaneous report was received from a consumer calling in regards to her 90 year old mother who "started hallucinating, seeing things, she was talking to people who weren't there". "She was awake for 24 hours", "she was in overdrive". The patient's medical history included, Dementia, High blood pressure and Low blood pressure. On 05-Feb-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 vaccine, Lot # 038K20A, intramuscularly into her left upper arm for prophylaxis of Covid-19 infection. On the night of 06-Feb-2021, the patient started hallucinating, "She was seeing things", "she was talking to people who weren't there". She "couldn't sleep, she was awake for 24 hours. "She was in overdrive". She was reaching for things that weren't there,"hearing babies crying", "people knocking at the door", " stay couldn't stay still, she was arranging things". "Things that didn't bother her before were now a big problem". She was , "out of her mind". The reporter further stated, she was stronger, "didn't need her walker anymore". Finally yesterday (07-Feb-2021) she slept for 24 hours straight. She stated her mother is now back to her "dementia" self. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the events, Hallucinating, seeing things,talking to people who weren't there, Couldn't sleep, Awake for 24 hours, in overdrive, reaching for things that weren't there, hearing babies crying, people knocking at the door, couldn't stay still, arranging things. Things that didn't bother her before were now a big problem, out of her mind. stronger, didn't need her walker anymore", were considered recovered/resolved. Company comment: the reported events Hallucinations, Abnormal Behavior, and Sleep disorder" were considered possibly related to mRNA-1273.; Reporter's Comments: This report concerns a 90--year-old female who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # 038K2A and started hallucinating, seeing things, she was talking to people who weren't there". "She was awake for 24 hours", "she was in overdrive". 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.

extreme weakness, shaking extremities, diarrhea, loss of bowel/bladder control, mental disorientation, unable to walk

Hallucinating; Urinary tract infection; A spontaneous report was received on 22 Feb 2021 from a consumer concerning a 90-year-old female patient who received Moderna's COVID-19 vaccine and developed a medically important event of hallucinations, and in addition urinary tract infection. The patient medical history was not provided. Relevant concomitant medications provided included acetylsalicylic acid, vitamin d3, unspecified vitamin b12 , donepezil hydrochloride, levothyroxine, melatonin, omeprazole, permethrin and hydrocortisone. The patient received their first of two planned doses of Moderna's mRNA-1273(BATCH/LOT # 032L20A) on 22 Jan 2021 for the prophylaxis of COVID-19 infection. On 12 Feb 2021, patient received their second of two planned doses of Moderna's mRNA-1273(BATCH/LOT # 013M20A) in the left arm for the prophylaxis of COVID-19 infection. On 20 Feb 2021, in 9 days of receiving vaccine, patient started hallucinating, and has urinary tract infection manifested by an odor and painful urination. Treatment for events were not provided. Patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable. The outcome of the events, hallucinations, urinary tract infection, 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 these events, a causal relationship cannot be excluded.

Moderna COVID-19 Vaccine EUA The day after receiving her shot she exhibited significantly worse dementia symptoms (Very forgetful, repeating questions over and over, confusing close family members, etc.)

3/12/2021 Presented to the hospital with altered mental status, and was ultimately diagnosed with a urinary tract infection. The patient was admitted for IV antibiotics with resolution of the patient's mental status.

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.

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.

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

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

Patient described onset shoulder pain approximately 1 week after 2nd covid vaccine injection. Patient presented to PCP office on 4/5/21 for initial evaluation following pain with no resolve after trying exercises etc. At this time during evaluation PCP discussed possibility of vaccine related injury. Since this time, patient has undergone oral pain medications, PT exercises, and steroid injection, TENS treatment. Seen today 6/24/21 for continued evaluation. Major ongoing symptom is near constant pain. Bothers even at night, making it hard to sleep. Does not use arm because of the pain. Painful if tries to reach behind herself. Does not feel she is improving. PCP diagnosed as SIRVA, and next plan is MRI of shoulder.

ADR: decreased HR, decreased BP, and Altered mental status Treatment: Benadryl and EPI Pen Outcome: Resident was not transferred and remains in facility

15 minutes following administration of Moderna vaccine, patient felt funny feeling on left side of her head, had increased saliva in mouth and her tongue began to burn. Patient denied shortness of breath, chest pain or swelling. No swelling to lips or mouth was noted and patient was able to swallow secretions without difficulty. Benadryl 25mg was given and patient's symptoms resolved after about 30 minutes. Patient was able to be discharged home with her daughter

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

1055 S/p vaccination reports "feels anxious" w/associated palpitations and "feels like sugar is going down" Medical monitoring begins x 30 min, vitals assessed; BP 140/85 P137 RR 19 Po hydration offered/ given; symptoms improve during this time 1115 BP 145/80 P89 RR 18

Date and time adverse event started: 2-12-2021 at 8:15am with confusion, slurred speech. daughter had her rest and reports she is now okay. followed up with daughter, states she did not take the patient to the ER. had her rest and is now at baseline. Informed her of potential risks of waiting, went over life threatening reactions to look out for and call 911. verbalized understanding, states if symptoms occur again she will then go to an ER.

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.

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

After correct administration of the shot, patient described feeling "funny" almost immediately after shot. Felt she had pressure in chest, throat closing up, heart racing. Administered a dose of epinephrine to the IM thigh, roughly 5 minutes after administration of vaccine. Patient reported feeling better, advised her to seek medical attention at an emergency room to follow-up. She was driven there and PCP contacted by caretaker, who was present.

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

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.

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)

Significant decrease in ability to function physically and mentally. Increased confusion. Unsteadiness resulting in two falls. Weakness of muscles. Facial numbness which lasted for several hours. These symptoms showed up within a few days of the second dose of the Moderna vaccine. The effects lasted for about one month. Since then, the person is back to normal functioning with no weakness, or confusion. She is doing well now but for one month following the Moderna vaccine was very debilitated and unable to function in normal activities of daily living.

blood pressure became very low; experienced cellulitis in her legs; Diagnosed with COVID a week later; she couldn't even remember anybody; acute Alzheimers; had mild dementia but towards the end it seemed to have exacerbated; This spontaneous case was reported by a consumer and describes the occurrence of DEMENTIA ALZHEIMER'S TYPE (acute Alzheimers), DEMENTIA (had mild dementia but towards the end it seemed to have exacerbated), HYPOTENSION (blood pressure became very low) and CELLULITIS (experienced cellulitis in her legs) in a 91-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 Dementia. In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DEMENTIA ALZHEIMER'S TYPE (acute Alzheimers) (seriousness criteria death and medically significant), DEMENTIA (had mild dementia but towards the end it seemed to have exacerbated) (seriousness criterion medically significant), HYPOTENSION (blood pressure became very low) (seriousness criterion hospitalization), CELLULITIS (experienced cellulitis in her legs) (seriousness criterion medically significant), COVID-19 (Diagnosed with COVID a week later) and MEMORY IMPAIRMENT (she couldn't even remember anybody). The patient died on an unknown date. The reported cause of death was death was acute alzheimers. It is unknown if an autopsy was performed. At the time of death, DEMENTIA (had mild dementia but towards the end it seemed to have exacerbated), CELLULITIS (experienced cellulitis in her legs), COVID-19 (Diagnosed with COVID a week later) and MEMORY IMPAIRMENT (she couldn't even remember anybody) outcome was unknown and HYPOTENSION (blood pressure became very low) had resolved. Treatment included unspecified pressors. No concomitant medications were reported. Patient received the 1st dose of the Moderna COVID-19 vaccine in FEB-2021. Caller did not know the exact dates of administration of the two doses. Patient was then diagnosed with COVID a week later. Patient did not have much of a reaction to the 1st dose or any symptoms from COVID. She then received her 2nd dose of the Moderna COVID-19 vaccine in middle of FEB-2021, per the caller. In the end of APR-2021 or beginning of MAY-2021, patient experienced cellulitis in her legs. Her blood pressure became very low and she was hospitalized for treatment. She was put on pressors. She recovered from it and was sent back to her assisted living facility. However, on 25-MAY-2021, she passed away at the assisted living due to acute Alzheimers. Patient had mild dementia but towards the end it seemed to have exacerbated, where she couldn't even remember anybody. Her diagnosis at the time of death was acute Alzheimers. This case was linked to MOD-2021-034532 (Patient Link).; Sender's Comments: This is a 91-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch unknown) who experienced exacerbation of her DEMENTIA, ALZHEIMER'S DEMENTIA, HYPOTENSION and CELLULITIS after her second dose of vaccine, leading to her death from ACUTE ALZHEIMERS. Advanced senior age also could be attributed to the development of the events. It is unlikely, that the events are related to the vaccine based on long standing illness of DEMENTIA. . Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: death was acute Alzheimers

Approximately 15 minutes after receiving the vaccination the patient began to feel a tightness in the throat and difficulty speaking with a sense of anxiety and fright. The EMT and paramedic summoned me and after arriving at the observation area and ascertaining the patient's symptoms i asked the medic to administer the .3ml of epinephrine via EpiPen which he then did. Responding paramedics then arrived and took over assessment and treatment of the patient. An ambulance had previously been called and the patient remained stable with slight improvement in the sense that she became less anxious and frightened. She exhibited no urticaria or angioedema. Vital signs included initial B/P of 183/95 with improvement to 176/76 and 99% pulse ox . Patient was transported to hospital and per daughter was released about 2 hours later.

Client unexpectedly collapsed and passed away on 1/13/21 from suspected sudden cardiac death. Prior to her death, she was in skilled care for rehabilitation following hospitalization from 12/21-12/31/20 for an acute lower GI bleed. Her hospitalization and skilled care stay were complicated by delirium and she was being treated for delirium with olanzapine (Zyprexa) at time of death.

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.

Client signed up for a vaccination clinic today. She answered no to having a first dose of vaccine. Her home health nurse called and said she's very confused and had her first dose of Pfizer on 1/25/21. She got Moderna today 2/10/21.

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

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

Pt experienced altered mental status and chest pain the day after second vaccine. Pt was transported to Medical Center.

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.

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.

Body started to shut down/ Can't open the eyes; Can't do anything, can't feed herself and can't go to bathroom; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ILL-DEFINED DISORDER (Body started to shut down/ Can't open the eyes) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything, can't feed herself and can't go to bathroom) in a 92-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 medical history reported. ). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ILL-DEFINED DISORDER (Body started to shut down/ Can't open the eyes) (seriousness criteria hospitalization and life threatening) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything, can't feed herself and can't go to bathroom) (seriousness criteria hospitalization and life threatening). At the time of the report, ILL-DEFINED DISORDER (Body started to shut down/ Can't open the eyes) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Can't do anything, can't feed herself and can't go to bathroom) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case concerns a 92-year-old female hospitalized with serious unexpected events of ill-defined disorder and loss of personal independence in daily activities. Event onset with unknown latency 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. Reporter did not allow further contact; Sender's Comments: This case concerns a 92-year-old female hospitalized with serious unexpected events of ill-defined disorder and loss of personal independence in daily activities. Event onset with unknown latency 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.

Pt. stated she was light headed and hadn't ate any lunch or had any water. She also reported being anxious. BP 180/100 P78. Pt given a bottle of water and banana and observed for 30 mintues. Dizziness resolved and BP down to 150/80 at discharge.

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.

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.

vivid hallucinations lasting 48 hrs. saw clowns, ants on floor and crawling up walls, Piles of dirt on floor and furniture that must be cleaned. people sitting on furniture. Man sleeping on patio, people having picnic in back yard, backyard completely relandscaped. floor covered in snakes and lizards, then bedroom full of puppies. She became very agitated if you disagreed. Insisted on cleaning 'dirt'. slept 2 hrs first night. Second night finally went to bed at 4 AM. Woke up at 10 AM and was fine. She has bad knees, and they hurt from all the night's activities. She was combative at times, and insisted that you help clean, sweep, remove 'snakes', etc.

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.

Rash first starting to present mildly on 1/8/21 after receiving the first vaccination on 1/6/21. However after the vaccination on 2/3/21, the rash spread and became more severe. On 2/10 the nurse manager stated the following: The rash is located on bilateral arms, back, chest, upper bilateral thighs, and groin area. The areas present as little bumps that are raised and have been scratched open. Resident is saying they are extremely itchy and causing her much distress. Resident went to the ER on 2/10/21 and received a steroid, antihistamine, and diflucan and they also prescribed Doxycycline and Triamcinolone cream.

24 hours after the vaccination, was a "zombie" did not drink or eat or take morning medications. Did not know if she had taken any meds (she had not). After getting her to drink fluids, eat some food, and take morning blood pressure medications, about 6 hours later, she started to act more normal.

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.

Felt as if drunk, off balance, had to hold furniture to walk, lasted into 2nd day. No fever or soreness.

SOA, hives, anxiety started immediately after getting vaccine. Treated with Benadryl, methylprednisolone, Pepcid. Pt was in ER for one hour and discharged home.

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.

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.

Pacemaker Surgery; patient did end up missing the date of her second vaccination and has not received it; feel itchy; feeling very funny and real strange; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of CARDIAC PACEMAKER INSERTION (Pacemaker Surgery) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included RIVAROXABAN (XARELTO), VITAMIN C [ASCORBIC ACID] and VITAMIN D NOS for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PRURITUS (feel itchy) and FEELING ABNORMAL (feeling very funny and real strange). On an unknown date, the patient experienced CARDIAC PACEMAKER INSERTION (Pacemaker Surgery) (seriousness criterion hospitalization) and INCOMPLETE COURSE OF VACCINATION (patient did end up missing the date of her second vaccination and has not received it). At the time of the report, CARDIAC PACEMAKER INSERTION (Pacemaker Surgery), PRURITUS (feel itchy) and FEELING ABNORMAL (feeling very funny and real strange) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (patient did end up missing the date of her second vaccination and has not received it) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Feb-2021, Electrocardiogram: normal (normal) heart was operating properly. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was taking unspecified blood pressure medication concomitantly. Following the administration while the patient was in the clinic, she began to feel itchy, very funny and real strange. At this time the EMS on site were concerned and preformed an electrocardiogram (EKG) on the patient to make sure that the heart was operating properly. It was deemed that it was and the patient was then sent home. After that time no other side effects were present but the patient did eventually have to go into the hospital for a Pacemaker Surgery that was believed to be unrelated. The date of this surgery could not be remembered at the time of the call. 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.; 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.

Admitted 6/10/21 w/current covid illness. Partial vaccination noted. 6/17/21 urine culture w/no growth. Progressed to release from Covid unit to general population in recovery status on 6/22/21. Seen/Assessed by NP/MD /IDNP during stay. 6/26/21 urine culture w/no growth. 6/27/21 seen by MD d/t increased falls and confusion. Fall on 6/29/21 w/increased confusion and immediate transport to ER for increased confusion, decreased oxygen saturation and fall w/possible head injury r/t unwitnessed fall and increased confusion. She expired at the hospital 7/3/21 w/respiratory failure.

very agitated, unusually low blood sugars, feeling of something crawling under her skin, picking at and cutting fingers

Nurse: the resident received her vaccine at 09:25 am and immediately began to feel cold. This nurse was notified at 0945 at which time the resident complained of nausea and dizziness. The resident was also emotional, confused and experiencing high blood pressure (170/78) .

*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.

States had felt her heart beating fast, had a swollen tongue and a weird feeling. PHN checked BP and was 142/84, pulse 94 apically, O2 sats 94% on RA. Patient stated that the feeling lasted for just a minute. PHN gave juice to patient after checking vitals and she stated she felt much better. Asked if would like some Benadryl and she said she took an allergy medication this morning as part of her normal routine. Patient also stated she has a history of an irregular heart rhythm. She stated she ate well for breakfast this morning to ensure she did not have a low blood sugar while waiting for her shot. Note time of incidence at 1139am and had not eaten since breakfast. Patient stated she was fine to go home after her 30 minute wait time. Her VS were good at this time. PHN requested that patient contact her PCP if there were any further concerns following her leaving the site for the vaccination.

Mania lasting 2 days ( not sleeping or eating, constant talking, constant activity, hearing things that weren't there.

Started having hallucination; A spontaneous report was received from a consumer concerning a 94-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273). Medical history included unknown pre existing medical condition. Concomitant medications were not provided. On 05 Feb 2021, approximately nine days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 28 Feb 2021, 2 weeks after first vaccination dose (on 14 Feb 2021) the patient had hallucination and was hospitalized, she had history of recent hospitalization on 26 Jan 2021 prior to vaccine administration but the details were unknown. The reporter was also concerned about her mother receiving the second dose of vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, hallucination was not provided.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

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

Resident had acute onset of confusion with difficulty following directions, severe decrease in safety awareness, and significant weakness x2 days leading so several falls.

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

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

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.

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.

Resident has developed new episodes of confusion, behavioral changes, and visual hallucinations as of 4/4/21

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.

Weakness and dizziness. Not fully coherent to take evening blood pressure pill at 7:30 pm. Right hand motor skills not good. Could not hold water bottle to take pill.

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

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

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.

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.

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

Could not stand or walk Shooting Ppin in right arm Achiness Confusion High Blood Pressure High Heart Rate - 116 Trouble speaking No appetite

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.

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.

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.

Pt. received her 1st Moderna Covid vaccine on 1/28/2021 with lot number of 010M20-A at 0906 am. Family reports since the first vaccine pt. has had weakness and has fallen. Pt. received her 2nd Moderna vaccine on 2/24/2021; see information above for lot, etc. Pt. was brought into ER with c/o falls, weakness and confusion. Pt. had fallen on 2/27 and 2/28. With one of the falls pt. fx. her right radius and ulna. PCP due to altered mental status, right sided weakness and aphasia at times is r/o stroke.

102 female who is a COVID survivor.. had a mild case of COVID in May 2020. Received first dose of Moderna at assisted living facility on approximately January 20th and suffered no ill effects. Had second Moderna vaccination late afternoon of February 8th. Later that evening or in the early morning of February 9th tried to go to the bathroom and either fainted or fell onto the bathroom floor on her face. Lay on the bathroom floor face down until assisted living facility staff found her in the morning when they were passing out medications. Taken to ER at hospital on 2/9/2021. Was not admitted to hospital- all CT scans and x-rays and blood work were normal. Taken back to assisted living facility where she exhibited dramatic change in behavior- uncooperative, refusing to eat or take meds, refusing to get OOB. Mentally a decline in cognition. Transferred to different facility with higher level of care on February 15th and is improving somewhat.