Moderna

Having Peeing / semi diarrhea problems. Lucky I had a catheter with me; first time needed in a year. Semi diarrhea was something new. Did not eat anything after breakfast, fruit as usual that morning. Bad Headache went away after 48 hours. Felt good after that. Had no fever, ever.

Headache, Dizziness, Nausea, Fainted and hit my head on tile floor. Started at 2:30 a.m. on 1/10/2021 and culminated with fainting on same day at 12:30 p.m. Have continued with weakness, tiredness and dizziness. Other reactions have subsided.

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.

Patient wife reports begn feeling achy last evening ; this monsring began with severe nausea , followd by voimiting and unable to keep fluids down for several hours. Reported to Oncolosgist ( who cleared patient for vaccine injection ) . Patent /wife advised to go to ER for assessment / IV fluids ( 5pm Friday 15Jan 2021)

WOKE UP AT 0700 THIS AM WITH BODY ACHES, NAUSEA/VOMITING, CHILLS, DIZZINESS, WEAK, TEMP 102. ADMITTED 1/21/2021 INPATIENT. IV NS @ 100ML/HOUR, ZOFRAN 4MG IV, LOVENOX 40MG, SOLUMEDROL 125MG IV.

Severe diarrhea. Contacted PC at 8:00am. Advised to begin Imodium, and adult pedialyte and follow. BRAT If it got worse contact urgent care. Projectile vomiting twice at 10:30 pm. None of the written information mentioned diarrhea as a side effect!

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!

Muscle and joint aches, shot site ache, headache, chills, fatigue, no appetite Treating with Tylenol. No abatement yet (9 hours later)

Don't know if related to shot or not. Friday night 11:50 pm woke up from sleep with upset stomach. Took two rolaids and set on toliet in case I needed to throw up or had dirarerra. Nothing happened so 30 minutes later took acid reducer pill and went back to bed. Saturday morning pooped and it was black. Extremely tired all day and about 11:00pm again got an upset stomach. Threw up dark red liquid and had dirarerra and it was black. Sunday again extremely tired and drank lots of water and avoided alcohol drinks. (Had drank some beer on Friday and Saturday.) Poop still black but no upset stomach. Monday felt much better and poop became more brown. By Tuesday I felt back to normal.

1st vaccine mild headache began 3 days after shot and lasted about 24 hours 2nd vaccine severe chills, diarrhea, fatigue began about 24 hours after shot and lasted about 24 hours

Patient received Moderna COVID vaccine on 1/20/2021. Shortly after (with in 1 week) patient experienced addominal pain, diarrhea, loss of appetite, and chills.

About 1:35 am I was experiencing acid reflux, I prepared some alka-seltzer. As I was beginning to drink it I started to feel faint, My legs started to give out, my glass dropped into the sink, and a was flat on my back on the floor. I got up and went to bed. As I lay there uncovered I began to perspire, but that soon stopped. After 10 minutes I pulled the sheet over me and 30 minutes later I pulled the blanket over me. At about 2:30 am I was feeling normal except for the reflux. I took a full dose of alka-seltzer and have had no more problems since then. I believe the acid reflux was from eating and drinking wine that evening. I don't know of the fainting was from the vaccine or a touch of flu for one hour.

Veteran received vaccine 02/04/2021. He felt very tired/fatigued from Thursday (2/4) until Sunday (2/7). Veteran stated he felt much better on Monday. Then on Friday (2/12) he started having fatigue, diarrhea, headache, and rash from elbow to injection site. He went to a local Urgent Care (2/15), where he received flu and COVID testing (both negative) and steroids. He reported this information to me via phone in the vaccination clinic today (2/16).

1. Intestinal upset and no appetite. Re-flux, Stomach Ache, excessive gas in stomach and colon. 2. Muscle and joint aches strong enough to remain in bed or a chair "attempting Not to move" 3. Momentary and random loss of balance in excess of normal events in both severity and frequency

Pt called to report having chills and diarrhea on 2/24/2021. Spoke to pt on 2/25/2021 and he only reported chills and he took some Tylenol and they subsided. Pt is having no issues reported on 2/25/2021.

Vomiting x3, chills, headache, sweats started 2/24/21 Denies fevers but also admits he has been on Abx and Motrin prior to taking vaccine for his tooth being pulled.

Moderate nausea, loss of appetite & mild fever with chills - all expected. Unusual/ Adverse effect was a significant change in heart rhythm. Patient is consistently in A-Fib post PaceMaker insertion (June 2020). He is paced at 70 bpm when in A-Fib. His hearth rhythm went into sinus ~2.5 days post vaccine, and has remained so since. Change is quite unusual and has only occurred once since pacemaker insertion (October 2020) when he had a significant flu/cold event. More relevant is the increase in systolic blood pressure by over 20 pts.

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

Pt developed severe fevers, myalgias, headache, inability to take PO day after vaccine, developed significant AKI and required hospitalization - overnight observation. Was hospitalized 2/23 - 2/24 and had resolution of symptoms, improvement in AKI and was stable for discharge home.

Starting afternoon after vaccine, extreme fatigue, sore muscles, achy, fever 100%, oxygen level lower than norm (95%). No appetite.

Patient states 10 days after his first injection, he experienced sore arm, muscle/joint aches and diarrhea x 3 days, and went to the ER.

Vaccinated at 11:00 a.m. Started adverse reactions at 3:00 a.m. Fever of 103 degrees, nausea, diarrhea. Overall tiredness.

2 days of fatigue, 1 day diarrhea, 1 day mild fever and five days of a dry cough - all starting 3rd day after second vaccination

The day after the first shot, I experienced a severe case of constipation...which I very seldom had over the last 20+ years. I finally had to resort to using a laxative a day later. During this period, due to the constipation I developed a inguinal hernia. The constipation eased slightly until the second shot when it returned in full force. Both times I had severe stomach cramps.

Presented to healthcare with c/o N/V throughout the night. VS show tachycardia and fever. 156/87, 108, 20, 101.3. IV fluid for hydration, Zofran for nausea and Tylenol for fever. Monitor

New onset Myasthenia gravis. Patient initially presented in the ED on 2/23/2021 with complaint of left facial droop, slurred speech and double vision. His stroke score was 2, for left facial droop. nAChR antibody test this test has come back positive, making it likely that this patients symptoms are due to acute myasthenia gravis. The patient continued to experience double vision and eye weakness associated with trouble swallowing that has continued to worsen and was brought the hospital for re-assessment at the request of his wife.

Started 5 days after vaccine with dizzyness, nausea, sever headache, stabbing pain in left thigh, and continued soreness left arm at injection site. Has doctors appointment on 03/15/2021

Second injection at 1:00 PM- around 7:00 PM * 6 hours later ) Fever, chills, nausea, skin is sensitive, loss of appetite, and severe tiredness. As of 24 hours after injection, side effects remain the same or worse. Severe chills throughout the night, only waking to urinate. He did wake up, took a shower only to have alot of coughing and chest discomfort.If he is not better soon, we will take a trip to the ER.

The usual headache, nausea, fatigue, but the worst was and still is four days later extreme to the point of screaming with any kind of movement, pain in my left arm. I need help getting dressed and can't pull up my own pants without a little cussing and groaning.

SHORTNESS OF BREATH ISOLATION-INFECTIOUS DISEASE SIRS (systemic inflammatory response syndrome) Hypokalemia Hypomagnesemia Lactic acid acidosis Hypoxia Transaminasemia Generalized weakness Abdominal pain, unspecified abdominal location Suspected COVID-19 virus infection

Approximately 8 hrs after the second Moderna vaccination I starting having chills. These continued and increased in intensity along with the onset of fever. I did not have an accurate means of taking my temperature at the time. Over the course of the night on the 17th/18th of February the chills and fever never subsided, even with two doses of Tylenol. The day of the 18th, fever and chills continued along with a feeling of intense malaise. My sternum was very sore and it hurt to breathe as a result of the prolonged shivering. I had no appetite and ate absolutely nothing the day of the 18th. In the early morning hours of the 19th my fever broke as did the chills. However, later in the day, a thermometer was obtained and my fever was 101.4 degrees. When taken at bedtime, it was down the 99 degrees and returned to normal later with no future spikes. On the morning of the 20th when I awoke, I noticed a stinging soreness in my mouth and lip area, followed later in the day with my nostrils and inner nose. This turned out to be an intense outbreak of Herpes. The roof of my mouth, gums, upper surface of my tongue, lips, nostrils, and inner nose ultimately became covered and extremely painful. These lesions were not typical blebs, but were tiny, albeit most painful. After five days they resolved and I have had no further issues. As a possible area to investigate - I had had the second Shingles booster 14 days prior to my first Moderna COVID vaccination. I understand Shingles is also a Herpes family virus.

Patient and caregiver report redness 7" x 4" around site, hardness, heat to left deltoid with tenderness that developed 3/18 accompanied with low appetite, muscle weakness, and fatigue. Arm symptoms were reported on 3/22 and improving by 3/23. Other symptoms reported on 3/23. They report that on 3/23 symptoms were still present but starting to improve.

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.

Light headed, assed out in hallway, wife called ambulance Still light headed, fatigued, loss of appetite

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.

4/2/21- increased fatigue and right arm reddened and itching in right arm 4/3/21- Temp to 101.7, decreased appetite, worsening tremors and weakness. worsening Parkinson's symptoms that lasted 24 hours.

swelling voice; swelling neck; swelling gland; nausea; Abdominal pain radiating to left side of body; Abdominal pain radiating to left side of body; leg pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Abdominal pain radiating to left side of body) 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 information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced PAIN (Abdominal pain radiating to left side of body) (seriousness criterion disability), ABDOMINAL PAIN (Abdominal pain radiating to left side of body), PAIN IN EXTREMITY (leg pain) and NAUSEA (nausea). On 07-Jan-2021, the patient experienced SWELLING (swelling neck) and LYMPHADENOPATHY (swelling gland). On 08-Jan-2021, the patient experienced DYSPHONIA (swelling voice). At the time of the report, PAIN (Abdominal pain radiating to left side of body), ABDOMINAL PAIN (Abdominal pain radiating to left side of body), PAIN IN EXTREMITY (leg pain), DYSPHONIA (swelling voice), SWELLING (swelling neck), LYMPHADENOPATHY (swelling gland) and NAUSEA (nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details include prednisone, Benadryl and oxycontin. Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded Reporter did not allow further contact; Sender's Comments: Limited information regarding these events has been provided at this time and a causal relationship cannot be excluded

a couple of days after the shot, I started getting muscle pain, a fever and chills that would come & go and headache with nausea. On april 8th, after lunch I had to lay down on the floor because I thought I was going to pass out. After about ten minutes & breaking out in a sweat, I was ok.On saturday the 10th, I sat down for supper & could only eat a few bites before I thought I was going to throw up.

Congestion; Respiratory issues; Oxygen breathing is off; Sweats; Coughing; Fever 100 point something; Really tired; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY CONGESTION (Congestion) 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. The patient's past medical history included Double vessel bypass graft. On 17-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. In March 2021, the patient experienced PULMONARY CONGESTION (Congestion) (seriousness criterion medically significant), RESPIRATORY DISORDER (Respiratory issues), DYSPNOEA (Oxygen breathing is off), HYPERHIDROSIS (Sweats), COUGH (Coughing), PYREXIA (Fever 100 point something), FATIGUE (Really tired) and NAUSEA (Nausea). At the time of the report, PULMONARY CONGESTION (Congestion), RESPIRATORY DISORDER (Respiratory issues), DYSPNOEA (Oxygen breathing is off), HYPERHIDROSIS (Sweats), COUGH (Coughing), PYREXIA (Fever 100 point something), FATIGUE (Really tired) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Body temperature: 100 point (Inconclusive) 100 point. In March 2021, Respiratory rate: 92-96-97 (Inconclusive) 92-96-97. Concomitant product use was not provided by the reporter. 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.

Patient admitted to the hospital for abdominal pain/Small bowel obstruction with incidental finding of +COVID-19 test. Per MCIR, patient received two doses of the Moderna COVID-19 vaccine, 1st on 1/30/21 and 2nd on 2/27/21.

Chief complaint : syncope, vomiting, and weakness. Assessed by on site Medical and transported to Hospital.

Lethargy, widespread muscle soreness, nausea lasting 4 days. Signs slightly less severe each day until at day 5 (today) almost normal

Fever, Sick on stomach, aches, fatigue, extreme weakness. Symptoms were extreme. Generally felt terrible after being very stable and active. No improvement and condition worsened daily with loss of appetite. Death occurred on March 13, 2021.

on feb 21, 4 days after second dose, developed a chronic persistent headache in setting of no prior history of significant headaches. --headache: no change in vision or blindspots; blurry vision noted (just had an eye exam in early February - slight change in prescription), location frontal top of hairline, continuous - every waking minute since Feb 21, has surges of intensity (never crippling, but always there), seems to be worse in evening, able sleep, appetite has been down -- nothing improves the headache (meds have no effect), no photophobia, no phonophobia, temperature does not impact it

passing blood in his stool; stomach pain; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HAEMATOCHEZIA (passing blood in his stool) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) 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 14-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced HAEMATOCHEZIA (passing blood in his stool) (seriousness criterion medically significant) and ABDOMINAL PAIN UPPER (stomach pain). On 07-Apr-2021, HAEMATOCHEZIA (passing blood in his stool) and ABDOMINAL PAIN UPPER (stomach pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included unspecified blood thinners. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

swollen and tendered arm; swollen and tendered arm; nerve pain; sore gut; blisters due to shingles; Severe case of shingles; abdominal pain; kidney pain; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Severe case of shingles) 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. The patient's past medical history included No adverse event (No medical history reported.). On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced HERPES ZOSTER (Severe case of shingles) (seriousness criterion medically significant), ABDOMINAL PAIN (abdominal pain) and RENAL PAIN (kidney pain). On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen and tendered arm), TENDERNESS (swollen and tendered arm), NEURALGIA (nerve pain), GASTROINTESTINAL PAIN (sore gut) and BLISTER (blisters due to shingles). At the time of the report, HERPES ZOSTER (Severe case of shingles), ABDOMINAL PAIN (abdominal pain), RENAL PAIN (kidney pain), PERIPHERAL SWELLING (swollen and tendered arm) and TENDERNESS (swollen and tendered arm) outcome was unknown and NEURALGIA (nerve pain), GASTROINTESTINAL PAIN (sore gut) and BLISTER (blisters due to shingles) had not resolved. Not Provided No concomitant medications were reported. On 20APR2021, patient went to the emergency room. Patient is currently taking famciclovir 500 mg for his symptoms. Company comment This case concerns a 76-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected abdominal pain, gastrointestinal pain, renal pain, peripheral swelling, tenderness, neuralgia, and blister. SAE onset 12 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD21-81574, MODERNATX, INC.-MOD-2021-089399 (E2B Linked Report).; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of herpes zoster, and nonserious unexpected abdominal pain, gastrointestinal pain, renal pain, peripheral swelling, tenderness, neuralgia, and blister. SAE onset 12 days after second dose mRNA-1273. Event outcomes ongoing or unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-81574:Wife case MODERNATX, INC.-MOD-2021-089399:Husband case

patient stated that he had to call the ambulance because he couldn't move. He vomited, was nauseous and aspirated his vomit. He was in the hospital with pneumonia

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

Rheumatoid factor elevated at 45, CRP 122 Patient was in good health, with distant history of Graves Disease until April 5 when he presented to Hospital with complaints of chest pain, worse with sitting up. CAD was ruled out with troponins and he was taken to the cath lab and found to have essentially normal coronary arteries. He was started on colchicine with improvement in chest pain. On April 30th he presented to Hospital with low grade temps, cough and right sided chest/abdominal pain. He was found to have moderate pleural effusion. Because he was on Eliquis, for episode of afib thought related to pericarditis, pleurocentesis was delayed until May 3 when 1.5 L of fluid was removed from his pleural space. He continued on colchicine and 3 days later reported feeling essentially normal. Blood and fluid cultures were negative. Pleural fluid cytology showed predominantly chronic, inflammatory lymphocytes and macrophages/monocytes, reactive mesothelial cells. There was no overt morphologic evidence of malignancy. Patient was feeling well. Dr stopped Eliquis, Cochicine and patient did well until May 17 when he again reported aches, chills and pleuritic chest pain. Pleural effusion recurred and patient restarted cochicine with improvement

The day after receiving the second dose he was working outside and after coming inside he started complaining of pain in his lower back and legs. He said the pain was not consistent at first. It would come and go. Over the next few weeks it progressively got worst. The pain had increased making it hard for him to walk, sit on lay to sleep. On 4/2 he went to the ER at Hospital because the pain was very bad. He was treated with IV muscle relaxers and steroids. He as discharged with diclodenac, methocarbamol and prednisone for Radicular pain. He has progressively gotten worst as he has lost over 50 pounds. He recently visited the ER at second Hospital where an extra showed diffusers increase bone density. He was discharged with 600mg IBprofen , Dexamethasone and prednisone. He continues to get worst. He is now hardly eating and in pain all the time. He is week and have trouble walking

Worsening abdominal pain and distention on 3/2/21 which progressed to include shortness of breath for which he did not seek medical care. He was found unresponsive on the couch on 3/11/21 and resuscitation was unsuccessful.

One week after 1st shot came down with multiple symptoms excluding vomiting and fever. After 2nd shot at 9:30 AM at 12:oo noon came down with like symptoms that lasted in the neighborhood of 2 weeks. 2nd shot had a temperature rise to 100.3 from a normal of 67.00 to 97.0 Temperature was intermintent.

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.

Loss of appetite; I had fever and chills which lasted three days; headache a couple days; itching started and hasn't stopped - arms, back, body - it comes and goes away - there is one or to places there's a little red but that's from my scratching but otherwise don't see anything; Feeling more fatigued. Loss of appetite - these lasted for at least a month; shortness of breath issues - continued for three or four weeks before it got to be a real struggle. I was going two or three steps and was having real bad shortness of breath. My son said it was called exertion something. ER - CAT scan- multiple blood clots on lungs - 4 of my 5 lobes were not functioning at the time - Bilateral Massive Pulmonary Thrombolism - I got there just in time. They sent me to Catheter lab - two catheters with Antivase and multiple bags of Heparin and other blood thinner with three day stay. Eliquis - prescriptions - 5 mg - twice a day for 6 months minimum and maybe for the rest of my life. They put me on oxygen on three days - 40's and 50's when I got to the hospital but within a day on oxygen it was back up to 90's. Kidney= Creatine levels were high when I got there but close to normal at release. Blood glucose levels were normal. Blood pressure was 120/80 when I left - laying down. When active it was 130 something over. They put me in Surgical ICQ and then they needed the bed and sent me home to rest. Six foot distance between me and the refrigerator - I do have my appetite back now 1200 calories a day in my diet. I am doing some light walking. Minimized stair climbing but I'm in a three story house so have to do it. Doing light construction work for my son so I'm banging nails. Not any running right now. Telephone follow with doctor - I don't have a primary because I hadn't seen a doctor for 35 years.

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.

Beginning of a blood clot in the middle of the left calf muscle; Eye lids right on the edge bilaterally and it is upper and lower eye lids has an irritation; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Beginning of a blood clot in the middle of the left calf muscle) 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. Concurrent medical conditions included COPD and Asthma. Concomitant products included FEXOFENADINE for Allergy, ALBUTEROL SULFATE for Asthma, PARACETAMOL (TYLENOL) for Migraine, TIZANIDINE, ASPIRIN [ACETYLSALICYLIC ACID], POTASSIUM CHLORIDE, VITAMIN C [ASCORBIC ACID], CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]), ACETAMINOPHEN, MULTIVITAMINS [VITAMINS NOS], MINERALS NOS, COLECALCIFEROL (VITAMIN D3), GABAPENTIN, PRIMIDONE, RANITIDINE, CLOPIDOGREL, BUTALBITAL, CAFFEINE, MELATONIN, TERAZOSIN, ZINC, FINASTERIDE, MONTELUKAST, LUBIPROSTONE (AMITIZA), TAMSULOSIN, SIMVASTATIN, ATENOLOL, CHLORTALIDONE, PANTOPRAZOLE, MIRABEGRON (MYRBETRIQ), POLYETHYLENE GLYCOL [MACROGOL], FENOFIBRATE, SODIUM HYDROXIDE, MAGNESIUM HYDROXIDE (MILK OF MAGNESIA), SULFADIAZINE SILVER (SILVER SULFADIAZINE) and FLUTICASONE for an unknown indication. On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 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 THROMBOSIS (Beginning of a blood clot in the middle of the left calf muscle) (seriousness criterion medically significant), EYE IRRITATION (Eye lids right on the edge bilaterally and it is upper and lower eye lids has an irritation) and DIARRHOEA (Diarrhea). At the time of the report, THROMBOSIS (Beginning of a blood clot in the middle of the left calf muscle), EYE IRRITATION (Eye lids right on the edge bilaterally and it is upper and lower eye lids has an irritation) and DIARRHOEA (Diarrhea) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient normally stays with diarrhea because takes double of the normal amount of the polyethylene glycol daily, takes 17 grams twice a day. And there is the beginning of a blood clot in the middle of the left calf muscle which may be related to his COPD, but he had to see a doctor about it. Treatment information was not provided. 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. Limited information regarding the event Thrombosis have been provided. Further information has been request. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. This case was linked to MOD-2021-163528 (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. Limited information regarding the event Thrombosis have been provided. Further information has been request. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.

Developed Guillian Barre Syndrome. Lost mobility in legs and unable to walk, shortness of breath, heartburn, severe burning in the chest.

Patient is a 76-year-old male with a past medical history significant for dementia, CVA 5 years ago with right-sided hemiparesis, functional parapalegia/wheelchair bound, chronically aphasic, hypertension, type 2 diabetes which is diet controlled and history of BPH who presented to the emergency room on 1/26/2021 with diarrhea that began on jan 18th 2021 and was admitted to the hospital.. Patient spouse reported that the patient got his first dose of the Moderna vaccine on January 14 and then the patient began having a fever on January 18 of 103 degrees and then developed diarrhea which continued. He was started on Imodium by his PCP on 121 with minimal results and was encouraged to follow a brat diet. He was then encouraged by the PCP to come to the ER for further evaluation of dehydration or colitis. Patient was on trimethoprim 100 mg daily for chronic UTIs which was discontinued on admission and therafter. In the ER he tested positive for C. difficile and he was started on vancomycin p.o. 4 times daily. He was also noted to be hypotensive and dehydrated and was started on IV fluids. He remained in the hospital for 4 days and was discharged home on 1/30/21 on vancomycin orally for 10 days with improvement. . He returned back to the hospital on 3/17-3/19 for recurrent c difficile, sepsis and colitis and was discharged on a prolonged vancomycin taper with improvement. He returned back to the hospital from 6/26-7/2 for again c difficile colitis, ileus and sepsis and was seen by infectious disease and gastroenterology and was discharged home on vancomycin orally qid for a prolonged taper. If he again fails this treatment the plan will be for a fecal transplant. He was again admitted on 7/6/21 and remains hospitalized with severe c difficile colitis/diarrhea not responsive to treatment. Now having some streaks of blood in stool. Stool occult blood was neg on admission, however. Also now has concurrent Pseudomonas UTI. CT abd/pelvis 7/7 showed "Marked irregular thickening of the wall of the rectum demonstrating cystic changes. Findings extend into the distal sigmoid colon. Differential diagnosis includes severe protosigmoiditis and neoplasm." and "increased feces throughout the colon consistent with constipation." Pt has been having 2-3 watery BM's per day since admission. Infectious disease concerned about possible undiagnosed malignancy, which may be driving his clinical picture rather than C diff. Recommended colonoscopy and to continue PO vanc x 10 days then resume taper. -pt was transferred to hospital for GI involvement for a colonoscopy/sigmoidoscopy on 7/8/21 where he remains hospitalized awaiting further work up.

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.

Stomach Bleed; Flu symptoms; From that week on I've had no energy/ Ive felt weak; Dizzy; Short of breath / anything I do I feel out of breath.; Fever for a week.; This spontaneous case was reported by a consumer and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INFLUENZA (Flu symptoms), ASTHENIA (From that week on I've had no energy/ Ive felt weak), DIZZINESS (Dizzy), DYSPNOEA (Short of breath / anything I do I feel out of breath.) and PYREXIA (Fever for a week.). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed) (seriousness criterion medically significant). On 11-Mar-2021, INFLUENZA (Flu symptoms) and PYREXIA (Fever for a week.) had resolved. At the time of the report, GASTROINTESTINAL HAEMORRHAGE (Stomach Bleed), ASTHENIA (From that week on I've had no energy/ Ive felt weak), DIZZINESS (Dizzy) and DYSPNOEA (Short of breath / anything I do I feel out of breath.) had resolved. No concomitant medication was reported. The patient stated that per his doctor, his chest, heart and veins were all tested (type of tests were not specified) and all tests were negative. No treatment medication was reported. Patient reported that later found out it was a stomach bleed but said not related to vaccine. Is all fine now and does not want to be contacted for follow up. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information to clarify causality for the event gastrointestinal bleeding is not expected due to patients denial to be contacted. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up added. Added event and upgraded case to serious. Outcome of case updated to recovered.; 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 to clarify causality for the event gastrointestinal bleeding is not expected due to patients denial to be contacted.

low blood pressure; Central sleep apnea; passed out while on the toilet; chills; nausea; tiredness; headache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out while on the toilet) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sleep apnea (Recent change in status of chronic condition took place. On 8 Apr 2021 a sleep study found that the patient have Central apnea.) since 13-May-2009, Hypothyroidism since 01-Jul-1977 and Allergic reaction to analgesics (Hydrocodone). Concomitant products included ATORVASTATIN from 2000 to an unknown date for High cholesterol, LEVOTHYROXINE SODIUM (SYNTHROID) from 1977 to an unknown date for Hypothyroidism, VITAMIN D [VITAMIN D NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out while on the toilet) (seriousness criterion medically significant), CHILLS (chills), NAUSEA (nausea), FATIGUE (tiredness) and HEADACHE (headache). On 06-Apr-2021, the patient experienced SLEEP APNOEA SYNDROME (Central sleep apnea). On an unknown date, the patient experienced HYPOTENSION (low blood pressure). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 04-Feb-2021, LOSS OF CONSCIOUSNESS (passed out while on the toilet) had resolved. At the time of the report, SLEEP APNOEA SYNDROME (Central sleep apnea) had not resolved and HYPOTENSION (low blood pressure), CHILLS (chills), NAUSEA (nausea), FATIGUE (tiredness) and HEADACHE (headache) outcome was unknown. Patient needed a machine for central sleep apnea. Concomitant medication also included Multivitamin daily for an unknown indication. For 10 years, the patient have been treated for obstructive sleep apnea with a dental appliance. At that time and on 03 Jug 2016, The Patient was diagnosed with obstructive sleep apnea. In order to get a new appliance the patient needed a recent sleep study. That sleep study on 08 Apr 2021 showed that the patient now have central sleep apnea. The patient have to use a CPAP machine. 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-2021-024979 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Reporters information was updated, Patients demographics and race was updated , Patients relevant historical condition was added, Vaccine facility information added, concomitant medications added, New events chills, nausea, tiredness, and headache was added and outcome of the events 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.

patient had severe abdominal pain for several days. He visited 3 different ER departments in the days following immunization.

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.

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

Patient complained of Nausea and dizziness on following evening and and vomited few times after that and symptoms were relieved after that. on January 19th , about 80 hours after the vaccination patient complained of being very weak and lost strength to move which lasted for about 30 minutes and family called ambulance. They checked vitals. They were okay. After that patient felt better and went to rest.

Narrative: 1/20/21 Vomited x3 nonbilious and was found to have a fever (100.4 degrees F). Pt reports fullness, saying his belly feels hard. on exam abd distended / tympanic abdomen, decreased bowel sounds. Trafered from clinic to acute care to r/o acute abdomen. 1/19 vaccine given 1/17 - abdomen visibly rounded, patient looks uncomfortable. Patient denied pain x 3, reports feeling full. Abdomen is soft, nontender. Normoactive bowel sounds x 4 - scheduled to receive enema on 1/18. 1/16: noted to have a distended stomach, positive bowels sounds denied pain or discomfort. Ate 50% of dinner, During pm care abdomen noted to be more distended than at the start of shift. - txed with suppository Patient has BM. PMH includes dementia, hypothyroidism, dysphagia, ataxia, drug-induced tremor, schizoaffective disorder, chonic constipation, anemia, bipolar, HL

Passed out cold around 8 a.m. when heading to bathroom. He doesn't remember anything; woke up at some point half in and half out of his closet; injured elbow. Other symptoms beginning during the night were dizziness, weakness, headache, nausea, fever of 101, chills, extreme fatigue.

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.

Next day diarrhea all morning, imodium , he was cold, clammy, wet with sweat, week pulse at 40 , in profound shock, Stimulated him by shaking and hitting and had him take deep breaths . Pulse was 120/82 pulse up to 60 20 minutes into the event he was stable and alert .

Received first dose of Moderna vaccine on Friday 1/22 no acute reaction, no fevers or chills. On Saturday afternoon noted "very dark yellow" urine, which persisted despite increasing water intake. Sunday felt a little nauseated. Monday came for previously scheduled visit with me and found to have elevated bilirubin and transaminases No recent changes in meds. Carpal tunnel surgery approximately 3 months ago. No recent travel or unusual meals.

Felt well until later that night of the vaccination, Saturday. About 11 pm I began to have chills, fever, shoulder and back muscle pain and vomited. Slept through the night and felt relatively well the next day. Sunday, felt extremely fatigued but slept well. Monday felt better, less fatigued but at 4pm came down with the chills for 2 hours and then fever up to 102.7 and muscle pain in my hip muscles. Have been drinking electrolytes and water dur to vomiting. Tuesday awoke with minimal muscle pain and only 99.2 fever. Currently feel better had light breakfast and lunch and temperature is 98.9.

EXTREMELY DIZZY, SWEATING, LACK OF APATITE. I HAD TO HOLD ONTO THING WHEN WALKING. TODAY 1/ 28/2121 I AM BACK TO NORMAL. NO SIDE EFFECTS. JUST ONE DAY OF COMPILATIONS

Began with extreme fatigue, some nausea and constipation that persisted and worsened to the point that patient saw PCP on Monday, January 25, 2021. Abdominal x-ray done on 1-25-21 showed stool in upper colon. Mag Citrate and Fleet's enema prescribed and administered on 1-25-21. Extreme fatigue and weakness continued. Patient called PCP on Tuesday, 1/26/21, but did not receive call back. Patient called PCP again on 1/27/21. Patient was told that abdominal x-ray done on 1/25/21, also showed possible left kidney stone on x-ray report that was read by radiologist. CT scan scheduled and completed on 1/28/21. PCP called patient and confirmed kidney stone lodged in lobe of left kidney that appeared spiked and possibly unable to pass. Presently unable to get immediate appointment with urologist, and pain medication prescribed. Please also not that patient has absolutely no prior history of any type of kidney stone. Still awaiting relief.

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.

Symptoms started on 2/4 SOB, nausea, diaphoretic. Pt admitted on 2/5 with STEMI with stent placement and thrombectomy

Chills, headache, loss of appetite and loss of energy, and feeling like I am overly hot. Symptoms started within a few hours of having received the shot and have continued through today, 8 February 2021. Taking Advil seems to help somewhat but I still have no appetite and no energy.

Moderna COVID- 19 Vaccine EUA: soon after vaccination patient reported feeling warm and naseated. Symptoms resolved within one day. Six days after vaccination patient developed an itchy rash on the face that is warm to the touch, stomach cramping, dizziness, and chest discomfort. Physical exam remarkable only for rash: patient presented alert and oriented, well-appearing. Patient prescribed hydrocortisone cream.

Rash x 3-4 days began 3 days after receiving first dose Covid-19 vaccine. Presented to walk-in clinic after trying benadryl and coconut oil. Also with chills and headache. Patient prescribed Medrol Dosepak. Also advised to try OTC benadryl/claritin as needed, OTC hydrocortisone cream as needed. Patient instructed to follow up with his PCP in 1 week and to go to the ER for shortness of breath, swallowing troubles, worsening rash, or worse symptoms.

I arose at 7, took a shower and felt fine. Then while making the bed with my wife I suddenly felt vey week, needed to sit on the side of the bed. My wife said my face was white. I had some mild intestinal cramping so went to the toilet. I was doubled over sitting on the toilet and in a cold sweat with diarrhea. There was no nausea. I felt weak afterwards and napped most of the morning with one more episode of diarrhea, very mild this time, at 10:45. I did not seek medical help, was able to eat lunch and dinner with no problem, but was very low on energy for the remainder of the day. I went to bed early with 2 Acetaminophen and slept 11 hours. Felt better the next day.

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.

Woke up the next day, vomited, ate little balance of day, weak, could not crawl from floor to bed, slept on floor, next morning we called 911, he was taken to the Hospital, for Wed/Thurs/Fri/Sat/Sun, then transferred to a Rehab Facility for three weeks for therapy, still at rehab,

pt states that he developed a pain in his abdomen. He woke light headed, nauseated, had diarrhea and gastro intestinal issues but does not have fever. PCP called the VA today and was told to call us to make report and FU w/ them tomorrow if he isnt feeling any better.

Chills, headache, body aches, oral mucous membrane burning, runny and stuffy nose, feet "hot", cough, chest pain, difficulty breathing, crampy abdominal pain, rash - Henoch-Schonlien purpura purpura and petechiae, edema, proteinuria, hematuria, decreased appetite, dizziness

8 days following the first vaccine, extreme chills came on rapidly. Vomit. Unable to sit alone in bed. Paramedics called and to ER. Treatment included EKG, CTscan, antibiotics, etc. Sent home at 1:00am. Still too weak to stand and walk independently. 4:00am rolled off of bed onto floor; collapsed. Unable to raise his body. Paramedics called again. Hospital said being treated for vaccine reaction. Sent home again at 4:00 by ambulance. Continues to feel extremely fatigued and upset stomach. He is ambulatory. We are being told for him to get his next Covid Vac this Friday, the 2/19. Worried

Headache, Chills, Hot Flashes, Fatigue, Nauseous, Muscle and joint pain. No Fever. These symptoms have continued with no improvement for approx 20 hours since injection.

Client reports that approximately 75 minutes after his vaccine was administered he began to have a difficult time swallowing. He was driving at the time and drove to Hospital of where he was seen in the Emergency department. Patient continued to have a difficult time swallowing and was given a "spitoon" to spit in. He describes the saliva as "white and foamy. " He also reported that that over the course of the 4-5 hours he spent in the emergency department the saliva began to be stringy, and that he believed it was mucus. The client was treated for an "esophageal blockage - food". The client reports he was treated with valium but does not know what other medications he was given. He did report that none of the medications he was given made his heart race.

Patient reports at least two falls following COVID vaccine. Requiring assistance to stand up. Legs reported as "giving out" resulting in falls. Reports being shaking within 24 hours following vaccination. Reports extreme weakness and needing to be lowered to the floor at least twice. This is new for him. Did not report feeling dizzy; blood sugar was reported as normal during the time. No confusion or feeling out of it reported at the time. Ended up with abrasions. Patient has been having bilateral leg weakness since Friday evening, patient had Covid-19 vaccine on Thursday. Wife called Sunday at 0130 after 2nd episode of leg weakness and fall (see previous note). His first fall was Friday evening around 2030. Saturday his wife reports that he was walking on his own without his walker but did have complaints of fatigue and decreased appetite, which she attributed to his Covid-19 vaccine. Sunday morning at 0130 was his second fall, an ambulance was called and patient refused ED after being assisted by EMS. Patient did not have any dizziness or syncope, just states that his legs were too weak and gave out. Wife states that patient has improved today, is using his walker and walking without difficulty. Yesterday she states that she pushed food and fluids due to decreased urine output. Urine output has returned to normal last night and today, appetite and fatigue have also improved. Assessment 1. Fall from standing, initial encounter 2. Multiple abrasions 3. Adverse effect of vaccine, initial encounter 4. Generalized weakness PT EVAL AND TREAT 5. Decreased strength, endurance, and mobility PT EVAL AND TREAT I suspect his falls and weakness are due to Covid-19 vaccine reaction. I think he has more baseline weakness than he realizes- recommended PHYSICAL THERAPY for strengthening and he agrees- already planning to see them for shoulder pain. Feeling better overall today. Recommended getting up every 2 hours to walk around, use walker for now. Call if more falls or continued extreme weakness.

Patient received 1st dose of COVID vaccination on 2/17/2021 (lot: 031M20A exp 3/11/2021). Wife called today (2/19/2021) to report patient has been experiencing adverse drug reactions: tired, lack of appetite, temperature of 102.9 (eve of 2/18/2021) and 102.4 (am of 2/19/2021), vomiting (phlegm). Patient said he was feeling better this morning and is managing the temperature with acetaminophen. Of historical note, patient did test positive for COVID virus a few months ago. I instructed wife to continue monitoring side effects and encouraged use of acetaminophen to help with fever. I educated that the side effects are "expected" with the exception of vomiting. I also informed her that I would be filing a report with VAERS to report the adverse reaction. At this time, I do not believe these side effects exclude him from receiving the second dose, and I encourage him to still receive the 2nd dose when due (3/17/2021).

On the fourth day after receiving the first dose of Moderna Covid 19, I started experiencing abdominal which doctors determined was appendicitis. I had laparoscopic surgery for it. Don't know if there is any causal effect between the vaccine and my developing appendicitis. Info online says Pfizer, not so much Moderna, more than double the number of clinical development volunteers developed appendicitis than did those that took the placebo. Am just reporting; don't know if there is a causal effect.

1/23/21 First shot: sore arm only. 2/20/21 Second shot in afternoon. By evening, fever 102.8 (then took Tylenol and fever reduced to 101). Fever, nausea, severe leg pain, moderate low back pain, severe fatigue. 2/21 morning through evening: 101 to 102, nausea, fatigue. 2/22 fatigue, temp 100 to 101. 2/23 fatigue, low temp 99.0.

Received 2nd dose of Moderna on 1/26/2021. Had a hospital visit 2/1/21-2/4/21 for anemia and colitis.

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

sore injection site next day. 2 days later started feeling sick, headache, chills and upset stomach, patient has been feeling worse with fever and wanting to vomit and aching all over. Each day goes by he feels worse, Called Doctors office let the nurse know he is not feeling well, no response back yet.

Vaccine received 2/15. Slight soreness the next day then no further symptoms until 2/25. 2/25 Watery diarreha during night. Light rash/itch mainly on torso and right arm. Itch comes and goes 2/26 Light rash/itch mainly on torso and right arm. Itch comes and goes. No diarreha. No bowell movement. 2/27 Watery diarreha during night and this morning. Took 2 Imodium tabs this morning. Light rash/itch mainly on torso and right arm. Itch comes and goes.

Reported via Nurse Triage / PCP: Fainted earlier, eyes rolled back, mouth was drooping. Nausea, weakness, and chills. BP was 107/75, HR in the 70s. Currently alert and resting. States that patient had his 2nd covid vaccine yesterday AM and then develop chills and clammy skin last night. Symptoms worsened today and patient became weak and fainted. Was unconscious for about 5 minutes and while unconscious, mouth was open and drooling and became incontinent and eyes rolled back in head. Is awake and alert now, but still weak and only able to take 1 or 2 steps. No chest pain or breathing difficulty and no fever. Feeling very nauseous. Caller requesting prescription for zofran. Yesterday AM 2nd vaccine. Last night chills. This AM feeling weak. Today at 11am he felt weak with ambulation. He fainted. Was unconscious for 5 min. Had drooping of the face. He was unresponsive during this time. Had incontinence of urine. Then became awake but very weak still. Only able to walk a few steps. He is communicating. No chest pain. No current fever. No shortness of breath. BP 107/75 with HR 70. He has been very nauseated. He is drinking only small sips of water. Does not seem like a usually COVID-19 vaccine reaction. Given the LOC with urinary incontinence and sustained weakness, I advised ER evaluation to rule out neurological issues. Pt's daughter in agreement. They will go to ER. From Emergency Department: Patient presenting with chief complaint of syncopal episode which was witnessed by his wife. He reported the got dizzy and lightheaded and then passed out while seated. The reported duration of his loss of consciousness was somewhat inconsistent, unclear how long he passed out for, there was however no postictal state. He was not noted have any shaking or seizure activity, he did have an episode of urinary incontinence. He has not been feeling well ever since receiving his 2nd COVID-19 vaccine. By the time of my exam patient states that he is completely asymptomatic, he states he is feeling much better after receiving IV fluids. His lab work is remarkable for a slightly low sodium, compared to his previous levels which were many months ago. Unclear of the acuity of this, although upon further discussion with the patient he has been drinking large amounts of water since his vaccine trying to stay hydrated. I advised him to substitute to some electrolyte balanced fluids and to have his sodium rechecked by his PCP to ensure that this is transient. With negative testing and resolution of his symptoms he is stable for discharge home. Close return precautions were given.

Fever as high as 101.8 on 02/28/2021 Fever 99.1 morning of 03/01/2021 severe headache (starting to subside as of this writing 4:30 PM 03/01/2021) nausea (starting to subside as of this writing 4:30 PM 03/01/2021) Tiredness

Patient states that a day after having the vaccine, he developed severe stiffness in his hips and shoulders, muscle aches, had a headache on and off, chills, felt tired, had night sweats, lost his appetite, and taste was off. There symptoms lasted 10-12 days. He was tested for Covid 19 on 2/28 with an antigen test and was negative and tested again on 3/2 with a PCR and was negative . He is starting to feel better now. Called his physician who felt that these symptoms were due to the vaccine, encouraged him to go ahead and get second dose.

pt stated that he got chills the night after receiving the vax. Early hours in the morning his temp was 98.7 and reached 101.7. He was nauseated at this time. Next morning he woke up 99.4 temp but all other symptoms were gone. He contacted his PCP at the hospital and they instructed him to call us to file report.

Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Fever-Medium, Systemic: Headache-Mild, Systemic: Nausea-Severe, Systemic: Vomiting-Severe, Systemic: Weakness-Severe

I had strong stomach cramps for about four hours. This is something that I have not experienced in as long as I can remember. I had not ingested anything that would cause this condition. It eased up and eventually ended after I took several tablets of a generic form of Pepto-Bismal.

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.

UTI; Anemia; Colitis; A spontaneous report was received from a healthcare professional concerning a 77 years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed anemia, colitis and Urinary Tract Infection (UTI). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number: 039k208) on 29 Dec 2020. On 26 Jan 2021, approximately 6 days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 019K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 01 Feb 2021, the patient had a hospital visit for anemia and colitis for which patient was admitted and was discharged on 04 Feb 2021.The patient was again admitted to the hospital on 22 Feb 2021, for UTI and was at the hospital at the time of reporting. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events was not reported.; Reporter's Comments: Very limited information has been provided for this cases Although, a temporal association exist between the product use and the reported events of anemia and colitis, critical details such as the patient's medical history concomitant medication list lacking. Urinary tract infection is of an infective etiology as such a causal relationship is unlikely.

Chronic constipation, since receiving the first dose of the vaccination. My doctor has no explanation for it.

Severe vomiting accompanied by severe diarrhea starting around 10pm and lasting over 2 hrs. Finally stopped and allowed me to return to bed sleeping until 7am next morning. Felt good in morning.

patient reported that he started to experiance: vomiting, diarrhea, difficulty breathing, muscle sorness, difficulty swallowing, and headache on 03/03/2021 @2230.. patient reported that today 03/07/2021 he is doing fine and all his symptoms are getting better.

Heavy flu like...upset stomach...headache...cold and hot sweats...shivering almost uncontrollably...extreme tiredness.. Lastedv3 days...day 4 feeling 90 percent better

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.

#1 2/12/21 #2 3/12/21 - headache started noon 3/18/21, not much appetite, got worse throughout the day, went to ED, INR 16.7

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.

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.

On 3/23/2021, Patient became ill, vomiting uncontrollably, throughout the day. On 3/24/2021, he continued his vomiting episodes, and developed a fever with chills. At about 2100 hrs, patient was extremely weak, he went to the bathroom, urinated, and attempted to crawl back to his bedroom, less than 10 steps away. His wife, called 911, and went down stairs to allow entry for the fire department, The fire department, found patient unresponsive, not breathing, and no pulse. He was pronounced dead in his home.

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.

77 yr old covid +, symptom onset 2 weeks prior, date positive 4/3, admitted to the hospital on 4/3. Also admitted for acute appendicitis with appendectomy and purulent ascities; DM, HTN, received first covid vaccine April 1.

Moderna COVID-19Vccine EUA 14 hours after the injection I had a strong intestinal reaction with copious water expelled through the colon - a couple of much smaller but similar episodes ensued over the next few hours.

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 came to office for complaints of body aches, chills, hot flashes, sweating and lightheaded. Nausea and loss of appetite.

Patient complained of intense abdominal burning sensation across abdomen followed by intense flushing redness of face and lightheadedness. Symptoms resolved within 5 minutes, cool wash cloth to face. Patient on home oxygen canula. BP 142/84. HR 64 and regular. Resp 20-22. Patient observed for 45 minutes after vaccination without further complaints or symptoms

Severe vomiting: Onset 13-14 hours post injection. Duration: 6 hours. Severe diarrhea: Onset 13 - 14 hours post injection. Duration: 48 hours. Nausea: Onset: 13 - 14 hours post injection. Duration: 96 hours.

Gastro intestinal hemorrhage associated with chronic gastritis; Chronic gastritis; Nurse reports patient has fallen twice since being home; Abdominal pain; Acute Kidney Injury (found during hospital workup); Seven weeks and 3 days between shots; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (Gastro intestinal hemorrhage associated with chronic gastritis), CHRONIC GASTRITIS (Chronic gastritis), FALL (Nurse reports patient has fallen twice since being home), ABDOMINAL PAIN (Abdominal pain) and ACUTE KIDNEY INJURY (Acute Kidney Injury (found during hospital workup)) in a 77-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. The patient's past medical history included No adverse event (No medical history was provided). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Seven weeks and 3 days between shots). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (Gastro intestinal hemorrhage associated with chronic gastritis) (seriousness criteria hospitalization and medically significant), CHRONIC GASTRITIS (Chronic gastritis) (seriousness criterion hospitalization), FALL (Nurse reports patient has fallen twice since being home) (seriousness criterion hospitalization), ABDOMINAL PAIN (Abdominal pain) (seriousness criterion hospitalization) and ACUTE KIDNEY INJURY (Acute Kidney Injury (found during hospital workup)) (seriousness criterion medically significant). The patient was hospitalized from 23-Mar-2021 to 02-Apr-2021 due to ABDOMINAL PAIN, CHRONIC GASTRITIS, FALL and GASTROINTESTINAL HAEMORRHAGE. On 09-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Seven weeks and 3 days between shots) had resolved. At the time of the report, GASTROINTESTINAL HAEMORRHAGE (Gastro intestinal hemorrhage associated with chronic gastritis), CHRONIC GASTRITIS (Chronic gastritis), FALL (Nurse reports patient has fallen twice since being home), ABDOMINAL PAIN (Abdominal pain) and ACUTE KIDNEY INJURY (Acute Kidney Injury (found during hospital workup)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Nurse reported history of fall, non-compliant with cane use. Supra-therapeutic INR, watchman procedure was scheduled on 15-Apr-2021. Nurse reports patient had fallen twice since being home. Treatment information was not provided. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. 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.

Had the first shot on 02-02-2021 Arm was slightly red and itchy Diarrhea started 4 days later on 02-04-2021 Diarrhea has continued unabated through 04-09-2021 at which time it started to let up. I still have diarrhea but to a milder extent, only going twice a day with somewhat formed stool.

Patient stated he initially started throwing up while at church a few days after receiving his second shot. He was brought to the local hospital and diagnosed with acute pancreatitis, then sent to a different facility where he was treated for his condition for 10 days.

After a couple days, the patient because nauseous for a day or two and then developed stiffness in his arm, neck, back, and clavicle area. He has had these symptoms for about 5 weeks. Suspected administration being too high and accidental injection into the shoulder joint resulting bursitis.

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

He is falling asleep all the time and continues to get worse, not better; He is falling asleep all the time and continues to get worse, not better; Freezing cold all the time; feeling horrible; walking feebling at times; He has lost at least 10#, and lost three inches in waist,; stomach is bloated; he shuffles his feet-like his legs are stiff; balance is worse than ever; balance is worse than ever; no appetite; This spontaneous case was reported by a consumer and describes the occurrence of HYPOTHERMIA (Freezing cold all the time) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOTHERMIA (Freezing cold all the time) (seriousness criterion medically significant), VACCINATION COMPLICATION (feeling horrible), GAIT DISTURBANCE (walking feebling at times), WEIGHT DECREASED (He has lost at least 10#, and lost three inches in waist,), ABDOMINAL DISTENSION (stomach is bloated), MUSCULOSKELETAL STIFFNESS (he shuffles his feet-like his legs are stiff), BALANCE DISORDER (balance is worse than ever), CONDITION AGGRAVATED (balance is worse than ever), DECREASED APPETITE (no appetite), SOMNOLENCE (He is falling asleep all the time and continues to get worse, not better) and CONDITION AGGRAVATED (He is falling asleep all the time and continues to get worse, not better). At the time of the report, HYPOTHERMIA (Freezing cold all the time), VACCINATION COMPLICATION (feeling horrible), GAIT DISTURBANCE (walking feebling at times), WEIGHT DECREASED (He has lost at least 10#, and lost three inches in waist,), ABDOMINAL DISTENSION (stomach is bloated), MUSCULOSKELETAL STIFFNESS (he shuffles his feet-like his legs are stiff), BALANCE DISORDER (balance is worse than ever), CONDITION AGGRAVATED (balance is worse than ever), DECREASED APPETITE (no appetite) and CONDITION AGGRAVATED (He is falling asleep all the time and continues to get worse, not better) outcome was unknown and SOMNOLENCE (He is falling asleep all the time and continues to get worse, not better) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-May-2021, Stool analysis: negative negative (Negative) Stool sample was negative for blood. No concomitant medications were reported. Treatment information was not provided. Very limited information regarding the events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-125899 (Patient Link).; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

21 days later i was out walking my oxygen level began dropping down to 80 and I started throwing up. then i and took my blood pressure it was 125/80 and I tried to eat a cookie and I threw up. I went straight to ER. He gave me EKG, and he sent me straight to the Operating Room. 10 minutes after I saw the doctor he started the stint and that's when the oxygen dropped to 0, They knocked me out completely and I was in surgery and that is all I remember. I had a full blown heart attack on the table, called a widow maker- means the main arteries shut down completely, and my oxygen dropped to 0. The doctor put a stint in. Since then I started taking baby aspirin and brilinta 90 mg - 2x day, both are blood thinners. I took the 2nd Moderna shot on 5/18/21, which was advised by my doctor to wait 90 -100 day. I didn't have AE just a little swelling in the arm. I'm recovered from the AE from the 1st Dose, but my arms and legs are still a little. Not able to build up the muscles to were they were.

Pt experienced abdominal pain, emesis, leukocytosis. Admitted to hospital on 5/25/2021 and was diagnosed after workup with small bowel obstruction due to a single abdominal adhesion, which was lysed on 5/28/2021. No prior history of abdominal surgery. Discharged from hospital on 6/7/21 in stable condition. On 6/12/2021, pt developed further abdominal pain. Workup revealed SBO with multiple abdominal adhesions that had redeveloped.

Patient started experiencing nausea and vomiting per his appointment on 03/30/2021 since the day after vaccination. From the 03/30/2021 appointment, he continued to have more symptoms such as loss of appetite, fatigue, weakness, incontinence... Patient came in to see his provider on 06/07/2021 and informed him of his tremors, involuntary movements and jerking.

Severe diarrhea after second shot. Ongoing. Severe diarrhea after first shot as well. Diarrhea after first shot lasted 4 days. Went to doctor.

07/22- Patient is a very pleasant 78-year-old gentleman with a history of pancreatic cancer on chemotherapy who presents today for evaluation of fever and chills. Patient states he began feeling unwell overnight last night. He developed shaking and chills. He contacted the clinic and was referred to the emergency department. He states he has had a mild cough. He has had no abdominal pain. He has had diarrhea which is somewhat chronic. He has had no urinary symptoms.

I got lightheaded on the drive home. Since I got home I had cramps, gas and diarrhea. I've recovered some but not 100%. Ate no dinner last night. Its been 5 days with these symptoms.

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.

Dizziness and Nausea starting 01/17/2021 thru today 1/22. Some days stronger than others, with today being very minor and hopefully over. I am prone to motion sickness and these symptoms are very similiar, even to the point of looking up to see the horizon and getting some relief. Took some Meclizine with mixed results.

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.

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.

SOB, Fatigue, weakness Narrative: F: Telephone call: Pt's wife called and said that patient is in the hospital- He went into hospital on 1/24/21. He had the Covid injection here at facility on 1/22/21@0945. He was feeling fine till approximately 1800 that night. His symptoms included the following: chills- fever of 102- he took Motrin 11PM on 1/22. On 1/23- @0200 fever was 99 on 1/23- he was fatigued feverish was back @ 101 degrees. He had no appetite all day. He was tired- weak- trouble breathing with SOB- Call was made to to this facility at 0230 but there was no answer. On 1/24/21- 0230AM patient could not breath and 911 was called. The EMT came- Sao2 was 65 %- couldn't walk- very short of breath. He was taken to hospital where he has been since. He was Dx with Pneu and placed on IV/ABT. Covid test was done and was negative at hospital. He has been on Oxygen since. His wife was very tearful. Family says that he may need O2 at home and a HHA.

Severe and rapid onset of two chronic conditions, sciatica pain in glutes and upper legs. As well at the same time a rather severe onset of GERD symptoms. Next day all day bad symptoms, 3rd day much improved, 4th day both almost all gone. Prior history of COVID-19 event for myself in March 2020.

1/31/21 - Light Headed all day. Nausea at 7:00 pm. Slight temperature rise at 8:00 pm. Arm sore at vaccination site. 2/1/21 - Light headed all day til now. Arm sore at vaccination site.

We don't know what happened. 25 hours after the shot, he started gagging and stopped breathing. He was pronounced at OSF at 8:07pm after we took him off life support.

Moderna COVID-19 EUA Severe fatigue, chills, lack of appetite, sore arm for 3 days, slight headache off and on Did not report to physician. Bed rest and as much fluids and food as could tolerate. 3 doses of ibuprofen Symptoms persisted with diminishing severity until February 1, 2021

Patient had a sore arm on the evening of vaccination. The next morning at 8am he had a fever of 103 degrees, violent shaking, and his lips were numb. He was transported by ambulance to the ER and admitted. He received IV therapy and acetaminophen. He states he vomited February 4th. An X-ray was performed on his abdomen and he was given a diagnosis of Ileus. The next day, February 5th, he was able to have a BM and eat. After he was able to eat, he was released from the hospital. Shortly after being released from the hospital his lips started breaking out in fever blisters. He estimates he had 50 or so cold sores and his lips were extremely swollen and red. After seeing his regular health care provider, he started a round of Valcyclovir. On February 10th, the date he reported the adverse reaction, he stated his lips were getting better and he still had more Valcyclovir to take.

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.

pt stated around midnight after getting the vax he had some GI issues, fever of 101, body aches, fatigue, felt like he had the flu. Said it hurt to touch the hair on his body. The left arm was sore around the injection site. After about 30 hours after his vax his symptoms subsided.

He developed a fever on 1/8, become unable to swallow and bedbound. He was already end of life and Hospice care at the time of the vaccine.

Nausea, vomiting, dizziness, distorted vision, sore arm, fever, injection site swelling, ambulatory deficiency. Admitted to Hospital

911 called to patients house for trouble breathing and abdominal pain. Patient coded, wife presented DNR paperwork. Patient presented to Hospital DOA at 0958.

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.

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

Patient is a resident in a LTC facility. Patient was COVID positive in October. Patient received the 1st Moderna COVID 19 vaccine on 1/11/2021 lot # 027L204. Patient received the 2nd Moderna vaccine on 02/8/2021 with Lot # 037K20A. Abbot rapid COVID 19 anitigen test were performed on patient on 2/9/2021, 2/11/2021, 2/15/2021, 2/18/2021, & 2/22/2021 all with negative results. Res had a general decline of fatigue, decreased appetite and foley catheter complications and was sent to ER on 2/25/2021. It was reported to our facility on 2/26/2021 from a nurse contacting the Dr. about another resident that patient had a COVID 19 PCR obtained in the ER and was positive.

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.

3/2 I got my first moderna shot yesterday. Last night I started developing chills, a couple degree fever, overall body aches much like the flu and persistent slight nausea. Did not throw up but was uncomfortable for sure. Slept in 2 to 2.5 hour shifts then up to pee and back to bed. Finally this morning I lslept from 10 am to 2 pm. 4 wonderful hours of blissful unconsciousness. My O2 this morning was 98/74 BP 135/81/69. I just took my bp 315 pm and it was running 141 high end. O2 was good at 97 but heartrate was 99 and temp was 99.7 to 99.1.

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.

Patient presented to ED with constipation and near syncope. Patient sustained a left radial fracture after slipping on the ice a few weeks ago, and was prescribed oxycodone before and after surgery. Patient's constipation was treated with repeat enemas and stool softeners with resolution and patient is to be discharged today with daily miralax.

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

Within 48 hours of receiving covid vaccine, patient started experiencing severe headaches, mild nausea, and moderate chills. patient had tried OTC medication to help with symptoms with little to no relief. Same reaction/symptoms happened after 2nd covid dose. Symptoms are still present as of 3/9/2021 and not getting any better. 2nd covid shot was 2/11/2021 LOT:016M20A

day 1- Mild soreness Day 2 -more soreness-boneache Day 4-11- intestinal distress and high volume Day 10-14-Renewed soreness in shot area

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.

Got the vaccine, and he got home and his whole body was like he was freezing with chills, could not walk, could not talk, had a headache, could not eat, felt like he was dying. Really bad. The arm is swollen up like a balloon, black and blue from the injection. Took aspirin, and still having the chills and he can hardly move his arm.

Pt presented to ED with c/o nausea, shaking, chills and loss of appetite with onset approximately 2-3 hours post vaccination

After vaccination that evening I started vomiting, the fatigue started the next day and it was mild. Day 6 or 7 in the middle of the night I had an itchy arm that woke me up,went back to sleep, woke up the next moring my arm was blown up like a balloon and I was worried about cellulitis, but this lasted about 4-5 days and I was back to normal.

About 5 days after vaccination, I started experiencing low grade fever. chest congestion, exhaustion, digestive issues. I went for a COVID test which was negative. Symptoms have gradually diminished except for exhaustion which continues.

He developed very labored breathing on Tuesday night. By Wednesday morning , upon waking it was severly worse. I would have taken him to the ER had I been home. When I returned home around 11am, he was having a very hard time breathing. I got him a rescue inhaler to use. He had a dailysis treatment that day, during the treatment they kept him on oxygen. I called Dr office to inform them, they ordered a new inhaler and told me if the symptoms did not decrease by 72 hours to inform them. His breathing did get somewhat better but he did not have his enegry levels that he had previously or his appeatite. 12 days after his 2nd dose of the Moderna vaccine he went into cardiac arrest in the home with myself and husband present.

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.

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.

Patient reports chills, fatigue, aches, diarrhea, and dizziness/imbalance approximately 24 hours after vaccination. Patient advised to see primary care physician given his balance issues/concerns. Given that patient was referred to make an appointment to see PCP, I am submitting a VAERS report on that basis.

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.

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.

?Can?t get a full breath? Nauseated, Dizzy, balance was off. ?Thought I was having a heart attack. Couldn?t walk without a cane because of pain and weakness.?

Severe pain in abdomen; pancreatitis; Swelling in gallbladder; Swelling in kidney; weakness; A Spontaneous report was received from a Consumer concerning a male patient of 78-year-old who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pancreatitis, Asthenia, Abdominal pain, Gall bladder edema, Hydernephrosis. The patient's medical history included heart problems, 13 stents, high blood pressure, high cholesterol, borderline diabetic, thyroidectomy (28 years), bilateral knee replacement, and arthritis. Allergy history included sulfa. Concomitant medications included metformin, metoprolol, lisinopril, levothyroxine, clopidogrel for unknown indication. On 25 Feb 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch: 023M20A) on left arm for prophylaxis of COVID-19 infection. The patient had experienced difficulty in exercise and weakness, after first dose of vaccination. On 17Mar2021 he had severe pain in abdomen and hospitalized for seven days until 23 MAR 2021. The patient was diagnosed with pancreatitis and the patient also had swelling in gallbladder and kidney. The patient was treated with intravenous fluids but other meds were not reported. Laboratory details were not provided. Action taken with mRNA-1273 in response to the events was not reported. On date of this report, the outcome of the events Pancreatitis, Asthenia, Abdominal pain, Gall bladder edema, Hydernephrosis unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Saturday and was fine until Tuesday evening I felt discomfort in my stomach and started having diarrhea all day on Wednesday and it's slowed down some but very uncomfortable and its coming out almost black. And today I've gone four times since 3:30am.

My neuropathy consists of pins and needles in my feet and heat going down the back of my legs. On the first day of the reaction, there was a significant increase in both pins and needles and heat. Also, started to experience restless leg syndrome which I had never had before. The next day I suffered from nausea. The next night the pins and needles and heat was even greater and the restless leg syndrome continued. Eventually, I had what felt like a hot flash and I thought I was all sweaty. My wife felt my shirt and body and said I was not sweaty. Immediately, after the hot flash, the restless leg syndrome disappeared and the pins and needles feelings were greatly reduced. I have never experienced anything like the hot flash, before.

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.

Patient received 2nd dose of vaccination on 03/01/2021 and developed symptoms on 03/03/2021. He presented with bilateral numbness in feet ascending to his mid shins and weakness complicated with multiple falls due to severe ataxia. He did not report any head injury or loss of consciousness. He also reported mild dysphagia, changes in voice and left arm weakness. Neurological examination showed bilateral leg strength 4/5 and numbness. The patient was admitted to hospital and given IVIG for 7 days before transfer to an acute inpatient rehab facility. The patient was discharged from rehab facility on 04/05/2021 and still has some residual weakness and numbness.

Patient had second covid 19 vaccine on 2/2/21 at pharmacy. Was admitted on 4/6/21 to hospital with Shortness and Breath, Vomiting, and COVID-19 (tested positive on 4/6/21). Patient expired on 4/8/21 @ 1954.

SPOUSE REPORTS THE FOLLOWING FOR PATIENT 4/21/2021 @ 9PM GENERAL MALAISE 4/22/2021 APPROX 4AM SEVERE HEADACHE TOOK IBUPROFEN 4/23/2021 AFTER LUNCH, PATIENT WAS UNABLE TO WALK AS PREVIOUS AND HAD 4 FALLS, ALSO COMPLAINED OF A SORE THROAT. 4/24/2021 DID NOT FEEL WELL, TEMP UP TO 100.4, NAUSEA AND VOMITTING X 1 AND CHEST PAIN, CALLED EMS AND WAS TRANSPORTED TO MEDICAL CENTER ER. 4/26/2021 PATIENT WAS DISCHAGED HOME AFTER TREATMENT FOR RHABDOMYOLYSIS AND RETURNED TO THE HOSTPITAL AGAIN ON 04/27/2021 WITH RHABDOMYOLYSIS AS PRIMARY DIAGNSOSIS. RESIDENT DISCHARGED TO SNF ON 04/28/2021.

on April 30,2021 I woke up thinking I was having a CVA, the room was spinning and I felt nauseous . I went to the ER at the regional Hospital. When admitted the check my vital signs, chest x-ray, CT brain scan . CVA negative, chest clear, heart rate elevated to 155bpm

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.

Nursing home pt w/hx of dementia and recent hospital stay (5/1-5/7) for treatment of healthcare associated PNA, recurrent UTI, recent antifen CDiff+ but toxin negative. Pt p/w worsening SOB, generalized body aches, abdominal pain, chills and test positive for COVID (5/8) despite having received Moderna vaccine (1/18 & 2/15). Was admitted for additional management of acute hypoxic respiratory failure due to COVID complicated w/chronic hypoxic resp failure d/t COPD. Pt treated with dexamethasone and bronchodilators as well as diuretics for volume overload in setting of diastolic heart failure. Pt was ultimately discharged to nursing home on 4L of O2.

Procedures - documented in this encounter Procedure Name Priority Date/Time Associated Diagnosis Comments SARS COV-2 RNA ROUTINE 04/23/2021 9:14 AM EDT Sick 4/26/2021COVID-19 virus infection +1 more Dx Progress Notes Encounter Date: 4/26/2021 ? ? Signed Expand AllCollapse All History of Present Illness: Patient ID: Patient is a 78 y.o. male who presents today, via phone, with the following complaints: Tested April 24 positive Covid 19. He got the first vaccine 3 weeks ago and was supposed to get the second one tomorrow. o When did symptoms start? 4/20/2021 o Fever: ?Yes ?No o Cough: ?Yes ?No "terrible" Productive--phlegm o Shortness of Breath: ?Yes ?No o Chest Tightness:?Yes ?No o Body Aches: ?Yes ?No o Headaches: ?Yes ?No o Sore Throat: ?Yes ?No o Nasal Drainage: ?Yes ?No A lot: Thin and wet o Sinus Pressure: ?Yes ?No o GI Symptoms: ?Yes ?No o Ear Pain/Fullness: ?Yes ?No o Loss of Taste or Smell: ?Yes ?No Both o Medications Taken: Mucinex, Tylenol, Zyrtec o Sick contacts:?Yes ?No Cough is the most bothersome symptom.

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.

Patient has a red sore arm and loss of appetite still on 7/14/21 since the date of vaccinations. Patient was vomiting on 7/10/21 but has stopped

Pt presented to the ED on 07/19/21 with complaints of nausea, vomiting, sore throat, and generalized weakness. Pt was found to be COVID positive that same day. Pt has been fully vaccinated.

Resident had lunch on 01/14/21 and after lunch around 2:00pm, he vomited and stopped breathing. We coded the resident and 911 paramedics came. They pronounced him dead at 2:18pm.

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.

received moderna covid 19 1/14/21 12 noon. 1600 hours developed severe sharp 7/10 peri umbilical abdominal pain that did not radiate, no associated signs/symptoms. Pain persisted until 2300 hours, took one tab acetaminophen, went to sleep. Upon arising in AM pain resolved. Has not recurred. Upon arising did experiencing more typical side effects including fatigue and thought he had fever, no thermometer to check, these symptoms subsided over 1-2 days. No recurrence of any above symptoms.

Generalized feeling of being ill. Greater sensitivity to pain in right index finger which is arthritic; Stomach upset. Oral body temp 97.3. Chills

7 hours after the vaccine tiredness and mild nausea started. Approximately 26 hours after the vaccination extreme dizziness occurred and he lost consciousness for a few seconds. He was clay and completely lost his coloring . His son is a retired HCP and we took vitals and within 30 minutes after drinking electrolytes he was back to normal. We believe he was dehyrated. He has had vertigo in the past and has a pacemaker. His blood pressure was taken in 3 positions and within less than 30 minutes after having him hydrate all symptoms subsided. I emailed these symptoms to his Medical Doctor. We also had him use his pacemaker monitoring system to send a report to his healthcare specialist.

Patient received COVID-19 vaccine on 1/27/21 and had episode requiring ED visit on 1/28/21. He had nausea, chills, SOB, hypoxia on exertion and syncope with collapse. He went to ED and they found no reason for these issues. He has COPD at baseline but his lungs sound fine and he did not have Issues at the ED. ED did not provide any treatment, we provided 4mg Zofran. Vitals are at baseline 1/29/2021 and he reports he feels excellent, no further nausea, chills, lightheaded ness or SOB.

Local pain level 3 to 4, that evening I started to feel weak and chills and shivering. Then I started to feel nausea and then I vomited. Day 2 stomach upset and diareahha, pain level diminished to 2 to 3 Day 3 pain level reduced to 2 and general feeling of weakness.

Pt reports that he had diarrhea that began 1 week after receiving first dose of Covid vaccine by Moderna. Pt received the second dose of Covid vaccine on 1/1/25/2021. Pt states that even after 2 weeks after receiving the second dose of Covid vaccine by Moderna the diarrhea has continued. Pt reports not issues with diarrhea prior to receiving the Covid vaccine by Moderna.

I had minor difficulty swallowing 6 hours after vaccination. This lasted about 12 hours. No swelling of tongue, lips or face.

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.

Patient began throwing up at 3:00 a.m. 2/12/2021, had severe chills, blacked out. Extreme fatigue, headache, joint pain. Patient has been sleeping for approximately 14 hours at this time (5:45 pm PST). He is able to slowly walk to bathroom, couch, bed. He is slurring his speech.

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

Very sore arm for two days, slight headache for 1 day, Upset stomach that comes and goes after waking in the morning and after meals. persistent and still ongoing after4 days

79 Yr old pt had Covid Vaccine 2nd injection on Tuesday. Pt became ill on Tuesday noc with generalized bodyaches and loose stools. No fever. No cough nor HA. No redness nor swelling of arm. Injection was the Moderna. Last voided this evening. Last normal meal was AM of vaccine injection. 2. Increased dependent lung base atelectasis 3. Mild gallbladder wall edema suggesting choleycystitis. No biliary ductal dilitation or calcified stone. 4. Mild pancreatitis without abscess or necrosis 5. Colonic diverticulosis without diverticulitis. Impression: 1. Mild-Moderate Dehydration 2. Reaction to second dose of Covid -19 Moderna vaccine 3. Elevated LFT's suggesting CD Obstruction 4. Elevated wbc most likely related to #3 or #5 5. Bibasilar atelectasis with low lung volumes and accounting for Hypoxia; suspect related to #6 6. Acute Pancreatitis with Amylase 348 and Lipase 1109 7. Elevated D Dimer ; DISCHARGE SUMMARY Date of Admission: 2/11/2021 Date of Discharge: 02/12/2021 Admitting Diagnosis: Acute pancreatitis, acute cholecystitis Discharge Diagnosis: Acute pancreatitis, acute cholecystitis, sepsis History of Present Illness: Pt presented with 2 days of generalized malaise, abd pain, and diarrhea, starting shortly after his second Moderna COVID-19 vaccination. In the ER, he was found to have acute pancreatitis and cholecystitis as determined by CT scan and U/S without biliary tree involvement. Given new O2 requirements, CT chest performed and was negative. Labs showed elevated amylase/lipase, elevated bilirubin, AST/ALT/alk phos. Disposition: Transfer to Medical Center for further management Condition: Fair

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

Currently waiting for dental work (crown removal and replacement to treat cavity). 2/18/21 Started to experience toothache (R) which got worse as the day progressed. Tylenol didn't help. Took one tab of Percocet (5-325) to allow me to sleep. 2/19/21 Contacted dentist and was prescribed Penicillin VK 500 mg. Started Penicillin around 3 pm. 2/19/21 ~6 pm onset shakes, chills, sweating, low grade fever (~100.2), nausea, headache, weakness, difficulty in standing. Took more tylenol, lay down, fell asleep for approximately 3 hours. Woke briefly took my nighttime meds (atrovastatin, metoprolol, ranolazine, baby aspirin.) Additional information for Item 18: 2/20/21 Felt better when I woke up. Temp normal. Ate breakfast. Mild stomach ache. Around 3 pm onset of sweating and chills, shakes. Low grade temp (~100) 2/22/21 Fully recovered. No lingering issues. Not sure whether what I experienced is related to the Moderna vaccine or a reaction to the Percocet I took to alleviate the severe pain associated with my toothache.

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.

Mentation has declined since hospital discharger for fall on 2/6/20201. Patient has also had significant poor oral intake. Brought in due to apneic episodes. Abdominal pain - diffuse tenderness (right sided) Elevated liver enzymes - likely secondary to dehydration Increased serum creatine kinase - likely due to dehydration

The next morning, I looked flushed and short of breath and had a temp pain was severe in my arm and all over. couldn't eat. Last night i was able to eat a little but it was hard to get down. i wasnt tasting things right. called Dr said to take a couple of Tylenol and to call vaers for advice. Was very weak.

Woke up with body aches, head ache and slight nausea. Symptoms lasted thru the day after the shot and into the following day. Still a little tiredness in to the second day after the shot.

sudden onset sever vertigo with severe nausea and vomiting, diagnosed by ENT doctor as vestibular neuronitis. Treatment was physical therapy and symptoms 95% resolved in 5 weeks

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.

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.

patient had to be hospitalized after getting chills, a fever, severe diarrhea and vomiting 3 hours after receiving vaccination. Patient did not report having adverse reactions to previous flue shots at the time of visit, but his wife did report that he has severe reactions to the flu shot each year.

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.

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.

Fever ( temp 100.5 ), chills and body shaking Legs very week, barely walk and legs collapsed twice so went to bed for most on day. Slight metal taste in mouth. Didn't want to eat. Shot on Sun., down for count on Mon.,felt better on Tues and Ok by Wed.

Narrative: 78-year-old male veteran reports diarrhea for the past 3 weeks. He states that every time he eats food "I can't grumbling in my stomach and then after going to the bathroom" His appetite has been normal. This been no blood in his bowel movements blood tarry stools. He does state that the bowel movements "smelled different." He also states that the stools are watery but has "droplet" size formed stools and denies any presence of mucus. There is no associated abdominal pain, nausea, or vomiting. There is no fever or chills. There has been no recent travel or camping. There has been no eating a game meat or any other atypical foods. He relates his symptoms back to started after receiving his COVID-19 vaccine 3 weeks ago. There has been no recent antibiotic use. There are also no known sick contacts or similar symptoms in others. see gi issues that patient relates to starting after receiving his COVID-19 vaccine 3 weeks ago.

5 min after vaccination had abdominal pain, emesis x1, bradycardia, bigeminal PVCs, rigors, chills, fever 101.2, low Mg+ 1.3, SOB , ground glass opaque appearance on CT chest in lungs bilat, needing 2L O2, and normallly only needs room air. Admitted to hospital medical unit.

Chills 1:20 am Very stiff right arm 1:20 am Lethargy for 6 days Mild diarrhea days 1 and 2 Urine more frequently than usual

KEY POINTS Had the first dose of the Moderna vaccine on Mon. Jan 11. Symptoms started Tuesday, January 19, 2021 1st hospitalization, January 27, 2021 o Discharged, January 29, 2021 o Diagnosis: High leukocytes, inflammation. Diagnosis, acute pancreatitis. 2nd hospitalization, February 2, 2021. o Discharged February 4, 2021. o Diagnosis: Diagnosis, Deep vein thrombosis (DVT) of popliteal vein and pneumonia Details in notes section. NOTE This is an updated and correctly filed version of a form that I attempted to email to the regulatory authority. No evidence that it went through. Use this version if you have the earlier version. DETAILED DESCRIPTION OF EVENTS AFTER VACCINATION PROGRESSION OF SYMPTOMS TUES. JAN 19: At night, felt like hunger pangs – but not really relieved by eating. In the morning tried 2 Tums. Had temporary relief for about an hour. Had symptoms for the last three days. Chronic, varied between almost negligible to mildly annoying. Bowel habits usually very regular. WED. JAN 20. Had major bowel movements in the middle of the night THUR. JAN 21. Had major bowel movements in the middle of the night FRI. JAN 22. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) SAT. JAN 23. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) SUN. JAN 24. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) MON JAN 25. Extremely mild feelings of bloatedness over the last couple of weeks (0.5 on 1 to 10). A slight loss of appetite, but did not interfere with eating. Sometimes slightly nauseous. (0.5 on 1 to 10) TUES. JAN 26. Problems persisted and got worse. On Jan 26, Daughter GP suggested getting blood analysis to test for inflammation. WEDS, JAN. 27. Hospitalized. Findings: High leukocytes, inflammation. Diagnosis, acute pancreatitis. THURS. FRI. JAN 28. Hospitalized. FRI. Jan 29. Discharged. Wt 193 lbs! Usual, ~176-183. MONDAY FEB 2. Readmitted to hospital. Felt feverish, easy fatigue, bilateral stiffening of the calves, some edema. Diagnosis, DVT of popliteal vein and pneumonia. Given an iv bolus of a broad spectrum antibiotic. Started on Eliquis two 5mg pills twice a day for one week and the one tablet am and one pm. Given Lasix bolus and then started on 5 mg Lasix/day. Swallowing tests more or less OK WEDNESDAY FEB. 4. Discharged. MONDAY, MARCH 8, Check up with GP, Blood pressure 127/76. Lasix discontinued. THURSDAY, MARCH 11, Check up with GI doctor, Blood pressure consistently 150/90. Sent to adjacent cardiologist's office (next door). High BP reading confirmed and reconfirmed the next day. Dose of Metropolol succinate increased to 5 mg 2xday. Note 1: Still have the DVT. Note 2: Received 2nd dose of Moderna vaccine on Feb 11. Note 3. All medical records available either through hospital, GP or by contacting me. Note 4: This is not a crank report. I have had 50 years teaching and doing funded research in 3 medical schools rising to the rank of full Professor in each.

Patient is an 79 year old male who had his 2nd Moderna vaccination in his dominant right arm Thursday afternoon. Upon awakening Friday morning, he had difficulty walking. His legs were strong enough to hold him, but he was unstable. He also had some numbness on the palmar surfaces of some index and middle fingers of his left hand. His speech was somewhat garbled, but when his wife would encourage him to repeat himself, he could enunciate more clearly. He had some nonspecific difficulty swallowing. He attributed this all to adverse reaction to the vaccination, which would pass... Friday mid day his wife took him to the barber, and on return home he was briefly nauseated and vomited. Later in the day on Friday they went for car ride, and on return home he was briefly nauseated and vomited. He had no other episodes of nausea. He had no fevers or chills. He had no visual disturbances. He had no other numbness or paresthesias. He was aware of no clear weakness. Finally today, the gait instability persisted and the numbness in the left hand, so he came to the ER for evaluation. Patient is currently recovering in the hospital

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.

belching queasiness slight vomitus, feeling cold no fever, nasal congestion and left lower back and hip pain.

Patient became weak and unable to hold his head up one day following injection. Following day, low appetite. Day 2, had vomiting and unable to take in any PO. Day 3, was able to start eating. Day 4 and 5, he had improvement of neck pain. Day 5, had drop in blood pressure into the 70-80s systolic and 40-50s diastolic at home and then again in the clinic with no other signs of illness. Day 6, found to have Acute Kidney Injury on his CKD with creatinine rising into the 5's with baseline creatinine of 1.4-1.6. His liver function was abnormal also with elevated bilirubin to 6 (baseline normal 1), Alk Phos 522. He was hospitalized 2/25-2/28/2021 for these issues.

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.

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

Moderna COVID-19 Vaccine EUA Side-effect symptoms: vomiting (once), fatigue Recovery was complete by 4/5/2021, the next day.

Approximately 3 hours after vaccine administration, patient experienced the following: Nausea, Vomiting, Abdominal pain, and the following day: Bloody Bowel Movements. Patient went to the emergency department the day after vaccine administration. Patient was made NPO, started on IVF and Zosyn. Patient was seen by GI who agreed with supportive management of ischemic colitis. Around 1730 on 2/6, patient unresponsive and rapid response was called. Patient responded to Narcan. On 2/8/2021, 0358, patient was seen as not breathing and code blue was called. Interventions were unsuccessful and patient was pronounced dead at 0439am.

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.

Patients significant other states that patient had been in the bed since the vaccine on 4/8/21. He was told that he was positive for COVID. She advised the patient not to come in for vaccine. She reports that he had dizziness, chills, fever, and nausea along with lethargy. He was told by a physician that he was dehydrated. He has been resting since the last vaccine and drinking fluids. As of today, she states that the patient is out of the bed and improving.

Patient came for vaccination in the morning, then went out to breakfast. During breakfast, the patient slumped forward in his seat and was unresponsive for about a minute. There was no incontinence or seizure activity. On regaining consciousness, patient seemed to quickly get back to his usual level of mentation. He was diaphoretic and nauseous. He denies any preceding lightheadedness, nausea, visual changes, chest pain or palpitations. He presented to the emergency room, also had nosebleed and UTI. Was admitted for observation overnight and discharged the next day.

Fatigue lasting more than 24 hours. Diarrhea around 8:00 pm on 4/25 (took loperamide 4mg). At 8:33 pm, no more diarrhea.

developed rectal bleeding on 4/3/21, admitted to hospital on 4/5/21, discharged on 04/07/21 post EGD and Colonoscopy with blood transfusion x 2 units, no findings on upper/lower endoscopy, Meloxicam for arthritis discontinued, doctor advised bleed may be due to NSAIDS. Prescribed Protonix

Initially, had no strength to get out of bed (1 - 2 minutes) Long lasting / Persistent: Phlegm cough Loss of appetite Runny nose Fatigue / low energy Indigestion Feeling of weight / pressure around eyelids and head Low alcohol tolerance

Patient presented to the ED and was subsequently hospitalized on 3/22/21 with upper GI bleed. This was within 6 weeks of receiving COVID vaccination.

1/19 vaccination 1/24 Woke up, I was so dizzy, nauseated, vomiting I couldn't stand. I crawled to the bathroom. My wife came home and helped me. Vestibular Neuritis Symptoms diminished that evening as I was able to walk around. I mildly continued if I turned quickly for 2-3 weeks. Didn't keep me from regular activities but I was unstable during this duration. *recommended PT and still currently doing even though discharged at this point

extended moderate diarrhea and lower back ache (not pain) from soon after second shot to current time

On the next day, 06/02/2021 and lasting 4 days, I experienced the following: painful left shoulder/arm, headache, extremely tired, uncontrollable diarrhea. Note: Daughter living in another city also had trouble over 4 days with the second shot. My Mother had Guillen-Barre Syndrome over 40 years ago and was incapacitated for a year.

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.

History of Present Illness:   Patient is a 80 y.o. male who presents with chest pain. Patient reported that he 1st had the chest pain approximately 2 weeks ago when he woke from sleep. At that time patient pain lasted about 5 minutes or so and resolved when he got out of bed. He did well for the rest of the day up until yesterday. Patient reported that yesterday morning he woke up with the pain at the lasted about 30 minutes or so. Patient also had associated burping felt that it is likely GI in nature. The pain was located mainly in the left side of the chest without any radiation. No diaphoresis. No shortness of breath or palpitation. No radiation for the pain. Since yesterday morning he had another 3 episodes of pain the last after dinner tonight. Patient reported that this pain was located more on the left side of the chest, likely lasted about 10 minutes or so. There was no exertional component to the pain. No known history of heart disease. Due to rather recurrent nature of the pain patient was brought to the hospital by his son who is a cardiologist to be evaluated. No fever or chills. No cough . Patient reported that he got vaccination for COVID 2 days ago-of a concern that this may be a side effect of the vaccine. No dizziness lightheadedness. Patient with history of GI bleed in the past at that time patient was on NSAIDs. Patient with burping associated with the pain

Patient reports abdominal tenderness that was spread evenly across his abdomen. Reports the pain was a 6 out of 10. 10 being the worst, and that the pain was steady and not stabbing. Patient reports there was no diarrhea, gas, or constipation, but that he did experience nausea.

Pt got home at 3pm. Pt passed out and fell down. Pt did not hit head, but did bite his tongue. Pt reported to feeling nauseated and tired the rest of the evening.

Saturday morning (30 hours after vaccination) onset of widespread abdominal pain and tenderness, extending all over the whole surface of the abdomen; tenderness to pressure over the same area; pressure accentuated the abdominal pain symptom. The pain was associated with mild nausea. These symptoms continued through Sunday and into Monday following vaccination. Moderate to severe lethargy, expected with COVID vaccination. On Monday, the symptoms stopped. No cramps, diarrhea, constipation, fever, cough, loss of smell or taste or other expected side effects of COVID or its vaccinations. No symptoms relative to an allergic reaction. No treatment was necessary, other than bedrest. I am a retired public health physician. My theory: peritoneal inflammation. Question: should I take the second dose?

Sudden severe abdominal cramps and heavy diarrhea; after several minutes, problem subsided and has not recurred.

Received the vaccine 1/19/21. On 1/20/21, states hurt all over - generalized aches and pains, nausea, diarrhea. Did not get out of bed all day. Denies any chills. Subsided over the next 2 days and was gone by Friday. All s/s gone by Saturday. Also c/o arm soreness at injection site for the same time frame.

Moderna COVID-19 Vaccine EUA Adverse Events: (one day later) Severe back pain & general muscle fatigue Nausea & Vomiting Bloating stomach Took full strength Asprin pills 2 times, and slowly recovered the next day.

severe explosive diarrhea on 1/20/2021 and 1/22/2021 with generalized abdominal pain stayed at home and forced fluids, recovered slowly over three days

He had slight fever and chills, diarrhea, muscle weakness, arrhythmia asserted itself. Home health nurse came out and checked on him and put him on bed rest.

Client developed a mild covid infection 12/8/21 and recovered. He was admitted 12/25 with hypogycemia and mild weakness and sent home He was given his first dose of the Moderna vaccine 1/4/21 at approximately 9AM covid vaccine clinic He developed weakness the next day (1/5) prompting admission to a hospital and then transition to subacute rehabilitation briefly Work up at hospital revealed progressive respiratory failure and pneumonia requiring intubation and progressive ascending weakness and sensory loss without upper motor neuron changes. MRI : nerve root enhancement LP : protein 40, +/- 80 lymphocytes, cultures negative B 12 and B6 normal extensive CSF testing still pending campylobacter and Musk antibodies negative Neurology diagnosed likely AIDP (Guillain-Barre) and an EMG is planned for the near future. Neurology felt the cause of his GBS was likely his covid infection verses his Moderna vaccination He was treated with plasmapheresis. Client received dexamethasone, remdesivir, and zosyn and doxycycline when progressive leukocytosis and procalcitonin elevation was noted. Candida was cultured from tracheal aspirates but felt most likely d/t colonization with an option to treat further if he did not continue to improve. He is now extubated, unable to swallow and has profound weakness and distal sensory loss. He will transition to Acute rehab in the near future. Comorbidities:as described in the above section and... DM2, CKD3, HTN, DJD, BPH ( h/o prostate surgery), h/o Lumbar surgery and hernia repair, GERD, hypothyroidism, hyperlipidemia. Possible etiologies of his AIDP ( GBS) would include his recent covid infection, the Moderna Vaccine, or other undiagnosed infection. He got his flu shot 9/25 ( fluzone sanofi) so this is not likely to be the culprit

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.

Had my second shot on Tues 2nd Feb. Had some discomfort during the night and took one Tylenol tablet. The next day around 11am, started to feel very achy, weak nauseous and a headache. Then had severe shakes and felt very cold had to put on a jacket. Lasted about 4 hrs then gradually diminished but not 100% Unable to eat. .Today.(Thurs )feeling much better 90% normal. I feel I could have been given a little more warning about the possible adverse effects. Thanks

Veteran states that he had diarrhea on and off for a few days. Symptom resolved Other Relevant Hx: Diarrhea

20 minutes after receiving shot had difficulty in breathing Wife rushed home and started using nebulizer, had to take two treatments before able to breathe a little better

Headache, chills, vomiting started on the morning of February 12, 2021. The vomiting happened twice but the chills and headache lasted almost 24 hours. He felt much better on February 13, 2021.

81 YOM with hx of RA, PUD and HLD presents to GVH ED with 3 days of LUQ abdominal pain. He states pain stared after he received his 2nd mederma covid vaccination. He stats 1-2 days after 2nd shot on 1/28 he had expected fever and chills but then developed LUQ pain worse with inspiration. Pain is minimal at rest and no other associated sx, denies CP, SOB (only hurts with deep breath) adn no N/V. CT abd/pel with contrast showed multiple peripheral wedge-shaped hypoenhancing dense regions consistent with splenic infarcts . Pt was placed in observation for starting AC and monitoring on tele.

Nausia, chills, fever, and taste modification. Modification in tongue sinsitivity. Soreness in arm of injection Taste and toungue sensitivity lingers. Fever and chills lasted one day .

Had shortness of breath, chills, and fever up to 102 for the first day and half. On Sunday it came back to normal finally. Night sweats that are still continuing. Just during the day and get hot flashes. Flushing, upper body clamminess and then goes away and then has chills. His breathing has improved but is still not real steady on his feet. He is about 80-85% on his balance, 95% on his breathing. His biggest problem at this point is the hot flashes and the chills. He also has had loss of appetite and has had weight loss.

Over the weekend 2/27/21, 15 days after vaccination, Patient Just experienced symptoms similar to those he initially experienced after receiving the immunization. Patient reported diarrhea, fever, body aches and pain and swelling at the injection site. The symptoms lasted about 48 hours.

Patient had gotten up to the bathroom and collapsed in the hallway after using the restroom. Patient was unresponsive upon EMS arrival with vomitus coming out of the mouth per the report when they rolled patient over onto his side the emesis was pouring out of his mouth. ER course: Examination. Epinephrine 1 mg IO x4 CBC, CMP, cardiac panel MDM: 1447 patient arrival, per EMS report patient had been sick and vomiting all morning. Bradycardia noted at arrival with rates in the 30s, CPR was initiated patient had received 3 rounds of epi prior to arrival. 1450 CPR continues via the Lucas device, 1 mg epinephrine given IV push 1451 CPR pause rhythm check. CPR resumes 1453 CPR paused for rhythm check. No central pulses, CPR resumed, glucose of 99 per fingerstick 1454 King tube removed. Oral airway placed respirations by BVM. 1 mg epinephrine IV push 1455 CPR pause for both pulse and rhythm check. No central pulses noted. CPR resumes via Lucas 1456 pupils are fixed and dilated bilaterally 1457 CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed via Lucas. 1 mg epinephrine IV push 1459 warm blankets applied. CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed 1501 CPR pause for pulse and rhythm check. No central pulses. CPR resumes 1502 1 mg epinephrine given IV push 1503 CPR pause for pulse and rhythm check. No central pulses noted. CPR resumed via the Lucas device 1506 resuscitation is ceased at this time. Time of death recorded at 1506

Chills and violent shaking at 7:30pm temp 99.0. Gave 2 Tylenol. At 10:00 temp 101.6 then went to 101.7 and gave Ibuprofen 400mg. At 11:00 pm temp down to 99.7 and fell asleep. 9:00 a temp 97.5. Had no appetite all day 2/26 injection site red, swollen and bad pain. When fever went high had no mobility and could not sit up to take meds. Next day tired and listless.

A few days after vaccination patient had an unusual dry cough/ and then a pain in his chest, He called our Doctor she said call your cardiologist now, patient called Dr and told him he wanted to go to his office, explained the pain he was experiencing - the doctor told him said he couldn't see him wanted to do a telemed exam. and proceeded to tell patient to see an gastro entomologist, take Tums, no tomatoes, no coffee and a few other foods and that patient was suffering from Acid Reflux and to call him back net week.

My husband has kidney problems that have nothing to do with the vaccine; C-diff infection; My husband has a tube connected to his kidneys.; My husband had diarrhea not sure if it is due to the vaccine or not; My husband has had issues with hypertension; My husband has had dehydration; husband would be missing his scheduled 2nd dose; A spontaneous report was received from a consumer concerning her husband, an 80-year-old, male patient who missed their second scheduled dose of Moderna (mRNA-1273) vaccine. The patient was admitted into the hospital. The patient's medical history provided included the patient was diagnosed with urine cancer when the patient was 57-year-old, had ongoing Hypertension and Kidney issues. Concomitant products known to have been used by the patient was not provided. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unknown date. On 10 Mar 2021, the patient missed his second scheduled dose of mRNA-1273. The patient was hospitalized due to the kidney problem, C-diff infection and had diarrhea and not sure if it is due to the vaccine or not. Patient had ongoing issues with hypertension. The reporter stated that the patient might have had dehydration and had diarrhea that also lead to having kidney issues, the patient's numbers went down due to dehydration. The Patient had a bag connected to his kidney and a tube, the patient had blockage and the bag was to clear out the patient's urine. Due to prolongation of hospitalization the patient missed the scheduled second dose of vaccine administration. The patient was still in hospital. No laboratory details were provided. Treatment information was unknown since the patient medical issues were still ongoing. Action taken with mRNA-1273 in response to the event(s) was unknown. On an unknown date, the outcome of the events were considered Not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Reporter stated that the events were not related to the vaccine and the patient has hx of hypertension and kidney issues Further information has been requested.

Explosive diarrhea, several times a day, primarily in mornings, occasionally in evening, usually starting at 4:00 am until system completely cleaned out.

passed out; Golf ball sized knot from hitting head somehow, believes he passed out; Nauseous and sick; Dry heaves for 10-15 minutes; Nauseous and sick; A spontaneous report was received from a consumer concerning a 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of loss of consciousness, haed injury,malaise, nauseous and retching, believes he passed out, dry heaves for 10-15 minutes, golf ball sized knot from hitting head. The patient's medical history was not provided. Concomitant medications reported were blood pressure meds for drug use for an unknown indication. On 5 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot number: 031L20A) via unknown route for prophylaxis of COVID-19 infection. 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: 011A21A) via unknown route for prophylaxis of COVID-19 infection. On 11 Mar 2021, the patient experienced the event(s)loss of consciousness, head injury, malaise, nauseous and retching, believes he passed out, dry heaves for 10-15 minutes, golf ball sized knot from hitting head. Treatment information was unknown. Action taken with mRNA-1273 in response to the events was not applicable. On 12 Mar 2021 the outcome of event(s), nauseous and sick, believes he passed out, dry heaves for 10-15 minutes, golf ball sized knot from hitting head was considered as recovered/resolved..; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient called the office stating that his arm is red and hot and his arm is swollen all the way around. He has been feeling dizzy and nausea and has fallen. He was having a fever of 100.0. Patient was also having arm pain. Patient was advised to go into UC.

Fatigue to staying in bed for 2 days, followed by six days of diarreha for the first injection. The second injection resulted in very severe stomach pains on second day which lasted overnight.

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 received Moderna vaccine initial dose at clinic on 4/2/21. Patient presented to the Emergency Department on 4/14/21 with complaints of dizziness and mild nausea. CT angio chest w& wout contrast identified pulmonary embolus within the intermediate pulmonary arteries bilaterally. Treatment started 4/14/21 with Eliquis (apixaban) patient admitted for observation overnight and discharged in stable condition on 4/15/21.

Narrative: 2/8/2021 UTI, sepsis, hyperglycemia, staphylococcus, MRSA infection-discharged to hospice care from Medical Center 2/9, passed 2/11.

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

stiffness; rigidity; swallowing disorder; freezing phenomenon; worsened blood pressure fluctuation; Dementia aggravated; wrong technique in product usage process; stoma site pain; Abdominal pain; complication associated with device; stoma site granulation; pain in arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Abdominal pain) in an 80-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. Concurrent medical conditions included Weight loss in December 2019, Aspiration pneumonia since 06-Feb-2021, Stomach ulcer, Chronic pancreatitis, Anxiety, Arthritis, Dementia, Pulse pressure wide, Urination impaired, Parkinson's disease, Abdominal pain since 21-Jan-2021, Abdominal discomfort since 21-Jan-2021, Abdominal bloating since 21-Jan-2021, Device migration since 21-Jan-2021, Distended abdomen since 21-Jan-2021, Nausea since 21-Jan-2021, Dementia aggravated and Blood pressure fluctuation. Concomitant products included CARBIDOPA, LEVODOPA (DUOPA) for Parkinson's disease, LINACLOTIDE (LINZESS), MACROGOL 3350 (MIRALAX) and ACETAMINOPHEN for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in arm). On 08-Mar-2021, the patient experienced ABDOMINAL PAIN (Abdominal pain) (seriousness criterion medically significant), COMPLICATION ASSOCIATED WITH DEVICE (complication associated with device) and STOMA SITE PAIN (stoma site pain). On 10-Mar-2021, the patient experienced WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process). In March 2021, the patient experienced STOMA SITE HYPERGRANULATION (stoma site granulation). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (stiffness), MUSCLE RIGIDITY (rigidity), DYSPHAGIA (swallowing disorder), FREEZING PHENOMENON (freezing phenomenon), BLOOD PRESSURE FLUCTUATION (worsened blood pressure fluctuation) and DEMENTIA (Dementia aggravated). On 10-Mar-2021, WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process) and STOMA SITE PAIN (stoma site pain) had resolved. At the time of the report, ABDOMINAL PAIN (Abdominal pain), COMPLICATION ASSOCIATED WITH DEVICE (complication associated with device) and PAIN IN EXTREMITY (pain in arm) had resolved, STOMA SITE HYPERGRANULATION (stoma site granulation) and DEMENTIA (Dementia aggravated) outcome was unknown and MUSCULOSKELETAL STIFFNESS (stiffness), MUSCLE RIGIDITY (rigidity), DYSPHAGIA (swallowing disorder), FREEZING PHENOMENON (freezing phenomenon) and BLOOD PRESSURE FLUCTUATION (worsened blood pressure fluctuation) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Computerised tomogram: abnormal Abdominal: Revealed the internal retention plate of the G tube was rubbing up against the abdominal wall causing the pain. On 08-Mar-2021, X-ray: abnormal Abdominal unclear; PEG J Placement was okay. On 10-Mar-2021, Computerised tomogram: abnormal Abdomen: Balloon was pushed up against the stoma. On 10-Mar-2021, X-ray: abnormal Abdomen: PEG J Placement was okay. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PAIN IN EXTREMITY (pain in arm) to be probably related and ABDOMINAL PAIN (Abdominal pain), STOMA SITE HYPERGRANULATION (stoma site granulation), COMPLICATION ASSOCIATED WITH DEVICE (complication associated with device), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (wrong technique in product usage process), STOMA SITE PAIN (stoma site pain), MUSCULOSKELETAL STIFFNESS (stiffness), MUSCLE RIGIDITY (rigidity), DYSPHAGIA (swallowing disorder), FREEZING PHENOMENON (freezing phenomenon), BLOOD PRESSURE FLUCTUATION (worsened blood pressure fluctuation) and DEMENTIA (Dementia aggravated) to be not related. Treatment: The patient's PEG tube was moved back in from position 2 to position 4. The patient received treatment with silver nitrate and trimethobenzamide (Tigan).

ruptured appendix; Cramps in his lower intestine; Shoulder started getting a little sore; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS PERFORATED (ruptured appendix) in an 80-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 ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), SIMVASTATIN, ALLOPURINOL and TOPIRAMATE for an unknown indication. On 12-Jan-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) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced ARTHRALGIA (Shoulder started getting a little sore). On 13-Jan-2021, the patient experienced GASTROINTESTINAL PAIN (Cramps in his lower intestine). On an unknown date, the patient experienced APPENDICITIS PERFORATED (ruptured appendix) (seriousness criterion hospitalization). At the time of the report, APPENDICITIS PERFORATED (ruptured appendix) had resolved and GASTROINTESTINAL PAIN (Cramps in his lower intestine) and ARTHRALGIA (Shoulder started getting a little sore) outcome was unknown. The patient took Tums antacids which helped for a little while and he took milk on 14-Jan-2021. For ruptured appendix, patient had surgery in the hospital. Although a temporal association exists, based on the current available information, the mechanism of action of mRNA-1237 vaccine and the pathophysiology of appendicitis, the event of appendicitis perforated is assessed as unlikely related. The event of gastrointestinal pain is in consistence with the symptoms of appendicitis perforated. The causality of the event of arthralgia is assessed as possibly related. Most recent FOLLOW-UP information incorporated above includes: On 12-Apr-2021: An event ruptured appendix was added with treatment information.; Sender's Comments: Although a temporal association exists, based on the current available information, the mechanism of action of mRNA-1237 vaccine and the pathophysiology of appendicitis, the event of appendicitis perforated is assessed as unlikely related. The event of gastrointestinal pain is in consistence with the symptoms of appendicitis perforated. The causality of the event of arthralgia is assessed as possibly related.

The Patients leg gave out and he fell. Per doctors at hospital, he did not hit his head. He could not get up and he vomited. Ambulance was called and he was taken to the Hospital. The family was told that he had a brain bleed near the thalamus. A few hours later the patient was unresponsive. He was intubated and taken to neuro ICU. Within less then 24 hours from first symptom the patient died.

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.

Fall down completely to the floor; Felt extremely dizzy; Bad stomachache; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Fall down completely to the floor) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025J20-2A) 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 DIHYDRATE (LISINOPRIL [LISINOPRIL DIHYDRATE]), HYDROCODONE, SIMVASTATINE and CYCLOBENZAPRINE for an unknown indication. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Fall down completely to the floor) (seriousness criterion medically significant), DIZZINESS (Felt extremely dizzy) and ABDOMINAL PAIN UPPER (Bad stomachache). On 29-Apr-2021, LOSS OF CONSCIOUSNESS (Fall down completely to the floor) had resolved. On 05-May-2021, DIZZINESS (Felt extremely dizzy) and ABDOMINAL PAIN UPPER (Bad stomachache) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable. Treatment for the events included antacid. 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 US-MODERNATX, INC.-MOD-2021-128874 (E2B Linked Report). This case was linked to MOD-2021-128772 (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. US-MODERNATX, INC.-MOD-2021-128874:Husband 2nd dose

Within 5 minutes of receiving the shot I knew something was wrong. The attendants took my blood pressure, which was high. It kept going up and when it reached 220/110 they called an ambulance. I became nauseous and lost consciousness in the ambulance. In the emergency room they gave me several shots. I don't know what they were. After about 5 hours I was discharged and went home. I followed up with a visit to my doctor who told me not to get the second shot. I am not fully vaccinated, so what do I do?

Reports soreness to injection site since 5/24/21 however developed increased swelling and warmth at the injection site on 5/26/2021. On 5/27/2021 the swelling and redness began to spread down his arm and he started to not feel well with chills and nausea. The patient was then seen by primary care this a.m. on 5/28/2021 who obtained blood work and an ultrasound. The patient was then instructed to present to the emergency department for IV antibiotics. He reports the arm is painful however declines need for pain medication. The patient does have a scabbed over area to the right hand which he reports is from his daughter's puppy that happened approximately 3 weeks ago. He has been applying bacitracin to this at home.

Initially had fatigue, diarrhea, and loss of appetite. Tested positive for COVID 19 on 5/28/21 , during surveillance testing related to a facility COVID Outbreak. He went to ED 5/28/21 for decrease level of consciousness, high blood pressure, low blood sugar, anorexia. Once stabilized, transferred back to facility. On 6/7/21, transferred to ED for COVID pneumonia and hypoglycemia, treated with Dexamethasone and oxygen. Discharged back to facility 6/10/2021. On 6/12/2021, went to ED for ischemic stroke. Died 6/13/2021.

4/29/21 hpi admission to inpatient: 80 y.o. male with a past medical history notable for Diabetes, history of CVA, arthritis, reflux, BPH, hyperlipidemia, hypertension. The patient presents for evaluation of Worsening issues of weakness and hyperglycemia in addition to being worsening itchiness. Patient states he has had some issues with worsening reflux. Patient has not any emesis. Patient's wife thinks he may be slightly jaundiced. Upon further evaluation patient was found to have pancreatitis. Patient was placed in-patient will hold patient NPO and provide IV fluids. Patient has had pancreatitis previously. Patient's itchiness is probably due to elevated transaminases. Patient's past medical history, past surgical history, social history, family history, medications allergies were reviewed. Transferred to hospital 5/1 HPI: 80 y.o. man with a history of type II DM, hypertension, and remote h/o CVA who presented to hospital following transfer from another hospital for acute pancreatitis. Patient was initially admitted to their facility on 4/29, treated for pancreatitis with IVF, pain medication, and antiemetics. He LFTs failed to improve. RUQ US with no evidence of gallstones. Transferred here for MRCP/ERCP. He currently denies any abdominal pain. No chest pain. Breathing stable. No fever or chills. He states he has been having some belching and acid reflux for the last 1-2 weeks, worsening after a trip 1 week ago. 5/17/21 radiology: Malignant neoplasm of pancreas Admitted 5/20 - 5/24: Open biopsy of liver/Pancreas, ECRP 6/14 Office Vist : oncology, pancreatic carcinoma metastatic to liver

Pneumonia; Very ill; Dysphagia; Got 3 Moderna vaccines; This spontaneous case was reported by a nurse and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 040B21A and 043B121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pre-existing disease. On 13-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) (unknown route) dosage was changed to dosage form. On 06-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 06-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Got 3 Moderna vaccines). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), ILLNESS (Very ill) and DYSPHAGIA (Dysphagia). On 06-May-2021, EXTRA DOSE ADMINISTERED (Got 3 Moderna vaccines) had resolved. At the time of the report, PNEUMONIA (Pneumonia), ILLNESS (Very ill) and DYSPHAGIA (Dysphagia) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medication were provided. Lot number of 3rd dose of mRNA-1273 - 043B121A. Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-May-2021 contains no significant information. Updated lot number of 3rd dose of mRNA-1273. On 16-Jun-2021: Updated events - Pneumonia (medically significant), Illness and Dysphagia. Updated historical condition - comorbid conditions.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.

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.

Chief Complaint ; Right ICA occlusion; History of Present Illness; Patient is an 80-year-old white male with a past medical history of HTN and gout brought to the ICU after undergoing R ICA angioplasty & stent placement with the NeuroIR team on 7/22/2021. The patient was admitted by the Stroke Service on 7/20/2021 after transfer from an OSH where he had presented earlier that day for aphasia and dysphagia. Of note, the patient was found to be COVID-positive at the OSH before his transfer to this facility for a higher level of care. The patient was diagnosed with R cerebral infarction (mechanism: atherothromboembolic) and found to have severe stenosis of the R ICA. He was started on dexamethasone and remdesivir on 7/20 by the stroke team.

Received COVID-19 Moderna vaccine on 12/28. Developed nausea, vomiting, diarrhea, fever, and hypoxia at facility the day follow vaccine administration (12/29). He was sent to the hospital on 12/29 and admitted for post vaccine fever where he had a chest x-ray that showed infiltrates but WBC count was normal and fever resolved upon admission to hospital. Provider documented "expected reaction to vaccination in a patient with previous COVID exposure". He returned to the facility on 12/30.

COUGH, RIGORS, NAUSEA, VOMITING, URINARY URGENCY/FREQUENCY, DYSURIA - FOUND TO HAVE LLL PNEUMONIA, CONCERNING FOR POSSIBLE CYRPTOGENIC ORGANIZING PNEUMONIA

Patient presented to the emergency department with generalized body aches (head, abdomen, and chest) and nausea. Patient did not experience respiratory distress. Patient was given IV NS bolus and discharged home is stable condition.

Light headedness,Loss of balance, vomiting, sick feeling on 2nd day @ 12:00 pm recovered after laying down for 3 hrs.

Acute pancreatitis; Acute renal failure; Low blood pressure; Weakness; Decreased appetite; Fatigue; Alanine aminotransferase increased; Aspartate aminotransferase increased; Troponin increased; Lipase increased; Blood bilirubin increased; A spontaneous report was received from a physician concerning an 81-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed an odd presentation of acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue. The patient's medical history included advanced dementia, heart disease, pulmonary embolism and possible leukemia. Concomitant product use was not provided by the reporter. On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. On 08 Jan 2021, three days after vaccination, the patient developed symptoms of weakness, decreased appetite, and fatigue. On 11 Jan 2021, the patient was admitted into the hospital with a diagnosis of low blood pressure,acute renal failure,acute pancreatitis,alanine aminotransferase increased,aspartate aminotransferase increased, troponin increased,lipase increased and blood bilirubin increased. Abnormal lab results included "significantly elevated" aspartate transaminase, alanine transaminase, bilirubin, lipase up to 1900, and "slightly elevated" troponin of 0.079. On 13 Jan 2021, the patient's symptoms had improved, and he was discharged. Treatment for the event included two liters of intravenous fluid and supportive care. Action taken with the second dose of mRNA-1273 in response to the event was not provided. The events, acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue, were considered resolved on 13 Jan 2021. The physician assessed the events, acute pancreatitis, acute renal failure, low blood pressure, weakness, decreased appetite and fatigue, as not related to mRNA-1273. The physician's rationale was that the patient may have had a gallstone obstructing the pancreatic duct and once the stone passed, the patient got better with supportive care and slow administration of fluids.; Reporter's Comments: This case concerns a 81-year-old male patient with medical history of dementia, heart disease, pulmonary embolism, and possible leukemia, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of acute pancreatitis, acute renal failure, low blood pressure, the non-serious listed event of fatigue, and the non-serious unlisted events of weakness, decreased appetite, elevated aspartate transaminase, elevated alanine transaminase, elevated bilirubin, elevated lipase, and elevated troponin. Very limited information regarding these events has been provided at this time. Based on the current available information and in agreement with the physician reporter's assessment, the events are assessed as unlikely related to mRNA-1273, noting the rapid improvement after administration of IV fluids.

1/21/20 ,6 p.m. Queasiness and elevated heart rate. Blood pressure 192/97. 10 pm BP 209/119 1/22/20 M.D consulted. Started 25 mg HCTZ. Stopped hydrocodone/acetaminophen. Severe malaise until 1/24. 1/23 Blood pressure in acceptable range. Mild soreness in arm when touched. 1/25/20 Symptoms resolved

(1) Noted vertigo approx 200AM - 1-9-21, & nausea, dizziness and weakness. Continued with improving after Day 7. Initial No pain or redness & injection site - (2) Noted -

SORE ARM AND SHOULDER, VERY LETHARGIC, CHEST CONGESTION, NO APPETITE, HEADACHE, UPSET STOMACH. DID NOT SEEK MEDICAL ATTENTION.. GETTING BETTER. ACCEPTED AS PART OF IT SINCE I HAD HEARD STORIES THAT THE SECOND VACINE WAS GOING TO BE WITH MORE SIDE EFFECTS.

Patient started feeling very dizzy, sick like, and weak starting about 24 hours after getting the vaccine. He was taken by ambulance to the local hospital and treated with fluids I believe. After regaining strength, he went home and was given meclizine for nausea and dizziness. He was told to keep up fluids and rest.

January 20 received first shot-Moderna 005J20-2A at the hospital. Arm sore for about a day c. January 22 onward-slight headaches January 26 began having severe chills. These lasted for about 4 days. They were most severe on January 29. Concurrent with chills was the onset of fatigue. c. January 29-severe pain in hips and shoulders rendering me almost immobile. It was very difficult to get out of bed and to walk. I used a cane for support. Also the onset of diarrhea and loss of appetite. Tried extra strength Tylenol, but it did not help. Never had a fever, respiratory symptoms, of loss of taste or smell. Had nasal Covid test of February 1 which was negative. Saw Doctor on February 4. He ordered blood tests, one of which was to check potential source of joint pain. The test was negative for that, but showed some lessening of kidney and liver function. February 8-blood test showed considerable improvement on kidney and liver function. All symptoms except the fatigue have gone away. I did lose about 5 pounds during this reaction period. The fatigue is improving.

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.

10:45 pt reported not feeling well; He complained of feeling nauseas and weak. Assisted pt to lie down on cot; Nursing assessment done, vital signs taken, pt offered water, history taken from pt and wife; mental status assesed; 911 called;RN stayed with pt until EMS took pt to hospital via ambulance for further evaluation.

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

Two days after the vaccine I received inordinate back and midsection pain every time I tried to sit, bend or lay down to sleep. This has continued through today although it shows some, but not complete, but complete signs of subsiding.

Vaccine given Wednesday 4:40pm. Nausea and throw up Friday 11am through Friday 7pm. Nauseous and low-grade headache since Friday 11am. It?s now Sunday at 2:50pm and still low grade headache and little appetite.

Patient ended up going to hospital, so don't know if they did a VAERS or not. He was vomitting and had elevated liver enzymes and gall bladder issues

1st day severe headache, diarrhea, weak 2nd day " " " " needed help to get up. Then collasped 02/23/2021 in hallway couldn't move at all, heaving sweating, Temp 100 degrees shakes, irregular heart beat B.P. 101/84 before got him up, weak for several days

3/6/2021 9:30 AM: Client experienced dizziness, lightheadedness, all over body weakness, light sensitivity, nausea, and vomiting. Episode lasted for about 30 minutes, client was in a parked car at time of incident. Once client returned home he slept for 4-5 hours and woke up feeling "100% better."

Beginning eight hours after injection, severe flu-like symptoms - high fever, headache, chills, shakes, nausea and vomitting. Confined to bed for 24 hours. Fever broke the next evening, One additional day required to return to normal activity. Also, several hours following administering of vaccine, upper left arm was in extreme pain extending to the elbo. Continued to be very sore for 36 hours, and slightly bothersome for 72 hours.

At 9:30 am Saturday morning client got light headed, dizziness, bright lights became bothersome, and experienced weakness all over body which lasted approximately 30 minutes. Client then became nauseous and threw up within 30 minutes of other symptoms. Once client got home he slept for approximatley 4-5 hours, woke up feeling 100 % better.

02/26/2021 my father woke up with a headache, chills, pain across his shoulders and his arm felt like it had lead in it. In the afternoon, around 3:30pm he was in the bedroom to change clothes and got severely weak and fell. He felt like he was going to vomit too. He was so weak that he could not get up off the floor by himself. My son lifted him up. He also noticed Friday night that there was a bubble where the vaccine was given in his arm. 02/27/2021, the bubble had burst and liquid was coming out. It was an open wound which was sore and really red. He also had a headache and continued weakness. 02/28/2021, he still had a headache and the arm was sore. 03/01/2021, felt pretty good.

Rash at injection site. Cleared up in approximately 1 week. Body rash appeared yesterday (1 month after 2nd vaccine) Headache and diarrhea also.

Difficulty breathing; Legs have also itched; Hives painful to touch; Hives; Little nausea; A spontaneous report was received from a consumer, who was a 81-year-old, male, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed nausea, hives, difficulty breathing, legs have also itched, and hives painful to touch. The patient's medical history included afib (atrial fibrillation). Products known to have been used by the patient, within two weeks prior to the event, included finasteride, warfarin, sotalol, simvastatin, mesalamine, metoprolol, and oxygen. On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient reported that he felt a little nausea for the first few days after vaccine administration. On 25 Jan 2021, the patient woke up at 1:00 AM with hives on his right arm from the elbow to the shoulder. He stated the hives were painful to touch. The patient took diphenhydramine and the hives disappeared that morning. Later that day, the patient developed difficulty breathing and the hives appeared on his left arm from the elbow to shoulder. The patient went to the emergency room and was hospitalized overnight due to breathing issues. He was given diphenhydramine and steroids and was released from the hospital on 26 Jan 2021. On 27 Jan 2021, the hives reappeared from the patient's hands, spreading to the arms, shoulders, head, neck, and face. He described some of the hives as being nearly a quarter-inch high and he stated they looked like water blisters. On 28 Jan 2021, the patient went to the emergency room again because he was having a lot of trouble breathing. On an unknown date, the patient's legs had also itched but there were no spots. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, nausea, hives, difficulty breathing, legs have also itched, and hives painful to touch, was unknown.; Reporter's Comments: This case concerns an 81 year old, male patient, with medical history of atrial fibrillation, who experienced serious unexpected event of dyspnoea, and non-serious unexpected events of urticaria, pruritus, pain, and non-serious expected event of nausea. The event of nausea occurred on day 1 after mRNA-1273 (Lot# Unknown). The event of dyspnoea, urticaria, and pain occurred 14 days after mRNA-1273 and the event of pruritus occurred on an unspecified date after mRNA-1273. Treatment included diphenhydramine and steroids. Concomitant medications included finasteride, warfarin, sotalol, simvastatin, mesalamine, metoprolol, and oxygen. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.

my grandfather suffered a stroke affecting his left side. it took us over a day to conceive him to see a Dr. he was finally taken by ambulance to our local hospital and transferred to another hospital about an hour away. they did multiple tests to make sure he wasn't in further danger and released him to the care of my mother. it didn't damage his ability to think. he struggles to speak, swallow, and walk, and can't move his arm at all.

Shortness of breath, chest tightening, nausea, lightheadedness. Chest pain while in the ER. Intubated after cardiac arrest. Transferred to ICU. Life support removed 3/22/21. Pt expected to expire today.

Within an hour after the injection I developed stomach pain. Within 5 hours after the injection, I developed a fever of 1-2 degrees with chills and lethargy. In the next hour (6 hours after the injection), I believe my ulcers ruptured with extreme stomach pain and discomfort. Pressure began building in my stomach and I felt worse and worse. By the evening, I was in pain, had pressure, was chilled, nauseous, and sick. I felt unwell the next day, but did not begin passing blood and black stool until 2 days after the injection. I saw my doctor that day. I went on a low fiber restricted diet. This continued for 10 days. I am still recovering.

Diarrhea; Felt hot, but no temperature; Nausea; Vomiting; Appears the Botox did not work; Shaking from the Parkinson's is aggravated; He was not feeling well; A spontaneous report was received from a consumer concerning a 81-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced he was not feeling well, diarrhea, nausea, vomiting, felt hot, but no temperature, shaking from the parkinson's is aggravated and appears the botox did not work. The patient's medical history, as provided by the reporter included parkinson's. Concomitant medications reported included botox injection. On 08 Mar 2021 at 01:00 pm, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 003A21A) unknown route of administration in the left arm for prophylaxis of COVID-19 infection. On the 09 Mar 2021, after receiving mRNA-1273, the patient experienced he was not feeling well, shaking from the parkinson's is aggravated and appears the botox did not work. On 10 Mar 2021, the patient experienced, diarrhea, nausea, vomiting, felt hot, but no temperature. Lab details was not provided by the reporter. Treatment for the events was not provided by the reporter. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events experienced he was not feeling well, diarrhea, nausea, vomiting, felt hot, but no temperature, shaking from the parkinson's is aggravated and appears the botox did not work 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

Passed out on driveway; Arm Pain; Tremors in hand; Could not get up; Headache; Nausea; Vomiting; A spontaneous report was received from a consumer concerning an 81-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain/ pain in extremity, headache, nausea, vomiting, passing out on the driveway/ loss of consciousness, could not get up/ hypokinesia and tremors in hand/ tremor. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included xylometazoline hydrochloride, simvastatin, cyanocobalamin, folic acid, metformin, lisinopril, propanol, hydrochlorothiazide and levothyroxine. On 01 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly on right upper arm for prophylaxis of COVID-19 infection. On 01 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Batch number: Unknown) intramuscularly on left upper arm for prophylaxis of COVID-19 infection. On 02 Mar 2021, the patient experienced arm pain, headache, nausea, vomiting, medically significant event of passing out on the driveway, could not get up and tremors in hand. Treatment for the event included nausea medication. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable. The outcome of the events, arm pain, headache, nausea, vomiting, passing out on the driveway, could not get up and tremors in hand was resolved on 06 Mar 2021.; Reporter's Comments: Based on the current available information which shows a temporal association between the use of the mRNA-1273 and the reported events, a causal relationship with the events cannot be excluded. Fever, nausea and vomiting are consistent with the product safety profile.

stomach and colon pain, headache, weakness, a-fib, short of breath, loss of taste. All symptoms occurred subsequent to suspected COVID 2/15/2020 (was not tested at the time because there wasn't much COVID in Utah where I lived at that early date). Symptoms continued for a year, was getting better the last couple of weeks before the 2nd COVID shot and then relapsed (including had regained sense of taste for 2 weeks. then lost it again after the shot).

Sore shoulder; Extreme Diarrhea; Extreme vomiting; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Extreme Diarrhea) and VOMITING (Extreme vomiting) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 041L20A) 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 reported). Concomitant products included LOSARTAN, GABAPENTIN, GLIMEPIRIDE, FLUOXETINE, ATORVASTATIN, OMEPRAZOLE, VITAMIN D2 and ASPIRIN [ACETYLSALICYLIC ACID] 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 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced DIARRHOEA (Extreme Diarrhea) (seriousness criterion medically significant) and VOMITING (Extreme vomiting) (seriousness criterion medically significant). On an unknown date, the patient experienced ARTHRALGIA (Sore shoulder). At the time of the report, DIARRHOEA (Extreme Diarrhea), VOMITING (Extreme vomiting) and ARTHRALGIA (Sore shoulder) outcome was unknown. Concomitant drug included Pilomisitone 50mg. Treatment medication included equate anti diarrhea (loperamide, and its controlling the symptom). This case concerns an 81 Y/O M with a serious unexpected event of severe diarrhea and vomiting along with nonserious unexpected arthralgia. Event onset on day 2 after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an 81 Y/O M with a serious unexpected event of severe diarrhea and vomiting along with nonserious unexpected arthralgia. Event onset on day 2 after second dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Developed general weakness, occational productive cough, diarrhea, and anorexia starting on 03/20/2021. Tested positive for COVID-19 on 03/25/2021.

EXTREME WEAKNESS (could not get out of bed in the morning even with assistance), shakiness, loss of appetite

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.

Stomach cramps, vomiting (coffee ground emesis), diarrhea that started on 04/06/2021 and lasted for 2 days.

broke into hives; cannot walk; muscles were stiff; diarrhea; throwing up; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050A21A and 022M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided). On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced URTICARIA (broke into hives) (seriousness criteria hospitalization and medically significant), GAIT DISTURBANCE (cannot walk) (seriousness criteria hospitalization and medically significant), MUSCULOSKELETAL STIFFNESS (muscles were stiff) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization) and VOMITING (throwing up) (seriousness criterion hospitalization). The patient was hospitalized from 24-Mar-2021 to 25-Mar-2021 due to DIARRHOEA, GAIT DISTURBANCE, MUSCULOSKELETAL STIFFNESS, URTICARIA and VOMITING. At the time of the report, URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Computerised tomogram: fine normal (Inconclusive) CT Scan was fine.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication list was not provided by the consumer. On 24Mar2021 around 2:00PM, he broke into hives, cannot walk, muscles were stiff, was throwing up and had diarrhea. An ambulance was called and he was taken to a hospital where he stayed until 4:00AM today (25Mar2021). Blood works and computerised tomogram (CT) scan was done. They were informed that the CT Scan was fine. He was prescribed with Flexeril (cyclobenzaprine) and Tylenol (paracetamol) and was sent home. At around 11:00am (25Mar2021), they again called 911 for the same symptoms. They were about to go the hospital when the call was made. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050A21A and 022M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided). On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced URTICARIA (broke into hives) (seriousness criterion hospitalization), GAIT DISTURBANCE (cannot walk) (seriousness criterion hospitalization), MUSCULOSKELETAL STIFFNESS (muscles were stiff) (seriousness criterion hospitalization), DIARRHOEA (diarrhea) (seriousness criterion hospitalization) and VOMITING (throwing up) (seriousness criterion hospitalization). The patient was hospitalized from 24-Mar-2021 to 25-Mar-2021 due to DIARRHOEA, GAIT DISTURBANCE, MUSCULOSKELETAL STIFFNESS, URTICARIA and VOMITING. At the time of the report, URTICARIA (broke into hives), GAIT DISTURBANCE (cannot walk), MUSCULOSKELETAL STIFFNESS (muscles were stiff), DIARRHOEA (diarrhea) and VOMITING (throwing up) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, Computerised tomogram: fine (Inconclusive) fine. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication list was not provided by the consumer. On 24Mar2021 around 2:00PM, he broke into hives, cannot walk, muscles were stiff, was throwing up and had diarrhea. Treatment information included an ambulance was called and he was taken to a hospital where he stayed until 4:00AM today (25Mar2021). Blood works and computerised tomogram (CT) scan was done. They were informed that the CT Scan was fine. He was prescribed with Flexeril (cyclobenzaprine) and Tylenol (paracetamol) and was sent home. At around 11:00am (25Mar2021), they again called 911 for the same symptoms. They were about to go the hospital when the call was made. 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 presents with multiple complaints. He complains of all of his symptoms started after his Moderna vaccine in 1/2021. He complains of fatigue, and in particular muscle fatigue, muscle wasting, urinary frequency, urinary urgency (but denies dysuria), myalgias involving his legs, leg weakness, unsteady gait, frequent falls, nausea without vomiting, dyspnea walking across the room. He is wheezing a lot this morning, it started after the Moderna vaccine.He had a recent heart cath that did not show any significant blockage. He had a recent MRI of his head that was normal. He reports his wife had covid 19 in the latter part of 11/2020. He never developed symptoms. He was not tested after she became ill. He admits to significant reaction his first covid 19 vaccine in 1/2021. All symptoms resolved except for his complaints as listed above. He is a very active 81-year-old. He states he was winning weightlifting contests. He would do 3 sets 50 pushups, bench press 150 pounds and do pulled downs with 160 pounds daily. He now experiences dyspnea and muscle fatigue walking across the room.

Vaccine was given on 4/1 and the next day nauseated, dry heaves, cannot eat and lives on protein shakes and he's lost 20lbs and he's weak and been in the hospital twice and the doctors cannot find why. He has passed out four times. He is a cancer surivor but nothing shows that the cancer has returned.

passed out 4 times; Withering away and is dying/wont live long enough; lost 20 pounds; He is still experiencing dizziness and too weak to get out of bed; Weak; Nausea; dry heaving 3-4 times/day; Swollen arm; Stopped eating; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-May-2021 and was forwarded to Moderna on 19-May-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out 4 times) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), RETCHING (dry heaving 3-4 times/day) and NAUSEA (Nausea). On 23-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out 4 times) (seriousness criteria hospitalization and medically significant), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed) and ASTHENIA (Weak). On an unknown date, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough) and WEIGHT DECREASED (lost 20 pounds). The patient was hospitalized until 23-Apr-2021 due to LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (passed out 4 times), GENERAL PHYSICAL HEALTH DETERIORATION (Withering away and is dying/wont live long enough), WEIGHT DECREASED (lost 20 pounds), PERIPHERAL SWELLING (Swollen arm), FOOD REFUSAL (Stopped eating), DIZZINESS (He is still experiencing dizziness and too weak to get out of bed), RETCHING (dry heaving 3-4 times/day), ASTHENIA (Weak) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. Treatment with Reglan and magnesium oxide pertained to the events experienced. 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.; 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.

24 HOURS LATER HE BECAME RIGID, BODY BEGAN TO DISCHARGE URINE AND BOWELS WITH NOT CONTROL I CALL 911 AND HE IS STILL IN THE HOSPITAL.

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

Fully vaccinated patient admitted to hospital with positive COVID PCR test. Patient seen in ED for headache and increasing shortness of breath, and occasional (chronic) cough, abdominal pain. Denied chest pain, nausea, vomitting, change in bowel habits, vision changes, weakness, paresthesias. Denied known sick contacts. Patient was in A fib with RVR and PVC's. Rate 114 per EKG. US showed gallstones, labs showed elevated liver enzymes and bilirubin of 4.5. Patient seen by GI no intervention recommended at this time as patient reported all symptoms had resolved on day after admission. Patient to follow up with PCP and d/c'd from hospital.

Shortness of Breath, Difficulty Breathing, Difficulty Swallowing, Extreme wait loss, Low energy level. Progress over 2 month period

12/28/2020, Pharmacy staff administered Moderna COVID Vaccine. 12/29/2020, he had not eaten breakfast or lunch but did consume fluids and take his medications. BP =150/70, Temp. = 101.6, Pulse= 102, Respirations= 18 and Oxygen saturation= 97%. Tylenol 650 mg given. It was difficult for him to swallow. Also had no use of right upper extremity and unable to move lower extremity, mouth was drooping and was drooling. Physician in attendance and ordered to send to ER. 1/1/2021, received information from nurse at hospital that patient received a Peg Tube this afternoon and Clinical indication of a stroke.

Nausea started at 03:15pm vitals taken all wthin normal. Observed for 15 more mins, pt continue to report symptoms, 8mg sublingual zofran given at 03:45pm, observed for 15 more minutes, symptoms slightly improved. Sent home with one more dose of 8 mg, zofran. Advised to go to ER if symptoms persist or worsened and other worrying side effects to watch for. Pt, spouse and son verbalized understanding.

On 1/13/2021, resident had sudden emesis. Immediately following emesis he was noted without a pulse and pronounced deceased. No acute symptoms noted prior to this episode. Resident does have a significant cardiac history.

weakness, dizziness, and one day of diarrhea, onset 2 days after receiving covid vaccine, resulting in ER visit. (ER evaluatiion done, included labs, chest xray and EKG, reportedly normal)

My dad got the Moderna Vaccine on Tuesday, January 12, 2021 in his left arm at the Mall injection site for the Health Department. He was told that the side effects could mean his arm hurting, tiredness, headache, and even a low grade fever. Additionally, the site informed us both (as I was with him to get the injection) that this was all normal and not to seek medical attention unless these symptoms last longer than 72 hours. That evening, my dad was experiencing all of those symptoms, and went to bed at 7pm. A little after 10am on Wednesday, January 13, 2021, when he awoke, my dad went to the bathroom vomiting. This was where he collapsed and went into cardiac arrest. Fire/Rescue was dispatched about 10:30am after my mom started CPR. County Fire Rescue EMTs and Paramedics continued CPR and other attempts at reviving him all the way to Hospital Emergency Department. He was pronounced dead at 12:14pm on Wednesday, January 13, 2021. We have no doubt my dad, following the instructions of the injection facility, thought he was just experiencing the side effects of the vaccine. He had no chance. Had this injection been done in the RIGHT arm, perhaps he could have recognized the arm numbness being that of an impending heart attack. We really miss Dad. He served this country with distinction for over 50 years, and we believe his country failed him.

Woke up with Nausea and vomiting all day 4 days later. Took Zofran for the vomiting. Also had a migraine and fatigue. Resolved in approx 8 hours

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

Pain between shoulders in shoulder blades, frequent urination, dizziness/unsteadiness beginning evening 1/26/21 Followed on 1/27/2021 by increased dizziness/unsteadiness, more frequent urination and very frequent diahrea - lasting through the day/evening. On 1/28/2021 - pain between shoulders is slightly subsiding, unsteadiness remains along with frequent urination and diahrea

Second Moderna vaccine received on 1-28-2021 at about 9:00AM. Severe nausea vomiting and diarrhea began on 1-29-2021 about 7;00 PM, lasting several hours with temp to 100.5 at time of chills and rigors. Basically resolved in 12 hours but malaise and tiredness continued for several more hours.

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.

Pt awoke on 2/8 feeling tired and weak. On 2/9 patient developed fever to 102 and shortness of breath and vomiting. Was seen in ER and admitted for presumed UTI as well as small PE.

NAUSEA VOMITTING DIARRHEA CHILLS MUSCLE JOINT PAIN GENERAL MALAISE LIKE HAVING A HEAVY FLU NO FEVER SLEEPY STAYED IN BED UNTIL 02/12/2021 SLOWLY RECOVERING

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.

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.

2/18/21 about 2:30 pm started to not feel well. By 3:30pm had extreme chills, aching all over, headache, loss of appetite but no fever temp was 98.5. By 7:30pm was feeling much better. 2/19/21 Just felt tired all day until 6pm when he started to feel very unwell, weak, aching and loss of appetite. This lasted a few hours. 2/20/21 Felt well until he got up at 7:30am, then felt weak, sick in his stomach, some chills and generally not feeling well. We are assuming these are all just normal reactions to his 2nd shot. We expect them to subside completely in a few days

2/6 (vaccine given): No side effects. 2/7: mild fever and chills (expected), weakness, low appetite 2/8: Severe weakness and fatigue, subjective fever/chills, low appetite, nausea, in evening diarrhea started. 2/9: Symptoms not improved in the morning. Went to ED. Hospital stay: Dehydration, give IV fluids. Continued symptoms, plus vomit and diarrhea with blood. Placed on clear liquid diet. GI consult. Diagnosed with duodenitis and gastritis. Started on oral PPI, no improvement in symptoms, switched to IV PPI. Vomiting resolved after a few days. Stool cultures all negative. Onset sore throat (possible reflux/esophagitis). Confirmed gastritis, gastric erosions. Fevers recurred. Consult with ID, possible TB, placed on isolation. Blood cultures and stool cultures all negative. AFB negative x2 (results of 3rd AFB pending as of today). Rheumatology consult for continued fevers, weakness, fatigue. Started on prednisone ~2/15, fevers resolved soon after. Severe weakness (bed bound), fatigue, low appetite, and diarrhea throughout hospital stay. Started on Megace and Immodium with slight improvement in appetite and diarrhea, respectively. 2/19: ALT and ALT increased, prednisone was dc'd (received 4 of 5 day treatment of prednisone). Crestor held. Anticipate dc for PT/rehab once LFTs are back to baseline.

Patient states that 5 days after getting the vaccine he developed severe diarrhea which has persisted. He has not been able to eat much as every time he eats he has diarrhea, sometimes to the point he can't make it to the toilet. He has not sought medical attention. Upon arrival for 2nd vaccine dose today he asked to speak with someone and it was noted he had lost 30 lbs in the last 4 weeks. He was advised to contact his regular physician immediately for complete evaluation and told this may or may not be vaccine related. Second dose was held today as precaution and once cleared by regular physician he can call us to get the 2nd dose. Patient did admit to history of "bacterial infection" causing diarrhea many years ago from drinking well water but doesn't drink well water currently. He also had body aches, headache after vaccine but these resolved and also complained of his hands swelling up like arthritis.

angina; a stomachache that lasted for 10 hours; nausea; vomited 1 time; A spontaneous report was received from a consumer concerning an 82-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced angina (angina pectoris), stomachache (abdominal pain upper), nausea and vomiting 1 time. The patient's medical history included 3 stents in the heart and angina. Concomitant product use was not reported. On 03 Feb 2021, approximately 26 hours prior to the onset of symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number unknown) in the left arm for prophylaxis of COVID-19 infection. The reporter stated that 26 hours after receiving the vaccine, he had a stomachache that lasted for 10 hours. The patient also experienced nausea and vomited 1 time. Early in the week of 08 Feb 2021, the patient reported experiencing angina, which he stated he had not had for a very long time. The patient reported that no treatment medications were taken for these side effects. The patient stated that he will follow up with his cardiologist. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, angina, was unknown. The events, stomachache, nausea, and vomiting, were considered recovered/resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event of abdominal pain, nausea and vomitting, a causal relationship cannot be excluded. The patient's medical history of 3 stents in the heart and angina confounds to the causality of Angina Pectoris.

fatigue - muscle pain - chills - diarrhea Felling better the second day after the second injection. No problems existed after the first injection.

From around midnight the day of the shot until 6 pm the following day: Gallbladder spasms Heartburn Headache Fatigue

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.

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

Inability to urinate 12 hours after the shot, frequent bowel movements (not diarrhea) Severe bladder pain the next morning. Catheter relief at Urgent Care in early morning. Doctor prescribed antibiotic. Saw Urologist on March 8. No infection was found. Urologist believes that the excess bloating may have impacted my enlarged prostate which in turn restricted the bladder. arc u

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.

Lump and itchiness at vaccination site on day 1, took 10 mg Cetirizine Hydrochloride tablet Flu symptom like muscle and joint aches, tiredness, headache, no appetite. on day 2, took 500 mg acetaminophen (2) caplets Severe vertigo, nausea, tiredness, and no appetite on day 3, took 12.5 mg of Meclizine caplet

c/o Progressive Redness warmth of injection site (about the size of palm) with mild pain still 10 days post injection. Loose stools x 2 days

water and blood coming out the legs; paralyzed feeling in my legs completely, cant even walk around the house; uncontrollable diarrhea; severely decreased appetite; severe bloating; high body temperature of 103; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HAEMORRHAGE (water and blood coming out the legs) and PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (water and blood coming out the legs) (seriousness criterion medically significant), PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house) (seriousness criterion medically significant), DIARRHOEA (uncontrollable diarrhea), DECREASED APPETITE (severely decreased appetite), ABDOMINAL DISTENSION (severe bloating) and PYREXIA (high body temperature of 103). At the time of the report, HAEMORRHAGE (water and blood coming out the legs), PARALYSIS (paralyzed feeling in my legs completely, cant even walk around the house), DIARRHOEA (uncontrollable diarrhea), DECREASED APPETITE (severely decreased appetite), ABDOMINAL DISTENSION (severe bloating) and PYREXIA (high body temperature of 103) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was included TORSEMIDE, CEFUROXIME and MUPIROCIN cream. Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded.

Extreme diarrhea; This spontaneous case was reported by a non-health professional and describes the occurrence of DIARRHOEA (Extreme diarrhea) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetic. On 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 2 dosage form. On 25-Feb-2021, the patient experienced DIARRHOEA (Extreme diarrhea) (seriousness criterion medically significant). At the time of the report, DIARRHOEA (Extreme diarrhea) outcome was unknown. No relevant concomitant medications were provided. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.

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.

11 days of extreme flu like symptoms. High fever, chills, nausea, severe body aches, loss of appetite and thirst. Turned into a lung infection. Took antibiotics and steroids

Spinal infarct @ T 10-12, resulting in paraplegia. Symptoms began 4 days after receiving vaccine. Leg numbness and flaccidity, loss of bowel and bladder function.

Death Acute Kidney Failure E87.5 - Hyperkalemia M54.9, G89.29 - Chronic back pain N17.9, N18.9 - Acute on chronic renal failure VOMITING DIARRHEA BACK PAIN DIZZINESS LEG SWELLING

Dad had been feeling dizzy and tired much of the time when he first knew something was not right and went to his primary doctor and his heart doctor. From the date of 02/13/2021,the first COVID-19 vaccine shot, Dad?s condition worsened but once he was administered the second dose of the COVID-19 vaccine it quickly accelerated. One month and one day after the second vaccination shot he was dead from internal bleeding, an excellerated decrease in hemoglobin, red blood cells, platelets, and the complications this caused after surgery which removed a portion of his colon to stop the bleeding. Following is a chronological list of occurrences to the best of my recollection: 1) 2/25/2021 NP, received lab results which she had ordered earlier. Red blood cells 2.21 MIL/uL, hemoglobin 6.7 GM/DL, platelets 92 THOUS/uL. 2) 2/28/2021 admitted to the hospital to receive 3 units of blood and a bone marrow biopsy. Discharged 3/2/2021. 3) 3/3/2021 diagnosis: anemia, unspecified Melena, and ocult blood in stools. 4) 3/5/2021 Dr. with lab results: red blood cells 2.7 MIL/uL, hemoglobin 8.6 GM/DL, platelets 56 THOUS/uL. 5) 3/10/2021 Video Capsule Endoscopy. 6) 3/12/2021 Outpatient blood transfusion. 7) 3/15/2021 Dr. with bone marrow report. Diagnosed with Myelodysplastic Syndromes. Received first shot of ARANESP with orders to receive the ARANESP shot every two weeks and see a specialist at Hospital. 8) 3/16/21 transported to ER by ambulance with GI bleed. Received blood transfusions and admitted. Received several more tests and blood transfusions. Diagnosis: Arteriouvenous Malformation in descending colon. Treatment: 4 clamps in bleeding veins. Discharged: 3/19/2021. 9) 3/29/2021 Dr. office visit, labs, and second ARANESP shot. Ordered transfusion, no blood match. 10) 3/29/2021 Taken from Dr. office to ER and admitted to Hospital. Transfusions and additional tests performed. Test showed additional bleeding in colon. A colonoscopy was performed and several areas in the colon were sealed. 11) 4/2/2021 Discharged 12) 4/4/2021 Hemorrhaging from colon. Transported by ambulance to Hsopital. More transfusions and tests. 13) 4/5/2021 Performed surgery to remove part of colon. My dad continued to worsen over the next 9 days. 14) 4/14/2021 My dad died.

Early morning day following 2nd shot. EXTREME/VIOLENT shaking/chills for 2 hours....very concerning---upset stomach =slight temperature. General sickness. Extremely sore arm/shoulder at injection location. 2nd day was bet ter. 3rd day most symptoms gone gone with exception of shoulder pain. In the last few weeks pror to this date the pain in the shoulder has increased SUBSTANTIALLY and migrated in the the lower area of the shoulder. It is now difficult to LIFT my arm and have use of it do the the pain and decreased ability to use it. Having had major joint surgeries in the past I know what pain and lack of function can be. This is something different and becoming worse quickly.

Patient was hospitalized due to vomitus material in mouth, concerns for aspiration pneumonia, decreased alertness, unresponsive verbally, obtunded

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.

Patient received Moderna Covid Vaccine on February 5 and March 5 2021. Pt with past hx of appendectomy 70 years ago and presented with new/sudden significant mid mesenteric inflammation and suggestion of mesenteric volvulus resulting in a small bowel obstruction on 6/16 when he presented to the hospital with severe abdominal pain, nausea and vomiting. - - CT abdomen and pelvis Consistent with distal small bowel obstruction. There was associated significant mid mesenteric inflammation and suggestion of mesenteric volvulus. He responded to non surgical management consisting of an NGT, NPO status and iv fluids. He was discharged on 6/18/21

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

Pt had the Moderna vaccine on 1/16/2021. called into the nurseline around 2000 on 1/17/2021 stating the pt had dizziness and shaking for about 15 mins around noon today and in the last 30 mins has vomited 3 times.

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.

shoulder discomfort vaccination site, mild covid symptoms, fatigue, chills, lack of appetite, mild temp

Resident had an emesis, complaints of cough, congestion, and headache, increased respiratory rate, tachycardia, and fever.

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.

Diarrhea pronounced after 2nd Moderna vaccination. Though some occasional incidences happened prior to the covid-19 vaccination, the regularity and intensity increased greatly, especially after the 2nd shot.

Patient experienced an episode of emesis and loss of consciousness several hours after vaccine on 2/16/21. He was taken by EMS to the hospital and was noted to be hypoxic and hypotensive. He was admitted to the hospital and subsequently intubated. He was also found to have a small bowel obstruction and a nasogastric tube was placed to decompress the bowel. He required pressor support as well. He expired on 2/17/21.

swollen, tender left shoulder, nausea, vomiting, syncope referred to primary provider if symptoms worsen

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.

Chief Complaint Patient presents with ? Rash C/o rash to extremities and buttock that started about 3 days ago. ? Edema C/o edema to lower extremities and abdomen. ? Shortness of Breath Having shortness of breath on exertion. Had to stop and take a break twice on the way to the office from the lobby. Subjective: HPI Patient is 83 y.o. year old male that presents for acute problem as noted above. Received call from patient late yesterday evening complaining of petechial rash to extremities. States they originally were pruritic. Now states they no longer itch. Patient states that the rash started about 3 days ago. His main lower extremities and buttocks. Also complained of increased edema to lower extremities. Also feels like his abdomen is swollen. Patient was treated for diverticular flare middle of February. Has completed antibiotic specifically Augmentin about 2 weeks ago. Patient having increased shortness of breath. States he does have a productive cough in the morning producing yellow sputum. Afebrile. Patient does have history of atrial fib. Has had no nausea vomiting but states any time he eats he can only eat a small amount then feels full. Patient is on Coumadin chronically. Recent INR has been within normal limits. Patient does have some tenderness to his abdomen more so to the upper quadrants. Denies any change in bowel habits. States he is mildly constipated. Denies any change in color stool. Denies any actual chest pain. Does get remarkably short of breath. Review of Systems A 10 point ROS was completed and negative except as noted in HPI 3/12 Presented to Emergency Room - admitted inpatient @ 1144

On day of Wednesday day of Moderna vaccine shot, felt good all day, got ready for bed at 9 PM. Felt very warm and took my temperature it was 99.7. Not too bad. My hands and feet were very cold. Put socks on my feet and climbed in bed. Feeling ok. Woke up around 4 AM my tee shirt is soaking wet, had to pee. Got out of bed and walked to bathroom no problem. Sat down and then my wife said she heard a loud noise in bathroom. She comes to check on me and I?m sitting on toilet passed out, I?m leaning to my right against the shower door. She?s hollering and talks to me to wake up and shakes me and eventually I wake up, get up and walk to the bed no problem. Then I feel the urge to vomit. Go through a series of dry heaves, lay on my back and feel urge to vomit again. Wife tells me to lay on my side, not on my back, that works and I fall asleep. Woke up Thursday at 8 AM, wife is in the kitchen, I make the bed get dressed and feel ok. Walk out to the kitchen and wife is amazed I?m OK. She proceeds to tell me about my passing out in the bath room. I have no recollection that occurred. Had some tea and toast, drinking water to rehydrate and felt better. Walked outside, got leaves out of the pool. Feeling better. No further reaction, just a little tired the rest of the day. Had light lunch, soup. Took a nap at 3 PM woke refreshed and had normal dinner with a glass of wine. Today Friday had normal breakfast and feel completely normal. All in all not a bad reaction.

Slight fever, cold chills that lasted for hours. Soreness in joints, soreness muscles, aching all over body. Complete loss of appetite

After the patient received the 2nd vaccine dose on 03/17, he became weak and unable to walk. He also experienced headache, nausea, and diarrhea. On 03/18, he was sent to the emergency department where we received a diagnosis of acute on chronic hypoxia related to the 2nd dose of COVID-19 vaccine. He required up to 2 L of O2 during the night time. He was given his regular home medications and Lovenox 40 mg SQ QD for DVT prophylaxis. On 03/21 he was discharged as his SpO2 improved. His hypoxia returned to his baseline level upon discharge.

Blood on their stool was found; Patelet count has been going down; A spontaneous report was received from a healthcare professional concerning a 83-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood in his stool and platelet count decreased. The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the event, included sacubitril valsartan sodium hydrate, ivabradine hydrochloride, sitagliptin phosphate, Isosorbide mononitrate, Clopidogrel, and Rosuvastatin. On 11-Jan-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 027720A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 8/Feb/2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. A week or two after the second dose, blood in his stool was found and happened 5 times approximately, and platelet count went down and then went slightly back up. The patient does not have any bruises, no fever, or any other reactions. The patient was on blood thinners, but once he complained about the blood in his stool, they were stopped. Treatment details were not provided. Action taken with mRNA-1273 in response to the events is not applicable. The outcome of events, received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood in his stool and platelet count decreased, was considered recovered resolved.; Reporter's Comments: Based on the current available information which includes a temporal association between the use of the product and the start date of the reported events, and excluding all other etiologies, a causal relationship with the event cannot be excluded

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.

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

Injection was given Sunday pm, he woke up at 2 am Monday vomitting. He vomitted until 5am. It is now 3pm on Tuesday and he is too weak to get out of bed.

Acute on chronic hypoxia; diarrhea; headache; nausea; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of HYPOXIA (Acute on chronic hypoxia) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Ventricular tachycardia, Arteriosclerosis coronary artery, Hypertensive and COVID-19 virus test positive (Hospitalized with mild hypoxemia at that time) in January 2021. Concurrent medical conditions included Latex allergy, Allergy (pregabalin), Weakness generalised, Dementia, Atrial fibrillation, Type 2 diabetes mellitus, Mixed hyperlipidemia, Depressive disorder, Polyneuropathy in diabetes, Peripheral vascular disease NOS and Cognitive impairment. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), AMOXICILLIN, FLUOXETINE, FUROSEMIDE (FUROSEMIDE ACCORD [FUROSEMIDE]), GABAPENTIN (GABAPENTIN "PCD"), MEMANTINE HYDROCHLORIDE (MEMANTINE ABDI), METFORMIN, METOPROLOL TARTRATE, PANTOPRAZOLE, POTASSIUM CHLORIDE, ROSUVASTATIN and ZINC OXIDE for an unknown indication. On 17-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced HYPOXIA (Acute on chronic hypoxia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 18-Mar-2021 to 21-Mar-2021 due to DIARRHOEA, HEADACHE, HYPOXIA and NAUSEA. On 21-Mar-2021, HYPOXIA (Acute on chronic hypoxia) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, Angiogram: chest clear with no pneumonia or pe (Inconclusive) chest clear with no pneumonia or PE. On 18-Mar-2021, Chest X-ray: chest clear with no pneumonia or pe (Inconclusive) chest clear with no pneumonia or PE. On 18-Mar-2021, Computerised tomogram head: negative (Inconclusive) negative. On 18-Mar-2021, Electrocardiogram: non ischemic (v-paced) (Inconclusive) non ischemic (v-paced). On 18-Mar-2021, N-terminal prohormone brain natriuretic peptide: 3620 pg/ml (Inconclusive) 3620 pg/ml. On 19-Mar-2021, Angiogram: chest clear with no pneumonia or pe (Inconclusive) chest clear with no pneumonia or PE. On 19-Mar-2021, Chest X-ray: chest clear with no pneumonia or pe (Inconclusive) chest clear with no pneumonia or PE. On 19-Mar-2021, Computerised tomogram head: negative (Inconclusive) negative. On 19-Mar-2021, Electrocardiogram: non ischemic (v-paced) (Inconclusive) non ischemic (v-paced). For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HYPOXIA (Acute on chronic hypoxia) to be related. After the patient received the 2nd vaccine dose on 03/17, he became weak and unable to walk. He also experienced headache, nausea, and diarrhea. On 03/18, he was sent to the emergency department where we received a diagnosis of acute on chronic hypoxia related to the 2nd dose of COVID-19 vaccine. He required up to 2 L of O2 during the night time. He was given his regular home medications and Lovenox 40 mg SQ QD for DVT prophylaxis. On 03/21 he was discharged as his SpO2 improved. His hypoxia returned to his baseline level upon discharge.; 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 was stable with ongoing care prior to incident. On 3/2/2021 patient had Covid vaccine number 2. On 3/9/2021, patient started to have dark brown emesis and was transferred to the hospital. On 3/12/2021, patient returned to nursing facility with hematemesis and melena due to GI bleed. Patient was started on comfort care. Had ongoing esophageal cancer with radiation therapy prior to incident. Patient expired on 4/8/2021. Of note, patient was covid positive on 12/14/2020 without any signs of infections. He had covid #1 vaccine on 2/2/2021 and #2 on 3/2/2021. Of note, his wounds worsened after covid vaccines per nursing notes.

Cerebellum Stroke, dizziness, vomiting, erratic blood pressure, low platelet count, increased AFIB activity, high BUN, increased creatinine levels, excessive and easy bruising, slurred speech, total body weakness (right side weaker), recovering.

Vomiting, nausea, diarrhea that has lasted over three weeks. It lasted only one week after the first shot.

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

My uncle started feeling unwell the evening he got his 2nd Covid 19 vaccine. By the next evening, he started vomiting violently, trembling and sweating. He lived in country and his caregiver didn't think to take him to the hospital. The symptoms calmed down after a while, but he was not able to hold any food or liquids down. Eventually, he fell asleep and his caregiver left for the night. He returned on Easter Sunday at 9:30 am and found my uncle deceased.

Within 3 days began diarrhea like discharge 3-4 times a day with loose stool, water & gas. Continued for 3 weeks and became less frequent in fourth week

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.

The resident was administered his second COVID vaccine (Moderna) on 5/19/21 at 9:30am. Per nursing, the resident tolerated the vaccine well and no problems were documented throughout the day. At 10:00pm the nurse who administered the vaccine recorded the resident's vitals as follows: BP 118/68, HR 72, Respiration 18, Temperature 97.0 F. At 10:20am the resident's CNA discovered him lifeless with vomitus around his mouth and neck. The resident was not breathing, bluish in color, and cool to the touch. Vital signs were checked and no pulse was detected. CPR was attempted with not effect.

Syncope; Injection site pain; Injection site swelling; Nausea; Vomiting; This case was received (Reference number: 1063219) 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 SYNCOPE (Syncope) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hyperlipidemia, Diabetes mellitus, GERD and Hypertension. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), METFORMIN, LISINOPRIL and ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced SYNCOPE (Syncope) (seriousness criterion medically significant), INJECTION SITE PAIN (Injection site pain), INJECTION SITE SWELLING (Injection site swelling), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, SYNCOPE (Syncope), INJECTION SITE PAIN (Injection site pain), INJECTION SITE SWELLING (Injection site swelling), NAUSEA (Nausea) and VOMITING (Vomiting) outcome 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 temporal association between the use of the product and the start date of the event, 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 event, a causal relationship cannot be excluded.

Developed blood clot; Sever pain in his stomach; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed blood clot) and ABDOMINAL PAIN UPPER (Sever pain in his stomach) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 016L20A) for COVID-19 vaccination. Concomitant products included RIVAROXABAN (XARELTO), AMLODIPINE, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) and AZILSARTAN MEDOXOMIL, CHLORTALIDONE (EDARBYCLOR) for an unknown indication. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Sever pain in his stomach) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Developed blood clot) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 28-Apr-2021 to 04-May-2021 due to ABDOMINAL PAIN UPPER and THROMBOSIS. The patient was treated with Surgery (leading to two and half feet of his small intestine removed) for Thrombosis. At the time of the report, THROMBOSIS (Developed blood clot) and ABDOMINAL PAIN UPPER (Sever pain in his stomach) outcome was unknown. Patient started having severe pain in his stomach on 27-Apr-2021. He was taken to the hospital on 28-Apr-2021, patient's doctor said that he had a clot in his intestine and that caused the pain, was operated removed to two and half feet of his small intestine. Patient was discharged from the hospital on 04-May-2021. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore action taken with the drug in response to the events was not applicable. Company Comment : Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

A few hours after receiving the vaccine on 6/2/2021, patient developed a low-grade temp. Then through the night he started having nausea, vomiting, and diarrhea which worsened on 6/3/2021. He had very poor appetite and very poor oral intake. Within 24 hours of receiving vaccine, he developed hypoxia and required 4L via NC to maintain an oxygen saturation in the low 90s. Stat CXR was obtained on 6/3/2021 with no acute findings. Patient received phenergan 12.5mg IM injection X 1 which did improve nausea and vomiting. Diarrhea continued. Patient has poor urine output. Tachycardia with pulse of 122, BP 118/62. Patient was seen for an acute visit by this NP on 6/4/2021. Patient is lethargic but does awaken to tactile stimuli. He tolerates PO fluids. He is lethargic. Stat labs obtained for concerns of dehydration. Will plan to order IV fluids for hydration after reviewing lab results.

Accelerated decline in condition with decreased input, decreased responsiveness, somnolence, and death

At 4am this morning woke up with headache, chills, nausea, slight fever, joint pain, muscle pain. Had COVID and bacteria pneumonia back in October Spoke with doctor this morning and said the symptoms were not unexpected. Doctor encouraged to file VAERS report.

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.

Pt. woke up the next morning after vaccination and "didn't feel well", described by wife as fatigue, no energy. At approximately 2 PM, he vomited. His wife checked on him at 4:20 PM and he wasn't breathing sitting in his chair. EMS squad was called but when they arrived he was asystole and mottling present. Did not start CPR since he was already gone too long. Pronounced by coroner on scene.

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.

It's been over three weeks and he still gets chills and a fever anywhere from 99.9 to 100.2. (His normal temp. is usually around 97.0. If he gets the least bit chilled he can't seem to warm up. We give him Tylenol and bundle him in blankets and put him to bed. Has no desire to eat when this happens but we do manage to get some hot broth into him. The next morning he is fine and we go ahead with with his Dialysis treatment and then it happens every few evenings again.

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.

Nausea, Night sweats, Joint Pain in legs and lower back, Headache, fever (99.3 to 100.9), fatigue. Treated with Tylenol , Naproxen , Lidocaine patch, fluids, heating pad and rest. Reduced fever, reduced joint pain, headache persisted. Time course: 24 hour period

Following morning a sore throat leading two days later an inability to swallow, constant mucus production, several boxes of tissues dsily; hospitalized for 4 days on intravenous fluids and anti biotics.

Dizziness, nausa, headache, weakness, tired. slept all afternoon. Some better in eve. today, 2-21-21, after sleeping 11 hrs, Much better.

At 4:30 p.m. became dizzy, had to hold on to walls to guide me to the bathroom. Could not control my bowels, regurgitated, no headache, ugly situation for about 20 minute, washed myself, wrapped myself in towels and slept on top of my bed from 5:45 to 8: pm. Felt better. Next day i continued to be somewhat groggy.

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

Pt called for Dose 2 appointment. Contracted COVID right after Dose 1 Moderna Vaccine. Hospitalized 2/08/2021. Discharged 2/10/2021. Admitted with nausea, diarrhea, lightheadedness, and weakness. Pt treated for Covid-19 Infection with GI symptoms, Acute Kidney Injury, Leukocytosis

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

severe headache, strong abdominal pain, started on right side, moved to left and then was all the way across, nausea but did not vomit, weak from pain.

loss of hearing/hearing completely gone in right ear; Ringing in left ear; probably vertigo; Extreme dizziness; blood pressure was 214/113; vomitng; Weakness; nasal drip; dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee; diminished hearing in left ear/sounds like listening through a drum; pressure in temples like a hammer on each side of head; headache in back of head; A spontaneous report was received from a consumer who was also an 84-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced extreme dizziness, nausea ,vomiting, nasal drip, weakness, loss of hearing/hearing completely gone in right ear (deafness unilateral), diminished hearing in left ear/sounds like listening through a drum (hypoacusis), blood pressure was 214/113 (blood pressure increased), pressure in temples like a hammer on each side of head (head pressure), headache in back of head, and dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee. The patient's medical history was not provided. Concomitant product use was not provided. On 28 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 020L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. The patient reported he felt fine for about one week after the vaccination. Then, in the early morning of 05 Feb 2021, right after midnight, he experienced extreme dizziness, vomiting, weakness, nasal drip, and loss of hearing including ringing in his left ear and no sound in his right ear. He also started to notice a dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee. The patient was taken by ambulance to the hospital. In the ambulance, he vomited and his blood pressure was 214/113. He was placed the COVID-19 wing of the emergency room (ER) and given tests including a COVID-19 test, sonogram, "echogram", MRI, and EKG (results not provided). The patient reported he was admitted to the hospital. He was told he probably had vertigo. After his ER visit, the patient had appointments with his general practitioner, an ear nose and throat specialist, and a hearing specialist. He was told his hearing was completely gone in his right ear and diminished in his left ear. The patient could still somewhat hear out of his left ear but it sounds like listening through a drum. He states he has to have his television up very loud to be able to hear it. At the time of this report, the patient continued to feel extremely weak, dizzy, and he had pressure in temples like a hammer on each side of his head, a headache in back of his head, and the hearing changes. Treatment for the events included unspecified medications in the ER. Action taken with mRNA-1273 in response to the events was not reported. The events of dizziness, weakness, loss of hearing/hearing completely gone in right ear, vertigo, weakness, diminished hearing in left ear/sounds like listening through a drum, pressure in temples like a hammer on each side of head, and headache in back of head were not resolved at the time of this report. The outcome of the events of blood pressure was 214/113, nausea, nasal drip, vomiting, and dry scaly rash on his temples, neck, shoulders, belt line, and back of his right knee was unknown.; Reporter's Comments: This case concerns an 84 year old, male patient, who experienced a serious unexpected event of Deafness (unilateral) among others, 9 days after receiving 1st dose of mRNA- 1273 (Lot# 020L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.

1st shot on 2-3-2021 at 2 PM, Bad diarrhea on 2-5-2021 at 1 AM, lasted about 2 hrs; 2nd shot on 3-3-2021,at 2 PM, bad diarrhea started on 3-7-3032 at 1 AM, lasted about 2 hrs

I was doing light yard work in the sun, them in the 70s, became dizzy and could not stand, fell backward to the ground, tried to get up and became nauseated, had the dry heaves so I laid down on my side. Every time I opened my eyes the area began spinning again. I had a fever and sweated heavily for about 1 hour. I took two aspirin with a glass of water. I had a short nap, lying on the ground, when I woke up the fever was gone and I started having chills. After about 30 min, my dizziness was less, but I still could not walk. I started sitting up and scooting backward into the house, which took about 30 min to get into the house. I laid on the floor, was still having chills, so covered up with many blankets. About 8pm, 5 hours after first getting dizzy, the chills were gone and I was able to get up and get in bed. About 10 pm I took 2 asprins and went to sleep.I had to get up

Fever, chills, nausea the morning After vaccine. Took out the trash and had a cardiac arrest and fell. 911 called went to hospital 3 1/2 days no change. 2 Dr.s said no improvement brain dead. Had a living will disconnected after 48 hrs. Disconnected at 7:00 pm died 8:17 pm. 2/7/21

Mini seizure; Diarrhea; Slight temperature; Vomiting; A spontaneous report was received from a consumer concerning an 84-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events of slight temperature/fever, vomiting, diarrhea and short seizure early in the morning. The patient's medical history include type 1 diabetic, history of mini seizures and had a pacemaker installed a week ago-did have check up after and was good. Concomitant medications reported were levetiracetam - anti seizure, Insulin 2 times per day taking for type 1 diabetes. On 22 Jan 2021, prior to the onset of the events the patient received the first of two planned doses of mRNA-1273 (lot/batch: 029120A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. He was fine after taking vaccine, but on 28 Jan 2021 started developing symptoms. On 28 Jan 2021, the patient experienced the events of slight temperature, vomiting and diarrhea. On the same day, patient experienced the event of mini seizers for about 5 min in early morning and took levetiracetam. No other treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was not reported.; 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's history of seizure was a strong confounder of the event of short seizure early in the morning.

On 2/1/2021 he vomited and his pulse began to drop. A doctor from the hospice visited him days before and found him in good health and pressure. Patient was in the Home Care hospice.

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

Hospital Course: Patient was admitted 2 days after having received his COVID-19 vaccine and had SIRS including hypotension. Was believed to be a possible reaction to the vaccine. He was admitted to the ICU and briefly he needed vasopressors. The hypotension resolved and did not recur. An echocardiogram showed that he had a moderate pericardial effusion, cardiology saw him and does not believe that this contributed to the hypotension. He also thought his stools were dark however he has had quite dark stools for many years he told me, ever since he was started on iron pills. He could not confirm whether or not the stools might be a little darker than usual for him and he also had 1 out of 3 stool occult blood test that were positive. He has chronic anemia with the hemoglobin slightly lower than his baseline, so GI was consulted and an EGD was performed. He does have Barrett's esophagus and GI discussed with him how he will need follow-up EGDs, and I reminded him of that as well. Warning signs and alarm symptoms were discussed. He was placed back on his Eliquis however he will not be taking the Effient medication. This was based on recommendation from cardiology. He will have lab work done and see his primary care provider within several days. He will also have a video capsule test done and pick this up either today or tomorrow and follow-up in several days with GI. Discussed going back on his low-dose Eliquis with GI. Discussed with cardiology and GI and discussed with the patient the risks, benefits and alternatives. He will watch for any signs of bleeding and stick with a low dose of Eliquis.

About 12 hours after first dose of vaccine, patient described extreme weakness and had an episode where he had to lower himself to the ground and could not get up, was very dizzy as well, and had been experiencing diarrhea for about 12 hours as well. Was back to normal after the 12 hours and was instructed to report is this occurs again after second dose.

My Father was ill for approx 3-4 days after first vaccine with fatigue and some minor chest pressure, this start approx 3 days after injection and had made a complete recover, he then recieved his 2nd vaccine shot and again 3-4 days later he again stated began having severe fatigue and mobility issues, ( he stated his legs felt like jello ) , no chest pains and no breathing issues were associated. 3 days later he was still feeling the same with symptoms and on the 4 day he was found deceased in his home.

2/22/21 - achy/weak, nausea/vomiting with clear vomit taste like blood, no fever 2/23/21 to 2/25/21 - continues with weakness and developed joint pain and red rash on arm that had injection - rash lasted 4 days 3/12/21 - developed pain behind left knee and down to left foot 3/15/21 - knee/leg pain contiues and goes to urgent care - diagnosed with DVT 3/22/21 - developed chest pain, goes to ER, diagnosed with kidney stones

3 days post vaccination patient experienced diarrhea, 10 days post vaccination patient experience fatigue, loss of taste and smell and was "bedridden"

Patient received vaccine on 4/15/21 2nd dose of 2 dose series. He woke up the morning of 4/22/21 at 6:15am with vomiting. His temperature spiked to 104.2 and his O2 sat dropped to 98%. He developed shaking chills, and a loose wet sounding cough. He had chest xray and labs. Started on treatment for pneumonia with rocephin, zithromax and solumedrol. Declined throughout the day and had increasing requirements for O2 and patient passed away at 1355 on 4/22/21.

NAUSEA, FATIGUE, MUSCLE ACHE, CHILLS, FEVER, LOSS OF APPETITE, UNABLE TO GET OUT OF BED WITHOUT HELP, UNABLE TO WALK WITHOUT HELP. THIS LASTED FROM THURSDAY UNTIL SUNDAY MORNING.

Approximately 12 hours after receiving his second COVID vaccination, patient began experiencing stomach aches & headaches. The next day he began coughing and it hasn't let up yet. Sputum is beige/blood-tinged. Afebrile. Scattered rhonchi heard upon auscultation. Offered azithromycin and ipratropium-albuterol nebulizers for sinobronchitis.

Reporting a symptomatic positive COVID swab after the completion of Moderna Vaccine series. Became symptomatic on 5/11/2021: Description of symptoms-Characteristics (severity/quality/duration) Runny nose Headache Body aches Nausea earlier-gone now Vaccinated with Moderna vaccine 2/9/21, 3/15/21

Covid-19; GI bleed; low blood pressure; Dehydration; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of GASTROINTESTINAL HAEMORRHAGE (GI bleed) in an 84-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 07-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 22-Feb-2021, the patient experienced COVID-19 (Covid-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced GASTROINTESTINAL HAEMORRHAGE (GI bleed) (seriousness criterion medically significant), HYPOTENSION (low blood pressure) and DEHYDRATION (Dehydration). The patient was hospitalized from 22-Feb-2021 to 28-Feb-2021 due to COVID-19. At the time of the report, COVID-19 (Covid-19), GASTROINTESTINAL HAEMORRHAGE (GI bleed), HYPOTENSION (low blood pressure) and DEHYDRATION (Dehydration) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medication provided. Treatment medications included dexamethasone and remdesivir. Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Correction for initial version: As per the initial source document, patient was admitted in hospital for 4 days due to COVID-19 but the case was not coded as serious based on hospitalization seriousness criteria. The correction has been made on 18-May-2021 upon identification. On 12-May-2021: Follow up received included events low blood pressure, dehydration, GI bleed were added

Moderna Dose 1 2/25/21 (041L20A) Moderna Dose 2 3/25/21 (011M20A) COVID Positive 5/10/2021 5/10/21: Presented to ED. 84-year-old male with history of liver transplant for primary sclerosing cholangitis currently on immunosuppressive therapy with CellCept and sirolimus, colon cancer status post partial colectomy with colostomy, prostate cancer s/p androgen deprivation therapy, CKD stage 4 and obstructive sleep apnea presented with cough. Patient reports symptoms started about 1 week ago with dry intermittent cough associated with shortness of breath, chest pain, generalized weakness body aches and worsening of chronic diarrhea. He was treated with Z-Pak but symptoms continued and he presented to the emergency room, found to be hypoxic requiring up to 6 L nasal cannula oxygen Patient also had fever no chills or rigors. Reports he has received both shots of COVID-19 vaccine. In the emergency room patient was hypotensive which was responsive to IV fluids and received levofloxacin. Chest x-ray showed bilateral pneumonia. WBC 15.5, lactic acid 2.8 and the creatinine 2 which is patient's baseline. 5/13/21: 84-year-old male with history of liver transplant for primary sclerosing cholangitis currently on immunosuppressive therapy with CellCept and sirolimus, colon cancer status post partial colectomy with colostomy, prostate cancer s/p androgen deprivation therapy, CKD stage 4 and obstructive sleep apnea presented with cough. Patient reports symptoms started about 1 week prior to hospitalization with dry intermittent cough associated with shortness of breath, chest pain, generalized weakness body aches and worsening of chronic diarrhea. Patient admitted for acute hypoxic respiratory failure secondary to COVID-19 pneumonia. Treated with dexamethasone and levofloxacin. With not a candidate for remdesivir based on poor renal function and ID consulted and did not believe patient qualifies for Actemra. Subsequently shortness of breath and hypoxia resolved and he was deemed stable for discharge and will complete 7 days steroid taper. Liver transplant team at pain clinic was consulted, recommended holding sirolimus while patient is on dexamethasone. I have clearly communicated to the patient and his wife to resume sirolimus after 1 week. On discharge patient was a febrile and hemodynamically stable. He was discharged home.

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.

No appetite, dizzy, rash around chest and very tired for 4 weeks. No treatment, Advised to consult with his primary care provider.

Pt showed up to the ER via EMS on 6/5/2021 with low back pain and weakness, bilateral leg swelling, shortness of breath. On 6/6/2021-developed bilateral upper and lower weakness that progressed to dysphagia and dysphonia. Transferred to ER on 6/8/2021 for Gillian Barre Syndrome On 6/11 had bilateral DVTS He was placed on palliative care and passed away on 6/19/2021

Initially, the night of January 18, the left arm was somewhat sore as expected. The next day, within about 24 hours after the injection, I felt slightly queasy, somewhat weak, what we called on the farm, being "off our feed." The left arm was increasingly painful, although I slept reasonably well that night. On the second day after the injection (Wednesday, January 20), the left arm was even more painful, I was actually nauseous, weak, and in the afternoon had a temperature of 99.8 (my normal temperature is 97.4). I had some abdominal pain for a few weeks before the injection and that pain had increased. But by bed time (about 10:30 p.m. CST) the temperature had returned near normal and I was feeling much better. Today, Thursday, January 21, I felt normal, no general weakness and minimal abdominal pain, and there was only very slight soreness in the left arm. My wife (81 years old with a history of nut allergies and asthma) received an injection at the same time I did and had minimal side effects from the Moderna vaccine with the same Lot Number. I note the EUA Fact Sheet says the Modern vaccine is still being studied so I hope is a small contribution.

Pt. woke up on 1/13/21 throwing up, this continued throughout the day about 5 episodes total. Pt. had no appetite that day and drank or ate very little. During the night on 1/13/21, he woke up and when his caregiver tried to help him to the bathroom, he had weakness on the right side of his body. Caregiver called on 1/14/21 letting us know the pt. has increased weakness. Caregiver encouraged to take pt. to Er. Pt. refused. Pt. seen in clinic on 1/15/21 and examination found pt. to have right hemiparesis including foot drip, right arm weakness, loss of motor control on the right upper and lower extremities. Facial droop on the right with disarticulation of speech and control of the tongue.

HYPOTENSION 2/4 AND 2/5, REQUIRED BUMEX REDUCTION THEN MEDICATION D/C, VERY POOR APPETITE UNABLE TO GET. REPEAT LAB WORK, RECEIVED PNEUMOCOCCAL CONJUGATE PCV-13 LOT DP5138, 1/19/2021

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.

Severe diarrhea starting at 0700 on Feb 11, 14 hours after receiving shot. Lethargic, weakness, no energy. Moderate soreness at vaccination site.

On 3/11/2021 the patient presented to the ED with diarrhea x 4 days, weakness, lightheadedness. The patient was found to have metabolic acidosis secondary to diarrhea. There are also liver lesions suggestive of metastatic disease.

This is an 85-year-old male, brought in by EMS, for evaluation of generalized fatigue, weakness, worsening since this morning. Patient received a second Covid vaccine shot yesterday. Family noticed worsening fatigue, and decreased appetite today which prompted evaluation. He has congestion, but no productive cough. No known fevers

Nausea - but this only lasted about 8 hours or so; Extreme exhaustion - still occurring; The most significant adverse reaction is uncontrolled high blood sugar; Patient is a type 1 diabetic and about 16 hours after receiving first dose, his blood sugar has been between 300-400 mg/dl. He has received large doses of insulin but he is not responding to the insulin as he normally should.

developed stomach pain beginning minuets after the shot administered. Left site 15 minuets after the shot and returned home. Stomach pain increased and in a sitting position vision started to become blurred and I passed out for a very short period of time. After that proceeded to have uncontrolled diaherrea and developed blood in the stool and on the toilet paper. Mild spotting continues the day after the shot. No other adverse symptoms.

symptoms started 1/23/2021 Hard Chills, temp spike 103, nausea, frontal headache, and muscular aches, recurrent chills and fever, most of my difficulty came after midnight, I'm not sure exactly when I went to the Dr maybe 6 days later and admitted me to the hospital, I was fine until two weeks ago I had chills fever and a little nausea and abdominal pain, lab results largely returned to normal and showed the same problem, liver enzymes, 785 amylase. My physician did not want me to get second dose.

Fainted; Left rib cage injured; Aches in the bones; Ill; Fell face first into the floor, fell on my hands; Bruised his hand; Face injured; Left hip and knee is injured; Nausea; Aches in the joints; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted) and CHEST INJURY (Left rib cage injured) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042821A and 003821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (Patient spent 50 days in the hospital) from October 2020 to 04-Dec-2020. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced SYNCOPE (Fainted) (seriousness criterion medically significant), CHEST INJURY (Left rib cage injured) (seriousness criterion medically significant), BONE PAIN (Aches in the bones), ILLNESS (Ill), FALL (Fell face first into the floor, fell on my hands), CONTUSION (Bruised his hand), FACE INJURY (Face injured), JOINT INJURY (Left hip and knee is injured), NAUSEA (Nausea) and ARTHRALGIA (Aches in the joints). At the time of the report, SYNCOPE (Fainted), CHEST INJURY (Left rib cage injured), BONE PAIN (Aches in the bones), ILLNESS (Ill), FALL (Fell face first into the floor, fell on my hands), CONTUSION (Bruised his hand), FACE INJURY (Face injured), JOINT INJURY (Left hip and knee is injured), NAUSEA (Nausea) and ARTHRALGIA (Aches in the joints) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Cardiac function test: normal (normal) normal (heart was ok). No relevant concomitant medications were provided. On 22 Apr 2021, patient experienced aches in his joints and bones, he was becoming ill and had nausea which triggered emergency and needing to go to bathroom. He was heading to the bathroom, he fainted and fell face first into the floor. He injured his face, fell on his hands. He had bruised his hand. His left rib cage and left hip and knee was injured. He went to the Emergency Department where he was told his heart was ok, he was not delirious and consciousness was ok. He stated, it has now been a week and the bruising is still there and the stiches will be coming off tomorrow. No treatment information was provided. Action taken with mRNA in respect 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 events, a causal relationship cannot be excluded. However, the events face injury, contusion, fall, chest injury and joint injury is unlikely related to m-RNA 1273.; 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 events face injury, contusion, fall, chest injury and joint injury is unlikely related to m-RNA 1273.

The day after 2nd Moderna vaccine: Syncope (suspect seizure) shortly after wife got him up from bed, minutes later saw him slumped over in chair, pale, prolonged loss of consciousness about 20 min, EMS called and took him to ER. Had bowel incontinence with this; no tonic/clonic activity, no tongue biting.

One month after the vaccine 2nd dose, I developed acute rectal bleeding and loss conscousness due to the blood loss. I went to the emergency room and given a unit of packed cells. Then I was transferred to Hospital and was hospitalized 5 days there. I continued to bleed once the hematocrit and hemoglobin stopped dropping, I was discharged. Etiology unknown.

Patient is breakthrough case with Moderna. First dose on 2/8/21 and second on 3/5/21. Vaccine info above.Tested antigen positive on 7/5 at Hospital. Tested PCR Negative on 7/9. Patient presented to ER with abdominal pain, nausea, generalized weakness, loss of appetite, significant sweats, and diarrhea. Patient stated this had started about 5 fays prior. Patient received Normal Saline IV fluids 1000 mL and ivermectin in the ER. Patient was transferred to floor on 7/9 and was still inpatient when this nurse called for follow up on 7/14.

12/29- resident stated to run temp of 100.7 and had nausea 12/30- nausea and vomiting, no temp, complaints of not feeling well 12/31- nausea, 1/1- no further symptoms

Patient received vaccine on 1/4/2021. He was in Hospice for CHF and renal failure, but was able to get up in his wheelchair and eat and take medications and talk. On 1/5/2021 am, he was noted to be very lethargic an could only mumble, could not swallow. No localizing neurologic findings. He was too lethargic to get up in chair.

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.

01/19/2021 patient received Moderna Vaccination. Later that evening patient began having abdominal pain. He took 2 tums and reported that he felt much better and slept well. On 01/20/2021 patient was seen by home health skilled nurse. All vital signs within normal limits with no complaints at skilled nurse visit. On 01/22/2021 patient participated in therapy with no complaints. Home Health notified today 01/26/2021 that patient was admitted to hospital on 01/22/2021 for abdominal pain.

86 y/o male, immediately post vaccine the patient became nauseated, pale and diaphoretic. MD called to eval, patient stated he had Hemodialysis yesterday. HD new since Oct 2019. No vomiting, no shortness of breath, no rash, no allergic symptoms. BP initially once back to medical area, 113/77, HR 103, RR 16, Po2 99. His blood pressure continued to drop to a point of 77/51 and a decision was made to transport via EMS to the ED . Time in medical area 55 minutes. During that time patient did not develop any rash, difficulty breathing or other allergic symptoms.

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.

Nauseas and diaphoretic. water and OJ provided .Denies tingling, SOB,BP 101/69, EMS notified MAP of 61 systolic 77 multiple low BP. EMS arrived 1415 evaluated MAP 70 SBP 99 no orthos done since he was Hypotensive was taken to ER.

Pt. recieved 1st dose of Moderna vaccine on 5 Feb and presented to the ED with new onset AFIB & abdominal pain on 5 Feb. Patient was discharged on 17 Feb. Home course unknown

extreme chills, fatigue, nausea, vomiting, diarrhea. chills started morning of the day following vaccination. Hours later extreme fatigue followed by nausea, vomiting and diarrhea. Today, 48 hours later feeling much better with slight nausea which appears to be better.

Patient was transferred from hospital for further evaluation and care by pulmonologist. He started having symptoms a week before with fatigue, emesis, decreased p.o. intake, shortness of breath, vomiting and diarrhea. The two previous takes before death required increasing oxygen and family wanted everything done including intubation. He was transferred to ICU.

Patient daughter notified me that patient started Stivarga on 2/25/2021 (appx). She states that on 2/26/2021 her father started having bloody diarrhea. She states he was "more fatigued than normal" leading up to this event. Labs were drawn and it yielded throbocytapenia. She states the oncologists states he does not believe it was from the medication but feels it was the vaccine that produced this. The patient is in the hospital receiving blood and platelet transfusions.

fatigue Narrative: Patient reported that 3 days after receiving the first dose of vaccine he developed nausea and vomiting as well as fatigue. Patient reported the N/V lasted only a day or two and the fatigue lasted approximately a week. symptoms have resolved since then.

Temp @ 10:30AM - 97.3; 4:30 PM - Rt. arm red, hot , muscle hard and sore @ inj. site; temp 99.8, took 10 gr ASA; 10:30 PM, temp 101.3, N&V, fever and chills, terrible body aching; took 15 gr ASA, applied cold cloth to head and neck. This lasted with fever, aching and flu like symptoms for 3 days and general fatigue and malaise with temp running 99, taking ASA. Did not return to normal until 5th day, but arm was still slightly wqrm, sore and itching. No problems after day 6. Only able to hold down soup and gingerale for first 3 days.

3-21-21 at 5:35am - Intermittent coughing during HS. Afebrile. Upper lung fields noted congestion; clearing when coughing/turned repositioned per staff, Afebrile. 3-21-21 at 9:30am - In residents room repositioning him, resident vomited tube feeding. Turned him on his side and swept out his mouth. Tube feeding pump turned off. Breathing became labored. Second nurse placed non-rebreather mask on him. Called 911 to take resident to hospital. 3-21-21 9:45am EMS now at bedside. Pulse palpable, Cheyne Stokes respirations. O2 on per non-rebreather mask. EMS assessed resident- now in VT/VF CPR initiated. Code cart placed outside of door. 3-21-21 10:00am Resident transferred out to Rig with an organized heart rhythm. Dr. ( on call for Dr.) notified of event and transport to hospital.

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.

One side of heart was not pumping right; Nauseous; Patient was not feeling well; Loss of appetite; Increased heart rate; Pale; hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DYSFUNCTION (One side of heart was not pumping right) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history reported). On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced CARDIAC DYSFUNCTION (One side of heart was not pumping right) (seriousness criterion hospitalization). On an unknown date, the patient experienced NAUSEA (Nauseous), MALAISE (Patient was not feeling well), DECREASED APPETITE (Loss of appetite), HEART RATE INCREASED (Increased heart rate), PALLOR (Pale) and DYSPNOEA (hard time breathing). The patient was hospitalized from 09-Mar-2021 to 19-Mar-2021 due to CARDIAC DYSFUNCTION. At the time of the report, CARDIAC DYSFUNCTION (One side of heart was not pumping right), NAUSEA (Nauseous), MALAISE (Patient was not feeling well), DECREASED APPETITE (Loss of appetite), HEART RATE INCREASED (Increased heart rate), PALLOR (Pale) and DYSPNOEA (hard time breathing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment of the events included diuretic medications. 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. 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 event, a causal relationship cannot be excluded. Further information has been requested.

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.

On day 10, after receiving 1st dose of Moderna vaccine ,Rectal hemorrhage during the night and, Bloody stool, Two weeks later, petechiae on stomach and blood on t shirt upon arising.

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.

reed blodd cells/hemoglobin down; white blood cells down; possible lymphoma; platelets down; Spleen enlarged; liver enlarged; Not feeling well overall; Dizziness; Throwing up bile; shortness of breath; Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), GENERAL PHYSICAL HEALTH DETERIORATION (Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly), HEPATOMEGALY (liver enlarged), ANAEMIA (reed blodd cells/hemoglobin down), LYMPHOPENIA (white blood cells down), LYMPHOMA (possible lymphoma), THROMBOCYTOPENIA (platelets down), SPLENOMEGALY (Spleen enlarged), MALAISE (Not feeling well overall), DIZZINESS (Dizziness) and VOMITING (Throwing up bile) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. The patient's past medical history included Blood transfusion (Patient has had 4 blood transfusions, has been hospitalized). Concomitant products included FLUOXETINE HYDROCHLORIDE (PROZAC), COLECALCIFEROL (VITAMIN D3), IRON, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), MACROGOL 3350 (MIRALAX), DOCUSATE SODIUM (COLACE), WARFARIN SODIUM (COUMADIN), ASPIRIN [ACETYLSALICYLIC ACID], CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced MALAISE (Not feeling well overall) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization) and VOMITING (Throwing up bile) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSPNOEA (shortness of breath) (seriousness criterion hospitalization), GENERAL PHYSICAL HEALTH DETERIORATION (Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly) (seriousness criterion hospitalization), HEPATOMEGALY (liver enlarged) (seriousness criteria hospitalization and medically significant), ANAEMIA (reed blodd cells/hemoglobin down) (seriousness criterion hospitalization), LYMPHOPENIA (white blood cells down) (seriousness criterion hospitalization), LYMPHOMA (possible lymphoma) (seriousness criteria hospitalization and medically significant), THROMBOCYTOPENIA (platelets down) (seriousness criteria hospitalization and medically significant) and SPLENOMEGALY (Spleen enlarged) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 7 days due to DYSPNOEA and GENERAL PHYSICAL HEALTH DETERIORATION. The patient was treated with OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) at an unspecified dose and frequency; CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) at an unspecified dose and frequency and IRON at an unspecified dose and frequency. At the time of the report, DYSPNOEA (shortness of breath), GENERAL PHYSICAL HEALTH DETERIORATION (Consumer called 3Jun2021 regarding her father who within the last 4 weeks has declined significantly), HEPATOMEGALY (liver enlarged), ANAEMIA (reed blodd cells/hemoglobin down), LYMPHOPENIA (white blood cells down), LYMPHOMA (possible lymphoma), THROMBOCYTOPENIA (platelets down), SPLENOMEGALY (Spleen enlarged), MALAISE (Not feeling well overall), DIZZINESS (Dizziness) and VOMITING (Throwing up bile) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy bone marrow: unknown (Inconclusive) Inconclusive. In 2021, Biopsy liver: unknown (Inconclusive) Inconclusive. In 2021, Blood smear test: unknown (Inconclusive) Inconclusive. In 2021, Haemoglobin: low (Low) Low. In 2021, Platelet count: low (Low) Low. In 2021, Red blood cell count: low (Low) Low. In 2021, White blood cell count: low (Low) Low. Concomitant medications also include an inhaler (unspecified). 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.

Severe shingles breakout on left side of groin, side and back. Worse case Dr ever saw! Started w/discomfort and pain in abdomen area. Developed and still has rare complications Psuedo Hernia Abdominal Protrusion (PHAP) and Post Herpetic Neuralgia (PHN). Still on meds and have pain into 5th month!!!! Have different doctor now, than when this started. Don?t think either doctor reported it, but believe the vaccine triggered this terrible breakout. Have found several reports on internet of others getting shingles 2 weeks after the1st shot.

Starting about 16-18 hours after shot - fever 102+, nausea (couldn't eat) , headache, body sore all over (like flu), weak as a kitten. Symptoms lasted for about 36-48hours. Took 2 extra strength tylenol three time during period of reaction.

4 hours after injection I became very tired followed by severe abdominal pain, cramping. and chills. No Fever. Blood pressure elevation. Pain was slightly relieved by burping and passing wind. After 3 hours of these symptoms I Called EMS, who checked and could find no other cause other than reaction to the injection. I took pepcid, gas pills and additional blood pressure pill but had no relief. After EMS visit I took Tylenol and was up for hours before finally falling asleep. Awoke this morning with no cramping but still very tender in abdominal area. Additionally I had a muscle cramp in my upper thigh this morning

Systemic: Nausea, Systemic: Vomiting, Systemic: shortness of breath, increased Heartrate, pulse ox fell to 88-93-Normal 95%, orthostatic hypotension

covid + on 1/21/21; admitted to hospital due to infection Narrative: Patient received the first dose of the COVID vaccine on 1/12/21. The patient tested positive for COVID 1/21/21. Admitted to Hospital on 1/23/21. Patient developed fever, cough, SOB, and diarrhea.

Severe headache that lasted 2 hours; site of injection is sore but only to the touch( 2 days so far); diarrhea lasted for only one day

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

Severe pain and swelling at the site. Chills and fever. Diarhea. Fatigue for two days after the injection.

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.

On 1/26 at breakfast table began vomiting. Continued thru am when at noon a caregiver did his O2 saturation and found it was 75%. This was confirmed, and resent sent to ER .

1/31/2021 03:56 Nursing Note Note Text: Pt. c/o R Abd pain at the waist line. Pt. stated it felt like a muscle being pulled. Not constipated, bowel sounds active. Took VS and they are charted. Writer called on call and spoke to NP and she stated to give him Tylenol and check the above. Bowel sounds and such. So writer did give him Tylenol at 3:45am. 1/31/2021 12:53 Admit/Discharge/Transfer Note Note Text: at 1030 pt stated that he had been having RLQ pain for the past hour. VS retaken. Described pain as constant but "increases suddenly" to an 8 on a 10 point pain scale. worsens with movement, alleviates with rest. RLQ pain radiates to R shoulder and around to his R lower back. bowel sounds x4, tender abd in right lower quadrant and upper right quadrant. follow-up assessment at 1220 found rebound pain. pt states last bm was yesterday and it was brown, formed, easy to pass. Lower posterior R lung sounds diminished and lower posterior L lung fields contain crackles. at 742: temp 98F, 140/68, 02 saturation 96%, respiration 16. denies n&v. ate pancakes, sausage, and fruit for breakfast. gave morning pantoprazole, held morning am medications. Called on call triage nurse and NP. on call NP suggested sending pt to hospital. transferred to hospital via ambulance and paramedics at 1240.

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.

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

fatigue, high heart rate, sob, low blood pressure, feels cold all the time, no appetitive, palpitations

Patient was vaccinated at pharmacy on 2/9/2021, first dose of Moderna COVID-19 vaccine. Per medical records from hospital: patient developed fever, diarrhea, nausea and abdominal pain on 2/25/2021 and presented to the hospital E.R. on 3/1/2021. Patient was diagnosed with Sepsis and Pneumonia. Cardiac arrest on 3/6/21, renal failure, seizures. Patient tested negative for COVID-19 on 3/1/2021 and 3/8/2021. Patient has declined, was placed intubated and placed on a ventilator. Patient admitted to hospice services on 3/8/2021 and plan is for compassionate removal of life support at hospice. Prognosis is poor.

Four days of feeling sick with aches, pains, upset stomach. On day 2 he was so sick he thought he would die. Sudden death on day 7.

Extreme chills. Uncontrolled violent shaking in my entire body for four hours during the night. Some slight nausea, no vomiting. March 5, extreme chills. No violent shaking. Wearing sweat pants, 3 sweat shirts --- I put a heavy blanket in the clothes dryer to get hot and wrapped it over my head and around my body. Extreme fatigue. No desire to do anything. Muscle pain in my shoulders, back and stomach until Monday, March 8. Diminish the incidence of crime --- THREATEN THE CRIMINAL-WANNA-BE with these effects instead of prison.

Narrative: Patient and wife contacted telephone triage nurse today requesting advice. States patient did fine with the first covid vaccine, but after he got his second covid vaccine on 2/20/2021 he became ill, has not recovered yet. Patient is c/o nausea/vomiting, "he looks jaundiced" per wife. Some mild SOB, + epigastric discomfort, chills, increasing weakness. No diarrhea, "some constipation." + Dark urine. This nurse asked wife to check V/S. [B/P: 116/65, pulse 75]. Pt still able to getup and walk around to use restroom, etc. - some lightheadedness with ambulation. No leg swelling. Patient has been vomiting several times daily since 2/20/2021. Emesis x 4 since last evening. Recommended local ER. Wife states she will take him to ER now. Please follow up, thank you.

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.

Pt is an 87 yo M, hypothyroid and peripheral neuropathy who presented to the ED with weakness. Pt reports that he was outside loading a trailer when he suddenly felt lightheaded and like he was going to pass out. Pt also enorses nausea, denies vision changes. Pt lowered himself to the ground and called his son to help him and take him to the hospital to be assessed. Pt reports that he frequently has episodes of lightheadedness in the mornings for the past 5 years, but they have been increasing in frequency and this episode was the worst he has ever had. On arrival to the ED he continues to have generalized weakness and is unable to sit up and feels unsteady on his feet.

10 min after patient received vaccine patient bent over and felt dizzy. After taking vitals patient reported that he felt as if he was going to vomit. Patient was assessed by provider, after several minutes patient felt better.

NASAL CONGESTION, COUGH, FATIGUED, WEAK, NO APPETITE, DEATH Narrative: 02/02-VACCINE GIVEN 02/22-pt not feeling well, dry cough, nasal congestion, weakness, loss of appetite, fatigued and weak; pt was exposed to "non-covid" virus through caregiver 02/23-caregiver called telecare to report pt with 3 days fatigue, admitted to hospital 02/25-alerted that pt passed away; they thought he might have been having a mild MI and later placed him on a ventilator and was told he had Pneumonia. He passed away on 2/24/21 at 1030AM confirmed by Daughter; no record of autopsy or death note no documentation of prior covid infection, acute adr to covid vaccine, teste negative to covid on 12/28 (exposed to daughter who have covid) hospitalized 09/23-09/29/2020 due to vomiting and diarrhea, found to have elevated troponins and abnormal kidney function, discharged home; was result of working in the sun and getting dehydrated not likely that covid vaccine contributed to patient's death, but death d/t advanced age and potential exposure to non-COVID virus shortly prior to death

covid+ Narrative: Patient with diagnosis of chronic respiratory failure with hypoxia secondary to COPD, dependent on oxygen/steroid, GERD, Rosacea secondary to long term steroid use, CAD, HLD, HTN, Diet controlled DM, Granulomatous disease of the lungs, Hx Abnormality Imaging of the lungs early 1990's- further imaging resolved without treatment, Vitamin D/B12 deficiency, Chronic rhinitis, Adjustment disorder with anxiety, Osteoarthritis of multiple joints. Patient admitted 3/19/21 with +COVID symptoms/test. Transferred to facility 3/27/21 with new onset Afib/further respiratory decompensation requiring NRB/Amiodarone gtt. Was made comfort care for Patient request and placed on MSO4 gtt. Patient passed away 3/31/21 at 1640 of Acute on Chronic respiratory failure secondary to COPD/COVID with daughter at side.

Severe lower back pain Severe thigh muscle pain both legs Strong neck pain Nausea for two days Dizziness when standing or walking Upper arm pain, both arms

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.

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.

BRIEF OVERVIEW: Discharge Provider: MD Primary Care Provider at Discharge: MD Admission Date: 4/22/2021; Discharge Date: 4/23/2021 Active Hospital Problems - Admitted for bilateral PE ? Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type (HCC) 04/22/2021 DETAILS OF HOSPITAL STAY: Patient is a 87 y.o. male with psoriatic arthritis, essential hypertension who presents today with right-sided chest pain. He reports onset starting yesterday. The pain radiated around to his back into the center of his chest. Thought he had pulled a muscle was having heartburn. Taking a deep breath made the pain worse. He tried Tums but no significant relief. It was not associated with shortness breath. Denied any, lower extremity swelling or calf pain. Today the pain was acutely worse so presented to the emergency department for evaluation. No prior DVT, PE, no FH of DVT/PE. No weight loss. No recent prolonged trip. On arrival to the emergency department his pulse was noted to be elevated to 120 but otherwise vitals unremarkable. CT angiogram thorax had significant findings of multiple bilateral pulmonary emboli involving segmental and subsegmental vessels. There was no evidence of right heart strain. He was started on heparin drip and transferred to another facility for ongoing care. He was switched to Eliquis 10 mg bid for 7 days, then 5 mg bid for 3 months. He has not sign of any malignancy, no weigh loss. He received Moderna COVID-19 vaccine on 3/4/21 and 4/1/21. It is conceivable that this PE could be complication of COVID-19 vaccine. He should follow up with PCP in 1 week. CTA also showed partial visualization of gas fluid collection within the right upper quadrant, likely reflecting a duodenal diverticulum which was present on 8/20/2012 CT abdomen, incompletely assessed. There is a small hiatal hernia. PCP to follow. Discussed with wife, and with daughter over the phone. Patient discharged home.

Patient has two admissions post vaccine, history of pancreatic cancer: 5/5 with worsening abdominal pain and jaundice which warranted ERCP. Patient treated and discharged. Second admission on 5/13 for ischemic stroke. Patient awoke with lower extremity weakness on standing and dizziness on standing; tingling sensation right leg, arm and face.

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.

2 days after the vaccine pt developed a stomach ache radiating to the back ,after several tests and seven weeks later pt. was diagnosis with multiple myeloma went blind and passed away,

Patient with longstanding ITP on nplate (romiplostin) with dramatic decline in platelets after 2nd vaccine to 0 (has been 0 since 04/2021. Have retried steroids, promacta, IVIG, and rituximab. Repeat bone marrow biopsy and pathology negative for primary process. Strongly suspect

10 minutes after vaccine was administered fever and diarrhea started. Extra Strength Tylenol was administered every 4 hours. Over the Counter anti-diarrhea was given. Highest temperature was 102.8. Ibuprofen was given when the fever was highest

1-9-2021 @ 1:45 AM Chills temp 98.4f. 4AM "I can't getup" helped to BR sat on commode while I prepared a cath and then assisted to cath while sitting. warm to touch temp 102.4f. " I need something to eat". I brought a glass of milk and his monitor BS 113 drank 1/2 cup of milk and helped back to bed. complained of nausea-no emesis. 4:35 temp 99.4f " I think I can sleep now" 8:36AM 98.8 T sleeping. 9:45AM ate 1/2 bowl cereal 10 U insulin, 1/2 cup coffee 1 glass water with medications. 10:15 resting in chair 98 t. 10:51PM 97.8 BS 228 28 u long acting Woosey most of day ate poorly "not hungry" 2 glasses of water during day. no other problem

on 1/13/2021 at 3:40am Cliff called for assistance. He lost his balance and had fallen. Cliff refused vitals, refused emergency department, denied hitting his head. As the day progressed patient developed a headache, diarrhea, and vomiting. He again declined the offer for the emergency room. At supper time wife and staff found Cliff unresponsive, 911 was called and he was taken to the emergency department. The ER did a CT scan and found an acute subdural hematoma. Patient was placed on comfort cares and expired at 3pm on 01/14/2021. Cliff did not have a history of falls.

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.

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.

2/28/2021 patient was admitted for rectal bleeding while taking apixaban Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine. This hospitalization does not appear to be related to the vaccine.

Having the feeling of a need to urinate, but inability to. A lot of pain in the groin area. High blood pressure. Diarhea all night.

Patient received 2nd Moderna vaccine on Friday, March 5. The next day, Sat. March 6, he started getting nauseated with a temp of 101. Didn't eat all day. This morning, March 7, he said he felt better and slept well. I fixed him a bowl of oatmeal. He took one bite and said he couldn't eat anymore. All of a sudden he appeared to fall into a state of unconsciousness and could not respond to anything I said. I tried to shake him with no results so I decided to call 911 and when they got here he came around a little and said he didn't want to go to the hospital. Still not eating and just wants to sleep. He is 88 years old. I am the same age and had no adverse event (yet).

Extremely cold, achy on first day, achy and vomiting on second day, third day sore to touch anywhere on body

Severe headaches, loss of appetite, jaw claudication, tongue discomfort, difficulty swallowing, elevated CRP. Treated with prednisone 20mg, 1 tablet by mouth three times daily. Continued headaches and jaw discomfort. Still treating with steroid.

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)

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 .

Sore arm for several days. Upset stomach and nauseous for several days, two days of watery stool. Weak in general for a week.

Patient's wife reported that patient died a couple of days after second Moderna vaccine. About 2 days after vaccine, patient presented with lumps all around body and doctor's could not figure out what was wrong. His digestive tract started to deteriorate and he passed away at home. Autopsy was performed but could not confirm cause of death.

Patient with extreme nausea and vomiting that started soon after receiving the Moderna vaccine. Patient with loss of consciousness, diaphoresis and garbled speech during a foley catheter exchange thought to be from dehydration. Patient was admitted to Hospital for observation for 2 days

89 y/o M with PHM of HTN, CAD, cardiomyopathy, HFrEF (EF 30%), Right Lobe thyroid nodule / L lobe cyst (declined biopsy), subclinical Hyperthyroidism, A fib, TIA, remote h/o PUD (bleeding ulcer s/p pyloroplasty and vagotomy 1999), internal hemorrhoids, spinal stenosis of lumbar region, HLD, asbestosis, BPH, anemia, goiter, osteoporosis, vitamin D deficiency, who underwent Right Hip Intertrochanteric ORIF on 6/11/20 s/p R hip fracture on 5/28/20 and was admitted to nursing home for SAR on 6/25/20.Patient reported weakness and loss of appetite on 12/29/20 18:36 s/p COVID- 19 vaccine received on 12/28 @13:09. Patient is being monitored.

MEDICATION REACTION (Pt got his covid shot and immediately had a reaction to it. Diaphoretic, nauseous, dizzy. Was given 4 of zofran in route.). Comes to the emergency department today after getting his 1st Monday and a COVID-19 vaccine at 7:30 p.m. and about 5 minutes after while sitting down developing significant diaphoresis, nausea, dizziness and feeling very warm. The symptoms lasted for about 15 minutes and then resolved. Since then the patient has felt a little off in his stomach but has not had any difficulty breathing, difficulty swallowing, difficulty speaking, chest pain, diarrhea, rash or itchiness. With this episode the patient did not have any changes to his vision or feel like he was going to pass out. Patient will be given 25 of Benadryl, 125 of Solu-Medrol, 20 of famotidine of concern for possible allergic reaction. Additionally the patient will be given a small bolus of normal saline. Given the patient's reassuring vitals and reassuring physical exam he will simply be monitored here were sure. I do not feel any lab workup is necessary this point this is resolved episode seems either like a mild allergic reaction or a vasovagal episode.

diaphoresis Narrative: Patient was clammy and pale and vomited after receiving Moderna Covid-19 vaccine. Patient BP dropped to 70/40 and HR 120. Patient felt dizzy. 2L of oxygen by nasal cannula given. 911 was called and patient taken to hospital and seen in ER. Patient was discharged from hospital. Patient previously tested positive for COVID-19

Second day after receiving vaccine, felt fatigue and slept most of day. Had some muscle and joint pain and loss of appetite. Never had a fever. Only symptoms to this date are fatigue and appetite loss. ON Thursday January 21 tested positive for Covid 19. No real bad problems never had a fever.

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 did have and still have soreness of shoulder where I got the injection. That I can expect to stay. When I woke up at 1:00 am my lips and my tongue were in lots of trouble. Its hard to describe, somewhere between numbness and whatever. They sent an ambulance, they looked at it and had me move my tongue and said the area wasn't swollen so they said it would be ok sooner or later. The second day that was a little bit improved but even until now my lips are not normal. By the second day i was having a swallowing problem, the back of my throat feels like the top of my throat. Even when I swallow saliva its not good. But i am still able to eat. So lips and throat are still a problem. When I went to get the shot I was quite able to walk but not long distance. By the second day i began to have a problem in my back, I assume just muscular unless something is wrong in the vertebrate. I can barely walk now, I just shuffle one foot ahead of the other. At any moment if I move I just collapse. I'm always using a cane and always have something to hold on to because I don't know the next minute I'm going to go down, it is very bad.

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.

2/4/21 Vaccinated at 1:15 pm. At 5:30 pm patient's throat began to swell and he could not hardly swallow water. At 10:00 pm, he noticed that his face was a little numb but proceeded to go to bed. 2/5/21 Patient feels better. He can swallow and eat. Face is not longer numb.

Vomiting since the 24th, cannot keep food down. Officially 2 days since second dose of vaccine. initial symptom at dinner time.

on 2/27 patient's wife called and stated that he had fatigue, body aches, low grade fever, and poor appetite. on 3/4, patient's wife called and stated he had some shortness of breath and extreme fatigue. on the evening of 3/4, he experienced sharp back pain and shortness of breath and was taken by ambulance to the hospital, where he was diagnosed with CHF exacerbation and NSTEMI and worsening CKD. he developed cardiogenic shock and renal failure. on 3/10 he was started on milrinone, then on 3/11 he went into pulseless VT and expired.

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.

Patient was on hospice for general debility for about 2 years. Patient was eating 100% and propelling self in wheel chair while living in nursing home. Received Covid vaccine #1 on 2/2/21 and #2 on 3/2/21. No other significant events occurred until starting 4/7/21 when patient started vomiting food. Then on 4/8/21 patient vomited large amount of coffee ground emesis. Then on 4/9/21 patient expired.

Patient developed rectal bleeding. Pt was thrombocytopenic at a platelet count of 1. He was given steroids and transfused platelets and PRBCs in the hospital with improvement in his platelets.

Was not eating; Hematuria; became extremely fatigue/ not improving extreme fatigue/he could hardily make it to the grocery store door back to the car without total exhaustion; weak/he could hardily make it to the grocery store door back to the car without total exhaustion; Pancytopenia; father who passed away; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DEATH (father who passed away), PANCYTOPENIA (Pancytopenia), HAEMATURIA (Hematuria), DECREASED APPETITE (Was not eating), FATIGUE (became extremely fatigue/ not improving extreme fatigue/he could hardily make it to the grocery store door back to the car without total exhaustion) and ASTHENIA (weak/he could hardily make it to the grocery store door back to the car without total exhaustion) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The patient's past medical history included Atrial fibrillation and Heart failure. Concomitant products included RIVAROXABAN (XARELTO), FUROSEMIDE, PRAVASTATIN and CARVEDILOL for an unknown indication. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced FATIGUE (became extremely fatigue/ not improving extreme fatigue/he could hardily make it to the grocery store door back to the car without total exhaustion) (seriousness criterion hospitalization) and ASTHENIA (weak/he could hardily make it to the grocery store door back to the car without total exhaustion) (seriousness criterion hospitalization). On 29-Mar-2021, the patient experienced PANCYTOPENIA (Pancytopenia) (seriousness criterion hospitalization). On 01-Apr-2021, the patient experienced HAEMATURIA (Hematuria) (seriousness criterion hospitalization). On 09-Apr-2021, the patient experienced DECREASED APPETITE (Was not eating) (seriousness criterion hospitalization). On 31-Mar-2021, ASTHENIA (weak/he could hardily make it to the grocery store door back to the car without total exhaustion) had resolved. The patient died on 15-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PANCYTOPENIA (Pancytopenia), HAEMATURIA (Hematuria), DECREASED APPETITE (Was not eating) and FATIGUE (became extremely fatigue/ not improving extreme fatigue/he could hardily make it to the grocery store door back to the car without total exhaustion) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Full blood count: low (Low) lowplatelets, low wbc and low hemoglobin. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable as the patient passed away.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, this patient's advanced age and underlying medical conditions (Atrial fibrillation and heart failure) remains a confounder. Further information can't be requested.; Reported Cause(s) of Death: Unknown cause of death

May 24, 2021 at bedtime I noticed I could not swallow my evening meds correctly, my wife noticed my left eye and mouth were drooping May 25, 2021 admitted to Hospital, underwent many tests and it was determined that I had suffered a minor ischemic stroke May 26, 2021 discharged from hospital