Moderna

This is a 40 y.o. female who presents with abrupt onset of nausea vomiting, diarrhea, myalgias, headache about 2 hours after receiving her 1st Moderna COVID-19 vaccine at 1300 hrs.. She describes myalgias extending from the area of her left deltoid injection site over her shoulders and over her entire upper body. No neck or back pain. She describes diffuse throbbing headache with no positional component. She has had relentless nausea vomiting and retching. She has been up vomiting stomach contents to bile multiple times. She has had loose watery brown diarrhea multiple times. She describes diffuse abdominal crampy pain with increased tearing retching and vomiting. She denies any shortness of breath cough or wheezing. Voice is normal. No swallowing dysfunction or pain. No intraoral or facial swelling. She denies rash or pruritus. No arthralgias. Patient reports prior anaphylaxis with shortness of breath and tight airways, difficulty speaking and swallowing, and relationship to coconut ingestion few years prior. No other known food/nut reactions. Patient is a CNA for care at home. Last Covid test was 2 weeks ago which was negative. She reports she has been tested every 2 weeks routinely. Review of Systems Cardiovascular: Negative for chest pain and palpitations. Gastrointestinal: Positive for abdominal pain, diarrhea and nausea. Negative for vomiting. Musculoskeletal: Positive for myalgias. Negative for arthralgias, back pain and neck pain. Neurological: Positive for headaches. Negative for dizziness, weakness and numbness. Physical Exam BP 126/73 | Pulse 120 | Temp 37.1 °C (98.8 °F) | Resp 18 | Ht 1.575 m (5' 2") | Wt 68 kg (150 lb) | SpO2 100% | BMI 27.44 kg/m² ED Course as of Dec 30 2340 Wed Dec 30, 2020 2128 Reevaluation: Nausea improved. Abdominal cramping resolved. No further diarrhea or vomiting. Still complains of headache and muscle cramping through her upper shoulders and arm. Will remedicate with steroid and acetaminophen 2258 Reevaluation: Patient improved. Pain/myalgias improved. Headache now mild and dull. Continues with no further.nausea vomiting or diarrhea. She would like to try fluids at this time. Assuming toleration we will plan on discharge home. 2326 Reevaluation: Patient feels improved. Headache essentially gone. Taking p.o. fluids well. Discharge instructions discussed. She is very familiar with an EpiPen because of her daughter's prior use. Discharge instructions discussed. ASSESSMENT and PLAN This is a 40 y.o. female who presents with nausea vomiting diarrhea, myalgias, diffuse abdominal cramping, severe global headache, onset about 2 hours after first dose Moderna COVID-19 vaccine. Exam with intact mental status, neurologic system. Abdomen with some diffuse tenderness but no evidence of peritoneal sign. She had diffuse palpable soft tissue muscular type tenderness through her upper extremity shoulder and bilateral paraspinal back. She had no meningeal signs. She had no cardiorespiratory signs or symptoms. Her chest was clear. Voice normal. Swallowing normal. Oropharyngeal region normal. Initial ED ED management focused on rehydration, antiemetics and subsequent treatment for presumptive anaphylaxis with likely system involvement gastrointestinal and neurologic. She was treated with Solu-Medrol, famotidine and acetaminophen. She improved during ED course and did not require epinephrine. Symptoms at ED reevaluation/discharge were resolved. Clinical impression favors anaphylaxis over medication side effect given time course and abrupt onset of symptomatology and signs. She has a distant history of anaphylaxis to coconut-based product in her past. She has no history of ongoing allergic chronic history otherwise. Other organ systems appeared stable at onset and through ED course including cardiovascular and pulmonary. Plan is for discharge home with rest fluids. She will have a course of steroids/prednisone and famotidine. She was sent home with an EpiPen and understands use and precautions. Discussed ED "return immediately if" parameters with patient. Ongoing FOLLOW UP evaluation/care coordination via PCP recommended. Patient voices good understanding of current evaluation, follow-up & return recommendations and discharge instructions. Encounter Diagnosis Anaphylaxis due to vaccination, initial encounter Plan: -d/c home. No work next 2 days. Off work note provided -COVID-19 testing pending -rest with activity as tolerated -diet as tolerated & increased fluids as discussed -acetaminophen PRN -Prednisone 40 mg daily to finish 4 more days -Famotidine 40 mg daily to finish 4 more days -Zofran as needed (patient has at home) -Loratadine 10 mg OTC as needed -PCP f/u -ED return for interval worsening -instructions discussed & as documented

Patient received the vaccine on 1/18/21. He awoke early on 1/20/21 with nasal congestion. By that afternoon, he was having difficulty breathing. He was evaluated at Hospital outpatient clinic and sent to the Hospital Emergency Department. On arrival he was placed on oxygen and given a rapid COVID-19 test and COVID-19 PCA test which were both negative. He was also provided pulmonology consult. He was admitted and remained unable to maintain adequate oxygen sats without 10L oxygen until 1/22/21 late in the evening when he abruptly no longer needed oxygen. He was provided steroids initially. Ceftriaxone IV was added. Respiratory therapy provided ipratropium inhalation and vest therapy. He improved rapidly 1/23/21 and was released from the hospital on 1/24/21.

Elevated heart rate (130 at rest for 10+ hours, my normal is 70-80) Elevated blood pressure (150/89 at rest for 10 + hours, my normal is 110/70) Extreme headache, light sensitive Nausea Mild anaphylaxis itching/burning/tingling in lips, tongue and throat Feeling of intoxication, disoriented, slurred speech, dizziness Rash/redness that spread beyond injection site on to back of shoulder Agitation Itchiness Peeling of skin in mouth/cheeks Blisters on roof of mouth Chest tightness with normal breathing Jaw pain Treatment as listed below; continue with Benadryl every 6 hours and ibuprofen; return if symptoms continue or worsen

Moderately severe tonic/clonic seizure of approximately 60 second duration observed by nursing staff at approximately 7:00am on 2/3/21. Patient was awake sitting at the dining table. Patient has no previous history of seizures. The only immediate treatment was continued observation, with no further seizures noticed to date. Patient visited his PCP later that day for follow-up, no treatment advised.

Pneumonia; A spontaneous report received from a healthcare professional concerning a 40-year-old, male patient who received Moderna's COVID-19 vaccine and developed pneumonia. The patient's medical history provided were, severe developmental disabilities, chronic constipation and allergy induced asthma. No relevant concomitant medications were reported. On 18 Jan 2021, patient received their first of two planned doses of mRNA-1273(Lot number: unknown), for the prophylaxis of COVID-19 infection. On 20 Jan 2021, within 3 days after injection, the patient was hospitalized for pneumonia. Patient received the vaccine because he received supported living services. The reporter was reluctant to agree to him receiving the 2nd dose. Treatment for the event was not provided. Action taken the first dose of mRNA-1273 in response to the event was not reported. The outcome of the event pneumonia was unknown.; Reporter's Comments: This case concerns a 40 year old male subject, with history of allergy induced asthma, among others, who experienced a serious unexpected event of pneumonia after first dose of mRNA1273 (Lot# unknown). Very limited information has been provided at this time. Further information has been requested.

Pneumonia; difficult time breathing; A spontaneous report was received from a health care professional concerning a 40-year-old male patient who was administered Moderna's COVID-19 vaccine and experienced having a difficult time breathing (dyspnea) and pneumonia. The patient's medical history included autism and mental retardation. Concomitant product use was not provided by the reporter. On 18 Jan 2021, approximately 2 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On 20 Jan 2021 early in the morning, the patient had a difficult time breathing. Around 17:00 the patient was taken to the emergency room and was given 10 liters of oxygen. The patient was admitted to the hospital. On 22 Jan 2021 everything cleared suddenly, so the patient was able to leave the hospital. The patient was diagnosed with pneumonia. The reporter indicated the patient did not have a history of lung problems, so she was concerned and wanted more information on what happened. Treatment for the event included 10 liters of oxygen. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, having a difficult time breathing and pneumonia, were considered recovered/resolved on 22 Jan 2021.; Reporter's Comments: This case concerns a 40 year old male subject, who experienced a serious unexpected event of pneumonia after first dose of mRNA1273 (Lot# unknown). Very limited information has been provided at this time. Further information has been requested.

3 days sustained fever over 102, cardiac arrest Thursday night, back & chest pain, vomiting, difficulty breathing. Went to ER, admitted to ICU, currently in ICU at hospital.

Stroke; Gotten very sick from vaccine; Tachycardia; Blood pressure issues; Dizziniess; Heart rate issues; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. #027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (hospitalized for 7 days; treated with Remdesivir; long recovery) from 11-Sep-2020 to October 2020. Concurrent medical conditions included Blood pressure (ongoing issues) and Heart rate (ongoing issues). On 05-Jan-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 hospitalization). On an unknown date, the patient experienced ILLNESS (Gotten very sick from vaccine), TACHYCARDIA (Tachycardia), BLOOD PRESSURE FLUCTUATION (Blood pressure issues), DIZZINESS (Dizziniess) and HEART RATE IRREGULAR (Heart rate issues). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), ILLNESS (Gotten very sick from vaccine), TACHYCARDIA (Tachycardia), BLOOD PRESSURE FLUCTUATION (Blood pressure issues), DIZZINESS (Dizziniess) and HEART RATE IRREGULAR (Heart rate issues) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 antibody test: 9.64 after one round of the vaccine. On an unknown date, SARS-CoV-2 antibody test: 220 natural antibodies after 2 months. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient reports that he had worked for an urgent care performing testing and contracted COVID-19 back in 11SEP2020. Patient was hospitalized for 7 days, was administered Remdesivir, and had a long recovery. Patient reports having issues regulating his blood pressure and heart rate so bad that he had almost died during that time. The recovery took up until 1st week of October and did not feel well until then. Patient reports it was advised to defer first dose of vaccination for COVID-19 for 3 months. Patient self-medicated with OTC Tylenol and Advil which did not help. Patient reports that he was hospitalized a second time around last month (03MAR2021 approximately) for experiencing a stroke. Symptoms felt like he was experiencing a mini-COVID-19 episode and was having a relapse of COVID-19. ER professional advised patient to never take the second dose of the vaccine. Patient reports taking an antibody test (after a single dose of the vaccine) for both natural and for the spike protein on 25MAR2021. Patient reports that he had gotten a 9.64 reading from just one round of the vaccine in comparison to the doctors he had worked who had received both doses of the vaccine, never gotten sick with COVID-19, and produced a 9.0 reading. Patient reports his natural antibodies after 2 months was at 220. Patient wishes to report this information to highlight that his natural antibodies were so high from the previous COVID-19 infection that when he had gotten the first round of the vaccine, he believes that his body rejected the vaccine so strongly that he presented with severe side effects from the vaccine. Patient would like to submit his information to show that he is proof that if someone previously had COVID-19, they should only need a single dose of the vaccine. In addition, patient expressed that if a patient's natural antibody is high, then a reduced dose should be provided or the vaccine should be deferred until natural antibodies reduce Most recent FOLLOW-UP information incorporated above includes: On 02-Apr-2021: Event details reported; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

Moderna COVID-19 Vaccine EUA: patient underwent L1-2 corpectomy, pedicle subtraction osteotomy, and extension of fusion from T4 to the pelvis two months after vaccination. During surgery patient became thrombocytopenic and required massive transfusion. Thirteen days after surgery found to have bilateral pulmonary embolisms and deep vein thromboses and placed on anticoagulation. Patient subsequently suffered cardiac arrest and was unable to be resuscitated.

He underwent routine monitoring for his testicular cancer and had CT of his lungs on April 6. He was found to have asymptomatic Pulmonary emboli. He was started on Eliquis 5 mg bid

Hives with red itchy painful rash on right leg within 30 minutes of vaccination. Did not resolve with Benadryl or hydrocortisone after 72 hours. Periodic bleeding and difficulty sleeping.

#2 Moderna Vaccine given on 4/20/21 On 5/7/21 patient became SOB before syncope to cardiac arrest, event was witnessed and CPR started immediately. Patient expired 45 min later at Medical Center.

Received vaccine at on 5/24/2021. Patient is a 40 y/o male with no significant PMH who initially presented to the hospital after being found down at a restaurant. Was found to have ST segment changes on EKG, somnolent, and hypotensive requiring pressors. Taken to the cath lab where he had equalization of diastolic pressures and subsequently received pericardiocentesis due to concern for tamponade from pericardial effusion. 350 ccs of fluid was drained and his hemodynamics immediately improved and he came off vasopressors. Pericardial drain was placed. Over the next several days he had ongoing workup for the etiology of his pericardial effusion. His pericardial drain output dropped off, was clamped 5/31 and repeat echocardiogram 6/1 did not show significant effusion. Unfortunately, patient went into PEA arrest in the afternoon and was coded for ~40 minutes without return of ROSC. Unclear etiology at this time, no evidence of significant effusion on echocardiogram

03/31/2021 received 1st dose of Moderna COVID-19 vaccine 04/01/2021 104 F fever, dizziness, nausea 04/03/2021 symptoms subsided 04/04/2021 case expired as a result of undetermined natural causes per medical examiner final report

Had stroke; Has loss of vision in right eye; Has headaches; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Had stroke), BLINDNESS (Has loss of vision in right eye) and HEADACHE (Has headaches) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. In June 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 21-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Had stroke) (seriousness criteria hospitalization and medically significant), BLINDNESS (Has loss of vision in right eye) (seriousness criteria hospitalization and medically significant) and HEADACHE (Has headaches) (seriousness criterion hospitalization). The patient was hospitalized on 21-Jun-2021 due to BLINDNESS, CEREBROVASCULAR ACCIDENT and HEADACHE. At the time of the report, CEREBROVASCULAR ACCIDENT (Had stroke), BLINDNESS (Has loss of vision in right eye) and HEADACHE (Has headaches) outcome was unknown. No concomitant medication information was provided by the reporter. Treatment information was unknown. It was reported that the patient experienced stroke 3 days after receiving the 2nd dose of the vaccine. He was hospitalized on 21Jun2021. Patient also had headaches and loss of vision in right eye, and both started the day of stroke. 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.

Blood clots (thrombus) found in my left thigh's vein, hence the swollen leg. I am not 100% sure if it's related to the vaccine though.

I have Peripheral Artery disease and have had bypasses done on both legs. It has been managed fairly well with a several minor "tune ups" by angio. I was able to walk pretty well with minimal pain. About a week after my second dose I started noticing increased pain in both of my calves which has become considerably worse since then. I cannot walk 1/10 of a mile without taking a break. Also, around July 1st, my fingers went numb in my right hand, then I started getting pain in my right forearm and cramping in my hand. That pain has made it so the way up my arm. I saw my vascular surgeon and an ultrasound revealed a clot in the bend of my elbow. I was asked how I think I could have gotten the clot, the only thing I've done differently was get that vaccine. It's extremely obvious to me that the vaccine has caused a severe reaction in me. I have a surgery scheduled on Wed. July 14 to have the clot removed.

DX: Pericarditis; S/S Headache, fever/chills, Acute chest pain or pressure, Chest pain made worse by lying down, deep inspiration, or cough,Chest pain relieved by sitting up or leaning forward-- onset 04/14/2021 "Progressive severe diffuse anterior chest pain radiates towards his anterior neck...describes a pleuritic component to his chest pain."

Employee received the vaccine at 0805, reported at 0812 that he was dizzy, lightheaded, nauseated and diaphoretic. Employee assisted to cot to lie down. Skin pale, continued to be diaphoretic, respirations in the 20's, BP 115/82, HR 110, O2 98% on RA, denied any difficulty breathing, no coughing or evidence of throat tightening, no sign of any swelling at vaccination site, no rash. Code called overhead, Code team arrived. No medications given at time in clinic. Near syncopal episode, No anaphylaxis. Employee taken to ED for further evaluation and observation.

Stroke two days after vaccination, CVA hemorrhage, aneurysm (hospitalized ICU 08 January 2021, currently requires daily physical therapy and has walker to ambulate).

Patient is a 41 y.o. male on no AC/AP with no pmhx reported presents 1/31 PM initially to Hospital for acute onset 10/10 headache refractory to 800mg motrin which started in occipital region then spread to whole head and neck, nausea and vomiting x 3. Symptoms started around 5pm when he was on a conference call and reports he got bad news so was stressed out. Denies any recent trauma. Pt received toradol 30mg, dexamethasone 10mg, benadryl 25mg and reglan 10mg at hospital prior to transfer. CT showed diffuse SAH and CTA showed no signs of obvious aneurysms. He then received 1g IV keppra and was started on Cardene for BP goal <140. He was transferred to NICU for further monitoring. While in the NICU, his exam and imaging remained stable. He underwent CTA which was unrevealing, and DSA which showed evidence of vasculopathy. BPs came down to <160 and he came off of cardene, did not require additional meds. He was transferred to the floor. Upon transfer, he had another thunderclap HA, accompanied by HTN to the 200s systolic, tachycardia to the 120s, diaphoresis, and blotchy macular rash over the anterior shoulders. Imaging was negative for vasospasm or recurrent bleed, and it was felt that patient's presentation was most c/w RCVS. Trigger felt either 2/2 caffeine intake (patient reported drinking 60 oz coffee daily) vs. Sympathetic discharge syndrome such as pheochromocytoma or carcinoid syndrome. LP was performed, which revealed no nucleated cells and protein elevated in proportion to blood, which confirmed the diagnosis of RCVS. Studies were sent off to diagnose carcinoid syndrome and pheo. Patient was started on nimodipine/gabapentin with standing tylenol and PRN oxycodone for breakthrough pain. Within days, the HAs had markedly decreased in intensity. He was taken off of keppra after 1 week with stable exam and no e/o seizures. He was briefly switched from nimodipine to verapamil but switched back prior to discharge. He was discharged with outpatient followup.

He had second dose of Moderna COVID vaccine on March 13th. He was admitted with progressive SOB and acute right leg limb ischemia 4/7/21. He was found to have massive Bilateral PE and right common femoral artery and right external iliac atery occlusion. He was unstable and required embolectomy, tPA and EKOS for PE and embolectomy for right leg arterial occlusions. He remains sedated in ICU now.

I suffered a stroke on March 19, 2021 that effected my Occipital and Temporal Lobes on the right side of my brain. The primary symptom was almost total and complete blindness. Taken to emergency room, made a stroke alert, tPA cleared clot, spent 5 days at the hospital.

Fever, chills, headache, and tiredness (2nd day of receiving the 2nd dose) Feeling good on the 3rd day Headache, stomach burn, throwing up, and heart attack (4th day of receiving the 2nd dose) Passed away on April 2, 2021

Approximately 3 weeks after Moderna Covid-19 vaccine administration, patient began to experience dizziness, transferred to Hospital, diagnosed with ischemic stroke, discharged, returned within days with worsening, diagnosed with new ischemic stroke (contralateral side), transferred to Medical Center, patient's condition worsened, presumably additional new ischemic stroke, patient ultimately died on 3/5/2021. Diagnosis was acute infarction of the brainstem/pons as well as acute bilateral cerebellar/occipital infarctions.

On April 27th, I went to local ER with acute shortness of breath. X-ray and CT scan showed possible fluid build up in lungs. I was admitted to hospital on April 28. Echocardiogram diagnosed heart failure, ejection fraction was 25%. Pulse was also quite high (120-135), and blood oxygen was low (88-90%). Cardiac catheterization showed no blockages in coronary arteries. Echocardiogram, EKG, and bloodwork were negative for heart attack. Ultimate diagnosis from doctor was idiopathic cardiomyopathy. Currently taking several medications and under care from primary care physician and cardiologist. At follow up appointment with primary care following discharge, she suggested I report the incident out of an abundance of caution.

After headaches and fatigue following the shot (within 24 hours) I began to notice slight shortness of breath 3-5 days following. I didn't give it much thought, but, roughly two weeks after my dose I began to experience severe intercostal pain and sharp pain in the lower lobe of my right lung upon inhalation. I thought this was musculoskeletal at first but after it didn't abate within days, I went to the hospital and was diagnosed with several distal pulmonary emboli. Luckily I survived and am currently on blood thinners while trying to determine the cause of this, having no history of blood clots personally or in extended family.

Approximately 14 days after first injection I went to ER with Atrial Fibrilation symptoms. Had been feeling weak and tired for about a week before but ignored symptoms. Awoken early March 21st with NEW Apple watch alerting to high heart rate while sleeping over 150 bpm. Ran ECG and stated Atrial Fibrilation was occuring.

Blood Clots noted all over lungs; Abdominal pain radiating from right side to left side then to collar bone; Abdominal pain-right side; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Blood Clots noted all over lungs) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037421B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Gallbladder pain. On 23-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 ABDOMINAL PAIN (Abdominal pain-right side). On 30-Apr-2021, the patient experienced PAIN (Abdominal pain radiating from right side to left side then to collar bone). On 04-May-2021, the patient experienced PULMONARY EMBOLISM (Blood Clots noted all over lungs) (seriousness criteria hospitalization and medically significant). On 30-Mar-2021, ABDOMINAL PAIN (Abdominal pain-right side) had resolved. At the time of the report, PULMONARY EMBOLISM (Blood Clots noted all over lungs) and PAIN (Abdominal pain radiating from right side to left side then to collar bone) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-May-2021, Computerised tomogram: Blood clot noted on lungs (all over). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient was given IV and oral blood thinner medication as a treatment. Company comment: Very limited information regarding this event has been provided at this time. It is not clear if abdominal pain was gallbladder pain and surgery was prior to onset of pulmonary embolism. Details of the events and discharge summary is required for further evaluation.; Sender's Comments: Very limited information regarding this event has been provided at this time. It is not clear if abdominal pain was gallbladder pain and surgery was prior to onset of pulmonary embolism. Details of the events and discharge summary is required for further evaluation.

had another heart attack¨; ¨Had 2 heart attacks¨; ¨Swollen feet¨; ¨Was very fatigued with little walking¨; ¨A lot of pain in the arm of the injection ¨( left arm); This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (¨Had 2 heart attacks¨) and MYOCARDIAL INFARCTION (had another heart attack¨) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Automated external defibrillator user (HOSPITALISED (07-MAY-2021 - 13-MAY-2021)), Coronary artery bypass graft (HOSPITALISED (07-MAY-2021 - 13-MAY-2021)) and Catheterization cardiac (HOSPITALISED (07-MAY-2021 - 13-MAY-2021)). Concurrent medical conditions included Diabetes, Blood pressure high and Hypertension (not adequately controlled "has high blood pressure levels but it is not constant so he doesn´t take medication for that".). Concomitant products included METFORMIN for an unknown indication. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (¨A lot of pain in the arm of the injection ¨( left arm)). On 07-May-2021, the patient experienced MYOCARDIAL INFARCTION (¨Had 2 heart attacks¨) (seriousness criteria hospitalization and medically significant). On 13-May-2021, the patient experienced PERIPHERAL SWELLING (¨Swollen feet¨) and FATIGUE (¨Was very fatigued with little walking¨). On 20-May-2021, the patient experienced MYOCARDIAL INFARCTION (had another heart attack¨) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 07-May-2021 to 13-May-2021 due to MYOCARDIAL INFARCTIONThe patient was hospitalized from 07-May-2021 to 13-May-2021 due to MYOCARDIAL INFARCTION The patient was treated with TICAGRELOR (BRILINTA) from 07-May-2021 to 13-May-2021 at an unspecified dose and frequency; ATORVASTATIN CALCIUM (LIPITOL) from 07-May-2021 to 13-May-2021 at an unspecified dose and frequency; BROMAZEPAM (LAXYL [BROMAZEPAM]) from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency; CARVEDILOL from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency; CLOPIDOGREL from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency; ACETYLSALICYLIC ACID (ASPRIN) from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency; VALSARTAN from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency and SPIRONOLACTONE from 13-May-2021 to 20-May-2021 at an unspecified dose and frequency. On 07-May-2021, VACCINATION SITE PAIN (¨A lot of pain in the arm of the injection ¨( left arm)) had resolved. On 20-May-2021, FATIGUE (¨Was very fatigued with little walking¨) had resolved. At the time of the report, MYOCARDIAL INFARCTION (¨Had 2 heart attacks¨) and MYOCARDIAL INFARCTION (had another heart attack¨) had resolved and PERIPHERAL SWELLING (¨Swollen feet¨) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient took the 1st dose of the vaccine on 28apr2021 and referred a lot of pain in the arm of the injection. On 07may2021 he was diagnosed with myocardial infarction and was hospitalized. On 13may2021 the patient got discharged to home with oral medication and an external defibrillator. During this period he had swollen feet and extreme fatigue. On 20may2021 the patient had another myocardial infarction, is currently hospitalized receiving Tridil as treatment and is requires a heart transplant. 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 the patient's comorbidities (diabetes and hypertension) are risk factors for myocardial infarction and pose as confounders of this event. Since the most recent event of myocardial infarction is life-threatening further information was requested regarding the event outcome.; 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 comorbidities (diabetes and hypertension) are risk factors for myocardial infarction and pose as confounders of this event. Since the most recent event of myocardial infarction is life-threatening further information was requested regarding the event outcome.

A few days after the second vaccination, patient started feeling poorly. Shortness of breath, tiredness and could not shake it. Ended up at hospital and after multiple tests he was flown to another hospital with a pulmonary embolism. He is currently in hospital being treated for PE and multiple clots in his legs.

Patient was vaccinated with the Moderna Covid-19 vaccine on 3-26-21 and 4-23-21. He was admitted to Hospital on 06-08-2021. He tested positive for Covid-19 on 06-11-2021. He passed away on 06-12-2021. It is unknown whether or not Covid-19 contributed to the case's illness, hospitalization, possible adverse vaccine reaction or death.

Shortness of breath, with low grade chest pain, and then the onset of symptomatic atrial fibrillation requiring cardioversion.

Slur; Bell's Palsy; Thought he was having a stroke; Face was tensed; Ear infection; Ear pain; Jaw pain; Was a little off; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's Palsy) and CEREBROVASCULAR ACCIDENT (Thought he was having a stroke) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported by the reporter. No treatment information was provided. Concomitant products included HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE 1A PHARMA) for Blood pressure. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced FATIGUE (Was a little off). On 08-Jun-2021, the patient experienced BELL'S PALSY (Bell's Palsy) (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (Thought he was having a stroke) (seriousness criterion medically significant) and REDUCED FACIAL EXPRESSION (Face was tensed). In June 2021, the patient experienced EAR INFECTION (Ear infection), EAR PAIN (Ear pain) and PAIN IN JAW (Jaw pain). On an unknown date, the patient experienced DYSARTHRIA (Slur). The patient was treated with PREDNISONE ongoing since an unknown date at a dose of 1 dosage form. In May 2021, FATIGUE (Was a little off) outcome was unknown. At the time of the report, BELL'S PALSY (Bell's Palsy), CEREBROVASCULAR ACCIDENT (Thought he was having a stroke), DYSARTHRIA (Slur), REDUCED FACIAL EXPRESSION (Face was tensed), EAR INFECTION (Ear infection), EAR PAIN (Ear pain) and PAIN IN JAW (Jaw pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal. On an unknown date, Computerised tomogram: normal (normal) normal. On an unknown date, Lyme disease: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient face was tensed and his face was seized. The left side of his face was drooping he had trouble closing his left eye. Water was dripping out of his mouth when he tried to drank he felt that something was not right and his eye was watering that morning constantly. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-229259 (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

Congestive HF diagnosis 6/30/2021. Symptoms of SOB beginning 4/15, issues with sleep except when sitting upright and anxiety. No history of medical conditions.

heart failure; had heart attack; heart palpitation; anxiety; heart was beating like crazy; had a burning sensation in the chest; very difficult for him to perform even a simple task; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FAILURE (heart failure) and MYOCARDIAL INFARCTION (had heart attack) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE (heart failure) (seriousness criterion medically significant), MYOCARDIAL INFARCTION (had heart attack) (seriousness criterion medically significant), PALPITATIONS (heart palpitation), ANXIETY (anxiety), HEART RATE IRREGULAR (heart was beating like crazy), CHEST PAIN (had a burning sensation in the chest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (very difficult for him to perform even a simple task). At the time of the report, CARDIAC FAILURE (heart failure), MYOCARDIAL INFARCTION (had heart attack), PALPITATIONS (heart palpitation), ANXIETY (anxiety), HEART RATE IRREGULAR (heart was beating like crazy), CHEST PAIN (had a burning sensation in the chest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (very difficult for him to perform even a simple task) outcome was unknown. Concomitant product use was not provided by the reporter. ? No treatment information was provided. Patient reported that he is a healthy person who exercises regularly, never used alcohol and never had a health issue. Patient also insisted that he had been to the emergency Room 3 times in the past two weeks. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

a month and a half after receiving the vaccine, I developed blood clots in legs; I was diagnosed with DVT; it travelled to the lungs; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (a month and a half after receiving the vaccine, I developed blood clots in legs), DEEP VEIN THROMBOSIS (I was diagnosed with DVT) and PULMONARY EMBOLISM (it travelled to the lungs) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-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 THROMBOSIS (a month and a half after receiving the vaccine, I developed blood clots in legs) (seriousness criteria hospitalization and medically significant), DEEP VEIN THROMBOSIS (I was diagnosed with DVT) (seriousness criteria hospitalization and medically significant) and PULMONARY EMBOLISM (it travelled to the lungs) (seriousness criteria hospitalization and medically significant). The patient was treated with APIXABAN (ELIQUIS) in March 2021 for Deep vein thrombosis, at a dose of UNK dosage form. At the time of the report, THROMBOSIS (a month and a half after receiving the vaccine, I developed blood clots in legs), DEEP VEIN THROMBOSIS (I was diagnosed with DVT) and PULMONARY EMBOLISM (it travelled to the lungs) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: he was diagnosed as having deep vein thrombosis (abnormal) CT scan of his lungs. He was diagnosed as having Deep Vein Thrombosis (DVT). In 2021, Ultrasound Doppler: he was diagnosed as having deep vein thrombosis (abnormal) An ultrasound of his heart and legs. He was diagnosed as having Deep Vein Thrombosis (DVT). Patient reports having to be hospitalized overnight, one month after vaccination. He stated that he was previously a healthy male with no underlying health conditions. Concomitant medications were not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; 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.

Approximately 12 hours after vaccination, the patient realized he had a heaviness in his chest and just didn?t feel ?right?. His Apple Watch told him he was in afib. So the patient was taken to the ER by his wife where this was confirmed with an EKG. He was cardioverted back to normal sinus rhythm and he was prescribed Eliquis. Patient has no prior heart arrhythmias or medical concerns. Patient is slightly overweight, but has not had any arrhythmia or history of a fib in the past. Patient was discharged to follow up with his family physician. All of his blood work was normal.

Idiopathic Thrombocytopenic Purpura, on 1 February 2021, I noticed significant bruising on my body and Petechiae under my eyes. I call the nurse line and requested a CBC. On 2 February, the Emergency Department called me back and stated my platelets were at 6K (over the last 10 years with CLL, they consistently are at 110K-120K). The emergency department directed me to come in and began treatment with Prednisone and platelet transfusion. I was transferred to Hospital where they started IVIG and 40mg of Dexamethasone for four days. I was discharged on 7 February with stable platelets at 42K

Patient was given vaccine Moderna vaccine at 09:45 and sent to the observation area. As patient was filling out information on sheet and information area he suffered a syncopal episode at 09:50 in which he collapsed and hit his head on the floor. He suffered a small contusion on the left rear of his head with some bleeding. Patient was unconscious for approximately 15 seconds. When he came too, he complained of nausea. Patient was pale anxious and had fixed dilated pupils. Patient reports that he is a stage four cancer survivor and is taking Xarelto. 911 was called and patient was transported to Emergency Department.

Diagnosed with a DVT of the left Axillary Vein. had received the Moderna vaccine in the same arm 10 days prior. Being evaluated for a PE at present.

pt states that 6 hours after recieveing the moderna vaccine he developed blisters on his right arm and right torso that were itchy. Blisters bled. Fever of 103. Pt states he took benedryl and blisters resolved with in 15mins. Pt states he has some labored breathing, howver, states it could have been from anxiety. ot denied any swelling of the throat or difficulty swallowing. Pt also stated that the area of the injection site turned black and that it has sinced resolved. Pt went to see his PCP who advised him not to receive the 2nd dose of Moderna, however; to get the J&J vaccine insteasd.

Symptoms started around a week after COVID-19 vaccine, when patient started having shortness of breath cough and nasal congestion. He was having yellow sputum production and he had chills. Upon arrival to the hospital on 4/18 the patient was tachycardic and chest x-ray that showed cardiomegaly with fluid overload. Progressively became severely hypoxemic and had to be emergently intubated and placed on mechanical ventilation. Patient developed cardiogenic shock which may be acute myocarditis and was placed on an Impella device and norepinephrine drip. The patient continued to worsen and developed acute kidney injury and hyperkalemia and was placed on CRRT. LFTs were also elevated. Patient also went into atrial fibrillation and was started on amiodarone drip. All of the above mentioned occurred within a 12 hour period.

As a citizen I took the Moderna vaccine on 15 APR 20201. Four days after taking the vaccine I developed a blood clot in my heart. On the morning of 19 APR 2021 at 0730 I began having chest pain, I thought I had pulled a muscle while exercising the night before. Throughout the morning the pain in my chest got worse until I called emergency services. The EMTs told me I had a blood clot in my heart and rushed me to the hospital. Once at the hospital I had an angioplasty . No stint was inserted. After the surgery the doctors told me I had very large veins and a strong heart after the clot was removed flow returned and no stint was needed. The doctors also told me that they could not rule out the COVID vaccine as the cause of my blood clot as the rest of me heart looked good with no visible plaques or build up. Official Diagnosis Anterior STEMI- POBA ot LAD Integrillin infusion Fit and Well Moderna vaccine 1 week ago Diagnostic Findings -Left Main Stem - Normal LMS Left Anterior Descending- LAD 100 % stenosis restored flow Conclusion -Aspirin 75 mg od for life - prasugrel 10mg of for 1 year - ECHo Sec prevention, Integrillin infusion 24 hrs - Card rehab I work out every day- prior to the blood clot Blood clot left in heart chamber- taking blood thinners to dissolve.

doesn't remember anything; muscle spasms in back and legs; very tired; very sore; fever; grand mal seizures; sweating and being soak and wet; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Epilepsy (The patient has a history of grand mal, petit mal and stress seizures. Patient stated that he has at least one minor seizure once a month and the last seizure he had with this great intensity was about 3 to 4 months ago.) and Drug allergy (aspirin). Concomitant products included MIDAZOLAM for Seizure, CLOBAZAM (ONFI), ESLICARBAZEPINE ACETATE (APTIOM) and TOPIRAMATE (TOPAMAX) for an unknown indication. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) (seriousness criterion medically significant). 04-May-2021, the patient experienced HYPERHIDROSIS (sweating and being soak and wet) and PYREXIA (fever). On 05-May-2021, the patient experienced MEMORY IMPAIRMENT (doesn't remember anything), MUSCLE SPASMS (muscle spasms in back and legs), FATIGUE (very tired) and MYALGIA (very sore). On 05-May-2021, GENERALISED TONIC-CLONIC SEIZURE (grand mal seizures) had resolved. At the time of the report, HYPERHIDROSIS (sweating and being soak and wet), MEMORY IMPAIRMENT (doesn't remember anything), MUSCLE SPASMS (muscle spasms in back and legs), FATIGUE (very tired), MYALGIA (very sore) and PYREXIA (fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-May-2021, Blood test: unknown (Inconclusive) Result not provided. It was reported that the patient took midazolam and swiped his magnet across his vagus nerve stimulator (VNS) for treatment. Action taken with mRNA-1273 in response to the event was Not Applicable It was reported that the patient was asymptomatic after first dose and experienced symptoms on 04May2021 at midnight after second dose of 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. The medical history of epilepsy was assessed as strong cofounder.; 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. The medical history of epilepsy was assessed as strong cofounder.

As per wife's account, patient died approximately 9 days after receiving vaccine on 4/21 of massive, unknown (suspected cardiac) event. Wife explained that patient was diagnosed with Wolff-Parkinson-White (WPW) syndrome prior to being vaccinated. PCP unaware of diagnosis, and patient did not disclose that on vaccine consent form. Patient reported to his wife that he was feeling unwell after receiving vaccine including unable to move legs well. Patient later diagnosed with thrush and supposedly treated by physician. Patient did not discuss concerns regarding vaccine or WPW with physician. Patient called his wife the day of death and asked her to bring him to the doctor the following day. Wife reported that patient experienced seizures but not concerned as it was similar to childhood seizure. Wife was done at work and drove home after phone call, arriving at house approximately 10-15 minutes after call. Patient supposedly dead when wife arrived. Wife performed CPR for ~15 minutes until EMS arrived, and EMS attempted for another 40 minutes for any electrical activity. Wife declined full autopsy from ME, suspecting that it was massive MI or clot. Wife and patient unaware that WCW could place patient at risk of clots and wondering if the vaccine was partially responsible.

Died due to heart attack; Lot of blood was on the floor; He fell on bathroom tiles; Feeling weakness/Could not coming out of bed; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died due to heart attack) and HAEMORRHAGE (Lot of blood was on the floor) in a 42-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 Diabetes (was on anti-diabetic medicine.). On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Mar-2021, the patient experienced ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills). On 23-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died due to heart attack) (seriousness criteria death and medically significant), HAEMORRHAGE (Lot of blood was on the floor) (seriousness criterion medically significant) and FALL (He fell on bathroom tiles). The patient died on 23-Mar-2021. The reported cause of death was Heart attack. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (Lot of blood was on the floor), FALL (He fell on bathroom tiles), ASTHENIA (Feeling weakness/Could not coming out of bed), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Concomitant medication included was anti-diabetic medicine. The treatment information was not provided. 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.; Reported Cause(s) of Death: heart attack

Patient got bruising and red spots on over his body about 7 days after receiving first dose of Moderna Covid vaccine. He also had bleeding gum and bloody nose. His platelet count dropped significantly to 5000. Patient was diagnosed with immune thrombocytopenia and was admitted to hospital for treatment over 2 days. He got 2 bags of IVIG over 2 days and given Dexamethasone daily for 4 days.

tonic-clonic seizures; Husband is now an epileptic; started convulsing; stop breathing; lots of blood coming out of his mouth; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (started convulsing), GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizures) and EPILEPSY (Husband is now an epileptic) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 036B26A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Appendectomy. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced SEIZURE (started convulsing) (seriousness criterion medically significant), DYSPNOEA (stop breathing) and MOUTH HAEMORRHAGE (lots of blood coming out of his mouth). On 22-Jul-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizures) (seriousness criterion medically significant) and EPILEPSY (Husband is now an epileptic) (seriousness criterion medically significant). At the time of the report, SEIZURE (started convulsing), DYSPNOEA (stop breathing), MOUTH HAEMORRHAGE (lots of blood coming out of his mouth), GENERALISED TONIC-CLONIC SEIZURE (tonic-clonic seizures) and EPILEPSY (Husband is now an epileptic) outcome was unknown. Weeks after taking his second dose of the Moderna COVID-19 vaccine, on 24May2021, the patient started having convulsions, stopped breathing and his wife had to bring him to the hospital. Also started having lots of blood coming out of his mouth, at the hospital they said he could have bitten himself when having convulsions but they could not find signs of that. On 22Jul2021 the same thing happened, he started having convulsions, but there was no blood coming out of his mouth this time. The patient is now an epileptic and wife thinks he is screwed and she's scared that she may loose him. They said they're tonic-clonic seizures. Patient did not take any medications prior to this. Concomitant medications information not reported. Treatment information not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further 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, more information is required for further assessment.

Minor itching on face, lower back, arms, legs, and belly. Elevated heart rate ranging from 80-95bpm. I took a Zyrtec to help with symptoms at 2:00pm. It did help reduce some of the symptoms. It is presently 3:23pm and some of the itching has subsided but my heart rate is still in the 80s.

On Wednesday 1/27 the day after my second dose I felt a minor pinch/discomfort on my lower leg. I did not think much of that is reason I did not report it right away. Day by day the discomfort and pain got worse. Exactly one week after my second dose I was not able to sleep due to the pain. On Wednesday 2/3 I decided to go urgent care. From there I was referred for an ultra sound a few hours after. After the ultra sound I was contacted by my doctor, letting me know that the results showed I had a blood clot on my left leg. I was put on Eliquis medicine right away. On 2/5 I was able to physically see my doctor who told me that this was caused by the second dose of the moderne vaccine that I took on 1/26.

Patient was found dead in his apartment. I'm not clear on details, but he was having some issues the week prior to being vaccinated. He was in acute distress when his attendant care worker came to give him his medications the day before.

without warning and approximatly 5 minutes after patient recieved vaccine patient passed out and fell face first onto floor. patient was approached lying face down on floor bleeding and sounds of gurgling coming from patient patient was unreponsive. When patient was brought around and returned to conciousness patient did not know where he was or what had happened. Patients pulse was very low at 58 and dropping to as low as 39. Patient pulse did not stabilize the entire time patient was under our care. Patient had about a inch and a half laceration about eye and possible facial fracture. It was noticed that patients face was swollen when leaving with ambulance to be transported to er.

Patient began experiencing pain in his right leg on 4/5, sought treatment at walk-in clinic on 4/12. Healthcare provider he saw sent him to ultrasound at a medical center, who then referred him to the emergency deptartment. Patient was diagnosed with a DVT and prescribed Eliquis 10 mg BID x7 days then 5 mg BID for 6 months.

Had first COVID-19 shot on 03/18/2021. 04/06/2021 started to have right lower leg pain. Was seen at urgent care were and xray was done that was negative. Urgent care doctor sent him for ultrasound right lower leg on 04/10/2021 which was negative. He was started on antibiotics and Prednisone. Was seen by PCP whom felt he needed to be seen by vascular. He was seen by Dr. on 04/16/2021 who felt it was a pulled muscle, but he want a repeat ultrasound of right lower leg done. 04/19/2021 ultrasound of right lower leg was done and showed a DVT. He was started on low does baby aspirin 81mg. A follow up ultrasound was ordered for 04/26/2021 to check status of DVT.

Initial reaction after the injection: Sore left shoulder, stiffness that continued for 2 days 04/12/2021 The patient went to the ER for left chest pain 04/15/2021 Chest CT obtained with pleuritic chest pain diagnosis CTA report: several pulmonary emboli in the left lower lung with lingular infiltrates; 04/15/2021 - 04/16/2021 admission to Hospital ER for pulmonary embolism and infarction 04/15/2021 admitted to hospital for observation for pulmonary emboli with hemoptysis He was started on Eliquis which he has tolerated. There was hemoptysis during this time and after admission. He experienced an increase in left-sided pleuritic pain followed by improvement after being on the Eliquis for several days. He continues to have discomfort with deep inspiration however asymptomatic with regular breathing and has been able to return to many of his routine activities. Started Eliquis 10mg twice daily x7 days, followed by 5 mg twice daily

SWELLING, PAIN, GRADUALLY WORSENING. DEVELOPED AN ABSCESS OVER LEFT UPPER BACK IN SCAPULAR AREA. CT SCAN, ABSCESS INCISION & DRAINAGE & PACKING, STARTED ON ANTIBIOTICS. DIAGNOSED WITH SEPSIS ALSO. ALSO BLOOD SUGAR FOUND TO BE 400 WITH NO PRIOR HISTORY OF DIABETES

Patient reported fevers, chills and myalgia after 1st dose of Moderna COVID vaccine 4/22. Poor PO intake and had syncopal episode on 4/24 when standing from the recliner. Initially admitted at hospital, and developed fever, leukocytosis, AKI. Transferred to other hospital for further evaluation and eventually developed acute hypoxic respiratory failure requiring intubation and mechanical ventilation, found to have new onsert heart failure with reduced ejection fraction. He is currently being evaluated for auto-immune and underlying infectious causes, with concern for glumerunephritis, cardiomyopathy and coronary artery disease. Patient extubated to NC as of today but remains in the ICU.

Patient diagnosed Pneumonia due to infectious organism, unspecified laterality, unspecified part of lung on 05-06-2021. As well as: oxygen saturation 95%, blood pressure 95/62 Pulse 89 BMI 18.31Respiration 18 Weight 135 Height 6' on 5-6-2021

Hospitalization kidney failure heart failure respiratory failure had to be ventilated. Six days in Medical Center and 10 days in Medical Center

Pt reports redness and tightening of his face, resolved by Benadryl. Next morning, pt had an episode of n/v, achiness, fatigued and SOB. Pt admitted to hospital for sepsis and cellulitis from a podiatry procedure. Pt in a state of hypercoagulability r/t to covid vaccine and sepsis. Pt advised not to receive 2nd dose of moderna or j&J.

Pt admitted to facility on 5/18 with shortness of breath, chest tightness and was found to have bilateral pulmonary embolism and mild patchy scattered groundglass opacities . Pt reportedly received 1st dose of Moderna COVID vaccine '2 weeks ago' (not vaccinated at this facility). Pt reportedly tested positive for COVID 1 week later (also not at this facility) and was also COVID positive on presentation here on 5/18. Admitted to ICU and currently being treated with Remdesivir, dexamethasone and enoxaparin for anticoagulation. Pt reportedly does have history of DVT/PE in past in 2012.

"Moderna COVID-19 Vaccine. Vaccine on 2/25. Took him to an urgent care on 3-7 because of swollen ankle, foot and lower leg. Had xray but nothing was broken. thought he had sprained ankle. Given prednisone. Ankle continued to be swollen for following days so we followed up with family dr. on 3-22 who sent him for ultrasound which showed an extensive blood clot - DVT. Sent to emergency room. Put on blood thinner shots for a week and sent to doctor on 3-24. He did many blood tests. He started eliquis on 3-30. Saw doctor again on 4-13. His blood tests had shown he has Factor 5--Leiden. On May 11 we saw doctor again. Remain on Eliquis. Another ultrasound and more bloodtests show clot is chronic, but blood thinner is doing its job. No active clotting.

Blood clots in both lungs; Feels really tired all the time; Joints hurt; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (Blood clots in both lungs) in a 43-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 Acid reflux (esophageal) and Retinal migraine. Concomitant products included RABEPRAZOLE SODIUM for Acid reflux (esophageal), METOPROLOL for Retinal migraine. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FATIGUE (Feels really tired all the time) and ARTHRALGIA (Joints hurt). On an unknown date, the patient experienced PULMONARY EMBOLISM (Blood clots in both lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 10-Apr-2021 to 15-Apr-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Blood clots in both lungs) and ARTHRALGIA (Joints hurt) outcome was unknown and FATIGUE (Feels really tired all the time) had not resolved. Treatment information was not provided. Action taken with mRNA-1273 in response to the events 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. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25 May 2021 contains no new information.; 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.

Serve flu like symptoms made myself feel very fatigued, tired, didn't want to do anything, had pulsation in the arteries ( left upper chest ) right lower calve and on right arm ) was seen and chest x-rays were order and a venous doppler was order.

ANAPHYLAXIS: Pt received his second Moderna COVID19 shot on 12Apr2021 at approximately 2:30pm. He waited the required 20 minutes to check for any adverse reaction and then left the facility to drive home. On his drive home, at approximately 3:30pm, he started feeling light headed and lost consciousness, striking a telephone pole. He was gasping and struggling to breathe, so the ambulance treated him with oxygen. When he arrived at the ER , the doctor assessed his condition and confirmed that he was experiencing an anaphylactic reaction related to the COVID vaccine and treated him with an epinephrine injection, steroids, benadryl, and nebulized albuterol.to open his airways. He remained at the ER for ~ 6 hours for observation until his blood oxygen levels increased and he was stable to be released. The car accident resulted in PT suffering a fractured sternum as confirmed via Chest CT Scan by his primary doctor. PT has no history of any allergic reaction to any medication or vaccine. Although he does have well-regulated asthma, this incident was not characteristic of any asthma-related reaction he has ever experienced.

Pain in leg presented several weeks after second shot. Symptom was dismissed until loss of consciousness/fainting occurred. Onlookers called 911 and after being transported to hospital CT scan revealed bilateral pulmonary embolisms and DVT blood clots were present. D-dimer blood test revealed a range 400 times the appropriate range. Number exceeded the scale. The number of clots on imaging were so numerous, the doctor that read the report said they would not even count them. Was treated on heparin IV and placed in cardiac ICU, prescribed Eliquis to thin blood allowing the body to not create additional clots. In process of establishing a medical team to treat.

Patient was seen once in my office complaining of persistent shortness of breath and chest tightness of sudden onset that happened few days after receiving second dose of covid vaccine. A CT angiogram ordered showing pulmonary embolism. Diagnosis made more than 10 weeks after vaccination. symptoms appeared in less than one week.

FAMILY PRACTICE was notified by a County coroner that the patient died on 12 June 2021. It is unknown to us if this is related to the Moderna vaccine received 19 May 2021. Dr. had seen this patient one time as a new patient of FAMILY PRACTICE to establish a primary care provider 25 May 2021 FAMILY PRACTICE provided the 1st dose Moderna vaccination 19 May 2021

Notified on 6/16 /2021 patient died. Death by PE 1 month after prime dose of Moderna-since unexpected- reported to VAERS

Patient developed a DVT in left calf that resulted in multiple pulmonary embolisms; patient complained of shortness of breath x 2 weeks and presented with a swollen and discolored lower leg. X-rays and scans confirmed DVT and PE's. Patient underwent thrombectomy and was on Heparin drip followed by Eliquis at home. Patient discharged from ICU after 3 days.

Nonsustained ventricular tachycardia; Chest discomfort; Rash; S.O.B; Palpitations; This spontaneous case was reported by a consumer and describes the occurrence of VENTRICULAR TACHYCARDIA (Nonsustained ventricular tachycardia), DYSPNOEA (S.O.B), PALPITATIONS (Palpitations), CHEST DISCOMFORT (Chest discomfort) and RASH (Rash) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030C20A and 011J20A) for COVID-19 vaccination. Concurrent medical conditions included COPD (Frequent exacerbation), Hypertension, Diabetes, Shellfish allergy and Allergy to antibiotic (Cipro allergy). Concomitant products included METOPROLOL for Arrhythmia, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for COPD, ATORVASTATIN for Hyperchloremia, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) and AMLODIPINE for Hypertension. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced DYSPNOEA (S.O.B) (seriousness criterion hospitalization), PALPITATIONS (Palpitations) (seriousness criterion hospitalization) and RASH (Rash) (seriousness criterion hospitalization). On 27-Mar-2021 at 12:06 PM, the patient experienced CHEST DISCOMFORT (Chest discomfort) (seriousness criterion hospitalization). On 26-May-2021, the patient experienced VENTRICULAR TACHYCARDIA (Nonsustained ventricular tachycardia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 25-Feb-2021 due to DYSPNOEA and PALPITATIONS, then on 27-Mar-2021 due to CHEST DISCOMFORT, then on 25-May-2021 due to RASH, and then on 26-May-2021 due to VENTRICULAR TACHYCARDIA. At the time of the report, VENTRICULAR TACHYCARDIA (Nonsustained ventricular tachycardia), DYSPNOEA (S.O.B), PALPITATIONS (Palpitations), CHEST DISCOMFORT (Chest discomfort) and RASH (Rash) had not resolved. Patient reported that he visited cardiologist, primary care, emergency room multiple more times. He experienced unknown rash from beginning and continues. One of the emergency room visit on 27-May-2021 and went for palpitation, shortness breath and non sustained ventricular tachycardia was present. He admitted to hospital. He experienced rash on arm, then face, torso and now mid section and thighs have rah. Experiencing palpitation/ arrhythmias daily as well shortness of breath. Treatment information was not provided. Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. However, the cardiac related disorders are confounded by the patient's underlying cardiac conditions) hypertension, arrhythmia, hypercholesterolemia) and diabetes; Sender's Comments: Based on the current available information and temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. However, the cardiac related disorders are confounded by the patient's underlying cardiac conditions) hypertension, arrhythmia, hypercholesterolemia) and diabetes

12/23/20 (Moderna #1) - Malaise, cough on 12/24, went to walk-in on 12/25 c/o cough, malaise, rx'd Augmentin x14d, Rapid covid negative (and PCR resulted negative). 12/27 slept all day, 12/28 back to work. 1/12/21 metallic taste in mouth, severe GI sx, malaise, aches, headache. 1/14 seen at walk-in and covid swabbed Negative. 1/21/21 exposed to parents who found out they were covid + on 1/22/21. 1/25/21 (Moderna #2) - Continued with persistent cough and GI sx. Then also developed urinary frequency and urgency. Seen at urgent care 2/1 c/o cough, dx URI, rx'd augmenting. Woke up morning of 2/2/21 abruptly, stood up, said something was wrong, and collapsed. CPR attempted immediately, EMS brought him to ER where he was pronounced dead.

Diagnosed with cellulitis; Diagnosed with sepsis; Temperature 102 degrees F/104 degrees F; Chills/Shivering; Discomfort; Difficulty breathing; Felt cold; Not feeling good; In a lot of pain; A spontaneous report was received from a pharmacist concerning a 44-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed cellulitis, sepsis, temperature was 102 and 104 degrees F/fever, dyspnoea/difficulty breathing, feeling cold, malaise/unwell, pain, discomfort and chills. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event were not reported. On 11 Mar 2021, the patient consulted wound care for his foot and was told to be fine. On 13 Mar 2021, prior to the onset of the symptoms, the patient received their dose of two planned doses of mRNA-1273 (batch number: unknown) for prophylaxis of COVID-19 infection. On 13 Mar 2021, within eight to ten minutes, after vaccination patient felt cold .The patient's temperature was noted to be 102 degree Fahrenheit. Also, patient reported a lot of pain and discomfort. Patient also complained about chills, cold and shivering and he was given an orange juice and blanket after five to ten minutes by the pharmacist. Pharmacist called patients wife and by that time patient developed breathing difficulty. Patient's temperature was raised to 104-degree Fahrenheit by that time and was taken by the emergency medical service to the hospital. The patient was hospitalised. On 16 Mar 2021, after 2 days, patients wife reported to pharmacist that the patient was diagnosed with sepsis and cellulitis and was given two antibiotics. The events sepsis and cellulitis were considered as serious (medically significant). The patient's wife reported that the patient was about to have an amputation in this past weekend. Treatment for the event included two unknown antibiotics. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events cellulitis, sepsis, temperature was 102 and 104 degrees F/fever, dyspnea /difficulty breathing, feeling cold, malaise/unwell, pain, discomfort and chills were considered to be 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 event, a causal relationship cannot be excluded.

PT EXP SHORTNESS OF BREATH AND CHEST PAIN; SELF REFERRED TO ER. D-DIMER ELEVATED. CHEST CTA SHOWS SOLITARY RIGHT UPPER LOBE PULMONARY ARTERY PULMONARY EMBOLISM. BILATERAL LOWER EXTREMITY ULTRA SOUND SHOWS THROMBOSIS FEMURAL ARTERY NO PERSONAL OR FAMILY HISTORY OF BLOOD CLOTS AND NO HISTORY OF BLEEDING EPISODES OR LONG TRAVEL OR SEDENTARYNESS.

FINAL DIAGNOSIS: o Acute pulmonary embolism and DVT SECONDARY DIAGNOSIS: Principal Problem: Pulmonary embolism and infarction (CMS/HCC) POA: Yes Active Problems: Tobacco abuse POA: Yes Opioid dependence (CMS/HCC) POA: Yes Pulmonary embolism (CMS/HCC) POA: Unknown DVT (deep venous thrombosis) (CMS/HCC) POA: Unknown Chest pain POA: Unknown Hemoptysis POA: Unknown Resolved Problems: * No resolved hospital problems. * PDMP Query Date: 03/24/21 PDMP Comments: 03/22/21 suboxone 8mg/2mg #14/14 days multiple fills ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- BRIEF HOSPITAL COURSE: a 44 year old male with h/o of anxiety, depression, substance use on Suboxone, history of alcohol abuse, admitted 3/24/2021 with pleuritic chest pain and shortness of breath. Evaluation was positive for bilateral DVT and pulmonary embolism Bilateral PE, infarction, bilateral DVTs -No obvious precipitating factors -patient underwent first COVID 19 vaccine injection, is actually due for second shot. Unclear if this is contributed, recommended to hold on getting second dose and discuss this with PCP. -Also follow-up with PCP for appropriate cancer screening -patient was treated with therapeutic subcutaneous Lovenox, remained hemodynamically stable and is feeling better today. Upon discharge we'll prescribe Elocon is 10 mg b.i.d. for another 5 days followed by 5 mg b.i.d. maintenance dose. He will be provided with coupon for 1 month supply, he was recommended to follow-up with PCP for further recommendations. He will probably need anticoagulation for at least 6 months or longer depending on further course. -Echocardiogram showed ejection fraction 50-55%, Mild mitral valve prolapse no evidence of RV strain. Hemoptysis -Most likely was related to PE and infarction -resolved. Pleuritic chest pain, h/o Afib -Most likely pain was secondary to PE, improved -Continue Cardizem as prior to admission -Stop aspirin since patient will be on anticoagulation therapy History of opioid dependence, alcohol abuse Continue suboxone Ongoing smoking smoking cessation was advised Disposition: Routine Discharge Home CONSULTS: Consults Ordered during this Encounter Procedures ? Ancillary Service Request - IV Team New IV Start (multiple sticks for labs) ? Ancillary Service Request - Social Services PROCEDURES: Procedures Ordered during this Encounter Procedures ? Patient is currently on therapeutic anticoagulation (warfarin, Pradaxa, IV heparin, Rivaroxaban) - no reassessment RADIOLOGY TESTS: CT CTA Chest Final Result 1. Segmental and subsegmental pulmonary emboli throughout the right lung, most prominent in the right lower lobe. Segmental and subsegmental pulmonary artery the left pleural effusion. 2. Wedge-shaped opacities at both lung bases concerning for small pulmonary infarcts. 3. No findings of right heart strain or pulmonary hypertension. Impression discussed with Dr of the ER at 20:44 on 03/24/2021 by phone. Electronically signed by: MD 3/24/2021 8:46 PM US Legs Bil Venous DVT Final Result Bilateral posterior tibial vein thrombosis. This critical result was called to the clinical team, including by telephone, at 6:00 PM by the sonographer, according to internal Department documentation. Electronically signed by: MD 3/24/2021 6:16 PM XR Chest PA and Lateral Final Result Small bilateral pleural effusions. Streaky left basilar opacity may reflect atelectasis or infiltrate. Small right basilar opacity of uncertain significance. All opacities are new since 2016. No pneumothorax. 4 week follow-up is recommended. If the abnormalities have not resolved by then, chest CT is recommended. Electronically signed by: MD 3/24/2021 5:36 PM ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- PROPOSED MANAGEMENT PLAN: Risk for readmission within 30 days: o Low Pending results: Unresulted Labs . . . Comprehensive Metabolic Panel [124639904] Collected: 03/24/21 1818 Updated: 03/24/21 1823 Specimen Source: Blood, Venous Morphology [124639439] Collected: 03/24/21 1700 Updated: 03/24/21 1715 Specimen Source: Blood, Venous Comprehensive Metabolic Panel [124637329] Collected: 03/24/21 1700 Updated: 03/24/21 1705 Specimen Source: Blood, Venous Troponin, HS [124637342] Collected: 03/24/21 1700 Updated: 03/24/21 1705 Specimen Source: Blood, Venous Recommended Testing: o Refer to Hospital Course DISCHARGE MEDICATIONS: Medication List STOP taking these medications aspirin 81 MG Chew TAKE these medications Dose Ordering Provider Morning Afternoon Evening Bedtime apixaban 5 MG Tabs Commonly known as: ELIQUIS Instructions: Take 2 Tabs (10 mg total) by mouth TWICE A DAY for 5 days, THEN 1 Tab (5 mg total) TWICE A DAY. Start taking on: March 26, 2021 Signed by: MD buprenorphine-naloxone 8-2 MG Film Commonly known as: SUBOXONE Instructions: Dissolve 1 Film under the tongue DAILY for 14 days. Instructions: NADEAN: xe2109242 Dose: 1 Film Signed by: MD diltiazem CR 240 MG Cp24 Commonly known as: DILACOR XR Instructions: Take 240 mg by mouth DAILY. Dose: 240 mg Where to Get Your Medication apixaban 5 MG Tabs High-risk Medication Changes: o Refer to Hospital Course PTA Medication Changes: o Refer to Hospital Course

death Narrative: Patient received Moderna covid vaccine #1 on 3/25/21. No notes entered after this time and date of death is recorded as 3/30/21. No scanned records. No autopsy results available. 5 days from date of vaccine to date of death.

Patient received his first dose of COVID vaccine on 4/8 and developed GI symptoms ~ 4/16. Patient tested positive for COVID on 4/25 when he presented to the ED. However, he was sent home at that time since he was stable to go home and was not hypoxic. Pt presented to the ED again on 5/4 due to dyspnea on exertion and pain in the back of his knee. Patient was found to be positive for DVT and PE and was started on therapeutic Lovenox. Patient doesn't have a history of VTE, but he does have a family history of VTE. Since patient wasn't found to be hypoxic, COVID treatment wasn't started in the hospital.

Pt presented to the hospital with abdominal pain and shortness of breath May 28, 2021 Noted to be thrombocytopenic - had normal platelet 20 days prior Had bruising, melena

Patient developed episode of diarrhea shortly after 1st shot in series, this was followed by lower extremity swelling and mild dyspnea on exertion, that quickly exacerbated after the 2nd shot on 5/15/2021, that resulted in severe dyspnea on exertion, severe lower extremity swelling with approximately 25 lb weight gain, orthopnea and hemoptysis. Patient reported temperatures of 99.2 F to 99.8 F. Outside CT chest abdomen pelvis angiogram showed moderate to large acute segmental/subsegmental pulmonary emboli with trace right heart strain and right lower lobe pulmonary infarction, moderate right pleural effusion, acute splenic vein thrombosis with extension to the proximal portal vein and associated splenic infarcts, bilateral renal infarcts, and evidence of portal hypertension. He was transferred to the Hospital for further management. Upon presentation here he was tachycardic but with stable blood pressures and requiring up to 5 L by nasal cannula. Initial laboratory studies were notable for WBC 21.0, INR 1.8, D-dimer 11653, NT pro-BNP 17684, troponins 603 to 579 to 574, CRP 127. He was started on a heparin infusion. He was admitted to the MICU for further management. Bedside ultrasound demonstrated reduced biventricular contractility. He was given two doses of 40 mg intravenous furosemide with about 3.5 L of urine output since admission (net negative 3.1 L). His oxygen was weaned to 1 L by nasal cannula. Lower extremity venous and arterial Dopplers were negative. Subsequent imaging demonstrated a transperineal inferior infarct with akinesis of the inferior septum, inferior and inferior lateral walls with apical and mid ventricle akinesis secondary to a complete occluded RCA. moderate pericardial effusion without tamponade noted. Upper extremity ultrasound demonstrated acute DVT in the lower right IJ, innominate, subclavian and proximal axillary veins. MRI venogram was negative for clots, but multiple acute and subacute enhancing infarcts within all 3 vasculature distributions consistent with embolic etiology were noted. TTE showed of mural thrombus along the septal and inferior walls of the LV apex, severely enlarged left ventricle with EF of 20%, severe hypokinesis. Patient was aggressively IV diuresis, with improvement in respiratory status. Maintained on high-intensity heparin for pulmonary emboli, DVT, and diffuse arterial and venous thrombosis. He was bridged to warfarin. Patient was prescribed LifeVest for primary prevention. Started on beta-blocker and ACE-inhibitor given EF. Patient planning on discharge 6/5-6/07, outcome pending.

On June 3rd, 2021 I was admitted to the hospital with multiple pulmonary embolisms in both lungs in multiple spots. No family history or any other medical history that would cause this.

anterior STEMI admitted on 5/11/21 with left chest and arm pain. Underwent stent to LAD pt stated he developed chest discomfort and SOB a few days after his 1st moderna vaccine in Mid April

I felt my body ache initially then fever sometimes. Headache. I was developing Rashes on my body I went to urgent care and they took a blood sample. At 8:30 PM I got a call from Dr the I have to visit urgent care immediately for a few more tests. Skin: Positive for rash (noticed rash on the trunk and abdomen yesterday. papular rash ). Neurological: Positive for weakness (feels tired and fatigued for last 2-3 days.). Negative for dizziness, tingling, numbness and loss of balance. Psychiatric/Behavioral: The patient does not have insomnia.

It was an hemorrhage with broken veins; He had his right feet hot, swelling and purple; He had his right feet hot, swelling and purple; He had his right feet hot, swelling and purple; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (It was an hemorrhage with broken veins), FEELING HOT (He had his right feet hot, swelling and purple), PERIPHERAL SWELLING (He had his right feet hot, swelling and purple) and SKIN DISCOLOURATION (He had his right feet hot, swelling and purple) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. In April 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 an unknown date, the patient experienced HAEMORRHAGE (It was an hemorrhage with broken veins) (seriousness criteria hospitalization and medically significant), FEELING HOT (He had his right feet hot, swelling and purple) (seriousness criterion hospitalization), PERIPHERAL SWELLING (He had his right feet hot, swelling and purple) (seriousness criterion hospitalization) and SKIN DISCOLOURATION (He had his right feet hot, swelling and purple) (seriousness criterion hospitalization). At the time of the report, HAEMORRHAGE (It was an hemorrhage with broken veins), FEELING HOT (He had his right feet hot, swelling and purple), PERIPHERAL SWELLING (He had his right feet hot, swelling and purple) and SKIN DISCOLOURATION (He had his right feet hot, swelling and purple) outcome was unknown. Concomitant product use was not provided by the reporter. The patient went to the hospital and was told that it was an hemorrhage due to broken veins and did not have clots. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. No treatment information was 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 was not applicable. Based on the current available information and temporal association between the use of the product and 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 events, a causal relationship cannot be excluded.

I developed a DVT in my lower left leg, which I noticed from the swelling, warmth and pain. Then, a few days later, on a Sunday so my Dr's office was closed, I started having extreme difficulty in my breathing. I went to the ER and, after having multiple testing, was diagnosed with the DVT and a PE in each lung (almost to the point of full blockage). I was kept in the hospital overnight so they could monitor my breathing to be sure I wasn't stopping breathing throughout the night. I'm now on blood thinners for life.

Patient presented to the ED and was subsequently hospitalized for severe sepsis with lactic acidosis within 6 weeks of receiving COVID vaccination.

The patient was found deceased at home about 24 hours after immunization. Date of Death:: 12/29/2020; estimated time of death 6:00pm

Patient received vaccine in afternoon of 12/28. She works in ER as housekeeper 7pm-7am. The day she received the vaccine she became ill with fever chills and nausea and left work at 2am. On 12/31 she developed hemianopia. She went to ER and they did CT scan. She was told it was complex migraine. She left and came Home. On 1/1/21 her vision was back to normal. On 1/3 she suffered bilateral cerebellum ischemic stroke. She is currently in medical center. In Trauma.

The patient did not have any adverse reactions during the 15 minute observation, nor any reported the day of the vaccine. Between his COVID diagnosis and the second vaccine, he had serval documented complaints of nausea, dizziness, body aches. The patient had a virtual visit on 1/21/2021 for dizziness, nausea and fever. At this time, these symptoms had been persistent for one month according to his medical records. Patient later presented to the Urgent Care for with a fever of 103.1, rigors, nausea and cough. Patient admitted to hospital for sepsis.

On 1/28/2021 at 0545 hours as I was on my way into work when I started to have severe right side chest pain, so much so that I had to pull over. Shortly thereafter ambulance arrived on scene at which time it was determined that I would be transported to the hospital. Once there, a series of tests were conducted, one of which was a D-Dimer blood test to rule out blood clots. That resulted in an elevated count to which a CT scan was ordered. The result of the CT scan revealed that I had 2 Pulmonary Embolisms, one in the upper lobe of my right lung and one in the middle lobe of my right lung. Due to me being what the doctors said was a healthy 45 year old with no underlying conditions or signs of DVT (deep vein thrombosis) they deemed me low risk at that time and advised I was at low risk of dying in the next 30days. However, they advised that at any time, the clot could possibly become dislodged and cause worse problems, possibly death if time is not given to the body to dissolve the clots. Ultimately it was determined that I be discharged and prescribed blood thinning medications to help thin the blood to prevent further clotting should I have a clotting issue (undetermined at this time).

Patient was in observation post vaccine and pharmacist saw patient looking different and began to call out SIr Sir as pharmacist was making way to chair when patient fell forward onto floor and hit his head on a display of cold medicines. Pharmacist and another associate helped patient up who was conscious. He asked what happened and if he were standing. He shared that everything went pitch black. He was placed on chair; pharmacist asked if he wouldl like to lie down and he declined. He stated he had felt nervous and scared about imz before his appointment. Patient did cut his lip in fall and was given napkins for bleeding and a cold compress for face and neck. Patient waited with us for 2 hours. His BP was 154-74 and pulse of 54 ; patient stated he was a runner with low pulse. Patient arranged for a ride from family member since he lived far and was not sure about driving. I recommend that he place a call in with his provider.

After about 30 minutes he said his throat felt weird. That night. Later he said he didn?t feel good and he said these are just normal reactions. I with pneumonia, or he thought he was catching pneumonia from me. Not possible he had the vaccine. Then the next morning he was still having difficulty breathing. Then Saturday 03/20/2021. afternoon he couldn?t catch his breath. I ran to get my phone and came back and he was dead. Called 911 and did CPR. They arrived and got a heart beat and put him on a breathing machine. He is in a medical induced coma. With a 50/50. Chance of survival.

I started coughing up specs of blood out of the blue. Called doctor and they said to watch it. Later that night I started coughing up Tablespoons of fresh blood that wouldn't go away. Took ambulance to ER. CAT Scan showed an inflammation in lung and showed source of bleeding. They diagnosed me with pneumonia though I had no other symptoms (no fever or elevated white count, cough, or anything). Gave me IV antibiotics and sent me home with more antibiotics. Following up with a GP next week and asking to see a pulmonary specialist.

The patient is a 45 y/o male prisoner who presented 4/3/2021 with 3 days of headache, neck pain and stiffness, sensitivity to light, and nausea. He was found to have extensive dural venous sinus thrombosis causing the symptoms. He has hypothyroidism was taking levothyroxine 150 mcg daily at time of vaccination. On admission on 4/3/2021 his TSH was found to be 12 and levothyroxine dose was increased to 175 mcg on 4/4/2021. He has no prior history of thrombosis and the only family member with thrombosis is his mother who had DVTs associated with lung cancer. He has a history of prior COVID-19 infection in April of 2020 and at that time reported 3-4 days of mild symptoms and was not hospitalized or given anticoagulation. He has not had fevers, chills, or other symptoms of infection. He received his first dose of the Moderna COVID-19 vaccine at the prison on 3/23/2021 which was 9 days prior to symptom on set 12 days prior to presentation at the hospital. He reports 2-3 days of arm soreness at the injection site in his right arm, mild neck soreness, and fatigue after the injection which had resolved prior to his current symptoms starting. He currently remains hospitalized and is being treated with anticoagulation.

I had an extensive oral surgery about 36 hours after getting the vaccination. I had non profuse bleeding after the surgery. I experience a condition called Liver Clot (currant jelly clot). This condition and the bleeding continued for over 5 days following the surgery or 6.5 days after the vaccine dose 1.

On 4/21/2021, 45-year-old male presents to urgent care for complaint of constant left lower extremity pain centralized in the calf area radiating to left posterior thigh area since April 12, 2021. He denies fevers, chills, chest pain, shortness of breath, palpitations, orthopnea, peripheral edema, claudication, nausea, vomiting or diarrhea. He reports that symptoms started after receiving the 1st dose of the Moderna Covid vaccine. Ultrasound of LLE completed 4/21/2021 results Acute deep vein thrombosis. Patient directed Hospital ED. Patient prescribed Eliquis 5mg.

Previously healthy 46 yoM received moderna dose 1 on 4/9. On 4/13 starts noticing a petechial rash on bilateral feet. This spreads up the legs with some involvement in the torso. On 4/15 notices mucosal bleeding with gums while brushing teeth, increasing spontaneous nose bleeds overnight. On 4/21 has a telehealth PCP visit, sent for lab work which shows thrombocytopenia with a platelet count of 2k as well as a hemoglobin of 12.9. Is sent to the ED with repeat platelet count of 1k. Previously platelets were 143k in 2019. Pt admitted for further work-up

massive blood clot in the right lung; painful knot under the skin on his arm; threw up about 20 times in 6 hours, and kept vomiting all the next day; massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him; next day when he got up and could barely walk; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (massive blood clot in the right lung), PULMONARY PAIN (massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him) and THROMBOSIS (painful knot under the skin on his arm) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Autoimmune disorder NOS in September 2020 and Broken bones. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced GAIT DISTURBANCE (next day when he got up and could barely walk). On 26-Mar-2021, the patient experienced PULMONARY EMBOLISM (massive blood clot in the right lung) (seriousness criteria hospitalization, medically significant and life threatening). On 04-Apr-2021, the patient experienced PULMONARY PAIN (massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him) (seriousness criterion medically significant). On an unknown date, the patient experienced THROMBOSIS (painful knot under the skin on his arm) (seriousness criterion medically significant) and VOMITING (threw up about 20 times in 6 hours, and kept vomiting all the next day). On 19-Mar-2021, GAIT DISTURBANCE (next day when he got up and could barely walk) outcome was unknown. On 28-Mar-2021, PULMONARY EMBOLISM (massive blood clot in the right lung) had not resolved. On 04-Apr-2021, PULMONARY PAIN (massive blood clot in the lung ended up in different parts of the lung causing extreme amount or pain\ Left lung is beginning to hurt again and his chest is killing him) had not resolved. At the time of the report, THROMBOSIS (painful knot under the skin on his arm) and VOMITING (threw up about 20 times in 6 hours, and kept vomiting all the next day) outcome was unknown. Not Provided Treatment information provided as blood thinners (IV heparin) and antibiotics were used to treat the events. 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-2021-081632 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-081632:2nd dose

This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Developed a pulmonary embolism) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-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 PULMONARY EMBOLISM (Developed a pulmonary embolism) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Developed a pulmonary embolism) outcome was unknown. Not Provided 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. The concomitant medications and treatment details were 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 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.

Patient stated he started having trouble breathing and became shaky about 5 minutes after the vaccine was given. An epipen, gatorade, and an icepack were given to the patient, and he immediately started feeling better.

at ER patient was diagnosed with a stroke and now remains hospitalized; fever; bodyache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (at ER patient was diagnosed with a stroke and now remains hospitalized) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PYREXIA (fever) and MYALGIA (bodyache). On 27-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (at ER patient was diagnosed with a stroke and now remains hospitalized) (seriousness criteria hospitalization and medically significant). On 18-Apr-2021, PYREXIA (fever) and MYALGIA (bodyache) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (at ER patient was diagnosed with a stroke and now remains hospitalized) had not resolved. Not Provided No concomitant medication was provided. Treatment included hospitalization. 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. Company Comment - 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. Fever and myalgia are consistent with the product safety profile.; 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. Fever and myalgia are consistent with the product safety profile.

Pt developed a spontaneous superior sagittal venous thrombosis with resultant subarachnoid hemorrhage and Frontal IPH and seizure. Pt had a sudden seizure at home and CTA/MRI showed Superior sagittal sinus thrombosis. Pt required intubation secondary to altered mental status. Pt underwent diagnostic cerebral angiogram which confirmed cerebral sagittal sinus thrombosis. Pt tolerated extubation on 5/11.

Patient presented to the ED with difficulty breathing and was diagnosed with pulmonary embolism prior to this visit. He then presented to the ED on 4/19/21 with similar sx and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.

Heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No Medical History information was reported. On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization, disability, medically significant and life threatening). The patient was hospitalized on 14-Apr-2021 due to MYOCARDIAL INFARCTION. 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 products were reported. No treatment information provided. It was reported that three days after vaccination the patient had a heart attack. He was admitted to the ICU for three days, starting on 14-Apr-2021. He had seen his primary care doctor and his cardiologist multiple times since that incident and he was unsure of whether he should get the second vaccine dose or not.. Company comment: Very limited information regarding the event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Further information has been requested.

Patient presented on May 15, 2021 with sudden right lateral inferior chest pain that awoke him. He noted a feeling of heaviness and mild dyspnea for two days prior. Worse when flat. Hypoxic. Right upper quadrant guarding and tenderness. Treated with anticoagulation as an outpatient.

On June 3 he developed a sore throat. His voice sounded like he had a frog in it. Early on June 4 he had to urinate about 10 - 15 times overnight in about a 6 hour timeframe. Later on Friday he left home and a short time later called 911 saying he couldn?t breath. When the paramedics arrived they couldn?t revive him and he died.

16 days after receiving my first Covid vaccine shot (The 1st of the 2 shots required) Around 7pm on May 5th I started having a hard time breathing & slight chest pains. I decided to lay down & that seemed to make it worse. I've never had any issues like this before so I figured it would eventually go away on its own & continued to try and lay down on my bed but as each hour passed it continued to get harder and harder to breath & each breath I took became increasingly strained & felt as though my lungs weren't letting me take in large breaths, only short gasps. By 2am May 6th, 2021, I knew something was obviously veryyy wrong! I drove myself to the closest ER (that being Hospital approx 5 minutes away) & was admitted. After running several tests, I was presented with the news that I had ACUTE RESPIRATORY FAILURE, PNEUMONIA, HYPOXIA, PLEURAL EFFUSION & ACUTE SYSTOLIC CONGESTIVE HEART FAILURE...

This patient was homeless. Partner was with patient on the night of 6/12 when patient complained of not feeling well and attributed it to side effects of his COVID vaccine, which he received two days prior. Patient declined to go to the hospital. When partner woke up the morning of 6/13, the patient was found dead. A coroner's report is expected sometime within the next 4-6 weeks.

Patient started having intermittent worsening chest pain and shortness of breath starting 5 days after 1st shot.

A friend of the patient called us today to inform us that the patient had recently passed away from a brain aneurysm. The friend asked it it were possible that this occurrence was somehow related to patient receiving his covid vaccination. The friend did not have a lot of information about the occurrence; he only stated that the patient's brain aneurysm was about 6 weeks after his 2nd dose of the covid vaccine. Patient was not a regular patient of ours so we have no additional medical history for him. We administered his first Moderna vaccine on 4-2-2021, and he returned for his second dose on 4-30-2021. I assured the friend I would report this to VAERS and thanked him for reaching out to us on behalf of patient.

Within days PT complained of headaches that become severe in intensity. No history of migraines or other health issues . Just had a full workup prior for insurance purposes. Pt went to ER as pain would not subside and was sleeping a lot. Was diagnosed with a infarction in the brain x2. Headaches have never really improved and now is currently admitted into hospital with two more blood clots in brain.

Patient reported chest discomfort after initial COVID-19 infection in 12/2020 - mild, lasting for 2 weeks - did not seek medical attention Received first dose of Moderna vaccine in 2/2021 - chest pain occurred and self resolved after 2 days. Received 2nd dose of Moderna vaccine on 3/19/2021 - chest pain start about 48 hours after wards and was constant prompting him to come to ER on 3/23/2021. Troponin-I was borderline elevated but flat (0.065, 0.054, 0.050, 0.045 ng/mL); echocardiogram did not show any regional wall motion abnormalities or pericardial effusion and preserved left ventricular ejection fraction. With no reported events of myocarditis related to the vaccine at the time and lack of cardiac MR imaging at the facility, patient was briefly treated for presumed NSTEMI with dual antiplatelet, high-intensity statin therapy and initiation of beta-blocker and ACE-inhibitor. On 4/19/2021, with inability to arrange for a local cardiac MR, and rule out underlying ischemic heart disease, a treadmill nuclear stress test was performed showing a moderate-sized fixed anterior and mid to apical anterolateral defect (sparing apex) with no evidence of ischemia on myocardial perfusion imaging or stress ECG. With ambiguity regarding the diagnosis and patient's reluctance to take empiric high-dose NSAIDs with colchicine for presumed myopericarditis, he eventually underwent cardiac MRI at a tertiary care facility on 5/5/2021 showing preserved biventricular size and function with myocardial edema and subtle left ventricular mid wall enhancement involving inferoseptal/inferior wall at the inferior RV insertion point consistent with myocarditis. Patient's aspirin and clopidogrel was subsequently discontinued. He was initiated on high-dose ibuprofen for 2 weeks followed by 3 months of colchicine therapy with interval resolution of symptoms.

Pt had L Upper chest pleuriti pain and DOE did not seek med attention 6 weeks later sought attention for R pleuriti pain and DOE - had pul infarct and LLE DVT

Notified by patient's sister on 1/26/2021 that patient died in his sleep on 1/25/2021. She did not know cause of death.

I received my 2nd dose of the moderna vaccine on 1/24/21. On 1/25/21 at approx 2am I had tremmors, feeling of intense cold, headache, body pain, fatigue. That lasted until approx 0300am 1/26/21. I slept most of the day 1/25 except for taking kid to school and monitoring another at home. I had read the side effects and I felt as though things were subsiding on 1/26 but I was still weak with body pain. I was not 100%. I was home alone with 2 kids (wife out of town). 1/25 I had a cough and was short of breath but didn't think much of it. The cough persisted. On 1/27/21 I was still short of breath. I went to a nearby fire station and had them put me on a lifepack. I was in atrial fibrillation. I could not do anything because my wife wasn't due back until 3pm. At 3PM she walked in and I walked out and drove myself to Hospital. I was diagnosed with A-Fib w/ RVR. I was in A-fib until I was cardioverted on 2/1/21 and was given a cryo-ablation.

Patient went to Emergency Room d/t UTI, C-diff colitis, PE/DVT admitted treated with IV heparin, Vancomycin/flagyl, antibiotics for UTI

12 Feb 2021 at 17:00 patient report electrical shoot pain felt from left foot to left knee. Pain lasted for approximately 10 sec. Pain repeated twice during the night, waking from rest. 13 Feb 2021 painful episode repeated at 7:30 am. Painful episode repeated at 7:00 pm and continued for every 20 minutes. Pt reported to ER on 13 Feb 2021 at 10:30 pm. Facility conducted ultrasound on 14 Feb 2021 and identified left popliteal near occlusive blood clot. Prescribed Eliquis 5 mg and discharged home; f/u with PCP and Hematology. Continued course of treatment: Continue Eliquis as prescribed for 6-8 wks, f/u with PCP and Hematology.

symptoms left lower leg pain one day after receiving 2nd COVID vaccine, diagnosed with left leg DVT 13 March

Injection site soreness (+3 hrs), High fever (+12 hrs), Headache (+12 hrs), AFIB (+22 hrs), Tachycardia (+22 hrs)

Resident was inoculated on 04/09. According to family members, he began to feel unwell that evening, cold sweats, high fever, dehydration. According to family members, he refused to get medical attention. After not hearing from him for a few days, family members called for a wellfare check on 04/12 at which time he was found deceased.

patient developed DVT shortly after recieving the vaccination. diagnosed on 4/15/2021 symptoms started about one week prior to this.

lot: 026A21A NDC 80777-273-99.he started with symptoms after vaccine which progressed. SOBOE, N/V, fever & fatigue x 1 week in setting of recent COVID vaccine. admitted to hospital via ED with pleural effusion, AKI, Labs notable for +ANA, +smith/RNP, SSA/SSB,+Scl-70, dsDNA, low complements, lymphopenia, leucopenia, thrombocytopenia, rhabdo,worseing renal failure (now on dialysis) with PU, kidney biopsy largely unrevealing. Bone marrow biopsy concerning or HLH. DDx HLH 2/2 to new onset SLE with overlap syndrome/MCTD.patient needed to be transferred to a tertiary center, now at another facility in critical condition with encephalopathy.

Developed L chest pain and headache late in evening 5-4-21 and diagnosed with pulmonary embolis 5-4-21. He was treated initially with high-intensity heparin nomogram and converted on 5-5-21 to oral apixaban. He has done well with this therapy. His risk factors for PE include immobility; however, the risk of a thrombotic event in quadriplegic patients should be that of the general population after the first year of disability, and he has been immobile for around 2.5 years. He has no known underlying malignancy, and his recent imaging of his chest and head are reassuring in this regard. The patient received his Moderna COVID-19 vaccine 12-23-20 and 2-2-21 with vascular events having been reported as being more common following this immunization. Without a clear cause for his PE, this will be reported on VAERS.

Patient presented to the ED on 4/4/21 with viral illness and left sided chest pain. Patient presented to the ED on 4/14/21 with chest pain and was subsequently hospitalized for NSTEMI. These visits are within 6 weeks of receiving first COVID vaccination dose.

Presented to hospital with headache, found to have a large left-sided intracranial hemorrhage and bilateral occipital intracranial infarcts

After 8 days I started feeling a headache I took ibuprofen then I felt numbness of my mouth and my right eye would not fully close only half way, my mouth started drooping sideways when I ate and swallowed food, my throat felt strange the liquid like water would come out a little. My eyes burned, predominately my right eye.

Vaccine has been calcified; Might develop sepsis; Night sweat; Cannot sleep; Cannot raise his arm pass his shoulder.; Injected the first dose about 2 inches high and they inject it in his shoulder socket; Shoulder pain / His shoulder really hurts.; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (Might develop sepsis) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Shoulder operation and Knee operation. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE CALCIFICATION (Vaccine has been calcified), SEPSIS (Might develop sepsis) (seriousness criterion medically significant), HYPERHIDROSIS (Night sweat), INSOMNIA (Cannot sleep), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Cannot raise his arm pass his shoulder.), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected the first dose about 2 inches high and they inject it in his shoulder socket) and ARTHRALGIA (Shoulder pain / His shoulder really hurts.). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE CALCIFICATION (Vaccine has been calcified), SEPSIS (Might develop sepsis), HYPERHIDROSIS (Night sweat), INSOMNIA (Cannot sleep), VACCINATION SITE JOINT MOVEMENT IMPAIRMENT (Cannot raise his arm pass his shoulder.), INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Injected the first dose about 2 inches high and they inject it in his shoulder socket) and ARTHRALGIA (Shoulder pain / His shoulder really hurts.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray limb: abnormal abnormal (abnormal) The X-ray showed that the vaccine has been calcified in his shoulder socket.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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 have underlying Afib which has been controlled on Sotolol for the last five years with occasional episodes of arrhythmia but my heart rate stayed controlled. After the vaccine my heart rate shot up to nearly 300 while I was driving home and it eventually came down but I stayed in Afib for nearly 2 months afterwards. I upped my dose to 400 mg daily from 320 mg of sotolol and eventually got some control of the Afib but now goes out of rhythm more frequently and when it goes out I am not rate controlled.

Pt received moderna vaccine 4/7/21 and 5/5/21, and developed nausea and vomitting about four hours after the second shot. These symptoms plus epigastric and RUQ pain and decreased po intake persisted until evaluation on 6/15/21 to medical center when pt was diagnosed with biventricular systolic congestive heart failure complicated by an RV thrombus and subsequent subsegmental LLL pulmonary embolus. FYI - lot number above for 2nd covid shot is either 025B21A or 025821A (the 4th digit is either a 'B'or '8'). shot #1 given at clinic and #2 given at clinic(both VA clinical areas)

3 days after receiving vaccine, developed a severe cold which was diagnosed as pneumonia which lasted 3 weeks. Then when back to the doctor for follow up and was then diagnosed with bronchitis, Consistent trouble breathing , chest pain, left arm pain for 3 months and has been prescribed multiple inhalers, steroids, antibiotics, chest xrays, ultrasounds, stress tests. Has developed allergic reaction to peanut butter and bee stings. Patient was previously a vigorous healthy man with no serious health conditions.

Dizziness, heart racing, nausea, severe body aches, fever, chills, difficulty breathing, extreme gas, cramps. Was transported the Hospital and received zofran, atavan, morphine and tested negative for COVID 19 and flu and pneumonia. released after four and a half hours but continued to experience pain in muscles and fever even today (01/14/2021).

48 hours post vaccine, patient developed low grade fever and respiratory complaints including shortness of breath. chest x ray showed RUL consolidation. when patient wosened over the next 48 hours from respiratory standpoint including new oxygen requirement and hypotension, decision was made to perform chest ct which confirmed presence of RUL pneumonia. the following day, the patient was bronched and the resultant bronchial alveolar lavage that was performed has thus far been completely negative. repeat chest xray four days later showed resolution of RUL consolidation and patient was no longer symptomatic.

Appears that ITP has come back. I have significant bruising on my left triceps, right triceps, and left hand. I have not sustained any significant trauma that would have caused this type of bruising. In addition, my right foot is very sore around the metatarsals.

Moderna COVID- 19 Vaccine EUA Patient was found deceased in the community near his home address on 2/24/21. The Medical Examiner's cause of death is currently listed as "Drug Intoxication - Accidental Overdose." Per the MEO, post mortem urine toxicology was positive for cocaine and fentanyl. His death is believed to be related to a cocaine product that was adulterated with fentanyl and is not believed to be related in any way to the Moderna COVID-19 vaccine. This was explicitly stated by the Medical Examiner's Office.

Approximately 45 minutes after injection mild onset of anaphylaxis response. Numb tongue, tingly lips, mild throat constriction but no issues swallowing or breathing. About 60 minutes post-injection, the patient self-administered two 25 mg tablets of Benadryl. Symptoms subsided 120 minutes later.

Patient Started having dizziness, feeling faint at around midnight on 3/3/2021. He then lost consciousness, had seizure-like activity and was taken to hospital via EMS. In the hospital patient was unresponsive and received resuscitation attempts unsuccessfully. Per family, after about 45 minutes, code was called and patient expired.

Pt had COVID in Early January 2021. He had mild symptoms and recoverec. On March 1 2021 had his first Moderna. Covid shot. Next day, ( March 2) headaches. fevers, chills and chest pain. Pt had EKG findings of STEMI myocardial infarction. He was sent to the cath lab from the cath lab he was admitted. Finding of normal coronary arteries. However, he appeared to have developed a cardiomyopathy compared to a prior study. He had a echo on March 3. . Appeared to have a cardiomyopahty with estimated EF or ejection fraction of 40%. He had normal cardiac function three years earlier . On March 3rd his EKG normalizec. He was sent home on March 4

Fever, headache, chills, night sweats. All on same day. 3 days later swollen knees. 10 days later blood clot in right leg.

Cardiopulmonary arrest, D-Dimer 55,000, TNKase administered, ACLS, needle thoracostomy, persistent PEA arrest, decompensated into asystole , pronounced

Patient reported DOE March 4, 2021, was subsequently diagnosed with pulmonary embolism, hospitalized and treated with Xarelto. He is currently recovering and will continue with Xarelto as an outpatient.

Pt started having headaches on 3/20/21. He was playing golf with a cardiologist and he recommended that he see his doctor.

Developed petichiae on 3/20. Labs drawn 3/22 showed Platelets of 20,000. Started 150mg prednisone 3/29. Neurological symptoms that week. Seizure and brain bleed noted on 4/3. Intubated and transferred from local hospital to neuroscience hospital.

Leg cramp alerted me to deep vein thrombosis (DVT) and pulmonary embolism (PE) . I had the second dose of Moderna Monday afternoon. First cramp Tuesday evening. Mild infrequent leg pain Wednesday. Intense morning cramp on Thursday, hospitalized Thursday night with confirmed DVT w/PÉ. Discharged Sunday afternoon. Was fully hidrates at the time, no recent travel by car or plane. No extended period of inactivity such as bed rest or sitting. No evidence I?d internal trauma or injury. No recent surgery. No sign of any form of cancer. Vaccine listed as suspected cause of the DVT

I received Vaccine on 03/05/2021 and the next day I noticed wheezing and could not take a deep breath.. The following day I felt like something sitting on my chest. On 03/07/2021 I could not walk across the parking lot without giving out of breath. From 03/08/2021 up until now I have been to several Hospitals and Doctors. Diagnosed on 3/16/2021 at A Medical Center with Acute Systolic and Diastolic CHF .

Patient developed myocarditis resulting in hospitalization at medical center. He was treated with medications for heart failure, symptoms resolved and he was discharged home with follow up in heart failure clinic.

Numbness on top of young and my lips. I had confusion, anxiety headache, lungs were feeling extremely hot, nauseous, increase heart rate and elevate blood pressure extreme confusion . I was rushed inside the Er. I received a Ct scan, ,lab work, and a EKG I received IV ,fluids,Ativan,, Diphenhydramine, famotidine and Prednisone.

Patient is a 47 y.o. pleasant man with history of diabetes, presented to hospital with intractable vomiting. He was lethargic and unresponsive. He was found to have bilateral transverse and straight sinus thrombosis, multifocal ischemia consistent with venous infarction. He was treated with heparin drip from diagnosis 5/11 and transitioned to apixaban 5/22. His mentation improved. As of today, he is conversant, disoriented, ambulatory, no longer requiring a feeding tube.

3 days after 2nd dose of moderna patient presented to our er in cardiac arrest; lacking extensive cardiac history other than a-fib; he had reported anginal like symptoms to his wofe during the day and then collapsed in v-fub and was unrecusitatble; no autopsy or further information; unclear if vaccine is contributory but within 3 days i agreed with patient's wife in that the temporal relation should be reported

STEMI treatment: went into V fib arrest and did CPR and went to cardiac cath and received PCI discharged home

Ventricular tachycardia and presumed myocarditis. Was feeling well until 4 days after vaccine developed palpitations found to have monomorphic VT followed by cardiac arrest.

Vaccine information (brand name, dosage, lot number) Date, time, and location administered: Date: 4/27/2021; Time: ? m; Location: Pharmacy Date and time when adverse event(s) started: Date: 4/28/2021; Time: afternoon Description of the adverse event, including medical treatment and diagnosis: Description: Symptoms include: Worst headache of life Exam Findings include: No focal neurologic findings but given history, CT head ordered.

The day after the first dose I experienced a subarachnoid hemorrhage. I was hospitalized for 10 days due to the hemorrhage.

Coroner stated that 3 weeks after patient received 2nd dose of COVID-19 Moderna vaccine, patient collapsed from cardiac arrest, which lead to death.

Patients appointment was either 2:15 or 2:30. His Apple watch recorded it's last heart beat reading at 3:15 pm, 05/21/2021, within an hour after receiving his second Moderna Covid-19. His heart rate increased rapidly from 3:00 to 3:15, reading 104 - 106 - 108 - 116 bpm. I can provide a photo of these last four readings if you need them. I don't know other symptoms. His body was found by police who were called for a well-check three days later, 05/24/2021. Patient died unattended, at home, alone. I only know for sure the vaccine was administered at a Target store near his home. Patient texted me at 2:48pm saying that Target gave him a $5 coupon for getting his vaccine, and he was going to use it to buy Tylenol.

I had the vaccine on Saturday and Monday early morning something woke me up, I was sweating and my heart was pounding like crazy. I thought it was the side effects of the vaccine. It took 3-4 hours to stop. After 2 weeks at 4AM something woke me up again and I was sweating for no reason. The same symptoms I had after getting the vaccine. On 06/18/2021 again 4AM something woke me up and I had the same sweating and I was throwing up. I thought it was the vaccine so I did not go to the hospital. I did not think this was a heart attack since I am young, healthy, non-smoker, non-drinker. Again, something woke me up. I went upstairs with my neighbor and she took me to urgent care because she thought it was COVID and I thought it was just the vaccine and they said to call ambulance immediately because I was having a heart attack. They took me to the hospital, and they started the procedure. They said it was impossible to open here. By helicopter they took me to another hospital. I was on the doctor on Friday and they told me I still have a blood clot and they try to open but they were not able to open so they left it like clotted. Now they told me they need to do the bypass surgery. No heart attack history in my family. I am not having that surgery because doctors do not care here. I am going to another country to have surgery since they do care over there and it is less expensive. They prescribed a lot of medications for my heart.

Patient presented to provider office visit 2 days after 2nd dose of Moderna vaccine with testicular pain for last 2 days, bluish color on tips of left fingers. Was prescribed levofloxacin x 7 days to cover for possible epididymitis and was told to monitor the finger discoloration and return to PCP next week for recheck. The following day (7/17), he presented to the Emergency Department for evaluation of the fingertip discoloration. He reported that the testicular pain had improved. ED provider noted: Fingertips on 2 or 3 fingers of a few small thin lines that are purplish in color almost as if discoloration of the fingerprint itself. But it is no more than 1 or 2 lines to 2 or 3 fingertips. There is no erythema no swelling no tenderness. There is no muscle soreness. No axillary lymphadenopathy. No ascending lymphangitis. ED Course Differential Dx: Adverse reaction to Covid vaccine, DVT, electrolyte imbalance, coagulopathy, electrolyte imbalance, localized trauma Lab normal white count hemoglobin platelet count mildly elevated hematocrit of 51.3. CMP showed a low CO2 22 I suspect this is due to prior elevated respiratory rate he does admit that he slightly anxious. Glucose was elevated 142 BUN was 6. Liver function studies normal. Coags normal Did do ultrasound of his arm since he recently was vaccinated there is no evidence of DVT or any occlusion. Patient's fingers are warm he has intact sensation I am not sure if this is an adverse reaction to the recent vaccine, some sort of unknown localized trauma. I suggested patient follow-up closely with primary care for reeval this week if no improvement and return if any acute worsening symptoms or problems.

After the first vaccine next day at 9:00am I have shooting headache,severe pounding in my ear. I told my wife (physician) what happened she recommended me to go toER. I went to ER they thought I had a stroke,CT scan diagnosed with subarachnoid bleeding. I was transferred to another hospital 1 day had another CT scan, MRI Scan and was seen by a Neurosurgeon. I was told I have a revolving bleeding in my brain, loss sensation right side and double vision. I'm scheduled for Cerebral Angiogram in Feb.

Bilateral PE with right heart strain and pulmonary infarct. COVID negative. Symptoms started 2 days after the vaccine progressively worsened. Diagnosed to day - 02/13/2021. Unknown whether this is an adverse event, but no history of coagulopathy or risk factors

Patient developed sob. Admitted on 2/16/21 with cardiogenic shock, acute renal failure and liver inflammation. Diagnosed with multisystem inflammatory disorder from COVID-19. Thought to be related to diagnosis on 1/25/21 but given recent receipt of vaccine reporting in case there are trends.

Stroke; A spontaneous report was received from a consumer concerning a 48-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke (cerebrovascular accident). The patient's medical history was not provided by the reporter. Concomitant product use was not reported. On 30 Dec 2020, approximately 11 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot #: 037K20A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection. The reporter stated that on 10 Jan 2021, the onset of symptoms of stroke began. The patient reports that he was discharged from the hospital on 20 Jan 2021 and was later discharged from patient rehabilitation on 26 Jan 2021. Treatment for the event included apixaban, acetylsalicyclic acid, and atorvastatin as advised by patient's HCP (health care provider). Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, stroke, was unknown.; Reporter's Comments: This case concerns a 48 year old male who experienced stroke 11 days after the vaccine was administered. Very limited information regarding this event has been provided at this time. Further information has been requested.

Notified by police department that patient was found dead at his home on 3/12/21. Per the officer, the family reports patient reported diarrhea on 3/11/21 and fatigue on 3/12/21. The family found him in his home deceased later in the day on 3/12/21

Patient found dead two days after vaccination; A spontaneous report was received from a healthcare provider concerning 48-year-old, male patient who received Moderna's COVID-19 vaccine (mrna-1273) and died. The patient's medical history includes bipolar disorder, colon polyps, hypertension, benign tremors & other Comorbidities. Concomitant product like iron sulfate, Fluticasone, Gabapentin, Lamotrigine, Methocarbamol, Propranolol hydrochloride was reported by the reporter . On 11 mar 2021, approximately 2 days prior to the event, the patient received their first dose of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 13 Mar 2021, the patient died. No other details were reported. Treatment information was unknown. The patient died on 13 Mar 2021. The cause of death was not provided. Plans for an autopsy were unknown.; Reporter's Comments: 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

I began feeling sick with symptoms like fever, chills, nausea, vomiting, rash/spots. Symptoms got worse over the next few days, and I ended up being admitted in the hospital for thrombocytopenia for 5 days.

Patient reports around 5 days after receiving Moderna vaccine he experienced fever, diarrhea, n/v and SOB. Pt presented 4/07/21 to LGH ED with unremarkable blood work and negative chest x-ray, Covid negative- Pt discharged. 4/12/21 pt represented to LGH ED for some concerns and worsening sob with talking and walking and found to have PE and pneumonia

PER PATIENT REPORT, PAIN A WEEK LATER MY LEG WAS ACHING. I USED ICY HOT, MASSAGER. STARTED SWELLING, WENT TO WALK IN. THEY DID AN ULTRASOUND AND SAID I HAD A BLOOD CLOT IN MY LEG AND IT WAS TRAVELING TO MY LUNGS. THERE WERE A COUPLE SPECKS ON LUNG PER XRAY.

Suspected stroke; Bell's palsy; High BP; A spontaneous report was received from a healthcare professional concerning a 48-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced bell's palsy, suspected stroke, and high blood pressure. The patient's medical history, as provided by the reporter, included hypertension. The patient stopped taking hypertension medications since Aug-2020.The concomitant product use was not provided/unknown by the reporter. On 16 Feb 2021, approximately 9 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 004M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, approximately 9 hours of receiving vaccine, the patient developed left ear fullness/pain/pressure. On 17 Feb 2021, the patient developed left eye watery and pain behind left ear. On 18 Feb 2021, the patient dribbled when drinking water when working overnight shift. On 19 Feb 2021, upon awakening in the afternoon, patient's speech was "off" and noted left side of face drooped and unable to close left eye. The patient went to Urgent care and referred to ED for suspected stroke due to High blood pressure. The patient was diagnosed with bell's palsy. Treatment for the vent included steroids, eye ointment and metoprolol. Action taken with the drug in response to the event was not provided The outcome of the events, bell's palsy, suspected stroke, and high blood pressure, were 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 events, a causal relationship cannot be excluded.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-026086:Same reporter

#1 = 011J20A on 1-6-21 #2 = 028L20A on 2-3-21 patient presented after sudden onset of chest pain early in morning and found to be covid +. ECG demonstrated diffuse ST elevation, troponins negative. CT without contrast didn't have much in it. He was found to be COVID rapid test+ and IGG negative. He was admitted into isolation, no oxygen needs. DDIMER was over 2000 and friction rub noted on physical exam. Cardiology ruled out STEMI, thought maybe viral pericarditis - but wanted echo done after out of isolation. CTA was planned for AM on 4-28-21, but patient died 4-27-21 PM after being found down in room. ROSC was not able to be achieved despite aggressive resuscitation efforts

Patient found dead after receiving vaccine. At 11:44 on 3-30-2021 Medical Investigator was able to return call after leaving scene where there was no phone service. Police were on the scene requesting Medical Investigator Contact was made between Medical Investigator and member of the police force. Narrative was that the patient, who is handicap with considerable health issues which he was born with, and his parents had been to healthcare facility to receive COVID vaccination. Returning they had traveled in order to arrive at their residence. The decedent had asked to be dropped off close to parents home. The parents arrived at the residence and after waiting ten to fifteen minutes walked searching for the decedent. He was located unresponsive and 911 was initiated.

Developed symptoms around 4/25, presented to ED with complaints of chest pain and something being stuck in his throat. Subsequently died on 4/27.

5/07 general ill feeling; runny nose, watery eyes. continued until 5/10. Wife denied fever or cough. continued until 5/10. 5/11 at work, patient collapsed. Was awake but non-responsive, breathing on his own, vomited shortly before EMS arrived. EMS arrived, patient stopped breathing, was bagged until arrival at hospital where he was intubated. 5/12 Patient was extubated and died in early AM 5/13. Medical records state cerebral brain hemorrhage.

Was seen in the ER on 04/08/2021 for left calf and leg pain. He stated that symptoms started a few days before but worse on the visit date. He has had hx of 3 other DVTs in the past. Denies sob

Pt received vaccine 5/11. Does not recall events thereafter. Admitted to hospital 5/13 due to altered mental status. MRI c/w encephalitis, and in rhabdomyolysis for several days with acute kidney injury requiring dialysis. Treated with high dose solumedrol and IgG and improving. Still requiring dialysis but hoping for renal recovery.

Pt. received 2nd Covid vaccine on 05/14/2021. On 05/15/2021 pt. reports not feeling well with s/s of body aches and chills. Pt. reports that on 5/16/21 that he noticed fever, cough and increased SOB. Pt. presents with c/o increase SOB on 05/18/2021. Pt. was admitted with diagnosis of right upper and middle lobe pneumonia on 05/18/2021. Pt. required 2-3 L of O2 per nasal cannula. Pt. was also on antibiotics on Rocephin 1 gm IV every 24 hours. Pt. received a one time dose of Azithromycin 500 mg in ED.

Patient representative, I believe his wife, called and stated he had a stroke about 1 week after his second dose. She states he is admitted to Medical center so outcome is unknown.

Started feeling light headed at 4am and had syncope x 2, his wife stated he was talking nonsense during this time, at 8am he had a fib, HR went from 40-155s, B/P 116/60, went to ER with chest pain and SOB, temp. 100.2, spent 3-4 hours in ED. He was sedated and converted.

Patient is 48yo, presented 48h after 2nd Moderna vacccine with an acute right MCA stroke, required IV tpa and thrombectomy. Only known risk factor is active cigarette smoking.

VF arrest 1 week after second Moderna vaccination. Successfully resuscitated, good neurologic outcome. Initial ejection fraction was low, 25%, currently improving. MRI with late gadolinium enhancement suggesting myocarditis. Troponin normal. Genetics panel without polymorphism predisposing to cardiomnyopathy.

After receiving the 2nd Moderna Covid Vacine I noticed shortness of breath, chronic dry coughing and fatigue/tirdness. Each week was progressively getting worse and rapid declining in my ability to fuction. I was gaining weigh and felt very tired, but thought it was respitory infection and tried to rest hoping it would clear up and improve. After several weeks, I noticed that both feet and legs started to swell and wouldnt return to normal. The decline was rapidly getting worse and I was not able to simply tasks. I tried to get an appointment at my primary physisan and was unable to get an appt, they recommeded I visit urgent care, so I went and was told to go to ER, where I was admitted to the hospital for congestive heart failure.

patient developed pleuritic pain , dyspnea, flulike symptoms shortly after receiving 2nd Moderna dose on 05/11/2021. He went to ED 05/13/2021 and was found to have pleural effusion, loculation and pneumonia and transferred to another hospital were he underwent 2 pigtail catheter placement. He had negative Covid testing and negative cultures. No surgical intervention required. All cultures, AFB and SARS COV 2 testing were apparently negative(per intial hospitalization DS) though results are not available. unknown if cytology was completed. Patient seen by this provider to review labs and screening CT chest on 04/28. He was asymptomatic at that time. CT chest dated 03/31/2021 showed minimal stable bibasilar subsegmental atelectasis and/or linear fibrosis unchanged from previous year. He reported receiving his 1st Covid 19 vaccination on 04/18 without side effects . On may 11th he received his second covid 19 vaccination and later that day reports he developed cough and right sided rib pain worse with coughing and deep breathing. The following day he felt like he "was run over by a truck" with increased cough, pleuritic pain, malaise and dyspnea.

Fever, Tachypnea, HYPERtension, Tachycardia & HYPERglycemia Narrative: Was inpatient overnight in a telemetry until. DC with diagnosis of DM and CHF

Onset of shortness of breath and cough on 1/3 that progressively got worse. Clinical diagnosis of pneumonia without fever was made, patient started azithromycin on 1/5 and albuterol treatments every 4-6 hrs. Initially he improved, but then worsened. chest xray on 1/6 was negative for pneumonia, PCR covid test was negative, albuterol treatment did not bring much relief. He started respiratory distress on 1/10 and was taken by car to the local ER where another covid test was negative and chest CT revealed multiple bilateral pulmonary emboli. The leg US revealed blood clots in both of his legs. He had an emergency catheter-delivered thrombolysis and was discharged home from the ICU on 1/12 on oral anticoagulants. He is gradually improving, but very weak. He tires easily and gets a drop in oxygen to 90- 93%, as well as an increase in the heart rate to 120 when walking less than half a mile. He runs out of breath with exertion.

Pt developed symptoms of anaphylaxis: nausea, anxiety, chest tightness, throat tightness about 13 minutes after injection. Was given 0.3 mg epinephrine and sent by ambulance to ER.

very much like a blood clot; R leg swelling; very hematoma; big red patch; warm sensation in the the leg; pain that he never had; normal pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (very much like a blood clot) in a 49-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 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced VACCINATION SITE PAIN (normal pain in the injection site). On 04-Apr-2021, the patient experienced THROMBOSIS (very much like a blood clot) (seriousness criterion medically significant), PERIPHERAL SWELLING (R leg swelling), HAEMATOMA (very hematoma), ERYTHEMA (big red patch), FEELING HOT (warm sensation in the the leg) and PAIN IN EXTREMITY (pain that he never had). At the time of the report, THROMBOSIS (very much like a blood clot), PERIPHERAL SWELLING (R leg swelling), HAEMATOMA (very hematoma), ERYTHEMA (big red patch), FEELING HOT (warm sensation in the the leg), PAIN IN EXTREMITY (pain that he never had) and VACCINATION SITE PAIN (normal pain in the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.; Sender's Comments: Very limited information regarding these events has been provided at this time. The events are probably related to the patient's comorbidities

extensive DVT left LE. diagnosed on 4/10/21, however symptoms started in week prior. Had almost immediate cramping/pains after vaccine that worsened after first week

Patient was seen in hospital after receiving 2nd Moderna vaccine at 8am on 1/21/2021. He developed left sided chest pain a few hours earlier. Presented to hospital next day with multiple bilateral pulmonary emboli

12-18 hours after vaccine had feeling of hot/cold/shivering/myalgia. Few days later started to have chest pain, shortness of breath that progressed and eventually was severe. seen at ER 2/22/21 and found to have large pericardial effusion on bedside u/s and acute ST changes on EKG. transferred to second hospital and admitted 2/22/21-2/25/21. He was treated with pericardial windows to remove fluid and discharged on ibuprofen and colchicine for presumed viral pericarditis.

Memory lapse, difficulty with memory recall; Confused; Blood clots; Cerebral Ischemic Attack; Brain Fog; Headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MEMORY IMPAIRMENT (Memory lapse, difficulty with memory recall), CONFUSIONAL STATE (Confused), THROMBOSIS (Blood clots) and TRANSIENT ISCHAEMIC ATTACK (Cerebral Ischemic Attack) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart valve operation. Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced MEMORY IMPAIRMENT (Memory lapse, difficulty with memory recall) (seriousness criterion hospitalization), CONFUSIONAL STATE (Confused) (seriousness criterion hospitalization), THROMBOSIS (Blood clots) (seriousness criterion hospitalization) and TRANSIENT ISCHAEMIC ATTACK (Cerebral Ischemic Attack) (seriousness criterion hospitalization). On 15-Apr-2021, the patient experienced FEELING ABNORMAL (Brain Fog) and HEADACHE (Headache). The patient was hospitalized from 10-Apr-2021 to 12-Apr-2021 due to CONFUSIONAL STATE, MEMORY IMPAIRMENT, THROMBOSIS and TRANSIENT ISCHAEMIC ATTACK. At the time of the report, MEMORY IMPAIRMENT (Memory lapse, difficulty with memory recall), FEELING ABNORMAL (Brain Fog) and HEADACHE (Headache) had not resolved and CONFUSIONAL STATE (Confused), THROMBOSIS (Blood clots) and TRANSIENT ISCHAEMIC ATTACK (Cerebral Ischemic Attack) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Apr-2021, Computerised tomogram: abnormal (abnormal) revealed blood clots. On 10-Apr-2021, International normalised ratio: low (Low) Low. On 10-Apr-2021, Magnetic resonance imaging: abnormal (abnormal) revealed blood clots. On 15-Apr-2021, International normalised ratio: low (Low) Low. It was reported that the patient still has difficulty with memory recall, brain fog, headache, and still having trouble with low INR. The patient did not have any side effects after the first dose. Treatment for the events included Levonox injections and Coumadin (increased dose). 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. Headache is consistent with the product known safety profile.; 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. Headache is consistent with the product known safety profile.

I had a massive stroke at work a few weeks after the 1st vaccine shot. Rushed to hospital for emergency surgery to remove blood clot in right side of brain. My paralysis was reversed after surgery but lingering headaches exist.

The patient developed high fevers, profound watery diarrhea up to 13L/day, requiring IV administration of replacement fluids. He ultimately developed ARDS and succumbed to this illness.

Patient hospitalized from 4/18/21-4/23/21 4/18 Hospital Day 1: Patient (pt) presented to the ER via EMS for aphasia/altered mental status that began that AM. Pt had received his 2nd COVID19 vaccine (Moderna) x3 days prior. Pt had generalized body aches/fever and was taking acetaminophen for his symptoms with mild relief per wife. Per ER notes, patient had clear speech but was not making sense and easily agitated. 4/19-4/21 Hospital Day 2-4: Patient with altered mental status. Was non-verbal and easily agitated. There was concern for encephalitis, infectious vs autoimmune. On 4/19, antibiotics were discontinued and patient was being treated with steroids for possible autoimmune encephalitis. 4/22 Hospital Day 5: Patient was doing better and more talkative. Patient was able to have a limited conversation, appeared alert and oriented with some slow speech. Per medical chart, family reported patient was at "50% back to baseline." 4/23 Hospital Day 6: Patient was back at baseline and completed 3 days of IV steroids. Patient reported not being able to recall anything from "Saturday 4/17 to Wednesday 4/21". Patient was discharged on 4/23 and recommended to follow up with neurology and was not discharged with any steroids. Treatments: Fever: APAP 1 IVPB x1 (4/18-4/19), APAP 650 mg PO x1 (4/20-4/21) Encephalitis: Methylprednisolone 125 mg IVPB x1 (4/18); Methylprednisolone 500 mg IVPB BID (4/19-4/23) ID: Acyclovir 700 mg IVPB q8h (HSV infection) [4/18-4/19]; Cefepime 2 g IVPB x1 (Sepsis) [4/18]; Ceftriaxone 2 g IVPB q12h (CNS infection) [4/18-4/19]; Vancomycin 2.25 g IVPB x1, 1.5 g IVPB q12h (CNS infection) [4/18-4/19]

Patient states he developed fatigue myalgias 8 hours after vaccine, then about two hours later, he became short of breath. He subsequently reported intermittent shortness of breath and leg swelling. May 5 noted to have atrial fibrillation/ flutter with rapid rate. Unclear if patient had atrial fibrillation at time of initial symptoms and unclear if related to the vaccine at all.

Acute bilateral pulmonary embolism and acute right leg deep vein thrombosis, both of unknown etiology

The patient was last seen well at 3:30 PM. He was found unresponsive, face down in his own vomit, cyanotic, apneic by family. Patient was unable to be resusitated. He was pronounced dead at 6:51 PM.

Was feeling fine the day before, went to sleep around midnight and passed away during the night while sleeping.

Fever, nausea, headache, abdominal pain, sepsis upon admission with negative blood cultures, UA, fever to 104 F; diagnosed with proximal descending thoracic aorta thrombus

12/18/2020: ER visit showing Patient Chief complaint of Left lower leg pain; plt count 243x10^3 WNL; Given Clindamycin 600mg IV in the ER and discharged on Bactrim 800mg PO for Acute Cellulitis diagnosis. 1/2021: Follow-up at PCP office showed plt wnl on routine labs. Resolution of leg symptoms per patient. 3/15/21 & 4/15/21: Received Moderna vaccine one & two at Public health clinic (Additional Information for Item 12: Cigarette smoker 10.5 Pack years, hypertension) Additional information for Item 18: 4/19/2021-4/27/21: Presented to Medical Center ER with complaints of Left leg redness and weakness. Stated he felt weak and tired after receiving the second dose and has been feeling worse since. His friend brought him to the ER stating "he didn't seem like himself." Admitted for acute cellulitis of Left lower extremity, altered mental status, and started on IV Vancomycin (4/19/21-4/22/21) and Levaquin (4/19/21-4/26/21). Baseline plt 74 at admission. Rivaroxaban 10mg PO QD was given 4/19/21 until 4/21/21. Plt count continued to downtrend during admission. Hematology/Oncology service consulted on 4/22/21 who initially suggested thrombocytopenia possibly due to infection or DIC. Yet, worsening thrombocytopenia despite improvement of infection and clinical status was noted. The etiology was then suggested to be Vancomycin induced thrombocytopenia, so Vancomycin was stopped on 4/22/21. Platelet count Patient was discharged with p.o. prednisone and p.o. Levaquin on 4/27/21. Patient stated almost full resolution of LLE pain and redness. Plt count upon discharge was 51. Instructed to stop Rivaroxaban. 5/1/21:Patient presented to ER at Medical Center for Leg pain. US Doppler was negative and patient given Clindamycin IV 600mg in the ER and discharged with Bactrim 800mg qd to be continued until his PCP appointment. May 5, 2021: PCP placed patient on Clindamycin for recurrent cellulitis. 5/14/21-5/22/21: Patient presented to Medical Center ER with worsening left leg cellulitis. Patient was afebrile with a normal wbc count. Upon admission, Plt count was 36. Patient was started on Linezolid 600mg q12h and Ceftriaxone qd. Antibiotics were changed later to Tefalo 600mg Q12Hto be started on 5/15/21. ID consult recommended Daptomycin given patient's thrombocytopenia. Patient was continued on Daptomycin throughout admission and upon discharge, patient's leg was almost back to baseline. Plt count was 138. To rule out other causes of thrombocytopenia, patient medications were reviewed and imaging was done in addition to labs drawn during this admission. See above for the labs. All alternative causes during this admission were ruled out.

Patient passed away on April 27, 2021, which was two weeks after receiving second dose of Moderna Covid-19 vaccine.

received notification that patient was hospitalized 06/02/2021 at Medical Center with COVID-19 infection and CVA

The pt had his first Moderna covid vaccine on 3/19, and after the vaccination, he developed left upper lateral calf pain that lasted several weeks. He then had his second Moderna covid vaccine on 4/22, with left knee pain, and again left upper lateral proximal calf pain. He denies any chest pain, heaviness, tightness, pressure, palpitations, or dizziness. He contacted his PCP, and he was advised to come to the ER for evaluation of a possible DVT. This is very suspicious for a direct thrombotic side effect of the pt's Moderna vaccine. The pt has a very high d-dimer, and we can not rule out a mid-distal thigh and left popliteal DVT, so the pt will be covered with Lovenox, and he will present to hospital tomorrow to obtain a venous duplex. They can then, based on clot burden and his subsequent complaints on continuing lovenox bridge to warfarin or a direct acting anticoagulant.

After moderna vaccine he having stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (After moderna vaccine he having stroke) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form once. On 09-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (After moderna vaccine he having stroke) (seriousness criteria hospitalization prolonged and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (After moderna vaccine he having stroke) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Very limited information regarding the event has been provided at this time. Patient's history of diabetes may be a confounding factor. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time. Patient's history of diabetes may be a confounding factor. Further information has been requested.

Patient experienced a major onset of cardiac arrhythmias --Atrial tachycardia, Ventricular tachycardia and ultimately Ventricular Fibrilation-- he was resuscitated with his internal defibrilator-- this resulted in a 23 day stay in the hospital, most in the ICU to deal with "arrhythmia storms". Alhtough patient has been a cardiac patient for his entire life, he has never expreience the arrhythmia issues of this nature until he was given the vaccine.

1. Significant discomfort around the left chest, heart area. Feel null and pain around the armpit, upper left arm and left back area. The discomfort and pain reached peak a day after the 2nd shot. When writing this report, 48 hours have passed. The discomfort is not completed gone. 2. Accelerated heart beat rate (90-100 a minute) for 2 nights, with 38.5 deg C fever. 3. Elevated blood pressure (135/95).

Patient's last known normal 7/10 at 0300. Presented to ER on 7/11 with symptoms of imbalance, slurred speech, difficulty swallowing, left side felt week. The previous day, the patient woke up with slurred speech, imbalance, fatigue and slept all day. Patient has no history of stroke, CVD. Does have history of hypertension and hyperlipidemia that is untreated. Patient did not qualify for TPA and was admitted for treatment on the general medical floor. Patient's blood pressure and heart rate continued to rise and was transferred to ICU.

Developed pain in lower left leg that became so concerning that a doctor appointment was made. Visited doctor on 3/4/21 and doctor thought it might be a blood clot. Ultrasound ordered 3/10/2021, blood clot in left leg confirmed. Second ultrasound done on 3/12/2021 and blood clot was again re-confirmed

Cerebrovascular accident; This case was initially received via another Manufacturer (Reference number: PVIUS2021001059) on 14-Jun-2021. The most recent information was received on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021. The license partner had received the report from FDA VAERS (Reference number: 1422940). This regulatory authority case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details was provided. No treatment medication details was provided. Very limited information regarding the event has been provided at this time. Patient's history of diabetes may be a confounding factor. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Event verbatim Updated. Sender's Comments added. Report type of this case updated from spontaneous to Regulatory Authority.; Sender's Comments: Very limited information regarding this event has been provided at this time. Patient's history of diabetes may be a confounding factor.

Chief Complaint Patient presents with ? Generalized Body Aches     Pt presents via EMS c/o DOE, dry non-productive cough, subjective fevers Tmax 101.9, decreased appetite, aches since testing + for COVID on 1/5.   Patient is a 50 year old male with PMH of Crohns/MS on fingolimod presenting to the Hospital for fevers, shortness of breath and weakness. Patient received COVID vaccine on 12/29. Patient had initial left arm discomfort though has had worsening weakness, cough, shortness of breath and fevers since that time. Patient tested positive for COVID19 on Patient has shortness of breath with exertion that is relieved by rest. Patient denies N/V/D. Patient has taken tylenol at home to attempt to alleviate symptoms.

The patient became short of breath and decreased oxygen saturation at home around 2000 on 01/18/2021. He reported to the ED on 01/19/2021 at approximately 0500. The patient was found to have bilateral pulmonary emboli.

Narrative: Patient is a 49 year old man with past medical history of hypertension and kidney stones who presented with a chief complaint of word finding difficulties and slurred speech. Patient was last seen normal at 1230 pm on 1/21/2021. He got his covid vaccine and shortly after he developed a headache that was on both sides of his head. Felt like 8/10 pain. He then had difficulty with speaking - he didn't know what word to say so he would make a noise. He was on the phone, and that person recommended that he come to the ED to get evaluated.In the ED, a stroke code was called. BP 169/97. NIHSS 0. A CT non con did not show any acute bleed or any signs of a stroke. After the stoke code was ended, the patient has a headache severity 1/10 and did not have any word finding difficulties. Patient was non focal by the time that the stroke code was ended. In the setting of hypertension, a blood pressure of 169/97 on admission and fluctuating symptoms, most concerning on the differential is a TIA. Given his risk factors and episodic presentation, he will need to be worked up for a stroke. The differential also includes post-vaccination reaction vs complex migraine.

On January 21, 2021 I started feeling pains in my right shoulder (1st shot was left shoulder) and the following day it had spread across my body, shoulders, chest, arms, legs and calves. I also had a severe headache along with the muscle pains and woke up each day since in a pool of sweat with the sheet soaked to this day. Due to the severe muscle pains, I started taking Tylenol and all the symptoms pointed to the virus itself. I was tested for the virus on Monday, January 25th with negative results on the morning of the 26th. I continued to self-medicate with Advil every four hours to remove the severe muscle pains noted above. To back track slightly, I had a colonoscopy on January 19, 2021 and one large polyp was removed without issue. Due to the full body muscles pains and taking the Advil, it likely caused bleeding from the polyp site of the colonoscopy and went to the ER and they transferred me back the hospital on January 28, 2021, the location of the colonoscopy, and hospital found nothing wrong with the colonoscopy during my 2.5 day stay there. The did an x-ray of my chest to test for the flu and related items and found everything to be clear. They also a CT of my abdomen to look for any abnormalities and found none. Through all this the muscle pains continued when I would move, the muscles would fire up and intense pain persisted until I could calm them down after about 30 mins of intense pain. Hospital also tested me twice for the COVID virus and each turned out negative. Overall, I?ve been tested for the virus nearly 12 times and all were negative. From the visit to Hospital, with the colonoscopy and no additional bleeding occurring, Hospital gave me a steroid called Prednisone to mask the pain on Saturday, January 30, 2021 at about 1pm and by 4pm they fully released me with no idea what was causing the severe muscle pain across my body when I moved. I literally just walked out of the hospital since the steroid masked the muscle pain issue. The steroids worked but I was still walking up in a pool of sweat and very clammy and wet each morning from 1am until I woke up. On February 2, 2021 I had 3 bowel movements that were all dark purple and full of blood clots which led me back to Hospital and the ER could not get in touch with the Hospital Doctors for transfer so they admitted me to the Hospital, thank God. On February 4, 2021 Methodist performed an emergency colonoscopy to clamp the polyp site, took two additional polyps out and did an endoscopy to ensure my upper and lower GI track were clear, and it was and the two additional polyps were benign. Through all this the serve muscle pains persisted and Hospital moved me to a patient room and out of the ER. Over the next several days, February 4 thru the 11th Hospital cleared me of everything they could test for, over 85 different tests were ran based on MyChart. All my blood counts were all over the place, WBC were 19,000, Platelets were nearly 700, my sedimentation rate reached 64+ and the server muscle pains persisted and I was basically incapacitated during my entire stay at Hospital. Hospital had several specialists seem me from Internal Medicine, Infectious Disease, Neurology to Rheumatoid ologist and none of them found anything wrong with me other than my COVID anti-bodies were enormously high with not signs of slowing down. The conclusion by each of the specialist is that my symptoms all point to an Adverse Level 3 Inflammatory Reaction to the first COVID Vaccine shot. The Infectious Disease specialists emphasized that I DO NOT get the second vaccine shot since it would like have killed me. (We had cancelled my 2nd shot, scheduled for February 3, 2021 via Cancer Center the week of January 30, 2021.) Hospital concluded that they could not do anything further for me since all their extensive testing all came up negative other then the COVID antibody levels and started me on the same steroid via IV on February 10, 2021 and on February 11, 2021 I was released from Hospital with a 28-day gradual reduction of the steroid over that timeframe to see if the COVID antibody production would simply stop. They had no other recourse or follow up with for any of the specialists. I?m on my own at this point and scared. To help with the inflammation the only thing my wife and I saw we could do is see a health and well Doctor to try and purge myself of the inflammation and assist my bowel and liver health with trying to rid me of the vaccine and hopefully the antibody production. I?m on a strict diet and taking supplements to assists in the reduction of inflammation and cleaning my system out. Starting today, February 18, 2021 I start stepping back on the steroids prescribed by Hospital and praying that the symptoms and pain simply go away but I?m still having night sweats, weak and shaky.

UNKNOWN MEDICAL IN THE PARKING LOT AT THE MASS VACCINATION CLINIC. PATIENT WAS FOUND BY A BYSTANDER ON THE GROUND AFTER HE RECEIVED HIS SHOT. MEDICAL ON SCENE RESPONDED AND FOUND PATIENT IN CARDIAC ARREST. CPR AND ACTIVATION OF 911 EMERGENCY MEDICAL SERVICES AT 11:59. ON SCENE PATIENT RECEIVED CPR, THEN PLACED ON A LUCAS DEVICE, DEFIBRILLATION X2(VFIB) AND PLACED A KINGS TUBE TO SECURE THE AIRWAY. ROSC ON SCENE, CODE 3 TO CARDIAC CENTER. PATIENT CURRENTLY IN THE ICU AT HOSPITAL.

Ischemic stroke with aphasia, dysarthria, and right hemiparesis, s/p TPA and thrombectomy with resolution of symptoms

11pm same day as shot. Started having chills, fever (101.6). Tired. Slightly winded. Symptoms lasted until 6PM the next day. fever went back to normal around 4pm next day after shot. * I NEVER had a fever when I had covid. I had an Antibody test completed back in January. It was positive for Antibodies. I had an antibody test back in 2020 BEFORE I had covid. It was negative. A week late after 1st does of vaccine. My heartrate started to increase and had symptoms of Afib again. same symptoms of the Afib and heartrate and breathing, back after I had covid. Exact same feelings and symptoms. The Afib/heart symptoms, stopped last week. I am supposed to get 2nd dose this Thursday, and I am most likely not going to. I don't want the heart rate to increase again. I am having problems making an appointment to ask my doctor. My PCM changed, so it is all confusing and a pain. Its best I just don't it. I had antibodies as of january. I just had the 1st dose last month. I think I am god to go. Not worth the risk for me. I am sick of having covid symptoms, so why force it upon myself again....

10 days after 1st shot. Blood clot traveled to right lung. Placed on blood thinners, and pain meds, follow up treatment scheduled for mid May. Unknown reason for blood clot. No prior injuries or surgery.

Patient began not feeling well the day following vaccination, with vomiting, diarrhea, and fever. Patient became confused today, family called EMS. He was found to have multiple areas of hemorrhage in his brain (SAH) with a critically low platelet count of 24. He is currently in ICU intubated and sedated.

CC: patient was watching TV as reported by his mother. started seizing and having difficulty breathing. EMS was called for transport. On arrival to ED, patient was breathing 60-70 BPM, tachy at 135-140 sinus rythym. B/P stable at 140's/90's. his pupils were equal and reactive to light. no response to aggressive sternal rub. slight seizure like activity with arm and leg jerking. Ativan IVP given Patient is on non-rebreather sao2 at 90-100 fluctuating. IV established. he desats to 80-85 on room air. Has frothy sputum from mouth. RSI performed with succs and versed to secure airway and ventilate patient. 7.5 tube placed with one attempt at 27/teeth. verified via direct auscultation and capnography. Tube secured. maintanence medications given to ensure sedation. transfer initiated and airmed launched. Dr. accepted. patient left building at 1940 via airmed. Patients labs (electrolytes WNL) normal wbc. D-dimer at 1500. suspect for PE or flash pulmonary edema although his breathsound are clear bilateral. 18:10 03/27/21. BP: 124/89. MAP: 100. HR: 135. RR: 54. O2 saturation: 94%. Temp: 99.2 F. Pain level now unable to obtain due to patient condition. --20:05 3/27/21 Weight: 81.6 kg estimated

Got his vaccine, that evening he felt as if his face was on fire like a windburn. The next morning had an incredible cold chill as soon as air hit him, bone shaking. Then had cold chills/sweating with soaking of his groin area. He can go to sleep with extreme chills and then wake up in a puddle of sweat. He had a headache at first, took Tylenol and it went away. Numbness in his foot like it's falling asleep, left hip hurting, left wrist pain. Today both calves hurt./sore like workout burning pain. Two days ago his father went to have bypass and was at the hospital with him, and walked painfully in but had difficulty hobbling along and was unable to walk back to his truck and had to borrow his dad's cane to be able to walk. Yesterday he was going to cut the grass, knelt down to do something, and when trying to stand up was not able to walk due to the throbbing pain and had to use the cane again. Also having swollen left ankle with discoloration. The calf pain is extreme and throbbing, and the pain when he's not able to walk is in the calf. The ankle has been swollen since Sunday, 4/18/21. He spoke with the ICU nurse in the hospital and he told her about it and she grabbed his ankle and asked if he was sure he didn't have a blood clot. He has not been able to shake the symptoms. The issues with walking are intermittent, some days he can walk fine, the other days he has to use the cane. He still continues with every day hot sweats/cold chills. It's 74 where he is right now and has a sweatshirt on as he is cold. Also the legs hurting, ankle swelling that he ices down at night but the swelling does not go away. Feels like a hard knot in his ankle. He has not sought any treatment for this at this point.

We have information concerning a member that received the Moderna Vaccine (first dose) on Sunday April 11, 2021; Patient denied any side effect immediately following vaccination. However on Sunday April 18, 2021 , patient had complains of shortness of breath, chest pain. At which time presented to the Hospital and was admitted on Sunday April 18, 2021 with a diagnosis of Pulmonary Embolism. Patient remains hospitalized as receiving treatment of blood thinner, and embolectomy procedure.

Was sweaty, unresponsive, and breathing shallow a few mins after administration. BP 97/68. Within a few mins, patient became responsive and BP 146/81. Patient chose not to go with EMS and walked out of store after they were feeling better. Today (3 days later) received report from medical examiner that patient passed away.

HYPOTENSION (SARASOTA EMS RESPONDED TO PHARMACY); CLAMMY/SOB, EXTREMITY TINGLES; DEATH WITHIN 6-7 HRS

On 4/13 Patient underwent aortic root replacement with saphenous vein graft reconstruction of the right coronary artery. He had no prior coronary disease. This operation was done for an enlarging aortic root aneurysm in the setting of Marfan syndrome. The right coronary was anomalous and needed vein extension for reimplantation. He recovered very well and was seen in our clinic on 4/23, with no unusual findings. He had a normal echo, EKG and DVT study performed. On 4/28 he had his first Moderna COVID19 dose. on 5/1, he developed malaise, myalgias, painful lymph nodes, chills, and chest pain. He called my clinic and was instructed to go to the ER, but then felt better and didn't go. He was then found unresponsive later that afternoon and was pronounced dead on arrival of EMS.

Patient received vaccine on 04/23/21. Four days later developed chest pain. Patient believed this was related to normal symptoms post vaccination. His pain worsened and patient eventually presented to hospital and found to have inferior infarct, with 100% RCA complicated by VSD and RV failure requiring ECMO support

Visited ER on 5/3/21 with symptoms of shortness of breath, cough, fatigue, oxygen sats 90-91% on room air, tachycardia (HR 114), BP 182/127

Dizziness while grocery shopping, next day racing heart beat and minor chest pain, call ambulance that night. Minor Heart attack. Had cath lab done. No blockage found. Outside of high BP and hormone found in system from heart attack no explainable cause.

Acute ST-elevation myocardial infarction; highly unusual dual artery occlusion including acute proximal occlusion of the RCA and simultaneous proximal LAD occlusion. At 24 hours later, both arteries re-occluded and required repeat stenting. Patient has critically low platelets and a positive PR4 antibody. Physicians seeing pt feel this is most consistent with vaccine-induced thrombotic thrombocytopenia.

Patient complained of tingling to his hands 15 minutes post-vaccination. Patient had no other s/sx of reaction. Patient observed for another 15 minutes and tingling did not worsen. Patient left observation area and returned to work. Patient returned to observation area around 4:40 p.m. and complained that tingling to hands was still present and he felt tightness in his forearms. Patient is a coach for the children and was outside in the 90+ degree heat during the afternoon. Patient came into observation area to cool down. Patient's blood pressure taken and was elevated, although patient stated that he had HTN. Paramedics called on site to evaluate patient. Patient began to complain of dizziness and was transported to local hospital. On the way to the hospital, the patient developed chest pain and shortness of breath. Patient was diagnosed with a non-STEMI at the hospital and transferred to higher level of care. The patient is currently undergoing observation and tests to determine the cause of the MI. The patient received epinephrine 0.5 ml at the hospital to cover any underlying vaccine reaction.

Death occurred outside of pharmacy 22.5 hours post vaccination. Cause of death being the vaccine is unknown.

Severe swelling and bruising of right arm started on day of injection. Pain and swelling increased following day, Then on Friday evening I had a heartache.

Tightness in chest. Shortness of breath. Sore jaw. Pain in left arm. Called 911 and paramedic took EKG and informed me I was having a heart attack on the way to the hospital. Once at the hospital they measured my TnT-Gen5 and the baseline was 2658 ng/L with another test taken an hour later showing 2873 ng/L which led to additional tests listed in box 19. Final diagnosis was perimyocarditis and I received a prescription of Colchicine 0.6 MG to be taken twice a day for 6 weeks and then follow up with a cardiologist.

New onset PE treatment: started on Eliquis 5 mg BID outcome: discharged home after treatment of COVID as well

temporal stroke presented with left visual field cuts in an otherwise pretty healthy 50 year old without known vascular or cardiac disease.

Around 6:30 p.m. my skin started to burn all over my face begin to swell shortly after that my tongue and throat begin to swell I feel pressure on my chest I can barely breathe when I was put into the ambulance I passed out when I woke back up the symptoms seems to have gotten worse the EMT called in a head to the hospital and ask what to do she was told to give me an EpiPen as we got closer to the hospital I begin to shake and tremble uncontrollably that lasted for at least another 30 40 minutes after being admitted to the emergency room my diagnosis was anaphylaxis.

Patient presented to the ED and was subsequently hospitalized for severe sepsis and pneumonia within 6 weeks of receiving COVID vaccination.

Acute MI (Heart Attack) - treatment at Hospital- underwent Cardiac Catheterization and had stent placement in LAD, medications prescribed as further treatment, currently living

"The second shot of Moderna in AM -2 days later had a Non- STEMI- Chest pressure in middle of night around midnight in 24 hours post Second Moderna vaccine Son took him to ER. 5/5- got the second Moderna . 5/6 around Midnight had chest pressure that woke him up - he also had chest pressure .

acute nephrotic syndrome treating with high dose steroids symptoms included global edema/anasarca complications include pulmonary embolus and DVT

7/19/2021: Patient came to ER due to weakness, diarrhea and abdominal discomfort. One week prior he developed decreased appetite as well as abdominal cramping with increasing pain. Patient tested positive for COVID on 7/19/21. diagnosed with: sepsis due to COVID-19 infection, bilateral pneumonia 7.25.21: discharged home. Note: COVID-19 vaccinations status: S/P 2 doses of Moderna Vaccine in April of 2021

Right after the vaccine I just had a slight head ache. I had pretty typical symptoms. Around 8pm my arm got to 8/10 pain. I have waves of Tachycardia and nausea. I had pretty bad diarrhea the first day and second day, this was also a side effect from the Celexa. The Tachycardia was going up to 130-140 . Very much flu like symptoms, heart pounding, head pounding and very light headed. I was having trouble controlling BP when I stood up. I felt feverish, I kept checking my temp but it was normal. This went on for two day, I wasn't able to eat or drink liquids. I ended up going and getting a Covid test on Tuesday morning, I was feeling somewhat ok. Then in the evening all my same symptoms came back. I spoke with a Dr. who informed me I was probably dehydrated. I almost went into the Emergency Room because my high heart rate and thought I was having a heart attack. I didn't due to high volume of Covid in the ER. I have a follow up meeting with my PA before my second dose to come up with a strategy. The left side of my face started to get numb and the left side of neck. My neck started to get still and went to my jaw.

51 year old M with h/o O2 dependent COPD, Severe pulmonary fibrosis became increasingly hypoxic around 1800hours 1/7/2021. He was transported to hospital for acute on chronic hypoxia respiratory failure. On 1/12/2021 he decompensated further, and after discussing with family and palliative care, He was changed to comfort care. He expired on 1/12/2021@2325 at medical center.

1/22/2021 this resident was found on his kitchen floor having severe Grand Mal seizures and was profusely foaming from the mouth. RN (writer) responded to the emergency. Resident had 8 seizures between the time of calling 911 and them arriving. They had been IV pushing Ativan and Versed. The seizures did not stop. He was rushed to Hospital, intubated, placed on life support and admitted to the ICU. Resident had an emergency craniotomy and they did not find any infection or cause of the seizures. Many other tests were done and nothing was determined to be the cause at this time. Reported to ICU nurse on 1/23/2021 that resident had received the Moderna vaccine a couple days prior.

Lethargy/altered level of consciousness lead to hospital admission. Multiple interventions during hospitalization. Final hospital diagnoses: Acute respiratory failure with hypercapnia, acute pansinusitis.

Fever. Hypoxia. SOB. Hospital admission diagnoses: Aspiration, right lower lobe pneumonia, hyponatremia.

For two days after receiving the first vaccination for Covid-19 I ran a temperature of 101.9 and was not able to go to work. When I returned to work on Friday February 12, 2021 at approximately 8:40am I had a stroke and was rushed by ambulance to the hospital.

Pneumonia, hypoxemia, Dyspnea, Tachycardia,SIRS, increased lactic acid level, dehydration,fever, HTN, hypomagnesemia

fever to 104, thrombocytopenia. Started 2/28/21. had leukocytosis, near syncope and high recurrent fever with all cultures negative. Is improving as of 3/2/21.

Headache and nausea starting 5:30am 15 Jan with exertion. Same symptoms on 16 Jan, 17, and 21 Jan with sexual activity. BP started to be in 150-160/110 range (used home BP cuff) on 19 Jan. No neurological deficits. Presented to ER on 21 Jan with c/o headache an d nausea. BP was 160+/110+. CT scan showed SAH. Transferred to hospital for eval. Was in neurosciences ICU x 1 night and neuro ward x 2 nights. Discharged on 24 Jan. DSA and MRA showed no AVM or aneurysm. LP showed no inflammatory or infectious process. CBC WNL. PT/PTT WNL. Lipids showed hyperlipidemia. Working diagnosis is Reversible Cerebral Vasoconstriction Syndrome.

Vaccine administered on 01/20/2021 followed by erythema followed by cracking of the skin with bleeding of the palm to the hands and fingers occurring during the next few days following administration of the 2nd dose. These were improved significantly with prednisone taper of 60-40-20 with 5 day dosing. Patient was also placed on betamethasone cream. During prednisone treatment patient had resolution of symptoms, but following discontinuation patient's symptoms have returned to a lesser extent.

Initial vaccination January 11, 2021 mild injection site soreness. Second dose vaccine 02/12/2021. Patient developed myalgias lasting for 1 day. 02/16/2021 patient developed fever chills and body aches. Temperature upwards of 104. Darkening of the urine. Symptoms persistent.

Severe Allergic reaction; Heart attack; Neurological issues was unable to think straight; Extreme inflammatory response; A spontaneous report was received from a consumer and physician concerning a 51-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe allergic reaction, extreme inflammatory response, heart attack, neurological issues was unable to think straight. The patient's medical history was not reported by the reporter. Concomitant medication was not reported. On 22 Jan 2021, 15 minutes prior to the onset of the event, the patient received first of the two planned doses of mRNA-1273 (Lot number: unknown) through intramuscular route at right arm for prophylaxis of COVID-19 infection. On 22 Jan 2021, 15 minutes after the vaccination, patient had a severe allergic reaction. Patient had extreme inflammatory response, heart attack, neurological issues was unable to think straight, urinator catheter placed in on sight as fluid build and kept coming out, pulled out 1500ml. Patient was hospitalized 22 Jan 2021 through 24 Jan 2021. Laboratory information at the time of event was not provided. Treatment activities for event was unknown. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, severe allergic reaction, extreme inflammatory response, heart attack, neurological issues was unable to think straight 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.

syncopal event. 911 was then called. Once EMS arrived he was found unresponsive and was in V fib.; transferred to the cath lab where he was found to have a proximal LAD occlusion deceased 3/17/2021

shortness of breath; weakness; diffuse chest tightness; confusion; dizziness; cardiac failure; pulmonary failure; A spontaneous report was received from a consumer concerning a 51-year-old, male patient who developed cardiac failure, pulmonary failure/respiratory failure and died. The patient's medical history included hypertension, obesity, bee allergy and bipolar disorder. Concomitant product use was not provided by the reporter. Patient received first dose of vaccine prior to two weeks to his death (died on 09 Mar 2021). A week prior to his vaccination as shortness of breath, weakness, diffuse chest tightness, confusion, and dizziness. These symptoms progressed following his vaccination and he was hospitalzed for two days prior to his death on 09 Mar 2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 09 Mar 2021 The cause of death was reported as cardio/pulmonary failure with secondary and tertiary causes of hypertension and obesity. Plans for an autopsy were not provided. The outcome of the events, cardiac failure and pulmonary failure were fatal.; Reporter's Comments: This is a case of death in a 51-year-old male subject with a medical history of HTN, obesity, bee allergy and bipolar disorder,who died 7 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: cardiac failure; pulmonary failure

Patient with history of AFIB reported a hospitalization due to entering AFIB the morning after receiving his first dose of Moderna vaccine.

death Narrative: Patient with noted history of ALS was given Moderna covid vaccine #1 on 2/27/21. On 3/5/21, notes were entered in system for family requesting a specialty bed as he was having difficulty sleeping as it was hard to breath when he laid down. He was sleeping sitting up in his wheelchair. On 3/8/21, a note was placed that he was planned to have a trach placed on 3/12/21 and that he was now under hospice care. No further notes entered and a date of death was recorded as 3/17/21. No autopsy results available. 18 days from date of vaccine to date of death.

After receiving the 2nd dose of the Covid 19 Moderna vaccine started having seizure auras culminating on April 17 with a grand mal seizure. Paramedics came to the scene and took to the hospital. He was evaluated by the ER doctor and given a CAT Scan that didn't show any change from previous scans.

Patient received COVID-19 Moderna vaccine series doses on 2/11/21 and 3/11/21. On 4/12/21, patient presented to the ED with chief complaint of left sternal border chest pain. Patient was evaluated by PCP and was found to have elevated D-dimer. Patient was sent to the ED for CTA and was found to have bilateral segmental and subsegmental emboli. Patient was discharged home on Xarelto to treatment of PE.

Fever, sweats, chills, headache, burning eyes, loss of taste were expected side effects. Was admitted to the ICU on 3/27/2021 with heart failure. Felt fine before the shot.

Pt with R lower leg pain on 30 Apr 2021. Duplex U/S on 04 May 2021 showed deep venous thrombosis from ankle to mid femoral vein. Initiated on rovaroxiban

Arrived to emergency department via ambulance from nursing home with complaints of "looking like he was about to have a seizure". Patient became unresponsive and a code was called. ACLS performed but the patient did not recover from cardiac arrest.

it cause him to have more strokes n more sizures n more chest pain n emotially melt done makes bipolar worse as well

Patient received first dose of Moderna vaccine after which he immediately experienced weakness, myalgias, fatigue. Progressive weakness in limbs continued and by day 13 following his vaccine patient presented to hospital with difficulty speaking and inability to walk. Admitted to acute care hospital for progressive extremity weakness, bulbar weakness, and respiratory failure. EMG testing demonstrated findings of demyelinating neuropathy. Patient transferred 3/31/21 for intensive inpatient rehabilitation and remains currently hospitalized.

Acute hypoxic respiratory failure; adynamic ileus; Pneumonia; Progressive Extremity Weakness; demyelinating neuropathy; Bulbar weakness; Respiratory failure; Weakness; trouble walking; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of RESPIRATORY FAILURE (Respiratory failure), ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure), ILEUS PARALYTIC (adynamic ileus), PNEUMONIA (Pneumonia), DEMYELINATING POLYNEUROPATHY (demyelinating neuropathy), BULBAR PALSY (Bulbar weakness) and MUSCULAR WEAKNESS (Progressive Extremity Weakness) in a 51-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 Diabetes mellitus, Hypertension, Glaucoma and Hyperlipidemia. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced RESPIRATORY FAILURE (Respiratory failure) (seriousness criteria hospitalization prolonged and medically significant) and BULBAR PALSY (Bulbar weakness) (seriousness criteria hospitalization prolonged and medically significant). On 15-Mar-2021, the patient experienced DEMYELINATING POLYNEUROPATHY (demyelinating neuropathy) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure) (seriousness criteria hospitalization prolonged and medically significant), ILEUS PARALYTIC (adynamic ileus) (seriousness criteria hospitalization prolonged and medically significant), PNEUMONIA (Pneumonia) (seriousness criteria hospitalization prolonged and medically significant), MUSCULAR WEAKNESS (Progressive Extremity Weakness) (seriousness criterion hospitalization prolonged), ASTHENIA (Weakness) and GAIT DISTURBANCE (trouble walking). The patient was hospitalized from 06-Mar-2021 to 31-Mar-2021 due to ACUTE RESPIRATORY FAILURE, BULBAR PALSY, DEMYELINATING POLYNEUROPATHY, ILEUS PARALYTIC, MUSCULAR WEAKNESS, PNEUMONIA and RESPIRATORY FAILURE. At the time of the report, RESPIRATORY FAILURE (Respiratory failure), ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure), PNEUMONIA (Pneumonia), DEMYELINATING POLYNEUROPATHY (demyelinating neuropathy), BULBAR PALSY (Bulbar weakness), MUSCULAR WEAKNESS (Progressive Extremity Weakness), ASTHENIA (Weakness) and GAIT DISTURBANCE (trouble walking) outcome was unknown and ILEUS PARALYTIC (a dynamic ileus) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Electromyogram: abnormal (abnormal) consistent with demyelinating neuropathy.. On 30-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. 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 reported by investigator. Patient was presented to hospital on 3/6/21 with progressive extremity weakness, bulbar weakness, and respiratory failure attributed to AIDP s/p 5days IVIG. He had received his first Moderna COVID vaccination approximately two weeks prior to this and immediately following administration began experiencing weakness and trouble walking. EMG 3/15/21 consistent with demyelinating neuropathy. Hospitalization was complicated by the development of adynamic ileus which is improving and acute hypoxic respiratory failure (previously requiring O2 support). Patient was also treated for pneumonia with a 5 day course of azithromycin. Once medically stable he was deemed appropriate for inpatient rehabilitation and was transferred from Hospital to rehab on 3/31/21 under care. The patient tested negative COVID-19 on 3/30, and repeat testing since also has been negative. 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.

Headaches, nausea, passed out, EMT administered Narcan, went into afib in the ambulance 160 beats per minute. Toxicology negative. Given eliquis and metoprolol. CT scan, MRI and ECG showed nothing. AFIB resolved itself without a cardioversion or ablation. No AFIB to date.

Patient presented to PCP office 5/17/2021 for intermittent SOB, pain with breathing, and acute pain to left lower calf. Calf pain began 5/16/2021. SOB had been intermittent and ongoing since after receiving 2nd COVID vaccine per patient. He was dx with acute DVT of LLE. Chest CT was not performed to evaluate for PE as patient reported improvement with SOB/breathing over the prior few days. He was started on Xarelto for blood clot. Blood clot was unprovoked, no prior history of clots/bleeding disorders. He is a generally healthy and active 51 year old male. Unclear if there is a correlation between recent COVID vaccination.

Approximately 4 hrs after vaccine administration, dark, red, raised rash appeared on torso, arms, buttocks, and legs. So severe that dexamethasone started. Rash did not improve for weeks and steroids continued during that time. Patient noted to then go into congestive heart failure, had 2-3+ pitting edema, "ground glass"/pulmonary congestion in lungs, rapid A-fib with RVR 170-180s. treated at Hospital with admission from 5/15-5/17/2021. Patient complained of chest pain and trouble breathing starting 5/13/2021. Patient has mostly recovered, and is at home now. Now on high dose beta-blockers and eliquis for the new onset A-Fib.

adverse events -Shortness of breath, elevated heart rate, hacking cough - Found to have be tachycardic, with pericardial effusion treatment - pericardiocentesis performed to drain fluid Outcome - heart rate slowly came down over days

Patient was first diagnosed with bursitis at his pcp and sent home. Patients elbow was swollen and referred to urgent care by the pharmacist pharmacy. Patient was seen by Dr, and found to have a blood clot when doctor tried to aspirate the elbow. Patient has fully recovered at returned to work

Blood clot / deep vein thrombosis in left leg developed less than one month after 2nd dose. Acute pain behind left knee, muscle ache radiating through calf to foot. Swelling. Warm to touch. Felt like a pulled muscle for a week before doctor visit.

Pt admitted for L lower extremity DVT and bilateral extensive PE's. No known medical history, family/personal history of clots, no known clotting risk factors. Pt noted swelling in his leg 2 days after getting second covid vaccine and later developed SOB leading to presentation.

Very fast beating heart, irregular heartbeat taken to hospital via Ambulance?. diagnosed with A-fib and given cardiac medications

This was very unfortunate 51 years old male with past medical history of hypertension, hyperlipidemia, obesity. Patient presented with chief complaint of shortness of breath and chest pain. EMS reported that the patient has been complaining of some shortness of breath and chest pain intermittent for couple of weeks. 12 leads EKG showed evidence of anterior ST elevation myocardial infarction. Code heart was called. Patient developed PEA arrest in the Cath Lab. CPR ACLS was initiated. ROSC was achieved initially after 30 minutes of CPR. Intra-aortic balloon pump was placed. Coronary arteries were essentially clean. Due to high suspicion for massive PE-TPA was given 100 mg without meaningful clinical improvement. CPR was continued for more than an hour. Despite all aggressive measures patient continued to deteriorate. At 3:26 PM patient has no spontaneous breathing, no peripheral pulses, no heartbeats by auscultation or by monitor. Pupils were fixed and dilated. No cough no gag reflexes . patient was pronounced dead.

Patient went to ER 6/28/21 with complaints of chest tightness that began 6/27/21. Discharged home. Went back to ER twice on 7/1/2021 with body aches, fever, chest pain, abdominal pain, diarrhea. Diagnosed with acute pulmonary embolism, enteritis,

high range d dime test / blood clot; brain fog; breathing issues; Exhaustion; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (high range d dime test / blood clot) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011dz1a and 022cz1a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (high range d dime test / blood clot) (seriousness criterion medically significant), FEELING ABNORMAL (brain fog), DYSPNOEA (breathing issues) and FATIGUE (Exhaustion). At the time of the report, THROMBOSIS (high range d dime test / blood clot), FEELING ABNORMAL (brain fog), DYSPNOEA (breathing issues) and FATIGUE (Exhaustion) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Fibrin D dimer: normal (normal) normal and .55 (High) There is concern for patient that there is a blood clot. The patient treatment data was not provided. Patient allergies and medical history was not reported. Patient concomitant medication was not reported. Action taken with m-RNA1273 (moderna COVID-19 Vaccination) (Intramuscular) in response to events was not applicable. In between the doses of vaccine patient had done test (d-dime) and original came back in fine range but after second dose patient test came back in high range .55 so there is concern for patient that there is a blood clot. 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-2021-243110 (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.

Atrial fibrillation; Loss of consciousness; Headache; Nausea; This case was received via FDA VAERS (Reference number: 1317402) on 06-Jul-2021 and was forwarded to Moderna on 06-Jul-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) and LOSS OF CONSCIOUSNESS (Loss of consciousness) in a 51-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 Hypertension. Concomitant products included HYDROCHLOROTHIAZIDE and FISH OIL for an unknown indication. On 20-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 27-Apr-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Loss of consciousness) (seriousness criterion medically significant), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with APIXABAN (ELIQUIS) at an unspecified dose and frequency and METOPROLOL at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), LOSS OF CONSCIOUSNESS (Loss of consciousness), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Computerised tomogram: negative Negative. On 27-Apr-2021, Electrocardiogram: normal normal. On 27-Apr-2021, Heart rate: 160 beats per minute.. On 27-Apr-2021, Toxicologic test: negative (Negative) Diagnosis vasovagal syncope and atrial fibrillation. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Magnetic resonance imaging head and Magnetic resonance imaging heart test was done 27-APR-2021. 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.

Chest pains, heart fluttering, dizziness, unusual heart rhythm First admission: Diagnosed with Atrial fibrillation Second admission: Pericarditis and a pacemaker was administered

Blood clot on left leg from knee to the groin area. Never had problems before, not 1 person in my family ever had this , not long trips , ground or Arial.

1-2 weeks after the second vaccination, pt. began experiencing fatigue, headache, muscle aches. He then developed a rash all over his body, and sores on his tongue. Then he developed a fever, was unable to leave his bed, passed out multiple times, and was eventually admitted to the hospital with a 105 degree fever and pneumonia on the morning of July 10th. They could not keep his blood pressure up and put him on three different drugs to keep him alive, and by the end of July 10th, just 12 hours after he was admitted, he was put on a ventilator because he was not able to breathe on his own anymore. His white blood cell count was 0.2, and every time they changed the IV bags and momentarily discontinued the BP medicine, he would drop to critical levels. On the second day they were fairly sure he was not going to make it, but he has since gotten a little better. They have been giving him blood transfusions and platelets. He has remained on a ventilator for 18 days now, and has developed fevers every afternoon, up to 102 degrees, which they keep bringing down again with medication and ice. They have tested him for practically ever disease known to man for 18 days. There is no cause they can find. Not cancer, not autoimmune disease, nothing. Pt. has not been to the hospital since he was a child and it was for injury, not illness. He has never had any sort of major disease or cancer or chronic illness. The hospital or me, his mother, can be contacted for any further questions.

Pt. with dizziness, then Afib with RVR, then massive cerebral hemorrhage Pt. non oriented & unable to give history - History provided by S.O and daughter

signs of anaphylaxis after eating granola.. full body itching, lightheaded, wheezing, shortness of breath, sensation of throat swelling up

Significant coughing post-vaccine. Found unresponsive at home in hot tub 2 days post-vaccine (03/07/2021). Resuscitation efforts were made during EMS ride to helipad, but death was pronounced at the helipad prior to flight at 1850 hrs.

ANAPHYLACTIC REACTION THE EVENING VACCINE WAS RECEIVED: DIFFICULTY BREATHING, FEVER, DROWSINESS, DISORIENTATION. 7 DAYS LATER: FEVER, PLAQUE PSORIASIS, RASH, BURNING/ITCHING SKIN, FEVER

Per RN at Group Home where patient worked, on 3/19/21 he called the RN with complaints of a "low grade" fever (99-100 degrees) but otherwise reportedly felt fine. He was advised to stay home, was offered Covid testing but refused. On 3/22/21 the RN received an email from patient's supervisor that he still felt unwell and reported vomiting and diarrhea. Was offered a Covid test but refused. -Per patient's friend (a nurse who informed us of the case) various friends spoke with patient up until the morning of 3/25 and he reportedly had no respiratory or cardiac complaints. They were unable to reach him the evening of 3/25, nor the morning of 3/26 so sent the police for a well check and patient was found dead. He lived alone. -Per OSME. Patient did not receive an autopsy but did have an "inspection" which includes an external exam, toxicology and other testing including Covid testing which was positive. The specimen has been sent for sequencing. -Of note, Patient worked in a group home that had an outbreak of Covid in Jan/early Feb. His last exposure to a + person was likely 2/8/21 but possibly 2/10/21. He had a Covid test 2/15/21 that was "inconclusive". The test was re-run (same assay) and was also "inconclusive"

Patient called to follow up on what may be an adverse effect of the vaccine, according to him and his doctors. After both vaccines patient did not complain any adverse effects. It was on Sunday 4/11/2021 that he suffered from a stroke. At work he was walking around and began to feel his left side of his body and face go numb. This lasted for 4-5 hours. He went to Hospital after a few hours and the ER did many imaging tests to which no abnormal results were revealed. Patient has no damage from stroke, paralysis of face is gone. His current treatment is baby aspirin and he will follow-up with neurology. Patient has not complains as of right now but did make it a point to want to document his experience. Pt has no medical hx, is not a smoker, and lives a healthy lifestyle. Patient was encouraged to call if any new follow-up information occurs.

Transient ischemic Attack; Double vision; Sore injection site; Red injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischemic Attack) and DIPLOPIA (Double vision) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site) and VACCINATION SITE ERYTHEMA (Red injection site). On 02-Apr-2021, the patient experienced DIPLOPIA (Double vision) (seriousness criterion medically significant). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischemic Attack) (seriousness criterion medically significant). On 01-Apr-2021, VACCINATION SITE PAIN (Sore injection site) and VACCINATION SITE ERYTHEMA (Red injection site) had resolved. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischemic Attack) and DIPLOPIA (Double vision) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported by investigator. Treatment of these events included aspirin, Lipitor and Plavix. 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.

I started to retain water and eventually gained 26lbs in the next week and ended up in congestive heart failure. Doctor was able to get water retention reduced and all is back to normal

REPOERTED BY FAMILY MEMBER THAT THEY FOUND PATIENT DEAD IN SLEEP, NOT BREATHING SUSPECTING HEART ATTACK...AUTOPSY WILL BE PERFORMED

Mini-stroke transient ischemic attack; Room spinning; Winking eyelids involuntarily; Felt like he was falling to his right side; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke transient ischemic attack), VERTIGO (Room spinning) and BLEPHAROSPASM (Winking eyelids involuntarily) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The patient's past medical history included Open heart surgery. Concomitant products included POTASSIUM, FUROSEMIDE (LASIX [FUROSEMIDE]), WARFARIN, METOPROLOL SUCCINATE (TOPROL XL), MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Mini-stroke transient ischemic attack) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), VERTIGO (Room spinning) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required) and BLEPHAROSPASM (Winking eyelids involuntarily) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required). The patient was hospitalized from 19-Mar-2021 to 21-Mar-2021 due to TRANSIENT ISCHAEMIC ATTACK. On 21-Mar-2021, TRANSIENT ISCHAEMIC ATTACK (Mini-stroke transient ischemic attack), VERTIGO (Room spinning) and BLEPHAROSPASM (Winking eyelids involuntarily) 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. Patient received vaccine in right non-dominate deltoid muscle to prevent COVID-19. Patient was admitted to hospital from 19Mar2021 to 21Mar2021 for a magnetic resonance imaging (MRI) and computerized tomography (CT) scan, with observation and Low-Dose Aspirin. Patient was feeling much better and his cardiologist recommended that he receives his second Moderna vaccine as soon as required and to take an extra Vitamin D supplement as a precaution. Scheduled second dose was due on 08Apr2021. Treatment included was low dose aspirin.; 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.

52-year-old male with no significant past medical history presenting with acute hypoxic respiratory failure and pancreatitis. Admitted to hospital on March 1, 2021 at Medical Center, for presentation of abdominal pain, elevated lipase and pancreatitis. Was airlifted to Medical ICU unit at a Larger Hospital on March 6, 2021. Was in the hospital until March 17, 2021 and was sent to Rehabilitation until discharge on March 26, 2021.

52 m active alcoholic with lab abnormalities c/w heavy etoh including pancytopenia (anemia to 7s, throbocytopenia to 70s, mild leukopenia-since 12/20); 2 recent admissions (feb march 2021) with likely etoh-induced pre-renal AKI; DM; who received 2nd dose of moderna 4/8/21. After not being in contact with his family for several days, family sought him at his residence where he was found pulsless and apneic on the floor with some scant blood near his face. CPR-- >transported to hospital where upon attempting to intubate profuse bleeding into larynx/pharynx noted. Despite ongoing cpr and mechanical ventilation team in ER was unable to re-establish pulse. He was pronounced dead at about 8 PM 4/9/21.

Approximately 3 weeks after 1st Moderna COVID-19 vaccine, patient began experiencing pain and swelling below right knee. Patient was diagnosed 10 days later with DVT and prescribed anticoagulant therapy. Patient received 2nd dose of Moderna vaccine after the onset of pain and swelling, but before being diagnosed with DVT.

4 days (4/20/2021) post vaccination pain in right calf was experienced. As the pain did not resolve over the next week and felt similar to a DVT experienced post a spinal fusion in 2018 I consulted, on 4/16/2021, with the vascular surgeon, who treated my post surgery DVT in 2018 . He performed an ultrasound and identified a clot in my right calf. On 4/21/2021 he prescribed a course of Eliquis (initial dose 20 mg per day) to resolve the clot. As of today (4/23/2021) the pain has lessened but not resolved. In addition to the DVT I experienced a significant level of fatigue for 3 days post the vaccination. While the fatigue has lessened it has not completely resolved.

TIA; Lips numb; Face numb; Eyes spinning; Right eye winking; Feeling Cloudy vision; Dizziness; CHILLS; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA), HYPOAESTHESIA ORAL (Lips numb), HYPOAESTHESIA (Face numb), EYE MOVEMENT DISORDER (Eyes spinning), EXCESSIVE EYE BLINKING (Right eye winking), VISION BLURRED (Feeling Cloudy vision) and DIZZINESS (Dizziness) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) 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 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced CHILLS (CHILLS). On 19-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion hospitalization), HYPOAESTHESIA ORAL (Lips numb) (seriousness criterion hospitalization), HYPOAESTHESIA (Face numb) (seriousness criterion hospitalization), EYE MOVEMENT DISORDER (Eyes spinning) (seriousness criterion hospitalization), EXCESSIVE EYE BLINKING (Right eye winking) (seriousness criterion hospitalization), VISION BLURRED (Feeling Cloudy vision) (seriousness criterion hospitalization) and DIZZINESS (Dizziness) (seriousness criterion hospitalization). The patient was hospitalized from 19-Mar-2021 to 21-Mar-2021 due to DIZZINESS, EXCESSIVE EYE BLINKING, EYE MOVEMENT DISORDER, HYPOAESTHESIA, HYPOAESTHESIA ORAL, TRANSIENT ISCHAEMIC ATTACK and VISION BLURRED. On 21-Mar-2021, TRANSIENT ISCHAEMIC ATTACK (TIA), HYPOAESTHESIA ORAL (Lips numb), HYPOAESTHESIA (Face numb), EYE MOVEMENT DISORDER (Eyes spinning), EXCESSIVE EYE BLINKING (Right eye winking), VISION BLURRED (Feeling Cloudy vision) and DIZZINESS (Dizziness) had resolved. At the time of the report, CHILLS (CHILLS) had resolved. CT scan of the head was done and MRI. Patient said he was discharged on Sunday, March-21st. He said his symptoms were gone after that and he was given baby aspirin. The action taken of all the events with the suspect drug Moderna COVID-19 Vaccine was not applicable. The causality of all events was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's medical history and concomitant medications are necessary for assessment. Further information has been requested.

Diminished sensation of the right arm and leg with diminished sensation of the left side of face, pain of left occipital extending to temporal area over ear

shot on wednesday, on thursday, i began experiencing pain in right leg? by sunday pain in the calve muscle? went to ER on Monday afternoon? and was Diagnosed with a DVT? (note, I have no history of blood clots/DVT)

Patient was found unresponsive on 4/15/2021. Patient seemed to pass in his sleep per family member. The coroner deemed myocardial infarction. No autopsy completed.

On Wednesday evening April 21st around 11:00 pm i could not catch my breath while trying to lye down or sit up, i went to the Hospital ER on Thursday morning at 8:00 am and they did a cat scan with contrast and found multiple blood clots (PE ) in my right lung.

Patient was vaccinated with Moderna Covid Vaccine on Thursday, May 6, 2021. We were informed the following Monday that the patient had passed away unexpectedly on Friday, May 7, 2021. Family members did not reach out to us to ask any questions or to let us know what had happened. We do not know that this patient passed away due to vaccination with the Moderna Vaccine.

On 5-13-21 the patient began complaining of dizziness, weakness, and left side chest pain. The patient was sent to a hospital via 911 ambulance and admitted to the hospital from 5-13-21 to 5-18-21. He was diagnosed with a Pulmonary Embolism, Acute Venous Thrombosis, and a Pulmonary Embolism.

54 days after the first vaccination with Moderna Covid-19 Vaccine, and 25 days after the second vaccination, at approximately 0730 on Day 1, a 52 year old male, height 175.2cm, weight 95.5kg, without significant medical history or prodrome, had an acute onset of dyspnea manifesting as a small sigh at intervals of 4-6 minutes, which increased in frequency to intervals of 2-3 minutes over the course of the day. At approximately 1400 he had a one minute episode of tachycardia >120 bpm. At 1515, his forehead became diaphoretic. He had neither chest pain nor a pericardial friction rub at any time. He went directly to the local emergency department. Additional information for Item 18: Blood pressure at admission was 155/87, pulse 97, respiratory rate 22/minute, SpO2 98%, and Temperature 37.2. ECG at 1539 interpreted as: "NSR at 85, Lateral ST depressions; ST elevations in aVR, ischemia / Posterior wall MI". ECG at 1541 showed: NSR at 82, unchanged from prior ECG. ECG at 1552 interpreted as: "Sinus tachycardia at 102, ST depressions remain in lateral leads but now also in V3 and V4; persistent ST elevations in aVR CW evolving posterior wall MI". PR depression in leads II and V4-6, and reciprocal PR segment elevation in aVR (pericarditis ECG Stage 1) Atypically for pericarditis, ST depression, rather than ST elevation, was present in leads V3-V6. Owing to a working diagnosis of an evolving posterior wall myocardial infarction, an emergent cardiac catheterization was performed, which demonstrated non-obstructive CAD and a small myocardial bridge. Initial laboratory values were notable for a white blood cell count of 11.89 K/mm3 (4.5 - 11.5), monocytes 1.1 K/mm3 (0.0 -1.0), 9.4% (2.0 - 9.0), neutrophils 7.9 K/mm3 (1.5 - 6.6), 66.9% (40.0 - 75.0). Troponin was negative at admission and 18 hours later. D-Dimer was negative. Viral panels including SARS-CoV-2, Influenza A, Influenza B, and RSV were negative. He was admitted for overnight observation. On Day 2 an echocardiogram was normal with no effusion, and ECG was notable for the absence of PR depression and persistent ST depression in leads (PR segment normalization part of pericarditis ECG Stage 2)…... His dyspnea persisted, with a moderate sigh every 1-2 minutes at rest. He was discharged with a presumptive diagnosis of coronary vasospasm or a pulmonary etiology, and told to follow up with his pmd. Over the next several days, his dyspnea was continuous and progressively worsened, and he had diaphoresis of the forehead every morning approximately 0900 until Day 20. Sleep remained normal. On Day 5 he was sighing deeply more than once per minute at rest, causing him distress, and ECG showed (?persistent ST depression in V4-6 with reciprocal changes in aVR). On Day 12, ECG showed T-wave inversion in V1-6 and ST depression in V3-6 (ECG Stage 3); a computed tomography of the chest was normal; and blood tests notable for normal monocyte count .57 K/microliter (0.0 - 0.8), normal CRP 2.15 (1.0-3.0), and an ANA titer of 1:80 (elevated) described as a speckled pattern, which is associated with several autoimmune diseases. Repeat echocardiography on Day 26 showed a small, generalized pericardial effusion and was otherwise normal. Cardiac MRI on Day 29 showed delayed gadolinium uptake. Pulmonary function tests on Day 38 were normal. Stress echocardiography on Day 44 was normal. Cardiac CT angiogram on Day 46was normal. The patient was diagnosed with pericarditis of unknown origin and started on aspirin 650 mg p.o. b.i.d. An ECG on Day 80 showed PR depression in II and V4-6, continued ST depression in II and V3-6, without T wave inversion (T wave normalization c/w ECG Stage 4). Symptoms progressively worsened from onset to nadir around Day 12, on which he had continuous moderate dyspnea upon awakening with severe dyspnea with mild exertion. Symptoms then generally improved until after Day 47, he began to have alternating periods of several days without symptoms followed by several days of mild dyspnea. Clinical symptoms resolved on Day 85.

ON 3/15/21 patient was found unresponsive by spouse. EMS was called. Patient was found to have cardiac arrest Was given Epinephrine, Amiodarone and External Ventricular defibrillation Patient passed away on 3/15/21

My brother took the day off work on May 12, 2021 to receive his 2nd dose of the Moderna vaccine. He communicated with friends later that same day saying he was tired and needed to rest. On May 13, 2021, a work colleague followed up with a text message to see how he was doing to which my brother did not respond. This same colleague went to his house a few days later to find him dead lying on his couch.

Patient developed dizziness, chills, fever, body ache, sore throat, difficulty breathing, and stopped eating beginning April 26, The adverse effect is the belief that a breakthrough case of Covid-19 will be less severe if you had the shots. A false sense of security.

Seizure; Acute kidney failure, unspecified; Hypo-osmolality and hyponatremia; Thrombocytopenia, unspecified

After receiving the 2nd vaccine on 5/15/21, on 5/16 patient had a "stomach ache", on 5/17 he went to work. At 9:30am, the camera's show him going into the women's restroom to service it, a lady tried to go into the restroom and could not go in, she called the supervisor, when the supervisor arrived there was no pulse. Report source believes he goes into work around 7:00AM. Report sources states she was told " his blood sugar was not elevated". Report source states that the death certificate states he had a cardiac arrest.

06/01/2021 PATIENT EXPERIENCED LEG PAIN AND SWELLING, ON 06/05/2021 PATEINT WENT TO THE ER WITH SEVERE LEG PAIN AND WAS ADMITTED TO THE HOSPITAL WITH A DVT. ON 06/07/2021 PATIENT WAS RELEASED FROM THE HOSPITAL AFTER A VASCULAR DOCTOR REMOVED A SUBSTANTIAL CLOT. PATIENT IS CURRENTLY TAKING XARELTO.

Acute Myocardial Infarction in the setting of nonobstructive coronary artery disease (angiography 3/30/2021) due to Acute MYOCARDITIS proven by cardiac MRI (3/31/2021)

Patient vaccinated on 6/23/2021. Patient later found down by guard in cardiac arrest. Patient revived and transported via EMS to HCF. Patient admitted 6/24/2021 and tested positive for COVID-19 (patient's first known positive in October 2020). Patient currently in the COVID unit on a telemetry monitor.

Patient developed severe headache 5/9/21, described as squeezing pain as a band around his head. Headache not relieved by meds. Symptoms worsened and 2 weeks later wife noticed abnormal gait then found patient unresponsive. Admitted to hospital and found to have intracranial and subarachnoid hemorrhage.

On 05/30/21 I woke up about 5am with chest pain, shortness of breath, palpitations, heart racing. Drove myself to the ER. Had EKG, labs done, Metoprolol given in ER. Was told I was in Afib. I stayed in ER until shortly after 4pm. I saw Cardiology doctors and then given discharge instructions for a follow up appt for Echo and cardiology doctor appt. Before leaving the ER I returned to normal sinus rhythm.

DVT - Cramp and Pain in right calf approximately 2 weeks after the 2nd dose of Moderna. Leg Swelling and rash 27 days after 2nd dose with diagnosed blood clot in right leg.

Heart enzyme elevated; Small blood clot; Chest pain; Soreness; Low grade fever; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated) and THROMBOSIS (Small blood clot) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 020B214) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical history was provided. Concomitant products included LOSARTAN and SIMVASTATIN for an unknown indication. On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated) (seriousness criterion medically significant), THROMBOSIS (Small blood clot) (seriousness criterion medically significant), CHEST PAIN (Chest pain), MYALGIA (Soreness), PYREXIA (Low grade fever) and FATIGUE (Fatigue). The patient was treated with APIXABAN (ELIQUIS) for Thrombosis, at an unspecified dose and frequency. At the time of the report, MYOCARDIAL NECROSIS MARKER INCREASED (Heart enzyme elevated), THROMBOSIS (Small blood clot), CHEST PAIN (Chest pain), MYALGIA (Soreness), PYREXIA (Low grade fever) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: abnormal (abnormal) found a clot in his right lung.. On an unknown date, Myocardial necrosis marker increased: increased (High) increased. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Labs include ultrasound, chest x-ray ,strep tests whose results are not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-237494 (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 called as part of booster follow up and declined vaccine, shared he was in rehab due to stroke. No other details shared

He passed in his sleep that night.; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (He passed in his sleep that night.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 22-Jul-2021 The patient died on 22-Jul-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication was given. No treatment information was given. Patient received the 1st dose of the Moderna Covid-19 vaccine. He died in his sleep that night. This a report of dead one day after the first dose of the product in an 52-year-old patient with no comorbidities. Very limited information regarding the event has been provided for inferring causality. Further information is not expected.; Sender's Comments: This a report of dead one day after the first dose of the product in an 52-year-old patient with no comorbidities. Very limited information regarding the event has been provided for inferring causality. Further information is not expected.; Reported Cause(s) of Death: unknown

Patient was at a gym watching his daughter. He slumped over unconscious. EMS was called. He was found to be in fine ventricular fibrillation and resuscitation efforts failed. He was brought to Hospital ED where he was pronounced dead. He had underlying cardiac disease but his family requested I report this event as possibly related to the recent COVID vaccination.

Patient is a 53 year old man with a past medical history of follicular lymphoma diagnosed in 2008, more recently with DLBCL with CNS involvement (involving hypothalamus; dx 8/2018; s/p HD MTX, s/p BMT- followed by Dr.), autoimmune hepatitis, obesity, adipic DI, central hypothyroidism and type 2 DM who presented to Hospital via EMS after a fall at home with multisystem organ failure leading to intubation in the ED and subsequent transfer to Oncology ICU for further management. He was in his usual state if health until Sunday. On Saturday he got COVID vaccine at 4pm, that evening he had no issues. Sunday night around 10pm he didn't make complete sense and his wife was concerned because of his history of DM and treated CNS lymphoma. BG was 320-340 at that time. Monday he was good and Monday night he started to have shaking of his left hand. Tuesday he had one episode of diarrhea. Later he was more shaky in the shower and he started to fall and his wife was unable to grab him and he slid down the wall and could not get up. Family was called to help and he was not making sense so they called EMS. Wife reports that he was down approximately 3 hours before EMS was able to get him up. In EMS he was noted to have a large area of skin desquamation from the right posterior knee to the ankle. His GCS was 15. He had stable blood pressure and heart rate. He was hypoxia to the 50s and oxygen was applied. In the ED he was found to be in multisystem organ failure and was intubated and had rapid progression of shock requiring Epinephrine, Levophed and Vasopressin. Crash lines were placed and he was sent to hospital. Upon arrival he was noted to have a cold pulseless right lower extremity and surgery was called. He was evaluated by Trauma Surgery, Orthopedic surgery and Vascular surgery and eventually underwent above the knee amputation. Unfortunately they were not able to remove all nonviable tissue and he continued to deteriorate. He was taken level 1 back to the OR and an additional 10 cm of nonviable tissue was removed. Unfortunately upon arrive he suffered cardiac arrest in the setting of severe lactic acidosis and hyperkalemia.

Patient report to have been in A-fib for three days after receiving first dose of vaccine; Throat closure; Felt like anaphylaxis; A spontaneous report was received from a consumer who was a 53-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed atrial fibrillation and an anaphylactic reaction. The patient's medical history included heart failure and allergies to butter and NSAIDS. Products known to have been used by the patient, within two weeks prior to the event, included metoprolol, diltiazem, apixaban, lisinopril and loratadine. The patient received their first of two planned doses of mRNA-1273 (Batch number: 040A21A) on 11 Mar 2021 in the left arm for prophylaxis of COVID-19 infection. On 11 Mar 2021, the patient reported that he experienced a moderate reaction; throat closure (not complete). He stated that it felt like anaphylaxis. He also reported having a numb tongue. He reported that the reaction was not immediate and that it started about four hours after the vaccine. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event, atrial fibrillation, was considered recovered/resolved. The outcome of the event, anaphylactic reaction, was considered recovering/resolving.; Reporter's Comments: This case concerns a 53-year-old male who experienced a serious anaphylactic reaction with serious unexpected event of atrial fibrillation and throat closure. Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Atrial fibrillation resolved, and anaphylaxis resolving. 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.

Small Right Side Pontine Stroke confirmed by CT and MRI. Treatment includes statin, and anti-platelet med. Symptoms: Left sided hemiparesis up to 85% loss of function for 10 days with small improvments over days/weeks.

fevers, chills, shortness of breath (acute respiratory failure requiring intubation) 1 day after vaccine administration

Pt states he woke up early and couldn't stand due to head spinning, but was okay laying flat. Lasted 20 seconds then able to stand slowly. Reports continues to have <5-10 second vertigo episodes 3-4 times a day ever since. Describes vertigo as if riding on a roller coaster and feels room spin in back of head by his neck area behind ears bilaterally. No issues with eyes or ears. Quick position changes or moving from flat to sitting/standing or turn head quickly side to side triggers sensation. No neck pain.

Right Lower Extremity DVT confirmed on U/S Presented to our office to rule out hypercoaguable state, however previous work up has been negative

Presented to ED with shortness of breath on exertion and tachycardia. Patient reported getting covid-19 2nd vaccine 4/11 (moderna) Lot #037B21A. Patient found to have acute saddle pulmonary embolism and right leg femoral DVT. Placed on heparin drip then transferred to hospital on 4/16/2021. Converted from heparin IV to Apixaban PO.

Acute bilateral pulmonary emboli without known risk factors for this condition. Onset of symptoms consistent with acute pulmonary embolism started 2 days after vaccination. Formal diagnosis made on CT chest on 4/13/2021 after worsening symptoms of shortness of breath with exertion prompted evaluation in ER

Pt was administered second Moderna vaccine at 12:55 pm. Pt stood up from seated position at 1:01 pm and fell to floor, unresponsive to touch, verbal commands, noxious stimuli, and sternal rub. O2 satting at 86%, normal HR, at time of fall. At 1:02 RRT was initiated at Health Center. At 1:03, 911 was called. At 1:07, pt had no pulse or respirations for 30 seconds, during which 20x compressions were administered and AED shock was not advised. ROSC at 1:08, unable to obtain VS. Paramedics responded within 10 minutes and took pt to Emergency Room

Arrhythmia - burst of a-fib, pain in joints, weakness, chills, inability to sleep continued for 3-4 days. After consultation with cardiologist returned to normal activities over the course of the following week. Recommended not receiving second dose.

Immune mediated thrombocytopenia. Presented with altered mental status, found to have Platelets at 10,000.

Patient reported to onsite health clinic to see nurse at 1930. Complaints of not feeling well. Vomited then dyspnea. Went into cardiac arrest, AED used x1. EMS called at 1945. CPR, intubation until 2055. Time of death 2055.

Patient states that he ended up in the ER on 4/7/21 and was diagnosed with a stroke. He states no previous health conditions prior to vaccination/stroke. He also states he experienced chills, fatigue, headache, nausea and breathlessness after first dose.

Chills, fever, muscle pain especially on the legs and the left side of the kidney. Tremors and has visited several emergency rooms as symptoms get worse. Patient had a prostate biopsy done on 4/26/21 a day before getting vaccinated. Patient is currently admitted to a Medical Center for symptoms related to the prostate. Bloodwork have been done and as of today he is presenting thrombocytopenia and low hemoglobin levels.

patient's girlfriend stated that patient got the vaccine on Thursday 4-1-21 and that he had to go to the ER on Friday 4-2-21 because he could not speak or walk. she stated that he had pain behind his right eye and blurred vision. she stated that one week later his doctor ordered a CT scan and determined that he had a stroke. spoke with the Nurse Practitioner at the office. she stated that the patient did have a stroke, but they did not know the cause of the stroke. I am unable to get the lot number of the vaccine because it was entered through the state system and the lot number did not go over. No lot number is associated with the vaccine.

Presents to ED 4/21 with complaints of L side CP starting at approx 2100. Pt reports shooting pain to L side of chest and armpit with palpating area. Pt reports recently diagnosed with LLE blood clot on 4/13, put on eliquis and has been taking for the past 11 days. Pt reports resting makes pain better, palpating makes pain worse and standing makes pain worse in LLE. Pt denies SOB, DOB or cough. Pt denies history of PE, reports multiple bilat lower extrem DVT's. Patient CBC is normal, metabolic panel is normal, troponin is normal. CTA of the chest was obtained and shows no signs of pulmonary embolism. There is some prominence of his pulmonary arteries bilaterally. BNP is also negative. The patient's pain is mostly reproducible on that left chest, doubt ACS in this patient. Patient will be discharged home have him follow-up with his doctor as an outpatient. Patient is stable for discharge.

Eight days after receiving the Moderna shot I woke up in the morning (3/22/2021) with irregular heartbeat. My family doctor confirmed via EKG that I was in Atrial Fibrillation (Afib). Blood samples were taken, test results were normal. Blood thinners were described. Went to see a cardiologist (3/23/2021) where the Afib was confirmed. Following that visit an echocardiogram of the heart was performed, results were normal. Afib turned into persistent mode and I decided to undergo a cardioversion (4/21/2021) to bring my heart back into regular sinus rhythm. Even though the cardioversion turned out to be initially unsuccessful, I experienced the last Afib episode at the end of last month (4/28/2021).

Hospitalized after vaccination with acute submassive PE. ASSESSMENT / PLAN: Patient is a 53-year-old male in no significant past medical history who presented with complaints of progressively worsening shortness of breath, chest pressure and was found to have acute submassive pulmonary embolism for which he underwent successful mechanical thrombectomy per Interventional Radiology. Subsequent bilateral lower extremity DVT ultrasound demonstrated acute DVTs in the left popliteal, posterior tibial, peroneal veins. DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Acute pulmonary embolism, unspecified pulmonary embolism type, unspecified whether acute cor pulmonale present (HCC) [I26.99] HOSPITAL COURSE: The patient is a 53-year-old male in no significant past medical history who is admitted for Acute Saddle Pulmonary Embolism. In the ED, the patient was tachycardic, tachypenic requiring 2 L of O2. CT angiogram thorax showed saddle embolus with extensive bilateral pulmonary emboli and evidence for right heart failure. He was immediately started on IV Heparin. PERT Team was activated and the patient underwent a successful mechanical thrombectomy with IR. Dopplers of the lower extremity showed Left lower popliteal, posterior tibial and peroneal DVTs. After 24 hours of hemodynamically stable vitals, the patient was transition to Eliquis. The patient stay was complicated with elevated blood glucose along with Hba1c of 9.7. Endocrinology was consulted and started the patient with Lantus and LDC. The patient will be discharged with diabetic regimen and followed up with PCP/outpatient Endocrine. The patient was stable, AOx4, without complications and discharged safely to his home with his wife.

Blood seepage and clot from nose. After expelled blood clot, no blood seepage from nose until after 2nd Moderna vaccine (May 5 to May, 14 2021 #048B21A). Expelled blood clot from nose again. No blood seepage from nose after expelling blood clot.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was severe sepsis.

Patient came in for swelling and pain to left calf, he also had a nodule to the medial posterior aspect of the calf. He reported the symptoms were since approx the 5/17/21. Pt said it possibly started sooner on the 15th. Pt came in today 5/21/21 because he received an ultrasound at a clinic by referral from his pmd and was dx with a DVT to the left calf. His pmd then referred him to come to ER where I triaged him in the triage department. He mentioned that began feeling bad after the Moderna Shot he received on 4/28/2020 and stated the now he has this new problem that he never had in the past. Only hx was mild htn he said.

I was diagnosed with A Fib on 5/13/21. I have never had any history or issue with my heart that I know of before this. It may not even be related

Patient manifested with flu-like symptoms (myalgias, fatigue, cough, abdominal discomfort, shortness of breath) with high-grade fevers (TMax 103F) approximately 4-6 hours following administration of 2nd Moderna vaccine on 5/4/2021 per patient's wife. The symptoms progressively worsened to the point that he presented to an outside hospital on 5/12/2021 at which time he was found to be tachycardic and febrile (T 103.1F). Labs at that time were notable for significant thrombocytopenia, elevated creatinine, elevated lactate, elevated procalcitonin. Chest imaging showed bilateral airspace disease. CT of the abdomen noted hepatosplenomegaly with no evidence of lymphadenopathy. Echocardiogram showed normal cardiac function. He was empirically started on broad-spectrum antibiotics. Labs on 5/13/2021 were notable for a markedly elevated ferritin level, fasting hypertriglyceridemia, elevated CRP, elevated transaminase levels, hyperbilirubinemia, markedly elevated CXCL-9 level, markedly elevated IL-18 level, normal natural killer cell function. Of note, while his blood and urine cultures were negative, he was found to have elevated EBV viral load on peripheral blood draw. He had a bone marrow biopsy which reportedly showed rare evidence of cells with what appeared to be erythrocytes within their cytoplasm, concerning for HLH. Given strong clinical and serological suspicion for HLH, he was transferred to our hospital for a higher level of care. Upon transfer to our facility on 5/18/2021, his inflammatory markers were persistently elevated. He unfortunately developed worsened renal and respiratory failure, and required both hemodialysis and intubation respectively. He was continued on empiric broad-spectrum antibiotics, however we additionally initiated high-dose steroids as well as anakinra for treatment of HLH. Given EBV viremia, we also began rituximab therapy. He was successfully extubated, however as of 5/26/2021 remains dialysis-dependent with continued improvement in urinary output. His post-intubation course has been complicated by encephalopathy of unknown etiology. We have consulted infectious disease to proceed with a diagnostic lumbar puncture to ascertain potential CNS pathogens explaining the cause of his altered mental status. MRI of the brain showed no evidence of pathology. CNS involvement by HLH remains on our differential.

Patient reported signs and symptoms of SOB/right leg pain 1 week after receiving the Moderna vaccine. He stated that he was "breathing fire" and woke up with an extremely painful and swollen leg. Upon coming to the ED, it was found to be bilateral PE and right leg DVT.

They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine; His lungs were filled with fluid; After 2nd dose, next day morning at 9AM, he didn't feel well while at work; He had upset stomach; He started feeling light headed while driving/very light headed; When he walked in the house, he was short of breath; Turned gray/about a minute and half later, he turned purple and blue; His oxygen was dropped to low 70s; His BP dropped to 80/50; His entire torso was covered in a rash; Very nauseous; On the way home, he started vomiting; He felt little achy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine) and PULMONARY OEDEMA (His lungs were filled with fluid) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine) (seriousness criteria hospitalization and medically significant), PULMONARY OEDEMA (His lungs were filled with fluid) (seriousness criteria hospitalization and medically significant), VACCINATION COMPLICATION (After 2nd dose, next day morning at 9AM, he didn't feel well while at work), ABDOMINAL DISCOMFORT (He had upset stomach), DIZZINESS (He started feeling light headed while driving/very light headed), DYSPNOEA (When he walked in the house, he was short of breath), SKIN DISCOLOURATION (Turned gray/about a minute and half later, he turned purple and blue), OXYGEN SATURATION DECREASED (His oxygen was dropped to low 70s), BLOOD PRESSURE DECREASED (His BP dropped to 80/50), RASH (His entire torso was covered in a rash), NAUSEA (Very nauseous), VOMITING (On the way home, he started vomiting) and MYALGIA (He felt little achy). The patient was hospitalized from 13-May-2021 to 14-May-2021 due to ANAPHYLACTIC REACTION and PULMONARY OEDEMA. At the time of the report, ANAPHYLACTIC REACTION (They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine), PULMONARY OEDEMA (His lungs were filled with fluid), VACCINATION COMPLICATION (After 2nd dose, next day morning at 9AM, he didn't feel well while at work), ABDOMINAL DISCOMFORT (He had upset stomach), DIZZINESS (He started feeling light headed while driving/very light headed), DYSPNOEA (When he walked in the house, he was short of breath), SKIN DISCOLOURATION (Turned gray/about a minute and half later, he turned purple and blue), OXYGEN SATURATION DECREASED (His oxygen was dropped to low 70s), BLOOD PRESSURE DECREASED (His BP dropped to 80/50), RASH (His entire torso was covered in a rash), NAUSEA (Very nauseous), VOMITING (On the way home, he started vomiting) and MYALGIA (He felt little achy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-May-2021, Blood pressure measurement: 80/50 (Low) 80/50. On 13-May-2021, Oxygen saturation: low 70s (Low) low 70s. Patient's concomitant medication included nasal spray. He was admitted to the hospital. They diagnosed him with delayed (about 18 Hours) anaphylactic reaction due to the vaccine. The patient was discharged from the hospital on 14-May-2021 evening. The patient was treated with Epi-pen and steroids. 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.

heart attack; grand mal seizure episodes "for the first time in over 2 years", he didn't remember the episode; he was freezing and was cold; throwing up profusely; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (heart attack) and GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure episodes "for the first time in over 2 years", he didn't remember the episode) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history provided by the reporter. Concomitant products included LACOSAMIDE (VIMPAT) for Seizure. On 21-Apr-2021 at 3:30 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-May-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure episodes "for the first time in over 2 years", he didn't remember the episode) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), NASOPHARYNGITIS (he was freezing and was cold) and VOMITING (throwing up profusely). The patient was hospitalized on 22-May-2021 due to GENERALISED TONIC-CLONIC SEIZURE and MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (heart attack), GENERALISED TONIC-CLONIC SEIZURE (grand mal seizure episodes "for the last time in over 2 years", he didn't remember the episode), NASOPHARYNGITIS (he was freezing and was cold) and VOMITING (throwing up profusely) outcome was unknown. Patient was admitted to hospital on 22-may-2021.patient lips were purple and had no pulse for 12 minutes, but was resuscitated.The hospital took out patient's breathing tube at on 23May2021, and hospital staff stated he will remain there for a while. Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Vomiting is consistent with the known safety profile of the product.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the reported events, a causal relationship cannot be excluded. Vomiting is consistent with the known safety profile of the product.

Patient had his 2nd Moderna vaccine at pharmacy at 2:00 and was struggling to breathe a few hours later. We were at the emergency room around 6:00pm and he was placed on a ventilator between midnight and 1:00am. He died 10 days later after experiencing clots that led to seizures and congestive heart failure. I have a death certificate if needed.

Died on the night of 05Jun2021 or Morning 06Jun2021 not Sure; Gastritis; The reaction came back with a vengeance; was doubling over; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Died on the night of 05Jun2021 or Morning 06Jun2021 not Sure) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart disease, unspecified. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, the patient experienced DISEASE RECURRENCE (The reaction came back with a vengeance) and CONDITION AGGRAVATED (was doubling over). On 01-Jun-2021, the patient experienced GASTRITIS (Gastritis). The patient died on 05-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, GASTRITIS (Gastritis), DISEASE RECURRENCE (The reaction came back with a vengeance) and CONDITION AGGRAVATED (was doubling over) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Jun-2021, Ultrasound scan: abnormal (abnormal) confirmed gastritis.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Labs included electrocardiogram (EKG) whose results were not provided. It was reported that on 01-jun-2021 at Emergency room, gastritis was diagnosed and patient was sent home. Treatment information was not provided. Company comment: This is a case of sudden death in a 53-year-old male patient with a history of Heart disease, who died 1 month 14 days after receiving last dose of vaccine. Very limited information has been provided at this time. This case was linked to MOD-2021-211580 (Patient Link).; Sender's Comments: This is a case of sudden death in a 53-year-old male patient with a history of Heart disease, who died 1 month 14 days after receiving last dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death

Seizures; Bood clots; Stuggling to breathe; Struggling to walk; ARDS; Acute hypoxic respiratory failure; Acute exacerbation of heart failure and sepsis; Acute exacerbation of heart failure and sepsis; Cardiac arrest; Blood infection; Fever; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS), ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure), SEPSIS (Acute exacerbation of heart failure and sepsis), CARDIAC FAILURE ACUTE (Acute exacerbation of heart failure and sepsis), CARDIAC ARREST (Cardiac arrest), SEIZURE (Seizures), THROMBOSIS (Bood clots), DYSPNOEA (Stuggling to breathe) and GAIT DISTURBANCE (Struggling to walk) in a 53-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 Obesity. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021 at 2:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) (seriousness criteria death and medically significant), ACUTE RESPIRATORY FAILURE (Acute hypoxic respiratory failure) (seriousness criteria death and medically significant), DYSPNOEA (Stuggling to breathe) (seriousness criterion hospitalization prolonged) and GAIT DISTURBANCE (Struggling to walk) (seriousness criterion hospitalization prolonged). In May 2021, the patient experienced SEPSIS (Acute exacerbation of heart failure and sepsis) (seriousness criteria death and medically significant), CARDIAC FAILURE ACUTE (Acute exacerbation of heart failure and sepsis) (seriousness criteria death and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death and medically significant), INFECTION (Blood infection) and PYREXIA (Fever). On 17-May-2021, the patient experienced SEIZURE (Seizures) (seriousness criteria hospitalization prolonged and medically significant) and THROMBOSIS (Bood clots) (seriousness criteria hospitalization prolonged and medically significant). The patient was hospitalized from 15-May-2021 to 25-May-2021 due to DYSPNOEA, GAIT DISTURBANCE, SEIZURE and THROMBOSIS. The patient died on 25-May-2021. The reported cause of death was Cardiac arrest, Acute hypoxic respiratory failure, ards and acute exacerbation of heart failure and sepsis. It is unknown if an autopsy was performed. At the time of death, SEIZURE (Seizures), THROMBOSIS (Bood clots), DYSPNOEA (Stuggling to breathe), GAIT DISTURBANCE (Struggling to walk), INFECTION (Blood infection) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-May-2021, Blood pressure measurement: elevated (High) Twice normal. On 15-May-2021, Glycosylated haemoglobin: elevated (High) High. On 15-May-2021, Oxygen saturation: low (Low) Required intubation and was placed on ventilator.. On 15-May-2021, SARS-CoV-2 antibody test: negative (Negative) 1 negative COVID antibody test. On 15-May-2021, SARS-CoV-2 test: negatie (Negative) 3 negative COVID antigen tests. No concomitant medications were provided. It was reported that within few hours after second dose of vaccine patient was struggling to walk and to breathe. The reporter and her husband went to see the patient and took him to an emergency room (ER). In the ER his blood pressure was markedly elevated (twice normal) and his oxygen level was low and by midnight he required intubation and was placed on a ventilator. His HbgA1c was noted to be elevated. Two days after admission (17-May-2021), he developed seizures which the medical team believed to be due to blood clots and he was anti-coagulated. It was determined that he did not have blood clots on his heart valves as the source of the clots. The source of the blood clots was never identified. He later developed fever and was diagnosed with a blood infection and treated with antibiotics. At one point his oxygen requirement on the ventilator went down to 65% but later returned and remained at 100%. He ultimately died on 25-May-2021 and as per copy of his death certificate he had 4 causes of death as cardiac arrest, acute hypoxic respiratory failure, acute respiratory distress syndrome (ARDS) and acute exacerbation of heart failure and sepsis. Treatment included, anticoagulants, antibiotics, intubation and ventilator. Very limited information regarding these events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-219410 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Cardiac arrest; Acute hypoxic respiratory failure; ARDS; Acute exacerbation of heart failure and sepsis

The pt received his 2nd Moderna covid vaccine on 6/13/21 at 10:45 am (approximately). Starting at 5pm he c/o pain, redness and tenderness in the injection site, chills, and lethargy . The next day he did not go to work b/o he felt tired and he stayed home with his 7 y/o daughter while his wife went to work. His wife spoke with him in the am and he reports he was making breakfast for their daughter and he was going to lie down and sleep afterward. He made lunch for daughter about 1 pm and he went to lie down in his chair. His brother called his wife at about 4:30 pm stating he was blue. 911 was called and they were unable to revive him.

Pt reported syncope and collapse on 6.13.21, onset of LEFT leg swelling, chest pain and dizziness 6.17.21. Pt was diagnosed with extensive DVT of LLE and bilateral PE with significant clot burden on 6.22.21

Community acquired pneumonia Transaminitis Hyperlipemia Hospitalization to treat the pneumonia, May 13-15 and May 20. Continued treatment at home with antibiotics and steroid , nebulizer and rescue inhaler.

I had chest pains. My platelets cell was 543 and white blood cells count was 26000. I went in to the ER after 4 days and was diagnosis as having a heart attack. Cholesterol 203 results. triglycerides was 85.

Diagnosed with Blood clots; Never received the second dose; Hospitalized for one day; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Diagnosed with Blood clots) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced THROMBOSIS (Diagnosed with Blood clots) (seriousness criteria hospitalization and medically significant) and HOSPITALISATION (Hospitalized for one day). On 19-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Never received the second dose). The patient was hospitalized for 1 day due to THROMBOSIS. At the time of the report, THROMBOSIS (Diagnosed with Blood clots) and HOSPITALISATION (Hospitalized for one day) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Never received the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported that he was currently taking Blood thinners. No concomitant medications were provided by the reporter. This 53 year-old consumer called on 19Jul2021 to report that he received the first dose of Moderna COVID-19 vaccine on 29Mar2021 (Lot#006B21A). On 14Apr2021 patient was diagnosed with Blood clots and was hospitalized for one day. He mentioned that he never received the second dose . Patient is currently taking Blood thinners. No Lab data was provided by the reporter. This report refers to a case of product dose omission for mRNA-1273 (lot # 006B21A) with associated AE reported of thrombosis. Based on the current available information and temporal association between the use of the product and the start date of the event thrombosi, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: This report refers to a case of product dose omission for mRNA-1273 (lot # 006B21A) with associated AE reported of thrombosis. Based on the current available information and temporal association between the use of the product and the start date of the event thrombosi, a causal relationship cannot be excluded. Further information has been requested

Deep vein thrombosis left calf; Difficulty breathing; Pulmonary Embolism; Felt doggy, sluggish, punky; Arm hurt; A spontaneous report was received from a nurse concerning a 54-year-old, male patient who experienced pulmonary embolism, deep vein thrombosis, vaccination site pain, sluggishness and dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 12-Feb-2021, approximately 2 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient received his vaccine on 12-Feb-2021 and reported that his arm hurt a little for a few days. On 14-Feb2021, he reported that he started feeling sluggish and on 20-Feb-2021 he began to have difficulty breathing and pain in the right lower base of rib cage. He went to urgent care where he was diagnosed with a pulmonary embolism for which he received treatment. On the evening of the same day, he again started having difficulty breathing with pain upon inhalation. He returned to urgent care and was subsequently admitted at 12:30 AM on 21-Feb-2021. That Monday, 22-Feb-2021, a doppler ultrasound revealed a deep vein thrombosis in the left calf. Patient was treated with heparin intravenously (IV). He was discharged 22-Feb-2021. Treatment for the event included Xarelto 20mg twice per day for two weeks and Heparin IV. Action taken with mRNA-1273 in response to the events was not provided/unknown. The outcome of the events, pulmonary embolism, deep vein thrombosis and dyspnea, was considered recovering/resolving as of discharge on 22-Feb-2021. The outcome of the events, vaccination site pain and sluggishness, 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 events, a causal relationship cannot be excluded.

After 1st injection (1/11/21) experienced severe shortness of breath with minimal activity with accelerated heart rate and drop in O2 stat. within 2 days of injection then developed wheezing cough. Primary MD prescribed Augmentin nd prednisone with eventual success. With normal blood work, chest x-ray and negative Covid test all done by 1/15. On 3/9/21 (28) days after second dose (2/11/21) experienced burning and swelling on right leg. Went to Hospital, ER and found extensive blood clots in right leg and saddle pulmonary embolism . Also had 50% Platelet blood count decrese since the 1/15 bloodwork Admitted for 3 nights on heparin dip. Discharge on home Lovenox injections for 30days.

Pt presented to the er on 3/12/2021 with c/o 5 days of worsening chest pain and sob. found to have a inferior STEMI and transported to different hospital for urgent angiogram. acute lateral MI found on angio resulting in placement of drug eluding stent

Cardiac Arrest Narrative: Patient received vaccine at 1209 on 3/13/2021, observed for 15min no reaction noted. Later that evening patient was not feeling well presented to ER where he was admitted. Had cardiac arrest during hospitalization on 3/16/2021 where patient passed away. Had a Hx of CHF, A-Fib, had a cardiac stent placement in 2020..

Unknown information regarding side effects from first Moderna Covid vaccine. Second Covid vaccine on 2/12/2021 and there were no issues. Patient died on 31/10/2021. Postmortem Covid test is negative for SARS-CoV2 RNA.

My husband died of a sudden massive heart attack. He was one of two teachers who died after the moderna vaccine, second dose. A third teacher had a stroke.

Heart attack; A spontaneous report was received from a physician assistant, concerning a 54-year-old adult male patient who received Moderna's COVID-19 vaccine and experienced heart attack/myocardial infarction. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 25 Feb 2021, prior to the onset of event, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for COVID-19 infection prophylaxis. On 07 Mar 2021, after first dose of vaccine, the patient had chest pain and shortness of breath. On 12 Mar 2021, patient had a heart attack and was airlifted to hospital. He was hospitalized from 13 Mar 2021 to 14 Mar 2021. Patient did not have history of heart condition nor was taking any medications prior to having the heart attack. During hospital stay, he had angiogram done, stents were placed. Treatment also included cholesterol lowering medicine, blood pressure medicine and acetylsalicylic acid. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, heart attack was resolved on 14 Mar 2021.; 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 of myocardial infarction, a causal relationship cannot be excluded.

Per mom who called to report- about 2 hrs after vaccine on saturday 03/27/21 pt started to have a headache, she gave him some ibuprofen. He was still having headache and sick at stomach she gave him phenegran that evening. States he is paralyzed on left side of body and uses wheelchair but still gets around some on own- he fell 3 times that evening- lost strength in right arm. Monday he slept a lot of the day and when he woke up at 5pm mom states he couldnt talk right- he kept repeating words and trying to smoke a cigarette but had not cigarette in his hand. Was taken to hospital monday evening and at hospital now- mom states some confusion and trying to be combative with nurses. Per mom doctor believed he had a stroke on Saturday.

Received 2nd Moderna Covid shot on 03/29/2021 and on 03/31/2021, felt what I thought was a muscle cramp that never went away. Went to urgent care where the shot was given on unspecified date and they diagnosed what I thought was a muscle cramp area, as a blood clot.

Patient had a acute occlusive DVT of the left femoral vein from the proximal thigh down to the proximal calf involving the femoral vein, popliteal vein, proximal tibial veins on his left lower extremity. He is now being treated with anticoagulant medication p.o. He is currently being evaluated for possible pulmonary embolism as well.

Patient was returning to unit. When patient reached unit doors, patient collapsed. Health Care called, 3 nurses and Mini Ambulance deployed. Upon the Staff's arrival CPR was in progress, AED in place, Narcan administered. Ambulance call, transported to Facility. Patient pronounced 0724 hours

VTE legs, large intestine, & lungs Narrative: Patient reports received his first COVID vaccine dose of Moderna on 2/17/21 and reports in the early morning of 2/23/21 he began feeling pain in his right side. Patient states he thought his appendix had burst and he went to get checked out. Patient states they ran test and could not determine what was wrong, so he was sent to hospital. Patient states they found clots in his legs, large intestine, and lungs. States he underwent surgery to remove the clot from his large intestine and he now on Eliquis. Patient states he was "perfectly healthy" before receiving the COVID vaccine. Active meds: Ibuprofen 800mg TID for pain, Lidocaine 5% patch; 1 patch daily for 12 hours, and Sodium fluoride 1.1% oral cream; apply to mouth 1-2 times daily when brushing teeth

Patient was given 2nd Moderna vaccine at about 7:30. Patient was pale and diaphoretic and was lowered to the floor by RN and another patient receiving the vaccine who was a cardiologist. He had several beats of clonus and then woke up. He was awake when his first vital signs were obtained. HR 110, BP 190/96, O2 sat 100%. When he was more awake he was assisted in to a reclining chair. BP monitored every few minutes and dropped as low as SBP 104, HR 70-80s. Pt reported that he periodically syncopizes, last 6mo ago. He reported feeling lightheaded after seeing his arm bleed and be swollen after vaccination. After about 1 hours the patient's vital signs were stable but he continued to have symptoms of lightheadedness which worsened when I sat him up (though BP was stable). EMS was called and he was transported to the ED.

Taken into emergency with sudden onset of seizure at 3 :30am while sleeping at home. Had another seizure when arrived at the hospital. After multiple exams abs tests, diagnosed as subarachnoid hemorrhagic stroke. Don?t know if it?s related to the vaccine received 2 weeks prior

8 days after 2nd moderna covid vaccine kept waking up due to pain upon inhalation. by 2:48 am I could only take shallow, open mouth breathes because it hurt too much to take a deep breath. All mucles were sore, but especially the thigh muscles, headache, chills, temp = 100,

A few hours after the shot I felt heat on my right side, face, hands and leg. It progressed and became numb and tingling the next day. I thought these were normal side effects from the second shot, but when I had trouble moving my right foot by two days later, I went the emergency room.

8 days 9.5 hours after 1st moderna vaccine. emergency room visit for a "thunderclap" headache. diagnosed with a subarachnoid hemorrhage. (brain bleed). no avm, no aneurysm found after 7 days hospitalized with a multitude of scans performed. zero reason for this to have happened?!?!

My husband stated that he did not feel good after the vaccine the next morning, later he went to pick up hay and died on someone's property from the acute coronary syndrome.

High fever 104 degrees Loss of Taste Loss of smell Body aches Sore throat Nausea Chills Fatigue Shortness of Breath - trouble breathing Headache runny nose

Subsequently developed respiratory distress and pneumonia after testing positive for COVID. Pt died due to illness.

Patient states that 1-2 hours after receiving vaccine became nausea and had severe headache. Patient stated he sought medical attention and physician stated that " he had developed a blood clot on the right back side of head."

About 5 minutes after receiving the vaccination, the patient passed out rolling onto the floor from his chair and incurred some cuts to his nose/face. In addition to bleeding from his abrasions, he was vomiting/dry heaving repeatedly. An ambulance was called, and care was taken over by paramedics. He was taken to local hospital to be examined and treated as needed. He received the vaccine at 1;15 pm, passed out at 1:20 pm and was taken away by ambulance about 2:00 pm.

Patient experienced HA on way home from receiviong vaccine. HA persisted on 4-23-21 throughout morning and into early afternoon. Patient became catatonic at home, family called 911 and pateint was rushed to hospital via ambulance in hypertensive crisis and seizure activity. Patient diagnosed with brain bleeds in two sepearte areas of brain. Original commentary by neurosurgeon was this was unrelated to Moderna vaccine, current neurologist thinks it could have been related. Patient was in hospital for several days then released on 4-28-21. Patient is healing, going to therapy and compliant with all neurology follow ups. Patient still not released to return to work or to driving as of 5-26-21.

Per medical record, the patient complained of a productive coughing, difficult breathing, wheezing an chest pain. His discharge diagnosis was noted to be Saddle embolus of pulmonary artery.

First 10 days: High fever, chills, high blood pressure, headache, inability to swallow, entire left side numb (face, head, shoulder, arm), loss of voice Next 28 days and current: loss of voice, swallowing hard, shoulder pain, limited shoulder movement, tight neck in the left side

Deep Vein Thrombosis (DVT) in right lower leg. Symptoms initially occurred about two days after feeling sick with a high fever. Initially, the pain in the right calf muscle was thought to be a muscle or tendon strain. On May 22nd, during a campout, there was pain along the entire right leg, but at the time I thought it was just related to lower back pain from sleeping on the ground. On May 27 and 28th there was sharp pain at the bottom of my right foot, then on May 29th I noticed sweeling and a hard warm spot just above the inside right ankle. I reported to a local urgent care clinic first then was referred to Medical ER.

Stroke; Blood clots; Brain bleed; Wife found him on the floor after he collapsed; Still struggling to move left hand; Felt really weird; Acting differently; Kept rubbing his arm and saying it was burning; Wife found him on the floor after he collapsed and fell off the couch; Unable to move or talk; Can't speak / unable to talk; Can not stand up; Arm hurting like crazy / arm was killing him; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), THROMBOSIS (Blood clots), CEREBRAL HAEMORRHAGE (Brain bleed), LOSS OF CONSCIOUSNESS (Wife found him on the floor after he collapsed) and HEMIPARESIS (Still struggling to move left hand) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. 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 CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), THROMBOSIS (Blood clots) (seriousness criteria hospitalization and medically significant), CEREBRAL HAEMORRHAGE (Brain bleed) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Wife found him on the floor after he collapsed) (seriousness criterion medically significant), HEMIPARESIS (Still struggling to move left hand) (seriousness criterion medically significant), FEELING ABNORMAL (Felt really weird), ABNORMAL BEHAVIOUR (Acting differently), BURNING SENSATION (Kept rubbing his arm and saying it was burning), FALL (Wife found him on the floor after he collapsed and fell off the couch), HYPOKINESIA (Unable to move or talk), APHONIA (Can't speak / unable to talk), DYSSTASIA (Can not stand up) and MYALGIA (Arm hurting like crazy / arm was killing him). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), THROMBOSIS (Blood clots), CEREBRAL HAEMORRHAGE (Brain bleed), LOSS OF CONSCIOUSNESS (Wife found him on the floor after he collapsed), HEMIPARESIS (Still struggling to move left hand), FEELING ABNORMAL (Felt really weird), ABNORMAL BEHAVIOUR (Acting differently), BURNING SENSATION (Kept rubbing his arm and saying it was burning), FALL (Wife found him on the floor after he collapsed and fell off the couch), HYPOKINESIA (Unable to move or talk), APHONIA (Can't speak / unable to talk), DYSSTASIA (Can not stand up) and MYALGIA (Arm hurting like crazy / arm was killing him) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. It was reported that, the patient felt really weird and was acting differently. Four days after the patient received the vaccine, his wife found him on the floor after he collapsed and fell off the couch and was unable to move or talk. He was taken to hospital and was in ICU for 5-6 days. Treatment information was not 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.

SOB started 5/3/21, got worse today at walking. advise ER - Pt was admitted to hospital because bilat PE.

Second vaccination received 4/17/21. Leg and knee pain/discomfort and some difficulty walking noted six days after vaccination on 4/23/21. Discomfort continued intermittently for several days. Developed rib/side pain and difficulty taking a deep breath on 5/9/21. Went to ER on 5/10/21. Following extensive blood work, x-Ray and CT scan, was diagnosed with multiple bilateral pulmonary emboli. Started treatment on blood thinner (Eliquis) same day and symptoms have improved. Currently under care of a Hospital.

VITT: cerebral venous thrombosis and thrombocytopenia with positive PF4 antibody and no heparin exposure. Symptom onset on 6/4/21 which was 2 days after 2nd dose moderna vaccine (6/2/21) and diagnosed on 6/17/21. Started on bivalrudin. Clinically stable.

54 year old male with no known past medical history who received 2nd dose of his Moderna COVID vaccine at the end of May 2021 (unsure of actual date). The day after he received his second moderna vaccine he developed polydipsia, polyuria and substantial fatigue in addition to muscle aches, nausea, and malaise. His symptoms initially improved but then slowly worsened again, developing shortness of breath, palpitations, heat intolerance, and continued polyuria, polydipsia. Three days prior to presenting to our hospital (which was 3 weeks after his 2nd vaccine dose), pt developed worsening nausea with vomiting and substantial worsening of shortness of breath. On admission to our hospital, he was found to be in Diabetic ketoacidosis (no prior history of Diabetes, auto-immune Diabetes labs pending) as well has having new pulmonary embolism, Atrial fibrillation with RVR, and hyperthyroidism with anti-tpo abs (other's thyroid antibodies still pending). Given the time course of his presentation, it seems to us that he developed these conditions as a complication of his 2nd dose of the Moderna vaccine.

I had a lot of pain and aches after the second vaccination. I rested in bed for the whole afternoon and night, and I felt better the next day

I had HO Apriitis never had in my life Pericardiocentesis Pericardial effusion Anti-inflammatories My heart rate was 180 bpm

I had something that I never had in life. Pericardiocentesis. Pericardial effusion. Anti-inflammatories. My heart rate was 180bpm.

After the 1st dose vaccine, I had a little bit of a sore arm and mild flu like symptoms of low grade fever and headache. On 5/2/2021, I started to notice a pain in my leg and went to my normal routine physical and brought that to my doctor's attention. I was sent to get an ultrasound on 5/6/2021 and 2 blood clots were detected. DVT thrombosis on my right calf and another behind my right knee. My 2nd dose of vaccine was schedule for 5/7/2021 and my doctor approved me to go ahead to receive the vaccine (2nd dose Moderna lot #041B21A IM LA). After getting the vaccine, I went to pick up my prescription (Rivaroxaban) for blood thinner for my blood clots. I am going to be on that medication for 6 months. I have also been on Androgel testosterone gel for 10 years which has a warning for blood clots. My doctor have taken me off of the medication for now.

I developed severe pain and rushed to ER and after CT Scan, I was found to have blood clot in my lungs on the right side. I was also told by the lung specialist that I have inflammation all around my lungs. I have been on blood thinner since. However, I continuing to feel pain in my both left and right chest. The pain has continued to increase and I feel it all the time. Sometimes more severe when I lie down on my back. I feel the pain all around my ribs and sometimes going down on my lower back. I have also been having headaches and some coughing, however no blood. I am having pains in my joints in my fingers and ankles.

Patient presented to the ED on 3/15/2021 with acute chest pain. Patient presented to the ED on 4/9/2021 for NSTEMI and was subsequently hospitalized. These visits were within 6 weeks of receiving COVID vaccination.

12 hours after vaccine I had severe muscle pain, vomiting, severe headaches, and swollen arm, dizziness and blurry vision and that lasted about 24 hours. 2 days after the vaccine in the morning, I was at work and about 10 am I got very dizzy to the point of losing my balance dizzy. I drove home about a 1/2 hour later. I drove about 90 miles stopped at stop light and experienced vertigo, I went to ER. As, I got out of car, they sent a wheelchair and asked me my symptoms and they immediately told me I was having a stroke. They did cat scan and injected me with TPA. After that they then asked me when did the symptoms started, I told them after my vaccine. They admitted me into the ICU of hospital.

I63.9 - CVA (cerebral vascular accident) I63.9 - Stroke determined by clinical assessment N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia R29.810 - Facial weakness

Serious anaphylaxis started at 630 PM the day after the Moderna dose was administered . I ended up at the Medical Center ICU for two days before conditions abated and I could be discharged .

Developed severe pleuritic chest pain x 5 days, went to ER on 2/5/2021, D Dimer over 4000, CT chest showed bilateral segmental and sub segmental Pulmonary Emboli. Initial Ultrasound of legs was negative for DVT, follow-up U/S on 2/9/2021 was positive for large Femoral vein DVT. All family history, medical history and other risk factors for coagulation disorder was negative. I was initiated on anticoagulation therapy. (Enoxaparin)

bilateral pulmonary embolism; multiple areas of infarct; back pain; ateltheisis; chest pain; left leg pain; deep vein thrombosis; pulmonary effusions; fever; Chills; myalgia; A spontaneous report was received from a physician who was also a 55-year-old, previously healthy male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever/pyrexia, chills, myalgia, chest and back pains, bilateral pulmonary embolism/pulmonary embolism, multiple areas of infarct/pulmonary infarct, ateltheisis/atelectasis, left leg pain, and deep vein thrombosis. The patient's medical history included daily exercise and no personal or family history of clotting issues and no trauma. Products known to have been used by the patient were not provided. On 02 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 039k20-2a) intramuscularly for prophylaxis of COVID-19 infection. On 30 Jan 2021, approximately 28 days after the first dose, and prior to the onset of symptoms, the patient received the second of two planned doses of mRNA-1273 (Lot number: 012m20a) intramuscularly for the prophylaxis of COVID-19 infection. On 30 Jan 2021, the patient reports that for the first 18 hours, he experienced fever, chills and myalgia. On 01 Feb 2021, the patient reports that he thought the myalgia was continuing, as he had pain in his chest and back. The chest pains gradually worsened. On 05 Feb 20221, the patient went to the emergency room and was admitted. He was diagnosed with a pulmonary embolism. He was started on enoxaparin sodium but switched to apixaban. A computerized tomography study of the lungs showed that he had bilateral pulmonary embolism, multiple areas of infarct and atelectasis. His dimer was 4800. COVID-19 test was negative. An echocardiograph was performed, no results were reported. An ultrasound of the legs was performed and ruled out deep vein thrombosis. Date of discharge was not specified. On an unknown date two days after discharge, the patient experienced left leg pain and returned to the emergency department. Patient was diagnosed with deep vein thrombosis that ran the entire length of the femoral artery. Patient was switched back to enoxaparin sodium and taken off the apixaban. A repeat computerized tomography study was done to see if the pulmonary embolism was progressing and it was not, however, it showed pulmonary effusions. All current lab work was reported as normal, except for an increased prothrombin time. COVID-19 test was negative. Patient continues to be followed by a pulmonologist and hematologist. Consent to contact patient, pulmonologist and hematologist was obtained. Action taken with mRNA-1273 was not applicable. The outcome of the events, fever/pyrexia, chills, myalgia, chest and back pains, bilateral pulmonary embolism/pulmonary embolism, multiple areas of infarct/pulmonary infarct, ateltheisis/atelectasis, left leg pain, and deep vein thrombosis, was considered not resolved.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Mild case of pneumonia; Tested positive for COVID; Shortness of breath; A spontaneous was received from a healthcare facility staff member concerning 55 years of old, male patient who developed shortness of breath, mild case of pneumonia and tested positive for COVID. The patient's medical history included back issue. The patient had an epidural for bulging disk in back in an unknown date in December. Concomitant product use was not provided by the reporter. On 29-JAN-2021, eight days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) on left arm for prophylaxis of COVID-19 infection. On 20-JAN-2021, the patient had COVID symptoms including congestion and cough but tested negative on rapid testing. Since tested negative, the patient received first dose of Moderna COVID-19 vaccine as scheduled on 29-JAN-2021 at Hospital. On 06-FEB-2021 after experiencing shortness of breath, the patient was retested by rapid test, which was also negative. However, the patient tested positive for COVID on Polymerase Chain reaction test at Urgent Care. The patient had a mild case of pneumonia The reporter believes that the patient probably was positive before, as patient had been home since 19-DEC-2020 due to a back issue. Thinks that the patient's son may have been asymptomatic and all eight members in the household tested positive except the reporter. Treatment for the events included antibiotic azithromycin 5 days z-pack. The events shortness of breath, mild case of pneumonia and tested positive for COVID were considered recovered/resolved on an unknown date.; Reporter's Comments: Based on reporter's causality and high probability of corona infection from the close contacts where all eight members in the household were tested positive except the patient immediately before the vaccination, the event is assessed as unlikely related to mRNA-1273.

Nursing staff was informed that the patient was having a hard time walking and was not able to speak, just mumble. Presented with rapid eye movement, lip smacking, equal grips bilaterally although difficulty lifting arms. When asked about pain, pointed to R forehead. 136/99, 79, 20, 99.6. Appears uncomfortable and continuous mumbling. To local hospital via ambulance and admitted. Presumed CVA

1-2 hours after receiving Moderna vaccination patient began complaining of chest pain to family members but refused to seek medical attention. He was found deceased this morning (03/19/21) by his family. Medical Examiner determined time of death was around 8:40pm on 03/18/21.

Patient had Moderna covid vaccine #1 on 3/21/21. Patient presented to the emergency dept on 3/23/21 complaining of a discolored right arm (turning purplish) and swollen. Patient had a blood clot in Sept 2020 and was on anticoagulation until Jan 2021. Ultrasound of the RUE found an occlusive thrombus, R subclavian and right axillary vein as well as a nonocclusvie thrombus within the inferior R internal jugular. Patient was initiated on apixaban anticoagulation. Patient was seen back in the office and had a repeat ultrasound due to lack of improvement on 3/26, thrombus was unchanged. Patient continued on apixaban. Patient called the office on 3/29 with no improvement in his arm. Patient to be re-evaluated

Experienced a heart attack on the evening of March 23, 2021 quickly followed by cardiac arrest. Was resuscitated during transport to the hospital. The hospital discovered a coronary artery embolism with myocardial infarction. I was taking a blood thinner at the time so the blood clout should not have formed to begin with. No heart disease was found and once clout was removed by heart function returned. I had had my first COVID-19 shot the Thursday before the event so I thought I should report the event in case there's a connection.

After 1 hour I started Serious AFIB issues. I had not had serious AFIB since March 2020 That was the time I had surgery to correct it. The time of the shot and the AFIB is NOT a coincidence. I suffered through this attack until Wednesday March 24. On advice through Dr.'s nurse I went to the emergency room at the hospital. After 3 hours and IV's to reduce my heart rate I was okay to go home. This is still happening periodically since the ER visit where it was EXTREMELY rare before. I have decided NOT to get the 2nd dose as I am worried I will have to go to the ER again. Will one dose be enough to combat the virus? Please e-mail an answer if possible.

experienced blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (experienced blood clot) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. Concurrent medical conditions included Factor V Leiden mutation. Concomitant products included RIVAROXABAN (XARELTO) for Factor V Leiden mutation. On 16-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 THROMBOSIS (experienced blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (experienced blood clot) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was treated with blood thinner Xarelto (rivaroxaban) on a daily basis for factor V mutation and was treated with the same for blood clot.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded

within 1-2 days of vaccine, he developed confusion/dizziness/myalgia/weakness. He also had intractable headache which had been persistent for the past month. Patient underwent outpatient MRI 4/14 and was found to have new subacute right MCA ischemic infarction with hemorrhagic conversion. Patient continues to be apraxic with continued cognitive effects. He has recovered from the transient weakness and dizziness.

Heart attack; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion hospitalization). The patient was hospitalized on 30-Mar-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, Heart rate: 209 (High) beats per minute. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. No treatment information was provided.; Sender's Comments: Based on the current information available and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.

rcvd shot 3/25/2021, symptoms started 2 days after ... two days later swollen neck glands , higher bp than usual, numb face...Mar 30 th 6:am faceial numbness, thick tongue, anaphylaxis went to ER, could not breathe , trouble speaking...by the time got to er BP diastolic was about 200. discharged after 4 hrs. Multiple body symptoms since include all over numbness, balance, Balance issues, fatigue, loss of taste, Heat spikes, myoclonus and stare seizures, sense of Euphoria, infusion, many more symptoms, contact me

55 y/o male with PMHx of obesity, LLE cellulitis (hospitalized in 2018), and varicose veins seen in unit 4/19/21 due to LLE cellulitis not responding to bactrim DS. Patient reports remote history of bilateral cellulitis and hospitalized once for IV abx for 4 days in 2018. He denies DVT history. He was prescribed compression stockings, unsure of compression grade but he isn?t wearing them due to the ongoing pain. He was seen by nursing on 4/2/21 reported leg erythema and swelling starting that day. He was given Rocephin and had Bactrim ordered. The leg swelling/erythema/pain improved minimally with Bactrim DS but still had symptoms so he was seen today. He reports posterior calf tenderness. he denies fevers, chills, sweats, dyspnea, chest pain, SOB, palpitation, abdominal pain, N/V/D/C at this time. exam shows LLE with anterior erythema, tenderness, warmth, and (+) homan sign. 1-2+ BLE edema. He was COVID 19 positive on 11/10/20 and again on 3/15/21. Received moderna on 3/9/21 and 4/6/21. Labs sent to local hospital show D-Dimer >1000 and CBC with thrombocytopenia to 111K per lab with 3+clumping.

patient received second dose of Moderna vaccine on 4/10/2021, and he developed his first symptoms 7 days after. He ultimately came to hospital with sob, diagnosed wtih bilateral PTE. no clots noted in his legs bilaterally. He did well, was on Room Air throughout his stay, which was less than 24 hours and went home on Eliquis for Anti-coagulation.

5 days after first dose of Moderna Covid-19 vaccine, pt noticed his leg was swelling and told his doctor that his leg was swollen at a routine doctor visit that was scheduled ahead of time prior to vaccine. The doctor told the patient to go next door to vascular clinic. They did an ultrasound and found an acute DVT and chronic deep vein thrombosis. Pt was put on Eliquis the same day (4/12/21) to treat the issue. Mild swelling is still present in leg, but pt was cleared by Dr. to receive second dose which he did on 5/5/21.

Engorgement/Swelling of lower right extremity from hamstring to foot, significant discomfort in right calf weight bearing, flexion of right foot/ankle, and to touch (e.g., massage).

Thursday following vaccing chills, friday headache. saturday through monday well/fine. 5/12/21 woke up one sided weekness, pale, could not talk, wife, called 911. episode lasted 15-20 minutes per wife. went to ER, was diagnoses with TIA, suspecting vaccine but not confirmed at this time.

pt developed right upper leg DVT 2 days after receiving second covid vaccine, first administered on 4/7

Patient w/h/o afib, but was regular prior to the vaccine, showed up to the hospital approx. 1 mo after their 2nd moderna vaccine w/afib w/RVR and failed cardioversion.

Patient presented with on 5/12/21 with headache, nausea and vomiting, malaise, and decreased responsiveness. Headache and malaise had been present on/off since late April after patient had received the second dose of Moderna COVID-19 vaccine. Head CT in ED revealed venous sinus thrombosis. MR venogram with near complete occlusion of the superior sagittal sinus, right transverse and sigmoid sinuses, right internal jugular vein), possible mastoiditis on the right side. Started on heparin drip, unasyn, and transferred to neurosurgical ICU. 5/13/21 underwent mechanical thrombectomy; of the superior sagittal sinus, bilateral transverse and sigmoid sinuses and the right vein of Labbe - flow has been restored. Partial clots remained in right internal jugular vein. Heparin drip was changed to antiXa goal 0.3-0.7. HNS consult - no strong evidence of mastoiditis. 5/14/21 repeat MRI/MRV - thrombus within the right transverse sinus, sigmoid sinus and right jugular bulb, no thrombi in the dominant left transverse sinus or SSS - anticoagulation was changed from heparin to enoxaparin 1 mg/kg every 12 hours 5/15/21 patient was observed in the ICU 5/16/21 discharged home in stable condition

On 4-18-21, 17 days after 1st dose of Moderna, he developed upper abdomen pain, chest discomfort. He thought it was indigestion and treated it as such. When he got no relief he went to Emergency room where a cardiac alert was initiated. After he died I was told he had developed myocarditis,/pericarditis and they had to remove a liter of blood from the sac around his heart, but that his heart had gone into cardiogenic shock and that he died. They were prepared to insert a stint thinking he had a blocked coronary artery, but his arteries were clear and they had no idea what had caused this to happen. When he died so soon after the vaccine there were people who wanted to blame the vaccine but I checked into it and there were NO links between the vaccine and myocarditis, pericarditis or cardiogenic shock. Within a few weeks of his death, there began to be possible links between the vaccine and myocarditis. I know 55 is older than what is being looked at, but he had absolutely no previous cardiac history prior to this and this case should e looked at as well

Approximately 9 days after the vaccination, tender left axillary lymphadenopathy, malaise, chills, and high fever (to 104F) developed; followed several days later by development of marked erythema and warmth over the left chest wall, left axillary region, and onto left back. This presentation required brief hospitalization for treatment of a presumed cellulitis and further diagnostic workup of fevers and lymphadenopathy. The patient was treated with antibiotics for cellulitis and empirically for possible tick-borne illness (early Lyme, glandular tularemia) with notable improvement in the skin erythema and fevers.

This is a 55 yo male who contacted his care team on 4/28/21 to report that following his covid vaccine (Moderna dose #2 on 4/24/21), he developed Afib (symptoms = palpitations). Patient does have a history of Afib, diagnosed in 2011, last seen by cardiology in 2017. Patient reports that he will have Afib episodes every few months, they last 6-10 hours (with palpitations), then he self-converts back. In this current episode, it has been persistent. He was advised to report to ED and f/u with his cardiologist. No notes regarding an ED visit. Cardiology visit took place on 5/5/21. BP=134/90, HR=147, Ht=77in, wt=162.8kg; Labs wnl except chol=224, Trig=180, LDL=142. EKG=Afib with RVR, rate 125bpm. Patient was initiated on anticoagulation (apixaban) and completed a cardioversion and TEE on 5/13/21. Patient was managed on diliazem and flecainide. On 5/18, patient called to report he was back in Afib, however he self converted within 24hr. Although patient has a history of Afib and the vaccine is not a clear cause, I will report to VAERS as a potentially clinically significant event.

CT of the chest revealed significant bilateral PE with possible heart strain. Was given TPA. Monitoring after receiving after TPA and improved

Pt received his 2nd vaccine on 4/10/21. he reported that after that he began to experience intermittent palpitations which came and went before they persisted with associated near syncope prompting him to come to the emergency room on 6/1/21 where he was diagnosed and admitted with new onset rapid atrial fibrillation. He has no history of sleep apnea, does not drink alcohol, his tsh was normal, troponins were normal, cardiac crp was normal, d dimer was neg and PE was ruled out. he was started on metoprolol and eliquis and broke to sinus rhythm. echo was normal with no atrial enlargement and normal ejection fraction, no valvular disease, chest x ray normal, cmp and cbc normal. He was discharged home on 6/2/21. He will need follow up with cardiology.

Acute stroke CT and MRI. MRI showed acute infarction in left cerebellar and occipital lobe started on aspirin 81 mg and crestor 40 mg for management.

I had a sharp pain in my back and pressure in my chest. The ER doctor said that I had a small case of pneumonia. I'm not sure if it had anything to do with the vaccine.

Patient called and stated he felt heart fluttering that was diagnosed as a fib that progressed to acute congestive heart failure.

difficulty breathing during a regular exercise time and eventually even walking at all due to severe water retention, after visiting my doctor and having an exam as well as an ekg he determined that i was in afib/congestive heart failure. i was sent to a heart doctor who performed a cardio version which did not convert my heart, later i was hospitalized for the afib and water retention and another cardio version was performed and again it was not successful for more than a day. i am currently scheduled for a cardio ablation on 7-9-21.

Starting 03/01/2021, I had a massive headache that lasted 7 or 8 weeks. On 05/20/2021 a MRI was done a discovered I had a blood clot in the brain. I'm now on blood thinners, I have to do repeat scan of my brain, frequent doctor visits to monitor clot.

Received 2nd Moderna COVID-19 dose on 5/8. Experienced sore calf and sore groin around 6/17. Woke up morning of 6/21 with lower left leg pain and ended up passing out twice in 20 minutes (15 minutes unaccounted for). Experienced extreme sweating and shortness of breath. Called 9-1-1 and was treated by paramedics, then taken to ER.

Acute saddle pulmonary embolism. S/p pulmonary embolectomy. Spent 3 days in ICU + 2 days recovering at the Hospital

I experienced heart fluttering. I have an app that can check for A-fib. It registered for A-fib. The number one thing that was related to this was low heart rate. Since I've been taken off nabibolol 2.5mg, I haven't had this experience in three days. While I was taking nabibolol 2.5mg, I was having this experience regularly. When I was 45, I learned that I had coronary artery disease and I had 2 stints put in. I have not experienced any other heart issues since then, until now.

Feels like onset of pneumonia; Congested; Coughing; Chest is heavy; Increased BP 161/97; A spontaneous report was received from a consumer who was a 56-year-old, male patient who received Moderna's COVID-19 Vaccine, and who experienced feels like onset of pneumonia, congested, coughing, chest is heavy and increased BP 161/97. The patient's medical history included post-traumatic stress disorder, depression and asthma. Concomitant product use was not provided by the reporter. On 07-Jan-2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. On 07-Jan-2021 the patient received the Moderna vaccine. On an unknown date, he reported that he felt as if pneumonia was setting in. He stated that he was congested, coughing and had chest heaviness. Additionally, he stated that his blood pressure was elevated to 161/97. Treatment information was not provided. Action taken with mRNA-1273 in response to the events, feels like onset of pneumonia, congested, coughing, chest is heavy and increased BP 161/97, was not provided. The outcome of the events, feels like onset of pneumonia, congested, coughing, chest is heavy and increased BP 161/97, was unknown.; Reporter's Comments: This spontaneous report refers to a case of a 56-year-old female patient with medical history of post-traumatic stress disorder, depression and asthma, who experienced events of feels like onset of pneumonia, congested, coughing, heavy chest and increased BP 161/97 after the administration of the first and only dose of mRNA-127 (Lot number unknown, Exp date-unknown). Based on temporal the information provided and the absence of any other etiology factors a causal association between the events and vaccine administration cannot be excluded. However, the patient has history of asthma and post-traumatic stress disorder which are confounding factors.

Died of a heart attack; A spontaneous report was received from a consumer concerning a 56-year-old male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and died due to a heart attack. 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 additional medications. On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. - On an unknown date, the reporter stated the patient received Moderna's COVID-19 vaccine and sometime after he was found dead by his bedside around 02:30 am. The patient died on an unknown date. The cause of death was due to a heart attack. Plans for autopsy were not provided.; Reporter's Comments: This case concerns a 56 year old, male patient, who experienced fatal unexpected event of myocardial infarction. The event occurred on an unspecified date after mRNA-1273 (Lot# Unknown). Treatment details not provided. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death

1/26/2021: Fatigue, Soreness & headache; Severe chills (0120 a.m.); Body aches, joint pain, nausea/vomiting, pale/cool/diaphoretic skin, chest tightness and lightheaded/Dizziness. Bed rest for remainder of day. 1/27/2021: Continued fatigue, soreness, more lightheaded/dizziness, onset of sustained Ventricular Tachycardia around 1400 hours,Tx at work with Advanced Cardiac Life Support, Emergency Transport to Emergency Room, Amiodarone Drip/Oxygen/IV-TKO,EKG. Emergency Room-Continue Cardiac Care with continued IV drip and Amiodarone. Echo-Cardiogram and admit to Hospital. 1/28/2021: Cont. Hospitalization-Cardiac Cath,monitoring on ICC floor. Hospitalization stay 1/27/2021-02/03/2021. Transfer to another hosp by ambulance. Transferred to Hospital (1/30/21). Further treatment and monitoring. Cardiology tests and procedures (Cardiac MRI, Electro-Physiological Study and defibrillator insertion). Discharged on 2/3/2021. Still under doctor's care during recovery for next 5 weeks and ongoing into the future.

"Moderna COVID-19 Vaccine EUA" Hypersensitivity & fleeting / flowing pains spread throughout left side of body from tip of nose across face, up and down neck and left side of head out through fingers of left hand, down left side of back, down left thigh / leg and out through toes of left foot. It was as if the left side of my body was in a different time zone than the right side. I called the nurse line; they suggested a visit to the ER. My BP was way up, and I panicked just a little; but, tried to use my mindfulness practice to observe the unfolding events, rather than being consumed by them. There was a CT of my skull wherein they found indications of "an old" stroke; so, they decided that it was possible I had a stroke. I was transferred from the Medical Center to the Stroke Center at the Medical Center under the care of Dr. Another CT with contrast and a MRI confirmed "OLD" stroke, but nothing new. I was assured the vaccine had nothing to do do with my symptoms, and that I most likely experienced a Trans Ischemic Attack (TIA), and that the situation was merely a coincidence as they believe the vaccine had nothing to do with the TIA. However, based on my personal experience of the events as they unfolded, it is my sincere belief that the vaccine was incidental to the effects as I experienced them. I was kept overnight for further observation, released the next day, and had a follow-up with my primary care physician at the Med Center. I am now taking an 81 mg aspirin, Plavix, and 80 MG Clopidogrel as a precaution, and my symptoms have been gradually fading away.

Found lying face down without respiration or pulse, believed to be within 5 minutes of event. ACLS procedures unsuccessful. Unable to get autopsy. Believed to be heart attack secondary to COVID infection, but unconfirmed. Relative contribution of recent vaccination unknown.

Anaphylactic reaction; A spontaneous report was received from a physician concerning a 56-year-old, male patient, who received their first of two planned doses of mRNA-1273, and who developed anaphylactic reaction. The patient's medical history included blindness and severe allergies to shellfish. Products known to have been used by the patient, within two weeks prior to the event, included Losartan and Melatonin. On 28 JAN 2021, approximately 15 minutes prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Patient's wife called to indicate that her husband had an anaphylactic reaction to the mRNA-1273 vaccine. Patient received the vaccine on 28 JAN 2021 in his left arm. Patient's wife indicated that her husband texted her at 3.21 pm to let her know that he has gotten the shot, indicating that he must have received it around 3.19 pm. Patient's wife indicated that around 3.34 pm, patient said he'd had an anaphylactic reaction, that he had administered a shot of epinephrine and that an ambulance was on its way. The patient's wife noted that the reaction happened within 15 minutes or so. Once in the hospital, the patient was administered Pepcid and Steroid orally. Additional treatment medication for the event included the previously epinephrine and a shot of Benadryl. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the event was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. Patient's significant medical history included severe allergies to shellfish.

According to NJIIS registry, patient received Moderna dose 1 at "Rite Aid 00994" on 3/3/2021. Patient arrived in ED on 3/4/21 at approx 9AM via ambulance. ED physician note: "56-year-old male brought in by EMS intubated with CPR in progress. It was reported that he arrived to work and then passed out. CPR was initiated almost immediately. BLS determined that he was pulseless and AED was applied. He was defibrillated twice. He was then intubated by ALS and administered epinephrine twice with return of spontaneous circulation. He maintained a pulse for approximately 20 minutes when he again developed cardiac arrest. ACLS guidelines were again initiated and there was no return of pulse for approximately 20-25 minutes until he arrived in the emergency department. Emergency department CPR was continued and he was administered an additional epinephrine with return of a pulse. Is reported that he had no complaints prior to the event." Patient was intubated and ventilated, started on norepinephrine drip in ED. Twelve-lead EKG demonstrated right bundle branch block with left posterior fascicular block and diffuse QRS widening and diffuse repolarization abnormalities. Family consented to Cath Lab. Per Interventional Cardiologist note: "1. Angiography demonstrated proximal to mid LAD hazy 90-95% lesion likely culprit for cardiac arrest. 1 stent placed. 2. Diffuse distal right coronary disease that is likely nonculprit for cardiac arrest. 3. Left ventriculography demonstrated severe anterior wall hypokinesis with overall left ventricular ejection fraction of 40%. 4. Patient electrically and hemodynamically stable. Levophed has been stopped. Amiodarone bolus given in the Cath Lab for frequent ventricular ectopy. No drip was continued due to resolution of ectopy. 5. Dyslipidemia he will be on high-dose statin therapy. 6. Diabetic management as per primary team. 7. Quad-Lumen placed by me. Hypothermia protocol to be initiated in the ICU given GCS score less than 8 with no purposeful movements. Head CT scan completed before cardiac catheterization that demonstrated diffuse cerebral edema. 8. Prognosis guarded and likely poor. The next 24 to 40 hours will be critical. Family was updated in detail." Patient transferred to ICU post Cath Lab. Remains intubated, ventilated in ICU.

Pronounced dead on 3/9/21 approximately 72 hours after receiving vaccination. Unknown symptoms prior.

Patient states that he woke up the next day extremely fatigued. About 3pm, he could not move his arm/right hand and had trouble walking. He called his doctor's office who told him to call 911. At the hospital, he was given emergency medication for a blood clot. He states the ER told him his stoke was from the covid vaccine.

Leg pain Shortness of breath , rapid heart rate , Dizziness , Nights sweat Symptoms started March 24 .Went to Urgent care April 2, they referred me to the ER . I went to the Hospital ER April 6 , They admitted me at noon after finding Blood Clot down my right Leg and Chest . 2 shots of Lovinox for 3 to for days

Followed up with our clinic on 4/1/2021 after hospital admission for sepsis, pancreatitis, and cholycystitis. Admitted to medical center on March 23rd, discharged home March 27th. Was seen at a smaller facility close to home, Medical Center, prior to adimission to . Pt states he was admitted to the ICU. We have not yet received copies of his medical records from admissions for additional information on presenting symptoms or labs. No previous hx of pancreatitis or cholycystitis. Pt was ambulatory and without acute complaints of abd pain, chest pain, or dyspnea at the time of his office follow-up. Reported to our providers that he was advised to have surgical follow-up for cholycystectomy within 1-2 weeks. No surgery while admitted.

Sent patient to the hospital for further evaluation. 911 called. Noted to be sent out for right-sided weakness and re-admitted with a noted diagnosis of stroke.. noted history of HTN

Presented to the ER on 3/19 at 23:57 with 2 days of worsening shortness of breath. HR 60, Pulse Ox: 85% on Room air. Placed on BiPAP. could not maintain oxygen, intubated. The patient rapidly decompensated and went into cardiac arrest with PEA. ACLS performed for 35 minutes without the ability to reverse. Patient expired at 0222 on 3/20/21.

56 year old gentleman with only medical history being COVID-19 infection in October. Admitted on 4/13/2021 for a cerebral vascular accident due to thrombosis of right posterior cerebral artery hemorrhagic conversion (I63.331). Has left-sided weakness. Patient also tested positive by PCR (Panther Aptima) on 4/14/2021.

2nd dose Moderna administered on Feb 3rd, fatigue/ shortness of breath week of Feb 23rd, admitted to Hospital on March 1st, spent 18 days in ICU, developed Blood CLOTS which one attached to lung, blood clots In left leg as well, no family history of blood clots and no injuries to cause blood clots.

Previously diagnosed with Covid PNA in 11/2020 that was treated with course of Remdesivir and steroids, has 2 negative covid tests in the interim. He received his first Moderna COVID vaccine on 1/4/2021, but did not get the second dose. He had recently been hospitalized at a healthcare provider for COPD/CHF exacerbation was discharged 4/13/2021, returned this morning with URI symptoms, found to by hypoxic with O2 sats in the 80s, encephalopathic, and Covid test was subsequently positive (4/15/2021). Pt transferred that evening to our hospital for ICU level care.

No information really known. Office was notified yesterday by county coroner that patient was found deceased in his home on 4/9/19. Coroner was requesting patient records. Unknown if death related to the Moderna Covie-19 vaccine but reporting this as death occurred 3 days after the vaccine and coroner gave office no information. You can contact the coroner involved with this case.

Blood clot in lower leg. After ultrasound, Doctor gave treatment protocol. Still undergoing treatment course.

Information received by wife. Patient was fatigued 4/10/21 after vaccination. His wife stated that she talked with him and he seemed fine. When his wife went to bed early that evening, the patient was sitting in the recliner in the living room. On the morning of 4/11/21, patient's wife found him unresponsive in the recliner. She called an ambulance but patient was deceased. Patient's wife stated that she noted a trashcan next to the chair the patient was sitting in. The trashcan did not have emesis in it but patient's wife assumes he had been nauseated that evening before he passed away.

Patient care coordinator on PCP team learned of patient death, as documented: TC to pt family for a welfare ck d/t co-worker mentioned saw in social media pt had passed? PCC-spoke with pt daughter states father passed on 4/18/2021 in the PM unknown exact time of death at home. PCC gave family condolences for their loss. Patient reports father got covid-19 vaccine on 4/13/2021 and he started having severe HA's on this day. Sx increased for the next few days, he had dry cough,sore throat,chest pain,SOB. States father declined for family to called an ambulance while sx were increasing. States ambulance was called on Sunday 4/18/2021 to take body to the morgue. States they are awaiting for autopsy results,and death certificate. States father's body will be taken to his family. On what date did they pass away? 418/2021 unknown time, at home Do you know what the cause was? Family is not sure of cause of death

Pneumonia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in a 56-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). Concomitant products included AMLODIPINE, LEVOTHYROXINE, IRBESARTAN and LANSOPRAZOLE for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion hospitalization). At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, X-ray: pneumonia pneumonia. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient went to hospital on an unspecified date and x-ray exam showed that he had pneumonia. The patient was prescribed with antibiotics and cough medicine. The patient was to check if doxycycline and promethazine medicine will effect on his second dose schedules on 21-APR-2012. The reporter did not provide an assessment for the event , pneumonia. Company Comment: 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.

Patient started complaining of being short of breath, weak and dizzy a day or two after receiving the shot. He started taking the asthma inhaler constantly rather than just once in months. He lay down for a nap and never woke up exactly 3 weeks after getting the shot. (more exact details will need to come from his wife).

Family friend of the wife, called our pharmacy on 04/28/2021 and reported that wife's appointment would need to be canceled for 04/29/2021 because her spouse passed away the previous night. This prompted our staff to look further and it was noted that her spouse, received his first Moderna vaccine on 4/26/2021 at our pharmacy. Friend was not reporting his death due to the belief that the injection was the cause. Only to report, so upcoming appointment for his wife could be canceled. It was reported to our Medical staff that Patient n has Chronic COPD and had difficulty breathing on the evening of 4/27/2021 and was taken to the hospital where he later passed away. Patient was on portable oxygen and resembled shortness of breath while ambulating at the time of his vaccination appointment on 4/26/2021. Patient immediately recovered from Shortness of Breath once seated in exam room for injection for a few minutes.

Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COPD. Concurrent medical conditions included Immunocompromised. Concomitant products included OXYGEN for an unknown indication. On 12-Apr-2021 at 12:45 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 12-Apr-2021 The patient died on 12-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. No treatment information were reported.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death

Patient was given the Moderna covid 19 vaccine on the morning of Saturday May 1. His wife came in to the pharmacy today (5/5/21) and explained his adverse reaction which started Sunday evening. His symptoms included high temp (102.8), confusion, blue lips, bad headache, decrease in blood pressure He was taken by his wife to local hospital then transferred to another facility. His wife said he had sepsis. He was treated and released from hospital. She said he still had a headache.

Pt was walking up a gentle hill, felt chest pain radiating to both shoulders, pt was driven to ER and diagnosed with a massive bilateral saddle pulmonary emboli with right heart strain. No prior history of lower extremity DVT. Inpatient admission. Pt was discharged on 3/22/21 and follow up with PCP and ONC for blood thinner medications.

Pt developed R calf and knee pain about 24 hours after his first dose of the Moderna Covid vaccine. We saw him first on 5/4/21 and he had a R LE doppler which showed a deep vein thrombosis in his Right posterior tibial vein.

Pt presented with tongue and throat swelling associated with scattered hives. Pt was treated for anaphylaxis and responded to IM epinephrine x1. He was observed in the emergency department and then discharged safely.

sometime between 4:30 and 5:00 PM (1-1.5 hours after the vaccination) Patient felt bad and went to take his BP with a monitor. He passed out before he took it and woke up face down in carpet with a bloody nose and had urinated on himself. He called his daughter for help. Upon her arrival, he passed out several times, complained of severe headaches, had severe vomiting, has trouble breathing, pain shot up up his neck and face, his BP reading was around 83/60 with a heart beat of 45. The Ambulance service arrived an confirmed he was having an active stemi heart attack. He was taken to hospital where the heart attack was confirmed again and he was taken immediately to the Cath Lab to have a stent placed. He was placed in ICU

Patient came to vaccine site on 4/23/21 to get second COVID Moderna vaccine. He reported a stroke a day after his previous 1st dose Moderna on 3/24/21. He was hospitalized with stroke and seizures. He has a history of uncontrolled diabetes, high cholesterol, and triglycerides. He smokes and has a history of cirrhosis. Dr. spoke with the pt and approved the second dose administration. No reactions documented following the vaccine.

diagnosed with bilateral Pulmonary Emboli on 5/11 (8 days later). Patient had immediate fatigue, myalgias and shortness of breath on exertion the day following his vaccination until the diagnosis of PE.

Patient received first dose Moderna vaccine on 3/31/2021. Approximately two weeks after receiving the first Moderna vaccine patient states he started to have pain in the lower leg which was not normal. Pain increased to a point that patient seeked care and was evaluated for a blood clot which he was told was "negative" as no clot was initially found. On 4/28/2021 Patient presented to pharmacy to receive second dose. Pharmacist asked how patient tolerated first dose to which he replied he had no issues, so the second dose was administered. AFTER the second dose, patient did state he was seen by a CNP for leg pain but a clot was ruled out. Approximately 3 weeks after the second dose of Moderna vaccine the patients leg pain increased to a point that he presented to the local ER and it was determined at that visit that he did indeed have a large blood clot in the leg and a second smaller clot in the upper thigh. He was sent home on Eliquis. He subsequently presented to another ER approximately one week later for uncontrolled leg pain due to massive size of blood clot in leg. At this point, patient is at home recovering.

patient had 2nd dose moderna vaccine and 2 days later developed dizziness followed by numbness left upper extremity and then fine motor difficulty left hand.

Patient received first dose of Moderna on 4/15/2021. Patient tested positive on 4/19/2021 for Covid. Patient admitted to hospital on 4/25/2021. Patient expired 5/14/2021

Admitted to Tri-Valley Medical/Stanford in Pleasanton, CA for shortness of breath and chest pain, on June 1st. Diagonosed with Pulmonary Embolism in Right Lung. Admitted to Tri-Valley Medical/Stanford in Pleasanton, CA on June 14th for shortness of breath and chest pain, later diagnosed with a Heart Block

Can't even walk; Couldn't catch his breath; fatigue; Acute hypoxy respiratory failure; Pleuritic chest pain; Red ithcy eyes; HS pneumonitis; Decreased level of conciousness; ILD; non necrotizing granuloma; Flushing; Pulse ox reading in the 70's; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY FAILURE (Acute hypoxy respiratory failure), CHEST PAIN (Pleuritic chest pain), OCULAR HYPERAEMIA (Red ithcy eyes), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness), INTERSTITIAL LUNG DISEASE (ILD), PULMONARY GRANULOMA (non necrotizing granuloma), FLUSHING (Flushing), OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's), GAIT INABILITY (Can't even walk), DYSPNOEA (Couldn't catch his breath) and FATIGUE (fatigue) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination. No adverse event reported. The patient's past medical history included Type 2 diabetes mellitus. Previously administered products included for an unreported indication: Accupril in 1996 and Accupril. Past adverse reactions to the above products included Ankle swelling with Accupril; and Knee swelling with Accupril. Concomitant products included HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) for Blood pressure, METFORMIN, SERTRALINE, CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), IBUPROFEN, TADALAFIL (CIALIS), INSULIN LISPRO, CALCIUM, COLECALCIFEROL (CALCIUM VITAMIN D) and INSULIN GLARGINE (BASAGLAR KWIKPEN) for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, the patient experienced OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's) (seriousness criterion medically significant), GAIT INABILITY (Can't even walk) (seriousness criterion hospitalization), DYSPNOEA (Couldn't catch his breath) (seriousness criterion hospitalization) and FATIGUE (fatigue) (seriousness criterion hospitalization). On an unknown date, the patient experienced RESPIRATORY FAILURE (Acute hypoxy respiratory failure) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Pleuritic chest pain) (seriousness criterion hospitalization), OCULAR HYPERAEMIA (Red ithcy eyes) (seriousness criterion hospitalization), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis) (seriousness criteria hospitalization and medically significant), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness) (seriousness criteria hospitalization and medically significant), INTERSTITIAL LUNG DISEASE (ILD) (seriousness criteria hospitalization and medically significant), PULMONARY GRANULOMA (non necrotizing granuloma) (seriousness criterion hospitalization) and FLUSHING (Flushing) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 02-Apr-2021 due to CHEST PAIN, DEPRESSED LEVEL OF CONSCIOUSNESS, FLUSHING, HYPERSENSITIVITY PNEUMONITIS, INTERSTITIAL LUNG DISEASE, OCULAR HYPERAEMIA, PULMONARY GRANULOMA and RESPIRATORY FAILURE. At the time of the report, RESPIRATORY FAILURE (Acute hypoxy respiratory failure), CHEST PAIN (Pleuritic chest pain), OCULAR HYPERAEMIA (Red ithcy eyes), HYPERSENSITIVITY PNEUMONITIS (HS pneumonitis), DEPRESSED LEVEL OF CONSCIOUSNESS (Decreased level of conciousness), INTERSTITIAL LUNG DISEASE (ILD), PULMONARY GRANULOMA (non necrotizing granuloma), FLUSHING (Flushing), OXYGEN SATURATION DECREASED (Pulse ox reading in the 70's), GAIT INABILITY (Can't even walk), DYSPNOEA (Couldn't catch his breath) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glycosylated haemoglobin: 7.6. 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 While hospitalized, the consumer was started on 100mg Prednisone, now at 60mg of Prednisone, calcium, vitamin D, insulin lispro, protonix, bactrim, and is currently on oxygen. Concomitant medications Glucometer, Insullin pen and Lansets. Company Comment: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities. Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: Follow-up received on 09/6/21: New event added: Acute hypoxy respiratory failure, Pleuritic chest pain, Red ithcy eyes, HS pneumonitis, Decreased level of consciousness, ILD, non necrotizing granuloma and Flushing.; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Causality is also confounded by the patient's comorbidities.

Chest Pain - Heart Attack like, Dizziness, Nausea, Fainting, and eventually AFIB. First emergency room visit was via ambulance on May 3, 2021 approximately 3 weeks after firs vaccination. 1st vaccination date was May 14 at 9:30AM. Was transported by ambulance as heart attach symptoms were severe. Monitored by EKG and in emergency room cardiac unit for the day. Ran two blood tests and troponin levels were acceptable so released at approximately 6:00 PM. Second event was two days after receiving second vaccination. Vaccination occurred on May 19 at 9:00 AM and was again transported to the hospital with Heart attack symptoms at 10:00 AM on Friday May 21. Monitored by EKG and in emergency room cardiac unit for the day. Ran two blood tests and troponin levels were acceptable. Prescribed a Heart Monitor for 14 days and released at approximately 5:00 PM. Third occurrence was Monday May 31. Heart attack symptoms chest pain, accelerated heart rate. Went into AFIB. Transported to Hospital. (Morton Plant). Verified AFIB reading by heart monitor. Admitted to the hospital for two days. EKG monitors, Blood tests. Released Tuesday at 4:00 PM. Prescribed Multaq by on call Cardiologist to prevent AFIB. Met with Cardiologist Monday June 7th. Diagnosed as Pericarditis or myocarditis. Prescribed Mutlaq for the AFIB, Indomethacin for anti inflammatory and Low dose aspirin for stroke and blood thinner. Recover expected to be Long.

Patient received Moderna #1 on 4/20/21 and Moderna #2 on 6/15/21. Our office was notified on 6/19/21 that this patient was found deceased and appeared to have passed away several days prior due to level of decomposition. The cause of death is unknown at this time and is being evaluated by Medical Examiner due to recent Covid vaccination and recent drug overdose on 6/2/21. No foul play suspected.

lost short term memory temporally; sight was affected; Mild stroke/that affected the area of the brain (mentioned occipital lobe) that processes images and memory; teeth were chattering/chills; fever; headache; a numbness in the jaw and his hand; lips tingling; left arm was weak; arm were tingling and left arm was tingling; face was red; felt like crap; This spontaneous case was reported by a patient and describes the occurrence of CEREBROVASCULAR ACCIDENT (Mild stroke/that affected the area of the brain (mentioned occipital lobe) that processes images and memory) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History details provided. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced HYPOAESTHESIA (a numbness in the jaw and his hand), PARAESTHESIA ORAL (lips tingling), MUSCULAR WEAKNESS (left arm was weak), PARAESTHESIA (arm were tingling and left arm was tingling), ERYTHEMA (face was red), FEELING ABNORMAL (felt like crap), PYREXIA (fever) and HEADACHE (headache). On 18-Apr-2021, the patient experienced CHILLS (teeth were chattering/chills). On 08-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Mild stroke/that affected the area of the brain (mentioned occipital lobe) that processes images and memory) (seriousness criteria medically significant and life threatening). On an unknown date, the patient experienced AMNESIA (lost short term memory temporally) and VISUAL IMPAIRMENT (sight was affected). The patient was treated with ATORVASTATIN CALCIUM (LIPITOR) at an unspecified dose and frequency and CLOPIDOGREL BISULFATE (PLAVIX) at an unspecified dose and frequency. On 17-Apr-2021, HYPOAESTHESIA (a numbness in the jaw and his hand), PARAESTHESIA ORAL (lips tingling), MUSCULAR WEAKNESS (left arm was weak) and PARAESTHESIA (arm were tingling and left arm was tingling) had resolved. On 18-Apr-2021, ERYTHEMA (face was red), FEELING ABNORMAL (felt like crap), PYREXIA (fever) and HEADACHE (headache) had resolved. On 20-Apr-2021, CHILLS (teeth were chattering/chills) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Mild stroke/that affected the area of the brain (mentioned occipital lobe) that processes images and memory) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging: stroke (abnormal) stroke. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No Concomitant medications were provided by the reporter. Patient taking unknown medications for anxiety. Patient was admitted to a clinic one afternoon on an unknown date ,had a cat scan and was overnight in observation. The next day he was discharged. Following week he had MRI, Battery of tests to his heart: to his carotid arteries are being done,"bubble test", he is wearing a 30-day monitor; they will also be performing a sleep apnea test. 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.

5/15/21 - 2nd Moderna shot given to me. No reaction 1st 15 minutes. 5/15/21 - small fever in the evening 5/16/21 In bed all day with Fever and Fatigue. 5/20/21 Becoming short of breathe going upstairs in my residence. Complained to my wife after a couple of days saying I was getting winded just climbing the stairs. I thought maybe it was common chest cold. 5/29/21 1:00 am - woke up to 102 degree fever. Fever went down to 99 and up to 100.8 over the next 4 days cycling throughout the day and night. Shortness of breath was getting a little worse and it would take 10 seconds to recover going up the stairs in my home, after several deep breathes. June 1st, I went to CVC pharmacy to take a COVID19 test. The scheduled me for the next morning, June 2, 2021 at 10:00 am. I completed that test and returned home. At about 2:00 - 2:30 pm, I stood up from the couch and walked out to my front porch. I bent over to pick up some light items from the porch so the gardener could trim the bushes near the porch. As I walked to the garage (main front 2 car entrance), I suddenly became very short of breathe, my heart began racing, and I could not get a full breathe. I walked slowly inside my house and used my blood pressure cuff and oximeter. Blood pressure was at 170/121 heart rate 112, and the oximeter showed oxygen level 75 %SPo2 with heart rate 110. I was taken directly to the Emergency Room where X-ray and CT scans showed I had numerous blood clots throughout my lung arteries. I am on oxygen and blood thinners for an indefinite amount of time.

I had a Lifeline screening ( they did an EKG and a Carotid and Blood tests on me) after the vaccine- I got a odd reading on a c-reactive protein - inflammation and infection in the body - Can get those records from them. Started taking my blood pressure and I noticed thing weren't right with my heart. I went to my doctor his office clinic they are moving their office, though next month) with a federally funded program for the testosterone replacement therapy- he had give me testosterone replacement therapy which I have since stopped with recommendation by the cardiologist - it makes my blood very thick ) and he told me I had A-Fib - gave me samples of Xarelto and he said to come back on Monday and confirmed the A-Fib. doctor cardiologist and he confirmed A-Fib and recommended a procedure - to reset the heart with the paddles - I haven't done that yet. Since then, I have had chronic fatigue, heart palpitations, difficulty breathing; I think it's related to my heart. I am taking naps every day. I wake up and I'm just wasted. I go run errands and then I'm exhausted. Chronic fatigue. I will be seeing my brand new primary care doctor on Thursday and I want to talk to Doctor provided me with a whole bunch of diagnoses for all of it. They are saying on the diagnoses paperwork that I could have "blood cancer." But it could come from TRT treatment. Dental at first and then went to Affordable Dental - Periodontal work done - there was an infection there and they gave me antibiotic mouthwash. I will be going back in three months. I have not recovered from A-Fib - have to get Cardio Version test and I have chronic fatigue - it comes and goes. The blood cancer - I haven't had a chance to talk to anyone about it yet and no one has been in touch with me about it. I went to Hospital ER the other day - mostly to get a more accurate diagnosis - I do have chemical disorder history in past. I had mental confusion - it was chemical - it was just like what I had in 2000. But hospital misdiagnosed it.

He presented to the emergency room at Hospital 4/16/21 with chest pain and shortness of breath. D-dimer was elevated. Bilateral pulmonary embolism diagnosed by CT 4/16/21

I received dose 1 on 3/19/21 at 10:30 AM. I went on with my day and evening and noted no issues. The next morning I woke with lower leg pain in my R leg. I thought it may be a pulled muscle as I work out at a gym 5 days a week. The pain persisted as did some swelling in my lower leg so I sought out a medical opinion thinking it may be a torn muscle. I was finally able to get in to see a DR. on 4/1/2021 at which time an ultrasound was ordered which showed multiple blood clots in my R leg (Ankle, Calf and behind the knee). I was immediately placed on XARELTO. I have never had any issues before with clotting. Dr. referred me to Oncologist. Dr. examined me and the ultrasound test results and agreed with the assessment. I have follow a up scheduled with both doctor's. I have been on XARELTO since. I did get the second COVID shot because both doctor's could not agree as to if I should or should not get it.

Death. Body was found and pronounced dead on 6/14/2021. It is assumed he died on 6/4/2021 as body was badly decomposed at time he was pronounced dead.

Developed left lower leg discomfort on day 5 post-vaccination with dose 1 of Moderna COVID-19 vaccine. Developed worsening pain, swelling and mild erythema of the left lower leg distal to the knee over the next 48 hours. Seen on 1/05/2021, and STAT venous duplex ultrasound ordered, which revealed a prominent deep vein thrombosis partially occlusive, partially nonocclusive extending from the left femoral vein distally. Started on anticoagulation with apixiban. No signs/symptoms of pulmonary embolus. No precipitating event that would raise risk of acute DVT (He does not have any open areas of his skin concerning for infection in the leg. No recent injury to the leg. No recent surgeries or period of immobility. No prior personal history of DVT, provoked or unprovoked. He does not smoke. He does drink alcohol in small amounts, to moderate amounts on occasion. No history of alcohol misuse or abuse.). He has chronic HIV infection, well controlled. He does have a family history of DVT (his mother had 1 provoked and 1 non-provoked DVT).

per recipient spouse - vaccine recipient became ill during the night of 1/21/21 or early morning of 1/22/21 and was deceased in the morning of 1/22/21.

Narrative: Patient evaluated for stroke. No bleeding. Maybe ischemia - Further testing results still pending at the time of this initial report

At 10:45 am on 02/11/2021 begin to have difficulty speaking. Reports the symptom as "losing his voice". He states that the symptom continued to get worse and at 11:15 am he could not speak and was experiencing shortness of breath and throat tightness. He was taken to the local emergency room by another staff member. Does report he has had a history of having a anaphylatic response but not to a vaccine. He does not have a epinephrine pen prescribed to him.

Anaphylaxis reaction manifesting as hives; most pronounced on both hands and both elbows. I have taken 50 mg of OTC diphenhydramine HCI, and 180 mg of fexofenadine hydrochloride which has lessened the severe itching

For two days after the second injection, which I received on Wednesday, February 3, I had fever and chills. I did not feel myself that Saturday or Sunday. Sunday evening, February 7, at 8:00pm, I had a Grand Mal seizure. I was transported to the emergency room by EMS, treated and released.

Developed Shortness of Breath about four days after being vaccinated. Went to the ER 2/21. Had bloody fluid removed from around his heart or lung 2/22//2021.

Moderna Covid-19 Vaccine EUA - 3/6/2021 Went to hospital at 4pm because I was coughing up blood and having a hard time breathing. Air lifted to another Hospital. admitted 19:00 hrs. Chest X-rays 2 sets, CT Scan, Ultrasound, Bloodwork and 2 Covid-19 test. I was told i had pnuemonia followin first chest x-ray on 03/06/2021. on 03/07/2021 after CT Scan and 2nd chest x-ray I was told I did not have pnuemonia or Bronchitus. I was dischrged on 03/08/2021. I have shortness of breath with little to no energy. I am not retired. I own a business and have not been sick until 03/06/2021

NO ADVERSE EVENT NOTICE RECEIVED ON DATE OF VACCINE. RECEIVED NOTICE FROM CORONOER THAT THIS PATIENT EXPIRED 2/28/2021. COLLECTED URINE, BLOOD, AND TOXICOLOGY SCREEN. NOT SENT TO HOSPITAL. SENT TO FUNERAL HOME

Death; A spontaneous report was received from a consumer concerning a 57 years old male patient who received mRNA-1273 for prophylaxis of COVID-19 infection and had died (death). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 2 Mar 2021, approximately three hours prior to the onset of the symptoms, the patient received hia second of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection. It was reported that the patient died three hours after receiving the 2nd dose in the ER. Treatment information was not provided. The cause of death was unknown. Plans for an autopsy were unknown. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the event of death was considered as fatal.; Reporter's Comments: This is a case of sudden concerning a 57 year old male who died three hours after receiving the second dose of the vaccine. Very limited information regarding this event has been provided at this time.; Reported Cause(s) of Death: unknown cause of Death

atrial Fibrillation with rapid ventricular response Narrative: Patient presented in Atrial fibrillation with rapid ventricular response within 24 hours of receiving second dose of MODERNA COVID-19 vaccine. Required inpatient hospitalization and IV anti-arrhythmic medications.

A stroke occurred approximately 3 hrs after receiving vaccine. He was flown by helicopter to Medical Center. He had dysphasia which did resolve by the time he was admitted into the ER. He has since had CHF and Afib and is now on anticoagulation and diuretics. He continues to have problems with CHF, SOB, weakness and is undergoing treatment as outpatient. He is now followed by Cardiology, Neurology.

Diagnosed with DVT; Leg got really swollen/swelling of the lower calf area; Sore arm; Sore arm; Pulled a muscle; A spontaneous report was received from a consumer concerning a 57-years-old male patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, DVT/ deep vein thrombosis, pulled a muscle/myalgia, swelling of the lower calf area(leg got really swollen)/peripheral swelling and calf pain(sore arm)/pain in extremity. The patient's medical history was not provided. No relevant concomitant medications were reported. On 12 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 09 FEB 2021, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 013M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, after receiving the vaccine the patient had sore arm. On an unspecified date in Jan 2021, the patient had experienced a pull in his muscle in his calf and lower calf area got swollen. On 09 Feb 2021, after receiving the second dose of vaccine he had experienced a sore arm. On 11 Mar 2021, his leg got really swollen and on 12 Mar 2021, he visited hospital where it got diagnosed as DVT in his right lower calf. Treatment for the events included blood thinner Apixaban. Patient is concerned about possibility of indirect relation of events to the vaccine. 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 event DVT, leg got really swollen, swelling of the lower calf area and calf pain were unknown at the time of this report. The event pulled a muscle is not resolved. The event sore arm which the patient experienced for both the doses got resolved on 13 Jan and 14 Jan 2021, respectively.; Reporter's Comments: Based on the information provided which includes a strong temporal association a causal association between the event of sore arm and the administration of mRNA-1273 cannot be excluded. The evens of DVT , pulled muscle and swelling of lower calf is assessed as unlikely related to mRNA-1273. Events were all attributed to muscle strain.

Had a stroke; A spontaneous report was received from a healthcare professional concerning a 57-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had a stroke. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10-Mar-2021, at 13:30, the patient received first of two planned doses of mRNA-1273 (batch: not provided) intramuscularly for prophylaxis of COVID-19 infection. On 10-Mar-2021, at 15:30, the patient had a stroke and was admitted. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event had a stroke was considered resolving.; 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.

blood clot in lower leg; achy; Pain in the back of leg that would not go away; body ache/ache; headache; A spontaneous report was received from a consumer concerning a patient age ,57 years old male patient who developed Blood clot in lower leg/Thrombosis, Body ache/Myalgia, Headache/Headache and pain in the back of the leg that would not go away/pain in extremity. The patient's medical history included Central Retinal vein occlusion (CRVO). Concomitant product use was not provided/unknown by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on unknown date. The patient received their second of two planned doses of mRNA-1273 (Batch number not provided) on 03 Feb 2021, intramuscularly in the (unknown injection site) for prophylaxis of COVID-19 infection. On the same day as receiving the vaccine 03 Feb 2021 patient reported as having pain in back of the leg that would not go away. Patient also had body aches, felt achy and had headache. Patient went to Emergency room on 03 Feb 2021 and was diagnosed a blood clot in lower leg. The event blood clot in lower leg was assessed as medically significant based on IME list. Treatment information was not provided/unknown. Patient is following up with a hematologist. The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable. The outcome of the event(s), Blood clot in lower leg/Thrombosis, Body ache/Myalgia, Headache/Headache and pain the 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 (pain, myalgia, and headache) a causal relationship cannot be excluded. A very limited information regarding these event (Thrombosis) has been provided at this time. Noting the history of central retinal vein occlusion may remain as a risk factor for thrombosis. Further information has been requested.

Chest pain onset day of vaccine, tested positive COVID-19 3/29/2021- 2 days after vaccine. Left heart cath placed 3/29/2021

procedure in which his heart was cut from top to bottom/pacemaker dependent; fast heart rate; afib; red dots on both of his arms; rash on both arms; dizzy; sick; very weak/no energy; hard time walking; cannot do the simplest of tasks; flutter; A spontaneous report was received from a Consumer concerning herself, a 57-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, fast heart rate, cardiac pacemaker dependent, atrial fibrillation, red dots on both of his arms, rash on both arms, dizziness, sick, Atrial flutter, very weak and no energy, hard time walking, and cannot do the simplest of tasks. The patient's medical history included atrial fibrillation and had a pacemaker placed about 8-9 months ago. Products known to have been used by the patient, within two weeks prior to the event were blood pressure medication, antiarrhythmics. On 01 Mar 2021, prior to the onset of events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: 030m20a) via unknown route for prophylaxis of COVID-19 infection. On 01 Mar 2021, after vaccination, the patient developed red dots on both of his arms. For next two days, the patient had rash on both arms, was dizzy, felt sick, developed fast heart rate; went to hospital twice for heart rate either 07 Mar 2021 or 13 Mar 2021.During first visit to hospital, fast rate was brought under control, while in the second visit, the patient had a procedure in which his heart was cut from top to bottom and was made pacemaker dependent. The atrial fibrillation could not be controlled for 26 hours and had a flutter which was not identified and could not be controlled. Flutter returned after stopping amlodipine and hence patient was restarted on amlodipine. The patient now feels very weak, has a hard time walking, has no energy, cannot do the simplest of tasks, still experiences fast heart rate and flutter every now and then. No Laboratory investigations were provided. The Treatment information included pacemaker, amlodipine. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, fast heart rate, cardiac pacemaker dependent, atrial fibrillation, red dots on both of his arms, rash on both arms, dizziness, sick, atrial flutter, very weak and no energy, hard time walking, cannot do the simplest of tasks were unknown.

Patient developed acute mental status change, gait instability, confusion, and seizure like activity several hours after vaccine administration. Presented to the ER the following day for evaluation and was found to have acute CVA with embolic phenomenon confirmed on MRI, radiologist felt possible demyelination

Developed fever and chills that evening through next day. April 16, 2021, I began having pain in my left leg with tightening and deep pain inside. Right leg experienced pain when touched. After first Moderna vaccine I experienced arm pain, fever and chills the evening of the vaccine March 16m 2021 and the next day. The third day was tired. The swelling of legs came a few days after it on about March 18, 2021.

Acute pulmonary embolism/two blood clots in lung; Chest pain; Pain over left arm; pain all over joints; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history was provided). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PAIN IN EXTREMITY (Pain over left arm), ARTHRALGIA (pain all over joints) and NAUSEA (Nausea). On 12-Apr-2021, the patient experienced CHEST PAIN (Chest pain). On 13-Apr-2021, the patient experienced PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Acute pulmonary embolism/two blood clots in lung), CHEST PAIN (Chest pain), PAIN IN EXTREMITY (Pain over left arm), ARTHRALGIA (pain all over joints) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Computerised tomogram: abnormal (abnormal) diagnosed acute pulmonary embolism.. Two blood clots in lung. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Description: The patient experienced pain over left arm, pain all over joints, nausea after vaccine administration. On 12 Apr2 021, the patient experienced chest pain and went to Emergency. Room where blood test and D-dimer was done. The treatment information included apixaban. Company Comment: 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.

Day following shot it felt flu like, days following shortness of breath, stopped to rest and catch breath. 04/04/21 after getting coffee in hotel I could not regain my breath, became pale, sweaty and chilled. Was taken to emergency room, given oxygen and CT was taken of lungs, CT showed numerous blood clots throughout lungs with two larger at the bridge between, one on either side. Was give oxygen to help breathing, given Heparin to stop clot growth and T__ (something) to dissolve clots. Morning 04/05 was taken off oxygen and that evening clot medication was removed. Discharged morning 04/06 and put on Eliquis and to be reevaluated in three months by PCP. Sometime in the spring of 2020 I was asymptomatic for COVID, it was not until June last year until I knew after donating blood and it was test for COVID antibodies and I was positive.

12:30PM - dizziness in cheeks 1:30PM - dizziness moves to top of his head 5PM - dizziness changes to pain, took 2 Tylenol 8PM - started to throw up, lost balance due to numbness on left side of his body - tried to sleep it off as he thought he was just exhausted and a side effect of the shot NEXT DAY 7AM - called ambulance had a "Stroke Ischemic"

On 2/23/2021 patient had to have carotid endarterectomy to remove a clot from his aortic arch to his carotid siphon. Patient also had several mini strokes per wife and now has neurological deficits. He received his second Moderna vaccine on 3/8/2021 at another pharmacy and 5 days after he had another series of mini strokes.

Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 57-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 (Medical history was not reported). On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 14-Apr-2021 The cause of death was not reported. It is unknown if an autopsy was performed. Not Provided Concomitant product use was not provided by the reporter. No treatment information was provided. Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested. The cause of death was not reported. It is unknown if an autopsy was performed. Action taken with mRNA-1273 in response to the event was not applicable.; Sender'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. The cause of death was not reported. It is unknown if an autopsy was performed.; Reported Cause(s) of Death: Unknown cause of death

On 3/23/21. Pt admitted w/R sided, pulsatile HA associated w/vomiting. Patient was found to have occlusive dural venous sinus thrombosis involving the dominant R transverse and sigmoid sinuses, extending into upper jugular vein. He received his second COVID-19 vaccination 5 days prior to onset of HA. Report this for record keeping.

Patient's wife stated that on Sunday he was feeling weak most the day. She took his blood oxygen because he is on oxygen for COPD and it was lower than normal. She turned his oxygen up to 5%, then took his blood pressure. His blood pressure was 256/136, so she called the ambulance. When he was brought into the hospital they put him on a ventilator. He is still on a ventilator as of 5/8/2021. The hospital staff said he had double pneumonia and they plan on trying to take him off the ventilator on 5/10/2021.

Palpitations, sweats, nausea/vomiting, chest pain. Transported by EMS to hospital, found to be having massive MI requiring emergent open heart surgery.

Patient was vaccinated on May 6,2021. On Friday May 14 ,2021 a relative of the patient report that the patient died on May 9,2021..She report that the patient doesn't take the prescriptions needed for a vascular condition he have and was suppose to received medicines by mail on tuesday before vaccination

Patient came to hospital 6 days after vaccination on 4/19/2021. He was diagnosed with cryptogenic stroke. Patient was on anticoagulation at the time of his stroke. Thought that patient was non-compliant with his medications but patient and family insist he took his Xarelto consistently.

Stroke due to blood clot in right side of brain. Severely affected speech, mildly affected left hand. Is currently going through speech therapy.

First vaccine dose administered on 4/20/21. Patient was admitted on 4/29/21 with shortness of breath and pleuritic chest pain. CT scan revealed pulmonary embolism and doppler showed vascular access (Hero graft) thrombosis. Patient was treated with heparin and warfarin, and was discharged on 5/5/2021 after being converted to apixaban. Patient missed scheduled dialysis treatment (no call/no show) on 5/8/21 and 5/11/21. Subsequent welfare check found the patient expired at home.

Patient did not seek medical care following vaccination. Coworkers report patient was feeling ill on 13 May 2021. Coworkers report patient was experiencing difficulty swallowing, difficulty speaking, unable to use hand, and off balance walking. Patient expired between 14-17 May 2021 (coroners report pending).

Systemic: death (unknown cause)-Severe, Additional Details: Patient was found deceased roughly an hour and a half after receiving Moderna vaccine. He waited 20 minutes at the pharmacy and left however later died. Details are unknown. Sister may have more information.

Patient admitted to hospital a few weeks after his second Moderna vaccine with an acute febrile illness of unclear etiology. Patient was felt to be septic due an atypical infection with an elevated procalcitonin level. All tests for infectious etiology were negative. He responded to ceftriaxone and doxycycline and was feeling better at transitional care management follow-up on 5/21/21.

Condition aggravated; Mitral valve incompetence; Condition aggravated; Steroid diabetes; pyrexia; Lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at; Diarrhea; Weight fluctuation; Limb discomfort; Rash; Acute hypoxemic respiratory failure; pulmonary arterial hypertension; Influenza B; COVID-19; COVID-19 pneumonia; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ACUTE RESPIRATORY FAILURE (Acute hypoxemic respiratory failure), COVID-19 PNEUMONIA (COVID-19 pneumonia), COVID-19 (COVID-19), PULMONARY ARTERIAL HYPERTENSION (pulmonary arterial hypertension), INFLUENZA (Influenza B), the first episode of CONDITION AGGRAVATED (Condition aggravated), MITRAL VALVE INCOMPETENCE (Mitral valve incompetence), the second episode of CONDITION AGGRAVATED (Condition aggravated), STEROID DIABETES (Steroid diabetes), PYREXIA (pyrexia), OEDEMA PERIPHERAL (Lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at), DIARRHOEA (Diarrhea), WEIGHT FLUCTUATION (Weight fluctuation), LIMB DISCOMFORT (Limb discomfort) and RASH (Rash) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products TREPROSTINIL DIOLAMIN (ORENITRAM) for Pulmonary arterial hypertension, METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) tablet for Systemic lupus erythematosus and an unknown indication and NIFEDIPINE for Hypertension. The patient's past medical history included Calcium deficiency, Obstructive sleep apnea syndrome, Peripheral arterial disease, Shortness of breath and Continuous positive airway pressure. Family history included COVID-19 (Brother covid-19 positive). Concurrent medical conditions included Pulmonary arterial hypertension (PAH/ High BP disorder/ increased pressure of pulmonary circulation) since 01-Aug-2019, Systemic lupus erythematosus (on CPAP), Hypercalcemia, Hypertension, Systemic lupus erythematosis, Peripheral arterial occlusive disease and Dyspnoea. Concomitant products included AMBRISENTAN (LETAIRIS), SILDENAFIL CITRATE (REVATIO), CALCIUM CITRATE, ERGOCALCIFEROL (CITRACAL + D [CALCIUM CITRATE;ERGOCALCIFEROL]), DIGOXIN (LANOXIN DIGOXIN), EPINEPHRINE (EPIPEN), ESCITALOPRAM OXALATE (LEXAPRO), FOLIC ACID (FOLVITE [FOLIC ACID]), HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]), FAMOTIDINE (PEPCID [FAMOTIDINE]), FUROSEMIDE (LASIX [FUROSEMIDE]), SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) and APIXABAN (ELIQUIS) for an unknown indication. On 01-Aug-2019, the patient TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .25 milligram every eight hours. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) 1 milligram every eight hours On an unknown date, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.5 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to .125 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 3.875 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 3 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to 2.875 milligram every eight hours, TREPROSTINIL DIOLAMIN (ORENITRAM) (Oral) dosage was changed to at an unspecified dose and TREPROSTINIL DIOLAMIN (ORENITRAM) (unknown route) dosage was changed to at an unspecified dose., METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) (unknown route) 16 milligram once a day and NIFEDIPINE (unknown route) at an unspecified dose. On 23-Mar-2021, the patient experienced COVID-19 PNEUMONIA (COVID-19 pneumonia) (seriousness criteria hospitalization and medically significant). On 06-Apr-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). On 16-Apr-2021, the patient experienced ACUTE RESPIRATORY FAILURE (Acute hypoxemic respiratory failure) (seriousness criteria hospitalization and medically significant), PULMONARY ARTERIAL HYPERTENSION (pulmonary arterial hypertension) (seriousness criteria hospitalization and medically significant) and INFLUENZA (Influenza B) (seriousness criterion hospitalization). On an unknown date, the patient experienced the first episode of CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion hospitalization), MITRAL VALVE INCOMPETENCE (Mitral valve incompetence) (seriousness criteria hospitalization and medically significant), the second episode of CONDITION AGGRAVATED (Condition aggravated) (seriousness criterion hospitalization), STEROID DIABETES (Steroid diabetes) (seriousness criteria hospitalization and medically significant), PYREXIA (pyrexia) (seriousness criterion hospitalization), OEDEMA PERIPHERAL (Lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at) (seriousness criterion hospitalization), DIARRHOEA (Diarrhea) (seriousness criterion hospitalization), WEIGHT FLUCTUATION (Weight fluctuation) (seriousness criterion hospitalization), LIMB DISCOMFORT (Limb discomfort) (seriousness criterion hospitalization) and RASH (Rash) (seriousness criterion hospitalization). The patient was hospitalized from 23-Mar-2021 to 29-Mar-2021 due to COVID-19 PNEUMONIA, then on 06-Apr-2021 due to CONDITION AGGRAVATED, COVID-19, DIARRHOEA, INFLUENZA, LIMB DISCOMFORT, OEDEMA PERIPHERAL, PULMONARY ARTERIAL HYPERTENSION, PYREXIA, RASH, STEROID DIABETES and WEIGHT FLUCTUATION, and then on 16-Apr-2021 due to ACUTE RESPIRATORY FAILURE. On 29-Mar-2021, COVID-19 PNEUMONIA (COVID-19 pneumonia) outcome was unknown. On 26-Apr-2021, INFLUENZA (Influenza B) outcome was unknown. At the time of the report, ACUTE RESPIRATORY FAILURE (Acute hypoxemic respiratory failure), COVID-19 (COVID-19), PULMONARY ARTERIAL HYPERTENSION (pulmonary arterial hypertension), MITRAL VALVE INCOMPETENCE (Mitral valve incompetence), the last episode of CONDITION AGGRAVATED (Condition aggravated), STEROID DIABETES (Steroid diabetes), PYREXIA (pyrexia), OEDEMA PERIPHERAL (Lower extremity edema, 2+ pitting edema, to knees 1+ dependent edema at), DIARRHOEA (Diarrhea), WEIGHT FLUCTUATION (Weight fluctuation), LIMB DISCOMFORT (Limb discomfort) and RASH (Rash) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Weight: up by 4 lbs since discharge from hospital (Inconclusive) up by 4 lbs since discharge from hospital. On 21-Apr-2021, Catheterisation cardiac: abnormal (abnormal) Revealed moderate pulmonary hypertension with right atrium (RA) 7, right ventricle (RV) 12, pressure wave (PW) 15, PA 62/ 25/40, PA saturation 63 %, CO 7, CI 3.52. On 24-Apr-2021, Blood creatinine: 1.68 (Inconclusive) 1.68. On 24-Apr-2021, Blood glucose: 90 (Inconclusive) 90. On 24-Apr-2021, Blood potassium: 4.1 (Inconclusive) 4.1. On 24-Apr-2021, Blood sodium: 141 (Inconclusive) 141. On 24-Apr-2021, Blood urea: 39 (Inconclusive) 39. On 24-Apr-2021, Haemoglobin: 8.4 (Inconclusive) 8.4. On 24-Apr-2021, Platelet count: 146 (Inconclusive) 146. On 24-Apr-2021, Red blood cell count: 3.31 (Inconclusive) 3.31. On 24-Apr-2021, White blood cell count: 4.79 (Inconclusive) 4.79. On 25-Apr-2021, Blood creatinine: 1.59 (Inconclusive) 1.59. On 25-Apr-2021, Blood glucose: 117 (Inconclusive) 117. On 25-Apr-2021, Blood potassium: 4.4 (Inconclusive) 4.4. On 25-Apr-2021, Blood sodium: 141 (Inconclusive) 141. On 25-Apr-2021, Blood urea: 39 (Inconclusive) 39. On 25-Apr-2021, Haemoglobin: 8.2 (Inconclusive) 8.2. On 25-Apr-2021, Platelet count: 159 (Inconclusive) 159. On 25-Apr-2021, Red blood cell count: 3.24 (Inconclusive) 3.24. On 25-Apr-2021, White blood cell count: 5.51 (Inconclusive) 5.51. On 26-Apr-2021, Blood creatinine: 1.54 (Inconclusive) 1.54. On 26-Apr-2021, Blood glucose: 90 (Inconclusive) 90. On 26-Apr-2021, Blood potassium: 4.4 (Inconclusive) 4.4. On 26-Apr-2021, Blood sodium: 141 (Inconclusive) 141. On 26-Apr-2021, Blood urea: 37 (Inconclusive) 37. On 26-Apr-2021, Haemoglobin: 8.3 (Inconclusive) 8.3. On 26-Apr-2021, Platelet count: 159 (Inconclusive) 159. On 26-Apr-2021, Red blood cell count: 3.30 (Inconclusive) 3.30. On 26-Apr-2021, White blood cell count: 5.41 (Inconclusive) 5.41. In 2021, Body temperature: 101.1 (High) 101.1 F. In 2021, Weight: stable at 155 lbs slowly coming down (Inconclusive) stable at 155 lbs slowly coming down. 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, the mRNA-1723 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information, the mRNA-1723 does not contain a virus capable of causing infection and with the occurrence of COVID-19 infection after vaccination, this event is assessed as unlikely related to mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the rest of the events, a causal relationship cannot be excluded.

fever 102 starting day after vaccination, and 12 days later diagnosed with Left lower lobe atypical pneumonia. Symptoms SOB, Fever, cough, hospitalized at medical center 5/16/21 to 5/17/21 Initially fever without sob or cough: with normal CXR but elevated ESR, CRP. Was treated with Solumedrol dose pack 2 days before he developed symptoms.

tested covid positive by PCR on 5/23/2021, may have pneumonia, mild, unclear if covid or bacterial cause. Patient presented with a seizure after binge drinking, relapsed alcoholism

Patient presented to the ED after being found down outside. Initially hypotensive, was intubated in ED. Required increasing pressor support. Found to have profound anion gap metabolic acidosis with lactate peaking at >27. Initial workup also significant for WBC 40s, AKI with Cr peak at 2.5. Transaminitis likely 2/2 shock liver. Toxicologic workup was negative for alcohol, Tylenol, salicylates, urine drug screen. Blood cultures grew S. hominis. Other infectious workup including covid, hepatitis, hiv, rocky mountain spotted fever, respiratory panel, GI PCR, all negative. Also found to have a PE which was removed via thrombectomy. Developed DIC requiring multiple transfusions of cryo, FFP, and RBCs. Condition improved slowly with lactate downtrending currently and pressor requirement weaning.

Patient presented to the ED and was subsequently hospitalized on 5/10/2021. Diagnosis was Intraparenchymal hemorrhage of right temporal lobe of brain, nontraumatic. He was also admitted on 5/19/21 for angiogram. These visits are within 6 weeks of receiving COVID vaccination.

About 3 weeks after receiving the first Moderna shot I developed, what i believed to be a severe charlie horse in my left lower leg that lasted about. week and disopated. A few weeks later May 9,2021; I noticed discomfort and swelling in the same lower left leg and my, medical alert service dog, kept alerting to it. I had a regular appointment with my cardioligist on May 10,2021 and advised of my issue and he ordered an ultrasound. The ultra sound revealed blood clots on my llower left leg. I have never had clotting issues in my life and absolutely believe that this colt was caused by the Moderna vaccine, since i have been on anticoagulants and asprin theray since 2008.

Swelling, pain, warmth, and tightness started in left leg the same night I had the second dose of vaccine. Approximately 10 hours after second dose

48 hours after the shot began experiencing Vertigo and a dryness headache. 8 Days after the shot had a TIA and Stroke.

on Sunday 6-13-2021 10:45am Had a stroke and blood cot in head. Was take to emergency and is still currently there.

Three days after the vaccine I started to have tightness in my chest when exercising. On June 9, I had a mild heart attack. One June 10th, heart catheterization revealed that I had blockage in two arteries

About two weeks after vaccination I noticed my heart beat was irregular. The episodes we initially short, 3-5 minutes. After 4 weeks, the episodes lasted longer, up to 3 to 4 hours. On April 27th, I was taken by ambulance to the Emergency Room as I was in AFIB.

Pt. got shot on 5/25 but started feeling real bad arm pain on day 2. The pain got worse in arm and patient reached out to pharmacy questioning arm pain to which he was told it was an expected side effect of the shot but because he was still in pain he made an appointment with his doctor on the coming Monday, but unfortunately, he passed away on Sunday 5/30/21 and was found by neighbors. Brother wants to report death because he took the vaccine

Within 12-14 hours of getting the Maderna shot(1st shot), not only did I have a sore arm, but my shoulder had pain. Each day the pain got a little worse and started stretching to my chest. My chest and heart were uncomfortable. My wife was having the same symptoms so we just tried to manage through the pain. One April 28, the pain was so severe it woke me up in the middle of the night. I took some antacids and that seemed to help. The next 3 days the pain was on and off until May 1 evening, the pain was so severe and I was vomiting that we decided to go to the hospital. It was determined that I had a heart attack.

Block; cardiac arrest; This spontaneous case was reported by a nurse and describes the occurrence of CARDIAC ARREST (cardiac arrest) and CAROTID ARTERY OCCLUSION (Block) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A,) for COVID-19 vaccination. Concomitant products included TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CARVEDILOL PHOSPHATE and ROSUVASTATIN CALCIUM for an unknown indication. On 03-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced CARDIAC ARREST (cardiac arrest) (seriousness criterion medically significant). On an unknown date, the patient experienced CAROTID ARTERY OCCLUSION (Block) (seriousness criterion medically significant). At the time of the report, CARDIAC ARREST (cardiac arrest) had resolved and CAROTID ARTERY OCCLUSION (Block) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) Normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were reported. 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. Patients age, and concomitant medication with ticagrelor, aspirin, rosuvastatin suggest an underlying cardiovascular disease that is a potential confounder. Additional 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. Patients age, and concomitant medication with ticagrelor, aspirin, rosuvastatin suggest an underlying cardiovascular disease that is a potential confounder. Additional information has been requested.

Patient is a 57-year-old male currently in rehab facility with past medical history of heroin dependence, mood disorder, nephrolithiasis, history of 20 foot fall 5/21/2021 from fire escape to concrete floor with polytrauma , burst fracture L1 and L2 vertebral bodies, right lateral malleolar fracture, open right calcaneal fracture, sacrococcygeal fracture and left avulsion fracture of tibia, admitted to hospital, patient status post posterior fusion T11-L4, incision and drainage of right calcaneal wound and pinning, I&D left leg abscess, patient has resultant neurogenic bladder and neurogenic bowel post fall and has been self catheterizing, patient was initially discharged to current and rehab on 5/29/2021 and patient was discharged to rehab facility on 6/15/2021, presented to Medical Center emergency room with 3-day history of palpitation and shortness of breath, 2-day history of hematuria,, work-up in the emergency room at Medical Center included CTA of the chest which showed bilateral pulmonary embolism, CT scan of the abdomen pelvis showed multiple bilateral nonobstructive renal stones, bladder stones, fracture of L1-L2 vertebrae with postoperative changes, fracture of coccyx. Patient started on IV heparin, patient received 2 L of IV fluids and patient was also given Rocephin and cefuroxime initially hospital was contacted for transfer apparently they did not have any beds and patient was transferred to Hospital. When seen patient noted to be alert awake oriented x3 patient has a indwelling Foley catheter with gross hematuria, patient is on heparin drip, patient is complaining of pain lower back, numbness left foot.

Shot 1: Vaccine was given on March 24, 2021 and I woke up at 2:00/am March 25, 2021 with horrible headache and pain behind right eye. Seen ophthalmologist on April 2, 2021. Pain and headache continued and became worse. Continued regular visits with ophthalmologist. Pain continued behind right eye so I was sent for CT scan of brain, which showed normal at that time. Pain behind right eye continued. I had my second vaccine on April 21, 2021 and April 25, 2021 woke up feeling very strange. Throat was getting numb and left side of body was numb. Layed back down for a few hours and then went to work. By 6:15/pm was not feeling well at all and went home and went to bed. April 26, 2021 8:00/am was headed to Ophthalmologist and started having very blurry vision and numbness again and went straight to ER instead.. Was given MRI and CT scans and diagnosed with a Arterial Stroke of the Occipital lobe. Was admitted to Hospital Pain behind right eye went away after stroke but now have no vision midline to the left out of either eye. Currently being treated by the specialist of for vision issues

Blood clots in both their lungs; though they had covid-19; Difficulty breathing; Sharp pain in chest; Though they have pulled a muscle; Spiting up blood; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Blood clots in both their lungs), DYSPNOEA (Difficulty breathing), CHEST PAIN (Sharp pain in chest), MUSCLE STRAIN (Though they have pulled a muscle), HAEMOPTYSIS (Spiting up blood) and SUSPECTED COVID-19 (though they had covid-19) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061C21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021, the patient experienced DYSPNOEA (Difficulty breathing) (seriousness criterion hospitalization), CHEST PAIN (Sharp pain in chest) (seriousness criterion hospitalization), MUSCLE STRAIN (Though they have pulled a muscle) (seriousness criterion hospitalization) and HAEMOPTYSIS (Spiting up blood) (seriousness criterion hospitalization). On 04-Jul-2021, the patient experienced SUSPECTED COVID-19 (though they had covid-19) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY THROMBOSIS (Blood clots in both their lungs) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 04-Jul-2021 to 05-Jul-2021 due to CHEST PAIN, DYSPNOEA, HAEMOPTYSIS, MUSCLE STRAIN, PULMONARY THROMBOSIS and SUSPECTED COVID-19. At the time of the report, PULMONARY THROMBOSIS (Blood clots in both their lungs), CHEST PAIN (Sharp pain in chest), MUSCLE STRAIN (Though they have pulled a muscle), HAEMOPTYSIS (Spiting up blood) and SUSPECTED COVID-19 (though they had covid-19) outcome was unknown and DYSPNOEA (Difficulty breathing) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jul-2021, Oxygen saturation: unknown (abnormal) unable to have a good oxygen level. 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 medications included High blood pressure medication and cholesterol medication. Treatment medications included antibiotics and pain medication. Reportedly, the patient was scheduled to get the second dose on 20-Jul-2021. Company Comment: 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.

Severe pain in the left side of his chest; Pain in calf; Had to use a cane to walk; Severe pain in the left side of hip and knee; First dose drained him; Nerve root disorder; The first dose drained him, and he made his whole right side numb; Severe pain in the left side of his temple; It feels like he had a mini stroke; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke) and NERVE ROOT INJURY (Nerve root disorder) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 20-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke) (seriousness criterion medically significant). On 25-Jun-2021, the patient experienced HEADACHE (Severe pain in the left side of his temple). On 27-Jun-2021, the patient experienced HYPOAESTHESIA (The first dose drained him, and he made his whole right side numb). On 05-Jul-2021, the patient experienced NERVE ROOT INJURY (Nerve root disorder) (seriousness criterion medically significant). On an unknown date, the patient experienced CHEST PAIN (Severe pain in the left side of his chest), PAIN IN EXTREMITY (Pain in calf), GAIT DISTURBANCE (Had to use a cane to walk), ARTHRALGIA (Severe pain in the left side of hip and knee) and FATIGUE (First dose drained him). The patient was treated with PREDNISONE at a dose of 20 mg. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (It feels like he had a mini stroke), NERVE ROOT INJURY (Nerve root disorder), HYPOAESTHESIA (The first dose drained him, and he made his whole right side numb), CHEST PAIN (Severe pain in the left side of his chest), PAIN IN EXTREMITY (Pain in calf), GAIT DISTURBANCE (Had to use a cane to walk), ARTHRALGIA (Severe pain in the left side of hip and knee), FATIGUE (First dose drained him) and HEADACHE (Severe pain in the left side of his temple) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medication was reported. Limited information regarding the events has been provided at this time and is insufficient for causality assessment.; Sender's Comments: Limited information regarding the events has been provided at this time and is insufficient for causality assessment.

Patient reported having left arm swelling for about 2 weeks. Both injections were done on his left deltoid. Underwent screening, patient had a positive left upper extremity DVT and was given an apixaban prescription to take 10 mg by mouth twice daily for 7 days followed by 5 mg twice daily. Doctor reached out to the patient after discharge from the emergency department, patient did not pick up the call on 07/12/21 or the second follow up call on 07/13/2021. They are waiting for the patient contact them back regarding his symptoms.

Pt. came into ED with chest pain. Labs were done and pt. has an elevated troponin. Was diagnosed with NSTEMI and transferred to a hospital with a cath lab.

Patient is a 58-year-old male with above-mentioned comorbidities presented with feeling hot and faint. Patient was found to have A. fib with RVR which was new onset received IV Cardizem. Patient was kept on telemetry serial cardiac enzymes were negative for acute coronary syndrome. Echo done showed an ejection fraction of 58%. Cardiology evaluation was done by Dr. Cardiology did not recommend any long-term anticoagulation, recommended outpatient follow-up and possible Holter monitor. Patient reverted to normal sinus rhythm) clinically stable. Patient was cleared for discharge per cardiology.

Patient awake at 0300. When going into the room to get him ready for dialysis he was cold to touch, unresponsive other than to sound, and nonverbal. O2 sat was 67 via finger probe. Oxygen immediately initiated and a venturi mask retrieved and initiated. When unable to arouse him via sternal rub this RN called 911. Send to ED. Febrile 39.2 and hypotensive 58/43. Admitted. unknown after that as patient expired in hospital.

Patient had a heart attack two days after receiving first Covid Vaccine. Doctor reports that artery was 99% blocked.

The patient, who was a pharmacist, developed fatigue and shortness of breath hours after receiving vaccine. Two days later, on 01/28/2021, the patient went to local urgent care for worsening shortness of breath and was referred to Hospital for worsening dyspnea and hypoxia. The patient was admitted to the hospital We was found to have bilateral pulmonary infiltrates and treated for pneumonia with Rocephin and azithromycin. He was tested for COVID-19 multiple times, but each of the results were negative. Despite the negative results, there was high clinical suspicion for COVID-19 and the patient was started on Remdesivir and Decadron. The patient's oxygen requirements continued to worsen and the patient was transferred to another facility for higher level of care. There his hypoxia worsened and he required mechanical ventilation. Patient then developed hypotension and required vasopressors for blood pressure support. Furthermore, patient developed acute renal failure requiring hemodialysis. Despite mechanical ventilation with FiO2 100%, and for vasopressors, patient clinically deteriorated and family decided to palliatively extubate on 02/05/2021.

started having tachycardia on 2/4/21 while watching TV, HR from 110-150. Went to ER in am on 2/5/21 and admitted with A-Fib RVR.

Abdominal pain, nausea and vomiting, shortness of breath, acidosis, hypoglycemia, death. Onset of abdominal pain was 30 minutes after administration of the vaccine followed by 20+ episodes of vomiting and dry heaving.

Moderna COVID-19 Vaccine EUA 1h15min after injection - inital symptom of sweating without chills or fever, 2hr after injection - significant episode of atrial fibrillation, flutter, and PVCs for approx 90 minutes. I have a history of a-fib which was successfully treated in 2008 with a PVI, this is only the second episode since that treatment

Per MD Clinical Note 3/14/21, "Further discussion with his daughter today-patient has not been able to walk and has had unclear mentation for approximately 8 years after an alcohol related decline. Was in a nursing home until he moved into his parent's house. His mother actually passed away and December and his stepfather has been trying to take care of him since. Patient may periodically stand but is a house where he is pretty much confined to his bedroom and bathroom. Patient received his COVID-19 vaccine at the prescription shop 03/04/2021 and since then he has had a steady decline starting with aches and pains to increased weakness and confusion and then collapse which brought him to the emergency room. Assessment and plan Syncope with altered mental status/toxic metabolic encephalopathy Acute on chronic respiratory failure with hypercapnia Sepsis Supratherapeutic Coumadin level INR greater than 9 Anemia Small hemoperitoneum Hypotension Chronic pain syndrome COPD UTI Enteritis Subsegmental atelectatic changes with nodule left lower lobe the-recheck 3 months Cirrhosis Nicotine dependence CHF-chronic diastolic Functional quadriplegia One week post COVID-19 vaccination Agitation Other: GI bleed, PAD, hypothyroidism, history of DVT left leg, neuropathy, depression, BPH, CAD, subdural hematoma, acquired thyroid disease, GERD, Wernicke -continue to trend the LFTs downward. Is on Precedex currently to allow him to further recover. He was using accessory muscles and poor inspiratory effort today but maintaining his oxygenation. BiPAP was reinstituted to avoid CO2 retention. One possibility is that the patient consumed a significant amount of Tylenol due to the discomfort exacerbated with the cirrhosis. LFTs are trending upward still. -hypercapnia patient consume both the benzodiazepine and morphine supported initially for the 1st 36 hours with BiPAP. Has had periods where he is off and answers appropriately. -consider rescanning in a.m. To further evaluate the hemoperitoneum. Continue broad-spectrum antibiotics and hemoglobins. Patient is NPO until further delineation Patient is a functional quadriplegic year and at home is fairly dependent on his stepfather for a total care family seeking long-term care which may mentally benefit the patient with broadening his activities -blood cultures pending. " Per Clinical note 3/13/21, "Assessment and plan Syncope with altered mental status/toxic metabolic encephalopathy Acute on chronic respiratory failure with hypercapnia Sepsis Supratherapeutic Coumadin level INR greater than 9 Anemia Small hemoperitoneum Hypotension Chronic pain syndrome COPD UTI Enteritis Subsegmental atelectatic changes with nodule left lower lobe the-recheck 3 months Cirrhosis Nicotine dependence CHF-chronic diastolic Functional quadriplegia Other: GI bleed, PAD, hypothyroidism, history of DVT left leg, neuropathy, depression, BPH, CAD, subdural hematoma, acquired thyroid disease, GERD -patient is more awake and wakening a hourly on BiPAP will remove 1 fully alert and functioning will use BiPAP overnight. Nicoderm avoid tobacco. NPO unless ammonia level is elevated. Continue empiric antibiotics. Last evening required to units packed RBC. If hypotensive and or increase in anemia will rescanned. Monitor for DTs and withdraws. Was advised by the nursing staff patient is following orders. Functional quadriplegic rotation every 2 hours had bed at 20-30 degrees to avoid aspiration. Patient and his family confirm DNR status. Long-term placement required as his stepfather is unable to care for him without assistance. Anticipate restarting diet in a.m.. One fully alert will ascertain if this was delivered or accidental. Drug screen was positive for both benzos and morphine. He has been and prescribed the morphine. The dual combination liver failure patient with depression likely ill-advised "

COVID and stroke December 2020. Patient's mother talked to him at 4:30 and he said he was not feeling well. Driving to work when coworkers found pt after he curbed his vehicle with AMS. Right side deficit with aphasia, unknown last normal. Pt had sz upon EMS arrival and 2.5mg versed given. was initially unresponsive while going into the CT suite and apparently had a seizure as soon as he arrived to the ED. but alert by the time he was done with CT head, CTA and CTP. He was followed to the ED assigned room and he was more alert but aphasic and only say 'yep' and did not follow commands. He was able to move his left side initially but not to command. about 2 minutes later he was able to move his right lower extremity to pain followed by right upper extremity. He is febrile with temp >103F. Diagnosed with seizure and Left acute arterial ischemic stroke, MCA.

A few days later I began to feel muscle aches and chills, I thought it would pass but it was increasing Until the 23rd I went to the emergency room and they determined that I could have a pseudo pneumonia but it continued to advance or we had to return to the emergency room on the 26th and they told me it was pneumonia but with many symptoms of covid, although they did not give the tests Never in my life did I get pneumonia Now they suspended my second dose for April 7

Began with weakness of March 24th and stroke- like symptoms despite a clear CT Scan and EKG. Trouble walking or staying awake. Heart stopped on March 28th. Deceased.

sore arm, lethargy, chronic fatigue, fever, fluid on lungs, lack of oxygen, death Husband received first dose of MODERNA vaccine on 1/30/21. Mild side effects. Received second dose on 2/24/21. For the first week after the second dose, the side effects seemed normal. By the second week he was gasping for air. Rused to ER via ambulance on 3/9/21. High heart rate, poor oxygen. Received numerous blood transfusions over 3-days (typical treatment for his blood disorder), yet body would not retain the transfused products. Died on 3/12/21 at 4:35 am from cardia arrest caused by respiratory failure.

Pt was found deceased at home on 3/10/21. He had had a cough prior to, recent hospitalization for pneumonia/acute on chronic resp. failure.

Developed Pneumonia Started with Fever (101.5) within 90 minutes, chills, aches, soreness. Next several days continued with fever as high as 102.5, continued chills, aches soreness Went to urgent care on 4/6/2021 and was diagnosed with Pneumonia and developed rash on arm where blood pressure was taken. Rash was 6 x 6 inches (I have a picture).

Swelling of the legs began on the 28th of February, Patient went to ER on March7th and diagnosed with DVT. Patient was discharged about 12 hours after arrival and put on rivaroxaban. Patient returned to the ER on March 13th and was diagnosed with bilateral Pulmonary Embolism patient was kept overnight put on heparin drip and then transitioned to rivaroxaban. Patient does not know if the vaccine was the cause as patient has had 2 previous DVT's (no previous PE's). DVT's both occurred after transcontinental flights. This recent DVT and PE occurred with no know reason. Patient is positive for Leiden5

We both got our shot at the same time on March 17, 2021. Then on March 22, 2021 at 9:20 PM my husband suffered cardiac arrest and a seizure. His heart was revived however, due to lack of oxygen to his brain he suffered brain damage and never regained consciousness and passed on 4/3/21 with acute respiratory failure.

No adverse symptoms from vaccination. Decedent died day after 2nd vaccination, death not related to vaccination

Pressure in chest at 24 hours afterwards lasting 5 minutes, again 10 days later lasting 10 minutes then 11 days after lasting longer and went to the ER. EKG test good, heart enzyme (troponin) tests showed slightly increasing damage over the first 6 hours, then decreasing. chest X-Ray, Lexiscan, heart Cath and stent in the MLAD on 4/3/21.

Patient's sister, spoke to Public Health staff to say that he passed away suddenly on 4/3/21 from a cardiac arrest, he had no underlying health conditions she states but did take some medications, she believes for blood pressure.

He got his vaccine, and on Easter he thought that he had a cramp in his leg, and asked his wife and told her that he had this. By that afternoon he still had the cramping feeling, and started drinking water as his wife is a nurse and felt that he may be dehydrated. Throughout the week he had a Charlie Horse pain in his left calf, and felt that it was getting worse and not going away. The whole week he went to work and on the 7th day it started swelling and went to Hospital after he got off of work, and he saw a resident who said that his leg was swollen and told him that she was going to schedule an ultrasound. He had that on Friday on 4/16/21, and was scheduled for 4:00 but due to the pain went to the ER and gave him IV and checked his blood work. The ultrasound showed that he did have a blood clot and prescribed Eliquis and gave him a dose while in the ER. He told him that he would be on 2 a dat for 7 days and then 1 a day, but did not tell him how long. He is supposed to see the resident this afternoon for recheck. He is still having pain and wanting to know where he is going to do from this point. He does work out every day at his home gym and has not smoked, and now wanting to know how this is going to affect his life from this point into the future. He also jumps rope 3 times a day and now not able to do this.

He got his vaccine, and on Sunday he thought that he had a cramp in his leg, and asked his wife and told her that he had this. By that afternoon he still had the cramping feeling, and started drinking water as his wife is a nurse and felt that he may be dehydrated. Throughout the week he had a Charlie Horse pain in his left calf, and felt that it was getting worse and not going away. The whole week he went to work and on the 7th day it started swelling and went to Hospital after he got off of work, and he saw a resident Dr. who said that his leg was swollen and told him that she was going to schedule an ultrasound. He had that on Friday on 4/16/21, and was scheduled for 4:00 but due to the pain went to the ER and gave him IV and checked his blood work. The ultrasound showed that he did have a blood clot and prescribed Eliquis and gave him a dose while in the ER. He told him that he would be on that for a while. He is supposed to see the resident this afternoon for recheck. He is still having pain and wanting to know where he is going to do from this point. He does work out every day at his home gym and has not smoked, and now wanting to know how this is going to affect his life from this point into the future. He also jumps rope 3 times a day and now not able to do this.

Could not walk; Leg was swollen; Nurse told him his leg was hot; blood clot in both his lungs; Blood clot in both his legs; Fast heartbeat; Soreness in left calf; Ultrasonography NOS abnormal; CT abnormal; Ankle and foot still swollen; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Soreness in left calf), GAIT DISTURBANCE (Could not walk), PERIPHERAL SWELLING (Leg was swollen), FEELING HOT (Nurse told him his leg was hot), PULMONARY EMBOLISM (blood clot in both his lungs), DEEP VEIN THROMBOSIS (Blood clot in both his legs), HEART RATE INCREASED (Fast heartbeat) and ULTRASOUND SCAN ABNORMAL (Ultrasonography NOS abnormal) in a 58-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. The patient's past medical history included No adverse event. Concomitant products included IRBESARTAN and LEVOTHYROXINE for an unknown indication. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Soreness in left calf) (seriousness criterion hospitalization). On 17-Mar-2021, the patient experienced GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization), PERIPHERAL SWELLING (Leg was swollen) (seriousness criterion hospitalization), FEELING HOT (Nurse told him his leg was hot) (seriousness criterion hospitalization), PULMONARY EMBOLISM (blood clot in both his lungs) (seriousness criterion hospitalization), DEEP VEIN THROMBOSIS (Blood clot in both his legs) (seriousness criterion hospitalization) and HEART RATE INCREASED (Fast heartbeat) (seriousness criterion hospitalization). On 14-Apr-2021, the patient experienced JOINT SWELLING (Ankle and foot still swollen). On an unknown date, the patient experienced ULTRASOUND SCAN ABNORMAL (Ultrasonography NOS abnormal) (seriousness criterion hospitalization prolonged) and COMPUTERISED TOMOGRAM ABNORMAL (CT abnormal). The patient was hospitalized from 17-Mar-2021 to 20-Mar-2021 due to DEEP VEIN THROMBOSIS, PAIN IN EXTREMITY and PULMONARY EMBOLISM. At the time of the report, PAIN IN EXTREMITY (Soreness in left calf), GAIT DISTURBANCE (Could not walk), PERIPHERAL SWELLING (Leg was swollen), FEELING HOT (Nurse told him his leg was hot), PULMONARY EMBOLISM (blood clot in both his lungs), DEEP VEIN THROMBOSIS (Blood clot in both his legs), HEART RATE INCREASED (Fast heartbeat), ULTRASOUND SCAN ABNORMAL (Ultrasonography NOS abnormal), COMPUTERISED TOMOGRAM ABNORMAL (CT abnormal) and JOINT SWELLING (Ankle and foot still swollen) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: abnormal (abnormal) Abnormal. In 2021, Ultrasound scan: abnormal (abnormal) Abnormal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

He had a lung infection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (He had a lung infection) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Cancer. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (He had a lung infection) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (He had a lung infection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient was on immunotherapy. Treatment for the event included amoxicillin as an antibiotic. Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of this event, a causal relationship cannot be excluded.

Patient present with altered mental status and fevers, headache generalized body ache fever chills at the time of admission (4/21) generalized rash mild splenomegaly mild thrombocytopenia and elevated ferritin and CRP. He did not have any evidence of coagulopathy. His lactate and LDH are also within normal limits. Vasculitic workup and infectious disease workup till date have been negative. His CSF protein and glucose were within normal limits. He developed Worsening altered mental status as well as renal failure requiring hemodialysis. treatments for the most part have been supportive including steroids, intubation for altered mental status, antibiotics empirically, hemodialysis for renal failure. To date ( 04/27/2021) there has been no significant improvement in patient's status.

Blood clot on 2/9/2021, just thought it was a severe calf cramp and took ibuprofen for several days until the calf felt somewhat better. Went to ER on 3/20 for dual pulmonary embolisms.

Blood pressure have been high,can't walk far ,hard to breed,,light headed,A-fib,and the hospital E.R. done scans ,Blood tests, and everything came back negative,,,

Patient was diagnosed with an extensive DVT of Left-lower leg on 4-27-21. He had second Moderna vaccination on 4-8-21 and stated 4 days later he was mowing his yard and afterwards started having leg pain. Over the next two weeks he stated his leg swelled and pain became more intense and he presented to me as an acute visit on 4-27-21. He was sent for a state venous doppler and was diagnosed with above. Patient was started on Eliquis and his leg is improving. Follow up today in office. (5-3-21). Will be sent to Hematologist for further evaluation as he had no prior known risk factors

Superficial blood clot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Superficial blood clot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 018B21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced THROMBOSIS (Superficial blood clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Superficial blood clot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Ultrasound scan: abnormal (abnormal) Ultrasound of left arm was done and determined a blood clot in that arm.. Patient went to the emergency room on 24 Apr 2021, approximately 7 pm. The patient was a healthy individual and used to do bike ride 11 miles per day with average speed 16mph. He did bike ride the evening of his second covid shot. No relevant concomitant medications were reported. Treatment information included anti-inflammatory medicine. Action taken with mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Additional information was received on 26 Apr 2021. Added lab data and treatment; 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.

tongue and face swelling occurring on 5/7/21. shortness of breath and chest pain 5/8/21. Confirmed pulmonary embolus and left lower extremity DVT on 5/11/21-5/12/21

He started hemorraging and throwing up necrotic Tissue. It started 8 days after the first vaccine. It continued happened March 17th, then about two weeks later on March 30, then he had the second vaccine on April 8th and it happened again on April 16th and then the 20th. He was given 5 units of Blood during that time.

My husband was sleeping the night of getting his 2nd Moderna Vaccination... He, during his sleep, had a SEVERE Grand Mal Seizure with NOTHING leading up to it and NO PREVIOUS HISTORY WHATSOEVER of having ANY Seizures in his lifetime, nor ANY Epilepsy... EVER! It was TERRIFYING, to me - I ran to his bedside (I happened to be in the livingroom watching television) after hearing loud grunts and a crash and came to find him convulsing, severely spewing blood and frothing at the mouth. Grunting, convulsing, and thrashing. Stiffening, arms and hands (both in a fist) tight and stiff in front of his chest, legs straight, rigid as a board and thrashing about spitting blood, eyes rolled back in his head. As things began to becoming a little less severe, while waiting for the Fire Dept & EMTs to arrive I felt his legs which were hit to the touch and his face was drenched in sweat! With NEVER EXPERIENCING Anything like this before, and after 30 years of marriage, I thought my husband was dying ???????? He did NOT go with the EMTs, since once he was awake and somewhat cognitive we realized he was over it for the moment and we're in a wait and see basis. He saw our GP first thing the next morning.

-1 day post Dose #2 of Moderna Covid-19 Vaccine: Patient awoke on Tuesday, May 11 with symptoms of dizziness, off-balance gait where he is leaning on something, stuttering speech, difficulty swallowing resulting in coughing, but trumped that to possible side effects of the vaccine. Patient woke up on Wednesday continuing to have further weakness to the point where he is holding onto rails just to stay upright and walking and he was stumbled down the stairs but catching himself before he impacted the floor. -MRI is positive for acute left stroke.

PATIENT FELT DIZZY AND FELL AS HE WAS WALKING OUT OF THE IMMUNIZATION ROOM. HE WAS BROUGHT BACK INTO THE IMMUNIZATION ROOM AND BLEEDING WAS STOPPED. HE STATED HE WAS FINE AND DID NOT WANT US TO FILE A CLAIM/REPORT. HE LATER CONTACTED US TO LET US KNOW HIS KNEE WAS SWOLLEN. WE FORWARDED TO OUR CLAIMS DEPARTMENT AND THEY ARE HANDLING IT FROM THERE.

Cellulitis left calf; Scratch of left calf; difficulty in walking; cognitive issues; unable to taste food; Double Vision; pain in right jaw; losing eye sight; not remembering to eat or take medications; hot sensation on leg; weeping fluid from extremities; difficulty moving; swelling of the left lower extremity; fluttering in right eye; little tremors; sweat; body soreness; Numbness of head; tingling in head; blurred vision; freezing; headache; fatigue; Fever; Sepsis; This spontaneous case was reported by a physician and describes the occurrence of CELLULITIS (Cellulitis left calf), SEPSIS (Sepsis) and SCRATCH (Scratch of left calf) in a 61-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. Co-suspect product included non-company product CARBIDOPA, LEVODOPA (DUOPA) suspension for Parkinson's disease. The patient's past medical history included COVID-19 virus test positive in April 2020, Weight loss (lost total of 15 pounds sue to poor eating habits; gained 6-7 pounds since) from August 2020 to December 2020 and Dementia. Previously administered products included for Product used for unknown indication: dicyclomine, gabapentin, lisinopril, oxycodone, zolpidem and metamucil. Concurrent medical conditions included Giant cell arteritis since February 2019, Chronic kidney disease stage 3, Dementia, Blood pressure high, High cholesterol, Drug allergy (linsinopril and 2-3 unknown medications), Nonsmoker, Living in care (assisted living facility) and Parkinson's disease. Concomitant products included PREDNISONE for Giant cell arteritis, CARBIDOPA MONOHYDRATE, LEVODOPA (SINEMET) and CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA) for Parkinson's disease, CYCLOBENZAPRINE for Product used for unknown indication, AMLODIPINE, IRBESARTAN, TRAMADOL, ATORVASTATIN, DOCUSATE SODIUM, SENNOSIDE A+B (LAXATIVE STOOL SOFTENER WITH SENNA), LORAZEPAM, PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE (MIRAPEX), BENZONATATE, PRAMIPEXOLE, FLUCONAZOLE (FLUZONE [FLUCONAZOLE]), CLONIDINE, METOPROLOL and ACETYLSALICYLIC ACID (ASPIRIN [ACETYLSALICYLIC ACID]) for an unknown indication. On 02-May-2018, the patient started CARBIDOPA, LEVODOPA (DUOPA) (Enteral) 100 milligram. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced CELLULITIS (Cellulitis left calf) (seriousness criteria hospitalization and medically significant). In April 2021, the patient experienced SCRATCH (Scratch of left calf) (seriousness criterion hospitalization). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criterion medically significant), GAIT DISTURBANCE (difficulty in walking), COGNITIVE DISORDER (cognitive issues), AGEUSIA (unable to taste food), DIPLOPIA (Double Vision), PAIN IN JAW (pain in right jaw), VISUAL ACUITY REDUCED (losing eye sight), MEMORY IMPAIRMENT (not remembering to eat or take medications), FEELING HOT (hot sensation on leg), SECRETION DISCHARGE (weeping fluid from extremities), MOBILITY DECREASED (difficulty moving), PERIPHERAL SWELLING (swelling of the left lower extremity), BLEPHAROSPASM (fluttering in right eye), TREMOR (little tremors), HYPERHIDROSIS (sweat), PAIN (body soreness), HYPOAESTHESIA (Numbness of head), PARAESTHESIA (tingling in head), VISION BLURRED (blurred vision), FREEZING PHENOMENON (freezing), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (Fever). The patient was hospitalized from 08-Apr-2021 to 11-Apr-2021 due to CELLULITIS and SCRATCH. At the time of the report, CELLULITIS (Cellulitis left calf) and SCRATCH (Scratch of left calf) was resolving, SEPSIS (Sepsis), AGEUSIA (unable to taste food) and HYPERHIDROSIS (sweat) had resolved and GAIT DISTURBANCE (difficulty in walking), COGNITIVE DISORDER (cognitive issues), DIPLOPIA (Double Vision), PAIN IN JAW (pain in right jaw), VISUAL ACUITY REDUCED (losing eye sight), MEMORY IMPAIRMENT (not remembering to eat or take medications), FEELING HOT (hot sensation on leg), SECRETION DISCHARGE (weeping fluid from extremities), MOBILITY DECREASED (difficulty moving), PERIPHERAL SWELLING (swelling of the left lower extremity), BLEPHAROSPASM (fluttering in right eye), TREMOR (little tremors), PAIN (body soreness), HYPOAESTHESIA (Numbness of head), PARAESTHESIA (tingling in head), VISION BLURRED (blurred vision), FREEZING PHENOMENON (freezing), HEADACHE (headache), FATIGUE (fatigue) and PYREXIA (Fever) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Blood culture: positive (Positive) Positive. In April 2021, SARS-CoV-2 test: negative (Negative) Negative. In April 2021, White blood cell count: elevated (High) Elevated. 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. The patient was positive for COVID-19 in April 2020 and since then, had 10 additional tests on unknown dates which were all negative. Treatment for left leg cellulitis included 11 unknown multiple intravenous antibiotics, paracetamol, and an unknown pain medication while in the hospital. The patient was discharged to home on ciprofloxacin. The patient underwent physical therapy on uknown dates. 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.

sustained a stroke; lot of chest pain; experienced difficulty in breathing; heart rate went high up; headache; tingling sensation over the face, tingling sensation in the tongue; problem to speak well; " face felt wearied", "squeezing felling of the face"; 'I can't see clearly, can't read clearly, all letters are seen double; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (sustained a stroke), CHEST PAIN (lot of chest pain) and DYSPNOEA (experienced difficulty in breathing) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C211A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Stent placement. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) and PRASUGREL for an unknown indication. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced PARAESTHESIA (tingling sensation over the face, tingling sensation in the tongue), SPEECH DISORDER (problem to speak well), FEELING ABNORMAL (" face felt wearied", "squeezing felling of the face"), VISUAL IMPAIRMENT ('I can't see clearly, can't read clearly, all letters are seen double) and HEADACHE (headache). On 19-May-2021 at 5:00 AM, the patient experienced CHEST PAIN (lot of chest pain) (seriousness criterion hospitalization), DYSPNOEA (experienced difficulty in breathing) (seriousness criterion hospitalization) and HEART RATE INCREASED (heart rate went high up). On 20-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (sustained a stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 20-May-2021 to 23-May-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (sustained a stroke), CHEST PAIN (lot of chest pain), DYSPNOEA (experienced difficulty in breathing), PARAESTHESIA (tingling sensation over the face, tingling sensation in the tongue), SPEECH DISORDER (problem to speak well), FEELING ABNORMAL (" face felt wearied", "squeezing felling of the face"), VISUAL IMPAIRMENT ('I can't see clearly, can't read clearly, all letters are seen double), HEART RATE INCREASED (heart rate went high up) and HEADACHE (headache) outcome was unknown. 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 included blood thinner medications started while the patient was at the hospital. The patient saw their healthcare provider on 23-May-2021 who advised them to cancel the scheduled second dose of the vaccine until the patients health is stabilized. The stent placement is in the heart. Company Comment: Very limited information regarding these events have been provided at this time. Further information has been requested. Subject's history of stent placement in the heart can be a confounding factor.; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested. Subject's history of stent placement in the heart can be a confounding factor.

patient expired 3 days after first vaccination. Did not present to our facility for care after vaccination; did not have any adverse reactions during vaccination waiting period. Per the Medical examiner, patient passed away at his residence, and his death was not related to the COVID vaccine.

2 heart attacks happened 2 days after first dose of vaccine. patient was hospitalized. It could have been not related to the vaccine.

Mother reporting. He got his vaccine, approximately 3 weeks later he came home from work, was not feeling good, laid down, went to sleep and when he woke up he was not able to walk, paralyzed on left side. He called 9-1-1 and was taken to the ER. In the ER he was diagnosed with a stroke, and is still in the hospital undergo rehab. They are hoping that he is going to make a full recovery. He is still totally paralyzed on his left side. He was initially admitted to the Hospital, and then transferred to rehab unit at Rehabilitation Hospital since 6/5/21.

Patient presented to the ED and was subsequently hospitalized for Cerebrovascular accident (CVA) due to occlusion of left middle cerebral artery within 6 weeks of receiving COVID vaccination.

I am submitting this report because I am hoping to help others with the vaccine and to see if the CDC can assist with any guidance for my treatment with Cardiologist. I am glad to share any of my medical records if it?s helpful I had a heart condition in 2018 that was fully cleared and recovered over 2 years prior to the moderna vaccine. In Dec 2018 I had congestive heart failure (high heart rate, afib, and swelling). The congestive heart failure was resolved within a week with medication only, no stints or surgery. The recovery of my heart to a health condition was confirmed with a heart MRI on Feb 5th 2019. I still had afib that was confirmed cleared on Feb 12th 2020 by an office visit with my cardiologist. He recommended I continue medication and monitoring. I continued in a fully cleared condition with no Afib or any issues for a year and 3 months up to my 2nd moderna shot. I had an annual heart MRI on May 3rd 2021 showing no issues and no afib. I had a visit with my cardiologist who said the test results were great. On May 15th 2021 I had my second moderna shot. My shot was Moderna 025C21A, at Pharmacy. Within 24 hours I was in an afib condition with my heart rate between 90 to 100 bpm resting. I contacted my cardiologist. On 6/11/21 he confirmed the afib condition and the elevated heart rate. He is now guiding me through procedures to clear my afib. I am quite concerned that my health had fully recovered and now have heart issues directly related to the 2nd moderna vaccine. Any assistance you can give me, my cardiologist to help us thru this is appreciated. I hope the information I am sharing can help others with the vaccine.

Shortness of breath while exercising on 4/24/21, progressively got worse. Went to ER on 5/5/21 where they discovered numerous DVTs in right leg and Pulmonary Embolisms in both lobes of lungs. Heparin administered in ER and admitted for two nights to regulate dosage and to have echo cardiogram performed which also showed a thrombus in right atrium of heart. Doctors said no other underlying cause of clotting and attributed it to the vaccine. Now on maintenance course of Xarelto.

choking; Burping after the first dose; Hands and face red; Hands and face swollen; Hands and face swollen; Anaphylactic shock; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Thyroid cancer (history of thyroid cancer). Concurrent medical conditions included HIV infection (HIV positive and on a regimen and undetectable for 20 years) and Renal pain (kidneys hurt once in a while and stated as not taking booster dose in October). Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LEVOTHYROXINE SODIUM (LEVOTIRON), OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) and COBICISTAT, ELVITEGRAVIR, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (GENVOYA) for an unknown indication. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-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 ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), CHOKING (choking), ERUCTATION (Burping after the first dose), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen). At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), CHOKING (choking), ERUCTATION (Burping after the first dose), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen) had resolved. The patient reported having anaphylactic shock after receiving vaccine on 12-Mar-2021. Patient reported burping, hands and face red after reaching home about 45mins after receiving the first dose and was rushed to Emergency room where the patient experienced choking and swollen hand and face. No corrective treatment was provided. The 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. This case was linked to MOD-2021-209375 (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.

Anaphylactic shock; choking; Burping; Hands and face red; Hands and face swollen; Hands and face swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 04-Jun-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Thyroid cancer (history of thyroid cancer). Concurrent medical conditions included HIV infection (HIV positive and on a regimen and undetectable for 20 years) and Renal pain (kidneys hurt once in a while and stated as not taking booster dose in October). On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), CHOKING (choking), ERUCTATION (Burping), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen). On 17-Apr-2021, ANAPHYLACTIC SHOCK (Anaphylactic shock), CHOKING (choking), ERUCTATION (Burping), ERYTHEMA (Hands and face red), SWELLING FACE (Hands and face swollen) and PERIPHERAL SWELLING (Hands and face swollen) had resolved. No corrective treatment was provided. It was reported that, after receiving 2nd dose, patient was having similar reaction in 5 minutes when under medical supervision and was revived." to "Patient reported as burping, hands and face red after reaching home about 45mins after receiving the first dose on 12th Mar 2021 and was rushed to Emergency room where caller mentioned as experienced choking and swollen hand and face. Caller received second dose on 17th Apr 2021 and mentioned as having similar reaction in 5 mins when under medical supervision and was revived. 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-2021-209326 (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.

Acute inflammatory demyelinating polyneuropathy that developed ten days following first dose of Moderna vaccination. Patient developed progressive weakness/numbness/tingling and presented to outside hospital 6/10; weakness progressed to near immobility with associated respiratory distress, resulting in intubation 6/19. EMG consistent with AIDP. S/p 5 days of IVIG without improvement; now started on PLEX s/p 2 days. LP with protein, which can also be explained by AIDP. Remains intubated and hospitalized presently.

Within a couple of days feet started swelling and breathing became more labored on runs. I was diagnosed with DVT and PE

Low grade Fever started overnight. Severe Pain in location of injection. Zero engergy, slept for 24 hours. less than 24 hours later: Verigo/dizzy, could not swollow, impated breathing, Arterial Ischemic Stroke, veryebrobasial, brainstem, actute

blood clot in the brain (poor, wavy eyesight, slurred speech, extreme exhaustion within 20-30 minutes of clot onset); poor, wavy eyesight; slurred speech; extreme exhaustion within 20-30 minutes of clot onset; This spontaneous case was reported by a consumer and describes the occurrence of CEREBRAL THROMBOSIS (blood clot in the brain (poor, wavy eyesight, slurred speech, extreme exhaustion within 20-30 minutes of clot onset)), OCULAR DISCOMFORT (poor, wavy eyesight), DYSARTHRIA (slurred speech) and FATIGUE (extreme exhaustion within 20-30 minutes of clot onset) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No relevant medical history was reported. The patient's past medical history included Cerebral thrombosis on 09-Apr-2021, Cerebral thrombosis on 26-Apr-2021, Cerebral thrombosis on 13-May-2021, Cerebral thrombosis on 19-May-2021, Cerebral thrombosis on 05-Jun-2021 and Cerebral thrombosis. Concomitant products included OMEPRAZOLE, SIMVASTATIN, LOSARTAN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication. On 27-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 29-Mar-2021, the patient experienced CEREBRAL THROMBOSIS (blood clot in the brain (poor, wavy eyesight, slurred speech, extreme exhaustion within 20-30 minutes of clot onset)) (seriousness criteria hospitalization, disability, medically significant and life threatening), OCULAR DISCOMFORT (poor, wavy eyesight) (seriousness criteria hospitalization, disability and life threatening), DYSARTHRIA (slurred speech) (seriousness criteria hospitalization, disability and life threatening) and FATIGUE (extreme exhaustion within 20-30 minutes of clot onset) (seriousness criteria hospitalization, disability and life threatening). The patient was hospitalized from 29-Mar-2021 to 01-Apr-2021 due to CEREBRAL THROMBOSIS, DYSARTHRIA, FATIGUE and OCULAR DISCOMFORT. The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) for Thrombosis, at an unspecified dose and frequency and AMLODIPINE for Thrombosis, at a dose of 5 mg. At the time of the report, CEREBRAL THROMBOSIS (blood clot in the brain (poor, wavy eyesight, slurred speech, extreme exhaustion within 20-30 minutes of clot onset)), OCULAR DISCOMFORT (poor, wavy eyesight), DYSARTHRIA (slurred speech) and FATIGUE (extreme exhaustion within 20-30 minutes of clot onset) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Ultrasound scan: unknown (Inconclusive) unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. While admitted, the patient had "a bunch of tests done" and was started on clopidogrel and amlodipine. After discharge, the patient had an ultrasound of the arteries in his head and neck, the results of which were not provided. The reporter stated that the patient had five known episodes (and one episode on an unknown date and time) that mimicked the events on 29March2021 except without the eyesight and speech problems. These occurred on 09April 021 around 1730, 26April 2021 around 1300, 13May2021 around 1600, 19May2021 around 0940 and 05June2021 around 0739. 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.

Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chills-Severe, Systemic: Flushed / Sweating-Severe, Additional Details: He called saying he had a lot of side effects. I recommended to go to urgent care or ER due to the generalized reaction.

Presented on 7/5 2 months of intermittent dyspnea and chest pain. Patient states it all began about 2 weeks after his first Moderna covid vaccine at mid/end of April. He developed exertional chest pain that felt like a squeezing. He was recommended a stress test at that time, but didn't have health insurance and wanted to wait until he was covered. He was put on a 5 day course of prednisone, that seemed to improve his symptoms and he felt back to baseline and was able to proceed with the 2nd moderna vaccine in the middle of May. Shortly after that, he developed intermittent dyspnea on exertion and chest tightness. It was difficult to take a deep breath in, felt like something was grabbing him when he tried to take a full deep breath. This has been becoming more constant over the last 2 weeks. Today, he was outside moving a lawnmower when his symptoms significantly worsened. He felt lightheaded. His wife convinced him to go to clinic, where he got a CTA that showed an saddle PE.

Pt received his moderna vaccines on 5/7/21 and 6/4/21. Prior to vaccination pt was working full time, active with no significant health concerns other than controlled blood pressure on 1 medication. After his first vaccine in the left arm he reported his arm was very sore, swollen, painful and red which lasted 3 days and he reported he could not move his arm due to pain. He reports for days after he then had extreme fatigue but then recovered and went on with his life. He got his 2nd dose of the vaccine on 6/4/21 and then was hospitalized on 6/16/21 with severe pancytopenia with pathology ultimately showing Acute myeloid leukemia, severe cellulitis of the L lower leg, and ultimately developed a left lower extremity deep vein thrombosis in that leg as well. Interestingly he injured his right leg just before vaccination and did not develop any cellulitis or poor healing in that leg just a week before his first dose. He remains hospitalized in guarded condition as of 7/9/2021 currently receiving chemotherapy treatment with decitabine and venetoclax and has receving multiple transfusions of blood, antibiotics, steroids and now anticoagulation.

I experienced weakness on my right side along with numbness/dizziness and a headache and went to see my doctor who informed me that I was having a stroke while I was at the clinic from work. I was immediately transported to the hospital by the fire department (feeling in my right side started to return while being transported to the hospital). I was admitted to the hospital and a series of tests were administered to find out the cause of my stroke. I was administered medication to reduce my blood pressure and cholesterol along with aspirin 81mg and Atorvastatin during my 3-day stay. I received a prescription for the medication upon being released from the hospital.

Patient had 1st dose of Moderna COVID-19 vaccine on 5/10/2021. Several days after he complained of "not feeling well" and fatigue, but did not give more specific symptomatology. On 5/17/2021 he had a sudden collapse at home and was transported to local hospital, where he was pronounced dead. Case accepted as medical examiner jurisdiction due to no apparent medical history and sudden death after vaccine administration. Full autopsy completed on 5/19/21 revealed obstructive pulmonary thromboemboli as cause of death, with lower extremity DVT. Both portions of the pulmonary thromboembolus and the DVT show organization, thus raising question of whether this process started before or after the vaccination. No known history of thrombophilic disorder, recent injury, or prolonged stasis/immobility. Not known to be current smoker. See below for additional autopsy information.

58 years old gentleman seen today. He has anticoagulant therapy is a 58-year-old gentleman otherwise quite healthy COVID-19 vaccination , received in May 2021. Approximately 6 weeks later He developed acute shortness of breath, tightness in the chest evaluated emergency room(6/16/2021).. 80 NGO was done and he was diagnosed of bilateral pulmonary embolism with subsegmental blood clots in both lungs. Placed on heparin and subsequently switch him to Xarelto charged home seen by cardiology with subsequent referral to us additional evaluation including the duration of anticoagulant therapy.

no known cardiovascular disease. He has been feeling less well recently . About 1 month ago, he received the 2nd dose of the Moderna COVID-19 vaccine, and he developed an erythematous, non-raised rash involving the upper and lower extremities. This has subsided, but still persists on his thighs. He presented to the emergency department on 7/3 with worsening dyspnea. and diagnosed with pulmonary emboli. After a week in the hospital deteriorating with the following the patient expired. Pulmonary embolism Active Problems: Cardiogenic shock NSTEMI (non-ST elevated myocardial infarction) Cardiomyopathy Acute liver failure without hepatic coma Rheumatoid arthritis Renal failure Aortic stenosis Lactic acidosis Cardiac arrest Cerebral anoxia

1st shot was in the left arm, 2nd shot was is in the right. Experienced overwhelming headache for several days from Friday afternoon through Monday Morning. Was given a CT scan and was found to have bleeding on the base of the brain and swelling so heavy, they could not determine where the leak was.

I felt very tired, no energy, couldn't really walk, I was out of breath. The day I went to the hospital they took me in an ambulance. I was admitted for a week and 3 days. They did blood work, x-rays, and stuff like that. They gave me two types of IV, Diltiazem in liquid form and sodium chloride. They diagnosed me with A fib, I was already an A fib patient.

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium

Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Tachycardia-Medium

Family notes patient started to have issues controlling blood glucose levels, prior to day of event patient had syncope episodes. 7/21/2021 patient had sudden cardiac arrest.

Started with symptoms similar to sinus infection. Stuffy nose, headache. Turned in to extreme spasms at base of neck/brain stem on 5/7. Telehealth visit diagnosis was Sinus Infection, given a Z-Pack. 5/8 pain was better throughout the day. Later in the evening pain worsened. 5/9 pain was severe. Continued with Z-pack and Tylenol and Advil. 5/10 pain was a 15 on scale of 1-10. Went to ER, blood pressure was extremely high and a cough had developed. Upon triage patient did not have a fever. After CT was done and was clear fever was checked and it was 102.3. Spinal Tap was performed and chest X-rays and bloodwork. Patient admitted to hospital for four days. Later diagnosed with double pneumonia, sepsis and viral meningitis. The Spinal Tap came back as borderline. Doctors felt the results were skewed due to Z-Pack.

After the second moderna vaccine on May 10th I started having stroke symptoms May the 11th dizziness could not walk straight in the morning of the 12th my speech was slurred and my mouth was crooked and could not swallow my food so my family rushed me to the emergency room at straub hospital where they diagnosed me having two strokes I remained in straub hospital for 5 days after once I was transferred to the rehab hospital for further stroke therapy where I am undergoing speech therapy occupational therapy and physical therapy and I'm walking with a cane because of the weakness in my right side of my body and am currently still an outpatient for further stroke therapy

Day of injection patient was experiencing fever and chills, also had sore arm. 2 days after the injection the patient was found dead

Large pulmonary embolisms in both lungs resulting from DVT in left leg. About 2-3 weeks after receiving 2nd Covid-19 vaccine shot, I started to have unusual breathing/fatigue symptoms. I did not seek any treatment for these symptoms but now believe that these were due to several small blood clots in my lungs. After another 3 weeks on May 10, 2021, I suffered a pulmonary embolism from a blood clot in my left lung. I still did not seek treatment. Two days later on May 12, I suffered a pulmonary embolism from a blood clot in my right lung. This was sufficiently painful that I went to the Emergency Room on May 13 where an MRI diagnosed blood clots in both left and right lungs. I was hospitalized until May 15 and now am required to take blood thinner Eloquis. In the hospital, a DVT was identified in my left leg as a source for the clots, though I had no reason to develop such a DVT. 10 years prior in 2011, I had a DVT resulting from a long plane flight but no symptoms since.

presented to ED 3 days post injection with c/o palpatations and some SOB,. Patient was found to be in AFib with RVR. Labs showed severe hypokalemia. Three doses of potassium chloride were administered with improvement of potassium. Patient underwent a DC cardioversion Patient also reported positive COVID 19 test on 1/15/2021

Systemic: no issues during observation period-Severe, Additional Details: patient received moderna immunization during the morning of 2/17/2021. patient was found by facility staff at 2:38pm with no pulse CPR was started, aed was used and ems was called. time of death 3:15pm

2/22/21 positive for covid and flu b 2/23/21 requested bamlanivimab infusion d/t not eating and weakness 2/24/21 emergency room after infusion: HPI 59 y.o. male who presents with left-sided posterolateral chest pain. Pain has been present 4-5 days time. It is worsened by deep inspiration or coughing. The patient has also had nausea and vomiting. Fever has been as high as 101.6°. He was tested and found to be positive for both influenza and COVID-19. He denies anterior or central chest pain dyspnea or orthopnea palpitations sputum production. 3/1/21 emergency room for worsening condition: 59 y.o. male presented to the emergency room with a several day history of intractable nausea vomiting and severe weakness. The patient does have a known history of recent coronavirus (COVID-19) infection. He was diagnosed on February 22nd and did receive Bamlanivimab. He started feeling a little bit better after this, but a few days ago started having increasing weakness and nausea/vomiting. He called me this morning and stated he had been unable will keep anything down for several days and was extremely weak and I asked that he go to the emergency room. In the emergency room is lactic acid was found to be elevated. His CT scan of his chest with contrast showed severe coronavirus (COVID-19) pneumonia. This was run after he was found to have an elevated D-dimer. He was found to be extremely weak and deconditioned. His oxygen saturations at times or found to be in the low 90s. Because of all of this he will be admitted and treated for sepsis from coronavirus (COVID-19).. 3/2/21 currently remains hospitalized

Death Narrative: Death was not determined to be related to COVID vaccination. COVID vaccination (dose 1) occurred on 1/27/21 with no noted side effects. Death occurred on 2/14/21.

Development of blood clots in lower right leg causing swelling and pain. Pt. visited doctor who prescribed an ultrasound which revealed the clots. Doctor has now put pt. on blood thinners indefinitely.

cardiac arrest Narrative: Per medics, Patient was gardening when he stated he felt dizzy and collapsed. Wife started CPR until medics arrived. Patient arrived at the hospital after 20min of pulseless V tach and 10 min of PEA.

Patient had no reactions to first vaccine post dialysis. The morning after the patient received the vaccine, patient expired at home. Police stated that the death was vaccine related.

Patient did not have any symptoms at the time of covid vaccination or during the observation period. Patient started having left arm and foot numbness the day after moderna covid vaccination. He developed left facial droop 2 days after vaccination and went to local ER on 02/28/2021. CT/MRI revealed acute right occipital and right thalamic infarct and old left occipital infarct. Carotid US showed fully occluded left carotid. Patient smoked for 40 years and quit March 2021 and previously used crack cocaine and quit 1 year ago. He was discharged from hospital on amlodipine, clopidogrel, atorvastatin, and aspirin, which were new medications. Patient has returned to work for over 2 weeks.

Brought in from ED, family concerned for altered mental status, hyperthermia, Tmax in 105. The patient stated that after the covid-19 vaccine on Friday, he experienced acute onset of R shoulder pain, constant, associated with decreased ROM. On PM Monday, he noticed first episode of chills, that lasted a few minutes, accompanied with sweating. This episode recurred 4 times over the week, then the family started noticed the patient was unable to answer questions and was somnolent. Blood Cultures in the ED were positive for MRSA 2:2. He was positive for endocarditis (previous dental work). Acute metabolic encephalopathy due to severe sepsis most likely 2/2 MRSA bacteremia complicated by NSTEMI and AKI in setting of newly diagnosed aortic valve endocarditis complicated by septic emboli to the bilateral cerebral hemispheres

Patient received vaccine at hosptal. Presented to ER on 3/9 due to shortness of breath. Patient received vaccine the day prior (3/8). Patient states that shortness of breath started a few hours after COVID vaccine. Dx in ER: Acute on chronic CHF, Dyspnea, elevated BNP level, acute resp failure with hypoxia. H&P states that patient felt fever, chills, N/V, joint pain and shortness of breath. CXR had bilateral opacities/pleural effusion- likely pulmonary edema. Patient is still currently admitted- appears more related to fluid overload/CHF.

At approximately 30 minutes post vaccine, pt felt short of breath, had throat closing sensations, and had hives, EMS was activated. En route to the ED, EMS gave the patient epinephrine 0.3 mg IM, benadryl 50 mg, and a breathing treatment.

Husband and wife came in 4/5 and received their COVID vaccines at 11am. They waited the 15 minutes to check for reactions and were unsymptomatic when time was up. The pharmacy did a courtesy call around 3:15 pm on 4/7 to check in with them and see how they were feeling. The wife stated that her husband had passed away the night of 4/5. Wife stated that they were getting ready to go to bed and husband felt hot and shaky so he laid in front of a fan. Wife eventually had to do CPR and stated that she thinks that he passed away during the time while they were waiting for EMS, which took about 45 minutes. Patient was pronounced dead night of 4/5. Wife stated that patient has a history of heart problems including hypertension and multiple stents place and that she does not think the vaccine had to do with her husband's death.

Woke up with A-fib (6:00 am) on 3/29/2021. Had old medication on hand Metoprolol tartrate 50 mg Took 50 mg at 9:00 am and then at 9:00 pm. Took same dose next day (3/302021). Third day dropped dose to 25 mg every 12 hours; continued with that for a total of 3 days. Then dropped to 25 mg per 24 hours for 2 days total. By bed time of same day A-fib started (10:30pm) heart beat was not in A-fib, but erratic - skipped beats, long pauses. Waking up the next day (3/30/2021) rhythm was mostly normal with occasional skips or pause. This has slowly stabilized to normal all the time about a week after A-fib started. Note: I have had 2 pulmonary vein ablations. The last one was about 7 years ago. I have been in normal rhythm ever since except when I contracted the flu in January 2018. I was treated at that time with the Metoprolol and normal rhythm was restored in about a day.

Stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 038AZIA) for COVID-19 immunisation. The patient's past medical history included No adverse event (No medical history reported). On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-Mar-2021 to 25-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) was resolving.; 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.

admitted to hospital on 3/25/21 for Cholelithiasis and during the workups had an Ultrasound - VL Lower Ext Veenous Duplex Bilateral study on 3/26/21.

Extensive bilateral numerous large central pulmonary emboli including a saddle-type embolism. Right heart strain with the reflux of contrast into the inferior vena cava (per CT angio Chest PE protocol) Started on Eliquis, has follow up ECHO today

sent to the emergency room because his doctor thought he was having a stroke.; blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (Medical history was not reported.). Concomitant products included DULAGLUTIDE (TRULICITY) for an unknown indication. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) (seriousness criteria hospitalization and medically significant) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 14-Apr-2021 due to CEREBROVASCULAR ACCIDENT and PURPURA. At the time of the report, CEREBROVASCULAR ACCIDENT (sent to the emergency room because his doctor thought he was having a stroke.) and PURPURA (blood vessels had burst in the brain, the hands, and the neck (describes it looking red, purple, like a chemical burn)) outcome was unknown. The lot number of the second vaccine was thought by the patient to be 0L161521A but patient was unsure. The patient was hospitalized for one day due to the events. Magnetic resonance imaging (MRI) and computerized axial tomography (CAT) scan were performed (results not provided). Treatment information was not provided. 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 US-MODERNATX, INC.-MOD-2021-080378, US-MODERNATX, INC.-MOD-2021-080378 (E2B Linked Report). This case was linked to MOD-2021-080340 (Patient Link).; 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-2021-080378:Physician case -MODERNATX, INC.-MOD-2021-080378:

5 days after receiving Moderna vaccination suffer acute myocardial infraction. Requiring stent placement of the right coronary artery. Recovering from MI.

Pneumonia; Atrial Fibrillation; Heart damage; High Blood Pressure; Chills; Body aches; Fever; Very sick; Breathing difficult; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PNEUMONIA (Pneumonia), ATRIAL FIBRILLATION (Atrial Fibrillation), HEART INJURY (Heart damage), DYSPNOEA (Breathing difficult), HYPERTENSION (High Blood Pressure), ILLNESS (Very sick), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced DYSPNOEA (Breathing difficult) (seriousness criterion hospitalization prolonged) and ILLNESS (Very sick) (seriousness criterion hospitalization). On 09-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion hospitalization), ATRIAL FIBRILLATION (Atrial Fibrillation) (seriousness criterion hospitalization), HEART INJURY (Heart damage) (seriousness criterion hospitalization), HYPERTENSION (High Blood Pressure) (seriousness criterion hospitalization), CHILLS (Chills) (seriousness criterion hospitalization), MYALGIA (Body aches) (seriousness criterion hospitalization) and PYREXIA (Fever) (seriousness criterion hospitalization). The patient was hospitalized on 09-Apr-2021 due to ATRIAL FIBRILLATION, CHILLS, DYSPNOEA, HEART INJURY, HYPERTENSION, ILLNESS, MYALGIA, PNEUMONIA and PYREXIA. At the time of the report, PNEUMONIA (Pneumonia), ATRIAL FIBRILLATION (Atrial Fibrillation), HEART INJURY (Heart damage), DYSPNOEA (Breathing difficult), HYPERTENSION (High Blood Pressure), ILLNESS (Very sick), CHILLS (Chills), MYALGIA (Body aches) and PYREXIA (Fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Chest X-ray: Inconclusive. In April 2021, Echocardiogram: Inconclusive. In April 2021, Ejection fraction: 35 percent. In April 2021, Electrocardiogram: Inconclusive. In April 2021, Heart rate: (High) increased. In April 2021, Laboratory test: (Negative) tested for viruses, Covid-19 and other Infectious diseases all came back negative. In April 2021, Magnetic resonance imaging: Inconclusive. In April 2021, SARS-CoV-2 test negative: (Negative) Negative. In April 2021, Viral test: (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was fine until 05-Apr-2021 and felt very sick, with trouble breathing, body aches, fever, chills, pneumonia and heart damage. He went into atrial fibrillation, high blood pressure, high heart rate, and an ejection fraction of 35%. He had an EKG, echocardiogram, MRI, and chest x-ray. He was tested for viruses, COVID-19 and other Infectious diseases all came back negative. He went to the emergency room on 09-Apr-2021 and was admitted to the hospital for 6 days. Concomitant product use was not provided by the reporter. Treatment information was not provided. Very limited information has been provided at this time. Further information has been requested. Based on the current 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-2021-081630, US-MODERNATX, INC.-MOD-2021-081642 (Patient Link).; Sender's Comments: Very limited information has been provided at this time. Further information has been requested. Based on the current information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

We were notified by company on 4/28/21 that patient had died between the afternoon of 4/23 and Saturday morning 4/24/21. No other information was given to us.

Acute hypoxemic respiratory failure; Hypokalemia; Lactic acidosis; Muscle weakness (generalized); Weakness

The patient developed a blood clot in the left calf 2 weeks after the first dose of Moderna COVID vaccine, which required treatment with Eliquis 5 mg twice daily. The patient also reported hearing loss that needed treatment with a tapering steroid protocol. The sense of hearing did not recover after the most recent loss event.

TIA Stroke (transient ischemic attack); loss of memory for 15 minues could not spell the word "side" nor "effect"; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history was reported. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) (seriousness criterion medically significant) and AMNESIA (loss of memory for 15 minues could not spell the word "side" nor "effect"). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA Stroke (transient ischemic attack)) and AMNESIA (loss of memory for 15 minues could not spell the word "side" nor "effect") 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. Treatment medication included vitamin-c and fish oil 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.

12h after administration, patient developed dysphagia and dysarthria with RL facial droop. Diagnosed with acute ischemic CVA of left corona radiata.

Became extremely disoriented about 10 hours after vaccine. Could not "find"words, speaking complete nonsense. Felt very, very out of it and confused. Fell asleep and felt still confused but not as badly and could talk. Arm and mouth felt tingling / numb. Went to work but left as felt similar symptoms to mini-stroke 15 years previous. Went to urgent care and then ER. ER stated EKG was abnormal indicating heart attack at some point.

Admitted with moderate pulmonary embolism 9 days after vaccine, not sure it's related. He had a long travel prior as well and could be cause for thromboembolism too.

PATIENT'S SPOUSE REPORTS PATIENT WAS ADMITTED TO HOSPITAL ON 031421 FOR SEVERE SEPSIS WITH ACUTE ORGAN DYSFUNCTION, ACUTE METABOLIC ENCEPHALOPATHY, BILATERAL PNEUMONIA AND ACUTE HYPOXEMIC RESPIRATORY FAILURE THEN PASSED AWAY ON 3/27/21.

Atrial Fibrillation episodes became much more frequent and longer lasting over the course of the next 24 days.

First dose was on 01/09/21 no reaction 2nd dose was on 02/06/21 cold and flu symptoms for 1 day. With in 2-3 weeks increase abdominal pain, and discomfort, I thought it was a Crohn?s flair, so I just tried to wait it out. Early April I went to the ED, for eval and treatment , it was discovered via CT of abdomen I developed Portal Vein Thrombosis, admitted for anti coagulation, and further studies like JAK 2. Place on heparin, followed by lovonox SQ injections, and bridged to Pradaxa. Symptoms returned after a couple of weeks, and persisted, ,back tp the hospital new CZt scans, showed increase in Portal vein thrombosis, but now included splenic vein thrombosis, and mesenteric vein thrombosis. Went back on anticoagulation therapy, transferred to hospital for Intervention Radiology procedure to have a portal vein shunt placed in, and thrombectomy of the spleen, and mesenteric veins. Had bleeding issues, returned to OR for a second IR procedure, and finally a 3rd procedure of splenectomy, blood transfusion for hemorrhagic shock. Discharged on warfarin, and lovonox as needed

Atrial fibrillation; Blacked out; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LOSS OF CONSCIOUSNESS (Blacked out) and ATRIAL FIBRILLATION (Atrial fibrillation) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included DVT. Concurrent medical conditions included Chronic pain and Spinal stenosis lumbar. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (Blacked out) (seriousness criterion medically significant). On 12-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant). At the time of the report, LOSS OF CONSCIOUSNESS (Blacked out) and ATRIAL FIBRILLATION (Atrial fibrillation) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Feb-2021, Blood test: inconclusive (Inconclusive) Inconclusive. On 12-Feb-2021, Chest X-ray: abnormal (abnormal) Abnormal. On 12-Feb-2021, Electrocardiogram: abnormal (abnormal) Abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication used was not provided. No Treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-194935 (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.

Pt was admitted to hospital with acute respiratory failure on 4/15/21 after receiving first dose of vaccine on 4/8/21. Per guidelines, all hospitalizations are reported

Patient received 2nd Moderna vaccination on 6/14/2021. Had labs drawn on 6/22 notable for AKI (Cr of 3.55 above baseline 1.6). Also had R calf pain and swelling. Presented to ER and found to have acute DVT of RLE femoral and popliteal veins. Given IVFs and AKI improved, and started on Apixaban for RLE DVT

suffered a massive heart attack; Feeling of faintness; Palpitations; Shortness of Breath; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (suffered a massive heart attack), SYNCOPE (Feeling of faintness), PALPITATIONS (Palpitations) and DYSPNOEA (Shortness of Breath) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-May-2021, the patient experienced SYNCOPE (Feeling of faintness) (seriousness criterion medically significant), PALPITATIONS (Palpitations) (seriousness criterion medically significant) and DYSPNOEA (Shortness of Breath) (seriousness criterion medically significant). On 09-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (suffered a massive heart attack) (seriousness criteria death and medically significant). The patient died on 09-Jun-2021. The reported cause of death was suffered a massive heart attack. It is unknown if an autopsy was performed. At the time of death, SYNCOPE (Feeling of faintness), PALPITATIONS (Palpitations) and DYSPNOEA (Shortness of Breath) outcome was unknown. No concomitant information was reported. No treatment information was reported. Action taken with mRNA-1273 was not applicable. A Patient called to report that two weeks after the first dose of the Moderna Covid-19 vaccine on 27-May-2021, his boyfriend began to experience palpitations, shortness of breath and feeling of faintness. The caller stated that her boyfriend did not want to go to the emergency room and only set an appointment with his Health Care Provider, but on the 09-Jun-2021, the day that he was going to the appointment, he suffered a massive heart attack and passed away. This is a case of sudden death in a 59-year-old male subject, who died 23 days after receiving first dose of vaccine. Very limited information has been provided at this time. Patient medical history was not provided.; Sender's Comments: This is a case of sudden death in a 59-year-old male subject, who died 23 days after receiving first dose of vaccine. Very limited information has been provided at this time. Patient medical history was not provided.; Reported Cause(s) of Death: suffered a massive heart attack

Admitted to hospital -- almost lost leg -- almost died -- 16 hours of surgery to clear blood clotting in left leg.

Blood clotting in left leg that got so serious that I went to the ER and experienced four days of surgery.

Blood clot; feels like his skin is going to rip open; arm was a little sore; Left leg was swollen, Twice the size of his right leg; Really tight; Very uncomfortable; Can't walk dog; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033c21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, the patient experienced PERIPHERAL SWELLING (Left leg was swollen, Twice the size of his right leg), MUSCULOSKELETAL STIFFNESS (Really tight), DISCOMFORT (Very uncomfortable) and GAIT DISTURBANCE (Can't walk dog). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion medically significant), SKIN DISORDER (feels like his skin is going to rip open) and PAIN IN EXTREMITY (arm was a little sore). At the time of the report, THROMBOSIS (Blood clot), PERIPHERAL SWELLING (Left leg was swollen, Twice the size of his right leg), MUSCULOSKELETAL STIFFNESS (Really tight), DISCOMFORT (Very uncomfortable), GAIT DISTURBANCE (Can't walk dog), SKIN DISORDER (feels like his skin is going to rip open) and PAIN IN EXTREMITY (arm was a little sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was not given No concomitant medication information was 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.; 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.

Died of cardiac complications, heart attack, stroke or blood clot were all mentioned. Collapsed at work, grabbing his chest. Was revived 5 times before dying. Doctors mentioned his chest was oddly discolored so they thought blood clot but ekg was abnormal as well so heart attack was also mentioned.

three days before the patent died he started having sloop apnea and for several days before the event he started having memory problems and the day before the event he started having a issue with his heart where he just said his heart felt irregular.

1st COVID dose was 5/14/21 and 2nd COVID dose was6/29/21 he started w/ right calf pain on or about 6/21/21. he came to PCP for appointment on 7/12/21 and a sonogram was ordered to r/o DVT. he was unable to get to hospital until 7/13/21 and the songram revealed right DVT from groin to knee

admitted on 4/1/21 for respiratory failure, COVID positive after completing 2 dose vaccine series, requiring ICU cares. expired in the ICU.