Moderna

Day 2 (12/29/20): Fever (<100 degrees), Mild muscle aches, Fatigue Day 3 (12/30/20): Fatigue, Muscle aches Day 4 (12/31/20): Alternating chills and profuse sweating starting at 8am, Full body flushing, Grand Mal Seizure at 4:30pm

DVT in right leg 4 days after injection, severe pain in thigh/calf, difficulty walking Placed on Xarelto 15mg 2X daily for 21 days and then 20mg daily for 9 days. Next Doctor visit is 1/26/2021 at 9:00am Next scheduled Covid 19 vaccine is scheduled for 2/5/2021 at 7:15am

DVT blood clot; A spontaneous report was received from a 60-year-old male consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and developed deep vein thrombosis (DVT) blood clot. The patient's medical history, as provided by the reporter, included factor V Leiden, enlarged prostate, DVT, pulmonary embolism and hypertension. Concomitant medications reported included valsartan, alfuzosin, and acetylsalicylic acid. On 07 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 11 Jan 2021, the patient developed DVT blood clot and experienced leg pain so intense that he could not walk. A doppler exam showed the DVT was from the top of the calf to mid-thigh. Treatment for the event included a rivaroxaban starter pack with dose tapering. Action taken with mRNA-1273 in response to the event deep vein thrombosis (DVT) blood clot was not reported. The outcome of the event, DVT blood clot, was unknown.; Reporter's Comments: This case concerns a 60-year-old male patient with a relevant medical history of factor V Leiden, DVT, pulmonary embolism and hypertension who received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. Patient experienced the medically significant unlisted event of Deep vein thrombosis approximately four days after administration of vaccine. Treatment for the event included rivaroxaban. Based on the temporal association between the use of the product and the event occurring after receiving the vaccine, a causal relationship cannot be excluded and the event of Deep vein thrombosis is possibly related to the product. Of note, the patient's underlying Factor V Leiden which predispose to developing abnormal blood clots, and prior medical history of DVT with pulmonary embolism are considered risk factors to the occurrence of the event.

Fever and diaphoresis 2/12/21, followed by neck pain starting 2/13/21. Hospital admission with sepsis with right-sided cervical lymphadenitis without abscess 2/17/21. Treated with Unasyn.

Deceased received second Moderna dose on 3/11/2021 at unknown location and unknown time. Complained of 'side effects' which are unclear at this time. Had a sudden witnessed cardiac event on 3/14/2021 and was rushed to a local emergency department. Diagnosed with ST elevation MI and could not be fully resuscitated.

3/4/21 out of breath , peaked 3/08/21. 3/09 pain in right lower leg Hospitalized 4 days - 5 hour procedure for Acute DVT and Acute Saddle pulmonary Embolus

pt presented to emergency department on 3/6/21 with change in mental status first noted at 10am; per reports, his employees noticed he was not acting himself, and he went home to rest; ED notes indicate he reported a right sided headache and was confused and had difficulty with word finding, but did say, "I can't remember anything." Pt also had elevated BP in ED; he was able to follow some commands but continued to have difficulty forming words and hand squeeze noted to be weaker on the right side and he could not keep his right leg elevated; pt fell asleep during exams; patient's neice, who is an ED physician, reported that pt had become encephalopathic with severe DKA and AKI in the past; he was started on IVF and insulin drip and transferred from ED to ICU; he went into rapid atrial fibrillation and was then started on diltiazem drip; cardiology was consulted, adjusted medications, and anticoagulation was not recommended as the episode was transient; he started spiking fever with Tmax of 101; blood cultures were drawn and he was started empirically on ceftriaxone, vancomycin, and acyclovir; IR was consulted for LP with results showing WBC 123, RBC 41, 90% neutrophils, glucose 186, protein 100; he was seen by ID and noted that CSF profile was consistent with most likely an early viral infection

The day after the shot 3/9/2021 pt had 104 degree fever and shortness of breath and chest pain. This continued for a couple days. By 3/13/2021 pt went the hospital and he was confirmed to be having an active heart attack.

Patient called me this morning to advise me that he experienced heart attack symptoms 45 minutes after receiving his first does of Moderna and self-admitted to the ER. ER confirmed that he had experienced a heart attack and had one clogged artery. He asked about reporting and I told him I would report to VAERS on his behalf as his doctor and the hospital refused to do so. He asked whether or not I would suggest he receive his second dose and I suggested that he speak with his cardiologist and doctor to make that decision. I also informed him that he can search VAERS to see what the other reactions may have been that were reported. Patient indicated that he felt well and has recovered.

I am a physician working for the state. I have a history of PAF and had tow prior pulmonary vein isolation ablations in November 2019 and July 2020. I was atrial fibrillation free for 7 months, no medications, until two days after my second Moderna COVID-19 vaccine. Since then, i have had recurrent atrial fibrillation and some episodes of atrial flutter which my cardiologist believes could be related to the vaccine.

anaphylaxis requiring intubation, stable after extubation and discharged from hospital intubation required the morning after he got the vaccine at around 11am the previous day

Patient had history of COPD, MS. Treated for pneumonia in February. Recently discharged from the hospital 2/24/2021 for pneumonia. Seen in the office on 3/1/2021 as a follow up. Given Covid vaccine on 3/15/2021. Patient was reportedly feeling well the day of vaccine. Patient collapsed on 3/19/2021 and died.

Patient with prior Covid infection Nov 2020, fully recovered, received first dose Moderna vaccine on 3/13/21 and next day developed body aches, fevers, chills, shortness of breath. Admitted 3/17/21 due to hypoxia, had ground glass opacities on CT. SARS-CoV-2 PCR negative x 2. Vigorous immune response could have caused lung inflammation and hypoxia, similar to a covid infection, but from the vaccine. 60YM with a history of a chronic inflammatory arthritis on methotrexate, hospitalization in November 2020 with Covid pneumonia, he was discharged on 1 to 2 L of home oxygen, and reports that he was told by his PCP about a month after discharge that he was able to come off the oxygen as his oxygen saturations had normalized. He returned to his usual state of health and activity with no issues until he received the first dose of his Moderna covid-19 vaccine through his primary care office on 3/13. The next day he developed arm pain and then progressive body aches, headaches, fevers, chills, and shortness of breath. He presented to the ER and was found to be febrile with hypoxia and admitted for treatment and evaluation. Acute hypoxemic respiratory failure with ground glass opacities on CT : oxygen 87% on RA in ER, 84% on room air 3/19, resolves with oxygen support of 2lpm. CTA was negative for pulmonary embolism. SARS-CoV-2 PCR negative x2 as well as respiratory virus panel, CT shows ground glass opacities, patient was started on ceftriaxone and doxycycline for empiric treatment for possible community-acquired pneumonia, although procalcitonin was negative. BNP was elevated at 458, so an echocardiogram was performed which showed a normal EF, and grade 1 diastolic dysfunction. Patient was given 2 doses of furosemide during the hospitalization and BNP normalized. Patient was started on prednisone to calm down a possible inflammatory response triggered by the COVID-19 vaccine in a person who likely already has antibodies, causing hypoxia. With this patient significantly improved and at discharge is on room air at rest, but still requires 2 L/min with exertion. CRP was markedly elevated, supporting an inflammatory process. Autoimmune lung disease panel was sent and is in process at time of discharge. Patient requested discharge home, Discharged on a slow prednisone taper to avoid rebound with abrupt discontinuation of steroids. Patient will complete 2 additional days of Augmentin and doxycycline at discharge.

stroke; couldn't walk; Breathing was shower; eye sight was been worse; bad headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 245A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product AMLODIPINE for an unknown indication. The patient's past medical history included No adverse event (No medical history reported. ). On 24-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started AMLODIPINE (unknown route) at an unspecified dose. On 25-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant), GAIT DISTURBANCE (couldn't walk), RESPIRATORY RATE DECREASED (Breathing was shower), VISUAL IMPAIRMENT (eye sight was been worse) and HEADACHE (bad headaches). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), GAIT DISTURBANCE (couldn't walk), RESPIRATORY RATE DECREASED (Breathing was shower), VISUAL IMPAIRMENT (eye sight was been worse) and HEADACHE (bad headaches) had not resolved. Not Provided Treatment for the event included clonidine, aspirin (81mg) to try to thin the blood, losartan, atorvastatin and cyclobenzaprine. Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

On 4/7/2021 I was hospitalized with a heart attack due to an embolism in my LAD. Had to be re-stented. In ICU for 5 days- regular hospital 2 and discharged after total of 7 days

Purpuric rash; Accelerated hypertension; Systolic congestive heart failure exacerbation; nausea; Generalized non-itchy, non-painful rash a day after receiving the vaccine; Thrombocytopenia; few loose stools; Fever; Chills; This literature-non-study case was reported in a literature article and describes the occurrence of RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), THROMBOCYTOPENIA (Thrombocytopenia), PURPURA (Purpuric rash), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation) and NAUSEA (nausea) 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. Purpuric Rash and Thrombocytopenia After the mRNA-1273 (Moderna) COVID-19 Vaccine. Cureus. 2021;13:4 Previously administered products included for Viral hepatitis C: Interferon. Concurrent medical conditions included Viral hepatitis C, Chronic kidney disease (Stage 4, with a baseline creatinine of 3 mg/dl.), Uncontrolled hypertension, Systolic heart failure (Ejection fraction of 35%.) and Liver cirrhosis. 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 RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine) (seriousness criterion hospitalization), THROMBOCYTOPENIA (Thrombocytopenia) (seriousness criteria hospitalization prolonged and medically significant), PURPURA (Purpuric rash) (seriousness criterion hospitalization), ACCELERATED HYPERTENSION (Accelerated hypertension) (seriousness criterion hospitalization), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation) (seriousness criterion hospitalization), NAUSEA (nausea) (seriousness criterion hospitalization), DIARRHOEA (few loose stools), PYREXIA (Fever) and CHILLS (Chills). The patient was hospitalized for 3 days due to ACCELERATED HYPERTENSION, ACUTE LEFT VENTRICULAR FAILURE, NAUSEA, PURPURA, RASH and THROMBOCYTOPENIA. At the time of the report, RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), THROMBOCYTOPENIA (Thrombocytopenia), PURPURA (Purpuric rash), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation), NAUSEA (nausea), DIARRHOEA (few loose stools) and CHILLS (Chills) outcome was unknown and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. In March 2021, Alanine aminotransferase: 90 (abnormal) 90 U/L. In March 2021, Aspartate aminotransferase: 196 (abnormal) 196 U/L. In March 2021, Bilirubin conjugated: 5 (abnormal) 05 mg/dl. In March 2021, Blood albumin: 1.9 (abnormal) 1.9 gm/dl. In March 2021, Blood alkaline phosphatase: 216 (abnormal) 216 U/L. In March 2021, Blood creatinine: 3.2 (Inconclusive) 3.2 mg/dl. In March 2021, Blood lactate dehydrogenase (122-222): 381 (High) high. In March 2021, Chest X-ray: abnormal (abnormal) Findings consistent with pulmonary edema.. In March 2021, Glomerular filtration rate: 19 (Low) eGFR - 19. In March 2021, International normalised ratio: 1.13 (Inconclusive) INR - 1.13. In March 2021, Platelet count: 84000 (Low) 84000/uL. In March 2021, Serum ferritin (24-336): 2400 (High) 2400 mg/ml. In March 2021, Ultrasound liver: abnormal (abnormal) Ultrasound of the liver confirmed liver cirrhosis.. 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 considered THROMBOCYTOPENIA (Thrombocytopenia) and PURPURA (Purpuric rash) to be possibly related. No further causality assessments were provided for RASH (Generalized non-itchy, non-painful rash a day after receiving the vaccine), ACCELERATED HYPERTENSION (Accelerated hypertension), ACUTE LEFT VENTRICULAR FAILURE (Systolic congestive heart failure exacerbation), NAUSEA (nausea), DIARRHOEA (few loose stools), PYREXIA (Fever) and CHILLS (Chills). Concomitant medications were not provided. Hepatitis panel showed a heavy viral load of more than 11 (no reference range was provided). Per reporter, on presentation to the emergency room the patient was afebrile, had a blood pressure 183/106 mmHg, pulse rate of 82 per minute and oxygen saturation of 96% on room air. Treatment included anti-hypertensives and intravenous diuretics. On day 3 of hospitalization, patient left the hospital against medical advice. Based on reporter's causality, the event purpuric rash is assessed as possible related to mRNA-1273. However, the reporter also indicated it could have been precipitated by the underlying thrombocytopenia, liver cirrhosis and Hepatitis C infection. Very limited information regarding the other reported events has been provided at this time. Further information has been requested.; Sender's Comments: Based on reporter's causality, the event purpuric rash is assessed as possible related to mRNA-1273. However, the reporter also indicated it could have been precipitated by the underlying thrombocytopenia, liver cirrhosis and Hepatitis C infection. Very limited information regarding the other reported events has been provided at this time. Further information has been requested.

In summary this is a 60 year old male who was normal functioning presenting to hospital 4 days following second moderna COVID-19 vaccination with AKI, Rhabdomyolsis, Confusion/Delirium with agitation, multiple acute brain infarcts, DVT, and multilobar pulmonary embolism. 24 hours following vaccination patient began to become slightly confused while driving his wife to her vaccine appointment. Symptoms progressed and included severe fatigue and muscle aches. Patient was taking tizanidine and oxycodone to manage muscle / body aches which had been prescribed for his chronic back pain issues. Patient was noted to be excessively sleeping, and also had fallen twice between vaccination and hospital presentation. 4 days following vaccination he presented to the emergency department with severe lethargy and confusion. He was admitted with presumption of overdose of medication, given activated charcoal. A CT of the head (4/11/2021) was completed which demonstrated No acute intracranial hemorrhage, extra-axial fluid collection or acute territorial infarct. Suggestion of a chronic lacunar infarct involving the left lentiform nucleus. Regions of low attenuation involving the cerebellar hemispheres, right greater than left, which, allowing for image degradation secondary to patient motion artifact, are likely artifactual in nature; follow-up is recommended to assess for stability/resolution.For first several days patient suffered delirium with agitation, he was disoriented to place and time. CK on admission, 4/11/2021, was 17,086, indicating rhabdo. Creatinine on admission was 4.39, indicating new acute renal failure. Liver enzymes were elevated with AST of 477 and ALT of 218. PT was 10.6, INR 0.99. ABG demonstrated metabolic acidosis with pH of 7.22, co2 45, HCO3 18.4. Over several days his mentation improved however was noted to still need light supplemental oxygenation. Because of the delirium a brain MRI was completed on 4/13/2021, which demonstrated acute ischemic infarcts on DWI sequence noting bilateral, right greater than left, acute cerebellar infarcts. Small acute lacunar infarcts at bilateral basal ganglia/genu internal capsule. Due to the infarcts a stroke workup was completed. Carotid duplex was performed and notable for only small bilateral carotid plaque. Renal ultrasound unremarkable. A CTA of the chest was completed on 4/15/2021 for continued hypoxemia, need for nasal cannula to maintain spo2 saturation. Findings included multilobar pulmonary embolism. Venous duplex dopplers of the lower extremities were also completed on 4/15/2021 demonstrated an isolated left popliteal vein DVT. No evidence of right leg DVT. Over several days CK and Cr returned to baseline / normal levels. He remains hospitalized and is still undergoing treatment.

Received vaccine, and hour later felt nauseous and dizzy, went home, laid down and had shallow breathing, next day(3/24/21) couldn't do much, fatigued, legs felt like giving out, midnight on 25th he jumped out of bed to check on animals before he made it to the door he felt really bad and had to sit down, wife checks him and speech was slurred, face was droopy, 40m later went to emergency room, emergency room said he was fine in grants. Hospital said he had a stroke possible bell's palsy. Still not doing well headaches, right side of body weak, blurry vision which is getting worse, one day doing well next moment he's not.

2 lower- left leg Superficial blood clots; ~ a DVT Deep Vein Thrombosis per Ultrasound on 4/12/21, was diagnosis ; ER Dr. on 4/12/21 prescribed Eliquis 60 day Treatment.

Day after getting vaccine shot i had a scheduled dr appointment with my dr, she noticed my heart not beating regularly during examination she gave me EKG it showed my heart was in AFIB, (i never had any heart issues) sent me immediately to cardiologist who confirmed AFIB, and had me wear heart mointer later that evening mointer notified the cardiologist my heart was racing at 200 bpm, i was told to go immediately to emergency room , all test were negative EKG was normal, blood work normal, i was put on medication Amiodarone and Eliquis for 40 days , then taken off these two medications when Heart Mointering results showed no other episodes of AFIB, it should also be noted I didn?t feel any symptoms of AFIB even when my heart was racing at 200 bpm.

Four hours after the 2nd shot he had a stroke. The ambulance took him to Hospital where he was transferred to another facility. He had to be in the hospital for 7 or 8 days. He is partially paralized on his left side. His symptoms were dizziness and collapse. Sweating profusly. He will have to go undergo extensive physical therapy, occupational therapy, doctors visits, and loss of his ability to work, or maintain any sort of regular daily living without assisstance. For the rest of his life. He was also the primary support of the household.

Afib and now an irregular heart rhythm, a never before heart arrhythmia.. Also newly diagnosed PVC.. And constantly breaking out in cool clammy sweats and shortness of breath. Never had this issue until 2 weeks after my first moderna vaccination

COVID-19 symptoms starting 3/25/21, hospital admission 4/14/21 - 4/24/21 with hypoxia, multiple pulmonary emboli

After second dose 3/10/21 started having chills, myalgia. On 3/24/21 hospitalized with respiratory failure, kidney failure, heart attack, sepsis and liver malfunction. Had subsequent GI bleed

On 4/9/20 patient developed bilateral numbness and tingling to arms, hands, feet and legs. Went to ED on 4/16/20 Labs and CT head were normal. Had decreased strength and sensitivity in extremities and Babinski's were upward going. Discharged to home without medication and to F/U with PCP in 4-6 days. Saw PCP on 4/20/21. He had S&G hyeresthesia, + Rhomberg, failed tandem walk, and dysdiadochokinesia. Neuropatic pain in shoulders, arms, legs, hands, and feet with weakness in hands and arms and sensory loss in left leg. Was unable to get immediate MRI so patient was admitted directly to hospital. MRI showed concern for transverse myelitis felt to be secondary to Covid 19 vaccine. He will not get second dose. Improved to near baseline with treatment of high dose steroids. He also had an STEMI and was taken to the Cath lab where they found 50% blockage in a coronary artery. They felt STEMI was caused by spasm. Pt was discharged home on 4/26/21 and is having physical therapy to help regain his mobility.

Pt developed symptoms of COVID-19 and was placed on bedrest on 03/28/2021. The patient was sent to local ED on 04/01/2021 and then tested for COVID-19 with a positive result. Patient was intubated and placed on ventilator. Pt. spent 22 days in ICU. Pt expired on 04/22/2021 with cause of death listed as MODS and COVID-19 related PNA. Related causes of death were listed as HTN, DMII, and ARDS.

This 60 year old black male received the Covid shot on 4/15/21 and went to the ED on 4/23/21 with the following diagnoses listed below and died on 4/27/21. K92.2 - Gastrointestinal hemorrhage, unspecified

Patient had anaphylaxis several minutes following injection. Received oxygen, benadryl and Epi. He was monitored following.

Patient stopped breathing five days after the vaccine (5/29/21) He was taken to Hospital by paramedics and was put on ventilator in Intensive Care. They took him off the ventilator and he died 6 days after (5/5/21).

Extreme pain experienced on right side just below rib cage. Went to Emergency Room and Pulmonary Embolism in both lung was diagnosed.

05/06/21 PATIENT RECEIVED 2ND DOSE OF MODERNA COVID 19 VACCINE AT JOBSITE CLINIC . PATIENT FELT FINE AFTER THE CLINIC BUT LATER AT HOME STARTED FEELING SICK. PATIENT WAITED UNTIL SUNDAY 5/9/21 TO SEEK MEDICAL ATTENTION AT THE HOSPITAL AND WAS ADMITTED FOR STROKE. PATIENT REPORTED LOSS OF VISION IN ONE EYE. THE HOSPITAL NEUROLOGIST TOLD PATIENT THAT IT WAS DUE TO CLOTS IN HIS EYE. PATIENT IS WATING TO SEE AN OPTHALMALOGIST ABOUT THE EYE CLOTS. PATIENT HAS NOT BEEN BACK TO WORK SINCE FEELING SICK. EMPLOYER STATES HAS NOT RECEIVED ANY NOTICE FROM DOCTOR STATING ANY CAUSE OR RELATION TO VACCINE

Patient was diagnosed with bilateral LE DVT's on 5/10/21. Sx started a few days after the vaccine as per patient's report. No prior hx of DVT or known thrombophilia or other major antecedent clinical event prior to diagnosis.

The morning of April 13,2021, I was taken to the emergency room with heart attack like symtems. After blood test a CT was done and multipul blood colts were found in both my lungs. I was then placed on blood thinners a low salt diet. I remained in the hospital until the April 16,2021.

Three days after first vaccination I went into AFIB for 13 hours where I stayed at home. Three days after second vaccination I went into AFIB again, this time my heart was racing at 176 and went to emergency. I was admitted, observed overnight where my heart reset @ 8 hrs later

Three days after the first vaccination I went into AFIB, I waited 13 hrs at home until my heart reset itself. Three days after the second vaccination, I went into AFIB once again and went to emergency with heart racing at 176. Approximately 8 hrs later my heart reset with the aid of medication. I stayed in the hospital over night for observation then released @ 2 PM. I am now under the care of a cardiologist monitoring and now taking other medications for my heart

Stroke; Patient received his first dose of Moderna COVID19 Vaccine on 05-APR-2021 and second dose on 30-APR-2021; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021 at 10:30 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first dose of Moderna COVID19 Vaccine on 05-APR-2021 and second dose on 30-APR-2021). On 06-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). The patient was treated with Rehabilitation therapy for Cerebrovascular accident. On 30-Apr-2021 at 10:30 AM, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received his first dose of Moderna COVID19 Vaccine on 05-APR-2021 and second dose on 30-APR-2021) had resolved. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-May-2021, Blood test: normal (normal) Normal. On 01-May-2021, Computerised tomogram: normal (normal) Normal. On 01-May-2021, Electrocardiogram: normal (normal) Normal. Concomitant medications were not reported. On 30 Apr 2021, the patient's right arm was numb and he had no feeling in it. He went to the emergency room on 01 May 2021. They thought he had a blood clot. His EKG, blood tests and CAT scan were normal. The patient reported his arm was still numb on 04 May 2021. It's like it was limp; he couldn't coordinate his hand when he tried to mow the law. He stated that he had no feeling in his arm and can't control his right hand. The patient was reported to have been diagnosed with a stroke on 06 May 2021 2021 and was to start rehab on 07 May 2021. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. 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 06-May-2021: Stroke added as an event.

On or around April 15th I developed a pain in my left calf. As a senior citizen and avid golfer I chalked this up to age and activity. But the problem didn't go away and on some days would be more painful than others. Additionally, the point where my calf hurt seem to move around and sometimes be higher on my calf behind my knee. Some days the pain was gone altogether only to return the later that same day or the next. At the beginning of May I started to develop a cough. I had no fever or other symptoms so I thought it might be seasonal allergies. The cough continued to get worse so I made an appointment with my doctor on 5/26/21 and was seen that day. I was given a COVID test even though I had taken the vaccine and scheduled for an ultrasound on Friday 5/28/21. During the ultrasound they discovered a DVT in my left calf that extended from my ankle to behind my knee. Since I was also coughing they scheduled me for a CT scan that same day. The CT scan showed multiple PE's in both lungs. They sent me to the hospital.

Patient presented to the ED on 3/29/2021 "for evaluation of right groin, right flank pain and gross hematuria." Patient presented to the ED on 4/4/2021 for UTI. Patient presented to the ED on 4/19/2021 for dependent edema. Patient presented to the ED and was subsequently hospitalized for alcoholic intoxication. Patient had second vaccination on 4/26/2021. Patient presented to the ED and was subsequently hospitalized on 5/19/2021 for atrial fibrillation. These visits are within 6 weeks of receiving COVID vaccination.

5/16- symptoms started- cough, fever body aches. admitted 5/19 with SOB in addition. COVID pnuemonitis, 5/23-sudden decrease in saturation - placed on BiPAP and transferred to the ICU. further decline and arrested on 5/27. PEA and agonal breathing. intubated and ACLS meds given. Coded a second time and family elected to halt heroic measures.

Patient sustained DVT on 5/26/2021 after receiving Moderna COVID-19 vaccine on 5/17/2021. patient has history of prostate cancer that was diagnosed 6 weeks ago with prostate cancer. No previous clot history.

Admit 5/17. Vaccine 2/10. CHief complaint in ED lower back pain. Hx of Leukemia, degenerative disc disease. Developed high feveral. Admit COVID PNA. Elavated LFT, inflammatory markers. Neg CXR, CT shows lower lobe PNA. Treated w/antibiotics, steroid. Remained asymptomatic respiratory wise, stable on RA. DCd to home

COVID vaccine on 2/27/2021 & 3/27/2021 (Moderna); tested positive for COVID-19 by PCR on 5/28/2021; Medical records mention pneumonia, hypoxia, non-sustained ventricular tachycardia, altered mental status, cardiomyopathy, septic shock, and multiorgan failure; also tested positive for haemophilus influenza.

He got his vaccine, had extreme pain in his right arm. He went back to the pharmacy and let her know that it hurt for several days and then went away, and he is still having the tenderness in the arm. It was so painful that he could not sleep on it due to the pain. He then had no problems up until 5/24/21 when he noticed some swelling on his ankle of his right leg. He put it in cold water to see if the swelling would go down and it did not. Then he didn't think about it again until it was stiff, swollen and wanted to turn to the right side and hard for him to drive and taking his anti-inflammatories. It progressively got worse and around 5/25/21 the swelling was severe and doubled in size and getting worse and on 6/3/21 he could not get his pants off due to the swelling and he went to the Dr. The next day. He had pain behind the knee, ankle, pain in the leg. He went to the doctor, and they sent him to the ER for an US which showed DVT of the right leg. He was informed that it was large and that it was in the thigh of his right leg and not returning blood to his heart. He was put on Eliquis 5 mg twice a day and is doing well for him. The swelling is a little better, the ankle is still swollen, and the leg is still swollen, the top of his foot is really bad, front of his leg and thigh. The knee does not seem to be swollen, but the thigh is. He has no problem with the left side. He is to follow up with his doctor on Thursday. He is on Hydrocodone as well for the pain as needed for his neck pain and lower back.

After first dose of vaccine on 4/23 complained of fatigue and tiredness. After second dose on 5/26 complained of fatigue, dizziness, nausea and body aches. Expired on 5/28.

On the evening of the 27th day (02/11/21) after the first Moderna shot, I had an ischemic stroke on my Right Middle Cerebral Artery and was hospitalized

Atrial fibrillation; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product SELEXIPAG for Pulmonary hypertension. The patient's past medical history included Arrhythmia (Abnormal heart beat Rhythmn) on 26-Apr-2021. Concurrent medical conditions included Pulmonary hypertension. Concomitant products included AMBRISENTAN (LETAIRIS) and TADALAFIL (ADCIRCA) for an unknown indication. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started SELEXIPAG (Oral) 1600 mcg twice a day. On 10-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 10-May-2021 to 15-May-2021 due to ATRIAL FIBRILLATION. The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for Blood disorder NOS, at a dose of 1 dosage form. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) 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. The patient was seen by his primary care physician on 10-May-2021, 12 hours after getting the Moderna vaccine. The physician admitted the patient to the hospital due to atrial fibrillation. The patient was discharged on 15-May-2021. The patient reported that he was in the hospital from 26-Apr-2021to 01-May-2021for abnormal heartbeat rhythm and the hospital ended up having to shock his heart to get it back to normal. The patient had the second Covid vaccine done around 1 week before reporting date 02-Jun-2021 and said he seems to be doing well. Treatment was not reported. 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. No further information is expected. However, patient has a history of pulmonary hypertension,arrythmia and concomitant medication use of Selexipag considered as co-suspect that can be stated as confounding factors that may play a possible contributory role.; 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. No further information is expected. However, patient has a history of pulmonary hypertension,arrythmia and concomitant medication use of Selexipag considered as co-suspect that can be stated as confounding factors that may play a possible contributory role.

I went to the ER on 06-14-2021 due to having symptoms I was experiencing to my heart. At the hospital they told me I had a condition called A-fib, they kept me there for one day for observation and performed complete lab work. I am currently following up with my cardiologist for treatment of A-fib.

Patient presenting with a segmental pulmonary embolism 2 weeks after first dose of the Moderna COVID-19 vaccination. Has history of provoked DVT from knee replacement surgery.

about 14 hours after vaccination I experienced what appeared to be a severe case of Cytokine storm. I had a moderate case of COVID in May 2020 and had positive IgG AB in August. The symptoms started with heavy shaking chills, lasting 1 1/2 hours , fever and most concerning sustained tachycardia with heart rate of 180' to 200' over hours, which then destabilized into runs of Vtach and complex ventricular dysrythmia, low BP, profound weaklness, head aches and joint and muscle pains ( similar to the experienced COVID symptoms )

No immediate reaction. Patient-reported deceased four days later on Jan. 19, 2021. As of this date cause of death is unknown to our clinic.

patient received the Moderna Covid 19 vaccine on 1/23/2021 around 5:45pm wife called management today and reported that he had collapsed and passed away today around noon

Pt had slurred speech and left-sided weakness day after vaccine he presented to ER and appears to have CVA

Tightness in chest several times about 1 week and 2 weeks after 1st round. Difficulty sleeping on left side 20 and 21 days following 1st round. Severe pain with inhaling AM of 22 day. Diagnosed at ER Hospital, with DVT left calf and PE both lungs. On Heparin IV for 4 days inpatient. Now on Eloquis 10mg BID for a week, 5mg BID thereafter.

No reported adverse reactions from 1st or 2nd vaccine doses Patient died on 2/6/2021 at Correctional facility- autopsy was performed at medical examiner's office. The COD was artherosclerotic cardiovascular disease

First vaccine received on Sat 1/23. On Tues 1/26 began to experience body aches, chills, headache. Spoke to triage nurse on Wed 1/27 who thought were symptoms of vaccine. On Wed 1/27 continued with body aches, extreme chills, headache and developed a 101 fever. On Fri 1/29, went urgent care who continued to attribute the symptoms to the vaccine. On Sun day 1/31, went urgent care again experiencing the same symptoms along wot a 104 fever. Sent to ER and admitted to the hospital. Hospital stay from Sun 1/31 to discharge on Fri 2/5. Admitted to the hospital with pneumonia attributed to my immune system going after the vaccine allowing for the the development of pneumonia.

had lack of appetite before second dose. When received the second dose, he started vomiting on the way home. Was sick on and off for the next few days. Died suddenly on 2/23/2021

Patient died on 2/25/21 in the AM after receiving his COVID-19 Moderna vaccine #1 at approximately 2:30P on 2/24/21. I do not have a time of death. I contacted the County Medical Examiner's office who stated that they received his body after he was determined to be deceased at the shelter. No autopsy was performed and his body was released to a funeral home on 2/26. The ME's office said that "permit for burial/cremation is pending" and no other information on COD was available. Per staff, he was also tested for COVID as part of shelter protocol on 2/24 and PCR was negative. He arrived to the shelter on 2/19/21.

EMS reported sudden onset of shortness of breath, patient grabbed his chest and collapsed. He stopped breathing. Wife began CPR with chest compressions at 5:00. Fire dept. arrived resumed CPR and attached AED but there was no shock advise. They placed an OPA as well (inserted an airway) and started ventilation. Asystole was confirmed, they continued CPR. After 5:25 they gave 3 rounds Epineferin and ended CPR at 5:46. They also checked his blood sugar and it was 136. Possible reaction to covid vaccine. Possible death due to history of cardiac issues. His PCP is requesting an autopsy

Next day developed right leg pain. Following day diagnosed with a new deep venous thrombosis of the popliteal vein, right leg

1. Shaking chills, fever and flu symptoms for one day followed by a day with malaise. 2. Daily diarrhea, watery stool, cramping and bleeding lasting one month. Currently slowly resolving. Treated with a variety of remedies over the month, individually and in combination. ( Pepto bismol, charcoal capsules, imodium, rice, tumeric, and Xifaxin) Imodium would stop the cramping but not the wateriness of the stool. Unlike any diarrhea over the course of my life. I will not be taking any booster shots.

Received vaccine, and no reactions. Nine days after the vaccine slowly had drooping on the right side of his face, numbness on the right side of his face, mainly around the mouth, a little on the eye, hard to close the right eye. General soreness around his mouth when he tries to eat or talk a lot. Limited movement of his face do to swelling, difficulty closing his eye, and headache. Went to the ER on 3/7/21 and admitted him as they believed he had a blood clot, diagnosed him with Bell's palsy on Monday 3/8/21. Was given corticosteroids for 9 days Prednisone 60 mg. The symptoms are slowly improving but still has the Bell's palsy.

experienced extreme shortness of breath a day or two after receiving 2nd COVID-19 vaccine. Breathing became worse at night, more so in reclined position than upright. Thinking it was a vaccine side effect waited for it to subside, when it did not sought medical attention. Doctors determined to be acute congestive heart failure exacerbation. Treated with diuretics and blood pressure medications. Hospitalized from 3/14/2021 to 3/19/2021.

death 2 and half hours after receiving the first Moderna vaccine; A Spontaneous report was received from a health care professional concerning a 61 year old male patient,who received Moderna's COVID-19 vaccine (mRNA-1273) and reported death. The patient's medical history as provided by the reporter included diabetes, history of shortness of breath, cardiac history. Concomitant medications included metoprolol, metformin and glipizide. On 05 Mar 2021, prior to the onset of events the patient received his first dose of their two planned doses of mRNA-1273 (Batch N0: 030a21a) intramuscularly for prophylaxis of covid 19 infection. On 05 Mar 2021,it was reported that the patient died 2 and half hours after receiving the first Moderna vaccine. The patient had no symptoms during observation 15 minutes after receiving fist Moderna vaccine.The patient's PCP ordered an autopsy. Treatment information not included. Action taken with mRNA-1273 in response to the events was not applicable. On 05 Mar 2021, it was reported that the patient died.; Reporter's Comments: This is a case of sudden death in a 61-year-old male subject with hx of diabetes, history of shortness of breath and cardiac history, who died 2 1/2 hours after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death

Patient had first Moderna Covid IMZ on 3/6 and had a stroke on 3/18. His doctors do not believe this was related to the vaccine and want him to get the second dose.

patient experienced heart attack and subsequently passed away approximately 2 weeks following vaccination. it is not believed to be related to the vaccination.

Please note: The vaccination record I received with lot number is very difficult to read!!! My first vaccination was 12/31/20 and lot number written down but hard to read is (U37K2OA but could be V37K20A) The second shot was 1/27/21 and lot number written down could be (0412OA, or could read O912OA!) I had symptoms of a Pulmonary embolism while cross country skiing March 18 and officially diagnosed with PE on March 22, 2021. I was tested for Covid 19 on March 23, 2021 with negative results. I had been reporting my side effects (which were none) for the previous 6 weeks following the second vaccination. I did have cramping like feeling in my right calf following a x-country ski weekend about 4 weeks prior to the actual PE (2/22/21) but it appeared to resolve after about 7-10 days

During daytime of 3/25/2021, began to feel discomfort on the left arm. The discomfort worsened to inability to move the left arm, left hand, or fingers. Admitted to the emergency room, then hospitalized for 3 days. Diagnosed as an Ischemic Stroke.

On April 8, 2021 patient received his second dose of Moderna COVID-19 vaccine at pharmacy at 1:08pm. Patient waited the appropriate 15 minutes, and then left pharmacy. He reported no adverse reactions to our staff during that time, and did not call afterward to report any adverse reactions. At approximately 4:30pm on April 10, 2021, I received notification that patient was found DOA at his residence. No other information is available at this time.

Atrial fibrillation; Tested positive for COVID; Minor Aches like he was getting a cold; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) and COVID-19 (Tested positive for COVID) in a 61-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. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYALGIA (Minor Aches like he was getting a cold). On 25-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion hospitalization) and COVID-19 (Tested positive for COVID) (seriousness criterion hospitalization). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), COVID-19 (Tested positive for COVID) and MYALGIA (Minor Aches like he was getting a cold) outcome was unknown. She said they had been very careful, but had met with some friends and 2 of their friends also tested positive. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The day after he received the vaccine he felt minor aches, like he was coming down with a cold. On that Thursday he went into a fib. She took him to the ER and it took several hours to regulate his heart rate. While making arrangement to transfer him to a new hospital they did a COVID test and it was positive. They were shocked as he had not been showing any symptoms. He spent the night in the hospital. Very limited information regarding the even tof A fib has been provided at this time. Further information has been requested. However the event of Covid 19 and myalgia is unlikely related to vaccine. Covid 19 is a confounding factor for the event of myalgia and base of the available information, the vaccine is not known cause of Covid 19.; Sender's Comments: Very limited information regarding the even tof A fib has been provided at this time. Further information has been requested. However the event of Covid 19 and myalgia is unlikely related to vaccine. Covid 19 is a confounding factor for the event of myalgia and base of the available information, the vaccine is not known cause of Covid 19.

Pt found unresponsive in hospital room with large amount of vomit. Patient pronounced dead shortly after with cause of death noted to be aspiration pneumonia with hypoxemia leading to cardiac arrest. Pt received vaccine 1 month prior so I wanted to report this.

He was given the Covid vaccine at a pharmacy and not at my office. 4 days after the vaccine he noticed discomfort in the right calf. Initially he dismissed it but then gradually the calf started to swell. Once he noticed some shortness of breath he decided to come into the office. He was seen on 4/12/21 and diagnosed with a pulmonary embolism. He was then admitted to Hospital for IV therapy and monitoring.

Client's wife called and reported that client had a heart attack 5 days after receiving the vaccine. He also had blood clots.

Received Moderna Covid Vaccine on 3/3/21 and 4/8/2021. Nted onset 4/24 of right calf discomfort, swelling and firmess and at same time began to have exertional dyspnea with chest heaviness. U/S RLE - extensive DVT. CTA - multiple segmental vessels with clot, dilated right ventricle

Monday night Fever and chills Tuesday - Sat Pain in elbows and shoulders and back EKG Wednesday Bad pain Thursday and Friday 4:30 am Sat admitted to Yale : heart attack back dated to Tuesday. Needed 1 stint

Covid-19 J96.90 - Respiratory failure (CMS/HCC) N39.0 - Urinary tract infection A41.9 - Sepsis (CMS/HCC) U07.1, J12.82 - Pneumonia due to COVID-19 virus

right leg DVT and bilateral pulmonary embolisms. Symptoms of cough, chest pain and dyspnea on exertion started on (about) 4/19/21. Patient presented to urgent care on 4/26/21 and again on 4/30/21 at which time the diagnosis was made.

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

32 hours after the vaccine, he suffered a massive heart attack due to a blood clot and a massive clot in the right arm. He went to the hospital and under went surgery at 12 am on Saturday. The coronary surgeon mentioned that this was not from heart disease as all vessels were clear. Rather, this was due to an embolism due to an unknown origin. A further work up concluded that he also had blood clots throughout his body (both lungs, one kidney, heart, liver, legs, arms, and possibly brain). By 12 p.m. we were asked back to the hospital as he was worsening. Treatment options included a heparin drip, which caused a brain hemorrhage. He was just at the doctors two times this week, on Tuesday and Wednesday and was fine no issues found. They went through with the 2nd dose and came to our home on Thursday.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was respiratory failure with hypoxia due to COVID-19 infection.

vertigo; Migraine type headaches; Flu like symptoms; Fever; Blood clot in right upper arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VERTIGO (vertigo) and THROMBOSIS (Blood clot in right upper arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VERTIGO (vertigo) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot in right upper arm) (seriousness criterion medically significant), MIGRAINE (Migraine type headaches), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). The patient was hospitalized on 28-Feb-2021 due to VERTIGO. At the time of the report, VERTIGO (vertigo), THROMBOSIS (Blood clot in right upper arm), MIGRAINE (Migraine type headaches), INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) outcome was unknown. No concomitant medications were reported. No corrective treatment was provided. 28-Feb-2021, he was hospitalized for vertigo for 3 days. 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. Very limited information regarding these events have been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding these events have been provided at this time. Further information has been requested.

I fell while helping my neighbor move a box into her apartment. When I tried to get back up, I found I had no strength in my left arm.

Complained of chest pain at 3:50 pm may 15th. He went and layed down across his bed was coherent and talking, suddenly passed out. 911 was called and chest compressions were started. Ambulance arrived his condition was 60/40 bp and heart rate of 40. Taken to hospital where he never recovered and passed away.

Started with slurred speech, difficulty with balance, weakness on 5-1-21. Symptoms worsened on 5-2-21 with garbled speech, inability to walk without assistance, weakness. Admitted to hospital and was diagnosed with stroke.

Diagnosed with Afib. Tiredness,/fatigue for 3 days, palpitations, elevated heart rate 2 days in the hospital receiving intravenous drug treatment (don't know the drugs). Drug treatment got me to atrial flutter. Had to have a cardioversion to get back to normal sinus rhythm. Fine since then.

passed away suddenly a day after getting his first Moderna covid vaccine. He got the vaccine said he felt fine other that having a sore arm he has in good spirits and joking around according to his coworkers. He died suddenly a day later circumstances are unknown ,He had passed before he was discovered. No autopsy was done. Aneurysm is suspected.

Went in to physician due to shortness of breath. Found pericarditis. The physician went in to do a pericardial window and the patient experienced bleeding so the surgeon had to perform a sternotomy to determine where the bleeding originated. Once the chest was opened the surgeon noted a mass that appeared to look like a fungus on the heart. Biopsy of the heart mass, pericardial fluid and a mass on the liver were performed. The biopsy results originally came back as adenocarcinoma of the urinary (bladder, kidneys) origin. The physicians noted that that would be highly unlikely since there were no tumors noted in the urinary area. Pathology was sent off again from the pericardial fluid that was obtained by "extracting RNA from tumor enriched sections. This pathology showed the cells to be squamous cell carcinoma with 90% probability of coming from the lung. The doctors are finding this very unusual . My husband was very healthy prior to this with no symptoms. Could this be caused by the vaccine?

Heart failure with reduced ejection fraction (15 to 20%) Atrial fibrillation with RVR at a ventricular rate of approximately 100 bpm.

Losing breathe; Paralysis of face; Bells Palsy; Guillain-Baire syndrome,; Numbness in hands; Could not swallow; Tingly in hands; Impaired vision; Speech impairment; Could not walk; Paralysis in his head from neck up.; Pneumonia; Totally impaired; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (Paralysis in his head from neck up.), PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Plasmapheresis in April 2021, Feeding tube insertion in April 2021, Tracheostomy tube insertion in April 2021 and Mechanical ventilation in April 2021. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Apr-2021, the patient experienced PARALYSIS (Paralysis in his head from neck up.) (seriousness criteria hospitalization, disability, medically significant and intervention required), PNEUMONIA (Pneumonia) (seriousness criterion medically significant), DYSPNOEA (Losing breathe) (seriousness criteria hospitalization, medically significant, life threatening and intervention required), FACIAL PARALYSIS (Paralysis of face) (seriousness criterion hospitalization), BELL'S PALSY (Bells Palsy) (seriousness criterion hospitalization), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,) (seriousness criteria hospitalization, disability, medically significant, life threatening and intervention required), HYPOAESTHESIA (Numbness in hands) (seriousness criteria hospitalization and medically significant), DYSPHAGIA (Could not swallow) (seriousness criteria hospitalization and medically significant), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired) (seriousness criterion disability), PARAESTHESIA (Tingly in hands) (seriousness criterion hospitalization), VISUAL IMPAIRMENT (Impaired vision) (seriousness criterion hospitalization), SPEECH DISORDER (Speech impairment) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Could not walk) (seriousness criterion hospitalization). At the time of the report, PARALYSIS (Paralysis in his head from neck up.) had not resolved and PNEUMONIA (Pneumonia), DYSPNOEA (Losing breathe), FACIAL PARALYSIS (Paralysis of face), BELL'S PALSY (Bells Palsy), GUILLAIN-BARRE SYNDROME (Guillain-Baire syndrome,), HYPOAESTHESIA (Numbness in hands), DYSPHAGIA (Could not swallow), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Totally impaired), PARAESTHESIA (Tingly in hands), VISUAL IMPAIRMENT (Impaired vision), SPEECH DISORDER (Speech impairment) and GAIT DISTURBANCE (Could not walk) outcome was unknown. Non-drug therapy included: The patient had 7 plasmapheresis, trachea to breathe, feeding tube and put on a ventilator. 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-2021-141559 (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 presented 5/22 with acute onset right sided weakness and aphasia, found to have left MCA stroke. He was last normal at 0200 and was found at 0600 when he was found by hi wife. He was not a candidate for tPA as he was outside of the time window once he arrived to ER. He underwent IR thrombectomy with TICI 2B, residual clot in the left A1 and left M3 vessels. He suffered a large territory stroke with malignant cerebral edema requiring emergent decompressive hemicraniectomy. He has been unable to be extubated thus far, as he is unable to protect his airway. He has severe aphasia and right hemiplegia.

Cardiac Arrest (38 days after second vaccine); This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC ARREST (Cardiac Arrest (38 days after second vaccine)) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CARDIAC ARREST (Cardiac Arrest (38 days after second vaccine)) (seriousness criteria death, medically significant and life threatening). The patient died on 08-May-2021. The reported cause of death was cardiac arrest (38 days after second vaccine). It is unknown if an autopsy was performed. It was reported that Lot number 023M20A was the only lot on the vaccination card. Caller was not sure if this lot is from first or second vaccine." Treatment information was not reported but it was reported "Paramedics were there at home and they could not resuscitate him." Concomitant medication was not reported. 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.; Reported Cause(s) of Death: Cardiac Arrest (38 days after second vaccine)

Had shortness of breath and admitted to hospital for blood clot/pulmonary embolism on 4/28/21 * Hematologist suggested I should report for information purposes. Not stating this is believed to be the cause of the event - just reporting as requested

Moderna Dose 1 3/5/21 (029A21A) Moderna Dose 2 4/16/21 (027B21A) COVID Positive 5/20/21 5/20/21: Presented to ED. The patient presents with fever. 61 year old male presents to the emergency department for a fever with an onset of 1 day. Patient was diagnosed with pancreatic cancer in April 2021. Patient states he has had 2 rounds of chemotherapy but states he could not have his 3 round last week because his white count was too low. Patient is also complaining of dull chest pain that is exacerbated with deep breathing, cough, and a headache but denies vomiting, diarrhea, neck pain, dysuria, hematuria, and nausea. Patient was diagnosed with blood clots on 05/09/2021 but states that he is not having similar symptoms to when he was diagnosed with blood clots. Patient is taking Xarelto. He has never had COVID but is vaccinated. Patient sees Dr. (Name) at the UI Oncology clinic. 5/25/21: 61-year-old male on chemotherapy for pancreatic cancer, also recently diagnosed pulmonary embolism on rivaroxaban, presents with 1 day of fever. Initially, did not have any cough or shortness of breath, was admitted to the hospital, where a chest x-ray, urinalysis and examination failed to reveal an exact source of the fever. His absolute neutrophil count was less than 500, so he was admitted for neutropenic fever. Cultures were obtained. IV antibiotics started. COVID-19 was tested and, surprisingly, came back positive. The patient has actually had both of his COVID-19 vaccines and basically, does not have pneumonia, shortness of breath, or hypoxemia. We did not use any medications for COVID while in the hospital, watching for any signs of respiratory compromise, but none developed. Blood cultures were negative. He was switched from ceftazidime to doxycycline at time of discharge. Will follow up with Dr. (Name) for his next cycle of chemotherapy. Because of his COVID-19 positivity, we will not schedule any immediate followup appointments, although the patient will call if he has persistent fever, dyspnea, or signs of hypoxemia. For the past 2 days, the T- max has been 99.9, and most the time 98.6. He was seen the day of discharge, doing quite well. Blood pressure 153/80, pulse 90, regular, oximetry 95% on room air. Glucose was 210. Discharged on Rivaroxaban 15 mg b.i.d., doxycycline 100 mg b.i.d., Robitussin AC as needed for cough, Lantus 28 units at bedtime, atorvastatin 80 mg daily, aspirin 81 mg daily. The patient did get 1 dose of Neupogen 480 mcg subcu while in the hospital.

Patient presented to emergency department around 7:00pm with signs and symptoms consistent with stoke. In the drive to the hospital, patient could not speak, move the right side of his body, and was drooling. Patient was immediately taken for a head CT and was diagnosed with a massive hemorrhagic stroke. The on call neurosurgeon wall called in the perform and emergency craniotomy. Patient underwent craniotomy and neurosurgeon was unable to find source or cause of bleed. Patient was sent to ICU for recovery. Patient was on a ventilator and receiving hypertonic saline for brain swelling. Patient never regained mobility in right side of body or speech. Patient tried rehabilitation, but patient's brain continued to swell with increase neuro-cognitive decline. Neurosurgeon was unable to determine cause of recurring edema and patient was not a candidate for repeat surgery. Patient failed rehab qualifications due to repeat brain swelling and was eventually placed in hospice care to pass.

DVT- developed leg pain and swelling for several days. Presented to ED for evaluation. Found to have RLE DVT

Shortness of breath, injection site soreness, fever, weakness, night sweats first night following injection and progressively worsened.

new A fib started on Eliquis 5 mg BID, carvedilol 6.25 mg BIDWC, amiodarone 200 mg BID, and aspirin 81 mg discharge home

Mini-stroke; Mini-stroke; Stroke; Blood pressure was high; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke), the second episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) and the first episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 017B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Stenosis. Concomitant products included TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN 81) and EVOLOCUMAB (REPATHA) for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 09-Mar-2021, the patient experienced the first episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) (seriousness criteria hospitalization and medically significant). On 10-May-2021, the patient experienced the second episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure was high). The patient was hospitalized from 06-Mar-2021 to 07-Mar-2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with NITROGLYCERIN on 10-Mar-2021 for Hypertension, at a dose of 1 dosage form. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), the last episode of TRANSIENT ISCHAEMIC ATTACK (Mini-stroke) and BLOOD PRESSURE INCREASED (Blood pressure was high) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. On 06March2021 he was taken to the hospital by ambulance where he was diagnosed with having had a stroke. He was discharged home on 07March2021. The evening of 09March2021 he had a mini-stroke but remainded at home. Early morning on 10March2021 he had another mimi-stroke and was taken to the emergency room by ambulance. Patient states his blood pressure was high and he thinks he was treated with nitroglyercin but cannot recall the names of other meds given. He was discharged from the emergency room later that night of 10March2021. Patient declines to give me his full list of daily meds because that are too many 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. Other contributing factors were reported (concomitant disease). This case was linked to MOD-2021-209430 (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. Other contributing factors were reported (concomitant disease).

3 days after vaccine, patient started getting petechial rash to legs and then multiple bruises to thighs. Took him some time to seek care but was found to have thrombocytopenia. with Platelets as low as 20. Required admission to the hospital, platelet transfusions/IVIG/ and long term steroid course. Still undergoing treatment but is recovering.

Chest pain down right arm into right hand, radiating down into abdomen. Symptoms started 0800 hours 06/17/2021. Symptoms returned 06/18/2021 at 0600 hours. Emergency Department visit Dx: STEMI Treated with IV heparin and metoprolol

My husband fell ill within hours of getting the first dose of the vaccine, he started running fever, chills, body aches-within 7 days he was admitted to the hospital and 12 hours after admission to the hospital he was diagnosed with Covid Pneumonia. or they thought- his lungs were showing signs of being attacked. He had no illness, no fever, no underlying health concerns, no allergies, he was not over weight, he was not diabetic, he was still young and within 6 weeks of getting the vaccine he was dead. Doctors could do nothing to save his life. The Moderna vaccine killed my husband and it is killing other perfectly healthy people.

Pt was vaccinated on 3/31/2021. His long time partner reported that he started feeling a little off 2 days post vaccination, he thought he had indigestion. Over the next few weeks he began feeling worse especially with exertion. While at work on 4/19/2021 he told his friend that he hadn't been feeling well for 3 weeks. Shortly after reporting this he went into Cardiac arrest. He was transported to Medical Center, where he was pronounced dead. His partner reports he was healthy with the exception of hypertension. She reports he was thin, never smoked, didn't drink alcohol and rarely used marijuana. She reports only a visual autopsy was performed and pt was cremated.

developed afib after 2nd shot, treatment on going, doctor has prescribed metoprolol, and zeralta, still experiencing afib daily

My husband passed away June 3, 2021 resulting from complications which began a few hours after receiving his 2nd Moderna shot on April 29, 2021. He never tested positive for Covid19, however his first symptoms were the typical fever, muscle aches, rash. He declined daily from a host of mysterious symptoms including full body rash, blood clots, muscle spasms, atrial fibrillation, ulcers lining his esophagus and colon, and exorbitant WBC (157K) with extremely high eosinophils (90%). He was treated with a host of drugs including antibiotics, steroids, blood thinners, ivermectin and finally chemotherpay (Campath). His ICU team included hematology, pulmonology, ... oncology and infectious disease. After an incredible amount of diagnostic testing ( daily routine blood work, EKGs, chest x-rays, CT scans, MRI, bone marrow biopsy, endoscopy, colonoscopy, skin biopsy, genetic testing) no definitive diagnosis could be made, however, he was given the possible diagnosis of chronic eosinophilia leukemia in late May. The big question among the medical staff was, "Did the shot trigger something?" He was eventually treated with the chemotherapy drug Campath, which reduced the WBC and EOs some, but his organs, especially, lungs had been very compromised by the high WBC and eosinophils. Several days after being placed on a ventilator and given a feeding tube at the end of May, a CT scan and MRI confirmed patient had suffered multiple strokes. He passed away a half hour after being taken off the ventilator the morning of June 3, 2021. His death certificate read: A. cardiopulmonary arrest B. acute hypoxic respiratory failure C. hypereosinophila

rapid heart beat; Palpitations; Shortness of breath; Chest pain; Chest heaviness; Dizziness; Weakness; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (rapid heart beat) in a 61-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 Liver transplant in 2011 and Cardiac ablation on 16-Jun-2021. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (rapid heart beat) (seriousness criteria hospitalization and medically significant), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue). At the time of the report, ATRIAL FIBRILLATION (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (Chest pain), CHEST DISCOMFORT (Chest heaviness), DIZZINESS (Dizziness), ASTHENIA (Weakness) and FATIGUE (Fatigue) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, Heart rate: high. On 15-Jun-2021, SARS-CoV-2 test: negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient had heart Ablation Surgery on 16/Jun/2021 at (Hospital name) as a treatment for atrial fibrillation. The patient had been tested for COVID-19 on 27/Jun.2021. 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. However, very limited information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.; 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, very limited information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been request.

61 yo man with HLD and a family history of premature CAD, who recently underwent a total knee replacement for osteoarthritis, and has been experiencing exertional chest pain with rehab. He was sent to the ED by his PCP, where he ruled in for an NSTEMI. An Echo demonstrated and LVEF of 40-45% and both anterior and apical hypokinesis. He underwent cardiac catheterization today and was found to have MV-CAD. An IABP was placed and he was referred for CABG. He is now symptoms free and stable hemodynamically.

Confirmed that pt passed away 3/13/21, 5 days after 1st covid vaccine. Per relative who rec'd the autopsy report, pt had no obvious health problems prior to death, was a smoker, but otherwise very fit and active, healthy eater. On day of death, pt had gone hiking for a few hours on a camping trip, they were sitting around eating dinner and pt said he had to go to the bathroom and never came out. Pt's family feel sure something was triggered by vaccine. Relative I spoke to retrieved the autopsy results during the call and read them on the phone as they were reported on paper. Final dx on autopsy was: I. atherosclerosis, generalized, severe. A. Atherosclerotic coronary artery disease i. atherosclerosis, coronary arteries w/ 75% occlusion of LAD, 90% occlusion of L obtuse marginal and 80% occlusion circumflex coronary artery. a. Ruptured acute myocardial infarction, transmural, posterior left ventricle i. cardiac tamponade ii. hemopericardium 350cc COD listed as: ruptured, acute MI d/t atherosclerotic coronary artery disease, tox report was clear.

Death caused by probable cardiac arrhythmia on May 10, 2021. No previous heart symptoms. Had the normal reaction to the second dose (body aches, chills, low grade fever), but was recovering as of April 19. First dose was administered 3/21/21. Second dose was administered 4/18/2021.

Day of vaccine - I had fatigue and soreness on my arm; then the next morning I had fatigue; everything - chills, fever, arm soreness, headache. It all lasted about five or six hours. Then five days later, that night, on the 13th, I had fatigue again and on 14th - tired, headache, chills, and in the middle of the night on the 16th - 103 degrees fever, throwing up, hallucinating, chills, muscle weakness and arm soreness ( I still have arm soreness - at the injection site) and my wife had to call 9-1-1 and EMT's took me to hospital and I was hospitalized for four days. Hospital. I am recovering from the medications still but I have recovered from the health event from the vaccine.

Cerebral venous sinus thrombosis Symptoms - daily headache that started around 7/11/21 which is about 10 days after first dose of the vaccination

Intermittent HA x 1week- ER found extensive dural sinus thrombosis involving the superior sagittal sinus, torcula, and bilateral transverse sinuses, right cortical vein thrombosis overlying the frontal convexity on CT Head with Contrast seen 7/17/21 in hospital

Diagnosed with AFIB; rapid heart beat; Palpitations; Shortness of breath; chest pain; chest heaviness; Dizziness; weakness; ftigue; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Liver transplant and Cardiac ablation (Patient had heart Ablation Surgery on 16-06-2021) on 16-Jun-2021. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Diagnosed with AFIB) (seriousness criteria hospitalization, disability, medically significant and life threatening), HEART RATE INCREASED (rapid heart beat) (seriousness criteria hospitalization, disability and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization, disability and life threatening), DYSPNOEA (Shortness of breath) (seriousness criteria hospitalization, disability and life threatening), CHEST PAIN (chest pain) (seriousness criteria hospitalization, disability and life threatening), CHEST DISCOMFORT (chest heaviness) (seriousness criteria hospitalization, disability and life threatening), DIZZINESS (Dizziness) (seriousness criteria hospitalization, disability and life threatening), ASTHENIA (weakness) (seriousness criteria hospitalization, disability and life threatening) and FATIGUE (ftigue) (seriousness criteria hospitalization, disability and life threatening). At the time of the report, ATRIAL FIBRILLATION (Diagnosed with AFIB), HEART RATE INCREASED (rapid heart beat), PALPITATIONS (Palpitations), DYSPNOEA (Shortness of breath), CHEST PAIN (chest pain), CHEST DISCOMFORT (chest heaviness), DIZZINESS (Dizziness), ASTHENIA (weakness) and FATIGUE (ftigue) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Heart rate: high (High) High. Concomitant medication and Treatment medication use was not provided by reporter. Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested. This case was linked to MOD-2021-238357 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

Heart attack; Irregular heartbeat; This spontaneous case was reported by a non-health professional and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HEART RATE IRREGULAR (Irregular heartbeat). The patient was hospitalized on 24-Mar-2021 due to MYOCARDIAL INFARCTION. At the time of the report, MYOCARDIAL INFARCTION (Heart attack) outcome was unknown and HEART RATE IRREGULAR (Irregular heartbeat) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included Beta blocker (unspecified) and statin (unspecified) for an unknown indication. Treatment included few stents inserted for the heart attack. 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.

3 days after Moderna C19 vaccination on 4/23/21 Patient suffered a massive stroke on 04/26/21. He is now a hemi-plegic with severe apraxia and aphasia, unable to work, communicate or care for himself. He had no health issues prior to the vaccination. He was in ICU, Intensive care and hospital for 2 months and rehab continues.

Patient was vaccinated Dec 30, 2020. Prime dose of Moderna vaccine. Observed for full 15 minutes post-injection. No complaints when asked during observation. Released. Subsequently, vaccine clinic staff learned from the patient's supervisor that on Jan 4, 2021 that the patient had expired on Jan 2, 2021. By report from the supervisor, the patient was found dead at his home. The patient's primary care provider was unaware of his death when contacted by this reporter today (Jan 6, 2021). Electronic Medical Record without any information since the vaccination.

rib pain/shortness breath/Pulmonary Embolus and viral pneumonia Narrative: Development of symptoms beyond the 48-72 window. Tested at time of ER visit Negative for Covid. Repeated Covid NP swab on 01/05/2021. Was not hospitalized overnight discharge home on oral anticoagulant medications.

Narrative: Respiratory failure / respiratory depression went to ED / ICU 2/1/2021. Frail patient. 1st vaccine 12/23/2020 Moderna Lot 039K20A exp 6/20/2021, 2nd vaccine 1/20/2020 Moderna Lot 013L20A exp 7/8/2021

Almost immediate headache per wife. Developed fever around 4 pm. Headache all day. Took Tylenol at 4 and 10 pm. Gradual development of SOB and cough. Temp of 101.4 at 10 pm. pulse ox 92% at 10 pm. Went to sleep, woke up at 0050 with increasing SOB. Pulse ox 82%. Used albuterol inhaler, wife called emergency services at 0113. EMS arrived around 0130 to patient's home. pulse ox 86%, coughing, sob, hard time breathing. Walked to stretcher. Became unresponsive. Found to have no pulse, stopped breathing. CPR initiated at about 0140. King airway placed in field, I/O in left tibia. Patient from PEA to asystole, to vfib, to asystole. ACLS followed. Unrecoverable asystole and patient time of death 0213.

Pt was administered Moderna Covid-19 Vaccine on 2/4/2021. Pt exhbited no symptoms of an adverse reaction of any sort. Pt was ambulating alert and attentive. Pt was observed for the alloted 15 mins by pharmacist and case worker who had escorted pt to vaccination clinic. It was reported that Either on sunday 2/7/2021 or monday 2/8/2021 pt had passed away. Circumstances revolving patient death is still unknown.

Patient discovered unresponsive in cell, blue coloration to skin, vital signs, undetectable. CPR initiated, Ambulance summoned. Following EMS arrival with additional unsuccessful attempts to revive patient, patient was determined to have expired.

Vertigo, slurred speech, difficult swallowing, numbness on left side of face/chin area; extreme weakness in both arms and both legs but more pronounced in left arm & left leg; blurred vision, extreme fatigue

sudden death, while sleeping 2 days after injection Vaccine 3/12/21 last seen conversant and comfortable at 3a 3/14/21 Found nonresponsive and not breathing at 8:30a 3/14/21

Pt went unresponsive at home per wife, was transported to hospital by EMS and died after getting to the hospital. This is not a suspected allergic reaction to the COVID Moderna vaccine at this time.

Pt developed a RT Leg DVT Deep Vein Thrombosis and Pulmonary emobolus. Started haveing symptoms of dyspnea. , low oxygen saturations in the 80s and RT pleuritic chest pains one week after getting the shot. He had never had a DVT or PE before. Was seen in Emergency on 03-23-2021 . He was admited on 02-23-2021. Started on anticoagulation and went to the cath lab to have intraarterial administration of TPA in pulmonary arteries.

3/25/21 developed chills, muscle aching, diarrhea evening of vaccination--symptoms continued for 48 hours with poor appetite/nausea. lost 4 pounds over the next few days. 3/28/21 c/o dizziness, heart fluttering/irregular. 3/30/21 saw dr, and EKG showed afib. medication changes. 3/31/2021 repeat EKG a flutter. admitted observation to hospital. NOTE: Does have a history of episodic afib/flutter--no episodes for the last few years

contact dermatitis; significant rash which is very itchy; bruise; Afibrillation; A Spontaneous report was received from Consumer concerning 49-year-old of male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and afibrillation, noticed a significant rash which was very itchy on his hips where he got a bruise, stated his wife thought it was contact dermatitis. The patient's medical history was not reported. The concomitant medication included Zoloft, Aspirin, Fish oil and Vitamins. On 11 Mar 2021, 1 day prior to the onset of the event, the patient received their first dose mRNA-1273 (Lot number: 038A21A, Expiration date: not provided) via intramuscular route in the right arm for prophylaxis of COVID-19 infection. On same day, patient experienced afibrillation which was resolved on 13 Mar 2021. On 15 Mar 2021 he noticed a significant rash which was very itchy on his hips where he got a bruise and he stated his wife thought it was contact dermatitis. Action taken was unknown with respect to events. The outcome of other events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

After receiving the first Moderna vaccination in my Left arm, I started feeling pain in the area of the vaccination site on the evening of 03/22/21. As time progressed I started to realize I was losing all motion in my arm and weakness on my entire left side of my body, but assumed this was a side-effect of the vaccination . I was not concerned until my wife alarmed me in the morning when she looked at me and noticed the left side of my face drooped and had that I had difficulty standing, no balance, little use of my left leg and no use of my left arm and hand. At that point, 7:00am 03/23/21, my wife drove me to the ER. I was admitted and an inpatient for 15 days including PT/OT/ST therapies at the hospital for Stroke.

death Narrative: Patient received Moderna Covid #1 on 3/11/21 in his home by nurse. On 3/25/21, a note was entered to indicate that is wife had called EMS the day before as "his heart stopped" and he passed en route to the hospital. No further details available. No autopsy results available. 13 days between date of vaccination and date of death.

major stroke; cannot speak; cannot move his arms; declining quickly; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (major stroke) in a 62-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 effect. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (major stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced SPEECH DISORDER (cannot speak), MOVEMENT DISORDER (cannot move his arms) and FEELING ABNORMAL (declining quickly). At the time of the report, CEREBROVASCULAR ACCIDENT (major stroke), SPEECH DISORDER (cannot speak), MOVEMENT DISORDER (cannot move his arms) and FEELING ABNORMAL (declining quickly) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. Treatment information were not reported. The patient was now in intensive care at the Hospital of Bay City in Michigan and he was declining quickly. Company comment:Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of cerebrovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.; Sender's Comments: Very limited information regarding the events has been provided at this time. The events were consistent with increased risk of cerebrovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.

I had a (first ever) stroke. I was attempting to take Flecainide for atrial fibrillation to reduce palpitations, the week prior and during the day of the stroke. I tried to take Flecainide twice before in the past few months, but I was unable to tolerate it. When I had the stroke, I didn't realize I was having one since I'm in very good health. I emailed my electro-cardiologist about my symptoms that day and found it difficult to use the appropriate words and reading the email later, I could see a number of mistakes. My ability to comprehend spoken language that day was impaired. I could only keep a few sentences in my head at a time and my attention span was poor as well, like having significant ADHD, which I don't have. I was unable to retain simple amounts of information the day of the stroke. I didn't seek treatment on the day of the stroke since I felt it was more of the side effects I had been experiencing from Flecainide. After going to the hospital I felt good and much improved, cognitively. An ER neurologist said that my stroke was a 2 on a scale of 1 to 42. Over the remainder of March and until this day (April 16, 2021), I have made steady and rapid improvement. I attribute my recovery to the lower level of stroke damage and the fact that I worked out every day with physical exercise and I worked out cognitively by doing a series of activities that I chose myself: reading out loud, reciting poetry and tongue twisters, playing logic and puzzle games on the PC, returning to my writing tasks for work, practicing grammar, and speaking at length with family and friends as a way to practice speaking. I had one appointment with an occupational therapist and two appointments with a speech therapist and have completed assessment. I now feel I am nearly completely recovered with an odd sense of some improvement in certain areas such as heightened mood and quicker connections for noticing practical matters.

On 4/6/2021 woke up with severe left muscle cramp in left leg. Next 3 to 5 days tried massage, ice, compression and Motrin - no relief. Did no treatment for the next couple of days. Went to primary care doctor and then got an ultra-sound on 4/14/2021 at clinic - by Doctor. Results showed had three blood clots in left leg. Started on Eliquis that day.

Extensive DVT requiring surgery. Received second Moderna vaccine approximately one week prior to admission, presented with acute onset of left leg swelling and pain. Left lower extremity ultrasound demonstrated an extensive deep venous thrombosis extending from the common femoral vein into the peritoneal and posterior tibial vein with a patent IVC. He was given a treatment dose of enoxaparin and admitted to the hospitalist service. Overnight he developed diminished sensation in his toes and vascular surgery was consulted. On 3/31/2021 he underwent mechanical thrombectomy of the left superficial femoral and common femoral veins as well as stenting of the left common iliac vein stent. Of note he was noted to have May Thurner physiology with compression of the left common iliac vein by the external iliac artery on the right. Post procedurally the patient's swelling and edema was significantly improved. He did not have any significant pain or difficulty ambulating. On postoperative day #1 he was evaluated and found to be hemodynamically stable with improvement of his symptoms and stable for discharge home. Prior to discharge it was discussed with the patient that he will need to be on a loading dose of Eliquis for 7 days, followed by a maintenance dose of 5 mg twice daily. No h/o COVID.

On 3/4/21 noticed my left calf was swollen. I did not think much of it at first. A week later the swelling had progressed to include my ankle. Saw Dr. and ordered an ultrasound on both of my legs. Right leg was normal & left lower leg had a clot(s) in it. Dr. ran blood work then prescribed Eliquis. Saw him in follow-up on April 14. Swelling down but not gone. Renewed the prescription for Eliquis and set a followup visit for Friday June 18. He ordered additional blood work to be drawn on Wednesday June 16 to have results at the next visit.

Vague RLE discomfort 3/16/21-4/4/21, DVT RLE greater saphenous vein discovered in the ER 4/9/21. He is on eliquis and may need to continue this for his lifetime given this is a second thrombotic event

63-year-old male who complains of sudden mid upper back sharp tightness pain sensation worse with inspiration unlike pain ever felt before that occurred while he was exercising on the rowing machine earlier today. The patient denies any injury or fall and he does not take any anticoagulation therapy.

The vaccine was given outside of the system (? county program). Patient's daughter thinks diffuse or migrating arthralgias started about 4 days after the vaccine was given. He visited ED on 3/09 complaining of pain in multiple joints for 3 weeks. No labs were done then. He returned 3/19 with difficulty walking and talking, was sent to SNF after MRI with diagnosis (probably incorrect) of acute cerebral infarct. He returned to the ED on 3/29 less alert, and no longer able to speak. LP showed 10 WBC (mostly lymphs) and protein 70. MRI was repeated, looked similar to previous scan , but reinterpreted as diffuse cerebritis, worst in basal ganglia. By 4/02 he was deeply obtunded ... (cont. on next page)

On day 4 following dose 2 of Moderna series, pt developed fever, chills, fatigue, malaise and self-medicated with ibuprofen and acetaminophen. After a "few" days of feeling unwell despite treatment, presented to ER and was found to have AKI, hyponatremia, and thrombocytopenia. Over the course of several days rapidly deteriorated and developed MSOF, including liver failure, DIC, respiratory failure requiring intubation, and shock requiring pressors. Workup for VTE, including V/Q scan, LE dopplers, and head CT negative for thrombosis. Ferritin was found to be highly elevated (12,000) suggestive of hemophagocytic lymphohistiocytosis (HLH). Per ER report, marrow positive for hemophagocytosis on smear. At time of report, transferred to Cancer Center for HLH treatment, currently in ICU, intubated, sedated, and on pressors. PF4 antibody pending.

Patient reported to his primary care provider, Dr, on or about 4/2/21, that he was experiencing swelling in his left arm. He was advised that he could be seen in the office the following Monday, 4/5/21, or may report to the nearest emergency department. He opted to wait until 4/5/21, and was evaluated in the office. Dr's staff reported to the pharmacy that a Doppler was ordered for patient, which revealed an "acute DVT in the left proximal / mid-subclavian vein and axillary vein", and it was suspected that the Moderna 1st dose may have been related. Pharmacy was contacted by the County Health Department ( nurse), and staff from County Office of Epidemiology , and instructed to obtain further information from Dr's office to file this VAERS report. Pharmacy was NOT able to successfully contact patient for further clarification on medications/prior conditions/allergies, as calls were not returned prior to completing VAERS report.

Patient admitted with left sided weakness on 4/21/21. First covid-19 vaccine (Moderna) received on 3/23/21. MRI/MRA shows acute infarcts of the right caudate body and striatum. H/o HTN, hep C with cirrhosis, COPD, tobacco abuse, alcohol use disorder, GTC seizure disorder. ECHO on 4/21/21 which was normal. Patient thought to be actively overusing alcohol at home. Patient was treated for stroke and discharged on medications to help with alcohol withdrawal symptoms (clonidine, gabapentin) as well as aspirin, plavix, and atorvastatin for new stroke. Thrombocytopenia noted (platelets 50K), however patient?s platelets have historically been low likely related to alcohol use. Per hospitalist discharge summary, low suspicion for vaccine induced thrombocytopenia. HIT Ab test ordered on 4/21/21, resulted negative. It seems to be coincidental that stroke occurred about a month after patient?s first covid-19 vaccine but reported to VAERS for completeness. Did not add covid-19 vaccine to patient?s allergy list. Patient received second covid-19 vaccine (Moderna) on 4/28/21.

Bloody nose x 2, blood blisters inside mouth including tongue, cheek, and lip. These symptoms showed up on 04/23/21. Went to the dentist on 04/24/21 due to having tooth extraction on 03/18/21. Dentist confirmed that had healed completely and recommended getting blood work done. Went to Urgent Care had blood drawn, report showed ZERO platelets. I was sent to ER where they ran a blood test again, platelets were ONE. 2 bags of platelets were infused, that brought platelets to 5. I was then admitted to the hospital and four hours later platelets were down to 2. They infused another 2 bags of platelets. Blood test showed platelets at 10. Four hours later the platelets were down to 4. On 04/25/21 I was diagnosed with ITP and was given an infusion of IVIG, on 04/26/21 my platelets were up to 16. They infused another IVIG on 04/26/21 and on 04/27/21 platelets were at 41. I was discharged on 04/27/21. Went to clinic on 04/29/21 and platelets were at 130.

I cannot confirm the type of vaccine the pt received as it didn't occur in our health system. Pt experienced out of hospital cardiac arrest a few days after vaccination. Pt resuscitated; however never regained consciousness. Coronary angiogram revealed normal coronary arteries.

On 4-15-21, patient started having breathing problems and shortness of breath. He had a cough that he had productive phlegm. He continued to get worse. On 4-18-21, he fell getting out of the shower and slumped onto the floor, stating that he couldn't breathe. His wife and neighbor took him to the local ER. His condition improved with oxygen. He was admitted on 4-18-21 and then was transported by Air Evac to ICU. He was placed on the ventilator prior to leaving on 4-21-21 and transferred to hospital. His condition continued to deteriorate and he passed away on 4-25-21.

Hospitalized twice 4/18-4/21 and 4/24-28: Flu-like systems for 6 weeks. Nausea, headache, dizziness, muscle ache, inflammatory markers CRP 23.6, ESR 97, Chest pain, shortness of breath, pericardial effusion, pleural effusion, A-Fib. Manually drained right pleural cavity 400 cc. Fluid came back. Was put on prednisone for 10 days. Fluid was reduced.

Developed signs and symptoms of left posterior thalamic stroke with sensory loss and pain. Began approximately 10 hours post injection and has persisted since that time.

Recieved obituray on patient. Called pt. ER contact and she stated that she was unaware how patient died. Pt. died at home but states that pt. had been having flu-like symptoms in bed with chills after vaccination. Pt. ER contact is unaware of pt. medical history or current medications. Pt. ER contact that pt. PCP was not us but another medical facility. Called funeral home and spoke to employee and she stated that the coroner cause of death listed was acute MI. Employee stated that she does not have a certified copy of death certificate at this time.

Persistent fever began on 4/6/21 and persisted until diagnosis of acute pericarditis with pericardial effusion on 4/24/21.

Began as low grade fever and night sweats on 4/5/21. After two weeks began having difficulty breathing, and fever reached 102°F and was more constant. Pulse rate increased by almost 50% over 2-1/2 weeks. On 4/23/21, after 2-1/2 weeks of increasing fever, pulse rate, and breathing difficulty, pulse rate shot up past 200 so I went to the ER. Kept in ER for 4 days, was on oxygen for first 3 days. Diagnosed with Pericardial Effusion caused by Viral Pericarditis. Treated with anti-inflammatory medications. Have had two more SVT (SupraVentricular Tachycardia) episodes since; had to go back to ER for one of them Slowly recovering over several weeks.

The 2nd dose of Moderna was administered on 05/12/2021 at 9:40 am, patient waited for 15 minutes he was feeling well and left the pharmacy at 09:50 am. The patient-caregiver contacted us at 12pm on 05/13/2021 stating that the patient passed away today. She stated he was feeling fine yesterday and had his breathing treatment at night and in the morning he didn't wake up.

acute ischemic stroke left thalamus. Right sided numbness. Began hours after receiving second vaccination dose

Patient was provided with the COVID-19 vaccine outside of the hospital and begain having shortness of breath approximately 15-20 minutes after receiving the vaccination. In route home, the patient could not catch his breath. The patient was found slumped over at home. EMS arrived and the patient received ACLS and ROSC was achieved. Days later, the patient arrested again and passed away on 5/13/21.

Patient reported fatigue and progressive weakness since given vaccination. Now admitted to ICU in hypercarbic and hypoxemic respiratory failure on invasive vent support.

Stroke; Vertigo; Dizziness; High Blood Pressure; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant), VERTIGO (Vertigo), DIZZINESS (Dizziness), HYPERTENSION (High Blood Pressure) and HEADACHE (Headache). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), VERTIGO (Vertigo), DIZZINESS (Dizziness), HYPERTENSION (High Blood Pressure) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant products were reported. Treatment information provided included steroids. Patient stated he in now in a walker due to having a stroke. Very limited information regarding these events has been provided at this time. Further information has been requested. However, the patient may deny additional follow-up. Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Event fell diagnosed as stroke (Seriousness criteria - medically significant).; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested. However, the patient may deny additional follow-up.

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

Blood clot in his lung; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY THROMBOSIS (Blood clot in his lung) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012a21a) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included BRINZOLAMIDE (AZOPT) 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 11-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PULMONARY THROMBOSIS (Blood clot in his lung) (seriousness criterion medically significant). At the time of the report, PULMONARY THROMBOSIS (Blood clot in his lung) outcome was unknown. No treatment information was provided. Action taken with mRNA-1273 in response to 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 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

Hospital Course: Patient was admitted to the medical floor with altered mental status, placed on empiric Rocephin/Zithromax for presumptive bacterial pneumonia. It was later revealed that he received his 2nd Moderna COVID19 vaccination on 5/18, having recovered from COVID19 in Dec 2020. This certainly raises the question as to if his symptoms are related to immune-response to the vaccine. He certainly seems to think so, based on timing of his symptoms and being in his usual state of health prior to getting it. Nonetheless, he is being treated initially for presumptive straightforward community acquired pneumonia. Quite unexpectedly, within 24 hours of his abrupt decompensation, he has returned to baseline. Off O2, mental status sharp and at baseline, no further fevers. This rapid improvement confirms suspicion that his presentation is likely adverse effect/immune mediated response to the 2nd COVID vaccine (Moderna). He became acutely ill within 24 hours of vaccine and resolved almost exactly 48 hours afterwards. Creatinine has returned to baseline 1.9-2.0 after IV fluids. Cultures remain negative.

Fever highest 103F, head ache, body ache, chills, tired, unable to eat symptoms lasted 3 days and during that time my heart went back into atrial fibrillation

After my first and second Moderna shots my heart raced and 3 weeks after the second shot I started to retain body fluid from heart failure and Edema. also my mother died 3 weeks after her first Moderna shot and also my aunt (her sister) died 3 weeks after her Moderna shot.

Dizziness; Aches; Weak; Fever; Nausea; DIED; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (DIED) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea). The patient died on 18-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DIZZINESS (Dizziness), PAIN (Aches), ASTHENIA (Weak), PYREXIA (Fever) and NAUSEA (Nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. It was reported that the vaccine was not the cause, he had other medical issues too. This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: New event (death) and narrative was updated.; Sender's Comments: This is a case of sudden death in a 62-year-old male patient with unknown medical, who died 12 days after receiving first dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: Unknown cause of death

Upon arrival to the ED, the patient reported symptoms starting on Sunday with exertional SOB. SOB was significant while laying flat and awakening at night SOB. Patient was admitted to the hospital and stayed in the ICU for a few days. Medications received during the patients stay included: APAP 650 mg, ASA 81 mg, Atorvastatin 40 mg, Colchicine 0.6 mg, diphenhydramine, enoxaparin 40 mg, fentanyl citrate, heparin. lidocaine hcl, metoprolol tartrate, midazolam hcl, ondansetron, miralax and NS. The patient was admitted 6/4/21 and discharged 6/10/21.

62-year-old male with history of hypertension presented to the hospital with chest pain. Chest pain centrally located, pressure-like sensation radiating to the left upper extremity and left side of the jaw. Associated with sweating. He had difficulty breathing when he had the chest pain. Patient was nauseous. NSTEMI. Cardiac Catheterization performed.

1- Palpetations and Aflutter which was controlled prior to second shot was exacerbated and evolved into AFIB within 1-week of second shot. (26-March-2021) 2- Sought treatment subsequently and required cardioversion. (3-April-2021) 3- Another cardioversion was undertaken and finally, the installation of a pacemaker was completed to avoid total heart block condition which evolved. 4- Placed on maintenance dose of Amioderone beginning 2-April. Palpetations continue

March/April 2021 began having palpitations and shortness of breath. EKG at PCP office confirmed new onset atrial fibrillation. Stress ECHO and Holter monitor confirmed a reduced ejection fraction and mild cardiomyopathy. Cardiac angiography confirmed suboptimal ejection fraction

As reported to me by Patient On 6-29-2021 patient had a stroke on 6-30-2021 sister came to get him and took him to Hospital in city Stroke on left and has affected his right side of body. He is still recovering. His Blood was very high. However, he has never been to see a physician so no baseline Blood Pressure.

Anxiety directly related and due to the vaccine; I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.; his chest hurt so bad; he got sick very bad; He has elevated immunity; More than 35 days after the first dose without receiving the second dose; I felt like I was having a heart attack; my knees were aching; When I woke up the next day, felt like a truck ran me over; lost all appetite; it attacked both my knees so severely I could hardly walk; Couldn't get off my toilet seat; I can't sit in my couch; had all kind of symptoms; 101 fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (his chest hurt so bad), MYOCARDIAL INFARCTION (I felt like I was having a heart attack), ANXIETY (Anxiety directly related and due to the vaccine) and INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Endocervical) at an unspecified dose. On 22-Mar-2021, the patient experienced GENERAL SYMPTOM (had all kind of symptoms), PYREXIA (101 fever) and CHILLS (chills). On 23-Mar-2021, the patient experienced INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.) (seriousness criterion hospitalization), FEELING ABNORMAL (When I woke up the next day, felt like a truck ran me over), DECREASED APPETITE (lost all appetite), GAIT INABILITY (it attacked both my knees so severely I could hardly walk), DYSSTASIA (Couldn't get off my toilet seat), SITTING DISABILITY (I can't sit in my couch) and ARTHRALGIA (my knees were aching). On 06-Apr-2021, the patient experienced CHEST PAIN (his chest hurt so bad) (seriousness criterion hospitalization) and MYOCARDIAL INFARCTION (I felt like I was having a heart attack) (seriousness criterion medically significant). On an unknown date, the patient experienced ANXIETY (Anxiety directly related and due to the vaccine) (seriousness criterion hospitalization), PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose), ILLNESS (he got sick very bad) and IMMUNE SYSTEM DISORDER (He has elevated immunity). The patient was hospitalized from 06-Apr-2021 to 07-Apr-2021 due to CHEST PAIN. At the time of the report, CHEST PAIN (his chest hurt so bad), MYOCARDIAL INFARCTION (I felt like I was having a heart attack), ANXIETY (Anxiety directly related and due to the vaccine), INSOMNIA (I got Insomnia,10 days without sleeping,Lack of sleep directly related and due to the vaccine.), GENERAL SYMPTOM (had all kind of symptoms), FEELING ABNORMAL (When I woke up the next day, felt like a truck ran me over), DECREASED APPETITE (lost all appetite), GAIT INABILITY (it attacked both my knees so severely I could hardly walk), DYSSTASIA (Couldn't get off my toilet seat), SITTING DISABILITY (I can't sit in my couch), ILLNESS (he got sick very bad), IMMUNE SYSTEM DISORDER (He has elevated immunity), ARTHRALGIA (my knees were aching), PYREXIA (101 fever) and CHILLS (chills) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2021, Body temperature: 101 (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Endocervical) was unknown. Patient reported that he wont get the second one, as he got sick very bad. He had elevated immunity, his antibodies level is off the charts, that was documented in his hospital. Concomitant medications was not reported . Treatment history was not reported . 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.

Heart attack; Blood clot; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) and THROMBOSIS (Blood clot) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033b21a) for COVID-19 vaccination. No Medical History information was reported. On 16-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jun-2021, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criteria hospitalization and medically significant) and THROMBOSIS (Blood clot) (seriousness criteria hospitalization and medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and THROMBOSIS (Blood clot) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. Patient received first dose of Moderna COVID-19 on 19-MAY-2021 with lot number 045b21a intramuscularly. No concomitant medications were provided. No lab data was provided. No treatment information was provided. Company comment: Based on temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Based on temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding the events has been provided at this time. Further information has been requested.

I had a pulmonary embolism that required hospitalization. I had blood clots in my lungs which traveled from my left calf. I noticed a shortness of breath when running 4 days after my first vaccination. Subsequent runs featured extremely elevated pulse rates, too high in my opinion given I was only running at a moderate pace. That led me to think there was something wrong. I went to the doctor who ordered tests for me. The tests confirmed that I had blood clots and I was told to go to the emergency room immediately. I was hospitalized for 2 days, and was prescribed Eliquis. I have to take Eliquis for 6 months. Bloodwork confirmed that I was not genetically predisposed to blood clotting. If I was not active, I would never had known a problem existed. I was told that I could have died if I did not go to the doctor to check this out.

Cardiac Infraction; This spontaneous case was reported by a patient and describes the occurrence of MYOCARDIAL INFARCTION (Cardiac Infraction) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 030M20A) for COVID-19 vaccination. No relevant medical history was provided. Concomitant products included TICAGRELOR (BRILINTA), ACETYLSALICYLIC ACID (ASPIRIN LOW) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Cardiac Infraction) (seriousness criteria medically significant and intervention required). At the time of the report, MYOCARDIAL INFARCTION (Cardiac Infraction) outcome was unknown. Patient stated that they put a stent in there. Company 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.; 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.

This is being reported because of the incident occurring 2 days after the Moderna Covid-19 vaccination. It was reported that the patient expired on 1/9/21, 2 days after receiving the Moderna vaccine. Upon screening of patient prior to administration on 1/7/21, the patient completed paperwork answering NO to the following "Do you currently have any active infections or acute respiratory illness or fever."

On 1/15/2021 at 1800, resident noted to be lethargic and shaking, stating "I don't care." repeatedly. C/O head and neck pain. T100.6. Given Tylenol with no relief of pain. Order received for Aleve and administered.. Assisted to bed as usual in evening. Monitored during night shift and noted to be resting comfortably/sleeping.. Noted agonal breathing at 4:10 AM 1/16/2021 , T 99.4, Absence of vital signs at 4:15AM 1/16/21 and death pronounced at 4:40AM 1/16/21.

admitted to shady grove hospital for ITP(immune mediated thrombocytopenia) plts were 1 on admission have not responded to typical ITP therapies, platelets still 4 today after 4 days in hospital workup shows ITP no other risk factors or history of itp or autoimmunity

We were made aware that days after vaccination the patient suffered a "major brain hemorrhage" according to patient's wife. He is currently admitted at a different hospital. After vaccine administration on-site, the patient became unconscious for a few minutes. However, this is common for him - he informed us that he almost always "passes out" after vaccine administration. He slowly returned to consciousness without any issues. He was seen by an ED physician prior to leaving the facility. Deemed to be in good health, patient also stated that he felt fine and believed he was okay to leave as these episodes occur frequently following vaccination.

Arm tenderness; Runny nose; Cough; Anaphylactic reaction; A spontaneous report was received from a 63-year-old male who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, arm tenderness, runny nose and cough. The patient's medical history was not provided. No relevant concomitant medications were reported. On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:011(J/5)20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, patient started to experienced cough which got progressively worse, runny nose and his heart started racing. He could not swallow water, his airway was shutting down, and he stated that it was an anaphylactic reaction. Patient also felt exhausted with arm tenderness and pronounced discomfort. Treatment for the events were not provided. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome for the events, anaphylactic reaction, arm tenderness, runny nose and cough was unknown.; Reporter's Comments: This case concerns a 63-year-old, male patient, who experienced a serious unexpected event of anaphylactic reaction, and non-serious unexpected event of cough, and rhinorrhea, and a non-serious expected event of pain in extremity. The events occurred 1 day (same day) after first dose of mRNA-1273, lot # 011(J/5)20A. No treatment was administered. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.

resident was on hospice, chronically ill w dementia, COPD, HTN, failure to thrive, passed away 1/13/21. Not certain injection related as he was declining already.

I am being treated through medication for A-Fib of which I've had 0 episodes since August 9th, 2021. I received the Covid Moderna shot on 1/29/2021 at noon. That night and into the following morning I experienced 3 A-Fib episodes. . I have not had any since then.

1/31 - received 2nd dose of Moderna vaccine at MD (where I work as M.D.) Approximately 8 hours later, experienced severe chills, fever 102, chest pain, and shortness of breath. Fever lasted two days, however ,still not feeling well then experienced palpitations, irregular heartbeat. Went to cardiologist on 2/8. Tests revealed pericardial effusion and pleural effusion.

Patient experienced a grand mal seizure approximately 4 hours after receiving his first dose of the Moderna vaccine.

Passed away; tired; nonresponsive; cold; difficulty breathing; swelling; sore arm; feeling weird and funny; A spontaneous report (United States) was received from a consumer concerning a 63 year old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and the patient experienced limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal and the patient passed away . Medical history included treatment for tuberculosis and dialysis. Concomitant medication included calcium acetate, Renvela, glipizide, omeprazole, aspirin, vitamin D, losartan, furosemide, rifampin, and Sensipar. On 14 Jan 2021, the patient received the first of their first planned doses of mRNA-1273 (lot number 030L20A) for prophylaxis of COVID-19 infection. On 13 Jan2021, the patient tested negative for COVID-19). On 16 Jan 2021, the patient experienced a sore arm, and feeling weird/funny. On 17Jan2021, the patient experienced difficulty breathing and swelling. On 18 Jan 2021, the patient declined dialysis, was tired and wanted to lay down. At 8 am, the patient was found nonresponsive and cold and is believed to have passed away around 4 am. The coroner tested the deceased for COVID-19 and the test was positive. No autopsy was reported. No death certificate was issued at the time of the report but the reporter believes it will list cause of death as COVID complications. Action taken with the mRNA-1273 was not applicable. The outcome of the events of limb discomfort, feeling abnormal, dyspnea, fatigue, swelling, unresponsive to stimuli, body temperature abnormal, was fatal. On 18 Jan 2021, the patient was died. Cause of death was COVID-19. Autopsy details were not provided.; Reporter's Comments: The events developed on four days after first dose of mRNA-1372. Dyspnea, unresponsive to stimuli, and death were consistent with infection in pandemic set up confounded by age of patient and refusal of dialysis Cause of death was reported as COVID-19. Autopsy details were not provided. Based on reporter's causality the events are assessed as unlikely related to mRNA-1273.; Reported Cause(s) of Death: COVID-19

Patient is meeting diagnostic criteria for multisystem inflammatory syndrome post-vaccination. He received his 1st Moderna COVID vaccination on 12/31/2020 (037K20A) and his second COVID vaccination on 2/5/21 (029L20A). He began developing high grade fevers on 1/22/21 and was admitted to our facility on 2/8/21 due to "fever of unknown etiology" associated with hepatitis and coagulopathy on laboratory studies. He underwent an extensive evaluation which failed to reveal any other infectious, rheumatologic, or hematologic explanation for his clinical syndrome. He was ultimately discharged to outpatient care with ongoing supportive care for his fevers. His liver associated enzymes were improving at discharge.

Cardiac arrest just stopped breathing fortunately at home wife called 911 within five minutes of noticing not breathing responders there in 3-5 minutes worked on him for 15 minutes at home before transporting to ER hospital. No heart beat pulse etc... used CPR machines and paddles Patient had walked 6 1/2 miles that morning no problems did about 50-60 miles weekly outside. This was sudden and me, his wife, say it was a reaction to something in shot that contributed to this event- there is absolutely nothing you could say to make believe differently. This happened 1 1/2 hours after getting shot.

Pre-existing condition of kidney failure; Pre-existing conditions of heart failure; Skin rash; A spontaneous report was received from a 63-year-old male, consumer who received Moderna Covid-19 Vaccine (mRNA-1273) and who experienced pre-existing conditions of heart failure / cardiac failure and kidney failure / renal failure. The patient's medical history, as provided by the reporter, included preexisting conditions of heart failure and kidney failure. No relevant concomitants were reported. On unk Feb 2021 (during the first week of February), prior to onset of symptoms, the patient received their first dose of two planned doses of mRNA-1273 (Lot number 026L20A) intramuscularly in the right arm for the prophylaxis of Covid-19 infection. On unknown date, the patient experienced a rash, but no other reaction. He reported taking no other medication when he had received his first dose. On 17 Feb 2021, the patient was hospitalized for his pre-existing conditions of heart failure and kidney failure. He was discharged on 21 Feb 2021. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, rash, pre-existing heart failure and kidney failure red, were not reported.; Reporter's Comments: Based on reporter's causality the serious events kidney failure and heart failure are assessed as unlikely related to mRNA-1273 but possibly related to the consumer's pre-existing conditions of renal failure and cardiac failure, while the non-serious event of rash may be possibly related to mRNA-1273.

3/17/21 63 y.o. male who presents with sudden onset of chest pain and palpitations, which occurred while patient was exerting himself. Pain is substernal, radiated to the left arm, associated with lightheadedness. Denies diaphoresis or nausea. Per EMS there were short runs of nonsustained ventricular tachycardia 3/18: - remains inpatient admission as of 3/18/21 @ 0900 63 y.o. male with a past medical history of nonsustained ventricular tachycardia. He states he was lifting a couch yesterday and his heart started beating fast. He did not really have any chest pain, but felt a little bit lightheaded. He called an ambulance and they brought into the ER. In the emergency room his EKG did show some frequent PVCs. However, he did not really require any intervention. He was given 3 nitro, but it really did not make any difference in the way he was feeling. The patient denies multiple times that he actually had chest pain. He states he just felt like his heart was beating funny. The patient's most recent stress test was a nuclear stress test in May of 2019. Overnight, the patient has felt very well. He denies any significant chest pain. He denies any further heart palpitations. On the monitor he would occasionally going to bigeminy, which is not abnormal for him. EKG this morning was unremarkable. After speaking with the patient's wife, she told me that he has had a several month history of very limited exertion. She states every time he exerts he becomes extremely dyspneic and has heart palpitations and sometimes almost passes out. She states last night he was extremely diaphoretic and very nearly passed out.

Received call from his exwife that patient had passed away. Death Certificate states date of death as March 14, 2021. Causes of death are listed a. Cardiac Pulmonary Arrest. b. Myocardial Infarction

vaccine recieved 3/29/21, on 3/30/21 patient expired in his home. cause of death assumed to be cardiac related. Pt. was not feeling well after covid vaccination, therefore refused to go to dialysis (3/30/21). Collapsed in basement and was found by spouse 30 minutes later. Patient was DNR. spouse stated she feels death was not directly related to vaccine because he had several health conditions in which he has been noncompliant with and has not been following his medical providers treatment plans.

Death Narrative: Patient with gastric cancer received COVID-19 vaccine, first dose on 2/8/2021 and second dose on 3/9/2021. Chart note indicates that patient passed away on 3/26/2021 while on home hospice. Patient has never tested positive for COVID. Patient had metastatic cancer and was referred to hospice on 3/5/2021, note from provider indicates patient likely had only weeks to live. Patient had no documented reaction from COVID vaccine administration. Patient had no hospitalization around time of COVID vaccination. The patients most likely cause of death was the metastatic cancer, with date of death closely aligning with cancer providers' estimations of remaining life span on 3/5.

Grand mal seizure at 11:30 a.m. Continued having seizures until 2:00 a.m. 3/29/21 He had not had a seizure for 3 weeks. He had not had seizures for this long a period of time for as long as we have on record. His neurologist stated to give him Ativan each time they were becoming constant,

Had a stroke Mar 16, 2021. 12 days after shot. This is nonsense adding all this data. It is as though you don't want to hear. Mistakes on pages are mot clear and easy to figure out. Such as no months if over 2 years of age. Idiotic.

wife of the patient called came in for her COVID-19 vaccine appointment on 4/8/2021 and explained that her husband passed away in his sleep suddenly after a wonderful evening on 3/25/2021. She expressed that physician said it was not COVID related. Wife did not want to discuss the death of her husband at this time so the information is limited for this report.

Patient got 1st Moderna Covid vaccine on 3/24/21. On 3/29 patient started getting a runny nose. By 4/2 patient started getting fatigue with loss of appetite and on 4/3 started getting right sided abdominal pain with movement. Seen in the clinic on 4/5 with tachycardia 112 apical and temp 99.1, abdominal pain was feeling a little better and only reproducible with use of abdominal muscles. No resp symptoms except intermittent runny nose. Patient appeared very dehydrated on exam, IVF were offered but patient declined. Labs were done and patient was encouraged to aggressively hydrate at home. US abdomen was ordered STAT. Patient declined US on 4/6 because he was busy so it was scheduled 4/7. Covid test scheduled for next available apt. On 4/6: Labs showed mild increase in WBCs and dehydration but otherwise no major abnormalities. Patient reported new onset swelling, redness, and pain in his R leg and concern for DVT. He reports family history of DVT in his mother. US of the leg was added to his testing on 4/7. He also reported on and off chills. 4/7: Report called for US Abdomen was negative but patient did have extensive DVT in the right leg. Eliquis was called in and patient instructed to pick up and begin immediately. He denies any respiratory symptoms today but still intermittent chills. He reports that abdominal pain has resolved.

Immediate excessive bleeding. Immediate pain compared to previous vaccinations. Arm and shoulder became increasingly more painful through out the next several hours. By evening I was unable to lift arm. Any movement resulting in extremely sharp pain. No movement and the arm and shoulder had high degree of aching. Next day same and stayed in bed for next 3 days due to pain. On 4th day some improvement and could move arm by lifting with other hand. 5the day slight improvement. 6 the day small improvement still can not lift objects or reach out without severe pain

Patient received the 2nd dose of Moderna COVID Vaccine on Wednesday 4/7/2021. He called the office today 4/12/2021 at approximately 9:00AM. He stated that his left arm was swollen from the shoulder, down to the his fingers. He said that the swelling started on Thursday 4/8/2021, and has not improved. I scheduled him to come into the office for an appointment with PA, at 10:20AM today, 4/12/2021. Patient was sent him to have an ultrasound, which showed DVT in the left subclavian vein and internal jugular vein.

Pt complained of dizziness for 2 weeks prior to hospitalization 4/10/2021, and passed out 6 times in the 2 days prior to admission. Upon admission was found to have acute pulmonary embolism. Physician requested VAERS report.

Pulmonary embolism resulting in atrial fibrillation with rapid ventricular response. Hospital treatment included IV anticoagulation, IV anti arrhythmic medications, and subsequent cardioversion.

Patient had the COVID vaccine 5 days prior to admission, this was followed by diarrhea, body aches, intermittent shortness of breath and general feeling unwell. Most resolved but the diarrhea and intermittent respiratory distress, this worsened on day of admission (4/11/21) with decline in mental status. Nausea with no vomiting, no fever, no cough. Patient was admitted to the ICU with acute respiratory failure with hypoxia and pneumonia. Placed on BiPAP, IV fluids. Patient is currently in the ICU with diagnosis encephalopathy, bilateral aspiration pneumonia, right pleural effusion and UTI. Discussed patient with Health Department who requested patient be reported to VEARS for review.

Blood clots in left leg, hip, bilateral lungs; treated with blood thinners; was admitted to hospital from 4/1-4/3; discharged to home, stable

Patient reported after 1st vaccine experiencing some itching. Patient also reported an increase in his BS after vaccine 1. Provider prescribed Atarax to patient for this, patient had previously been prescribed this as he has had a similar reaction to other vaccines and medication changes. Patient was seen by provider for high BS, patients insurance stopped paying for his insulin and they were transitioning him to Trulicity. Patient came to vaccine clinic on 4/13/2021. Patient was given 2nd dose of vaccine and monitored for appropriate period of time post vaccination. Patients family reports that patient had been feeling SOB for the past several weeks and more fatigue than usual. 4/14/2021, patient triggered an alert thru the monitoring system, nurse reached out to patient to discuss and schedule appointment for further DM education and appt with provider. Nurse had difficult time reaching patient, but patient did call back same day and scheduled appt on 4/23/21. Family reports they went to bed on 4/14/2021, brother went upstairs for bed checked on patient and he was unresponsive. 911 called, paramedics and fire department responded, but CPR was unsuccessful. Patient pronounced dea 4/15/2021 @ 12:26am.

woke up with trouble breathin like couldn't get enough air into lungs, happened when sleeping for several nights

Patient came to pharmacy today w/ his wife to pick up Rx for XARELTO. He has developed multiple DVT's in his leg. He reported symptoms started the day after (Saturday) his second dose of Moderna COVID 19 vaccine on Friday 4.9.21. His leg was swollen by Sunday 4.11.21. Symptoms would get worse and then get better. He finally went to see Dr. today 04.20.21. They found several blood clots in the leg via doppler. Patient was therefore prescribed Xarelto. Pt wife advised that Dr said clots were due to Moderna vaccine and they should let pharmacy know also. Their next appointment will be in 2 weeks.

Vaccine on 04/10/21.Shortness of breath, dizziness, nausea 04/13/2021. Death on at hospital on 04/14/2021 Autopsy found Bilateral pulmonary thromboemnbolus

received the vaccine on Monday 4/19/21 into his left arm Tuesday 4/20/21 he went to work but after lunch became extremely fatigued and achy, went home to sleep it off Wednesday 4/21/21 he woke up with right UE/LE numbness and weakness which persisted until Thursday 4/22/21 so sought medical attention

In order of progression: - numbness/tingling in hands - double/blurry vision - affected speech, loss of some tongue/pallet mobility - partial paralysis of face - headache - loss of functioning in throat (unable to swallow) - loss of bowel control - loss of reflex (especially in upper body) - not able to open eyes - respiratory arrest

Patient received the moderna vaccine (1st dose). Shortly after was hospitalized for a potential MS flare and was treated with pulse dose steroids, discharged home. He then started to feel progressively fatigued and was readmitted to the hospital on 4/19/21 with a diffuse pneumonitis complicated by hypoxemic respiratory failure. He is currently being treated with IV steroids.

Anaphylaxis reaction; fast heartbeats; stomach ache; shortness of breath; orthostatic hypotension; sore shoulder; headache; minor nausea which increased the third day; dizziness; body ache; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylaxis reaction) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN (body ache). On 16-Apr-2021, the patient experienced DIZZINESS (dizziness) and NAUSEA (minor nausea which increased the third day). On 21-Apr-2021, the patient experienced ANAPHYLACTIC REACTION (Anaphylaxis reaction) (seriousness criterion medically significant), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), ARTHRALGIA (sore shoulder) and HEADACHE (headache). At the time of the report, ANAPHYLACTIC REACTION (Anaphylaxis reaction), HEART RATE IRREGULAR (fast heartbeats), ABDOMINAL PAIN UPPER (stomach ache), DYSPNOEA (shortness of breath), DIZZINESS (dizziness), ORTHOSTATIC HYPOTENSION (orthostatic hypotension), PAIN (body ache), ARTHRALGIA (sore shoulder), NAUSEA (minor nausea which increased the third day) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant meds were reported. No treatment information was provided. Company comment:Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.; Sender's Comments: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the reported events, and excluding other etiologies, a causal relationship with the product use cannot be excluded. Arthralgia, myalgia, nausea and headache are consistent with the product known safety profile.

Within 12 hours of vaccine patient complained of being short of breath and asked his wife to call 911, he then stopped breathing and she did CPR until rescue squad arrived. Pt was unable to be revived and died.

3 weeks after Patient got this shot he got blood clots in his leg and amputated next week .The problem is he has ITP platelets were 12,000 He can't make blood clots!!!

CHF (congestive heart failure) Pneumonia Respiratory distress Hypoxia Suspected COVID-19 virus infection

4/24/2021. Extensive bilateral pulmonary emboli with hypoxia: Uncertain of the cause of the emboli. Did have COVID-19 in January and also received his 1st COVID vaccine within the last week. No recent surgeries in no recent travel. CT chest PE protocol demonstrates extensive right more than left pulmonary emboli with evidence of right heart strain. Small pulmonary infarct in the right posterior lower lobe. Started on heparin drip with full bolus and will continue heparin drip per protocol.

COVID -19; high fever (for over two weeks); pneumonia; difficulty breathing; headache/similar to sinus headache; achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (pneumonia) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 28-Mar-2021, the patient experienced DYSPNOEA (difficulty breathing), SINUS HEADACHE (headache/similar to sinus headache), MYALGIA (achy) and FATIGUE (tired). On 12-Apr-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced COVID-19 (COVID -19) and PYREXIA (high fever (for over two weeks)). At the time of the report, PNEUMONIA (pneumonia), DYSPNOEA (difficulty breathing), COVID-19 (COVID -19), SINUS HEADACHE (headache/similar to sinus headache), PYREXIA (high fever (for over two weeks)), MYALGIA (achy) and FATIGUE (tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Computerised tomogram: she had pneumonia. On 12-Apr-2021, Drug specific antibody: Positive. No concomitant medications reported by investigator. Treatment included Levofloxacin, inhaler (albuterol) and steroid dexamethasone. Based on the information provided, a causal association between the administration of mRNA-1273 and the event of Covid-19, pneumonia is assessed as unlikely as pneumonia is of an infective etiology. Although the other events are consistent with, the known safety profile for mRNA-1273, based on onset of the events, they are more likely symptoms of pneumonia, This case was linked to US-MODERNATX, INC.-MOD-2021-095621 (Linked Report).; Sender's Comments: Based on the information provided, a causal association between the administration of mRNA-1273 and the event of Covid-19, pneumonia is assessed as unlikely as pneumonia is of an infective etiology. Although the other events are consistent with, the known safety profile for mRNA-1273, based on onset of the events, they are more likely symptoms of pneumonia, US-MODERNATX, INC.-MOD-2021-095621:1st dose

This 63 year old male received the Moderna Covid shot on 3/26/21 and went to the ED on 4/5/21 and was admitted on 4/5/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident)

headache; Pneumonia; covid-19; difficulty breathing from copd; Achey; tired; high fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) and COVID-19 (covid-19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced CHRONIC OBSTRUCTIVE PULMONARY DISEASE (difficulty breathing from copd), MYALGIA (Achey), FATIGUE (tired) and PYREXIA (high fever). On 12-Apr-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant) and COVID-19 (covid-19) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, PNEUMONIA (Pneumonia), COVID-19 (covid-19), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (difficulty breathing from copd), MYALGIA (Achey), FATIGUE (tired), HEADACHE (headache) and PYREXIA (high fever) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Mar-2021, SARS-CoV-2 test positive: positive (Positive) positive. On 12-Apr-2021, Computerised tomogram: positive (Positive) positive for pneumonia.. On 12-Apr-2021, SARS-CoV-2 antibody test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient finished treatment with antibiotics and was tested positive for antibodies. Patient took Levofloxacin, inhaler (albuterol) and steroid dexamethasone medications as a treatment. There are no concomitant medication 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. Based on reporter's causality history a positive SARS-CoV-2 viral test event is assessed as unlikely related to mRNA-1273 This case was linked to MOD-2021-095577 (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. Based on reporter's causality history a positive SARS-CoV-2 viral test event is assessed as unlikely related to mRNA-1273 MOD-2021-095577:

63 yo male received 1st dose of Moderna Vaccine on 3/31/21. Admitted to hospital on 4/6/21 then transferred to another Hospital on 4/12/21 for idiopathic pericardial effusion, acute kidney injury then released home on 4/23/21. He presented to hospital on 4/25/21 with acute respiratory failure, septic shock, cardiogenic shock, acute myocarditis and acute on chronic kidney injury. Transferred to different Hospital on 4/30/21

patient died aprox 1 week after the 2nd dose . presumed cause of death stated by son was GI bleed. Not confirmed to be caused by the vaccine. Autopsy not performed according to the son.

Pt states that he woke up the next morning and his entire left arm was swollen and numb. The following day, two days after the vaccination, the entire left side of his body was swollen and numb. The patient went to the hospital on April 6, 2021, and was hospitalized for ten days. Upon admission, he had bloody urine, swelling and numbness on the left side of his body, and was short of breath and coughing up blood. Pt was diagnosed with pneumonia while admitted to hospital.

5-19-21 Patient self-reported to that 8 days after receiving his first dose of Moderna (3/18/21), he began coughing up blood, was taken to the hospital, transferred to the ICU with thrombosis. He states he was in the ICU for 6 days. He then received second dose on 04/09/21 and was ill for 5 days again. States he currently remains fatigued, short of breath and "just not himself." Patient is concerned that the blood clots were related to his COVID Vaccines.

onset of respiratory failure on 05/14/2021 to be eventually diagnosed with pulmonary embolism. hospitalized at facility .

He got his vaccine, he had no reactions. The next morning he woke up his arm was sore, and it was that was for 2 days. Then his breathing starting getting worse. He started coughing, couldn't lay down, could not sleep due to that. He went to the ER and they told him that there was nothing wrong and that it was just allergies. They told him to go home and take some OTC cold medicine and that everything would be okay. A week later he went to another ER for the same thing as he continued not to be able to breath, they did a bunch of tests and said that nothing was wrong and that it was just a call. He then went to Hospital ER and they released him stating it had just a cold. He then called his cardiologist and they told him to go back to Hospital, was admitted on 5/11/21 and they did more tests and said that he had a blood clot in his left lung and said that it had nothing to do with the vaccine. He was discharged on 5/13/21. They put him on Heparin while in the hospital and sent him home as a disgruntled patient. They also told him that he had fluid around his heart and gave him medicine to get that taken away. They sent him home on Lasix and Eliquis. He then went to another hospital on Friday 5/14/21 as he was going crazy about the blood clot and went there and was kept there for 3 days and discharged on 5/16/21 with the same medications, Lasix and Eliquis. He was also told that he had fluid around his heart again. Before the vaccine he was very healthy, and was able to jog around his neighborhood and now he's not able to do so, and they told him that he was now having heart failure and is having trouble breathing because his heart is swelling up. He went to see his cardiologist last Friday and that's when she told him about his heart failure. ADMISSIONS: ADMITTED 5/11/21 TO 5/13/21; 5/14/21 to 5/16/21.

2/19/21- Patient presented with shortness of breath that appears to be chronic, but potentially worse (this was 5 days after 2nd Covid vaccine). Lab tests showed thrombocytopenia (unknown if this is new or old) as well as mild transaminitis (again, not known if new) 3/23/21- Patient presented with a stroke involving the R frontal and parietal lobe. Echo normal at that time 4/22/21- presented to urgent care again and was found to have elevated troponin (without associated chest pain or EKG changes). Echo was normal, but cardiac MRI showed evidence of myocarditis

After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet; sweating; started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013; started walking slow; sleeping a lot; they were leaking out; got real sick; could not drive; what used to be daily life ended; arm hurting; my husband died in the hospita at 4:30 AM"; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (my husband died in the hospita at 4:30 AM") in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart failure since 2013. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMORRHAGE (After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet), HYPERHIDROSIS (sweating), ASTHENIA (started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013), GAIT DISTURBANCE (started walking slow), SOMNOLENCE (sleeping a lot), URINARY INCONTINENCE (they were leaking out), VACCINATION COMPLICATION (got real sick), IMPAIRED DRIVING ABILITY (could not drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (what used to be daily life ended) and VACCINATION SITE PAIN (arm hurting). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGE (After the 2nd shot they started bleeding a few days later/body changed/started bleeding, I don't know where, may be the toilet), HYPERHIDROSIS (sweating), ASTHENIA (started feeling weak I thought their heart gave up since they were diagnosed with heart failure in 2013), GAIT DISTURBANCE (started walking slow), SOMNOLENCE (sleeping a lot), URINARY INCONTINENCE (they were leaking out), VACCINATION COMPLICATION (got real sick), IMPAIRED DRIVING ABILITY (could not drive), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (what used to be daily life ended) and VACCINATION SITE PAIN (arm hurting) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Colonoscopy: normal (normal) Normal. In 2021, Endoscopy: normal (normal) Normal. Reporter could not provide the list of concomitant medications or hospital details. 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. Regarding the event death, very limited information has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Regarding the event death, very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death

I went to emergency and was hospitalized for 4 days due to rhabdomyolysis; Urine darkened; Chills; Slight fever; Tired; This spontaneous case was reported by a consumer and describes the occurrence of RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pancreatic cancer. Previously administered products included for an unreported indication: Keytruda. Concomitant products included PEMBROLIZUMAB (KEYTRUDA) for Pancreatic cancer. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced CHROMATURIA (Urine darkened), CHILLS (Chills), PYREXIA (Slight fever) and FATIGUE (Tired). On 22-Apr-2021, the patient experienced RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 22-Apr-2021 to 26-Apr-2021 due to RHABDOMYOLYSIS. At the time of the report, RHABDOMYOLYSIS (I went to emergency and was hospitalized for 4 days due to rhabdomyolysis), CHROMATURIA (Urine darkened), CHILLS (Chills), PYREXIA (Slight fever) and FATIGUE (Tired) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood creatine (70-90): high (High) Patient reported a blood creatinine level should have been 70-90 but was 38,000, which then dropped over 2 days. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded; 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

Muscle close to hip that gave me a lot of pain; I had a short heart attack. It was a pretty severe pain.; mid chest, left side pain; Felt lousy; Had flu-like symptoms; Cough; Sore throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Scarlet fever (Patient had as a child, about 13 or 14 yrs old.) since an unknown date. On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced MALAISE (Felt lousy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache). On 24-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.) (seriousness criterion medically significant) and CHEST PAIN (mid chest, left side pain). On 27-May-2021, the patient experienced MYALGIA (Muscle close to hip that gave me a lot of pain). At the time of the report, MYOCARDIAL INFARCTION (I had a short heart attack. It was a pretty severe pain.), CHEST PAIN (mid chest, left side pain), MALAISE (Felt lousy), INFLUENZA LIKE ILLNESS (Had flu-like symptoms), COUGH (Cough), OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) outcome was unknown and MYALGIA (Muscle close to hip that gave me a lot of pain) had resolved. Concomitant medications were not provided.Treatment information was not reported. 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.

Acute bilateral pulmonary embolus and right lower extremity DVT. No typical risk factors such as recent trauma or surgery and no personal history of DVT/PE. Received Moderna COVID-19 vaccination series in February and March of this year.

left leg pain and swelling developed on 5/26/2021, did not seek treatment until 6/9/2021 as not resolving. Evaluated in ER 6/9/21, identified on ultrasound left popliteal and calf deep vein thrombosis. Started on anticoagulation therapy, Eliquis 10mg BID, ongoing treatment, reduced to 5mg BID after 7 days and will continue to monitor renal function.

Pt received 2nd dose of Moderna COVID-19 vaccine 5/5/21. In mid June patient developed SOB symptoms, dyspnea on exertion, and upon CT imagining in ER found to have bilateral pulmonary emboli with evidence of right heart strain on CT and EKG.

The evening of his second shot, he collapsed. He said he became light headed, but I believe he may have lost consciousness briefly. He rand a low fever for 12 hours. Afterwards, he complained that he had "not felt right" since the second shot. He died of a heart attack on May 27, roughly one month after his second shot.

24-36 hours after second Moderna covid vaccine, patient began experiencing greying-out of the left superior quadrant of his vision in both eyes. He presented to care by 4 days after his vaccine date and was found to have right sided occipital lobe ischemic stroke.

Foot swelling due to Blood clot in left leg. Went to hospital ER on 2/22/21, received ultrasound showing clot. Prescribed Eliquis.

The patient began having body pain, diaphoresis, dyspnea, abdominal pain, and fatigue approx 14d post-COVID vaccine (2nd dose, Pfizer). He presented to our hospital on 6/18 with these complaints and was found to have significantly altered mentation, acute kidney injury, and profound thrombocytopenia. Workup was positive for TTP and he was started on PLEX therapy x 5d. Hematologic parameters, renal function, and mentation have improved with PLEX therapy. ADAMTS-13 activity <5% c/w acquired TTP.

blood clots in his right leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clots in his right leg) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History was reported. Concomitant products included ENOXAPARIN for an unknown indication. On 30-Mar-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 11-May-2021, the patient experienced THROMBOSIS (blood clots in his right leg) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) from 06-Apr-2021 to 24-May-2021 for Clot blood, at a dose of 10 milligram twice a day. At the time of the report, THROMBOSIS (blood clots in his right leg) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Ultrasound scan: confirmed blood clots (abnormal) confirmed blood clots in patient's in right leg. 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. Further information has been requested This case was linked to MOD-2021-220788 (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 event, a causal relationship cannot be excluded. Further information has been requested

Blood clots in his left leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots in his left leg) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No relevant medical history was reported. Concomitant products included APIXABAN and ENOXAPARIN for an unknown indication. On 30-Mar-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 06-Apr-2021, the patient experienced THROMBOSIS (Blood clots in his left leg) (seriousness criterion medically significant). The patient was treated with APIXABAN (ELIQUIS) for Clot blood, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (Blood clots in his left leg) 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. 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. Further information has been requested. This case was linked to MOD-2021-220804 (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 event, a causal relationship cannot be excluded. Further information has been requested.

I started feeling cold and shaking and very bad headache and discomfort all over. I was bedridden for a couple of days, then it got a little bit better and then it got worse again. Then it got hard to breath. So I lost over 30 pounds in the matter of a month and that is unlike me, I have always been overweight and a food addict and so I called the DR and they told me to get a covid test because the symptoms were similar. I got the test and it was negative. I went to the ER and they said I got pneumonia, which I do not know is related or not but it did happen after the shot and seemed pretty odd. I tend to be the person to just tough things out. At the ER they told me pneumonia in my right light and gave me antibiotics. I called my pulmonologist when home because it was getting worse and he prescribed more antibiotics. I went to see him and he took another x-ray of my lungs. I still had stuff in my lungs so he gave even more antibiotics. He took another x-ray and CT scan recently that I do not have the results of yet. I have vertigo which just started about two weeks ago as well, I read about exercises to do for that and it helped a bit but it came back and now cannot get rid of it. It still is kind of hard to breath as well. I have no appetite which is weird for me and I am cold which is also very strange. I usually could go in a cold place of like 35 degrees and be fine and now I am just always cold. Even when I know I'm hot and know it's hot, I am cold and using a blanket. I shiver and shake so much from being so cold but my bed is soaking wet from sweating, it just doesn't make sense. I have a hard time going to sleep because I am cold and uncomfortable. Even today I am still very tired and now with the vertigo it is hard to do anything today, just talking a lot like right now I am out of breath.

Recurring bouts of fever, aches. Pain when taking deep breath. eventually shortness of breath and pressure high in chest. Diagnosis : Pericardial Effusion. Treatment : Surgery to drain fluid. install drain. install pericardial window. 5 days in hospital.

Systemic: Chest Tightness/ Heaviness/ Pain-Severe, Systemic: Flushed/ Sweating-Severe, Systemic: Heart Attack-Severe, Systemic: Nausea-Severe

Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Heart Attack-Severe, Systemic: Nausea-Severe

4/15/21 At local Hospital with double vision, neuropathy, Bells Palsy type face with droopy eye, altered gate, swallowing issues. Hospital tested for stroke but could not find evidence ( CT, EEG, Xray Bloodwork) History did not include that he had neurological side effects for the first Moderna vaccination. He was rushed by ambulance to a much larger hospital. I realized the error of not telling the history of the Moderna neurological adverse event from the hospital and called the hospital. The hospital had already sent him on to a larger hospital. I then contected his spouse regarding the adverse event from the first dose of Moderna. 4/15/21 at secondary Hospital, MRI, CT, EEG, Xray, Bloodwork still found no evidence of stroke. Precious time was lost. I called the nurses station to relay the information regarding the neurological adverse event from the first vaccination and told them that he had just taken his second dose. Soon they had their diagnosis and a path to treatment. He was diagnosed with Guillaine-Barre Syndrome with Variant caused by the Moderna Vaccination. Ventilator inserted, causing pneumonia 04/17/21 Feeding tube inserted 4/17/21 Treatment started plasmapheresis plasma exchanges done 4/17, 4/18, 4/20, 4/22. 4/24, 4/26, 4/28 4/20/21 No infection of brain 4/24/21 patient suffered a respiratory arrest when left unattended. Died temporarily. 4/25/21 starting to respond to commands 4/29/21 trach inserted 5/10/21 Patient breathing on own, Trach sealed with red cap 5/16/21 getting physical therapy sessions Released to spouse and sent home. Hospital records may be obtained by going directly to the patient if he has recovered enough to help.

Admitted to the ER complaining of 103-104 fever, extreme fatigue, headache, weakness, and nausea. Initial diagnosis was inflammation and sepsis from unknown origin. Patient was slightly anemic and had borderline enlargement of the heart on Xray. Pulse Ox levels were 91-93 prior to giving 02. Patient had traces of blood and protein in urine. WBC levels were normal. Blood cultures failed to reveal a bacterial, viral, or fungal infection. IV Antibiotics were administered and patient was discharged with no fever after 5 days. However, patient began experiencing mild afib onn the 5th day. Metoprolol was prescribed and patient scheduled a follow up echocardiogram. No infection ever located.

Head pressure; Dizziness; Headaches; such imbalance he couldnt stand for an hour; Started losing balance and kept getting worse every day; vertigo; Mini strokes; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Head pressure), DIZZINESS (Dizziness), HEADACHE (Headaches), TRANSIENT ISCHAEMIC ATTACK (Mini strokes), BALANCE DISORDER (Started losing balance and kept getting worse every day) and DYSSTASIA (such imbalance he couldnt stand for an hour) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced BALANCE DISORDER (Started losing balance and kept getting worse every day) (seriousness criterion hospitalization). On an unknown date, the patient experienced HEAD DISCOMFORT (Head pressure) (seriousness criterion hospitalization), DIZZINESS (Dizziness) (seriousness criterion hospitalization), HEADACHE (Headaches) (seriousness criterion hospitalization), TRANSIENT ISCHAEMIC ATTACK (Mini strokes) (seriousness criterion medically significant), DYSSTASIA (such imbalance he couldnt stand for an hour) (seriousness criterion hospitalization) and VERTIGO (vertigo). On 26-May-2021, BALANCE DISORDER (Started losing balance and kept getting worse every day) had resolved. At the time of the report, HEAD DISCOMFORT (Head pressure), DIZZINESS (Dizziness), HEADACHE (Headaches), TRANSIENT ISCHAEMIC ATTACK (Mini strokes) and DYSSTASIA (such imbalance he couldnt stand for an hour) outcome was unknown. Concomitant product use was not provided by the reporter. 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. Very limited information regarding medical history and the events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Very limited information regarding medical history and the events has been provided at this time. Further information has been requested.

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

Massive PE with R heart strain. Possible RA thrombus. Duplex LE with extensive residual B/L lower extremity clot. Was given heparin and needed tPA due to high risk for decompensation. Transitioning to Eliquis

Fully vaccinated patient who tested positive for COVID upon admission screening to hospital. Admitted through ED for STEMI. No fever, cough, or loss of taste or smell. No s/s of COVID throughout stay. Discharged on 07/17/21. Of note - patient recovered from COVID in 11/2020.

husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred; can't drive anymore; first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred) and CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) in a 63-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 Knee replacement and Carpal tunnel syndrome. Concurrent medical conditions included Overweight and High cholesterol. On 10-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) (seriousness criterion medically significant). On 26-Jun-2021, the patient experienced FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred) (seriousness criterion hospitalization). On an unknown date, the patient experienced IMPAIRED DRIVING ABILITY (can't drive anymore). The patient was hospitalized for 2 days due to FALL. The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at a dose of 325 milligram once a day and ATORVASTATIN CALCIUM (LIPITOR) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, FALL (husband also fell 16 days after the vaccination and she believes that is when the second stroke occurred), CEREBROVASCULAR ACCIDENT (first stroke occurred sometime within a 2-week period after receiving the Moderna vaccination) and IMPAIRED DRIVING ABILITY (can't drive anymore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications 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. The patient's medical history of Hypercholesterolemia and being overweight are possible confounding factors.; 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 patient's medical history of Hypercholesterolemia and being overweight are possible confounding factors.

On 12/31/2020, at approximately 00:15, pt developed a fever of 102.9 F and tachycardia with rate of 120. He was treated with acetaminophen. Later in the morning, he complained of nausea, generalized muscle aches, intermittent increase in confusion. At approximately 14:00, he had a fall out of bed and at that time noted to be short of breath, tachypneic. He was taken via ambulance to Emergency Department. From there he was transferred to Hospital for admission with acute respiratory distress, suspected sepsis with lactic acid 7.4 and Bilateral Pulmonary Emboli. He was started on heparin and broad spectrum antibiotics and transitioned to ELIQUIS on 1/3/2021. Infectious etiology of sepsis was unclear. He continued broad spectrum antibiotics with clinical improvement. Abdominal CT scan was obtained due to intermittent nausea, vomiting, abdominal pain, loose stools. His heart rhythm flipped to Atrial Fibrillation with RVR on 1/2 and his rate improved with titration of metoprolol. He was also treated with prednisone for suspected underlying undiagnosed COPD. It is noted in his hospital summary that PEs presumed provoked in the setting of his recent COVID 19 infection. He was discharged from the hospital on 1/8/2021 and readmitted to the Veterans Home. He has been stable.

Pt and other foster home residents and CGs received COVID shot #1 at 11:30 am within the foster home after POA consented to pt's vax. At ~9p, CG heard pt vocalize a loud sound, CG checked on him and entire body and stomach so rigid, lips were pressed together/pale and pale throughout. Stopped breathing for a few seconds. CG couldn't get BP or pulse initially. Say tears rolling down face. 87/45, 56, 97.2F, 91% on RA. After 10 mins was 129/53, 48, 91%. Called 911, 79/47, couldn't get pulse. Due to POLST comfort measures, EMS did not transfer pt to ER. After EMS left, pt "came to" again, pt signed EMS consent NOT to be transferred to ER. Pt's POA didn't pick up the phone. Current VS: 111/64, 69, afebrile. POA does not want pt to receive the second COVID shot.

Pt likely presented to vaccine appt with asymptomatic/early infection of COVID-19, as he presented 2 days post-vaccination and tested positive for COVID-19 on rapid and PCR test. He was hospitalized where he eventually died of complications from COVID-19 while in ICU. Date of death was 1/15/2021.

Narrative: Patient with history of seizures was given his 1st dose of Moderna COVID- 19 vaccine toward the end of a stable dialysis treatment. 15 minutes post immunization, patient experienced hypotension and grand mal seizures. Hypotension resolved with saline administration. Oxygen via NC administered. EMS called due to ongoing seizure activity. Transported to hospital where he was admitted for an undisclosed diagnosis.

Vaccine given in clinic per protocol - patient monitored for 15 minutes, no adverse reactions noted at the time. Patient stated he felt fine following 15 minute monitoring time. Patient left facility- it was later reported that pt had a fall at home. Upon review of pt's medical record - Pt's wife had to initiate CPR and call EMS for transportation and life saving measures enroute to the Emergency Room. Pt was intubated as pt was in asystole upon arrival to the ER, ACLS was continued, pt was noted to have a traumatic brain injury from his fall at home, and pt was pronounced dead at 1620.

on 2/218/2021 the patient was at home and developed chest pain. Patient was transported by family to urgent care then to the ED where the patient later died.

1-25-2021- Phone call: pt had cold and cough prior to vaccine. cough worsened 1-28-2021 Phone call: pt requesting provider visit, cough is same and taking tessalon pearls 1-29-2021 Provider in office visit: pt complain of cough and SOB for 6 days. Getting worse. Temp 101.2, pulse ox 87%, BP 128/70. level of distress- leaning forward to breath. appeared ill. diffuse rales throughout both lung fields, more at bases. Diagnosis Pneumonia due to COVID 19 virus. Sent to ER

The second shot was on February 19. On February 20 and 21, patient experienced a sore arm and flu-like symptoms. On Febuary 28, he had a stroke. Hospital where the ambulance took him initially diagnosed it as Bells Palsy and prescribed prednisone and an anti-viral. After an MRI the next day on Monday, he was diagnosed correctly as a stroke. On Tuesday, he was airlifted to another hospital and was in the ICU for more than 2 days. Patient spent the next 7 days in the neuro-trauma step-down unit with the results of the debilitating stroke. He is unable to swallow and his entire left side is affected as well as vision and hearing.

Chills started within five minutes then within an hour fever of 104. Patient taken by ambulance to Hospital and patient diagnosed with sepsis and cellulitis and shortness of breath

Patient died with an unknown cause. He was found on the kitchen floor with no blood present. We requested an autopsy but because the County Coroner said there was no foul play suspected, that they would not perform an autopsy on the body to determine the cause of death even though the family had requested an autopsy. The Funeral Home stated to us that it had the looks of a heart attack, but he was not qualified to make that determination. He stated that the way the blood had stopped and purpled in his neck, gave him the indication that the heart was unable to pump all the way.

HEART ATTACK 14 HOURS AFTER VACCINE. EMS TOOK TO ER. TAKEN DIRECT TO OPERATING ROOM, FOUND ONE 95% BLOCKAGE AND STENT PUT IN. HAS HEART DAMAGE NOW

More recently (around 2/1) he started having intermittent chest pressure again, then developed dyspnea, cough, intermittent mild fever ~ 101, and hypoxia noted on home monitor. Felt to have pneumonia and was placed on antibiotics 2/4/21 without improvement of symptoms. Seen by his PCP on the day of admission, he was much more dyspeptic and tachycardic with heart rates in the 150s. He was sent to the ER for further w/u and management.

Right Arm DVT and superficial venous thrombosis on ultrasound done on 3/30/2021-Pt noticed right arm soreness and discomfort then he started to have firmness which continued to get worse.

on 2/8 developed cough on 2/13 to Hospital Emergency Room, diagnosed viral pneumonia on 2/15 back to ER, admitted, diagnosed with pulmonary embolism on 2/20 to ICU, intubated and put on ventilator on 3/3 died from pneumonia due to COVID-19 per death certificate

Day after the shot (March 3) he started having shortness of breath and then continued up until March 16 started running fever of 102.9 and still having difficulty breathing-went to ER and then diagnosed with blood clots in lung "acute pulmonary emboli" and pulmonary infarct and his heart was enlarged-by CAT scan. In ICU for 3 days and discharged at that time out of ICU to home.

14 days after 2nd dose severe shortness of breath, fatigue, lightheaded, near syncope. Diagnosed with bilateral DVT and bilateral PE

patient experienced onset of subjective and eventually objective fevers 4 days after receiving the second Moderna vaccination. He experienced malaise, and fatigue as well and some shortness of breath with chest tightness and was ultimately diagnosed with pericardial effusion and pericarditis.

Anaphylaxis (SOB, throat closing, wheezing, tachycardia, change in mentation over 10 minutes) Given Epi-Pen and Benadryl, Transported via EMT to ER

patient reports he spent many days in hospital after 2nd Moderna vaccine wtih severe blood clots. Informed he did not tell hospital that he had the 2nd Moderna shot but informed the other hospital. It was the other hospital that instructed the patient to contact the Health Department to inform of the same

Developed a blood clot in his right leg, inner thigh, up toward groin area. ER diagnosis on 4/20/21 at healthcare facility.

1st moderna lot number 027A21A given 3/14/21. Pt woke up with right side weakness and aphasia. Still ambulating on his own. At 0800 he went with his wife to get his second Covid-19 vaccination. Symptoms progressed until he was unable to speak or move his right side at all. Family called 911. Pt admitted to hospital with Dx of Left MCA Stroke.

Please note the patient did not receive the vaccine at this hospital so lot # is not available. Submitting to VAERS since patient had an anaphylactic reaction and unsure if vaccination site submitted. 64 y.o. male who arrived to the emergency department for Allergic reaction. Patient developed airway, tongue, lip swelling 5-10 minutes after receiving his second Moderna COVID vaccination today. He was given 2 IM Epipens at site where the vaccine was administered then transferred to ED by EMS. EMS gave him Benadryl and a DuoNeb treatment. Patient reported mild relief. He still reported tongue, oral floor, and throat swelling. Discharged from ED in stable condition after 4 hours of observation

Severe pain to lower left leg without injury hx. Went to doctor on 3/17/21 and was examined and doppler to left leg showing no blockage. Dr prescribed nsaid as needed for pain and monitor. Monitored and pain continued until approx 4/9 and noticed swelling starting and some redness to skin slightly warm. Returned to dr on 4/13 and was placed on antibiotics. On 4/14 noticed slight shortness of breath on exertion and on 4/15 shortness of breath worsened and some irregular heartrate. I went to hospital. Bloodwork, EKG, Chest xray and CT showed multiple pulmonary embolisms and several DVTs in left leg. Admitted to hospital and placed on Heparin drip and monitored for three days. Released from hospital on 4/19 on Eliquis and advised to follow up with personal physician and report severe breathing problems or CP.

Sore arm for three days after shot. Cough increasingly more frequent w/ rib soreness at the intercostal anterior of primarily right side but occasionally left side as well. Increasing difficulty breathing on exertion, increase in altitudes over 8,000 feet, entering cold environments. Severity increased to point where entered ER on APR 26th. Massive PEs found in both lungs. D-Dimer score of 10,000.0 ng/mL. CTA Chest w/ contrast found multiple PEs. ALS transport transferred to Hospital for treatment. Released from the hospital APR 29.

Patient presented to the ED on 2/24/21 with STEMI and was subsequently hospitalized. He also presented to the ED on 3/18/21 with stable angina.

My Father received the first dose of CV19 on 03/02/21 and the second dose on 03/03/2021 in the morning, and at night he had a stroke, we called 911 they hospitalized him within a week he was out of danger and had physical therapies for a month at facility he got out on the 31st of March 2021 and on April 4th he once again went into the hospital for lack of oxygen, they detected blood clots in his legs and his lungs and also an aneurysm in his heart.

patient suffered significant heart attack (100% blockage right coronary artery) on 4/18/2021. He has NO risk factors for coronary artery disease (no HTN, DM, hyperlipidemia, smoking, obesity, family history of CAD). He exercises by swimming one hour 7 days per week.

Patient presented initially to his PCP on 4/24/21 for on going muscle aches after his COVID vaccine. Pain is on other arms, takes tylenol for treatment but no relief. Blood pressure elevated at the time of visit, no limited ROM, bruising present. Patient denies sx of cough, fever, SOB or chills, chest pain/pressure, GI or GU issues, HA. Patient provided prescription for celecoxib 200mg PO daily prn pain. Presented to hospital emergency room on 4/27/21 for chest pain, found to have anterior wall STEMI. The patient was started on IV heparin and medical therapy with intravenous beta-blocker before being transferred to another healthcare facility. His initial troponin was 0.2. His CBC with diff and electrolytes are all within normal limits. Patient was immediately taken to the cath lab for PCI. In route to hospital the patient was given 1 dose of nitroglycerin, aspirin, morphine for pain. Cardiac catheterization was performed with placement of drug-eluting stent into the Mid LAD. Patient started on aspirin and Brilinta. Echocardiogram showed mild left ventricular hypertrophy, severe mid to distal anterior septal hypokinesis, apical akinesis with an EF of 45 to 50% and grade 2 diastolic dysfunction. Patient has had no return of his symptoms since the PCI, tolerated p.o. intake without difficulty. No nausea/vomiting, or shortness of breath. Able to ambulate without difficulty.

Patient received vaccine on 4/26/21 and had mild fatigue and malaise, otherwise in his usual state of health. On 4/30/21 he was working in his barn and towards the end of his work he began to feel some palpitations and chest tightness. This did not go away despite resting causing him to come to the emergency department. No known history of cardiac arrhythmia, does not follow with cardiologist. No recent travel. No significant alcohol use. No new medications. No unusual events over the last few days. Found to have new-onset atrial fibrillation on EKG. He was given diltiazem to reduce rate.

He had a recent bout of chest pain (like a ligament tear, worse with lying down x 2 days)- which he dates to end of March/early April; he didn't seek care right away. He subsequently mentioned the episode to EP and was diagnosed with pericarditis with moderate pericardial effusion on 4/8/21. CRP 77. No viral symptoms. He received the Covid vaccine 2/12 and 3/12. Repeat echocardiogram on 5/3 showed resolution of pericardial effusion. He was prescribed colchicine but told to stop it after the echo showed resolution. He also had a stress SPECT which showed normal perfusion but severe calcification of LM and LAD. He has no symptoms of chest pain. Pericarditic chest pain completely resolved. LDL was 110 and atorvastatin was increased from 60mg to 80mg 2 months ago. He has no chest pain or shortness of breath. Takes lasix for LE edema. Very active. Walked 5 miles yesterday without issues. Occasionally gets short of breath climbing stairs.

This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Myocardial infarction) and CHEST PAIN (Pain in the chest) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy. Concomitant products included LISINOPRIL and ATORVASTATIN. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MYOCARDIAL INFARCTION (Myocardial infarction) (seriousness criteria medically significant and life threatening), CHEST PAIN (Pain in the chest) (seriousness criterion life threatening), LETHARGY (Lethargic), DYSPEPSIA (Heart ache) and FATIGUE (Tired). On an unknown date, the patient experienced HEADACHE (Headache). On 14-Apr-2021, MYOCARDIAL INFARCTION (Myocardial infarction) and CHEST PAIN (Pain in the chest) outcome was unknown. At the time of the report, LETHARGY (Lethargic) and FATIGUE (Tired) had not resolved, DYSPEPSIA (Heart ache) was resolving and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Electrocardiogram: abnormal Showed mild Heart Attack. His doctor gave him nitroglycerin which he could not take due to headache and full aspirin. His cardiologist appointment is coming up on 25MAY2021. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-114362 (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 event, a causal relationship cannot be excluded. Further information has been requested.

confusion, didnt know where i was driving home. fever, headaches and body aches feet and hands numb brain fog memory issues. very very tired super weak ... second shot, same but with added lower back pain and leg cramps. massive headache, went to the doc, he told me that first event was a stroke. now i have a blockage carotid left side in my neck. sent me for ultra sound them ct scan. waiting to see vascular doc after discovery 80% blockage. sill very tired very weak. brain fog, hands going numb eye sight weaker. bad smell in my nose sometimes., not sleeping well. short of breathe.

CLIENT HAD FEVER AND BLUE/GRAY SKIN TONE FEW DAYS PRIOR TO DEATH. MISSED DOCTORS APPOINTMENT ON 5/14/21, FOUND DESEASED AT HOME ON 5/15/21.

Patient had received his first Moderna Covid vaccine on 4/8/21 (time unknown). He left the pharmacy after wait period of 15 minutes. Wife said that he complained of sore throat later in the day. Wife said "he started having fever almost like COVID symptoms". Wife said he went to the doctors office and received prescription for ibuprofen. on 4/10/21 at 10am. Wife said he didn't get any better so he was hospitalized at the Hospital 8 days later and he passed away.

The second day I woke up and my arm was on fire. That night I started with a fever. for 10 days I had a fever of 102-103. I had blood in my urine. I had a lung infection where I could not inhale.

Person experienced vertigo, vomiting, double vision, low body temp of 95*. Took him to the ED Hospital. It was determined that he had suffered a small Ischemic Stroke. He was given Asprin and Lipitor (Atorvastatin) and an anti nausea medication. Several tests were done as outlined in Item 19 below.

6/14/21, admitted for shortness of breath, initially thought to be CHF exacerbation, persistent hypoxia, underwent V/Q scan 6/16, showing bilateral pulmonary embolism, starte don heparin and then lovenox, still with persistent hypoxemia

On 6/18/21 heart transitioned to AFIB state. Prior occurrences have all occurred due to ingest of caffeine and ended between 6 and 24 hours after start. No caffeine is known to have been ingested since September 2019 (last accidental ingestion). I have not sough medical assistance yet.

Patient was vaccinated on 3/18/21. 1 to 2 weeks later patient reported fatigue and general malaise. Reported to PCP. PCP obtained CMP, CBC with differential. Patient was found to be hyponatremic with a serum sodium level of 110. Patient was admitted to hospital on 4.12.21. Workup showed that patient was in AKI and had DVT. Patient was treated with 3% sodium chloride infusion and was given diuretics. AKI resolved through his course of admission. Patient was treated with enoxaparin for DVT.

Atrial fibrillation with RVR I woke up on 6/26/2021 in AFib. Went to the ER and they confirmed that I was in AFib. I was given Metoprolol through IV to lower my heart rate and they also doubled the Metoprolol prescription that I was taking. They added Eliquis to keep me from having blood clots and a stroke. I was admitted to the hospital overnight. The AFib began about 1:00 am on 6/26 and it went back to normal sinus rhythm about 10:00 pm on 6/26. I was released from the hospital the following day. I have an appointment with my cardiologist (listed above) on 7/9/21. I do not know if the AFib will return or how long I will need to remain on the new prescriptions.

I had brief episodes of atrial fibrillation lasting about 30 seconds; I woke up with tachycardia of a heart rate about 130 to 140 beats per minute; my arm had some swelling; I felt a little fatigue; This spontaneous case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 250202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds) (seriousness criterion medically significant), TACHYCARDIA (I woke up with tachycardia of a heart rate about 130 to 140 beats per minute), PERIPHERAL SWELLING (my arm had some swelling) and FATIGUE (I felt a little fatigue). On 28-Feb-2021, ATRIAL FIBRILLATION (I had brief episodes of atrial fibrillation lasting about 30 seconds), TACHYCARDIA (I woke up with tachycardia of a heart rate about 130 to 140 beats per minute), PERIPHERAL SWELLING (my arm had some swelling) and FATIGUE (I felt a little fatigue) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided by the reporter. No treatment information was provided by the reporter. Patient received vaccine in left non-dominant deltoid. 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.

passed away; short of breath; unwell & very unwell; extremely thirsty; dry mouth; This spontaneous case was reported by a pharmacist and describes the occurrence of DEATH (passed away) in a 64-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 Oxygen therapy (Required Oxygen Assistance in the office). Concurrent medical conditions included Diabetes and Brain tumor. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 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 DYSPNOEA (short of breath), MALAISE (unwell & very unwell), THIRST (extremely thirsty) and DRY MOUTH (dry mouth). The patient died on 16-May-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (short of breath), MALAISE (unwell & very unwell), THIRST (extremely thirsty) and DRY MOUTH (dry mouth) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information is not provided. Concomitant medication is not provided. Reporter states that the friend stated that the patient had other underlining conditions, patient needed oxygen assistance in the office,friend advised patient to go to the ER and Patient refused Action taken with mRNA-1273 in response to the events was not Applicable. Company Comment: Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death

What started everything was that I had gall stones. It caused an infection in my gall bladder and it spilled over into my blood stream. They treated the infection with antibiotics. I was in the hospital for about a week. I'm having surgery around 07/20 to have my gall bladder removed. They found that I have diabetes. They said that it could be from the gall stones and it may go away after the removal of my gall bladder.

Symptoms: Fatigue, dizziness, and shortness of breath Diagnosis: small blood clots in right upper lung Treatment: Eliquis

Unable to Breath, Excessive pain, Pulmonary Embolism. Resulted in Hospitalization. No prior history of PE's.

Resident was fully vaccinated. Tested positive for covid on 7/2/2021. Had two subsequent covid tests which were negative. Did pass away on 7/24/2021 but not from covid.

Patient did not report any signs or symptoms of adverse reaction to vaccine. Patient suffered from several comorbidities (diabetes and renal insufficiency). Patient reported not feeling well 01/06/2021 and passed away that day.

Patient was tested positive for Covid-19 on 12/9/20. Patient received Covid Vaccine on 1/21/21. Patient was observing for 15 minutes in treatment room by Nursing staff. Patient denied any signs/symptoms adverse effect: headache, dizziness & weakness, difficulty breathing, muscle pain, chills, nausea and vomiting, and fever . Patient seated on treatment table appeared to be relaxed, respiration even and unlabored. Health teaching provided. Patient educated to report any changes in condition to staff immediately. Patient verbalized understanding and able to verbalize signs and symptoms and adverse effects to be aware of related vaccine. On 1/22/21: patient was seen by medical provider for "altered behavior". Per medical provider's documentation: "Patient was fallen on 1/2/21 and was sent out to outside hospital on 1/4/21. CT head: no intracranial abnormality, age-related changes. Patient had labs (B12, RPR, folate) were within normal limit". We did MMSE today: 22/30 score "mild dementia" On 1/23/20: "Patient was inside his cell. He was walking towards cell door to obtain his breakfast, when custody witnessed him collapse and activated the alarm. Nursing staff arrived at cell front at 06:34 am and found the patient pulseless and unresponsive, and CPR was immediately initiated. AED was attached at 06:35 am and no shock advised. AMR then arrived and patient did not have ROSC, and was pronounced dead at 06:54 am."

Found dead at home slumped on the floor; Loss of appetite; Body aches; Feverish; A spontaneous report was received from a physician, concerning a 65-years-old male patient, who received Moderna's COVID-19 Vaccine and experienced feverish, body aches, loss of appetite, and death. The patient's medical history, as provided by the reporter, included diabetes, hypertension, Hashimoto's, smoker, cataracts, atrioventricular block, occasional premature ventricular contractions, and hypertriglyceridemia. Concomitant medications reported included metformin, glimepiride, lisinopril, atorvastatin, aspirin, methimazole, propranolol, and cilostazol. On 05 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 037k20a) for COVID-19 infection prophylaxis. On an unknown date in Jan 2021, some time after receiving the vaccine, the patient was feeling feverish with body aches and loss of appetite. On 09 Jan 2021 at approximately 21:30, the patient was found dead at home slumped on the floor. According to the paramedics, the patient was dead longer than when his wife found him, and no resuscitation was performed. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the events, feverish, body aches, loss of appetite, was considered resolved. The patient died on 09 Jan 2021. The cause of death was not reported. The reporter assessed the event, death, as not related to Moderna's COVID-19 Vaccine. The reporter did not provide assessment for the events, feverish and body aches, in relation to Moderna's COVID-19 Vaccine.; Reporter's Comments: This case concerns a 65 year old male patient with medical history of diabetes, hypertension, Hashimoto's, smoker, cataracts, atrioventricular block, occasional premature ventricular contractions, and hypertriglyceridemia, who experienced the serious unexpected event of death, non-serious unexpected event of loss of appetite, and non-serious expected events of fever and body pain. The event of death occurred 5 days after the first dose of mRNA-1273. The events of fever, body pain and loss of appetite occurred an unspecified period of time after the first dose of mRNA-1273. Very limited information regarding these events 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. Definitive causal association is confounded by age and medical history of diabetes, hypertension, Hashimoto's, smoker, cataracts, atrioventricular block, occasional premature ventricular contractions, and hypertriglyceridemia.

Received Moderna Covid Vaccine #1 on 12/26/20 in left arm. Had arm pain first few days. On 12/28/20 he began having right calf pain that worsened over the next few days. Was evaluated in Urgent Care and diagnosed with an extensive DVT. No history of previous DVT or venous issues. Pt was on Plavix and ASA at the time for dx of CAD.

Client's sister called crying and said the family just found out yesterday that Client had died some time last week. The last time any family talked to him was on the 19th of January, missed calls show on the phone on the 21st. His last internet search was sternum pain. . She will also call the Agency and report this. The vaccine isn't in Registery at this time, do I don't know the lot number but she said he was due back in one month. She said he was very healthy and ran triathalons.

CHF exacerbation with new a fib/flutter, and AKI, elevated troponin,aspiration pneumonia, lactic acidosis

The patient received the vaccine on the afternoon of Thursday, 1/28/21. He was observed for at least 30 minutes following administration of the vaccine with no reactions noted. He was found dead in his car on Sunday, 1/31/21. It is unknown if the vaccine contributed to his death.

Patient received COVID19 vaccine at clinic at 11:52 am, discharge post treatment stable. Got home around 2:30 pm went to bed. He usually got tired post dialysis. He did not wake up at 6 pm. His wife went check on him. found patient cold and unresponsive. 911 pulseless PEA. ER Medical hospital. Pronounced death at 7:40 pm

I saw the patient in consultation during his hospitalization for pancytopenia which proved to be severe aplastic anemia after bone marrow biopsy. He has been a blood donor. 1/4 Moderna vaccine HGB 1/8 12.8 - blood bank refused him to be a donor due to the HGB being too low. Recommended to repeat CBC at his primary care office. 1/26 7.8 1/29 7.1 1/30 5.7 No reticulocytes

This individual's employer informed our facility that he passed away at his home on 2/14/2021. Since he was not brought into our hospital, we do not have information regarding other health conditions or active medications. Since this individual received his second covid vaccine three days prior, this was reported to Moderna in addition to this VAERS report being completed. The coroner for County can be contacted.

Anaphylaxis, hives, whips around waist and butt, itching ,swollen lips . Was given epic Pen and Benadryl , Pepsi?s and steroids 24 hours and it returned when to doctors office and received another steroid shot

Went to pcp two hours after vaccine. EKG given and was told by my doctor I was in AFIB and needed to go to the ER immediately. Spent a couple hours in the ER and then admitted for six days. I am still in AFIB

severe reaction within 48 hours of the vaccine , sent to the hospital with uncontrollable bleeding, in ICU with thrombocytopenia

Patient was given COVID vaccine shot #1 on 1/4/2021. As of 1/8/2021 he was prohibited from donating blood due to a hemoglobin of 12.8. 2 weeks later he presented to donate again on 1/26/2021 and his hemoglobin had dropped to 7.8 without evidence of bleeding. He was subsequently admitted to hospital on 1/29/2021 - where he was found to be severely leukopenic and thrombocytopenic. A bone marrow biopsy revealed a diagnosis of severe aplastic anemia. He remains hospitalized but is now at another location. This has also been reported through VAERS.

Passed away; A spontaneous report was received from a Pharmacist concerning a 65 years-old, male patient who passed away/MedDRA PT: death, days after receiving the second dose of the Moderna COVID-19 vaccine. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Lot #012L20A) on 12 Jan 2021. On 11 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Lot # 030M20A) (route of administration and injection site not provided) for prophylaxis of COVID-19 infection. On an unknown date, days after receiving the second dose of the Moderna COVID-19 vaccine, the patient passed away. The patient did not come to the hospital; therefore the Pharmacist had very little detail of the situation but believed it was due to aspiration based on report received from the patient's boss. The Pharmacist reported there was no report of any issues from the first vaccine. The patient was found at home by spouse and had yellow stuff on face and chest. Action taken with mRNA-1273 was not applicable as the patient deceased. The patient died on an unknown date. The cause of death was reported as unknown. Plans for autopsy were not provided.; Reporter's Comments: Very limited information regarding the event of death has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Death days after receiving the second dose of the Moderna Covid-19 Vaccine

Received vaccination at 14:20 2/26/21. Was observed until discharged at 15:15. Discharged per wheel chair to lobby in alert/stable condition, to wait on bus to take him home. At 18:00 his neighbor heard him fall, could not get patient to answer phone, found him unresponsive. Neighbor called 9-1-1, ambulance personnel could not revive patient. Coroner's office ruled his death as Natural Causes due to Hypertension, Cardiac disease, Diabetes, ESRD. There were no indication of anaphylactic reaction noted when I questioned the coroner's office. The Coroner's office/EMS were aware the patient had received the Moderna COVID 19 vaccination that day.

ER admission on February 27th, discharged with a diagnosis of Bilateral Pulmonary Embolism and DVT of lower limb

Possible PEA arrest unclear etiology ~1 hour after receiving first dose COVID-19 moderna vaccine, s/p ROSC in field after 3 minutes CPR, no meds given. Intubated in field, extubated after 2 days.

65 Y male who is referred for c/f dyspnea and chest pain. Per clinic notes: "Brief summary covid vaccine 1/21 with side effect within 12 hr lasting 3 d By around 1/26-1/29 had cp w/ exertion and sob TST 2/2 w/ Minor ekg changes and min workload per pt (mod workload per note) nuc study pending. Cough and sob worse over the last 5 d or so, sleeping in recliner, and having trouble sleeping. Though no desat on march test, he has freq intermittent coughing and he was tachycardic to 110 on exam this am." Pt states symptoms worsening over past week. No symptoms at rest. With exertion has anterior chest tightness and dyspnea. No radiation of pain or migration. He can walk usual distances but much slower. Improved at rest. Cannot lay flat at night. Cannot sleep much at night. Dry cough. No wt changes or LE pain/swelling. No f/c. No ill contacts. No chest pain currently. Pt underwent exercise treadmill stress test on 2/2/21 that showed borderline ischemic changes (so a myocardial perfusion study was planned) but patient's dyspnea on exertion worsened so he was seen in clinic on 2/10/21 where he was noted to have elevated BNP and D-dimer, was sent to the emergency department where CT angiography was negative for pulmonary embolism but it revealed pulmonary edema with bilateral pleural effusions. Patient was admitted, noted to have elevated troponin, anterolateral ST depressions on EKG, noted to have rapid atrial fibrillation, had NSTEMI so he underwent cardiac cath on 2/10/21 that revealed multivessel coronary artery disease, was hypotensive so IABP was placed, percutaneous coronary intervention of left main, LAD and RCA were done and admitted to the ICU. TTE on 2/11/21 showed LVEF 45% with moderate posteriorly directed MR, was diuresed, started IV amiodarone for SVT and atrial fibrillation, IABP was removed on 2/12/21, dopamine IV drip was weaned and patient was transferred to telemetry on 2/13/21 for further care. Heparin was transitioned to Pradaxa on 2/14/21 and dopamine drip was weaned off on 2/16/21. Patient then had an episode of epistaxis on 2/18/21 (resolved with pressure and Afrin spray), had cough on 2/18/21 and chest x-ray showed mild worsening bilateral central patchy parenchymal opacification so IV Zosyn was started (2/18-2/21/21) then changed to Augmentin (with plans to complete course on 2/24/21), Lasix give for diuresis, CT chest and abdomen was done on 2/20/21 for anemia that showed no obvious hematoma or soft tissue collections. Patient continued diuresis and cardiac medications adjusted. Coronary artery disease, paroxysmal atrial fibrillation, NSTEMI status post percutaneous coronary intervention, cardiogenic shock, systolic dysfunction congestive heart failure, moderate MR: Patient was continued on current cardiac medications including aspirin (for 1 month post cath until 3/10/21), clopidogrel, atorvastatin, Pradaxa, losartan, spironolactone. Continued lasix 80mg PO daily as maintenance diuretic regimen per cardiology recommendations. Patient's current weight is 178 lbs (admission weight was around 189 lbs). Patient was not started on beta blockers given recent cardiogenic shock. Acute kidney injury: Seems to have resolved with current creatinine of 1.2. Leukocytosis: Resolved. Will complete about 7 day course of antibiotics with Augmentin until last dose on 2/23/2021. Tobacco smoker: Patient was counseled on smoking. Patient was advised to quit. Discussed smoking cessation classes. Continued nicotine patch. Anemia: No evidence of active bleeding. Will repeat CBC on 2/26/21 as patient is on dual antiplatelet therapy as well as anticoagulation. Patient was also placed on pantoprazole for GI ulcer prophylaxis. Patient got 2nd COVID19 Moderna vaccine as outpatient on 2/27/21.

My husband had a stroke one week after his 2nd dose. The blood clot affected his occipital lobe. Ten years ago he had a stroke in the same area below this area. On that Monday around 7 PM, he took our refuse out to the curb in front of our home. When he came in he did not recognize me or his surroundings. I took him to the hospital by car as I was not sure what happened to him. After testing the doctors said he had a minor infarct. The stroke affected his memory. He was very confused and did not remember anything from the moment of the incident until moments before exiting the MRI machine, approximately 2 hours later. He still cannot recall anything surrounding the incident. We questioned if this was related to his recent vaccination and the doctors stated no, however, we believe it is something that should be reported since it occurred a week after the vaccination.

Prior to the vaccine on 2/13/21, He was a healthy 65 year old active college professor. 32 hours after the vaccination on 2/14/21, He had acute pancreatitis, which led to septic shock and respiratory failure, and he was placed on a ventilator at Hospital. On 2/24/21, he was transferred to Hospital and continued to have additional diagnoses, including polyneuropathy critical illness, acute gangrenous cholecystitis, abdominal pain, anemia, impaired mobility, oropharyngeal dysphagia, pulmonary embolism, and assistance with ADL. On 3/19/21, he was transferred from Hospital to Acute Rehab Unit for acute physical, occupational, and speech therapy. He remains there today. We do not know if this sequence of events is related to the vaccine, but because it occurred one day after the vaccine, we thought it should be reported.

Swollen right lower leg. Doppler study revealed multiple blood clots. Stared on Eliquis. Continues on Eliquis at this time and leg still swollen

Patient's wife states that he reported a bad headache about 3 hours after vaccination, that had improved by the next morning. The afternoon of 1/27/21, within 24 hours of receiving the vaccine, patient suffered from a stroke.

Haven't had afib in over two years. At about 9:30pm on March 18 while watching TV I had a severe afib event that lasted over an hour. This was followed by two hours of tachycardia. I finally got it under control by administering additional metoprolol tartrate. If this had continued I would have gone to the ER to have them cardiovert me.

Patient was found deceased at home on 2/20/2021, 8 days after receiving the 1st dose of COVID-19 vaccine.

2/16/2021 He was transferred to the Regional Hospital of due to low pressure (systole), received CPR in the ambulance on the way to the hospital. He died on 2/19/2021 due to various complications, including pneumonia.

not feeling; Patient was found deceased; Stiffness in neck; Extreme fatigue; A Spontaneous report was received from a consumer concerning a 65-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stiffness in neck/ musculoskeletal stiffness, extreme fatigue and patient was found deceased/Death. The patient's current condition included obesity and diabetes. Concomitant medication was not reported. On an unknown date, the patient received his first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 14 Mar 2021, prior to the event, the patient received his second of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 14 Mar 2021, after receiving the second dose of the vaccination the patient began to complain of not Feeling. On 16 Mar 2021, the patient began to complain of stiffness in neck and extreme fatigue. On Wednesday 17 Mar 2021, the patient was found deceased in their home. The event deceased was reported as serious. The family member states they would hate to link the Moderna vaccination to their uncle's death but the vaccination was the only alteration of the patient normal diet and medications. Treatment medication was not reported. The patient died on 17 Mar 2021. It was unknown if autopsy was performed. Action taken with the drug in response to the events was not applicable. The outcome of the event patient was found deceased was fatal whereas outcome of other events stiffness in neck, extreme fatigue was unknown.; Reporter's Comments: This is a case of sudden death in a 65-year-old male subject with a hx of obesity and diabetes who died 3 days after receiving the second dose of vaccine. Very limited information has been provided at this time." Further information is requested.; Reported Cause(s) of Death: Death

Patient was fully vaccinated (dose 1: 1/19 dose 2: 2/16). Patient developed fatigue on 3/1 then tested positive for COVID the following day (3/2). Was self-isolating at home and did not receive any COVID therapies. He reports progressively worsening fatigue, productive cough (white sputum), loss of taste, disorientation, and poor PO intake. Patient arrived to the ED for COVID-19 symptoms (3/13), tested positive and was admitted for severe hypoxic respiratory failure due to COVID-19. Patient with AKI (creatinine =2.48) Patient escalated to HFNC then down to 6L NC to 4L then slowly weaned to RA. Received dexamethasone 6 mg daily x 10 days. Patient was admitted from 3/13 to 3/18 for COVID-19. Creatinine on discharge was 1.29

Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Medium, Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Flushed / Sweating-Medium

Deep Venous Thrombosis, 5 days of calf/leg swelling, diagnosed 8 days later, treated with Xarelto. Currently being treated.

On March 30th started with headaches then progressed to shortness of breath while moving. Then on April 4th transport to hospital via EMT was tested for Covid 19 results was negative. It was determined that blood clots where found in Right leg & Left leg and both lungs and now blood clot was found in heart. PT has low platelets, low blood pressure. While in the hospital pt was given herapin . Patient has remained in ICU since the 4th to present time.

Swelling in lower right leg, ankle, foot; Venous Doppler ordered; blood clot detected; doctor examination; Eliquis prescribed.

ten days after the second moderna shot I had a TIA event and was hospitalized. I am in general very healthy and since both JJ and astro- vaccines have had reports of clotting, I thought it appropriate to enter my event into the statistical analysis

Patient received first Moderna mRNA vaccine 2/20/2021, second Moderna vaccine 3/20/21. Severe flulike symptoms after Moderna vaccine intermittently over 1 day. 3/23/2021 chest pain hospitalized severe pericarditis 750 mL. Also cardiac Cath Lab one of his blood vessels 80% occluded (I do not currently have hospital report) coronary artery stented. Failed Plavix of in-stent thrombosis and myocardial infarction recatheterization fixed thrombotic stent. Following couple weeks has had recurrent pericarditis requiring several hospitalization recurrent chest pain including recently requiring pericardial window.

Patient presented to our facility due to progressive swelling of his LLE. Patient is an avid cyclist and reports he began training again for the spring season approx. 1 mo ago. He had L calf tightness present for a few weeks as well as slightly painful knees which he attributed to his age and mild deconditioning over the winter. He traveled with infrequent stops on 4/2/2021 to visit family. He continued to have discomfort and increasing ankle pain, thus presented to ER. LE ultrasound venous dopplers performed showing extensive DVT: L femoral, popliteal, posterior tibial and peroneal veins. CT also demonstrated acute PE w/in distal R and L main pulm artery and w/in bilateral segmental and subsegmental pulm arteries involving all the lobes. Patient had remote history of LE DVT in 2017 after mild bumping of leg and placed on Xarelto for 6 mo. Had genetic testing completed at that time which was negative. He has had no clotting issues since. ( Received Moderna COVID-19 vaccines on 2/3/21 and 3/3/21. Reports brain fog and fatigue approx. 20 hours after vaccination followed by the above.) Patient discharged on rivaroxaban.

Moderna COVID19 EUA chest tightness and shortness of breath, covid negative per rapid test, tachycardia and HR in 180s-190s. elevated BP and hypoxic, narrow SVT found through EKG, adenosine ineffective, admitted for pneumonia later developed chest pain and transferred to Hospital

stroke; Completely lost vision in right eye which came back; migraine; fatigued kicked in, very tired,exhausted; nauseated; throwing up; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. ASKU and ASKU) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Stroke. Concomitant products included METFORMIN, LISINOPRIL, GLIMEPIRIDE, ROSUVASTATIN CALCIUM (CRESTOR), PIOGLITAZONE HYDROCHLORIDE (ACTOS) and CANAGLIFLOZIN (INVOKANA [CANAGLIFLOZIN]) for an unknown indication. On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced MIGRAINE (migraine), FATIGUE (fatigued kicked in, very tired,exhausted), NAUSEA (nauseated) and VOMITING (throwing up). On 06-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion hospitalization) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) (seriousness criterion medically significant). The patient was hospitalized from 06-Apr-2021 to 09-Apr-2021 due to CEREBROVASCULAR ACCIDENT. On 01-Apr-2021, MIGRAINE (migraine), FATIGUE (fatigued kicked in, very tired,exhausted), NAUSEA (nauseated) and VOMITING (throwing up) had resolved. On 09-Apr-2021, CEREBROVASCULAR ACCIDENT (stroke) and BLINDNESS TRANSIENT (Completely lost vision in right eye which came back) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment reported during hospital included IV blood thinner ,Xarelto 20mg. Metoprolol Tartrate 25mg, Amiodarone 200mg, after second dose. Company comment: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded. This case was linked to MOD-2021-076248 (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 these events, a causal relationship cannot be excluded. .

Bell"s palsy, followed by retractable hiccups, and AFib. Bell's palsy was treated with acyclovir and steroid. Still has symptoms, but beginning to resolve. Hiccups lasted 17 days. Two hospital stays for IV medications to try and stop hiccups and get AFib under control. Will begin physical therapy for Bell's palsy on April 29, 2021. Hospitalized at facility two times for total of 5 days

Receiver of vaccine was reported dead on 04-22-2021 TOD 0809 to Medical Examiner's Office Report # 052-EMF-79-21

Called to verify coming in for second dose on 4/21/21, family member confirmed death a few weeks ago (a few weeks after first covid dose). Cause of death unknown

Patient developed sweilling his left calf about 10-14 days after second dose of his vaccine. He had an ultrasound which demonstrated deep venous thrombosis of the left calf.

Moderna COVID-19 Vaccine EUA: patient presents to emergency department one day after vaccination reporting shortness of breath and left flank radicular pain. Found to have widely metastatic urothelial cancer involing the chest, abdomen, and pelvis. Patient admitted to the hospital for medical management. Discharged to hospice care.

stroke; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 024M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included AMLODIPINE, LOSARTAN, ATORVASTATIN, ALBUTEROL [SALBUTAMOL], ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN C [ASCORBIC ACID], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), COLECALCIFEROL (VIT D3), CLOPIDOGREL BISULFATE (PLAVIX), GARLIC [ALLIUM SATIVUM], LIDOCAINE, TIOTROPIUM and CYANOCOBALAMIN for an unknown indication. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criteria hospitalization and medically significant). The patient was hospitalized for 2 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Mar-2021, Computerised tomogram head: abnormal (abnormal) CT scan of head and was told that he had a stroke. No treatment information was provided. Additional concomitant medications included Circulant for an unknown indication. Additional diagnostic tests included magnetic resonance imaging, results not provided.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded

Pt received dose #1 of Moderna on 1/20/2021 at clinic. On 1/24/2021, developed self reported fatigue and sleep disturbances with pruritis. Sought no medical care. Routine labs were obtained on 2/23 which demonstrated new-onset transaminitis and hyperferritinemia (ALT 2366, AST 1260, alk phos 362, ferritin 32,000) and was admitted to hospital for evaluation. No etiology for acute liver failure identified, including comprehensive evaluation for viral hepatitis and other common causes of hepatitis common after transplant. Concern raised for hemophagocytic lymphohistiocytosis (HLH) due to extreme hyperferritinemia, although bone marrow biopsy negative. Ultimately transferred to another hospital for further care at patient's request. No specific treatment was given and transaminitis ultimately resolved. Soluble IL-2 receptor (CD25) level checked on 3/2, at time of admission, markedly elevated at 2338.6, consistent with diagnosis of HLH. Pt discharged on 3/5. Ultimately readmitted on 3/9 and found to have rapidly progressive Legionella pneumonia and died on 3/16. Two events felt to be unrelated and pneumonia not felt to be cause of HLH due to patient's status at time of initial admission.

death; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (death) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Cirrhosis of liver. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 17-Apr-2021 The patient died on 17-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Limited information regarding the patient's death has been provided at this time and a causal relationship cannot be excluded. It is not clear if the patient was hospitalized at the time of their death, only that they died in hospital; Sender's Comments: Limited information regarding the patient's death has been provided at this time and a causal relationship cannot be excluded. It is not clear if the patient was hospitalized at the time of their death, only that they died in hospital; Reported Cause(s) of Death: Unknown cause of death

On 04/20/21 at approx. 1:30 AM he awoke disoriented, lightheaded, "feeling funny" - knew something was different. States he could not make works come out his mouth, make complete sentences. This lasted for 7 or 8 minutes, then cleared up. He called his PMD that morning and was told to go to ER. He went to Hosp. ER, but was then sent to another Hospital. Hospitalized from 04/20/21 and discharged late afternoon of 04/22/21. Extensive blood work done, CAT scan, MRI, Carotoid ultrasound, Echo cardiogram. No signs of A-fib, cholesteral slightly elevated. DX. with TIA. Referred back to his cardiologist Has been under care of his cardiologist for 7 plus years - Pt is an active runner - Runs approx. 6 days a week for 2 1/2 to 3 miles per day. For the past few months he has switched to interval walk/run. After 1st dose of Moderna 03/03/21 - Reports no issues expect slight injection site discomfort. After his second dose of Moderna 03/31/21 - Reports chills 12 hours after injection, low-grade fever (99.0 - 100.0) started 14 hours after the injection. All symptoms resolved 30 hours after injection date and time. Stated he kept notes of this.

I have experienced an increased amount of Afib following my Moderna covid-19 vaccinations. I used to be able to expect at least two weeks Afib free between episodes, but on the evening of my first shot on March 12th I had Afib only four days after a typical episode. Then again on March 22nd and 30th. On April 8th I had my second Moderna dose. On April 11th I had Afib again and didn't think that much of it being related to the shot as I had been fever free for over a day at that time. But with episodes on the 13th, 14th, 17th, 18th, 20th(3 episodes) of April that far surpass the frequency of Afib in my history, I have become quite suspicious of the shots as the trigger. The episodes have thankfully been shorter than in the past, some ending within 15 minutes and some as long as four hours. My historical events had often lasted 12 to 18 hours. The arrhythmia events have significantly subsided with only one three minute arrythmia (likely flutter) in the last 12 days and less short duration palpitations as well.

Patient became suddenly short of breath, unresponsive, attempted CPR unsuccessfully and patient expired.

Heart pain/ chest pain. Hard to breathe Lack of energy Swollen legs Erratic heart rate Outcome: death 3 days after. Heart failure

J18.9 - Pneumonia of both lungs due to infectious organism, unspecified part of lung U07.1, J12.82 - Pneumonia due to COVID-19 virus U07.1 - COVID-19 multiple hospitalizations

I have had mild AFIB for years, minor short term less than 4 days perhaps once a year. On February 28th I started a very symptomatic AFIB, breathless with little energy and stamina , it lasted 8 days which is double previous events. It then subsided and recurred about 2 weeks later for 11 days. Again a severe episode which prompted me to seek out medical help. I just finished a cardiac ablation because of these episodes. They were far more severe and persistent than previous events.

First symptoms were severe back pain bent over when walking. Later pain in left shoulder and shortness of breath climbing stairs with heartbeat racing. Later developed pain in right thigh and calf. On May 30 emergency room determine blood clots in right leg and both lungs. First Symptoms appeared about one week after second dose on April 19

Patient received his second dose of Moderna on 4/9/21. The evening following the second Moderna vaccine, he developed fever, chills and sweats. He started to develop chest pain in May 2021 that lead to an Emergency Department visit, in which he was treated and released. On May 25, 2021, he was hospitalized at Hospital due a Myocardial Infarction that lead to Cardiac Arrest. He was successfully resuscitated spent 5 days in the Intensive Care Unit. He was informed that he developed Kidney Damage as a result of this event.

1st Moderna vaccine 3/18/21, no symptoms/adverse events. 2nd moderna vaccine 4/14/21, no adverse events until 5/28/21 had lost ability to move left side, was found on floor in home 4 days later on 5/26. Taken to hospital and was diagnosed with stroke. I asked the physician to report this to VAERS and he wouldn't because he didn't believe the vaccine was the cause. CDC states healthcare providers are required by law to report any unplanned hospitalization, disability (no date limit) after covid-19 vaccination, but physician kept refusing to report this to VAERS. My husband was from home independently and is now disabled, unable to move his left side and is going to a facility for long term care.

heavy legs; Stroke; runny nose; a little temp; Not feeling himself; headache; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and LIMB DISCOMFORT (heavy legs) in a 65-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 Atrial fibrillation since 2017. On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 28-Jan-2021, the patient experienced LIMB DISCOMFORT (heavy legs) (seriousness criterion hospitalization) and FEELING ABNORMAL (Not feeling himself). On an unknown date, the patient experienced RHINORRHOEA (runny nose) and BODY TEMPERATURE ABNORMAL (a little temp). The patient was hospitalized from 29-Jan-2021 to 02-Feb-2021 due to CEREBROVASCULAR ACCIDENT and LIMB DISCOMFORT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident and Rehabilitation therapy for Limb discomfort. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), LIMB DISCOMFORT (heavy legs), RHINORRHOEA (runny nose), BODY TEMPERATURE ABNORMAL (a little temp) and FEELING ABNORMAL (Not feeling himself) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications included blood thinners which patient had reportedly been taking for approximately four years to treat atrial fibrillation. Treatment included rehabilitation and learning how to ambulate with a walker. 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. This case was linked to MOD-2021-008992 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: Case updated to serious, events added.; 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.

1 week history of shortness of breath and nonproductive cough beginning shortly after receipt of second dose. Patient became hypoxic and had diffuse consolidation through left lung with wedge-shapes consolidation involving the right upper and midlateral lungs. Leukocytosis and bandemia noted and acute renal failure. Developed atrial fibrillation and rapid ventricular response. Multilobal pneumonia, septic shock, non-q-wave myocardial infarction, acute renal failure. Patient expired.

Atrial Fibrillation (4 days non-stop). Doctor administered 20mg Xarelto and 25mg Metoprolol day 3 with AF resolved within 24 hrs. Blood pressure within normal range during episode. Blood pressure has been resistant to treatment since AF resolved. Increased Metoprolol to 50mg approximately 5/6/21. Increased to 100mg 6/16/21. Blood pressure remains elevated at average 145/97.

Arm pain following vaccination. Was found deceased the following morning (less than 24 hours after the vaccine). Death was not attributed to the vaccination; cause of death was hypertensive and atherosclerotic heart disease.

In May, I suffered transient ischemic attack TIA, as a result of that I started taking blood pressure medication. I was not taking blood pressure medication prior to the medication.

After my shot I thought I did really good. I did have soreness and sensitivity but if I touched my arm it was sore. No fever, aches, or pains. I didn't think anything of it. I've had breathing issues for 5 years and I kept telling the Doctor I cant breath and I can't mow my yard. I did a medical stress test and a nuclear imagining afterwards and I assumed everything was OK because they weren't worried about anything. I still had the problems though. 05/13/2021 after lunch my chest felt heavy and that afternoon I had a heart attack and went to ER and it turned out that I had a blockage and the next day on 05/14/2021 Dr. put in 2 stents. I have to carry a card now. First stents in the OM, second stent in RCA. I don't feel the shot caused this but you never know. Now I'm feeling really good. Dose 2 Lot # could be 00821A or 008Z1A

Heart attack; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Heart attack) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Heart attack) (seriousness criterion medically significant). At the time of the report, MYOCARDIAL INFARCTION (Heart attack) and DIARRHOEA (Diarrhea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications reported. No treatment information was provided. Company comment: This case concerns a 65-year-old male with a serious unexpected event of myocardial infarction, and nonserious diarrhea. Event latency 1 day after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Added new adverse event myocardial infarction and upgraded the case to serious.; Sender's Comments: This case concerns a 65-year-old male with a serious unexpected event of myocardial infarction, and nonserious diarrhea. Event latency 1 day after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

June 16, 2021 Heart Ablation - because I had been in A-Fib and in order to get me off the medicine, I had to have the ablation. So that it would get me to stay out of A-Fib. Also I gained a bunch of weight very fast - after the second vaccine. I had been on a bunch of steroids from January hospitalization when I had COVID pneumonia. I waited until March to have the COVID vaccine - on the 10th (the first one). I got the second one on the 9th of April. I had tiredness and flu like symptoms - body aches and slight fever (99.1) the first day after the 2nd vaccine and all the other symptoms went on another day. I felt good enough to try to play 9 holes of golf on the Saturday after - although I was pretty wiped out after. So I was fine - until lately when I had shortness of breath after the ablation. The weight gain had been coming on - I was pretty active until that Ablation of time - I go to the gym and was getting rehab for my shoulder. But now with having the Ablation and then after having shortness of breath after the Ablation, I haven't been able to do that. I just tried to start a little walking again yesterday for the first time. I think the shortness of breath is getting better - it's better today than it was last week. Note: I got a Pneumonia vaccine at doctor's office in February; I got a 1st Shingles shot after I had both COVID vaccines - in the latter part of May probably; I haven't had the second shingles shot yet - should probably get that next month.

patient began running a fever day 1 after vaccination, this exacerbated a seizure, he was admitted to the hospital on 3/13/21 and stayed in a coma until his death

Dx: Myocarditis first s/s 02/04/2021 Pt with h/o chronic cardiovascular disease, HTN< Poissble alternative etiology: possible cardiac sarcoid and T cruzi infection as cause for cMRI findings; these were on the differential in the absence of other definitive cause

5 days after Moderna vaccine, developed severe abd pain, mid epigastrium. No Nausea or vomiting. No fever. Mild diarrhea. after 48 hrs with no improvement went to ED

Extreme bouts of nausea first few days after vaccine. Estimated that patient died at home within 3-4 days after receiving the vaccine. Last phone call to daughter expressed extreme nausea and seemed to have altered mental status. Found dead by daughter on 01/04/2021.

Patient is a 66 y/o male with a PMH of adenocarcinoma of the colon s/p sigmoidectomy and colostomy, currently receiving chemotherapy, CKD3, single R. kidney, R. Hydronephrosis, pulmonary hypertension, presented to the ED from clinic due to weakness x 2weeks. Pt reports feeling weak and dizzy when he stands up, which improves with laying down. Denies any head trauma. Pt reports his BP usually ranges from 120-140 in clinic, but it has been consistently less than 120 for the past couple of weeks. Associated with brown colored urine, sometimes with a small amount of blood when initiating urination, general malaise, nausea, and vomiting a small amount of clear fluid every 2-3 days. Pt does endorse decreased PO intake for the past few months since starting this cycle of chemotherapy but is still able to keep food/water down. Pt denies recent changes in colostomy output, last changed yesterday. Denies fever/chils, urinary frequency/urgency, hematemesis. Assessment/Plan: * Sepsis - WBC 1.54, Hypotensive on admit - Likely 2/2 UTI - 1L IVFs in ED - Lactic Acid: wnl - BNP: wnl - CXR: Calcified granuloma left upper to midlung zone. Small nodular opacities questioned right upper lung zone and right midlung zone. Left subclavian Port-A-Cath again noted. - UA: 1.010, 2+ blood, 3+ leuks, 66 RBCs, >100 WBCs, many WBC clumps, 4 Hyaline casts - No urinary complaints on admit - Received an additional 30cc/kg of fluids - Day 3 of Neupogen - BCx pending - Continue broad spectrum abx (Vanc/ Zosyn), will de-escalate pending cx - Urine gram stain pending Anemia - H/H baseline 11-12 - H/H slowly dropping, today 8.8/26.5 - Denies any hematemesis, no bloody output in colostomy - s/p sigmoidectomy - Not symptomatic - Will continue to monitor - Transfuse if hemoglobin <7 or becomes symptomatic Hypotension due to hypovolemia See Sepsis Acute kidney injury superimposed on CKD - Patient presented with Serum Cr 3.5, with a baseline Serum Cr of 2.7 - Resolved. Serum Cr 2.2 today - Most likely due to sepsis - Gabapentin held at admit due to AKI superimposed on CKD3 1. Challenge with gentle IVF's 2. Maintain UOP at 0.5ml/kg/hr 3. Hold nephrotoxic medications 4. Renally dose current meds if applicable 5. Bladder scan if suspicion of retention, followed by retroperitoneal US to evaluate for hydronephrosis hydronephrosis. Foley if retention. 6. Avoid hypotension 7. Stricts I/O's 8. Monitor renal function closely Neutropenia - WBC on admit: 1.54 - Last chemotherapy 1/25 - ANC 494 today, down from 774 yesterday - Day 3 of Neupogen - See Sepsis NSTEMI (non-ST elevated myocardial infarction) - Troponin mildly elevated on admit: 0.052, repeat plateau will not trend - EKG on admit: NSR, no ST changes or evidence of ischemia present - Likely 2/2 sepsis, low concern for ACS - No CP on admit - Will hold off on initiating ACS protocol - Cardiac monitor Adenocarcinoma of colon metastatic to liver - History of Stage IIC (pT4bN0Mx) poorly differentiated adenocarcinoma of the colon in 2016 with recurrent disease in 2018 and 2020, now p T4b N2 Mx - Followed by CMC Oncology - Last Oncology appt 1/26/2021: Received Irinotecan but leucovorin of Folfiri held - Will continue to monitor Neuropathy VTE Risk Mitigation (From admission, onward) Ordered heparin (porcine) injection 5,000 Units Every 8 hours 02/04/21 2026 IP VTE HIGH RISK PATIENT Once 02/04/21 2026 Place sequential compression device Until discontinued 02/04/21 2026 pt admitted for inpatient stay from ED on 2/4/2021 and discharged to home on 2/8/2021

Pt was found to have ITP-low platelets of 1000 during routine lab work done on 2/2/2021. Pt is asymptomatic--unknown if this is due to recent COVID infection in late Dec/early Jan or due to vaccine. He has responded to steroids and counts are improving.

I had COVID19 Vaccines EUA on 1/12/21 & 2/9/21. Most adverse effects I had after the first shot. On the same day around 7:30 p.m. head started to burn and the rest of my body shiver. Whole body skin became super sensitive - it hurt to move sharply. I took Tylenol 1300mg and Advil LiquiGel 400mg. Temperature was up & down (97 to 100.7) for 2 days. Friday 1/15 temperature became normal, but my body started to feel severe muscle twisting aches and that continue for 4 days straight. I've continue to take Tylenol and Advil every 4-6 hours. After muscle aches subsided on Tuesday 1/19, all joints started to hurt (two days of nagging & strong pain, most-knees & hands). Suddenly I started to cough for no apparent reason.

syncope, c/o itchy throat Narrative: Patient was seen prior to administration of the Moderna COVID-19 vaccination. He has allergies to bees/egg and a h/o anaphylaxis 2/2 receiving an injection of penicillin in the past. Discussed that prior h/o anaphylaxis to PCN injection was not a contraindication to this vaccination, but is a precaution. Discussed risks of receiving the vaccination vs benefits of the vaccine, which patient states "I already had this discussion with Dr.!" He has multiple comorbidities which place him at a higher risk for more severe illness from COVID-19. Again received the risk vs benefit discussion. Patient stated understanding and desire to proceed with the vaccination. He will be monitored for at least 30 minutes in area where staff can directly observe him. Patient received the COVID vaccination at 13:00. At 45 minutes later, staff alerted that he was c/o palpitations. Due to confusion and weakness, we were unable to transport him to an examination room. Oxygen, water, and vitals machine were brought to him. He presented with SOB, confusion, lightheadedness. Exam demonstrated acute distress, speaking in staccato sentences. HR in 80s, with lungs CTAB and no stridor - despite increased RR to 20s. Vitals with HR in 70s, SpO2 remained 97% or greater on RA. BP was initially 140/72. A code blue was called and Drs. presented to the area. Patient c/o itchy throat and still p/w confusion/combativeness, loss of orientation, and SOB. No visible swelling noticed. At around 13:58, patient syncopized. HR and SpO2 remained 70-80s and >98% on room air respectively. Pulse remained palpable. At that time, an epipen was administered. Patient woke up. During the entire episode, he was able to recognize a staff member with whom he was previously familiar. EMS arrived, vitals remained stable. EMS transported patient to the ER for further monitoring and f/u. Concern for immediate allergic reaction 2/2 vaccination. After event, patient in need of referral to allergy provider for evaluation prior to consideration of 2nd dosage.

Patient had COVID vaccination on 2/3 with no adverse s/s before leaving unit. Upon coming to treatment Friday 2/5 he reported to the RN that he had fallen on thursday 2/4 due to "getting up fast" did not hit head or hurt anything per RN discussion. Began treatment without difficulty. About 3/4 way through treatment was talking with staff and became unresponsive - code was called and pt expired after 30 minute resuscitation efforts.

-Approximately 5 hours after injection, developed 12 hours of chills (no fever), diffuse aching, fatigue, and very low energy. -Approximately 3 days after vaccine noted difficulty completing usual daily exercise routine-stamina appeared low. -Approximately 3-5 days after vaccine noted difficulty completely taking in deep breath, with "catch" or discomfort in substernal area. -During early morning hours of day 7 after vaccine, was awakened with sharp, intense toothache pain right flank. With change of position was able to get comfortable after which pain resolved. This reoccurred the next two nights prompting ED visit. -First ED visit focused on right flank pain and CT Abdomen and pelvis was negative except for "atelectasis" right lung base -Due to more pleuritic symptoms, second ED visit occurred, and CT chest with contrast demonstrated bilateral PEs (approximately 5 on right and 2 on left) with evidence for RV strain -Hospitalized and started on anticoagulation (Lovenox SQ for one dose and then Eloquis). Echocariogram confirmed mild RV dilatation. Interventional Radiology did not feel removal/lysis of clots necessary. -Completed exhaustive evaluation with Hematology--no underlying clotting disorder identified to date -Have returned to 100% activity without significant symptoms at present

Per family, patient has been feeling sick since he was vaccinated, patient went to ER on 02/15/2021, and after few hours at ER patient passed away.

Tested 1/14/2021 positive, fever & malaise 1/19-21/21, admitted with severe CoVID pneumonia 1/22/2021 – 1/25/2021, required supplemental O2 1/22-24.

Patient's wife reported at 3:30 PM (about 1.5 hours after vaccination) that patient described having weakness in the right side of his body. Patient described as "stroke symptoms". Patient was transported by ambulance to Hospital. MRI performed at 10 PM that night. Told that brain and carotid scans were fine. Patient's wife told me that ER department ruled as a light stroke, but dissolved by itself. Patient was allowed to leave hospital due to no beds available.

He complained of dizziness the evening of the shot. He went to bed and when he woke up the next morning he was having double vision. Is eye drifted off to the side and he was too dizzy to get up. He was taken to the hospital. They did a CT scan which didn't give a diagnosis, and they were unable to do a MRI scan due to a medical reason, so they could not determine for sure if he had a stroke. They are assuming that he did have a stroke and he has oculomotor nerve paralysis on the right side. The nurse practitioner saw him today and she reports he is doing very well now. He had been staying in a assisted living type facility when this occurred, but he is expected to return home tomorrow.

9 days after vaccination, the patient was found deceased in his home, sitting on his couch. Determined to be due to pulmonary embolism.

Patient was found deceased in garage. Neighbor who is a nurse did CPR until ambulance got there and took over, started IVs and pushed medicine and did CPR as well. Patient was pronounced deceased over th ephone with the JP and Police due to the icy weather conditions on Feb 16th 2021

Patient wife called on 3/11/21 to state that she would like us to cancel her husband second dose appointment for his COVID-19 Moderna vaccine. Wife stated that 24 hours after receiving vaccine patient died. Hospital told patient wife that it could be due to receiving COVID-19 vaccine. Unable to get anymore pertinent information from patient representative.

fatigue, body aches, chills, poor appetite Narrative: Patient is a 65 year-old-male who received the Moderna COVID-19 vaccine on 2/12/21. On 2/23/21, patient contacted his primary care nurse to inform he was having side effects from the vaccine, including headache, fever, chills, fatigue, body aches, rash on top of his feet that extends to his knees, bumps on his chest, bleeding from nose, mouth, and gums, and hyperglycemia. Patient reported took aspirin and Airborne for the symptoms. His primary care provider ordered bloodwork to be done the next day. On 2/24/21, patient had the following labs done: BMP (WNL except for glucose which was 363 mg/dL), CBC with diff (notable for very low platelets of 1 K/mm3), and PT/INR/PTT (all WNL). PCP examined patient and noted no obvious rash on chest, skin fair but not pale, no significant bruising or acute bleeding but petechial rash from the knees down. Patient had been sent home to rest while awaiting lab results. Once lab results returned, patient was contacted and instructed to go to the local ED due to his critically low platelets. Patient went to the local ED, bloodwork showed platelets of 4000 at that time. He was tested for COVID-19 on presentation and was found to be COVID-positive. Patient was diagnosed with idiopathic thrombocytopenia purpura. He was given a total of 4 platelet transfusions as well as IVIG for 2 days and prednisone for 4 days. Platelets reached 78,000 before patient was discharged on 2/26/21. At the time of this reaction, patient's active medications included: metformin, testosterone cypionate inj, allopurinol, atorvastatin, carvedilol, dulaglutide, empagliflozin, lisinopril, aspirin, calcium/vitamin D, multivitamin. He also received the TDaP vaccine 1/21/21 (22 days prior to the COVID-19 vaccine). Post-discharge follow up with primary care provider on 3/5/21 revealed patient feeling better, no bruising, bleeding, fever, or chills since discharge. Patient finished the course of oral prednisone started in the hospital. Glucose remains elevated. PMD to recheck CBC for platelets once patient is done with his mandatory quarantine for positive COVID-19 test results.

Narrative: ON 3/9/21--RECEIVED VACCINE DOSE#1 OF THE MODERNA,APPROX. 0915AM PT STATED HE WENT STRAIGHTHOME--THAT EVENINGPATIENT STATED HAD COLD CHILLS--PT STATED HE THOUGHT IT WAS THE BEGINNING OF THE FLU, BODY WAS HOT. ON 3/10/21-- IN THE AM FEELING SLLUGGISH/WEAK/NO ENERGY, WAS BABYSITTING GRANDSON, IN THE AFTERNOON WENT TO LAY DOWN. (PATIENT DOES NOT REMEMBER THE REST OF THE EVENTS--REPORTED TO HIM LATER BY SPOUSE OF WHAT HAPPENED) PT FOUND GURGLING BY SPOUSE, WIFE CALLED SON-IN-LAW, HE CAME IN BUT AT THE TIME PATIENT HAD STOPPED BREATHING, HE STARTED CPR ON THE PATIENT, AND SOMEONE CALLED 911. PATIENT WOKE UP IN THE AMBULANCE.

Developed sore throat on March 3, then had negative strep test. Sore throat persisted and saw ENT with normal exam. Lost sense of smell and taste on March 7th. Negative Covid test on March 10. Developed swelling in left leg on March 9, and had ultrasound on March 10 that showed DVT. Was hospitalized on March 10 and had second negative Covid test by PCR.

Death Narrative: Around the end of January 2021, patient was admitted to a home hospice program due to worsening of patient's Parkinson's Disease and Dementia. It was noted on the hospice programs Plan of Care that patient had severe, progressive dysphagia due to disease. Patient lost 20 pounds over the last 2 months prior to admission to hospice program. Patient had severe tremors, dystonia, and was dyspneic with minimal exertion. Patient received Moderna's Covid vaccine on 3/3/21. On 3/13/21, patient got progressively worse. He stopped eating and drinking and started to exhibit Cheyne-Stokes breathing. Hospice nurse noted that patient only had a few days remaining. On 3/18/21, patient passed away.

2nd day started fever, reached 101.2. Pulse increased to over 110 and BP up to 153/106, and I went into AFib.

Cardiac arrest five days after administration of the 2nd dose at 9pm, ambulance was called and EMTs attempted resuscitation, but no pulse was detected after 1 hour of compressions and CPR; time of death was recorded at 10:06pm

On Friday night, 3/19/21, patient spiked a fever, had shortness of breath, and had blood coming out of his nose and mouth per patient's daughter-in law. 9-1-1 was called, paramedics arrived at the home at 5AM on Saturday, 3/20/21 per patient's daughter. Patient died.

Two days after vaccination on 3/3, deep, sharp pain in the upper right portion of the chest and the upper right back, to the point of painful inability to breath beyond shallow breaths. This pain subsided, but returned shortly after contracting and testing positive for Covid-19 on the 3/12, at which point i decided to go to the hospital emergency room, Well I was tested for and found to have a PE (pulmonary embolism ) in the upper right portion of my right lung.

Atrial fibrillation began 6 days after first immunization. Patient needed cardioconversion. Atrial fibrillation began 5.5 days after second immunization. Patient currently awaiting cardioversion. Patient has underlying hypertrophic cardiomyopathy and 2 prior episodes of atrial fibrillation (December 2019, and February 2020) apparently triggered by surgery/anesthesia. However, the atrial fibrillation was completely controlled for more than one year by the addition of a beta-blocker (atenolol) to long-standing (30+ yrs) of a calcium channel blocker (verapamil).

Pt is always stable on dialysis. Pt was 30 min from completing his treatment and he stopped breathing. Fluid was given, oxygen was placed and sternal rub was performed, pt regained consciousness.

I received the second vaccine injection, and in about an hour felt a little warm and clammy, I was having some joint and muscle pain, and stomach upset. I had no appetite and did not eat lunch. At supper I still did not want anything, so ate cereal instead. During the night I was restless, and expelled quite a bit of gas throughout the night. Stomach still uneasy. When I awoke, about 6:00 AM, I was hungry and attempted to pour a bowl of cereal but could not due to shaking. My wife found me in the middle of a grand mal seizure and called the ambulance. The ambulance, police, and fire company all responded. They provided medical care onsite and in route to Hospital. I had a fever of 102 degrees, had been biting my tongue raw, flailing arm and hyperventilating. I was somewhat disoriented and delusional. During my hospitalization the injection site was found to be very swollen and red. Ice was applied. An MRI was performed of the head and found to be normal. Several other blood tests were also completed. I remained inpatient from 3/25/21 through 3/21/21.

presents to the ED via EMS in cardiac arrest. EMS report patient was in agonal respiration upon arrival and has had no pulse since 2109. Patient had a syncopal episode on the toilet prior to EMS call. EMS notes they gave patient 4 epinephrine, 1 bicarbonate, and 1 Narcan. Patient arrived with a lucas machine in place and intubated. Patient's intubation was verified to be a 7.0 ETT and 23 cm at the lip. Cardiac Activity noted in ED at 2150. See nurses notes for times medications were administered. Further history limited due to unstable vital signs. Pt hypotensive, started and maxed on levophed, epinephrine infusions and additional push dose epi given. Right femoral central line placed. Pt began to brady down, was given atropine, ultimately again became pulseless and CPR resumed. After 2 further rounds of ACLS, total down time approached 1 hour without return of pulse. On echo, there were occasional agonal beats, but no organized cardiac activity. EKG and case had been discussed with Dr. Friday and decision was to attempt therapeutic hypothermia prior to second cardiac arrest as EKG showed inferolateral STEMI

Stroke; Itchiness on the back of the head; Bad headache; Lost mobility on one side; Muscles went all mushy; A spontaneous report was received from a consumer regarding a 66 year old, elderly male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and had his muscles went all mushy/muscle weakness, lost mobility on one side/mobility decreased , stroke/cerebrovascular accident, itchiness on the back of the head/pruritus and bad headache. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included an unspecified blood pressure medication and clopidogrel busulfate. On 10 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 048A21A) in left non dominant arm for prophylaxis of COVID-19 infection. On an unspecified date, the patient experienced Itchiness on the back of the head and bad headache. On 20 Mar 2021, the patient's muscles went all mushy and lost mobility on one side. On 23 Mar 2021, the patient was hospitalized for stroke. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event bad headache was not resolved and outcome of Itchiness on the back of the head, muscles went all mushy, lost mobility on one side and stroke was unknown at the time of this report. .; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient received Moderna vaccine dose #1 on 3/3/21 at approximately 0900. In the afternoon of 3/4/21, patient had sudden onset shortness of breath while at home, as well as fatigue and low energy. Patient knew that a potential side effect of vaccine was fatigue, so he assumed this was just a normal side effect to be expected. States that his difficulty breathing and fatigue continued for about a week. After continued urging from wife to seek medical care, patient visited urgent care center on 3/15/21. The urgent care did a D-Dimer lab, and an x-ray of chest. X-ray "showed something abnormal" so they did a CT scan as well, which showed a "huge pulmonary embolism." D-Dimer lab was elevated. Patient was transported to hospital by ambulance and had immediate surgery to remove blood clot from lungs at approximately 2100 on 3/15/21. Per patient, the surgeon said the clot was about the size of his palm. Surgeon reported that there was "100% blockage to left lung from the aortic artery and 90% blockage to right lung from aortic artery." A DVT in popliteal vein was identified, and the surgeon assumes the clot started in the popliteal vein and broke off and traveled to lungs. Patient was admitted and hospitalized until he was discharged home on 3/18/21. During course of hospitalization, genetic testing was done and it was determined that the "genetic marker for clots was negative, so they think the clot is from a one-time event--patient's family does not need to be concerned that they have clotting issues." Patient states that he was started on heparin in the hospital, and was discharged home on Eliquis blood thinner, which is being tapered. Patient states that the doctors think he will be on Eliquis for about 6 months and will not need to be on it for life. Doctors say the DVT in leg will dissolve on its own. During hospitalization, an echogram and cardiac cath was performed, which showed "an old heart attack on the left side, but that collateral vessels have built up already." Right side of heart was weaker from having to work so hard due to blood clots in lung, but prior to discharge from hospital, the right side of heart was already showing improvement. A heart cath was done to check vessels and it was determined no stents were needed, although there was a small clot in left anterior descending artery. Patient was also newly diagnosed during course of hospitalization with Type II Diabetes in a non-obese person, HTN (which patient had never had before), Coronary Artery Disease, Hyperlipidemia, 1st degree AV block. Was discharged home with metformin, losartan, chlorthalidone, atorvastatin, and Aspirin. The chlorthalidone was discontinued, due to "blood pressure dropping too low--they think his high blood pressure was situational" per wife of patient. Medical doctors advised against receiving the 2nd dose of Moderna vaccine. Patient being followed by Internist at hospital. Patient's shortness of breath resolved "immediately after clot was removed" but is continuing to be followed while on new medications and blood thinner dosing. The above information was provided during telephone interview of patient and his wife.

My father received his second dose of the moderna vaccine on 3/27/2021. Around 5PM he started to feel unwell and went to lay down. My mom found him unresponsive at 10PM and called an ambulance. She was told at the hospital that he had a massive brain bleed. He passed away the following morning around 10AM.

Day of second shot, pt arm felt sore. 2 days later pt start feeling flu like symptoms. 6 days after shot pt starting feeling numbness down right side. Had to go to ER and was informed he was having a stroke.

Patient experienced right-sided weakness 24 hours after Moderna vaccine received. He did not seek medical attention until 3/11/21, at which time he was hospitalized and diagnosed with a CVA.

5 days after second Moderna Covid vaccination, patient had sudden onset severe right leg swelling and pain, found to have extensive right lower extremity DVT and bilateral pulmonary embolism

Notified by pt's family member that pt stated at the dinner table he was not feeling well and went to lay down. Pt then later called out for his family member stating he was bleeding from his dialysis access in his leg. Pt's family member called EMS, pt was transported to the hospital. Pt member stated the pt passed away that evening "because of all the blood he lost from his access." Pt's nephrologist and NP were notified. Pt's death per nephrologist was felt to be due to blood loss from his graft and not related to the vaccine.

Patient received vaccine 3/2/2021, second dose. Uneventful. On 3/16, patient was found unresponsive and sent to hospital. Hospital course: altered mental status, pneumonia, acute hypoxia, acute encephalopathy. Treated in hospital, recovered and returned to nursing home. Patient tested negative for Covid on 3/16/21 before transfer to hospital. Before sent to hospital vitals were: Temp 101.7, pulse 104, BP 130/78, blood sugar 172, oxygen on room air 95%.

3/13/2021: Red rash/hives on arms, neck, scalp, chest, back / was treated at ER with benedryl, given albuterol inhaler to take 2 puffs, 4X day for 7 days; prednisone, 40mg daily for 5 days 3/16/21: had mini stroke at home, called ambulance, they administered a series of tests and determined that all his vital signs were normal and asked if he wanted to go to hosp for addt'l testing and pt refused. 3/17/21: had 2nd mini stroke in vehicle, went straight to Hosp ER and was admitted. CT scan and MRI determined that I had suffered 2 strokes due to blood clots in the rt side of brain. Was told to take 325 mg of aspirin a day and released on 3/19/21 with instructions to f/u with PCP and Neurologist. PCP recommends that I should NOT take the 2nd dose of the Moderna vaccine.

Deep Vein Thrombosis in left calf. Pain in leg. Treating with Eliquis for three months. Still in treatment but no more pain.

right leg pain starting 1-2 weeks after first Moderna COVID vaccine (admin 2/24/21). 2-3 days after second COVID vaccine (admin 3/24/21) right leg pain intensified and was followed by right pleuritic chest pain On 3/29/21 ultrasound showed right superficial femoral DVT. CTA showed bilateral pulmonary emboli

Patient reported to ED with severe dizziness, emesis and left arm heaviness that started at about noon on 4/1/21. Found to have a cerebral infarct.

RLE DVT dx'd 4/16/2021, sx onset approx. 4/9/21. Pt also c/o sharp stabbing pain between shoulder blades 2 days after 2nd moderna dose, lasted 4 days, resolved. and mild cough since then, persisting.

Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015N2OA) for COVID-19 vaccination. The patient's past medical history included No adverse event (no reported medical history). Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], METOPROLOL, TRIMEBUTINE (BUMETIN [TRIMEBUTINE]), EZETIMIBE (EZETIMIB ALKEM), FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), LOSARTAN, ATORVASTATIN CALCIUM (LIPITOR), MONTELUKAST, ALBUTEROL [SALBUTAMOL], AZELASTIN [AZELASTINE] and GLYCERYL TRINITRATE (NITROLINGUAL) for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information included 7 days of oral antibiotic treatment as outpatient. 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.

deep vein thrombosis, blood clot in left leg and 2 clots in lung, pneumonia, in hospital 3 days, released 2 days and back in for 3 days with gastrointestinal hemorrhage with melena

The patient presented to our clinic with left calf pain and swelling, shortness of breath without chest pain, low grade fever. He was slightly tachycardic with elevated blood pressures to 160s/90s but had O2 saturation of 99%. DVT US showed extensive thromboembolism of left superficial femoral vein down to popliteal vein and calf veins. CTA chest showed bilateral sub-segmental PE. He was transferred to the the ED for PE workup and treatment.

Developed atrial fibrillation with rapid ventricular response within 24 hours of vaccine administration. Symptoms progressed and he presented to hospital where heart rate brought under control with amiodarone drip and converted to flecainide. d/c to home following day.

Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient presented to the ER on 3/8/21 after being sick the prior 2 weeks with loose, bloody/tarry stools, frequent falls, and hypotension. Hospital course progressed to worsening encephalopathy secondary to decompensated alcoholic cirrhosis. Developed pneumonia that did not improve with antibiotics and progressed to palliative care with him passing away on 3/24/21. Comorbidities include COPD, alcoholism, Takotsubo cardiomyopathy, HTN, cirrhosis, HLD, former smoker.

Patient received first Moderna Vaccine on 02/26/2021 and second Moderna Vaccine on 03/26/2021. Health Department was notified of patients death on 03/27/2021, today 04/22/2021. Any further information is unknown by the health department for patients cause of death that occurred on 03/27/2021.

Exact time of symptom onset unknown. Clinic was notified by family at 10am on 4/21 that patient had expired at home. Family member reported that patient was tired and achy and was found deceased on the floor in his room. Patient had a history of Covid-19 in January, 2021.

Patient received the second dose of Moderna vaccine on 4/1/21. Approximately 5 days afterwards he began to have a headache. This lingered and progressed to the point that presented to the emergency room. A CT head revealed cerebral venous sinus thrombosis. No evidence of thrombocytopenia but notably, the patient's platelets clump.

Pt presented to pharmacy to receive his 2nd Covid19 dose. During counseling he stated that he received his first dose of Moderna Covid19 on Monday, 04/05/2021. On Friday, 04/09/2021 he experienced pain on his left side ('pain in lungs). Then, on Saturday, 04/10/2021 he went to the hospital, where an x-ray showed a clot in his lungs, He also experienced a stroke. He we home on Eliquis 5 mg : TAKE 2 TABLETS BY MOUTH 2(TWO) TIMES DAILY FOR 7 DAYS, THEN 1 TABLET 2(TWO) TIMES DAILY FOR 23 DAYS. INDICATIONS VENOUS THOMBOEMBOLISM ('Dr not sure this was related to vaccine'. His doctor 'approved a second dose of Covid19')

Approximately 36 hours after I received the first Moderna vaccine, I developed a high fever 101.5, chills and body aches lasting about 4 days. I went to healthcare facility and had a negative influenza and Covid tests at that time. 2 days later, I started to have difficulty breathing. I had a routine doctor appt scheduled for 3/25. When I arrived, my O2 sats were 80% and I was sent to the ER. There I had another negative Covid test. I was diagnosed with bil PE's and had a 8 days stay in the hospital, 6 days in ICU. I was sent home on long term medications and oxygen.

2 weeks later developed DVT (leg pain, also found to have ACL tear of unknown duration), loss of appetite, and bilateral stiffness in hands. Hospitalized for DVT on blood thinners since Diagnosis: Acute embolism and thrombosis of unspecified deep veins of right lower extremity ; Unspecified abdominal pain ; Nausea with vomiting, unspecified ; Strain of muscle, fascia and tendon of the posterior muscle group at thigh level, left thigh, initial encounter ; Essential (primary) hypertension

Encephalopathy; Pneumonia; Hypoxia; Unresponsive to stimuli; Mental status changes; This case was received via FDA VAERS (Reference number: 1182714) on 11-May-2021 and was forwarded to Moderna on 11-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ENCEPHALOPATHY (Encephalopathy), PNEUMONIA (Pneumonia), HYPOXIA (Hypoxia), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) and MENTAL STATUS CHANGES (Mental status changes) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. Concurrent medical conditions included Epilepsy, Dementia, Hypertension, Diabetes and Benign prostatic hyperplasia. Concomitant products included AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID], ATORVASTATIN, CALCIUM CARBONATE, ERGOCALCIFEROL (CALCIUM/VITAMIN D [CALCIUM CARBONATE;ERGOCALCIFEROL]), CARBAMAZEPINE, CARVEDILOL, DONEPEZIL, FINASTERIDE, GABAPENTIN, HALOPERIDOL, HYDRALAZINE, INSULIN, LEVETIRACETAM, LISINOPRIL, OXYBUTYNIN, POLYETHYLENE GLYCOL 3350, TAMSULOSIN and SENNA ALEXANDRINA EXTRACT (SENNALAX [SENNA ALEXANDRINA EXTRACT]) for an unknown indication. On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced ENCEPHALOPATHY (Encephalopathy) (seriousness criteria hospitalization, medically significant and life threatening), PNEUMONIA (Pneumonia) (seriousness criteria hospitalization, medically significant and life threatening), HYPOXIA (Hypoxia) (seriousness criteria hospitalization, medically significant and life threatening), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) (seriousness criteria hospitalization, medically significant and life threatening) and MENTAL STATUS CHANGES (Mental status changes) (seriousness criteria hospitalization and life threatening). At the time of the report, ENCEPHALOPATHY (Encephalopathy), PNEUMONIA (Pneumonia), HYPOXIA (Hypoxia), UNRESPONSIVE TO STIMULI (Unresponsive to stimuli) and MENTAL STATUS CHANGES (Mental status changes) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood glucose: normal (normal) normal and 172 172. On 16-Mar-2021, Blood pressure measurement: 130/78 130/78. On 16-Mar-2021, Body temperature: 101.7 (High) 101.7. On 16-Mar-2021, Heart rate: 104 104. On 16-Mar-2021, Oxygen saturation: 95 % 95. On 16-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment drug 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.

In the evening of 25-Jan-2021, after my dinner I was watching the TV that after 15 minutes my Left arm from shoulder downwards felt suddenly numb with no sensation. I called my wife and sensing that it may be a stroke took 4 tablets of 81 mg of Baby Aspirin. Some sensation seem to come back after some time (may be an hour or so afterwards), but half of my left palm and little finger remained some what numb. Night passed quietly and kids were anxious that I did not call ambulance or go to ER. Next morning I went to the nearest ER and was diagnosed with Transient Ischemic Attack. All the tests were negative CT scan of Head & Trunk did not reveal anything, only D-Dimer was slightly elevated. I was given a tablet of Aspirin 325 mg and prescribed Eliquis 2.5 mg twice daily for use and advised to follow up with a Neurologist. ER did advise for admission in hospital and a MRI work up, but I declined.

Patient spouse reports to me the following: patient felt normal most of the day, later in the evening he felt extreme fatigue went to bed around 9pm. She found him deceased around 2am.

My husband had a stroke on 01/25/2021, with one large blood clot and many small blood clots. He was put on a ventilator until 02/06/2021 when I asked to have it removed. I died within 5 minutes after it being removed.

Severe Painless petechial hemorrhage w/o vision impairment, lasted for almost 2 weeks, spontaeouly cleared. No history prior similar event, no drama, etc. I do not wear contacts, etc.

Patient admitted to referring hospital on 5/18/2021 for fatigue and SOB, found to have pulmonary embolism (CT with central pulmonary emboli with right heart strain), alteplase was given at referring hospital and was admitted to ICU for continued monitoring. Venous duplex done also revealed bilateral DVTs. Patient was doing well after fibrinolytic with heparin anticoagulation, but had sudden decompensation on 5/21 (hypotension and respiratory failure requiring intubation). Transferred to current institution for ECMO evaluation due to severe cardiopulmonary compromise. Patient deemed not ECMO candidate based on co-morbid conditions based on CT findings. He underwent mechanical thrombectomy with improvement. He was continued on heparin infusion, then had sudden decrease in platelet on 5/25 with worsening cardiopulmonary status. HITT was suspected and heparin was transitioned to argatroban. Results of heparin induced platelet antibodies (PF4 ELISA assay) and Serotonin Release assay was negative. Repeat imaging revealed increase clot burden and therefore patient underwent catheter directed thrombolysis followed by aspiration suction thrombectomy. Due to high clinical suspicion of HITT, repeat heparin induced platelet and SRA sent and pending at the time of report. Of note, patient still in hospital at the time of this report

sick as a dog; Kidney's almost shut down both times; had 2-3 attacks; Unexplainable pain in lower stomach area; Health declined quickly; Heart issue after first shot of vaccine; Lungs have gotten worse since the first shot; grabbing and pulling at his chest; Unable to sleep; Foul smelling diarrhea; Terrible chest pain; Could not breath/Very difficult to breathe; Could not eat anything; didn't take the second dose of the Moderna COVID-19 vaccine; Sick as a dog; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RENAL IMPAIRMENT (Kidney's almost shut down both times), MYOCARDIAL INFARCTION (had 2-3 attacks) and ILLNESS (sick as a dog) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Peanut allergy, Fruit allergy (citrus allergy was reported.), Milk allergy (Dairy allergy was reported.), Drug allergy (demerol), Kidney disorder (Kidney disease was reported.) since 2008, Chronic pancreatitis since 2012, COPD since 2001, Heart disease, unspecified since 2000, Drug allergy (tramadol), Drug allergy (lorazepam), Food allergy and Food allergy. Concomitant products included ONDANSETRON, PANTOPRAZOLE, BUPRENORPHINE and SALBUTAMOL SULFATE (PROAIR HFA) for Chronic pancreatitis, LOSARTAN POTASSIUM (LOSARTAN [LOSARTAN POTASSIUM]) for Hypertension, FLUOXETINE HYDROCHLORIDE (PROZAC) for Mood depression, AMMONIUM BROMIDE, POTASSIUM BROMIDE, SODIUM BROMIDE (BROMIDES), TIOTROPIUM BROMIDE (SPIRIVA) and DIAZEPAM (VALIUM) for an unknown indication. On 03-Mar-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced RENAL IMPAIRMENT (Kidney's almost shut down both times) (seriousness criteria hospitalization, medically significant and intervention required), MYOCARDIAL INFARCTION (had 2-3 attacks) (seriousness criteria hospitalization, medically significant and intervention required), PRODUCT DOSE OMISSION ISSUE (didn't take the second dose of the Moderna COVID-19 vaccine) and ILLNESS (Sick as a dog). On 06-Mar-2021, the patient experienced ILLNESS (sick as a dog) (seriousness criteria hospitalization, medically significant and intervention required), DYSPNOEA (Could not breath/Very difficult to breathe) and FEEDING DISORDER (Could not eat anything). 06-Mar-2021, the patient experienced CHEST PAIN (Terrible chest pain). On 19-Mar-2021, the patient experienced DIARRHOEA (Foul smelling diarrhea). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Unexplainable pain in lower stomach area), GENERAL PHYSICAL HEALTH DETERIORATION (Health declined quickly), CARDIAC DISORDER (Heart issue after first shot of vaccine), LUNG DISORDER (Lungs have gotten worse since the first shot), CHEST DISCOMFORT (grabbing and pulling at his chest) and INSOMNIA (Unable to sleep). The patient was treated with TIOTROPIUM BROMIDE (oral) on 05-Mar-2021 at an unspecified dose and frequency; SIMETHICONE ongoing since an unknown date at an unspecified dose and frequency; PREDNISONE at a dose of 10 mg and OXYGEN at an unspecified dose and frequency. At the time of the report, RENAL IMPAIRMENT (Kidney's almost shut down both times) had not resolved and MYOCARDIAL INFARCTION (had 2-3 attacks), ILLNESS (sick as a dog), DYSPNOEA (Could not breath/Very difficult to breathe), FEEDING DISORDER (Could not eat anything), DIARRHOEA (Foul smelling diarrhea), ABDOMINAL PAIN UPPER (Unexplainable pain in lower stomach area), GENERAL PHYSICAL HEALTH DETERIORATION (Health declined quickly), CARDIAC DISORDER (Heart issue after first shot of vaccine), LUNG DISORDER (Lungs have gotten worse since the first shot), CHEST PAIN (Terrible chest pain), CHEST DISCOMFORT (grabbing and pulling at his chest), PRODUCT DOSE OMISSION ISSUE (didn't take the second dose of the Moderna COVID-19 vaccine), ILLNESS (Sick as a dog) and INSOMNIA (Unable to sleep) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal other. On an unknown date, SARS-CoV-2 test negative: negative negative. On an unknown date, Troponin: high (High) high. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient is on nebulizer treatment of tiotropium bromide and a lot of simethicone. Patient do not know if using either medication helped or not but that was my immidiate reaction. Now patient is on prednisone and feels like he's taking it just to breathe. Patient has had to go on 24 hr. oxygen since the first shot. Patient was negative for Covid-19 over the past 3 months at three different times. He continued to have terrible chest pain where he was grabbing and pulling at his chest, pain creeping up to his chest, could not breath or eat anything for 1 week after his first shot. Patient was in the ER on 10Mar2021. Caller stated he has chronic pancreatitis and breathing issues for which he was prescribed steroids, his doctor told him to decrease the prednisone to 10mg for 2 days prior and day of vaccination. Caller thinks he had a week long stroke since he had high Troponin level which resulted in visit to the hospital where the doctors thought he had septicemia. Caller stated he has not been able to sleep because he keeps having attacks of chest pains that last approximately 15 minutes in the middle of the sleep which occurs 4+ times per night. Kidney's have gotten worse since 1st shot vaccine. Doctors said "the kidney's took a shot" after the first shot of vaccine. Patient was admitted to the Hosp twice after the first shot because his kidneys almost shut down both times. Unexplainable, excruciating pain in chest and very difficult to breathe for approx. 10-15 minutes each attack. New, unexplainable pain in lower stomach area since 1st shot of vaccine. Doctors cannot explain. Patient is seeking legal action against Moderna. Most recent FOLLOW-UP information incorporated above includes: On 18-May-2021: Follow up received on 18 May 2021,included patient demography (Ethnicity, race, height, weight), allergy to peanuts, citrus, dairy, Demerol, tramadol, lorazepam. Current medical condition kidney disease was updated. concomitant medications were buprenorphine, pantoprazole, ondansetron, losartan, Prozac with product indications were updated. Laboratory information EKG was updated. Events Kidney's have gotten worse, unexplainable pain in lower stomach area, my health has declined, lungs have gotten worse was updated. On 23-May-2021: follow-up appended, conmeds added, NF added to events, new events added, new allergies coded, generated narrative.; Sender's Comments: This case concerns a male patient of unknown age who missed second dose due other adverse events experienced post first dose of mRNA-1273. The other events show temporal association with the use of mRNA-1273 and a causal relationship cannot be excluded. However, the patient has concurrent history that confounds the reported events to include chronic pancreatitis, COPD, kidney and heart disorder. Missed dose is assessed as not applicable

he felt achey and weak for a day or two then had syncope then he had syncope again this morning. found to have NSTEMI. received PCI with a DES x1. recovered and discharged home

AFib; I cant walk; Heart cant send blood to rest of my body; This is ruining my life; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (AFib) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 17-Feb-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced ATRIAL FIBRILLATION (AFib) (seriousness criteria hospitalization and medically significant). 17-Feb-2021, the patient experienced POOR PERIPHERAL CIRCULATION (Heart cant send blood to rest of my body) and ANXIETY (This is ruining my life). On an unknown date, the patient experienced GAIT DISTURBANCE (I cant walk). The patient was treated with DIGOXIN at an unspecified dose and frequency and ACHILLEA MILLEFOLIUM, CRATAEGUS MONOGYNA, OLEA EUROPAEA, VALERIANA OFFICINALIS, VISCUM ALBUM (BP (BLOOD PRESSURE)) at an unspecified dose and frequency. On 17-Feb-2021 at 12:00 PM, ATRIAL FIBRILLATION (AFib) had not resolved. At the time of the report, POOR PERIPHERAL CIRCULATION (Heart cant send blood to rest of my body), ANXIETY (This is ruining my life) and GAIT DISTURBANCE (I cant walk) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Patient's daughter came in to find out when he received Covid vaccination because he just had a stroke. It occurred exactly 4 weeks after receiving his second dose. Patient's daughter is trying to get him into a rehab facility that would not accept him without his vaccine card.

My Brother was found dead at home - Not sure it's vaccine related - but he did not have major or urgent health issues .

Outcome: Patient Death CHIEF COMPLAINT in ER: chest pain, SOB History of Present Illness: Patient is a 66 yo with PMH of chronic afib on chronic anticoagulation who presented to the ER with a chief complaint of shortness of breath and increased fatigue over the past several weeks that has progressively become worse. Patient denies orthopnea or PND but does have some palpitations and occasional chest pain associated with increased fatigue with exertion. On evaluation emergency room patient was noted to be tachycardic consistent with chronic atrial fib, also acute renal insufficiency likely secondary to dehydration. Patient is admitted to the medical service for further treatment and evaluation. DEATH SUMMARY Date of Admission: 04/07/2021 Time of Death: 04/10/2021 at 0737 Final Diagnoses: 1. Sudden Cardiac Death 2. Acute Renal Impairment Secondary to Hypovolemia, A TN 3. Chronic Atrial Fibrillation w/ RVR, Resolved 4. Atypical Chest Pain, Resolved 5. Hypokalemia, Resolved 6. Obstructive Sleep Apnea 7. Chronic Diastolic Heart Failure Hospital Course: Patient is a pleasant 66yo admitted for acute renal impairment secondary to significant o hypovolemia resulting in ATN as well as atrial fibrillation w/ RVR after presenting to ER with complaints of chest pain, dyspnea, malaise, and anorexia that began after receiving his second COVID vaccine on 4/01/2021. Please see H&P for full details. Patient reported that on the day after his COVID #2 vaccine, he lost his appetite and was not able to eat or drink. He continued to take his home medications as prescribed including losartan, chlorthalidone, and meloxicam. After experiencing progressive worsening of symptoms for 5 days, patient presented to ER for further evaluation. Upon arrival to ER, patient was noted to be hypotensive and tachycardic. EKG showed atrial fibrillation w/ RVR. Routine labs were obtained and were remarkable for elevated creatinine and mild hypokalemia w/ normal BNP and negative cardiac enzymes. CXR showed enlarged cardiac silhouette, but no evidence of pulmonary edema or other acute abnormalities. Patient was subsequently admitted for further evaluation and medical management. He was staited on aggressive IV hydration for his hypotension and hypovolemia w/ PRN IV metoprolol as needed for HR> l lObpm. He was continued on anticoagulation. Serial cardiac enzymes were obtained and were negative. TIE report from Dr's office that was performed recently was obtained and showed EF of 55-60% with Grade 1 diastolic dysfunction. Patient's wife brought his CPAP from home and patient wore his CPAP while sleeping during his hospital stay. During the course of hospitalization, patient's blood pressure & HR improved, though he remained in atrial fibrillation. His creatinine continued to trend up consistent with ATN, but patient continued to produce adequate urine and he had no signficant electrolyte derangements. IVF were adjusted based on urine output and volume status. Patient had no recurrence in his presenting complaint of chest pain and he overall reported feeling better throughout his course of hospitalization despite reporting that he continued to have little appetite. Patient was monitored closely on telemetry throughout his hospital stay. On the morning of 4/10/2021, lab tech and nurse walked into the patient's room to obtain specimen for AM labs. Patient reportedly tried to get out of the bed independently, grabbed at his chest & pulled off his telemetry, and fell to his knees. Staff called Code 99 and patient was placed back in the bed. He was noted to be in asystole. ACLS was performed and despite maximal efforts, patient subsequently expired at 0737. I personally called the patient's cardiologist & personal friend, to discuss the events leading up to the patient's death. Upon review of the patient's course of hospitalization, it was felt that patient most likely experienced sudden cardiac death. Of note, Dr reports that the patient frequently contacts him via text message with concerns or complaints. He states that the patient did not message him during the hospitalization to report any chest pain or other concerns. Disposition: Patient Expired

Progressive swelling and pain around and below the right knee, first noticed 11 days after second covid vaccination.

It felt a little sore for the first day or two. I am semi retired. Everything was good until 5 days later at 3am. I could not breathe and my fever was 103 degrees. My wife called an ambulance and sent me to the hospital after breathing treatment. I was on a-fib and the doctors/nurses trying to send me back to life. I spent 7 days in the hospital. Blood work, Nuclear tests, fluid tests, lung tests, X-rays, biopsy into my lung and got tissue to get an amount (Bronchoscope). I was very scared. I had pneumonia too. Every 6 hours, breathing treatments.

Patient had massive heart attack, lost consciousness and hit his head as he fell. Patient had pain in his left arm approximately 5 days before the event. on 6/16/2021 patient lost consciousness again, this time due to low blood pressure. the low blood pressure was said to be due to dehydration.

Atrial Fibrillation Episode; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial Fibrillation Episode) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The patient's past medical history included Atrial fibrillation and Cardiac ablation on 03-Jun-2021. Concomitant products included APIXABAN (ELIQUIS), LOSARTAN, LEVOTHYROXINE, LOVASTATIN, CHLORTALIDONE (CHLORTHALIDONE) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial Fibrillation Episode) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 01-Jun-2021 to 04-Jun-2021 due to ATRIAL FIBRILLATION. The patient was treated with METOPROLOL ongoing since an unknown date for Atrial fibrillation, at an unspecified dose and frequency. At the time of the report, ATRIAL FIBRILLATION (Atrial Fibrillation Episode) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product included Balance of Nature Supplement. 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.

much more frequent AFib episodes than prior to vaccine, frequent racing heart, heaviness in the chest, feeling of a lump in the throat

Stroke; numbness in left hand; Headache; Ataxia left arm,; Motor skill issues/steadiness, unbalance; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042C20A and 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder. Concomitant products included LEVOTHYROXINE for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), ATAXIA (Ataxia left arm,), BALANCE DISORDER (Motor skill issues/steadiness, unbalance) and HEADACHE (Headache). On an unknown date, the patient experienced HYPOAESTHESIA (numbness in left hand). The patient was hospitalized from 25-Jan-2021 to 26-Jan-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) had resolved, ATAXIA (Ataxia left arm,) and HYPOAESTHESIA (numbness in left hand) had not resolved and BALANCE DISORDER (Motor skill issues/steadiness, unbalance) and HEADACHE (Headache) 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. It was reported that on an unspecified start date the patient is currently in OT. Treatment information not 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. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received by safety 10-Jun-2021 included an ADR added. Reporter address is updated. Patient height, weight, race and ethnicity is captured. Information of first and second vaccination updated. Event information was updated. new events, stroke and ataxia in left arm added and the events led the patient to visit ER.; 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.

Sore arm; Dry cough; Mind fog; Feeling weak; Tired; Low grade fever; Headache; Lung infection; Covid-19 positive; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Lung infection) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Smoker. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In May 2021, the patient experienced PNEUMONIA (Lung infection) (seriousness criterion medically significant) and COVID-19 (Covid-19 positive). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm), COUGH (Dry cough), FEELING ABNORMAL (Mind fog), ASTHENIA (Feeling weak), FATIGUE (Tired), PYREXIA (Low grade fever) and HEADACHE (Headache). On 01-Jun-2021, COVID-19 (Covid-19 positive) had resolved. At the time of the report, PNEUMONIA (Lung infection), PAIN IN EXTREMITY (Sore arm), COUGH (Dry cough), FEELING ABNORMAL (Mind fog), ASTHENIA (Feeling weak), FATIGUE (Tired), PYREXIA (Low grade fever) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, SARS-CoV-2 test: positive (Positive) positive. On 01-Jun-2021, SARS-CoV-2 test: negative (Negative) negative. No concomitant medication reported. The patient experienced a sore arm and feeling weak and tired. The patient experienced low grade fever, dry cough, mind fog, and headaches for 2-3 days. The patient developed a lung infection and had to be placed on antibiotics. 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. Headache fatigue and pyrexia are consistent with the product known safety profile. Based on biological implausibility, Covid-19 and pneumonia are assessed as not related to product use; 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. Headache fatigue and pyrexia are consistent with the product known safety profile. Based on biological implausibility, Covid-19 and pneumonia are assessed as not related to product use

The pharmacist was contacted by patients daughter on 6/23/2021. She said that patient was found deceased on the morning of 6/20/2021. They believe he passed away sometime on 6/19/2021.

INITIALLY HAD RASHES AND BUMPS ON BOTH HT AARMS AND LES. ON 5/29. 2021 SUFFERED HEART ATTACK. ANGIO SHOWED CLOTS IN CORONARY ARTERIES

Sudden cardiac death; Acute kidney injury; Atrial fibrillation; Cardiac arrest; Cardio-respiratory arrest; Cardiomegaly; Chest pain; Chronic left ventricular failure; Condition aggravated; Decreased appetite; Dehydration; Diastolic dysfunction; Dyspnoea; Fall; Fatigue; Feeding disorder; Fluid intake reduced; Hypokalaemia; Hypotension; Hypovolaemia; Malaise; Palpitations; Renal impairment; Renal tubular necrosis; Sleep apnoea syndrome; Tachycardia; This case was received via DA VAERS (Reference number: 1391483) on 22-Jun-2021 and was forwarded to Moderna on 22-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of SUDDEN CARDIAC DEATH (Sudden cardiac death), ACUTE KIDNEY INJURY (Acute kidney injury), ATRIAL FIBRILLATION (Atrial fibrillation), CARDIAC ARREST (Cardiac arrest), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), CARDIOMEGALY (Cardiomegaly), CHEST PAIN (Chest pain), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure), CONDITION AGGRAVATED (Condition aggravated), DECREASED APPETITE (Decreased appetite), DEHYDRATION (Dehydration), DIASTOLIC DYSFUNCTION (Diastolic dysfunction), DYSPNOEA (Dyspnoea), FALL (Fall), FATIGUE (Fatigue), FEEDING DISORDER (Feeding disorder), FLUID INTAKE REDUCED (Fluid intake reduced), HYPOKALAEMIA (Hypokalaemia), HYPOTENSION (Hypotension), HYPOVOLAEMIA (Hypovolaemia), MALAISE (Malaise), PALPITATIONS (Palpitations), RENAL IMPAIRMENT (Renal impairment), RENAL TUBULAR NECROSIS (Renal tubular necrosis), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) and TACHYCARDIA (Tachycardia) in a 66-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 Coronary artery disease, Congestive heart failure, Hypertension, Atrial fibrillation (Chronic Afib), Pulmonary hypertension, Cholecystectomy, Hernia repair, Tonsillectomy and Anticoagulant therapy on 02-Apr-2021. Concomitant products included CHLORTHALIDONE, LOSARTAN POTASSIUM (LOSARTAN POTASSIUM ACCORD), MELOXICAM and METOPROLOL SUCCINATE for an unknown indication. On 01-Apr-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 02-Apr-2021, the patient experienced ACUTE KIDNEY INJURY (Acute kidney injury) (seriousness criteria hospitalization, medically significant and life threatening), ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization, medically significant and life threatening), CARDIAC ARREST (Cardiac arrest) (seriousness criteria hospitalization, medically significant and life threatening), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest) (seriousness criteria hospitalization, medically significant and life threatening), CARDIOMEGALY (Cardiomegaly) (seriousness criteria hospitalization and life threatening), CHEST PAIN (Chest pain) (seriousness criteria hospitalization and life threatening), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure) (seriousness criteria hospitalization and life threatening), CONDITION AGGRAVATED (Condition aggravated) (seriousness criteria hospitalization and life threatening), DECREASED APPETITE (Decreased appetite) (seriousness criteria hospitalization and life threatening), DEHYDRATION (Dehydration) (seriousness criteria hospitalization and life threatening), DIASTOLIC DYSFUNCTION (Diastolic dysfunction) (seriousness criteria hospitalization and life threatening), DYSPNOEA (Dyspnoea) (seriousness criteria hospitalization and life threatening), FALL (Fall) (seriousness criteria hospitalization and life threatening), FATIGUE (Fatigue) (seriousness criteria hospitalization and life threatening), FEEDING DISORDER (Feeding disorder) (seriousness criteria hospitalization and life threatening), FLUID INTAKE REDUCED (Fluid intake reduced) (seriousness criteria hospitalization and life threatening), HYPOKALAEMIA (Hypokalaemia) (seriousness criteria hospitalization, medically significant and life threatening), HYPOTENSION (Hypotension) (seriousness criteria hospitalization and life threatening), HYPOVOLAEMIA (Hypovolaemia) (seriousness criteria hospitalization and life threatening), MALAISE (Malaise) (seriousness criteria hospitalization and life threatening), PALPITATIONS (Palpitations) (seriousness criteria hospitalization and life threatening), RENAL IMPAIRMENT (Renal impairment) (seriousness criteria hospitalization, medically significant and life threatening), RENAL TUBULAR NECROSIS (Renal tubular necrosis) (seriousness criteria hospitalization, medically significant and life threatening), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) (seriousness criteria hospitalization and life threatening) and TACHYCARDIA (Tachycardia) (seriousness criteria hospitalization and life threatening). The patient died on 10-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, ACUTE KIDNEY INJURY (Acute kidney injury), ATRIAL FIBRILLATION (Atrial fibrillation), CARDIAC ARREST (Cardiac arrest), CARDIO-RESPIRATORY ARREST (Cardio-respiratory arrest), CARDIOMEGALY (Cardiomegaly), CHEST PAIN (Chest pain), CHRONIC LEFT VENTRICULAR FAILURE (Chronic left ventricular failure), CONDITION AGGRAVATED (Condition aggravated), DECREASED APPETITE (Decreased appetite), DEHYDRATION (Dehydration), DIASTOLIC DYSFUNCTION (Diastolic dysfunction), DYSPNOEA (Dyspnoea), FALL (Fall), FATIGUE (Fatigue), FEEDING DISORDER (Feeding disorder), FLUID INTAKE REDUCED (Fluid intake reduced), HYPOKALAEMIA (Hypokalaemia), HYPOTENSION (Hypotension), HYPOVOLAEMIA (Hypovolaemia), MALAISE (Malaise), PALPITATIONS (Palpitations), RENAL IMPAIRMENT (Renal impairment), RENAL TUBULAR NECROSIS (Renal tubular necrosis), SLEEP APNOEA SYNDROME (Sleep apnoea syndrome) and TACHYCARDIA (Tachycardia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Apr-2021, Blood creatinine: increased (Inconclusive) increased. On 02-Apr-2021, Chest X-ray: abnormal (abnormal) CXR showed enlarged cardiac silhouette.. On 02-Apr-2021, Echocardiogram: normal (normal) normal. On 02-Apr-2021, Ejection fraction: normal (normal) 55-60% with Grade 1 diastolic dysfunction. On 02-Apr-2021, Electrocardiogram: abnormal (abnormal) atrial fibrillation. On 02-Apr-2021, Myocardial necrosis marker: normal (Negative) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Advanced Cardiovascular Life Support (ACLS) was performed and despite maximal effort, the patient subsequently expired at 0737. Company Comment : This is a case of death in a 66-year-old male patient with medical history of Coronary artery disease, Congestive heart failure, Hypertension, Chronic Atrial fibrillation and Pulmonary hypertension, that occurred 10 days after receiving second dose of vaccine (Lot number unknown). The patient experienced sudden cardiac death during hospitalization for worsening dyspnea in the past weeks prior to hospitalization. No further information is expected.; Sender's Comments: This is a case of death in a 66-year-old male patient with medical history of Coronary artery disease, Congestive heart failure, Hypertension, Chronic Atrial fibrillation and Pulmonary hypertension, that occurred 10 days after receiving second dose of vaccine (Lot number unknown). The patient experienced sudden cardiac death during hospitalization for worsening dyspnea in the past weeks prior to hospitalization. No further information is expected.; Reported Cause(s) of Death: unknown cause of death

Pt was healthy prior. Approx 4-6 weeks after the 2nd vaccine injection the pt was noted to have joint stiffness in the R shoulder which then progressed to knuckles, wrists, and legs with weakness at his artificial knees. Stiffness was initially worse in the am and was without relief with NSAIDS. Pt had trouble with ambulation and getting up and down from chairs/sitting. He became significantly debilitated and f/u with MD ensued. Steroid dose pack helped but after several days post completion the s/s returned. C-RP & ESR were elevated but all other RA and autoimmune markers were neg on his labs. Repeat f/u with MD a Ketorolac Injection was given that didn't touch the s/s. As the s/s continued the pt was then put on Celebrex 200mg bid and instructed to f/u with Rheumatology. The pt gets relief with the Celebrex bid but if the dose is decreased to 200mg x 1 q day > the pt has immediate return of s/s. Repeat C-RP and ESR were again elevated on the second set of labs also. We are in the process of follow up with Rheumatology who after first visit said he didn't know what was wrong with him. We are pending additional labs and xrays this week. The pt has always been very active and healthy with no medical problems other then slight hypertension. His body has gone into a systemic inflammatory response acutely for no reason.

On 1/9/2021, my son noticed I had symptoms of bells palsy. I had droopy lips and left eye lid was also droopy. He rushed me to the ER. At the ER, they did CT scan and found I had a stroke. They took me to the OR and tried to do a thrombectomy. They were unsucessful to do a full thrombectomy . They were able to do a partial thrombectomy. I was kept in ICU for 1 week. My left side was paralyzed at that time. After a week, I was discharged to a rehab hospital Sheltering Arms and I was there for 2 months. I received physical therapy and occupational therapy. I was prescribed a holster monitor and started a new medication called Plavix. I am also to continue taking my previous medications prior to the vaccine. Currently, my left hand is fully paralyzed and my left leg is partially paralyzed.

Irregular heartbeat noticed approximately 36 hours after first Covid19 Moderna vaccination. Symptoms continued periodically to, and through, the date of the 2nd Covid 19 vaccination. Subsequently confirmed via EKG and 2-week heart event monitor to be AFIB. Echocardiogram shows Tricuspid Valve Regurgitation and dilated right atrium. AFIB episodes are paroxysismal and typically last 8-10 hours each. No previous symptoms or problems prior to the two Covid 19 vaccination doses.

Heart Failure; troubled breathing; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart Failure) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COPD since an unknown date and Arteriosclerosis since an unknown date. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced DYSPNOEA (troubled breathing). On an unknown date, the patient experienced CARDIAC FAILURE (Heart Failure) (seriousness criteria death and medically significant). The patient died on 29-May-2021. The reported cause of death was Chronic obstructive pulmonary disease, Heart failure and Atherosclerosis. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (troubled breathing) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. No concomitant product information was provided. No treatment information was provided. This is a 66-year-old male patient who experienced CARDIAC FAILURE and died 30 days after receiving mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown). Patient had a concurrent CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and ARTERIOSCLEROSIS. It is unlikely, that the events are related to the vaccine based on long standing illness of COPD and Arteriosclerosis. Very limited information has been reported at this time. Further information is expected.; Sender's Comments: This is a 66-year-old male patient who experienced CARDIAC FAILURE and died 30 days after receiving mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. unknown). Patient had a concurrent CHRONIC OBSTRUCTIVE PULMONARY DISEASE, and ARTERIOSCLEROSIS. It is unlikely, that the events are related to the vaccine based on long standing illness of COPD and Arteriosclerosis. Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: Chronic Obstructive Pulmonary Disease; Heart Failure; Atherosclerosis

Anaphylactic reaction, Severe edema and raised red rash entire body, Severe itching ,Soft tissue edema of throat. Swelling of, eyes, lips, face. Multiple trips to ER, treated with steroids, Benadryl, prevacid. , CURRENTLY IN ICU ON EPINEPHRINE DRIP, STEROIDS, MULTIPLE MEDS

Large, bilateral, unprovoked pulmonary emboli 3 days after a Moderna first dose vaccine in a patient with no risk factors for DVT or PE and no history of any sort of pro-thrombotic disorder. He is in the hospital and work up is in progress, and so we might find another reason for his PE, but as of now we have no other explanation.

Pt presented to ER via EMS at 1556 3 days after receiving vaccine. pt was breathing approximately 50 times a minutes and o2 sats in the 70's upon arrival. NP decided to intubate, Rocuronium and Versed given. Pt became bradycardic and 1 amp of Atropine was given without improvement. No pulse felt, CPR started per ACLS protocol. 7 Epi's given. Time of death- 1632. After TOD pt was swabbed for COVID-19 and the results were positive.

The patient developed an acute right posterior frontal stroke with weakness, dysarthria and hemineglect at 1015pm on 1/26. He had received the Moderna vaccine second dose on 1/25. He received tPA and is now in the ICU for monitoring. Also found to have atrial fibrillation on EKG which seems to be a new finding.

The patient had an acute myocardial infarction of the anterolateral wall of the heart. He was brought to the emergency room . He arrived at the hospital at 1605, was stabilized and transferred at 1705 to a different hospital.

Pt admitted from home with intermittent nausea, dry heaving, and central chest pressure which self resolve in 2 minutes since 2/6/21. Called 911 on 2/12/21 due to sustained episode that did not resolve. EMS treated with aspirin and nitroglycerin prior to arrival to ED. In ED patient became unresponsive and went into full cardiac arrest -CPR and ACLS care initiated. STEMI with AV conduction block. 2nd degree a-v block type II - significant bradycardia - temoprary pacemaker placed - Vfib -PEA. Time of death 0955 on 2/12/21 Patient recieved first dose of Moderna Covid vaccine on 2/4/21

patient had vaccine injected at village health facility experienced ataxic gait for several weeks brought to office by family initial impression cva seen at ER, admitted had myocardial infarction next day treated immediately with balloon and and stent placement of affected artery RCA underwent bypass coronary becuase of more severe disease that could not be treated by cardiologist

About3 days after the second vaccination on Feb 4th, I started feeling unwell. I had respiratory issues. I went to the doctor on Feb 15th 2021 and she diagnosed me with pneumonia after taking an x ray of my lungs. She prescribed a course of Azithromycin anti biotics that cleared the pneumonia but I am still suffering from ongoing breathing issues

The day after my second dose ( February 18th) I felt sore at injection site and slight headache/neck ache and fatigue. next day (February 20th) I noticed a tightness in chest and started checking pulse and ECG on my apple watch. Results came back as showing signs of AFib. Never saw this before. I have checked the ECG app on the watch on and off since getting it in December. Every time before the second dose of the Moderna vaccine the results came back as normal Sinus rhythm. Since February 18th my ECG on the apple watch has indicated Afib, going on 11 days now.

Patient received Moderna COVID-19 vaccine on 2/25/2021. Patient found dead by family the morning of 2/26/2021. Family requested an autopsy.

6 days after first dose, went for checkup with (cardiolist). Afib was acting up for the first time in seven years. Dr. increased his carvedilol. After the second dose of covid, we checked his pulse rate and it was 34 beats per minute. Irregular heart pattern was occurring. Went to NP, who told him to go back to original dosage. Still reading in the thirties, so called (Internal Medicine doctor) He told him to get off medicine. It took 10 days to get to 70 beats per minute with no afib. Still not taking the carvedilol.

Narrative: 67 year-old male received his 1st COVID vaccine dose at a clinic on 2/25/21 at ~ 11:45am. No known prior COVID infection. No history of vaccine allergies or allergies to any component of the COVID vaccine. Does have history of allergic reactions including hives, angioedema or anaphylaxis to some medications (neomycin, Neosporin, bacitracin) and environmental allergens (yellow jackets, fir trees). Patient reported previously daily use of diphenhydramine (2 caps every morning) and kept an epi-pen on hand. The afternoon of 2/26/21, patient presented to his neighbor's house requesting assistance with an epi-pen. Neighbor reported significant swelling around tongue and lips, and ability to faintly speak. Neighbor administered epi-pen, but unsure if it worked, so administered a 2nd epi-pen. Within a minute or two after the 2nd dose, patient slumped over and became non-responsive. EMS was called and neighbor began CPR. EMS reported that patient was non-responsive upon arrival. A King airway was placed and a Lucas device used for chest compressions. Three rounds of epinephrine were administered during transport to the local emergency room. Patient remained unresponsive with evidence of PEA during transport. Arrival at the ER occurred ~ 4:25pm. On arrival patient noted to be unresponsive with CPR in progress. Dose of epinephrine administered ~ 3 minutes after arrival in ER. No femoral pulse palpable, cardiac monitor did show some electrical activity. Evaluation of oral cavity showed significant swelling of tongue. Additional dose of epinephrine given. Patient remained with no palpable central pulse and showed continued evidence of PEA. Patient was estimated to have been down > 45 minutes. Patient pronounced deceased at 4:59pm.

Onset of leg pain began four days after vaccination (vaccination on 2/27 onset of leg pain 3/3). DVT behind left knee confirmed with ultrasound on 3/8 and started on apixiban 3/9. No history of clots and no activities that would contribute to an elevated risk: no family history, no recent injuries or surgeries, not sedentary, nonsmoker, and drink only in moderation.

Injection to shoulder went in vein rather than muscle; bleeding. A week later left ankle swelling, turned worse, calf starting cramping and swelling. On next Monday went to Hospital for ultrasound. Diagnosis: 2-foot long blood clot, DVT. CT Venogram taken February 11 no cause found. Went to hematologist did full blood panels. No cause found. Diagnosis: only alternative cause: COVID-19 vaccine.

Two hours after receiving the vaccine on 3/4/21, he started feeling very tired and had a 100.2 temp. By evening he was feeling very cold and not eating much. On 3/5/21 he was sleeping alot, had headache, chills and fever, no appetite, diaphoretic. At 8pm he could not get up out of his chair and was disoriented. Wife call an ambulance. He was admitted for altered mental status. Blood cultures showed streptococcus pneumoniae. He was hypoxic at 89%. BP 171/96, pulse 85, temp 37.3C. Chest xray showed bilteral infiltrates and a masslike density in the right lung apex. Encephalopathy, pneumonia and sepsis diagnosed. Ct of head normal.WBC count 19 and amonia 24. Wife told me he had a spinal tap on 3/9/21 and that it showed bacterial meningitis. I do not have the lab reports on that yet. THe infection control doctor told wife he is critical.

Developed Idiopathic thrombocytopenic (ITP), admitted to the hospital with platelet count of 6, hospitalized for 8 days. Receiveds teriods, Ivig treatment and rituxan infusion.

The patient became ill two days after the vaccination, and was hospitalized. He was diagnosed with COVID pneumonia on the 15th, and subsequently died.

Information here obtained from daughter: on Thursday patient had an uneventful fistulagram with angioplasty. Patient got vaccine at end of usual Friday am dialysis treatment. He was observed for about 30" and no untoward event noted, vitals usual. At home on Saturday morning, seemed not quite himself by wife as reported by daughter, from whom i got his information. He gets up late as hemodialysis starts at 515 am. No reported problems on Friday. On Saturday morning, he seemed not himself but sat down and ate breakfast around 9 am. On getting up from table he got suddenly weak, his head rolled back and his eyes rolled up. 911 called and he was given resuscitation efforts of unknown duration which were unsuccessful. He was pronounced dead at 11 am and the mortuary was called. No premortem labs, et al.

you got second Moderna vaccine on March 10, Wednesday. Saturday night began with left leg swelling and pain. Thought it was a side effect of the vaccine. Tuesday, march 16 the pain got so bad he went to ER. Has bleed clots in main artery in leg femoral artery. Pt. was transferred to larger hospital.

I suffered a heart attack on March 11, 2021, at approx 145pm, while sitting at my desk - WFH. My symptoms were sweats, nausea, followed by chest pains beginning on the left side of my chest; sweats and nausea subsided for approx 1 hr, returning again, followed by chest pains radiating the across the full chest approx. I left my desk at the onset to wash my face, returning to my desk to talk a scheduled phone call at 2pm, lasting until 3pm. I left desk to walk outside to take in some fresh air, my wife ask me if I was ok, I said no. She ask if I was having a heart attack, to which I replied, I don't know. shortly there after we left for the ER at arriving approx 4pm. At that point ER staff did a quick assessment, taking my to an ER patient room where i was advised by the attending Dr that they thought I was having a heart attack. Shortly thereafter I was taking to the Cath lab where a stent was insert and then taken to ICU. Where I remained until I was released on 3/12/2021 at 3pm. There was no detectable heart damage and I was placed a regime of blood thinner, a beta blocker and cholesterol med. I do not have high blood pressure, high cholesterol or history of heart problems. My last physical was Feb 2021.

Garbled Speech lasting 20 seconds/Disassociation/Dizziness; Believed to be TIA;Every possible test was administered to determine source; ALL TESTS RETURNED NORMAL RESULTS; Dizziness/Disassociation/Balance Issue persists on and off; TREATMENT RECOMMENDED: One 325 mg aspirin daily

Around 11:35 PM on Thursday March 12, my father dropped his dish and drinking glass. Awokened by the noise, we rushed to him and noticed that his speech was slurred and he was not walking well. His SpO2 was 94 and his heart rate was in the 140's. His blood pressue was elevated. He has suffered a stroke in November 2020 and he was acting like he did on that day. Once he sat down, he could not get himself up. The paramedics and my brother had to help him into the ambulance where they administered oxygen. The paramedics took him to the hospital, where he was admitted to the ICU. An MRI did not reveal any damage to the brain. He was diagnosed with a TIA and discharged from the hospital on Sunday, March 14. I am not sure if the vaccine had anything to do with this episode, but I thought it should be reported just in case.

Jan 27th Began to run fever from the shot Jan 28th Continued to experience fever, uncontrollable chills, upset stomach, diarrhea through the day around 6PM I began to sweat, my stomach became upset again, diarrhea grew worse. Chest pain began and call to 911 was placed. Taken to hospital by flight

Systemic: Death. Unknow cause as of reporting date. -Severe, Additional Details: PT caregiver called to report that the Pt passed away on 3/8/21 2 days post vaccince, Caregiver was distrot and not very able to provided more details due to reccent nature of report.

Treated for Pneumonia, has not yet fully recovered. Patient also has low back pain, very lethargic, collapsed while walking, legs painful, tingling in hands and feet, incontinence, headache, unsteady while walking and standing

No immediate adverse reaction. No fever. Day 2 post vaccination fatigue, blurred vision, confusion, weakness, lethargy, inability to concentrate, loss of balance, anxiety feeling weird. Symptoms would come- had to lay down-last ~2 hours-feel okay. Again, same symptoms would start; 4-5 times a day every day. By day 7 post vaccination symptoms were severe; activities of daily living severely compromised. Blood pressure elevated 180's/100's (no history of hypertension). Emergency room visit was unremarkable. Next morning, 03/15/2021, EMS called to home. Blood pressure 217/112 finger stick 178 (no history diabetes). Transported to ER. B/P remained elevated. Cardiac negative. Head CT negative. Medications given in ER: Labatelol 10mg IV. Monitored and released to home. Diagnosis: Hypertensive Encephalapathy with TIA's. New onset hypertension. Meds: Lisinopril 10 mg daily. Seen by primary care on 03/17/2021. Elevated blood pressure continued 150/100's.

Participant felt flushed, feverish, fatigued with general aches and dry cough over the weekend after receiving injection, took acetaminophen and cough syrup on Monday. He became short of breath on 1/20/2021 and was hypoxic on oximeter check, was sent to the ER. He was intubated in ER and went into respiratory failure with sepsis due to COVID19. He was treated with tocilzumab, became paralyzed and DVT in left lower extremity was found. HE required pressors and diuresis, he developed AKI and hyperkalemia. On 2/21 he was in multi-organ failure. His level of cognition decreased until he was no longer responsive and he died on 2/24/2021.

Patients representative notified pharmacy today to cancel patients second appointment as the patient had died this morning due to a staff infection in hospital. Representative did state they did not believe it was related to vaccination as patient has been having difficult time with underlying conditions (pulmonary fibrosis and atrial fibrillation).

Mild aphasia effecting speech. Went into the ER and was hospitalized. MRI and ultrasound confirmed stroke.

Per family patient reported c/o nausea and vomiting at home post treatment on 3/30/2021, he went to bed and was found unresponsive on 3/31, EMS was contacted and pronounced deceased at home on 3/31/2021. (exact time unknown).

Patient passed away; Heavy breathing; Shortness of breath; Low temperature; Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (Patient passed away) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046AZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication. On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Mar-2021, the patient experienced BODY TEMPERATURE DECREASED (low temperature) and FATIGUE (tired). On 20-Mar-2021, the patient experienced DEATH (Patient passed away) (seriousness criterion death), DYSPNOEA (heavy breathing) and DYSPNOEA (shortness of breath). The patient died on 20-Mar-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (heavy breathing), DYSPNOEA (shortness of breath), BODY TEMPERATURE DECREASED (low temperature) and FATIGUE (tired) outcome was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. The fatal outcome may be related to the patient's pre-existing comorbidities. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death

Pulmonary embolism, multiple, with no known cause, with symptom onset within 48 hrs of second Moderna vaccine administration. PE documented on chest CT 4/5/21

67 y.o. male with past medical history of asthma, prostate cancer, GERD, hyperlipidemia, hypertension who was admitted with chest tightness and sob was found to have b/l PE after moderna vaccine for COVID (3/26) second dose otherwise nothing different in his life and PE could have been caused by COVID 19 vaccine.

It was reported by the Sheriff's Dept. that patient was found expired on 4/13/21 - sitter reported that patient went to take a nap and the sitter went to check on him and found him unresponsive and called 911; patient was DOA on arrival

67-year-old male with PMH of asthma history of prostate cancer, GERD, hypertension, hyperlipidemia presents on 4/2/21 from doctor's office for evaluation of shortness of breath with exertion over the prior 3 days associated with some chest pain. He received COVID vaccine on 03/26 with Moderna vaccine (second dose) and was doing well until 3 days PTA. In the doctor's office patient had an EKG that was read as atrial flutter and doctor sent patient to the ED for rule out PE and evaluation of chest pain and shortness of breath. CTA chest showed numerous bilateral pulmonary emboli and evidence of right heart strain. Of note, his father had history of pulmonary embolism as well as rectal cancer. Patient was evaluated by pulmonologist and cardiologist and was started on full-dose anticoagulation for PE treatment. Patient did not report anything different in his life that may have contributed to development of PE (besides COVID vaccine). He denies any prior cardiac history and indicated maintaining an active lifestyle. Patient had symptomatic improvement and was discharged on full-dose rivaroxaban.

3 days after 2nd Moderna vaccine developed fevers, chest pain, shortness of breath. Now found to have probable constrictive pericarditis without clear etiology.

THREE DAYS AFTER GETTING HIS 2ND DOSE OF MODERNA THE PATIENT DEVELOPED SOB AND WAS FOUND TOP HAVE BILATERAL PULMONARY EMBOLISM AND DVT

The patient called to make us aware that he was diagnosed with a blood clot on Saturday and he wasn't sure if there was a connection or not but wanted us to report it.

stroke; Couldn't keep his balance; severe dizziness,; nausea; he kept throwing up constantly and couldn't keep his balance.; temperature of 101°F; fatigue; severe headache on one side of is head; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cholesterol. Concomitant products included NYSTATIN (STATIN [NYSTATIN]) for Cholesterol, FINASTERIDE for an unknown indication. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (temperature of 101°F), FATIGUE (fatigue) and HEADACHE (severe headache on one side of is head). On 01-Apr-2021, the patient experienced GAIT DISTURBANCE (Couldn't keep his balance), DIZZINESS (severe dizziness,) and NAUSEA (nausea). On 03-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced VOMITING (he kept throwing up constantly and couldn't keep his balance.). The patient was hospitalized on 03-Apr-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), GAIT DISTURBANCE (Couldn't keep his balance), DIZZINESS (severe dizziness,), PYREXIA (temperature of 101°F), FATIGUE (fatigue), HEADACHE (severe headache on one side of is head), NAUSEA (nausea) and VOMITING (he kept throwing up constantly and couldn't keep his balance.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) degrees Farenheit. On an unknown date, Computerised tomogram: cva (Inconclusive) Narrowed artery in cerebellum. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. On 03-Apr-2021 patient went to urgent care facility and was transferred to a hospital. Upon discharge he was given a prescription for 40mg of a statin.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

DEATH! About 24 hours after getting his 2nd Moderna Covid-19 shot, patient got deathly ill with explosive vomiting and diarrhea. Not long later he was passing out. Paramedics were called, and he was taken to the hospital where he passed away from a massive heart attack. The doctors gave him clot-busting drugs in an attempt to save him. He has never had problems with blood clots in his life. He was the healthiest one of us all, and was almost never sick. The doctor said that it was probably no coincidence that he died so soon after receiving his Covid shot. I am convinced that they are connected. A healthy man suddenly gets blood clots in his heart 24 hours after getting his shot? Not a coincidence!!!!!!!!!!!!!!1

SHORTNESS OF BREATH; multiple pulmonary embolism; NAUSEA; MIGRAINE; low grade fever / 100 degree Fahrenheit; MYALGIA; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021. This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (multiple pulmonary embolism) and DYSPNOEA (SHORTNESS OF BREATH) in a 67-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 Drug allergy (allergy to Nonsteroidal anti-inflammatory drug and Salsalate.Fluconazole) since an unknown date, Hives since an unknown date, Rash (patient develops rash with Zipro.) since an unknown date, Hypertension since an unknown date, Hypercholesterolemia since an unknown date, Prostate cancer since an unknown date and Chronic back pain since an unknown date. On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced PULMONARY EMBOLISM (multiple pulmonary embolism) (seriousness criteria hospitalization and medically significant). On 27-Mar-2021, the patient experienced PYREXIA (low grade fever / 100 degree Fahrenheit ) and MYALGIA (MYALGIA). On 28-Mar-2021, the patient experienced MIGRAINE (MIGRAINE) and NAUSEA (NAUSEA). On 29-Mar-2021, the patient experienced DYSPNOEA (SHORTNESS OF BREATH) (seriousness criterion hospitalization). At the time of the report, PULMONARY EMBOLISM (multiple pulmonary embolism), DYSPNOEA (SHORTNESS OF BREATH), MIGRAINE (MIGRAINE), PYREXIA (low grade fever / 100 degree Fahrenheit ), MYALGIA (MYALGIA) and NAUSEA (NAUSEA) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: for pulmonary embolism in lungs. On an unknown date, Ultrasound Doppler: Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Treatment included were Sumatriptan, Prednisone and home nebulize albuterol. Action taken with mRNA-1273 in response to the event was not applicable. There was complete workup done and he was diagnosed with pulmonary embolism with CAT scan with dye, multiple pulmonary embolism in the lungs, Ultrasound in legs which was negative. He reports that his D-dimer were very high. In conclusion his imaging and D-dimer pointed towards the pulmonary embolism diagnosis. Company comment: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-068247 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-068247:Same reporter/Different patient

pulmonary embolism; shortness of breath, shortness of breath was getting worse; Nausea; migraine; Myalgia; low grade fever; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (pulmonary embolism) and DYSPNOEA (shortness of breath, shortness of breath was getting worse) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047821A and 014M2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Prostate cancer and Proctectomy. Concurrent medical conditions included Asthma, Hypertension (Controlled), Hypercholesterolemia (Controlled), Failed back surgery syndrome, Chronic back pain, Drug allergy (NSAIDs), Drug allergy (Fluconazole (Fluticasone)) and Drug allergy (Zipro). Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine, DENOSUMAB (PROLIA), ALBUTEROL [SALBUTAMOL], ALPRAZOLAM (XANAX), CELECOXIB (CELEBREX), RIVAROXABAN (XARELTO), TADALAFIL (CIALIS), CEFIXIME (FLEXERIL [CEFIXIME]), MAGNESIUM, ZONISAMIDE (ZONEGRAN), OXYCODONE, EZETIMIBE (ZETIA), PRAVASTATIN, RAMIPRIL and CARVEDILOL for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced MIGRAINE (migraine), MYALGIA (Myalgia) and PYREXIA (low grade fever). On 28-Mar-2021, the patient experienced NAUSEA (Nausea). On 29-Mar-2021, the patient experienced DYSPNOEA (shortness of breath, shortness of breath was getting worse) (seriousness criterion hospitalization). On 02-Apr-2021, the patient experienced PULMONARY EMBOLISM (pulmonary embolism) (seriousness criteria hospitalization and medically significant). The patient was hospitalized from 02-Apr-2021 to 05-Apr-2021 due to DYSPNOEA and PULMONARY EMBOLISM. On 28-Mar-2021, PYREXIA (low grade fever) had resolved. At the time of the report, PULMONARY EMBOLISM (pulmonary embolism), DYSPNOEA (shortness of breath, shortness of breath was getting worse), MIGRAINE (migraine), MYALGIA (Myalgia) and NAUSEA (Nausea) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Physical examination: normal (normal) no findings. On 27-Mar-2021, Body temperature: 37.8 degree Celsius (High) Self Test. In April 2021, Computerised tomogram: abnormal (abnormal) pulmonary embolism with CAT scan with dye, multiple pulmonary embolism in the lungs.. In April 2021, Fibrin D dimer: high (High) High. In April 2021, Ultrasound scan: negative (Negative) Negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PULMONARY EMBOLISM (pulmonary embolism) and DYSPNOEA (shortness of breath, shortness of breath was getting worse) to be possibly related. No further causality assessments were provided for MIGRAINE (migraine), MYALGIA (Myalgia), PYREXIA (low grade fever) and NAUSEA (Nausea). Treatment medications included sumatriptan (for migraine), and prednisone and home nebulize albuterol (for asthma exacerbation). Company Comment: Very limited information regarding these events has been provided at this time. Further information has been requested. 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 This case was linked to US-MODERNATX, INC.-MOD-2021-070707 (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 event, a causal relationship cannot be excluded US-MODERNATX, INC.-MOD-2021-070707:Same reporter/Different patient

Patient hospitalized Hospital Admission Diagnoses: Severe sepsis (CMS/HCC) [A41.9, R65.20] Discharge Diagnosis: Patient Active Problem List Diagnosis Date Noted *Elevated troponin 03/30/2021 *B12 deficiency 03/30/2021 *Acute systolic heart failure (CMS/HCC) 03/25/2021 Discharge Diagnoses: Patient Active Problem List Diagnosis Date Noted *Elevated troponin 03/30/2021 *B12 deficiency 03/30/2021 *Acute systolic heart failure (CMS/HCC) 03/25/2021 *Acute respiratory failure with hypoxia (CMS/HCC) 03/24/2021 *Acute pulmonary edema (CMS/HCC) 03/24/2021 *IVH (Intraventricular hemorrhage) (CMS/HCC) 06/06/2018 *Brain edema (CMS/HCC) 06/06/2018 *Brain compression (CMS/HCC) 06/06/2018 *Benign essential HTN *Coronary artery disease * Type 2 diabetes mellitus with hemoglobin A1c goal of less than 7.0% (CMS/HCC) *Nontraumatic right thalamic hemorrhage (HCC) 06/05/2018 Consults: IP CONSULT TO PULMONOLOGY IP CONSULT TO CARDIOLOGY INPATIENT CONSULT TO PHARMACY INPATIENT CONSULT TO PHARMACY IP CONSULT TO NUTRITION SERVICES IP CONSULT TO NUTRITION SERVICES Procedures: Intubation Catheterization Significant Diagnostic Studies: Cardiac Catheterization

I went into AFib and unabated get out of it. Was cardio converted on January 27, 2021. Received second vaccine on January 28, 2021. Went back into AFib on February 3rd. Remained in AFib until being converted again on March 5,2021

Received vaccine 04/08/2021. Was admitted to the hospital later in the day with cardiac arrest. Deceased 4/9/2021

I had a stroke; I now have weakness on my right leg; I now have weakness on my right arm; I now have weakness on my right face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (I had a stroke) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetes. On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (I had a stroke) (seriousness criteria hospitalization and medically significant). On 19-Apr-2021, the patient experienced MUSCULAR WEAKNESS (I now have weakness on my right leg), MUSCULAR WEAKNESS (I now have weakness on my right arm) and FACIAL PARESIS (I now have weakness on my right face). At the time of the report, CEREBROVASCULAR ACCIDENT (I had a stroke), MUSCULAR WEAKNESS (I now have weakness on my right leg), MUSCULAR WEAKNESS (I now have weakness on my right arm) and FACIAL PARESIS (I now have weakness on my right face) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerized tomogram: results are not mentioned (Inconclusive) Results are not mentioned. On an unknown date, Electrocardiogram: results are not mentioned (Inconclusive) Results are not mentioned. On an unknown date, Magnetic resonance imaging: 1 inch spot in brain (Inconclusive) Admits that the MRI showed that he had a 1 inch spot in his brain that was killed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. The patient was admitted, couldn't talk and started to drool. The patient was taken to the hospital by the paramedics. The patient's reports that he bites his lip every time he chewed. Patient was wearing a heart monitor for 30 days. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's past history of diabetes Miletus may remain as risk factor for this event.; 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 past history of diabetes Miletus may remain as risk factor for this event.

extremly high blood pressure; severe headache; DVT to right leg starting at the groin and going down to the foot; worsen edema with 4+and 5+ pitting edema in right leg; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 030A21A) 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.). Concomitant products included DUPILUMAB (DUPIXENT) from 09-Mar-2021 to 06-Apr-2021 and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot) (seriousness criterion medically significant) and OEDEMA PERIPHERAL (worsen edema with 4+and 5+ pitting edema in right leg). On an unknown date, the patient experienced HYPERTENSION (extremly high blood pressure) and HEADACHE (severe headache). At the time of the report, DEEP VEIN THROMBOSIS (DVT to right leg starting at the groin and going down to the foot), OEDEMA PERIPHERAL (worsen edema with 4+and 5+ pitting edema in right leg), HYPERTENSION (extremly high blood pressure) and HEADACHE (severe headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Apr-2021, Ultrasound Doppler abnormal: abnormal (abnormal) Causative extensive occlusive thrombus", DVT in the right leg starting from the groin going down to the foot. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient had an ultrasound of the leg performed. The diagnosis showed "causative extensive occlusive thrombus". Patient reported taking heparin and acetaminophen(Tylenol) ad treatment for the symptoms. This case was linked to (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. MOD-2021-079102:1st dose

I had a Coronary Artery Spasm which led to a Heart Attack. on 3/13/21 at 6:30 am at home. I was stabilized in the Ambulance with sublingual nitroglycerin. The Coronary artery was blocked. The Dr. did a Heart Catheterization which showed that the blockage had receded and no further procedure was performed. I spent 2 Days in Hospital having another heart spasm on 3/14/21 at 05:00 pm which was relieved by Nitroglycerin. I was released and experienced 8 more episodes over the next week. I have been prescribed Calcium channel blockers, blood thinner, and cholesterol drugs as treatment I have constant aching and 2 more episodes requiring Nitroglycerin last week. I do not have high blood pressure heart disease or coronary artery disease

ATRIAL FIBRILLATION on 04/05/2021. discovered on 4/15/2021 . started on Xarelto 20 mg at a cost of $488. gout dxed on4/16/2021 by dr behar. started on mitigare 0.6 mg bid.

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

Patient started to experience stroke like symptoms at 2pm after receiving his second dose of the Moderna Vaccine. He was rushed to the emergency room a 6pm. Diagnosed with stroke at 8pm. As of 4/27 patient is still at the Medical Center. He will be transferring to a Rehabilitation Center on 4/27/21 for stroke Rehabilitation.

Patient received the COVID-19 vaccine on Thursday, March 25, 2021. On Tuesday April 6, 2021 he had a massive stroke, blood clot to left side of his brain. On Friday morning April 9, 2021 doctor's advised he had another stroke due to bleeding in the brain (paralysis on right side and racing heart beat). He died on Saturday, April 10, 2021 @ 5:45 AM.

Patient developed shortness of breath on 4/6/2021 after getting the Moderna vaccine #2 on 3/26/2021. He saw me (his doctor) on 4/22/2021 for this and had positive D dimer and we did CT angiogram of chest showing pulmonary emboli. He was put on Eliquis and is now feeling better. He has never had DVT or PE in the past.

On 4/10/2021 pt developed headache, nausea and vomiting and eventually ataxia. Admitted to Swedish Medical Center 4/12/2021 diagnosed with dural venous sinus thrombosis with associated left parietal intracerebral hemorrhage. Did not have thrombocytopenia. No records of hospital staff checking PF4 antibodies. Patient was treated with catheter thrombectomy X 2 and anticoagulation. Discharged 4/20/2021 on dabigatran. All symptoms resolved and patient doing well. Plan for outpatient neurology follow-up.

Acute renal failure, admitted to the hospital on 4/6/21. Underlying source never identified, died on 4/9/21.

Patient became short winded a few days after receiving the vaccine. He came to my office and was found to be short of breath and testing was done he was found to have bilateral PEs at our local hospital.

Patient hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis: Atrial fibrillation with RVR

4/2/21 Vaccination #2 given, 4/3 fatigue, decreased appetite and energy, increased confusion. 4/6/21 PCP ordered CT angiogram of chest-no PE but suspicious infiltrates in upper lung for Covid-19 pneumonia. DVT negative. 4/7/21 Hospital ER CT of head/neck -no stenosis, no intercranial abnormalities, Covid test negative, RIDP positive for rhinovirus and entrovirus. Neuro consult, full admit. Treated with Rocephin, zithro and oxygen, eventually vented then transferred to another location on 4/11/21. Acutely ill and in shock, Extensive workup showed no other identifiable source of infection. Died 4/18/21.

Pulmonary Embolism requiring hospitalization, Heparin Drip for 2 days in hospital followed by Eloquis 5mg twice daily indefinitely, Survived

Bleeding, bruising Platelet Count dropped to 2 Immediate Platelet Transfusion Prednisone and Promacta Receiving Treatment for ITP Diagnosis

Pt was in the hospital treated for NSTEMI in the week after receiving Moderna COVID vaccine. Patient is now out of the hospital.

About 10 days after the vaccine, leg started hurting. After a week of pain, went to doctor and was diagnosed with a blood clot via ultrasound.

03/09/21(2:00PM):received dose 1 moderna vaccine - no ill effects; 04/07/21 (10:00AM): received dose 2 Moderna vaccine; 04/11/21 (11:00PM): experienced what seamed muscle cramp in left upper calf muscle; 04/19/21: cramp diminished, some swelling left upper calf, slight swelling left inner ankle; 04/22/21: swelling entire left ankle and top left foot; 04/22/21: visited primary care, diagnosed possible Baker's cyst or venous thrombosis - sent to hospital for ultrasound; 04/22/21: ultrasound revealed deep venous thrombosis, upper left calf vicinity (popliteal vein); 04/22/21: hospital performed blood tests, prescribed Xarelto 15mg (2 daily) for 21 days; 04/26/21: primary care follow up, prescribed Xarelto20mg (once daily) for 90 days. 05/22/21: slight swelling inner left ankle persists, slight fullness upper left calf persists, otherwise no other ill effects; 05/22/21: further blood tests pending (as per primary care physician): cbc with differential, pcrp, ante, esr, 83891, cmbp, tshr, ptp, leid, misc, acab, lupus; NOTE: Moderna dose 1: lot # 048A21A, intramuscular, left arm

This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (blood clot in each lung) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CALCIUM FRUCTOBORATE, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE, HYALURONIC ACID (MOVE FREE JOINT HEALTH) for Joint disorder NOS, MINERALS NOS, VITAMINS NOS (ONE A DAY [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 21-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced THROMBOSIS (blood clot in each lung) (seriousness criteria medically significant and life threatening). On 28-Feb-2021 at 6:00 PM, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, THROMBOSIS (blood clot in each lung) outcome was unknown and DYSPNOEA (shortness of breath) had resolved with sequelae. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Feb-2021, Computerised tomogram: blood clot (abnormal) Blood clot in both lung. On 21Jan2021, patient had received the first dose of Moderna Covid-19 vaccine and about 4-5 days later, he began to noticed that his breathing was labored. At the time of the report, the patient did not think much about the labored breathing since he was older in age and thought it was due to exercise. Patient received second dose of Moderna COVID-19 Vaccine on 18-Feb-2021 and he reported that his breathing became more laboring where he needed to stop walking to catch his breath. He had 2 scan which revealed that he have a blood clot at each lung and he was prescribed Xarelto 15 mg twice a day, then he will begin Xarelto 20mg once a day on 20-MAY-2021. Patient is on Kirkland C 500mg as a concomitant medication as well. Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Significant FU- outcome of the event.

After being stable for over a year, I went back into AFib the morning after my second dose. I went in and out for 9 days and then stayed back in a normal sinus rhythm since. I monitored my condition with my Kardia 6L and reported the events to my Electrophysiologist via my on-line chart. They monitored me closely but were pretty sure it would settle out, which it did. I would still take the vaccine again.

COVID-19, Pneumonia, Mucus discharge, Nauseous, COVID-19 recurrent; pneomonia; Mucus discharge; COVID-19 recurrent; nausea; headache; body ache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19, Pneumonia, Mucus discharge, Nauseous, COVID-19 recurrent) and PNEUMONIA (pneomonia) in a 67-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 IBRUTINIB (IMBRUVICA) capsule for Chronic lymphocytic leukemia. No Medical History information was reported. On 10-Apr-2019, the patient started IBRUTINIB (IMBRUVICA) (Oral) 140 mg twice a day. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jan-2021, the patient experienced COVID-19 (COVID-19, Pneumonia, Mucus discharge, Nauseous, COVID-19 recurrent) (seriousness criterion hospitalization) and PNEUMONIA (pneomonia) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced SECRETION DISCHARGE (Mucus discharge), COVID-19 (COVID-19 recurrent), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body ache). The patient was hospitalized from 08-Jan-2021 to 12-Jan-2021 due to COVID-19. On 13-Jan-2021, COVID-19 (COVID-19, Pneumonia, Mucus discharge, Nauseous, COVID-19 recurrent) and PNEUMONIA (pneomonia) was resolving. At the time of the report, SECRETION DISCHARGE (Mucus discharge), COVID-19 (COVID-19 recurrent), NAUSEA (nausea), HEADACHE (headache) and MYALGIA (body ache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: normal (normal) Had CT scan 2 weeks ago, which is clean and clear.. On an unknown date, Coronavirus test: positive (Positive) Covid-19 test positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medication information provided. Patient had COVID in January, was hospitalized for 5 days, lost his sense of smell and taste, which hasn't fully recovered, but is feeling better and still had fatigue. Patient had pneumonia with shortness of breath which is dissipating. Patient had taken Moderna covid vaccines, stated reactions with first time felt like he had covid again for a couple of days, and the second one gave him headaches and body aches for a day. Patient stated his doctor says he did build up immunity from vaccine, noted from test. The medication was held when had covid for a week or two. No relevant treatment medication information provided. Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273. Very limited information regarding these event (pneumonia and other events) has been provided at this time. However, it is not clear if COVID-19 and pneumonia occurred prior to 1st dose of mRNA-1273.; Sender's Comments: Based on the mechanism of action of mRNA-1273, the event (Covid-19) is assessed as unlikely related to mRNA-1273. Very limited information regarding these event (pneumonia and other events) has been provided at this time. However, it is not clear if COVID-19 and pneumonia occurred prior to 1st dose of mRNA-1273.

PATIENT REPORTED DIFFICULTY BREATHING UPON EXERTION AND CHEST PAIN STARTING AROUND 05/08/2021. PATIENT WENT TO MD ON 05/12/2021 WHERE MD FOUND EKG ABNORMAL. PATIENT PASSED AWAY THAT EVENING

eosinophilia, cardiac tamponade/ pericarditis. Pericardial fluid was eosinophilic. One month later, he developed patchy pulmonary infiltrates.but biopsy was not obtained and ANCA was negative.

AFIB; chest pain; he couldn't see the road; He's sluggish; chest discomfort; fogginess in head; he sleeps a lot; fogginess in head; Headache; chest discomfort; high blood pressure; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain) and ATRIAL FIBRILLATION (AFIB) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COPD. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (high blood pressure), the first episode of CHEST DISCOMFORT (chest discomfort), the first episode of FEELING ABNORMAL (fogginess in head) and HEADACHE (Headache). On 14-May-2021, the patient experienced ATRIAL FIBRILLATION (AFIB) (seriousness criteria hospitalization and medically significant) and SOMNOLENCE (he sleeps a lot). On 24-May-2021, the patient experienced the second episode of CHEST DISCOMFORT (chest discomfort) and the second episode of FEELING ABNORMAL (fogginess in head). On 25-May-2021, the patient experienced VISUAL IMPAIRMENT (he couldn't see the road) and SLUGGISHNESS (He's sluggish). The patient was hospitalized from 05-Apr-2021 to 06-Apr-2021 due to ATRIAL FIBRILLATION and CHEST PAIN. At the time of the report, CHEST PAIN (chest pain), ATRIAL FIBRILLATION (AFIB), BLOOD PRESSURE INCREASED (high blood pressure), VISUAL IMPAIRMENT (he couldn't see the road), SLUGGISHNESS (He's sluggish), SOMNOLENCE (he sleeps a lot), the last episode of CHEST DISCOMFORT (chest discomfort), the last episode of FEELING ABNORMAL (fogginess in head) and HEADACHE (Headache) outcome was unknown. Unknown On 03-Mar-2021, Blood pressure measurement result was unknown. On 09-Mar-2021, patient had head scan and coronary test and results were unknown. On 05-Apr-2021, patient had Electrocardiogram and X-ray tests and results were unknown. On 19-Apr-2021, lab work result was unknown. On 27-apr-2021 patient wore heart monitor for two days. On 28-Apr-2021, Angiogram result was unknown .On 25-May-2021, Electrocardiogram result was unknown. No concomitant medications were reported. No treatment information was provided. Patient was in the emeragncy two times and hospitalized one time. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow-up was received on 25-may-2021 contains new laboratory data and new event.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Admitted for syncopal episode on 5/14/21, found to have lung lesion with necrotizing granulomatous inflammation, deceased 5/20/21

stroke left bode a vegetation state nursing home; need to figure how we r going to pay for this; we dont have the kind of money for his care; long term;

03.22.2021 - AFib Episode 1; hospitalized at hospital - 03.22-25.2021 04.18.2021 - AFib Episode 2; hospitalized at hospital - 04.18-20.2021

Had 1st Moderna shot on 4/22/21 and the 2nd shot on 5/20/21 (I recorded for #4) and he ends up in hospital with a blood clot, went to ER on 6/6/21 and was diagnosed with a blood clot that is why I reported since it was so close to date of Vaccine on 5/20/21. He got sick on 6/3/21 chilling, getting hot, temperature, coughing-went to Urgent care did x-ray-said had pneumonia-6/6/21 had hurting in side, chest, breathing problems-took ER found a blood clot in his chest, no pneumonia. (not sure of time of vaccine)

Prior to getting my COVID19 vaccination, I was rarely (but occasionally) in A-Fib, most likely caused by my Mitral valve stenosis. After my 2nd Moderna vaccine, I went into A-Fib, and have not had a normal sinus rhythm recording since then (almost 3 months straight, every day). I have a ECG monitor, so can read my ECGs anytime, and was checking them 3-5 times per day for several weeks after my 2nd shot. I know the vaccination did not CAUSE my A-Fib, but since the vaccine seems to have some metabolic effects beyond just producing protective antibodies (helping folks with long-haul, etc.), I believe it may act as a catalyst which precipitated events leading to "pushing" me into A-Fib 24/7. I just thought you would want to know.

On 3/31/2021 went blind in left eye. Diagnosed with major blood clot in left eye. Has had injections into eye on 3/31, 5/12, 6/23. Scheduled for another 8/4/21.

Patient presented to the outside hospital on 6/27 due to having congestion and feeling much worse. Patient symptoms started on Friday (6/25) with congestion and cough. This was not able to be remedied by Mucinex. Patient then went to an urgent care clinic on Saturday and after listening to his lungs was sent to the emergency room. While in the emergency patient received a CT scan of his abdomen and pelvis which showed signs of liver cirrhosis and Covid. Patient then had a rapid Covid test that came back positive. They then obtained a confirmatory test but that is still pending. Patient then had agitation while he was in the hospital to the point where he almost struck a nurse. Patient's confusion got a little bit better but was found to have an elevated ammonia which was thought to be the cause of his delirium.

Patient found down at home unresponsive on the floor. EMS was summoned the patient was found to be in asystole. EMS was able to get a heartbeat. Pt intubated and transferred to hospital. Shortly admission to ICU patient began having severe myoclonic jerking and seizures. Patient was extubated and made no respiratory attempts. Patient expired

Blood clots in heart with extremely low blood pressure and shortness of breath. Symptoms suddenly appeared on 04/02/21. Hospitalization and rehabilitation Until discharge of 05/03/2021. Extremely low blood pressure, weakness and shortness of breath continued until he was hospitalized again 06/02/2021 He passed away 06/09/2021. He was labeled as Covid 19

Acute myocardial injury/ Myocarditis; MIS-A; Hypertensive; Worsening shortness of breath; Orthopnea; Fever; Chills; Nausea; Increasing fatigue; acute exacerbation of CHF; hypoxia; tachycardia; tachypnea; This literature-non-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Acute myocardial injury/ Myocarditis), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A), HYPERTENSION (Hypertensive), DYSPNOEA (Worsening shortness of breath), ORTHOPNOEA (Orthopnea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Increasing fatigue), CONDITION AGGRAVATED (acute exacerbation of CHF), HYPOXIA (hypoxia), TACHYCARDIA (tachycardia) and TACHYPNOEA (tachypnea) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Acute myocardial injury following COVID-19 vaccination: a case report and review of current evidence from vaccine adverse events reporting system database. The patient's past medical history included Stent placement and Coronary artery bypass graft. Concurrent medical conditions included Hypertension, Type 2 diabetes mellitus, Hyperlipidemia, Coronary artery disease, Congestive heart failure (with preserved ejection fraction), Chronic obstructive pulmonary disease (without any home oxygen requirement), Hypothyroidism and Gastroesophageal reflux disease. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN, CLOPIDOGREL, FUROSEMIDE, ISOSORBIDE MONONITRATE, LEVOTHYROXINE, LISINOPRIL, METFORMIN, METOPROLOL TARTRATE, POTASSIUM CHLORIDE, SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) and TIOTROPIUM for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Acute myocardial injury/ Myocarditis) (seriousness criteria hospitalization prolonged and medically significant), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A) (seriousness criteria hospitalization prolonged and medically significant), HYPERTENSION (Hypertensive) (seriousness criterion hospitalization prolonged), DYSPNOEA (Worsening shortness of breath) (seriousness criterion hospitalization prolonged), ORTHOPNOEA (Orthopnea) (seriousness criterion hospitalization prolonged), PYREXIA (Fever) (seriousness criterion hospitalization prolonged), CHILLS (Chills) (seriousness criterion hospitalization prolonged), NAUSEA (Nausea) (seriousness criterion hospitalization prolonged), FATIGUE (Increasing fatigue) (seriousness criterion hospitalization prolonged), CONDITION AGGRAVATED (acute exacerbation of CHF) (seriousness criterion hospitalization prolonged), HYPOXIA (hypoxia) (seriousness criteria hospitalization prolonged and medically significant), TACHYCARDIA (tachycardia) (seriousness criterion hospitalization prolonged) and TACHYPNOEA (tachypnea) (seriousness criterion hospitalization prolonged). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to CHILLS, CONDITION AGGRAVATED, DYSPNOEA, FATIGUE, HYPERTENSION, HYPOXIA, MYOCARDITIS, NAUSEA, ORTHOPNOEA, PYREXIA, SYSTEMIC INFLAMMATORY RESPONSE SYNDROME, TACHYCARDIA and TACHYPNOEA. The patient was treated with FUROSEMIDE (intravenous) for Adverse event, at an unspecified dose and frequency; HYDRALAZINE for Adverse event, at an unspecified dose and frequency; CEFTRIAXONE for Sepsis, at an unspecified dose and frequency; AZITHROMYCIN for Sepsis, at an unspecified dose and frequency; Physical therapy (BiPAP (12/8 cm H2O setting)) for Dyspnoea and Physical therapy (BiPAP (12/8 cm H2O setting)) for Hypoxia. At the time of the report, MYOCARDITIS (Acute myocardial injury/ Myocarditis), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A), HYPERTENSION (Hypertensive), DYSPNOEA (Worsening shortness of breath), ORTHOPNOEA (Orthopnea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Increasing fatigue), CONDITION AGGRAVATED (acute exacerbation of CHF), HYPOXIA (hypoxia), TACHYCARDIA (tachycardia) and TACHYPNOEA (tachypnea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood bilirubin: 1.9 (High) mg/100mL. In 2021, Blood culture: negative (Negative) negative. In 2021, Blood gases: abnormal (abnormal) pH 7.294, HCO3 21 mmole/L, PaCO2 39.9mmHg. In 2021, Blood lactate dehydrogenase (135-225 units/l): 239 (High) units/L. In 2021, Blood lactic acid: 5.7 (High) mmol/L. In 2021, Blood potassium: low (Low) hypokinesis of the ventricular wall in 2 regions on TTE with an acute presentation. In 2021, Brain natriuretic peptide (Unknown-124 pg/ml): elevated (High) 43134 pg/mL, elevated (High) 39813 pg/mL and elevated (High) 4796 pg/mL. In 2021, Breath sounds: abnormal (abnormal) coarse crackles in both lung bases. In 2021, C-reactive protein (0-0.5mg/dl): elevated (High) elevated 15.5 mg/dL and elevated (High) 11.5. In 2021, Chest X-ray: abnormal (abnormal) cardiomegaly and pulmonary edema without any focal conslidation. In 2021, Echocardiogram: abnormal (abnormal) mildly dilated left atrium, a left ventricle ejection fraction of 50%-54%, mild hypokinesia in the mid-septal and mid-anterior walls and grade 2 diastolic dysfunction. In 2021, Electrocardiogram: abnormal (abnormal) sinus tachycardia with non-specific ST/T wave cganges. In 2021, Fibrin degradation products (Unknown-500 ng/ml): 2010 (High) ng/mL. In 2021, Haemoglobin: 18 (High) g/dL. In 2021, Influenza virus test: negative (Negative) negative. In 2021, Oedema peripheral: 1+ (High) pitting edema in his lower extremities. In 2021, Oxygen saturation: 86% (Low) on lL/min of oxygen via nasal canula. In 2021, Red blood cell sedimentation rate (0-20 mm/h): elevated esr (High) 41 mm/h and 34 (High) mm/h. In 2021, Respiratory rate: 40 breaths/min (High) tachypneic. In 2021, SARS-CoV-2 test: negative (Negative) negative. In 2021, Serum ferritin (30-400 ng/dl): 550 (High) ng/dL and 454 (High) ng/dL. In 2021, Sputum culture: negative (Negative) negative. In 2021, Troponin (Unknown-19ng/l): 180.8 ng/l (High) elevated high sensitivity troponin, 117 (High) ng/dL and 85.2 (High) ng/dL. In 2021, Urine analysis: normal (normal) normal. In 2021, Venous pressure jugular: elevated (High) elevated. In 2021, Vital signs measurement: high (High) BP, mmHg= 169/96 HR, beats/min=141 Temperature (degree F)=101.2 RR, breaths/min= 26 oxygen saturation, %; oxygen requirement=92% 15L oxygen by NRB mask, high (High) BP, mmHg= 134/61 HR, beats/min=92 Temperature (degree F)=98.6 RR, breaths/min= 21 oxygen saturation, %; oxygen requirement=99%; BiPAP (12/8); 40% FiO2 and borderline (Borderline) BP, mmHg= 129/73 HR, beats/min=87 Temperature (degree F)=98.3 RR, breaths/min= 22 oxygen saturation, %; oxygen requirement=96%; 2L/min by NC. In 2021, White blood cell count: 17.86 x 1000/µl (High) leukocytosis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (Acute myocardial injury/ Myocarditis), SYSTEMIC INFLAMMATORY RESPONSE SYNDROME (MIS-A), HYPERTENSION (Hypertensive), DYSPNOEA (Worsening shortness of breath), ORTHOPNOEA (Orthopnea), PYREXIA (Fever), CHILLS (Chills), NAUSEA (Nausea), FATIGUE (Increasing fatigue), CONDITION AGGRAVATED (acute exacerbation of CHF), HYPOXIA (hypoxia), TACHYCARDIA (tachycardia) and TACHYPNOEA (tachypnea) to be possibly related. Patient denied history of previous COVID infection or contact with a patient with known COVID-19 infection. Acute exacerbation of CHF was treated with diuretics and supplemental oxygen therapy. Tachycardia and Tachypnea improved with bronchodilators. A literature case with some reported events approximately 6 hours after the 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. Probable confounding factors are the patient's medical history of Hypertension, Type 2 diabetes mellitus, Hyperlipidemia, Coronary artery disease, and Congestive heart failure, with procedural history of Stent placement and Coronary artery bypass graft.; Sender's Comments: A literature case with some reported events approximately 6 hours after the 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. Probable confounding factors are the patient's medical history of Hypertension, Type 2 diabetes mellitus, Hyperlipidemia, Coronary artery disease, and Congestive heart failure, with procedural history of Stent placement and Coronary artery bypass graft.

Went to ICU with 4 blood clots in the left leg from the hip-down; Pulmonary embolism; Unable to walk; Used to go to the bathroom (pee) 3-4 times at night; Not too well; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Went to ICU with 4 blood clots in the left leg from the hip-down) and PULMONARY EMBOLISM (Pulmonary embolism) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included High cholesterol and Nerve pain. Concomitant products included ATORVASTATIN for High cholesterol, GABAPENTIN for Nerve pain, APIXABAN (ELIQUIS), ACETYLSALICYLIC ACID (BABY ASPIRIN) and TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]) for an unknown indication. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Went to ICU with 4 blood clots in the left leg from the hip-down) (seriousness criteria hospitalization and medically significant), PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criteria hospitalization and medically significant), GAIT INABILITY (Unable to walk), POLLAKIURIA (Used to go to the bathroom (pee) 3-4 times at night) and MALAISE (Not too well). The patient was treated with Surgery (To clear blood clots) for Thrombosis. At the time of the report, THROMBOSIS (Went to ICU with 4 blood clots in the left leg from the hip-down), PULMONARY EMBOLISM (Pulmonary embolism), GAIT INABILITY (Unable to walk), POLLAKIURIA (Used to go to the bathroom (pee) 3-4 times at night) and MALAISE (Not too well) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: inconclusive (Inconclusive) His lungs were clear. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient received the 2nd dose on 23rd or 24th of February 2021. Patient reported being in ICU for 9 days and in acute care for 2 days. Prior to the surgery to clear blood clots, the Eliquis was stopped, had staples, put tubes through for the surgery and was put back on Eliquis afterwards.; 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- evening of and day after 2nd shot complained of severe headache 6/1- Suffered clot and hemorrhagic stroke/burst aneurysm. Husband was Airlifted to Hospital where he was rated a level 4, catastrophic event. He spent over 32 days in the ICU ON LIFE SUPPORT and as of day 52, remains in the hospital. His brain injury from the burst clot is life-changing. He is incapacitated and has lost 80% of his vision. He cognitively is significantly compromised and needs full assist and will likely never be Independant again- if he survives.

Completed 2nd COVID-19 vaccine March 16, 2021 - On May 13, 2021, he had massive pulmonary embolism resulting in cardiac arrest. Pulmonary embolism occluded pulmonary arteries to both lungs.

First part of April the patient leg started hurting more then usual. He was weaker. On April 18th patient walked to the end of the drive way when he walked back up he could not breathe. On April 19 patient went to hospital did a doppler on the left leg even thou the patient complained about pain the right leg. July 1st the patient passed out four time in less then thirty-minutes. Patient was transported to hospital. scan showed that patient had blood clots in both lungs. Patient was transferred to another hospital and they found that patient had a blood clot in the right leg. Patient is now on blood thinners.

Staff reported that patient was found Friday morning (Jan 8) sitting at a table with his head tilted forward and unresponsive to verbal or physical stimuli. Staff lowered patient to floor and started CPR. EMS was called and continued CPR at scene, however they were not able to revive patient. Patient was pronounced dead at the scene. Staff written statements following the death of patient show that he had a fall about 1 hr. prior. It is unknown if this fall contributed to patient's death. An autopsy has been requested.

Pericarditis with pericardial effusion. Treatment: Pericardiocentesis, Colchicine, Aspirin, Ibuprofen, Omeprazole Symptoms began (syncopal episode, retrosternal chest heaviness and aching worse with inspiration, fever, chills, lymphadenopathy for a for 9 days following vaccination) Outcome: Patient discharged home after 3 day hospitalization. Currently feeling better at 1 week follow up.

He had not been feeling well after his second Covid vaccination (on 01/23/2021) and was found unresponsive in his room at the nursing home (late evening on 02/02/2021). He was taken to a hospital where they did tests and he had pneumonia and kidney failure, but he was being transferred to a larger hospital when he arrested and died (02/03/2021)

patient developed headache, myalgia and nausea around 8-9 hours post injection. He felt he was having a sickle cell crisis. He worsened overnight and developed acute respiratory failure with respiratory distress and diaphoresis. EMS called around 7am on 2/9 and placed on BIPAP and admitted to ICU

cardiac arrest. Heart stopped, I fell to the ground, and was administered CPR by Police. I was admitted to hospital unresponsive and induced in a coma for two days. MRI results indicated I had a virus in my heart which caused Myocarditis. On 1/25/2021 i Had a cadiac catharization that indicated no blockages, or scar tissue. A defibrillator was surgically implanted in my chest on 1/27/21. Admitted to hospital 1/20/2021. Released 1/28/2021.

Patient had no reaction at the clinic. Patient is a medical doctor whose partner called in this death. States patient had no complaint on 1/13 nor 1/14 while at work. States patient died at home on 1/15 a.m. Physician who stated she was called to the patient's home @ 0157 1/15/2021 and found cyanotic from head to toe. State girlfriend found him sitting in the chair a few minutes before they called her. The Coroner did not order autopsy. Did not sent patient to the hospital. Sent him directly Funeral Home. Death Certificate Number 123-2021-002593 list cause of death as pending. I spoke with the patient's primary doctor who gave me the history of HTN, Diabetes, & High Cholesterol. States he had not seen this patient since April 2020. They were also friends and he was not aware of any medical problems. The Coroner state she thinks patient has a heart attack. Neither the Coroner nor PMD think death was related to COVID Vaccine. Informed both that MSDH would have to complete VAERS. Both voiced understanding.

Patient developed right sided hemiparesis on 2/5/2021. He presented to hospital on 2/7/2021 with these symptoms and diagnosed with an acute CVA and internal carotid artery occlusion. He was admitted to the hospital and discharged to inpatient rehab on 2/11/2021.

Death. My father-in-law was found unexpectedly deceased in his home Saturday morning. He worked the previous day.

2nd vaccine received on 2/22/2021, started feeling Atrial fibrulation on 2/23/2011 pulse 122-138. Normally is 56-70. Contacted cardiologist and he suggested to take double dose of Metoprolol. After several hrs heart went back to normal. Then on 2/27/2021 all the flu symptoms occured: fewer (101.5), chills, muscle and joint aches. Today is 3/1/2021, it looks like its better but not completely.

2-24-21 patient with development of cough, fatigue, increasing on chronic disability worsening debility and falls. scheduled for office visit 2-25.21 0900 call from spouse 0210 am patient was not breathing and lvad alarming low flow alarm on arrival of ems confirm asystolic not breathing and dead

Pulmonary Embolus, hospitalized. Released by hospital 2 days after event. Blood Thinners and pain medication.

Client passed away 8 days after being vaccinated. It is unknown if it occurred from the vaccine or other comorbidities.

Vaccine manufacturer and lot number unknown, vaccine given at alternate location. 2/23/21 8:27 PM: The patient is a 68-year-old male comes to the emergency department by paramedic ambulance for altered mental status that, began at around noon in association fever temp 102.9. PMH of myelofibrosis (on Jakafi and hydroxychloroquine), depression, anxiety, OSA, and history of AVR. Given history of myelodysplasia and Jak inhibitor predisposing to some opportunistic infections most notably viral reactivation with history of HSV and possible bacterial endocarditis he was admitted to the ICU for further monitoring and pressors. Patient has a MOS procedure 14 days prior - Status post MOSs procedure with large wound deficit on forehead -- Does not appear to be overtly infected at the time of admission. ED physician indicated mild facial cellulitis. 2/23/21- WBC 16.1 on admission. ECHO 2/26 indicated - no vegetation visualized. Of note second COVID vaccine 2 days prior to admission. Dr. felt incident was possible cardiogenic shock secondary to COVID vaccine. He did not feel the patient has a source of infection upon admission. Questionable given wounds on forehead Dr. (CMO) review of case- his impression was septic shock with and underlying case of chronic cardiac compromise making the hemodynamics worse

Felt bad after vaccine, had arm paint that went up my neck to my head, on 2nd day after shot I collapsed with a stroke. Blood Pressure was sky high. I was taken by Ambulance to Hospital, as I was at work at the time of the stroke. I have perfect bmi, never had high blood pressure, no health problems at all. No heart problems.

observed for 15 min after both vaccines and no reported issues after vaccination. Patient did expire 2/25/2021 but cause of death unknown.

Site: Swelling at Injection Site-Severe, Systemic: DVT-Severe, Additional Details: Patient presented to office with swelling of right upper extremity occuring after first COVID 19 vaccine dose. Was sent for duplex study which revealed acute deep vein thrombosis in right subclavian and axillary veins and superfficial thrombophlebitis of basilic vein in right arm. Pharmacy was contacted 3/10/2021 by MD at hospital to report vaccine adverse event

Pulmonary embolism with onset 1-2 days following 2nd dose of Moderna vaccination. No other precipitating events found

Patient developed nausea and vomiting 3/14/21. was seen at clinic by this provider 3/16/21 and reported at that time continued fatigue but overall symptom improvement. Vital signs were stable. pt was advised to orally hydrate and routinely monitor blood sugars and f/u as needed. On 3/18/21 patient was found down in his motel room by shelter staff unresponsive. 911 was called. pt transported to hospital by EMS receiving BLS. Clinic staff was advised by family that patient was pronounced dead that date.

Patient developed rib pain on Friday night March 12, chest and chest wall pain after the shot, Sat night it was more severe, could not lay down, thought it was muscle pain originally. It continued to get worse. Patient went to hospital on Monday March 15th, was diagnosed with a pulmonary embolism with partial infarction of right lower lobe. Was hospitalized until Wed March 17th.

Blood Clot in Leg; Tenderness; A spontaneous report was received from a consumer concerning a 68-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in leg and tenderness. The patient's medical history was not provided by the reporter. Concomitant medications reported included diltiazem hydrochloride, atorvastatin calcium and acetyl salicylic acid. On 13-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:031M2QA) through intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 13-Feb-2021, following administration of the vaccine, the patient had tenderness in his leg that continued until he sought out medical treatment. After medical treatment is was concluded that the patient has a blood clot in his leg and has to receive medical treatment to resolve that condition. The treatment information included rivaroxaban. Action taken with mRNA-1273 in response to the events was not applicable. The events, blood clot in leg and tenderness were considered recovered.; Reporter's Comments: There is not enough information to assess the causa association between the reported event of blood clot in leg and the administration if the mRNA-1273 vaccine. Critical details such as the patient's medical history is lacking. Additional information has been requested. Howe ever, based on temporal association between product administration and the event of tenderness, a causal relationship cannot be excluded.

Offer 4 hours development Cardiac anaphylactic shock with. Blood pressure dropping to 90 when sitting and would not read pressure when standing. Heart rate at 133 bpm throughout the nest 48 hours then slowing dropping. Was at 92 after 72 hours and normal 62 the next day.

Fever (103.7) with rigors 1 PM Mar 16, 2021 Night sweats Mar 17, 2021 Left Foot tenderness and swelling Mar 18-19, 2021 Left calf swelling with pain Mar 19, 2021. 5 PM Left leg DVT diagnosis Mar 19, 2021. 8 PM (UltraSound) despite warfarin treatment with INR 3.1 measured Mar 19, 2021. at 8 PM Admitted Medical facility Mar 19, 2021 with fever noted in chart through Mar 21, 2021 Switched from Warfarin to Lovenox anti-coagulation therapy due to warfarin failure Mar 21, 2021 Released from hospital Mar 21, 2021 Seen in clinic by Nurse Mar 25, 2021 for follow up Phone visit Mar 24, 2021 Coagulation specialist

Patient noted to be diaphoretic, tachypneic at regular rhythm, increased work of breathing, rales LUL, vocalizing with end expiration, O2 Sat 67% - was placed on 15 L nonrebreather with O2 Sat recovering to 96% - sent out via EMS to hospital where admitted for acutehypoxic respiratory failure from aspiration event. treated for possible PNA with IV antibiotics and discharged on oral antibiotics - on admission had elevated troponin to 0.9 with no EKG signs of acute ischemic changes and quick trending downward of troponin - treated with IV heparin but low suspicion for acute coronary syndrome and diagnosis of demand ischemia (type 2 NSTEMI) - discharged on aspirin chewable 81 mg daily

Stroke; This spontaneous case was reported by a physician and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No recorded medical history). On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization prolonged, medically significant and life threatening). The patient was hospitalized on 16-Mar-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) 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.

3/14/2021 Tightness in chest, attributed to physical work outside, 3/15 still felt tightness, 3/16 getting winded and went to the ER around 5:30pm, they took blood and ran test EKG, X-ray and ECHO complete with TTCV, ultrasound of chest, and test showed multiple blood clots in both lungs; by this time he was having trouble breathing and was admitted because of the blood clots. He was given Heparin and Vicodin through IV, on 3/17 they ran more test to see where blood clots came from and where they came from but nothing was found in legs. he was in a lot of pain Wednesday and he was sent home on 3/19.

Started wheezing on or about 3/23/2021; PCP prescribed Albuterol inhaler 3/25; SOB and wheezing worsened daily; 4/4/2021 was unresponsive 911 called and taken to ER with pulse ox of 58 and multiple bilateral PE noted on CT scan.

Vaccination 2-12-21 chest pains 2-12-21 evening heart attack 2-13-21 Flown from first hospital to second hospital 2-13-21 night stent applied, breakout in rash and hives on 2-17 severe.

The patient suffered a stroke and was admitted to the Hospital for 3 days after receiving his second dose.

Bilateral pulmonary embolism, clot in leg, pneumonia developed after the vaccine. Patient was hospitalized for 3 nights.

DVT leg leg: leg pain started around 3/24, then he developed swelling on 4/2 and a DVT was diagnosed on 4/3. He had been on Xarelto 10 mg daily for history of recurrent DVT (had never had one while on anticoagulation) at the time this was diagnosed.

Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Circumstances surrounding his death are not documented in chart. Comorbidities include Hepatitis C, HTN, T2DM.

Patient brought in by ambulance after cardiac arrest witnessed by patient's wife at 4/19/21 1:37AM. Per ED, the wife reports he had complained of feeling weak over the last few days without clear reason, then this morning patient had episode of emesis after which he told wife to call 911 and then suddenly became unresponsive. In ED was intubated, started on hypothermia protocol, Patient sedated on Propofol and started on a heparin drip, clopidogrel, aspirin and empiric antibiotics for aspiration Pneumonia

MY HUSBAND DIED WITHIN 24 HOURS OF RECEIVING THE VACCINE. I WANT TO CONFIRM THAT YOU KNOW ABOUT THIS. PLEASE CALL ME ON MY CELL PHONE , THANK YOU,

Pulmonary Embolism; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Pulmonary Embolism) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 07-Mar-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary Embolism) (seriousness criterion hospitalization). The patient was hospitalized on 07-Mar-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary Embolism) outcome was unknown. Not Provided Patient was prescribed Xarelto. 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. However, Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Difficulty in breathing, Left upper quadrant pain.ED visit 3/16/2021. Pulmonary emboli diagnosis. Unprovoked.

Clinic was informed that patient patient went unresponsive at home at 2pm on 4/21/21 and patient expired.

Blood Clot; left knee had red marks above it; pain in thigh; swelling from the knee up to the thigh; left knee was in pain tremendously; difficulaty walking; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood Clot) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013620A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced GAIT DISTURBANCE (difficulaty walking) and ARTHRALGIA (left knee was in pain tremendously). On 16-Jan-2021, the patient experienced ERYTHEMA (left knee had red marks above it), PAIN IN EXTREMITY (pain in thigh) and JOINT SWELLING (swelling from the knee up to the thigh). On an unknown date, the patient experienced THROMBOSIS (Blood Clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood Clot), GAIT DISTURBANCE (difficulaty walking), ERYTHEMA (left knee had red marks above it), PAIN IN EXTREMITY (pain in thigh), JOINT SWELLING (swelling from the knee up to the thigh) and ARTHRALGIA (left knee was in pain tremendously) 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. Concomitant medications like high blood pressure medication, cholesterol medication and medication for irregular heartbeat were reported. On 15 Jan2021, the patient said that his left knee was in pain tremendously and had difficulty walking. On 16 JAN 2021, the left knee had Red marks above it. He also had swelling from the knee up to the thigh. He also experienced pain in the thigh and knee. He went to the doctor on 20 JAN 2021 and was sent for an ultrasound. The doctor thought it could be related blood clot. No laboratory details were provided. On 20-Jan-2021, the patient was sent for an ultra sound, results unknown. Treatment included ibuprofen and paracetamol. 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.

Death; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Apr-2021 and was forwarded to Moderna on 28-Apr-2021. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No treatment information was provided. No concomitant medication was provided.; Sender's Comments: This is a 68-year-old, male patient who received mRNA-1273 vaccine (batch no. unknown) who died, on an unknown date after receiving first dose of vaccine. No medical history or conmeds were provided. Existing comorbidities probably could have been the causative factor in his death. Very limited information has been reported at this time. Further information is expected.; Reported Cause(s) of Death: unknown cause of death

Patient presented to the ED via ambulance with fever, nausea, vomiting. Patient noted to have 103 degree temperature at home. Patients heart rate was elevated in the 110s. Patient has rigors. Fever increased while at hospital. Patient admitted to the hospital for sepsis. Started on numerous antibiotics, fluid boluses.

Fever, Diarrhea, chills, sweating, weakness beginning 7 hours after injection. Hospitalized due to these symptoms on March 10, and died on March 13.

He became very ill and died this past Wednesday because he was told to get the shot even though he wasn't feeling well. There is no excused for perpetuating the myth that everyone should get the shot no matter what. A negative covid test and thorough physical should be required before people take this vaccine.

Patient received 2nd dose of the Moderna Covid vaccine on 4/24/21. On 5/3/21, patient called office complaining of redness, swelling, pain in left lower leg/calf. Patient was seen the same day and did have a STAT Ultrasound performed that did diagnose a DVT in the left leg.

Patient reportedly received Moderna Vaccines 02/01/2021 and 03/01/2021. On 4/30/21 he had chest pain and was found to have inferior STEMI. He was transferred for further care. Upon further investigation he was found to be COVID-19 positive on 4/30/21 at 01:39 via COVID PUI LIAT testing of nasopharyngeal source. The patient was reportedly asymptomatic from COVID-19. He underwent thrombectomy and DES to RCA for STEMI. He was discharged home 5/2/21.

I had the Moderna COVID-19 vaccine shot one on March 16, 2021 and shot two April 13, 2021. I am not sure when the headaches started, but I estimated about two weeks, or about April 9, 2021. The headache on April 23, 2021 was bad enough that my wife called our PCP. My PCP asked me a lot of questions and said for me to get a blood draw and an MRI without contrast STAT. The report dated April 23, 2021 was ?a Large 1.5 cm thick right frontoparietal subdural hematoma with transfalcine right to left herniation measuring 1.0 cm. Tiny parafalcine and left frontoparietal subdural hematomas. Given recent vaccination, consider contrast enhanced MRV to rule out venous sinus thrombosis.? I was ordered to go to the ER where I was admitted the same day. A neurosurgery team performed an operation on April 27 to drain the internal bleeding that had occurred (possibly for over a month). As I was about to be released on April 28, 2021, my heart monitor recorded a ventricular tachycardia (vtac); I exhibited 17 beats of vtac where no Potassium and magnesium levels were present. A cardiology team then got involved. An EKG and ultrasound were taken April 29, 2021. Since there were no recurring issues, I was released on April 29, 2021. I do not know if the spontaneous subdural hematoma or the ventricular tachycardia could have been an adverse reaction to the COVID-19 vaccine, but I thought I should report it.

Although I have heart disease, and had triple bypass surgery three years ago, I consistently take my blood pressure. My blood pressure has been in a normal range since the operation, and following receiving the first dose of the vaccine it became elevated and I needed to go back on an old medication. Even then, my blood pressure was erratic. Two weeks after my 2nd COVID shot I had a heart attack due to a blood clot. This clot was able to be removed by a heart cath-lab. This could be a coincidental flare up due to an old issue, but the timing aligns with both doses of the vaccine.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was atrial fibrillation with rapid ventricular response.

Neuromuscular weakness, tingling/numbness, and fall prior to admission. Progressed to acute hypoxic respiratory failure requiring intubation.

Clot; Stroke; Swelling began in the groin / swelling extending up to my upper thigh / swelling extending to the back; Problem with walking; Got mad and walked out of hospital byhimself; Nauseous; Pins and needles sensation; Felt chilly; Dizzy; Whole body(left side) went numb; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling began in the groin / swelling extending up to my upper thigh / swelling extending to the back), THROMBOSIS (Clot) and CEREBROVASCULAR ACCIDENT (Stroke) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced SWELLING (Swelling began in the groin / swelling extending up to my upper thigh / swelling extending to the back) (seriousness criterion hospitalization), FEELING COLD (Felt chilly), DIZZINESS (Dizzy), HYPOAESTHESIA (Whole body(left side) went numb), PARAESTHESIA (Pins and needles sensation) and NAUSEA (Nauseous). On 07-May-2021, the patient experienced THROMBOSIS (Clot) (seriousness criteria hospitalization and medically significant), CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant), GAIT DISTURBANCE (Problem with walking) and TREATMENT NONCOMPLIANCE (Got mad and walked out of hospital byhimself). The patient was hospitalized on 07-May-2021 due to CEREBROVASCULAR ACCIDENT and THROMBOSIS. At the time of the report, SWELLING (Swelling began in the groin / swelling extending up to my upper thigh / swelling extending to the back), THROMBOSIS (Clot), CEREBROVASCULAR ACCIDENT (Stroke), FEELING COLD (Felt chilly), DIZZINESS (Dizzy), HYPOAESTHESIA (Whole body(left side) went numb), GAIT DISTURBANCE (Problem with walking), PARAESTHESIA (Pins and needles sensation), TREATMENT NONCOMPLIANCE (Got mad and walked out of hospital byhimself) and NAUSEA (Nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-May-2021, Blood test: unknown (Inconclusive) Unknown. On 07-May-2021, Computerised tomogram: unknown (Inconclusive) Unknown. On 07-May-2021, Magnetic resonance imaging: unknown (Inconclusive) Unknown. On 07-May-2021, X-ray: unknown (Inconclusive) Unknown. Company comment: Although a temporal association exists, provided information is not adequate to assess the causal association between the events of thrombosis, stroke, swelling, hypoesthesia, paresthesia, gait disturbance and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Based on the current available information and temporal association between the use of the product and the start date of the events of dizziness, feeling cold, nausea, a causal relationship cannot be excluded. The causality assessment for the event of Treatment noncompliance remains Not applicable. This case was linked to MOD-2021-133656 (Patient Link).; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the events of thrombosis, stroke, swelling, hypoesthesia, paresthesia, gait disturbance and mRNA-1273. The detailed medical history and diagnostic report has not been provided. Based on the current available information and temporal association between the use of the product and the start date of the events of dizziness, feeling cold, nausea, a causal relationship cannot be excluded. The causality assessment for the event of Treatment noncompliance remains Not applicable.

Patient presented to the ED on 2/18/2021 with nausea and vomiting and was subsequently admitted for gastroenteritis. Patient presented to the ED on 3/5/2021 and was diagnosed with a lung infection, was subsequently admitted. These visits are within 6 weeks of receiving COVID vaccination.

Approximately 24 hours after 2nd shot, patient couldn't breath good. He was admitted to hospital where patient reported to go into kidney failure and having pneumonia. He had an extended stay for 2 weeks in the ICU there. Patient does not remember treating physician, This was all patient reported.

He died suddenly on May 13th. Had just had thorough physical prior to vaccines. Perfect health, weight perfect. No prior health concerns. Heart attack or stroke in his yard. After his first dose on March 16, 2021 he ceased his several mile walk each day stating he was tired and lethargic. He was a military man that rose each day of his life to that walk. His second dose was 04/16/21 he still did not continue the walks and on May 13, 2021 died suddenly of heart attack or stroke.

Received 2nd dose 2/18/2021 had fever that day, the next day, on the 20th it started at about 5:00pm then at about 6:00 pm I had severe left chest pains that soon went to the left shoulder. Emergency services was called and I was first taken to nearby hospital and they transferred me to a different Hospital. I had pericardial effusion was put on Lasix and Potassium. Tests done was a heart MRI, heart cathertization, lung CT scan, echocardiogram, EKG. Arteries were open and not clogged, it was determined that I did not have a heart attack. I've never had high blood pressure or any other heart related conditions. I was released after 5 days feeling well

I went into arrhythmia. I felt out of breath, lethargic, anxious. I called the doctor and sent him an ECG that I did on my watch. He said I was in a fib. We watched it for a few days, and then went in to the doctor. They did an EKG and determined I was indeed in afib. They switched my medication which did not really help. I began having intermittent episodes of the arrhythmia. I went back to the doctor and I was still in afib. They scheduled me for a cardioversion. When I went in for the procedure, they ran tests that determined I was not in afib. I was releases and I have been okay since.

This RN received a phone call from the wife of the client whom is reported in the VAERS. She reports that her husband received a 2nd shot on 2/25/2021 and on 3/20/2021 was in so much pain in his leg that she took him to the Emergency Room. Reports he then received an ultrasound where it was found that he had a blood clot in his upper leg (near groin). She has heard about the issues with COVID vaccine and blood clots and wanted to make sure that this was reported. He is following with his PCP and Vein specialist. Reports he received the shot from Pharmacy. She said she will probably do a VAERS report also. Reports is doing much better now, but thought they should have it reported.

ischemic stroke (cerabellar) * I realize this is not a recognized side-effect, but I am also not a believer in coincidence. Prior to receiving the vaccine, I was in excellent health, physically active (long walks, and gym 3-4 days/week), normal BMI, and excellent cholesterol numbers. BP had been "borderline high" for several years, but 3 different doctors agreed that no medical treatment was needed - just stay physically active and reduce fat and sodium in diet, which I did. I am retired with no financial worries, so stress is not a factor. Stroke occurred 5.5 weeks after receiving second Moderna vaccine.

Extreme pain in left calf. Diagnosed as Deep Venous Thrombosis, in upper thigh. No swelling or redness. Pain only. Admitted to hospital for 2 days for IV blood thinner. Prescribed Eloquis for 3-6 months & compression stockings

3 weeks after 1st dose of Moderna Covid-19 vaccine went into atrial fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (3 weeks after 1st dose of Moderna Covid-19 vaccine went into atrial fibrillation) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced ATRIAL FIBRILLATION (3 weeks after 1st dose of Moderna Covid-19 vaccine went into atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (3 weeks after 1st dose of Moderna Covid-19 vaccine went into atrial fibrillation) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. 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. This case was linked to MOD-2021-230057 (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 event, a causal relationship cannot be excluded.

2 weeks after 2nd dose of Moderna Covid-19 vaccine went into serious atrial fibrillation; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (2 weeks after 2nd dose of Moderna Covid-19 vaccine went into serious atrial fibrillation) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced ATRIAL FIBRILLATION (2 weeks after 2nd dose of Moderna Covid-19 vaccine went into serious atrial fibrillation) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (2 weeks after 2nd dose of Moderna Covid-19 vaccine went into serious atrial fibrillation) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Echocardiogram: inconclusive (Inconclusive) Inconclusive. No treatment medications were provided by the reporter. The doctors took an echocardiogram and his heart is wonderful and they can not figure out why he went into atrial fibrillation. He now have to take an expensive medication to prevent his heart going into atrial fibrillation and we are wondering if it was possible he got it from Moderna Covid-19 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. This case was linked to MOD-2021-230049 (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.

See initial presentation notes, patient collapsed out of hospital, and was diagnosed with left MCA stroke, diagnosed to be cardio-embolic in origin, from new onset atrial fibrillation.

July 3, 2021 - Admitted to ER for Chest Pains on Right side of Chest/Pelvis/Upper Legs at 2AM, Performed blood test and scans, diagnosed blood clots in both lungs by 4AM, origin from where blood clot came from are still not determined.

Within several days of vacine developed an irregular heartbeat. Went to my doctor on March 11th and was referred to a cardiologist. First appointment with cardiologist showed irregular heart beat and made appointment for further tests. On March 28th fitted with a moniter for 3 days. Returned to cardiologist on April 1st for further test and told I was in A-Fib. PLaced on blood thinner and beta blocker. After 2 weeks no change so scheduled cardioversion for following week. Cardioversion was successful but still on medication.

Patient presented to the ED for hypertensive emergency and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. On 6/6/2021 patient presented to the ED and was subsequently hospitalized for Acute arterial ischemic stroke, multifocal, multiple vascular territories.

Moderna COVID-19 Vaccine EUA Patient received two doses of Moderna Vaccine at a Facility on the reported dates of 3/16/21 and 4/14/21. On 7/5/21 patient presented to ED with complaints of breathing difficulties and was diagnosed with multifocal pneumonia and COVID Positive with symptom onset of 7/1/21. Patient subsequently developed acute renal failure.Patient expired on 7/19/21 from complications of acute hypoxic respiratory failure due to COVID-19.

Arm was immediately sore and still feels different. The bandaid was bloody and spasms are constant. Definitely much different from first injection.

On 7/16 c/o nausea and SOB , sent to the ER and admitted to hospital with: Acute hypoxic respiratory failure due to fluid overload and pneumonia. He was placed on BIPAP, received urgent HD and broad spectrum empiric antibiotics. He weaned off of BIPAP to NC, fever resolved and cultures were negative. On 7/20/21 Pt discharged from hospital and returned to Rehabilitation Center

I had vaccination prior to noon on Feb 9, that afternoon I exhibited signs such as labored breathing, exhaustion. The next day I was not alert, that night Feb 10, just before midnight I had a grand mal seizure . The ambulance and police were at my home a little after midnight. They took me to Essentia hospital emergency room. I was there for observation for several hours. I notified my VA doctor about what happened, he scheduled a brain scan. nothing showed that would indicate a medical brain issue. Subsequently; I lost my driving privileges completely for several months and currently am driving on a limited license, which is normal in the case of a seizure in our state. See continuation page:

Started having shortness of breath and dyspnea on exertion on 7/26/21, was tested positive with COVID-19 on 7/28. Pt also has bilateral pulmonary emboli with a saddle pulmonary embolism. Pt was admitted to ICU.

Not making sense; Left pontine ischemic stroke without hemorrhagic stroke; Double Vision; Slurred speech; Unsteady Gait; This spontaneous case was reported by an other health care professional and describes the occurrence of ISCHAEMIC STROKE (Left pontine ischemic stroke without hemorrhagic stroke), DIPLOPIA (Double Vision), DYSARTHRIA (Slurred speech), GAIT DISTURBANCE (Unsteady Gait) and FEELING ABNORMAL (Not making sense) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Hyperlipidemia, Cardiomegaly, Pulmonary embolism, Smoker, Ventricular tachycardia, DVT, Implantable cardioverter defibrillator insertion, Cough, Vasectomy in 1982, Pacemaker insertion (cardiac) (2005,2009,2015) in July 2002 and Colonoscopy (2015) in January 2005. Family history included Congestive cardiac failure (Mother had CHF). Concurrent medical conditions included Drug allergy (From Bactrim), Drug allergy (trimethoprim), Hypertension, Diabetes mellitus (Diabetes mellitus type 2), Peripheral neuropathy, Chronic back pain, Morbid obesity, Left bundle branch block, Ischemic cardiomyopathy, GERD, Hyperhidrosis, Insomnia and Chronic thrombocytopenia. Concomitant products included CODEINE PHOSPHATE, GUAIFENESIN (VIRTUSSIN AC) for Cough, ASCORBIC ACID, ACETYLSALICYLIC ACID (ECOTRIN), ATORVASTATIN CALCIUM (LIPITOR), CALCIUM CARBONATE (CALTRATE [CALCIUM CARBONATE]), CARVEDILOL (COREG), FLUTICASONE PROPIONATE (FLOVENT HFA), FUROSEMIDE (LASIX P), LISINOPRIL (ZESTRIL), MULTIVITAMIN WITH MINERALS, OMEPRAZOLE, LORATADINE, APIXABAN from an unknown date to 07-Jun-2021, VITAMIN D3, TRIAMCINOLONE ACETONIDE, CANAGLIFLOZIN, METFORMIN, PREGABALIN, PARACETAMOL, TRAMADOL HYDROCHLORIDE (TRAMADOL + ACETAMINOFEN), TRAZODONE, UBIDECARENONE (COQ10 [UBIDECARENONE]), ZOLPIDEM, NIACIN, CLOPIDOGREL, APIXABAN (ELIQUIS), LISINOPRIL and SALBUTAMOL SULFATE (PROAIR RESPICLICK) for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-2021, the patient experienced ISCHAEMIC STROKE (Left pontine ischemic stroke without hemorrhagic stroke) (seriousness criteria hospitalization and medically significant), DIPLOPIA (Double Vision) (seriousness criterion hospitalization), DYSARTHRIA (Slurred speech) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Unsteady Gait) (seriousness criterion hospitalization). On an unknown date, the patient experienced FEELING ABNORMAL (Not making sense) (seriousness criterion hospitalization). The patient was hospitalized from 07-Jun-2021 to 08-Jun-2021 due to DIPLOPIA, DYSARTHRIA, FEELING ABNORMAL, GAIT DISTURBANCE and ISCHAEMIC STROKE. The patient was treated with CLOPIDOGREL BISULFATE (PLAVIX) (oral) on 07-Jun-2021 for Adverse event, at a dose of 75 mg once a day and NICOTINIC ACID (NIASPAN) (oral) on 07-Jun-2021 for Adverse event, at a dose of 500 mg once a day. At the time of the report, ISCHAEMIC STROKE (Left pontine ischemic stroke without hemorrhagic stroke) had resolved and DIPLOPIA (Double Vision), DYSARTHRIA (Slurred speech), GAIT DISTURBANCE (Unsteady Gait) and FEELING ABNORMAL (Not making sense) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, SARS-CoV-2 test: positive (Positive) Positive Covid-19 virus test. On 07-Jun-2021, Activated partial thromboplastin time (24-36): 36.3 (High) high. On 07-Jun-2021, Alanine aminotransferase (1-50): 29 (normal) 29 u/L. On 07-Jun-2021, Albumin globulin ratio (1.1-2.2): 1.6 (normal) normal. On 07-Jun-2021, Anion gap (5-15): 6 (normal) 6. On 07-Jun-2021, Aspartate aminotransferase (17-59): 32 (normal) 32 u/L. On 07-Jun-2021, Basophil count (0-0.2): 0.0 (normal) 0.0. On 07-Jun-2021, Basophil percentage (0-2): 0.6 (normal) 0.6 %. On 07-Jun-2021, Blood albumin (3.5-5.0): 4.0 (normal) 4.0 g/dL. On 07-Jun-2021, Blood alkaline phosphatase (38-126): 70 (normal) 70 u/L. On 07-Jun-2021, Blood bilirubin (0.2-1.3): 0.8 (normal) 0.8 mg/dL. On 07-Jun-2021, Blood calcium (8.4-10.2): 9.0 (normal) 9.0 mg/dL. On 07-Jun-2021, Blood chloride (98-107): 108 (High) 108. On 07-Jun-2021, Blood creatinine (0.8-1.5): 1.1 (normal) 1.1 mg/dL. On 07-Jun-2021, Blood glucose (75-110): 147 (High) 147 mg/dL. On 07-Jun-2021, Blood lactate dehydrogenase (0.6-2.2): 1.6 (normal) 1.6. On 07-Jun-2021, Blood osmolarity (261-280): 270 (normal) 270. On 07-Jun-2021, Blood potassium (3.6-5): 3.7 (normal) 3.7. On 07-Jun-2021, Blood pressure measurement: 162/76 (High) at 10:40, 162/76 at 11:46, 165/78 at 07:49, 127/74 and at 09:48, 150/86 (High). On 07-Jun-2021, Blood sodium (136-146): 137 (normal) 137. On 07-Jun-2021, Blood urea (9-20): 20 (normal) 20 mg/dL. On 07-Jun-2021, Blood urea nitrogen/creatinine ratio (6-26): 18 (normal) 18 ratio. On 07-Jun-2021, Body temperature: 97.6 (normal) at 10:40, 97.6, at 07:49, 97.8 F, at 09:48, 97.8 F. On 07-Jun-2021, Carbon dioxide (22-30): 23 (normal) 23. On 07-Jun-2021, Coagulation factor (0.84-1.14): 1.36 (High) 1.36. On 07-Jun-2021, Computerised tomogram: no acute intracanal finding (normal) No acute intracanal finding. On 07-Jun-2021, Eosinophil count (0-0.5): 0.3 (normal) 0.3. On 07-Jun-2021, Eosinophil percentage (0-4): 6.1 (High) 6.1 %. On 07-Jun-2021, Globulin (2.4-3.6): 2.6 (normal) 2.6 g/dL. On 07-Jun-2021, Glomerular filtration rate (60-Unknown): 67 (normal) 67 ml/mil. On 07-Jun-2021, Haematocrit (41-53): 45.0 (normal) 45.0%. On 07-Jun-2021, Haemoglobin (13.5-17.5): 15.5 (normal) 15.5 %. On 07-Jun-2021, Heart rate: 60 (Low) at 10:40, 60 at 11:46, 61 at 07:49, 64 and at 09:48, 61. On 07-Jun-2021, Icterus index (0-7): <2.0 (normal) <2.0. On 07-Jun-2021, Immature granulocyte count (0.0-0.3): 0.0 (normal) 0.0 and 0.0 (normal) 0.0 %. On 07-Jun-2021, Influenza A virus test: negative (Negative) Negative. On 07-Jun-2021, Influenza B virus test: negative (Negative) Negative. On 07-Jun-2021, International normalised ratio (0.84-1.14): 1.38 (High) 1.38. On 07-Jun-2021, Lymphocyte count (1-4.8): 1.2 (normal) 1.2. On 07-Jun-2021, Lymphocyte percentage (23-45): 23.6 (normal) 23.6 %. On 07-Jun-2021, Mean cell haemoglobin (26-34): 33.2 (normal) 33.2. On 07-Jun-2021, Mean cell haemoglobin concentration (31-37): 34.4 (normal) 34.4. On 07-Jun-2021, Mean cell volume (80-100): 96.4 (normal) 96.4. On 07-Jun-2021, Mean platelet volume (9.4-12.4): 10.9 (normal) 10.9. On 07-Jun-2021, Monocyte count (0-0.8): 0.4 (normal) 0.4. On 07-Jun-2021, Monocyte percentage (0-9.0): 6.8 (normal) 6.8 %. On 07-Jun-2021, NIH stroke scale: 0 (normal) NIH Stroke scale score of 0. On 07-Jun-2021, Neutrophil count (1.8-7.7): 3.2 (normal) 3.2. On 07-Jun-2021, Neutrophil percentage (33-66): 62.9 (normal) 62.9%. On 07-Jun-2021, Oxygen saturation: 96 (Low) at 10:40, 96%, 97 (Low) at 11:46, 97% and 98 (normal) at 07:49, 98. On 07-Jun-2021, Platelet count (130-400): 93 (Low) 93. On 07-Jun-2021, Protein total normal (6.3-8.2): 6.6 (normal) 6.6 g/dL. On 07-Jun-2021, Red blood cell count (4.5-5.9): 4.67 (normal) 4.67. On 07-Jun-2021, Red cell distribution width (36.9-50.2): 44.9 (normal) 44.9. On 07-Jun-2021, Respiratory rate: 18 (Inconclusive) at 10:40, 18, at 11:46, 21, at 07:49, 20 and at 09:48, 16. On 07-Jun-2021, Respiratory syncytial virus test: negative (Negative) negative. On 07-Jun-2021, SARS-CoV-2 test: negative (Negative) negative. On 07-Jun-2021, Troponin I (0.0-0.12): <0.012 (normal) <0.012 ng/mL. On 07-Jun-2021, White blood cell count (4.5-11): 5.1 (normal) 5.1. On 07-Jun-2021, X-ray: no acute pulmnory finding. (normal) No acute pulmnory finding.. On 08-Jun-2021, Alanine aminotransferase (1-50): 31 (normal) 31 u/L. On 08-Jun-2021, Anion gap (5-15): 4 (Low) 4. On 08-Jun-2021, Aspartate aminotransferase (17-59): 23 (normal) 23 u/L. On 08-Jun-2021, Basophil count (0-0.2): 0.0 (normal) 0.0. On 08-Jun-2021, Basophil percentage (0-2): 0.7 (normal) 0.7 %. On 08-Jun-2021, Blood albumin (3.5-5.0): 3.2 (Low) 3.2 g/dL. On 08-Jun-2021, Blood alkaline phosphatase (38-126): 65 (normal) 65 u/L. On 08-Jun-2021, Blood bilirubin (0.2-1.3): 0.9 (normal) 0.9 mg/dL. On 08-Jun-2021, Blood calcium (8.4-10.2): 8.4 (normal) 8.4 mg/dL. On 08-Jun-2021, Blood chloride (98-107): 109 (High) 109. On 08-Jun-2021, Blood cholesterol (Unknown-200): 94 (normal) 94. On 08-Jun-2021, Blood creatinine (0.8-1.5): 1.0 (normal) 1.0 mg/dL. On 08-Jun-2021, Blood culture: no growth (normal) No growth after 5 days. On 08-Jun-2021, Blood glucose (75-110): 109 (normal) 109 mg/dL, 162 (High) 162 mg/dL and 157 (High) 157 mg/dL. On 08-Jun-2021, Blood potassium (3.6-5): 3.7 (normal) 3.7. On 08-Jun-2021, Blood sodium (136-146): 140 (normal) normal. On 08-Jun-2021, Blood triglycerides (Unknown-150): 186 (High) 186 mg/dL. On 08-Jun-2021, Blood urea (9-20): 18 (normal) 18 mg/dL. On 08-Jun-2021, Carbon dioxide (22-30): 27 (normal) 27. On 08-Jun-2021, Echocardiogram: 50-55 (abnormal) Left ventricle ejection fraction estimated to be 50-55%. Not well visualized. On 08-Jun-2021, Eosinophil count (0-0.5): 0.4 (normal) 0.4. On 08-Jun-2021, Eosinophil percentage (0-4): 7.9 (High) 7.9%. On 08-Jun-2021, Glomerular filtration rate (60-Unknown): >60 (normal) >60 ml/min. On 08-Jun-2021, Glycosylated haemoglobin (Unknown-5.7): 6.2 (High) 6.2 %. On 08-Jun-2021, Haematocrit (41-53): 43.6 (normal) 43.6 %. On 08-Jun-2021, Haemoglobin (13.5-17.5): 15.2 (normal) 15.2 %. On 08-Jun-2021, High density lipoprotein (39-Unknown mg/dl): 26 mg/dl (Low) 26. On 08-Jun-2021, Immature granulocyte count (0.0-0.3): 0.01 (normal) 0.01. On 08-Jun-2021, Low density lipoprotein (Unknown-100): 31 (normal) 31 mg/dL. On 08-Jun-2021, Lymphocyte count (1-4.8): 1.6 (normal) 1.6. On 08-Jun-2021, Lymphocyte percentage (23-45): 28.7 (normal) 28.7 %. On 08-Jun-2021, Mean cell haemoglobin (26-34): 33.6 (normal) 33.6. On 08-Jun-2021, Mean cell haemoglobin concentration (31-37): 34.9 (normal) 34.9. On 08-Jun-2021, Mean cell volume (80-100): 96.5 (normal) 96.5. On 08-Jun-2021, Mean platelet volume (9.4-12.4): 11.8 (normal) 11.8. On 08-Jun-2021, Monocyte count (0-0.8): 0.6 (normal) 0.6. On 08-Jun-2021, Monocyte percentage (0-9.0): 10.7 (High) 10.7 %. On 08-Jun-2021, Neutrophil count (1.8-7.7): 2.9 (normal) 2.9. On 08-Jun-2021, Neutrophil percentage (33-66): 51.9 (normal) 51.9%. On 08-Jun-2021, Platelet count (130-400): 84 (Low) 84. On 08-Jun-2021, Protein total normal (6.3-8.2): 5.5 (Low) 5.5 g/dL. On 08-Jun-2021, Red blood cell count (4.5-5.9): 4.52 (normal) 4.52. On 08-Jun-2021, Very low density lipoprotein (Unknown-30): 37 (High) 37. On 08-Jun-2021, White blood cell count (4.5-11): 5.6 (normal) 5.6. 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. The patient was admitted for further stroke workup. He could not undergo MRI evaluation due to his pacemaker. He was evaluated by Neurology who reviewed the outside hospital imaging and noted an acute ischemia in the pons. He additionally noted mild bilateral carotid atherosclerosis and bilateral PCA atherosclerotic stenosis. While admitted, the patient underwent an echocardiogram with bubble study. The results of the echo were limited dues to poor acoustic window availability and morbid obesity of the patient- Ejection fraction was 50% to 55%. Neurology advised dual-anti platelet therapy with aspirin 81 mg and plavix 75 mg daily for 3 months, then can resume monotherapy with aspirin 81 mg daily. Recommended continuing Lipitor 20 mg every evening and adding Niacin 500 mg daily due to elevated triglycerides. Neurology advised stopping Eliguis as the previous DVT and PE were provoked by long drive/ immobility and anticoagulation would not be needed from a stroke standpoint. His stroke is not suspected to, be cardioembolic. Speech Therapy evaluated the patient and advised no further treatment. physical Therapy evaluated the patient and advised no further services were necessary upon discharge. The patient was comfortable with discharge. The remainder of his conditions were managed with his chronic medical therapy. Company Comment: Very limited information regarding these events have been provided at this time. Further information has been requested; Sender's Comments: Very limited information regarding these events have been provided at this time. Further information has been requested

UNKNOWN/ASYTOLE Narrative: Please refer to section 6. 68y/o male with h/o severe peripheral vascular disease with previous left AKA 2/3/20, s/p bilateral bypasses in the past. Pt recently underwent right AKA on 1/12/21. Per Hospital remote data 1/10/21 pt c/o shortness of breath, CXR demonstrated right lower lobe opacity & left basilar infiltrate. Pt s/p >10 days emperic IV abx. Moderna vaccine 0.5ml IM was administered via left deltoid on 1/22/21 around 16:21. On 1/23/21@05:14 code blue was called as pt found to be unresponsive, breathless and pulseless, facial cyanosis noted, CPR started immediately.Pt found to be in asystole. ACLS guideline followed but no return of spontaneous circulation, At 05:32 pt remained pulseless and breathless and was pronounced. Autopsy currently pending.

69 YO M CARDIAC ARREST. PT HAD JUST RECEIVED HIS COVID VACCINATION AND WAS PULLING INTO THE OBSERVATION AREA WHEN HE LOST CONTROL OF HIS TRUCK, BECAME UNCONSCIOUS AND CRASHED INTO A LIGHT POLE. THIS OCCURRED IN FRONT OF THE STANDBY MEDIC UNIT AND OTHER FIRE DEPT STAFF. PT WAS IMMEDIATELY REMOVED FROM THE VEHICLE AND THE PATIENT WAS DETERMINED TO BE IN CARDIAC ARREST. CPR WAS INITIATED WITHIN SECONDS OF BEING REMOVED FROM THE VEHICLE. EMS WAS IMMEDIATELY AVAILABLE AND THE PATIENT WAS DEFIBRILLATED FOR WHAT APPEARED TO BE A SINE WAVE VT/COURSE VF WITHIN ONE MINUTE OF HIS ARREST. PT WAS PLACED ONTO A BACK BOARD AND MOVED TO AMBULANCE IN A PULSED VT AND WAS AWAKE AND RESPONSIVE. ONCE IN THE BACK THE PT WAS WIRED INTO THE FOUR LEAD AND WAS SYNCHRONIZED CARDIOVERTED AT 100 J WITH A CONVERSION TO A PULSED JUNCTIONAL RHYTHM WITH A RATE OF ABOUT 58. THIS RHYTHM CHANGED INTO A SINUS TACH AT ABOUT 100 BPM. IV ACCESS WAS OBTAINED AND 100 MG LIDO BOLUS WAS ADMINISTERED WITH A 2:1 LIDO DRIP HUNG. AMBULANCE BEGAN TRANSPORT TO ER. OVER NEXT SEVERAL MINUTES PT BEGAN HAVING VENTRICULAR ECTOPY IN THE FORM OF PVCs COUPLETS AND EVENTUALLY 4-5 BEAT RUNS OF VTACH WHILE ON PHONE WITH ER MD. DISCUSSED GIVING ANOTHER BOLUS OF LIDO AND INCREASING DRIP TO 3:1 DUE TO INCREASING VENTRICULAR ECTOPY. THE ER PHYSICIAN CONCURRED AND ANOTHER 75 MG LIDO BOLUS WAS GIVEN FOLLOWED BY INCREASING THE DRIP RATE TO 3MG/MINUTE FOLLOWING THE SECOND LIDO DOSE AND DRIP ADJUSTMENT THE PATIENT'S VENTRICULAR ECTOPY RESOLVED AND THE PATIENT REMAINED IN A SINUS RHYTHM / SLOW SINUS TACH THROUGHOUT TRANSPORT AND TRANSFER OF CARE TO THE ER. A 12 LEAD WAS OBTAINED JUST PRIOR TO ARRIVAL IN ED THAT SHOWED SINUS TACH WITHOUT VENTRICULAR ECTOPY BUT WHAT APPEARS TO BE PACs, FLIPPED T WAVES IN a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

The decedent experienced severe chest pain and dyspnea approximately nine days following the first series of the vaccine. He reported to family members that he was having a "severe reaction" to the vaccine and believed it was acute pericarditis due to the same symptoms he experienced prior. He reported that on 2/1/21 around 0300 hours, the symptoms were the most severe and he was going to seek medical attention, but did not. He waited till the convenient store opened and purchased OTC Tylenol for relief of symptoms. He continued to have dyspnea and chest pain up until 2/9/21, when he called 911 complaining of chest pain and was found to have a STEMI; subsequently died at Hospital in the ER.

Severe chest pain, upper back/shoulder pain, fatigue?? dx. Acute Myocardial Infarction? angioplasty with stent

Pt had syncopal episode due to atrial fibrillation with rapid ventricular rate. Admitted to hospital 5 days after vaccination. Treated with IV amiodarone. Prior to this he had history of atrial fibrillation converted to sinus rhythm via pulmonary vein ablation in 2012 - was in sinus rhythm for 8 years.

"Feeling Hot" without fever and nausea 10 hours post vaccine and resolved within 1 hour. Seizure, Hypotension, Unresponsive followed shortly by cardiac arrest and pulseless electrical activity 21 hours post vaccine. Pronounced dead 22 hours post vaccine

2/19/2021- PCP visit for 1-week history of constipation, malaise and bilateral leg weakness . Abnormal sCr and LFTs AKI: likely ATN from rhabdomyolysis. Requiring HD 2/23/2021 initial hemodialysis 2/23/2021 kidney biopsy 3/1/2021 second hemodialysis

Around 9:55 pm on 2/27/2021 client took Afrin nasal spray for nasal congestion. About 5 minutes later (10:00 pm) client states he went into anaphylactic shock. The ambulance was called by his wife. Per client, her received infusions of epi and Benadryl from ambulance staff. Client was taken to Hospital for further treatment. He was subsequently transferred to Heart Hospital for overnight observation due to possible heart issues. Note: Client has take Afrin nasal spray for over 30 years and has never had a reaction.

Patient was found dead at his home on 2/25/2021. He was last seen at home by his sister at 8:30pm on 2/24/21.

Fever, tiredness, headache, body ache and chills and cough. Patient passed away at homeThursday, March 5 around 5:00 a.m.

per the EUA, cases of COVID-19 vaccination that result in hospitalization or death are to be reported. This patient received Moderna on 2/10 and 1/13. Patient is admitted for mild congestive heart failure secondary to cardiomyopathy

Pt. received his second moderna vaccine on 03/05/2021 and his son reported that the pt. passed away after receiving his vaccine.

Patient at the time of vaccination on 3-8-21 has having issues with shortness of breath and edema consistent with congestive heart failure, the following day on 3-9-21, he was having more issues with shortness of breath, tachycardia, low O2 saturation. He was given meds in the clinic and monitored until he was feeling better with increased O2 sats. He was found unresponsive on his housing unit one hour later and failed to respond to resuscitation efforts and was pronounced expired at 1047.

at 6am 2 days after shot, he had slurred speech, face droop, confusion, weak left side, couldn't stand up. He went to the emergency room.

Multiple pulmonary embolisms both right and left lungs , coughing up blood 5 days after second moderne shot. Very healthy non smoker , no history of heart problems. Non drinker, Heath professional DDS degree.

The patient got the Moderna vaccine on 3/2/2021. On 3/3/2021 he suffered a dissection of the ascending thoracic aorta and died.

Patient developed shortness of breath and leg swelling as well as on and off episodes of palpitations after receiving 2nd dose of Moderna vaccine. Also developed fever and chills and a worsening cough (fever and chills had since resolved).

Sister in law called on 3-19-2021 to report that had died a day after receiving his Moderna vaccine. She stated he was found in his driveway and was unable to be resuscitated after being rushed to the hospital.

ON 3-20-2021 PATIENT SPOUSE REPORTED THAT PATIENT HAD SUFFERED A STROKE APPROXIMATELY 2 HOURS AFTER THE SECOND DOSE ON 3-18-21. SHE STATED THAT HE WAS CURRENTLY HOSPITALIZED.

According to daughter pt was in his usual state of health (pt was critically ill, so daughter provided hx) until he received his 2nd dose of the moderna covid 19 vaccination at 11am on 3/24/2021. He had not had any side effects from the first dose. Around 15 hrs after getting the vaccine he started having fevers, myalgias, fatigue, and sob. He has poor po intake following the vaccine. He arrived to the ER on 3/26 in hypoxic respiratory failure, septic shock, acute renal failure, nstemi, hyperkalemic with severe b/l pneumonia on chest x ray. He expired with in hours of arrival to the ER despite full attempts at resuscitation.

Stroke; Blood clot on the brain; I Just sort of zoned out on them; Arm soreness; I Just kept getting tireder; A spontaneous report was received from a consumer, concerning a 69-years old male patient, who received Moderna's COVID-19 vaccine and experienced stroke, blood clot on brain, arm soreness without redness and swelling, he just kept getting tireder, he just sort of zoned out on them. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 037K20A) via unknown route for COVID-19 infection prophylaxis. On 05-FEB-2021, prior to the onset of events, the patient received the second of two planned doses of mRNA-1273 (lot number 032L20A) via unknown route for COVID-19 infection prophylaxis. On 05 Feb 2021, after the second dose of vaccine, the patient experienced arm soreness and fatigue, He did not get any medication or treatments for his arm soreness without redness and swelling and and just kept getting tireder events. On10-MAR-2021 patient experienced just sort of zoned out of them, stroke, blood clot on brain. An ambulance was called for him and he was taken to the hospital where he received MRIs, and CT scans. He states they think it was a stroke. No treatment medication was reported. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the events (arm soreness without redness and swelling and he was just kept getting tireder) was recovered but the events (stroke, blood clot on brain, he just sort of zoned out on them) not resolved at the time of this report.; 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.

Started with stomach pain that continued to increase. Went to E.R. After variouse test found a blood clot near stomach in vein.

DVT right leg. Total obstruction of Popiteal vein, as well as anterior and posterior tibial veins. Subsequent Pulmonary emboli to both lungs. Symptoms started about a week following 1st vaccine. The symptoms got worse following the 2nd COVID vaccine, and required an ER visit.

Experienced two TIA events - first at noon & 2d again at 3 pm on 4/7/21 upon returning from 1 hour of water aerobic exercise at gym. Then I went straight to local ER where I was admitted for observation & testing. No other cause of TIA's was found, so my doctor urged me to make this report.

Patient has had L leg blood clot and multiple mental co-morbity-Anemia, hypertension, heart disease, hypokalemia, liver enzyme off per MD, poor nutrition, tremors, hypothyrodism, COPD, small vessel disease of the brain

Undergoing COVID-19 vaccinations and developed acute hypoxemic respiratory failure with bilateral palm infiltrates. Work up inconclusive for infectious etiology. Treated preemptively for pneumonia with antibiotics and glucocorticoids. Remains on oxygen but improving.

Critically low platelets presumed ITP Patient had no symptoms. Presented for routine lab work March 24, 2021. Platelet Count 10,000 Baseline Platelets 06/2020 261K Treated with dexamethasone 20 BID x 3d. Repeat platelets 03/29 83k Follow up 04/06 platelets 2,000 Admitted and treated with IVIG Follow up locally, 70K

Pulmonary embolus. seen in ED and started on anticoagulation on 3/11/2021. Admitted to hospital 3/25 through 3/30 due to pericardial effusion

? A new stroke 24 hours after receiving the second COVID-19 vaccination Moderna On Tuesday April 6, 2021 the patient showered by himself, walked up and down stairs in the home and was able to walk with the assistance of a cane. He received the Moderna vaccination second dose at 10:00am (I believe this was an adverse event caused by the vaccination) Wednesday April 7th at approximately 1:30pm I noticed he was unresponsive prompting me to call 911. His MRI at Hospital clearly diagnosed him as having another stroke, causing patient to no longer walk and use the restroom without assistance. He is still in the hospital. Hospitalization and Physical Therapy is needed to allow patient to continue practicing as an Attorney.

4/3/21 at 0052 during Q15 rounds the patient was found laying awake on the floor next to his bed. He denied falling. Vitals showed BP 95/57, Temp 96, O2 sat 77%. He was evaluated and transferred to an acute care hospital with cardiac specialty. He was found to have elevated triponin and chest x-ray showed lung infiltrates; COVID test was negative. Diagnosis was MI and pnuemonia. He received a right coronary artery stent. The patient was intubated on full ventilation support. On 4/4/21 the patient went into cardiac arrest 3 times and was resuscitated. On 4/5/21 his condition declined and he went into cardiac arrest again and was resuscitated around noon. The patient died in acute care on 4/7/21 at 0608.

5:30 pm 3/29/21 received phone call from aunt that ems had taken dad to hospital because he was feeling unwell. he vomited prior before and just didn't feel right. ems showed up and observed him, glucose was 139..not out of range...vitals stable..2nd moderna vaccine 5 days prior...ems said that is was probably side effects...asked if he really wanted to go in...said yes, took him to hospital...5:45 daughter called hospital to get status check....she is poa for medical...er doc said he was intubated and on vent.....er doc said he was very sick...6:50 pm daughter got to er and room he was on vent and knocked out...he had antibiotics, sleeping meds..meds to rise bp in iv.....er doc came in daughter asked why he was on vent...asked about o2 doc said he was fine just unresponsive...labs were being done at time...had him on dextrose, propofol, dexmedtominine,..asked to have him transferred to own hospital..8:10 dr. comes in with lab results...kidneys and livers were showing multi organ failure...triponin was high as well..red flags were: creatine 9.93, gsr-5, hemoglobin-7, liver lft-500, triponin 14, covid test was negative, white count was in range, daughter mentioned vaccine again and doc said nothing nor did she mention heart being in trouble, no answers regarding what the cause of this was...for the record he only had kidney issues due to type 2 diabetes, was not at dialysis level...9:30 ems shows up to take dad to another hospital were not ready from him yet...9:41 dad heart started to drop on monitor withing 15 secodes iit flatlined in front of daughter......med staff did cpr...brought in epi pens and manual cpr for heart...a little after 10 heart was started it ran for 4 minutes then crashed again..10:05 continued cpr until 10:28, dr showed that walls i heart not squeezing very damaged, brought in echo during process, 10:28 time of death

Patient said that he called 911 with SOB, and he was admitted to the hospital and he stayed in the hospital for about 2 weeks. He is unsure of the date that he went into the hospital. Pt said he had a blood clot in both lungs.

About 6 ? 7 days w/ side effects ? Significant Malaise, tiredness. Unable to function or concentrate. Likely a "self inflicted" situation by unknowingly sitting in chair in a daze ultimately developing blood clots (pulmonary edema), blood clots in legs, leading to mild heart attack, hospitalization. I believe there may be a direct connection to a medical procedure (vedolizumab (Entyvio) 300 mg intravenously infusion) that preceded the vaccination on the previous Friday (2/19/21).

NSTEMI; Septic shock; Hypoxic respiratory; Hyperkalemic; Bilateral pneumonia; Acute renal failure; Shortness of breath; Fever; Myalgia; Fatigue; Poor PO intake following the vaccine; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of ACUTE MYOCARDIAL INFARCTION (NSTEMI), SEPTIC SHOCK (Septic shock), RESPIRATORY FAILURE (Hypoxic respiratory), HYPERKALAEMIA (Hyperkalemic), PNEUMONIA (Bilateral pneumonia) and ACUTE KIDNEY INJURY (Acute renal failure) in a 69-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 concomitant product the patient had taken are Norvasc , vitamin D, Metoprolol , Dexamethasone , Levothyroxine, Lexapro ,Lisinopril. the patient had certain medical history : Renal Cell Carcinoma on Chemotherapy , Hypertension , Hypothyroidism and Type 2 Diabetes Mellitus. Concurrent medical conditions included Renal cell carcinoma (on chemotherapy), Hypertension, Hypothyroidism, Type 2 diabetes mellitus, Critical illness and Penicillin allergy. Concomitant products included AMLODIPINE BESILATE (NORVASC), METOPROLOL, DEXAMETHASONE, LEVOTHYROXINE, ESCITALOPRAM OXALATE (LEXAPRO), LISINOPRIL and VITAMIN D NOS for an unknown indication. On 24-Mar-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced FEEDING DISORDER (Poor PO intake following the vaccine). On 25-Mar-2021 at 11:00 PM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DYSPNOEA (Shortness of breath), PYREXIA (Fever), MYALGIA (Myalgia) and FATIGUE (Fatigue). On 26-Mar-2021, the patient experienced ACUTE MYOCARDIAL INFARCTION (NSTEMI) (seriousness criteria medically significant and life threatening), SEPTIC SHOCK (Septic shock) (seriousness criteria medically significant and life threatening), RESPIRATORY FAILURE (Hypoxic respiratory) (seriousness criteria medically significant and life threatening), HYPERKALAEMIA (Hyperkalemic) (seriousness criterion medically significant), PNEUMONIA (Bilateral pneumonia) (seriousness criterion medically significant) and ACUTE KIDNEY INJURY (Acute renal failure) (seriousness criterion medically significant). On 26-Mar-2021, ACUTE MYOCARDIAL INFARCTION (NSTEMI), SEPTIC SHOCK (Septic shock), RESPIRATORY FAILURE (Hypoxic respiratory), HYPERKALAEMIA (Hyperkalemic), PNEUMONIA (Bilateral pneumonia) and ACUTE KIDNEY INJURY (Acute renal failure) outcome was unknown. At the time of the report, DYSPNOEA (Shortness of breath), FEEDING DISORDER (Poor PO intake following the vaccine), PYREXIA (Fever), MYALGIA (Myalgia) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Chest X-ray: abnormal (abnormal) Severe bilateral pneumonia. On 26-Mar-2021, Electrocardiogram: abnormal (abnormal) ST depression on V2-V4. On 26-Mar-2021, Troponin: 8.496 (High) High. On 26-Mar-2021, pH body fluid: 7.12 (abnormal) Abnormal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient expired with in hours of arrival to the ER despite full attempts at resuscitation. Treatment for the events included resuscitation. Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded, although it is likely the patient's underlying critical state caused or contributed to the events. The cause of death is not specifically reported and event of death retained separately, although likely caused by MI, septic shock, respiratory failure, or a combination of these events; 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, although it is likely the patient's underlying critical state caused or contributed to the events. The cause of death is not specifically reported and event of death retained separately, although likely caused by MI, septic shock, respiratory failure, or a combination of these events

Diagnosed Two Pulmonary Embolism; DVT on left leg; Coughing; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Diagnosed Two Pulmonary Embolism), DEEP VEIN THROMBOSIS (DVT on left leg) and COUGH (Coughing) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Mar-2021, the patient experienced PULMONARY EMBOLISM (Diagnosed Two Pulmonary Embolism) (seriousness criterion medically significant), DEEP VEIN THROMBOSIS (DVT on left leg) (seriousness criterion medically significant) and COUGH (Coughing) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Diagnosed Two Pulmonary Embolism), DEEP VEIN THROMBOSIS (DVT on left leg) and COUGH (Coughing) outcome was unknown. After his 2nd dose of Moderna vaccine on 01-Apr-2021, the patient's coughing become worst again. His pulmonologist prescribed prednisone and his family physician prescribed him Azithromycin. No concomitant medications were not provided. Treatment included as Eliquis, Azithromycin, cough medicine, prednisone. 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 (Patient Link).

5/4/21 presenting to the emergency department for evaluation of cardiac arrest. Prior to arrival, the patient received his second COVID shot. While there, he went into v-fib arrest. Acute inferior posterior myocardial infarction with out-of-hospital cardiac arrest

Patient had his second Moderna COVID vaccine on 5/7 while at dialysis. He would then have a stroke a few hours later. He did receive TPA as well as thrombectomy, without significant improvement in his deficits.

patient received 1st Moderna dose on 4/30/21. The next morning on 5/1 he felt pain on his left leg. He waited to see if would get better or worse. On the afternoon at an unknown time, his leg had gotten worse. He had severe pain on his left leg; it was painful to the touch; it was swollen and was hard as a rock. He called 911. He was taken to Hospital. Pt wanted me to report that he did not receive any treatment for his blood clot. He received a Lidocaine patch on his knee and was given a prescription for Voltaren Gel. (he was expecting to receive TPA to dissolve the clot like a few times before when he had blood clots but this particular time he did not)

blood clots in both legs were detected on 5/11/2021, 18 days after receiving the 2nd dose of Moderna vaccine.

5 minutes after vaccination, patient suffered cardiac arrest in clinic. CPR started immediately, shocked, EPI given. EMS transported to hospital patient expired in ED.

Unaware of any adverse events between administration and death. Reporting agency became aware of patient's expiration on 05/14/2021.

Pt developed chest pain/shortness of breath by 4/20, proceeded to local Hospital ER by 4/21 w/ N-STEMI on EKG w/ elevated troponin >8000, ECHO with global hypokinesis and mod-severe AR,, Chest CTA neg for PA/PNA. Emergent cardiac catheterization negative for CAD, Transferred to another Hospital 4/22 where cardiac MRI confirmed acute edema. he was monitored by Dr's team for 10 days with improvement in LV function and reduction to near normal troponin level. Workup neg for eosinophilic carditis. Discharged home by 5/1 w/ rest precautions and adjustments made to his BP medications. Now followed by local cardiologist Dr.

Started 5/05/21 with shortness of breath - increasing over the next 2 weeks with dyspnea on exertion Congestive Heart Failure and Cardiomegaly

Case had a physical in late 2020 that was unremarkable. He saw his PCP and had EKG done on 3/23/21 and showed Atrial Fib. PCP was concerned and referred him to Dr who diagnosed him with Atrial Fib as well. He had his second dose of Moderna vaccine on 4/1/21. Has has since been placed on Eliquis. indicated that Dr could not rule out this was due to the Moderma vaccine and requested it be reported to VARES.

COVID -19 Vaccine, Primary care MD. Wife, 5/23/2021 patient admitted through ED for chief complaint of 5 days shortness of air, tested positive for COVID-19; patient vaccinated 3/30/2021 at 'local church'. 5/24/2021 admitted to ICU - Attending, 5/26/2021 rapid response due to vitals, 5/27/2021 patient intubated due to respiratory failure/distress/hypoxia; identified in septic shock. 5/31/2021 went to surgery for left forearm and hand compartment syndrome. 6/3/2021 Code blue called, 6/3/2021 date of death. Allergies: Losartan (other) and Verapamil (intolerance) Date of Vaccination: 3/30/2021, Dose: 2, Vaccine Manufacturer: Moderna Lot #: Clinic Administering Vaccine: "local church" - no specific name was provided, Injection site: Description of event/reaction: Patient does not have vaccination card and reports not knowing date of first vaccine or exact clinic location. Date of Hospitalization: 5/24/2021 Reason for clinic visit or hospitalization: Shortness of air COVID-19 positive test result: Yes or No; if Yes, date 05/23/2021

diagnosed with pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (diagnosed with pneumonia) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced PNEUMONIA (diagnosed with pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (diagnosed with pneumonia) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient's concomitant medication was not reported. No treatment 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 event, a causal relationship cannot be excluded. No further information is expected at this time.; 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. No further information is expected at this time.

a blood clot from the left groin to the foot. desolved using blood thinner process. Still receiving treatment as of today.

Took 600mg of Ibuprofen (200mg x3) orally at 7:45AM, 30 minutes later while viewing a medical webinar at my desk at home, I suddenly noticed significant itching of my entire hands which quickly became reddened and progressively swollen as the itching sensation become more generalized within 10-15 minutes. I got up from my chair to go tell my wife but as I walked a few paces, I became extremely weak with visual 'closing in' as I barely prevented myself from collapsing to the floor / losing consciousness. At the same time my tongue was now thickened and malfunctioning making my spoken words to my wife almost unintelligible - all consistent with a CLASSIC ANAPHYLAXIS REACTION. My wife helped me to the couch to recline where I carefully swallowed CHLORPHENIRAMINE 8MG, FAMOTIDINE 20MG; and 15 minutes later DIPHENHYDRAMINE 50MG (I did not have any Epinephrine available from prior 'bee sting kits'). At no time was my breathing impaired nor was there any audible wheezing or dyspnea. After ~45 minutes I was improving noticeably, and after ~2-3 hours I had made a 100% recovery with no sequelae thereafter. Although I had taken my routine morning medications several HOURS PRIOR, nevertheless, (after purchasing several vials of Epinephrine 1mg/1mL for protection in case of another reaction), after this event and over the succeeding days I re-added each of those medications separately / one-at-a-time to ensure that NONE of those was the offending agent - NO problems ensued. For obvious reasons, I have 100% AVOIDED ingesting Ibuprofen or other typical NSAIDs since this episode (although my routine single daily aspirin tablet has presented no problems). BOTTOM LINE: DESPITE HAVING USED IBUPROFEN 400MG OR 600MG PERHAPS 1-2 TIMES WEEKLY AS NEEDED FOR MUSCULOSKELETAL DISCOMFORT OVER MANY YEARS, NEVER UNTIL THIS ANAPHYLACTIC EPISODE 11 DAYS AFTER MY SECOND DOSE OF MODERNA'S COVID-19 VACCINE HAD THERE EVER BEEN ANY TYPE OF ADVERSE REACTION TO IBUPROFEN WHATSOEVER.

I had soreness in my arm the next day and an A-fib episode. I have a history of heart arrhythmias that usually last 8-11 hours at a time, but this episode lasted longer. On the night of February 1, I had a shorter episode but I went to the cardiologist on February 2. He ran tests that showed everything was ok and prescribed the drug Multaq.

The patient received the first dose of vaccine on March the 1st and the 2nd dose of the vaccine on March 28th. Patient had difficulty breathing with swelling feet and ankles that did not begin until April 12th. Patient had no history of breathing problems. Cardiovascular history is unknown at the pharmacy as we had only ever performed vaccinations on the patient. Patient was discovered in his house deceased. Exact date is unknown. The pharmacy was contacted by the patient's prescriber which requested we file this report. I apologize for the lack of precise information.

Patient died of a sudden heart attack at age 70, just 2 months after receiving his 2nd dose of the vaccine. His parents lived well into their mid-eighties and patient spent the last 17 years of his working years as a door to door, getting lots of cardio exercise every day. At the time of his death he was a very low stress person and taking good care of himself.

Pt began having SOB and lethargy around 03/2021. Increasing SOB in April until May. 6/11/2021 patient had emergent SOB and decreased LOC. Wife called EMS. Pt transported to ED for eval. Bilateral PE shown on CTA.

Patient presented to the ED on 5/2/2021 for acute back pain, unable to ambulate, unstable angina, NSTEMI and was subsequently hospitalized. Patient received second dose of vaccine on 5/24/2021. On 6/24/2021 he presented to the ED in cardiac arrest and did expire. These visits were within 6 weeks of receiving COVID vaccinations.

Was found on the floor, snoring with foam forming out of his mouth. Was sent to the emergency room suffered a heart attack, passed away June 21, 2021.

four 2 liters of pee flushed out of body; A-fib; 25 pound water weight gain; dry cough with phlegm; feeling tired; Water blisters on leg where skin was coming off; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (A-fib), FLUID RETENTION (25 pound water weight gain), URINE OUTPUT INCREASED (four 2 liters of pee flushed out of body) and PRODUCTIVE COUGH (dry cough with phlegm) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 5A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high. Concomitant products included IBUPROFEN, POTASSIUM and OMEPRAZOLE for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLISTER (Water blisters on leg where skin was coming off). On 13-Jun-2021, the patient experienced PRODUCTIVE COUGH (dry cough with phlegm) (seriousness criterion hospitalization prolonged). On 23-Jun-2021, the patient experienced ATRIAL FIBRILLATION (A-fib) (seriousness criteria hospitalization prolonged and medically significant) and FLUID RETENTION (25 pound water weight gain) (seriousness criterion hospitalization prolonged). On 27-Jun-2021, the patient experienced FATIGUE (feeling tired). On an unknown date, the patient experienced URINE OUTPUT INCREASED (four 2 liters of pee flushed out of body) (seriousness criterion hospitalization prolonged). The patient was hospitalized from 23-Jun-2021 to 26-Jun-2021 due to ATRIAL FIBRILLATION, FLUID RETENTION, PRODUCTIVE COUGH and URINE OUTPUT INCREASED. The patient was treated with GUAIFENESIN (MUCINEX) for Cough, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN (MUCINEX DM) for Cough, at an unspecified dose and frequency. On 26-Jun-2021, FLUID RETENTION (25 pound water weight gain) had resolved. At the time of the report, ATRIAL FIBRILLATION (A-fib), URINE OUTPUT INCREASED (four 2 liters of pee flushed out of body) and BLISTER (Water blisters on leg where skin was coming off) outcome was unknown and PRODUCTIVE COUGH (dry cough with phlegm) and FATIGUE (feeling tired) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information included blood pressure medication. Treatment information included Blood thinner (not specified) for A-fib. The patient reported four 2 liters of pee flushed out of his body where he went from 259 pounds upon admission to 226 pounds on 27June2021. The patient had an appointment with his cardia doctor for the A-fib 06july2021. Action taken with M-RNA-1273 (Moderna Covid-19 Vaccine) in response to the event was not applicable. Company Comment : Very limited information regarding these events have been provided at this time. The long latency period and patient's history of high blood pressure may be confounding factors to the events. Further information has been requested.; Sender's Comments: Very limited information regarding these events have been provided at this time. The long latency period and patient's history of high blood pressure may be confounding factors to the events. Further information has been requested.

Infection; Diverticulosis episodes; Shivers; Shattering; 2 small blood clots one in each lung; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (2 small blood clots one in each lung), INFECTION (Infection), DIVERTICULUM (Diverticulosis episodes), CHILLS (Shivers) and FATIGUE (Shattering) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011M20A and 029K20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high. Concomitant products included MORNIFLUMATE (FLOMAX [MORNIFLUMATE]) for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021, the patient experienced PULMONARY EMBOLISM (2 small blood clots one in each lung) (seriousness criteria hospitalization and medically significant), DIVERTICULUM (Diverticulosis episodes) (seriousness criterion hospitalization), CHILLS (Shivers) (seriousness criterion hospitalization) and FATIGUE (Shattering) (seriousness criterion hospitalization). On an unknown date, the patient experienced INFECTION (Infection) (seriousness criterion hospitalization). At the time of the report, PULMONARY EMBOLISM (2 small blood clots one in each lung), INFECTION (Infection), DIVERTICULUM (Diverticulosis episodes), CHILLS (Shivers) and FATIGUE (Shattering) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information included high blood pressure medication (unspecified). At the time of report, the patient was at the hospital. Treatment information included medication for blood clots (unspecified). 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.

DVT; MRSA; Left leg swelling; Pain; Hardened leg as hard as a rock; Skin is tight; This spontaneous case was reported by a patient and describes the occurrence of DEEP VEIN THROMBOSIS (DVT) and STAPHYLOCOCCAL INFECTION (MRSA) in a 69-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 Neuropathy and Blood pressure high. Concomitant products included CARVEDILOL (COREG) for Blood pressure high, GABAPENTIN for Neuropathy, DIGOXIN and SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) for an unknown indication. 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 DEEP VEIN THROMBOSIS (DVT) (seriousness criterion medically significant), STAPHYLOCOCCAL INFECTION (MRSA) (seriousness criterion medically significant), PERIPHERAL SWELLING (Left leg swelling), PAIN IN EXTREMITY (Pain), LIMB DISCOMFORT (Hardened leg as hard as a rock) and SKIN TIGHTNESS (Skin is tight). The patient was treated with APIXABAN (ELIQUIS) ongoing since an unknown date for DVT, at a dose of UNK dosage form; VANCOMYCIN ongoing since an unknown date for MRSA wound infection, at a dose of 1 dosage form and CEFEPIME ongoing since an unknown date for MRSA wound infection, at a dose of 1 dosage form. At the time of the report, DEEP VEIN THROMBOSIS (DVT), STAPHYLOCOCCAL INFECTION (MRSA), PERIPHERAL SWELLING (Left leg swelling) and PAIN IN EXTREMITY (Pain) outcome was unknown and LIMB DISCOMFORT (Hardened leg as hard as a rock) and SKIN TIGHTNESS (Skin is tight) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. For the last 6 weeks, patient was being treated with vancomycin and cefepime for MRSA infection. 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.

07/15/2021 patient became diaphoretic, nauseous and vomiting. Became hypotensive with BP 61/37. Sent to ED. Pt admitted to ICU for large subcapsular left renal hematoma with extravasation; large perinephric hematoma. Hematoma and inflammation extend into left pelvis; largest area of clot measuring 8.5 cm. No evidence of trauma or tumor. Pt also dx with Acute Kidney Injury. INR was 3.3. Pt treated with Kcentra, 2 units FFP and 2 units PRBCs.

vaccine dose 1 on 6/1/21 and dose 2 on 6/28/21 at pharmacy. arrived at hospital on 7/17/21 - in ER found to have bilateral pulmonary embolisms especially on the right side with possible right pulmonary infarct as of 7/18/21 currently being treated with heparin drip and admitted as inpatient IV dilaudid required to manage pain outcome unsure at this time - remains in hospital receiving acute treatment at time of report

About 2 weeks after the vaccine, I started having difficulty breathing and shortness of breath. I called my PCP who prescribed me Albuterol nebulizer 4 times a day. I was still having difficulty breathing so my PCP was going to order a chest x-ray. My symptoms were so bad I just decided to go to the ER. At the ER, they did blood work and chest x-ray and found fluid in my lungs. I was admitted to the hospital and stayed 6 days. I was hooked up to an EKG and given an IV. A cardiologist consulted with me and diagnosed me with A-fib. I was discharged with new medications, a portable defibrillator and to follow up with a cardiologist. I followed up with cardiologist who had to shock me 2 times to get me back into normal rhythm. I have reoccuring A-fib and will follow up with cardiologist for my plan of care.

About 2 weeks after first COVID-19 vaccine, patient states he had trouble breathing and called 911. He states he was diagnosed with multiple blood clots at the hospital. He doesn't recall exact dates, states the difficulty breathing started at 2am. Was taken to on .

Atrial fibrillation; Water rentention; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Apr-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 25-May-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criterion medically significant) and FLUID RETENTION (Water rentention). At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation) and FLUID RETENTION (Water rentention) outcome was unknown. The concomitant medications were not reported. The treatment information was not provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested

*Atrial fibrillation . No prior instances.* Vaccine 1/20/2021. On 1/21, 25 hours after vaccine felt slight pressure in chest and rapid heat beat. Heart rate 150. EKG in Cardiologist's office. Admitted to hospital On 1/22/2021 -- DC (Direct Current) Cardioversion Procedure Prior to the procedure, a transesophageal echocardiogram was performed which showed no evidence of left atrial appendage thrombus. The patient was successfully cardioverted on the 1st attempt after administration of 150 joules using a bi-phasic defibrillator. A post cardioversion EKG was obtained and reviewed. The patient tolerated the procedure well with no complications. Post-procedure vitals: HR 65 BP 119/71 O2 sat 99%

Patient has a history of advanced melanoma with brain metastasis. He developed seizure disorder as well and had some mild seizures at home over the prior month. He received the vaccine at 4pm and was monitored in the office for 15 minutes. He then went home with his daughter whom he lives with. He ate dinner with her and read until 8pm when he went to his room. She found him in his room at 9pm unresponsive with seizures. Hospice was alerted and recommend oral valium. He continued to be unresponsive and expired the following day at 7:30 pm.

had afib ablation 3 yrs ago with no indications of recurring until the day after receiving this vaccine. heartrate has been around 60 since ablation and pacemaker installed, now since shot, between 85-105. I have had dizziness, no energy, pain in chest and left shoulder, nausea, vomiting, fall, chills, no appetite, no energy, and unsteady. I am writing this 5 days after shot and still have effects.

Vaccine given on 01-25-2021. Wife reported on 01-29-2021 that patient had a ran a fever on 01-26-2021, Was better on 01-27-2021. She found him dead when she came home work on the evening of 01-28-2021.

Tachycardia >120, fever 101.3 , bp 169/104, difficulty breathing, atrial afib, headache patient had moderately severe covid disease 3/15/2020-4/10/2020

Experienced atrial fibrillation- after leaving site. Went to Hospital and without treatment, restored heart rhythm after several hours and was released to follow up with primary doctor

Following morning: patient was almost incoherent, had a temperature of 105.1, and terrible pains in his legs. Tylenol was finally able to reduce the fever, but the next day it rose to 102, and the following day also to 102, still having pains in his legs. On day 4, his oxygen level dropped to 80 (he did have congestive heart failure exactly one year ago, but it was corrected in ten days and his oxygen level had been perfect until the vaccine). We are now on day 6 and his oxygen is slowing improving after increasing Lasix. His body had an awful shock with this vaccine which medical people feel contributed to him almost sinking to congestive heart failure again. Even with all his medications he presents as a healthy individual usually.

per the EUA, cases of COVID 19 that result in hospitalization or death are to be reported: This patient received Moderna 1/7 and on 1/16 they were COVID positive. Patient was admitted for pneumonia Length of stay 15 days

Pt developed severe nausea vomiting 3 days after vaccine administration. Unable to tolerate PO including meds. Went into DKA and had NSTEMI following.

Received Covid vaccine in am. Last seen by family at 17:30 pm and observed to be well. About an hour later he collapsed, unresponsive. A 911 call was initiated at 18:29. Paramedics arrived to find the patient in cardiac arrest. CPR/ACLS was initiated, but resuscitation was unsuccessful. Pt. was transported to MC where he was pronounced dead at 19:32. There was no sing of an injection site reaction, nor of allergic reaction..

70 yo man with multiple severe medical comorbidities received his first dose of Moderna COVID-19 vaccination without incident. 8.5 hours later, he was noted by his family to be in his usual state of health. 9.5 hours after the vaccination, he was found down by his family in cardiac arrest. Resuscitation attempts were not successful, and the patient died.

INCREASED BEGAN DAY AFTER DOSE (FRIDAY), SPOUSE NOTICED SLURRED SPEECH AND DROOLING STARTING SATURDAY MORNING AND EXTREME FATIGUE ABOVE BEYOND NORMAL "ROCK BOTTOM TIRED". RIGHT SIDE OF FACE A LITTLE SLACK. SPOUSE GOT PT IN TO OFFICE YESTERDAY, WEDNESDAY THE 17TH, AND WAS DIAGNOSED WITH BILATERAL PNEUMONIA AND BELL'S PALSY. DR ADVISED THEM TO CONTACT US TO REPORT.

Pt received first dose of COVID-19 vaccine on 2/12/2021. Pt presented to ED 2/18/2021 with shortness of breath and confusion. He reported having an exposure to someone positive for COVID-19 prior to date of vaccination but was unaware of exposure until after. Pt had findings indicating pneumonia on chest X-ray and required supplemental O2 with admission to hospital (2/18/2021). Pt was discharged the evening of 2/21/2021.

Pt was hospitalized Jan 18, 2021 after he had fallen outside overnight and lay there approximately 12 hours until he was found. Hypothermic & rhabdomyolis diagnosis. Gradually improved w/ strength & mental status - was in swing bed @ hospital. He got his first Covid 19 shot on 2-8-21. Was fine @ 0300 on 2-9-21 and @ 0430 he was found unresponsive. Dx: probable arrythmia & pronounced dead @ 0454. Noted on pain scale @ 2/8/21 @ 21:11, clients pain was a 7/10 They offered pain med & he refused They repositioned & distracted him @ 2047 on 2/8/21 Pain had decreased to 3/10 and nothing given. Then @ 0300 check he was sleeping and @ 0430 unresponsive.

For the first time ever my pulse was erratic, going from 47 to 155. Then on 2/15, pulse was again erratic, and EKG showed AFib. Never happened before, no history

Patient received Covid Vaccine Moderna at 1145, multiple syncopal episodes at pharmacy, sent to ER. Outcome Death

Possible heart attack on 2/5/21. Complaint: " On Feb 5th l believe l experienced a mild hear attack" (Comment: He said he felt "clammy, sweaty, excruciating pain on my left side - including his left arm, and left leg, dizzy, exhausted." This happened after work, and after taking a shower. He said that was the first time he's experienced it, and that it has not happened since then. He said he has constant headaches, "It just went away yesterday."

Dead on the bed with his legs dangling off one side of the bed; Complained about an upset stomach; A spontaneous report was received from a nurse concerning a 70-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273). The patient's medical history included hypertension and diabetes. No concomitant medications were provided. On 20 Feb 2021, Saturday, the patient received their dose of mRNA-1273 (Batch Number: Unknown) for prophylaxis of COVID-19 infection. On 21 Feb 2021, Sunday 9:36 AM the patient's experienced an upset stomach and attributed it to dinner last night and later on 22 Feb 2021, Monday he was found dead on the bed with his legs dangling off one side of the bed. The cause of death was unknown. Treatment information for event upset stomach included half a spoon of an Indian thing. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of the event upset stomach was fatal and patient died on 21 Feb 2021.; Reporter's Comments: This is a 70-year-old, male patient, who received Moderna's COVID-19 vaccine and history of risk factors for CAD such as hypertension and diabetes, was found dead 2 days after vaccination. Very limited information regarding this events has been provided at this time. Further information has been requested; Reported Cause(s) of Death: Unknown cause of death

Pt went to ER due to shortness of breath one day after vaccine on 2-19-21. Pt was diagnosed with pneumonia and was given antibiotics. stated the antibiotics gave the patient leg pain and then had to get pain medications.

Pneumonia in left lung; A spontaneous report was received from a consumer concerning a 70-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and developed pneumonia in the left lung/pneumonia. The patient's medical history included a heart transplant and diabetes. No concomitant product use was reported. On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) in the left arm intramuscularly for prophylaxis of COVID-19 infection. On unknown date, post vaccination, the patient developed pneumonia in the left lung and was hospitalized. Treatment information included an unspecified antibiotic. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the event, pneumonia in the left lung/pneumonia, was considered unknown.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

2nd dose of Moderna on 3/9/2021 at 8:30am. At 9:00pm started having upper respiratory distress leading to vomiting and diarrhea (every 10 to 15 min) on 3/10 at 10:00 pm. Went to ER on 3/11 at 1:00am. Admitted to ER with initial diagnosis (following lab work, x-rays, etc.) of Anaphylactic Shock. Symptoms were allergic reaction, chest pain, hypotension, acute kidney failure, diarrhea, DM2, hives/rash/itching. Multiple IVs of saline, antibiotics, steroids were administered. Remained In critical care/ER for ~12 hours until stable and transferred to hospital room. Discharged on 3/12/2021 at 11:00 am.

Death Narrative: Patient with medical history significant for malnutrition and end stage COPD. Patient was on 5 to 6 liters/min of oxygen. On 3/10/21, patient received his first COVID-19 vaccination. On 3/12/21, patient was admitted to Hospice for home hospice care due to worsening of COPD. Per medical examiner, patient passed away on 3/13/21.

Light fever on evening of shot then achiness like flu symptoms, then fever spiked during the evening and around 10:00AM on Feb. 10, the fever had reached 102. But, by 10:00 PM that evening it was 98.6. I returned to work on Feb. 11 and 12. Then on Feb. 13, I developed a severe pain in my chest and back area and it persisted all day and thru the night. I could only sleep sitting up. The pain was pretty severe when I laid down flat on my back. On Feb. 15 at 7:00 AM my wife insisted I go to the ER . Initially, their computer showed I had a heart attack. So, I was admitted for Observation on Monday evening and Tue. morning the Dr. admitted me to the hospital and a heart cath. was conducted and ruled out that I had a heart attack, but they are treating me Pirocarditis. I feel that this is a side effect of the second vaccine since I have NEVER had any heart concerns prior to this.