Moderna

Pt complains of severe lethargy since injection (6 days). Severe enough that he is unable to leave the house as is his usual custom. Denies fever. Reports blood sugars lower than normal and he's had to adjust his insulin intake in response to this. Some nausea, but no vomiting. Denies fever.

About 8pm I began t experience total body itching. At 11pm the itching was too much to allow for sleep. I took two Gabapintin 300mg. At 4AM I went to sleep. I contactedmy dermatologist. He suggested the vaccine may have started a Grover's response. He asked that I add Zyrtec (over the counter) to my meds. He asked that I continue hydrating my skin with Vanicream cream. I folllowed his advice. The itching stopped on Sunday. I continued with the Zyrtec but stopped the Gabapintin. Today, Tuesday, I am having muscle tightening, especially in my legs.

Patient Began experiencing shakiness, tremor, feeling of ?rush? approximately 15 minutes after the vaccination. He was immediately assessed by EMS crew. Blood pressure 156/72 initially. Pulse is 64, respirations 20. He said he had a tight feeling in the neck and felt flushed. Oxygen saturation was 99%. Patient was given 25 mg oral Benadryl after five minutes of symptoms. He continued to be monitored. His symptoms improved mildly, But he continued to complain of a rush like sensation. It was recommended that the patient be transported to the hospital for at least six hours of monitoring. The patient declined and signed an AMA form. Patient monitored for a total of 45 minutes before allowed to be escorted out of the building with his wife, with instructions to present to the ER mediately if any symptoms worsen or did not improve within the next five hours.

Patient is reported to have died at home, the day after his COVID test. Family member states that he did good the afternoon and evening after his COVID-19 injection, but that he started not feeling good the next day. The patient "was having palpitations". The family tried to convince him to go to the Emergency Room, but he refused. Patient died at home.

Unable to use legs, extreme pain on both hip joints, nausea, very sore left arm, very weak left arm, needed assistance in and out of bed

Days 1-3: flushed, temp of 99-100, extreme pain in joints and muscles, dizziness, weakness, elevated blood sugar (400s), elevated blood pressure, couldn't stay awake. Treated with OTC cold/flu meds, no appetite~ Days 4-13 same plus wheezing cough, difficulty catching breath, difficulty talking, difficulty comprehension, focus, etc. Low oxygen level. Went to the ER on Day 8 with all of the above. Given oxygen and IV (of what another person had--as was my understanding), prescriptions: Promethazine-DM;methylPREDNISolone; albuterol;azithromycin. Currently--still difficulty breathing, coughing, difficulty focus, very weak. Treatment: walking, lots of water, cough syrup and albuterol

Marked involuntary movements, of whole body and especially left arm and leg. Loss of ability to communicate and feed himself. Vomited medication.

initially, nausea and "weird" feeling for approximately 12 hours.Tthe injection site continued to be uncomfortable , and on 8th day after injection, the injection site began to itch. On 9th day, there was intense itching, and injection site began to swell. by 10th day (today), the swelling and itching is subsiding, but not gone.

My husband had a 2nd series if symptoms beginning the night of the 26th. (4days) after first onset of diarrhea and vomiting the night of the vaccination. (01/22/2021. This required a trip to his primary care doctor on 01/28/2021. His vitals were good, no fever but low blood pressure. Doctor prescribed an anti nausea med. which stopped the vomiting. It is 2 days later and he has lethargic, no appetite, confusion and concerns about getting 2nd shot!

Slept all day on 2-5-2021 low grade fever. Very wobbly had to have help getting out of bed and to the bathroom. Was better on 2-6 but still wobbly but not as bad.

fever, muscle and joint pain, significant high fever, severe sinus headache, exhaustion. Symptoms started about six hours after injection. I had a significant fever that lasted for 18 hours. The first night I was unable to sleep because the body soreness and pain would not allow me to get comfortable. I started taking Tylenol shortly after the symptoms started but it did little to mitigate the symptoms during the first 24 hours. By the end second day following vaccination, symptoms were beginning to subside. On the morning of the third day, I pretty much back to normal.

Early next morning he got in his vehicle and drove around (he does not know why).He ended up behind a shell gas station and police were called as a suspious person. His windows werte down and he could not remember how to close them. He had been there for hours and unrinated in his clothing. He told the police he was making sure the waitesses were doing there jobs correctly. Again this was a Shell gas staion and not a resterant. The police closed his windows and sent him home. He hit the side of the house with the truck. Then when he got to the garage he could not remember how to put it in park. He is still having memory issues today but he can carry a conversation. Tuesday he could not complete a sentance

Beginning 1/24/21 - legs began feeling heavy- unsteady gait - weakness - stiffness - confusion . Parkinson meds appears to be no longer working- symptoms worse.

Patient called 2/17/2021 to report he had a very stiff arm (unable to lift arm) and arm was very painful after injection 2/16/2021. Patient took acetaminophen through the night and arm was still stiff and sore morning of 2/17/2021. He required assistance doing his farm chores/work.

Pt reported dizziness and disorientation the evening after vaccine. States he "got lost in my bathroom" and "felt like I was going to die". He did have body aches and headache

?COVID arm? The site of the injection began to itch (sometimes awakening me from sleep) and continued for about two days

Patient had the Moderna vaccine 1st dose roughly 5 days ago. Overnight, his wife woke to him having an episode of what appeared to be a tonic clonic seizure around 5 am on 2/23/21, followed by a period of disorientation and unresponsiveness consistent with a post ictal state. The patient has no history of seizures. It is unclear if this had anything to do with the Moderna vaccine, but I am reporting it due to the timing of the episode in conjunction with the vaccine.

caller stated he developed neurological issues a week after receiving the covid vax. Pt became weak, confused, unable walk, hallucinating. He fell 3 times in that week. Symptoms got worse to the point that 911 was called and he was admitted to the Hospital. He had a MRI and CT of brain. MRI on spine. Both had abnormal results w/ no bleeding. Blood Work was normal. He was treated and will be released on Hospice 2/25/2021.

weight loss, muscle weakness, abnormal crp level and liver test, loss of appetite, bed bound, falls, and unable to get up from floor. unable to make meals, dependent on care giver for food meals

Initially night of the vaccine 3/2/2021 body felt hot, felt sweaty but temp was 98.0, unable to sleep through the night. just felt uncomfortable. Morning of 3/3/2021 woke up with extreme pain in injection sight, sweaty, but cold, dizzy and weak, no fever., Could not stand up. Was sat down on sofa for maybe 2 mins. all of a sudden shoulders drooped, head fell forward, I asked "dad are you ok" there was not a response, I walked closer to him and his head flew back, his eyes were slit open, and he started gasping for air 3 times then slumped forward and passed out. 911 was called paramedics checked all vitals including blood sugar, oxygen, heart rate etc everything registered as normal.

Severe onset of autoimmune vasculitis and renal failure. Loss of movement & sensation (paralysis) of left arm and leg. Mild cognitive deficit and confusion. Fell due to loss of use of L leg. Hospitalized x 5 days, now in rehab facility slowly regaining function of L arm and leg, and relearning how to walk. Sudden renal failure (stage 4 renal disease) onset suddenly as well with this reaction.

Saturday- Started to develope a fever 99 around 7 pm, increased to 100.5 by 10 pm -took 325 mg Tyelenol-slight chills and aches - fever increased to 103.7 by 3:30 am -took 650 tylenol - fever around 102.8 about 8 am- strong chills throughout Sunday - fever in the 102 range - aches - just closed my eyes and was semi asleep. - Monday the fever was now in the 100 range-chills were not as violent - I stopped feeling like a zombie - Tuesday -no fever/chills, feeling better. ps -had covid in Dec 2020

After receiving vaccine patient became unresponsive and had ?posturing like behavior. After a minute or two patient responded to strong sternal rub and was transported to ER for further evaluation.

Chills, Fever (between 101 - 102), Severe Aches, It took effort just to get up out of bed. A very miserable day and a half. It is a little over 2 days since the onset of symptoms and it seems pretty much over. I had mild side effects after the first dose.

vomiting; diarrhea; not his true self; A spontaneous report was received from a consumer concerning a 76-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273), and experienced vomiting, diarrhea, and not being his true self (feeling abnormal). The patient's medical history was not provided. No relevant concomitant medications were reported On 01 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient was hospitalized overnight due to vomiting and diarrhea. The reporter stated that the patient was not his true self. The patient missed his second dose appointment that was due on 01 Mar 2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The events of vomiting, diarrhea, and feeling abnormal were considered resolved.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

About 4 hours after the vaccination the patient got agitated and did not know who I was and went next door and told the neighbor to call the police to get me out of his house. His memory of me came back about 4 hours later. 4 days later it happened again only more agitated. His memory came back again, but not for several hours. The 3rd episode happened 4 days after that and the agitation escalated into total psychosis and he tried to stab me with a steak knife. The police took him to the hospital and the doctors have been trying to adjust he meds to keep him from getting violent. He has been in a month now. Prior to the vaccination on February 20th things were normal, went out to lunch, he knew who I was.

Altered Mental state; Weakness, confusion, hospitalization by ambulance, fever 102 for 3 days; impaired speech, upper body shaking Reaction to 1st vaccine required hospitalization with similar symptoms but not as severe; Covid fog. He had similar symptoms to covid last summer with lingering problem. Hospital wanted to diagnose as Parkinsons Disease but he was cleared for Parkinsons last fall and last year. Hospital did not want to file an AE report and did not know the process.

Severe tinnitus in both ears beginning shortly after first dose and continuing to this date. difficulty sleeping and concentrating with this condition. Prednisone burst has not affected the severity. Able to sleep somewhat with 2 Gabapentin capsules. Blood pressure under control with Ramipril. Tried acupuncture with negative results. I have seen many other reports of this side effect.

76 yo M who presented to the ER with a history of confusion for the prior 24 hours. He was admitted for further evaluation regarding his mental status. Upon admission, patient tested positive for COVID-19, however, he had tested positive in October of 2020 also. Patient had received the first COVID-19 vaccine dose 2 days prior to admission, displayed no hypoxic symptoms. MRI of brain revealed a small area that could possibly be an acute infarction of right occipital lobe. His mental status improved during his admission, and he was discharged on 2/16/2021 with some intermittent confusion. Doctor recommended he still receive his second COVID-19 vaccination on time.

7-8 hours after injection slight soreness at shot location; 20 hours after injection sudden wave nausea & possible need to vomit, defecate, urinate, & dizziness; sat on toilet & collapsed forward onto floor into stack of towels remaining semi-conscious for a several minutes trying to determine location; worked way upright, got to bedroom, and tried to sleep but severe chills; chills subsided and slept 6 hours; felt feverish and in period of 2 hours had temperatures of: 99.6; 100; 100.4; 101.5; 101.8; 98.8 & went back to bed for night; awoke feeling relatively normal 03/13/2021; thereafter to the present time of 04/04/2021 days of feeling relatively normal, but often waves of feeling light-headed; blood pressure my blood pressure taken at home on Omron wrist device has been highly variable from 136/74/58 down to 101/64/72 with prior normal being about 115/65 to 130/70 at home and as taken at the eye doctor's office on 03/01/2021 the week prior to cataract surgery on 03/08/2021 it was 128/70, but is commonly higher at doctors office exams likely due to stress of driving to the doctor's office and on day of surgery was up to 158/80; on those days of being light-headed the blood pressure was commonly in the 101/64/72 to 114/65/61 range; my body temperatures remained in normal ranges of 97-98; beginning on 03/30/2021 there was some feeling of some throat or esophagus constriction and harder to swallow; this has continued & included acid reflux on 04/03/2021 and feeling very tired and went to bed about 05:00pm & slept to 08:00pm followed by going to bed at 11:00pm and unable to sleep the rest of night due to acid reflux in throat all night; but better on awakening this morning; it remains that there is the feeling of being light headed; a few times during this period after getting the Moderna vaccination the area of the injection has had a minor soreness, and/or itchiness. I have not yet seen a doctor about this reaction, but I did indicate to my eye doctor prior to the cataract surgery on 03/08/2021 that I would be getting my second Moderna vaccination 3 days after. He felt it should be okay. Similarly at the time of my first Moderna vaccination, I told the nurse practitioner that I would be having cataract surgery 3 days prior to the scheduled second vaccination. She also felt it should be okay, as well as having had a reaction to Amoxicillin for the first time about 11 months earlier. That reaction was hives all over the body that kept recurring for 3 weeks and thereafter at places on the body for another month. I am otherwise in excellent health for my age and the only medication taken is Timolol for glaucoma. I am active and frequently walk several or more miles several days per week. My reaction seems unusual. I have only now ceased taking the last of the cataract surgery eye medications, that being Prednisolone eye drops. If the symptoms persist after seeing my eye doctor tomorrow, and after elimination of the eye drop medication as of today, I will be scheduling an appointment with my regular doctor for a checkup.

Patient states that he felt "floaty" after receiving the vaccine today. It began within about 5 minutes. No chest pain. No shortness of breath. NO numbness or weakness. He does note he tends to be emotional and has been quite emotional about the vaccine. He has been under a lot of stress for the last ten years. Vital Signs HR 69 /min, 39 /min, BP 181/124, 195/126, Ht 59, RR 18, Oxygen sat % 95, 96, Oxygen Liter(s) Patient had EKG which showed bradycardia and flipped T waves inferiorly. He was sent to the ER where his blood pressure remained high. Pulse remained low initially but gradually improved. Cardiac work up was normal and patient was discharged to home.

Wife said the patient felt "jittery and aggravated". This started the day after his second dose and lasted two days.

death Narrative: Patient received Moderna covid vaccine # 1 on 2/26/21. Per scanned records on 3/18/21, he presented to the ER with reports of shortness of breath and was subsequently admitted and treated for acute CHF, NSTEMI and sepsis (ceftriaxone and azithromycin). He later developed AKI and surgery was consulted for placement of a Trialysis catheter. After placement of this catheter, he developed increasing respiratory distress and confusion and was transferred to the ICU where he received vasopressors, intubation and unsuccessful resuscitation after a code blue. Autopsy reports not available. 22 days from date of vaccine to date of death.

STARTING ON THE THIRD WEEK: SEVERE PERPETUAL LEFT-SIDE HEADACHE WITH LEFT BRAIN MODERATE CONTRACTION. NOT SURE AT FIRST BECAUSE OF SLEEPLESSNESS PROBLEM. OVER THE COUNTER COMBO TYLENOL IBUPROFEN ASPIRIN, THEN ADVIL, NOTHING WORKS AS BEFORE AFTER SEVERAL ATTEMPS OVER SEVERAL DAYS. THEN OUT OF THE BLUE WHILE SITTING TWISTING MY BACK TO CHANGE POSTURE, SUDDEN SHARP PAIN AROUND THE WAIST ON THE BACK NEEDING HELP TO WALK UP TO LIE DOWN WHICH USUALLY WILL RECOVER SOON, BUT NOT THIS TIME. TRIED THAI ASAIN BALM[CREAM] RUBBING ON THE BACK WAIST PAIN AREA AND USUALLY THE BALM'S MEDICINAL HERBS SMELL WILL FILL THE AIR AROUND THE BODY, BREATHING IN THE BALM AROMA USUALLY HELP FASTEN THE RECOVERY, SOMEHOW ALL ACHE/PAIN JUST STOP. SOMEHOW PERHAPS COINCIDENTLY ALL ACHE/PAIN JUST STOP FOR SEVERAL HOURS, SO DID NOT THINK IT WAS FROM THE VACCINE. AT THE END OF THE THIRD WEEK HEADACHE CAME BACK THOUGH NOT SEVERE WITH MILD BRAIN CONTRACTION THIS TIME UNTIL NOW THE FOURTH WEEK APRIL 19, 2021 AND SEEM PERPETUAL AS NO PAIN MEDICINE CAN CURE IT, JUST REDUCE THE PAIN A BIT. THAT IS WHEN I THINK IT IS FROM THE SIDE-EFFECT OF THE VACCINE, HENCE THIS REPORT. THE SECOND SHOT WILL BE THIS SATURDAY APRIL 24,2021; SHOULD I DO THE 2ND VACCINATION? TASTE, SMELL NORMAL THROUGHOUT WITH MILD FEVER, NO ACCURATE THERMOMETER AT HOME, STILL SLEEPLESSNESS EVEN INCREASE DUE TO THE HEADACHE WITH FEW MINUTES SLEEP DURATION IN BETWEEN HERE AND THERE THROUGH DAY AND NIGHT. BY THE END OF THIS WRITING HEADACHE REDUCED MUCH MORE AND DO HOUSE CHORES FINE.

Patient had received second vaccine of Moderna on 4/8/21. Since getting the second vaccine, he had experienced fever and right arm pain. When he presented to Medical Center on 4/14/21, he was acutely confused and febrile (102.8 degrees Fahrenheit). He was empirically treated for meningitis with Vancomycin and Ceftriaxone. His CSF was unremarkable, so antibiotics were discontinued. Patient continued to be altered and required intubation. So far, our other workups have been negative and we are pending the NMDA antibodies. He was extubated 4/19/21 and mental status has returned back to normal and is afebrile.

Woke up at approximately 4:00 am with headache and severe dizziness. It was so bad it forced me to go to Emergency Room at the Medical Center 3/7/21. They checked my eyes that were bouncing back and forth, gave me IV, did an EKG. Prescribed Meclizine 25 mg for the dizziness, three times a day. Absolutely no help. Went to Primary Care Physician, and he thought it might be an inner ear infection and gave me a prescription for progressive Steroid Treatment. No help. Got appointment for 4/9/21 with Ear, Nose and Throat specialist. At the same appointment was sent to see, an Audiologist in the same building. The two doctors determined it was not an inner ear problem. I was then advised to get a Cat Scan of my Brain and see my cardiologist. I am now in my 6th week of major dizziness which has affected all aspects of my life.

This is a 76-year-old male with dementia who is well cared for at home by his wife who brought him in the the ER on 4/16/21 for for altered mental status and not acting right. Patient is wife states he had his second Moderna Covid vaccine 2 weeks ago and has been declining steadily ever since. She notes he has had brain "fog" with increased confusion weakness and fatigue where he is no longer doing his baseline activities. She has noticed him getting more winded and tired with routine activity and then sleeps a lot. she feels like his dementia suddenly went on a rapid escalation. The morning of his ER visit her concern was he was acting as if his blood sugar was low described him as being sweaty, he was shaking, he was very weak and lethargic. She noted his temp at that point was 92.5 his blood pressure was 139/70 his heart rate was 70 and his blood sugar sugar was over 200. Patient also has a history of diabetes in addition to the dementia and he had a history of alcohol use disorder until 4 years ago when he suddenly stopped drinking. Her main concern was the rapid change since his Covid vaccine and now he is not sleeping at night and he is sleeping more significantly during the day and she is nearing exhaustion at this point. She saw the PCP and they said there is nothing they can do and told her to bring him to the ER

48 hours after 2nd COVID injection, severe shortness of breath. Unable to perform any activity, including getting dressed , walking from room to room any physical activity without sitting or lying down to catch a breath. Also during this time experienced chills, body aches, muscle weakness.

Patient, 10/31/44 was admitted Sunday night for confusion, weakness, and a fall at home. Patient had his Covid-19 vaccine here on 4/9 through the clinic. Per patient?s step-grandson (which is the most involved family member) patient had his first vaccine on March 4th at our clinic. On March 6th patient became extremely weak and step-grandson went to check on him and was unable to get into the house because patient was too weak to get off the couch. A window AC unit had to be removed for step-grandson to get access to patient. They did not seek medical attention at that time and patient improved within a few days back to baseline. Family was unaware that he was getting the second covid shot on 4/9. Patient was seen in grocery store the evening of 4/9 but family was unable to get ahold of patient on Saturday 4/10 and on Sunday (4/11) step-grandson went to his home and found patient on the floor. Patient has been a poor historian but states that he became weak and fell out of a chair. We think he may have been laying on his right side for about 36 hours at home. Patient was found to have blisters on his right forearm and right chest, liver enzymes were elevated on labs and he had dehydration. Patient has also had hallucinations and confusion but everything seems to be slowly improving with supportive care. He is still incontinent which is very unusual for him per family. He was negative for rhabdomyolysis, stroke, C-spine injury, negative for hepatitis, urine drug screen was negative. We are continuing to provide wound care for his blisters and PT/OT. Just a strange case.

Arthritis symptoms in both knees. Pain is excruciating, to the point patient remained in bed for over 3 days. Patient had a phone appointment with his family Dr. Dr was asked if the symptoms could be related to the vaccine, as he has never had such excruciating pain in his knees. He also has pain in most of his joints. The worst being his knees and shoulders.

Very severe brain fog and confusion. Left house at 5 am. Confused, left in Jeep with no one knowing. No phone, wallet, shoes. Had an accident ( no one else involved) found laying on ground after 11 hours of searching. Can?t remember what or why it happened, still remains in the hospital at this time. After his first vaccine he got the brain fog for 1 day, but recovered the next day. No incident due to severe confusion.

I COULD NOT GET AND KEEP MY BALANCE. I FELT LIKE I WAS REALLY DRUNK. I WAS TAKEN TO ARH BY AMBULANCE.

Approximately 2 weeks after receiving vaccination, patient developed confusion and lethargy. He presented to the hospital where he was found to be febrile. Alteration mental status continued to worsen, and then had a generalized seizure. Patient was empirically treated for possible meningoencephalitis but diagnosis is not confirmed.

Acute kidney injury; acute myocardial infarction; cardiac failure congestive; Confusional state; dyspnea; Respiratory distress; Sepsis; cardio-respiratory arrest; This case was received via VAERS (Reference number: 1213568) on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CARDIO-RESPIRATORY ARREST (cardio-respiratory arrest), ACUTE KIDNEY INJURY (Acute kidney injury), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction), CARDIAC FAILURE CONGESTIVE (cardiac failure congestive), CONFUSIONAL STATE (Confusional state), DYSPNOEA (dyspnea), RESPIRATORY DISTRESS (Respiratory distress) and SEPSIS (Sepsis) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CARDIO-RESPIRATORY ARREST (cardio-respiratory arrest) (seriousness criteria death and medically significant), ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization and medically significant), ACUTE MYOCARDIAL INFARCTION (acute myocardial infarction) (seriousness criteria hospitalization and medically significant), CARDIAC FAILURE CONGESTIVE (cardiac failure congestive) (seriousness criteria hospitalization and medically significant), CONFUSIONAL STATE (Confusional state) (seriousness criterion hospitalization), DYSPNOEA (dyspnea) (seriousness criterion hospitalization), RESPIRATORY DISTRESS (Respiratory distress) (seriousness criteria hospitalization and medically significant) and SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant). The patient died on 20-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient presented to the ER and was treated for acute CHF, NSTEMI and sepsis with ceftriaxone and azithromycin. After placement of Trialysis catheter, he developed increasing respiratory distress and confusion and was transferred to the ICU where he received vasopressors, intubation and unsuccessful resuscitation after a code blue on 20-Mar-2020. Company comment: This is a case of death in a 76-year-old male subject with unknown medical history, who died 22 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible. Concomitant medication use was not provided by the reporter.; Sender's Comments: This is a case of death in a 76-year-old male subject with unknown medical history, who died 22 days after receiving the second dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death.

On April 3rd after his second shot he felt headache and "fuzzy headed" continued to get worse until he suffered severe memory loss. Could not remember how to lock the front door or put on a seat belt. Went to Doctor who sent him immediately for a head scan. The scan showed a very large brain bleed and he was taken to the ED and they began reversal procedures to the Coumadin with platelets and injection of "K". He had brain surgery on April 23, Burr holes to relieve pressure. Returned home on April 26. On May 10th he was reading the paper and suddenly could not speak and did not have use of his arms or legs. Called 911 and he was rushed to the ED. They did a head scan and found that his brain had an additional bleed. He had brain surgery again on May 12th, Craniotomy. Returned home on May 16th and is still recovering.

MRI of brain showed I had two strokes, one recent and one older; Difficulty walking/limp; Numbness; Stumbling; Weird feeling; Left leg was very weak; Arm weak feels heavy/left arm felt heavy; Episode of vertigo with difficulty walking; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stroke. Concurrent medical conditions included Penicillin allergy. Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 26-Mar-2021, the patient experienced VERTIGO (Episode of vertigo with difficulty walking). On 18-Apr-2021, the patient experienced LIMB DISCOMFORT (Arm weak feels heavy/left arm felt heavy) and MUSCULAR WEAKNESS (Left leg was very weak). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older) (seriousness criterion medically significant), GAIT INABILITY (Difficulty walking/limp), HYPOAESTHESIA (Numbness), GAIT DISTURBANCE (Stumbling) and FEELING ABNORMAL (Weird feeling). The patient was treated with Physical therapy (Prescribed balance exercise) for Vertigo. At the time of the report, CEREBROVASCULAR ACCIDENT (MRI of brain showed I had two strokes, one recent and one older), VERTIGO (Episode of vertigo with difficulty walking), GAIT INABILITY (Difficulty walking/limp), HYPOAESTHESIA (Numbness), LIMB DISCOMFORT (Arm weak feels heavy/left arm felt heavy), GAIT DISTURBANCE (Stumbling), FEELING ABNORMAL (Weird feeling) and MUSCULAR WEAKNESS (Left leg was very weak) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Cardiac monitoring: normal (normal) normal- no AF. On 22-Apr-2021, Echocardiogram: normal (normal) normal. On 22-Apr-2021, Magnetic resonance imaging head: abnormal (abnormal) Showed two strokes. On 22-Apr-2021, Ultrasound Doppler: abnormal (abnormal) Showed two strokes. Treatment information were not provided. Action taken with mRNA-1273 in response to the event was not applicable. 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.

In case it was pneumonia; Not feeling good since the vaccine; severe dizziness; vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (In case it was pneumonia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. no medical history was reported by reporter. Concomitant products included OMEPRAZOLE, METOPROLOL TARTRATE, LOVASTATIN, CLOPIDOGREL, FINASTERIDE, HYDROCHLOROTHIAZIDE (THIAZIDE), MONTELUKAST, FUROSEMIDE, FELODIPINE, BUSPIRONE, SPIRONOLACTONE, DOXAZOSIN MESYLATE, LABETALOL, ASA and IRON for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DIZZINESS (severe dizziness) and VERTIGO (vertigo). On an unknown date, the patient experienced PNEUMONIA (In case it was pneumonia) (seriousness criterion medically significant) and FEELING ABNORMAL (Not feeling good since the vaccine). At the time of the report, PNEUMONIA (In case it was pneumonia), DIZZINESS (severe dizziness), VERTIGO (vertigo) and FEELING ABNORMAL (Not feeling good since the vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, X-ray: inconclusive not able to determine if he had pneumonia. On an unknown date, SARS-CoV-2 test: negative tested twice for Covid-19 with Negative results both times. On 23-APR-2021 with in one hour of vaccination the patient began to experience severe dizziness and vertigo. The patient did not receive any treatment medications for the reported events. The patient reported that he had not been feeling very good since the vaccine, stating "I don't think this is a coincidence me getting sick after I got the vaccine". He was evaluated at the Emergency Room this past Sunday on 5/23/2021, because he still wasn't feeling very good. He states he had an X-ray done and was they were not able to determine if he had pneumonia, however they treated him with IV antibiotics in case it was pneumonia. He reports feeling "a little better" since the IV antibiotics. Action taken with mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR: AE details. Case upgraded to serious. additional adverse events were updated and narrative information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

on 6/16/2021 at approx. 2:00 PM patient presented with hypertension (BP 184/115), Elevated Temp (104.1F), Increased confusion, lethargy, weakness. Was sent to ER via ambulance where he was admitted. Per admitting H and P primary Dx. "Fever, Probably acute viral illness versus post vaccination syndrome". Patient was treated inpatient at hospital with IV hydration, symptomatic care, lab monitoring. Patient is stable and planning to discharge from hospital back to this long term care facility over the weekend.

Seven weeks after the first dose I began to feel unwell. One week later I had fallen down the night before. I felt like my legs were very weak. My wife noticed that I was hallucinating. We went to Urgent Care and my D Dimer was high as well as my blood pressure. I had a slight fever. I was hospitalized on 05/26/2021. I was diagnosed with Pneumonia,, Community Acquired and ended up being hospitalized for 12 days. My blood pressure was hard to control and my hospitalization was extended. I had fluid in my Lungs. During the stay, I had bleeding in my stomach. It has been eight weeks and I have lost 24 lbs and my Stomach is still upset. I am still receiving Home Health Care.

7-8 hours after injection slight soreness at shot location; 20 hours after injection sudden wave nausea & possible need to vomit, defecate, urinate, & dizziness; sat on toilet & collapsed forward onto floor into stack of towels remaining semi-conscious for a several minutes trying to determine location; worked way upright, got to bedroom, and tried to sleep but severe chills; chills subsided and slept 6 hours; felt feverish and in period of 2 hours had temperatures of: 99.6; 100; 100.4; 101.5; 101.8; 98.8 & went back to bed for night; awoke feeling relatively normal 03/13/2021; thereafter to the present time of 04/04/2021 days of feeling relatively normal, but often waves of feeling light-headed; blood pressure Continuing description of events after second Moderna vaccination: my blood pressure taken at home on Omron wrist device has been highly variable from 136/74/58 down to 101/64/72 with prior normal being about 115/65 to 130/70 at home and as taken at the eye doctor's office on 03/01/2021 the week prior to cataract surgery on 03/08/2021 it was 128/70, but is commonly higher at doctors office exams likely due to stress of driving to the doctor's office and on day of surgery was up to 158/80; on those days of being light-headed the blood pressure was commonly in the 101/64/72 to 114/65/61 range; my body temperatures remained in normal ranges of 97-98; beginning on 03/30/2021 there was some feeling of some throat or esophagus constriction and harder to swallow; this has continued & included acid reflux on 04/03/2021 and feeling very tired and went to bed about 05:00pm & slept to 08:00pm followed by going to bed at 11:00pm and unable to sleep the rest of night due to acid reflux in throat all night; but better on awakening this morning; it remains that there is the feeling of being light headed; a few times during this period after getting the Moderna vaccination the area of the injection has had a minor soreness, and/or itchiness. I have not yet seen a doctor about this reaction, but I did indicate to my eye doctor prior to the cataract surgery on 03/08/2021 that I would be getting my second Moderna vaccination 3 days after. He felt it should be okay. Similarly at the time of my first Moderna vaccination, I told the nurse practitioner that I would be having cataract surgery 3 days prior to the scheduled second vaccination. She also felt it should be okay, as well as having had a reaction to Amoxicillin for the first time about 11 months earlier. That reaction was hives all over the body that kept recurring for 3 weeks and thereafter at places on the body for another month. I am otherwise in excellent health for my age and the only medication taken is Timolol for glaucoma. I am active and frequently walk several or more miles several days per week. My reaction seems unusual. I have only now ceased taking the last of the cataract surgery eye medications, that being Prednisolone eye drops. If the symptoms persist after seeing my eye doctor tomorrow, and after elimination of the eye drop medication as of today, I will be scheduling an appointment with my regular doctor for a checkup. Additional information as of May 24, 2021: I had an examination by Dr., Care Center on April 14, 2021. After discussing the reaction and symptoms that occurred thereafter an EKG indicated a slight heart beat abnormality. Combined with the continuing lightheaded symptoms that periodically recurred he considered the potential that the Timolol that I have used since my late 30s to reduce eye pressure from glaucoma could potentially have reacted with the Moderna shot. As such he later called my opthalmologist, Dr., at Eye Clinic in to discuss this possibility. Dr. also scheduled for me to have an echocardiagram to determine if there has been a resulting heart problem from the Moderna shot. Subsequently after discussing this with Dr. I discontinued taking Timolol for about 3 weeks with a subsequent eye exam to determine the pressure in my right eye to see if a new prescription may be necessary or other alternatives. This was on May 19, 2021. I had been taking my blood pressure daily, sometimes multiple times during the day since the collapse after the Moderna shot. Toward the end of the 3-week period of not using Timilol drops in my right eye the feeling of being lightheaded had become less frequent and blood pressure had become more consistently above 110/65. The feeling of being lightheaded had seemed to often correlate with blood pressure below that, but often my blood pressure was erratic going as low as 100/60 and upward to more normal areas of 120/68-130/75. However, it was not clear to me, or to Dr. if this was a result of having discontinued Timolol or if it was the needed period of time for the Moderna aftereffects to subside. He has me now using only 1-drop of Timolol per day, rather than 2-drops per day in my right eye as my eye pressure is just over borderline of concern for glaucoma in that eye. The cataract surgery on March 8, 2021, 3 days before the 2nd Moderna shot, had eliminated the need for taking Timolol in my left eye. As it stands, I continue to feel relatively normal. I had a second checkup with nurse practitioner at Unity Care Center on May 12, 2021 and she agreed that I should have the echocardiagram as scheduled on May 28, 2021 which is in 4 more days. Additional information as of June 25, 2021: I had an echocardiagram on May 28, 2021 and was provided the evaluation of the results on Jun 9, 2021 by nurse practitioner at Care Center. 1) overall results were good; 2) my ejection factor was 65% and normal; 3) the only abnormality is a mild resistance to ventricle heart relaxing when it is filling up with blood (she further indicated that in positions of some stress is when this was primarily occurring and could result in lower blood outflow and lower blood pressure potentially related to the feeling of being lightheaded and could possible pass out); 4) my heart valves look OK; 5) keep well hydrated to maintain a healthy blood pressure. At the time there was a period of several weeks of having felt relatively normal most of the time with few episodes of feeling lightheaded. However, during a period from June 11 to June 19 there reoccurred daily feeling of being lightheaded and at times the systolic blood pressure dropping to as little as 104 and often no more than 115. However, since that time the blood pressure has returned to the more normal range of 115-130 and feeling more normal. It remains unknown what part the second Moderna shot had to do with this, but there had not been these prior periods of feeling on the verge of passing out combined with lack of energy during these periods. However, the periods of feeling lightheaded seem to be shortening and the periods of feeling normal longer and whatever the causes are gradually subsiding.

Not having control of their bowels; Completely confused; Constant itching; Very lethargic; Never slept past 9am but after receiving the second dose they could not get up before 11am; This spontaneous case was reported by a consumer and describes the occurrence of BOWEL INCONTINENCE (Not having control of their bowels) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included VALSARTAN, METFORMIN, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and METOPROLOL for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced BOWEL INCONTINENCE (Not having control of their bowels) (seriousness criterion hospitalization) and CONFUSIONAL STATE (Completely confused) (seriousness criterion hospitalization) . On an unknown date, the patient experienced PRURITUS (Constant itching), LETHARGY (Very lethargic) and SOMNOLENCE (Never slept past 9am but after receiving the second dose they could not get up before 11am). At the time of the report, BOWEL INCONTINENCE (Not having control of their bowels), CONFUSIONAL STATE (Completely confused), and SOMNOLENCE (Never slept past 9am but after receiving the second dose they could not get up before 11am) outcome was unknown, and the events of PRURITUS (Constant itching), LETHARGY (Very lethargic) was not resolved. On 06July2021, the caller could not get a hold of the patient. The caller called 911 to check on the patient. The caller found the patient at home completely confused (not knowing themselves or recognizing any family members), the patient was in their underwear. The patient was admitted to the hospital and stayed for about 10 days. The health care providers have done every test possible according to the caller and tests have come back negative and the HCPs stating "the patient is 100% healthy. No treatment drug details was reported.; 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.

76 y/o male, PMHx of GERD, Hyperlipidemia, Coronary heart disease, CKD, Barrett's esophagus, abdominal aortic aneurysm without rupture, PVD, DM, admitted for confusion on 2/13/21. MRI indicates tiny focus of diffusion restriction within the right occipital lobe suggestive of acute infarction. Pt does not have acute Covid 19 infection. Pt discharged home on 2/16/21.

Increased mental confusion and forgetfulness. Can?t remember me from day to day, thinks there are 2 of me. Thinks we keep moving to a different house from day to day and someone moves our things for us each day.

Patient's spouse states that approximately 1.5 hours after receiving vaccine patient was at home and found to be confused and non- verbal. Unable to verbally express what was wrong. Spouse called into the clinic was triaged via phone and advised to go to the ER for further evaluation.

Arm was sore starting approximately 4 hours. after the shot. I usually set thermostat to 68, but got so cold last night i pushed it up to 74 and added a blanket. Around 4:00 I woke up to go to the bathroom. Problems similar to Cirpro. Did not have control over direction I was walking.. Had to rock back and forth to sit up so I could get out of bed. I estimate this was a 3-5 minute ordeal. Drank some Powerade and went back to bed. I had gone to bed just before midnight. Slept till 10:30 because maid was coming at 11. I was totally unstable. When she saw me she immediately made me sit in a recliner. Said my face was pale and my eyes were blood shot. I would have fainted within seconds.

Given Moderna COvVID-19 vaccine during vaccine event at facility. EMS was called 24 hours later for patient c/o nausea, vomiting and headache. EMS note reports they were told patient vomited black tarry fluids yesterday and again that morning. Patient confused but has history of dementia. BP 127/88 126/88 Pulse 96-100 EMS placed patient on oxygen via nasal canula and monitor. Transported to ER. No further info on outcome available.

leg cramps BL, shoulder cramps BL, head felt like it wa puffed up, rash started 1/11 around neck, back and front itchy

Abdominal pain, Headaches, chest pain, loss of appetite, confusion, elevated liver enzymes 1/8-1/15/21

After vaccination, could not sleep , hallucinations, didn't sleep until Friday night which he seemed to get a little better. Tuesday morning, he could not feed or dress himself. Went to see his PCP. He went to hospital for CT Scan. If he worsens, take him to the ER. Has appointment to see his Neurologist on Feb. 4.

1/17/21 midnight-fever as high as 103.8, chills, sweats, mental confusing, imbalance, weakness, COVID like symptoms (PT tested positive for COVID 11/21/20, patient had to take 2 aspirin to help with side effects. Present-sweating, chills, fever, ibuprofen/Tylenol rotated as needed

Headache, chills and weakness. Fever.12 hours after vaccination. Extreme confusion, seeing something not there, total weakness, 36 hours after vaccination. All back to normal 24 hours after vaccination.

1/17/21 midnight-fever as high as 103.8, chills, sweats, mental confusing, imbalance, weakenss, COVID like symptoms (PT tested positive for COVID 11/21/20, patinet had to take 2 asprinin to help with side effects. Present-sweating, chills, fever, ibuprofen/tylenol rotated as needed

On 1/20/21 the staff observed resident to be more restless constantly moving his legs. He had a decrease in his appetite and fluid intake and required assistance for consumption. His oxygen sats dropped to 89% on room air and was given oxygen at 2L. On 1/21/2021 the Resident observed moving restlessly, opened his eyes when this writer called his name, murmuring incoherent words, words were unclear, was observed taking off his Foley, attempting to grab something, dropped his hands and legs and at the same time restless. This writer was unable to auscultate lungs or heart, resident was moving uncontrollable. Resident positioned safely in bed. VS revealed high BP 147/101. MD ordered transfer to hospital. Resident was treated in the hospital for acute encephalopathy, sepsis with tachycardia and tachypenia and hypoxia.

The morning of Jan 20, 2021, Patient was disoriented, could not communicate well, and fell when he tried to get out of bed. He was taken to The Hospital by ambulance about 11:30 am. He is still hospitalized. Emerging symptoms include: passing a blood clot from his mouth, slight pneumonia, high white count, low kidney values, high fever, all of which fluctuated. A blood transfusion was given because of blood in the urine. He has been confused and disoriented until this morning.

Feeling normal before the vaccine, with exception of slight cough that Dr said was due to allergies. But then a fever, chills and aches the day after vaccine. Two days after, still febrile and feeling worse and experiencing shortness of breath and lightheadedness. Fatigue, fever and lightheadedness continue for three more days. On the 6th day post-vaccine, taken to ER and admitted to hospital with a pneumonia and blood counts dangerously low. Received 3 blood transfusions and is receiving 2 different IV antibiotics to treat pneumonia. Still in hospital and waiting to see how blood counts go. I can?t say the vaccine CAUSED this, but it all happened rapidly, immediately following the vaccine.

Moderna COVID-19 Vaccine EUA First Maderna COVID vaccine No Symptoms at all Second Maderna COVID vaccine on Monday Monday: 12 hours after: Headache Some soreness at injection site Could not sleep at all that night Muscle, joint soreness Chills Tuesday Headache Fever Muscle ache Nausea, little appetite Lethargy Napped in the afternoon for a few hours Could not sleep that night. Took 2 Advil at 10:30pm, then slept Wednesday Felt normal on awaking. No headache A few sweats, so probably some fever. Thursday Normal in every way.

On 1/07/2021 approximately 11:30 am patient started experiencing weakness; by 1:30 p.m. patient couldn't get out of a chair or walk without assistance of cane and person. Patient became increasingly weak and by 4 pm could not walk nor understood how to walk without caregiver telling him. Patient's doctor was called and at 5:30 pm patient was told to go to the hospital. Doctor thought patient could have had a mini stroke. Patient arrived at hospital at approximately 6:30 pm and underwent stroke test, COVID test, blood work; chest xrays and brain scans. All were negative.

By 1:30 am on 2/4/2021; patient was shaking uncontrollably. This continued about 1 1/2 hrs. then he could not get out of bed to go to the bathroom; thus wetting himself multiple times during the night; Patient was restless for about 5 hrs. but still could not get up even with me (his spouse) trying to help. He also could not understand how to help move his body to keep from falling out of bed (never fell out but I could not get his entire body on the bed until our daughter arrived around 9:30 am. It took our grandson who is 6'5" tall & 275 lbs. to help get patient up and walked him into our sunroon. throughout the day, patient could not stand without help & continued to urinate on himself. He could, however, feed himself breakfast & lunch. At 7:30 pm grandson and daughter had to walk patient into bedroom. patient could not walk without us telling him how and pushing his feet forward. It took both grandson and daughter to pull him onto the bed as he collapsed when he got to the bed. Patient slept until approximately midnight. at that time our daughter helped him to the bathroom and helped to change his underwear and tshirt which was wet from having a fever. Afterward, patient was able to go to the bathroom by himself but was very tired. He was able to walk outside with the help of a cane on 2/5/21 2 pm. On 2/6/21, patient complained of his back hurting and itching. We discovered he had shingles! Not a full body rash but shingles on his left side around his waist.

Trigeminal neuralgia has been totally under control using prescribed medications. Shortly after the first vaccination started having occasional episodes despite taking medications as prescribed. After second shot, INTENSE episodes that medication does not control. Losing work, cannot talk at times, excruciating electrical, jabbing pains in face. Definitely neurological issues exacerbated by the vaccine.

TODAY (7/10/2021 - VERY DIZZY FOR ALL DAYS AFTER SHOT, URINE BLOCKAGE, BEING SEEN ALSO BY DR , C FOR BLADDER CANCER, TREATMENT, CYTOLOGY, NURSE WEEKLY, CATHETER TREATMENT 9 WEEKS. TODAY 7/10/2021 AFTERNOON BECAME VERY DEPRESSED, SCARY, DRY MOUTH, SOME KIND OF 'HIGH SPEED HUMMING IN MY HEAD AFTER VACC, BALANCE PROBLEMS BUT A LITTLE UPLIFTED AFTER 2ND VACC, INSOMNIA, EVEN WITH OTC SLEEP AIDS, SUDDENLY, AROUND 7:00 PM PACIFIC, DEPRESSION 'FELL OFF' THANK GOD. VERY SELF-RELIANT, STRONG INDIVIDUA, NON-RELIGIOUS, EDUCATED, BA LITURATURE, AA COMPUTERS - PROFESSION NOW RETIRED

Ever since getting the vaccine a week ago his blood sugar has been out of range relative to before the vaccine. Also, he has not been acting himself mentally.

covid shot 2/2; feel bad 2/5; covid positive diagnosis - 2/8 s/s cough, fever, shortness of breath , hypertension, afib (in er) - admitted went into DIC per intensivist 2/11 patient died

diffuse fuzziness, tired, mild headache, some increase in blood pressure. Slept 12 hours second day of symptoms. Symptoms waxed and waned, worse in mornings. Finally cleared completely Jan 27(onset Jan 10) Treatment occasional acetaminophen although no fever.

1/30/2021 23:08 Nursing Note Note Text: Patient refused to use incentive spirometer at bedtime. Writer administered prn Mucinex at 1600 and 2130 for upper chest congestion. 02 at 1 liter per NC during thru the night for comfort. 02 sats at 95%. Writer encouraged fluids at bedside. Patient was compliant in taking a shower earlier this afternoon but refused supper. Patient has been mildly confused to place and time, reoriented easily. Will continue monitor vital signs and encourage incentive spirometer. 1/31/2021 00:15 Nursing Note Note Text: Patient had very large incontinent fowl smelling bloody stools at mid noc. Writer called Nurse supervisor also to assess stool. MD was called new order to send patient to hospital for evaluation. Wife was called and updated, bedhold obtained.

Patient reports approximately 12 hours post vaccination, he woke up with fever, sweating and unaware of his surroundings x 3 days. Patient reports his wife helped him with cares. Pt reports he was "out of his mind" for 3 days and cannot remember anything during that time. Pt reports it was a total of 5 days before he was back to normal.

FEBRILE - 101 (2200), TACHYCARDIA (100+ BPM), RAGING A-FIB (ARRHYTHMIA) & HYPOTENSION (75/50); SLEEP MEDICATION INEFFECTIVE. ALL SYMPTOMS PERSIST (NO DETECTABLE DEHYDRATION) , INTO 4 FEB 2021. NO PAIN OR FEVER ABATEMENT MEDICATIONS APPLIED. AT 1600, 4 FEB 2021, 10 MG ZALEPLON AND 5 MG AMBIEN ADMINISTERED. 75 MINUTES OF SLEEP, FOLLOWING WHICH SUB-LINGUAL TEMPERATURE WAS NORMAL, BUT OTHER SYMPTOMS PERSISTED. SLEEP IMPAIRMENT AND OTHER SYMPTOMS PERSISTED 4, 5 AND 6 FEB, BUT SLIGHTLY IMPROVING EFFICACY OF SLEEP MEDICATIONS AND OTHER SYMPTOMS. AT 2000, 6 FEB, 10 MG AMBIEN (SLEEP ONSET UNTIL 2130), 10 MG ZALEPLON AT 2200 (SLEEP UNTIL 0030, 7 FEB), 10 MG AMBIEN 0030 (SLEEP UNTIL 0430), 10 MG ZALEPLON 0430 (SLEEP UNTIL

Moderna COVID-19 Vaccine EUA. Several hours later develop sweats, feeling hot and cold, felt like a fever but temperature was normal, severe muscle and joint pains, unable to sleep, very tired next two days. Most symptoms have resolved although joint pains persist.

2/24/2021 admitted to hospital with hypoxia, lethargy, rash, altered mental status with HA. Altered mental status with HA, could be due to metabolic encephalopathy and reaction to COVID-19 vaccine. Will check ABG, CT head. Hold gabapentin. Check depakote level. Rash, likely due to allergic reaction to COVID-19 vaccine, hx of reaction to first COVID-19 vaccine with fever needing hospitalization. Start patient on Solu-Medrol and Pepcid. Benadryl p.r.n. Suspected right lower extremity cellulitis, start patient on Ancef. Check MRSA, will rule out right DVT Abn CXR, Bilateral LE edema, CXR seems stable to me, clinically no pneumonia. He does not have "hypoxia" when I was in room, however assisted living reporte 2/24/2021 admitted to hospital with hypoxia, lethargy, rash, altered mental status with HA. Altered mental status with HA, could be due to metabolic encephalopathy and reaction to COVID-19 vaccine. Will check ABG, CT head. Hold gabapentin. Check depakote level. Rash, likely due to allergic reaction to COVID-19 vaccine, hx of reaction to first COVID-19 vaccine with fever needing hospitalization. Start patient on Solu-Medrol and Pepcid. Benadryl p.r.n. Suspected right lower extremity cellulitis, start patient on Ancef. Check MRSA, will rule out right DVT Abn CXR, Bilateral LE edema, CXR seems stable to me, clinically no pneumonia. He does not have "hypoxia" when I was in room, however assisted living reported he was hypoxic this AM, wife said he was wheezy on Sunday could be due to acute on chronic diastolic congestive heart failure, IV Lasix x1. reeval in AM. Echo TTE is pending Abdominal pain and distension, CT abdomen without contrast to rule out other etiology that can cause altered mental status Hx of COVID-19 pneumonia, history of CVA with dense right hemiplegia and expressive aphasia, chronic atrial fibrillation, depression, Will reorder home meds after pharmacist reconciles medication list Generalized weakness, PT/OT DVT prophylaxis warfarin and SCD

Starting about 5 or 6 hours after the injection I became extremely tired and that persists through today, 7 days later. At times, I found even a small exertion like walking up a couple of flights of stairs to be exhausting. At times my head felt buzzy, although I haven't had a fever. At times I also felt fine but then would relapse. My sleep has also been erratic, although not very good normally. Arthritic joints are more painful.

I had to sleep all day the day after the injection. I think more should be said that people may have to plan on not being able to go to work the day after.

Very sore left arm, About 9 hours after injection began to feel cold, shaky, leg muscle ache and increasing temperature.

Feeling of impending doom. Felt like I was going to die. Symptoms of Anaphylaxis but did know that was what it was. Failed to call paramedics which I should have . Kept getting worse all night and the onset of vomiting, diarrhea, fever, which lasted three days.

Moderna COVID-19 Vaccine Around 8 hours after the shot, my left shoulder started to hur, when I raised my arm. Over the next few hours I grew more tired than usual with a very low-level, generalized ache. I went to sleep at 11. I woke up at 2 in quite a bit of generalized pain, left shoulder so painful I could not lie on my left side, unable to get comfortable in any position, feeling worse and worse. At 2:30 I got up, which immediately made me feel a bit better. I took an acetominophen, a half codeine acetominophen #3, and around 5 ml promethazine/codeine syrup. At around 4:00 I had some cheese and bread. At around 4:30 I was able to go back to sleep. I got up at 8:30, still achy/hurting, but distinctly better. I am writing this at 11 a.m. One other thing to note: after the shot I seemed to be having a very odd, mild allergic reaction intermittently, when I ate some foods that I eat every day. Mostly it was a case of my hard palate itching.

Severe dizziness, 4 weeks after first shot on 02/02/2021 and continues after second shot on 03/03/2021. Must use walking cane to remain upright. Cannot drive or work. Weakness

Severe Chills Fever Full body ache - joints/muscles Lost Balance - fell twice Incoherent Confusion ulcers in mouth and on tongue Swollen lips no strength - could not stand up on my own dehydration

Neurological, including trigeminal neuralgia and one Bell's Palsy symptoms. Tried to complete online at library on 2/24/2021 but timed out at 20 minutes. Item #18: CDC asked to report any Bell's Palsy symptoms (also trigeminal neuralgia is related to BP). 48 hrs post vax, mid-afternoon Sat, Feb 6th: Suddenly unable to comprehend book I was reading; and there was a physical sensation of irritation just inside my skull, wrapping around my brain (meninges?) - it did not intrude into brain. Felt lack of 'presence' in room. Slightly unstable on my feet. Believed these were related to vaccine, would soon abate, but, also, that this would be no way to go through life! These lasted 2-3 hours. (I neither drink alcohol or take recreational drugs.) About that time, a 'twinging' precursor to trigeminal neuralgia began – uncertain whether it was TN? Recurred every 3 hrs. But then awakened at 6:30 a.m. by two painful TN jabs, repeated more strongly at 9:40 a,m. At about 12:30 pm, return of light 'twinging' sensation, then nothing – no recurrence. 3rd TN episode in 3 years, the briefest, the only one not requiring oxcarbazepine. Checked for Bell's Palsy symptoms (which I've never had): The left side of my mouth wasn't producing any saliva at all – none. This improved very slowly, continuing for 5 or 6 days; by far the longest lasting symptom. About Monday, the 8th, experienced an expanded time warp driving to library – took forever to reach two roundabouts. Lucid, alert, vision & reactions normal. Speed was a mile or two above limit. No euphoria or nystagmus. At library, conversation and work seemed normal. Around the same time I had about an 18 hour complete memory loss with regard to medications. Two dose periods in succession. On Monday, Feb 8th, I called our 4 day a week neurologist. He said the symptoms were an immune response to the vaccine but that he's never seen them together before. It was scary. I'm not going to take the second dose at this time. And will depend upon PCP. Filling out this form because you've asked about any adverse reaction related to Bell's Palsy (which TN is closely related to). I wonder how many others have experienced trigeminal neuralgia symptoms following vaccination? It's a cumulative disease and devastating in advanced forms. :-(

Malaise, muscle & joint aches, brain fog, unusual memory lapses, night sweats...the issues have been experienced since evening of the 2nd vaccination...the only side effects after 1st vaccination was a sore left arm.

After nearly 2.5 months I still have pain in my upper left arm near the injection site and in the right arm from the second dose. This makes it difficult to put on jackets, shirts, etc without significant pain and also interrupts my sleep. This pain is constant but aggravated by movement. I would rate it 7 on a 10 scale. I am wonder if this might be SIRVA or something similar. I have never had issues with vaccinations previously.

Symptoms began the day after the patient received the second shot. He was very tired and weak. By the afternoon, he was so weak he could not lift himself out of the chair. Even with the help of another person, he was too weak to stand. I called for emergency help. He had a fever of 101, was vomiting, very disorientated, confused, could not understand what people were saying to him. At the hospital he continued to feel disorientated, had nausea, dizzyness, a headache, a fever of 104, was dehydrated. He was admitted to hospital and spent one night. Once home, he has begun to regain strength and other symptoms have diminished. Four days after coming home he is feeling stronger and more back to normal.

Impaired emotional state, the abdomen began to inflate, 8/2/2021 is taken by ambulance to the hospital where corresponding studies were carried out. He was having complications from cirrhosis. Then you are discharged on the same day 8/2/2021. On 2/18/2021 he was complaining of generalized pain, they call hospice to be evaluated, caregivers when they proceed to take vitals he was without vital signs.

At this point I am going to give you an account of my past 14 months health and how I know it is related to the covid virus. i am sure i have had long covid from december 2019 or january 2020 to the present based on symptoms i incurred on these dates. On my first night I ended up vomiting my guts out at 2:00 in the am. The following 2 weeks I had constant diarrhea. At the end of those 2 weeks, i ended up in emergency room. And this all happening when i haven't' vomited in over 30 years. vital signs and blood work were good at the hospital and the drs were confused as to why i felt so bad. i returned home the next day where our permanent home is, and 3 months later the covid thing surfaced. at first being thought of as a respiratory disease. then in the past months it is surfacing that it may now be considered a gastrointestinal disease that progresses to a respiratory disease. after checking the five main symptoms of long covid i discovered that i have at least 3 of the 5 common symptoms for this. Those being extreme fatigue, joint pain, and cough. In addition to the long covid symptoms, I have encountered tasting issues on and off again. I have had many discussions with my primary care doctor, and no results or conclusive information came from my inquiries. Then on feb 12, 2021 I got my first moderna shot. About 2-3 weeks later I encountered a sharp pain in a muscle in my neck left side. Shortly thereafter I got very light headed. Then another week later while driving a motor home, I encountered a frightening experience with my eyes, and the neck pain and soreness was still there. My vision was very blurred and I was seeing double vision at different angles. I ended up at the medical center and was admitted for 4 days. Before I was admitted, I saw a local ophthalmologist here and he diagnosed me with a condition known as ?edema in optic nerve, inferior, consistent with optic nephropathy?. The symptom I had to get me to the doctor was I was losing eyesight in my left eye. After hd steroid treatment for 4 days, and a plethora of tests, including spinal tap, multiple mri?s, and probably over 20 blood tests (11 at one draw), I was released 3-18-2021 and still can?t see above the equator line of my left eye. And I also am extremely sensitive to light. I also have sensitivity inside my eye as best described as a soreness, especially when I try to look upwards. I have a follow up appt with the ophthalmologists that I first saw that advised me to get to the hospital. And that is on mar 26th 2021. to mention another point of interest, my granddaughters boyfriends mother is a charge nurse at the emergency ward at the hospital, and she has said that they also have recently encountered emergency patients, who have recently received moderna, and are also having issues with eye problems. What problems in particular, I haven?t a clue at this time. This is at the very least, extremely alarming to me, and I have no idea whether I may completely lose all function of my left eye., or not. But I adamantly feel this should be investigated by the cdc and any and all other agencies that should be involved. I would be willing to have further discussions via phone or whatever to help you out with an investigation.

Hallucinations; Dizziness; Fatigue; Nausea; Vomiting; A spontaneous report was received from a consumer, concerning her husband, a 77-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hallucinations, dizziness, fatigue, nausea and vomiting. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On an unspecified date, the patient received their first of two planned doses of mRNA-1273 (Batch Number: unknown) via unknown route for prophylaxis of COVID-19 infection. On 01 Mar 2021, approximately three days prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 03 Mar 2021, after second dose of vaccine, the patient experienced nausea and vomiting, fatigue, dizziness, and hallucinations. The event hallucinations were considered to be medically significant. The patient was also not been out bed for seven days. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not applicable. The outcome of the events, hallucinations, dizziness, fatigue, nausea and vomiting 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 (dizziness, fatigue, nausea, and vomiting), a causal relationship cannot be excluded. Very limited information regarding these event (hallucination) has been provided at this time. Medical history and concomitant medications are required for assessment. However, further information has been requested. However, fatigue, nausea, and vomiting are expected for mRNA1273.

severe , unbearable pain starting in lower back within five days of vaccine - , tranversing to both shoulder blades , left and right sides of neck , ankles , and moving back and forth to each area over and over . have been seen in E.R . chropractic office,/ pain specialist , neorologist nd have another appointment on Wed. March 24th with a different neurologist./ HAVE TO USE A WALKER TO WALK ANYWHERE - CANNOT STAND ALONE FOR OVER 30 SECONDS ...CANNOT SLEEP ON LEFT OR RIGHT SIDE - PAIN SEVERE IN SHOULDERS , NEED SOLUTION TO THIS NIGHTMARE - NOW ....

Patient reported a generalized headache minutes after receiving the vaccine. Became diaphoretic, pale, nauseated immediately. Assisted him to a cot to lie down. Pulse weak and thready. B/P 90/60. HR=42. Resps=20. Pt. disoriented, lips slightly cyanotic. FSBS = 156. Pt. stated he had taken his insulin today and eaten prior to arrival. Continued observation for 15 min with vital signs improved but profuse diaphoresis continued. Denied SOA, O2 sats 99% on RA . Denied chest pain. Considering the history and ongoing symptoms, he desired to be evaluated. EMS notified and he was transferred to their care.

convulsions. I woke up at about 3:15 with my body shaking and i could not control it. this went on for about 1 hour. I have never had this experience. I literally could not function because of the shkes. the other reactions were, i slept from 4:30 +/- am till 5 pm, when i had Covid i slept for over 5 days. Other symptoms head ache, body aches, fatigue and lose of appetite. I write this at day 3 after the shot, and have tiredness and want to sleep It's like a compressed version of my Covid experience.

Hospitalized for 8 to 9 hours; Could not walk; Whole body shutdown; Swollen arm; nostalgic; A spontaneous report was received from a consumer concerning a 77 year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nostalgia, could not walk, swollen arm and whole body shut down, and hospitalized for 8 to 9 hours. The patient's medical history included allergies to bee stings. Products known to have been used by the patient within two weeks prior to the event include: unspecified cholesterol medication, aspirin and unspecified hernia meds. On 08 March 2021, the patient received the first of two planned doses of mRNA-1273 (lot/batch: 036a21a) intramuscularly for prophylaxis of COVID-19 infection. On 08 Mar 2021, the patient experienced nostalgia, could not walk, swollen arm, whole body shutdown and was hospitalized for 8 to 9 hours. Laboratory details were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. At the time of the report, the outcome of the events, nostalgic, could not walk, swollen arm, whole body shutdown and hospitalized for 8 to 9 hours, 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 the events, a causal relationship cannot be excluded.

Pt ingested a single martini two hours after injection . He loss conciousness for several hours. When he awakended he was confused , speech was slurred and appeared severely intoxicated

104 degree fever, disoriented, delirius (couldn't talk coherently, didn't know where was or what he was doing), achiness, couldn't walk, tired/fatigued. made an emergency room trip

He got the vaccine, and didn't have any real reaction, anything unpleasant, he had a numb lip and 2 fingers were numb. He called his doctor and she told him to go to the ER, which he did at Hospital. They did a CAT scan of his brain. They tried to do an MRI and they pushed his head against the machine as his back is curved and he stopped breathing. They had given him 2 narcotics for anxiety before the scan. He was then transferred to Hospital in . He saw Cardiophysiologist/IM and he found that he had a blood clot (? where), and they inserted a pacemaker through his groin as his pulse dropped to 40 BPM. He was hospitalized for 7 days, and discharged him with instructions on what he is able to do. They started him on new blood pressure medicines for his kidney's. On 3/26/21, lot# 028A21A. He subsequently had the 2nd vaccine, and all liquids emptied from his body (vomiting and diarrhea), at the same time, and then he was fine once everything settled down which lasted for about 3-4 minutes and then he was fine.

Patient became light headed and blacked out, did not know where he was. Indicated his right eye was red and swollen.

Was in good health. Received 2nd dose of COVID19 vaccine on 4/7 with progressive weakness and confusion following vaccination. Admitted to hospital on 4/18 with confusion, fevers, thrombocytopenia, mediastinal adenopathy and elevated LFTS and inflammatory markers. Workup has been negative but ongoing fevers and confusion. Labs have improved without treatment.

Patient visited his doctor/pulmonologist on 3/18/21 and had a negative covid test- NO SYMPTOMS Patient became very sick AFTER the Moderna Covid Vaccine was administered on 3/20/21. Within 10 days he developed a serious cough/phlegm, he became weak, disoriented, had a hard time walking/ambulating, lifting his arms and communicating. He was diagnosed with Covid Pneumonia. Patient had underlying conditions (heart, lung and kidney disease)

Fever, Passing Out, Loss of Apatite, elevated calcium levels, shakes, nausea, tired, chills, memory loss. Near death. Has been in the hospital for 7 days. Was released yesterday without notice to the family to a rehabilitation facility. Doctors have not released the results of test or diagnosis and resolution or time frame for recovery. Very little communication to my mom and zero communication to the family members who were visiting the hospital daily. I was present when nurse was giving a shot in the stomach as a blood thinner. Only other relevant communication was told to my mom that 4 other patients at the hospital had similar effects from the vaccine and were in the hospital. It is important to point out that after getting the first dose of the vaccine and falling deathly ill, Doctor told him to NOT get the second dose or he could die

Felt like he had COVID; Balance was off; Could not walk straight; Fell against wall, Busted left elbow from fall; Big bruise on left elbow from fall; Felt so bad, like he was going to die; Couldn't taste food; Couldn't smell food; seemed to have AFIB; Fever; Chills; Body hurt all over; Right arm was swollen; Right arm was red; Right arm hot like a firecracker fom the shot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (seemed to have AFIB) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red) and FEELING HOT (Right arm hot like a firecracker fom the shot). On an unknown date, the patient experienced ATRIAL FIBRILLATION (seemed to have AFIB) (seriousness criterion medically significant), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over). The patient was treated with Bed rest for Suspected COVID-19. At the time of the report, ATRIAL FIBRILLATION (seemed to have AFIB), PERIPHERAL SWELLING (Right arm was swollen), ERYTHEMA (Right arm was red), SUSPECTED COVID-19 (Felt like he had COVID), BALANCE DISORDER (Balance was off; Could not walk straight), FALL (Fell against wall, Busted left elbow from fall), CONTUSION (Big bruise on left elbow from fall), FEELING ABNORMAL (Felt so bad, like he was going to die), AGEUSIA (Couldn't taste food), ANOSMIA (Couldn't smell food), FEELING HOT (Right arm hot like a firecracker fom the shot), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body hurt all over) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: up (High) up. On an unknown date, Heart rate: 130 (abnormal) 130 per minute. On an unknown date, Hepatic enzyme: slightly elevated (High) slightly elevated. On an unknown date, White blood cell count: slightly elevated (High) slightly elevated. The patient was under doctor's care at the time of report.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

The patient has had severe joint pain since receiving the vaccine. He rates the pain at 3/10 when not moving. When up and moving it is hard for him to walk because he is stiff and sore. and it makes it difficult to do those tasks of ADLs.

Patient received first dose of vaccine 5/10, second dose administered 6/7. 6/8 patient presented to ER with complaints of Malaise and fatigue, found with mild altered mental status and eventually had to be intubated

The patient is a 77-year-old male with history of coronary artery disease, hyperlipidemia and hypothyroidism was hospitalized with confusion, fever, and generalized rash after receiving the first dose of the mRNA-1273 vaccine. Fever started one day after vaccine administration and was episodic, lasting for minutes to hours and recurring throughout the day. Over the next 48 hours, the patient developed a generalized body rash, starting from the trunk and spreading to the extremities. Thereafter, he began to experience headache, dizziness, and double vision, that later progressed gradually to severe encephalopathy in the course of 5 days. On dermatological examination, he was noted to have deep red, non-scaly, edematous papules coalescing into plaques on the abdomen, upper chest, proximal upper extremities, bilateral upper flanks and back, with scattered non-follicular pustules. On neurological exam, he had intermittent and irregular orofacial movements and bilateral upper extremity myoclonus. No other cranial nerve, motor or sensory deficits were noted on exam. Deep tendon reflexes were 2+ throughout, without signs of an upper motor neuron lesion. No nuchal rigidity was evident. The patient presented with leukocytosis and neutrophilia, elevation of creatine kinase, C-reactive protein and ferritin. Cerebrospinal fluid (CSF) analysis revealed 120 cu/mm leukocytes (77% lymphocytes), no erythrocytes, normal glucose (65 mg/dL, concomitant serum glucose of 106 mg/dL) and increased proteins (124 mg/dL). All CSF cultures were negative, and the CSF meningo-encephalitis panel did not detect any infectious agent through RT-PCR analysis. Blood and urine cultures, as well as an infectious respiratory panel were all unremarkable. RT-PCR of SARS-CoV-2 was negative. Antinuclear antibodies (ANA) (1:160) and rheumatoid factor (RF) (1:2) were positive. Further autoimmune testing demonstrated normal complement C3 and C4 levels as well as negative anti-double stranded DNA, ribonuclear protein, Smith, Ro, La and anticardiolipin antibodies. Brain and cervical spine MRI with and without contrast did not show any remarkable findings. Continuous video electro encephalogram (vEEG) monitoring revealed a generalized slow background in the theta range, with state changes and reactivity but no sleep features. The facial and upper limb movements were captured on video recording without an epileptiform correlate on EEG. Skin biopsy demonstrated intracorneal micro abscesses, edematous papillary dermis and a band-like infiltrate of predominantly neutrophils and histiocytoid cells with nuclear debris in the superficial dermis without vasculitic changes and rare eosinophils, consistent with a neutrophilic dermatosis. Evaluation for malignancy was unrevealing including serum protein electrophoresis, peripheral blood smear, peripheral blood flow cytometry, and computed tomography of chest, abdomen and pelvis. The patient initially received empiric broad spectrum antibiotics and antiviral coverage for suspected sepsis and meningitis, including vancomycin, cefepime (later switched to ceftriaxone), ampicillin, doxycycline and acyclovir (for 9 days) without any improvement. As no infectious etiology was found, antimicrobial therapy was deescalated. Given concerns that the clinical picture might be related to an inflammatory reaction to recent vaccination, we started a four-day course of 1 gram methylprednisolone once a day. After the first day of treatment, the patient had marked improvement in his neurological exam, and went from mumbling incomprehensible words, to formulating full sentences and regaining orientation to self and place. He was able to follow simple commands consistently. Myoclonus also quickly resolved as well as the orofacial movements. The patient progressively improved, achieving his baseline before the fourth dose of methylprednisolone. Moreover, the cutaneous findings significantly improved, with near complete resolution of the pustules within 36 hours of administration of steroids. At this time, he met both major and all 4 minor criteria for the diagnosis of Sweet syndrome. The patient was switched to prednisone 60 mg/daily with a plan to taper over the course of three weeks. He was discharged two days afterwards with no evidence of neurologic symptoms and normalization of initially altered laboratory evaluations.

EXTREME EMOTIONAL REACTION, HIGH ANXIETY, HALLUCINATIONS, HIGH PANIC, MEMORY FLASHES OF PAST, EXTREME AND CLEAR RECALL OF PAST ACTIVITY, FEAR, LOSS OF CONTROL....

on day of vaccination experienced "heavy duty shaking , HA, sore muscles, fever 101 - similar to symptoms of previous COVID+ event S/S lasted 1 day - Most concerning to patient is the insomnia and hallucinations he experienced the night of the vaccine, none since

Patient is extremely comprised due to a kidney transplant 7.5 years ago. The first day patient just had a sore arm. The next the day the 14th had chills, shaking then to bone pain and muscle pain and headache over a period about 4 or 5 days. Then patient started with very bad diarrhea, it was uncontrolled multiple times a day, about 3 days, he was getting dehydrated and muscle weakness. Patient went to the hospital 1/20/2021 and was admitted and the doctors are still trying to determine the cause of the diarrhea. Patient is extremely dehydrated and is still has the diarrhea. Patient is right now is hallucinating due to being so dehydrated. A stool culture has been preformed.

Arm hurt badly right after injection, swelling after a couple hours, then in the night got sick vomiting, then incontinence in the morning due to weakness not being able to get to bathroom in time, then had shakes and chills and fever for the rest of the night and into the day for at least 6 hours. Very weak and shaky for another 24 hours.

Received my 1st Covid shot yesterday at 11:45. No problem. Went home and went for a 4 mile walk. Still no problem. At about 2:00 AM this morning I woke up shivering. Added another blanked and turned up the heat. No improvement. Finally got up and woke up my wife. Temperature was 101.7° F. Blood pressure was 149/90. Took some ibuprofen and sat on the sofa with a heating pad on my chest for about two hours. Blood Pressure dropped back to its normal 125/75 (may have been high because I took it the moment I got up) but temp was the same. However, shivering had stopped, so I went back to bed. When I woke up this morning (about 8:00) temperature was 99.1° F, blood pressure was normal (125/71) and no other symptoms. My arm isn't sore either. It appears that the elevated temperature was my only reaction from the shot. It's interesting because during the entire time I did have COVID symptoms, I never had any elevated temperature.

AROUND 9:30 PM I BECAME VERY WEAK AND FEVERISH. I HAD CHILLS AND I COULD NOT EAT OR DRINK. I COULD NOT GET OUT OF BED TO GO TO THE BATHROOM. I THREW UP TWO DIFFERENT TIMES. THE NEXT DAY I WAS STILL VERY WEAK. I TRIED TO GET OUT OF MY CHAIR AND I FEEL. I WAS UNABLE TO GET UP WITHOUT ASSISTANCE. THE WEAKNESS AND FEVER CONTINUED FOR THE NEXT THREE DAYS. I AM STILL VERY WEAK AND CAN'T HARDLY WALK. MY HIP FLARED UP AND CAUSED ME GREAT PAIN AND IMBALANCE. ALL THE AREAS THAT I HAD OCCASSIONAL OSTEOARTHRITIS I AM NOW IN CONSTANT PAIN. I CAN NO LONGER SLEEP ON MY RIGHT SHOULDER. BOTH OF FEET FLARED UP AND HURT ALL THE TIME.

Symptoms started around 8:00 p.m. They were: Headache, Body aches, very tired. Went to bed by 9:00 p.m., Slept all night, Slept through the next day and night with just a few times awake to go to the bathroom. Monday not as tired, but still headache and body aches. Tuesday feeling a bit better.

One is as yesterday progressed I got more and more tired. I had trouble staying awake. I was extremely tired. I tried my hardest to stay up awake until bedtime to try and not mess up my sleep schedule. When I went to bed I slept for 10 hours which is unheard of for me. I am still tired this morning. The other thing is on my Eliquis I take it twice a day, I set my cell phone to go off. I apparently just turned my phone when it went off in the evening, I didn't remember to take my 2nd dose of my medication. I worried if the vaccine caused some confusion. I am going to call my Primary Care doctor today. I did call the VA as well and talk to a nurse who said that I should be feeling better today.

Within one minute of my injection l felt numbness surround my mouth. Three minutes later I felt flushed. I asked my wife if my face was red and she said, ?yes?. I felt somewhat weak and paramedic called the Dr over. We talked and he determined that I had not eaten. Walked me around car, put me in the passenger seat. My wife then drove. I was a little disoriented late but didn?t complain. Since then I have felt like I did in July 2019 when I had coronial virus. Felt bad, 93oxygen, 77 heart beat which is high for me. Friday I did not get out of bed nor went outside. Sat more of the SamE. Woke up at midnight sat and felt better. I?m better but weak.

About 4 hours after his vaccine, the injection site starting hurting, but not bad. He could not sleep on it at night as he felt like he was sleeping on a red hot pocker. On Saturday he was extremely tired in the afternoon. Had to come in from yard work as he could not function. He also had pain in his neck and shoulders. On Sunday he the feelings were going away, but his muscles started aching. On Monday he felt really strange, felt like he was in a fog, and his muscles ached. He could not get relaxed, did his normal Monday chores, laundry and house cleaning. He then tried to relax but his muscles and nerves were very tense. He went to bed around 9:30 on Monday, fell asleep and awoke at 2:00 AM and could not go back to sleep his muscles in his arms and legs were in spasm and his arm would jump like a shock reaction and jump off of the mattress, as well as his leg. It was worse on the left side than the right arm. This went on every 10-15 minutes for about 3-4 hours. Around 4:00 AM this morning it eased off to sleep and woke up at 10 and felt better today. He hasn't had any more of the seizure type feelings in his arms or legs. He did speak with Moderna who told him that he was the 4th one with this reaction and to report this to us.

immediate sensation in left chest and down left side at the moment on injection. Sore shoulder developed during the next hour. Difficult to sleep that night. Painful to lift my left arm all day today.

Upset stomach, no appetite, chills, headache, disorientated. Temp went as high as 104.6, given Tylenol and put cold rags on extremities, Pulse oximeter read as low as 85and varied to 90. Applied CPAP and pulse Oximeter began to register 91 Pulse was as high as 103 and blood pressure was 152/92. This occurred over a time from 4:30 P.M. to approximately 6:40 when temp dropped to 102.8, and 7:45 temp was 101.8, Pulse oximeter was 86-89. By 9:05 pm Pulse oximeter went to 90 and rose to 92 and then 93 in the next couple hours. Patient had aching all over and felt disorientated the next day.

On Thursday following shot. Legs of both legs became itchy. Felt like they were on fire. skin was still clear. . After applying a some steroid cream it settled dawn and I went to sleep. Next morning I awoke with spots on my legs, and over the last few days, there were deliniated spots everywhere on my body - front and back - with the exception of my face. I thought it was measle, though my temperature was nomal (no fever) . I've not been able to contact my doctor. The spots have becom less definite and delineated, have grown into one another.. In general they're not teribly itchy, but they're everywhere. I'll see my Doctor tomorrow. I have spent the days in bed, not feeling my usual self. I feel a little better today but the spts (rash are everywhere.

My mid back is aching and sleep is difficult. I have not experienced this type of back ach in the past. I am taking ibuprophen to help with ach. This may get better but I wanted to report the problem in case it gets worse. Don't know the cause.

2/16 10PM felt soreness in neck and shoulder area. Soon developed chills. Had trouble sleeping. Took temperature at 2AM (2/17) - 100.4. Got out of bed 7AM - temperature 100.3. Took 2 full strength asperin. By noon on 2/17 temperature down to 98.8, still soreness neck and shoulders and very tired. Less discomfort at 10PM and got good night sleep. Still somewhat sore and tired 2/18 and 2/19. No ill effects at all by 8AM on 2/20

Hallucinating; Urinary incontinence; Lack of awareness / became unaware and didn't know where he was; Lethargic; Couldn't find the bathroom; Couldn't get off the end of the couch; Temp of 102-103; A spontaneous report was received from a consumer concerning a 78-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced temperature of 102-103, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. The patient's medical history was not provided. No concomitant medications were reported. On 20 Jan 2021, before the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient developed temperature of 102-103 degree fahrenheit, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. The reporter stated that these side effects began approximately a day to two days prior to the vaccine. The treatment information included paracetamol. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, temperature of 102-103 degree fahrenheit, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch were unknown.; Reporter's Comments: This report concerns a 78--year-old male who received Moderna's COVID-19 Vaccine (mRNA-1273), Lot # not provided, and experienced temperature of 102-103, urinary incontinence, lack of awareness, hallucinating, lethargic, couldn't find the bathroom and couldn't get off the end of the couch. Very limited information regarding these events has been provided at this time. Further information has been requested.

arm became really itchy around injection site; thought it be cellulitis; whole arm around injection site was swollen up like a balloon; whole arm around injection site was red; doses given 14 days apart; very nervous; became nauseas; ended up throwing up; very low fever 100F; just tired; This spontaneous report was received 10FEB2021 from a consumer which refers to a 78-year-old male patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced nausea, vomiting, tired, itchy around injection site, arm swelling at injection site, arm red around injection site, first and second dose were given 14 days apart. The patient's medical history included current cancer, dermatomyositis (autoimmune disease), Concomitant medications included chemotherapy (Keytruda infusion). On 15JAN2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly (Lot number: 039K20A). On 29JAN2021, the patient received the second of two planned doses of mRNA-1273 intramuscularly (Lot number: 028L20A). Doses were given 14 days apart, out of window 15 days early. The event(s) were, " injection site soreness, fever he became nauseas, "I never get nauseas", ended up throwing up, very low fever 100F, tired, the arm became really itchy around injection site, whole arm around injection site was swollen "up like a balloon" whole arm around injection site was red, first and second dose were given 14 days apart". The action taken for Moderna COVID-19 Vaccine was reported as taking Tylenol after the first vaccine injection for fever and Amoxicilin after second shot, 1x1000mg. The outcome of the events was reported as Resolved.; Reporter's Comments: This report refers to a 78 Y/O male with Inappropriate schedule of vaccine administered (second dose at 2 week interval) for mRNA-1273 (lot # unknown) with serious unexpected cellulitis 5 days after second dose and NS Vaccination site pruritus, vaccination site erythema, vaccination site swelling, fatigue, fever, nausea, vomiting. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

I felt like I had a bowling ball inside my stomach that was being pushed up through my throat. Forced myself to throw up to relieve pressure and acid 4 different times. Unable to get comfortable enough to sleep until the next morning. Took Alka seltzer, drank water and club soda. 12 tough hours

pt stated that after he got his covid vax he had no symptoms so had normal activities. Pt woke up feeling bad and was constipated on 2/26/2021. He has 101.6 fever. Pts wife called the PCP but wasnt able to speak to anyone. She asked them to call back but office closed for the day and they did not get a CB. She will try to call back. Pt has taken decalux for the constipation.

pt stated that a couple of days after the vax he was headed to get lab work done at the hospital for a upcoming procedure when he started having shortness of breath. He was only able to walk about 20-30 yards and was gasping for air. He had the procedure and went home but was not able to sleep without sitting up. He has a C-PAP machine but has not been able to use due to having excessive mucus. He also had some body aches and pains that have since subsided. Pt went to the Hospital on 2/16/2021. He was given a chest XRAY, took blood work and was given O2. Pt was discharged and told to FU w/ PCP and Cardiologist ASAP. Pt took Covid Test on 2/19/2021 and is waiting for results. Pt has an appt w/ his Cardiologist on 3/17/2021 where they will and echo cardio- gram and he has also has an order to take a chest XRAY due to his SOB symptoms. Pt starts radiation on 3/1/2021 for prostrate cancer.

Chills, confusion, fevers, nausea, confusion Subsequent precipitous decline in kidney function, required a 4 day in-patient stay

weakness Narrative: 77 y/o male patient with h/o Parkinson's disease, CAD (s/p stents), supraventricular tachycardia, received first dose of COVID19 (Moderna) vaccine on 02/11/21. On 02/12/21, legs were weak and shaky, had a fall. On 02/13/21, continued to feel weak. On 02/14/21, fell and felt chest pressure. Ambulance called and was taken to outside facility and found to be in afib RVR, treated with diltiazem. Had cardiac cath on 02/15/21 which showed NSTEMI due to extensive CAD, not a surgical candidate therefore medical management optimized. Started on amiodarone for afib. Discharged on 02/17/21. Has no prior ADRs to vaccines or anaphylactic reactions to medications. No prior COVID19 infection.

OK FOR 2 DAYS AFTER 2ND SHOOT THEN SEVERE PAIN DEVELOPED IN RIGHT HIP AND LEG MUSCLES AND THEN SPREAD TO OTHER LEG OVER 1-2 DAY PERIOD. SEVERE PAIN CONTINUES NOW IN BOTH LEGS AND HAS NOT SIGNIFICANTLY DIMINISHED. PAIN HAS BEEN AND CONTINUES TO BE SUFFICIENT TO INTERRUPT DAILY ACTIVITY AND SLEEP. TEMPORARY MINOR RELIEF ACHIEVED WITH MAX DOSES OF OTC PAIN MEDS BUT STILL DISRUPTIVE. INTEND TO CONSULT WITH FAMILY DOCTOR TOMORROW. VERY UNPLEASANT!

Patient started feeling weak, stomach pain, neck pain, respiratory problems, confusion, low blood pressure which led to death on February 21, 2021, 7 days after the vaccine was given.

March 3, 2021 SUBJECT: Moderna COVID-19 Vaccine, Side Effects This letter/email is addressed to a number of individuals with a request that you seriously evaluate the below discussion, take action to alert medical staff of your respective agencies of these side effects, and work with the manufacturer, Moderna, to address them. As the recipient of them it has thus far been debilitating and interfered with my daily activities. It is my hope that the medical community can find ways to prevent or treat them such that daily activity can be unimpeded. I will first provide a chronology of my medical history and my Moderna vaccine experience. Then I will discuss my observations. My medical history: Age: 78 Gender: Male Pre-existing Conditions: Medications Hypertension: Blood pressure medication, 50 mg of Metoprolol Succinate ER daily Cholesterol: Atorvastatin, 40 mg daily Medical History 2018: Triple By-Pass Surgery 2019: Passed out, Hit head on falling, Brain bleed: Subdural Hematoma, Hospitalized: No surgery required and released. Subsequently, pacemaker installed. 2021: Moderna COVID-19 Vaccine administered. First Dose: Lot Number: 011J20A, Date: 01/08/2021, Clinic Site: Pharmacy Second Dose: Lot Number: 032L20A, Date: 02/05/2021, Clinic Site: Pharmacy Side Effects to Moderna Vaccine administration First Dose: Administration Site: Swelling, Site Redness and Fever. All dissipated within week after administration Second Dose: Fever and Chills day following administration. Lethargic for several days following administration. These symptoms disappeared. Observations February 24, 2021: Began to experience dizziness, symptoms progressed to mild vertigo. Based on history of presentation of these symptoms, assumed I had an inter-ear problem and began taking Zyrtec D, half a tablet. Experience with Zyrtec D has been that ear dries out and symptoms of dizziness and disorientation disappear. In this case the symptoms of vertigo progressed to the point of difficulty in walking and loss of balance. Stopped taking Zyrtec D on Friday, February 26th. February 26, 2021: Had more severe vomiting, walking difficulty and lose of balance. Used walker to stabilize walking. At approximately 7 to 7:30 PM, following consultation with wife and daughter, decided to go the emergency room of the Medical Center (MC). Was quickly seen by emergency room staff. Following questions on medical history, the ER doctor, based on head bleed history, I believe, had a CT conducted. I do not recall any questions about COVID-19, but do think we told them that both myself and my wife had been vaccinated for COVID-19. I specifically recall that prior to my transport, a nurse came in to do a nasal swab for COVID-19. I informed her that I had been vaccinated, but she said this was a requirement for admission to the location where I was being transported. Following the CT scan, the ER physician determined he believed there was a possibility of a small new brain bleed. At approximately 2 to 2:30 AM I was transported by ambulance to Health Center at approximately 5:00 AM. I am not certain about the exact times here. February 27, 2021: Health Center administered a number of tests including CT scan, EKG, and an echocardiogram. While there, physical therapists came to see me twice and exercised me to improve my balance and walking ability. The last one recommended exercises to help reset my vestibular system. Based on the administered CT scan there, the physicians saw no evidence of a new brain bleed and were prepared to release me. At the time of that discussion in my room, the attending nurse pointed out to the physician there that my blood pressure was elevated. He ordered a new EKG and deferred on releasing me until a cardiologist reviewed the results. Their concern was that I was experiencing episodes of atrial fibrillation (AFib). Subsequently, the cardiologist reviewed the new EKG and concluded the episodes were within the normal range, my understanding, but did note that my heart rate was elevated. At no time did the medical staff raise or question the possibility of COVID-19 side effects as being a possible explanation for my disorientation or heart rate problem. I was released later that day. February 28, 2021: While speaking to her sister, my wife shared with her my experience of dizziness and disorientation. Her sister related that her husband had and was experiencing a similar event. Further, her husband?s sister had experienced a similar event. Additionally, the husband?s sister had experienced vertigo. On further discussion it was determined all three of us had received the Moderna Vaccine, and approximately three to four weeks post second dose administration, developed these symptoms of vertigo. This prompted me to go to the internet for information on vaccine side effects. The Food and Drug Administration Fact Sheet, revised 12/2020 in the Section Titled: What are the risks of the Moderna COVID-19 vaccine? speaks of severe allergic reactions including: a fast heartbeat and dizziness and weakness. I believe that I have suffered these two reactions. March 1, 2021: Called both hospitals to alert them to inform their respective staffs of the need to question the possibility of these side effects should other patients present in their emergency rooms. In my case, it may have helped to alleviate my concerns had I been informed of these possible side effects. At MC I left a voice mail for the Chief Medical Officer and at Health Center I spoke to the Nursing Supervisor. The nursing supervisor advised me to report my side effects and directed me to call the entity who had administered the vaccine doses. I called the Pharmacist and spoke to her. She said she would report my concerns through her reporting system. Further she informed me that there was a medication my primary care provider could prescribe. I called my primary care provider, and he has prescribed Meclizine, 25 mg tablets. I am currently taking ½ tablet, three times per day. A whole tablet made me drowsy. As of today, March 3, 2021, I am still experiencing disorientation. Hopefully this will subside and disappear. The above discussion is provided to assist medical professionals to further assess the side effects of the Moderna COVID-19 Vaccine. I am glad that I received it. I have no complaint about the care I received at the two medical facilities referenced. In fact, I think it was excellent. However, it would have helped me to have raised by either or both of them that my symptoms may have been COVID-19 Vaccine related. Further, it may have changed how they proceeded in assessing my situation. As an industrial hygienist with statistical training, it seems to me somewhat unusual to have three members of my extended family experiencing similar dizziness and weakness side effects, and for us all to have similar time periods following the administration of the second dose. Perhaps, if related to the vaccine, this cluster would suggest that this side effect may be more common than a ?remote chance.? Should any of you have further questions or wish to speak to me, please do not hesitate to call. Since I get a lot of calls from numbers I do not recognize, I do not always answer, but a voice mail left with a return call number normally results in a return call. Today, I received a return call from the Chief Medical Director of MC and told her she would receive a copy of this document. Thank you for your attention to this matter.

2/27 Saturday - vomit and severe body tremors, upper and lower body 2/28 Sunday - body tremors and unaware of situations around him for less than 1 minute 3/6 & 3/7 &3/8- welts and itchy rash over both arms and entire both legs Fatigue and no appetite

He was fine until 2/22/2021. He suddenly started having left leg weakness. He started becoming more dizzy next day and skipped his daily walk. On 2/25/2021, his left leg weakness became worse. His wife gave him cane and took him to PCP who diagnosed him with BPPV and gave him meclizine. Next day, he started having jaw stiffness and had difficulty in brushing his teeth. He was complaining of blurry vision in both eyes. He denied any double vision. He stated he could not read things which he was able to read 2 days ago. A day before he presented to Hospital, he was not able to walk at all and he required walker. According to his wife, when she went to see him at Hospital around 7 PM on 03/05/2021, his oxygen saturation dropped twice and internist decided to transfer him to ICU. Later on, the decision was made to transfer him to Medical Center. Pt was intubated, developed diffuse segmental myoclonus, required intense sedation; /ivig ineffective, now giving plasmapheresis. pt underwent imaging of CNS, LP and extensive laboratory testing.

Day 1 totally exhausted and slept for 24 hrs. Day 2 totally exhausted. Day 3 felt better but tired. Day 4 woke up dizzy and exhausted. Day 5 dizzy and exhausted. Day 6 dizzy and exhausted. Day 7 dizzy and exhausted. Day 8 still dizzy and tired, but beginning to feel better. Slightly dizzy for days 9, 10, and 11. This affected my work where I couldn't work. I will not get the second shot.

Dizziness blood pressure increased, shot injection area swelled and was red the size of an orange. Light headed, stomach cramps, overall fatigue, not able to sleep.

After severe confusion, delusion, and paranoia, he was taken to the er. Encephalopathy, autoimmune and antibody disorders

After six (6) days of getting my 1st Muderna vaccination I'm still having bad headaches all day with chills on & off during the day. Also I seem to be in a fog at times & having trouble paying attention. I'm taking Tylenol Extra Strength medicine twice a day, not helping.

headache, fever, ad confusion since getting vaccine; worsening generalized weakness over the next 2-3 days causing inability to perform ADLs or ambulate

extreme weakness, collapsed, ultimately patient was determined through repeated multiple blood tests excessively high inflammatory markers over a period of weeks, severe shortness of breath, confusion, fluid accumulation around the lungs. All is documented in Dr records as well as Hospital

Dehydrated; Vomiting; Severe diarrhea; Didn't get out of bed; Wasn't feeling good; A spontaneous report was received from consumer, concerning himself, a 78-year-old, male patient, who received Modena's COVID-19 vaccine (mRNA-1273) and experienced a diarrhea, dehydration, vomiting, malaise, feeling abnormal. The patient's medical history included diabetic (insulin dependent) and rheumatoid arthritis. The concomitant medications included as otilimab and insulin. On 17 Mar 2021, he got the first of two planned doses of mRNA-1273 (lot 038A21A) in his left arm, intramuscularly for prophylaxis of COVID-19 infection. On 18 Mar 2021, the patient experienced diarrhea, vomiting, malaise, feeling abnormal. On 19 Mar 2021, patient had dehydration. The patient was hospitalized for vomiting, diarrhea and dehydration. Treatment included treated for dehydration, monitoring his heart, and giving his insulin, Action taken with mRNA-1273 in response to events were not provided. The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Further information has been requested.

First day of shot had fever of 101, joint aches, breathing difficulty. Lasting for 3 days. Didn?t feel normal for a week.

Feeling spacey; severe diarrhea; Sweats; severe body aches; Chills; A spontaneous report was received from a consumer concerning a 78 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe body aches, severe diarrhea, sweats, chills and feeling spacey. The patient's medical history was not reported. Current condition included lung cancer. Concomitant products included chemotherapy pill for lung cancer. On 05 Mar 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 05 Mar 2021, 3 hours after receiving vaccine, the patient developed severe body aches, severe diarrhea, sweats, chills and feeling spacey. Treatment information was unknown. The event of feeling spacey was considered to be serious with criteria of important medical event and the rest events were considered as non-serious. Action taken with mrna-1273 in response to the events was unknown. The outcome of event, feeling spacey was considered resolved on 08 Mar 2021 and the remaining events were considered resolved on 07 Mar 2021.; 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.

difficulty thinking "Spacey"; sweats; severe diarrhea; severe body ache; chills; A spontaneous report was received from a consumer concerning a 78-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe body ache, severe diarrhea, sweats, chills and difficulty thinking. current condition of patient include lung cancer. No relevant concomitant medications were reported. On 5 Mar 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 5 Mar 2021, the patient experienced the events, severe body ache. severe diarrhea, sweats, chills, difficulty thinking spacey. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. Seriousness of events not reported. Event difficulty thinking(mental impairment) upgraded to medically significant based on IME list. Events Pain, hyperhidrosis, chills, diarrhea was considered to be recovered/ resolved on 7 Mar 2021.The patient recovered from the event difficulty thinking (mental impairment) on 8 Mar 2021.; Reporter's Comments: This case concerns a 78-year-old male on chemotherapy for lung cancer, who had a serious unexpected event of mental impairment along with events of unexpected pain, diarrhea, hyperhidrosis and expected chills. Event onset occurred the same day after the first dose of mRNA-1273. Treatment not reported. 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.

Extremem muscle weakness, especially in legs, unable to stand, low grade fever, disoriented, confused, no appetite. Had to have 2 people help me up off the floor.

This was second dose, exactly one month after first. Both at Pharmacy. Evening of 3/26 restless, little or no sleep. Morning of 27th seemed normal until about 11am when daughter tells me I was stumbling, sluring words which quickly got worse. Family tells me it got progressively worse and became like a daylong, staggering drunk completely unable to walk without assistance, showing some belligerance until finally asleep around midnight. This am (3/28) woke about 10am feeling normal except a bit weak and uncertain balance. After eating grew stronger with recovered balance.

Day 1 after vaccine, patient experienced extreme weakness and confusion. Found on the floor. Admitted to hospital that day for two day admission. Day 2 after vaccine mild weakness persisted and confusion started to resolve. Day 3 after vaccine- confusion resolved, mild weakness persisted. Patient still in PT. Discharged from hospital.

Approximately 36 hours after vaccination was administered experienced mild confusion & memory failure. There was mo pain or other physical manfestations. Confusion resolved itself overnight; mild memory lapses continue. It seemed to be a very specifc event -- perhaps a TIA?

went to ED c/o chest pain, Pain was non-radiating, intermittent substernal aching. It improved with sublingual nitroglycerin and PO ASA 324mg. Mild SOB was noted. No syncope reported. After arrival to the ED and administration of the above meds, symptoms improved. This AM he described mild worsening SOB during his stress test and an episode of chest tightness shortly thereafter which has now resolved. He also reports anxiety about his stress test result. A 1/2019 stress test was a normal, low risk study. Today's stress test was read as an intermediate risk study with a medium-sized fixed perfusion defect suggestive of infarction, with associated mild hypokinesis.

"On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights."; "He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"; woke up sweating; Inappropriate schedule; Extremely hurt; Last couple of nights could not sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights.") in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Bone fracture (not spontaneous) (The patient broke his collar bone and pacemaker was placed on the left side.) in August 2020, Neck pain (The patient was hospitalized for bad neck pain and couldn't sleep for 3 nights.) on 12-Mar-2021, Cerebral haematoma (On the day of hospitalization, It was thought that he had dried blood in his brain.) on 12-Mar-2021 and Pacemaker insertion (cardiac) in August 2020. Concomitant products included ATORVASTATIN, CARVEDILOL, CHOLECALCIFEROL, ENALAPRIL, ESCITALOPRAM, FISH OIL, GLIMEPIRIDE, METFORMIN HYDROCHLORIDE (METFORMIN SANDOZ), OXYBUTYNIN, TAMSULOSIN, PANTOPRAZOLE, ACETAMINOPHEN, MULTIVITAMINS [VITAMINS NOS], TADALAFIL, ATORVASTATIN, CARVEDILOL, CHOLECALCIFEROL, ENALAPRIL and ESCITALOPRAM for an unknown indication. On 07-Mar-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights.") (seriousness criterion hospitalization). On an unknown date, the patient experienced RIB FRACTURE ("He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"), HYPERHIDROSIS (woke up sweating), INSOMNIA (Last couple of nights could not sleep), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule) and VACCINATION SITE PAIN (Extremely hurt). At the time of the report, NECK PAIN ("On 12th Mar 2021, he was hospitalised for bad neck pain and couldn't sleep for 3 nights."), RIB FRACTURE ("He also mentioned that when reaching under the bed, he is thinking that he cracked one of his ribs"), HYPERHIDROSIS (woke up sweating), INSOMNIA (Last couple of nights could not sleep) and VACCINATION SITE PAIN (Extremely hurt) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule) had resolved. Based on the case description and the patient's prior medical history, the events are assessed as unlikely related to mRNA-1273.; Sender's Comments: Based on the case description and the patient's prior medical history, the events are assessed as unlikely related to mRNA-1273.

I experienced this rather immediate unexpected gradually increasing dizziness with impaired balance while walking at accustomed pace over approximately 12-15 minute time period. I was compelled to leave the track and lay down on an exercise mat where fortunately my wife came by t Within half hour of this attack i coiuld not stand and walk independently without support. My first time to a hospital ER in my 78 years of life. Recommended for observation and additional tests I stay overnight in observation unit. Diagnosis appeared to be perplexing for physicians. My wife came by to assist me in standing , walking to the car and driving me to nearby ER. What happened to me was a frightening, anxiety-producing and dangerous situation. I could have easily fallen with substantial head or other bodily injury. Being in excellent health and with nothing else unusual having occurred recently to affect my general health (no changes, no illnesses), I cannot help conclude this episode was a serious adverse reaction to my 2nd Moderna vaccination. I now consider what happened on 3/28/21 a "Vestibular Attack". I think possibly my body for some reason related to the vaccine might have been attacking itself, if that makes sense to scientists. I hope this doesn't happen to others. I am not anti-vaccination. But individuals should be warned about this possible dangerous reaction or adverse side effect, which in my case did not occur immediately after the 2nd Moderna dose. I've complained to the hospital that possibility of severe dizziness with extreme loss of balance being related to recent Moderna 2nd vaccination was NOT discussed or commented.

Patient came to pharmacy to say that for about 3 hours around 5 days after his 2nd dose of Moderna Covid-19 vaccine he experienced some temporary confusion/stroke like symptoms. His physician is currently trying to rule out other causes, such as an actual stroke/blood clot. At the present time, the patient feels like his normal self.

worse with the second shot.; worsening tremors; weak and dizzy; weak and dizzy; extremely nervous; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weak and dizzy), DIZZINESS (weak and dizzy), NERVOUSNESS (extremely nervous) and FEELING ABNORMAL (worse with the second shot.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced ASTHENIA (weak and dizzy) (seriousness criterion intervention required), DIZZINESS (weak and dizzy) (seriousness criterion intervention required), NERVOUSNESS (extremely nervous) (seriousness criterion intervention required) and TREMOR (worsening tremors). On 03-Feb-2021, the patient experienced FEELING ABNORMAL (worse with the second shot.) (seriousness criterion intervention required). At the time of the report, ASTHENIA (weak and dizzy), DIZZINESS (weak and dizzy), NERVOUSNESS (extremely nervous), FEELING ABNORMAL (worse with the second shot.) and TREMOR (worsening tremors) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. This case concerns a 78-year-old male with medically significant serious unexpected events of asthenia, feeling abnormal, dizziness, nervousness and nonserious unexpected tremor. Event onset 5 days after first dose. 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. This case was linked to MOD-2021-049775 (Linked Report). Reporter did not allow further contact; Sender's Comments: This case concerns a 78-year-old male with medically significant serious unexpected events of asthenia, feeling abnormal, dizziness, nervousness and nonserious unexpected tremor. Event onset 5 days after first dose. 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. MOD-2021-049775:

bladder infection; Not feeling good in general; Chills; muscle aches and pain; low fever; This spontaneous case was reported by a consumer and describes the occurrence of CYSTITIS (bladder infection) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Bladder cancer. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced FEELING ABNORMAL (Not feeling good in general), CHILLS (Chills), MYALGIA (muscle aches and pain) and PYREXIA (low fever). On 12-Jan-2021, the patient experienced CYSTITIS (bladder infection) (seriousness criterion medically significant). At the time of the report, CYSTITIS (bladder infection), FEELING ABNORMAL (Not feeling good in general), CHILLS (Chills), MYALGIA (muscle aches and pain) and PYREXIA (low fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Jan-2021, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was 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. Further information has been requested.

dribbles; heart rate when down to 38 beats per minute; loose bowels; breathing situation has gotten worse; feels terrible; increased amount of phlegm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (heart rate when down to 38 beats per minute) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 032L20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Coronary artery disease, COPD, Enlarged prostate, Atrial fibrillation and Bronchitis. Concomitant products included WARFARIN for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced DIARRHOEA (loose bowels), DYSPNOEA (breathing situation has gotten worse), FEELING ABNORMAL (feels terrible) and PRODUCTIVE COUGH (increased amount of phlegm). On 21-Mar-2021, the patient experienced BRADYCARDIA (heart rate when down to 38 beats per minute) (seriousness criterion medically significant). On an unknown date, the patient experienced URINARY INCONTINENCE (dribbles). At the time of the report, BRADYCARDIA (heart rate when down to 38 beats per minute), DIARRHOEA (loose bowels), URINARY INCONTINENCE (dribbles), DYSPNOEA (breathing situation has gotten worse), FEELING ABNORMAL (feels terrible) and PRODUCTIVE COUGH (increased amount of phlegm) outcome was unknown. Not Provided Treatment of these events included steroids. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.

Oxygen saturation low; Difficulty breathing; Hallucinating; Incoherent; Wheezing; does not recall anything after that for the next 12 hours; Extreme Painful L arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen saturation low), DYSPNOEA (Difficulty breathing) and HALLUCINATION (Hallucinating) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (Medical history was not reported.). Concurrent medical conditions included Type 2 diabetes mellitus and Asthma. Concomitant products included INSULIN ASPART and INSULIN DETEMIR (LEVEMIR) for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen saturation low) (seriousness criterion hospitalization), DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization), HALLUCINATION (Hallucinating) (seriousness criterion hospitalization), INCOHERENT (Incoherent), WHEEZING (Wheezing), AMNESIA (does not recall anything after that for the next 12 hours), PAIN IN EXTREMITY (Extreme Painful L arm) and CHILLS (Chills). On 21-Mar-2021, OXYGEN SATURATION DECREASED (Oxygen saturation low), DYSPNOEA (Difficulty breathing), HALLUCINATION (Hallucinating), INCOHERENT (Incoherent), WHEEZING (Wheezing), PAIN IN EXTREMITY (Extreme Painful L arm) and CHILLS (Chills) had resolved. At the time of the report, AMNESIA (does not recall anything after that for the next 12 hours) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, COVID-19: negative (Negative) Negative. On 17-Mar-2021, Oxygen saturation decreased: abnormal (abnormal) oxygen 72. 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. Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.

weak and dizzy; Worsening tremors; Extremely nervous; weak and dizzy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASTHENIA (weak and dizzy), TREMOR (Worsening tremors), NERVOUSNESS (Extremely nervous) and DIZZINESS (weak and dizzy) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jan-2021, the patient experienced ASTHENIA (weak and dizzy) (seriousness criterion medically significant), TREMOR (Worsening tremors) (seriousness criteria disability and medically significant), NERVOUSNESS (Extremely nervous) (seriousness criterion medically significant) and DIZZINESS (weak and dizzy) (seriousness criterion medically significant). At the time of the report, ASTHENIA (weak and dizzy), TREMOR (Worsening tremors), NERVOUSNESS (Extremely nervous) and DIZZINESS (weak and dizzy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was unknown. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-049791 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-049791:

Patient on 4/18/21 experienced "chicken wire" vision (never before an issue), after vision issues patient said he lost vision on and off for the next 24 hours, accompanied with mental confusion, and was unable to get out of bed on the morning of 4/19/21. Next two days a continued decline in in ability to ambulate and demonstrated neurological deficits on 4/20/21 of impaired vision, cognition and experienced difficulty in moving limbs. Patient was in a car accident on 4/21/21, is now hospitalized, unable to ambulate, and has further neurological deficits with impaired speech, cognition, and movement as well as pneumonia.

My father experienced an acute stroke, 1month +7days after receiving his 2nd shot. We are reporting this because when we mentioned the stroke to members of our church, there were at least 2 others who knew of someone in my fathers age group who also had a stroke 1 month after their 2nd covid vaccine shot. My father is currently at hospital, and is being moved to Rehab Center today. (April 28, 2021) On Saturday, April 24th, he woke up with wobbly legs around 3am, accompanied with an odd sensation in one of his arms, and legs. He went on about his day, but felt off. He fell around 2:20pm, I was called by mom. My husband and I arrived about 10 minutes later. He was up, and walking at that point, but his speech was very slurred. We checked his blood levels (159), and went through the stroke symptoms, and drove him to Hospital, where they immediately took him in under stroke protocols. It was determined he had an acute stroke.

3/21/21 - Pt emails MD that he'd had SOB + fatigue since 3/10 when given first dose of infliximab, no energy, sitting all day. smell ok. taste reduced. poor appetite. +dyspnea on exertion. no chest pain or edema. HR nontachy at baseline, to 105 ambulating to bedroom. BP 164/97. COVID test scheduled for 3/23, which returned negative 3/24. 3/28 - Pt went to healthcare facility for generalized weakness, worsening SOB over days, R pleuritic chest pain, diagnosed with bilateral pulmonary emboli, left popliteal vein DVT. Required 5L O2. echo w/o LV strain. At the time he stated it may have been going on for 4 months. during hospitalization also had altered mental status, MRI/neuro diagnosed with hypoxic brain injury 3/30 - transferred to another healthcare facility given IV abx, lasix, 2-4L NC, 4/11 - discharged to another healthcare facility.

Vaccine site left arm. Left hand joints at pointer finger and thumb are swollen and have sever pain. Right arm elbow pain. Can not lift right arm to even shave. Symptoms started 2 days after vaccination. Three weeks later with no improvement.

4/22/21. Patient was very lethargic, His normal patterns of behavior changed. He would sleep through his alarm daily . I would have to wake him up by shaking him. He was confused as to date and time. He had a non productive cough, he appeared flushed, wheezing SOB on exertion. He had hallucinations, told me i had a delivery of bees for my garden. He must have been dreaming? He remained lethargic sleeping on & off throughout the day with confusion. I pushed fluids I notified his PMD Dr. on 5/6/2021 He advised to take the patient to the Emergency Room for a Covid test and a chest x-ray. The patient refused to go. On 5/7/2021 I took him to Immediate Care (Urgent Care Center) they Did a. Chest X-Ray and a Covid Test, results pending in 2. Days. Chest X-ray was Negative. The doctor ordered a Azithromycin, and Methylprednisolone taper . Should he hold off getting the second vaccine?

Blood Clot Left Lung; Has not received 2nd dose; ow 90's and high 50s oxygen levels; Feeling bad; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood Clot Left Lung) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. The patient's past medical history included Chronic kidney disease, Thrombus and Cancer. Concomitant products included SODIUM BICARBONATE (SODIUM BICARB.PED), HYDRALAZINE, Folic Acid, SEVELAMER CARBONATE (RENVELA), AMLODIPINE BESILATE (AMLODIPINE (ALS BESILAAT) SANDOZ), FUROSEMIDE, POTASSIUM CHLORIDE (LASIX + K), PRAVASTATIN and MONTELUKAST for an unknown indication. On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced PULMONARY EMBOLISM (Blood Clot Left Lung) (seriousness criteria hospitalization and medically significant), OXYGEN SATURATION ABNORMAL (ow 90's and high 50s oxygen levels) and FEELING ABNORMAL (Feeling bad). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose). At the time of the report, PULMONARY EMBOLISM (Blood Clot Left Lung), OXYGEN SATURATION ABNORMAL (ow 90's and high 50s oxygen levels), FEELING ABNORMAL (Feeling bad) and PRODUCT DOSE OMISSION ISSUE (Has not received 2nd dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment with warfarin to treat the blood clot as provided by the patient. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD21-087825, US-MODERNATX, INC.-MOD-2021-114702 (E2B Linked Report).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-114702:Case for husband

<48 hours following 2nd vaccine, altered mental status leading to hospitalization and dx of encephalitis. symptoms resolved completely within 12 hours

Sudden inability to move and delirious and hallucinating. Hospital ran numerous tests to find problem without being able to determine.

Jab 5pm; 11pm brief dizziness, slight headache (rare for me); 5am diarrhea for 3 hours; very tired for two days, on/off headache; next four days woke before dawn to very strong heart palpitations... jumping heart... each time soon following with strong headache; I could at strongest beats see the beats through 'flashes' in my eyes; standing or walking to bathroom felt faint, sometimes wondering if will pass out; always begins while lying down; sleeping on both sides, on back the same; sitting in chair seemed to eventually help; once up and eventually more active palpitations have settled down to a few 'reminders' during the day and evening. Fear going to bed now., eleven days after 2nd Moderna.

Four months after the second injection I was awakened after midnight by a painful red rash from my neck to my feet that burned and itched for about 2 hours. I put a wet towel on my chest and neck, but it did not stop the pain and the redness. I began rubbing my body from my neck down to my waist. After about 20 minutes the pain and redness began to disappear very slowly. I then began to rub my chest and legs for another 20 to 45 minutes and the pain and redness begin to be releaved. Last night (7/23/2021) I awoke at 1:30 AM with a painful red rash on both legs that itched like mosquito bites. The rash was primarily on the inside of both legs and down to my feet. I started using Cortizone 10 (it did not help), then I switched to Triamcincolone Acetonide Cream USP, 0.1% (that did not help) and then Halonate .005% (that did not help). It took almost an hour of rubbing my legs before the itching and burning subsided.

Pt. presented to UC with change in mental status; arrived from extended care facility; discharged home on 05/20/21 to hospice care. Pt.'s son called to cancel subsequent appointments because pt. passed away on 05/27/21.

Vaccine at 10:45 am. At 2 am patient awoke with severe chest, left arm, back of the head, neck, stomach and shoulder pain and was breathing heavily, in a panic attack. Said he feared he was having a heart attack. I gave him an extra strength tylenol, rubbed his neck, back of head, shoulders and suggested he was having a vaccine reaction. After about an hour, he fell asleep. He awoke around 8:30 am with a slight headache but otherwise feeling fine.

falling out of his wheelchair and having altered levels of consciousness every since receiving his COVID vaccine 2 days ago. Admitted with multiple pelvic fractures from fall and NSTEMI with elevated trop

Total confusion and disorientation - he did not know where he was or how he got here the morning after the shot. He has Alzheimer's, so he is confused and disoriented normally but this was way above and beyond his ususal state. Not sure if it was the vaccination that caused it, but reporting it just for your information.

Patient rec'd vaccine on 1-25-2021. Patient woke up on 1-26-2021 feeling so bad with joint stiffness and trouble breathing, he called 911. He was taken to Hospital where he was admitted. He says by 1-27-2021 he was feeling much better with each passing hour. He was discharged on 1-27-2021. Then on 1-28-2021 he noticed a red and very itching rash at the injection site and all across his back.

After monitoring time was complete, client stood from sitting position and fell forward and sustained ecchymosis to forehead and nose. He became less alert with delayed response to verbal commands. VS measured; BP 78/50, Pulse 65, O2 Sat 96% Room Air, R 16. He became clammy with repeat of BP 161/60, Pulse 63, O2 Sat 91% Room Air. EMT summoned and client transferred to ER for further assessment and treatment. Call to local hospital confirmed ER visit and release same day.

On morniing of 1/30/11 patient presented with confusion, unilateral weakness - diagnosed and admitted with CVA - embolism of R middle cerebral artery per CT scan. Noted to be in atrial fibrillation during admission. Discharged to rehab center on 2/3/21.

Five hours after no reaction to the vaccine chills commenced, nausea, vomiting, loss of appetite and severe muscle weakness; unable to ambulate even with walker; lost control of bowels and bladder functions; fatigue. Was bedridden for 36 hours . At about 28 hours upon recommendation from oncologist, took one Benadryl and within 2 hours started to improve. Took 1 Benadryl every six hours for next 48 hours and was feeling better except for residual whole body weakness. Would have been helpful to know about Benadryl before hand. Will take Benadryl 30 minutes prior to getting 2nd shot on March 5. Thanks. Hope this information is helpful to others.

When I got the shot, It was painful but everything was fine. I was fatigued that evening and then when I went to bed I slept excessively. On a scale of 1-10 I was experiencing a 4 in pain. I took Extra Strength Tylenol and am still having pain. I feel tired.

Nausea first day Next morning chills and fever 103.4 Incoherent Couldn?t function, like pull self out of chair Nausea Wet chair Inflammation in lungs after being checked at hospital

Severe chills , no fever, body aches , brain fog,lack of appetite Had COVID diagnosed 10 - 27 - 2020. Should be told at time of injection possible worse side affects if had COVID previously also need to inform of possible brain fog

Extreme fatique and weakness, slight confusion, cough, severely decreased appetite, constipation lasting more than 2 weeks.

Patient became dizzy 15 minutes after vaccination. Emergency services was called. Patient went into a sleep state for about 15 seconds but with stimulation was responsive and was able to speak to me immediately. Patient then became nauseated and approximately 10 minutes from start of event vomited. After this the patient began to feel better. Paramedics arrived and evaluated patient. Blood pressure, pulse, oxygen level, glucose level were all normal. Patient was convinced to go to Emergency Room with paramedics to be evaluated.

Site: Pain at Injection Site-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: slurred speech, confusion, possible seizure, minimal right side of body function-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Seizure-Severe

HE WOKE UP AT 4:30 CONFUSED, TALKING OUT OF HIS HEAD, THEN WENT BACK TO SLEEP AND WOKE UP AT 0630 WITH HARD SHAKING CHILLS, JOINT PAIN (SHOULDERS AND KNEES), ALTHOUGH HE HAS HAD 2 TOTAL KNEE REPLACEMENTS), HEADACHE, FATIGUE AND MALAISE, AND TEMPERATURE OF 101,5(NOT RESPONSIVE TO EXTRA STRENGTH TYLENOL) 20BENADRYL 25MG EACH , PEPCID 20MG AND GATORAID. . COULD NOT RAISE EITHER ARMS AND STATED THAT THE "BALL JOINTS" IN SHOULDER WERE VERY PAINFUL. AT 4;20 PM TEMP WENT DOWN TO 101.4, AT 6;30 TEMP 100.3 AND 8:45PM TEMP 99.3. AFTER THIS HIS SYMPTOMS SUBSIDED EXCEPT FOR SORE ARM AND SHOULDERS, SIDE EFFECTS LASTED ABOUT 14 HOURS. BUT STRANGE THING HAPPENED ON 02/21/21 HIS ENTIRE MIDDLE FINGER ON LEFT HAND TURNED VERY RED, BUT NO SORENESS OR PAIN. , AND NO OTHER FINGERS WERE RED AND RESOLVED ON 2/22/21

Resident had severe CAD, DM type 2, and hx of RBKA and left 5 digits on foot amputation. Hx of osteomyelitis post surgical. After last surgery, resident did not have a good appetite, more restless, increased confusion with dementia. Significant other passed away on 12/30/20, resident began refusing meals, decreased eating. Vaccinated on 1/13/21. On 1/25/21 Resident labs showed kidney failure. Dr. spoke with family and transitioned to Comfort care, on 2/5/21 went hospice. Patient passed away on 2/13/2021.

Both knees hurt and had pain. Both wrist (back side of thumb) hurt /pain. Had fatigue for 3 days. Had the moderna vaccine. Felt strange for 3 days. No energy

During the early morning hours of Friday, February 19, approximately 12 hours after the vaccination, I awakened to a 102 degree temperature, chills, nausea (triggering dry heaves), strange dreams, and very weak legs. Over the course of the day I alternated taking Ibuprofen (200mg) and Acetaminophen (500mg) every two hours for eight hours to drive down the temperature. I also pushed water, and took naps. I continued this treatment throughout the day of Feb. 19, and once on Saturday, Feb. 20. I experienced a deep degree of lethargy beginning these days and continuing for several days later. I did not "feel like my old self" until Friday, Feb. 2, eight days following the vaccination.

Arm was a little sore after shot, but the next morning pt. wasn't able to walk when he tried to get out of bed. He fell on the floor and was unable to get up. His face was very flushed and he broke out in a sweat several times. We had to have fire dept come and pick him up off the floor. He was able to get around a little bit with a walker, but spent most of the day in bed and was transported to bathroom by wheelchair. He was also a bit confused. He had very little appetite and was unable to eat very much. At dinner time, he ate a little bit of soup and when he stood up at the table, fell again onto wood floor. We had to call fire dept to pick him up from floor and EMT's/ambulance to come out and check him over. VItals were all normal. He was just a little bit better on the next several days. We made an appointment for him to see Dr. on 3/3. Doctor did blood work which came back normal. Pt. is still not back to normal.

I received the vaccine at 4:30 PM on the 26th of Feb 21. At 11:PM I started to get ready for bed. Felt uneasy...wobbly. Irritating small pain the full length of my spine. Laid down and attempted to sleep no luck. I checked my pulse...very week and uneven. Missing beats...3-small beats in a row many times. Very erratic. It was like that till 5:AM in the morning. I must have finally fallen to sleep and by the time I got up at 8:30AM...my heart beat was back to normal again. Small muscle pains now but nothing else.

patient presented to ED with confusion and weakness. Given IV fluids and vasopressors for hypotension. Patient's condition continued to worsen, requiring oxygen, AKI with continually worsening renal function on discharge. Patient treated with IV Zosyn for possible infection. Patient continually lethargic and family decided to discharge to home hospice care. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine

3/6 at 8 AM collapsed to the floor with generalized weakness, headache (5/10), severe nausea with dry heaves, copious sweating & minor nosebleed. No loss of consciousness. Was able to get to sofa about 8:30 AM and vomited scant amount of whitish fluid. Temp at 5:30 PM 98.1. Slept all day and all night. On 3/7 felt fine and resumed all normal activities. On 3/8 felt extremely fatigued from awakening at 7:30 AM until 11:00 AM. Fatigue resolved midday on.

By 3:00 he had a whole body chill. He was then incoherent, lost all control of all body muscles and was incontinent both bladder and bowel. He continued as such when Dr. said to give him Prednisone along with the Benadryl he was receiving every six hours starting at 3:30 p.m. 3/8/2021. He was given a Prednisone at 4:00 p.m. 3/9/2021 and again at 8:00 p.m. on 3/9/2021 along with his Benadryl. He was unable to ambulate or even turn his body over in bed. He was able sip water and sports drink but ate nothing since noon on 3/8/2021. It wasn't until early Sunday morning that he was able to move his legs and get to a walker and use the toilet. He slow, very slowly has improved since then. Late Sunday he was able to get up, and sit in a chair. Later he was able to take a sit down shower and shampoo and be an to feel "nearly human" again. He has slowly progressed since then and Monday morning was able to navigate by himself and to descend and ascend a 13 stair step to the basement. In discussing the 24 hours he spent in bed he was unaware of any of the things going on such as not being able to move, but knew he was in pain if he moved his legs. He also had a temperature of 102.3 which rose to 102.9 and then with cold compress on his forehead and time his fever dropped to 95.4 and the back up to a normal of 97.5. These are similar symptoms he had after the first injection of the Covid 19 Moderna vaccine and he had had a similar reaction in 2017 from the first flu shot he ever had in his life. He felt he needed to take this vaccine in order to be able to "have a life" even though we assumed he would have such a bad reaction. He is slowly improving and if it is like the first injection it will take him nearly two weeks before he can ambulate at the level he was before the vaccination. Still, he is grateful to Center for being so proactive as to have available the vaccine and it being more convenient for cancer patients than waiting in line at a mass inoculation center. He would appreciate an acknowledgement that this information has been received and could possibly passed along to help others in his situation. Thanks.

Admitted to local hospital 2/24 with weakness, malaise, cough and altered mental status 2 days after receiving 2nd dose of moderna SARS COV2 vaccine. He was initially tachycardic, febrile and had leukocytosis 18K, with admission labs with creatinine 1.8, lactate 2.4. He had need for supplemental oxygen and was placed on broad spectrum antibiotic therapy. Respiratory viral panel including SARS COV2 PCR was neg. Blood cultures from 2/24, 2/27, 3/3 were negative. CT chest showed some prominent mediastinal adenopathy which was increased from prior CT 2017. Also had axillary and inguinal lymphadenopathy. 2/27 he had a code blue called for bradycardia in context of receiving ativan for a CT study. Antibiotics were changed to Vancomycin, ceftriaxone and ampicillin, acyclovir on 2/28. Multiple attempts by multiple providers at doing a lumbar puncture have been unsuccessful. Bronchoscopy 3/2 with left lower lobe secretions. Cultures negative. He has stayed incessantly febrile and working diagnosis is probable underlying lymphoproliferative neoplasm immunostimulated by vaccine. At this time a bone marrow and lymph node excisional biopsy is planned. Patient is unstable to proceed for MRI imaging at this time due to hypotension.

Within 4 hours of vaccination my arm swelled up noticeable, became very stiff and sore and made it painful to move my left arm. By 8:00pm I began to feel weak, tired and poorly. By 11:pm I had developed a fever and aches and pains in most joints and muscles which mimicked flu symptons. During the night I became chilled and found it hard to sleep from all of the discomfort. Most of these symptons were almost gone by the next night except for the swelling, which took another 2 days to go down. I have had no other symptons since then.

He woke up the next day after the vaccine he did not know where he was and was confused. He did not take his medications, did not remember to take it. He came out to his wife and she heard some noise and he looked over to the dog dish to refill it and didn't refill it as he usually does. Just a lot of forgetful things that he did. He had dizziness and was hanging on the door frame and went to bed, and told his wife that he did not know anything and did not know what he was doing. They took him to the doctor and was seen by the doctor who checked his VS and said that he was okay, and told them that he was having a reaction to the vaccine, and was starting to come around and remembering things while he was in the doctors office. They were advised to take him home and let him rest, and he did and didn't eat until last evening. He had the same reaction that he had when he had the COVID virus. He knew everything this morning and back to his baseline.

Patient received 2nd dose of Moderna COVID vaccine at approx. 10am on 03/10/21. At approx. 5pm on 03/10/21, he developed typical side effects including fever, chills, and lethargy. Additionally, he became confused. The next morning, he remained lethargic and minimally responsive. He was febrile to 106 F per daughter and somewhat hypotensive with SBP into the 80s. The afternoon of 03/11/21, he also developed right facial droop and weakness. EMS was called and he was found to have suffered a left MCA stroke. He was admitted to the hospital for this and underwent thrombectomy. Of note, he was febrile and hypotensive on admission.

On the fifth day after vaccination I found myself disorganized in routine, everyday activities, such as washing & dressing, preparing meals, etc.; for example, I omitted washing my ears and forgot to put the kettle on. In the afternoon I was troubled by a headache of a novel sort, not with indefinite perimeter, but more specifically delimited, with ragged edges. Then that evening after ascending a flight of stairs, I heard a loud thumping, then suddenly realized that it was my own heartbeat that I could hear in my head. These bizarre effects disappeared by the next day. On the seventh through fourteenth days after the vaccination, I experienced a soreness in my trunk below the rib-cage, at first toward the sides, but then becoming more insistent and less localized; this was accompanied by headache (normal dull sort), along with irritation at the back of my nasal passages, and a feeling of being tired already upon waking.

patient's wife reported that he passed out in a restaurant about an hour after he left the pharmacy and received his vaccine. He started to feel bad and stood up from his seat to use the resteroom and fainted. The staff called and ambulance but he refused to go to the hospital. Patient's wife reports the EMT's did check him over and said his vitals were okay and appeared fine. His wife then met him and took him home to rest.

Wife called clinic on 3/3/21. Said he had a serious reaction requiring EMS to be called twice. Was seen by PCP on 3/3/21. Chief complaint of recent falls, no appetite, and cognitive issues since 2/26/21. HPI Per PCP Note: 79 yo male with Celiac, mild type 2 DM and prostate cancer on Leuprolide and Xtandi here for f/u Diabetes and to get advice following adverse reation to first COVID vaccine received 2/25/21. He has chronic RUE tremor. He was diagnosed with a TIA from an endocardial lesion many years ago. No cardiovascular disease history. He experienced increased generalized weakness and poor balance following the vaccine. He felt restless for 4-5 hours. He fell to the floor twice and next morning and afternoon and EMS evaluated both times. Glucoses 140-150. No hypotension or tachycardia. No arrhythmia. No focal hemiplegia or slurred speech. Did have sluggish cognition but not obtunded and could communicate wishes to remain at home. Spouse feels he was 80% better on Saturday and is 95% better today (Tuesday). No low glucoses. Hydration and rest the first 48 hours seemed to help but he doesn't feel completely normal yet (still has fatigue and no appetite). He can walk but is not confident of his strength. He was anxious about getting the vaccine. No prior hx of COVID but spouse did have it in August. Spouse had localized reaction only. Patient weaning off Gabapentin taken for tremor and neuropathy.

I had my 2nd Moderna Covid 19 vaccine on Thursday morning March 18, 2021 at the hospital. Everything went fine. At approximately 4.00am Friday morning. I was awakened and barely made it to the toilet where i vomited 3 times. Following that took my temperature and it was 102.5. I was shaking all over, ached all over as well as a headache. very similar to my 1st vaccine reaction only much worse. Again i was planning to play golf Friday and Saturday mornings but cancelled. Can't play golf when you can barely walk. I drank pedialyte and gatorade to rehydrate and basically had no energy to do anything but sleep off and on for the next 2 days. It wasn't until Tuesday that I began feeling normal. Temperature slowly went down and finally was normal Monday night.

Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: nervousness-Medium, Systemic: Hypertension-Severe, Additional Details: Patient felt chest pain and nervous after receiving moderna COVID vaccine in left arm. 2pm: BP 200/11 HR 68, 2:05pm BP 186/106 HR 67; 2:37pm BP 208/118 HR 71. Patient mentioned he did not take his BP medications today. Cound not establish what patient's baseline BP is. Ambulance was called to make sure patient was not having hypertensive emergency. EMS took patient to the hospital.

3/24/21 -Evening after shot had fever 3/30/21- nausea (vomit, once) - evening 3/31/21/-fever and delirium - night 4/1/21- fever (101.5), sniffles, cough - night 4/2/21 - fever (101.5) in morning - given Advil, 11:00 a.m. fever reduced

started with chills and slight fever. Went to bed; however, wears a CPAP. At around 2am spouse awoke and heard strange gurgling sounds. Husband sleeps on back due to CPAP. Upon turning on light discovered he had thrown up and had regurgitated the vomit into his mask and back down throat. Very high fever, body hot all over, in state of confusion and slid off bed; tongue swollen and hard to understand him. Called paramedics and they took him to hospital immediately saying "he was in bad shape". Admitted to Hospital at around 6am after being in emergency room and treated with antibiotics and steroid. Stayed in hospital 4 days. Diagnosis: aspirated pneumonia. Home but with health care.

About 4 days after the second dose my lymph nodes near the injection site started to hurt. Over the next few days the pain got worse so that I couldn't lie on that side of my body. The symptoms progressed towards my shoulder and neck and other lymph nodes became painful. The next phase a few days later was red spots and blisters around the injection site on my chest near my neck on my left side. At the present time the blisters have mostly gone away but they've been replaced by welts where the red spots were these are swollen and red. All of these symptoms are accompanied by fatigue and muscle pain also around my left shoulder. I have been treating it for the past 3 days with ice and am now taking an antihistamine Benadryl.

Severe Pain in left arm fro injection site down the forearm. Severe Pain radiating through the left chest and the left shoulder blade. Inability to sleep unable to find a comfortable position for my arm due to tingling, numbness and lack of ability to use my arm in greater than 70 % movement.

Patient describes extreme weakness and disorientation to time, describing the event as "losing one whole day"

lost most the hearing in the left ear; had a bad day generally; This spontaneous case was reported by a patient and describes the occurrence of DEAFNESS UNILATERAL (lost most the hearing in the left ear) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 022M20A) 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 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DEAFNESS UNILATERAL (lost most the hearing in the left ear) (seriousness criterion medically significant) and FEELING ABNORMAL (had a bad day generally). In April 2021, DEAFNESS UNILATERAL (lost most the hearing in the left ear) was resolving. At the time of the report, FEELING ABNORMAL (had a bad day generally) outcome was unknown. No relevant concomitant medications were reported. The patient confirmed lost most of the hearing in the left ear by a visit to the clinic after a hearing exam was done. The patient stated that he can hear better now but the left ear was not usable and could not use a telephone. It was better now but still not ok and was still "metallic." The patient does not know if 2nd dose had influenced the hearing and stated that he did not have prior history of hearing issues. Action taken with mRNA-1273 in response to events was not applicable. No treatment information was provided. 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.; 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.

Acute intertribal hemorrhage; Stroke; Starting getting confused; Had a fall; Brain bleeding, brain hemorrhage; Induced coma; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL HAEMORRHAGE (Acute intertribal hemorrhage), CEREBROVASCULAR ACCIDENT (Stroke), CONFUSIONAL STATE (Starting getting confused), FALL (Had a fall), HAEMORRHAGE (Brain bleeding, brain hemorrhage) and COMA (Induced coma) in a 79-year-old male 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) Dosage form. On 24-Mar-2021, the patient experienced COMA (Induced coma) (seriousness criterion medically significant). On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Acute intertribal hemorrhage) (seriousness criterion death), CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), CONFUSIONAL STATE (Starting getting confused) (seriousness criterion medically significant), FALL (Had a fall) (seriousness criterion medically significant) and HAEMORRHAGE (Brain bleeding, brain hemorrhage) (seriousness criterion medically significant). The patient died on an unknown date. The reported cause of death was intra cerebral hemorrhage. At the time of death, CEREBROVASCULAR ACCIDENT (Stroke), CONFUSIONAL STATE (Starting getting confused), FALL (Had a fall), HAEMORRHAGE (Brain bleeding, brain hemorrhage) and COMA (Induced coma) outcome was unknown. Not Provided Concomitant medication not provided. No treatment information/hospitalization information provided. This case concerns death of a 79-year-old male patient who expired from acute intertribal hemorrhage after receiving mRNA-1273 vaccine. three days after vaccine administration, the patient developed confusion and fell with subsequent events ensuing. Based on the available information causal association between the event if confusion leading to fall and product use cannot be excluded. The other events are assessed as directly related to the fall and unlikely due to product use.; Sender's Comments: This case concerns death of a 79-year-old male patient who expired from acute intertribal hemorrhage after receiving mRNA-1273 vaccine. three days after vaccine administration, the patient developed confusion and fell with subsequent events ensuing. Based on the available information causal association between the event if confusion leading to fall and product use cannot be excluded. The other events are assessed as directly related to the fall and unlikely due to product use.; Reported Cause(s) of Death: intra cerebral hemorrhage

chest pain; Shaking legs/ Tremors in hands; legs buckled; anxiety; Weight loss; fell to ground; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain), TREMOR (Shaking legs/ Tremors in hands) and LIMB DISCOMFORT (legs buckled) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 038K20A) 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced FALL (fell to ground) and WEIGHT DECREASED (Weight loss). On an unknown date, the patient experienced TREMOR (Shaking legs/ Tremors in hands) (seriousness criterion disability), LIMB DISCOMFORT (legs buckled) (seriousness criterion disability) and ANXIETY (anxiety). On 04-Apr-2021, CHEST PAIN (chest pain) had resolved. At the time of the report, TREMOR (Shaking legs/ Tremors in hands), LIMB DISCOMFORT (legs buckled), FALL (fell to ground), ANXIETY (anxiety) and WEIGHT DECREASED (Weight loss) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) Normal. In March 2021, Computerised tomogram: normal (normal) Normal. In March 2021, Weight: 148 (Inconclusive) Inconclusive. On 06-Apr-2021, Weight: 125 (Inconclusive) Inconclusive. On an unknown date, Blood pressure measurement: elevated (High) BP Elevated. On an unknown date, Heart rate: elevated (High) Elevated. The patient underwent CAT scan of the stomach, complete gastro work-up and complete blood work up. All tests were result normal. On 3 Apr 2021 he experienced severe chest pain and was transported to the hospital they concluded it was not heart related but he was hospitalized overnight. His BP and heart rate were also elevated. Concomitant product use was not provided.Treatment information was unknown. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

stated that he had a reaction that started 13 days after his second dose of the moderna vaccine. She states he had fever, chills, headache, and could not get out of bed. The fever, chills and headache lasted about 4 days. She states his strength did not return for about a week.

Ankle swelling with extreme foot pain(has neuropathy) No symptoms in 15 minutes after injection on both injections After the second injection had complaints of being shaky, not feeling well with generalized weakness

Dyspnea and fatigue and low back pain starting 4/26. Seen at Urgent Care 5/1 and recommended to go to ED for ACS rule out. Declined. Followed up on 5/3 with persistent dyspnea, no hypoxia or tachypnea but visible increased work of breathing in office.

Pt reports with the 1st dose he had little bit of pain in his arm which went away the next day. With 2nd dose the symptoms did not occur until March sometimes, pt. experienced pain the in right shoulder which then travels to the left shoulder, down his legs and groin area. Pt reports he cannot turn in bed bc everything was hurting especially his hip and arms. Pt reports it was hard to lift his arms "feels like someone was pulling out my arms", had difficulty tying his shoes or picking anything up. The pain run down his spine and radiate to his right leg "hurt to even talk about it". Currently he is experiencing very little muscle pain in his left shoulder. Pt reports he had tried Tylenol and Ibuprofen but that did not provide him with any relief. Pt had been seen by PCP

Lost the function in right side/ could not write; Tremor; Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid; Hematoma on the left side of the brain/ slight hematoma on the right side of his brain; Could not hold anything at all in right hand even a spoon, almost like he had a stroke; Dragging right foot; Headache; Total fatigue; Totally wiped out, took everything out of him to go to the bathroom; Could hardly get up and had no control in his fett; He was not acting right; Something going on with his eye, movement to the eyes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBRAL HAEMATOMA (Hematoma on the left side of the brain/ slight hematoma on the right side of his brain), MOBILITY DECREASED (Lost the function in right side/ could not write), TREMOR (Tremor), CRANIOTOMY (Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid) and LOSS OF CONTROL OF LEGS (Could hardly get up and had no control in his fett) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 pneumonia on 03-Nov-2020. Concomitant products included FINASTERIDE. In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CEREBRAL HAEMATOMA (Hematoma on the left side of the brain/ slight hematoma on the right side of his brain) (seriousness criteria hospitalization prolonged and medically significant), CRANIOTOMY (Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid) (seriousness criterion hospitalization prolonged) and EYE MOVEMENT DISORDER (Something going on with his eye, movement to the eyes). On 20-Apr-2021, the patient experienced FEELING ABNORMAL (He was not acting right). On 22-Apr-2021, the patient experienced LOSS OF CONTROL OF LEGS (Could hardly get up and had no control in his fett) (seriousness criterion medically significant) and ASTHENIA (Totally wiped out, took everything out of him to go to the bathroom). On an unknown date, the patient experienced MOBILITY DECREASED (Lost the function in right side/ could not write) (seriousness criterion hospitalization prolonged), TREMOR (Tremor) (seriousness criterion hospitalization prolonged), MUSCULAR WEAKNESS (Could not hold anything at all in right hand even a spoon, almost like he had a stroke), GAIT DISTURBANCE (Dragging right foot), HEADACHE (Headache) and FATIGUE (Total fatigue). The patient was treated with BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) at an unspecified dose and frequency; PARACETAMOL (TYLENOL) at an unspecified dose and frequency and Physical therapy for Mobility decreased. At the time of the report, CEREBRAL HAEMATOMA (Hematoma on the left side of the brain/ slight hematoma on the right side of his brain) and MOBILITY DECREASED (Lost the function in right side/ could not write) was resolving, TREMOR (Tremor) had resolved, CRANIOTOMY (Drilled a hole to put a drain into his head and got 9 milliliters of blood/ drill another hole and drained 7 milliliters of fluid), LOSS OF CONTROL OF LEGS (Could hardly get up and had no control in his fett), MUSCULAR WEAKNESS (Could not hold anything at all in right hand even a spoon, almost like he had a stroke), EYE MOVEMENT DISORDER (Something going on with his eye, movement to the eyes), FEELING ABNORMAL (He was not acting right), GAIT DISTURBANCE (Dragging right foot), ASTHENIA (Totally wiped out, took everything out of him to go to the bathroom) and HEADACHE (Headache) outcome was unknown and FATIGUE (Total fatigue) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Magnetic resonance imaging: abnormal (abnormal) Hematoma on the left side of the brain. On 20-Apr-2021, Scan: hematoma reduced in size No hematoma was present on the base of the spine. On 22-Apr-2021, Scan: improved Scan showed improvement. Patient stayed in the intensive care unit for 5 days then in critical care unit for 1 day and then sent home. On 20 Apr 2021 patient was again taken to Emergency Room. They gave him pain medicine which helped with the headache and send him home. On 22 Apr 2021 patient was again taken to hospital due to some conditions along with fatigue. and given medication for sleep. On 18 May 2021 the patient was seen by the neurosurgeon. Hematoma did not go away by now. Patient is in physical therapy to regain the use of his hand, can write now, sensory issues have cleared up. 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.

Soon after 1sr injection, experienced dizziness, fatigue. Within hours of 2nd shot, experienced loss of appetite; Fatigue; Confusion; Nausea; he fell several times; lack of grooming was noted.

Really bad headache first 3 days Horrible Chills still ongoing Disoriented and almost like hallucinations Most interesting randomly talking to himself. I mean like a full conversation with someone that isn?t there. He also sometimes feels like when holding something he doesn?t see it or feel it and drops it or vice versa ?.. thinks holding something and isn?t Balance is off Shortness of breath No fever thank goodness and taste and smell are normal

With in 10 min after shot I began to feel flush and my tee shirt became wet . Felt sweat heavily even wit car AC on. Felt out of sync. On-site nurse took me to emergency room and gave me a bed . Headaches starte. Nurse practice right stayed with me ,took vitals and said she heard heart murmer. Never been told I had a heart murmer by my heart doc. After an hour and a half I felt a little better. Drove home went to bed early - stil had headache and felt week. Sept well. Woke up in am with headaches and physically weak.Waiting on my doctor to call.

Patient received casirivimab instead of intended COVID vaccine. At 48-hour follow up, patient reported Soreness to arm, fever of 99.9 and high blood pressure. Wife thought he was anxious. Follow up 2 hrs later and next morning, he reported he was "fine". Received COVID vaccine on December 31

As a 1a health provider I received my vaccination a weekend half ago resulting in dizziness, difficult mentation eg, administering my clinic, headache, a firey, red, rash over 90% of my upper body and 30% of my lower body, joint pain and muscle ache, worsening So far all the medical help I have received advices cortisone for the itch but I am really trying to understand what I need for my immune system and should I, or should I not get the 2nd dose

Weak; Collapsed; Delirium; Night sweats; Chills; Discomfort; Did not sleep at all that night; A spontaneous report was received from a physician, who was also an 80-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, chills, discomfort, night sweats, did not sleep at all, delirium, collapsed, and felt weak. The patient's medical history, as provided by the reporter, included type II diabetes, diabetic neuropathy, heart failure, acid reflux, and urinary retention. Concomitant medications included metformin, gabapentin, furosemide, spironolactone, omeprazole, and tamsulosin. On 06 Jan 2021, hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On the evening of 06 Jan 2021, hours after vaccination, the patient began feeling chills and discomfort. Overnight he began to experience night sweats and did not sleep at all. During the night on 07 Jan 2021, the patient experienced night sweats and had delirium. When he tried to get out of bed, he collapsed. No treatment information was provided. On 11 Jan 2021 and 12 Jan 2021, the patient began to feel better. He no longer had night sweats or delirium. He returned to his exercise routine at about 50 percent of what he normally did although he continued to feel weak. Action taken with mRNA-1273 in response to the events was not provided, although the patient reported he was not sure if he would take the second dose. The outcome for the events, night sweats and delirium, was considered resolved. The outcome for the events, chills, discomfort, did not sleep at all, and collapsed, was considered resolving. The event, weak, was considered not resolved. The reporter assessed the events, chills, discomfort, night sweats, did not sleep at all, delirium, collapsed, and weak, as related to Moderna's COVID-19 vaccine due to feeling well before the vaccine and feeling more or less disabled after receiving it.; Reporter's Comments: This case concerns a 80-year-old, male subject with medical history of type II diabetes and diabetic neuropathy, who experienced a serious unexpected event of delirium and non-serious unexpected event of asthenia, discomfort, insomnia, fall, and night sweats, and non-serious expected event of chills. The event of discomfort, insomnia, chills and night sweats occurred 1 day; the event of delirium, and fall occurred 2 days and asthenia occurred 6 days after mRNA-1273 administration. The subject was on metformin for diabetes ty II and gabapentin for diabetic neuropathy, Lasix and spironolactone for heart failure, omeprazole for acid reflux and Flomax for urinary retention. Treatment details not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

blurred vision chills white hands fever muscle pain confusion swelling and redness in limbs headache

wife called this morning at ~ 9:00 a.m. to report that he woke up with a fever of 101, has been throwing up, is dizzy and disoriented since he woke up this morning. I advised that he remain seated or lying down, to give Tylenol per dosage on pkg/bottle. To call 911 if symptoms worsen. Wife stated that did have COVID infection in Sept. 2020. He walks with walker. I called wife back at 1:50 pm. States took Tylenol, fever went down to 99, and he has been able to keep small amt of fluid down. He has remained seated to avoid risk of falling. Wife has him urinating in bucket. Re-emphasized calling PCP to consult, or 911 if symptoms worsen. To continue Tylenol per pkg instructions. Wife voiced understanding.

NURSE WAS CALLED TO FACILITY. PT WAS NOTED TO BE MORE CONFUSED THAN USUAL. HE TOLD NURSE THAT THINGS WERE "FLYING THROUGH THE AIR". HE DID HAVE 2+ PITTING EDEMA TO BLE(NEW TO HIM). HE DID THINK THE DATE WAS MARCH 4, 2091. LEFT EYE ALSO SLIGHTLY RED/SWOLLEN. VSS AT THIS TIME. MD NOTIFIED. CG INSTRUCTED TO MONITOR FOR WORSENING EDEMA, INCREASED SOB, INCREASED CONFUSION/HALLUCINATIONS.

Started shaking violently at 8 p.m., Cold but not feverish. Went to bed and slept for next 24 hours. Got up with help to go to bathroom. Very weak. Had bowl of soup next day at 8:00 p.m. and returned to bed. Slept another 12 hours. Felt better. Gradually regained strength. No further reaction.

Swelling and redness at site, nightmares several nights, fatigues, had labs done today and has appointment with MD 2/11.

Was vacinnated with first shot on 01/17/2021 at 1:30 PM and had no side effects until the next morning and had some fatigue which passed after the first day. Had second shot on 02/14/20121 about 12:30 PM. No side effects the afternoon, and during the night. The next morning had fatigue and headache so rested and eventually by end of day went away, 1 day passed all OK but on 02/17/2021 had severe headache and loss of all balance, equilibrium, and was very dizzy and lasted all day. Standiing up I would have to prop myself or hold onto furniture, By next day, began to regain balance and by end of day, was able to walk balancing with cane. With the dizziness came halicunations at times, especially if laying down.

Next day confusion, problems with balance and inability to walk, mumbling speech, scattered thought, unable to follow or understand speech which lasted 24 hours and resolved spontaneously without medical intervention.

Loss of taste, smell, brain fog. Am not currently being treated. Side effects began the next day after my 2nd dose on March 1st.

Pt here with concerns of numbness and tingling of his body since his COVID vaccine. He had it on 2/3 in his R deltoid. He notes started to feel bad on 2/6. He went to urgent care and was told that he probably had TIA. He came into clinic that next week and I ordered an MRI of his brain. MRI brain showed senescent changes and mastoid congestion, but no evidence of stroke/acute event. His symptoms started with R hand numbness (R thumb and R index finger), then progressed to R leg and arm numbness, R facial numbness with trouble speaking, which he describes as feeling like he had a lidocaine shot at the dentist. He denies any acute illness at that time, but did sleep alot more. Currently the only symptom he has left is R index and thumb numbness as well as feeling like the R side of his face feels different than the L.

Day 1 following shot - slept all day Day 2 headache, chills, low grade fever 99.7, sharp pain on side of head every 20 seconds Day 3 headache, chills, sharp pain on side of head every 20 seconds; Significant upper lip swelling started at noon. Still swollen at same level at 7pm. No additional swelling .

Mental confusion, delusional thinking, crawling on floor for hours; lifting, moving, breaking heavy furniture; unusual physical strength. Paranoia, fear of being killed. Beligerant, combative behavior. Constant motion for over 24 hours. Less than 3 hours total sleep in 48 hours (minutes at a time) There are more details. Resulted in Police being called, ambulance transport to hospital ER. Admission to hospital on 3/16/21. Still there. Sedation for combative behavior. Lumbar puncture re spinal menigitis or brain infection. Aspiration. 10 L O2.

Sudden onset of memory loss while paying for gasoline. Had been driving and stopped for gas. Paid and then couldn't recall where he was or what he was doing. EMS responded and transported to Hospital.

1. Inability to sleep after doses of Xyrem. 2. Loss of Consciousness ×3. 3. Falls x3--injuries to RIGHT arm, and lower back. 4. Confusion 5. Loss of Time Awareness 6. Reduced breathing, alamingly, during sleep 7. Clamminess; cold extremities 8. Shortness of Breath Lasted approximately 12 hours into March 21, 2021.

Pneumonia; Feeling weird; Stomach problems; Sinus problems; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Ulcers aphthous oral and Hernia. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling weird), ABDOMINAL DISCOMFORT (Stomach problems) and SINUS DISORDER (Sinus problems). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), FEELING ABNORMAL (Feeling weird) and SINUS DISORDER (Sinus problems) outcome was unknown and ABDOMINAL DISCOMFORT (Stomach problems) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient became lethargic, increasingly suffered from delirium & hallucinations, leading to inability to walk. ER visit resulted in no explanation. Took him off meds, patient returned to normal, added them back one at a time. After adding Metformin, delirium began again so took him off medication again & he again returned to normal. Doctors didn't prescribe new meds for diabetes, so Metformin was again re-added to control blood sugar, & again delirium and hallucinations began. Patient had no issue with medication prior to 2nd dose of vaccine. This occurred between 2/9/21 to currently. He was recently in hospital after a car accident and was mistakenly given Metformin again, symptoms resumed and he's still recovering.

0200/02/26/2021 awakened by being EXTREMELY cold as if laying in snow - nude, Attempted to crawl to bathroom. Was not strong enough. Pulled my way up to a standing position and slowly and unsteadily got to bathroom for water, then to a mountaineering clothes storage closet and put on warmest down trousers and jacket. Stumbled back into bed and fell immediately asleep. Slept12 hours during daylight on 02/27/2021 0215/02/27/2021 Awakened by being EXTREMELY HOT and soaked in sweat. I was wearing normal bed clothes. Able to walk to bathroom for two glasses of water then returned back to bed, I could not get into bed, falling once even with wife assisting. Fell immediately asleep once comfortable in bed. Wife had changed sheet. It did not occur to us to take my blood pressure (we have a battery operated BP device) nor my temperature. Upon waking I was just a little weak and able to continue normal activities fully recovered.

Severe chills, fever (99.6+ F), lasted about 60 min., treated with 500ml APAP.. Accelerated heart rate (~105), ache at injection site persisted overnight. Difficulty sleeping. Mild cough from onset of symptoms until present.

Flu again after second vaccine dose; Pulse oxygen level dropped to 75 after second vaccine dose; Hard time breathing after second vaccine dose; Lungs had fluid after second vaccine dose; Horrible mouth sores after second vaccine dose; Very weak after second vaccine dose/No energy after second vaccine dose; Patient feels like he was hit by a big truck; Trouble sleeping at night; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of INFLUENZA (Flu again after second vaccine dose), HEART RATE DECREASED (Pulse oxygen level dropped to 75 after second vaccine dose), DYSPNOEA (Hard time breathing after second vaccine dose), PULMONARY OEDEMA (Lungs had fluid after second vaccine dose), STOMATITIS (Horrible mouth sores after second vaccine dose) and ASTHENIA (Very weak after second vaccine dose/No energy after second vaccine dose) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history was provided.). In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced INFLUENZA (Flu again after second vaccine dose) (seriousness criterion hospitalization), HEART RATE DECREASED (Pulse oxygen level dropped to 75 after second vaccine dose) (seriousness criterion hospitalization), DYSPNOEA (Hard time breathing after second vaccine dose) (seriousness criterion hospitalization), PULMONARY OEDEMA (Lungs had fluid after second vaccine dose) (seriousness criteria hospitalization and medically significant), STOMATITIS (Horrible mouth sores after second vaccine dose) (seriousness criterion hospitalization), ASTHENIA (Very weak after second vaccine dose/No energy after second vaccine dose) (seriousness criterion hospitalization) and INSOMNIA (Trouble sleeping at night). On an unknown date, the patient experienced FEELING ABNORMAL (Patient feels like he was hit by a big truck). The patient was hospitalized from 13-Mar-2021 to 16-Mar-2021 due to ASTHENIA, DYSPNOEA, HEART RATE DECREASED, INFLUENZA, PULMONARY OEDEMA and STOMATITIS. At the time of the report, INFLUENZA (Flu again after second vaccine dose), HEART RATE DECREASED (Pulse oxygen level dropped to 75 after second vaccine dose), DYSPNOEA (Hard time breathing after second vaccine dose), PULMONARY OEDEMA (Lungs had fluid after second vaccine dose) and STOMATITIS (Horrible mouth sores after second vaccine dose) had resolved, ASTHENIA (Very weak after second vaccine dose/No energy after second vaccine dose) and FEELING ABNORMAL (Patient feels like he was hit by a big truck) outcome was unknown and INSOMNIA (Trouble sleeping at night) had not resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: normal (normal) normal. No concomitant medications were provided. Treatment medications included anti-herpes and mouth wash for mouth sores. Action taken with mRNA-1273 in response to the events was not Applicable. Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-078124 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, excluding other etiologies causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-078124:Case for patient 1

3 days post vaccination resident had increase confusion, new hallucinations, combative behavior. UA, blood work, CT of head, negative for acute findings, Hospital stay x 2 occurrences, including psychiatric evaluation. Follow up with neurologist pending .

Sudden Onset Atypical Parkinson's diagnosed by neurologist. Symptoms began in early to mid March and progressively got worse. Posture & Balance, Mental Confusion, Thinking difficulty, Dexterity, Speech changes, Writing changes, Tremor, Emotional changes, Swallowing problems, Fatigue.

trouble with breathing, breathing difficult, " my breathing went to hell"; Could not sleep; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included APIXABAN (ELIQUIS) and DOXAZOSIN for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") (seriousness criterion hospitalization). On an unknown date, the patient experienced INSOMNIA (Could not sleep). The patient was treated with ALBUTEROL [SALBUTAMOL] at an unspecified dose and frequency. At the time of the report, DYSPNOEA (trouble with breathing, breathing difficult, " my breathing went to hell") had not resolved and INSOMNIA (Could not sleep) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. The patient stated that two weeks after the vaccination he went to Emergency room due to breathing difficulty and was admitted. He reportedly spent two days in the ICU. The patient continued to have trouble and did not get the second dose due to the breathing difficulty he experienced. The patient reported that he could not sleep since he could not breathe. Additional concomitant medications included heart medications and heart burn medications. Treatment medications included an Albuterol inhaler. This case concerns an 80-year-old male hospitalized with a serious unexpected event of dyspnea, and nonserious unexpected event of insomnia. Patient treated with antibiotics. Event latency 15 days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Case upgraded to serious, Patient demographics updated, additional event reported (could not sleep).; Sender's Comments: This case concerns an 80-year-old male hospitalized with a serious unexpected event of dyspnea, and nonserious unexpected event of insomnia. Patient treated with antibiotics. Event latency 15 days after mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Symptoms start evening 2-1-2021 slight fever 2-2-2021 fever 99.6 muscle pain legs 2-3-2021 fever 99.7 extreme muscle pain whole body, headache, difficult to sleep, aspirin, Tylenol did not help 2-3-2021 fever 99.9 extreme muscle pain whole body, headache, difficult to sleep, aspirin, Tylenol did not help 2-4-2021 fever99.4 muscle pain whole body easing 2-4-2021 fever, pain gone called Urgent Care, told to take Tylenol did not see a doctor, under lock down in this state,

Received dose 2 of Moderna vaccine on 3/11/21. Symptoms worse after 2nd dose, and on March 31, 2021 get worse. On April 4 at church, became very hot and weaker and weaker. Came home and put him to bed and slept some. At lunch time, ate a bite of jello and sipped 7 up and said he did not feel very good. Took an Alka Seltzer for heart burn, but it did not help. Went to sleep. Wife unable to waken him later that day. Died 4/4/21.

The clinic gave me the shots --But the doctor at Medical Center checked by hearing losss. Shoulders hurt very bad and could not sleep on side. Still hurt now. My hearing went bad between my two shots. I did have hearing add's but after shots it really got bad and Doctor says I am a candidate for hearing implants now.

Starting on 1/2/2021 patient started experiencing intermittent tremors of upper /lower extremities that have been impacting on his mobility including transfers, ADLs and eating. Staff has now given the resident cups with lids to decrease spilling with meals. Provider was updated on resident's condition on 1/5/2021. On interview on 1/6/2021 resident stated he was feeling better, less tremor. Still felt unstable with transfers. Was able to eat and drink normally 1/6 and 1/7/2021. On exam on 1/6/2021 no tremor seen with rest or movement. In update from nursing staff 1/7/2021 no tremor noted, back to baseline. Had been on Losartan K 25 mg daily which was d/c'd 1/6/2021

Presented to Urgent Care for weakness and confusion, transferred to ED, patient had a cardiac arrest and was unable to be resuscitated

Muscle twitching, lost balance and fell in the bathroom and couldn't get up for 15 minutes, extremely dry mouth, stated he kept feeling like his body was "pulling to the right".

36 hours after vaccination, the patient had increased respiratory distress. He was placed on high flow nasal cannula oxygen with mild improvement. He then continued to be hypotensive requiring IV fluids and subsequently IV vasopressors. Patient's BP was stabilized with vasopresor, however he continued to deteriorate clinically with altered mental status and lethargy, concerned for bowel peroration based on physical exam by MD. He was then emergency intubated and placed on mechanical ventilation. He was then transferred to acute care hospital near by.

We are not sure if this is because of the vaccine, but we haven't found anything else. On January 27 my husband who has had mild Alzheimers Disease for 3 years, woke up completely confused and disoriented. He is still in a vastly changed mental state that came on suddenly.

T 99.8, R 44, O2 94%, Pulse 132, Bp 199/82. Patient lethargic, confused, weak. Sent to local ED, and ED reported resident had MI and was transferred to another hospital for further workup. Patient tested positive for Listeria in urine at local ED as well, which may have contributed to this reaction.

Patient receives home health, the home health nurse came to patient's home and gave the vaccine. By the next morning he had sore arm and minor weakness. The Sunday 1/31/2021 he was fine till that evening around 6PM he became confused and experienced memory loss. That lasted all evening until he went to bed. The morning when he woke up he seemed okay.

The first day, he did not feel real good, felt weak. On Saturday had fever, no appetite. Sat down and couldn't get up, joint pain had no balance. The fever kept going and down. Felt weak, didn't feel like moving and slept most of the time. Felt better on Sunday, a little weak.

On February 11, 2021 around 10:15 am, patient was given the Moderna brand COVID-19 vaccination. After his vaccination, he was instructed to wait around for 15 minutes after the administration of the vaccine. During this time, there were no reported issues with the patient. On February 15, 2021 around 9:15am, patient's wife called the pharmacy and spoke with the pharmacist informing her that patient had passed away in his sleep on Saturday evening. Patient's wife inquired about whether death may have been caused by an adverse reaction to the vaccine. During the call patient's wife mentioned that patient slept a lot the day of the vaccine and the day after. patient's wife mentioned that patient woke up Saturday to eat breakfast and lunch. She states that later that evening, she found patient asleep and cold which she then realized that he'd passed away.

Shaking terrible for like 18 hrs about 24 hrs after shot, vomiting, diarrhea, disoriented. A week later he is very weak. Has decided not to do the 2nd shot

Patient presented to ED due to AMS, syncope. Wife reported that he became confused with generalized weakness and dropped his food on the floor and became unresponsive with his eyes and mouth open. Patient was febrile to 103 on admission w/o leukocytosis. He was admitted to hospital medicine for acute encephalopathy with associated loss of consciousness. Neurosurgery consulted but no neurosurgical intervention needed. Patient improved & discharged home 2/24/21.

Patient admitted for fatigue, dry throat, generalized weakness, dyspnea on exertion. Durion hospitalization was identified to have an acute ischemic CVA -- unclear time of symptom onset, possibly evening of 2/9 or morning of 2/10. Time course suspicious for possible COVID vaccine adverse event. He received his first Moderna COVID vaccine on 2/2/21 per WIR. Per PCP note on 2/9/21: Patient is here today accompanied by his wife with concerns for fatigue, headaches, head pressure and tremors. Received vaccine last Tuesday. Around 10 PM that evening he developed pressured in the head. On Wednesday morning, he states he got out of bed and was in a cold sweat - he states he pajamas were soaked in sweat and he felt chilled. He experienced brief numbness of the left arm down to his fingers. On Thursday, he felt fine - he went out to snow blow. Friday he developed headaches and head pressure. At night, he felt his breathing was labored as he was "gasping for air." On Saturday and Sunday, he sat and laid around all day. On Monday, he wakes up at 125 AM and his blood pressure was 165/104 and it remained elevated for 3 separate readings. Patient was then admitted on 2/10/21 with weakness and confusion, then on 2/11 MD noted ?word finding difficulty, slurred speech, possible subtle right upper lip droop, and possibly some mild right hemineglect? with MRI showing likely embolic source of infarcts and cerebral MRA with possible acute thrombus. His symptoms the day after the vaccine seem a bit suspicious for TIA. Per Drug Policy Manager call to Moderna, no current reports of TIA/stroke secondary to COVID vaccine, so time course may be incidental. Patient had echocardiogram without right to left shunt or clot identified, no known history of atrial fibrillation. Was monitored on telemetry for the duration of his hospitalization without any noted arrhythmias, discharged on e patch for 14-day outpatient monitoring.

2/28/21 Patient presented and was admitted through the emergency department for confusion, weakness, and low grade temperature (100.1 F). On admission, pertinent labs were Hgb of 5.1, WBC 60k which was consistent with autoimmune hemolytic anemia (AIHA).. Patient was diagnosed with chronic lymphocytic leukemia in 2016. The patient has had a prior history of AIHA in 2017. Per the Agency, hospitalizations are to be reported irrespective of attribution to vaccine.

Blood pressure went down until he died; Couldn't hear his heartbeat; neck was sweating; He was cold; Couldn't get up; Death; Sick; immediately very tired; he was tired; Hands were shaking; Slept for too long; A spontaneous report was received on 18 Feb 2021 from a consumer concerning a 81-years-old, male patient who received Moderna's COVID-19 vaccine and developed immediately very tired, hands were shaking, neck was sweating, was cold, sick, couldn't get up, couldn't hear his heartbeat and blood pressure went down until he died. Patients' medical history, as provided by patient's spouse, was emergency room(ER) admission in November 2020 because he had a congested chest (he had fluid around his heart). At that time, they gave him pills for kidney function. Other concomitant medication reported was Coumadin, blood thinner. Two weeks before receiving the vaccine, patient's EKG was normal. On 11 Feb 2021, in the morning, patient received their first of two planned doses of mRNA-1273(BATCH/LOT # 007M20A) probably in the right arm for the prophylaxis of COVID-19 infection. On 11 Feb 2021, approximately after 15 minutes of receiving vaccine, they left and patient was immediately very tired, his hands were shaking. So, patient's spouse made them down sleep for too long. On Friday, 12 Feb 2021 she tried to pick him up, but he was tired, exhausted, and sick. On Saturday, 13 Feb 2021, she brought him a coffee and he couldn't hold it because his hands were shaking, so she gave him the coffee and then made him pee on the bed because he couldn't get up. At lunch time she made him eat something and he fell sleep again. His wife was hanging around him all day and around 7:30pm she realized that he was cold, and his neck was sweating, she couldn't hear his heartbeat. So, she called emergency services and when they arrived, her husband's blood pressure went down until he died. Treatment for the events were not provided. Action taken with mRNA-1273 was not applicable. Patient was pronounced dead on 13 Feb 2021 20:00. The cause of death was not provided. The plans for an autopsy were not provided. The events of blood pressure went down until he died and couldn't hear his heartbeat were fatal. The outcome for the remaining events were unknown.; Reporter's Comments: This case concerns an 81 year old, male patient, who experienced a serious event of death among others, 2 days after receiving mRNA- 1273 (Lot# 007M20A). Very limited information regarding this event has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

Shot taken 9:30AM 2/25/21 DaQuil taken around 3:30PM Chills, violent shakes. Around 6:00PM 911 called , EMT arrived I did not know birthdate, where I lived, date, or where I was. Transported to ER do not remember any part of the trip or arriving at the ER. Bright red circle around shot with fever still have 3/4/21 plus sore.

Per neurology consult: "Patient was at his baseline until when he received his 2nd dose of SARS-CoV-2 vaccination. He complained of dyspnea and fear of impending doom after waking up the following morning with some disorientation. He was found to be in AFib with RVR after it was brought to ER the following morning and the rhythm was converted to normal sinus rhythm. Patient continues to have confusion after admission yesterday that seem to get worse today to the point where he did not know his own name or birthdate, and seemed to have global amnesia. Patient has been more drowsy this afternoon after receiving lorazepam 1 mg IV for potential seizure activity so no reliable neurologic exam was obtained. Patient remains afebrile with pulse ox in the low 90s on 4 L of supplemental nasal oxygen in the hospital. He had moderate decrease in kidney function upon admission that has improved. He has baseline anemia with hemoglobin at around 10. Incidentally patient had shingles in the right thoracic dermatome week ago for which he received valacyclovir.

arm could hardly be raised in evening and had large lump at injection site, woke up around midnight with bad chills, felt feverish and dizzy. Stayed in bed and slept pretty much until 2:30 when was woken up by wife. around 11:00am on 03/05/2021 face looked swollen and still feverish and dizzy. Wife called the hospital and spoke to a nurse who wanted him to be woken up to check facial swelling and advised going to a walk in clinic or emergency room. face looked better so did not go, he went back to bed around 7:00 p.m and the next morning on 03/06 still felt light headed and not normal. Today 03/10/2021 still doesn't feel right still some light headedness, just not normal at all.

ANAPHYLACTIC NEUROLOGIC SYMPTOMS INCLUDING HALLUCINATIONS DEVELOPING WITHIN 7 DAYS OF VACCINATION, SECOND DOSE NOT ADVISED BY CDC, SECOND DOSE DUE 3/12/2021, SECOND DOSE NOT ADMINISTERED AND DOCUMENTED AS ANAPHYLACTIC REACTION TO FIRST DOSE

Pt reported that he start sweating and could not understand what TV saying - he was very confused. He is living alone. He called 911 and 911 came to his home and checked him. Once they arrived at his home, he started feeling better. His blood pressure was normal per patient. He thinks they didn't check his temp. He told me once I asked him if he has any heart problem. He has 4 stents and he thinks he had similar problems about 4 months ago.

Moderna Covid-19 Vaccine EUA After receiving the first vaccine, started making gasping noises at night, lethargy, fit bit would not register sleep at night, some breathing issues during waking hours. HR observed to decrease to under 40 over the last week of his life. 5 days after 2nd vaccine had extreme fatigue, nightmares, forgot to take regular meds in the morning, 6 days after he woke up very confused and had nightmares and 7 days after vaccination woke up late, exhausted, with shortness of breath all day and refused to go to ER. Went to bed early and died in the night with his CPAP machine on.

hypertensive ermergency/ encephalopathy causing acute confusion, Narrative: Admitted for acute confusion related to hypertensive emergency one day following second dose of COVID-19 vaccine. Hospital notes reviewed. No correlation with COVID vaccine noted as a concern per providers. Reported given timing of vaccine + hospitalization. History of HTN. Recent diagnosis of lacunar stroke (between COVID-19 vaccine dose 1 and 2).

81 y/o male patient was vaccinated 3/3/21 and died 3/6/21. Patient's wife reported he was having "some trouble breathing" but could not remember whether this problem started before or after being vaccinated.

About 20 hours after the (2nd) shot I got up from my chair after watching the 6:30 PM News and walked about 4 steps and had a breathing "seizer." I could not get any oxygen and in a near panic tried to hyperventilate. After 45 sec I was able to walk another 4-10 steps but the seizer occurred again. Took me 5 minutes to get from the living room to the kitchen and then another 5 to get to the bedroom. In the morning I was reasonably "fine." but then had flu like systems for 1.5 days and then was totally over it all.

nausea, vomiting, diarrhea, change in mental status, and generalized weakness about 36 hours from time of vaccine. Initially treated with supportive care. He returned 5 days later with continuing symptoms plus headache and was diagnosed with a intracerebral hemorrhage.

He received the vaccine on 3/4/2021 and by Monday morning 3/15/2021 he was running a fever and not feeling well. Fever continued until Friday March 19 when he went to the dr. Dr did a lung xray and said he had cloudiness on his lungs so she started antibotics. On March 22 he was brought to the ER because he was too weak to walk and wasnt feeling well still had the fever. The switched his antibotics and he went home. On March 24 he was rushed back to the hospital via the ambulance and they admitted him. He stayed in the hospital until March 30 when they finally let him leave to a care center. He had finally not had a fever. Had confusion and weakness. The confusion comes and goes from day to day sometimes min to min.

Patient received the Moderna covid vaccine on 3/11/2021. Starting the day after that, the patient's wife reported that the patient began to display confusion, weakness, and fatigue. The patient also presented to the clinic on 4/2/2021 with complaint of "sinus pressure" and was prescribed an antibiotic. He progressively worsened to the point where he was only able to speak a few words, and presented to hospital on 4/7/2021. Given extremely low platelet count on presentation, a diagnostic workup for TTP vs. ITP was commenced. It was determined by the inpatient hematology/oncology service that the patient was likely experiencing alterations in mental status and weakness and thrombocytopenia due to TTP. Fresh frozen plasma was administered. Plasma exchange daily x 5 days and corticosteroids were initiated.

sudden high fever (101-104) sudden confusion sudden extreme exhaustion sudden extreme leg weakness (couldn't walk) pneumonia kidney infection

Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 81 and presented to the ED w/ altered mental status on 2/18/21 after receiving COVID vaccine on 2/16/21. Patient was also previously admitted earlier that month for a retroperitoneal hemorrhage that had similar presentation of altered mental status. CT this admission showed a new CVA. He was eventually transferred to the ICU for nonconvulsive status epilepticus and eventually transitioned to hospice care after further decline in status. Wife elected to stop dialysis and he passed away on 3/23/21. Comorbidities include ESRD on dialysis, CVA, DM, prostate cancer.

fever, lack of energy and queasy stomach (did not feel like eating which means I am sick). Slept 2 hours during day after 11am and then slept about 10 hours that night, Next morning I felt fine. I also had same reactions to both Shingrex vaccinations in the last 4 years but not as severe the reaction to Moderna. Also no reaction to first Moderna vaccination

Patient ran fever the day after shot, Saturday, didn't take temp Sunday or Monday. Tues evening the patient felt tired, Wednesday patient felt bad and was running a fever of 101.7 that evening. Thursday patient took Tylenol every 4 hours as doctor directed. Friday morning at 7 am his fever was 103.1. I took him to ER. Prior to these events he was in wonderful health.

The injection site began to hurt the evening of the day of the injection. I did not sleep well that night and was generally achy and fatigued the next day. Additionally I had a very dry mouth . By that evening I began to feel better although I was still a little tired but by the next day began to feel normal. The injection site is still tender (day 3) but getting better.

Night terrors, vivid, confusing, and terrifying dreams. Animals, bugs, etc. Occurs everynight since vaccine at about 4 AM

Adverse Event - High temperature, too weak to stand and walk, confused Treatment - Taken to hospital by ambulance - hospital treatment unsure ( 1 over night stay) Outcomes - continued pain in his neck, ?fuzzy? head, and dizzy 11 days after vaccine

Began experiencing cold sweats, felt awful, a bit sick to my stomach, slight headache. It lasted about 30 to 45 seconds.

Severe shoulder joint pain(level 9) first night following injection, unable to sleep. Second night some sleep with pain medication. Third night(last night ) some sleep without pain medication. Pain located deep in arm/shoulder joint. Getting better each day, still painful lifting arm straioght up or swing out. WHERE SHOULD I GET MY SECOND INJECTION?

Ten hours after I had a Severe allergic reaction. My eyes were itching and watering. I was incredibly nervous and anxious. I couldn't relax or sleep. NO SHOULDER OR ARM PAIN. Swelling and puffiness in my face ( eyes, nose, and sides of my head). I was fine the next day.

constant dizziness and headache; pain and stiffness in arms, shoulders, and neck; occasional numbness in both arms; tightness in the chest, brain fog

Extremely SOB around 1AM...tremors in arms & legs. Did not respond to any options available, oxycodone, Ventolin, Nebulizer, for approximately 2 hrs. Couldn?t get air in or out. Did not call 911 because he didn?t want to die in hospital. Gave Boost drink & sipped on drink for dehydration. Breathing finally calmed a bit. Oxygen now at 84-92. Extreme weakness, arm has big red blotch. Next day still extremely weak & SOB. Must use walker & assistance getting to bathroom. No appetite. Can?t dress, cook, or anything. 6 days later, still weak, low appetite, has to double up on Nebulizer.

EXTREMELY extremely WEAK. - he had to use wheelchair to move, and fell off chair. nausea, insomnia. I could not move him and had to call fire deparment. They said his extreme weakness was concerning and took him by ambulance to hospital.

2/13 0800 Post second vaccine. Weak, dizzy, unable to walk per self as usually does. SBP 80 when getting up to use commode with diarrhea. Syncope lasting approx 15 seconds. Came to et was oriented X3 at that time but having times of confusion. Staff reports pt felt weak and same way after first Covid vaccine. Encouraged hydration, bed rest, use of stand aide for use of BR. Gave Claritin 24 hour tablet. Held lisinopril. 2/14 @ 10 am. Feeling some better, mostly oriented with episodes of intermittent confusion. Drank lots of fluids over past 24 hrs. SBP 99. Continued with some diarrhea. Held lisinopril et gave another Claritin 24 hr. Tablet and encouraged hydration. Monday 2/15. SBP. 114/51. Gave Claritin 24 hour tablet and held lisinopril. Encouraged fluids. Feeling some better. Not as weak. Denies dizziness. Able to walk some per self. In evening used stand aid. 2/16 dayshift. BP 123/47 et heart rate 78. lisinopril held. Able to ambulated in room with supervision. Mentation at baseline. 2/17 dayshift.: lisinopril held. Ambulation per self in room and hall with supervision. BP 114/59 with heart rate of 57. No confusion. Mentation at baseline.

Patient was found the next morning on the floor, disoriented and weak. Once he was found he became unresponsive. Ambulance was called, low blood pressure was noted. Taken to hospital emergency room from home. Patient recovered after about 2 days

Pt had initial dose of vaccine 2/13/21 and noticed being short of breath/feeling bad the following day. He did not attend rehab on Monday, 2/15/21, as scheduled 2/2 SOB exhaustion. He did attend today, 2/17/21< but 3 minutes into exercise on treadmill he was unable to continue. He recovered quickly, refused clinic visit, and went home.

UTI, urinary/bowel incontinence Narrative: first COVID19 vaccine 1.11.21, ER visit with hospitalization 1.15-1.18.21 for SIRS/Sepsis, initially thought to be urosepsis but post discharge UA and blood cultures were negative; source was not identified. Beyond symptoms listed, patient just reported he "felt terribly bad" prior to spouse calling EMS. VAERS reported by hospitalist as well from the facility where he was treated. He was discharged home with Augmentin for UTI and Physical Therapy for strengthening. Patient follows local PCP and this facility PCP. Responsible physician listed on this form is this provider's facility Medical Director.

Excessive sleeping, hand shakes and had trouble holding spoon and fork. Use walker and could not balance (very groggy). Kept wanting to fall. Had to have wife help to get into bed on Friday night. Saturday was better, but still needed help. Sunday better and today Monday doing better. If Moderna second shot is known to be much worse for side effects, should it be taken?

2/17 first occurrence: symptoms = confused speech, memory impairment diagnosis = TIA 2/20 second occurrence: symptoms = confused speech, memory impairment 2/21: symptoms = confused speech, memory impairment, cognitive difficulty understanding others 2/23: unusual behavior (perhaps due to confusion), difficulty driving (almost hit a parked vehicle and a mailbox; and ran off the right side of the road), agitation (upset, because he considered it a waste of time to visit the ER and have more tests run on 2/23; and also upset that people were "questioning his driving")

Moderna COVID- 19 Vaccine EUA: one day after vaccination patient reported increasing fatigue after flying on an airplane to a high altitude destination. Two days after vaccination patient fell out of bed overnight and awoke confused with a temperature of 104 degrees Fahrenheit. Patient was transferred to another hospital by ambulance, admitted, received antibiotics, but developed acute hypoxemic respiratory failure. Eight days after vaccination patient transferred to intensive care unit at current hospital with acute respiratory distress syndome and bilateral pulmonary infiltrates requiring intubation and mechanical ventillation three days after arrival. Patient remains in the intensive care unit receiving antimicrobials and steroids.

Episode of confusion, fever to 104, and bilateral pulmonary infiltrates consistent with ARDS. Negative infectious diseases workup. Response to steroids. Patient was intubated due to need for supplemental FIO2 100%.

Pt co lightheadedness after covid vaccine. Has waited over 15 minutes. Reports "floaters". Declines water. States" I just don't feel right". BP 120/62, Pulse 67. Denies difficulty breathing or diziness. Pt taken to ER via wheelchair with wife.

slight pain at injection site, extreme fatigue, muscle and joint pain in areas where arthritis had caused discomfort, abdominal pain, one incident of vomiting, and most concerning, I felt "foggy" till March 1.

Passed Out; Felt really bad and weak; Achy in his shoulders and neck; Chills; Temperature started at 99.6 then 100-101F; Burn really bad when he urinated; Traces of blood in urine; Threw up really bad; Fatigue; Joint Pain; Nausea; A spontaneous report received from a Consumer concerning, 82-year-old male patient who received first dose of the Moderna COVID-19 vaccine and experienced a lot of incidences. /MedDRA PT: [Incidences] The patient's medical history included Type 2 Diabetic. Patient's concomitant included Metformin 500mg daily. On 13FEB2021, the patient received their 1st dose of the two planned doses of mRNA-1273 in right arm (Batch #: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. Patient friend stated he got the Moderna vaccine on 13FEB2021 at 2:30pm in the right arm. He urinated fine at church the next day on 14FEB2021. At 2:30pm, Patient friend stated he started feeling bad and weak and could barely unlace his shoes. Patient friend stated that he had achy in his shoulders and neck, and chills. Patient friend stated he is a type 2 diabetic and he thought his blood sugar was very high and took a 500mg metformin (usually takes it once a day). Patient checked blood sugar which was 99 (low for him). Patient friend stated that she gave him apple juice to bring it back to normal. Patient friend stated his temperature started at 99.6F and an hour later it was 100-101F. Patient was told by HCP to take Tylenol. Patient friend stated that he had burning and traces of blood in his urine. Patient friend stated that the second time he urinated; it was less burning. Patient friend stated that he had severe vomiting and passed out. Patient went to bed at 7PM and then at 8:45PM, without the Tylenol, temperature went back to 99.6F. Patient friend stated that he feels completely fine now. Patient friend stated that she only gave him only two 500mg Tylenols for the whole 24 hours of the reactions. Patient friend stated that he had other symptoms including fatigue, muscle pain, joint pain, chills, nausea, vomiting, and fever but no headache. Patient friend would like to know if the Moderna COVID-19 do something to his kidney or bladder? Patient friend would like to know if he should get the second Moderna COVID-19 vaccine. However, the patient still would like to get the second vaccine to be protected from COVID-19. Patient was treated with 1 500mg Metformin and 2 500mg Tylenols. Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: This case concerns an 82-year-old male who experienced a serious unexpected event of Loss of consciousness along with NS unexpected feeling abnormal, dysuria, blood in urine, and NS expected fever, chills, myalgia, arthralgia, nausea, vomiting, fatigue. Event onset 1 day after the first dose of mRNA-1273. Treated with Tylenol. 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.

at midnight client got up to go to the bathroom. His legs became weak and he fell and hit his head on the wall. He called for his wife and said he didn't feel right. He denied any pain. She called EMSA and he stopped breathing while she was waiting on them. She gave him CPR with instructions from the dispatcher. He was pronounced dead at 1:30am. She has tried to call the clinic 3 times and left messages and no one has called her back, Her PCP told her this needed to be reported .

On Monday, 3 days after, just felt weak, like a zombie, but didn't have swelling or hurting at injection site or headache. But in the days following, felt whoozy, dizzy, and had low blood pressure, once took a nitro for my heart and then blood pressure went down to 68/36, another time 75/45, another time 90/55,

Day 5: upset stomach and blurry vision Day 6: Brian fog Day 7: flu like symptoms and slept or 12 hours

NERVE TINGLING IN HANDS AND ARMS FOR SEVERAL DAYS, WEAKNESS IN LEGS, SEVERE DEBILITATING JOINT PAIN , SHOULDERS, ELBOWS, BACK, HIP, KNEES, THIGHS ,CALVES AND GROIN. CHILLS, SLIGHT HEADACHES AND SLEEP DISTURBANCE

After vaccine I woke up about 1am extremely cold, chills and shaking, I tried to go to the bathroom and really started shaking and couldn't sleep, had a headache and couldn't sleep. I had no appetite when I woke up at 6am, took my morning meds and went back to bed. Noon I felt a little better and it gradually went away and it seem to gradually go away. Because I have an auto-immune disease I seem to have had a reaction to the vaccine because it did not bother my wife, except for her being a little tired.

confused, not walking well, fever, fatigue. Went to ER by ambulance and was given IV fluids which helped improve pt's status and was discharge home in stable condition. Was diagnoses with dehydration and fatigue. All symptoms were resolved on 3-15-21

Death Narrative: Patient received dose 1 of COVID vaccine on 1/27/21. Was observed x15 minutes, no reactions noted. Later that day patient's spouse reports patient has been acting out (reports behaviors the night before) and that she cannot care for him any longer. Patient falls sometime in the 48 hours after vaccine and is admitted to the hospital with an unknown diagnosis. Not certain of patient's history after this hospitalization until 2/9 when patient is admitted again to the hospital with hepatic encephalopathy. Patient is switched to hospice status by 2/12, and passes on 2/21/21.

45 minutes after the vaccine, daughter and pt. stopped at a restraint for breakfast. Pt. stated that he had to go to the bathroom and he felt limp and needed assistance with ambulation to the bathroom. Went home and sat in the recliner and said he felt like a limp noodle and was incontinent of urine. Pt. states that he had a fever (did not check it), brain fog and weakness.

On 3/04/2021, patient experienced a seizure. It was an isolated incident and lasted less than a minute. There did not seem to be any residual effects. This was the first and only incidence of a seizure in patient. On 2/27/21 patient experienced fever of 100.8 , exhaustion and delirium. On 2/28/21, temperature was 99.9 and patient slept most of the day. He was restless and cried out in his sleep, speaking to people who were not present. On 3/1/21 temperature was normal and patient was tired but otherwise non symptomatic.

Had confusion; They said it is due to the reaction from covid vaccine / it is just getting worse; It was hot as a fire cracker; Rash on arm of injection; It was hot as a fire cracker and was so red; 101 F Fever; A spontaneous report was received from a consumer concerning her husband, a 82-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced confusion/confusional state hallucinating/hallucination, wasn't even able to sleep/insomnia,, he didn't even know where he was/daydreaming, very restless/restlessness, he couldn't walk or anything/gait inability, they said it is due to the reaction from covid vaccine/it is just getting worse/vaccination site reaction with seriousness criteria as intervention/medically important, rash on arm of injection/vaccination site rash, it was hot as a fire cracker/vaccination site warmth and was so red/vaccination site erythema, 101 F fever/pyrexia. The patient's medical history was not provided by the reporter. Concomitant medications reported included carbidopa, levodopa(25/100mg), tamsulosin, acetylsalicylic acid, pravastatin, rivastigmine, irbesartan, levothyroxine sodium. On 10 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 040A21A) through unknown route of administration for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced my husband is hallucinating, wasn't even able to sleep, had confusion, he didn't even know where he was, very restless, he couldn't walk or anything. They took him to ER on Thursday and they did all the tests, but everything was good. Then it just got worse they said it is due to the reaction from covid vaccine/it is just getting worse, rash on arm of injection, it was hot as a fire cracker and was so red, 101 fever. On an unspecified date, lab details included flu test, covid test, strep throat, EKG, lung, and all the other blood work, body temperature (101 F) but everything is normal. Treatment for the events were not provided. Action taken with mRNA-1273 in response to the events were not reported. The outcome of the events, my husband is hallucinating, wasn't even able to sleep, had confusion, he didn't even know where he was, very restless, he couldn't walk or anything, they said it is due to the reaction from covid vaccine/it is just getting worse, rash on arm of injection, it was hot as a fire cracker and was so red, 101 fever were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

82 year old male with history of hypertension, hyperlipidemia, mild dementia presented with progressive worsening weakness over the past 2-3 weeks. Patient reported that he has noticed whole body weakness that has progressively worsened over the past few days. Reported that he has noticed feeling weak, fatigue and requiring more energy to do his daily activities over the past few weeks. He went to his PCP's office yesterday and had laboratory tests for further evaluation. Initially his PCP thought he might have PMR since he had bilateral UE soreness. However, the labs returned reassuring and does not seem to suggest the diagnosis of PMR. Since yesterday, he has noticed worsening of his weakness. Reported that last week, he was still able to play golf. Today, he was unable to get out of his car or get up from a sitting position without help. Associated with unsteady and poor gait. And reported that he has numbness in both hands and feels like his grip is weak. Denied fever, chills, nausea, vomiting, diarrhea, constipation, chest pain, shortness of breath, headache, vision changes, no urinary/fecal retention or urinary/fecal incontinence. Primary Discharge Diagnoses 1. Guillain Barr syndrome., 03/16/2021 Secondary Diagnoses: Guillain Barre Syndrome (AIDP) Hypofibrinogenemia Thrombocytopenia and Anemia, have been fairly stable for more than a week Hypokalemia Hyperlipidemia Hypertension, BPs controlled Mild dementia

82YM Admit 3/18/21 to hospital for small bowel obstruction within 1 week of second vaccine dose. PTA bowel obstruction led to a syncopal episode following use of laxative, and several episodes of vomiting in the days prior . Upon admission Patient was receiving conservative therapy for a partial obstruction when he developed increasing shortness of breath. The patient was transferred to the ICU for worsening respiratory status and eventually developed significant hypercapnic and hypoxemic respiratory failure requiring intubation. Neurology was consulted for altered mentation in the setting of respiratory failure. Patient with ascending paralysis. MRI of the head and neck as well as CTA were obtained x2. Patient was ultimately diagnosed with Guillain-Barre, variant and received 5 days of Intravenous Immune Globulin therapy. Patient's small bowel obstruction resolved and ultimately patient required percutaneous tracheostomy tube and gastrostomy tube placement for prolonged respiratory failure and neurologic compromise. The patient had uneventful ventilatory requirements and ultimately was performing intermittent spontaneous breathing trials; however, still had episodes of apnea, but improved. He was tolerating tube feeds at goal with resolution of his small bowel obstruction, which was thought secondary to his Guillain-Barre. The patient did develop abnormal LFTs which were thought secondary to cholecystitis not requiring operative intervention, with improving LFT findings on antibiotics. The patient had a nonobstructive cholecystitis. The patient's mentation was improving to the point where he was able to communicate and open his eyes upon discharge, as well as was working with Physical Therapy for strengthening. He was able to move his upper extremities and followed commands and lower extremities were improving in strength as well. Patient was discharged via private air flight to acute care ICU facility.

very confused and didn't remember the first day, diarrhea, and nausea, couldn't move or walk; this was similar to when he had covid, chills, nausea and fever also. I was so weak I couldn't get into bed. I still have foggy thinking and blurry vision.

After taking the vax the patients blood pressure went from 130/60 up to 170/70. His heart rate was around 60 and went to 80 and 90. Patient was having difficulty sleeping. He was exhausted and fell when trying to walk. He went to the hospital on 3/8 or 3/9. He had an X-Ray of his left hand/thumb. Nothing was broken. Blood pressure and heart rate is better but still not back to normal. His seems to be sleeping more now and feels some better.

Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was transferred to behavioral health unit at an outside nursing home on 2/15/21 after hospitalization for psychiatric evaluation on 1/29/21 w/subsequent Law for erratic behavior w/ delusions/hallucinations. Patient passed away on 4/12/21 at an outside facility with details surrounding death unknown. PMH significant for CKD, AAA, PVD, anemia, CAD, Dm, HTN, COPD, advanced age.

Patient presented to the ED for low oxygen saturation and confusion on 4/5/21. He presented to the ED on 4/5/21 and was subsequently hospitalized for acute respiratory failure with hypoxia. He presented to the ED on 4/28/21 and was subsequently hospitalized for pneumonia. These visits are within 6 weeks of receiving COVID vaccination.

My husband was living at home and able to perform normal daily activities until the morning of May 13th when he woke up in his bed at home. He got out of bed to go to bathroom and ended up on floor due to no use of left side. I called emergency services and they took him to hospital ER where he was diagnosed with a stroke. His left side is still not functioning and he was sent to rehab facility for after stroke rehab to relearn use of his left side. The stroke occurred within 20 days of his second dose of the Moderna vaccine.

Patient complained of feeling unwell and having headaches after his second dose of Moderna vaccine on 2/2/2021. He became increasingly confused, paranoid and started occasionally refusing medications. On early March 2021, he started refusing all medications. Around 3/17/21, his increasing confusion and paranoia prompted suspicion for UTI which was confirmed with a urinalsis. Unfortunately, he refused antibiotic treatment. On 3/20/2021, nursing staff noted that patients right lower extremity was purple from toes to mid-calf, cold to touch and pedal pulse were not present. He complained of right leg pain. He was evaluated and diagnosed with probable thromboembolic event, since patient refused his oral anticoagulant for weeks prior to these event. Patient was sent to the local Emergency Department (ED) and diagnosed with acute critical right limb ischemia. At the local ED, he had a CTA which showed as per radiology: "Occlusion of the right superficial femoral artery beginning just beyond the origin. Occluded right popliteal, anterior tibial, tibioperoneal, peroneal, and posterior tibial arteries without reconstitution on arterial and delayed phases. Patent right deep femoral artery with minimal luminal stenosis in the proximal segment. Patent mid and distal right external iliac artery with up to mild luminal stenosis." Per discharge summary, "vascular surgery evaluated patient in the ED and did not feel operative revascularization with fasciotomy would provide any benefit; recommended continued anticoagulation with amputation/palliative management." He was admitted to the general medicine service which consulted orthopedic, infectious diseases and palliative care. Medicine Service also contacted patient's daughter who is his next of kin who opted for comfort care. He was discharged to facility on 3/25/2021 and started in the Comfort Care Program. He was pronounced dead on March 27, 2021 at 0807 hours. His autopsy showed that he also had thrombi on: 1. Pulmonary embolism, Left pulmonary artery 2. Left renal infarct

Blood clots which resulted in multiple strokes starting the day following the vaccine and the next few days afterwards. Incapacitated my Dad with severe loss of motor function and is confined to bed in nursing home. Complete loss of swallowing and is fed through a g-tube. Cannot do any independent functioning.

CONFUSION, DIZZINESS, BODY ACHES, FEVER, AND HEADACHE STARTED ABOUT 7-8 HOURS AFTER VACCINE. HEADACHE, AND HTN, UP TO 250/113, SINCE VACCINE AND STILL ONGOING. PT HAS BEEN TO DOCTOR NUMEROUS TIMES. TRIED GABAPENTIN 400MG AND AMLODIPINE, AND THEY DIDN'T HELP. HE STARTED ON LOSARTAN 50MG 6/29.2021 AND REPORTS HIS BP IS BACK TO NORMAL, BUT HEADACHE, DIZZINESS, AND PROBLEMS WITH BALANCE IS STILL PRESENT.

Congestive heart failure, he had 32% of his heart; Patient asked caller to "help him with suicide"; escape from house, Confused; Super sick; medication having opposite effect on him; his kidney levels were also not where they needed to be; died after receiving the Moderna vaccine; Nails were blue; Very cold; Fidgety; Vomiting; Wasn't breathing right/abdomen breathing; Continued to deteriorate; Went outside and could barely make it up the steps; Neck veins distended; Had not slept the night before; Didn't feel good; right arm was swelling; Pale in the face; Right arm red; Chills; Nausea; This spontaneous case was reported by an other caregiver and describes the occurrence of DEATH (died after receiving the Moderna vaccine), CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) and SUICIDAL IDEATION (Patient asked caller to "help him with suicide") in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 044A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced PALLOR (Pale in the face), ERYTHEMA (Right arm red), PERIPHERAL SWELLING (right arm was swelling), CHILLS (Chills) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced INSOMNIA (Had not slept the night before) and FEELING ABNORMAL (Didn't feel good). On 13-Apr-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps) and VASODILATATION (Neck veins distended). On 25-May-2021, the patient experienced VOMITING (Vomiting). On 26-May-2021, the patient experienced DEATH (died after receiving the Moderna vaccine) (seriousness criteria death and medically significant), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold) and RESTLESSNESS (Fidgety). On an unknown date, the patient experienced SUICIDAL IDEATION (Patient asked caller to "help him with suicide") (seriousness criterion medically significant), CONFUSIONAL STATE (escape from house, Confused), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him) and RENAL IMPAIRMENT (his kidney levels were also not where they needed to be). The patient was treated with HALOPERIDOL (HALDOL [HALOPERIDOL]) at a dose of 1 dosage form and DIAZEPAM at a dose of 1 dosage form. The patient died on 26-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, CARDIAC FAILURE CONGESTIVE (Congestive heart failure, he had 32% of his heart), SUICIDAL IDEATION (Patient asked caller to "help him with suicide"), PALLOR (Pale in the face), ERYTHEMA (Right arm red), INSOMNIA (Had not slept the night before), FEELING ABNORMAL (Didn't feel good), DYSPNOEA (Wasn't breathing right/abdomen breathing), GENERAL PHYSICAL HEALTH DETERIORATION (Continued to deteriorate), GAIT DISTURBANCE (Went outside and could barely make it up the steps), VASODILATATION (Neck veins distended), CONFUSIONAL STATE (escape from house, Confused), CYANOSIS (Nails were blue), PERIPHERAL COLDNESS (Very cold), RESTLESSNESS (Fidgety), ILLNESS (Super sick), PARADOXICAL DRUG REACTION (medication having opposite effect on him), PERIPHERAL SWELLING (right arm was swelling), RENAL IMPAIRMENT (his kidney levels were also not where they needed to be), CHILLS (Chills), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Renal function test: abnormal (abnormal) Kidney levels were also not where they needed to be. No concomitant product 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. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request. This case was linked to MOD-2021-248336 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Additional information added in laboratory data, treatment drug and events.; 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. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; Reported Cause(s) of Death: unknown cause of death

Patient contacted the office 3/31/21 with complaints of arm/shoulder/axillary pains since receiving the vaccines, treated in office 4/5/21 for lump at injection site and continued axillary pain, treated 5/25/21 for shingles outbreak on chest, contacted office again 5/28/21 with elevated bp, heart rate and confusion- possible med reaction, contacted office 6/9/2021 with low blood pressure, dizziness, confusion, increased edema, treated 6/15/21 for urinary tract infection. Treated with oncology - notes from 4/13/21 notes patient is doing well, but with 'knot' on arm and axillary tenderness following COVID vaccine, then notes from oncology 6/24/21 notes patient found to have new retroperitoneal and pelvic lyphadenopathy, along with new splenic lesions with sudden rapid change in mental status and new diagnosed pulmonary hypertension. Patient placed on hospice and deceased as of 7/7/2021

His arm is still shaky; Has difficulties with function in his had doing daily activities; He has trouble getting out of bed; Patient is worried he will lose function in that arm as well and eventually die; did not receive the second dose; Arm is very painful; Patient describes full paralysis in that arm; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (Patient describes full paralysis in that arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LISINOPRIL, AMLODIPINE, EZETIMIBE, ALOGLIPTIN and METHYLPREDNISOLONE SODIUM SUCCINATE (PREFORIN) for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced MONOPLEGIA (Patient describes full paralysis in that arm) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (His arm is still shaky), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has difficulties with function in his had doing daily activities), VACCINATION COMPLICATION (He has trouble getting out of bed), ANXIETY (Patient is worried he will lose function in that arm as well and eventually die), PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) and VACCINATION SITE PAIN (Arm is very painful). At the time of the report, MONOPLEGIA (Patient describes full paralysis in that arm), TREMOR (His arm is still shaky), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Has difficulties with function in his had doing daily activities), VACCINATION COMPLICATION (He has trouble getting out of bed), ANXIETY (Patient is worried he will lose function in that arm as well and eventually die) and VACCINATION SITE PAIN (Arm is very painful) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (did not receive the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included exercise nerve tests with electricity. The patient has been to his hospital and has not seen any success in his treatments. 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.

A feeling of significant lassitude, pain at injection site and also the site opposite in the right shoulder. I could not sleep after 3 am, awake until 7:30 am. January 13: in the morning, body aches, requiring bed rest. After 12 pm, relief came with normal feeling.

I heard patient coughing about 10 minutes after his vaccination so I sent the staff member to check on him. I went to his room,I told the staff to call 911. He had started eating his lunch and felt that the food was stuck at the notch at the bottom of his neck. I prepared to give the EpiPen. He stopped coughing and said he was feeling better, but the staff member . said he didn't sound right. I decided not to give the EpiPen. The Depot Runner asked to see his throat and tongue and agreed that he didn't need the EpiPen. Several other staff members came. Asked a staff member to take his vitals. EMS arrived and took him to the ER.

These symptoms lasted 3-4 days: Extreme sleepiness; inability to open eyes; tremors; delusions/hallucinations; non-ambulatory; required assistance to sit, in and out of bed, in and out of chair, in and out of bathroom; tremors; anorexia; difficulty swallowing; slurred/difficult speech; hypotension; aches on right side hip, waist, leg, back; Required 24-hour supervision/caregiving. Marked improvement on Day 5; by Day 6, at 80% improvement. FOR ITEM 20 BELOW, we are indicating "unknown" as the patient is still not 100%. FOR ITEM 21 BELOW, we had a conference call with the primary physician, but not an in-person office visit.

MODERNA COVID-19 Vaccine: My dad has never had any sort of odor in his life and 3 days after getting the first vaccine shot, he has an incredibly foul odor (that he cannot smell) and it has not yet gone away. He showers frequently and I wash all his clothing and pajamas but this odor is strong and relentless. It's not a typical body odor smell though...it's like a "medical odor," or something else very strange that is quite hard to describe. I cannot seem to attribute this new odor to anything other than a negative side-effect to his first shot of the Moderna vaccine as nothing else has changed in his day-to-day life. He also began experiencing cold symptoms about 4-5 hours after receiving his first dose of the vaccine. He was stuffed up, very congested, and extremely tired. He slept a LOT more than usual. I believe it is quite possible he actually just ended up with a cold because his immune system was so busy responding to the vaccine. (Is this possible/likely?) Please let us know if others are experiencing this too, or if something can be done about it. Is his body not metabolizing an ingredient to this vaccine or something?

A day after the shot was given, my husband began to feel very sleepy. He will get up or 1/2 an hour and then go back to sleep. It seems to have gotten worse. Yesterday, he slept most of the day and then slept for 11 1/2 hours. Today he got up about 7 am and stayed up for about 1/2 an hour. Then went back to bed. He wolkeup about 12:30 pm and I gave him some lunch. He has gone back to sleep for the rest of the afternoon. I don't know what is going on.

Rash over much of body -- legs, back, stomach, chest, arms. Skin has spotty red areas. Much itching. Symptoms began about 24 hrs after vaccination. Because of itch, difficult to sleep on nights 3,4,5,6 after vaccination. Applied Desoximetasone Ointment (0.25%) to red spots morning and evening. Itching and redness are beginning to decrease.

First Day: At first: Tense, Restless; Later off and on: Headache, Chills, Fever 98.2*, Hands Numb and Cold Took Tylenol with Codeine for Headache Second Day: Off and on: Headache, Chills, Fever <100*, Hands Numb and Cold Took Tylenol with Codeine for Headache Third Day: Off and on: Headache, Chills, Fever 100.2* Took Tylenol with Codeine for Headache

1st five days i was fine then wed morning felt like i was hot by a truck. I have dizziness, cant walk straight, headache, muscles pain and joint pains

At 5:30, started getting woozy in a fog. Could not remember what happened. For the next 2 days patient was in bed. The following morning patient went to bathroom, urine is red, which hasn't happened in years. Patient may think dizziness is from blood loss. The following days it slowly cleared. Patient contacted doctor. A few days after MD appointment patient was back to normal.

Increased weakness, confusion. All occured after surgery but was doing well postoperatively until 2nd dose given 2/4/2021 Then became confused, weak and unable to care for self.

For approximately 30 hours I was extremely sleepy. I felt all right otherwise, but I slept about 20 hours in that period of time. I had very little soreness in my arm. After the first shot I had quite a bit of soreness. I feel normal today.

At 12:22 on Tuesday, February 9, the second day, I was awakened by violent shivering and shaking uncontrollably. This lasted for four hours, with concomitant loss of sleep throughout the night and, when up, walking like a drunken man. In the morning , no appetite (managed a cereal breakfast). Ibuprofen administered. A pronounced feeling of weakness and lassitude throughout the morning, with slow recovery until mid-evening. Now at February 10th, return to normal feeling and strength.

1437: Pt arrived to observation area pale, diaphoretic and drooling. Pt disoriented for 4-5 minutes. Per daugher, pt not at baseline. Bp 84/52, 89, o2 sat 98% room air. 1443: Vital signs improved 142/74, 98%sat room air, no longer pail. Daughter request 911 and transfer to ER. Daughter stated pt had previously had a similar episode. 1452: pt care transferred to 911 and pt transferred to ER.

I noticed the reaction about 2 days ago, my husband has memory lost but says it was there longer and it has been itching. He has a rash on his back, it is little pin point red spots. I gave him Benadryl Wednesday evening, and I put hydrocortisone 1% cream on his back. Yesterday I gave him one Loratadine 10 MG. It is still there today, it looks like it spread more

He became very weak and kiss all strength and mobility in his legs. Increased confusion and inability to concentrate. This also happened after the first vaccine and went away the following day.

Patient reported swelling in his legs, knee trouble (making walking difficult), dizziness, headaches, temporary memory loss and tired. These were all experienced for about 2 1/2 weeks post 2nd dose of Moderna vaccine.

Patient states he was called a few minutes prior to 1000 today to remind him about his vaccine appointment; he relays he didn't know about his appointment and therefore he did not eat breakfast. Patient states he was observed for 15 minutes following the vaccine administration and was advised he could then go home. He states while driving home, he began to feel dyspneic, nauseous, and lightheaded. Patient also states he felt as if his voice changed. He states he then started to drive back to the hospital. When he arrived back to clinic, he was unable to park properly as he felt he was going to vomit.

Daughter calling to ask about side effects of COVID vaccine? She said her 83 yr old dad got the COVID- 19 yesterday and overnight he became confused, had severe weakness, couldn't get out of bed, and became feverish. She said mom said they both got first dose of COVID vaccine yesterday around noon- then last night he started to feel unwell. Around 2am- her mom said her dad- became very weak, couldn't get out of bed, confused, started coughing, he had chills, felt feverish. She said so concerning by 4am her mom called EMS who came and took him to the Medical Center. She said he had pretty severe case of COVID in December that he need hospitalized for-she said he as really weak, foggy headed at that time, kind of out of his mind- she said was told that is how he was acting last night. After being seen in ED and getting put on some fluids and then antibiotics he now seems to be acting more like himself. They hydrated- have some concerns about possible pneumonia dx so they started him on antibiotics- was told this might be due to his rxn post + COVID vaccine - which is what prompted her to call today. He is supposed to follow up with his PCP doctor. He seemed better when he got home this morning- she said just left him a little bit ago after eating early lunch with him. She is not sure if getting him hydrated & sent home with antibiotics is what helped or just time since now about 24 hours post vaccination dose. Confirmed he has had no prior rxn to any other vaccines in the past.

DEATH - PT'S WIFE CALLED 3-11 TO TELL US PATIENT WAS FEELING BAD, AND TO ASK WHAT TO DO. WE SENT A PULSEOXIMETER, AND ADVISED TO CONTACT DR. - ON MORNING OF 3-12, PT'S WIFE CALLED TO TELL US HE HAD PASSED AWAY DURING THE NIGHT.

Patient's wife stated on 3/12 patient became extremely confused, weak and fell 3 times. She stated that they were having difficulty getting him up and her daughter called EMS. Patient was taken to hospital and admitted. Patient is still in hospital, she stated he is more lucid. Patient has history of Parkinson's

I lost the hearing in my left earon March 4 three days after receiving the 2nd shot of Moderna vaccine, See details below: Report of adverse reaction (hearing loss) following second injection of COVID-19 vaccine on March 1, 2021. I believe I have had a bad reaction from the second COVID-19 vaccination, which occurred on March 1 at Three days after the injection I could not hear through my left ear. The vaccine identification is: Moderna vaccine, 2nd dose, 3/01/21, Lot#: 006M20A The sequence of events to date (3/14/21) is as follows: Mar 1, Mon: I received the second Moderna vaccination at Retirement Community. No reaction. Ran 2 miles in the afternoon. Mar 2, Tues: Felt slightly ill. Headache. No energy. Vaccination arm very sore. Did not feel well enough to work at my desk or to run. Mar 3, Wed: Felt better. Worked as volunteer at vaccination clinic, but tired easily. Did not run afterwards. In the evening, noticed some hearing difficulties in left ear, including greatly increased tinnitus. Mar 4, Thur: Awakened in morning with no hearing in left ear, and growing diminishment of hearing in right ear. No running. Mar 5, Fri: No hearing in left ear and diminished hearing in right ear. Tinnitus level high. Called my otolaryngologist; doctor not available; scheduled appointment for March 16. Visited Urgent Care; physician assistant found no obvious problem. Visited Clinic; (my primary care physician) not available; nurse practitioner advised me to wait to see Dr. on Mar 8 at my scheduled annual wellness checkup. Ran 2 miles. Mar 6, Sat: No hearing in left ear. Right ear continues to lose hearing. Ran 2 miles. Mar 7, Sun: Left ear deaf. Right ear hearing is poor and distorted. No running Mar 8, Mon: Left ear deaf. Right ear hearing is deteriorating. Had difficulties understanding speech. Reported hearing problem to Dr. at my annual wellness exam. She said I should report it to FDA. I requested that she do so because I had some difficulty in trying to make the report. She prescribed Mirtazapine for several concurrent health issues. Ran 2 miles. Mar 9, Tue: Met with Dr. (otolaryngology) and Dr. (audiologist). A hearing test showed left ear functionally deaf and right ear poor as before. Given order for a head MRI and prescription for prednisone and instructed to return in two weeks. Dr. urged me to report problem to the CDC. Ran 2 miles. Mar 10, Wed: Hearing problems as before. Deaf in left ear and hear with difficulty in right ear. Tinnitus very loud. No running. Tried to send report to CDC/VAERS (email not successful). Mar 11, Thur: Started 20 mg of prednisone; within 6 hours hearing began to slowly return in left ear. Ran 2 miles. Mar 12, Fri: Hearing in left ear returned to 70-80% of normal and right ear improved also. Had head MRI in evening. No running. Mar 13, Sat: Hearing continued to improve in both ears. Tinnitus remained loud. Ran 3 miles. Mar 14, Sun: Hearing has plateaued in both ears, although TV audio seemed a bit muffled. No running. Mar 15 onwards: Awaiting lab results of head MRI. Next appointment with Dr. is March 23. (End of report)

tightening in his throat muscle; unable to move much; unstable blood pressure; unstable oxygen; bled due to blood thinner; weak in terms of walking; coughing; every joint and muscle from neck to toe in pain; every joint and muscle from neck to toe in pain; cold; entire body in excruciating pain; A bit off; Bruising in arm; A spontaneous report was received from a consumer concerning a 83-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the following events: bruising in arm (contusion), a bit off (feeling abnormal), entire body in excruciating pain (pain), every joint and muscle from neck to toe in pain (arthralgia/myalgia), tightening in his throat muscle (throat tightness), unable to move much (hypokinesia), unstable blood pressure (blood pressure abnormal), unstable oxygen (oxygen saturation abnormal), bled due to blood thinner (haemorrhage), cold (feeling cold), weak in terms of walking (muscular weakness), and coughing (cough), The patient's medical history included small cancer treated last year with 38 radiation treatments. No concomitant medications were reported. On 11 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031620A) intramuscularly for prophylaxis of COVID-19 infection. On 11 Feb 2021, the patient experienced little bruising in the arm. On 12 Feb 2021, the patient was a bit off. On Sunday, 28 Feb 2021, in the evening, the patient got cold, and within minutes his entire whole body was in excruciating pain, every joint and muscle from neck to toe were in pain. It felt like it was invaded with COVID. He went to hospital and got tested for COVID, Strep throat and Flu, and all three test results were negative. On an unknown date, the patient experienced tightening in his throat muscle and he went to the hospital where he was admitted. While there, they did every possible test, chest MRI, Neck MRI, all possible viral tests, and rapid and full COVID test. The rapid and full COVID tests came back negative. Results for chest MRI, neck MRI and viral tests were not provided. The hospital also performed a blood culture for bacteria. Results were not provided. The patient was unable to move much, his blood pressure and oxygen were a little unstable. On 06 Mar 2021, the hospital did a major blood test which came back negative and the patient was released from a hospital. He stated that he was still weak in terms of walking and coughing. He stated that he recently bled due to taking blood thinner. Treatment included major antibiotic treatments and steroids for pain during the hospital stay. The patient was still taking prednisone at a tapering dose. Action taken with mRNA-1273 in response to the events was unknown. The events of weak in terms of walking, coughing were unresolved, while the outcome of the events of tightening in his throat muscle, unable to move much, unstable blood pressure, unstable oxygen, bled due to blood thinner, Bruising in arm, cold, entire body in excruciating pain, every joint and muscle from neck to toe in pain, every joint and muscle from neck to toe in pain was unknown.; Reporter's Comments: Based on a strong temporal association between the reported events and administration of mRNA-1273 vaccine, a causal association cannot be excluded. Myalgia and arthralgia are consistent with the known safety profile of the vaccine

about 7 hours after injection of sedond Moderna Covid-19 vaccine, the left arm became very sore and by the next morning was noticeable red and slightly swollen; very tender to the touch (skin hurt); this symptom lasted for about 4 days. A low fever 99F was observed in midafternoon for 3 or 4 days but subsided by suppertime. Chills seemed to occur in midevening and into bedtime, requiring hot drinks to comfort him, and extra blankets on top while watching TV or retiring for bed. Tired easily; would drift off to sleep sitting in chair about 10 or 11 AM; trouble focusing on reading or doing computer games. Took 3 and 4 hours naps in the afternoon but still felt like going to bed earlier than normal. Day 7 or 8 felt significantly nauseous and queeezy on and off for three days, and didnt eat very much. Sudden headache in upper forehead area lasted about 3 hours on two consecutive days. Constipated days 8-14 so took a stool softener days 12 and 13 and ate more fruit. Joints hurt, especially the right hip, to the point of not being able to dress himself days 6-13; could not do normal activities (stopped his daily exercise and walks, avoided getting up off couch or chair and asked me to bring things to him, used a cane when walking inside the house due to balance issues that got worse. Tylenol and Tylenol PM were taken to manage pain and for sleep. Took additional vitamin C and ate mandarin oranges for healing.

Stroke; Passed out; Was flailing like a fish; Could not walk; lost motor skills and had to be fed; Could not speak; Did not understand where he was; was in La La land; A spontaneous report was received from a consumer concerning his father a 83– years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke, passed out, was flailing like a fish, was in la la land for many day, could not walk, he lost his motor skills and had to be fed, he could not speak, did not understand where he was and he was wheelchair bound. The patient's medical history, as provided by the reporter, included blindness in one and lost some hearing. Concomitant medications reported included diazepam, bisacodyl and oxycodone. On 12 Feb 2021, approximately three days prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (batch 013m20a) via unknown route for prophylaxis of COVID-19 infection. On 15 Feb 2021, the patient experienced stroke, passed out, was flailing like a fish, was in la la land for many days, could not walk, he lost his motor skills and had to be fed, he could not speak, did not understand where he was and he was wheelchair bound. No tests were done, and it was previously agreed that he would not go to the hospital if anything should happen to him. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event, he lost his motor skills and had to be fed, was considered resolving. The outcome of the events, stroke, passed out, was flailing like a fish, was in la la land for many days, could not walk, he could not speak, did not understand where he was and he was wheelchair bound 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 the events, a causal relationship cannot be excluded.

Chest pain; felt really bad; Death; Vomited that night; Sore arm and pain in both arms; A spontaneous report was received from a consumer concerning a 83-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and pain in both arm /pain in extremity, felt really bad/feeling abnormal, chest pain and the patient died. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 04 Mar 2021, patient experienced sore arm and felt bad. The patient vomited that night. On an unknown date patient reported chest pain and pain in both arms. On 05 Mar 2021, at 12:46pm the patient died. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 05 Mar 2021. The cause of death was reported as unknown. Plans for an autopsy were unknown.; Reporter's Comments: This is a case of death in an 83-year-old male subject with unknown medical history, who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death

Lethargy and "achy" the first day after the second injection. increase in symptoms through that day and overnight. The following day unable to get up out of chair/walk. Confused and disoriented. Wheezing and SOB. Had to call an ambulance for transport to ER. Admitted. Became completely unresponsive. Testing revealed Ammonia level of 104. Liver function studies/scans negative for liver problems. MICU for 10 days, rehab for 3 weeks.

stroke (left facial droop, left side of body weakness, slurred speach, confusion, inability to express self)

March 30, Weakness, light headed , no energy, upset stomach. March 31 slept 24 hours could not wake up, April 1, weak, could not sit up, wanted food, too weak to eat. My brother , retired fire caption medic, called 911 to ha e my father transported to ER

Stroke; went through an inflammation state and since then has been in a fog; can't remember his birthday; doesn't want to eat; bleeding in the brain which they called it second stroke; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and CEREBRAL HAEMORRHAGE (bleeding in the brain which they called it second stroke) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hip fracture. Concurrent medical conditions included Polycythemia. Concomitant products included IBUPROFEN for Joint pain, SIMVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], LISINOPRIL and METOPROLOL for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant) and CEREBRAL HAEMORRHAGE (bleeding in the brain which they called it second stroke) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (went through an inflammation state and since then has been in a fog), AMNESIA (can't remember his birthday) and DECREASED APPETITE (doesn't want to eat). The patient was hospitalized from 30-Mar-2021 to 12-Apr-2021 due to CEREBRAL HAEMORRHAGE and CEREBROVASCULAR ACCIDENT. The patient was treated with Physical therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), CEREBRAL HAEMORRHAGE (bleeding in the brain which they called it second stroke), FEELING ABNORMAL (went through an inflammation state and since then has been in a fog), AMNESIA (can't remember his birthday) and DECREASED APPETITE (doesn't want to eat) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The reporter states that the patient was given a "clot buster" to prevent further damage. Patient was transferred to a nursing facility on 12 Apr 2021 and is still there. 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. However, the patients advance age and past medical history of polycythemia may remain a risk factor for this event. Further information has been requested. This case was linked to MOD-2021-086187 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patients advance age and past medical history of polycythemia may remain a risk factor for this event. Further information has been requested.

Moderate Stroke in front of brain - unable to speak, disoriented. Went to ER. Treated and observed in the hospital for 2 days. Outcome - mild aphasia

moderate stroke in the front of his brain - complete loss of speech, disorientation Outcome - mild aphasia

My uncle, died on February 17, 2021. He was admitted on February 2, 2021 6 days after taking the COVID-19 Moderna vaccine (1/28/2021). After the shot was administered, he developed all the COVID-19 symptoms (loss of taste, smell, high temperature, and had trouble breathing). He was deprived of oxygen and had labored breathing and was acting confused. The home health nurse contacted his primary care physician and was instructed to bring him into the ER.

Started slowly, but progressed overtime to present. DR. prescribed several medication for allergy and Afrin to relieve congestion temporally. The result was congestion relieved, not the breathing problem- negative. I then saw an ENT, Dr.. He treated cough, but said I should see an Allergist. This was because of my breathing problem. At night I cannot fall asleep. I gasp for air and have not had a good nights sleep in months-it's getting worse. I am seeing an Allergist this coming week. If he cannot help me, then reasonable suspect may be the final injection shot on 03/11/2021. I have a cough that won't quit and heavy breathing at night which keeps me from falling asleep. Before 03/11/2021 I was fine.

patient passed out; shot may him whoosy however he stayed in bed; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (patient passed out) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (patient passed out) (seriousness criterion medically significant) and CONFUSIONAL STATE (shot may him whoosy however he stayed in bed). At the time of the report, LOSS OF CONSCIOUSNESS (patient passed out) outcome was unknown and CONFUSIONAL STATE (shot may him whoosy however he stayed in bed) had resolved. Concomitant and treatment information not provided. This case was linked to MOD-2021-033479 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Moderna COVID-19. Vaccine EUA Exactly 12 hours after my injection, 1:30 am, I awoke with a severe coughing attack. In addition, my chest was wheezing and felt as if "bubbles" were in my chest. My arm felt very hot and tender at the injection site. This attack lasted for half an hour. I went back to sleep and awoke the following morning feeling very weak and confused. Feeling extremely fatigued, all I wanted to do was sleep. I also lost my appetite. The next day, I had occasional coughing which subsided with my over the counter cough medicine.

Weakness started at night and got progressively worse until I slid off the bed and could not get up without assistance. The problem continued thruout the day but diminishing in intensity until the following morning that I was able to get up but feeling very tired.

patient developed progressive diffuse muscle weakness, altered mental status including excessive drowsiness, decreased oral intake starting on 1/31/2021. Symptoms continued to worsen overnight and he was evaluated in the emergency room on 2/2/2021 and admitted with dehydration and altered mental status. He was aggressively hydrated overnight, but showed persistent diffuse muscle weakness, altered mental status with decreased responsiveness progressing, but no focal neurological findings noted. CT scan of the head on 3/3/2021 showed no findings other than age-related diffuse cerebral atrophy. The patient did spike a fever to 103 on the morning of 2/3/2021. CBC, CMP, procalcitonin and lactic acid levels remained normal. He remains hospitalized in stable condition as of 2/3/2021 @1300.

Saturday 01/30/2021 lost peripheral vision. Went to hospital Was given Mri and ultra sound of head and neck stayed until sunday afternoon. Slept Sunday night Now have not been able to sleep at night at all since

Patient describes headache that is excruciating soon after the injection. On the fourth day post injection, he states he had pressure in the left side of his chest, the left side of his nose swelled up and is very painful, he had a "slight" temperature, and decreased appetite. He states he is still feeling bad and the headache and his nose is what bothers him the most. He called his cardiologist and the cardiologist advised him that the doctor did not think he needed to be seen for the chest pain. The patient states that if the pain does not improve he is going to the Emergency Department. He noted that the injection was done in his left arm and the left side of his body is what is reacting so strongly.

Resident came up to staff and approximately 1400 and said, "I have a fever" - temperature was assessed and was 98.4 resident came back several minutes later and stated again, "I have a fever" - temperature assessed again and was 98.2 - staff asked if resident had his window open, he stated no - staff suggested maybe he open up his window because it is quite warm in the building at this time. Resident said ok - went back into room - staff told writer he had c/o "I have a fever" while staff was in change of shift report and they assessed fever and it was 97.1. Around 1525, Resident noted to have sudden SOB. PRN albuterol neb given. RR before neb was 40 and did not improve. BP 136/66, pulse 158, temp 101.7 tympanic, and O2 sats 76% RA. Placed on supplemental O2 and sat came up to 86% on 3 L. Resident then started to complain of chest pain. Resident was weak and unsteady and insisted on standing but was guided to his chair to sit down. Resident said he wished to go to ER and daughter in agreement. 911 called. Writer assisting with transferring resident out to hospital. While waiting for ambulance, patient restless and visibly short of breath. Lips with blue discoloration, pale appearance, and breathing with accessory muscles. Changing positions frequently from lying to sitting and standing due to being uncomfortable. Temp 103.2 in left hear and 102.5 in right ear. Respirations 36. Blood pressure unable to be checked due to restlessness and moving around. Pulse 167. O2 92% with nasal cannula on 3L. Asked him to point to the pain and he pointed to his upper abdomen, but describes it as chest pain. Per EMTs he is being sent to clinic instead of the other clinic due to abnormal EKG readings. Received update from EMT around 1700 that patient arrived to ER and heart attack was confirmed so patient was being sent to cath lab for angioplasty procedure.

February 11, 2021 – Arm pain – He starts taking Tylenol as prescribed on day of Vaccination. February 13, 2021 – Stabbing pain on the left side of the head (above his ear) – Poor sleep the next 2 days February 14, 2021 – Spoke to Dr – He ordered a CT Scan and recommended for him to take Tylenol Extra Strength. The headache continues to escalate. February 15, 2021 – He is taken to ER (Hospital) February 16, 2021 – He is released with pain/insomnia medication February 20, 2021 – He is confused, disoriented, repeats things, forgets things, has difficulty functioning normally and sleeping February 21, 2021 – He has difficulty standing, he falls, he has difficulty swallowing. He is taken to ER (Hospital) February 21-26 - He is still at the Hospital. Was diagnosed with Viral Meningitis/Shingles

My grandpa got his second covid vaccine on Thursday. Saturday he complained of stiff neck. Sunday he had low grade fever, nausea and vomiting, chills, and mild headache. He was feeling bad enough to call squad at 3 pm. The paramedics did evaluation and thought he was just experiencing normal side effects from vaccine and felt no need to transport to hospital so my grandpa decided to stay home and just rest. At 2 am that same night he went into cardiac arrest and was not able to be brought back

Upon attempting to get out of bed about 9:15 AM on Saturday, February 27, pain in my right knee was so severe I collapsed back onto the bed. Pain in my left knee was strong but less severe than the right. I did not seek treatment, but limited walking, aided by two canes, to necessary movement. By evening the pain seemed to be lessening and through Sunday and Monday continued to diminish. By Tuesday I was able to walk without noticeable pain.

Early afternoon of date of administration complained of tiredness and went to bed. The next day at about 6PM I received a call that he was confused and non responsive in bed, EMS called and he was transported to ER. Admitting diagnosis at admit was Delirium. He remained inpatient at Hospital from 2/24/2021 and transferred to Hospice on 3/6/2021. His condition deteriorated while hospitalized. Transfer diagnosis was Dementia, A-Fib and Diabetes.

02/21/2021 Patient was found on the floor of his room at 0800am hitting the right temple resulting in a laceration of the area. Patient complaining of Right arm pain within the location of vaccination site. 02/21/2021 1215 pm Patient fell forward out of his wheelchair hitting his right temple resulting in bruising and hematoma arm. 02/23/2021 1300 patient with increased agitation, combativeness, and change in mental status. Patient sent to emergency room for evaluation to rule out intercranial bleeding. Patient has fallen 3 times since the vaccine striking his head twice and now with changes in mentation.

Patient states that twenty-four hours after administration (3/4/21) he spiked a fever, went into a state of delirium, and had difficulty breathing. When he presented at the Emergency Room he had low SpO2. They supplemented him with oxygen and gave him acetaminophen and after the fever broke he was sent home (3 hours in ER) with normal mental status. Emergency Room ran some tests to determine if he had stroke or cardiac event which came back negative.

Temp elevation to 104.2, increased pulse, drop in O2 sat., irregular reparations, disorientation, followed by diarrhea

& altered mental status Narrative: Pt reported the following adverse reaction from his covid vaccine dose #1. Taken from the nurses note- "Veteran reports serious altered mental status folowing first vaccination. reports hulicinations felt like he was "very small in size" and, that he was totally "out of it" but could not elaborate. he denies any other preeding event that could have contributed to his mental status. he is alert oriented and in a good mood during our conversation. no signs of distress or confusion. he denies any other symptoms. all symptoms resolved. advised veteran to discuss with pcp before proceeding with 2nd vaccination, and Veteran agrees" He reported this to nurse at his dose #2 covid vaccine appointment. Pt declined vaccine dose #2 at this appointment.

Anxiety and jittery feeling: Started 03/19/2021 - Still occurring Pt did not take any medication or seek any medical care to relieve symptoms Pt was advised to schedule an appointment with primary doctor. SPI was consulted and Dr. was notified.

Moderna COVID-19 Vaccine EUA First few days felt bad with no energy as the days progressed Medications no longer effected Essential Tremors and they have become worse. Nervous all over.

Patient has long standing COPD and asthma. He has been stable on his home medications for years. No hospitalizations for these issues in the past. During Covid times he has been very restricted to his home with no visitors. Approximately 5 days after receiving the 2nd Moderna Covid-19 vaccine, he started having increased difficulty with breathing. Over the next few weeks he continued to get worse and required home oxygen and an adjustment with his medications. He was started on steroids and antibiotics about 3 weeks after the vaccine and then hospitalized on 3/16/2021 with COPD exacerbation and pneumonia. He tested negative for Covid at that time. He was in the hospital for 9 days and discharged home on steroid taper and home oxygen. A few days after being at home, he had gradual onset of subacute dementia/delirium. All workup has been negative. MRI/MRA normal. He is currently continuing on oxygen and again on steroids and mental status may be starting to improve. The concern here is that patient was stable and had been stable on his medication regimen for years. He was doing well until approx 5 days after his second Covid vaccine when he started having worsening pulmonary complaints and eventually ended up in the hospital. He continues to be on oxygen at home and was recently started back on steroids. There has been no explanation for his subacute onset of Dementia/Delirium. MRI/MRA normal. This has been discussed with both Pulmonology and Neurology specialists.

Person was disoriented. Confused. Did not know where he was at , hallucination , thought people were in the room when the were not

acuate shortnee of breath; weak and feeble/turned into a skeleton; cannot perform daily activities smoothly; suffering badly; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (acuate shortnee of breath), ASTHENIA (weak and feeble/turned into a skeleton), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot perform daily activities smoothly) and EMOTIONAL DISTRESS (suffering badly) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No reported medical history. Concomitant products included METFORMIN. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (acuate shortnee of breath) (seriousness criterion hospitalization), ASTHENIA (weak and feeble/turned into a skeleton) (seriousness criterion medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot perform daily activities smoothly) (seriousness criterion medically significant) and EMOTIONAL DISTRESS (suffering badly) (seriousness criterion medically significant). The patient was hospitalized from 13-Apr-2021 to 17-Apr-2021 due to DYSPNOEA. At the time of the report, DYSPNOEA (acuate shortnee of breath), ASTHENIA (weak and feeble/turned into a skeleton), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (cannot perform daily activities smoothly) and EMOTIONAL DISTRESS (suffering badly) outcome was unknown. Treatment information also included Levothyroxine, Lisinopril and Metoprolol. Patient was discharged from hospital without any improvement and there is no benefit in patient's health. Very limited information regarding the event onset date has been provided at this time and is insufficient for causality assessment. A causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding the event onset date has been provided at this time and is insufficient for causality assessment. A causal relationship cannot be excluded.

Patient contracted COVID-19 after receiving two COVID-19 vaccine doses (Moderna series completed on 2/27/21). Patient was admitted to the hospital on 5/16/21 for worsening confusion and was stable to discharge to Agency on 5/21/21. Patient had tested positive for SARS-CoV-2 on 5/21 while in agency

Patient presented to the emergency department on the morning of 5/25/21 with decreased ability to walk and increasing confusion (has mild dementia at baseline), as well as nausea, burping, stomach pains. The patient received 2nd dose of Moderna vaccine at 5PM the evening prior (5/24/21). Also noted to be febrile. Patient's son reports after receiving the second vaccine dose the patient started to take very short steps and took a long time to get anywhere. Had to be held up by his son. Normally he uses a walker to ambulate and get around most places. Also the patient's son reports that he was poor to respond when given directions and will instead stare straight ahead. Son also reported frequent belching with the patient occurring overnight. No vomiting or diarrhea. Patient did have AKI on admission (creatinine 1.7, baseline ~ 1.1) and had been on gabapentin 900mg TID outpatient (this was reduced inpatient) which could have contributed to confusion. The patient did not have any reaction to the first vaccine. Attending physicians attributed acute metabolic encephalopathy, gait abnormality, and fever to Moderna vaccine. Acute encephalopathy was noted to be resolved on 5/27/21. Patient discharge home with home health 6/1/21.

hospitalized overnight because of problem related to heart.; blood pressure was high in hospital; feeling crappy.; fatigue.; feels dizzy; feels weak / doesn't have lot of strength; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of CARDIAC DISCOMFORT (hospitalized overnight because of problem related to heart.) and BLOOD PRESSURE INCREASED (blood pressure was high in hospital) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced DIZZINESS (feels dizzy) and ASTHENIA (feels weak / doesn't have lot of strength). On 04-Mar-2021, the patient experienced FEELING ABNORMAL (feeling crappy.) and FATIGUE (fatigue.). On 12-Apr-2021, the patient experienced CARDIAC DISCOMFORT (hospitalized overnight because of problem related to heart.) (seriousness criterion hospitalization) and BLOOD PRESSURE INCREASED (blood pressure was high in hospital) (seriousness criterion hospitalization). The patient was hospitalized on 12-Apr-2021 due to BLOOD PRESSURE INCREASED and CARDIAC DISCOMFORT. At the time of the report, CARDIAC DISCOMFORT (hospitalized overnight because of problem related to heart.), BLOOD PRESSURE INCREASED (blood pressure was high in hospital), DIZZINESS (feels dizzy), ASTHENIA (feels weak / doesn't have lot of strength), FEELING ABNORMAL (feeling crappy.) and FATIGUE (fatigue.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood pressure measurement: high (High) Blood pressure increased. Concomitant medication included Blood pressure medicine. Treatment included Blood pressure medication. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

he fell flat on his back facing the ceiling and didn't know where he was at that moment,He fell down 3 times; Vaccine nearly killed; He fell down 3 times going to use the bathroom and when he tried to stand up he couldn't feel if his leg is there/numbness in his leg bilaterally; Confused/messed up in the head; Unstable/Feels like he does not have much longer to live/feels like he is in a nightmare; Disoriented; Memory worsen; Fallen between the bed and table/fell multiple times in the hallway; Weakness; Felt unstable on his feet/off balance; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (he fell flat on his back facing the ceiling and didn't know where he was at that moment,He fell down 3 times) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History was Reported. Concomitant products included ASA for an unknown indication. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-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 experienced LOSS OF CONSCIOUSNESS (he fell flat on his back facing the ceiling and didn't know where he was at that moment,He fell down 3 times) (seriousness criterion medically significant), VACCINATION COMPLICATION (Vaccine nearly killed), HYPOAESTHESIA (He fell down 3 times going to use the bathroom and when he tried to stand up he couldn't feel if his leg is there/numbness in his leg bilaterally), CONFUSIONAL STATE (Confused/messed up in the head), FEELING ABNORMAL (Unstable/Feels like he does not have much longer to live/feels like he is in a nightmare), DISORIENTATION (Disoriented), MEMORY IMPAIRMENT (Memory worsen), FALL (Fallen between the bed and table/fell multiple times in the hallway), ASTHENIA (Weakness) and BALANCE DISORDER (Felt unstable on his feet/off balance). At the time of the report, LOSS OF CONSCIOUSNESS (he fell flat on his back facing the ceiling and didn't know where he was at that moment,He fell down 3 times), VACCINATION COMPLICATION (Vaccine nearly killed), HYPOAESTHESIA (He fell down 3 times going to use the bathroom and when he tried to stand up he couldn't feel if his leg is there/numbness in his leg bilaterally), CONFUSIONAL STATE (Confused/messed up in the head), FEELING ABNORMAL (Unstable/Feels like he does not have much longer to live/feels like he is in a nightmare), DISORIENTATION (Disoriented), MEMORY IMPAIRMENT (Memory worsen), FALL (Fallen between the bed and table/fell multiple times in the hallway), ASTHENIA (Weakness) and BALANCE DISORDER (Felt unstable on his feet/off balance) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. This case concerns an 84-year-old male with a serious unexpected event of loss of consciousness, and nonserious vaccination complication, hypoaesthesia, confusional state, feeling abnormal, disorientation, memory impairment, fall, asthenia, and balance disorder. Event onset with unknown latency after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 21-Jun-2021: Added Vaccine Dose dates, New events Feeling abnormal ,Disorientation, Confusional State, Fall, Asthenia, Balance disorder added.; Sender's Comments: This case concerns an 84-year-old male with a serious unexpected event of loss of consciousness, and nonserious vaccination complication, hypoaesthesia, confusional state, feeling abnormal, disorientation, memory impairment, fall, asthenia, and balance disorder. Event onset with unknown latency after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient presents today with his wife and son. He was recently hospitalized having developed a fever the day after his Covid vaccine 1 with associated confusion and some ataxia. He was admitted to the hospital overnight where an MRI scan suggested no acute change showing only moderate cerebral atrophy and some small vessel occlusive changes. He tested positive for Covid by PCR in the emergency department on 1/22. His oxygen saturation was stable. He did have a fever and describes falling off the toilet because of some generalized leg weakness and uncoordination. He has had some chronic left greater than right upper extremity sensory loss following prior cervical spine stenosis requiring urgent surgery in 3/2019. He has had some chronic left foot drop as well. He reports being somewhat deconditioned having spent some time in bed to the above episode but is now ambulating with a cane at home and has occupational and physical therapy in place. He has been mildly dyspneic on exertion above baseline but attributes this to some deconditioning. He did have an episode of lower dental pain with ambulation in the office that was more than usual though denies associated chest pain or pressure and has had no jaw or shoulder pain with exertion. Review of systems is negative for headache.

On Tuesday after receiving the vaccine Lowell fell out of bed and was unable to get up. I called 911 and the EMTs helped him up into his wheelchair. Since he has Parkinson's and has balance problems he is unable to stand on his own for very long. All day Tuesday he was incoherent and fell twice in the bathroom where on the floor he was incontinent of his bowels. Later in the day he was incontinent of urine while sitting in his chair and was unaware of it. Two days later he says he doesn't recall any of that but his cognition seems to be better now. I think this should be a warning for Parkinson's patients.

Aprox. 5 minutes post vaccination patient complained of dizziness. When interviewed he stated he had not had any water only coffee today. Patient was provided a bottle of water to sip on while he finshed waiting in the vechile for observation for 15 min. About 5 mins later, checked on patient and patient reported to be doing fine, no complaints and dizziness had resolved. 5 minutes later patients wife called over observation staff reporting patient was having chest pain. Patient appeard altered, but with history of dementia. 911 was called and patient was transported via ambulance. Complaining of 5/10 dull pain in his left upper chest improved when given nitroglycerin en route ED department. No SOB and patient denies ever having pain like this in the past. Observed in the ED for approx 6 hours. Patient then discharged home. Per ED provider "85 y/o male who presents w/ CP s/p COVID vaccine inj. Low clinical suspicion for acute cardo pul pathology give atypical hx, neg ED workup. No recurrence of sx while being observed in ED. Dc w/ con sx care, f/u PCP

I am a four-year resident of facility and have never experienced a serious illness or traumatic injury in all of my adult life (I turn 86 this year). So on January 23rd I received my initial shot of the Moderna vaccine, for which I experienced no reaction, whatsoever. One month later I returned to hospital for my Moderna Booster shot on Saturday, February 20. I felt a few chills that evening, with nothing to speak about, but awoke on Sunday morning feeling so ill that I could barely sit up in bed. I borrowed my wife?s walker and managed to make it to and from the bathroom, and got back to bed again, whereupon I called my son, an emergency-room physician, who told me to take two Advil tablets (or its equivalent), and welcomed me to the club. I stayed in bed through the rest of Sunday and continued to sleep and rest throughout Monday morning, only feeling well enough to get out of bed without assistance by noon on Monday, thereby missing the February meeting of the monthly meeting that had been scheduled for that morning (and for which I had regularly been a member of and had attended every meeting for over three years). My personal takeaway from all this was that ?the cure was worse than the disease.?

Lethargy, Brain fog, night sweats, huge increase in Arthritis pain all for three days, still lingering

Thick congestion in back of nose and throat; pounding rapid irregular pulse; heavy breathing; no sleep that night. Next morning all symptoms rapidly disappeared. No further problems.

Severe whole body pain (similar to the flu), cold, chills, not accompanied by fever. Unable to sleep, extreme fatigue. Treated with Tramadol, external heat sources, etc but not effective. Lasted all night & all the next day

After getting the second Moderna vaccine, 0.5 ml, Lot 031M20A on Friday, Feb 26, 2021 at 1020, I got back home without any problem. That evening I had started to get a headache (don't normally get headaches) and felt very tired. I went to bed about 8 PM after having some rice/tomato soup. On Saturday, Feb 27, I awoke about 0700 (7AM) and did not feel well. I normally get 7 hours of sleep a night arising at 0630. Stayed in bed until noon. Came downstairs and laid on the couch. I took my temperature at 1300 at 96.8. Took my temperature at 1700 and it was 100.4o. Started to feel better by 8 PM. Took my temperature at 20

general weakness My whole body is "soft"; He cannot walk; I cannot sit; I can't do anything; A spontaneous report was received from a Consumer concerning an 85 Year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Asthenia, Walking disability, Sitting disability, and Impaired work ability. The patient's medical history was not provided. No Concomitant medications used by the patient was reported. On 25 Feb 2021, prior to the onset of the events, the patient received the second of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for prophylaxis of COVID-19 infection. On 26 Feb 2021, the patient was unable to do anything. His whole body was soft and disabled .Also he was not able to sit,walk and do nothing. All the events were considered as medically significant. No Laboratory details were provided. No Treatment details was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events were reported 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.

Patient is diabetic, but well controlled with insulin. He had his second COVID vaccine on March 5. His wife noticed some increased confusion and drowsiness for the last 2 days (starting 3/9). He came to the ED on 3/11 with a blood sugar of over 600. He was admitted for observation to our unit 3/11.

Altered mental state/semi-conscious. Awake but unable to respond to questions., unable to rise from seated position. Lasted approximately 5 hours. Has no memory of this time period. Headache, weakness, fatigue persisted beyond 5 hours. Was fatigued for approximately 48 hours. Typically, he has excellent cognition, and is alert and oriented. His wife spoke to Dr., but didn?t have office visit.

Frequent falling down, dizziness, inability to walk normally, confusion, inability to breathe , heavy chest

E83.42 - Hypomagnesemia R77.8 - Elevated troponin A41.9, R65.20 - Severe sepsis (CMS/HCC) R50.9 - Fever, unspecified fever cause A41.9 - Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (CMS/HCC) R41.0 - Delirium N39.0 - Urinary tract infection A41.9 - Sepsis (CMS/HCC)

death Narrative: Patient received Moderna covid #1 on 1/9/21 and #2 on 2/8/21. On 2/24/21, he was sent to the ER at a facility from a nursing home where he was admitted for skilled nursing care. He was sent to the ER due to fever, decreased mental status, renal failure, possible UTI and possible pneumonia. He was admitted and received IV fluids, Zosyn and Solu Medrol. On 2/26/21, a consult was placed for hospice care and he was accepted for hospice care at a contract nursing home. Upon review of scanned records, it appears he had a stroke/intercranial hemorrhage on 2/10/21 and that is why he was admitted to the nursing home for skilled nursing services. A date of death of 3/18/21 is recorded. No autopsy results recorded. 38 days from vaccine #2 and date of death.

Extreme headache, and this what we would like to report....hallucinations. Still having some hallucinations but getting better after 3 days.

Case tested positive for COVID-19 on 12/7/2020; vaccinated on 1/8/2021 and 2/5/2021 with Moderna; re-tested positive for COVID-19 on 4/1/2021. Case was admitted to hospital on 4/2/2021 for surgery due to a previous fall. Case had altered mental status and fever. Case was found to have an acute CVA.

Pt presented from a nursing home due to AMS. Was found to be COVID positive post vaccination. Pt was diagnosed with COVID pneumonia.

he crippled; not able to move; he has extreme pain/stabbing pain; he has overactive immune system; he can hardly walk; he can not do anything by himself/can not go to bathroom; can not get out of bed; he can not come down to eat so I need to bring food; when he is trying to lie down I need to lift up his feet,; he can barely feels his feet, its numb; This spontaneous case was reported by a consumer and describes the occurrence of DISABILITY (he crippled) and IMMOBILE (not able to move) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Polymyalgia. Concomitant products included PREDNISONE for Polymyalgia. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced DISABILITY (he crippled) (seriousness criterion medically significant), IMMOBILE (not able to move) (seriousness criterion medically significant), PAIN (he has extreme pain/stabbing pain), IMMUNE SYSTEM DISORDER (he has overactive immune system), GAIT DISTURBANCE (he can hardly walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he can not do anything by himself/can not go to bathroom), BEDRIDDEN (can not get out of bed), MOBILITY DECREASED (he can not come down to eat so I need to bring food), HYPOKINESIA (when he is trying to lie down I need to lift up his feet,) and HYPOAESTHESIA (he can barely feels his feet, its numb). At the time of the report, DISABILITY (he crippled), IMMOBILE (not able to move), PAIN (he has extreme pain/stabbing pain), IMMUNE SYSTEM DISORDER (he has overactive immune system), GAIT DISTURBANCE (he can hardly walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (he can not do anything by himself/can not go to bathroom), BEDRIDDEN (can not get out of bed), MOBILITY DECREASED (he can not come down to eat so I need to bring food), HYPOKINESIA (when he is trying to lie down I need to lift up his feet,) and HYPOAESTHESIA (he can barely feels his feet, its numb) had not resolved. Not Provided Additional concomitant medications included blood pressure medication (not otherwise specified). Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. Though the events reported are expected due to the patient's medical history of polymyalgia, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-114778 (Patient Link).; Sender's Comments: Though the events reported are expected due to the patient's medical history of polymyalgia, 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 for treatment of hematuria and altered mental status on 4/21/21 When we were preparing to discharge patient to nursing facility, he had a COVID-19 test that returned positive (PCR) even though he was vaccinated (3/5/21; 4/2/21) and had COVID-19 in January. The patient only stayed in the hospital because of the positive COVID test. Patient was placed on isolation however he never displayed any symptoms of COVID infection. Repeat COVID swab on 5/7 was negative.

Blood clots; felt he was having a heart attack; He lost control of his ability to walk; Became Worse; He lives a sad limited life; Angry; Purple like having a blood clot; Pain; Completely ill/sick; Weaker Heart; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) and MYOCARDIAL INFARCTION (felt he was having a heart attack) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cancer (Was on Chemotherapy and radiation treatment), Handicap, Penicillin allergy, Sulfonamide allergy (Sulfa) and Drug allergy (Morphine). Concomitant products included APIXABAN, FUROSEMIDE and METOPROLOL TARTRATE for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced THROMBOSIS (Blood clots) (seriousness criteria hospitalization and medically significant), MYOCARDIAL INFARCTION (felt he was having a heart attack) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (Weaker Heart), VACCINATION COMPLICATION (Completely ill/sick) and VACCINATION SITE PAIN (Pain). On an unknown date, the patient experienced GAIT DISTURBANCE (He lost control of his ability to walk), CONDITION AGGRAVATED (Became Worse), DEPRESSED MOOD (He lives a sad limited life), ANGER (Angry) and VACCINATION SITE ERYTHEMA (Purple like having a blood clot). The patient was hospitalized from 17-Feb-2021 to 26-Feb-2021 due to MYOCARDIAL INFARCTION and THROMBOSIS. At the time of the report, THROMBOSIS (Blood clots), MYOCARDIAL INFARCTION (felt he was having a heart attack), CARDIAC DISORDER (Weaker Heart), GAIT DISTURBANCE (He lost control of his ability to walk), CONDITION AGGRAVATED (Became Worse), VACCINATION COMPLICATION (Completely ill/sick), DEPRESSED MOOD (He lives a sad limited life), ANGER (Angry), VACCINATION SITE ERYTHEMA (Purple like having a blood clot) and VACCINATION SITE PAIN (Pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The first dose of Moderna vaccine reportedly given on 08 Jan 2021. The patient's wife reported that he would not take the second shot. However, it was reported that patient's events started 10 Feb 2021, 2 days after vaccination. Therefore, the date of first dose and whether patient received second dose (and if he did, on what date) are unclear. Patient has received home therapy. Patient stated that on 22 Jun 2021 his health was failing daily and he had radiation from his cancer treatments in his body when the shot was given. It was felt the shot had taken his health to a point of no return - "bad call on the people who set him up for the shot and did not screen his health ". Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Patient details, medical history, and suspect product details were updated. Events and concomitant medications were added. Case upgraded to serious.; 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.

Myasthenia Gravis; Death; Hallucinations; confusion; shortness of breath; dizziness; stroke like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), MYASTHENIA GRAVIS (Myasthenia Gravis) and HALLUCINATION (Hallucinations) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart attack (20 years ago). On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYASTHENIA GRAVIS (Myasthenia Gravis) (seriousness criteria death, hospitalization prolonged and medically significant), HALLUCINATION (Hallucinations) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms). The patient died on 12-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HALLUCINATION (Hallucinations), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms) outcome was unknown. Patient started experiencing side effects 2 weeks after taking the vaccine. He was taken to the hospital for stroke like symptoms but it was ruled out by X-ray. He went to the hospital as symptoms persisted & got admitted on 13March2021. He died 24 hour later after being diagnosed with Myasthenia Gravis and thymus removal refusal. Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death

Pt received Moderna covid vaccine on 1/11/21. Began experiencing "violent shaking" and decreased appetite yesterday morning, throughout the day yesterday became delirious and unable to recognize people, understand speech, control his bladder or walk without falling.

Patient woke on 1/12 with violent shaking, nausea, fatigue and decreased appetite. Throughout the day on 1/12 pt became delirious, no longer recognizing people, not able to understand speech, incontinence of bladder and is unable to walk without falling.

Patients daughter called and reported the patient started to feel badly last night with vomiting and diarrhea, she also reported a fever today of 103. MD was called and advised patient go to the hospital to be evaluated. The patient was evaluated at the hospital and has since been discharged to home without further incident.

Initially had the pain in the arm, went to bed and woke up at 3-4 AM with shaking, body aches all over and just washed out feeling and weak. The symptoms are going away, still weak but feeling better. He took 3 Tylenol at 3:00 AM. Shaking has gone, body aches are not as bad as they were but still occasionally has some. Pain in the arm is subsiding as well.

Fell out of bed, couldn't walk, talk and had severe heath palpitations sleep on floor. Later crawled to bathroom and could get on toilet. Wife helped me up.spent the rest of the night on floor. Next day the same situation got on bed slept all day. Third day made it to the living room and slept all day. Drowsy and confused for 3 days. I did not remember much of this my wife helped me.

He was brought into the ER via EMS for altered mental status. He does have an underlying dementia but is normally able to hold a conversation and take care of himself. He was standing at kitchen sink staring off and drooling from his mouth. He was not able to answer questions, unable to find the words, and was weak. Admitted to hospital.

The day after receiving his second COVID19 vaccine, he comes to our ER brought in by his neighbor. Patient apparently was found down in the house. He was covered in feces. Patient is confused, and is not able to give a good history. Apparently his daughter called and was not able to reach him. She called his neighbor to check on him. He does not have any complaints but he is confused. He does have generalized weakness. Tested for COVID19 on admission per policy and was incidentally found to be positive. Patient was hydrated and became stronger and discharged.

Patient complaining of flu-like symptoms beginning on day following second vaccination. Exceptional symptoms included severe abdominal pain and hallucinations, lasting 24-48 hours. Little or no fever noted. Did not follow with physician. Self reported to Health Department due to noted abdominal pain and hallucinations.

Patient was in usual state of health when received first Covid Moderna vaccine on 2/2/21 and did fine until about 2/17. He started c/o discomfort and appetite decreased. 2/18/21 had low grade fever. 2/22 fever and generalized weakness and abnormal labs (elevated potassium). 2/22 hydration was started. 2/25 antibiotic started for UTI for 7 days. Patient seem to improve except appetite. Since vaccine, patient remained on frequent IV hydration and had poor appetite through February into March. On 3/2/21, patient received 2nd dose of Moderna Vaccine while on Augmentin for UTI, issue with dehydration and appetite. By 3/4/21, patient was noticed to have trouble chewing and swallowing. Speech was ordered. On 3/5/21, it was noted patient had continued poor appetite, weakness, dehydration risk, debility. On 3/8/21, it was noted patient had intermittent confusion. By 3/10/21, patient was more alert. Patient remained fairly consistent from that time with poor appetite, dehydration issue, weakness and dysphagia management. Then on 3/27/21 he became disoriented, wheezing, labored breathing, Vitals were 92% oxygen on room air, Temp 97.5, 158/62, pulse 94. Oxygen started and sent to ER. Family reported patient is admitted to hospital with mild stroke and UTI. The vaccine seemed to change patient's state of health about 2 weeks post first dose with multiple sequelae. This seems similar to timing of actual COVID infection pattern when it is the actual virus.

Client reports got really sick with pain in elbows, feet, hands, and knees right after vaccination on 04-16-21. He didn't think he could drive home, felt like he needed to stop at a friend's home, but did not make it home. Could barely walk and had a hard time getting out of bed the next day. Reported he did get sick to stomach and had diarrhea on Saturday, did not have a fever. Reports Sunday through Monday he felt better but still painful in his joints. He wanted to go to ER but his daughter told him to wait it out.

Fluid in lungs; Positive COVID test; Feeling poor; Dehydration; Loopy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY OEDEMA (Fluid in lungs), COVID-19 (Positive COVID test), DEHYDRATION (Dehydration), CONFUSIONAL STATE (Loopy) and FEELING ABNORMAL (Feeling poor) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PULMONARY OEDEMA (Fluid in lungs) (seriousness criterion hospitalization), COVID-19 (Positive COVID test) (seriousness criterion hospitalization), DEHYDRATION (Dehydration) (seriousness criterion hospitalization), CONFUSIONAL STATE (Loopy) (seriousness criterion hospitalization) and FEELING ABNORMAL (Feeling poor) (seriousness criterion hospitalization). The patient was hospitalized from 22-Mar-2021 to 23-Mar-2021 due to CONFUSIONAL STATE and DEHYDRATION. The patient was treated with Surgery for Pulmonary oedema. On 23-Mar-2021, PULMONARY OEDEMA (Fluid in lungs), DEHYDRATION (Dehydration), CONFUSIONAL STATE (Loopy) and FEELING ABNORMAL (Feeling poor) had resolved. At the time of the report, COVID-19 (Positive COVID test) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications include Blood Thinners (unspecified). The reporter did not mention any treatment medications for the events. 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. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient experiences weakness in the lower extremities causing daily activity to be difficult. Patient pushed through and continuously worked out the weak body parts until normal feeling was regained.

After receiving the vaccination in the evening, spouse has Altemizer disease he became non communitive, lethargic, physical depressed, lack of energy and lack of ability to interactive. Depressed or declined in interaction, action. No treatment and the next day he was fine and was better than usual bounce back to his usual self.

reaction to the nitrofurantoin mono-mcr; brain fog (which came and went); weight loss (lost 20 lbs); very little energy; bleeding from the bladder/bleeding from his bladder lasted for a couple of weeks sporadically/ passed a blood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URINARY BLADDER HAEMORRHAGE (bleeding from the bladder/bleeding from his bladder lasted for a couple of weeks sporadically/ passed a blood clot) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Gluten intolerance and Allergy to antibiotic (nitrofurantoin mono-mcr). On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 14-May-2021, the patient experienced FEELING ABNORMAL (brain fog (which came and went)), WEIGHT DECREASED (weight loss (lost 20 lbs)) and ASTHENIA (very little energy). In May 2021, the patient experienced URINARY BLADDER HAEMORRHAGE (bleeding from the bladder/bleeding from his bladder lasted for a couple of weeks sporadically/ passed a blood clot) (seriousness criterion medically significant). On an unknown date, the patient experienced ADVERSE DRUG REACTION (reaction to the nitrofurantoin mono-mcr). The patient was treated with ACETAMINOPHEN at a dose of UNK dosage form and NITROFURANTOIN at a dose of 100 mg, 1 dose. In June 2021, URINARY BLADDER HAEMORRHAGE (bleeding from the bladder/bleeding from his bladder lasted for a couple of weeks sporadically/ passed a blood clot) had resolved. At the time of the report, FEELING ABNORMAL (brain fog (which came and went)), WEIGHT DECREASED (weight loss (lost 20 lbs)), ASTHENIA (very little energy) and ADVERSE DRUG REACTION (reaction to the nitrofurantoin mono-mcr) outcome was unknown. No relevant concomitant medications were provided. Patient experienced the events within a week after receiving the second dose of the vaccine. Patient had visited the emergency room (ER) multiple times for the bleeding from the bladder and tests were done. It is stated that within a week, the patient experienced bleeding from the bladder, brain fog (which came and went), weight loss, which started shortly after second shot (lost 20 lbs), from start had very little energy (which was sporadic but had improved). This was not on 14-MAY-2021. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-220964 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Insomnia, change in sleep pattern used to go to sleep around 1am, waking up around 7am, now can't go to sleep until 5am, waking up around 10am.

Resident displayed with confusion/shaking at 1400, condition worsens at time went. Resident unable to state where he is, knows his name. can tell you he does not feel right. Temp 97.3, p 88, O2 91%, Bp 214/116 Transferred to ED with fever, temp of 103, and shortness of breath, admitted to ICU Positive COVID-19 test at hospital. Diagnoses include acute COVID-19 pneumonia and hypoxia. PO had confusion, fatigue, weakness, hypoxia, increased BP

Weakness and some dizziness started about 1 1/2 hrs after shot was given. It lasted the rest of the day the shot was given and continued on the next day, 01/12. The feeling was far from normal for me. Better this AM, 13th. Called Moderna on 1/12 and they said this was not unusual.

Severe pain at injection site with some swelling, lethargy, and fever to 101.6 degrees F the day after the injection. He was given acetaminophen, which reduced fever to normal. Low grade fever (99-100 degrees F) two days after vaccine. On the third day after vaccine, on 12/31, he became confused and anxious. Temperature was 104.8 degrees F. He was given acetaminophen and oral hydration overnight. He continued to have a fever to 102 on the following day and was taken to the ED. He was COVID-positive and admitted to the hospital for treatment of COVID-19.

The day after vaccine 01/14/2021, he had no strength once so ever in his body. We had to have help from a man and a women to help get him on the toilet, off the toilet, to sit him up on the couch, getting in and out of bed. He could not function on his own. It effected him mentally. Right now he couldn't even that this happened. On the 15th he seemed normal. But now like a week later his memory and strength was bad. Today he is not that bad. It seems to be coming and going with the problem mentally. I took him to the doctor today.

Patient felt light headed for 30 minutes. No associated symptoms. Thinks just nervous. Patient monitored for 45 minutes with resolution.

got at 11:00 Am and around 6:00pm i got chills and ran a slight fever and just felt bad. this morning, i feel cold but don't feel too bad.

Systemic: Rash (other than injection site)-Mild, Systemic: Other- Elevated heart rate, difficulty swallowing, nurse reports mental status changes-Mild

During the observation period, client started to complain of "feeling goofy," blurry vision after 24 minutes of receiving the 1st dose of the Moderna vaccine at 2:48pm. Client stated she was very anxious regarding vaccine and missed her meds. At 3:22pm, juice, water, meds (Xanax 1mg, lisinopril 5mg, eye med po) was given with improvement. She denied shortness of breath, oral/airway symptoms, rash, pruritic, faintness, weakness or nausea.

Nightmares/Night Terrors after sleeping for a couple of hours. His friend who received the vaccine the day before had the same reaction. Very vivid and scary dreams.

My dad had the covid vaccine on Thursday & Friday morning we couldn't wake him up. He had a significant change in mental status. An ambulance needed to be called & he was hospitalized for a week. He is currently in a rehabilitation hospital.

Very sharp pain in arm a few seconds after injection. Felt sore and strange in the evening , and fever and chills started at night. Following day high fever, chills, nausea and fatigue.

He had the vaccine, everything was fine until he got up around 12:30 AM. He was shaking really, really bad with tremors. His wife got up and he had urinated on himself, and his wife felt his forehead and he did not feel hot. Went back to bed, he went to sleep and the next morning 2/13/21, wife got up and when he got up around 7:30 he was dressed, but not buttoned right and had his hat on and was confused. He sat in front of the fireplace not moving, and starting talking nonsense until 9:00 - 9:30 when he started talking to her. He could not differentiate between morning and night, and then slowly progressed back to normal. Did not eat much, and said that he could eat anymore. He was pacing back and forth and then finally cleared mentally and was ok around 10:00 AM. He is now back to his normal self today 2/16/21. She gave him 250 mg of Tylenol around 9:30 AM on 2/13/21 as his temp was 100.1. HIs blood pressure at that time was 103/59 and pulse 100. She then checked it in the other arm and it was 104/60, pulse 99. She then checked it again on Monday and it was 108/61 with 68 pulse rate which is normal for him.

Patient described feeling nervous, anxious the next morning (Wednesday) after the vaccine. He later fell in the bathroom after using the restroom, his legs gave out (his words) and consequently was on the ground for 23 hours before being transported to the hospital. That was Thursday afternoon. He was diagnosed with COVID-19 on Saturday night and died the following Friday morning.

Moderna COVID19 vaccine EUA given at Cheyenne Wy 2/6/2021 1:45 p.m. can't sleep, harder to breathe, anxiety, light headed - dizziness, loss of appetite, no energy

received a phone call from the daughter of the patient. On 01/21/2021, patient came in and got his first Covid Vaccination. 3 days after the vaccination, the patient experienced really bad diarrhea, and was sleeping for 22 hours a day. 2 weeks later he perked up a little bit. On 02/23/2021, patient received his booster. Daughter states that 2 days later, patient shut down completely, not eating or drinking. The patient ended up passing away on 03/05/2021.

total scalp area, ear to ear became sore to touch. Minor headache was infrequent. Several days later the tender scalp receded to the right side only. Unable to sleep but in one position. The soreness has now traveled to include my right eye socket. Dr unable to determine a fix.

delirium started after first dose. Exacerbated greatly after second dose along with psychosis and deliriums. Had to be admitted to geripsycyh unit and subsequently to long term care.

Got the vaccine, had no problems at all. He woke up the next morning on 3/24/21 with extreme pain in his legs, buttocks area, arms, and all muscles for some reason he got quite a bit of pain in his right hand and wrist. He was spared any pain or discomfort in his left hand which is his dominant hand. All of his limbs are very sore, and has a difficult time and having the feeling that he could not use a lot of his muscles. He enjoys walking a couple of miles, bike riding, and push ups and he's not able to do that anymore and very limited in his mobility since his vaccine. He now he cannot get in a car due to having difficulty lifting his legs, he has to use his hands to get his legs in the car now. Getting up and down from a sitting position is also more difficult since the vaccine. He found that bedrest is not what he needs and has to exercise as much as he can, and waking up in the morning is the worst part of the pain that he has, and a little bit better by moving around, and then it returns to the same in the morning. He is not able to walk fast or as far as he used to before. He went to the doctor for his physical and he checked him out and the blood tests which showed no inflammation but otherwise were normal other than some anemia, which they felt came from the vaccine. Now this has caused depression for himself and his wife as they are not able to do the things that they used to be able to do, camping, vacationing and doing yard work as they used to be able to do before the vaccine.

Patient passed out (reported as "blacked out") the day after receiving the vaccine. He was transported by ambulance to hospital. This was the second incident (same incident reported after first dose). He does not have any memory of having passed out.

pt was feeling strange tuesday morning. He wouldn't eat but his wife made him drink. By Wednesday morning he couldn't answer questions about the day, who wife was, and couldn't identify himself in a picture. At that point his wife called the ambulance. He was hospitalized there. He was given the Covid test Wednesday.

Swollen hand starting on 3/26/2021, his hand and fingers were swollen with decreased ROM to extremity. 4/8/2021 presented with persistant elbow pain/swelling with continued limited ROM and ADLs.

Began with slower response to questions and reaction to events. By Feb 10, was having hallucinations, hearing things that weren't there, fear, etc. Hospitalized Feb 12 when he could no longer respond or figure out what was reality and what wasn't. Within days, the doctor did not know if he would live or die. He couldn't eat, slept alot, etc. They new it was a virus in his brain, but not what kind.

ED to Hosp-Admission Discharged 3/8/2021 - 3/9/2021 (14 hours) Hospital MD Last attending ? Treatment team Dementia without behavioral disturbance (CMS/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine Inpatient Discharge Summary BRIEF OVERVIEW Admitting Provider: MD Discharge Provider: MD Primary Care Physician at Discharge: CRNP Admission Date: 3/8/2021 Discharge Date: 3/27/2021 Discharge Diagnosis Hospital Problems POA * (Principal) Dementia without behavioral disturbance (CMS/HCC) Yes Aortic stenosis Yes Atrial fibrillation (CMS/HCC) Yes Chronic obstructive pulmonary disease (CMS/HCC) Yes Congestive heart failure (CMS/HCC) Yes Coronary artery disease with history of myocardial infarction without history of CABG Not Applicable Depression Yes History of aortic valve replacement Not Applicable Hyperlipidemia Yes Hypertension Yes Peripheral vascular disease (CMS/HCC) Yes Ambulatory dysfunction Yes Dementia (CMS/HCC) Yes CKD (chronic kidney disease) Yes History of TIA (transient ischemic attack) Not Applicable Dementia with behavioral disturbance (CMS/HCC) Unknown DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission AKI (acute kidney injury) (CMS/HCC) [N17.9] Dementia with behavioral disturbance (CMS/HCC) [F03.91] Generalized weakness [R53.1] Patient is an 87 y.o. male with past medical history of hypertension, hyperlipidemia AFib not on anticoagulation, sick sinus syndrome status post pacemaker, aortic stenosis status post valve replacement.Coronary artery disease status post CABG, CHF, history of peripheral vascular disease, history of carotid stenosis, severe vertebral artery stenosis, diabetes, CKD, dementia, chronic respiratory failure on 2 L nasal cannula post COVID-19 pneumonia 11/2020 was brought to the emergency room by the family due to worsening confusion and agitation, as per wife after the patient was discharged back in November in few weeks patient dementia started to get worse, more confused, more agitated and few times he was violent to his family members, well for the last few days patient's wife reported that his confusion was very bad so she decided to bring him to the ED for further evaluation management. Hospital Course -For the above presentation patient was admitted to the hospital services, patient was started on oxygen supplementation, Covid repeat test continue to be positive, started on IV antibiotics, IV hydration due to worsening kidney function, in the evening of 3/8 patient was found without any spontaneous respiration, patient was pronounced dead by the RN and CRNP finished the discharge defecate, please refer to RN documentation for more details.

I think it was the patient's wife that told me that after the patient had his COVID vaccine, his mental status decreased. He wasn't able to add or subtract, thought they were moving, but they weren't moving. He has had symptoms for 2 weeks and getting worse. She told me that the doctor is doing a brain scan, not sure if patient has had a stroke.

legs became paralyzed; Within an hour of discharge I was walking wobbling outside,; sometimes brain fog; more like a sinus condition in my head; effecting my sleeping; nauseous; still tired; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MONOPLEGIA (legs became paralyzed) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021, the patient experienced MONOPLEGIA (legs became paralyzed) (seriousness criteria hospitalization, disability and medically significant), GAIT DISTURBANCE (Within an hour of discharge I was walking wobbling outside,), FEELING ABNORMAL (sometimes brain fog), SINUS HEADACHE (more like a sinus condition in my head), SLEEP DISORDER (effecting my sleeping), NAUSEA (nauseous) and FATIGUE (still tired). The patient was treated with Physical therapy (to gain strength) for Gait disturbance. At the time of the report, MONOPLEGIA (legs became paralyzed), GAIT DISTURBANCE (Within an hour of discharge I was walking wobbling outside,), FEELING ABNORMAL (sometimes brain fog), SINUS HEADACHE (more like a sinus condition in my head), SLEEP DISORDER (effecting my sleeping), NAUSEA (nauseous) and FATIGUE (still tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Scan brain: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. The patient took his second dose of the Moderna COVID-19 vaccine (Right Dominant Upper Arm) on 25-Mar-2021. About 1.5 hours after his second dose while he was eating lunch, his legs became paralyzed. He went to urgent care and they took an EKG which found nothing. They suggested he spend the night in the hospital which he did. 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. It is of note that date in RA report is not consistent with the narrative date of second dose (suspect dose), 25 March 2021, after which events took place. Age of subject can be a confounding factor in the event. No further information is expected.; 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. It is of note that date in RA report is not consistent with the narrative date of second dose (suspect dose), 25 March 2021, after which events took place. Age of subject can be a confounding factor in the event. No further information is expected.

ED to Hosp-Admission Discharged 5/21/2021 - 5/28/2021 (7 days) DO Last attending ? Treatment team E coli bacteremia Principal problem Discharge Summary , DO (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Patient: Date: 5/28/2021 DOB: Admission Date: 5/21/2021 PCP: , PA-C Length of Stay: 7 Days Discharging provider: , DO Discharge Date: 5/28/2021 Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) E coli bacteremia Yes Atrial fibrillation with RVR (CMS/HCC) Yes Mitral and aortic valve disease Yes Overview Signed 11/4/2020 5:08 PM by , LPN Note: Moderate AR, MR & TR 1'15 Note: Moderate AR, MR & TR 1'15 Type 2 diabetes mellitus (CMS/HCC) Yes Dementia due to Parkinson's disease without behavioral disturbance (CMS/HCC) Yes Acute metabolic encephalopathy Yes Chronic systolic CHF (congestive heart failure) (CMS/HCC) Yes Sepsis (CMS/HCC) Yes Anemia Yes COVID-19 Clinically Undetermined Overview Signed 5/28/2021 12:11 PM by, DO Asymptomatic, had been positive back in January, tested negative on admission then tested positive when planning for discharge. May just be persistent viral shedding from previous Covid infection Hospital Course HPI:I refer you to the history and physical for completeness. Briefly, patient presented to the emergency department with his family stating that he is a little bit more confused, not as alert, and little bit more short of breath and shaky. Noted to have an elevated white blood cell count lactic acidosis. Hospital Course: Patient was cared for in hospital. Placed on broad-spectrum antibiotics. Blood cultures revealed gram-negative bacteremia most likely due to to possible mild diverticulitis. Throughout the course of his hospitalization he steadily improved. Was transition to oral antibiotics. His cardiac issues were continue to be managed during his hospitalization. He did have some mild encephalopathy associated with the bacteremia and as his infection cleared that improved. Adjustments were made in his home medications. He is started on therapies. Due to his severe deconditioning associated with acute medical illness will need some higher level care and increased rehabilitation. Arrangements were made for him to receive ongoing care at . When he presented to the hospital he tested negative for COVID-19. In preparation to going to the he tested positive. He was completely asymptomatic as far as COVID-19 symptoms are concerned. He was previously positive in January 2021 for Covid. This could just be a prolonged positive testing from his infection in January. Nondetected COVID-19 test on 5/21/2021 could potentially be a false negative. At this point would recommend isolation for 10 days from 5/26/2021. Otherwise his vital signs are stable. Improved the point where he no longer requires hospital level care and can be discharged to

Itching at site and surrounding area. Most prevalent during sleep hours. Continued mildly throuh the day after injection and interfered with sleep on second night after injection. Tried Calendula the first day and Hydrocortisone the second day. No noticeable efficacy. Itching continues on third day after receiving shot.

Care giver reports patient experienced hallucinations the night/the next morning of the COVID-19 vaccine. The care giver states the patient is seeing his deceased wife. At the time the second dose was due, the symptoms have not gone away per the caregiver. The faculty contacted the doctor in regards to the reported side effect, however the doctor did not have a clear diagnoses or assessment regarding the patients condition. The Rph did not administer the second dose due the reported side effects. The daughter of the patient (who has power of attorney) was contacted by the faculty manager and she was okay with not giving the second dose.

felt delirious; felt lightheaded; had a terrible dream; felt nauseous; A spontaneous report was received from a consumer reporting on himself, an 88-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and felt delirious/MedDRA PT: delirious, felt nauseous/MedDRA PT: nausea, felt lightheaded/MedDRA PT: lightheadedness, and had a terrible dream/MedDRA PT: terrifying dreams. The patient's medical history was not provided. Concomitant medication use was not provided. On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. The patient reported that during the night, he felt lightheaded, had a terrible dream, felt nauseous and delirious. The patient felt better the following day and his primary care physician was aware of the side effects. Treatment for the events included paracetamol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events of felt delirious, felt nauseous, felt lightheaded and had a terrible dream were considered recovering/resolving.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the event to be unlikely related to company product.

Hypoxia, Decreased responsiveness, Narrative: 86yo male with PMHx HTN, Afib not on AC after head trauma, CVA, and colon cancer who was brought to the ED by his family on 2/17. Per documentation the pt was in his usual state of health until 2/16. Received Moderna covid vaccine #2 on 2/16/21 at 0900, and was monitored for 15 minutes following immunization no noted issues. Later that night, had myalgias and took Tylenol. Per the family he slipped on the ice and fell on his butt. Overnight, had several dark stools and vomitus. was brought to the ED by his family because he was being less responsive. Pt arrived to the emergency department in extremis. No pulse identified. CPR immediately initiated for several rounds lasting about 25-30 minutes. ROSC unable to be achieved. Patient expired on 2/17 at 1941. Of note, per previous documentation had waxing and waning mental status at baseline. No symptoms noted with 1st dose of Moderna vaccine, which was administered on 1/16/21.

22 hours after injection, woke up with generalized moderate to severe weakness, mild confusion and temperature elevation with sweats.

I came home and found my father on the floor in his bedroom just after 8am. He was disoriented and unable to get up. I had to lift him up and he was still off balanced. I asked him if he had fallen and how long he was on the floor. He couldn't give me a clear answer and I don't know how long he was on the floor. I noticed he seemed very weak and I asked him when was the last time he had something to eat and he wasn't sure. He said maybe 1 or 2 days. I asked if he didn't have an appetite and he couldn't answer me or give me a reason.

Patient stated he felt uncomfortable the day he got his vaccine. In the next few days, he had facial drooping, slurred speech and muscle sensitivities in legs. His face is still slightly drooped as of today 3/6/21. Per the patient, his doctor advised not to get the second dose of the vaccine.

-Rapid onset shortness of breath (10-20 minutes after vaccine administration). -Required ICU admission for acute respiratory failure and acute heart failure. -Acute reduction in ejection fraction (EF20-25%) in a patient that otherwise had a normally documented EF (>65%), see below. -Hospital course required BiPAP and dobutamine support and treatment for pulmonary edema with Lasix. -Cardiology consulted for acute heart failure management. Eventual wean of oxygen and dobutamine requirement and discharged on oral heart failure regimen. -Hospital course complicated by ICU delirium. -Total length of hospital stay 8 days

Patient states it started the day of shot with shoulder, arms, hip stiffness and so bad it was very difficult to get around. Presented to ER on 2/21/21 stating he hadn't felt good all week. C/o weakness, dizziness and shortness of breath and pain on right side ribs from coughing. Diagnosis: Pneumonitis, Hypoxia

Systemic: Body Aches Generalized-Mild, Systemic: Confusion-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Shakiness-Severe, Systemic: Weakness-Severe, Additional Details: Had nausea and diarrhea, not feeling as well as he was before the vaccine, weaker, poorer memory.

Gemeralized weakness; Lightheadedness; Dehydration (hospital diagnosis at time of emergency treatment) Sudden complete loss of bowel contol (day after vaccination (02/26/2021) Dizziness, loss of balance (02/27/2021) Confusion, low energy, constipation, diarhea, limited ability to use computer (02/28-03/14/2021)

Pt was given 3rd dose of Moderna Covid Vax in error on 3/11/2021 at the rehabilitation center. 3/12/2021 - according to nursing home pt was acting strange around 7:30 am. Pt was scheduled to be picked up by family members at 9:00 am. When family got there the pt was unresponsive and 911 was called. He was transported by ambulance to Medical Center ER. Pt was intubated. He had fever so was given 3 different types of antibiotics. He was given for blood pressure medicine and Chest X-ray. He was moved to ICU and considered critical. Family was called in to make final decisions. His organs were failing. He was on ventilator at 100%. On 3/16/2021 the family made the decision to remove him from the ventilator. He passed around 7 AM on 3/16/2021.

blood clots in his right leg and left leg; Emergency Room at 4am because he had trouble breathing and walking; found blood on both his lungs; chills especially at night that lasted 2 nights; He states he is still in misery; Patient was supposed to get second dose on 04-Mar-2021, but he is not going to get it; shoulder pain/hip pain; Pain in arms, leg; trouble walking due to his pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots in his right leg and left leg), DYSPNOEA (Emergency Room at 4am because he had trouble breathing and walking), HAEMOPTYSIS (found blood on both his lungs) and CHILLS (chills especially at night that lasted 2 nights) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Asthma since an unknown date. Concomitant products included MONTELUKAST and FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) for Asthma, METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced THROMBOSIS (blood clots in his right leg and left leg) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Emergency Room at 4am because he had trouble breathing and walking) (seriousness criterion hospitalization), HAEMOPTYSIS (found blood on both his lungs) (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (Pain in arms, leg), GAIT DISTURBANCE (trouble walking due to his pain) and ARTHRALGIA (shoulder pain/hip pain). On 04-Mar-2021, the patient experienced INTENTIONAL DOSE OMISSION (Patient was supposed to get second dose on 04-Mar-2021, but he is not going to get it). On an unknown date, the patient experienced CHILLS (chills especially at night that lasted 2 nights) (seriousness criterion hospitalization) and FEELING ABNORMAL (He states he is still in misery). The patient was hospitalized on 20-Feb-2021 due to DYSPNOEA, HAEMOPTYSIS and THROMBOSIS, and then for 2 days due to CHILLS. At the time of the report, THROMBOSIS (blood clots in his right leg and left leg), DYSPNOEA (Emergency Room at 4am because he had trouble breathing and walking), HAEMOPTYSIS (found blood on both his lungs), PAIN IN EXTREMITY (Pain in arms, leg), GAIT DISTURBANCE (trouble walking due to his pain), FEELING ABNORMAL (He states he is still in misery) and ARTHRALGIA (shoulder pain/hip pain) had not resolved and CHILLS (chills especially at night that lasted 2 nights) and INTENTIONAL DOSE OMISSION (Patient was supposed to get second dose on 04-Mar-2021, but he is not going to get it) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Chest X-ray: (abnormal) Found blood on both of his lungs. On an unknown date, SARS-CoV-2 test: (Negative) Negative. On an unknown date, Ultrasound scan: (abnormal) Found blood clots in his right leg and left leg. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient was taken to the ER (Emergency Room) on 20-Feb-2021 at 4 AM. Several tests including Chest X-Ray, MRI, Blood work, Ultrasound (groin and legs) were performed. Only few tests results were reported. Received treatment including Oxygen, Eliquis and Antibiotics. Patient has been on oxygen full time until 7Apr2021 Company comment: Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these event, a causal relationship cannot be excluded. Further information has been requested.

Emesis and increased nausea, hallucinations, and delusions along with restlessness. Resident is on health care and may be r/t change in condition of heart failure .

Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug adverse event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was admitted on 2/27/21 with acute encephalopathy and suffering progressively worsening mental status. He was admitted for over a month through 3/31/21 where he was eventually discharged on hospice before passing on 4/5/21. His hospital course consisted of treating community acquired pneumonia/bacteremia from hemodialysis catheter placement. Patient continued to have positive cultures despite antibiotics due to a found vegetation on the aortic valve. He experienced functional and cognitive decline over his admission. Comorbidities include vascular dementia, h/o stroke, ESRD on HD, HTN, DM2, HLD

Fell flat on my stomach, face first; After about 30 minutes I felt the surface descending and my walk pace increased; Finally I fell forward on my face; Suddenly felt like I was walking down a hill, I was descending. The street was flat.; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Fell flat on my stomach, face first), GAIT DISTURBANCE (After about 30 minutes I felt the surface descending and my walk pace increased) and FALL (Finally I fell forward on my face) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Prostate cancer since 01-Jul-1996 and Cane user. Concomitant products included LEUPRORELIN ACETATE (LUPRON) for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced MUSCULAR WEAKNESS (Fell flat on my stomach, face first) (seriousness criterion hospitalization), GAIT DISTURBANCE (After about 30 minutes I felt the surface descending and my walk pace increased) (seriousness criterion hospitalization), FALL (Finally I fell forward on my face) (seriousness criterion hospitalization) and FEELING ABNORMAL (Suddenly felt like I was walking down a hill, I was descending. The street was flat.). The patient was hospitalized from 07-Apr-2020 to 08-Apr-2020 due to FALL. The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 2 UNK. At the time of the report, MUSCULAR WEAKNESS (Fell flat on my stomach, face first), GAIT DISTURBANCE (After about 30 minutes I felt the surface descending and my walk pace increased), FALL (Finally I fell forward on my face) and FEELING ABNORMAL (Suddenly felt like I was walking down a hill, I was descending. The street was flat.) outcome was unknown. Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Follow up received medical history, concomitant medications and events were added and reporter information was updated and 1st dose details 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 the events, a causal relationship cannot be excluded.

After receiving Moderna vaccine, pt became increasingly tired, withdrawn, and confused, refusing to walk at home. He has begun to have mild memory changes after suspected COVID illness (covid testing negative) in November, but daughter of patient, with whom he lives, states that his memory and orientation now significantly changed- he seems to have forgotten the last "3 years" of memory. Presented to ER 1/16/21 as she checked his O2 and found him to be hypoxic in 60s. He is being treated for possible CAP with underlying perviously undiagnosed ILD vs post-covid lung changes (per pulmonology), and his energy and ability to walk have returned but memory is significantly impaired, confabulating and oriented only to self despite good oxygenation on 5L O2 by NC.

On 0126/2021-After 4 hours, left arm, became stiff in muscle down to wrist plus pain and ache upon movement plus itching from left armpit to stomach; subsided by 4pm; then next 4 days, patient awakened about 1:30 am to 2:30 am with constant pain in arm; took 2 Tylenol, lessened by 6 am. Then at 1:30 am 01/31/2021, flat in bed, awakened by a severe pain in both shoulders, arms, sides with movement of crushing sensation and weird feeling going down left side to belt line, crossing over and meeting at right side belt line; with crushing, paralyzed effect for about 30 minutes. i felt like about ready to die. Tried arms and legs to work with some exercise, helped little. Got up,for toilet to urinate, took 2 tylenol,

Per granddaughter's report, pt became very weak within hours of receiving the first dose of the Moderna COVID-19 vaccine and could not get out of bed the next morning without assistance, reported difficulty seeing, and did not recognize some family members. By Sunday, 1/31, pt was unable to be awakened, would not eat, and had low urinary output. Granddaughter reports that the morning of 2/1 he was awake and ate a small amount and seemed to be improving although still weak and unable to get out of bed. Granddaughter reported he died 2/1 around 10am in the morning.

I received a Moderna vaccine injection on January 19, 2021 at approximately 3:15 p.m. Later that evening at about 7:40 p.m, I was suddenly hit with pain in my back like someone had hit me with a board. The pain continued to surround the midsection in a swath of about 15 inches. I felt like my muscles were failing me. I made it to my bed where I started shivering and shaking uncontrollably feeling like I was having a seizure. The shaking was sporadic, lasting about an hour. I was covered with a blanket and continued with liquids for dehydration and was given an Xanax to calm nerves. Later that night while attempting to sleep, I was perspiring and my heart was beating 90 to 100 beats hindering sleep. Through the night I attempted to go to the bathroom but with absolutely no control over my arms and legs I was unable to stand. Rolling off the bed and unable to pull myself back, I lay on the floor and pulled a cover over me. At about 4:30 a.m. (Wednesday morning.) I was covered with another blanket and a pillow was put under my head. I slept until awakened at about 11 a.m My heart rate and oxygen level was chedked and appeared to be within normal range. I was greatly fatigued, and light-headed. Continuing a regimen of liquids, I was fed a small amount of soup and some fruit. I ate nothing the rest of the day. I slept most of the day. In the evening, I was fatigued and nauseated and spent 2-3 hours through the night on my knees in the bathroom attempting to vomit. Thursday morning I was awakened around 11.a.m. and was barely able to lift my head. I slept more until needing to use the bathroom and receiving more liquids. Two hours later I was able to eat only a half a piece of toast ? the first and only thing I was able to eat that day. Early evening having no control of my legs, I attempted to walk. It was difficult getting legs out of the covers, but I got up and walked a few feet with the help of a walker. However, an hour later (about 8:30) I went to the bathroom and was unable to pull myself up from the toilet and fell to the floor and crawl flat on my stomach to my bed. I had no strength in my legs and arms and needed assistance from two people to put me on my bed. Periodic rapid heartbeat and fatigue caused restless sleep. Some strength began to return on Friday and with caution over the weekend, and support from a loving family, I appear to be making a slow recovery. Checking with several family medical people working in hospitals, my experience with the serum seemed more extreme than most. Therefore, it was felt that I should report some information on how the Moderna injection affected me that it may be of help to others. (Some of the above information was related to me as I was not always cognizant of conditions at particular times.) I am still puzzled, as members of my family are, as to what happened to me. We would be grateful for any information that might be helpful for us to understand my situation as it relates to others that may have had similar experiences with the Moderna serum.

The day after receiving his second vaccine, he became very confused and anxious. For over 3 hours he was thinking he needed to get a bag from his "daughters sister." The following day, his confused remained and there was another period of 3 hours that he was confused and fixated at going out to the dumpster to get a bag. Resident typically doesn't have this level of confusion or anxiety.

acute pain in hip area, began suddenly and woke me up following morning after second shot has persisted for the last 6 days(and is still painful when walking though not quite as badly as it was.

Pt brought to ER by son on 2/7/21 after noting increased confusion. Patient states he is going to visitor or do things that have not been around for years. Son reports onset was 24 hour prior. Pt does have some cognitive decline historically but current behaviors are a sudden change. Patient admitted observation to hospital and then discharged to local nursing home.

Patient stated he felt "funny in the head" on 02/19/2021 at 4:00 pm. His wife stated that the patient had seemed confused. Gave patient 2L of fluids and discontinued trazodone. Patient returned to baseline and was discharged after 24 hours.

chest pain & weakness Narrative: Pt received his covid vaccine dose #1 on 1/29/2021. On 1/30/2021 he experienced a fever, chest pains and weakness. Pt reported this at his appointment to receive his 2nd dose of covid vaccine on 2/26/2021. Nurse administering vaccine informed pharmacist pt reported he was still feeling weak from the first vaccine dose, so weak he could not perform ADLs without assistance. Pharmacist recommended pt be sent to the ER evaluation, possibly pt has an illness unrelated to the vaccine and another dose may cause worsening of symptoms. Upon further investigation pt was seen at outside hospital ER on day after his dose #1 covid vaccine for chest pain, pleural effusion and weakness and low grade fever. Pt was evaluated and transferred to ER dept. ER gave him morphine iv, magnesium iv, & furosemide 40mg iv. Pt was admitted on 01/31/2021. Pt evaluated by cardiology, internal medicine & given a course of antibiotics. Pt was diagnosed with Chronic Right side pleural effusion, POA. Pt was discharged on 2/3/2021 with the following medication discharge instructions: "SUMMARY OF MEDICATION CHANGES NEW meds: -Start cefdinir 300mg by mouth twice a day for infection - take first dose evening of 2/3/2021 and last dose evening of 2/4/2021 - Start ferrous sulfate (iron) 325mg by mouth every other day - Start pantoprazole 40mg by mouth daily 30 to 60 minutes before breakfast CHANGED meds: -Metoprolol succinate 50mg by mouth daily changed to metoprolol tartrate 12.5mg (=1/2 25mg tablet) by mouth twice a day STOPPED meds: -Stop taking lisinopril until follow-up with your primary care provider -Stop taking omeprazole Of note pt's medical history includes the following comorbidities: *Gastroesophageal reflux disease *Coronary arteriosclerosis *Carotid atherosclerosis *Carcinoma of colon * Colostomy present *Hyperbilirubinemia On 2/26/2021 vaccine dose #2 was held. Pt was encouraged by nurse to follow up with PCP or to report to ER for further evaluation. Pt was given phone # to reschedule dose#2 if appropriate.

Started having confusion at 3#0 a.m. Sunday morning. Unstable gait and hypoxia at home. More congested than usual. Had 2nd COVID vaccine 4 weeks ago. Had visual hallucinations with seeing "bugs" Admitted with positive COVID and Influenza B diagnosis.

Patient received Moderna Dose #1-01/08/2021 and Dose #2-02/05/2021. He was admitted to Medical Center on 03/08/2021 with confusion and decreased O2 sats; date of death was 03/12/2021.

Very violent behavior; Very weak; Started saying crazy stuff that did not make sense; Slept a lot; Severe dreams; Hallucinations; A spontaneous report was received from a consumer concerning an 89-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and started saying crazy stuff that did not make sense (speech disorder), slept a lot (hypersomnia), had severe dreams (abnormal dreams), hallucinations, very violent behavior (aggression) and was very weak (asthenia). The patient's medical history, as provided by the reporter, included COVID-19 in Mar-2020. Products known to have been used by the patient, within two weeks prior to the event, included gabapentin, apixaban, pantoprazole, furosemide, carvedilol, tamsulosin, potassium, hydrocodone, metformin, zinc, vitamin d3, vitamins NOS, ascorbic acid, rosa canina fruit, magnesium and probiotics NOS. On 06-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 016M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. With the first dose of the vaccine, the patient experienced the patient experienced delirium, hallucinations and confusion. On 06-Mar-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch Number: 029A21A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 06-Mar-2021, within four hours after the 2nd vaccination, the patient started saying crazy stuff that didn't make sense, slept a lot and had severe dreams and hallucinations. The patient had very violent behavior and was reaching for things and eating things that were not there and was very weak. No treatment information was provided. Laboratory information included CT scans. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, saying crazy stuff that did not make sense (speech disorder), slept a lot (hypersomnia), had severe dreams (abnormal dreams), hallucinations, very violent behavior (aggression) and was very weak (asthenia), were unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

delirium; hallucinations; Great confusion; Vaccine attacking brain; A spontaneous report was received from a consumer concerning an 89-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced, vaccine attacking brain, delirium, hallucinations, great confusion, had to go to rehab for 8 days to learn how to walk all over again, saying crazy stuff that doesn't make sense, sleep a lot, had severe dreams, very violent behavior and it was very out of character for him, vaccine affected the front lobes of brain, still reaching for things and eating things that are not there, very weak. The patient's medical history, as provided by the reporter, included Covid -19 She wants to disclose that her dad was one of the first people to receive the COVID-19 disease on 17March2020. He was hospitalized for 3 weeks because at that time no one knew about the disease and how to treat it. He was positive with COVID-19 for 84 days (16 nasal swabs were done). She kept him in quarantine until 10June2020 in the basement as per doctors advice and no known allergies were reported. Lab data include Normal CT Scans. Concomitant medications reported included gabapentin 400mg Three times a day Eliquis 2.5mg, pantoprazole 40mg, furosemide 40mg ,carvedilol 6.25mg Half a tablet every morning and every night, Tamsulosin 0.4mg, potassium 10mq, hydrocodone 5/325 every day, metformin 1000mg ,zinc 50mg, Vitamin D35000IU, Multivitamin, Vitamin C 1000mg, Magnesium 400, Probiotic. On 06 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (lot number 029A21A) intramuscularly for prophylaxis of COVID-19 infection. She states that after the first dose on 6Feb2021, her father was admitted to the Hospital for 8 days due to the vaccine attacking his brain. He had delirium, hallucinations, and constantly did not know where he was due to great confusion. After 8 days in the hospital, he had to go to rehab for 8 days to learn how to walk all over again. The hospital, after testing him over and over again, decided that the vaccine was the cause of his symptoms. His mental symptoms took 5 days to clear. He took his second shot on 6 Mar 2021, and this time he was admitted to the ICU due to his symptoms returning 10 fold from the first time he experienced it. Within 4 hours after he took the vaccine, he started saying crazy stuff that doesn't make sense, then slept a lot and had severe dreams and hallucinations. She also mentions that her father had very violent behavior and it was very out of character for him. She states that she believes the vaccine affected the frontal lobe of his brain, even though both CT scans can through as clear. She discloses the Hospital will not do a MRI for her father since the two CT scans came back clear. She also mentions that he is still reaching for things and eating things that are not there, she mentions he is very weak and her biggest worry is that this time, he won't come back to her mentally like he did the first time due to the severity of the symptoms. She believes that because he had the disease for so long, his body has built antibodies to it and he probably was not a good candidate to receive the vaccine. Her main concern is that the hospital isn't doing anything for him, that the first time it took 5 days to clear his head, but she is scared that this time he won't come back to her. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, vaccine attacking brain, delirium, hallucinations, great confusion, had to go to rehab for 8 days to learn how to walk all over again, saying crazy stuff that doesn't make sense, sleep a lot, had severe dreams, very violent behavior and it was very out of character for him, vaccine affected the front lobes of brain, still reaching for things and eating things that are not there, very weak. Were considered Unknown.; Reporter's Comments: Based on the information provided which includes a temporal association between the reported events, administration of mRNA-1273 vaccine and excluded all other etiologies, a causal association cannot be excluded. as patient had exacerbation of symptoms that developed at first vaccine dose after administration of second dose.

My father begain feeling chills, anxiety on the evening of March 30th, 2021 following administration of the Moderna vaccine earlier that day. The following day and throughout the week his symptoms continued to worsen including episodes of shortness of breath, anxiety, chills. My mother treated him with tylenol, cool wash cloth. His appetite was decreased but be was able to eat warm soup/broth. My mother contacted his physician approximately 2 days after the episodes began for an appointment but he could not be seen until the following week. On day 6 after the vaccine, April 5, 2021 he complained of significant shortness of breath and anxiety, The following day, April 6, 2021 my mother took him to a local free standing emergency facility where they diagnosed a possible MI. He was then transferred to the local hospital. There he was admitted and diagnosed with heart failure and given fluids/medications. He remains hospitalized as of this submission.

At 15 min after vaccine 1145 asked patient how feeling he said he felt normal but had hesitation when stated. After asking again who he was feeling stated he was "woozy". Wife states he gets dizzy after eating breakfast & had eaten prior to getting to the home. Pt denies other sx. Checked bp 200/80 left arm manual 98F 59 P. Pt alert oreinted, no distress noted. At 1147 pt reports feeling better bp 165/65 P 59 denies dizziness. 1158 pt states feeling slight sob, had mask on & had remove mask. Called EMS for evaluation at 1158. Pt alert oriented x 4, normal even respiration, color normal for race. prior to EMS arrival pt ambulatory with walker to bathroom deneis dizzy. EMS arrived at 1205 Paramedics along with EMT evaluated patient EMS vitals 189/69 100%RA pt states feeling better & refused transport to hospital.

walked a mile a day and has always taken care of himself. He ran marathons. He never was bothered by walking the daily miles. Nothing happened while he walked even though he has a sarcoma. One night, after he got into bed, his hip and leg started hurting and have continuously hurt since then. His pain is debilitating and his leg is very heavy. He can not lift his leg to get into bed. His wife has to lift it with two hands. He cannot lift his leg to get into a car. He has been given Gabapentin, Norco, Tramadol, and Tylenol for pain. He needs ice packs during the day and night. He cannot sleep in his bed all night. He has gotten up to sleep in a recliner.

Tested positive for COVID on 5/24 after exposure to family member. Presented to ER with increased weakness, confusion, fevers and fall at home. Patient admitted to hospital for suspected superimposed bacterial pneumonia and treated with IV antibiotics then subsequently discharged on oral cefprozil to complete 7 days.

Progressively worse muscle and body aches, shortness of breath upon exertion, aggressive behavior, insomnia, confusion,

Crticial illness; He couldn't dress himself; The elbow on his left arm was killing him; he had a lot of pain in his left arm; Warmth of hands; swelling, pain, and the heat in his hands; Couldn't move his right arm; Both of his hands and fingers swelled; Pain in elbow; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ILLNESS (Crticial illness), MOBILITY DECREASED (Couldn't move his right arm), PERIPHERAL SWELLING (Both of his hands and fingers swelled), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He couldn't dress himself), PAIN IN EXTREMITY (The elbow on his left arm was killing him; he had a lot of pain in his left arm), ERYTHEMA (swelling, pain, and the heat in his hands), FEELING HOT (Warmth of hands) and ARTHRALGIA (Pain in elbow) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K0A) for COVID-19 vaccination. The patient's past medical history included Lyme's disease (4 years ago) and Paralysis (Both legs and one arm). On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced MOBILITY DECREASED (Couldn't move his right arm) (seriousness criterion medically significant), PERIPHERAL SWELLING (Both of his hands and fingers swelled) (seriousness criterion medically significant) and ARTHRALGIA (Pain in elbow) (seriousness criterion medically significant). On 17-Jan-2021, the patient experienced ERYTHEMA (swelling, pain, and the heat in his hands) (seriousness criterion medically significant). On 04-Jun-2021, the patient experienced ILLNESS (Crticial illness) (seriousness criteria death and hospitalization). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He couldn't dress himself) (seriousness criterion medically significant), PAIN IN EXTREMITY (The elbow on his left arm was killing him; he had a lot of pain in his left arm) (seriousness criterion medically significant) and FEELING HOT (Warmth of hands) (seriousness criterion medically significant). The patient was hospitalized on sometime in 2021 due to ILLNESS. The patient died on 04-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, MOBILITY DECREASED (Couldn't move his right arm), PERIPHERAL SWELLING (Both of his hands and fingers swelled), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He couldn't dress himself), PAIN IN EXTREMITY (The elbow on his left arm was killing him; he had a lot of pain in his left arm), ERYTHEMA (swelling, pain, and the heat in his hands), FEELING HOT (Warmth of hands) and ARTHRALGIA (Pain in elbow) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. on 17-Jan-2021. There the patient underwent bloodwork, ultrasound, and x-rays to rule out blood clots or anything else. Treatment included a steroid shot, antibiotic shot, and medication, steroids and antibiotics and 4 pain pills on 17Jan2021. No concomitant medications was provided by the reporter. Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Added reporter's email address. On 06-Jul-2021: F/U-1 : Case upgraded to serious: Patient has died on 04-Jun-2021.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

Fluid in lungs; Lethargic after second vaccine; disoriented/confusion; Dehydration; Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), DEHYDRATION (Dehydration), PULMONARY OEDEMA (Fluid in lungs), LETHARGY (Lethargic after second vaccine) and DISORIENTATION (disoriented/confusion) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018821A and 024M20A) for COVID-19 vaccination. Concurrent medical conditions included COPD since 06-Jan-2021. Concomitant products included PREDNISONE from 10-May-2020 to an unknown date for Bullous pemphigoid, ROSUVASTATIN CALCIUM (CRESTOR) and ACETYLSALICYLIC ACID, DIPYRIDAMOLE (AGGRENOX) for an unknown indication. On 11-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 10-Apr-2021, the patient experienced DEHYDRATION (Dehydration) (seriousness criterion hospitalization), LETHARGY (Lethargic after second vaccine) (seriousness criterion hospitalization) and DISORIENTATION (disoriented/confusion) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY OEDEMA (Fluid in lungs) (seriousness criteria hospitalization and medically significant). The patient died on 26-Jun-2021. The cause of death was not reported. An autopsy was not performed. At the time of death, DEHYDRATION (Dehydration), LETHARGY (Lethargic after second vaccine) and DISORIENTATION (disoriented/confusion) had resolved and PULMONARY OEDEMA (Fluid in lungs) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. After 2nd vaccine 09-apr-2021, 36 hrs later (name) Lethargic, Disorientated ems to hospital. Some dehydration, fluids, than he has fluid in lungs. 8 days hospital. Never the some after discharged 4/19/21. (name) declined until his DEATH on 26-Jun-2021. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-042828 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: Unknown cause of death