Moderna

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.

9:30 client became lethargic, diaphoretic, pale and taken via w/c to triage area. Oriented x 4 - drowsy. States the symptoms occurred immediately, that he felt too warm, felt clammy and light headed. States he has problems with claustrophobia. Cooled area by opening doors, patient removed layers of shirts. EMT personal at vaccine site in attendance. BP 136/78; HR 79; O2 sat 99% on r/a. 9:32 EMS activated 9:36 EMS cancelled per patient request. 9:50 states he feels much better and wants to leave, ambulated down hall and turned back stating he still felt lightheaded. Sat back in chair. States he last ate last night. provided juice. declined cookies. 10:00 States he feels much better, trial ambulation tolerated will without lightheadedness, gait steady. Left with wife to personal vehicle.

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

Pain in left shoulder, Sleeping for hours, Out of control shakes and chills, Hot face. High blood pressure, Temp 98.2

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

Mild Chest Pain Worse With Deep Breath/chest pain got worse; Felt warm and his temperature was 100 F; Now I have A-Fib; A spontaneous report was received from a consumer concerning a male 76-year-old patient, who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pain, fever, and atrial fibrillation. The patient's medical history, as provided by the reporter, included coronary artery disease. Concomitant medications included carvedilol. On 30 Dec 2020, the patient received their first of two planned doses of mRNA-1273 in the right deltoid for prophylaxis of COVID-19 infection. On 31 Dec 2020, the patient experienced chest pain that got worse when he took a deep breath. He also felt warm, and his temperature was 100 degrees Fahrenheit. The patient visited the emergency room where an electrocardiogram (EKG) was normal and his COVID-19 test were negative. Because of his history of coronary artery disease, he stayed in the hospital overnight. On 01 Jan 2021, the hospital cardiologist called it a reaction the vaccine, and he was discharged. On 05 Jan 2021, on a follow-up visit with another cardiologist, another EKG was performed, and the patient was diagnosed with atrial fibrillation. The cardiologist increased his carvedilol dose to 6.25 milligram from 3.125 milligram and added apixaban, 5 milligram, twice daily. At the time of the report, he felt fine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, chest pain and fever, was considered recovered/resolved on 01 Jan 2021. The outcome of the event, atrial fibrillation, was considered recovering/resolving.; Reporter's Comments: This case concerns a 76-year-old male patient with medical history of coronary artery disease, who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of chest pain and atrial fibrillation and the non-serious listed event of fever. Based on the current available information and temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. However, the events of chest pain and atrial fibrillation may be explained by the patient's history of coronary artery disease.

CARDIAC ARREST THAT LEAD TO DEATH - IT WAS REPORTED BY EMS THAT THE PT HAD RECEIVED THE VACCINE ABOUT 30 MINS PRIOR. HE ARRIVED HOME, BECAME SHORT OF BREATH & COLLAPSED. 911 WAS CALLED AND HE WAS TRANSPORTED VIA EMS TO HOSPITAL (16:17) WHERE HE LATER EXPIRED (23:01).

Patient received Moderna COVID vaccine on 12/30/2020 at a Pharmacy clinic where he was a resident. Nurses at the facility reported that he was responsive and showed no signs of any adverse effects until 1/2/2021 when he was observed slightly unresponsive and staring at the ceiling and trembling. He had a fever of 101F at this time. The facility ordered labs and a rapid COVID test (all of which came back normal) and started IV antibiotics. A few hours later, patient began bleeding from his eyes, nose, and mouth and was sent to the local ER. The patient refused being admitted to the ICU for possible sepsis/hemorrhage and died the following day on 1/3/2021. All healthcare professionals involved agreed that this was not likely due to the vaccine, but needed to be reported nonetheless.

The day after the vaccination, I am experiencing difficulty breathing and fast heartbeat. I'm still experiencing these effects after the 5th day.

1. OK day of innoculation 2. Next day 1/25/21, 7:30 am, Blood Pressure (BP) was 141/76. Temp 98.1, pulse 88. (note my normal temp is 95.5-96.5) 8:30 am BP dropped to 66/46, cold sweat, dizziness. Woozy, passed out, but woke when I hit the deck. 9:26 am, BP up to 85/50, 80 bps, 96.2 degrees. 10:08 am, BP 98/55, 82 pps, temp 96.1. 1:23 pm, BP 88/54, temp 96.1. 6:30 pm, BP 103/60, 82 bps. 8:19 pm, BP 156/72, 80 bps. Temp up to 100.4 degrees. 11:28 pm, BP 125/65, 68 bps, temp 98.4 degrees 1/26/2021: 5:15 am, BP 123/70, 71 bps, temp 99.7 degrees 8:14 am, BP 110/60, 64 bps, temp 97.4 8:02 pm, BP 124/70, 72 bps, temp 97.6 1/27/21: 1:06 am, BP 132/75, 62 bps, temp 97.6. 7:35 am, BP 123/75, 63 bps, temp 95.3 (back to normal range) 1/27/21

Patient stated to feel "light headed". He was brought to cot in back of facility. VS were taken: BP 176/90, R 61, R 20, O2 96%. Patient states to have high blood pressure. He stated to have eaten this morning. Denies diabetes or low blood sugar. Denies any other health conditions. Copy of medications obtained. Juice and crackers given. Patient lied down on cot for 5-10 min, ate crackers and finished juice, stated to feel better. Called wife (who was in parking lot) to pick him up. Patient was stable, walked to vehicle. He was advised to rest today, no strenuous activity. Call 911 or go to nearest hospital if severe symptoms occur such as difficulty breathing, swelling of face or throat, r fast heart rate.

After 15 minutes discomfort in Chest raising blood pressure also Numbness in lips after 6 hours and after 24 hours. Is it due to vaccine reactions

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!

I am not sure if this is a reaction but 3 weeks after the first vaccination I developed painful spots in my fingers that now have continued for 10 days and some new have developed and the old ones have changed it seems to me as a vasculitis of some kind I will see my PCP on 2/19/21 but for now I am going to skip the second dosage

App on phone and smart watch reported resting heart rate had increased 21 bpm on Feb 3. and elevated heart rate at rest of 162 bpm. Started to get up but felt dizzy. Took blood pressure with results less than 100/50 and 90 bpm heart rate. Rested for few hours and heart rate began to decrease and blood pressure started to increase. I was no longer dizzy

Patient had Covid-19 in October of 2020. He recovered. He received the vaccination on 12/30/2020 with no complaints. On 01-05-2021 it was noted to he was incontinent of urine and bilateral lower extremity edema. Lab work was completed showed acute kidney injury. He had decreased blood pressure and oxygen saturations on 01-06-2021 He was admitted to the hospital with rapid progression of symptoms and suggested multi-system failure. He had a long cardiac history. On 01-14-2021 he passed away with a diagnosis of Cardiomyopathic CHF, A.Fib contributory.

76 YO M WHO HAD JUST RECIEVED HIS FIRST COVID VACCINATION WAS IN THE OBSERVATION AREA POST-SHOT WHEN HE BEAG TO C/O OF CHEST DISCOMFORT THAT WAS DESCRIBED AS A BURNING PAIN FROM THE TOP OF THE STERNAL NOTCH TO THE XIPHOID PROCESS IN A STRIP. PT ALSO HAS RADIATION TO NECK AND IS SOB, AND SLIGHTLY SWEATY. PX DESCRIBED AS 4-5/10 AND HAD THIS PAIN FOR APPROXIMATELY 20 MINUTES BEFORE REQUESTING ASSISTANCE. NOTHING MAKES PAIN BETTER OR WORSE. PT SITTING A/O X4 IN NO OBV DISTRESS. HEENT - PERRL, NO JVD, SPEAKS IN FULL SENTENCES. CX - LS =/CLEAR, EKG ST WITHOUT ECTOPY. M-6 PERFORMED 12 LEAD AFTER PT TRANSFERRED TO THEM FOR TRANSPORT. EXTREM - PWD, GOOD PMS X4 Pt transported to ED

Potential allergic reaction - epinephrine administered PT had seizure activity at 11:45am, within 30 minutes after administration of first COVID vaccine (Moderna) Epinephrine (0.3mg) administered by provider at 11:47am PT had audible and palpable pulse, approximately 180 bpm that declined to 107 at time of arrival of the fire/ambulance department, respirations and heart rate did not cease during event PT in postictal state after seizure however able to dictate to Fire Department his name, date of birth and his last seizure which he states was "a month ago" Patient was transported to Hospital in stable condition Fire Department

Pt presents to ER with increased weakness, hypoxia, history of COPD, but not oxygen dependent., hypotension. Acute Kidney failure noted in labs, not previously diagnosed , new hyperkalemia. BP 73/39, HR 67. dopamine initiated, and switched to Levophed. Oxygen Sat 86%, requiring 10 L O2. Transferred from this critical access hospital to another Hospital. Expires later 2-13-2021

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.

bleeding from right ankle / lost a lot of blood; saw a pencil eraser/red looking spot; A spontaneous report was received from a non-healthcare professional (caregiver) concerning a 76 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and hemorrhage and erythema. Medical history included being mentally challenged. Concomitant medication included unspecified cholesterol medication, two unspecified blood pressure medications, baby aspirin, vitamin D, and lorazepam. On 04 Feb 2020, the patient received the first of their first planned doses of mRNA-1273 (lot number unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient experienced bleeding from a pencil eraser red looking spot on the right ankle, had lost a lot of blood. The bleeding had stopped and no treatment was reported. Action taken with the mRNA-1273 in response to the event was not reported. The outcome of the event of hemorrhage was considered resolved. The outcome of the event erythema was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Fever, achy all over, arm and shoulder pain, other pain consistent with joint inflammation, fatigue, headache. Concerning event was chest pain in the center and of my chest and a bit to each side.

patient was unresponsive for 2 minutes after vaccination. Reaction occurred 10 minutes after injection. Reports feeling sleepy. Difficult to arouse. Team alert was initiated. Patient's vital sign 100/55. HR 61. O2 99%. Patient then woke up and reports that he feel fine. Denies sob, chest discomfort, or difficulty breathing. He was sent to ED for further evaluation due to low BP.

Woke to pool of blood from blood blister on scrotum. Bleeding stop with direct pressure. NEVER had blood blisters, especially on my scrotum. Remembered that Nurse questioned me about "blood thinning medication". I said "No, just a baby aspirin (81mg)", she gave me a questioning look and vaccinated me. I have stopped the baby aspirin and the blood blisters are fading slowly.

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.

Temperature was mid-40s. I was wearing gloves (not heavy) and had an episode of Reynaud phenomenon in my R index finger. The distal phalanx was white, cold and painful for about half an hour. It resolved spontaneously. I had never had a previous episode, and it has not recurred since then.

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.

Have had muscle pain in left arm since 3 days after shot. Second shot on February 10 in right arm. Have had muscle pain in right arm since three days after shot. Muscle pain in both arms continues. Have had elevated blood pressure coincident with the first shot. Am being evaluated by my doctor for high blood pressure currently, although I suspect it is being caused by Covid vaccination. Keeping BP record.

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

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

ITP, platelet count 1 on 3/5/21 (has petechia, purpura in mouth, and right sided nose bleed). Admitted for steroid therapy.

Feeling cold weak fatigue very slow gate tired sleepy beginning 5 days after vaccination with moderate improvement in next two weeks with above symptoms, but repeated drops in blood pressure starting around day 8 and persisting to present with episodes of a fib episodes 2 days later and brief leading to present prolonged episodes of irregular beats and prolonged a fib.

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

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

Near syncopal episode after COVID19 vaccination. On direct questioning patient does not recall the episode, he does remember receiving the vaccination, but has no recall of later events. Patient was being observed after administration of COVID19 vaccination, and while being observed, he became less responsive, and he was noted with a decrease in his heart rate, and decreased strength of pulsations, a rapid response was initiated and he was transported to the Emergency Department (ED).

The patient transferred from Hospital's COVID-19 Vaccine Clinic to Emergency Department and evaluated by the provider for near syncope event post vaccination.

3 - 4 hours after dose ( Dose approx 1030 am reaction 2-230 pm) Light headed then dizzy blood pressure dropped to As low as 85 over 48 then appeared to have a small seizure and passed out. He recovered before ambulance arrived and blood pressure returned to 112 over 68. Then higher when EMT took it after arrival. Today (1day later) he has a bit of a sore neck and is still a little tired. Blood pressure 133 over 70 which is slightly higher than is normal.

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.

Fever, chills, very tired, extensive redness and swelling at injection site, large fluctuations in blood pressure and heart rate for at least a week, requiring hospitalization

My husband received the first injection on Feb 3, 2021 he developed a cough afterwards, cough would come and go. He was scheduled to receive 2nd dose on March 11 and I was concerned about having a cough at the time of 2nd vaccine. He went to walk-in clinic and got a covid test was negative, he said his exam was normal, they gave him prescription of Benzonatate 100mg he took one and it did not help so he never took any more. On March 5 while working in the yard he collapsed, paramedics arrived and he was in cardiac arrest, they started CPR, they used AED was in vfib, he was taken to Hospital then transferred to second hospital. I was told he had blood clots in both lungs, one in his leg, and possible clots in the mesenteric area of abdomen. His heart stopped due to the blood clots in his lungs. He remains in the hospital in the Intermediate Coronary Care Unit. He has not yet gained full consciousness.

Patient developed shortness of breath upon exertion on 2/16/21 after receiving his second COVID vaccine on 2/12/21. He had an office visit on 3/3/21 with his PCP where he was found to have an elevated d-dimer. He was sent to the ED for a CT-scan that confirmed an acute bilateral pulmonary embolism with large burden of thrombus within the right lung. He was admitted from 3/3 to 3/11. He underwent a pulmonary arterial embolism on 3/5. He was also on a heparin drip while inpatient. He was discharged on Eliquis.

Significant muscle pain starting in the upper right chest and then migrating to the left side about day 4. Sharp, stabbing pain occurred when moving affected muscles, especially after being in lying position.

Patient states he had a fever "a day or two" after he received the 2nd Moderna vaccine. The fever reached 101.7 degree F and resolved within 24 hours. A few days after that the patient states he had a "minor stroke." Patient states the doctor told him that there was a small clot on the left side of his brain. Patient has resulting numbness of the right side of his body. Per the patient the doctor says the clot had nothing to do with the stroke. When asked if the doctor had thought that the vaccine had anything to do with either stroke or clot the patient said the doctor said he didn't think so but also kind of ignored the question.

Pain at injection site, elevated blood pressure 157/89, 18 hours after injection. Took one Losartan 25 mg as usual in morning after taking BP.

Modern COVID-19 vaccine Patient collapsed on bathroom floor 20 hours post injection. Could not get up 911 summoned and taken to ER. Given fluids and Tylenol for excess immunologic response. Loss of fluids excessive about 12 hours post injection. Loss of taste 24 hours after injection. Dry cough 48 hours after injection. Long dormant herpes simplex eruption 72 hours injection. Fever continued for 48 hours after injection but controlled with tylenol.

I was diagnozed with borderline type 2 diabetes in early 2020. I test once or twice a week, and have managed to reduce my average blood sugar level from around 130 to 100. Beginning approximately 10 days after the first dose of the Moderna COVID-19 vaccine and lasting until approximately 10 days after the 2nd dose, my blood sugar average jumped to over 117. In the month since, my average blood sugar has dropped to under 98.

Symptoms: about 20 minutes after eating a headache in back of head and blood pressure drops. Some light-headiness also. After about 45 minutes the blood pressure stabilizes. Had routine Dr. appt. on 3/22 and Dr. suggested it could be an adverse effect from second dose of vaccine. Heart check was fine. It hasn't been quite as severe the last several days. Dr. said to report this to you.

No adverse symptoms at time of shots. After second Moderna shot February 23, 2021 I suffered a stroke seven day later on March 2, 2021.

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.

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

Heart Stroke; A spontaneous report was received from a consumer concerning a male patient of 76 years old, who received Moderna's COVID-19 vaccine(mRNA-1273) and experienced heart stroke. The patients medical history was not provided.No relevant Concomitant medications were reported. On 18 Feb 2021,prior to the onset of events, the patient received their first of two planned dose of mRNA-1273(Lot number: 006M20A) vaccine intramuscularly in the right dominant arm for prophylaxis of COVID-19 infection. On 02 Mar 2021,patient experienced stroke. The event was also considered to be medically significant. Treatment for the event included Blood Thinners. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The event of heart stroke was considered resolved on 02 Mar 2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.

Patient developed chest pain at 0500 on 3/26. He took 3 doses of Nitro without relief, mildly diaphoretic, left scapula pain. Emergency responders were called. EMTs performed EKG in ambulance and reported AFib. He arrived at hospital, and symptoms resolved prior to exam. EKG, Troponin checked twice, and patient discharge to home with recommendation to return if symptoms recur and to f/u with Cardiology.

Cardiology provider wanted to report that patient experienced an acute CHF exacerbation within 1-3 weeks after vaccine administration. Admitted to hospital for IV diureses.

Itching after 30 minutes. Full body hives after 45 minutes. Facial swelling and itching. Racing heartbeat. Took Tylenol at the one hour mark. The hives itching lessened after three hours. The facial swelling and under skin full body itching, extreme tinnitus and racing heart lasted at least 10 days. Two blood pressure readings during the first week confirmed higher blood pressure. Everything was normal after 14 days. My allergist recommended not taking the 2nd Moderna shot. I am now seeking his guidance on getting the J&J shot - hopefully a test on whether I can tolerate its polysorbate.

hard to understand when speaking; hiccups; sore throat; diagnosed with stroke; dizziness, dizziness continued to get worse, not spinning, but quickly moving from side to side; feeling cold; A spontaneous report was received from a consumer concerning a 76 year old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination and experienced a stroke (Cerebrovascular accident),, dizziness, dizziness continued to get worse, not spinning, but quickly moving from side to side/ Dizziness , hard to understand when speaking/ Speech disorder, hiccups, sore throat (Oropharyngeal pain) and feeling cold (Feeling cold). The patient's past medical history not provided. Concomitant product use was not provided by the reporter. On 06 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: unknown) via intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 07 Mar 2021, the patient experienced feeling cold which lasted for 48 hours. On 08 Mar 2021, the patient started experiencing dizziness, the dizziness continued to get worse until 13 Mar 2021 when it was described as not spinning, but quickly moving from side to side, and patient was taken to the emergency room. On 14 Mar 2021, the patient was diagnosed with a stroke, was extremely hard to understand when speaking, had hiccups and sore throat. The patient had been in the hospital since 14 Mar 2021. The action taken with mRNA-1273 in response to the events was unknown. The outcome of feeling cold was recovered on 09 Mar 2021. The outcome of stroke, hiccups and sore throat, hard to understand when speaking, dizziness was unknown at the time of this report.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

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.

COVID arm bullseye; Arm was red and swollen; Arm was red and swollen; His arm started itching; Oxygen level dropped; Little aching and fatigued; A rash on the same arm as his injection; Little aching and fatigued; 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 the following: little aching and fatigued (fatigue/pain), drop in oxygen levels(hypoxia), his arm started itching (pruritis),arm was red and swollen (erythema/peripheral swelling), rash on the same arm as injection (rash), and COVID arm bullseye (vaccination site reaction). The patient's medical history was not provided. Concomitant medications reported were metoprolol. On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient felt fatigued and a little aching after receiving the vaccine. The patient's oxygen levels were being monitored and had dropped from an average of 95 to 90-91. On 2 Feb 2021, the patient's arm started itching. By 3 Feb 2021, the patient's arm was red and swollen. On 4 Feb 2021, the patient developed the "COVID arm bullseye" that appeared to be swollen, hot and spreading down towards the elbow. On 9 Feb 2021, the COVID arm bullseye was bigger than a baseball, was starting to fade in color , but had spread further almost to the elbow. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, little aching and fatigued, drop in oxygen levels, arm started itching, arm was red and swollen, rash on the same arm as injection, and COVID arm bullseye, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

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

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

Sick; Cough; Chest pressure; A spontaneous report was received from a consumer concerning a 76- year old male patient, who received the first dose of the Moderna's COVID-19 vaccine (mRNA-1273) and experienced chest pressure/ chest discomfort, sick/ vaccination complication and cough. The patient's medical history was not provided. Concomitant medications included acetylsalicylic acid, vitamin d nos, famotidine, isosorbide mononitrate, levothyroxine, metoprolol, ascorbic acid, calcium, minerals nos, retinol, tocopheryl acetate, vitamin b nos, vitamins nos, zinc, fish oil, pantoprazole and simvastatin for unknown indication. On 13 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number: unknown) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, same day of receiving vaccine, the patient fell sick, has chest pressure and was taken to emergency room by ambulance on 19 Feb 2021. He is coughing and took cough medications that will not relief his cough. He was discharged 2 days later, on 21 Feb 2021. Treatment medication included Promethazine and Codeine 5mg: takes 5ml q6H, Benzonatate 100mg TID. 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.

24 hours after injection, i had lab work done. i received a call about the platelet level of 92 which is extremely low for me. they suggested I report this adverse event.

cardiac arrest Narrative: Patient received dose 2 series of Moderna COVID-19 vaccine. First dose was received on 1/17/21 and second dose received 2/14/21. After both doses patient was observed for 15 minutes and did not have any adverse reaction per administering RN. No data in database or database as to any other adverse events occurring 15 minutes post-vaccination. On 3/20/21, EMS was called to patient's home who was discovered on the floor with an unknown breathing status and pulse. AED was attached to the patient. A very weak pulse was found and patient had agonal respirations. Cardiac monitor was attached to patient with a HR of 32. 1mg of atropine was administered and patient's rhythm changed to PEA with no respirations or pulse. Per patient's wife and son, he was a DNR, therefore all resuscitation attempts were stopped (patient was never admitted to the hospital). Patient was never known to be previously positive to COVID. PMH that may have predisposed patient to this adverse event leading to death include h/o DVT on chronic anticoagulation, COPD, and abdominal aortic aneurysm. There is insufficient information to determine the exact cause of death or what led to the cardiac arrest given that the time from last vaccination to the adverse event was almost a month apart.

PATIENT WAS TIRED AND SORE AT SIGHT OF SHOT A COUPLE OF DAYS AFTER SHOT HE WAS DEHYDRATED AND HAD LOW BLOOD PRESSURE SO WEAK HE COULDN'T STAND NOT LIKE HIM AT ALL HE USUALLY IS VERY OUTGOING. CALLED 911 RUSHED TO HOSPITAL. ALL TESTS WERE TAKEN EVERYTHING IS NEGATIVE. SENT TO A REHAB FACILITY AT ADMISSIONS HAD TROULE BREATHING CALLED 911 BACK TO HOSPITAL. ADMITTED INTO ICU SAID HE HAS SWELLING ON THE BRAIN RAN EVERY TEST POSSIBLE NEGATIVE FOR EVERYTHING. DOCTOR HAS TREATED HIM FOR ANYTHING HE THINKS COULD BE WRONG. DISCHARGED TO A LONG TERM ACUTE CARE TO SEE IF ANY IMPROVEMENT FOR 25 DAYS. NO DIAGNOSIS OF WHY THIS IS HAPPENING. ONLY THING THAT MAKES SENSE IS THAT EFFECTS OF VACCINE.

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

Moderna COVID?19 Vaccine EUA After getting the 2nd Moderna COVID shot, the patient was ok for about 10-11 days. Then, suddenly on March 25, he started showing high levels of dizziness and increasing blood pressure. We didn't think much of it and thought it was fatigue and asked him to rest. But, by April 2nd, his blod pressure was around 200/110. We rushed to ER. They conducted all the necessary tests and released him with his blood pressure holding around 170/100 asking him to go to a general practitioner. Then, on Monday we visited Dr. who recommended we wait for 2 weeks to see if the effects will dissipate to determine if it is neurological or if it is vaccine effect. It has been a very very slow dissipation of the side effects. He still has to walk very carefully and feels dizzy all the time. The impact has diminished about 20-25% in about 10 days but 6 weeks after his vaccine, he is still in trouble and is worried.

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

death Narrative: Patient received Moderna COVID #1 vaccine on 1/28/21. On 2/3/21, he was admitted to a facility for fever, weakness, chills and rigor. Noted history of B cell lymphoma not on chemotherapy at the time. He also had reports of productive cough with thick brown/green sputum. He was admitted to the hospital and given 1 round of methotrexate and Rituxan. Hospital course was complicated with bacteremia (given vancomycin and cefepime), A fib, AKI, HTN, neutropenia (received Neupogen), acute popliteal VT (unable to anticoagulated due to thrombocytopenia - platelets as low as 20). No bleeding issues noted. On 2/18/21, family opted to change his status to DNR with hospice/comfort care and he passed on 2/19/21. No autopsy results available. 22 days from date of vaccine to date of death.

death Narrative: Patient received Moderna covid vaccine #1 on 1/22/21 and #2 on 2/24/21. On 3/4/21, he was admitted to a facility for shortness of breath x 1 week. Upon admission, he was found to be in heart block and was admitted to the ICU and placed on pressors. He did have a negative COVID PCR test on 3/4/21. He has a noted history of COPD, CHF and OSA. On 3/6/21, he underwent a new pacemaker placement. His course was complicated by the development of AKI, paroxysmal V tach and new aflutter and was initiated on apixaban. He was discharged on 3/18/21. No further records available and a date of death was recorded as 4/3/21. No autopsy results available. 38 days from time of second vaccine to date of death.

respiratory and cardiac arrest Narrative: Patient with PMH of esophageal cancer, larynx cancer, liver cancer, PTSD, A. fib, and alcohol abuse. He received his COVID-19 vaccines on 2/14/21 and 3/14/21. Both vaccines were administered without complications and patient was observed for 15 minutes post-vaccination without adverse effects. No other adverse events noted between time of last COVID-19 vaccinations and death. On 4/11/21, patient's wife called 911 in which EMS found patient unresponsive with abnormal breathing. Wife reported that patient was breathing up until 5 minutes prior to EMA arrival, but had been unresponsive. Wife reports that patient suffered from multiple forms of cancer, PTSD, and alcohol abuse. Wife believed that patient quit smoking and drinking but the morning of death found vodka and cigarettes in his coat. Wife reports that patient asked for help getting up from the stairs and then laid down in the bed, and went unresponsive afterwards. EMS attempted to revive the patient with CPR but were unsuccessful. Per EMS note patient suffered from respiratory arrest, cardiac arrest, then cardiac death. Patient was not brought to the hospital prior to death. It is very unlikely that the COVID-19 vaccinations contributed to this patient's death due to his extensive PMH with substance use disorder and cancer.

Leg swelling and discomfort. Saw primary care provider who thought this was varicose veins and referred to vascular surgery. Venous duplex revealed DVT involving left leg. Patient treated with at least six months of apixaban.

Stroke; Can not talk; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and APHASIA (Can not talk) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization) and APHASIA (Can not talk) (seriousness criterion hospitalization). The patient was hospitalized on 23-Mar-2021 due to APHASIA and CEREBROVASCULAR ACCIDENT. On 13-Apr-2021, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. At the time of the report, APHASIA (Can not talk) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The wife reported on behalf of her husband. On 13 Apr 2021, the patient was transported to another facility by ambulance. The wife had no information about the lot numbers and was not even and was not sure about the date of first vaccine however, she did mention it could be 03 Mar 21. No concomitant medications were reported. Treatment information was not reported.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded

stroke; trouble walking; Difficulty getting out of bed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant). On 19-Feb-2021, the patient experienced MOVEMENT DISORDER (Difficulty getting out of bed). On an unknown date, the patient experienced GAIT DISTURBANCE (trouble walking). The patient was hospitalized for 3 days due to CEREBROVASCULAR ACCIDENT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident; Rehabilitation therapy for Movement disorder and Rehabilitation therapy for Gait disturbance. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), MOVEMENT DISORDER (Difficulty getting out of bed) and GAIT DISTURBANCE (trouble walking) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: unknown unknown. In 2021, Magnetic resonance imaging: abnormal Abnormal. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The patient got worse so was sent for MRI was done and showed something. The patient stated the stroke has affected his right side and has trouble walking. He was in the hospital for 3 days. He then went back for rehab hospital and there for about a week. He is now home and doing out patient rehab. No concomitant medications were reported. Company comment: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded

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

pt states his right leg had pain and tightness from the inner thigh to the knee. It was painful to touch. Pt went to his PCP Dr. on 2/22/2021. He had blood work and ordered a sonogram for legs to check for blood clot. He was told to use a topical cream Voltaren which did not help. The sonogram showed that he had multiple blood clots on this inside of this leg down to his calf and was prescribed Xarelto. The blood clots disappeared after a couple of weeks.

1207 heart racing BP 164/88, HR 104, Resp 18, Sats 97%. Laid on cot in tx area 1217 BP 151/84, HR 84, Resp 18 Symptoms improved 1227 symptoms resolved, sat in chair BP 150/80, HR 80, sats 98, Resp 17. 1232Left ambulating with daughter for home.

Moderna COVID-19 Vaccine EUA. The vaccine activated a latent Chronic Myelo Monocyte Leukemia (CMML) The evening of the vaccine I became very fatigued and was freezing. (A topcoat was donned and I went to bed early. ) By day three the freezing dissipated; however, the fatigue di not. After three weeks of fatigue my physician ordered several blood analyses. High monocytes counts (4.0) and low Platelet counts (105) were revealed. I was referred to a hematologist who ordered a bone marrow biopsy. It revealed CMML 1. A A review of 18 years of monocyte and platelet showed the monocyte counts were hovering at the maximum and platelet counts hovering at the minimum until 03/29/2021 when they escalated to the counts reported above.

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

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

04/2021 Seen in ED for c/o left sided chest pain increased with deep inspiration. Blood work, chest a-ray and chest CT. DX with 2 blood clots left lung and pneumonia. COVID test done - Negative. Admitted to hospital and anticoagulated with Heparin. Numerous blood tests performed. Followed by Hospitalist and seen by Pulmonologist and Hematologist.

He received the vaccine and had a heart attack on May 3, 2021 and passed away on May 4th. They did an full autopsy

A week after receiving vaccine on May 22nd, patient says rash appeared at injection site for a couple hours and disappeared by noon. On the 23rd of May, the same thing happened, rash appeared in the morning and disappeared by noon. He also says whenever he takes a deep breath or presses on his chest, the place where he had a stent inserted over 20 years ago aches. He is seeing his cardiologist on 6/11/21 and will mention the chest pain also

rom: To: Cc: Subject: Patient Concerns Date: May 29, 2021 6:42 PM Dear Sir/Madam, I would have liked to include her in this message but am not in possession of her official email address. To recap the encounter on April 29, 2021 : I went with my friend to the clinic,where we spent 12 most frustrating hours I expressedly told the staff with my friend present, that I have been an extremely healthy individual, who has never seen a doctor,/ER/hospital in over 40+ years. I am happy to give you my previous employers contact info to verify that I never missed a day`s work. I told the staff I suddenly fell very ill 2 days ago 2-3 weeks after my 2nd CVID 19 vaccination. with sudden massive bilateral leg edema up to the groin and extensive lower leg blood staining and mottling of my skin. The attending dr just called it Pedal Edema. He was not interested in my history (present and past), no examination, had to remove no clothes. My friend and later neighbors in the community where flabbergasted that he did not see the state of my legs. Obvious other symptoms such as abdominopelvic ascites was also present. Further tests were done and inexplicably suddenly pulmonary atelectasis and cirrhosis of the liver become important. Could that really make me so sick in two days? Absolutely incomprehensible. there was an avalanche/cascade of blood destruction with destruction of RBCs, hemolysis, loss of platelets, obvious very high total bilirubin, hypoalbuminemia and ascites. My bed sheets still show numerous blood stains where I bled from many of the skin lesions and scabs Those were all results due to one common denominator:: reaction to COVID vaccination. Forget about pulm atelectasis or liver cirrhosis making me so sick in 2 days i AM INTERESTED TO SEE YOUR EXPLANATION A quick comment for her and her comment about compassion, She is probably unaware, that are quite a few nations in this world, where medical colleagues do not charge their colleagues/family and the pastor/family of their church, I lived/worked for a for a few years in another country. One night I was called to drive into one of the park's camps to attend to a colleagues wife who had an incomplete miscarriage and bleeding, This was quite a drive through the night back to the hospital, doing a D&C and the couple could happily continue their journey that afternoon. No charge by the hospital or me. That is compassion. Dr.

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

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

On the 9th, my father suddenly froze while standing up by thekitchen sink and stopped talking. He looked as if he was losing consciousness and couldn't talk and wouldn't drink. He suddenly collapsed into my arms after i ran to get a chair so he wouldn't fall on the floor. He could barely Sir in the chair himself. He got up and tried to walk but collapsed into the chair that i had dragged over to his new spot. He say and suddenly began to faint and seemed to be dying. I called 911 and the paramedics arrived and took his vitals and said he was fine now. By the time they'd arrived, he was up and alert and able to walk and talk. This was extremely scary as i truly though my father was dying. He had the first dose in May and also had a reaction. His lips blew up to a very large size. I didn't agree that he should have taken the 1st nor 2nd dose.

Initially - chest pain 10 on 1-10 scale, heart rate 145 BPM, headaches, paramedics said A-fib abnormal heart rhythm, converted as they were checking; went to ER, admitted patient, stayed 5/24-5/27, gave tests including cardiac catheterization, echocardiograms, C-T scans of chest & head - all negative. In ER also found elevated cardiac protein-enzyme. Also in ER, chest pain reduced to 3 on 1-10 scale. Repeated some of the tests next day.

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.

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

Patient found in respiratory arrest at 4:20am on 6/19/21. CPR initiated and continued by EMS, along with IV fluids and intubation, remained in asystole throughout course of CPR. CPR terminated by EMS.

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

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

Achy and felt tired, so went to bed early. When patient stepped out of bed, he fainted twice within a short period of time. He was found on the floor by wife at one point and had passed out. He then fell down and passed out on the way back to bed. Patient took some Tylenol before bed. When patient awoke the next morning, no other issues occurred.

'lost feeling of the left side'; still has some shingles; laid on his floor and went to sleep/passed out for 2 hours; got a stroke within 9 hours; got really tired; a small clot in the right side; lost feeling of the left side, couldn't walk, and couldn't do anything; lost control of his bladder/urinated in his pants; left arm went numb; the muscle was sore for about a week; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours), LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours), THROMBOSIS (a small clot in the right side) and HEMIPARESIS ('lost feeling of the left side') in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Injury, Back surgery, Gallbladder operation, Heart valve replacement and Heart valve disorders. Concomitant products included METHYLSULFONYLMETHANE (MSM 1000) for Joint disorder, CHONDROITIN SULFATE SODIUM, GELATINE HYDROLYSATE, GLUCOSAMINE SULFATE, HYALURONIC ACID (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE SODIUM;GELATINE HYDROLYSATE;GLUCOSAMINE SULFATE;HYALURONIC ACID]), CALCIUM, ZINC, COQ10 [ASCORBIC ACID;BETACAROTENE;CUPRIC OXIDE;MANGANESE SULFATE;SELENIUM;TOCOPHERYL ACETATE;UBIDECARENONE;ZINC OXIDE], COLECALCIFEROL (VITAMIN D3), LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL), VITAMIN E NOS, VITAMIN C [ASCORBIC ACID], MULTIVITAMIN [ASCORBIC ACID;CALCIUM PANTOTHENATE;COLECALCIFEROL;CYANOCOBALAMIN;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE] and FISH OIL (FISH OIL OMEGA 3) for an unknown indication. On 10-Jun-2021 at 5:00 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced HYPOAESTHESIA (left arm went numb) and MYALGIA (the muscle was sore for about a week). On 11-Jun-2021, the patient experienced THROMBOSIS (a small clot in the right side) (seriousness criterion medically significant), GAIT INABILITY (lost feeling of the left side, couldn't walk, and couldn't do anything), URINARY INCONTINENCE (lost control of his bladder/urinated in his pants) and FATIGUE (got really tired). On 11-Jun-2021 at 2:00 AM, the patient experienced CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours) (seriousness criterion medically significant). On 11-Jun-2021 at 3:00 AM, the patient experienced LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours) (seriousness criterion medically significant). On 22-Jun-2021, the patient experienced HERPES ZOSTER (still has some shingles). On an unknown date, the patient experienced HEMIPARESIS ('lost feeling of the left side') (seriousness criterion medically significant). The patient was treated with GABAPENTIN at a dose of 100 mg three times a day and LORAZEPAM at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (got a stroke within 9 hours), LOSS OF CONSCIOUSNESS (laid on his floor and went to sleep/passed out for 2 hours), THROMBOSIS (a small clot in the right side), HEMIPARESIS ('lost feeling of the left side'), HERPES ZOSTER (still has some shingles), GAIT INABILITY (lost feeling of the left side, couldn't walk, and couldn't do anything), URINARY INCONTINENCE (lost control of his bladder/urinated in his pants), HYPOAESTHESIA (left arm went numb), MYALGIA (the muscle was sore for about a week) and FATIGUE (got really tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: didn't find anything wrong (Inconclusive) didn't find anything wrong and patient mentioned the small clot in the right side.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 72 hours after receiving the first dose of the Moderna COVID-19 vaccine, the patient got shingles. He still had some shingles, and stated "it is leaving but still numbness in a belt from the stomach center to the back of the left side, front side is well, and back is numb". He was taking Gabapentin 100 mg three times a day for the shingles, which was the only prescription medication he was currently taking then. He was also prescribed pain medicine for the shingles which he no longer took as the pain had left. One of the pain medications is lorazepam. The patient received the second dose, and he stated his left arm went numb. The injection was in the top part of the shoulder, and it did not hurt up there, but the muscle was sore for about a week. In addition, the patient stated he "got a stroke within 9 hours" at 2AM on 11 Jun 2021 and lost feeling of the left side, couldn't walk, and couldn't do anything. He went to the bathroom and lost control of his bladder. He urinated in his pants and got really tired, so he laid on his floor and went to sleep at 3AM. He also described this as "passed out for 2 hours". At 5AM in the morning, he woke up and was fine. He went to the doctor on 18 Jun 2021, who told him that he had a TIS or a small stroke. The MRI didn't find anything wrong, and patient mentioned the small clot in the right side. He was never hospitalized. Prior medical history included spine injury, 2 back surgeries, gallbladder surgery, an artificial valve in his heart, and a clogged aortic valve in the patient's heart. He has taken vitamins and supplements daily for the past 20 years. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-231546 (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.

Patient died 5 days after receiving the covid vaccine of a heart attack or a blood clot that stop the heart

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

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.

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.

heart arrhythmia; It has been more than 36 days and the patient has not received the second dose; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of ARRHYTHMIA (heart arrhythmia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced ARRHYTHMIA (heart arrhythmia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 days and the patient has not received the second dose). The patient was hospitalized on 12-Mar-2021 due to ARRHYTHMIA. At the time of the report, ARRHYTHMIA (heart arrhythmia) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been more than 36 days and the patient has not received the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided. Treatment medication was not reported. This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 031M120A) with associated SAE reported as arrhythmia after the first dose of the vaccine.; Sender's Comments: This report refers to a case of inappropriate schedule of vaccine administered for mRNA-1273 (lot # 031M120A) with associated SAE reported as arrhythmia after the first dose of the vaccine.

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

3 or 4 days after shot he started getting a cough which caused chest pains, he started getting a tingling feeling in his right leg, heart rate went up and oxygen level dropped

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.

Narrative: Patient with severe aphasia and only able to say "hey, hey, hey" or "uh huh" or shake his head no as a way to communicate. Patient previously able to ambulate with significant limp and hyperextension of right knee, but mostly wheelchair bound over last several years as he had had a slow and steady decline in overall health and mobility. Patient developed aggressive behavior of shouting "hey" and grabbing of groin in 2016. This was worked up with CT scans, labs, referral to urology, neurology, and referrals to psychiatry. The exact etiology of this action was never able to be affirmed, but thought to be more psychiatrically related. It improved significantly with addition of antipsychotics, worsened when antipsychotics were reduced, and improved again with addition of injectable antipsychotic on 12-10-2020.Patient suffered from falls on occasion given his significantly impaired physical mobility. His last documented fall was 8-31-2019. Patient began utilizing wheelchair most of time following that fall. No significant injuries noted in documentation of the falls. In the last 3 months, patient would often refuse medications. He would sometimes indicate that they would cause dizziness, and other times he would simply refuse. We attempted to hide medications in his food/fluid (with wife's blessing) and when he detected this he would occasionally refuse to eat. Patient previously on DOAC. After pharmacy review in 12/2020 it was recommended to discontinue this as no clear indication to continue use. He was high fall risk and would often refuse this medication as well since 10/2020. Noted to be in NSR on EKGs and decision made to discontinue the DOAC. Patient had no evidence of adverse effects noted after vaccination on December 28th. Patient seen by provider on the morning of his death (1/4/2021) with no noticeable significant change in health condition. Temperature 36.8Con January 4th at 19:45. During routine bedtime cares, patient suddenly collapsed and death was pronounced January 4, 2021 at 20:05. Autopsy was requested from next of kin and no autopsy was granted. Symptoms: & DEATH Treatment:

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

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

APPROX 7 DAYS AFTER THE SHOT I EXPERIENCED VERY LOW BLOOD PRESSURE (92/71) HB OF 160 AND LATER TEST 96/80 HB OF 167

Flu-like symptoms, full body aches, short episodes of afib. I had a cardiac ablation over 10 years ago for afib and take flecainide as a prophylactic. Normally I don't not have any afib and haven't had an episode in several years.

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 1/23/2021, one day after receiving the mentioned vaccination, I was working as a volunteer and at about 11;30 am I became very dizzy and nearly passed out. a passerby helped me to a seat, a coworker brought me water, and called security for assistance, An EMT came and checked my vitals, gave me a small package of raw honey, and checked my blood sugar. Everything checked out ok, except my blood sugar was slightly low. I quickly soon felt better, and resumed my volunteer shift. I don't know if the vaccine was related to this incident, but felt it best to report it to you.

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 .

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

Pt complained of dizziness within 15 minutes of receiving Moderna COVID vaccine. Vitals were taken, pulse was in the 40's, pt alert and oriented, soda given to see if blood sugar dropped. Continued to monitor, pulse remained low and pt continued to complain of feeling dizzy. 911 was notified and EMS arrived by 12:35pm. EKG strip performed, along with vials from the EMT in the health department. Positive orthostatic hypotension found by paramedic. EMS notified ER doctor on call for recommendations. ER doctor said vitals were consistent with dehydration and could be admitted for IV fluids or return home and encouraged to increase fluids. Wife and pt declined ambulance ride and request to return home.

Severe difficulty breathing; Blood pressure shot up to 200; Troponin level jumped up; A spontaneous report was received from a non-health professional concerning a 77-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe difficulty breathing and that his troponin level and blood pressure (BP) had shot up. The patient's medical history included chronic obstructive pulmonary disease (COPD). Concomitant product use was not provided by the reporter. On 09 Jan 2021, at approximately 14:42, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09 Jan 2021 at 20:30, the patient experienced severe difficulty breathing and his BP shot up to 200. The patient went to the hospital and they found his troponin levels had jumped up. The patient reported no known heart issues. On 12 Jan 2021, he went to see his primary care physician (PCP). No treatment information for the event was provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, severe difficulty breathing and troponin level and blood pressure (BP) had shot up, were unknown.; Reporter's Comments: This case concerns a 77-year-old, male patient, with medical history of chronic obstructive pulmonary disease (COPD), who experienced a serious, unexpected event of dyspnoea, hypertension and raised troponin level. The event occurred 5 hours 48 min after the first dose of mRNA-1273 (Lot number: 039K20A). Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.

possible M/I chest pain Narrative: On 1/29/20 patient taken to local hospital via ems then was transferred to second hospital to rule M/I

Shortness of Breath, decreased oxygen saturation, irregular heart rhythm, hypertension, Positive for COVID, bilateral pneumonia

First, immediately after receiving the vaccine, I cycled 25 miles. Almost immediatly thereafter, my arm got very sore, I had a dull headache, my resting pulse went up about 20 bpm, and my blood pressure dropped from about 120/70 to 102/60. I felt "rough". I played couch potato for the rest of th eday, and was fine the next morning.

Cardiac arrest of unknown etiology. Sudden collapse with PEA requiring CPR and intubation. Now has severe anoxic encephalopathy and expect death.

CARDIAC ARREST, DEATH Narrative: The patient presents to the emergency department in cardiopulmonary arrest. CPR was continued upon arrival. The Combi tube was removed and an endotracheal tube was placed without complications. ROSC was obtained multiple times but the patient continued to go into PEA. The patient was seen in the emergency department by both critical care and Cardiology. EKG shows ST elevations, but the patient was unstable to go to catheterization. The patient had 1 episode of asystole. Despite best efforts and multiple attempts we were unable to resuscitate the patient. Time of death 1253 on 1/24/21.

PATIENT WAS IN CLINIC FOR 1ST CLINIC. WAS DISCHARGED BEFORE OUR 2ND CLINIC. HE CAME BACK TO OBTAIN HIS 2ND SHOT. WE WENT OUT TO THE CAR GAVE SHOT. THE NEXT DAY TO MY KNOWLEDGE, HE STARTED CODING AT HOME. AMBULANCE WAS CALLED AND HE CONTINUED TO CODE. THE AMBULANCE CREW TRIED CPR FOR 30 MINS WITH NO LUCK. PATIENT PASSED 2-3-21.

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

Post Covid vaccination patient appeared to be starting to fall from chair. He appeared lethargic and unable to speak or hold himself upright. Vitals where taken and 2 liters Via mask administered. Increased to 4 liters after no improvement in pulse o2. wife who stated he was released from the ED yesterday and stated he needed a stent. Patient nodded that he was having substernal chest pain without radiation. four 81mg Asa given and nitro administered after verbally ordered. EMS arrived and transported patient.

Moderna vaccine. I was fine and active until bed time 2/7/21. After shower I felt clogged, I did neti pot sinus drain with warm water and hydrogen peroxide 10 to 1. Went to bed (CPAP) and woke up at 2:30AM with nose running and unable to breath through nostrils. Got up and used warm compress over eyes and nose for about three minutes and congestion partially cleared. Upon returning to bed (CPAP} I began to again build up mucous. Repeated same routine at 06:00AM except returning to bed. Immediately became congested again. Took temperature reading 97.3F. Took Temperature again at 8:AM 96.8 BP 97-168 resp 66

pt received vaccine on 2/3. early on 2/4 developed chest pain, dyspnea, and was seen in ED and diagnosed with acute exacerbation of CHF and NSTEMI type 2, and anemia. on 2/5 transfusion was started and pt developed worsening dyspnea and then PEA arrest. Pt achieved ROSC and was transferred to the cardiac intensive care unit where he required vasopressor support. he subsequently declined and died on 2/7

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.

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

Respiratory distress, seizing, cyanotic, A-Fib with RVR occurring less than 24 hours after receiving his second dose of Moderna.

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

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.

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

1/28/21 - 9 pm nasal stuffiness/congestion; 1/29/21 - 2 am low grade fever 100.2; continued symptoms of malaise, weakness and joint soreness; around 12 pm increased lethargy, weakness unable to get up from chair - needed to use wheelchair. Difficulty breathing - pulse ox 87-90%. Dipped to 85% twice. Most symptoms including SOB resolved within 6-7 hours.

Patient received the vaccine on 1/31/2021. Patient complained of bleeding 2/7/2021. Went to clinic where labs were conducted. Patient had an INR of 12. Previous INR results were normal prior to vaccination. Patient was also diagnosed with UTI and given antibiotics. Patient was encouraged to go to ER. Patient died on 2/12/2021.

The patient experienced a cardiac arrest 2 days after receiving the second dose of the Covid-19 vaccine. He later died on 2-17-2021 with complications including respiratory arrest and acute kidney failure.

Patient admitted with acute stroke, no prior history of same. Mild hyperlipidemia, but otherwise no clear risk factors for stroke. Unclear if anything to do with COVID vaccine.

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

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

Increased weakness, fell twice at home. Unable to get back into bed. Admitted to observation status at hospital for weakness for until 2/23 when transferred to skilled care. On day of admission, patient was 2 assist when normally he was independent. IV fluids D51/2 normal at 75/hr

felt like crap; became hot; left hand suddenly started jerking and left hand was having spasms; Vasovagal Syncope, Post Immunization Reaction; became cold; sweaty; sore arm; achy; A spontaneous report was received from a consumer concerning a 77-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vasovagal syncope, post immunization reaction (syncope vasovagal). The patient's medical history, as provided by the reporter, included chronic cough, acid reflux, minor allergies, hypercholesterolemia and a penicillin allergy. Concomitant product use included esomeprazole, atorvastatin, famotidine, cetirizine, Montelukast, Vitamin D, zinc, fiber pills and antacids. On 10 Feb 2021, several hours prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot #:030M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. After the injection in the evening on 10 Feb 2021, the patient reported experiencing a sore arm. During the night, he became cold, sweaty and achy. On 11 Feb 2021, the patient stated he "felt like crud" and was still achy and his left arm hurt more. The patient sat down at the table and again became "hot" and "sweaty." His left hand suddenly started jerking and having spasms, and the patient's head went back and then forward and he became unresponsive for approximately 2 to 3 minutes. After the episode, he went to a sofa chair and fell asleep for 1 to 1.5 hours. The patient's wife called a nurse at the Hospital to report the events, and the nurse suggested to take him to the emergency room (ER) immediately. At the ER, a series of tests/labs were performed including complete blood count (CBC) differential with platelets, COVID-19 test, cardiac panel-acute, comprehensive metabolic panel, electrocardiogram (EKG), and chest x-ray. All test results were normal. The patient's COVID-19 test was negative. Treatment for the event included IV fluids (sodium chloride IV). The patient was discharged from the ER 2 to 3 hours after treatment with a discharge diagnosis of "vasovagal syncope, post immunization reaction." 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 event, vasovagal syncope, post immunization reaction, was considered recovered/resolved.; Reporter's Comments: Based on the current available information which indicates a strong temporal association between the use of the product and the onset of the reported events, a causal relationship cannot be excluded.

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

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.

The coroner called Dr. on 3.2.2021 to advise that he had a witnessed collapse and Mr. was taken to the ED where he was pronounced.

1010: After receiving the Covid vaccine, the pt began c/o CP x 3 min; initially moderate "4-5" 1013: BP 132/70 HR 65 RR 16 SpO2 100% 1014: CP decreased to "3-4" 1017: CP "1-2" 1022: CP "0-1" 1025: Pt now feels "normal" 1035: Pt offered UC but declined; pt encouraged to f/u w/PCP; rec'd ER precautions; pt released home

He received the vaccine and after 2 hours he went home and was paralyzed from the waist down. He tried to stand up and then he passed out on the floor for about 10-15 minutes. He went to sleep and woke up around 5 hours later. He then tried it again and urinated on himself and he fell down on the floor, passed out without getting up until the morning. He did call his doctor who was not available, spoke to the nurse and advised to go to the hospital. He is weak and cannot drive so he did not go to the hospital. He slept the rest of that day and the following day. Then when he saw his doctor about 2 days ago, he described his reaction and told to report the reaction and that he would report it himself. He was advised not to take the 2nd vaccination. He is no longer having the heavy reaction, his muscles are aching and his vision is blurred, especially on his back and the shoulder. His doctor did do blood work at the office visit.

Patient received first dose of vaccine on 2/8/2021. Was monitored properly with no adverse reaction, but had a stroke a few hours later after leaving facility. Patient is still hospitalized.

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.

Caller reports chest pain L>R; states it feels likes its in the breast tissue, but not relieved with Tylenol Recommend caller contact PCP d/t chest pain and symptoms developing over weeks after 1st dose of vaccine. Caller denies SOB, jaw pain, N/V or any other symptoms. He will contact PCP to r/o other causes of chest pain

Spouse reported that patient had been feeling achy, tired and fevered most of day and had spent day in bed. When he got up, he fainted face down on bed. EMT arrived and rolled him over. Oxygen level was at 88, fever of 99.9. Since a diabetic, finger stick done (171) Patient given oxygen and IV fluids before transport and he started to feel better. Transported to Hospital - unknown if admitted.

He had the injection, had the sore arm and approximately 3 hours after the vaccination he began to experience severe chest pain across his entire chest and into his jaw, which was exacerbated upon taking a deep breath. He called his cardiologist who advised him to go to the ER. He was worked up, subsequently admitted from 2/8/21 to 2/11/21, a lot was ruled out but no specific diagnosis made at that time. They did note some pleural effusion and pericardial effusion at that time. Upon discharge on 2/11/21, starting Thursday evening he continued to have pain in the chest, but not as severe as when he entered into the hospital. Every evening including last night has began with severe night sweats, low grade fever and the chest pains have continued. Went to see his PCP, Cardiologist and his Electrophysiologist several days later the following after discharge, he does have a pacemaker, and was told by all three of them that he has pericarditis and that the reaction could have been related to the vaccination. It seemed more than coincidental that the symptoms did not appear until 3 hours after the vaccine. Was put on Colchicine to treat the pericarditis and then received a 2nd opinion and has reinstituted the colchicine. His low grade fever has finally dissipated. During the day he feels okay, but still continues with the chest pains and the night sweats. His hemoglobin dropped in the hospital possibly related to the heparin and then put on Eliquis postop, and now discontinued, and received an iron infusion to boost his hemoglobin. He is scheduled for another iron infusion this Wednesday. He went to see GI physician and feels that he may have a bleed due to the infusion. He has had an anastomosis due to Crohn's disease and feels that's where the bleed may have been coming from as he did have an ulceration at last colonoscopy. He did have atrial flutter due this and was advised to have an ablation, and trying to reduce the pericarditis and FU later with other heart related problems.

Patient presented to ED with complaints of severe fatigue and generalized weakness. He complains of chills as well. WBC found to be elevated. No electrolyte abnormalities found. Patient is suspected to have a urinary tract infection. Patient received ceftriaxone for UTI. Patient was admitted to the hospital.

blood pressure was high at 160/90; Injection site reddish and oval shaped; Itching around the injection site; Left eye blood covered inside; Kind of sleepy; A spontaneous report was received from a consumer who was also a 77-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported left eye blood covered inside (eye haemorrhage), feeling kind of sleepy (somnolence), itching around injection site (injection site pruritus), injection site reddish and oval shaped (injection site erythema), and high blood pressure at 160/90 (blood pressure increased). The patient's medical history was not provided. Concomitant medications included flecainide acetate and finasteride. On 29 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 004M20A) intramuscularly for prophylaxis of COVID-19 infection. On 04 Feb 2021, the patient felt kind of sleepy. On 05 Feb 2021, his left eye was covered with blood inside and he felt itchiness at the injection site. On 07 Feb 2021, the injection site became very red and was oval in shape and it was about two an half by four inches. On that same day, his blood pressure was high at 160/90. He said his normal blood pressure was 20/70. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The event of blood pressure was high at 160/90 was not resolved at the time of this report. The outcome of left eye blood covered inside, kind of sleepy, itching around injection site, and injection site reddish and oval shaped 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.

His breathing problem worsened on 02/23/2021, short of breath and tired. He died of a pulmonary embolism and heart attack in the hospital on 3/9/21 after being there for 9 days.

Blood clot running from ankle to groin; entire leg swollen; still swollen after 6 weeks; received shot of heparin and put on Xarelto; blood clot was just short of where it could break off and go to heart or lungs.

Stroke; Diabetic Ketoacidosis; A spontaneous report was received from a consumer concerning a 77-years old, male patient who experienced the events cerebrovascular accident and diabetic ketoacidosis. The patient's medical history included hypertension. Concomitant product use was not provided by the reporter. On 06 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced stroke and diabetic ketoacidosis. which caused hospitalization. On 13 Feb 2021, the patient was admitted to the hospital. On 04 Mar 2021, the patient was discharged. Treatment details was not provided. Action taken with mRNA-1273 in response to the events was not unknown. The outcome of the events cerebrovascular accident and diabetic ketoacidosis was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. However, the patient's advance age, diabetes, Hypertension, may remain contributing factor for this event.Further information has been requested

I lost vision in my right eye. The Doctor tested my eye and told me I had a eye stroke. He said he did not think it was related to the vaccine.

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.

Not sure if covid vaccine caused this, but this is what happened - Received covid vaccine. two days later had violent shakes in the night. Immediately went to get a covid test out of precaution. Tested negative for covid, but positive for "flu b". Went home to treat flu with fluids and rest. Got no better. Went to heart doctor out of precaution, full work up...everything checked out great. Went home, got no better. Went to primary care physician, full work up...found a "spot" on left lung. Was given antibiotics and steroids, go home and in a few days will be getting better. 3 days later became incapacitated and had to be rushed to ER. Was admitted into hospital for 6 days to treat "pneumonia". Also possible UTI and sepsis. Also while in hospital found out that a mini stroke had happened. Treatment went well, oxygen levels were good. Was released with glowing reports. 24 hours later at home had to be rushed to ER again after becoming incapacitated.. Was admitted again 7 more days. During this time everything took a nose dive in succession. Lungs were failing, multiple unexplained strokes were happening (while on blood thinners, had been on blood thinner 15 years...after first stroke they changed to another blood thinner...only more strokes). After so many strokes and compounding of strokes, his neuro function started failing. He was put on life support. While on life support his organs started failing. He had to be put on comfort mode and was dead within 8 hours. A perfectly healthy 77 year old man who had never been sick a day in his life (literally) got his 2nd covid shot, two days later he fell ill. From that point on his health spiraled out of control until his death on March 19th. Every doctor (pulmonologist, cardiologist, neurologist, and all attending doctors said that it was "atypical and abnormal" what was happening. It should not have happened. 180 degrees from normal.

Dad had a heart attack either on February 19th or 20th. He was found dead on the morning of February 20th.

cardia arrest Narrative: 76 yo with CAD, carotid artery stenosis, abdominal aortic aneurism, history of MI, DM. Patient was given both COVID vaccinations with the 2nd and most recent on 2/27. On 3/20, patient was admitted to an outside local emergency room with cardiac arrest and passed away at the facility. They were unsure if this had anything to do with his covid vaccinations but thought we should at least report it.

77 yo male with past medical history of diabetes, stroke, aortic valve replacement, sleep apnea and hypertension. Admitted for COVID-19 infection, chest tightness, and acute kidney injury on 2/15/21. COVID was treated with bamlanivimab in emergency room (prior to acute kidney injury finding that led to hospitalization) and supportive care. Acute kidney injury was treated with IV fluids. Diagnosed with NSTEMI with cardiologist consult, outpatient stress test and conservative management. Patient discharged home on 2/18/21 with no change in home medications.

Blood pressure has been running inordinately high. Typically 185/90. I have blood pressure issues but has been controlled by prescriptions. The time coincidence has prompted me to think it could be related to the covid vaccine.

The patient described shortness of breath and a feeling of not getting enough oxygen starting 9 hours after the vaccination. He states this occurred when he tried to lie down on his side. He states he woke up the next morning feeling exhausted. He also stated that his heart was "pounding" all night long, however he stated when he checked his pulse it was normal. He states that his symptoms resolved after 4 days, and has no issues now.

Hospital ER then admitted for right Pon?s Stroke, then transferred for rehab then discharged to home for rehab at outpatient therapy. Continuing therapy now.

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

Low oxygen levels; Breathing was shallow; Breath deeper and faster; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 02-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (Low oxygen levels) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) 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 25-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 26-Feb-2021, the patient experienced HYPOXIA (Low oxygen levels) (seriousness criterion medically significant), HYPOPNOEA (Breathing was shallow) and HYPERVENTILATION (Breath deeper and faster). At the time of the report, HYPOXIA (Low oxygen levels), HYPOPNOEA (Breathing was shallow) and HYPERVENTILATION (Breath deeper and faster) outcome was unknown. Additional information:He does an average of 33 miles on a bicycle every other day. In 2017, he thinks he had scattered pulmonary embolism after a long flight and his oxygen level was lower this time than it did them. Based on the current available information and temporal association between the use of the product and the onset date of the reported event of hyperpyrexia, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of hyperpyrexia, a causal relationship cannot be excluded.

I was treated for atrial fibrillation in 2006 with ablation and have had no recurrent events until the COVID-19 vaccine was administered. Sudden and recurring afib events happened for 2 days at which time I made appointment with cardiologist. By the time the monitoring equipment was installed on my body (about a week later) the events had disappeared. The events recurred after receiving the second dose of vaccine but only lasted about 3 days.

3/16/2021 Received 2nd Moderna Covid-19 vaccine 3/25/2021 Trouble breathing when exercising so stopped after 5 min and usually do 20 mim; temp elevated for me normal 97.6 and was between 98.6 and 99.3, hacking up yellowish phelgm. Phelgm had been coming up for longer period of time. 3/26/2021 went to clinic and put on treatment for possible bronchitus. Z-Pak and Prednisone 5 days and asked to schedule x-ray to see if something more showed. 3/30/2021 Completed meds and x ray scheduled. No improvement in breathing 4/1/2021 was finally able to get chest x-ray 4/2/2021 x-ray showed nodule on lung & calcified grandular - told to schedule ct to check out nodule - told clinic still no change in condition 4/5/2021 called clinic again due to pain overnight in left lung. Trouble getting ct scheduled so clinic sent to me emergency room rather than schedule ct 4/5/2021 - At ER blood work, x-ray and ct scan completed. CT chest was significant for large bilateral pulomanry emboli w r ventricular strain. Also r middle lobe lung nodule and r adrenal nodule. Started on heparin drip and admitted. Hospitalized 4/5 and sent home 4/8. Sent home on Xarelto to continue at least 3 months and consult w family doctor to determine cause of submassive clots and further treatment.

Patient presented to the ER with right sided extremity weakness. Initial CT showed no hemorrhagic stroke so patient was admitted for treatment of ischemic stroke. Was started on IV Heparin drip and condition improved greatly. Subsequent CT showed small ischemic stroke on left. Patient recovered and was sent home on Plavix, Aspirin and Atorvastatin.

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.

On Tuesday, February 16, I received my 1st Moderna Covid vaccine. On Tuesday, March 16, I received my 2nd Moderna Covid vaccine at 11AM and Eylea shots (one in each eye) at 2PM. I have been receiving Eylea every 3 months for about 3 years in one or both eyes. On Saturday, March 20 at about 11:30AM, while sitting at traffic light, I saw what appeared to be a translucent sheet of plastic cover the left driver's window and the left half of the windshield. This was only visible in the left eye. Twenty seconds later, a yellow opaqueness developed in the left eye, which eventually cleared, but vision was still blurry. When I got home, I called my retinologist. He recommended I go into a dark room and close my eyes. At this time, I had white translucent vision in the lower left quadrant of vision in both eyes. My retinologist sent me to Eye Hospital Emergency Department, which is part of Hospital. After being assess at Eye Emergency Room, I was admitted to Hospital for a right occipital lobe stroke that was confirmed by multiple MRIs of the head. I was told that I was experiencing an ocular migraine (although I had no pain.) I was discharged on Monday, March 22, on Eliquis. As of April 15, all of the yellow opaque and white translucent visions are gone. However my left eye vision remains blurred and hazy. I have since been diagnosed with age-related cataracts in both eyes and a fast-moving cataract in top portion of left lens. I will also report this occurrence to the reporting system.

Patient began to develop progressive weakness on the night he received his first vaccine dose. This continued to progress over the course of two days and included left sided numbness and left sided deficit, including facial droop. Patient presented to the emergency department and was admitted for an acute ischemic CVA.

Fever at 103; Heart rate at 140; Blood pressure at 81/41; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever at 103), HEART RATE INCREASED (Heart rate at 140) and HYPOTENSION (Blood pressure at 81/41) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced PYREXIA (Fever at 103) (seriousness criterion hospitalization), HEART RATE INCREASED (Heart rate at 140) (seriousness criterion hospitalization) and HYPOTENSION (Blood pressure at 81/41) (seriousness criterion hospitalization). At the time of the report, PYREXIA (Fever at 103), HEART RATE INCREASED (Heart rate at 140) and HYPOTENSION (Blood pressure at 81/41) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Blood pressure measurement: 81/41 (Low) 81/41. On 10-Apr-2021, Body temperature: 103 (High) 103. On 10-Apr-2021, Heart rate: 140 (High) 140. 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. Concomitant product use was not provided by the reporter. The patient was currently in the ICU receiving 2 vasopressor Norepinephrine and Neosynephrine. 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 second dose of COVID-19 vaccine on 3/22/2021. Patient presented to ED on 03/29/2021 at 7:45AM complaining of dyspnea on exertion for 1 week since COVID-19 vaccine. Patient also complains of R lower ribcage pain on inspiration for 3 days. Patient became unresponsive and was revived twice. Patient became unresponsive a third time and could not be revived.

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

Resident found unresponsive and without vital signs the morning on April 17, 2021 at 6:35am. The nurse started CPR, called a code, 911 called, AED applied. Local EMS responded, took over the code. EMS had contact with the local hospital ER, code called at the facility. Resident expired.

Patient had COVID infection in 12/2020. Had 1st moderna vaccine 1/31/21. developed new headaches 2/12/21. 2nd dose of moderna COVID vaccine on 2/25/21. on 3/18/21 admitted to the hospital with right sided weakness, expressive aphasia, left gaze preference and right hemineglect found to have a left posterior parietal intracranial hemorrhage with vasogenic edema and extensive venous sinus clot involving the superior sagittal sinus, bilateral transvere sinsu and sigmoid sinus to the level of the jugular veins. He stabilized and was airlifted from one place to another to have hospice care.

Pt to ED on 3/1621 with : "pt c/o left sided chest and rib pain. pt states that other symptoms along with the pain started today. Pt is c/o SOB, numbness and tingling in bilateral upper extremities, bodyaches and "feeling cold." PT dx with PE of unknown origin

Veins was outside and sore; really big and sore red area; really big and sore red area; all the veins in his R leg was protuberate; two blood clot; DGThrombosis; Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (two blood clot) and THROMBOSIS (DGThrombosis) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leg injury (severe damage to right leg, hit by "protellier" small airplane.) in 1977, Surgery ("many surgeries") and Clot blood. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On 12-Mar-2021, the patient experienced MALAISE (Felt terrible). On 13-Mar-2021, the patient experienced THROMBOSIS (two blood clot) (seriousness criterion medically significant), THROMBOSIS (DGThrombosis) (seriousness criterion medically significant), VASCULAR PAIN (Veins was outside and sore), ERYTHEMA (really big and sore red area), PAIN IN EXTREMITY (really big and sore red area) and VEIN DISORDER (all the veins in his R leg was protuberate). At the time of the report, THROMBOSIS (two blood clot), THROMBOSIS (DGThrombosis), MALAISE (Felt terrible), VASCULAR PAIN (Veins was outside and sore), ERYTHEMA (really big and sore red area), PAIN IN EXTREMITY (really big and sore red area) and VEIN DISORDER (all the veins in his R leg was protuberate) outcome was unknown. Not Provided Concomitant medication included unspecified statin for high cholesterol. The patient reported that he is retired. He reported that his leg is functioning well, he has only one of the three arteries in the legs and many damaged veins. Treatment medication included Seroto to treat the blood clots. Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-077978 (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, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-077978:

Patient developed fever after second COVID-19 vaccine and over the next two weeks became increasing encephalopathic before presenting on 4/18 and being admitted for encephalopathy and persistent fever. He was found to have mediastinal lymphadenopathy There has been no cause for fever through infectious, rheumatologic, and hematologic evaluations.

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

77 y.o., male come to ED on 12/24/20, with complaint of SOB and neck swelling. Per ED notes, PE: Large left side neck mass (Erythematous, warm and tender). Possible abscess vs gland infx vs lymphadenitis , which started 4 hours PTA. Pt stated he woke up with the symptoms after having his COVID vaccination yesterday (12/23/20). Patient was given clindamycin in ED, had an anaphylactic reaction (neck, tongue and epiglottis swelling), developed progressive respiratory distress requiring intubation. Noted to develop complete heart block, had 2 cardiac arrests with preceding bradycardia, had transvenous pacer and and tolerated procedure well. He was discharged back to SNF on 1/02/21. Patient noted to have a subclavian DVT on DC, and will start Eliquis.

Information obtained from clients wife. patient received his first dose of Moderna 2/24/21 lot 024M20A with no reported issues except for a sore arm. patient received his second dose of Moderna on 3/24/21; Lot# 006B21A. No immediate effects from the vaccine. On day 2 post vaccination, patient became to have chills, per wife; did not check temperature and denied any symptoms such as flu-like symptoms. Day 3 post vaccination; patient began to have weakness in the legs. March 31st; patient was unable to stand and the rescue squad was called. patient was taken to the Hospital; where he was evaluated and released home. Pt collapsed at 1am 4/1/2021 and died 4/1/21.

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

Three days after vaccination, the patient was working outside when he suddenly died. Specific events are not known as he was alone at his work site. No bodily injuries were found. He was simply passed out and unresponsive when found. He had been deceased for hours upon his discovery.

This 77 year old white male received the Moderna Covid shot on 1/27/21 and went to the ED on 2/6/21 and was admitted on 2/9/21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident).

Patient presented to the ED and was subsequently admitted within 6 weeks of receiving COVID vaccination. Diagnosis was bilateral pulmonary embolism.

45 minutes after administration patient developed signs of a stroke: inability to speak, facial paralysis, inability to move

Approx. 6 weeks after 2nd shot, experienced shortness of breath, fatigue, chest tightness, sinus/head pressure. Cannot exercise for more than 10 minutes without resting. Heart monitor and stress test results show no abnormalities.

Woke up with Atrial Fibrillation that would not stop, Went to local hospital in They treated me with medications but they had no effect. I was transported to Medical Center in where they continued the medications. When they did not work, I was sedated and my heart shocked back into rhythm.

Couldn't Breath, Died due to Blood Clots on Lungs, Bilateral Pulmonary Embolism, Bleeding on the Brain.

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

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

COVID-19 2. Pulmonary embolism without acute cor pulmonale, unspecified chronicity, unspecified pulmonary embolism type

Patient developed sharp chest pain radiating to the jaw 3 hours after receiving his second COVID vaccine.

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.

On 5/22/21 patient presented to Emergency Room. Pt was diagnosed with the following: Syncope secondary to third-degree AV block, permanent atrial fibrillation, history of recurrent gastrointestinal bleed, morbid obesity, type 2 diabeties mellitus with peripheral neuropathy, chronic ataxia, coronary artery disease, obstructive sleep apnea, gout, hypertension, multiple contusions of lower extremities, community aquired pneumonia (recovered) and, Anemia chronic but stable. Pt give pacemaker and dischared to nursing home for after care.

cardiac arrest (V fib) treated: with amiodarone, magnesium, 6 doses of epi, calcium, bicarb. Achieved ROSC. outcome: withdrawal of care

Heart Rhythm problems increase infrequency after vaccination; Heart Rhythm problems increase infrequency after vaccination; Fever (Low grade); Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Heart Rhythm problems increase infrequency after vaccination) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 pneumonia (treated with ramdesivir during which he was coughing up blood.) in November 2020. Concurrent medical conditions included Dysrhythmias (heart rhythm problem which he has had for 6 years). On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced PYREXIA (Fever (Low grade)) and FATIGUE (Tiredness). On 22-Feb-2021, the patient experienced ARRHYTHMIA (Heart Rhythm problems increase infrequency after vaccination) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Heart Rhythm problems increase infrequency after vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 22-Feb-2021, PYREXIA (Fever (Low grade)) had resolved. At the time of the report, ARRHYTHMIA (Heart Rhythm problems increase infrequency after vaccination), CONDITION AGGRAVATED (Heart Rhythm problems increase infrequency after vaccination) and FATIGUE (Tiredness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19 pneumonia: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient reported that his heart rhythm problem which he has had for 6 years has gotten worse after vaccination. He used to have about 1 episode every month, it increased to about 1 episode every week after infection with COVID-19 and how now increase to about 1 episode every 2 to 3 days after the first dose of the Moderna vaccine. 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. No concomitant information 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.

I went into the hospital 5/7/21 with a blood platelet count of 2 8/21/20 platelet count was 230 9/8/2020 platelet count was 213 4/19/21 platelet count was 161 Since my transfusion in the hospital my platelets have varied from a high of 120 to a low of 55

Heart Failure; Bilateral DVT; Blood Clot; Exacerbation of pre existing medical conditions; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart Failure), DEEP VEIN THROMBOSIS (Bilateral DVT) and THROMBOSIS (Blood Clot) 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. The patient's past medical history included Deep vein thrombosis ('had an episode of DVT 30 years ago'). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CARDIAC FAILURE (Heart Failure) (seriousness criterion medically significant), DEEP VEIN THROMBOSIS (Bilateral DVT) (seriousness criterion medically significant), THROMBOSIS (Blood Clot) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Exacerbation of pre existing medical conditions). At the time of the report, CARDIAC FAILURE (Heart Failure), DEEP VEIN THROMBOSIS (Bilateral DVT), THROMBOSIS (Blood Clot) and CONDITION AGGRAVATED (Exacerbation of pre existing medical conditions) 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. 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. Of note, the patient's age and pre-existing medical conditions are confounding factors that may play possible contributory roles.; 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. Of note, the patient's age and pre-existing medical conditions are confounding factors that may play possible contributory roles.

Patient stated that he went into A-fib after getting the shot last month. He states that his doctor told him to go ahead and get dose #2 but just watch for any symptoms

Hospital Course: Complicated. Patient was brought in for ostomy reversal, had a colonoscopy performed through his colostomy which revealed the patient to have a right colonic mass, mass was an adenocarcinoma. Had a right colectomy performed , had a massive myocardial infarction and died. Complicated 1 year, started with COVID 19 - patient was admitted prolonged amount of time due to complications of COVID 19 , developed a large decubitus ulcer which was not healing. Was being followed by Dr wound care center. Multiple debridements. Failure to heal. Referred to me for a diverting colostomy to facilitate healing of the large decubitus ulcer. Diverting colostomy was performed September 2nd 2020. Patient had plastic surgery, flap surgeries, in December 2020 and January 2021. finally healed. Brought for a ostomy reversal, found large mass in the cecum attempted endoscopic removal, with micro perforation, taken to the operating room immediately from endoscopy suite had a right colectomy. Colostomy started functioning, patient was recovering, suddenly started having chest pain and had a massive myocardial infarction.

Pt was admitted to the hospital from ED with A-fib on 4/8/2021 after receiving first dose of vaccine on 3/30/21. Per guidelines, all hospitalizations are reported.

Received vaccine left deltoid has soft tender area 8 inches from injection site pain with palpation 4/10. No brusing or rash noted . Ice pack applied. Moderna information number given to client.

Deep vein thrombosis; Pulmonary embolism; This case was received via VAERS (Reference number: 1358680) on 15-Jun-2021 and was forwarded to Moderna on 15-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Parkinson's disease and Latex allergy. Concomitant products included CARBIDOPA, LEVODOPA (CARBIDOPA LEVODOPA), TAMSULOSIN, DROXIDOPA (NORTHERA), MELATONIN, CYANOCOBALAMIN (B-12), FINASTERIDE, POTASSIUM, CITALOPRAM and ROSUVASTATIN for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (Deep vein thrombosis) (seriousness criterion medically significant) and PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Deep vein thrombosis) and PULMONARY EMBOLISM (Pulmonary embolism) had resolved. 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. Treatment medication information was not provided. Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.

He then felt dizzines and a headache the following day. On 6/2/2021(4 days after vaccination) he had slurred speech which prompted his family to bring him to ER. CT brain negative for acute CVA. Pt was placed on DAPT (Plavix and ASA). On 6/25/2021-- pt was hospitalized again for severe mixed aphasia and dysarthria--- second stroke with hemorrhagic conversion.

Death; Adenocarcinoma of colon; Chest pain; Myocardial infarction; This case was received via Regulatory Authority on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death), ADENOCARCINOMA OF COLON (Adenocarcinoma of colon), CHEST PAIN (Chest pain) and MYOCARDIAL INFARCTION (Myocardial infarction) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 045B21A) for COVID-19 vaccination. The patient's past medical history included COVID-19, Plastic surgery in December 2020, Surgery in January 2021 and Stoma closure (surgery). On 15-Apr-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 05-Jun-2021, the patient experienced DEATH (Death) (seriousness criteria death and hospitalization), ADENOCARCINOMA OF COLON (Adenocarcinoma of colon) (seriousness criteria death and hospitalization), CHEST PAIN (Chest pain) (seriousness criteria death and hospitalization) and MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria death and hospitalization). The patient was treated with Surgery (Colectomy) for Death and Surgery (Colectomy) for Adenocarcinoma of colon. The patient died on 05-Jun-2021. The reported cause of death was Myocardial infarction. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jun-2021, Colonoscopy: abnormal (abnormal) Abnormal had a colonoscopy performed through his colostomy which revealed the patient to have a right colonic mass, mass was an adenocarcinoma.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication were not reported Treatment medication were not reported. Action taken with mRNA-1273 in response to the drug was not applicable. Additional information included the patient had decubitus ulcer which failed to heal multiple times and also had plastic and flap surgeries and finally healed . Patient had underwent Stoma closure surgery .Colostomy started functioning, patient was recovering, suddenly started having chest pain and had a massive myocardial infarction. Endoscopy large bowel was performed. Complicated 1 year, started with COVID 19 - patient was admitted prolonged amount of time due to complications of COVID 19 , developed a large decubitus ulcer which was not healing. Was being followed by Dr wound care center. Multiple debridements.Failure to heal. Referred to me for a diverting colostomy to facilitate healing of the large decubitus ulcer. Diverting colostomy was performed September 2nd 2020. Patient had plastic surgery, flap surgeries, in December 2020 and January 2021. finally healed. Brought for a ostomy reversal, found large mass in the cecum attempted endoscopic removal, with micro perforation, taken to the operating room immediately from endoscopy suite had a right colectomy. Colostomy started functioning, patient was recovering, suddenly started having chest pain and had a massive myocardial infarction. Company Comment : This case concerns a 77-year-old male patient who experienced adenocarcinoma of colon, myocardial infarction and chest pain and died 51 day following the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 77-year-old male patient who experienced adenocarcinoma of colon, myocardial infarction and chest pain and died 51 day following the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: myocardial infarction

I took my first shot 01/13/2021, second shot 02/11/2021 Moderna 029L20A Moderna 024M20A I had the standard sore arm about 4-5 inches below the site. This went on to be pain down my left arm extending to my left ring finger and middle finger. I have had cramps muscle pain over my chest left rib area. Pain down my left side ribs. pain down my back over my ribs. Neck pain muscle tightness left side. Pain on my left shoulder turned into a muscle pain/cramp shoulder down my back lasting 12 hours. The muscle was standing up over 1 inch. I called my doctor he wasn't available, went to the ER the next day. I saw Dr. 07/01/2021 he said he couldn't do anything for me. He said he could treat the symptom. He gave me

was admitted to hospital with symptoms of pericarditis, chest pain, on 3/25/21; chest CT and echo showed moderate pericardial effusion; no tamponade; improved with ibuprofen and discharge on 2nd day 3/26/21; DDimer was positive and sed rate and CRP were elevated; chest sxs all resolved by 2nd day of hospital and felt well; repeat cardiac echo 4/26/21 normal, no effusion; no recurrence of sxs after 3/26/21 and doing well as of 7/18/21

Heart Attack; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart Attack) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart Attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart Attack) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported. No treatment information was provided. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Woke up early in the morning with 150 bpm pulse, endured for hour; underwent cardioversion; released from ER by 6:30 a.m.

short of breath Narrative: patient complained of shortness of breath prior to getting covid vaccine, patient and wife stating it was his norm. After vaccine he complained of increasing shortness of breath, and hypoxic with bluish nail beds, lips, and greyish in color. Applied O2 via mask, and nail beds, lips, and facial color returned, sent patient to local ER for treatment and evaluation.

The patient was vaccinated at another facility, but presented to our Emergency Department with reported fever of 101 at home and malaise and weakness. Upon arrival, he was noted to be hypoxic at 91% on room air and tachycardic. His evaluation ruled out PE, PNA, ACS, sepsis. He was given oxygen therapy, nebulizer treatments and has been placed in observation.

About 30 hours later (next day), noted his Apple watch showed HR to be around 120's, he was essentially asymptomatic. Waited for 1 hr, spoke with colleague, where a decision was made to bring him to ED for monitoring. Had overnight stay in ED with spontaneous resolution of his tachycardia, elevated BP and had in hospital work up and discharged at 0920 hrs on 01/22/21.

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

Patient was in distress and had a Stroke ( per his wife). Ambulance called and pt was admitted to hospital.

Pain at shot site, chills, low blood pressure, rapid pulse. felling better now. went to doctor was diagnosed with atrial flutter. still gets out of breath and blood pressure jumps around.

Resident was desated, into the 80's, short of breath. We went him to the hospital same day as vaccine given

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

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

weakness, clammy, low blood kpressure, treated with rest and hydration sudden wide spread red rash with severe itching on day 3 treated with steroid injection, Benadryl and steoid cream

78 YEAR OLD MALE COMPLAINED OF CHEST PAINS. ONSITE EMS AND PHYSICIAN RESPONDED. BP WAS 180/68 HR 80. EMS DETERMINED IT WAS NOT RELATED TO HEART. HE REFUSED ADDITIONAL EVALUATION AND CARE.

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

Stroke and seizure ( In the past he had a stroke and seizure ) So this is not his first time and we are not sure if this is related to the vaccine.

Got up to go to the bathroom in the middle of the night, was dizzy. Wife walked with him because of the dizziness. On way back to bed he passed out and I tried to help ease him down. Came back almost immediately. Got on hands and knees and crawled to bed. Ran a fever of 100.3 all Wednesday and stayed in bed because of dizziness. By Thursday he was fine again and started doing his normal activities.

Oxygen level was down; Tested positive for COVID; 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 who experienced oxygen level was down and tested positive for COVID-19. The patient's medical history included heart disease and atrial fibrillation. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 18 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 012120A] intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced low oxygen levels. On 08 Feb 2021, the patient tested positive for COVID-19. Treatment for the event included hospitalization. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events oxygen level was down and tested positive for COVID were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

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

The patient received his first dose of the Moderna vaccine. He reports that approximately 2 hours after the injection he began to have right sided tongue swelling. He was assessed in the ED. He had no facial swelling but there was right sided tongue swelling present. Oral airway was patent. Tachycardia was present (HR 116) and BP 197/96. He was given Benadryl, Solu-Medrol, and IV fluids. He was later considered stable and was dicharged 3 hours later.

Extreme weakness to the point of being unable to stand, lightheaded, numbness, bilateral limb weakness progressing to stroke-like symptoms which persisted for approximately one day; palpitations and frequent PAC and PVCs which have persisted past initial treatment to current date. Patient was treated in the ER and given steroids, anti-histamines, and possibly anticoagulants for stroke-like symptoms, however ER notes not available and going off patient's verbal report. He was sent home on steroids and antibiotics and diagnosed with Vaccine injury from Moderna COVID19 vaccination.

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

severe back pain, pelvic pain for one week and hard time walking. irregular heart beat for 5 hours after the vaccine.

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.

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.

It was reported to staff that this gentleman suffered thrombocytopenia following his vaccine, a platelet infusion was done and he expired on 2-14-21

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.

Saturday 02/27 thru this morning: Low pains in upper left chest / Low pains in middle of left side of back Tuesday 03/02/2021: Headache and pain in left eye / Sitting watching tv on Tuesday 3/2/2021 and almost passed out Have never experienced anything like this before so think it may be vaccine related. Then saw the news report about women getting false positive mammogram results only on the same side they had their vaccine in and that seems to be the case with my events - all on left side.

Experiencing hypoxemia; A spontaneous report was received from a consumer concerning a 78-year-old male patient who received Moderna's Covid-19 vaccine (mRNA1273) and experienced hypoxemia. 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 dose of mRNA-1273 (Lot: 031L20A) intramuscularly on 02-FEB-2021 for prophylaxis of Covid-19 infection. On an unknown date, the patient experienced hypoxemia. The blood oxygen level of the patient went between 80-90% for a short time and then would recover. The patient reported "it was getting a little tiring." At the time of this report, the patient was still experiencing symptoms. The patient had not taken any treatment for the events. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, hypoxemia, was considered not resolved.; Reporter's Comments: This case concerns a 78 year old male patient, who was on hospice care experienced a fatal event of death, 4 to 5 days after receiving second dose of mRNA- 1273 (Lot# 031L20A). Very limited information regarding this event has been provided at this time. Further information has been requested.

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.

arm pain, fatigue, headache, muscle pain, fever 102.4, severe chills, nausea, dizziness, fast heartbeat

While eating breakfast the next morning after my shot, I got dizzy/light-headed and fainted, falling to the floor. I was "out" for ~2 minutes, according to my MD wife. After 2-3 minutes ,I felt fine and went and played tennis 15 Minutes later. I don't think that I have never fainted in my life time. I take no prescriptions for anything. I do still have a sore shoulder from the fall, since I was sitting in a "Bar stood" at a counter at the time of the fall.

Rheumotoid arthritis autoimmune compromised person who was told by multiple doctors that he should get the shot anyway. He had not had a RA flare for months but 1-2 days after shot he started having joint pain in hips, low back, between shoulders and neck. Pain shooting up head, random numbness in left pinky, wrist, and up to elbow which has not occurred before. Shortness of breath and heart racing. Went to PCP and they directed him to go to ER. 2 EKGs, Chest Xray, Bloodwork, Stress Test. Seeing Neurologist, Rhuemotologist and Cardiologist as symptoms are ongoing.

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

3/7/21 ER to inpatient Admission (covid positive 3/7/21) 3/11/21 Transferred to higher level of care Date of Service: 3/8/2021 Chief complaint: Chest congestion HPI: Patient is a 78 y.o. male with PMH significant for hypertension, obesity, coronary artery disease and CKD admitted to acute care from ED peR Dr with pneumonia due to COVID-19. Patient presented to ER brought in by EMS from local residence. Was complaining of chest congestion. Patient had been seen in ER earlier same morning complaining of cough. Was afebrile at that time. Oximetry 95%. Rapid COVID positive. Patient given Decadron 6 mg IV, albuterol inhaler, zinc and BAM(bamlarnivimab 700 mg) IV x1. Patient discharged home. Return later that evening per EMS with shortness of breath. Complaining that congestion was getting worse. Was now febrile & had fallen trying to get out of recliner. Vitals upon arrival-temp 102.8° pulse 87 respirations 24 blood pressure 169/71 oximetry 99% on 2 L. patient given Rocephin 1 g IV piggyback, azithromycin 500 mg IV piggyback, normal saline bolus 1 L & acetaminophen 1000 mg IV in ER. Labs revealed mild leukocytosis white blood cell count 12.5. Glucose elevated to a 9 but patient had received Decadron previously. BUN 32 creatinine 1.8. D-dimer 1240. No CT chest obtained due to patient's renal status. Patient subsequently admitted to acute care for further evaluation and treatment to include IV antibiotics supplemental oxygen pulmonary hygiene. Patient has received 1st COVID vaccine and due to have 2nd vaccine on March 20. Upon admission patient was continued on Rocephin and azithromycin IV piggyback & Decadron 6 mg IVPB. Continued hydration fluids normal saline at 100 cc/hour. Started on IV Remdesivir with loading dose. DuoNeb nebulizers q.6 hours. Patient continued on home regimen less Plavix. Was started on Lovenox 40 mg subcu daily for DVT prevention. Patient maintaining oxygenation on 2-3 L. Had initially been on 2. Was increased to 3 this morning due to decrease in oximetry down to 92%. Patient continues with exertional dyspnea. Does have loose nonproductive cough. Is complaining of pain to the left lower chest wall with cough. Describes as sharp. Denies any actual chest pain. No nausea vomiting. Last BM yesterday described as normal. Blood cultures pending no growth at present. Is currently resting in bed. Is in negative air pressure room. COVID precautions observed. CASE DISCUSSED WITH DR

Saddle Pulmonary embolus occurred on March 6th the day following his first COVID-19 vaccine. He was found to have an extensive right leg DVT but no symptoms. He has no prior history of DVT/PE, no family history of DVT/PE, No known risk factors for DVT/PE.

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.

03/13/2021: Presented with elevated blood sugar after having bilateral knee cortisone injections yesterday. Insulin regimen adjusted and patient discharged within 3 days.

3/17/21 ER Triage note: "Pt c/o lips and and facial swelling. No sob, no problems swallowing. Onset this am. Denies pain."

seizures; small stroke; A spontaneous report was received from a consumer (wife of patient) concerning a 78- year-old, male patient who developed seizure and a small stroke. The patient's medical history included seizure 4 years ago, stroke long time ago. Products known to have been used by the patient, within two weeks prior to the event, Cholesterol medicines, Blood pressure medicines and Aspirin. On 18 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot 031M20A) intramuscularly in the Right arm for prophylaxis of COVID-19 infection. On 18 Feb 2021, the patient developed seizure, small stroke . Treatment for the event was not reported. Doctors are not sure about the causality, but want to report it. They spoke to his doctor about not getting the second vaccine. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event's, seizure, stroke was considered unknown.; Reporter's Comments: The events were consistent with increased risk of complications associated with history of seizure confounded by elderly age of patient. Company assessed the events to be unlikely related to company product.

8 minutes after the vaccine was administered, he started to act funny. At first, he looked like he was having a vasovagal/ syncopal episode: he became non-responsive, stared straight ahead. then shortly thereafter he started to take be gasps for air, his lips turned blue. It soon became clear that he was having an anaphylactic reaction. we called for an ambulance, we administered one dose of an Epipen, and administered oxygen. His pulse ox was in the low 80's. within a minute or two, he started to react and started to moan, breathe more normally, then began to speak to us. His BP was checked and was 118/83. His oxygen sat went up to 100%. after a few minutes, We took the oxygen off and his sats dropped into the 80's so we restarted the oxygen. We are rural, so it took the ambulance 30 minutes to arrive. He was very stable at the time that he was taken to an emergency room for further evaluation.

Patient had dyspnea w/ exertion within 24 hours of getting 2nd moderna COVID19 vaccine. Continued for a couple weeks before coming into to office. CT chest demonstrated pulmonary embolism in primary branch of right upper lung. He was not symptomatic between his COVID diagnosis in Nov 2020 (after acute illness) and prior to receiving second vaccination.

Received the Vaccine Shot, waited 15 minutes with no issues. Went home, in about 15 minutes had extreme chest pain. Quickly moved to emergency room. Was given nitroglyercin paste on chest, Asprin to chew, Heprin and cardiac cautherization. Cautherization showing no real issues. Eventually the pain was gone. Cardiac doctor mentioned heart possibly being highly stressed earlier. I have some thoughts that it may have been a temporary blood clot, but not proven. Chest pain was very bad until emergency room starting getting it under control. never had that much pain before with previous heart attacks in 2004-05

Hypertension (systolic over 180). Treatment is addition of a second blood pressure medication. I have had onset of hypertension approximately 2 weeks after the first dose of the Moderna vaccine, and now again 2 weeks after the second dose. Note that I take losarten daily, and this event reflects sudden, uncontrolled hypertension onset two weeks after vaccination while on medication, with no other identifiable causes (sodium/caffeine intake was reduced after first AE).

78 year old man without prior DVT/PE history, who had first Moderna vaccine dose on 12/29/20 (lot 011J20A) and second Moderna vaccine dose on 02/02/21 (030L20A) (information from patient provided vaccination card) who presented to the ER on 02/20/21 with one week of subjective dyspnea and palpitations. Chest CT with bilateral pulmonary emboli. There were also groundglass opacities in the right upper lobe. Rapid test for COVID 19 on 02/20/21 was negative. Subsequent antibody testing for COVID19 on 03/01/20 (IgG, IgA. IgM) also interpreted as negative. The pulmonary embolus was considered to be unprovoked and an association with prior COVID19 vaccination is interpreted as possible but unproven. The patient was initiated on anticoagulation. Further workup for underlying thrombophilia hematological disorders is pending at this time however the current assessment remains as an unprovoked pulmonary embolus occurring 18 days after second Moderna vaccine dose. Current CT imaging without evidence of recurrent malignancy and there are no identifiable risk factors for pulmonary embolus. The physician submitting this report is a Hematologist Oncologist.

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.

Subacute fevers, cough, dyspnea for 2-3 weeks, found to be hypoxemic requiring up to max 5L nasal cannula, not responsive to coverage of community acquired pneumonia with 2 courses antibiotics. No bronch performed based on goals of care, empirically trialed on high dose steroids (soluemdrol 1000mg x3 days, then 500mg x1 day, transition to PO prednisone) as well as cefepime x7 days. Improvement to room air while continuing on steroids currently.

3/14/21 complaints of low-grade fever, cough, chills and difficulty with taking in a deep breath after receiving his second COVID vaccine about 5 days prior. New diagnosis of pericarditis given based on symptoms and cardiac MRI

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

Blood clot in his left lung and right lung; Blood clots in his right groin; Terrible pain on the left side of his upper body,It hurts so much; 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 terrible pain on the left side of his upper body, it hurt so much, blood clot in his left and right lung and blood clots in right groin. The patient's medical history was reported by the reporter as high blood pressure, prediabetes and hepatitis C due to a bad blood transfusion (treated with Mavyret). Concomitant medication was not reported. On 11 Feb 2021, three days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) through an unknown route at left arm for prophylaxis of COVID-19 infection. On 14 Feb 2021, 3 days after vaccination, patient had a terrible pain on the left side of his upper body and was hospitalized, the tests revealed blood clot in his left and right lung as well as in right groin, which was treated by Eliquis. Patient was observed overnight and discharged with a follow up in 3-6 months. Action taken with mRNA-1273 in response to the events was unknown. The reporting physician assessed the events as not related to the product, but did not recommend second of vaccine. The outcome of events was unknown.; Reporter's Comments: Based on reporter's causality and history of diabetes and Hepatitis C infection, the event is assessed as unlikely related to mRNA-1273.

First injection resulted in Nose Blead overnight and significant bleeding of the gums the second day resolved by the third day without treatment Second injection likely caused delayed reaction 17 days later, Significant swollen upper lip . Will seek medical attention when EMO opens

Five days after shot I had rapid pulse (120) and felt weak. Ten days after shot I felt very weak in morning and couldn't stand long enough to shave. Rapid pulse again (120).

Patient returned to immunization clinic for 2nd dose of vaccine. He reported that he had a stroke approximately 1 month after his COVID vaccine. I advised nurse to not vaccinate today as this may be a vaccine adverse event.

Approximately 10 minutes after vaccine administration, patient became lethargic and unresponsive. Ambulance was called and arrived within 5 minutes. By that time he was alert and was transported to hospital.

The patient had an ischemic stroke (confirmed by MRI) on Friday, 4/2, approximately 24 hours after the 2nd dose of the Moderna vaccine given on 4/1. The symptoms of the stroke began in the evening on 4/2 and consisted of left face, arm, and leg weakness.

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

3 days after injection developed left arm pain, swelling. persisted when presenting for second injection 4 weeks later which was deferred. evaluated next day in clinic. reported feeling feverish, left arm pain weakness which was in a sling. noted have swelling with moderate edema in hand. tender left lateral shoulder, hand. decreased strength in arm, hand possibly due to pain. no lymphadenopathy. afebrile. WBC normal.

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

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

Paitent had a stroke for no identifiable reason. They saw little bloodclots in his brain. Because he has heart stints, the doctors at the hospital said everything that prevents strokes was already being done for him. They had a heart monitor placed in his chest and today the cardiologist read the results. There is nothing in his heart that would cause the clots. Blood clots are not part of his family health history. The only thing "different" during the time previous to the stroke was the covid shots. Just reporting in case it is part of a trend. He hd mobility issues and had to be in physical therapy for a few weeks. His balance is still weak.

the next day, dizzy , 2 days later sore throat pain, chest pain short lived ( not like when he has had heart attacks in past ) , fever 99.2, coughing Advised may want to talk to PMD about breathing treatments, if chest pain seek medical attention. Placed follow up call on 4/16/2021 at 11:17: Pt reported that he is feeling much better today. Pt reported that the ADEs he had occurred within couple of days of rcvding his 1st Moderna vaccine, by the 3rd day all the symptoms had cleared up, and on day 4 he reported still had some running nose (which he contribute to his allergies). Pt reported for his symptoms he did not try anything to help alleviate his symptoms, he stated he is already taking Tylenol daily.

Call this afternoon regarding safety of in setting of recent Moderna COVID-19 vaccine receipt. Question related to autoimmune heparin-like thrombotic thrombocytopenia as currently in the news related to J&J vaccine. Reported incidents that led to FDA pause of J&J vaccine related to arterial events with overt thrombocytopenia and PF4 antibody positive. Limited data available to suggest link to mRNA vaccines at this time but data being collected daily regarding therapies. Reviewing chart, patient has several risk factors for VTE development (OSA, hx prostate cancer, age, PMR +/- steroids; there is also a mention of unilateral edema in which patient was referred for Doppler but date of this request is unknown to writer so unable to determine if occurred prior to or after vaccine receipt. Also mention of knee pain back to 3/2021 OV with Dr. so unclear if mobility issues although participants in cardiac rehab. Labs reviewed and mild thrombocytopenia today (148k) and 171k on 10/2020. Naranjo score 2, suggesting possible correlation but low score overall. Overall, given presentation and information provided, appears anticoagulation for acute PE is safe. Theoretically would consider enoxaparin 80 mg SQ BID over UFH infusion but defer to medicine. Additional notes: 2D echo: EF wnl, impaired LV diastolic filling bilat LE dopplers; negative for DVT He was transitioned to eliquis RX for PE treatment Discussed AC treatment with on call cardiology, as no stents are in place that I am aware of and the patient denies placement of stents, only CABG in 1995, then stop asa/plavix and continue only with eliquis at this time Recommend f/u with hematology/oncology in the next 2 weeks for PE management and evaluation Recommend f/u with Cardiology in the next 2 weeks for further management AC precautions was reviewed with the patient and his wife prior to discharge and including when to seen medical attention due to increased risk of bleeding events. They both verbalized understanding.

CALLED TO TRANSFER PATIENT FROM 2C ADMITTING AREA TO ENDOSCOPY UNIT AROUND 1410. UPON ARRIVAL IN 2C TO TRANSFER PATIENT, PATIENT WAS ALERT AND RESPONSIVE TO NAME. WHEN WHEELED TO BEDSIDE IN ENDOSCOPY UNIT PATIENTS RIGHT ARM SLUMPED AND HE BECAME UNRESPONSIVE. RAPID RESPONSE CALLED. PATIENT TRANSFERRED TO STRETCHER, CODE BLUE CALLED, AND CPR STARTED. DR. ANESTHESIA AT BEDSIDE MANAGING AIRWAY. CODE TEAM RESPONDED. REFER TO ARREST RECORD.

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

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.

Patient was given second dose of Moderna during clinic. He was sitting in the electric cart waiting the 15 minutes for any adverse reactions, also waiting for his family members to receive their doses when he started to slump over onto his daughter. I was behind the screen preparing another dose when I heard his daughter saying "daddy are you ok?" I immediately got up to help. I asked my technician to call 911. I got the blood pressure monitor to check his blood pressure after he finally came to. His blood pressure was within normal range. I also checked his temperature which was 96.5. His daughter said that he had a habit of passing out at home. I called my coworker to come up front to help before the paramedics arrived. The paramedics finally arrived to check him out.

dvt ER despense blood thiner Left arm swelled to twice its size from shoulder to tinger tips.

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

Patient was admitted from ED due to feeling week for approximately 1 week prior. Has passed out 2-3 times a day over past week. Patient tested on admission for Covid with a positive diagnosis via POC Rapid SARS-COV-2 Antigen. Patient was treated with remdesivir, albuterol, ceftriaxone, dexamethasone. Patient discharged after 5 days with dexmethasone as new med.

My uncle had a stroke almost exactly one month after second moderna shot. He is/was one of the most healthy older men I have ever known. Avid bike rider and exercise buff usually runs circles around guys half his age. I?m talking biking in the hills fit. He does have a pacemaker now and has to tame things done, but I think he got the pacemaker because he pumped so much blood through that thing doing all those hills for all those years. Not on any other meds expect whatever might be expected for the pacemaker. He was at the gym on May 1 working out and sitting down doing some arm curls when all of a sudden he passed out, he regained consciousness as a couple of guys were helping him to his feet, that?s all he could remember. He managed to drive himself home and then couldn?t shake the headaches and on coming symptoms, so one of his sons took him to the emergency room. Within 30 minutes it was already determined the doctors needed to operate fast. The stroke nightmare and recovery has process has been ongoing ever since. He was transferred to a rehab on May 19th where it looks like he will stay for at least a couple weeks, hopefully. He looks like he aged fifteen years, speech is ok, but he?s slow almost as if he is not hearing me? I think his hearing is fine but it seems like he works to formulate the thought of what he wants to say as I write this summary on May 23rd. He?s got two staples in his head, one pretty much top center and the other just a little off to his right. Drain blood I assume as I?ve never seen a post stroke victim up close like that. Our family do not get strokes! Maybe too much tequila and stuff like that, but my huge family usually all live into their 90?s and a few into their 100?s like my grandparents and my 104 year old great grandma. But of course they did not grow up with flu shots and vaccines. My grandparent grew a substance and stored in jars of olive oil or canola oil and rubbed that stuff on their our bodies if ailments go really bad. Other than that it?s highly concentrate oil of oregano. Couple drops on your tongue will set your mouth on fire. That?s the concentration we are talking about! Anyhow, my uncle hasn?t done vaccines or flu shots in the past, but all this gloom and doom from the mainstream media convinced him to get the shot. This now make the second person to stroke out after these unicorn shots. Yeah thanks big pharma and you scandalous mainstream media for just reading your script and following along. No thanks to all you physicians and nurses out there that also know better, but are keeping your fat traps shut and your hand out receiving your paycheck. We wonder why there is vaccine hesitancy? It?s not hesitancy, it actually watching family and friend bite the bullet right before our very eyes. You healthcare providers are going to have to pay pounds of flesh to our creator for propagating this mess we are in. Your stronger delusion excuse will only carry you so far, before it becomes unforgiveable. God Bless and let?s see how long this report really take to get published on vaers. The world see this one! You better WelcomeTheEagle!

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.

HPI/Subjective: 78 yo with above PMH who presents for new patient evaluation. He was admitted to hospital on 4/3-4/5 for acute episode of dizzines jaw pain found to be hypertensive with elevated troponin. Troponin peaked at 10K. Echo showed no WMAs. Angiogram showed mild distal PLA disease but no other obstructive disease. Cardiac MRI showed a focal area of mid wall LGE consistent with myocarditis. Supportive treatment. Additionally during this admission was found to have small acute L occipital infarcts and tiny infarcts vs artifact in the left thalamus and medulla. Lipid panel and HbA1c unrevealing. ECHO unrevealing. CTA was unrevealing. Patient will D/C with zio patch. Long term blood pressure goal is <130/80. Today, reports feeling OK. No recurrence of the dizziness or jaw pain that brought him into the hospital. No chest pain or pressure or syncope or dyspnea on exertion. No orthopnea, PND or LE edema. Walking 2 miles fast pace without any symptoms. Blood pressures are 130-200s (pre increase in Lisinopril) lower in the morning and worse in the afternoon/evening. Former smoker (quit in '85). Family history - Mom had a AVR in 70s

Oxygen level was dropping; Slight cough; He was very sleepy.; COVID-19 virus test positive; could not finish his sentences; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OXYGEN SATURATION DECREASED (Oxygen level was dropping), COUGH (Slight cough) and SOMNOLENCE (He was very sleepy.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Immunodeficiency (Common variable immune deficiency - Some doctors says he has it, some doctors says he does not have it.), Prostate cancer and COPD. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced OXYGEN SATURATION DECREASED (Oxygen level was dropping) (seriousness criterion hospitalization), COUGH (Slight cough) (seriousness criterion hospitalization), SOMNOLENCE (He was very sleepy.) (seriousness criterion hospitalization), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) and SPEECH DISORDER (could not finish his sentences). The patient was hospitalized on 15-Apr-2021 due to COUGH, OXYGEN SATURATION DECREASED and SOMNOLENCE. At the time of the report, OXYGEN SATURATION DECREASED (Oxygen level was dropping), COUGH (Slight cough), SOMNOLENCE (He was very sleepy.), SARS-COV-2 TEST POSITIVE (COVID-19 virus test positive) and SPEECH DISORDER (could not finish his sentences) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, SARS-CoV-2 antibody test: positive (Positive) Positive and. On 15-Apr-2021, SARS-CoV-2 antibody test positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment was reported. On 15 Apr 2021, the patient developed a slight cough, had difficulty finishing his sentences, the patient's oxygen levels had dropped and was sleepy. The patient was admitted to the hospital and tested twice for COVID-19, both times were positive. Company comment: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 except for the event of SARS-CoV-2 test positive which is unlikely.; 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 except for the event of SARS-CoV-2 test positive which is unlikely.

Patient reported to pharmacy to tell the pharmacist he had been having some pain in his chest (pectoral muscle) and armpit radiating to his back. He explained that he has lung issues from an injury he received as a younger man so he thought it may have been associated with that. I asked him if the pain felt muscular or internal/visceral, he said it felt muscular and noted that it really started after doing his 40 push ups for the morning, but that it has been 2 weeks since his second dose of Moderna covid-19 vaccine. I advised him to try acetaminophen for the pain and to reach out to his doctor if it does not get any better or if it worsens.

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.

Had a heart attack, 100% blockage of the right coronary artery, no heart disease or atherosclerosis present, no history of heart disease or any risk factors. Physician said have been caused by a blood clot.

- Developed heavy sweating and almost passed out, 3/30 @ 3:30am, recovered on own in 3 hrs - numerous periods of low energy days with slight temp - 6/20/21 developed A-Fib at 8:30am and brought to hospital - put on new meds, Metoprotol tartrate 12.5mg x2 per day, Rivaroxaban 20mg x1/day - presently under Cardo Phys care - before COVID 2 shot never had any cardio issues

Large DVT left leg stretching from mid-thigh to mid-calf Many multiple pulmonary emboli Small non-symptomatic saddle block Hospitalized, treated with lovence and subsequently discharged on Xarelto. Expect to be taking Xarelto for at least 3-4 months. Supplemental O2 4lpm 24/7

Pt had vaccination at city site. Waitied 15 min after shot and was cleared to go. Reported to wife that he was very thristy, so they stopped at a convenience store on the way home. While there, he felt worse and asked to go to the Emergency room. They chose Methodist to enter. Pt went to triage and while at triage, had syncopal episode, then full arrest. After short course of CPR and defib, he had ROSC. Was taken to cath lab for intervention (stents) and is now in ICU.

Vasovagal syncope several minutes after administration Patient transferred to the ER for cardiac evaluation and left against medical advice

New onset leukopenia/neutropenia with fever, unclear if related to vaccination, but temporally occurred the day after receiving 1st dose. No labs immediately prior to vaccination, so leukopenia may have preceded vaccine. No other new medications to explain neutropenia. Off chemotherapy since 8/2020. Possible relapsed disease though no other evidence in support of this as remainder of CBC stable.

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.

Chills 6 hours Headache I4 hours Fever 100.8 4 hours Dizzyness 6 hours High Pulse 101 High blood pressure 164-89 6 hours

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

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.

Starting noticing at 4:00 PM noticing pain in the shoulder. The pain in the shoulder got worse to where he had tightness in his chest, but was shaking uncontrollably shivering sensation but was not cold that continued for several hours. Today is still having the pain in his shoulder, and while laying down has the neck stiffness. While sitting up has pain in the shoulder and is applying ice on it now. He took some Acetimenophen as he was told to wait 24 hours before taking anything. Has chronic back pain for which he takes that as well, but now for the shoulder pain as well.

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.

BRAZO, HOMBRO, TOBILLO, PECHO, CUELLO, PARTE DE DONDE LA CABEZA SE JUNTA CON EL CUELLO UN DOLOR COMO CUANDO LE PONEN LAS INJECCIONES DE VITAMINAS. HE PERDIDO LA FUERZA. NO HE PERDIDO SENSIBILIDAD PERO NO HAY FUERZA MUSCULAR. CUANDO VIRO EL CUELLO ME DUELE. EL PIE SE HA MEJORADO, PERO EL TRONCO DEL MULO ME DUELE. EL PECHO ME DUELE CUANDO TOSO. NO TENGO NINGUNA FUERZA NI MOBILIDAD EN MI BRAZO IZQUIERDO Y UN DOLOR "CANSADO" EN EL CUELLO.

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

Pt called RN to car. He states he is feeling his eyes swell and some tightness in his chest. SpO2=95%, no wheeze on auscultation. Pt reports history of asthma and allergies. 25mg Benadryl PO given. Symptoms resolved. Pt observed 30 minutes by RN and MD and sent home with emergency precautions. Pt and wife state understanding.

patient received moderna covid 19 vaccine and then had chest pain. Blood pressure was elevated 171/92 HR 69 and pt has hx of HTN and has pacemaker. 911 was called, patient refused transport to ED and stated chest pain had resolved by 0916 and patient left at 0925.

2-3-2021 pt reported to ER c/o dyspnea, A-fib HR 91, SARSCoV2 RNA test positive in ER, dyspnea on exertion occasional cough, pt admitted to medical surgical floor with acute systolic CHF and COVID-19 with bronchitis, pt was discharged to a nursing home for rehab

Patient 5 to 10 minutes after immunization became unresponsive, The rn helped check out patient with other nurse. Pt had low blood pressure, and was not diabetic. RN gave patient .3 mg epi and patient vitals improved and was observed for 30 minutes by nurse and RN. Nurse later told RN that patient had pacemaker and had similar episodes at least 2 to 4 times in the last 2 to 4 weeks. Patient was fine when we left clinic.

5 days after vaccine given , patients started having chills for very short time twice, some chest pain, extreme fatigue , loss of equilibrium

Pt developed pain and swelling in his leg on 2/8/21. Sent to the emergency room on 2/10/21 and found to have DVT. No history of clots in the past.

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.

# days after vaccination I have heart palpitations - irregular heart beat. I have had afib in past but heart ablation solved problem until now. Don?t know if heart issue caused by vaccine or maybe my afib has returned after over 5 years and is just a coincidence it starting around same time as vaccination.

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

Admit date: 2/12/2021 Discharge date and time: 2/14/21 Admission Diagnosis: DOE (dyspnea on exertion) Hospital Problems: Active Problems: Pulmonary fibrosis (HCC) (8/24/2015) POA: Yes Elevated troponin (11/22/2020): Yes Cardiac pacemaker in situ (11/23/2020): Yes PAF (paroxysmal atrial fibrillation) (HCC) (11/23/2020) POA: Yes Recurrent major depressive disorder (HCC) (11/23/2020) POA: Yes DOE (dyspnea on exertion) (2/12/2021) POA: Yes Acute on chronic systolic (congestive) heart failure (HCC) (2/13/2021) POA: Yes

2/9/21 plt ct 33 (baseline 78), 2/10/21 plt ct 46, 2/11/21 plt ct 6 then 3, admitted to hospital, given high dose steroids and IVIG, symptoms now improving, but experiencing ongoing thrombocytopenia

Patient admitted and treated for respiratory insufficiency, CHF, hypotension, AKI, metabolic acidosis, and hyperuricemia

Patient had sore arm the first day, the second day patient had slurred speech, couldn?t remember or say words, went to the hospital, CT scan and it showed a stroke, AFib came back that had been resolved, he had to be bagged for 2 minutes because he stopped breathing, MD told him the covid shot may have reacted negatively with his previous heart surgery

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

Patient experienced generalized weakness and inability to ambulate. He presented to the ER on 2/24/21 and was found to be hypoxic 88% on room air and was stated on O2. He presented with a rash at site of vaccination on left arm over deltoid muscle. He had a red petechial rash on anterior chest and upper abdominal wall.

Pt received COVID injection at doctors office. Approximately 1 hour later while sitting in recliner, wife noticed patient pale and unarousable. Paramedics were called and found patient with agonal respirations in asystole. Pt was intubated, received epinephrine, amiodarone and atropine per ALS care. Pt wife stated patient complained of dizziness and headache, but no chest pain or shortness of breath. Pt transported to ER. Following testing and treatment in ER, pt transferred to ICU.

patient received moderna covid-19 vaccines on 1/22/2021 and 2/24/2021. he presented to the ED on 2/26/21 with fall and shortness of breath. patient had been generally weak and having difficulty ambulating for some time and was worse the last 2-3 days. patient fell in the evening and could not get back up due to weakness. he was found the following morning and EMS was called. patient was brought to the ED. he was admitted for acute respiratory failure with hypoxia, COPD, pneumonia, NSTEMI, and rhabdomyolysis. also treated for type 2 DM, HTN, and paroxysmal atrial fibrillation. some concern that covid-19 vaccine may have contributed to the patient's rhabdomyolysis. per physician note on 3/3/2021: "Covid 19 infection November 2020, got vaccinated in mid January and then again in February and got a bad reaction which was somewhat to be expected to lead to more marked myalgias and muscle weakness left him lying on the floor unable to get up and he developed rhabdomyolysis." patient is still currently admitted, though CK levels have improved.

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

Patient recieved 2nd dose COVID vaccine and had unresponsive episode in car after monitoring period, staff assessed in car and patient had recovered, staff encouraged family to take to ED for evaluation. From ER MDs note: EKG was normal sinus rhythm, narrow QRS, delayed transition, minimal lateral st depression V4. Patient IV access on arrival, would Brady down to the 40s 1 time as low as 27 but remained alert, blood pressure is not dip. Troponin was mildly elevated and decision was made to transfer the patient. Prior to transfer is necessary to rule out pulmonary embolism, intracranial injury Patient wished to proceed with CT angio chest and noncontrast CT of head which were without acute findings. Patient given aspirin 81 mg to supplement the 81 mg he had earlier today. Discussed with hospitalist, patient was accepted in transfer. Suspect this is combination of patient's beta blockade with underlying sinus node dysfunction. Patient does have prominent lower extremity swelling and suspect pulmonary hypertension despite treatment with CPAP but cannot exclude valvular heart disease. Patient was went to Hospital. Symptoms thought to be unlikely from seizure. Doubt CVA, ongoing cardiac ischemia.

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

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.

The morning after my shot (on Sat), on Sunday at about 6am, I woke with palpatations and high pulse, measuring 225/ 115 111pulse ....called 911 and taken to Emerg Room.

Patient was admitted to Hospital on 3/1/21. Blood Sugar of 758. Patient diagnosis with Acute respiratory failure with hypoxia and acute heart failure and Metabolic encephalopathy. Patient put on ventilator and passed away on 3/2/21 at 17:04.

blurred vision: unable to focus dizziness: blood pressure spike: gradually rising. 185/110 after 90 minues

Patient developed worsening edema and shortness of breath. Became fatigued and went to Emergency Department. He was admitted for 3 days with CHF atrial fib.

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

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

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

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.

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 reports experiencing chest discomfort, shortness of breath, and congestion after vaccine dose 1 and dose 2. Patient seen for televisit after recieving 2nd covid vaccine 4 days ago. He has a little trouble breathing and has pain around his chest with some muscle pains. He reports that the pain is increased in his upper chest. He is more short of breath walking up stairs, coughs up a little bit, does use advair, has rescue inhaler. Patient was directed to seek further care at immediate care. Has hx of chest pain and tightness prior to vaccine most recently documented in 3/2020

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.

Pt had his first Moderna COVID shot on 2/26. Approximately 10 days later on March 7th, pt noticed his blood sugars gradually began increasing.

Pt was found to be having stroke like symptoms 3/15 in the morning at nursing home. he was evaluated and was transported by ambulance from one hospital to another hospital as the CT scanner was down. patient had an injury on march 1 with a cabinet falling on him breaking his femur and family not sure if at that time he had hit his head. Patient was intubated in the ER CT scan showed a massive cerebral bleed with midline shift and transtentorial herniation

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.

Patient tested positive for SARS-COV-2. Patient positive for SARS-COV-2 in 09/2020. Patient tested negative x4 in 12/2020. Patient arrived to our facility with complaints of SOB, acute HTN, feeling warm and perhaps diaphoretic. Found with elevated BP, tachycardia, and tachypnea, afebrile, oxygen saturation 96% on 2L. Chest Xray consistent with COPD.

Symptoms: fatigue, SOB, chest pain middle of chest b/t breasts, tachycardia started 3/22pm and worsened overnight to morning of 3/23/21. "Felt like heart attack". Crick in neck developed overnight after fixing pillows to help with leaning forward b/c that position felt better. Ambulance called 3/23 around 10am. CXR, abdom ultrasound, CT angiogram, lab work completed. MI and PE ruled out. No gallstones, other organs ok on u/s. Small pericardial effusion noted on CT. Symptoms improved after Toradol 15mg x1. Chills developed around 3pm. Discharged to home. Tylenol given at home, chills subsided. Pt felt better later that evening 3/23. Minimal chest pain on 3/24 pm and 3/25 pm. Continues to improve.

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

My blood pressure and pulse rate that were previously consistantly at 120 / 70 pulse rate 60 has been all over the place with the pulse going down as low as 44. I have been attested as having an excellent auto immune system

Spots in left eye Feb 23, normal headache cleared Feb 25. March 2 bad headache returned, March 3 about noon I notice tightness in lower throat. Progressed into lung area around 2:00. It became difficult to breathe. I went to the emergency clinic about 5:00. They did an EKG found no serious problems and suggested I head to the hospital. I arrived there about 6:15 the breathing was exceeding difficult. I could not lay on my back. My lungs on both sides felt like they were on fire when I tried to inhale

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.

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

patient was administered Moderna vaccine (initial shot) and within 48-72 hours became short of breath. He presented to my office for evaluation 4/14/2021 and found to have right leg DVT and massive bilateral pulmonary emboli with left lung infarction.

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

Twenty hrs after shot began to have fatigue, this increased. By 24 hr after shot body aches began. This continued worsening so had very little control of legs and body. At about 30 hrs after shot had to call 911. BP & pulse not extreme but much higher than normal. I, his wife, had to help hold him in upright position so EMS tech could get his vitals. They helped get him in bed (refused ride to hospital). Approx 36 hrs after shot began to see some control returning. Approx 40-42 hrs after shot most side effects gone, only a little tiredness remained. By day 3 all better.

chest pain; Shaking legs/ Tremors in hands; legs buckled; anxiety; Weight loss; fell to ground; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain), TREMOR (Shaking legs/ Tremors in hands) and LIMB DISCOMFORT (legs buckled) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization). On 06-Apr-2021, the patient experienced FALL (fell to ground) and WEIGHT DECREASED (Weight loss). On an unknown date, the patient experienced TREMOR (Shaking legs/ Tremors in hands) (seriousness criterion disability), LIMB DISCOMFORT (legs buckled) (seriousness criterion disability) and ANXIETY (anxiety). On 04-Apr-2021, CHEST PAIN (chest pain) had resolved. At the time of the report, TREMOR (Shaking legs/ Tremors in hands), LIMB DISCOMFORT (legs buckled), FALL (fell to ground), ANXIETY (anxiety) and WEIGHT DECREASED (Weight loss) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Blood test: normal (normal) Normal. In March 2021, Computerised tomogram: normal (normal) Normal. In March 2021, Weight: 148 (Inconclusive) Inconclusive. On 06-Apr-2021, Weight: 125 (Inconclusive) Inconclusive. On an unknown date, Blood pressure measurement: elevated (High) BP Elevated. On an unknown date, Heart rate: elevated (High) Elevated. The patient underwent CAT scan of the stomach, complete gastro work-up and complete blood work up. All tests were result normal. On 3 Apr 2021 he experienced severe chest pain and was transported to the hospital they concluded it was not heart related but he was hospitalized overnight. His BP and heart rate were also elevated. Concomitant product use was not provided.Treatment information was unknown. Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

79-year-old male with history of Parkinson's disease who has become extremely weak since his second Covid vaccination 2 days prior to admission. He has chronic gait instability from his Parkinson's and he had difficulties walking over the last couple days. He slid from the couch onto the floor and was brought into the ECC for further evaluation. He could have been down about 48 hours per his wife and daughter. He injured his buttocks. He has chronic peripheral edema and is not using his compression stockings because they are too difficult. In the ECC, his temperature was 99.2. He did fall to 89% on room air but improved with nasal cannula. Patient was treated for 4 days an

Looked pale and no energy on day 4 after vaxx. Day 5 had stroke between 0700-1100. Thought he was sick with flu. Did not recover after Day 8 and called primary doctor.

Patient admitted after syncopal episode and fall. At time of admission, no respiratory needs, however did require supplemental O2 during current hospitalization. Positive COVID-19 result with admission, >14 days post vaccine completion.

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.

missing of scheduled second dose of vaccine / dose omission; stroke; right side of his body paralyzed, from his face to his feet; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and HEMIPLEGIA (right side of his body paralyzed, from his face to his feet) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stroke in October 2015. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant) and HEMIPLEGIA (right side of his body paralyzed, from his face to his feet) (seriousness criteria disability and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missing of scheduled second dose of vaccine / dose omission). The patient was treated with Rehabilitation therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown, HEMIPLEGIA (right side of his body paralyzed, from his face to his feet) had not resolved and PRODUCT DOSE OMISSION ISSUE (missing of scheduled second dose of vaccine / dose omission) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. After hospitalization, patient was transferred to nursing home, then a rehabilitation facility. The second dose of the Moderna COVID-19 Vaccine was scheduled for an incorrect date of 04-Mar-2021;however the patient did not receive this dose due to hospitalization. Products known to have been used by the patient, within two weeks prior to the event, included unspecified 15 pills. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start dates 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 dates of the events, a causal relationship cannot be excluded.

101.5 Fever, chills, headache, lower back pain on April 25,2021. Received Covid Rapid test on 4/25/21 - Result was negative. Was advised to follow-up with Primary Care Doctor. Went to Primary Care FNP on 4/26/21 and was given blood test and scheduled CT ABD/PELVIS W/O IV No Oral Con (Stone Protocol)

March 22 had a stroke, admitted, respiratory entire time, then rec'd death certificated Death Certificate

myocardial infarction with 100% vessel occlusion; Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (myocardial infarction with 100% vessel occlusion) and ANGINA PECTORIS (Chest pain) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 038A21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included VERAPAMIL, LABETALOL and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) 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 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced ANGINA PECTORIS (Chest pain) (seriousness criterion hospitalization). On 24-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (myocardial infarction with 100% vessel occlusion) (seriousness criterion hospitalization). On 26-Apr-2021, MYOCARDIAL INFARCTION (myocardial infarction with 100% vessel occlusion) had resolved. At the time of the report, ANGINA PECTORIS (Chest pain) outcome was unknown. The patient had an urgent coronary intervention and was discharged from the ER on 26Apr2021. He was informed about an additional 80% occlusion which will require stenting in a future. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

After the second shoe on 3/9/2021, and over the next few days I became increasing inactive and found that I was unable to breath deeply and had tightness in my chest area. On 3/20/2021 I went to the Emergency Room and Health Center.

Non-ST elevation (NSTEMI) myocardial infarction; Acute kidney failure, unspecified; Pneumonia, unspecified organism

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

Almost immediated weakness within 3 or four hours, collapsed the next day, repeated falls, taken to Emergency Room on Thursday, March 25, 2021--admitted to Heart Hospital with heart failure, lung failure ( no history of lung problems), and severe sepsis, placed on ventilator until Saturday, March 27, 2021. Died on March 28, 2021.

Admit date: 2/12/2021 Discharge date and time: 2/14/2021 Admission Diagnosis: DOE (dyspnea on exertion) Hospital Problems: Active Problems: Pulmonary fibrosis (HCC) (8/24/2015) POA: Yes Elevated troponin (11/22/2020): Yes Cardiac pacemaker situ (11/23/2020) POA: Yes PAF (paroxysmal atrial fibrillation)(HCC)(11/23/2020) POA: Yes Recurrent major depressive disorder (HCC)(11/23/2020) POA: Yes DOE (dyspnea on exertion)(2/12/2021) POA: Yes Acute on chronic systolic (congestion) heart failure (HCC)(2/13/2021) POA: Yes

I received my COVID vaccine on may 25 the next day i went for dialysis and had what they told me a seizure. So we stopped the treatment and continued it on Friday and literally 6 minutes into my treatment i went in to cardiac arrest. Was rushed to the hospital and they said my heart was not the problem and they don?t know what happened. So i am assuming its the vaccine because I?ve been downing dialysis now for 3 month and never had a problem.

Patient presented to the ED and was subsequently hospitalized for Atrial fibrillation with RVR within 6 weeks of receiving COVID vaccination.

daily fatigue pain in the right leg from the thigh and knee Knee is swollen went to doctor and told to get sonogram on June 17 after results of sonogram doctor prescribed Xzrelto

Pt received initial dose of vaccine on March 16, 2021. Pt received the second dose on April 15, 2021. Pt had CVA on April 16, 2021 affecting right hand and lower arm with generalized weakness. Pt was fully cognizant at this time. Pt developed pneumonia and was hospitalized in ICU on April 29,2021, requiring ventilation support. Pt died May 6, 2021.

TIA; Lost vision on the left side; lump in left leg; vasculitis in the varicose vein; Chills; Feels tired; This spontaneous case was reported by a health care professional and describes the occurrence of VASCULITIS (vasculitis in the varicose vein), TRANSIENT ISCHAEMIC ATTACK (TIA) and BLINDNESS (Lost vision on the left side) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 CHILLS (Chills) and FATIGUE (Feels tired). On 05-Mar-2021, the patient experienced VASCULITIS (vasculitis in the varicose vein) (seriousness criteria medically significant and intervention required). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion medically significant), BLINDNESS (Lost vision on the left side) (seriousness criterion medically significant) and LIMB MASS (lump in left leg). At the time of the report, VASCULITIS (vasculitis in the varicose vein), TRANSIENT ISCHAEMIC ATTACK (TIA), BLINDNESS (Lost vision on the left side), LIMB MASS (lump in left leg), CHILLS (Chills) and FATIGUE (Feels tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Patient required on full anticoagulation due to events experienced. Lab details were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.

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

considerable itching, formation of one hive (2" x 1" x 1/4 ") located 4" below injection site. Hive went away after 2 days. Itching continued for 3 days. Injection site very hot for 3 days. Blood glucose elevated two days. No treatment, just observation., Epinephrine on hand in case of greater reaction.

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.

Racing heart rate >100 woke him up out of a sound sleep around 10pm on day of vaccine. (Vaccine was given approx 1:40pm) lasted about 30 minutes then it calmed down to more normal heart rate. Next morning bad headache 5-10am. Took Tylenol for it. Also, pain at injection site, across shoulder and lower neck for approx 24 hours after shot.

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.

Began feeling dizzy shortly after receiving the vaccine. I notified the workers. They took my blood pressure and found it was hig. They took it several times and when it was 210/110 they called an ambulance to take me to the emergency room.

Right after the injection had warmth around injection site. Around 12:00 on 1/27/21, he looked wilted. Wife checked his temp and it was 103.8. Was given Tylenol and temp went up to 104. She called the doctor at 2:00 PM, told her to see the doctor. Lethargy and weakness. Tested him for COVID and flu and still had fever. Was negative for both, told to alternate Tylenol and Ibuprofen, went down to 102. At 6:30 PM went up to 103.8, at that point she called the doctor, could not speak to him until 6:45 PM instructed to bath down with warm rag, and was told it was probably a reaction to the vaccine. Was called in a steroid pack. He went to bed running about 103.6 at 8:30 PM. Was able to get up, was given more Tylenol/Ibuprofen and his fever finally broke around 101 about 4:00 AM. Got up this morning and does feel better. Running around 100-101 temp. The vaccine is the only thing that has been different in his normal routine. Still has warmth to the injection site, red.

PT HAD TO GO TO THE ER WITH HIGH BP 226/101. PT WAS PLACED ON ADDITIONAL LISINOPRIL AND HYDROCHLOROTHIAZIDE. HIS BP PRIOR TO THIS DATE HAD BEEN STABLE. IT SPIKED ON THE 18TH AND EVEN AFTER THE ADDED MEDICATIONS HE REPORTS THAT IT IS STILL RUNNING HIGH BUT NOT AS HIGH AS WHEN HE WENT TO THE ER

Patient waited 15 minutes after injection at the vaccine clinic. Shortly after leaving the clinic (less than 1 hour), the patient was taken by ambulance to the hospital experiencing cardiac issues. Patient was air-lifted to larger hospital and later diagnosed with myocardial infarction.

Pt. received Moderna vaccine at 10:45a.m. ten minutes later pt. started complaining of pain behind both ears. Pt. denied chest pain, SOB at the time. Pt. remained in the office. Approximately thirty minutes later, pt. developed chest pain on the left side. EKG was attempted but could not be performed due to pt. stated it was his chest was hurting when he laid back. Pt. was given 2 liters of Depo Medrol IM and placed call to 911. EMS arrived within fifteen minutes. Pt. was transported to ED.

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

Pt presented to ED 1/25/2021 with 1 week history of bilateral shoulder pain, started on right, left involved later, wore with movement. NKI. He was given IM ketorolac 30 mg and seen in Clinic by chiropractor with some relief 1 day. PT consult placed and is still pending. Known hx osteoarthritis right shoulder by x-ray 12/10/20 Pt returned to urgent care/walk-in clinic 2/8 with worsening bilateral shoulder pain. ROM of both shoulders quite limited. NKI. Treated for PMR.

Patient began feeling ill within 24 hours of getting second COVID19 vaccination. Presented to our hospital the evening of 1/28/21 with generalized weakness, fevers, near syncope. Extensive workup revealed likely hemophagocytic lymphohistiocytosis syndrome attributed to reaction to vaccine. Patient treated with blood transfusions, corticosteroid (dexamethasone 20mg) and folic acid 1mg daily. Patient also developed rectus sheath hematoma attributed to vaccine/reaction. Patient continues to remain hospitalized 15 days later. Clinically stable, yet critically ill with no significant / some worsening of laboratory results.

A few hours after receiving first dose of vaccine, developed extreme leg weakness (unable to stand). This persisted for two days and pt was sent to emergency room. Initial evaluation at ER revealed leg weakness only. After 24 hours observation, it was noted that the patient had left sided weakness and slurred speech. MRI confirmed acute infarct in right pons area.

I awoke with a slight headache and a stuffed nose. When I blew my nose and cleared my throat there was a dark brown, grainy substance in the nasal and throat mucus. this persisted for about 20 minutes and then cleared. I've not had any repetition of this since.

80 year old male history significant for multiple cormorbities who presented to the ER with reports of shortness of breath and pleuritic pain. He reports sudden onset of back pain in his thoracolumbar spine which was associated with shortness of breath. He notes the pain was intermittent and sometimes positional but exacerbated with deep inspiration. Due to concern for aforementioned symptoms he presented to his PCP earlier who referred him to the ER. Subsequent workup with CT revealed right sided subsegmental PE. Etiology of PE remains elusive as patient denies recent trauma/immobilization, denies history of prior PE/VTE or coagulopathy

Basically I came after the shot, I drank about 6 beers and got something to eat. About 6 hours after receiving vaccine, I started to develop a chest cold, and started coughing a lot, I was coughing up phlegm and it had blood in it. Yesterday I had chills, my fingertips were kind of a white in color. My temperature was 99.7. I had like a rumbling feeling in my chest and it caused an urge to cough. It went through all the next the day and including all last night. This morning I feel fine.

Muscle aches and pains, fever 100.4 few hours later atrial fib low blood pressure, fall, admit to ED then admit to hospital. Care continuing in hospital at this point.

Went to Dr office and was found to have bradycardia, hypoxia, and resp distress. Sent to ED and was found to have complete heart block, uncontrolled hypertension, worsening resp distress. Adm to ICU for plans for permanent pacemaker placemen, now placed. Patient received COVID vaccine 2 days prior. Specific vaccine information unknown since administered outside of facility.

Patient received his 2nd dose of Moderna Covid-19 vaccine, and approximately 5-10 minutes after receiving, while in the observation area, he lost conciousness while sitting up on the bench. Epi- Pen was administered and EMS arrived within 5 minutes, and transported him to the Clinic. At the time of EMS arrival, the patient was conscious.

Atrial fibrillation for 12 hours and then it disappeared. I have never before experienced AFIB. It was all recorded on my Apple Watch. My resting heart rate normally around 60 bpm was elevated to around 75. Around 10 am everything was back to normal.

Six hours after receiving the Moderna vaccine, the patient experienced palpitations and had a pulse rate between 115 and 130. He was seen in the ER and it was determined that he was in a.fib.

Platelet count: 01/28/2021 169 02/04/2021 130 02/11/2021 170 02/18/2021 134 02/25/2021 121 No bleeding or bruising issues noted

Severe muscle pain, stiffness in shoulders, hips and knees; ibuprophen; slowly improving 6 weeks after

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

Patient is an 80-year-old male that is admitted for observation status for recent TIA symptoms and bradycardia. He was seen in the emergency room this morning at approximately for complaints of posterior head and neck pressure, right arm numbness and tingling as well as a mild blurry vision in his right eye. Patient states that the symptoms from the right arm and eye blurriness lasted less than 1 hour. And has completely resolved at this time. Patient states that he still does have some posterior neck tightness. But most of this is on the left side at this point. Patient denies any increase in physical activity that he could attribute to the onset of the neck pain. Patient states that it does feel tight when he turns his head from side to side. Patient states that he no longer has a headache. He does have a history of a possible mini stroke approximately 10 years ago. He has had no other recent cardiac problems, or any other strokelike symptoms since that time. Patient takes medications for his cholesterol and a baby aspirin daily. Patient is fairly active and continues to drive a semi-5 days a week. TIA Neurochecks every 4 hours Carotid Dopplers 3/2 Bradycardia Echocardiogram 3/2 Last echo 1/4/2019, EF 60% Discharged home 3/2/21.

On 3/2/2021, clinic was notified by patient's family that patient had deceased on 2/28/2021 from a heart attack. Unsure of any relation to the Moderna vaccine but reporting for due diligence.

fever 102 , chills , myalgias on day after vaccine symptoms persisted for 12 days CBC done on 3/3/21 shows PANCYTOPENIA referred to hematology and plan is for monitoring of CBC for now fever has improved

This is to express our concern about the MODERNA and PHIZER vaccines and their possible SIDE EFFECTS, others than those already known. I had MODERNA 1st doses on February 14 and my wife had the 1st dose of PFIZER 1ST of March 1. After the vaccination, we both, have experienced a SIGNIFICANT increase in our blood pressure, issue that I explain below. My wife is 75 years old, weight 128 pounds and goes to the gym six(6) days a week. She has blood Pressure condition, but has been under control due to the medication she takes for few years. I monitor her blood pressure once a week and it have been ok.

Pt got shot at 12:37 pm and asked to wait 15 mins Around 12:42pm he went to bathroom and came back at 12:53pm, sat in waiting chair and begin to lose consciousness. Pharmacy tech associate noticed he was slumping over, breathing and making loud growling / humming sound. Pharmacist came over , shake him for responsiveness. Management called Emergency responders. His eyes open and closed a bit. After one minute he came to. We called code white, management, EMT and fire rescue came and took over. Escorted to hospital after that.

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.

Stroke 11 days (2-27) after first dose (2-16), discharged the following day (2-28). Spoke to PCP's office (nurse) who states stroke was likely due to patient's own decision to discontinue his blood pressure medications without doctor's approval. Stroke unlikely related to vaccination and determined patient should receive second dose on 3-16.

Around 4:30am on the day after administration of the vaccination, patient went into ventricular tachycardia and his ICD attempted anti-tachycardia pacing (ATP). Per electrophysiology note after interrogation of patient's ICD: "Multiple VT episodes beginning around 4:30 AM, and continuing intermittently through 10:15 AM, approximately. There were 19 treated VT episodes, mostly terminated with ATP therapy. There was a single 24J shock delivered at 9:43 AM after a VT episode lasting 1 min, 4 seconds, with average ventricular rate 171 bpm. This appeared to be an appropriate shock after exhausting 8 ATP attempts. On 5 other occasions the patient required 4 or more ATP sequences to terminate VT. The remainder terminated with 1-2 ATPs. Reviewing the far field electrograms, there appear to be 2 distinct VT morphologies. Average ventricular rates for both are about 170-180 bpm." Patient presented to the emergency room, where he received amiodarone IV, and was admitted to an inpatient cardiology service. He was restarted on amiodarone and was noted to be hemodynamically stable and not in VT; however, he opted to leave the hospital AMA on 3/15. As noted previously (item 11), he has a history of VT and had discontinued amiodarone due to side effects about 6 weeks prior to this episode. As amiodarone has a half-life of around 45 days, it is thought that his rhythm control was suboptimal at the time of this vaccination, and there is no evidence that it was the vaccination that caused the VT episodes on 3/14.

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.

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

Got the vaccine, yesterday afternoon he went to the bathroom and felt a little light headed, and was not able to move, but did not collapse. He did not have any muscle control and not able to stand up. He then went down on the floor, not able to get up and called an ambulance and they took him to the hospital, had a temp of 101.4, after Tylenol went down to 99.4 and checked him out, and was having heart arrythemia. They then suspected the adverse reaction to the vaccine and he was checked out of the hospital. They told him to take Tylenol. Told him to FU with his PCP.

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.

Episode of Atrial fibrillation for 20 minutes and then 2 hours later episode of bradycardia of 32 beats per minute with loss of consciousness. The bradycardia resolved in 20 minutes. History of unexplained syncoty 2.5 years ago

Passed out; A spontaneous report was received from a consumer concerning an 80-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and passed out/loss of consciousness. Patient's medical history was not reported. Concomitant product use was not provided by the reporter. On 17 Feb 2021, approximately 17 hours prior to onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: 023M20A) for prophylaxis of COVID-19 infection. On 18 Feb 2021, the patient experienced medically significant event of passed out. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the event passed out was not reported.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Presented to ED with dyspnea and lab showed elevated troponin and COVID PNA as well as CHF exacerbation. Steroids initiated, but no abx noted as needed ber ID physician. Bumex increased for CHF exacerbation. Discharged 4 days after admission oncce stable and recommended outpt follow up due to multiple comorbidities and poor overall prognosis. Patient had first dose of COVID vaccine followed by a positive COVID test at the hospital 21 days later.

Blood clot on his left leg, from his groin to his ankle/still having the blood clot; A spontaneous report was received from a consumer concerning an 80-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and had blood clot on his left leg, from his groin to his ankle. The patient's medical history was not provided. No relevant concomitant medications were reported. On 02 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039KZ014) intramuscularly for prophylaxis of COVID-19 infection. On 30 Jan 2021, approximately two weeks prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection. On an unknown date in Feb 2021, the patient reported having a medically significant event, blood clot on his left leg, from his groin to his ankle and is still having it. The patient taking medication for it. 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. At the time of this report, the outcome of the event had blood clot on his left leg, from his groin to his ankle was not 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, a causal relationship cannot be excluded.

Rapid onset in fever and myalgia. Dyspnea and hypoxia developed over days, and eventually patient was hospitalized with bilateral pneumonia consistent with COVID-19, however patient had multiple negative tests for SARS-CoV-2, both antigen and PCR. Patient eventually diagnosed with interstitial lung disease prior to expiring on 4/7/2021.

You got the vaccine, had no reaction initially. Arm never got sore, nothing at all. Approximately 8 days later he was watching TV, woke up, got up to use the restroom and walked about 40' to get to the bathroom and was breathing so hard that he had to sit down. He went to go back to the couch and was exhausted, got light headed and fell on the floor. He got his wife up, got her dressed and he went to the ER . They said he had a pulmonary embolism and kept him in ICU for 5 days. He has since been okay, been on Eliquis since he has been discharged. Admitted on 2/18/21 and discharged on 2/22/21.

Clot blood; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Clot blood) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medically reported history). On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced THROMBOSIS (Clot blood) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Clot blood) outcome was unknown. The patient was diagnosed with blood clots in legs and lung. Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

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.

3/26/21 Presents to ER with complaint of "cough x3 weeks after choking on some coffee with progressive shortness of breath" Wife reports O2 sat of 88% prior to coming to ER. HX of CAD, hyperlipidemia, COPD. Follows a pulmonologist. Scope was done after "choking" incident which was negative. Pulmonologist though maybe he had Pulmonary Fibrosis. Patient never heard anything back. Cough and Shortness of breath got progressively worse and came to ER. Patient is positive for pulmonary emboli, was admitted to the hospital, and is receiving Eliquis.

Vasculitis; Urticaria both hands; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VASCULITIS (Vasculitis) 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. The patient's past medical history included No adverse event (No medical history reported). On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, the patient experienced VASCULITIS (Vasculitis) (seriousness criterion hospitalization) and URTICARIA (Urticaria both hands). The patient was hospitalized on 05-Apr-2021 due to VASCULITIS. At the time of the report, VASCULITIS (Vasculitis) and URTICARIA (Urticaria both hands) 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. Reporter did not allow further contact

Shortly after waking the day after the shot I fell into unconsciousness for a period of about five hours with the exception of 3 brief return to consciousness. Also, I had Covid-19 the end of December 2020. I am fearful of getting the second shot.

Patient developed unspecified pneumonia which led to extremely high troponin levels. Patient died due to cardio pulmonary disease due to complications from COVID vaccine.

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

80 yo male received first dose of Moderna COVID-19 vaccine on 1/22. Received second dose on 2/19. He also had COVID in December 2020. Around 3/18, patient presents to the hospital with chief complaint of 3-4 days of dyspnea on exertion. He denies fever and cough. Nasopharyngeal swab obtained 3/18 at 1847. Coronavirus PCR test resulted positive a few hours later. Rapid nasopharyngeal test was done on 3/19 and resulted back negative. Patient was diagnosed and treated for community acquired pneumonia with hypoxia.

Left arm swelling, shortness of breath, leg pain, generalized discomfort 4/5/21 - was seen at Urgent Care - no orders 4/6/2021 - seen at Hospital ER - CT showed blood clots/pulmonary embolism of left arm and lungs and lymph nodes. Received IV fluids in ER. Kept overnight for observation and discharged from hospital next day. Sent home on Eliquis and Prednisone

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).

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.

Patient presented to the ED and was subsequently hospitalized on 2/27/21 for elevated troponin. He also presented to the ED on 3/31/21 for frequent PVC.

Hospital Course: Patient admitted to the ICU in cardiogenic shock. Intra-aortic balloon pump. Multiple vasopressors. Intubated-mechanical ventilation. Appropriate sedation. EMD arrest 5/2 spontaneous recovery. Family meeting wife and daughter agreed to A1 designation. 0725 recurrent hypotension nonresponsive to vasopressors, calcium, serum bicarbonate. Pronounced dead at 0754. _________________

This is an 81-year-old male with a history of dementia also a history non traumatic SAH over the right cerebral convexity in 7/17 thought due to amyloid angiopathy , stroke and TIA who is brought by his wife for evaluation of changes that she noted last night around 9:00. She stated around 9 when she was getting ready for bed she thought his speech was a little bit thick but thought she had worn about since they were outside doing a lot of walking and had been to a picnic. The morning of the admission he has been more tired his tongue has been thick his speech is been a little bit slurred and his gait was slow with a shuffling gait. In the afternoon when visiting her son he recommended she bring him in immediately for evaluation.head CT showed small amount of bilateral subarachnoid hemorrhage Neurosurgery at Medical Center was consulted and no surgical intervention was recommended. He was transferred to Hospital for further evaluation treatment . repeat ct head was stable. He was discharged on 5/20/2021 and his aspirin was stopped. He also tested positive for covid 19 despite being fully vaccinated. ddimer was 1787- venous doppler was not done. he did not require oxygen. He was placed on quarantine on dc. Called wife on 5/22 and she reports he is complaining of fatigue but no cough or sob. He also has a history of covid 19 on 12/20 and was hospitalized and discharged on 1/6/21 and tested negative on 1/7/21. during that admission he was treated with remdesivir and decadron. He did not require oxygen. His hospital stay was protracted due to deconditioning and confusion but he was ultimately discharged home . the baby aspirin was added on dc. mri during that admission was normal with no acute abnl seen.

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?

did not get second dose due to side effects from first dose; blood clot in lung; Really bad back pain; breathing was difficult; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (blood clot in lung) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced PULMONARY EMBOLISM (blood clot in lung) (seriousness criterion medically significant), BACK PAIN (Really bad back pain) and DYSPNOEA (breathing was difficult). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (did not get second dose due to side effects from first dose). The patient was treated with APIXABAN at an unspecified dose and frequency. At the time of the report, PULMONARY EMBOLISM (blood clot in lung), BACK PAIN (Really bad back pain), DYSPNOEA (breathing was difficult) and PRODUCT DOSE OMISSION ISSUE (did not get second dose due to side effects from first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products information was not provided. Patient experienced "really bad back pain" and "breathing was difficult". Went to see his doctor who then stated he had a blood clot in his lung. Caller stated he was then put on Eliquis and the doctor said he would have to take it for the rest of his life. Caller wanted to know if this was true or if he can eventually stop taking the Eliquis. He also wanted to know what caused him to get a blood clot. Company comment: Very limited information regarding the events has been provided at this time. Further information is expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is expected.

TIA; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078B20A) for COVID-19 vaccination. No medical history was reported. Concomitant products included DICLOFENAC and FINASTERIDE for an unknown indication. On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion medically significant). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at a dose of Low dose and CLOPIDOGREL BISULFATE (PLAVIX) at an unspecified dose and frequency. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment provided were unknown blood thinner medication. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

04/28/2021: Patient transferred from Hospital with shortness of breath, COVID-19 Positive 4/30-5/16: Patient condition deteriorated. Had repeated episodes of hypoxemia and hypotension - was intubated on mechanical ventilation, eventually switched to pressure control inspiratory pressure, extubated, had to be reintubated. Developed A-fib, leukocytosis worsened, Xray showed tension pneumothorax on right side - chest tube placed. 5/17: Family counseled - patient placed on comfort care, remained on ventilator. Time of Death: 05/17/2021, 16:00 Causes of Death: Bilateral Pulmonary infiltrate, Acute hypoxic type 1 respiratory failure, ARDS, Right Pneumothorax, Acute COVID-19 viral pneumonitis with probable bacterial superinfection, Atrial fibrillation with rapid ventricular response, Septic Shock, Bleeding rom lung/ETT - resolved, Possible Mucor in mouth, Candida tracheobronchitis, Previous history of prostate cancer status post radiation, dyslipidemia, hypertension present at admission.

Patient received first dose of the Moderna Vaccine on 2/15/2021 and second dose on 3/15/21. He initially developed minor flu-like symptoms and then developed chest discomfort accompanied by chest pain. Patient has history of cardiac stent placement and DVT. Patient contacted cardiologist, they initially believed he developed angina. Patient had an ECHO that was normal. Chest pain continued and cardiologist brought patient in for cardiac catherization where 3 stents were placed on 4/9/21. Patient still experienced chest discomfort post-stent placement. Severe pain began to develop after catherization. Pericarditis was diagnosed by cardiologist 12 days after catherization. Patient has been taking colchicine and pain was fully alleviated.

Pt had covid 19 infection in dec 2020 and recovered and was sent to rehab facility on 1/6/21 and ultimately discharged home with his family. He received his 1st and 2nd covid 19 vaccines on 2/10 and 3/12/21 and was admitted on 5/18 and shipped to another hospital after coming to the er with a non traumatic subarachnoid hemorrhage. He was discharged home on 5/20 and his daily aspirin was discontined. He returned back to the ER on 6/1/21 with the family c/o the pt not thriving , difficulty ambulating and progressive decline. Head CT and chest x ray were negative. cbc was normal, tsh normal. covid 19 negative. urinalysis was negative, cmp was normal, cbc was at his baseline. He was ultimately discharged to a nursing home on 6/4/21.

Increasing fatigue and lethargy, short of breath after shot. Trip to urgent care week later resulted in ambulance taking him to emergency room Diagnosed with Atrial fibrillation and resulting clot in heart. Has had a second hospitalization since then. Zero heart problems prior. Now considered a heart failure patient.

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.

bilateral pulmonary emboli-started on xarelto with complete resolution after 3 mo-sx started 3 weeks after second dose (first dose 1/6/21, second dose 2/3/21)

PATIENT FAINTED AND AS A RESULT SUFFERED A SKULL FRACTURE. WAS HOSPITALIZED AND IN A TRANSITIONAL CARE FACILITY.

Patient was feeling in good health prior to receipt of vaccination- Patient reported not feeling well right after receiving the dose; fainted the following day- sought medical care that same day- no issues detected; patient continued to say he did not feel like something was right. Patient died on June 4, 2021- brain bleed - transferred to different hospital-intraparenchymal bleed ---please note- there are NO LOT NUMBERS WRITTEN ON PT VACCINE RECORD!

Pt c/o rapid heart stated my heart beat is feeling very strong at this time which he stated unusual for him. Also pt c/o feeling very cold, body aches and muscle cramps. Pt stated feeling sick since he got his 2nd dose covid vaccine Moderna on 02/17/2021 and sx not getting better. Pt speech clear. AO X3. Answered Yes to emergency sx Rapid heart beat at this time. As per protocol advised pt to call 911 or immediately go to nearest ED for further evaluation and treatment.

Patient had the recommended two vaccine injections properly temporal spacing. A month later he was found to have rather severe hypertension, which he never had before the vaccine. When I saw him (a few days ago) he was on at least one blood pressure drug, and his BP on arrival in office was 195/100. None of his health care providers asked him about vaccination. I did, and was surprised to find the problem started just one month later. No symptoms other than marked hypertension. He states he had been quite healthy until this.

Patient had a concerning drop in his hemoglobin level after receiving the 1st Moderna shot on 3/26/21. He was suspicious at that time that it was due to the vaccine, nevertheless, he agreed to receive his 2nd dose on 4/22/21. The following day his hemoglobin level dropped AGAIN an alarming amount (from 11.8 to 7.7) which resulted in hospitalization and blood transfusion. The patient's platelets dropped extremely low and his graft for dialysis clotted, resulting in loss of the access and catheter placement. After this, the patient became convinced that the vaccine was the cause of dropped hemoglobin level BOTH times.

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.

Per records submitted by the hospital: Symptoms began 7/16, went to urgent care 7/19 with fever and cough, treated with albuterol and doxycycline. Hospital ED 7/22 after vertigo and a fall, hypoxic, placed on bipap. Diagnosed with CHF and pneumonia. Intubated 7/24/2021 and in ICU. Client had CABG 5/23/2021 and had post op complications with a-fib, AKI, hypervolemia and had 3 thoracentesis. Submitter does not have access to full medical record.

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.

Patient with unwitnessed fall after vaccine administration. Found down with small forehead laceration in front of post-vaccine observation area. Sent to ED. On review of hospital admission note, patient left vaccine observation area prior to 15 min observation period to assist his wife. Went to bathroom unassisted, had BM without issue. Upon leaving bathroom syncopized with head strike.

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

One week after first Covid vaccine I was diagnosed with atrial fibrillation. Needed treatment. Four hours after second Covid vaccine atrial fibrillation recurred

PATIENT FAINTED WITHIN 15 MIN OF RECIEVING VACCINATIONS - PT WAS ASSESSED ON SCENE BY ON SCENE MEDICS, THEN WERE CALLED TO SCENE FOR FURTHER ASSESSMENT/TREATMENT. PT WAS TRANSPORTED TO ER FOR ASSESSMENT BY ER PER PT. REQUEST

Per MD & RN notes from Emergency Dept Records: "Of note, patient received first COVID vaccine two days ago 1/14/21 and has had chills, sweats, and malaise over the past 24-48 hours." Pt also reports "not drinking enough water" leading to dizziness & syncopal episodes x3, with T-spine compression fractures secondary to at least one of these falls. Denies loss of consciousness, headache, vision changes, tinnitus, Nausea/vomiting, numbness/tingling/weakness in extremeties except for brief feeling of knees "giving out" just prior to falls. Pt admitted to Medical Ctr on 1/16/2021, w/ T7, T9 & T11 fractures, & comorbidities. Planned discharge for 1/25/2021.

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

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.

Client called to report that the night that he received the vaccine he noticed a small red rash around mouth and nose. Reported that he took Benadryl at that time. On 2/21/2021 he reported elevated B/P and rash has continued but now the redness is on face and jaw line.

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

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

Nurse was summoned to the dining room @ 0910 and found resident to be sitting in his wheelchair in an upright position with his head down with chin to chest. Lips were noted to be blue, resident was not responding to verbal or painful stimuli. Sternal rub resulted no change but a few small and deep breaths. Resident was assisted back to room , still remained unresponsive, assisted with 4 staff and hoyer back to bed. Noted VS at 98.3-54-12-87/46 O2 stats @ 85% on RA. O2 was started and increased up to 4 liters. Noted O2 stats at 86% @ 10:30 . Repeated B/P after 30 minutes was noted @ 75/35. Vitals @ 12:25 101/64 - 98 -57-14-O2 87% with O2 on, blood sugar 171, verbal response to questions @ this time.

two days after vaccination shoulder ache, cough, 4 days after RT calf upper muscle pain which moved into RT ankle, 5 days later previous symptoms gone, 8 days later same calf pain again but in LT, pt also noticed heart arrhythmia's occurring, pt took a beta blocker and symptom subsided

Cardiac arrest resulting in death on the third day post vaccine administration, 0224. Reported syncopal event post toileting. Rescue measures attempted but not successful. Time of death 0358, 02/06/2021.

Patient received his second dose of Moderna COVID vaccine on 2/6 at 12:40PM. Patient was observed for 15 minutes post-vaccination with no adverse events. On the evening of 2/6 (time unknown) the patient began to develop dry cough and fatigue. He was checked by a physician at that time (who was a family member). Patient continued to feel unwell into Sunday. His lungs were clear when checked Sunday afternoon (time unknown). At approximately 5:30pm on 2/7 the patient began experiencing sudden onset shortness of breath. A pulse ox was conducted at that time and it was 92%, and again shortly thereafter and it was 90% (as reported by family member). 9-1-1 was contacted at this time. CPR was initiated when he arrived at the emergency department, pulse ox was 60% (as reported by family member). The patient passed away shortly thereafter on 2/8/2021.

Received Moderna #1 on 1/12/2021. 1/15/2021 developed worsening shortness of breath. Went to hospital and diagnosed with anemia, 4 negative fecal tests, neg EGD and colonoscopy. Discharged and readmitted (circumstances unknown for this episode) then readmitted a third time 1/20/2021 for shortness of breath. Diagnosed covid + at third hospitalization and continued to get worse. He died 1/23/2021.

Unclear if related. Patient vaccinated on 1/22 with first dose of Moderna series (reportedly at his work place) and did well. Then on 2/5 had sudden onset headache found to have significant subarachnoid hemorrhage. Admitted to neuro ICU, EVD placed by neurosurgery. Later went on to develop aspiration pneumonia and MSSA bacteremia. Unclear if initial SAH may have been related to mRNA vaccine.

Stroke; A spontaneous report was received on 09 FEB 2021 from a consumer concerning an 81-year-old, male patient who received Moderna's COVID-19 vaccine and experienced stroke. The patient's medical history provided were, Alzheimer and Parkinson's disease. No relevant concomitant medications were reported. On 28 JAN 2021, patient received their first of two planned doses of mRNA-1273(Batch number 027L20A) injection for the prophylaxis of COVID-19 infection. On 03 FEB 2021, within 7 days of receiving vaccine, patient experienced a stroke. On 03 FEB 2021, patient was admitted to hospital. Patient was due for his second shot of Moderna's COVID-19 vaccine on 26 Feb 2021. Patient's hospital can only provide Pfizer's vaccine and not Moderna's COVID-19 vaccine. But patient wanted to get Moderna's COVID-19 vaccine. Patient's wife wanted to know the way she could arrange the administration of the Moderna's COVID-19 vaccine in the hospital for her husband. Treatment for the event was not provided. Action taken the second dose of mRNA-1273 in response to the event was not reported. The outcome of the event, stroke, was not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, patient's elderly age is considered a risk factor.

Got shot on 1-11-21 and on 1-13-21 am was totally unresponsive , oxygen level low and passed away on 1-14-21

Went into A-Fib. Had not had an A-Fib episode since an ablation in November, 2018. Saw cardiologist on Feb. 22, 2021. Had a cardiogram. Scheduled for a cardioversion on Feb. 26, 2021.

Possible Stroke; Increase pressure and numbness in fingers; Headache; A spontaneous report was received from a pharmacist concerning an 81-year old male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced possible stroke, face numbness, startled speech, increase pressure and numbness in fingers and headache. 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 alprazolam and hydroxyzine. On 02 Feb 2021, prior to the onset of the events, the patient received his first of two planned doses of mRNA-1273 (Lot number: unknown) in the left arm for prophylaxis of Covid-19 infection. On unknown date, days after the vaccine was administered, the patient reported that he started having a headache, increased pressure and numbness in fingers. Patient had been having intermittent symptoms for 9 days. Patient was admitted to hospital on 10 Feb 2021 due to possible stroke. On 11 Feb 2021, the patient began to have startled speech and face numbness. Patient was evaluated by Neurology and an MRI was done. No further information was provided. Treatment for headache included Excedrin Migraine, ibuprofen and acetaminophen. Action taken with mRNA-1273 in response to the events were not reported. The outcome for the events possible stroke, face numbness, startled speech, headache, increase pressure and numbness in fingers, were considered as unknown at the time of this report.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Patient received the vaccination and within 5 minutes began to feel a frontal head ache and sensation of palpitations without chest pain or SOB. During evaluation he reported significant improvement of sensations/symptoms but medic obtained EKG and he was then advised to be transported to ED for full evaluation.

Severe hives accompanied by shivering, significant itching, three fainting episodes close together about 8 hours after the onset of the hives and very low blood pressure following the fainting episode. At home treatment taken on phone advise from Doctorr with Benadryl and Fomantadine with no effect. Prednisone now prescribed. Doctor had suggested a visit to ER but this was taken as the patient was more stable at this time. Potential life threatening event due to the fainiting and low blood pressure/heart rate. These symptoms have occured on previous occassions as a result of virus and other infections.

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

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

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

Unwitnessed Cardiac arrest. ACLS protocols were performed. Cessation of resuscitation was called in the field by Dr.

Extreme loss of strength and energy at 2pm followed by and hour long bout of chills and uncontrolled shaking starting at about 9:15pm. On the following day (2/24) I felt extremely weak and fainted at about 7:00am. So weak it took about 15 minutes before I could raise myself up from the floor. Felt weak and unsteady all day and had muscle aches all over. Slept on and off for most of the day.

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

Developed soreness in left shoulder and chest area. On Mar 2, 2021 I measured my blood pressure at 5:00AM to be 163 over 99. My normal blood pressure is 130-135 over 71-75. Went to the emergency room where an EKG. chest ex-ray and blood work were performed. Doctor reported that all test were normal but blood pressure was still high at 146 over 89. I have continually monitored my blood pressure as follows: 3/2 @ 10:00 PM 144/73; 3/3 @ 7:00 AM 147/77; 3/3 @ 10:00PM; 165/83: 3/4 @ 7:00AM 165/83: 3/5 @8:00AM 157/77. The ER doctor Dr. indicated that the vaccine could have caused inflamation which caused the change in blood pressure

Pt reports chest pain started a few days ago. Brought to ED via EMS. Test done to rule out MI. Patient was monitored and test were negative, patient returned home with care giver.

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

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

Presented to ED with atrial fibrillation with elevated HR (130s) Also had potassium of 2.9 I think it is entirely possible this is NOT related to th vaccine

1100 Patient found unresponsive to verbal stimuli by RN, lips cyanotic, color pale, lowered carefully to ground. Pt then stated he could not breathe. 1105 epinephrine 0.5 mg IM administered to left vastus lateralis by EMT. Breath sounds clear in all fields per EMT. BP 124/70 per EMT. Pt began to report ease of breathing, alert and oriented to self. 1110 Benadryl 50 mg IM administered to right deltoid. Pt condition improving, color improving, alertness improving. 1115 Report given to responding ambulance crew and patient transported to higher level of care.

Patient went down in the parking lot while walking back to his vehicle with his wife. Pt was using a walker. When this nurse responded, the patient was on his side and responsive. Pt denied pain or injury. Upon assessment patient was responsive but had a left-sided facial droop, which his wife said was new. Checked grasps and left side was significantly weaker than the right. Unable to check the lower extremities as legs were under a vehicle. Blood sugar checked, which was 168. Pt is diabetic. 911 was called and patient was taken to hospital via ambulance. Pt was markedly improved at the time of transport but was still pale and ashen.

A-fib; Acute hypoxemic respiratory failure; Acute on chronic congestive heart failure, unspecified heart failure type; Arrhythmia; Febrile; Multifocal pneumonia; SOB (shortness of breath) on exertion

death Narrative: Patient received 1st dose of Moderna COVID-19 vaccine on 03/08/2021. Patient died 03/09/2021. Medical examiner received report that patient was alert before a fall on the night of 03/08/2021. Death certificate will report death likely due to arrhythmia due to underlying CHF. Contributing factors include diabetes.

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

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.

Stroke; Sleeps all the time; Extemely Tired; A spontaneous report was received from a consumer concerning, 81-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) who experienced stroke, was extremely tired and slept all the time. The patient's medical history was not provided. No concomitant product was reported. On 11-Feb-2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. As per reporter patient had been extremely tired and slept most of the day since injection. On 17-Feb-2021, patient experienced stroke. Magnetic resonance imaging confirmed stroke. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events experienced stroke, was extremely tired and slept all the time were considered 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.

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.

Patient developed COVID-19 symptoms and tested positive on 3/21/2021 after getting vaccinated on 3/20/2021. Patient has a history of COVID - he tested positive on November 16 of 2020. Patient's records also list "Acute respiratory failure with hypoxia (*) likely secondary to COPD exacerbation secondary to COVID-19 vaccine reaction" - this was listed as a Problem in his chart on 3/21/2021. - This is his listed prinicpal problem at admission to the hospital on 3/21/2021.

Stroke shortly after the first dose; A spontaneous report was received from a consumer concerning an 81 year old, male patient who experienced stroke shortly after the first dose (cerebrovascular accident). The patient's medical history was not provided. No relevant concomitant medications were reported. On 11 FEB 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. It was reported that the patient experienced stroke shortly after the first dose. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event of stroke shortly after the first dose (cerebrovascular accident) was considered unknown.; Reporter's Comments: This is a case of sudden death in a 93-year-old female subject with no medical hx reported who suffered a stroke (unspecified days) after receiving first dose of vaccine. Very limited information has been provided at this time. Further information will be pursued..

Pt was admitted on 3/25/2021 with a TIA and sudden word finding difficulty along with a headache and a sudden inability to make decisions

patient complained of shortness of breath of 3/22/2021 to primary care physician approximately 1 week post covid vaccine. CT Scan was ordered. Confirmed on 3/26/2021 as Left Lower lobe occlusion and diagnosed with Pulmonary embolism. On 3/26/2021 at Emergency department, he also showed bilateral PE with large clot burden. Patient is hospitalized a this point since 3/26/2021 and has been treated for PE since. He was discharged on 3/28/2021 and continue treatment as appropriate with Rivaroxaban.

03/19/21: Patient presented and was admitted through the ED for dizziness. Patient had a pacemaker placed about 4 years ago. While in ED it was noticed patient heart rate will drop down to 40s and 30s without any pacer spikes. His device was interrogated and it was felt that ventricle lead had refractured. Patient was evaluated by cardiology and was taken to Cath Lab and a transvenous pacemaker was placed through femoral approach. Patient's symptoms improved after placement of temporary pacemaker. Per the EUA, hospitalizations are to be reported irrespective of attribution to vaccine.

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).

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.

Blood clot in leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clot in leg) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039KZ014) for COVID-19 vaccination. The patient's past medical history included No adverse reaction (No reported medical history.). On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced THROMBOSIS (Blood clot in leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot in leg) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 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.

Patient experienced shortness of breath a few days leading up to the adverse event. On the evening of March 11, 2021, he collapsed. An ambulance was called and he was taken to Emergency Room. He stayed there until the morning of March 12, 2021 when it was discovered that he had multiple blood clots in his lungs. At that time, he was air lifted to Hospital Intensive Care where he stayed until March 17, 2021. At that time, he was moved to Health Rehabilitation Hospital of where he stayed until March 27, 2021. First vaccination was on 01/22/2021; Second was on 02/17/2021.

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

Patient had a sudden change in status one week after receiving his first Moderna Covid 19 vaccine. He had sudden onset of tachypnea RR = 40/min, apparent severe pain, greatly elevated blood pressure, with normal heart rate (on beta blocker), diaphoresis. had been enrolled in hospice for 14 months prior to this episode, but had experienced only slow decline prior to this acute event. He died at home under hospice care on 2/27/2021.

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

APRIL 9 EVENING LUMP IN RIGHT LEG, PAIN TENDERNESS AND REDNESS, SITE IS HOT AS WELL. SWELLED OUT, RUNS 2 INCHES, RIGHT ON INNER PART OF LEG, BELOW KNEE LEVEL, HAS HAD 2 NEW KNEE IMPLANTS ON RIGHT LEG.

NA Comfort Cares-acute hypoxic respiratory failure in the setting of bilateral pulmonary extensive infiltrates due to ARDS, pneumonia and possible component of CHF exacerbation. Non-ST elevation myocardial infarction.

4/14/2021 Two weeks after the 2nd Covid-19 vaccine,,about 11 PM. patient, developed a sudden numbness in his right are, hand & right side of the face. He had no sensation and could not feel anything. He immediately was taken to the emergency room at Hospital. They began testing and suspected a blood clot. They administered blood thinners, TPA by injection into the port, performed many tests including Ct scan, chest Xray, blood tests, EKG etc. He was being monitored & hooked up to various scanners. They decided to move him by Ambulance to the ICU Unit at Medical Center . He was in the neurology emergency room there for several hours & then moved the Neurology ICU. They kept him there, doing various testing, until Friday 4/16/2021 When they moved him to a regular Neurology floor. Staff neurologists continued to monitor his condition. On Saturday, 4/6/2021, an MRI showed a small blood clot in the Thalamus of the brain, which they believe caused the lack of sensation on the right arm, hand & face. He was discharged & went home on Monday 4/18/2021. New medication was prescribed, Physical therapy and was told to make an appointment with a Neurologist. On Thursday, 4/22/2021 patient had an appointment with his Cardiologist, Dr. the Dr gave him an examination & told him to proceed with the neurologist, etc. Patient has an appointment at PT in on Wed. April 28, 2021. He is waiting for an appointment with Dr. Neurologist at Neurology Group

Severe headache from the evening of Feb 25, 2021 to Feb 28, 2021, followed by a stroke incident on Feb 28, 2021 with slurred speech and left-sided weakness. Spent 18 days at hospital. (Field 21 was found to be not editable so we placed that information here).

Pt received his 1st moderna covid 19 vaccination on 4/8/2021. He was admitted to hospital on 4/15/2021 with c/o sudden loss of consciousness x 2 that morning after his AICD fired at home. Interrogation of the AICD noted recurrent episodes of ventricular tachycardia. He also tested positive for covid 19 on admission. He was ultimately discharged/transferred to another hospital on 4/28 after 7 days having been treated with amiodarone and lidocaine drip. He was hospitalized at this facility until his discharge to a covid rehab facility on 5/5/2021 as he is still testing positive for covid 19.

Patient presented to the ED with NSTEMI and was subsequently admitted, within 6 weeks of receiving COVID vaccination.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. patient had acute right ACA stroke.

recurrent episodes of ventricular tachycardia; covid-19; sudden loss of consciousness x 2; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (sudden loss of consciousness x 2), VENTRICULAR TACHYCARDIA (recurrent episodes of ventricular tachycardia) and COVID-19 (covid-19) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 immunization. The patient's past medical history included Intracerebral hemorrhage (hx intracerebral hemorrhage), Asthma, CABG since an unknown date and Implantable cardioverter defibrillator insertion since an unknown date. Concurrent medical conditions included Coronary artery disease (CAD), Hypertension, Carotid artery stenosis and Chronic atrial fibrillation. Concomitant products included LISINOPRIL, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), CARVEDILOL (COREG), VALSARTAN and ISOSORBIDE MONONITRATE (IMDUR) for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (sudden loss of consciousness x 2) (seriousness criterion hospitalization), VENTRICULAR TACHYCARDIA (recurrent episodes of ventricular tachycardia) (seriousness criterion hospitalization) and COVID-19 (covid-19) (seriousness criterion hospitalization). The patient was hospitalized on 15-Apr-2021 due to LOSS OF CONSCIOUSNESS, and then from 28-Apr-2021 to 05-May-2021 due to COVID-19. At the time of the report, LOSS OF CONSCIOUSNESS (sudden loss of consciousness x 2), VENTRICULAR TACHYCARDIA (recurrent episodes of ventricular tachycardia) and COVID-19 (covid-19) had not resolved. sudden loss of consciousness x 2 after his Automatic implantable cardioverter-defibrillator (AICD) fired DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Chest X-ray: negative (Negative) negative. On 15-Apr-2021, Full blood count: normal (normal) normal/ at his base line. On 15-Apr-2021, Metabolic function test normal: normal (normal) normal. On 15-Apr-2021, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was treated with Amiodarone and lidocaine drip at the hospital. Patient was discharged from the hospital to a covid rehab facility on 05-MAY-2021. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. with the patient's past medical history of ventricular tachycardia is confounder. Based on biological implausibility, the event of COVID-19 infection, causality is assessed as not applicable in relation to mRNA-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. with the patient's past medical history of ventricular tachycardia is confounder. Based on biological implausibility, the event of COVID-19 infection, causality is assessed as not applicable in relation to mRNA-1273.

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.

Patient presents to ER with chest pain that is constant, achy, occasional sharp stabbing, sometimes worse with deep breath and radiates to his back for the last 2-1/2 hours. He said it started at 10 PM. He said he has not had anything to eat since about 5 PM and says it does not feel like heartburn. Work-up included a CT angiogram of the thorax which showed findings consistent with pericarditis. Patient was noted to have diffuse but mild ST elevations on ECG. Cardiac enzymes remained negative however. Cardiology was consulted, and the patient was admitted to the hospital where he was started on colchicine and NSAIDs. Serial cardiac enzymes remained negative. The patient's chest pain steadily improved, and by last night it had completely resolved. He does have chronic shoulder pain due to osteoarthritis, and this is at its baseline. The patient will finish a 3-month treatment course with colchicine. I am discharging him on as needed ibuprofen for breakthrough pain. It should be noted that the patient did have a brief period of paroxysmal atrial fibrillation which resolved with 150 mg of amiodarone IV. The patient has been continuously monitored on telemetry, and atrial fibrillation has not recurred. After discussion with the patient and his wife, I have elected not to start the patient on aggressive anticoagulation as the period of atrial fibrillation was quite limited and occurred during an acute viral pericarditis episode. Patient's CHA 2 DS 2 score is 4. I recommended that he further discuss this with his primary care provider. Recommend considering an extended Holter monitor.

Persistent Sinus Tachycardia in previously well controlled pt with no new changes in chronic disease course. No new meds, no life changes. At risk of worsening/death as pt has history of thoracic aortic aneurysm, uncontrolled HR can potentially raise pressures and cause rupture.

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.

81 year old male who presented to Medical ER 6/4/21 with possible seizure like activity at home after having his second dose of COVID vaccine on 6/3/21. His first dose of COVID vaccine was given on 5/4/21. After the patient arrived to the ED he was able so my questions. The patient had an EKG performed was not concerning for ACS. He was given a total of 1 mg of Ativan IV. CT head CTA head and neck were negative for any acute findings. He was started on IV lactated Ringer's. CBC was reassuring. CMP showed a sodium of 125 and potassium 3.3. The patient was started on a liter of NS. Magnesium was found to be 1.7 was given 2 g of magnesium IV. Ammonia level blood alcohol level were negative. Initial lactic acid level was 5.9. Repeat lactic acid level is down to 1.9. I had spoke with on-call neurology felt that seizure is most likely due to the patient's electrolyte abnormalities. Did not recommend antiepileptics at this time. I spoke with Dr. who is willing accept the patient for admission to the ICU. When Dr. came down and spoke with the patient he started having another seizure. After the seizure he continued to not breathe. The patient was bagged and started having some spontaneous respirations however continued to have a low O2 sat if he was not bagged. We were able to speak with the neurologist again who recommended giving Keppra 1500 mg IV. Dr. was able to speak with the patient's next of kin his son and the patient's brother who both recommend the patient not be intubated or any other life-saving measures. Would like the patient be kept comfortable. The patient passed away shortly thereafter time of death was 2044.

Stroke at approx 1:10 p.m. on 5/4/21. Taken to emergency room. CT scan and given clot-buster mediation shortly after arrival at emergency room. Transport to hospital on 5/4/21 at 5:45 p.m. and subsequent CT scan revealed intracerebral hemorrhage. Administer medication to reverse clot buster medication and airlifted at approx 7:30 p.m. on 5/4/21. At medial center CT scans and EKG testing. Continued brain bleeding. Brain surgery to relieve swelling. Death on 05/08/2021.

Pt received his first and second COVID19 MRNA Vaccine on 2/4/21 and 3/4/21, respectively. Patient was admitted to our facility on 6/17/2021 w/ symptoms of generalized weakness that had been worsening over the past few days. His first symptoms began on 6/14/21 w/ nasal congestion. He began to have cough and weakness on 6/16/2021. Patient tested positive for COVID 19 on 6/17 via PCR on nasal specimen. As of this report, 6/23/21, pt is admitted to a step-down unit at our facility requiring supplemental oxygen via CPAP. His current O2 requirements are 100 fiO2 and 60lpm w/ 15 cmH20 of PEEP.

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.

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

Fully vaccinated patient who tested positive for COVID during routine admission testing at hospital. Patient admitted through ED for hypoglycemia (30's) and hypoxia (84% on room air). Patient does use O2 at home, but only when he sleeps. Other than hypoxia no other s/s COVID. Discharged home on day 3.

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.

The day following vaccination, 12/31/2020 at 1230, the patient had an acute onset of shortness of breath, tachypnea (rate 34)wheezing, tachycardia (rate 130s and irregular), oxygen desaturation (89 to 91% on room air), and clear rhinorrhea, non-productive cough. Earlier in the day he complained of not feeling well, but non-specific. He was assessed and given an albuterol nebulizer treatment. In the coming hour, his wheezing resolved, work of breathing improved, heart rate and respirations decreased. He was ambulating around without signs of activity intolerance. It was felt that he was stable and back to baseline, so he was monitored by the nursing staff. A chest x-ray was ordered but not completed. On 1/1/2021 at approximately 0925, a nursing assistant described loss of consciousness for 20-25 seconds. It appeared that he was not breathing, slumped over in the chair at the breakfast table eating cream of wheat, eyes rolled back in his head. He regained consciousness, breathing normally after coughing. He did not appear to be choking. His heart rate was recorded as irregular, rate 32 by the nursing staff. He was transported to the Emergency Department at Hospital for evaluation. No concerning findings.

Heart rate went from a normal rate to 144-150. At same time I took a serious cold and achy joints and muscles. Doctor has me taking Digoxin, Diltiazem and Eliquis to try and bring the heart rate down.

Patient presented to ER department with s/s of stroke. He was transferred from Hospital to another hospital

MODERNA COVID-19 VACCINE EUA Patient reports approximately 24 hours after receiving vaccine , he came in from a doctor's appointment and remembers opening the door and then woke up in the floor and there was blood on the floor. Patient had no other adverse reactions other than soreness in his arm. No follow-up treatment required per patient.

Within 15 minutes the patient was complaining of chest pain and shortness of breath. Epipen and Benadryl was administered and vitals checked every 15 minutes by facility's staff

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.

Resident received the first dose of Moderna Vaccine on 01/12/2021 and Tested for COVID-19 on 01/12/2021. Resident tested positive on 01/13/2021. Resident was transferred to acute hospital on 01/19/2021 due to desaturation. Resident expired at Hospital on 01/24/2021.

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

Patient received first dose of Moderna vaccine 1/27/21 and presented to urgent care 2/8/21 with complaint of sores on inside of lower lip. Patient reported that sores started on 2/5/21 and seem to be growing in size. Patient did not recall any injury and sees dentist regularly for annual cleaning. Patient also does not smoke or chew tobacco. Patient was referred to his dentist who was able to get patient in and felt that lesions and ulcerations were not infectious or cancerous. The NP ordered lab work and recommend patient follow up with PCP. Labs came back two hours later and showed patient had a platelet count of 1 (THOUS/uL). Patient was sent to ER at Hospital 1 and was transferred to Hospital 2 for a hematology work-up. Patient is currently admitted and receiving IVIG and steroids

ON DAY OF VACCINE NO PRESENTATION OF SIGNS OR SYMPTOMS OF ILLNESS. PRESENTED WITH FEVER AND SYMPTOMS OF UTI ON 2/5/2021. PCR COVID TEST POSITIVE. SUDDEN HYPOXIA ON 2/6/2021. TRANSFERRED AND ADMITTED TO MEDICAL CENTER.

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.

WOKE UP THIS MORNING NOT FEELING WELL, MANAGED TO SLOWLY WALK INTO KITCHEN, FELT PROFOUNDLY WEAK, BECAME DIAPHORETIC, UNABLE TO SPEAK, SYMPTOMS LASTED FOR 10-15 MINUTES AND GRADUALLY RESOLVED OVER COURSE OF 1 HOUR.

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

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

A fast heartbeat; Dizziness and weakness. Went to ED - "Patient is an 82yo male with a history of chronic Afib on Eliquis, HTN, and bradykinesia (thought to be PD) who presented to the ED with a CC of weakness after receiving 2nd dose of COVID-19 vaccine. He also had low-grade fever and difficulties ambulating. In the ED he was febrile at 38.5C and HR 159bpm. EKG revealed Afib RVR. BP was stable. He was given Cardizem 10mg IV x1. Basic labs were unremarkable. COVID negative. CXR negative. He was given Tylenol for fever and admitted under observation. He remained afebrile and heart rate remained controlled with home Cardizem dosing. Cardiology was consulted who will refer him to their clinic to establish routine care with their service. PT/OT recommended home with home PT/OT. The patient overall felt much improved compared to admission and felt ready for discharge. He was discharged home in stable condition.

rash appeared on torso day 5, diffuse blanching, slightly itchy, progressed, covering entire back by day 5 post vaccination.

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

Patient reports having chest pain developing 1 day post-vaccination. It improved 7 days after onset. The patient states he has a lingering dry cough that he believes is unrelated to the vaccine. Contacted patient's PCP at patient request to have a possible appointment at the office/ PCP recommendation for 2nd dose.

patient developed unprovoked deep venous thrombosis in left leg one day after receiving 2nd Moderna vaccine

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

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.

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.

Patient presented to the ED for evaluation of intermittent chest pain over the past week. Initial troponin negative, patient admitted for observation. Cardiology does not believe cath is warranted at this time. Patient remains hospitalized. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

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

On January 26, patient lost his balance and fell, no injury. On January 28, patient, fell, no injury. In both cases falls were observed and were not to the head. On January 29 patient could not maintain his balance. Taken to hospital. MRI revealed large subdural hematoma. Craniotomy on January 30, by Dr. Approximately 10 days later, Hbg, was down to 7, unexplained internal bleeding.

Client is elderly and has reduced mobility status. Client was ushered up into the bleacher seating at the vaccination site following the dose administration, and upon sitting down was experiencing shortness of breath (reported by the client to be from walking up the stairs). Client pulled out personal inhaler (albuterol) and self-administered a dose. Responder noted pallor and increased difficulty with speaking for the client, but client's breathing returned to a regular rate and rhythm in the minutes following albuterol administration. Client's pallor resolved. The client refused emergency medical services twice, and refused having his vitals taken. The client was monitored visually by responder until deemed appropriate for discharge from the observation area. When the client ambulated down the stairs, Responder noted unsteadiness in gait. Once the client was safely at the bottom of the stairs, a wheelchair was retrieved for the client so that the client could safely exit the facility. Client accepted the wheelchair at this time. Client refused a vitals check a second time at the checkout station, per responder.

On February 26 I got my second Moderna booster shot. On March 2 I got a blood test for my routine medical annual checkup. It showed my RBC and my WBC were below the minimum normal levels and my platelet count was 100, well below the 140 lower normal limit. Also, my lower lip was swollen and chapped. On March 8 I went in for a second blood hematology panel. My WBC was normal, my RBC was 4.31 where 4.5 is normal, and my platelet count was 123. My lower lip was still swollen and chapped. Today on March 13, my lower lip is still swollen and chapped.

Excrutiating leg pain from knee to groin began on day after first shot 1/28/2021 then after 2nd dose was given on 2/24//2021 a massive stroke occured within 8 hours.

pt started slurring his words and his face started drooping about 8 hours after taking the covid vax. pts wife took him to ER. They did a CT which did not show a hemorrhage. He was admitted to the floor but had a 'Stroke Code' so was transferred to ICU. Next day he had an MRI which showed he had a stroke. The following day he was given another MRI since his symptoms were getting worse and it showed additional bleeding. Pt is awake and starting to move around some but unable to communicate which speech at this time.

LEG WEAKNESS, CHILLS, SHORTNESS OF BREATH Narrative: Patient reported after taking his second dose of Moderna vaccine on 2/25/2021 he developed extreme leg weakness, shortness of breath, fever, chills and elevated blood pressure. States the fever and chills lasted for 5 days and the chills were so bad he "shook all over". Patient states the leg weakness and SOB are not completely resolved yet. He completed a chest xray this week and the results are: streaky opacities at the lung bases, likely atelectasis and/or scarring. Patient to complete PFT soon. States his BP has been running 167/88 until 3/15. However patient reports he doesn't take his metoprolol all the time. Legs are still weak 3/15, but began using an exercise machine yesterday for his legs and "feels that may help". Patient also reports he had purchased a "so clean" device to keep his cpap machine clean. He received a letter from the Clinic stating those devices have been linked to asthma and lung problems so he stopped it.

called received from the patients daughter that her father was admitted to the hospital with a PE 5 days after getting COVID booster. Daughter requested report be submitted as a side affect of the vaccine.

3/24/21 ER C/o high blood pressure. States he got up to use the restroom this morning and "felt like my legs wouldn't hold me up & then I checked my blood pressure & it was high". Ambulates from waiting area to room without difficulty. Pt denies dizziness, shortness of breath or pain.

Blood sugars out of normal range. Bed time reading 150 points above normal, to 295. Morning readings up 50 points. Noon time readings up 100 points, dinner time readings up 50 points.

Approximately four hours after administration of Moderna vaccine the patient had a sudden syncopal event without warning. He suffered a scalp contusion. His equilibrium, hearing and vision were diminished for 7-10 days thereafter, gradually returning to normal.

COVID positive with mild infection; Difficulty breathing; Nose bleed; A spontaneous report was received from an 82-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced nosebleed, difficulty breathing and COVID positive with mild infection. The patient's medical history included Pulmonary arterial hypertension and Concomitant medication include TREPROSTINIL SODIUM and TADALAFIL. Lab tests provided for COVID-19 tests positive. On 26 Jan 2021, patient received first of two planned dose and on 16 Feb 2021, received second of two planned dose. On 13 Mar 2021, the patient was hospitalized with nosebleed, difficulty breathing and COVID positive with mild infection and the treatment provided was unknown. Action taken with mRNA-1273 in response to the event was not applicable as the patient received both the planned doses prior to the event The outcome of events, nosebleed, difficulty breathing and COVID positive with mild infection was reported unknown; Reporter's Comments: Very limited information regarding these events has been provided at this time. Based on the known causative agent of COVID-19 infection, the event is assessed as unlikely related to mRNA-1273. It is likely that the patient was already infected with the virus but asymptomatic before being administered with the mRNA-1273 vaccine

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

PATIENT RECEIVED INJECTION AND WAS WAITING FOR THE 15 MINUTES AFTER INJECTION. PATIETN HAD BEEN TALKING TO OTHER PATIENTS IN ROOM WHEN PATIENT APPEARED TO BE MOVING IN CHAIR AND THEN FELL. PATIENT WAS UNRESPONSIVE AND SHOWING SIGNS OF RIGHT SIDED NEGLECT. PATIENT WAS UNABLE TO COMMUNICATE OR SPEAK. PATIENT WAS IMMEDIATELY TAKEN TO THE EMERGENCY ROOM WHERE HE WAS EXAMINED AND WAS THEN TRANSFERED TO A HIGHER LEVEL OF CARE DUE TO STROKE.

Minor brain attack; Partial loss of speech; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Minor brain attack) in an 82-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 reported medical history). On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Minor brain attack) (seriousness criterion hospitalization) and APHASIA (Partial loss of speech). The patient was hospitalized for 3 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Minor brain attack) and APHASIA (Partial loss of speech) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Products known to have been used by the patient, within two weeks prior to the event, included unspecified diabetes and blood pressure medications. Treatment medications included unspecified blood pressure and blood thinner medications. 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 patient's age and comorbidities may be confounding factors for causality assessment.; 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 patient's age and comorbidities may be confounding factors for causality assessment.

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.

He suddenly suffered a severe stroke/blood clot in brain on January 19, 2021 which was 12 days after he received his first dose of the Moderna vaccine. He went via ambulance to hospital and was inpatient there at Hospital for 2 nights.

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.

At 5 AM on 3/21/2021 my father was in bed sleeping and started to gurgle, he was unresponsive, 911 was called he was unresponsive and taken to the Hospital and died at 3:22 PM on 3/21/2021. from a C V A.

Finished 2 dose series in February. Tested + for COVID on 3/29 as outpatient. Admitted to- hospital on 4/14 w/ respiratory distress/dyspnea. Transferred to ICU level care for increasing hypoxemia on 4/15.

Patient's daughter called and reported he was hospitalized for a heart attack and passed away on 4/5/2021.

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

Covid-19 Pneumonia; Fainted twice and hit his head a few times/Oxygen level went below 53; Hit his head a few times from fainting; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 PNEUMONIA (Covid-19 Pneumonia) and SYNCOPE (Fainted twice and hit his head a few times/Oxygen level went below 53) in an 82-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 was reported). On 18-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 COVID-19 PNEUMONIA (Covid-19 Pneumonia) (seriousness criterion hospitalization) and SYNCOPE (Fainted twice and hit his head a few times/Oxygen level went below 53) (seriousness criterion hospitalization). an unknown date, the patient experienced HEAD INJURY (Hit his head a few times from fainting). The patient was hospitalized for 15 days due to COVID-19 PNEUMONIA and SYNCOPE. At the time of the report, COVID-19 PNEUMONIA (Covid-19 Pneumonia) outcome was unknown and SYNCOPE (Fainted twice and hit his head a few times/Oxygen level went below 53) and HEAD INJURY (Hit his head a few times from fainting) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Oxygen saturation: below 53% (Low) below 53%. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and medical history were not reported. The patient felt that he had COVID-19 before he took the vaccine because his family members had it as well. Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

blood clot in his pulmonary artery and several others in his legs; blood clot pulmonary artery; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot in his pulmonary artery and several others in his legs) and PULMONARY EMBOLISM (blood clot pulmonary artery) in an 82-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. Family history included Factor V deficiency, Factor II deficiency and MTHFR deficiency. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clot in his pulmonary artery and several others in his legs) (seriousness criteria hospitalization prolonged and medically significant), PULMONARY EMBOLISM (blood clot pulmonary artery) (seriousness criterion medically significant) and DYSPNOEA (shortness of breath). At the time of the report, THROMBOSIS (blood clot in his pulmonary artery and several others in his legs), PULMONARY EMBOLISM (blood clot pulmonary artery) and DYSPNOEA (shortness of breath) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event 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.; 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.

Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 81 and brought to the Hospital ER on 3/4/21 w/ a STEMI. He did not recover and later passed away there on 3/10/21. Comorbidities include diabetes, HLD, HTN, cardiac murmur.

Blood clots; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clots) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 031L209) for COVID-19 vaccination. Concurrent medical conditions included Cancer (The patient was in recovery from cancer). On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-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 THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Computerised tomogram: blood clots (abnormal) Blood clots. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Description: The patient developed blood clots (medically significant) two weeks after receiving his second dose of the vaccine . The patient was in recovery from cancer and was required to have computerized tomography (CT) scans. He had a computerized tomography (CT) scan within two weeks of taking his second dose and the blood clots were discovered. The patient had never had blood clots before. The patient had already been in contact with his oncologist and was prescribed apixaban. 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.; 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.

Patient had increased respirations, SpO2 declined, 15 seconds of apnea, mottling to BLE, minimally responsive

Pt presented to my office on 4/30 after being vaccinated on 4/20 with left arm swelling. Outpatient stat DVT study in LUE showed extensive thrombosis in veins of LUE and subobcclusive thrombosis in BL Internal Jugular veins. I referred pt to hospital for inpatient admission.

This 82 year old male received the Moderna Covid shot on 1/21/21 and went to the ED on 2/13/21 and was admitted on2/16/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) (CMS/HCC) R29.90 - Stroke-like symptoms I63.9 - Cerebral infarction, unspecified

Developing flushing of face within 15 minutes of vaccination, upon getting home, noted full body rash - itchy bumps. Headache and lightheaded with a slight little cough and able to taste something in mouth immediate. then one week later, 1/18/21 developed stabbing chest pain, medivac'ed 1/19/ 21 to tertiary facility hospital. had 2 stents placed on 1/20/21. Received second dose of Moderna on 2/09/21, again having flushing, headache, taste, smell of medicine, rash, less severe than first dose. Took a nap following. Hurt all over all night 2/10/21. 2/11/21 felt somewhat better. one week later, again experienced shooting chest pain on 2/16/21 (pain 'down my breast bone'). Has not followed up with medical care. Has been 'living with it' due to expense of Medivac. Finally does have a follow up appointment with Dr. on June 7th.

patient received first dose of Moderna on 4/14 and was admitted to the hospital on 4/17 for acute CVA and was discharge from Rehab to home on 5/7. Nurse contacted his provider prior given the second dose of Moderna and provider thought the s/s are sound more indicative of a TIA versus vaccine reaction and it was okay to give. Approximately 5-7 minutes after the second injection was given of MOderna, patient became pale and lethargic, patient reported not eaten all day, vitals were in normal limits, juice was offered to patient and legs were elevated. However patient reported feeling better however his appearance and what he was reporting did not match. Patient was wheeled to his provider team for further evaluation. Veteran was taken via EMS to the hospital due to hypotension.

Patient was admitted to the hospital with COVID + testing, hypoxia, and required treatment with IV dexamethasone, remdesivir and supplemental oxygen.

a stroke paralyzing left side; located in medulla oblongata initial tingling on left side of body; In ER for 3 days. transferred to rehabilitation hospital for 3 wks for basic rehabilitation. Then transferred to nursing facility which is on going. No fever

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

I started exp chest pain. I went to the doctor 40 days later had CT scan noticed scarring and pneumonia.

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.

Patient presented to the ED on 4/10/21 and was hospitalized for choledocholithiasis. Then on 5/9/21 he presented to the ED and was subsequently hospitalized for bilateral pulmonary embolism. This was within 6 weeks of receiving COVID vaccination.

had covid injections in March of Moderna doses at Health Center, stated had second shot 4 days prior to operation that ?went sour,? had hernia repair that was supposed to be ?in and out,? BP 65 systolic after procedure and received 5 units of blood, he is not sure of the cause of hemorrhaging, client did not provide dates of Moderna dosing but stated all in March and that hernia surgery was also in March 4 days after the 2nd Moderna dose.

Having an ICD for 8+ years (with no activations) and a checkup every 3 months with no problems (like afib) I had my first vaccine shot on 03-10/21. At a check up of the ICD on 04/08/21, the ICD reported that I went into afib on 03/31/21. An EKG on 05/07/21 proved the afib and I was cardioverted on 05/12. The cardivert went ok but I still was short of breath and felt (as before) that my heart was weak due to cardiomyopathy. I had had CM in 2007 and 2012 but no problems since. I am now feeling better since the CM seems to be gone but I do feel that ALL of the above problems are due to the vaccine.

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

Within 24 hours after the vaccine his blood pressure escalated out of control, 200's over 100's . He went to see his PCP and cardiologist Nephrologist ended up in the hospital in February and his aortic graphic had broken loose and they felt it was because of the escalation of the blood pressure which the doctor felt was a possibility caused by the vaccine. February 7 he was in the hospital for 4 days. On march 10 he went to the hospital to repair the aneurism that had broken loose, the doctor thought it could have broken loose from the hypertension of the blood pressure. He stayed in the hospital for 48 day and was transferred to a rehab center in anther hospital he was in the hospital for a total of 78 days . He came home on the 26 of May and had home health care, he also was ended up with pneumonia. he came home on antibiotics . He ended up passing away yesterday, May 30th, 2021

1 month after 2nd Moderna Covid vaccine patient developed an acute LLE Deep vein thrombosis despite taking therapeutic warfarin

Patient reports having some nose bleeding throughout the day of vaccination after receiving vaccine and a more serious nose bleed at 2am 5-18 (day after vaccination) that required 10 minutes of pressure. Patient is on Xarelto, spoke to PCP Dr. office and MD recommended holding Xarelto the day of 2nd dose if patient wanted to receive. Patient electing to not receive second dose per patient's discretion/ decision making after speaking with his family.

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

04/03/21 Redness and swelling in upper left arm. On or about 04/09/21 very bad cough and great difficulty in breathing. On advice of Dr. went to Emergency Room. After chest X-ray, EKG, and blood panels was diagnosed with congestive heart failure and furosemide was prescribed. On 04/27/21, 05/05/21 and 05/12/21 had previously scheduled with Dr. Echocardiogram, Stress Test, and Carotid Svan, respectively. As a result, it was found that there was abnormal perfusion scan with severe evidence of infarct in the apex apical inferior, mid inferior apical anterior and mid anterior segment(s). Abnormal left ventricular size with abnormal systolic thickening and systolic function..

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.

had COVID-19 in October; had a stroke; has been receiving therapy, physical therapy; Chills/it throw him in a hard loop of chills.; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (had a stroke) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in October 2020 and Stroke in 2020. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced CHILLS (Chills/it throw him in a hard loop of chills.). On an unknown date, the patient experienced COVID-19 (had COVID-19 in October), CEREBROVASCULAR ACCIDENT (had a stroke) (seriousness criterion medically significant) and PHYSIOTHERAPY (has been receiving therapy, physical therapy). On 26-Jan-2021, CHILLS (Chills/it throw him in a hard loop of chills.) had resolved. At the time of the report, COVID-19 (had COVID-19 in October), CEREBROVASCULAR ACCIDENT (had a stroke) and PHYSIOTHERAPY (has been receiving therapy, physical therapy) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was reported.

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

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

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

Redness, bumps, minor burning pain limited to forehead and chin. Pt washed hair and applied lotion to mitigate the minor burning sensation. Pt advised he noticed onset at about 6 hours post injection on same day, Saturday, January 2, 2021. As of this date, burning and bumps have dissipated and redness is only minor. Photos from Sunday evening, Jan 3, 2021 and Tuesday evening, Jan 5, 2021 showing progression of symptoms, are available upon request.

Patient passed out while driving, the patient called me when they got home. His wife stated that he felt fine and I advised them to get him checked out as their earliest convince.

Patient received vaccine on 1/8/2021. On 1/9/2021 I checked on patient via phone for symptoms or problems and he reported none but mild soreness at injection site. On 1/10/2021 family friend called me to tell me that patient had expired at about 8:00 pm. Patient reportedly complained of "pain" unspecific and collapsed at home. Hospital reportedly told family that it appeared to be a "heart attack".

Patient has end stage renal disease and rapidly worsening dementia, family could no longer care for him at home, and he was admitted for 14-day quarantine prior to admission to inpatient hospice. Received vaccine on 1/12 without apparent adverse reactions. Patient started refusing oral intake on 1/16, and CMP on 1/17 showed hypernatremia 165 (new issue). His BUN 138 CREAT 6.93 K 5.2 were his baseline. He was found to be deceased on 1/18 at 11:18 pm.

Injection was in right arm. Rash on right temple. Itching on right arm, right trunk, right thigh. Bleeding on right thigh and in right groin. Red spots on right arm. Smeared sites of itching with Mometasone Furoate cream, which stopped with itching. Some bleeding in the groin still occurs

Pt received second dose of COVID vaccine on 01/20/2021 at 1430. At 1600 Pt developed a wet productive cough with coarse crackles. Pt ate dinner at 5 pm cough persisted. At 18:30 the nurse went to Pt's room to give him his medications. Pt still had a cough, denied shortness of breath. Pt was in a good mood and joking with staff. Pt asked to be shaved. At 19:45 Pt was sitting in the lounge and a CNA noticed that Pt was pale/white in color and clammy. 02 Sat was 85%. Respirations were labored. Pt was placed on 4 L of 02. Increased to 5 L via face mask and 02 sat was 89-90%. Ambulance was called at unknown time. Pt arrived at Medical Center at 2120 and was pronounced dead at 2127.

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.

reports blood sugars have been higher than normal. Usually morning blood sugar is 120 and it has been 160 since the day of vaccination. Rash on head has flared up and is more painful and hot than normal. Pain at injection site. No fever no rash on arm or near site of vaccination.

Stroke like symptoms; Water in lungs; A spontaneous report was received from a consumer concerning an 83-year-old, male, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke like symptoms and water in lungs. The patient's medical history was not provided. Concomitant products known to have been used by the patient included, insulin aspart, insulin glargine, ticagrelor, sacubitril valsartan sodium hydrate, furosemide, carvedilol, omeprazole, and sertraline. On 04 Jan 2021, one day 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. On 05 Jan 2021, the patient began experiencing stroke-like symptoms and had water in his lungs. On 06 Jan 2021, the patient was hospitalized and had a computed tomography (CT) scan and magnetic imaging resonance (MRI) scan of the brain. On 09 Jan 2021, the patient was discharged from the hospital. Treatment information for the events was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, stroke like symptoms and water in lungs , was not reported.; Reporter's Comments: This case concerns an 83 year old male patient who experienced serious unexpected events of Cerebrovascular accident and Pulmonary oedema. The events occurred the next day of their first dose of their first of two planned doses of mRNA-1273. Concomitant medications included, insulin aspart, insulin glargine, ticagrelor, sacubitril valsartan sodium hydrate, furosemide, carvedilol, omeprazole, and sertraline. 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.

1406: After receiving COVID vaccine, pt c/o sudden lightheadedness, LE weakness, bilat ear pressure, tingling sensation to nose, HA pressure 1410: BP 118/78 HR 52 RR 16 SpO2 99% Add. RN called; head of car seat lowered; pt denied CP or SOB. 1417: HR 60 SpO2 98% Missed heart beats noted on auscultation by NP; pt denies cardiac hx; dizziness persisting 1430: HR 62 SpO2 97% Pt requested to stand; 3 RNs on standby to assist 1432: BP 117/70 HR 58 RR 16 SpO2 97% Pt states, "I feel totally normal." O2 1 L N/C 1450: O2 weaned; no missed beats noted; sxs resolved 1455: Emergency precautions given; pt verbalized understanding; released home

Patient received vaccine at clinic, waited the 15 minutes and was released. Passenger in car, wife driving shortly after departing from clinic - wife state he passed out in the car for approximately 10 seconds, no loss of bowel, or bladder control. Had some UE jerking movements, he was quite awake and alert once he woke up and did not exhibit and post-ictal symptoms. Synocpal episode at 1300 was in Vtac per Boston Scientific Reading.

Patient had heart attack. Spoke with spouse on 2/3/2021 stated had multiple health issues including heart and lung issues.

Ischemic stroke 2 days following vaccine administration resulting in hospitalization. Symptoms began with left lower extremity weakness. The patient also reported a low-grade fever as well as fatigue and generalized weakness following vaccine.

83 year old male was here at our clinic to receive his first COVID vaccine. After leaving the building he was getting into his car, fell and hit his head on the adjacent car. His wife came into the office asking for help, he could not get up himself . Clinician and three providers went out to the parking lot to assist and evaluate the patient. Patient was alert and talking. He was complaining of pain in his r ankle. He was assisted on to the wheelchair, brought back into the office and the ambulance was called. While he was waiting for the ambulance he had a loss of consciousness for 90 sec. Heart rate and pulse ok. EMS arrived and patient was taken to hospital for further evaluation. Pt required ORIF of the right ankle.

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

22 hours after injection; extreme weakness. Inability to stand, walk, rise from chair. Fell to floor of home, lay there. Wife called 911. In ER: some fever and high B.P. discovered. IV. Chest x-ray. After 2-3 hours felt improved. Discharged after about 5 hours. Diagnosis: "Vaccine reaction. Fatigue." Slept normally. Feel well, normal now (10:00 a.m. 2/12/21)

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

Approximately 9-10 days following receipt of the first Moderna vaccine, my father stated he observed a large rash appear at the injection site the covered a large area of his arm. The tissue was warm to the touch and he described feeling an occasional itchy / pulsating feeling in the surrounding tissue.

One week post vaccination, the patient developed bilateral lower leg rash - described as small pinpoint dots around the ankles feet and anterior and posterior calves in a stocking like distribution He awakened one morning with this development . No injury reported no tight clothing noted

Patient was admitted for pleuritic chest pain. It was determined during his hospitalization, that his pain was likely musculoskeletal in nature and was advised to follow up with PCP

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.

Stroke. I do not know if the vaccine was related or not, but the patient had a stroke and falls on 2/17/2021 and 2/18/2021 and was found to have two strokes. He does have atrial fibrillation, but with the proximity to the second vaccine, I cannot tell if they are just related temporally or if there is a true risk. Another patient at this facility had a stroke within same time frame post second Moderna vaccine, but not my patient, so I do not know if that was reported. Due to new nature of this vaccine, I felt it important to report this event for further investigation. Again, I am not sure if it is a true adverse reaction of the vaccine or not.

Pt had normal afternoon after vaccine without complications, went to bed. The patient passed away in the middle of the night. ER report indicates cardiac arrest

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

Patient was admitted at Hospital from 2/11/2021 to 2/17/2021 after a fall with presyncope. Patient sustained head trauma with scalp laceration and staple were placed. Patient has longstanding history of atrial fibrillation and has been taking Eliquis. He was initially seen in the office complaining of fatigue blaming it on the Eliquis that was started. Patient had a Covid vaccination on 2/8/2011. Patient denies any respiratory symptoms. No cough no chills no fever. Complain of exertional shortness of breath. He was seen in the emergency room at and tested positive for COVID-19.

pt returned to his skilled nursing facility after his 2nd covid vaccine and at approx 10:45 pm he was in cardiac arrest. CPR was started and transported to Hospital. Pt was pronounced dead at 1:06 am on 3/11/21

A home dialysis patient who received his first COVID-19 (Moderna) vaccine on 2/4/2021. He was screened prior to admission into the clinic and reported no signs of symptom of COVID-19. This patient was diagnosed with COVID-19 on 2/12/2021 and hospitalized on 2/16/2021 with COVID pneumonia. The patient's spouse and son (who lives with them) also tested positive for COVID-19. This patient developed COVID-19 complications while inpatient including stroke and mechanical ventilation was required. The patient was made a DNR by family and removed from mechanical ventilation and expired on 2/26/2021.

Patient's wife reports patient never reported feeling unwell. He had been working on painting the basement all week and on 02.12.2021 came in from outside, ate, and they sat down to watch TV. Around 9:30 patient reported being extremely tired and went to bed. Was found unresponsive the following morning, 02.13.2021. Patient's wife reports the doctor said it was a heart attack.

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.

Lightheaded, chest started to hurt. Patient fell down in line for vaccine. BP 132/67 (pulse 86), 99% O2 sat. Discharged from hospital on 3/7/21 (stayed ~ 2 weeks).

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

Patient had a mini stroke (TIA) approximately 14 hours after the 1st Moderna COVID vaccine which is when the doctors put him on Plavix, the blood thinner and an aspirin. The patient had a massive stroke with brain hemorrhage within 24 hours of the 2nd Moderna COVID vaccine which resulted in his death.

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

shortness of breath Hypokalemia Metabolic acidosis Pneumonia Chronic atrial fibrillation (CMS/HCC) Acute respiratory failure with hypoxia (CMS/HCC) Multiple myeloma not having achieved remission (CMS/HCC) Severe sepsis (CMS/HCC) ST segment depression

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

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

fainted; A spontaneous report was received from a consumer who was an 83-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and fainted. The patient's medical history was not provided. No relevant concomitant medications were reported. On 4 Mar 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 030421a) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 5 Mar 2021, the patient reported that he fainted and had to be taken to the hospital by a family member. He reported that he had been hooked up to multiple machines for testing. He believed that the syncopal event was related to his heart rate. No treatment information was provided. Patient received both scheduled doses of mRNA-1273, therefore, action taken with the drug in response to the event was not applicable. The outcome of event, fainted the day after 2nd dose, was considered unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

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.

Narrative: Patient received second dose of Moderna COVID vaccine on 3/11. per caregiver, was diagnosed with a stroke at hospital ~ 3/17/21. He was transitioned to hospice and expired last week.

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.

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

Moderna vaccine. A few weeks after the second vaccine the patient was diagnosed with DVT of the lower right leg.

death Narrative: Patient received Moderna Covid vaccine #1 on 2/12/21. On 2/17/21, his son contacted the clinic social worker to inquire about home health services as he thought Patient had had a stroke (no longer able to walk and slurred speech). Patient refused to go to the hospital and son agreed to not have him admitted for fear that he would die alone in a hospital. Patient receives primary care from a provider and social worker suggested that he contact his PCP regarding home hospice services. No further notes of what occurred after that conversation and his date of death is reported as 3/21/21. No autopsy results available. 37 days from date vaccine to date of death.

Had difficulty speaking and forming words. Thought it might be a TIA but next day he still was having difficulty forming words so probably a stroke

blood clot in his brain; Patient collapsed on the floor at night 2 days after receiving 2nd dose; brain was dead; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BRAIN DEATH (brain was dead), CEREBRAL THROMBOSIS (blood clot in his brain) and LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0021B21A and 001821A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history reported). On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) (seriousness criterion hospitalization prolonged). On 30-Mar-2021, the patient experienced CEREBRAL THROMBOSIS (blood clot in his brain) (seriousness criteria death and hospitalization prolonged). The patient died on 08-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, LOSS OF CONSCIOUSNESS (Patient collapsed on the floor at night 2 days after receiving 2nd dose) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, X-ray: blood clot (Positive) x-rays revealed blood clot in his brain. No concomitant medications were reported. After the 2nd dose, On 29Mar2021, at night, he collapsed on the floor and was taken at the hospital on same night by ambulance. So he was hospitalized on 30Mar2021 and upon doing tests and x-rays, they found blood clot in his brain. He stayed in hospital through out and transferred to hospice center on 06Apr2021 where he passed away on 08Apr2021. His brain was dead and never recovered from the clot. Unknown treatment medications were given at the hospital. Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.; Reported Cause(s) of Death: Unknown cause of death

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.

Patient was admitted to the hospital with pneumonia the evening after her received the vaccine in the morning. He had been struggling with his COPD/ pneumonia since 3/1/21. He was hospitalized and died 8 days later

Patient was administered dose 2 of Moderna vaccine on 2/22/2021 and on evening of 2/23/2021 patient experienced a witnessed cardiac arrest, was transported to the ED and expired

possible heart attack; possible stroke; pacemaker was not working; overdue 2nd dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (possible heart attack), CEREBROVASCULAR ACCIDENT (possible stroke) and COMPLICATION ASSOCIATED WITH DEVICE (pacemaker was not working) in an 83-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 Pacemaker insertion (cardiac). Concurrent medical conditions included Pre-existing disease. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (overdue 2nd dose). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (possible heart attack) (seriousness criteria hospitalization and medically significant), CEREBROVASCULAR ACCIDENT (possible stroke) (seriousness criteria hospitalization and medically significant) and COMPLICATION ASSOCIATED WITH DEVICE (pacemaker was not working) (seriousness criterion hospitalization). At the time of the report, MYOCARDIAL INFARCTION (possible heart attack), CEREBROVASCULAR ACCIDENT (possible stroke), COMPLICATION ASSOCIATED WITH DEVICE (pacemaker was not working) and PRODUCT DOSE OMISSION ISSUE (overdue 2nd dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information available. The reporter mentioned that patient has lot of pre-existing medical conditions.She does not know name of current medications he is taking which is tons of them. Patient is currently in rehab center and Hospital where he is admitted did not give him vaccine since he received his 1st dose at Rite aid. Rehab center does not have vaccine in stock. Limited information regarding the possible MI and CVA and pacemaker problems have been provided at this time and a causal relationship cannot be excluded. This report also refers to an event of dose omission. There were no AEs specifically associated with this medication error; Sender's Comments: Limited information regarding the possible MI and CVA and pacemaker problems have been provided at this time and a causal relationship cannot be excluded. This report also refers to an event of dose omission. There were no AEs specifically associated with this medication error

postpone the second dose due to the A Fib; Atrial fibrillation; fast heartbeat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and 01H021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma, Chronic obstructive pulmonary disease and Shortness of breath. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, ALPRAZOLAM, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for an unknown indication. On 28-Jan-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 28-Jan-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant) and HEART RATE INCREASED (fast heartbeat). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (postpone the second dose due to the A Fib). On 28-Jan-2021, HEART RATE INCREASED (fast heartbeat) had resolved. On 25-Mar-2021, INTENTIONAL PRODUCT USE ISSUE (postpone the second dose due to the A Fib) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications included "senadril," "hidrocloric," and medication for irregular heartbeat. The onset of the fast heartbeat was 1 and a half hours after the vaccine dose. Treatment medication included the medication for irregular heartbeat. 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. Additional information has been requested This case was linked to US-MODERNATX, INC.-MOD-2021-079299 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Updated medically confirmed to yes, patient medical history, concomitant medication 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. Additional information has been requested. US-MODERNATX, INC.-MOD-2021-079299:crosslinked case

Pt. experienced chest pain starting Monday morning (03/15/21). Went to the emergency room and found out he was having a heart attack. He underwent a heart cath procedure and while having the heart cath he ha a stroke (around 9pm). Pt is currently in recovery.

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.

Healthcare facility administered the vaccine. I do not have the lot number or vaccine site. He has also had the #2 vaccine given just over 7 weeks ago. Given his history of atrial fibrillation, it is entirely possible the CVA was a result of this, however he has been anticoagulated with Eliquis for a few years without recurrent stroke. He is still hospitalized with intention of transfer to rehab facility as mobility is impaired.

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

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

Pulmonary embolism; died - autopsy showed multiple blood clots all over his body - pelvic area, hearts,arteries, lungs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (died - autopsy showed multiple blood clots all over his body - pelvic area, hearts,arteries, lungs) and PULMONARY EMBOLISM (Pulmonary embolism) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 003A21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Prostate cancer and Memory loss. Concomitant products included METFORMIN for Diabetes. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced THROMBOSIS (died - autopsy showed multiple blood clots all over his body - pelvic area, hearts,arteries, lungs) (seriousness criterion death). On an unknown date, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion death). The patient died on 04-Apr-2021. The reported cause of death was Pulmonary embolism. An autopsy was performed. The autopsy-determined cause of death was multiple blood clots. Action taken with mRNA-1273 in response to the event was not applicable Other concomitant medications were reported included unspecified medications for memory loss and diabetes. No treatment information was provided.; Sender's Comments: This is an 83-year-old, male patient who received mRNA-1273 Vaccine who experienced multiple thrombosis and died, 2 days after receiving second dose of vaccine. Medical history includes Diabetes, and Prostate cancer. Conmeds including some unspecified medications for memory loss and diabetes. The autopsy-determined cause of death was multiple blood clots. Very limited information has been reported at this time. Further information is expected,; Reported Cause(s) of Death: Pulmonary embolism; Autopsy-determined Cause(s) of Death: multiple blood clots

Vitals of patient were taken in mornings after initial dose of vaccine. On the 12th day after said inoculation patient blood pressure dropped from normal 140/72 to 100/58 for period of 2 - 3 days. Patient demonstrated no additional adverse symptoms, i.e., fever, joint pains, respirator distress, headaches, etc.

Patient received the second dose of Moderna on 5/7/21. He had fever and chills later that night after the vaccine. He developed an ACUTE Stroke to right MCA on 5/9/21 while on Eliquis. He did not miss any doses of his Eliquis. He has no history of strokes.

Very high blood pressure with hospitalization required on April 2, April 17, and again on May 9. Catherization on May 11. Discharged late May 11 with additional blood pressure meds.

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

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.

blood clotting issues in his feet,clots on his legs; red places on both of his hands; bumps on legs/appeared as a raised portion on his leg; see the veins and blood in his feet; discoloration; veins more prominent in his feet and legs; headache; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs) in an 83-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. Concomitant products included CARVEDILOL for Heart disorder, FAMOTIDINE, MULTIVITAMINS [VITAMINS NOS] and SERENOA REPENS FRUIT (SAW PALMETTO PROSTATE COMFORT) for an unknown indication. On 18-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) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEADACHE (headache). On 27-May-2021, the patient experienced VARICOSE VEIN (veins more prominent in his feet and legs). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs) (seriousness criterion medically significant), ERYTHEMA (red places on both of his hands), RASH PAPULAR (bumps on legs/appeared as a raised portion on his leg), VARICOSE VEIN (see the veins and blood in his feet) and SKIN DISCOLOURATION (discoloration). On 28-May-2021, VARICOSE VEIN (veins more prominent in his feet and legs) was resolving. At the time of the report, DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs), ERYTHEMA (red places on both of his hands), RASH PAPULAR (bumps on legs/appeared as a raised portion on his leg), VARICOSE VEIN (see the veins and blood in his feet) and SKIN DISCOLOURATION (discoloration) outcome was unknown and HEADACHE (headache) had resolved. Treatment information included the patient using compression hose. After the vaccination the patient experienced a headache for a day.The patient's legs and feet looked much better on 28-MAY-2021. The patient reported he was not on any blood thinners. Company 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, 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. However, Further information has been requested.

Gets cold very easy; Out of breath; Strep through body; Swelled all over body/left foot still swollen; Weak; Paralyzed for over two weeks; Possible A-fib; Arthritis aggravated; Face was swollen; Hands were swollen; Not feeling well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARALYSIS (Paralyzed for over two weeks), FEELING COLD (Gets cold very easy), DYSPNOEA (Out of breath), STREPTOCOCCAL INFECTION (Strep through body), SWELLING (Swelled all over body/left foot still swollen), ASTHENIA (Weak) and ATRIAL FIBRILLATION (Possible A-fib) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis and Cane user. Concomitant products included HYDROCHLOROTHIAZIDE, FINASTERIDE, OLMESARTAN, SIMVASTATIN, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and PARACETAMOL (TYLENOL) for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced MALAISE (Not feeling well). On 04-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ARTHRITIS (Arthritis aggravated), SWELLING FACE (Face was swollen) and PERIPHERAL SWELLING (Hands were swollen). On an unknown date, the patient experienced PARALYSIS (Paralyzed for over two weeks) (seriousness criteria hospitalization and medically significant), FEELING COLD (Gets cold very easy) (seriousness criterion hospitalization), DYSPNOEA (Out of breath) (seriousness criterion hospitalization), STREPTOCOCCAL INFECTION (Strep through body) (seriousness criterion hospitalization), SWELLING (Swelled all over body/left foot still swollen) (seriousness criterion hospitalization), ASTHENIA (Weak) (seriousness criterion hospitalization) and ATRIAL FIBRILLATION (Possible A-fib) (seriousness criterion medically significant). The patient was hospitalized for 34 days due to PARALYSIS, then for 36 days due to ASTHENIA, DYSPNOEA, FEELING COLD, STREPTOCOCCAL INFECTION and SWELLING. The patient was treated with MORPHINE in April 2021 at an unspecified dose and frequency and Physical therapy for Paralysis. At the time of the report, PARALYSIS (Paralyzed for over two weeks) had resolved and FEELING COLD (Gets cold very easy), DYSPNOEA (Out of breath), STREPTOCOCCAL INFECTION (Strep through body), SWELLING (Swelled all over body/left foot still swollen), ASTHENIA (Weak), ATRIAL FIBRILLATION (Possible A-fib), ARTHRITIS (Arthritis aggravated), MALAISE (Not feeling well), SWELLING FACE (Face was swollen) and PERIPHERAL SWELLING (Hands were swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Apr-2021, Hepatic enzyme: elevated (High) Patient experienced elevated liver enzymes.. In 2021, Heart rate: high (High) Heart rate- increased possible a Fib. Concomitant medication also includes an unspecified blood thinner. Patient was prescribed with Tramadol which was provided at discharge. 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. However, patient's hx of arthritis and being a cane user are confounding factors that may play a possible contributory role providing an alternative explanation. FU1 received additional serious AEs after second dose does not change company comment. Further information has been requested. This case was linked to US-MODERNATX, INC.-MOD-2021-067304, US-MODERNATX, INC.-MOD-2021-067204 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 07-JUN-2021, upgraded case to serious with the addition of event paralysis and hospitalization.; 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, patient's hx of arthritis and being a cane user are confounding factors that may play a possible contributory role providing an alternative explanation. FU1 received additional serious AEs after second dose does not change company comment. Further information has been requested. US-MODERNATX, INC.-MOD-2021-067304:First dose case US-MODERNATX, INC.-MOD-2021-067204:Crosslinked (family member)

"blood pressure went nuts"; "soreness only when you touched it"; "arrhythmia skipping beats 1234 skip 1234 skip"; "a bump like the muscle was puffy"; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of BLOOD PRESSURE INCREASED ("blood pressure went nuts") and ARRHYTHMIA ("arrhythmia skipping beats 1234 skip 1234 skip") in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included NADOLOL, CLONIDINE and FINASTERIDE (PROSCAR) for an unknown indication. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PERIPHERAL SWELLING ("a bump like the muscle was puffy"). On 23-May-2021, the patient experienced BLOOD PRESSURE INCREASED ("blood pressure went nuts") (seriousness criteria hospitalization and intervention required) and ARRHYTHMIA ("arrhythmia skipping beats 1234 skip 1234 skip") (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY ("soreness only when you touched it"). On 24-May-2021, PERIPHERAL SWELLING ("a bump like the muscle was puffy") had resolved. On 12-Jun-2021, ARRHYTHMIA ("arrhythmia skipping beats 1234 skip 1234 skip") had resolved. At the time of the report, BLOOD PRESSURE INCREASED ("blood pressure went nuts") outcome was unknown and PAIN IN EXTREMITY ("soreness only when you touched it") had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: skipping beats 1234 skip. (Inconclusive) skipping beats 1234 skip.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Patient had call on 14Jun2021, with symptoms following his first dose of the Moderna COVID-19 Vaccine, which he received on 19May2021 in his left arm, lot#027C21A, expiration 10Oct21. He states that he had felt really good for a day or so and then he developed soreness on his arm only to the touch, "a bump like the muscle was puffy," and "blood pressure went nuts." He had states the puffy muscles and soreness on his arm lasted about 2-3 days. He also states he was hospitalized for his blood pressure and was told by the doctors in the hospital that he had "arrhythmia skipping beats 1234 skip 1234 skip" that was seen on an EKG they performed. At the hospital, doctor "loaded he up with meds and sent he home" and his arrhythmia went away around 12Jun2021 but he is still dealing with the blood pressure. He states he has been dealing with blood pressure issues since before his vaccine and has seen his cardiologist and primary care since hospitalization. Consents to follow up with Safety. 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. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Limited information regarding the events has been provided at this time. 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. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Limited information regarding the events has been provided at this time. Further information has been requested.

Death 04/23/2021 Causes of death listed on death certificate: 1) End Stage Renal Disease 2) Diabetes Type 2 with nephropathy 3) Hypertension 4) Coronary Artery Disease

Increasing weakness, fatigue and shortness of breath. Went to MD. Lungs clear, no wheezing, pulse ox sats 95-100%. Nothing made sense, blood work done. Diagnosis autoimmune hemolytic anemia and ITP triggered by vaccine.

Patient experienced onset of COVID symptoms 05/26. Tested positive for SARS-COV-2 by PCR on 06/09. Presented to ER on 06/12/21 c/o cough, SOB, and hypoxia. O2 sat was 72%. Patient was hospitalized and passed away on 06/18/2021.

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

Felt like a bloody nose, like blood running down his throat. Got up to go to restroom and spit out blood into the toilet.

Heart beat 100-103, Headache, Temperature 102.3, Muscle aches, extremely weak, needed help walking, fell down and needed help getting up

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.

Blurred vision, off balance, low blood pressure. Sent to ER and was admitted to hospital. Tested negative for Covid19 on 1/25/2021 at hospital. Returned to community 1/26/2021 and was sent to the ER within hours of being back from hospital. He remains at the hospital and will be returning on hospice.

Vaccine was given approximately at 1130. Patient was sitting in the waiting are for the 15 minute waiting period. At 1145 he stated he was getting up to leave and was putting on his jacket and "tripped" over it. He fell to his knees. Writer did not witness fall but he states that he did not hit his head and bystanders confirmed this. He was able to get up with assistance. He reported dizziness that started a few minutes after the vaccine. His heart rate was 97. Blood pressure was 152/88 at 11:50 AM and 148/80 at 12 PM. He states he had not yet eaten that day. At 12 PM he states he was feeling better. Denied dizziness, pain, nausea, palpitations, weakness. Hand strength equal. No facial drooping, clear speech. He was able to stand with no dizziness. He was able to put his coat on without assistance. I monitored him walking the length of the facility and out to his vehicle where he was able to get in with no assistance. He was advised to follow up with his doctor regarding elevated blood pressure and fall.

states that since his vaccine, his muscles are weak and he has a HA. Claims chills, fatigue and dry cough Temp 100.4, BP 151/68 HR 84 EKG indicated atrial flutter and low QRS voltage in the prechordial leads.

The morning following the receipt of the Covid-19 Vaccine the patient had an 8:30 check up appointment with his primary care doctor. BP was higher than normal (patient was unsure of the exact reading). Patient attended a cardiology appointment that same afternoon and his BP remained high. Patient monitors his BP at home and said it has been high sometimes and normal at times. Patients doctor advised patient to report the issue as a possible side effect of the Covid-19 Vaccine. Patient has no history of high blood pressure and does not take antihypertensive medications. No other symptoms were experienced by patient.

Syncopal episode at home lasting a couple minutes - taken to ER. Received IVF. No medications received. Fully recovered within minutes of the episode.

Shaking chills, cold extremities, livedo reticularis on the thighs, lasted about 2 hours on the night of vaccination. Treated with tylenol. The next afternoon, he had documented ventricular tachycardia and his defibrillator fired 4 times in 1 hour, requiring EMS activation and hospitalization. His last ICD firing prior to that (only once) was in August 2020 and prior to that more than 2 years of no ICD firing.

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

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

The coroner said it was some type of heart attack; A spontaneous Report Received from a Health care professional concerning a 84 year old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced a heart attack / myocardial infarction. The patient's had undergone triple bypass surgery years ago. Concomitant medications were vitamins. On 18-Jan-2021 prior to onset of events the patient received his first of first two planned doses of (mRNA-1273) COVID-19 vaccine of unknown batch no, unknown route and unknown site of administration for prophylaxis of COVID-19 infection. On 13-Feb-2021 the patient experienced death 27 days after the first dose of the vaccine. The coroner said it was some type of heart attack and think he expired sometime Saturday 13-Feb-2021. On 16-Feb-2021 the patient was supposed to have his second dose of (mRNA-1273) COVID-19 vaccine. The event, heart attack, was fatal.; Reporter's Comments: This is a case of death to heart attack in a 84-year-old female subject with a hx of triple bypass surgery, who died 27 days after receiving first dose of vaccine. Very limited information has been provided at this time. No death certificate provided. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of Death

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

No pulse and no heart beat; couldn't wake him up; passed away; A spontaneous report was received from a daughter concerning a 84-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) experienced no pulse or heartbeat, couldn't wake him up and passed away. The patient's medical history, as provided by the reporter, included high blood pressure and prostate cancer. No relevant concomitant medications were reported. On 19 Jan 2021, the patient had a blood pressure reading of 133/84 at a cardiology visit. On 13 Feb 2021, approximately 3 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number 031M20A) intramuscularly for prophylaxis of COVID-19 infection. On 13 Feb 2021 at 3:30 pm, the patient could not be woken up and was found with no pulse or heartbeat. Action taken with the drug in response to the events was not applicable. The outcome of the events, no pulse or heartbeat and couldn't wake him up, were not provided. The patient died on 13 Feb 2021. The cause of death was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. The patient's medical history of high blood pressure and prostate cancer remains the risk factors. The cause of death was unknown. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

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.

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

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

Death Narrative: 83 y.o. male with pmh of heart failure admitted on 3/9 for shortness of breath and weight gain. Had Vfib arrest on 3/12 and was intubated/xfer to ICU. Continued to require increasing levels of pressors. He suffered VF arrest in the setting of metabolic, septic and cardiogenic shock. He had end stage heart failure and required 4 pressors. Was made CMO and passed away. Noted to have not received 2nd does of Moderna likely due to hospitalization at the time that the second dose would have been due. Patients history of adverse drug reactions included: lisinopril, dabigatran, and penicillin.

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

Received his 2nd covid 19 vaccination on 3/19 and the following day was walking to the dining room of his facility and became weak and slumped to the floor with inability to get up. he presented to the ER with malaise, body aches, fever 101.4 and inability to ambulate and was admitted to the hospital with new leukopenia and thrombocytopenia

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.

Dizziness, weakness, elevated troponin, otitis media, COVID-19 infection Patient presented with elevated troponin likely secondary to rhabdomyolysis. CT suggestive of mass lesion rectosigmoid area. Brain MRI/MRA unremarkable for metastasis or acute CVA ECHO unremarkable for regional wall motion abnormalities

About 11:30 PM on 03/15/2021, started gasping for breath when laying down, sat up in lazy boy for a hour and half, beathing returned to normal. About 3:30 PM on 3/16/2021, started gasping for breath again. Called my daughter and she transported me to Hospital. They tested for covid - results negative. They did a C-Scan of my chest and saw a blood clot in each lung. While hooked to the monitors, they found I had Afib. They also did an ultra-sound of my legs and found a small clot in each leg below the knees in a small vein. I have never had any record of clots or Afib. They transferred me to Medical Center early on 3/17/2021. They started a heparin drip to soften the clots. In the afternoon of 3/17/2021, they performed a Suction Thrombectomy to remove the clots from my lungs. On 3/19/2021, they put me on Eliquis Tab. I was released from the hospital in the evening of 3/20/2021.

Patient apparently was in the bathroom, shaving. Patient's wife was in the kitchen. He does not recall exactly what happened other than he fell backwards. His wife heard a "thud." She went into the bathroom and the patient was not responding. Eyes were open but he was not focusing. He did have generalized shaking of his extremities. Nine-one-one was called at this time. Patient does complain of some mild back pain. He denies any significant headache. There has been no nausea or vomiting. He was diagnosed with syncope event and new onset bells palsy.

Became febrile, poorly responsive. Taken to the MGH ED. En route while in ambulance, he experienced a convulsion with rhythmic shaking in all limbs lasting several seconds. He had a second episode requiring midazolam and levetiracetam. On arrival to MGH ED, the patient was afebrile, heart rate 133, blood pressure 173/93, oxygen saturation 99% on a nonrebreather. He was found to be severely encephalopathic, mute, and not answering questions or following commands. He was admitted to the neuroICU and intubated for airway protection given his poor mental status. He was started on broad-spectrum antibiotics for empiric treatment of meningoencephalitis, but these were discontinued after his CSF was not concerning for a bacterial infection herpes simplex encephalitis. Antibiotics were discontinued. He was extubated on hospital day 2. After extubation he had persistent mixed receptive-expressive aphasia that was slowly improving over time. At discharge from the hospital, he was able to occasionally say a simple sentence, could repeat simple phrases, and could follow simple commands. He was discharged to Rehab

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

On 2/27/2021 at 12:46 pm, the patient developed chest pain. Not helped by nitroglycerin x 2. He was transported to the hospital where he died.

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

On March 23, 2021, 4 severe nosebleeds throughout the day, the last one ending at 8:30 p.m. 3/24/21 another severe nosebleed at 10:18 a.m. After that there were several minor nosebleeds with the last slight one being on 3/29/21. Additionally, blood pressure and heart rate were erratic, ranging from 113/58, HR 76 on 3/26/21 to 189/98, HR 76 on 3/29/21. Up to receiving the vaccination, there has never, ever been a history of nosebleeds.

Received Moderna vaccine on 2/29/21 and 3/19/2021. Health began declining 2 weeks later and died on 4/13/2021 (26 days post vaccination) with heart failure listed as cause of death.

death Narrative: Patient received his COVID #1 vaccine on 1/4/2021. He is noted to be a dialysis patient and on 1/21/2021 was given a RX for treatment of a UTI. On 1/24/2021, he was admitted to a facility with a syncopal episode. He remained there until 2/2/2021 when he discharged to home. On 2/4/2021, notes indicate that he passed away in his sleep that night. No autopsy reports available. 31 days from time of vaccine #1 and date of death, does not appear that he received vaccine #2.

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.

Patient admitted on 2/17 after noncardiac syncopal episode. He had recently gotten his first dose of Moderna on 2/15. He is normally ambulatory independently. He had mild rhabdo and was admitted from 2/17-2/19. DC'ed in stable condition.

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.

Worsening shortness of breath since the vaccination; collapsed in bathroom on day 10 post-vaccination

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

2/17, admitted 2 days after covid vaccine with syncope/rhabdo. Patient admitted for mild rhabdomyolysis after a noncardiac syncopal episode that was thought to be related to recent Covid-19 vaccination. Troponin is elevated 0.25, lactate is elevated at 5.5. BMP shows elevation in glucose and BUN. PT/INR is elevated. VBG is unremarkable. CBC shows a macrocytic hyperchromic anemia. Patient's CK came back significant elevated likely indicating rhabdomyolysis. Admitted for cardiology consult. Patient was treated aggressively with IV fluids. Patient had multiple reevaluations given his history of congestive heart failure. After evaluation- not sure what caused the patient to collapse, but the etiology does not appear to have been cardiac. The patient thinks it may have been due to a reaction to the COVID vaccine.

pt felt unwell shortly after vaccine with profound weakness after 2nd dose. later developed SOB and was diagnosed with pneumonia (in March approximately 1 month after the second dose) subsequently had ongoing respiratory symptoms and was later diagnosed with pulmonary embolism/DVT in May

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.

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

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

Death 5/31/2021 Causes of death listed on death certificate: 1) atherosclerotic heart disease Other: recent Cove at 19, pneumonia, peripheral vascular disease, hypertension, dementia, extensive squamous cell carcinoma of skin of scalp, protein calorie malnutrition

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

Atrial Fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial Fibrillation) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 016M20A) for COVID-19 vaccination. The patient's past medical history included Shortness of breath. Concurrent medical conditions included COPD (treated with prednisone) and Heart disorder. Concomitant products included PREDNISONE for COPD, BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) and ALBUTEROL [SALBUTAMOL] for an unknown indication. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Atrial Fibrillation) (seriousness criterion medically significant). The patient was treated with DILTIAZEM for Atrial fibrillation, at an unspecified dose and frequency; APIXABAN (ELIQUIS) at an unspecified dose and frequency; LISINOPRIL at an unspecified dose and frequency and OXYGEN at a dose of 1 liter. On 22-Feb-2021, ATRIAL FIBRILLATION (Atrial Fibrillation) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication included unknown medication that starts with the letter "T". The action taken for m-RNA-1273 Covid-19 Moderna Vaccine was not applicable. This case concerns a 84-year-old male with a serious unexpected event of atrial fibrillation. Event latency 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-238713 (Patient Link).; Sender's Comments: This case concerns a 84-year-old male with a serious unexpected event of atrial fibrillation. Event latency 2 days after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab; Shortness of breath is now really bad/ shortness of breath sometimes extreme/ shortness of breath a lot worse now; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Shortness of breath. Previously administered products included for Atrial fibrillation: Diltiazem; for an unreported indication: PREDNISON ("burst" (one-week course)). Concurrent medical conditions included COPD. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ALBUTEROL [SALBUTAMOL] and DULOXETINE HYDROCHLORIDE (DUAL [DULOXETINE HYDROCHLORIDE]) for an unknown indication. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (Shortness of breath is now really bad/ shortness of breath sometimes extreme/ shortness of breath a lot worse now). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Stroke, at a dose of 1 dosage form and LISINOPRIL ongoing since an unknown date for Stroke, at a dose of 1 dosage form. At the time of the report, CEREBROVASCULAR ACCIDENT (Suffered a stroke\ spent 2 to 3 days in the hospital\ spent 10 days in Rehab) and DYSPNOEA (Shortness of breath is now really bad/ shortness of breath sometimes extreme/ shortness of breath a lot worse now) outcome was unknown. Patient stated that he was on one litter of oxygen (unknown flow rate). Patient stated the stroke affected his right "writing" hand. He reported that he had no history of heart problems prior to receiving the Moderna COVID-19 vaccine series Action taken with mRNA-1273 in response to the events was not applicable. Based on current available information and the temporal association between product use and the start date of the events which is greater than two (2) months a causal relationship is unlikely. This case was linked to MOD-2021-238669 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events which is greater than two (2) months a causal relationship is unlikely.

The patient tested positive for COVID on 7/15/2021 after being exposed to family member(s) that were also positive. He came to the hospital on 7/19/2021 with symptoms of shortness of breath, hypoxia, and dyspnea.

Dizzy during observation period immediately after vaccine administration during occupational vaccine drive. Then the patient still decided to go back to work. Upon going back to work was noted to be flushed in the face. And was noted to have high blood pressure. Ultimately was sent to on-site ER for evaluation. Upon questioning, unclear if patient ate or drank prior to administration.

Upon awakening at 07:00 began an uncomfortable feeding in chest. Over the next few hours, the feeling became painful. The pain was radiating from the center of my middle chest outward. It became more painful to breath deeply. At about Noon I began feeling worse all over my body. Joint aches, sensitive skin and just feeling not well. It is now 1:48 and I feel no better, but no worse. A nurse from the facility, is going to give me and my wife a Covid-19 test momentarily.

bilateral neck pain, low back pain, Left arm pain. Pt reports he "passed out" at ER. Pt states he went to the ER at 6:00 due to symptoms- Pt reported all testing in ER came back normal

1/24/21 0445- patient presents to the ED with complaints of neck pain, chest pain, and back pain for about a week. States also feels SOB, intermittent fever with temperature 100.3 on arrival. Patient was worked up for his cardiac type symptoms, found to have elevated WBC and CRP with no explanation. D-Dimer was elevated with CT showing no sign of PE. Patient was sent home from the ED with instructions to follow up with primary care and/or return if s/s worsen. 1/24/21 1705- patient is returned to the ED via ambulance after becoming unresponsive and some seizure like activity. Patient was intubated. Head CT showed large brain bleed that was irreparable and not compatible with life. Patient was also found with positive blood cultures x2 with gram positive cocci in clusters growing after 9 hours.

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

ER visit 1/25/21 patient walked into a prompt care and collapsed, witnessed and pulseless CPR with ROSC after 6-7mins, no shock no meds. Awake and speaking upon arrival to ER. 2 plus pitting edema ble ER diagnosis Anasarca, cardiac arrest, hypotension, elevated troponin I levels, Acute kidney injury and syncope. ER notes reveal a syncopal episode in the shower prior to collapse at prompt care. Central line placed and plan to ship to another facility, patient continued to decline despite dopamine and dobutamine expired in ER prior to transfer.