Moderna

Within about 2 days a round red sore appeared on my left arm just below my elbow. Each day it became more sore and inflamed. Within one week it became filled with puss, erupted, bled and now seems to be filling with puss again. Now, within the last 2-3 days the injection site has suddenly developed a large red patch of mildly itchy irritation surrounding the site, with one or two other small patches starting to appear nearby. During the last few days I have also notice a dull pain coming and going in my left arm. Using my cell phone, I have taken photos of the sore in 3 stages and of the red injection area. Those photos could be submitted to my doctor or this office, via text, if helpful.

patient started to decline 1/10/2021, patient seen at facility by medical professional - patient deceased 1/13/2021

VACCINE received on Friday 1/15/2021 afternoon; Monday evening 1/18/2021 felt slight chills; early to bed. Tuesday AM awoke with severe 'bed-rocking' chills, nausea and fever 100-101 degrees. recommended I go to Hospital ER. At ER, temperature increased to 102 degrees. Covid test was negative, but cost X-ray showed reasons to suspect pneumonia. No one suggested I was just suffering acute reaction to vaccine. Returned home w/ prescription for doxycycline hyclate and request that I return to the ER the next day if I continued to feel ill. The next morning, 1/19/21, I again awoke with intense, somewhat frightening chills, vomiting and a mild fever. As instructed I returned to the ER. Assuming the COVID Test may have been a false negative, a second one was given; it too turned out to be negative, but I remained at the ER and then admitted to Hospital to remain under observation. Im the hospital the chills, nausea and fever came to an end, but acute headache and utter fatigue lasted until I was released on Jan 22. My discharge papers indicated no further signs of pneumonia or any other infection; my attending doctor, concluded that my experience was an unusually strong (and delayed) reaction to the 1st dose of the Moderna Vaccine.

1/9/21 At 3:50 am started with nausea, weakness, and complaints of body aches. Required more assistance with ADL's than previous. @ 4:28 am: complaints of SOB, O2 sats 85% on room air. Required supplement O2, with tremors noted. PRN Zofran administered for nausea. 7:42 am noted with fever, decreased O2 sats, Tylenol administered for fever. Fever continue to climb despite Tylenol, supplemental O2 increased to 4L, rapid covid test negative, new orders to start Rocephin IM x 3 days and stat Xray which showed pneumonia. Temperature continues to remain elevated- O2 status continues to decline. Sent to ER 1/9/2021 @ 4:53 pm via ambulance. Admitted to Hospital with ABT tx for pneumonia and UTI. Respiratory status continued to decline- pulmonology consulted- Placed in ICU 1/13/21 and started on steroids. Required BiPap and was eventually weaned to supplemental O2. Multiple Covid tests- all negative. GI complaints addressed with GI consult- unremarkable. Started on PPI and Linzess. Eventually was placed on telemetry floor, closely monitored by pulmonology, and was cleared for discharge on 1/19/2021 back to nursing home.

According to the staff at the Hospital, the patient was treated in their emergency room for a stroke this morning at approximately 730AM

Afib; Feeling uncomfortable; Blood sugar was around 150, which is higher than her normal levels; A spontaneous report was received from a consumer who is 76-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced atrial fibrillation, feeling uncomfortable, and increased blood sugar. The patient's medical history included diabetes and atrial fibrillation. Concomitant medications were not reported. On 02 Jan 2021, the patient received their first two planned doses of mRNA-1273 (Batch number: 025LZ0A) intramuscularly in her right arm for the prophylaxis of COVID-19 infection. On 02 Jan 2021, the patient experienced heart beating very fast and feeling uncomfortable; it lasted for a few hours. She stated it was atrial fibrillation, she had a diagnosis of this, and it only lasted a few hours. The patient also stated that her blood glucose was 150, which was higher than normal. Treatment for the events was not provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, increased blood sugar, was considered not resolved. The outcome of the events, atrial fibrillation and feeling uncomfortable, was considered resolved.; Reporter's Comments: This case concerns a 76 year-old female patient with a significant medical history of atrial fibrillation and diabetes, who experienced a serious unexpected event of Atrial fibrillation and non-serious unexpected events of Discomfort and Blood glucose increased. The events occurred one day (same day) after first dose of mRNA-1273, lot # 025LZ0A. Treatment was not reported. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded. However, patient's medical history of atrial fibrillation and diabetes were considered strong confounders.

Received first 1/15/2021 with no adverse reaction. Received 2nd dose 2/9 @ 0846 with no adverse reaction or report of feeling ill. Traveled to store and arrived approx. 2 hours after receiving vaccine. Daughter stated patient felt well and had to go to the restroom to have BM. Collapsed in bathroom. Transported by ambulance to Hospital @ 1439 in cardiac arrest. Was in PEA and went in v fib back to PEA. Resuscitation efforts initiated and patient expired with time noted at hospital records at 15:11.

Unknown onset of altered mental status. Last time known well was day of vaccination 2/3/2021. Found altered on 2/9/2021. Working diagnosis is encephalopathy: MRI unrevealing. CVA vs other etiology

Anaphylaxis shock, was given a shot of benadryl, put on an ambulance and taken to the nearest hospital. I was on oxygen therapy at the hospital for several hours then sent home.

The patient had bilateral Pulmonary Embolisms on February 8th. recommended we report this and any major incident a patient might have within 1 month of administering the vaccination.

Began walking on treadmill at 5:30 a.m. and left foot felt heavy and dragging, L hand tingling, and facial/neck numbness. Arrived at hospital at 8:15. Vitals, EKG, CT scan, and MRI conducted. MRI showed an acute mild stroke on R side of brain. Over-night stay was recommended. Echocardiogram was performed the following day and nothing was abnormal. I am now on a heart monitor for 30 days. Upon departure of hospital the symptoms in L leg and arm have nearly resolved but face is still numb/decreased sensation. Plan to contact PCP tomorrow.

Periodic pressure and tightness across chest and diaphragm especially on day of vaccination and following 2 days. Rapid heart beat followed by afib that was not terminated with normal medications. Dizziness and shortness of breath. Hospitalized with atrial fibrillation with rapid ventricular response. It resolved after getting two injections of a medication called diltiazem in the emergency department, after which I was monitored overnight in the hospital. Underwent stress test and echocardiogram - results normal. On the day I write this (March 1) continue to have shorter periods of rise in blood pressure and heart rate, diaphragm tightness, insomnia and lethargy.

Patient presented to ED with SOB and hypoxia. She stated that this is a chronic problem for her. She had a video conference with her physician who told her to go to the ER. Her O2 saturation was noted to be 87%. She was found to have pulmonary edema and received Lasix. She is also scheduled to have a cardiac cath to evaluate ventricular tachycardia. Patient remains hospitalized at this time. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

Sunday, Feb 21, 2021. Patient told her husband she didn?t feel well and she lay down next to him. She was tossing and looked like she was trying to get up. He was talking to her and she wasn?t answering him. She was having trouble breathing. Took her to the hospital right away at 7:30 pm. They put her into a comma with a respirator. Finally went from emergency room to ICU on Monday. Then on Wednesday they took the respirator out and I spoke to her ? told her we all love her and she could only say hoarsely ?terrible, terrible.? They said she might get moved to regular floor. But then Wednesday night couldn?t breathe again and put the respirator back in. Thursday morning husband had it removed and she died that evening at 10:51 on February 25.

2nd dose of covid19 vaccine administered on 1/25/21 AM. First dose was about 12/28/2021. Patient had a change in condition noted same day PM, which included worsening mental status with increased confusion such as disorientation and decreased functional status, as well as opening of pressure ulcer on coccyx. Patient became lethargic. Patient condition worsened over the next few days. Patient decreased oral intakes, including medications. Care and comfort measures were in place. Patient expired on 2/4/2021.

first vaccine (Moderna) was injected on 02/03/2021, second vaccine (pfizer) was injected on 03/02/2021, my Mother was dead on 03/08/2021. with no symptoms on 03/07/2021.

Sister reports that she was fine, the day before I took her to the dentist. Sister on 5/3/2021 called her and did not answer, so she goes to the nursing home where she resides. She finds her sister cold in the apartment's furniture. Massive heart attack

plates went from normal to 3000; A spontaneous report was received from a consumer concerning a 76-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced having platelets went from normal to 3000 (Thrombocytopenia-unspecified). The patient's medical history, as provided by the reporter, included leukemia. No relevant concomitant medications were reported. On 27 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030O20A) intramuscularly for prophylaxis of COVID-19 infection. On 07 Feb 2021, the patient had an infusion of obinutuzumab for leukemia because her platelets went from normal to 3000. She was at the hospital for three days. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event, platelets went from normal to 3000 was unknown.; Reporter's Comments: This case concerns a 76-year-old female who was hospitalized for infusion of obinutuzumab for leukemia because of a medically significant and serious unexpected event of thrombocytopenia. Event onset occurred 22 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

They proceed to take the round and at that moment they realize that she was not breathing, she was already compromised . He dies of heart failure.

02/20/2021Shortness of breath on climbing 15-20 stairs, 02/24/2021/D-dimer test very high, 02/24/2021Admitted to hospital. CT Angiogram showed blood clots in lungs. Administered IV Hyperin. scans of legs-no blood clots, Scan of heart and arteries. 02/26/2021Released with perscription of Eliquis. 03/04/21 Blood test by Hematologist Normal; 03/08/21 CT Scan of body-Normal-no tumors/cancer detected

Patient received 1st vaccine on 3/24 with no issues reported. Patient returned on FRiday for routine treatment and was afebrile, BP within normal limits and no compliants. Left the unit stable post treatment. Patient passed away on Saturday morning. There was no hospitalization. Patient went straight from home to the funeral home. Daughter states that patient had been feeling warm since Wednesday.

Pt is a previously healthy 76 year old woman who received her covid vaccine 2 wks ago. She received Moderna vaccine on 3/8/21. On 3/16/21 She developed symptoms of fatigue, chills, body aches, decreased exercise tolerance. 3/19/21 exercised at YMCA as she does regularly. She was not able to do her usual level of activity and was only able to exercise low level for 10 minutes. Yesterday was very sob and after washing 2 windows had to lay down and rest. In my office the nurse rooming the pt noted the pt to be very winded and sob just ambulating from waiting room to the exam room. Pox was down to 89% and took a while to come up to 94%. Transferred to Hospital ED. DiagnosedDiagnosis: Acute hypoxic respiratory failure secondary to massive Pulmonary Emboli, DVT without known precipitating factors. pt without previous history of clotting disorder, no known neoplasm, no recent travel or sedentary period. unprovoked DVT with MASSIVE PE. patient did not have previous pulmonary disease. Additional information for Item 19: studies: PO Chest Final Result Stable chest. No new opacities are identified in this patient with known extensive bilateral pulmonary embolus. US Venous Duplex Lower Extremity Bilateral Final Result 1. Acute DVT involving the right popliteal and posterior tibial veins. 2. No acute DVT involving the left lower extremity. CT PE Protocol WITHOUT legs Final Result 1. Positive exam: Large-volume central pulmonary emboli seen in both main pulmonary arteries with extension bilaterally into all lobes. Dilated right heart chambers suggesting acute right heart strain. 2. Peripheral groundglass opacities in the right upper lobe may represent small area of pulmonary hemorrhage or developing infarct. Red Level 1 findings were entered into the system. | Actionable Findings system for documentation and communications on 3/22/2021 4:31 PM, Message ID 191499. 3. Pulmonary nodules in the right lower lobe measure up to 4 mm maximally. See below consensus guidelines. TTE - INTERPRETATION SUMMARY: Left ventricle is normal in size. There is normal left ventricular systolic function. The quantitative LVEF based on modified Simpson's method is 62%. There is asymmetric septal hypertrophy with maximal wall thickness of 1.3 cm. There is mild (grade I) diastolic dysfunction with normal left atrial pressure. Right ventricle is normal in size. There is normal right ventricular systolic function. No previous echocardiogram in Froedtert Health system for comparison.

Patient had the 2nd Vaccine on 3-25-2021 and Passed away on 3-28-2021. our tech found out. No clue if it is related to the vaccine or not.

Mandatory EUA Reporting - Patient received Moderna COVID-19 vaccine on 1/4. She was living with someone who was diagnosed with COVID-19 on 1/11. Patient was tested on 1/11 and was negative for COVID-19. Then about 4-5 days later developed symptoms and tested positive. She was admitted to hospital on 1/20/2021 to medical floor, transferred to ICU on 1/27, and died on 2/5/2021.

Sore arm; Transient ischemic attack, symptoms of tia; A spontaneous report was received from a consumer concerning a 76-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced symptoms of transient ischaemic attack (TIA), transient ischemic attack/transient ischaemic attack and sore arm/pain in extremity. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 13 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unspecified date patient had sore arm like from a flu vaccine. On 24 Jan 2021, the patient went to emergency room thinking patient had a TIA (transient ischemic attack). TIA was not detected at that time but found one later which is considered as medically significant event. Patient had all the symptoms of TIA to the point where patient could not talk, right leg was numb, and eyes went grey. It is unknown whether the patient had history of TIA. The patient had a brain scan, heart tests, and an MRI whose results were not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

RECEIVED VACCINE ON 2/5/21 AND WAS FOUND DEAD MORNING OF 2/7/21. SHE HAD NO SIDE EFFECTS OTHER THAN SLIGHTLY SORE ARM UP TO THAT POINT. ED MD FELT SHE HAD SIGNIFICANT CARDIAC HISTORY AND LIKELY HAD MI. MEDICAL EXAMINER DID NOT ORDER AN AUTOPSY AND SHE WAS CREMATED. I FELT THAT I SHOULD JUST REPORT IT SINCE IT WAS SO CLOSE TO RECIVING THE VACCINE.

3/18/21 admitted via ER for Transient cerebral ischemia (left sided weakness/paralysis primarily left arm)- discharged 3/19/21 3/19/21 Acute Stroke (progression of symptoms, involving left arm and leg/foot drop)- transported via ambulance to ER and admitted again, then transferred to inpatient rehab ~3/23/21 and discharged to home 3/31/21

On 3/11, patient complained of shortness of breath with ambulation. She was sent to the ED and diagnosed with pulmonary embolism. Negative for DVT.

Issues with her heart pushing fluid; Cellulitis collecting fluid; Missed 2nd Dose due to hospitalization; Did not feeling well; Extreme pain because she is in need of reverse shoulder replacement bad knee and back; Extreme pain because she is in need of reverse shoulder replacement bad knee and back; Nausea; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of CELLULITIS (Cellulitis collecting fluid) and CARDIAC FAILURE (Issues with her heart pushing fluid) in a 76-year-old female 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 Cardiac catheterization. Concurrent medical conditions included Cellulitis. Concomitant products included APIXABAN (ELIQUIS) for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 23-Mar-2021, the patient experienced CELLULITIS (Cellulitis collecting fluid) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced CARDIAC FAILURE (Issues with her heart pushing fluid) (seriousness criteria hospitalization and medically significant), PRODUCT DOSE OMISSION ISSUE (Missed 2nd Dose due to hospitalization), MALAISE (Did not feeling well), BACK PAIN (Extreme pain because she is in need of reverse shoulder replacement bad knee and back), ARTHRALGIA (Extreme pain because she is in need of reverse shoulder replacement bad knee and back) and NAUSEA (Nausea). The patient was hospitalized on 23-Mar-2021 due to CARDIAC FAILURE and CELLULITIS. At the time of the report, CELLULITIS (Cellulitis collecting fluid), CARDIAC FAILURE (Issues with her heart pushing fluid), MALAISE (Did not feeling well), BACK PAIN (Extreme pain because she is in need of reverse shoulder replacement bad knee and back), ARTHRALGIA (Extreme pain because she is in need of reverse shoulder replacement bad knee and back) and NAUSEA (Nausea) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed 2nd Dose due to hospitalization) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. patient missed second dose of vaccination due to hospitalization. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter stated that hospitalization has nothing to do with the vaccine. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Reporter stated that hospitalization has nothing to do with the vaccine. Very limited information regarding the events has been provided at this time. Further information has been requested.

On 4/13 patient's daughter in law called public health department to report that patient was found by EMS on 3/12/21. They believe patient had passed away over night. No autopsy was done. Family member reported that EMS believed the cause to be heart attack or pulmonary embolism.

Two blood clots in right lung two days after second vaccine. I was hospitalized and I am now on oxygen 24/7 and I?m taking blood thinner Eliquis.

Initially had headache, sore arm, chills, but on 4/1/21 had to go to ER with a stroke, and then on 4/5/21 had a TIA

12 hrs after receiving, did not feel well headache , nausea, 48 hrs later had seizure during sleep ,affecting her speech , speech got worse over the day drs were running test , then had another seizure causing them to resuscitate, hospital was giving he4 seizures medications , she was giving 5 and a small amount of sedation, 1# days later they had them almost to a halt , ran several test to determine what could have caused the seizures and could find no reason , she never regained consciousness, she passed away 18 days later . I would like to know if the vaccine caused the seizures .

pain in right lower extremity few hours after first and second vaccine. pain then returned and was diagnosed with Right lower extremity DVT

Transient ischemic attack; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) (seriousness criterion hospitalization). The patient was hospitalized from 15-Apr-2021 to 16-Apr-2021 due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. Further information has been requested.

they did ultrasound and found a blood clot in her right leg behind the knee; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. Concomitant products included LIRAGLUTIDE (VICTOZA) and INSULIN GLARGINE (TOUJEO) for an unknown indication. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (they did ultrasound and found a blood clot in her right leg behind the knee) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Ultrasound scan: found a blood clot in her right leg behind the kne (abnormal) found a blood clot in her right leg behind the knee. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included xarelto 15mg. Concomitant medication included BP medicine. Her right leg started swelling and turned red a week ago(10Apr2021). She went to the doctor on 12Apr2021 and they did ultrasound and found a blood clot in her right leg behind the knee (12Apr2021). She is scheduled to get 2nd dose on 22Apr2021. She never had blood clot before so wanted to report it. 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

Patient received her 2nd dose of the Moderna Covid-19 vaccine on 4/20/2021 at 0935. On 4/25/2021, patient presented to the ER with SOB and mild CP that began after she walked a 1/2 mile to her nephew's home. Pt was diagnosed with bilateral PEs and admitted to the hospital for treatment. At this time patient is stable, improving , and remains admitted to the hospital.

Patient rec'd Moderna COVID vaccines 1/30/21 and 2/27/21. On 4/3 she presented to the emergency department following a syncopal episode. Prior to syncopal episode she had a 2 week history of dry, nonproductive cough, left side rib pain (Pain rating 8/10). She was admitted and treated for PE and possible pneumonia. She was discharged 4/5 on warfarin anticoagulation. She had follow up appointments with PCP and hematology and will likely be on anticoagulation for unprovoked PE x 6 months.

clot in her lungs; This spontaneous case was reported by a non-health professional and describes the occurrence of PULMONARY EMBOLISM (clot in her lungs) in a 76-year-old female 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PULMONARY EMBOLISM (clot in her lungs) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (clot in her lungs) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were provided. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the onset date of the reported event of pulmonary embolism, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-075030 (E2B Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported event of pulmonary embolism, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-075030:Patient's brother in law case; cross linked case

I got blood clots. I do not know if they were related to the vaccine or not. I was on Eliquis and took it as prescribed. I was put on another blood thinner.

Vaginal bleeding that started 1 day after receiving first dose; ultimately diagnosed with endometrial/uterine cancer

On 5/6, the patient reports she was hospitalized on 4/14 after experiencing myocardial infarction, syncope, and fall resulting in the patient hitting her head

I had my first vaccine in February and got along fine. My second shot was in March and the first thing I noticed was the shot hurt so bad, and I am not a whiner. The second day my arm hurt so bad i couldn't even lift it and could not use it for almost a week. The second day after the vaccine, I had a massive headache. The third day was Sunday and I was so sick with body aches, fatigue, the arm, and headache I couldn't go to church. For days and days I would wake up thinking I was better but by noon.I was a mess. A church friend mentioned she thought I had Covid bc my symptoms were so much like hers when she had the virus. Both my daughter and stepdaughter noticed how I was struggling with my speech, which has

This 76 year old female received the Moderna Covid shot on 1/30/21 and went to the ED on 2/26 /21 and was admitted on2/26 /21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident)

on post vaccine day #9 pt developed light bruising r antecubital [vaccine was l deltoid] and knots. she has had ongoing mild nontraumatic bruising here and sq nodular lesions ? clot. pt also has had generalized malaise and some mild shortness of breath with this and has generally felt sick.

According to patient's daughter, patient only complained of nausea the day of the immunization. Patient received 2nd dose of Moderna vaccine at 4:05pm and passed away around 8:30pm that same day per daughter's account. She had no pulse upon arrival to hospital. Autopsy was not performed.

PATIENT DEVELOPED HYPOXIA, PNEUMONIA, PLEURAL EFFUSION AND LEFT LUNG PULMONARY EMBOLI PATIENT WAS TREATED WITH ANTIBIOTICS, OXYGEN ANDF STARTED ON HEPARIN DRIP, WHICH WAS D/C AND PATIENT WAS STARTED ON LOVENOX PRIOR TO D/C. PATIENT ALSO NOTED TO HAVE PULMONARY NODULES ON IMAGING AND ARRANGMENTS MADE TO F/U OUTPATIENT FOR BIOPSY.

Fatigue, feeling dizzy, not having good vision, leg cramping/hurting, HA, and SOB. She was diagnosed with myocardial Infarction in the ER with SOB adverse effect of the vaccine. She has no prior cardiac history

Very strong a-fib attack, blood pressure spiked. From 3/19 on shortness of breath when walking and pressure in head and blood pressure rise. Heart ultrasound 3/26 ok. Stress test with ultrasound 4/30 ok. Bloodwork, chest x-ray 6/4 ok. Drs. don?t know what?s going on. ER said people coming in with problems from the vaccines.

Patient presented to PCP from group home residency on 05/21/21 with C/O cough, dyspnea, fever, chills, and body aches. Known exposure to COVID-19. Rapid test in PCP office was positive for COVID-19. Chest Xray showed pneumonia. Patient admitted to hospital on 05/21/21

I felt an immediate "anaphylaxis-like" reaction right away. I had swelling of my mouth, face, eyes and nausea. I felt dizzy and light headed and had fever of 101F, headache, body aches and I could not get out of bed. I had trouble sleeping. I had trouble concentrating, decrease cognitive abilities and extreme fatigue. I did take an antihistamine (Xyzal) prior to the vaccine. I took Tylenol and Zofran for nausea. The swelling subsided after 2 days, and the acute-flu like symptoms lasted about a week. I usually see my doctor every week for weekly injection for my RA . I still have nausea and he prescribed Zofran for that. I have small-medium lost my appetite and my taste and smell have change and also itchy eye. But I have noticed increased saliva excretion.

On April 18 I developed a headache and fever (101), fatigue, tightness/pressure in my throat/esophagus. Continued through April 20, when I called my GI physician to describe symptoms. Doctor recommended going to Urgent Care to be tested for COVID 19. Within an hour or two I went for the test, which was negative. The attending doctor then ordered EKG, blood tests, and CT scan to see what was going on. Found high white blood cell count and Pericardial Effusion. Sent me to hospital, where I was admitted and spent 6 days. The diagnosis was that the Pericardial Effusion was caused by inflammation, not infection, and I was started on a combination of drugs to eliminate the fluid. I was released on April 26 with only trace fluid around my heart.

Patient presented to the ED and was subsequently hospitalized for atypical chest pain, abnormal stress test, atrial fibrillation within 6 weeks of receiving COVID vaccination.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. The first time occurred on 03/09/2021 for severe sepsis, tachypnea. The second time occurred on 3/22/2021 for Acute cystitis without hematuria.

Pt received her Moderna covid vaccines in jan and Feb 2021. She was hospitalized from 5/26/21-5/31/21 with a complicated urinary tract infection with bacteremia and pyelonephritis due to a pansensitive e coli which progressed to bacteremia and pyelonephritis despite being treated with 10 days of keflex and 3 days of macrobid as an out pt. She also had severe sepsis and a NSTEMI as a result of the illness. It is unclear why she progressed despite appropriate treatment and it was suggested an immune deficiency work up be done if she has recurrence in the future.

Developed Atrial Fibrillation (24 hours) four days after 2nd immunization. One previous episode of this arrhythmia was2.5 years previously. On 6/8/2021, I had a cardiac ablation for the arrhythmia which began in February

Platelet count was 71,000/Platelet count was 112,000/Platelet count was 169,000; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOCYTOPENIA (Platelet count was 71,000/Platelet count was 112,000/Platelet count was 169,000) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-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 THROMBOCYTOPENIA (Platelet count was 71,000/Platelet count was 112,000/Platelet count was 169,000) (seriousness criterion medically significant). At the time of the report, THROMBOCYTOPENIA (Platelet count was 71,000/Platelet count was 112,000/Platelet count was 169,000) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Platelet count: 71000 (Inconclusive) Inconclusive. On 06-Apr-2021, Platelet count: 112000 (Inconclusive) Inconclusive. On 12-Apr-2021, Platelet count: 169000 (Inconclusive) Inconclusive. No concomitant medications were provided. No treatment medications were mentioned. This case concerns a 76-year-old female with a serious unexpected event of thrombocytopenia. Event latency 36 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns a 76-year-old female with a serious unexpected event of thrombocytopenia. Event latency 36 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

March 26 first vax, no prob except tired and no energy. a week and 2 days later she went to hospital could not even change clothes , went to Dr. , then ER. they did MRI, and found out she had a stroke on right side of brain. but right side was showing weakness. Week and half later weakness in right hand. 2nd MRI left side stroke on brain, inflammation on spinal cord, short term rehab. They found UTI after going back to ER. Son got call from The 2nd ER doctor and said she was diagnosed with neuromyelitis optica very rare disease. They said she had transverse myelitis (May, 14 2021) Returned to rehab then found out she had high white blood cell count , On May 16, 2021 readmitted to hospital and did not return to Rehab until June 18 2021 . Then returned and is still in on July 2, 2021. (Inflammation of gallbladder, 4th diagnose of Shower strokes, diabetes, On July 12, 2021 in hospital was diagnosed with Covid 19 and is still in hospital

My Mom suffered a series of debilitating strokes in the early morning hours of 04/09/2021 after receiving the second dose of the Moderna vaccine on 04/08/2021.

Brain aneurysm with no prior symptoms and no medical history or family history of aneurysms. Grade three hemorrhage at brain stem. Resulting in death

Tachycardia, Afib, Pounding, Flutter (Heart) Short of Breath, runnier nose, Weak & Shaky, no Apatite.

Very heavy postmenopausal bleeding including large clots began evening of 3/12/21; ended 3/22/21. Bleeding occasionally heavy for entire time. No other symptoms.

Moderna COVID-19 Vaccine EUA -Patient to emergency room 1/10/21 with debilitating atrial fibrillation easily treated with Cardizem and Mg.. discharged to home within 2 hrs. with heart rate in the 90s BPM. -HR soon stabilized to HR 100-110 BPM flutter treated 1/21/21 with cardioversion at Hospital Outpatient Surgery. Discharged to home with heart rate in to 60s BPM sinus rhythm but irregular. Pulse Ox 94-97. Continues to present

Had Covid vaccine Friday morning, Saturday morning at breakfast started shaking, couldn't talk. Called 911 and treated for TIA. Received blood thinners, had CT scan . MRI, and echo gram on heart. Released from hospital Monday morning, no after effects.

Left deltoid IM injection on 1/26/21 Left upper extremity swelling on 1/28/21 Presented to clinic on 2/2/21 and was found to have an acute LUE DVT and an acute PE on CTA chest

Ischemic attack; Severe high blood pressure; A spontaneous report was received from a consumer concerning a 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe high blood pressure (BP) and ischemic attack. The patient's medical history included diabetes. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin calcium, bupropion hydrochloride, gabapentin, ibuprofen, estradiol and metformin. On 08 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 12 Jan 2021, the patient was taken by ambulance to the hospital with severe high BP. During her hospital stay the patient's BP readings were 190s/109. The patient was diagnosed with ischemic attack. On 14 Jan 2021, the patient was discharged from the hospital. Her BP readings since then have been 179/85. On 19 Jan 2021, the patient's BP reading was 145/80. Treatment for the event included lisinopril. Action taken with the second dose of mRNA-1273 in response to the event was not reported. The outcome of the events, severe high BP and ischemic attack, was considered unknown.; Reporter's Comments: This case concerns a 77-year-old female patient with medical history of diabetes who experienced the serious unlisted events of Hypertension and Transient ischaemic attack that required hospitalization. The events occurred approximately four days after receiving their first of two planned doses of mRNA-1273 (Lot number: 027L20A), Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine. Of note, patient's elderly age and history of diabetes are considered risk factors for the occurrence of the events.

unknown if it was moderna or pfizer. Vaccine administered elsewhere so details are not known to me. Pt received vaccine on Friday and was admitted to hospital Sunday 1/17 with CVA, right sided weakness.

rapid heart beat followed by loss of breath. Couldn't get breath. Slight nausea called the nurse and she called 911. Then started in my intestines with numerous BMs that progressed to diarrhea . Breathing subsided back to normal within a half hour but the intestines continued through the next day.

Patient received vaccine on 2/5. We were told on 2/9 that the patient visited another emergency department on 2/6 but no information was given as to what prompted that visit. She was sent home. Daughter found her on 2/6 or 2/ 7 unresponsive and she died.

I woke up the next morning and I was very short of breath much more then usual, by the next day it was even worse and everyday after. By Feb. 10, 2021 I had low fever and difficulty breathing so I went to Urgent Care, after blood work, received chest X-ray, EKG, CT scan. It came back with pneumonia. My biggest quest is can safely take the second one or a different one, with emphysema you need protection. Thank you

Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: Unknown if patient experienced adverse effects 2-13 or 2-14, patient called facility 2-15 reporting body aches and chest pressure and was told by facility to seek medical attention, she passed later that day

Emergency Dept visit on 2/17/2021 at Hospital, with complaints of wrist pain. Diagnosed with possible gout from recent Lasix initiation or reactive arthritis from COVID vaccine received at pharmacy. Admitted to Hospital on 2/23/2021 with diffuse body aches, joint pains, weakness and episode of afib/RVR. Remains hospitalized on 2/24/2021

episodes of atrial fibrillation were triggered after each dose of the vaccine, both times requiring cardioversion

pt woke up at 0400 with fever, chills, and body aches progressing over 4 hours to the point when she became unresponsive. husband called 911, pt was declared dead at the time of EMS arrival around 1200

5-6 days after receiving first Moderna covid vaccine pt. began not feeling well. On 02/10/2021 she saw a provider in an office for eval of abdominal pain and diarrhea and sent home. On 02/15/2021 she presented to a local ED with continuing symptoms, transferred to Medical Center. She is currently an inpatient there with a diagnosis of multiple blood clots in abdomen and brain and antiphospholipid syndrome.

The patient had her second Moderna shot on Feb 17, 2021. At 3 am the next morning she reported to the ED c/o being "fluish" and short of breath. She was found to be hypoxic to the upper 80's on RA, and a CXR was consistent with CHF. She stated she had some off and on chest pain for the last few weeks, especially with exertion. Ultimately it was found that she had an elevated troponin and was felt to have had an MI. She underwent cardiac cath and a stent was placed in a 95% ostial right coronary stenosis. Although she was reported as having had a "hyperimmune" response to the vaccine, I can only say for certain she had flash pulmonary edema due to cardiac ischemia that was due to a stenosis in her RCA that had been there for quite some time, but possibly just happened to become critical right after her second COVID vaccine. It would be hard to blame the vaccine, but it is also impossible I guess to absolve it from any role in her MI.

Do not know if patient informed her physician that she received vaccine on 1/29/2021. She had appt at 3:15 pm on 1/29 and afterwards stated she received the Moderna vaccine. Reporter is uncertain if this was at a health office or clinic. She drove herself to the ER at about 3am on 1/30/2021 with increased cramping and pain.

Patient developed sudden SOB 1 week after she received #1 COVID vaccine on 1/28/2021 w/o associated chest pain/palpitation/cough. Her SOB was significant enough for her to seek Urgent evaluation on 2/8 then ED evaluation on 2/11 then again on 2/20/2021. she continues to have SOB/DOE even now. She also has dizziness intermittently. she had chills initially but no fever until she had transient fever for less than 12 hours 2.5 weeks later likely associated w/ unrelated problem( UTI). so far no causes found regarding her SOB after numerous tests( see below for tests).

This is a hospice patient. She died on 2/13/2021 from her underlying medical conditions. I just received notification of the death 3/11/2021 and am reporting this immediately.

patient status started to decline within a few hours of receiving her covid vaccine she was weak, developed increased shortness of breath and went to the emergency room were she was diagnosed with STEMI and within 2 days expired.

Four hours after vaccine shot, she began with a headache then severe vomiting. She became in coherent and when brought to the hospital she had a brain hemorrhage. She passed away on 3/3/2021 at 3:05pm.

Acute Myocardial Infarction due to severe dysphagia, odynophagia, cachexia, fluid and electrolyte abnormalities, due to advanced dementia

"Moderna COVID-19 Vaccine EUA" Hospitalized CHF Exacerbation and abdominal pain, increased swelling,

Ache in back of left leg. Thought it was a muscle strain from working in yard. Did not go away so went to Clinic February 2nd, 2021. They asked me my symptoms and then sent me for a Sonagram and discovered a DVT and later a Pulmonary Embolism in my right lower lung. I am now on Eliquis.

I had quite an adverse reaction to the second MODERNA vaccine. That afternoon and evening I developed symptoms. I was experiencing chills, fever, body aches, headache, sore throat, shaking and nausea. As the week went on, my reaction became worse. I was sweating profusely and had shortness of breath accompanied with burning pain on the top of my hands and feet and a rash. On Friday morning, 5 days after the vaccine, I collapsed and had a stroke. I was rushed to hospital and was admitted. It was confirmed that I had a stroke. through a Cat Scan and MRI. On Saturday, I had another stroke. This time I was transferred to hospital. I had a huge blood clot on the left side of my brain which has effected my speech and walking. My entire life has been effected and changed. I had a plethora of tests done, MRI, CAT SCAN, EKG, BLOOD WORK etc. I also have to have speech therapy, physical therapy and occupation therapy. I spent about weeks in the hospital. The doctors think it is a possibility that the 2 Moderna vaccine caused my two strokes. What can be done about this? I will have problems for the rest of my life.

Anaphylaxis reaction; A spontaneous report was received from a consumer concerning a 77 year old, female patient who developed Anaphylaxis reaction. The patient's medical history included allergies. Concomitant product use was not provided by the reporter. Vaccination details are not provided by the reporter. After she received vaccine developed Anaphylaxis reaction. Treatment for the event included steroid shot. Now her doctor says the shot is ineffective and she can't get the second shot. She wants to know whether that information true and she is willing to take second shot despite her doctors advice. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event Anaphylaxis reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

still having problems breathing; anaphylactic reaction; A spontaneous report was received from a consumer concerning a77-year-old, female patient who developed anaphylactic reaction and still having problems breathing (dyspnea). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received the unknown of two planned doses of mRNA-1273 (Batch number: 030M20A) on 24 Feb 2021 intramuscularly at unknown injection site for prophylaxis of COVID-19 infection. On 24 Feb 2021 the patient experienced anaphylactic reaction (lips went numb, face went numb, blood pressure went up, heart rate went up, her throat closed, and she couldn't breathe or talk). An ambulance was called and the patient was transferred to the ER (emergency room) where they administered intravenous diphenhydramine. Five hours later, the patient was okay, but reported that as of 25 Feb 2021, they are still having problems breathing. Treatment of the events included prednisone and diphenhydramine. Action taken with mRNA-1273 in response to the event was not provided. The event anaphylactic reaction was considered resolved. The outcome of the event, still having problems breathing, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

A-fib; difficulty breathing; sleeping on and off; dry heaving, feeling nauseated, not hungry; weak; chills; mild headache; Tired/fatigue; muscle pain on the arm; joint pain; Feeling nauseated; A spontaneous report was received from a consumer concerning a 77-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain. The patient's medical history, as provided by the reporter, included prior COVID-19 infection. It is not clear if the patient had prior A-Fib. No relevant concomitant medications were reported. On 25-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On 25-Jan-2021, patient was feeling fine right after first dose of the Moderna vaccine. On 26-Jan-2021, the patient felt difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tiredness, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain. Lab details was not provided by the reporter. Treatment for the events included rubbing gel. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events, difficulty breathing, chills, mild headache, sleeping on and off, fatigue, tired, A-fib, dry heaving, feeling nauseated, muscle pain on the arm, not hungry, weak and joint pain was unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Painful R Deltoid x 2 days, followed by chills, fever, diarrhea evening of day 3. Malaise day4. Tight feeling (semi headache) from then on (probably related to Increased BP) culminating in BP of 202/102 and TIA day 10. Taken to ED. CT scan performed-no bleeding. Physicians assumed TIA caused heightened BP. Not so. BP decreasing graduallly, today, day 13 now around 135/80 (still elevated for me). semi-H/A resoluved.

2/22/21- Resident began falling multiple time and reporting loss of feeling in her Rt leg. Sent to ER. Diagnosis with multiple acute CVA and Rt sided hemiplegia

Family stated she felt fine after shot. Had upset stomach night before her death. Took tums. Died in sleep.

Symptoms like a stroke; Slurring her words; Became uncoordinated; Not feeling 100%; Very nauseous; Little headache; Tired for a few days; A spontaneous report was received from a consumer concerning a 77-year-old female patient who experienced slurring her words (dysarthria), became uncoordinated (coordination) abnormal and had symptoms like a stroke (cerebrovascular) accident, felt very nauseous (Nausea) and not feeling 100% (Malaise). The patient's medical history was not provided. Relevant concomitant medications reported included Baby Aspirin and Vitamins NOS for unknown indication. On 10 Mar 2021, prior to the onset of symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number: 048AZIA) intramuscularly for prophylaxis of COVID-19 infection. On 11 Mar 2021, the patient began slurring their words, became uncoordinated and had symptoms like a stroke. The patient was also very nauseous and went to the emergency room. The event, symptoms like a stroke was considered medically significant. On, the same day, the patient was discharged. The patient still was not feeling 100% still. No Treatment information were provided. Action taken with mRNA-1273 in response to the event(s) was Not applicable. On an unknown date, the outcome of the event, was slurring their words, became uncoordinated and had symptoms like a stroke, felt very nauseous and not feeling 100% resolved on 11MAR2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Pt explained that she was sleeping and her cat woke her up, she said her heart was pounding and it wouldn't stop so she drove herself to the hospital thinking it was an anxiety attack. Upon arrival pt was examined and told it was likely a myocardial infarction and transferred to another hospital for higher level of care per pt.

allergic anaphylaxis; A spontaneous report was received from a consumer, concerning herself a 77 years old female patient, who received Moderna's COVID-19 vaccine and experienced allergic anaphylaxis reaction in which the throat is swollen and could not eat and drink liquids. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 08 MAR 2021 prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 030A21A) via Intramuscular route for COVID-19 infection prophylaxis. On unknown date, she experienced allergic anaphylactic reactions which the throat was swollen and could not eat and drink liquids. She took Benadryl (diphenhydramine) as the treatment. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event was considered to be 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 onset date of the reported event, a causal relationship cannot be excluded.

Patient admitted to the hospital with a CVA with right sided weakness and chest pain. Chest pain radiated to her right arm and had significant shortness of breath. Symptoms started one week prior to seeking emergency care.

Patient received her first Moderna COVID-19 vaccination on 03/11/2021. She did not have any ill effects directly afterwards. However, starting on 03/27/2021, she began complaining of left arm pain in the area of the injection. She continued to complain of pain in the injection site on 03/28/2021. On 03/29/2021, her roommate found her deceased on her bed due to a probable cardiac event.

A spontaneous report was received from a consumer who is also the 77-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced blood clots in lung/pulmonary embolism. The patient's medical history was not provided. No concomitant product use was reported. On 10 Feb 2021, the patient received first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 23 Feb 2021, the patient was admitted to hospital with blood clots in lung. Patient was put on blood thinner. On 26-Feb-2021, the patient was discharged from hospital. Treatment medication included unspecified blood thinners. Action taken with mRNA-1273 was unknown. The outcome of the event, blood clots in lung/pulmonary embolism, was reported as resolved on 26-FEB-2021.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.

As I was driving at 70 mph along the highway 4 days after I had my second dose of the COVID-19 vaccine, suddenly I went blind in my right eye. I was blind in that eye for about 10 minutes. We drove right away to my eye doctor, who sent me to the ER. The hospital is Stroke Certified. They admitted me and did a stroke workup. I was in the hospital for 1 day (24 hours) which included overnight. The treating HCP concluded that I had experienced an ocular stroke. Since it was exactly 4 days after my second dose of the Moderna COVID-19 vaccine, it most likely was caused by that vaccine.

Began having ever increasing visual /ocular migraines with very slight headache after first injection on February 1, 2021. After second injection, March 1, 2021 began having very frequent visual migraines and light headaches and went to emergency room. 7 days later I had an occipital stroke and was hospitalized for several days. I am slowly recovering. Symptoms were only visual but quite severe for a short time.

Within 5-10 hours of the second dose: nausea, vomiting, chills, fever, fatigue. Chills, fatigue and nausea continued for 10 days until death

Blood clot that caused total vision loss in right eye. It occurred on 04/03/2021. Was treated by ophthalmologist at eye Center, and at Hospital,

small stroke; heart went to into a-fib; light and dark spots; hurting badly at injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (heart went to into a-fib) and CEREBROVASCULAR ACCIDENT (small stroke) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Atrial fibrillation since an unknown date. Concurrent medical conditions included Drug allergy (Eliquis). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced ATRIAL FIBRILLATION (heart went to into a-fib) (seriousness criteria hospitalization and medically significant) and VACCINATION SITE PAIN (hurting badly at injection site). On 07-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (small stroke) (seriousness criteria hospitalization and medically significant) and VISUAL IMPAIRMENT (light and dark spots). The patient was hospitalized for 4 days due to ATRIAL FIBRILLATION and CEREBROVASCULAR ACCIDENT. At the time of the report, ATRIAL FIBRILLATION (heart went to into a-fib) and CEREBROVASCULAR ACCIDENT (small stroke) outcome was unknown, VISUAL IMPAIRMENT (light and dark spots) had resolved and VACCINATION SITE PAIN (hurting badly at injection site) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date. This case was linked to US-MODERNATX, INC.-MOD-2021-060976 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-060976:MOD-2021-060528 (Wife case)

Owner emailed the following message on 03/23/2021, "Patient was feeling not good after the vaccinations and we call 911. She refused to go to hospital . Today she did do good and we call 911 and they took her because her oxygen dropped down . As of now she passed away"

Patient was seen at healthcare clinic 3/5/21 for complaints of abdominal pain and diarrhea x 1 week, no fevers. Admitted to the hospital for IV fluids and Zofran. Lab work shows elevated WBC and patient was given x1 dose of Metronidazole IV and discharged to home with appointment to f/u at healthcare clinic 3/6/21. On 3/6/21 patient was not improved and was sent back to hospital for IV fluids. Lab worked showed further elevated WBC, CRP and PCT so CT abdomen was done and found to have inflammation throughout the colonic wall. She is then admitted to for further evaluation and antibiotic treatment. Patient remained afebrile and WBC, CRP and PCT all trended downward. During hospital course she was also treated for hypokalemia due to diarrhea. She was started on Budesonide for colitis and was discharged on 3/11/21. On 3/25/21 patient is again seen at healthcare clinic for N/V/D with dehydration and is sent to hospital for IV fluids. Lab is again elevated and patient improves and is sent home with instructions for f/u at healthcare clinic on 3/26/21. On 3/26/21 patient is then admitted to hospital for N/V/D with dehydration and fatigue with headache. CT again shows pancolitis. On 3/26 patient then experiences A.FIB with RVR and is stable but as the day progresses becomes unstable with elevated heart rate and low BP. Due to patient?s unstable condition she is flown to another hospital for increased level of care.

Within hours patient began studdering, slurring and became unable to form a sentence. She had difficulty doing regular tasks such as drive a car., she was tired and went to bed early. The next morning she complained of a headache, pain in her right arm at the insertion site, and could not walk without holding on to walls, speaking was difficult the same as above. She went to the ER by 1 pm where they found that she was having a double brain bleed. With a cat scan with contrast. They send her to a near by hospital with a Neurosurgeon on staff, Medical Center. They administer Vitamin K and Platelets and monitored her. At the first Hospital. She is presently being admitted to a Rehabilitation unit. She continued with difficulty with speaking, difficulty with simple tasks such as using the phone and the nurse reported that she is weaker today than yesterday.

Patient received the vaccine on 2/8/21. There was a continued gradual weight loss and decrease of appetite after vaccine. On 3/2, patient had unknown reason for elevated blood sugar of 303. On 3/4, patient had oxygen of 78% on room air, Pulse 127, RR 22, BS 158. Oxygen started. Lethargic, hypoxic, tachycardia. Transfer to hospital. Patient readmitted on 3/12/21 with community acquired pneumonia, bacteria in urine acute kidney injury. Treated with antibiotics and hydration.

on 4/15 pt. presents to local ED with c/o SOB. Husband poor hx. but reports that pt. was not taking medications as prescribed. Documentation from MD in ED uncertain if pt. taking her amiodarone, torsemide and elquis. Noted to have O2 sats on RA of 81%. Pt. was in respiratory distress upon arrival to ER. Pt. was transferred to higher level of care, another Hospital on 4/15/2021 placed on Bipap.

Body aches night of injection. Extreme bloody nose with clots on 3rd day after injection. Swollen and very itchy right wrist 3rd day after injection. Was able to stop bloody nose after 1 hour, did not need medical help. Have not experienced a bloody nose in over 50 years so this was quite unusual.

Patient developed thrombocytopenia with a platelet count of 13,000, found on routine blood test on 3/10/2021. Patient asymptomatic with no bleeding.

Congestive heart failure (Stage 2); occasional angina during acitivty; more fatigue; irregular heartbeat after cardioversion; Atrial fibrillation and 2 ER visits, 2 days in a row; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Mar-2021 and was forwarded to Moderna on 29-Mar-2021. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE CONGESTIVE (Congestive heart failure (Stage 2)), ATRIAL FIBRILLATION (Atrial fibrillation and 2 ER visits, 2 days in a row) and ANGINA PECTORIS (occasional angina during acitivty) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Mercury sensitivity (itching, tearing; reacted once), Shellfish allergy (rash) and Hypertrophic cardiomyopathy. Concomitant products included AMIODARONE from 06-Feb-2021 to an unknown date for Atrial fibrillation, METOPROLOL SUCCINATE (TOPROL XL) and RIVAROXABAN (XARELTO) for an unknown indication. On 05-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021 at 4:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation and 2 ER visits, 2 days in a row) (seriousness criterion medically significant). On 06-Feb-2021, the patient experienced HEART RATE IRREGULAR (irregular heartbeat after cardioversion). On 14-Feb-2021, the patient experienced CARDIAC FAILURE CONGESTIVE (Congestive heart failure (Stage 2)) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced ANGINA PECTORIS (occasional angina during acitivty) (seriousness criterion medically significant) and FATIGUE (more fatigue). The patient was hospitalized from 14-Feb-2021 to 16-Feb-2021 due to CARDIAC FAILURE CONGESTIVE. At the time of the report, CARDIAC FAILURE CONGESTIVE (Congestive heart failure (Stage 2)) and ATRIAL FIBRILLATION (Atrial fibrillation and 2 ER visits, 2 days in a row) had resolved and ANGINA PECTORIS (occasional angina during acitivty), HEART RATE IRREGULAR (irregular heartbeat after cardioversion) and FATIGUE (more fatigue) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ATRIAL FIBRILLATION (Atrial fibrillation and 2 ER visits, 2 days in a row) to be possibly related. No further causality assessments were provided for CARDIAC FAILURE CONGESTIVE (Congestive heart failure (Stage 2)), ANGINA PECTORIS (occasional angina during acitivty), HEART RATE IRREGULAR (irregular heartbeat after cardioversion) and FATIGUE (more fatigue). The patient was treated with cardioversion on 06-FEB-2021 and IV Lasix. Very limited information regarding these events has been provided at this time. The CHF was attributed to the use of the amiodarone for aggravated atrial fibrillation. No further follow-up information is expected. This case was linked to MOD-2021-006529 (E2B Linked Report). This case was linked to MOD-2021-006529 (Patient Link).; Sender's Comments: Very limited information regarding these events has been provided at this time. The CHF was attributed to the use of the amiodarone for aggravated atrial fibrillation. No further follow-up information is expected. MOD-2021-006529:Same patient, 1st dose

Patient states that she started having trouble feeling tired, having difficulty concentrating/making decisions, vision problems, and dizziness/lightheadedness after the first vaccine dose on 1/26/21. She was not very clear on timeframe of onset of individual symptoms. She received her second dose on 2/26/21. She was diagnosed with A-fib during the time between her 2 doses. She did not notify pharmacy where vaccine was administered of her suspected side effects until 4/20/21. Patient states she has seen several of her healthcare providers to see if they could find any reason for her to be experiencing these things other than the vaccine but she says they haven't found anything.

04/11/21 stroke event --unable to speak and not consistent with actions, CT 04/11/21 L MCA infarct no midline shift

The patient's husband stated she woke up after receiving her second dose of the Moderna shot & she couldn't move her fingers on left hand. Also, she says her arm was very weak, She called her doctor which preceded to tell her to go to the hospital. The patient arrived at hospital & was admitted for 2 days. Upon her discharge the doctors told her they believe she had a minor stroke. She starts rehab next week. I tried to reach out to patient several times about retrieving her current medication list but there was no answer.

Patient contracted COVID 19 and subsequently expired from respiratory distress, following completion of the serious of two vaccination shots. She received her Moderna vaccinations on 1/7/21 and 2/4/21. I do not have access to the lot # info- would have to contact vaccination site to obtain

Patient presented after being found down next to toilet found to have COVID-pneumonia and sepsis needing intubation for ARDS and CRRT for hyperkalemia and oliguria. Hospitalization complicated by GIB s/p rectal artery embolization by IR and GNR bacteremia requiring cefepime. Due to worsening hypoxia and shock, patient was made comfort care/hospice by family and passed away on 4/9.

Reports she was exhausted and weak for a few days after the shot. on 4/20 she went to the ER to receive treatment for a blood clot in her right leg. Reports she had been having trouble with her leg for 5 days before going to the ER. She has started taking Xarelto. She went for treatment. She was not admitted.

Afib; Lightheaded/dizzy; nervous; Dehydrated; Problems with vision; Tachycardia; Problems concentrations; Fatigued/Tired; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (Afib) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 098K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-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 ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), VISUAL IMPAIRMENT (Problems with vision), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired). At the time of the report, ATRIAL FIBRILLATION (Afib), DIZZINESS (Lightheaded/dizzy), NERVOUSNESS (nervous), DEHYDRATION (Dehydrated), TACHYCARDIA (Tachycardia), DISTURBANCE IN ATTENTION (Problems concentrations) and FATIGUE (Fatigued/Tired) outcome was unknown and VISUAL IMPAIRMENT (Problems with vision) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Treatment included metoprolol, digoxin and diltiazem. No concomitant medication was provided. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.; 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 advance age may remain a risk factor for the event Atrial fibrillation. Further information has been requested.

Case noted with increasing difficulty walking and writing. Once case noted with difficulty speaking s/o transported to hospital. Hospital dx CVA. Case now resides at LTC permanently.

Patient presented to ED on 04/25/2021 with complaints of abdominal pain, abdominal distension, and AMS. Patient was admitted to ICU with following diagnoses: 1) Septic Shock, 2) A/C hypoxic/hypercapnic respiratory failure, 3) Acute metabolic encephalopathy, 4) Palliative care patient, 5) AE COPD, 6) ARF w/ATN on CKD3, 7) CAD, 8) Chronic sys/dia CHF, 9) Malnutrition/Failure to thrive. Patient died on 04/26/2021 at 1826. Patient was also previously admitted to hospital on 03/23/2021-03/29/2021 for sepsis.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Primary diagnosis was acute on chronic respiratory failure with hypoxia and hypercapnia.

presented to local ED lethargic, disoriented and unable to provide clear history on evening of 5/1/21 with severe frontal headache and increasing lethargy throughout the day. Admitted to hospital with suspected subacute stroke. Overnight developed LT sided weakness and RT gaze. Transferred to another healthcare facility on 5/3/21 with suspected seizure / encephalitis.

Patient presented to the ED on 3/15/21 and was subsequently hospitalized with NSTEMI. She also presented to the ED on 4/14/21 with chest heaviness.

right side chest pain and mild heart failure with bilateral pleural effusion and increased SOB- seen in hospital ER twice in 24 hours

(Information gained secondhand from patient's close friend as patient was intubated and sedated at the time that potential relationship between events and vaccine administration recognized). 77 yo F with no known significant PMH (was independent in ADLs, active, line-danced twice/week) who developed nausea, headache, fatigue on first day after first dose of Moderna vaccine. Friend reports that patient complained of "just not feeling right" following vaccine administration. Complained of poor sleep, poor appetite, dyspepsia and began complaining of lower extremity swelling in the weeks following vaccine administration. Was no longer able to line-dance, etc. Was fatigued. Her friends became concerned and encouraged her to seek medical attention, patient reported that she had was prescribed "water pill" and told to "lay off salt,". Friends later found out that she had lied about doctor's visit and was self-medicating with over the counter "water pills" for all of the water weight she was gaining. Eventually developed worsening shortness of breath. Admitted to hospital on 5/4 with shortness of breath and worsening abdominal pain. Found to have systolic heart failure (EF 20-30%) and was in SVT. Also diagnosed with UTI and SMV thrombus. Grossly anasarcic on exam. Treated for heart failure with diuretic and for her UTI with antibiotics, was started on Heparin drip for SMV thrombus. Underwent left heart catheterization at OSH that was negative for significant CAD. Developed worsening septic shock and was transferred to our hospital for higher level of care. Unfortunately had ongoing decline, found to be fungemic. Eventually succumbed to her septic shock, passed away on 5/14/21. Patient had second dose of vaccine on 3/18/21 according to vaccine card in her purse. Friend states that because of symptoms she developed after first dose of vaccine, she was fearful of getting second dose. Friends insist that she was well before the vaccine---knee pain was limiting factor for her activity level, never shortness of breath. Of note, several friends tested positive for COVID on 2/11/21, the week prior to patient receiving her vaccine. Patient tested negative and reportedly got tested at frequent intervals and was always negative.

5/12 Admitted to medical center with new dysphagia and slurred speech. 5/17 Acute Hypercarbic respiratory failure; Neuromuscular dysfunction - 5/19 -CONCERN FOR GBS. Patient on BiPAP (no history of pulmonary disease)

Patient reports 3 weeks prior to presentation to our hospital bruising and petechial rash as well as gum bleeding. At time of presentation she was found to have platelets <5K, normal hemoglobin and WBC . Diagnosed with ITP and started on treatment

Onset urticaria 3/12/21. ED visit 3/14/21. Syncopal episode in context of rash 3/17/21 leading to hospitalization 3/17-8/21. Benadryl, loratadine, famotidine, cephalexin for UTI. 2nd Moderna shot 3/27/21. 4/2 Office visit dizzy, weak, headaches, nausea, loss of appetite since 2nd vaccine Na 127. 4/16 Office visit for Headache, neck pain. 4/25 ED visit for dizziness. MRI head NL, labs mild hyponatremia. Given meclizine. 4/27-8 Hospitalization for dizziness, orthostasis, URI symptoms. OC43 Coronavirus, orthostasis. Alb 2.7 Globulin 5. New cervical and axillary Lymph adenopathy. 5/8/21 admitted to hospital w/ new diagnosis of lymphoma (pathologic diagnosis Nodal peripheral T cell lymphoma w/ follicular helper phenotype. Large axillary lymphadenopathy, thrombocytopenia, elevated total protein, acute kidney injury, anemia. 5/15/21 patient passed away from acute hypoxic respiratory failure in the setting of new lymphoma diagnosis.

She received her vaccine. The next few days, she was extremely tired and slept a lot. A couple days after the vaccine, she complained that her stomach hurt slightly. Days went by and the pain slowly got worse. She didn't feel like eating. Then on 2/8/21 in the middle of the night, she woke up in excruciating pstomach pain and her husband called ambulance. They rushed her to ER. The determined that her colon had ruptured near her stomach and they took her in for emergency colonoscopy. The surgery was a success, but a couple days after, she was weak and said she didn't want to fight any longer. They put her on hospice measures and she died 2/15/21. We feel that she was doing fine before the vaccine, and then all of a sudden this occurred. Seems to be too much of a coincidence. Finally taking the time to report it, in case there are others having colon and or stomach issues.

Patient started having stroke like symptoms at approximately 1145am on May 30th. Pt was having difficulty dressing and generalized feeling of being paralyzed for a brief moment or two. Pt was also having trouble getting out her words/thoughts. Pt never had loss of function of her limbs, No weakness, No facial droop, No loss of bowel or bladder control. Once in ER at Hospital, pt was found to have irregular heart rhythm e on EKG (Sinus Tachycardia with possible AFib with rate in the 100's up to 130's) - CT Scan of Head was negative for bleed or acute ischemia. By 8pm the same day the pt had improvement of speech and getting out words/thoughts better and by the next day at 10am sounded back to normal self and still with no other neurological deficits. During that next day we learned that the patient had been to her Primary Care Dr on 5/24/2021 for routine visit when they did an EKG in the office and pt was thought to have an "irregular Heart rhythm" and referred to see a cardiologist. During course of hospital stay the patient was treated with heart rhythm medications and Eliquis for Diagnosis of Afib/TIA.

I63.9 - Cerebrovascular accident (CVA), unspecified mechanism (CMS/HCC) E87.1 - Hypo-osmolality and hyponatremia R29.810 - Facial weakness

Case is a vaccine breakthrough case of interest who died of COVID-19 pneumonia on 6/2/2021 after an approximately 2 week hospitalization. Whole genome sequencing resulted in identification of B.1.1.7.

massive stroke; This spontaneous case was reported by a nurse and describes the occurrence of CEREBROVASCULAR ACCIDENT (massive stroke) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (massive stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (massive 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. The patient did not have allergies to medications, food, or other products. Treatment information was not provided. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Massive stroke; This spontaneous case was reported by a nurse and describes the occurrence of CEREBROVASCULAR ACCIDENT (Massive stroke) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Massive stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Massive 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. Concomitant medications were not reported. No treatment information was provided. Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

On 06/15/2021 pt. presents to ED with c/o weakness, SOB, cough, increased sputum production, pleuritic pain, and leg edema. Pt. cont. to smoke. Pt. reports having difficulty getting out of her chair at home to go use the restroom. Pt. states that she collapsed in the hallway, a soft fall and was unable to get up. Pt. was able to activate her life-line button for assistance. Pt. was found to have an O2 saturation on RA of 84%. Pt. had IV placed, received an Albuterol HHN UD breathing treatment, a dose of Levofloxacin 500 mg, lab work, EKG and CXR. Pt. was transferred to higher level of care.

I developed a rash from my shoulder to my elbow. I had a fever for 24 hours, weakness in the legs, nauseated, went into AFIB. Went to hospital.

Patient presented to the ED and was subsequently hospitalized with Sepsis without acute organ dysfunction within 6 weeks of receiving COVID vaccination.

Death 4/30/2021 Causes of death listed on death certificate: 1) Covid Pneumonia 2) Chronic obstructive pulmonary disease, unspecified Other: none

death J18.9 - Pneumonia, unspecified organism E87.1 - Hypo-osmolality and hyponatremia N17.9 - Acute kidney failure, unspecified

Patient was a 77 year old, resident, past medical history of dementia, hypertension, schizophrenia, hyperlipidemia, Parkinson's disease. Patient presented to the ED with altered mental status and a potential seizure. In the morning of 3/24, patient reportedly had an episode of seizure that lasted 30 seconds, generalized tonic/clonic. It is unknown if she fell or hit her head. Per manager, patient is following Neurology, recent work up for possible syncopal month ago. Patient received her 2nd dose of Moderna Vaccine recently on 3/19. At baseline patient is independent, ambulates by her self. Patient has been ill after receiving a COVID vaccine last week. Patient has progressive weakness of the bilateral lower extremities and progressive difficulties with talking , had had multiple falls.

She was coughing blood clots and I took her to the ER and she was diagnosed with blood clots in her lungs.

Patient received Moderna COVID-19 vaccine Dose #1 on 3/15 and Dose #2 on 4/12, unsure where patient received vaccine. Admitted to hospital for syncopal episode at a store on 7/8. The ED provider note does mention that the patient reports increased weakness and fatigue over the last month with heart rates in the 40-50s. She had bleeding head laceration on admission. New Afib noted this admission. Platelets low on admission (9) with no prior CBC's in the chart. Three units of platelets were ordered to be transfused. Low platelets are an incidental finding.

Approximately April 16 (2 weeks after second shot) Left leg went out from under me unexpectledly. Few days later happened again but continued to be weaker and Blood pressure increased to 207/140 while I was out shopping. Drove myself to hospital ER and they admitted me. from 04/26 to 04/29. On 04/29 they did MRI brain scan and determined that I had suffered a right quadron brain bleed which left me left side leg weakness and balance issues. Sent me home on 04/29 and told me see primary Dr. right away.. They ordered in home therapy for a few weeks and in 2 weeks I start outpatient therapy . Since this 3 of my Dr's agreed to have a Heart loop monitor inserted in my chest which I agreed to. Staples come out next week.

Superficial bleeding left leg; Numbness in l. arm; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Superficial bleeding left leg) in a 77-year-old female 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 Rheumatoid arthritis (gradual improvement) since 1996 and Hypertension (stable) since 2018. Concomitant products included METOPROLOL from 2018 to an unknown date for Hypertension, METHOTREXATE from 1996 to an unknown date and HYDROXYCHLOROQUINE PHOSPHATE (PLAQUENIL [HYDROXYCHLOROQUINE PHOSPHATE]) from 1996 to an unknown date for Rheumatoid arthritis. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness in l. arm). On 16-Jun-2021, the patient experienced HAEMORRHAGE (Superficial bleeding left leg) (seriousness criterion medically significant). On 05-Jul-2021, HYPOAESTHESIA (Numbness in l. arm) had resolved. At the time of the report, HAEMORRHAGE (Superficial bleeding left leg) had resolved with sequelae. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Fibrin D dimer: elevated (High) Elevated. In 2021, Ultrasound scan: normal (normal) Normal. The patient reported that signs of bleeding were still present .Ten days later bleeding in left leg, area 4 in. x 8 in. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-163325 (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.

Prior to the administration of the COVID 19 vaccine, the nursing home had an outbreak of COVID-19. Patient was vaccinated and about a week later she tested positive for COVID-19. She had underlying thyroid and diabetes disease. She died as a result of COVID-19 and her underlying health conditions and not as a result of the vaccine.

Patient complains of left rib pain that started 3 hours after getting her first COVID 19 vaccine on 1/4/2021. Patient did have a chest xray that showed lower left penumonia and was started on antibiotics. Patient returned to PCP on 1/8/21 with continued complaint of left rib pain that had not gotten better. Chest Xray clear on 1/8/21.

Pneumonia in left lung; Pain in neck; Acute serious pain under her ribs, all the way around her body; A spontaneous report was received from a consumer concerning a 78 year old female who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed acute serious pain under her ribs, all the way around her upper body, pneumonia in her left lung and neck pain. The patient's medical history was not provided. Concomitant medications included non specified medication for blood pressure, calming down, dementia and thyroid. On 04 Jan 2021, approximately 2.5 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 04 Jan 2021, the patient developed acute serious pain under her ribs, all the way around her upper body that lasted ten days. The patient also experienced neck pain. On an unknown date, she was treated in the emergency room for pneumonia in her left lung and given antibiotics. She later followed up with her primary care doctor and additional x-rays were taken and she was treated with prednisone. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, acute pain under her ribs, all the way around her upper body, was considered resolved on 14 Jan 2021. The outcome of the event, pain neck was resolved on 19 Jan 2021. The outcome of the event, pneumonia in left lung, was unknown.; Reporter's Comments: Company Comment: This case concerns a 78-year-old female patient who experienced unexpected serious event of pneumonia and non-serious event of acute serious pain under her ribs, all the way around her upper body and neck pain. The event developed on the same day after the first dose and only dose of the vaccine mRNA-1273 vaccine (lot # unknown, expiration date-unknown). Although a temporal association exist between the event of pneumonia and the administration of the vaccine, in the absence of clinical details including diagnostic test, a definite diagnosis was not established. The events of acute serious pain under her ribs, all the way around her upper body and neck pain are also temporarily associated with vaccine administration and a causal association cannot be excluded. Main field defaults to ‘possibly related' for all events.

pt states that after vax she had fatigue and loss of appetite. The next day pt woke up w/ no appetite, dizzy, weak and felt like she needed to faint. She was experiencing angina type symptoms w/ short frequent episodes of AFIB. She went to bed and woke up around 11 PM on 1/31/2021 sweating and had a temp of 103. She took extra strength Tylenol and went back to bed. Next morning her temp 101.5. but had returned to normal during the day but had gone back up to 99 later that night. On 2/2/2021 states there was no temp but her arm is swollen, itchy and red with pain. She was able to eat and get hydrated. Pt is still dizzy and light headed at this point. On 2/3/2021 patient woke up feeling some better and able to focus but still has itchy, painful and pink arm that is hot to touch. She is going to call her PCP and Cardiologist today on 2/3/2021.

Feb 8 states she had a cold. Feb 9 added stomach ache and nausea. Feb 9 visited urgent care facility for exam and Covid-19 test. Rapid test results were negative. Appeared tired but fine. Told to go home and rest. Feb 10 at 9:00 am found dead on the floor in pool of blood and aspirated. Excessive blood in toilet, pooled on floor and hallway rug.

HISTORY OF PRESENT ILLNESS: Pleasant 78-year-old female with history of lung cancer with remote partial pneumonectomy, some element of COPD and chronic respiratory failure on home oxygen therapy. She presents with worsening shortness of breath, which started rather abruptly the day prior to presentation. On arrival to the ED she was mildly tachypneic and slightly tachycardic and appeared to be in mild respiratory distress. Her O2 had been titrated to 4 L/m nasal cannula in order to sustain SaO2 values in the 90% or above range. Patient also noted to have pallor. No hematemesis, melena, hematochezia, abdominal pain, fever, cough or known exposure to COVID. Patient reports having received her first COVID vaccination just over one 1 week ago. A hypochromic microcytic anemia, progressive, was noted with a hemoglobin of 7.4 g/dL. Patient reported that she was up-to-date on EGD and colonoscopy within the past year without findings of acute pathology or bleeding. A CTA of the chest was conducted with findings of bilateral pulmonary emboli. She denies lower extremity swelling, pain or tenderness. Patient placed in observation in order to provide palliative blood replacement therapy and commence with anticoagulation for venous thromboembolism. DISCHARGE SUMMARY/OBSERVATION COURSE: Uneventful observation course for this pleasant 78-year-old female who presented with somewhat sudden worsening of her chronic shortness of breath and was found to have CTA evidence of bilateral pulmonary emboli. This in the setting of a progressive iron deficiency anemia without evidence of active clinical gastrointestinal bleeding. The patient received 2 units of packed red blood cells in a palliative fashion for her presenting hemoglobin of 7.4 g/dL. Posttransfusion hemoglobin was 10.1 g/dL. Concurrently, she was placed on weight-based low molecular weight heparin for full anticoagulation. I examined the patient on the morning of February 12 and found her to be nondistressed. Her SaO2 value was 96% on 4 L/m nasal cannula O2. Recall that her baseline flow rate historically had been 2 L/m his cannula. Etiology of the patient's thromboembolism uncertain. She had no clinical findings of unilateral or bilateral lower extremity swelling or tenderness. Patient noted to be a survivor of both breast and lung cancers but without known evidence of active persistent malignancy. Of interest, she had received a COVID-19 vaccine just over one week prior to presentation. I contacted pharmacy in this regard and encouraged him to report possible adverse event via VAERS. I recommended a course of rivaroxaban and provided a prescription with a VTE dosing schedule. Patient was advised to followup with Dr in 10 days. M.D., Hospital Medicine MD Feb 12, 2021 08:40

ON 2/14/21 PATIENT WAS FOUND BY FAMILY CONFUSED, DIAPHORETIC, VOMITING, TAKEN TO E.D, CT SCAN REVEALED A SUBARACHNOID HEMORRHAGE, PT INTUBATED IN ICU PER DAUGHTER FOUND have 2 ANEURYSMS.

Admitted to hospital for acute on chronic respiratory failure following covid vaccination. (patient significantly fatigued, slept most of the day after vaccine, not on BIPAP as needed) HISTORY OF PRESENT ILLNESS: patient is a 78 y.o. female with a history of oxygen-dependent chronic obstructive pulmonary disease, obstructive sleep apnea, and persistent atrial fibrillation who presents today with general malaise. She received her 2nd COVID-19 vaccination yesterday and complained of fatigue, body aches, and general malaise all day. Later in the evening she noticed that her blood oxygen level was low. She denies having any more shortness of breath abnormal. She has had no vomiting, headache, or chest pain. On arrival she was noted to be febrile and required 6 L supplemental oxygen via nasal cannula. She usually uses 2 L nasal cannula at baseline, occasionally increasing it to 3 or 4 with exertion. She also had elevated troponin levels and noted leukocytosis. There was radiographic evidence of congestive heart failure. On exam, she is tired and wants to go to sleep. She is still requiring 4 L of oxygen via nasal cannula. Her daughter is at bedside. Plans are discussed for admission and she is agreeable. ASSESSMENT / PLAN: * Acute on chronic hypoxemic respiratory failure (HCC) Assessment & Plan Admit to medicine- hypoxic requiring 6 L nasal cannula, utilizes 2 L nasal cannula baseline Hypoxia appears to be secondary to robust immune response to COVID-19 vaccination Increased hypoxia, fever, leukocytosis, elevated troponin, radiographic evidence of congestive heart failure Will repeat troponin level in the morning, daily chemistry and blood count, will treat congestive heart failure as below CHF (congestive heart failure) (HCC) Assessment & Plan Transesophageal echocardiogram from October 2020 noted preserved left ejection fraction, and had no evidence for diastolic dysfunction Radiographic evidence of congestive heart failure, normal BNP, elevated troponin with an increase of 18 at the 2 hour mark, will recheck in the morning As this is her 2nd hospitalization since that echo with hypoxia and concern for CHF, will obtain repeat echocardiogram Received 80 mg IV Lasix in the emergency department, will continue 40 mg IV Lasix 2 times a day Daily weights, 2 L fluid restriction Patient was admitted with acute on chronic hypoxic respiratory failure. I think this is due to acute on chronic diastolic congestive heart failure that was brought on after she was sleeping most of the day without her BiPAP. She says she got her COVID-19 booster shot and felt so tired she slept all day. She did not think she needed her BiPAP during the day even if she was sleeping. She has not had a recent sleep study. Patient is diuresing and will likely be able to discharge tomorrow.

The medical facility did not treat patient as her primary care, but were informed that she passed away on 15 February 2021 of a stroke. I do not have further information on the medical aspect of this as we were not her treating provider but did administer the vaccine on 12 February.

The patient developed back pain one month after the first injection on February 24 she was diagnosed with pericardial effusion?s and 750 mL was drained from the pericardium. The work up is on going but it seems to be Pericarditis which occurred after the vaccination

Called nurse line 4 days after 2nd Moderna vaccine, SOB, fainting, can't eat, dry cough, nose bleeds since shot. Advised to go to ED, patient refused as she feels a bit better today. Called again the following day with same symptoms - again advised to go to ED and quarantine for flu/covid-like symptoms. Patient agreed to come to ED, found to have bilateral PEs and RLE DVTs. Covid/flu negative. LUE red/swollen at injection site - no cellulitis. Admitted overnight and d/c'd home the following day.

fell/passed out (unknown) at home, taken by ambulance to local hospital, small bleed noted on CT scan, transferred to tertiary care center, f/u scan after 6 hours unchanged. Sent home. next morning unresponsive, transported back to tertiary care center. required ventilation en route.. massive cerebral hemorrhage noted on CT scan in different area. due to advanced dementia and unresponsiveness life support removed around 9pm that night. passed away at 9am on 3/1.

patient expired 2/10/2021. Unknown whether the death was even related to the vaccine. Pt did not have any problems during 15 min observation period and no issues reported to HD after vaccination. reported because the person expired within 7 days of vaccination.

Hospice nurse reported patient started experiencing fatigue, nausea, dizziness, decreased appetite and shortness of breath immediately following vaccination. Hospice medications were ordered and patient began receiving morphine and nebulizer treatments. She then started having dysphasia. She then died on 3/5/21 from presumed respiratory failure.

2 days later, at night, I began an episode of rapid and irregular heartbeats. I was taken to hospital where atrial; fibrillation was diagnosed, After about 12 hours it converted to regular sinus rhythm. I was kept under observation for another 24 hours and then released. I have had several episodes since then.

blood clot in left forearm; Sore arm; A spontaneous report was received from a consumer concerning a78, year, old, female patient who developed a blood clot in the left forearm. The patient's medical history included hypertension, hiigh cholesterol and hypothyroidism. On 19-JAN-2021 the patient had two stents placed in her heart. Products known to have been used by the patient, within two weeks prior to the event, included clopidogrel bisulfate (One 5 milligram AM and PM) and apxaban (One 5 milligram AM and PM) and Asprin. On 10-FEB-2021, approximately six days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient had a sore arm for about a day after the vaccination. Six days later the left arm was red and swollen, inside forearm four inches down below the elbow it was stinging, slightly swollen, just to a soft touch she felt lumps of swelling. The patient went to the emergency room and had blood work and an ultrasound. The emergency room doctor told her that she had a blood clot in the left forearm four inches down below the elbow. The lab test done at the emergency were blood work and ultrasound. Treatment for the event included changing her current medication to one clopidogrel bisulfate 5 milligrams AM and PM and apxaban two tablets of 5 milligrams AM and PM and to discontinue the Asprin for one week. There was no change planned to the dosing schedule of mRNA-1273 in response to the event(s) and is scheduled to get her second vaccination 10-MAR-2021. The outcome of the events were considered as unknown. Follow up: No follow up information received.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

She had breathing problems, bowel movement problems, sharp pain -site unknown No appetite and nausea. Went to the Doctor on wednesday and they gave her a prescription for nausea (promethazine) 12.5mg She Passed away 03/12/2021 at 8:54pm waiting to be picked up by a friend that was going to take her to the emergency room/hospital.

Patient was awakened at 0400 on 3/18/2021, with shortness of breath and her entire right side hurting. Pain was in the lower right chest, right upper abdominal quadrant and right flank pain. Presented to the ED. CT of chest /abdomen showed pulmonary embolus in the right lower lung. Patient is being treated with Eliquis and was sent home from the ED on 3/18.

Stroke following administration; A spontaneous report was received from a consumer concerning a 78 year old ,female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a stroke/cerebrovascular accident. The patient's medical history was reported as previous stroke two years ago. Concomitant medications taken by the patient included losartan, glipizide, lintas, metformin, blood thinners, hydrochlorothiazide. On 26 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 023M20A) intramuscularly for prophylaxis of COVID-19 infection. On 28 Feb 2021, the patient experienced a stroke which needed emergency treatment. She received treatment for this condition and was back at home at the time of reporting and at that point she had no other side effects. Treatment activities for event was received but not provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of event, stroke was recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, patient's elderly age along with prior history of stroke are considered significant risk factors.

Breathing issues; Death; A spontaneous report was received from a consumer concerning a 78 years old, female patient who experienced breathing issues/dyspnoea. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 08 Mar 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in an unknown arm for prophylaxis of COVID-19 infection. The patient experienced breathing difficulty on 12 Mar 2021. The patient died on 12 Mar 2021. Treatment information was not provided. Action taken with the drug in response to the events is not applicable. The patient died on 12 Mar 2021. The cause of death was not reported. The reporter wanted to conduct a autopsy to find out if the death was caused by the vaccine.; Reporter's Comments: This is a case of death in a 78-year-old female subject with unknown medical history, who died 4 days after receiving first dose of vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

Patient states she received first COVID vaccination approximately one week ago (not a great historian); she tells me about 4 days later she became shorth of breath that progressively worsened - especially with exertion. She went to ER and was sent home on steroids and antibiotics. Shortness of breath became worsened so she presented back to ER and CTA was performed. There is no evidence of PE but patient has what looks to be a chronic DVT of left subclavian vein extending up to IJ junction. I do not believe this is for sure vaccine related but felt it was important to report it anyway. She cannot tell me why she takes warfarin at home but I do assume it is for this known chronic DVT. Unsure of Vaccine brand name. Most vaccines in this area have been Moderna.

Received Covid vaccine on 4/2 and then starting 4/3 starting experiencing nocturnal chest pain. Found to have bilateral pulmonary embolism on evening of 4/5.

Moderna EUA Pt started having left leg pain, discoloration (blue-purple) and swelling on 3/9/2021. Pt went to the hospital and was later called to come back to the hospital because she had a blood clot. Pt was sent to clinic and had a procedure by to remove clots. Pt states that the clot was "2/3 size of thigh." Pt states that she is scheduled to have a second procedure in May to remove blockages from iliacs.

Respiratory arrest and was out; Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen; Cough that felt like coming from another human being; Felt crappy; Covid red arm; Intermittent Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RESPIRATORY ARREST (Respiratory arrest and was out), DYSPNOEA (Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen), COUGH (Cough that felt like coming from another human being), FEELING ABNORMAL (Felt crappy), ERYTHEMA (Covid red arm) and CHILLS (Intermittent Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029120A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (patient reported hypertension as one of the health issues that she has.). On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-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 RESPIRATORY ARREST (Respiratory arrest and was out) (seriousness criteria hospitalization and medically significant), DYSPNOEA (Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen) (seriousness criterion hospitalization), COUGH (Cough that felt like coming from another human being) (seriousness criterion hospitalization), FEELING ABNORMAL (Felt crappy) (seriousness criterion hospitalization), ERYTHEMA (Covid red arm) (seriousness criterion hospitalization) and CHILLS (Intermittent Chills) (seriousness criterion hospitalization). At the time of the report, RESPIRATORY ARREST (Respiratory arrest and was out), DYSPNOEA (Diaphragmatic breathing (could not breathe) was on vent mask that delivered oxygen), COUGH (Cough that felt like coming from another human being), FEELING ABNORMAL (Felt crappy) and ERYTHEMA (Covid red arm) outcome was unknown and CHILLS (Intermittent Chills) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Erythema: (abnormal) (big - diameter 3.5 X 6 inches). In February 2021, White blood cell count: 15.5 (High) Her white blood cells were 15.5. In February 2021, X-ray abnormal: (abnormal) lung X-rays were horrible and was "tanked" due to all the diaphragmatic breathing (could not breathe). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient received treatment with 3 antibiotics, steroids and oxygen. Patient reported that they wanted to intubate her and ativan was pushed by RN. Patient was on "vent mask" that delivered oxygen and was in cardiac intensive unit for 4 days and then the doctor decided it was not covid or pneumonia and were looking at cardiac issues.They had to give Narcan to reverse the effects of Ativan. Patient stated in the call that Moderna pushed her off the end of the cliff and reports that prior to this she was healthy and walked daily on regular basis. Very limited information regarding this events has been provided at this time. Further information has been requested. The patient's concurrent medical condition of hypertension remains a risk factor and as per the reporter the doctor were looking at cardiac issues as a confounder. This case was linked to MOD-2021-065711 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. The patient's concurrent medical condition of hypertension remains a risk factor and as per the reporter the doctor were looking at cardiac issues as a confounder.

is not in rythm (think it's in A-FIB); Skipping of beats; the chest moved not in the right way; could not walk; dizzy; Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long; headache; nausea but did not throw up; have never ache and hurt as bad as they started hurting; sick; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Arthritis and Cardioversion (Had 2 cardioversions). Concurrent medical conditions included Atrial fibrillation. On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN (have never ache and hurt as bad as they started hurting), ILLNESS (sick), GAIT DISTURBANCE (could not walk), DIZZINESS (dizzy), ARTHRALGIA (Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long), HEADACHE (headache) and NAUSEA (nausea but did not throw up). On 29-Jan-2021, the patient experienced ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)) (seriousness criterion medically significant), EXTRASYSTOLES (Skipping of beats) and CHEST DISCOMFORT (the chest moved not in the right way). On 28-Jan-2021, PAIN (have never ache and hurt as bad as they started hurting), ILLNESS (sick), GAIT DISTURBANCE (could not walk), DIZZINESS (dizzy), ARTHRALGIA (Every joint was aching, ankles, knees, finger, hips, it keep hurting al night long) and NAUSEA (nausea but did not throw up) had resolved. On 29-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, ATRIAL FIBRILLATION (is not in rythm (think it's in A-FIB)), EXTRASYSTOLES (Skipping of beats) and CHEST DISCOMFORT (the chest moved not in the right way) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2021, Heart rate: 80 (High) 80. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment included paracetamol. 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.

The patient received her Moderna Covid vaccine and a couple of days later she had shortness of breath and was brought to the hospital a couple of days later. They found multiple blood clots in her lungs. The hospital discharged her too early and she had to go back, They told her to get her second dose on her regular scheduled date.

Extensive DVT(blood clots) involving both legs-- initially with tachycardia dyspnea. Now on 10a meds. Likely to have disability or permanent damage. History of post-op DVT with PEs following sholder surgery, subsequent placement of IVC filter.

Blood clot; Left leg pain; Discoloration (blue-purple); Swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of THROMBOSIS (Blood clot), PAIN IN EXTREMITY (Left leg pain), SKIN DISCOLOURATION (Discoloration (blue-purple)) and SWELLING (Swelling) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013L20A) for COVID-19 vaccination. The patient's past medical history included Clot blood in 2010. Concurrent medical conditions included Drug allergy (Dalaudid, Ambien and Demerol) and Hypertension. Concomitant products included DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), GLIMEPIRIDE (AMARYL), ACETYLCARNITINE HYDROCHLORIDE (NEUROTIN [ACETYLCARNITINE HYDROCHLORIDE]), COLECALCIFEROL (CALTRATE VITAMIN D DAILY), MINERALS NOS, VITAMINS NOS (CENTRUM A TO ZINC) and VITAMIN D NOS for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left leg pain) (seriousness criterion hospitalization), SKIN DISCOLOURATION (Discoloration (blue-purple)) (seriousness criterion hospitalization) and SWELLING (Swelling) (seriousness criterion hospitalization). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criterion hospitalization). At the time of the report, THROMBOSIS (Blood clot), PAIN IN EXTREMITY (Left leg pain), SKIN DISCOLOURATION (Discoloration (blue-purple)) and SWELLING (Swelling) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was sent to hospital to remove clots. The patient stated that the clot was 2/3 size of thigh. The patient scheduled to have a second procedure in May to remove blockages from iliac. Action taken with mRNA-1273 was not applicable. Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Prior medical history of blood clot is considered a significant risk factor.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded. Prior medical history of blood clot is considered a significant risk factor.

Next day 04/01/21 patient hallucinated that there were spiders on the wall, a-fib went crazy, shortness of breath, sweating, vomiting.

on 9th started with a sore throat.running nose,coughing, by the 12th throat was so sore could hardly swallow. Went to urgent care .Was treated for just a sore throat. Wed 14th in the evening I went into a-fib and ambulance called and taken to hospital. They tried two different meds to get me back to normal sinus rhythm..They sent me home that evening the 15th.Today I`m starting to feel better.

Diagnosed with rhabdomyolysis; Found on floor with knee in an awkward position; Strength has not come back in legs and now needs a walker; Did not have strength to lift legs to go to bed; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RHABDOMYOLYSIS (Diagnosed with rhabdomyolysis) and JOINT DISLOCATION (Found on floor with knee in an awkward position) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cholesterol. Concomitant products included LEVOTHYROXINE and ROSUVASTATIN for an unknown indication. On 04-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 11-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ASTHENIA (Did not have strength to lift legs to go to bed). On 12-Mar-2021, the patient experienced RHABDOMYOLYSIS (Diagnosed with rhabdomyolysis) (seriousness criteria hospitalization and medically significant), JOINT DISLOCATION (Found on floor with knee in an awkward position) (seriousness criterion hospitalization) and GAIT DISTURBANCE (Strength has not come back in legs and now needs a walker). The patient was hospitalized from 12-Mar-2021 to 18-Mar-2021 due to JOINT DISLOCATION and RHABDOMYOLYSIS. At the time of the report, RHABDOMYOLYSIS (Diagnosed with rhabdomyolysis), JOINT DISLOCATION (Found on floor with knee in an awkward position) and ASTHENIA (Did not have strength to lift legs to go to bed) outcome was unknown and GAIT DISTURBANCE (Strength has not come back in legs and now needs a walker) had not resolved. Treatment for events included fluids and shots in knee. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.; 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.

Unsure of cause/effect. Patient developed idiopathic thrombocytopenic purpura with platelets of 4000 from normal the month prior. With most recent different events being the COVID-19 vaccination and starting prolia twice yearly for osteoporosis. She developed purpura on left arm starting on 4/18 which enlarged and coalesced throughout the week. She then developed oozing from known wound and purpura on chest. Entire left arm developed diffuse bruising and swelling by 4/22. Left side of face also with spontaneous bruising. Developed mucosal bleeding of mouth and throat on 4/22. Presented tachycardic and mildly hypotensive.

I had tender areas on the inside of my left leg starting about mid or late March in the upper thigh region and some aching in the inner aspect of the calf portion of the leg. This became worse over the Easter weekend and I went to clinic on April 6, 2021. I had a superficial blood clot just above the knee on the inner aspect of my left leg. After that appointment the redness and soreness and very hard feeling of the veins extended up my leg 8 to 10 inches. I did not have a blood clots in the deep veins. I have had some varicose vein?s and surgery for such about five years ago. The clinic did not say the clot was due to the vaccine but I had no injuries, no recent surgeries and nothing unusual that would have caused the clot other than the vaccine

Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot; Woke up shaking; Eyesight effected; This spontaneous case was reported by an other caregiver (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot), TREMOR (Woke up shaking) and VISUAL IMPAIRMENT (Eyesight effected) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Seizure. 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot) (seriousness criteria hospitalization prolonged, disability and life threatening), TREMOR (Woke up shaking) (seriousness criterion hospitalization prolonged) and VISUAL IMPAIRMENT (Eyesight effected) (seriousness criterion hospitalization prolonged). The patient was hospitalized on sometime in March 2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with Rehabilitation therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke, Left side of her body effected/Something was wrong, Movement effected, Coordination abnormal, Blood clot), TREMOR (Woke up shaking) and VISUAL IMPAIRMENT (Eyesight effected) outcome was unknown. Unknown For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Products known to have been used by the patient, within two weeks prior to the event, included seizure medication. Treatment for the event included intensive care and stroke unit. 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 regarding this event 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. However, Very limited information regarding this event has been provided at this time. Further information has been requested.

Initially she experienced fever, fatigue, aches, chills. Then later, several days of tightening chest leading up to heart attack (20 days post vaccine). Doctor expressed surprise by heart attack. Not sure if there's a connection, but thought I'd submit.

Transient Global Amnesia on 3/14/21: when my husband got up I was already up. i was asking questions about where things were that I should have known. I came back to myself and was then ok, Because I was concerned by the strangeness of the incident i went to my doctor the next day. He sent me for tests and told me to follow up with cardiologist. which i did. t

Autoimmune encephalitis vs Listeria infection - 78 yo F with encephalitis. Second Moderna vaccine on 3/6/2021, admitted on 3/31/2021. 4/18 IM Progress NOTE states: #Limbic encephalitis, improving. Treating for Listeria given inflammatory findings in addition to lymphocytic CSF and few gram-positive cocci on stain. CSF paraneoplastic antibodies are negative therefore anticipating that the serum antibodies will also come back negative Depressed flat affect consistent with limbic inflammation -improving Repeat MRI 4/14 shows improvement Ampicillin, tentative plan for 4 to 8 week course for possible listeriosis Gentamicin, completed 1 week course 4/15. Continues on Keppra 4/20 Neurology Progress NOTE: Impression - Meningoencephalitis, presumed to be secondary to listeria. 4/27 ID progress NOTE : Patient found to have limbic encephalitis and possible infectious cerebritis. CSF exam, was performed after about 2.5 days of antibiotics due to patient anticoagulation, showed 27 white blood cells, 96% lymphocytes; protein 146, glucose 69. Meningitis encephalitis PCR panel negative. Gram stain with rare intracellular GPC's, culture negative. Per micro lab, 2 different techs each visualized 2 different fields with an intracellular GPC. Clinical picture was thought compatible with Listeria (which is a bacillus, but could be mistaken for a coccus). Completed 10 days of empiric vancomycin and ceftriaxone on 4/10. was on ampicillin CNS dosing, plus gentamicin for synergy started 4/9, now off of gentamicin. Ampicillin changed to meropenem due to drug eruptions. Continued slow clinical improvement; repeat MRI brain 4/13 showed radiographic improvement. Noted to have negative coccidioides serology but not titre came back at 1:8, repeat titre negative. Repeat LP shows similar findings with 28 WBCs, with lymphocytic predominant, slightly low glucose and elevated protein. Awaiting Coccidioides CSF and fungal cultures. Continue fluconazole 400 mg daily, renally adjusted. No evidence of QTc prolongation. Continue to monitor rash. No evidence of DRESS, TENS or SJS. Patient has eosinophiluria. Continue current plan of care. Diagnosis: -Limbic encephalitis -Positive coccidioides titre of 1:8 -Possible infectious cerebritis -Rash and pruritus - improving. -Breast cancer in remission s/p mastectomy, radiation, chemotherapy -Atrial fibrillation with RVR -AKI with eosinophiluria Discharged on 4/27/21

This 77 year old female received the Moderna Covid shot on 2/18 /21 and went to the ED on 3/16/21 and was admitted on 3/16/21 with the following diagnoses listed below. Thrombocytopenia, unspecified

Acute respiratory failure with hypoxia (HCC) (Primary Dx); Shortness of breath; Tachypnea; Pneumonia due to COVID-19 virus Office Visit 3/4/2021 Internal Medicine Internal Medicine Cough +2 more Dx Shortness of Breath ? Cough Reason for Visit Progress Notes (Physician) ? ? Internal Medicine ? ? Encounter Date: 3/4/2021 ? ? Signed Expand AllCollapse All Assessment/Plan Diagnoses and all orders for this visit: Cough - X-ray chest 2 views; Future - B-type natriuretic peptide; Future - CBC and differential; Future Iron deficiency anemia, unspecified iron deficiency anemia type - CBC and differential; Future - Iron + Transferrin + % Saturation; Future Shortness of breath - B-type natriuretic peptide; Future

Developed profound leukocytosis with WBC 173,000 and elevated LDH following first dose. Increased hydrea (already on for CNL). Developed transfusion dependent thrombocytopenia

My mom, got her first Moderna shot on Feb. 4th, 2021 and developed trombosis in the legs about a week later. She went to the doctor, who at first didn't want to see her and told her to elevate her leg. Pt. had a scheduled eye appointment on Feb. 12th with an other doctor and when she asked if she had any other issues, pt. showed her her leg. The eye doctor immediately told her to go to urgent care. When she did she received blood thinners and started injections in her stomach for 5 days. Feb. 18th pt. suffered a mini stroke and went to the hospital emergency room. She was transferred over to another facility in the afternoon and kept overnight. She had a phone appointment with the Dr. on Feb. 24th and on the 26th she received a heart monitor to wear for 2 weeks. She also had a check up about her leg, which was still swollen. On March 4, pt. received her second Moderna shot and she was feverish and very tired for days and weeks after. By March 18th her condition didn't improve at all and in fact she was felling really bad over night, so on March 19th she was admitted again to the hospital. She was monitored and kept over night, but during the early morning she suffered a stroke and a heart attack and passed way the next day.

pt. daughter called pharmacy on May 18, 2021 (approximately 5:00pm MST) stating pt. passed away and wanted info on reporting incident to authorities=Technician gave pt. daughter phone # to report incident.

Pt admitted to hospital from 5/21 to 5/22 discharged home, dehydration, atrial fibrillation, malaise, had second moderna covid vaccine 5/21, became ill 5/22 woke up with low grade fever, generalized weakness, malaise, no appetite, lightheaded, fall to ground stricking righ cheek, no LOC, baselilne memory losse, confusion improved, better on 5/22 morning, no need for follow up clinic visit. Can't get to fill in hospital information to unshade to fill in

Infection and hospitalization. 2/13/2021 admission with discharge on 2/22/2021. Worsening SOB and epistaxis upon admission requiring intubation and admission to ICU. Extubated on 2/17/2021. Dx during visit include hypoxia, sepsis, hypotension, anemia, aspiration into airway, creatinine elevation, epistaxis, atrial fibrillation, essential hypertension, diastolic heart failure

Moderna COVID-19 Vaccine EUA: three days after vaccination patient presents to clinic reporting cough, chills, and over one month worsening of dyspnea on exertion, lower extremity edema, and orthopnea. Patient immediately transferred to hospital, diagnosed with acute on chronic volume overload and acute diastolic heart failure exacerbation, diuresed, and discharged to home medically stable. On outpatient follow-up patient is improved clinically.

presented for a well exam and was noted to have an irregular heart rate. She was in atrial fibrillation with rapid ventricular response. now on beta blocker, digoxin and eliquis.

This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (In and Out of Rhythms (Atrial Fibrillation).) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included DESLORATADINE for Allergy, ASA and APIXABAN (ELIQUIS) for Anticoagulant therapy, LOSARTAN and METOPROLOL for Blood pressure, FUROSEMIDE for Diuretic effect, MACROGOL 400, PROPYLENE GLYCOL (SYSTANE) for Dry eye, FLECAINIDE from 14-May-2021 to an unknown date and CLONIDINE for Heart disorder. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced ATRIAL FIBRILLATION (In and Out of Rhythms (Atrial Fibrillation).) (seriousness criterion medically significant), HUNGER (Unusual hungry feeling) and BLOOD PRESSURE FLUCTUATION (Fluctuations of Blood Pressure readings). On 15-May-2021, the patient experienced VACCINATION SITE WARMTH (Large, round, red circle, not bright red, warm to touch), VACCINATION SITE ERYTHEMA (Large, round, red circle, not bright red, warm to touch), VACCINATION SITE RASH (Rash in the circle) and VACCINATION SITE SWELLING (Circle 4 inches below the injection site, size of a golf ball). At the time of the report, ATRIAL FIBRILLATION (In and Out of Rhythms (Atrial Fibrillation).), HUNGER (Unusual hungry feeling), BLOOD PRESSURE FLUCTUATION (Fluctuations of Blood Pressure readings), VACCINATION SITE WARMTH (Large, round, red circle, not bright red, warm to touch), VACCINATION SITE ERYTHEMA (Large, round, red circle, not bright red, warm to touch), VACCINATION SITE RASH (Rash in the circle) and VACCINATION SITE SWELLING (Circle 4 inches below the injection site, size of a golf ball) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-May-2021, Blood pressure measurement: 104/54 (Inconclusive) At 6:50am, 97/62 (Inconclusive) At 11:40am, 110/62 (Inconclusive) At 2:50pm, 142/89 (Inconclusive) At 8:45pm and 119/69 (Inconclusive) At 10pm. On 12-May-2021, Heart rate: 74 (Inconclusive) At 6:50am, 73 (Inconclusive) At 11:40am, 62 (Inconclusive) At 2:50pm, 109 (Inconclusive) At 8:45pm, 103 (Inconclusive) At 10pm and 97 (Inconclusive) At 2:50pm. On 13-May-2021, Blood pressure measurement: 110/87 (Inconclusive) At 7:12am and 117/76 (Inconclusive) At 8:06am. On 13-May-2021, Heart rate: 104 (Inconclusive) At 7:12am and 101 (Inconclusive) At 8:06am. On 14-May-2021, Blood pressure measurement: 116/80 (Inconclusive) At 7:32am, 129/78 (Inconclusive) At 1:02pm and 169/97 (Inconclusive) At 8:32pm. On 14-May-2021, Heart rate: 99 (Inconclusive) At 7:32am, 102 (Inconclusive) At 1:02pm and 107 (Inconclusive) At 8:32pm. On 15-May-2021, Blood pressure measurement: 140/83 (Inconclusive) At 7:03am, 147/88 (Inconclusive) At 9:19am, 146/96 (Inconclusive) At 4:55pm, 161/95 (Inconclusive) At 8:20pm and 112/83 (Inconclusive) At 10:00pm. On 15-May-2021, Heart rate: 78 (Inconclusive) At 7:03am, 104 (Inconclusive) At 9:19am, 108 (Inconclusive) At 4:55pm, 109 (Inconclusive) At 8:20pm and 95 (Inconclusive) At 10:00pm. On 16-May-2021, Blood pressure measurement: 136/75 (Inconclusive) At 7:03am, 101/67 (Inconclusive) At 9:12am, 101/62 (Inconclusive) At 2:03pm and 127/75 (Inconclusive) At 10:00pm. On 16-May-2021, Heart rate: 101 (Inconclusive) At 7:03am, 104 (Inconclusive) At 9:12am, 90 (Inconclusive) At 2:03pm and 70 (Inconclusive) At 10:00pm. On 17-May-2021, Blood pressure measurement: 139/86 (Inconclusive) At 7:03am. On 17-May-2021, Heart rate: 73 (Inconclusive) At 7:03am. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Very limited information regarding the event atrial fibrillation has been provided at this time. For the other events a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding the event atrial fibrillation has been provided at this time. For the other events a causal relationship cannot be excluded. Further information has been requested.

Passed out; Does not want to get 2nd dose; Head was hurting; Mini stroke; Speech difficulties; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) and CEREBROVASCULAR ACCIDENT (Mini stroke) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history was reported. Concomitant products included LOSARTAN, LEVOCETIRIZINE, TEMAZEPAM, ATORVASTATIN CALCIUM (LIPITOR), BISOPROLOL and BUSPIRONE for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criteria hospitalization and medically significant). On 01-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Mini stroke) (seriousness criteria hospitalization and medically significant), SPEECH DISORDER (Speech difficulties) and HEADACHE (Head was hurting). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Does not want to get 2nd dose). The patient was hospitalized from 01-Apr-2021 to 04-Apr-2021 due to CEREBROVASCULAR ACCIDENT and LOSS OF CONSCIOUSNESS. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out), CEREBROVASCULAR ACCIDENT (Mini stroke), SPEECH DISORDER (Speech difficulties) and HEADACHE (Head was hurting) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Does not want to get 2nd dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included generic Plavix and blood thinner. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

I happened to counsel patient's husband about his prescription 2 days ago and hear that his wife died of stroke approximately a month after the second dose of Moderna vaccine. I could not ask him further about exact date when she was admitted at the hospital because he was sick. I am not sure whether moderna vaccine caused her stroke, or not. Her husband said his wife had high blood pressure. They got Moderna vaccine on the same date. Her husband thought her high blood pressure caused the stroke. I don't have any info about her medical progress at the hospital.

Had chest pain and came into ED, found to have NSTEMI went to cardiac cath, no stent needed at this time. given aspirin 81 mg daily for life and plavix 75 mg daily for 1 year discharged home

Patient developed blood clots in her legs, heart, and lungs within 48 hours after receiving her second dose of the Moderna vaccine. She was subsequently treated with Eliquis (apixaban).

I experience face and ear swollen. Couldn't chew. Since vaccination I been diagnosis with A-Fib and Lymphocytic Leukemia.

COPD She was a resident at the Senior Living facility. My mother received the vaccine on Tuesday, May 18, 2021 at approximately 11:00 a.m. She was left by herself and called around at 11:32 to say she got the vaccine and she was having a hard time breathing. Around 1:40, the nursing home called to let me know CPR was being performed. My sister rushed to the site and she was pronounced dead around 2:10. p.m.

broken foot; Fall; Unevaluable event; Atrial fibrillation; Fall; Cerebral bleeding; Stroke; This spontaneous case was reported by a physician and describes the occurrence of ATRIAL FIBRILLATION (Atrial fibrillation), CEREBRAL HAEMORRHAGE (Cerebral bleeding), CEREBROVASCULAR ACCIDENT (Stroke), the first episode of FALL (Fall), FOOT FRACTURE (broken foot), the second episode of FALL (Fall) and UNEVALUABLE EVENT (Unevaluable event) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 023M20A) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Depression, Bladder disorder, Cholesterol, Abstains from alcohol and Non-smoker. Concomitant products included OXYBUTYNIN HYDROCHLORIDE (DITROPAN) for Bladder disorder, ATORVASTATIN for Cholesterol, BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression, METOPROLOL for Heart disorder, MIRTAZAPINE (REMERON) for Unevaluable reaction. In 2020, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. 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. On 11-Feb-2021, the patient experienced the first episode of FALL (Fall) (seriousness criteria hospitalization and disability). In February 2021, the patient experienced CEREBRAL HAEMORRHAGE (Cerebral bleeding) (seriousness criteria hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant). On 10-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Atrial fibrillation) (seriousness criteria hospitalization and medically significant) and UNEVALUABLE EVENT (Unevaluable event) (seriousness criterion hospitalization). On 08-Jun-2021, the patient experienced FOOT FRACTURE (broken foot) (seriousness criteria hospitalization and disability) and the second episode of FALL (Fall) (seriousness criteria hospitalization and disability). The patient was hospitalized from 15-Feb-2021 to 18-Feb-2021 due to ATRIAL FIBRILLATION, CEREBRAL HAEMORRHAGE, CEREBROVASCULAR ACCIDENT and FALL. On 08-Jun-2021, last episode of FALL (Fall) had resolved. At the time of the report, ATRIAL FIBRILLATION (Atrial fibrillation), CEREBRAL HAEMORRHAGE (Cerebral bleeding), CEREBROVASCULAR ACCIDENT (Stroke), FOOT FRACTURE (broken foot) and UNEVALUABLE EVENT (Unevaluable event) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Magnetic resonance imaging head: confirmed brain is bleeding (abnormal) Confirmed brain is bleeding. On 10-Mar-2021, Electrocardiogram: confirmed atrial fibrillation (abnormal) Confirmed Atrial fibrillation. On 08-Jun-2021, X-ray limb: confirmed broken foot (abnormal) Confirmed broken foot. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was sent to urgent care because the patient fell again and it was determined that her left foot was broken where a boot cast was put on her left leg and was advised to have bed rest and had the left leg elevated. The patient was waiting for brain bleeding to heal. 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.

Tried all the time, not eating, anemia, stopped making blood, hospitalized from may 21, 2021 to dying on June 29, 2021with ANCA vasculitis renal failure. My mother was never sick with this until She got the vaccine moderna

Major Stroke with bleed to brain. Medical providers were unable to determine the cause. I reported the vaccine given the week before the event three times to the Emergency room team, the Hospitalist and to the Rehab Unit.

Patient received her vaccination on 1/12/21 administered by pharmacy*+. She expired on 1/12/21 an approximately 7:30pm. Resident did not have any adverse reactions and was a hospice patient.

1/19/21: ER visit for evaluation 1/20/21: Hospital admit due to increased confusion and possible sepsis. Principle Problem listed: Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction; Acute encephalopathy SIRS likely due to COVID-19 vaccine but no current evidence of acute infection. Her acute encephalopathy is likely due to her SIRS response in the elderly and does not require acute intervention other than support.

Patient obtained initial dose of Moderna vaccine on Thurday, Jan 14. No adverse effects reported during initial 15 minute post vaccine waiting period. Saturday morning (Jan 16), patient developed severe cough, labored breathing, and fever. Additionally patient mental status changed suddenly, became non-communicative (unable to speak, but would scream if she was touched). O2 status was irregular, dropping to 78. Sunday morning, EMT and then hospice was hospice called. Monday morning, after hospice emergency kit was initiated, patient passed away.

Fever Feeling tired short of breath all night and morning after the vaccine My grandma had to be intubated and then passed away to a heart distress we think it was the vaccine because she was fine even with dialysis. When she got the vaccine it took hours and her health conditions changed.

After 1.5-2 hours after injection, patient blacked out on stairwell and fell down stairs. Patient struck head and received a concussion, broken nose, brain bleed, tear in the lip and damage to 6th cranial nerve in right eye. Patient has double vision now.

Acute onset of SOB presented to ED and diagnosed with a pulmonary embolism. Tested positive for SARS-Co-V-2 on 01/25/21 using NAT.

Stroke like symptoms; Couldn't speak; Shortness of breath; Legs and arm weakness; Dizziness with Nystagmus; Throat swelling; Dizziness with vertigo; Dizziness with vertigo; A spontaneous report was received from a nurse concerning a 79-year-old, white, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke like symptoms, dizziness with nystagmus, legs and arm weakness, couldn't speak, shortness of breath, throat swelling and dizziness with vertigo. The patient's medical history, as provided by the reporter included anemia, overactive bladder, fibroid cystic disease, allergy to fluoroquinolone, ciprofloxacin, povidone iodine, morphine and adhesive tape. The concomitant medications reported included atorvastatin, calcium, colecalciferol, metoprolol succinate, pramipexole hcl and prasugrel hcl for unspecified indications. On 07 Jan 2021, 11 hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. The patient experienced stroke like symptoms, couldn't speak, shortness of breath and throat swelling. It was reported that the patient was hospitalized for acute stroke. On an unknown date, while still being hospitalized, the patient developed, dizziness with nystagmus and dizziness with vertigo. The lab findings included, magnetic resonance imaging (MRI) and computed tomography (CT) scans as negative for acute findings, electrocardiography (EKG), complete blood count (CBC), X-ray and chemistries were reported as within normal limits. The patient remained hospitalized for 2.5 days while the symptoms improved. On 09 Jan 2021, the patient was discharged. On 20 Jan 2021, the reporter stated that the patient felt weak and tired without other symptoms. It was also noted that the patient's discharge summary stated the patient's symptoms may be worse following a second dose of mRNA-1273 vaccine. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, stroke like symptoms, dizziness with nystagmus, legs and arm weakness, couldn't speak, shortness of breath, throat swelling and dizziness with vertigo. were considered as resolved on an unknown date.; Reporter's Comments: This case concerns a 79-year-old, white, female patient with medical history of anemia, overactive bladder, fibroid cystic disease, who experienced the serious, unexpected event of stroke, Aphasia, dyspnea and non-serious, unexpected events of , dizziness, vertigo, pharyngeal swelling, nystagmus and muscular weakness. The events of stroke, Aphasia, Dyspnea and pharyngeal swelling occurred 11 hours after the first dose of mRNA-1273 (Lot number: 025J20-2A) administration and the events of dizziness, vertigo, pharyngeal swelling, nystagmus and muscular weakness occurred on an unknown date while the patient was still hospitalized. 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.

Moderna COVID?19 Vaccine EUA Patient received her first dose of Moderna on 2/10/2021. On 2/11/2021 she developed chills and fever of 104. She was sent to Hospital. Was admitted and chest Xray showed patchy spots suspicious of pneumonia. She remained inpatient for two days with antibiotic treatment. Was discharged home on 2/13/2021 with oral antibiotic and follow up appointment with pulmonary. PCR and rapid COVID testing while inpatient was nagative for COVID-19

Blacked out; fell down the stairs; concussion; damaged or severed 6th cranial nerve to right eye; brain bleed; split lip; A spontaneous report was received from a consumer concerning a 79-years-old, female patient who received Moderna's COVID-19 Vaccine, and who blacked out, fell down the stairs, brain bleed, concussion, damaged or severed 6th cranial nerve to right eye and split lip. The patient's medical history included diabetes, two unspecified high blood pressure medications and naproxen sodium. Products known to have been used by the patient, within two weeks prior to the event, included Sitagliptin and blood pressure medication. On 21 Jan 2021, approximately one and half hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number 027L20A) intramuscularly for prophylaxis of COVID-19 infection. On 21 Jan 2021, the patient "blacked out" while walking downstairs after one in and half hours of receiving vaccination. Patient was hospitalized from 21 Jan 2021 until 22 Jan 2021. Patient has a brain bleed and a concussion, damaged 6th cranial nerve to right eye, and split her lip which need stitches. Treatment for the event included Tylenol as needed. Action taken with mRNA-1273 in response to the events was withdrawn. The events blacked out and fell down the stairs was resolved on 21 Jan 2021. The outcome of the events brain bleed, concussion, damaged or severed 6th cranial nerve to right eye and split lip was unknown.; Reporter's Comments: This case concerns a 79 year old female patient with medical history of diabetes, two unspecified high blood pressure medications and naproxen sodium, who experienced serious unexpected events of fall, cerebral hemorrhage, loss of consciousness, concussion, damaged or severed 6th cranial nerve to right eye and split lip. The event occurred approximately one and half hours after first dose of the study medication administration. Treatment included Tylenol as needed. 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. Noting the subject's underlying medical condition could remain a confounder.

Patient developed lethargy and malaise several hours after vaccine with a low grade fever. The following morning she reported to her husband inability to taste food or drink. She developed nausea and vomiting which persisted from 1/30/21 through her death. She was found deceased in bed by her husband this morning.

Woke up with severe dizziness, nausea/vomiting and increased while at work(denies palpitations). In ER 1/2/2021-CT of head(WNL), MRI (saw lesion and physician thought she had a stroke). Neurologist consult on 1/3 and felt it was not a stroke and unsure the reason of dizziness.. 1/3 no arm or leg weakness. Order to see a cardiologist d/t residual dizziness and advised against 2nd moderna covid 19 vaccine.

left sided weakness; Stroke like symptoms; Slurred speech; Pneumonia; spontaneous report received from a Consumer concerning, 79-year-old female patient who received the first dose of Moderna COVID-19 vaccine and woke up the next morning not feeling well. /PT: [Not Feeling Well]. The patient's medical history included COPD, hypertension and hyperlipidemia. Patient allergies included sleep medications. Patient's concomitant included Gabapentin, Simvastatin, Advair, Spiriva and Proventil. On 04-FEB-2021, the patient received their first of two planned doses of mRNA-1273 in left arm (Batch #: 016M20A) intramuscularly for prophylaxis of COVID-19 infection. Patient daughter called on behalf of her mother. Patient daughter stated that her mother received the Moderna COVID-19 vaccine on 04FEB2021 and on 05Feb2021 her mother woke up and wasn't feeling well. She stated her mother had weakness on her left side. The daughter stated that ambulance took her mother to hospital. The daughter stated that her mother had stroke like symptoms. The daughter stated her mother had difficulty speaking and slurred speech. The daughter stated the doctor Called it "Neglect for sensation". The daughter stated her mother was treated like she had a stroke. The daughter stated that the doctor gave her mother a "Clot buster" treatment and it started to normalize. The daughter stated the MRI was negative. She daughter that her mother was still hospitalized and now has pneumonia. Wanted to know if this has been previously reported. Treatment that was given in the hospital was a "Clot Buster" Action taken with mRNA-1273 in response to the event was not provided/unknown. The outcome of the event was unknown/not reported.; Reporter's Comments: The events developed on same day after first dose of mRNA-1372. Hemiparesis, dysarthria, and pneumonia were consistent with increased risk of cerebrovascular accidents related to high blood pressure confounded by elderly age of patient. Very limited information regarding this event/s has been provided at this time. 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.

Anaphylaxis Patient "went into cardiac arrest", was taken to ER. Physician stated this was a reaction from the vaccine.

Initial flulike symptoms with fever Tues -Friday. Had a right side stroke 6 AM Saturday morning . Rushed to hospital and had a procedure involving a catheter through the body to the clot in the brain. Came out of that with a weekend left side and was medicated through Sunday night. At 10:30 PM Sunday night had a second stroke on the right side. Did not wake from that. Now I?m not expected to survive.

A-fib; Rapid heart beat; A spontaneous report was received from a consumer concerning a 79 year old, female patient who experienced rapid heartbeat and atrial fibrillation (A-fib). The patient's medical history included hypertension and renal disease. Concomitant product used were losartan potassium ,levothyroxine, fluorseminde ,levotiroxine, multivitamin, zinc , vitamin for knee joint movement, vit D3 , alpha lipoic acid, rosuvastatin calcium , elequis, milatonin , probtotic 10. On 27 JAN 2021, approximately 30 minutes prior to the onset of the symptoms, the patient received her first of two planned doses of mrna-1273, batch number was not provided, intramuscularly in an unknown injection site for the prophylaxis of COVID-19 infection. On 27th JAN 2021, after receiving the vaccine she experienced rapid heartbeat and she reached out to the pharmacy where she took the vaccine. From there the pharmacist called 911. On 27th JAN 2021 she was hospitalized, and the hospitalization prolonged for four days and discharged on 31 JAN 2021. Treatment for the event included Eliquis 5 milligrams (mg) and Metoprolol Succinate ER 25mg. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events rapid heart beat and A-fib were unknown.; Reporter's Comments: This case concerns a 79-year-old female, with medical history of hypertension, who was hospitalized with serious unexpected events of atrial fibrillation and heart rate increased. The events occurred the same day as the first dose of mRNA-1273 and were treated with Eliquis and Metoprolol. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient came with husband to Vaccine clinic today 3/5 for 2nd dose of vaccine. Did well during and immediately after vaccine. Husband states patient has c/o severe chest pressure and pain for several weeks but has refused to come to ER for evaluation. Today, after getting vaccine dose and going to local bank, patient was in passenger side of truck when chest pain started again. Husband begged patient to let him take her to the ER but she said no, I?m fine and I don?t want to go. She then went unresponsive. At a stop light, he was next to a couple of cops who he was able to wave down and proceed to escort them in to ER. Upon arrival to the ER, patient was unresponsive and pulseless. CPR was initiated, 1 defib, and 1mg of epi was given. Return of pulse was obtained, but husband asked for no life support and only comfort measures. Patient was admitted for comfort measures. I do NOT think this was related to her vaccine, but rather the unfortunately end to a sub-acute chest pain patient that declined multiple urgings to seek care. Patient then expired on 3/5/21 at 2037.

2/26/21 History & Physical- History of present illness: "Pleasant 79 years old female who started to develop recurrent episodes of nausea and vomiting of nonbilious none bloody material 1 week ago then started to have frequent watery bowel movements with the last bowel movement was associated with rectal bleeding, she started to develop generalized weakness and fatigue, she had 3 falls in the last week without hitting her head, she did not have loss of consciousness, over the last 2 days she has been complaining of numbness and tingling to the hands and feet, she was not able to walk due to generalized weakness. She denied fever or chills she had no chest pain or shortness of breath. 2 weeks ago she got her second dose of COVID-19 vaccine. There was no change to her medications according to her, she denies sick contacts." Intubated and ICU transfer 2/28/21 for "Possible Guillain-Barré syndrome and impending respiratory failure" extubated 3/10/21.

5. Brief History and Hospital Course: Patient is a/an 79 y.o. female with a past history significant for HTN, HLD, and DM who presented to facility on 3/9/2021 with complaints of severe 8/10 right jaw pain lasting 3 minutes. EKG with new left BBB and troponin mildly elevated 8-17-35-26. She was seen by Cardiology and determined to have NSTEMI and taken for cardiac cath with drug eluting stent placed to LAD. Echo was also ordered with evidence of murmur. Cavity size is normal. Wall thickness is normal. Systolic function is normal. The estimated ejection fraction is 55%. Dyssynchronous interventricular septal motion, likely related to conduction abnormality/bundle branch block. Grade I diastolic dysfunction. Annulus is severely calcified. Severely calcified and restricted opening of posterior mitral leaflet. Mild mitral valve stenosis at the max. She remained stable post stent placement. She remained on dual antiplatelet therapy

Pt became encephalopathic, developed afib, and urinary retention. Admitted to the hospital for 2 week stay until encephalopathy resolved. Afib broke spontaneously. Required foley catheter placement.

Developed fever and chills around 6pm on day of vaccination. Severe febrile reaction. Developed respiratory distress and became unresponsive. Transported to ED where O2 sat'n on room air was 45%. Intubated and transferred to ICU. Extubated on 2/24/21 and transferred to telemetry floor with nasal cannula. Ultimately stable on room air. Treated for pulmonary edema, cardiogenic shock and acute on chronic CHF. Resolved and back to baseline by 3/4 when she was discharged.

Son reports the day after the vaccination, the patient had a stroke while waiting in the pre-op area for a trigger finger surgery. Patient had not been asked about pending surgeries or other medications on day of vaccination. Son reports patient stopped taking blood thinning medication 2 days earlier because of surgery. According to son, patient's symptoms have resolved and patient did return for second dose on 2/26/2021.

shortness of breath, pain in chest increasingly more severe as time went on. Noticed shortness of breath about 12 days after the vaccine was given. I am a 2 mile a day walker and very healthy. It was below freezing and I attributed the shortness of breath to weather. I went to an ER on March 8, 2021 after realizing symptoms were worse. I was admitted with Pulmonary embolism in both lungs and pneumonia in both lungs. The hospitalist could not give me a reason why this happened. He encouraged me to report this incident. You would need to contact him for tests and such. I am a patient. I live where medical help is limited. The vaccine was administered at a clinic but the ER I went to was a different system.

Patient had chills and low fever (99.4) 8 hours after vaccine. Patient went to bed early (8 PM). Patient awoke about 2 AM on 03/09/2021, walked through a dark hallway, and fell down a flight of steps. Injuries include 17 fractures (5 vertebrae, 9 ribs, 1 clavicle, 1 area of lower rear skull, and nose), collapsed lung, brain bleed, and cognition issues. This may be a sleep walking or hallucination issue. Patient has no previous history of sleep walking or hallucinations.

I HAD HEADACHES, CHILLS, DIARRHEA, ACHES AND TIREDNESS BUT MY BIGGEST CONCERN IS THE FACT THAT I WOUND UP IN THE HOSPITAL ON FEB 8 WITH BLOOD CLOTS DOWN MY ENTIRE RIGHT LEG AND IN MY LUNGS. I NEED TO KNOW IF THE MODERNA CAUSED THESE OR MADE THEM WORSE. I HAD NO IDEA I HAD BLOOD CLOTS BUT MY FOOT, LEG WERE SWOLLEN AND I ACHED FROM MY HIP DOWN THAT LEG. I ACTUALLY THOUGHT IT WAS SIADACA.

Pt. presented to ER on 3/19/2021. Family reports that pt. received her Covid vaccination on 3/17/2021. Since then her stomach started hurting and pt. is lethargic. Pt. did not open eyes when asked questions and was quite pale. Son reports increased confusion last day or two. Pt. reports that she started feeling ill immediately after receiving the injection. Complains of generalized weakness and fatigue. Denies dizziness or lightheaded. C/o abd. pain. Denies nausea, vomiting, but admits to diarrhea. Denies fevers, cough congestion. She is alert to place and name, but unsure of date at time seen in ER. When seen in ER she was afebrile, but hypoxic and hypotensive. Initial saturations were in mid 80's, but dropped to low 60's. With a non-rebreather mask she maintained at 90%. BP 60's systolic but with fluids increased to 90's . No rectal bleed or hematemeis. Diagnosis of septic shock, anemia, elevated LFT's, pneumonia, and UTI.

Vaccine given Dec 27th 2020, patient couldn?t swallow eat or drink the next day, patients family notified Dec 29th 2020 and patient passed away on Dec 30, 2020 at 1 pm EST.

Stroke; Dizziness; Blurred Vision; Slurred speech; Felt numbness; Tiredness; A sponatenous report was received from a consumer concerning a 79 years old female patient who experienced dizziness, tiredness, slurred speech, numbness, blurred vision, stroke, very very lethargic and had tingling in face and fingers, lost speech, lost eyesight. The patient's medical history as reported by the reporter includes hypertensive, diabetic and had circulation problems. Concomitant medications taken by the patient was not provided. On 25 Feb2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025A21A) through intramuscular route at unspecified site for prophylaxis of COVID-19 infection. On an unknown date, patient had dizziness, tiredness (which is very unusual for patient), slurred speech numbness and blurred vision and then patient was taken to the ER and diagnosed with having stroke. She was admitted and discharged when her condition improved. As per the follow up report received, the reporter reported that patient ended up in having a stroke which was a medically significant event and she was very very lethargic and had dizziness, felt numbness and tingling in face and fingers. Patient had also lost speech, lost eyesight which was a medically significant event. Patient went to the hospital where she was diagnosed. Patient was feeling better at the time of reporting and mostly recovered but feeling weak. Patient went to hospital and treatment activities for events was unknown. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, experienced dizziness, tiredness, slurred speech, numbness, blurred vision, stroke, very very lethargic and had tingling in face and fingers was recovering/resoving and lost speech, lost eyesight was unknown.; Reporter's Comments: There is not enough information to assess the causal association between the reported events and the administration of the mRNA-1273 vaccine. Critical details such as the onset date of the event is lacking. Event is also confounded by the patient's advanced age and underlying medical conditions of hypertensive, diabetic and had circulation problems.

To er for eval of seizure activity at hospital . Nurse reported that seizure activity lasted 1.5 min and took approx. 30 minutes for her to start " coming around" to her self. Patient was bradycardic en route to hospital. er hpi: "79 y.o. female who presents with seizure activity. Patient is brought to the ER via EMS from nursing home with new onset seizure. Nursing home staff reports patient had tonic-clonic seizure which lasted approximately 1 min. Patient was apneic. Patient is slightly postictal but no urinary incontinence. Patient has no known history of seizure disorder. Patient is resident of nursing home and is a DNR comfort care. Patient with underlying dementia. In speaking with patient she denies any current headache, chest pain, shortness of breath, abdominal pain, nausea, vomiting, diarrhea, fevers, or chills. She is alert only to name." Inpatient admission to hospital 3/24/21 dx acute hepatic encephalopathy, new onset seizure without head trauma

Pt suffered a TIA. She had right sided weakness and difficulty speaking. She was taken to the ER, CT waa preformed and no abnormalities were detected. The symptoms resolved in 24 hours.

Blood clots in both legs; Cramps and spasms on her right and left legs; Painful nodules under both arms and shoulders; Itching down to her toes and left side of the body; Injection site itching; A spontaneous report was received from a consumer concerning a 79-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Cramps and spasms on her right and left legs, injection site itching, itching down to her toes and left side of the body/pruritus, painful nodules under both arms and shoulders/nodules and blood clot in both legs/Thrombosis. Medical history was not reported. Concomitant medications included losartan, cetirizine hydrochloride and pantoprazole. On 30 Jan 2021, the patient received her first planned dose of mRNA-1273 (batch number: 007MZ0A) intramuscularly for prophylaxis of COVID-19 infection. On 27 Feb 2021, she had her second planned dose of mRNA-1273 (batch number: 01021A) intramuscularly on left arm. Soon, she developed itching at injection site down to her toes and left side of the body. She developed painful nodules on shoulders as well as both under arms and it was mentioned that the one on left side was severe. On 09 Mar 2021, she began experiencing cramps and spasms on her right and left legs. She was diagnosed with blood clots in both legs while in the emergency room (ER). She was treated with hydroxyzine and apixaban. The event blood clot in both legs was considered to be medically significant. The action taken with mRNA-1273 in response to the events injection site itching, itching down to her toes and left side of the body, painful nodules under both arms and shoulders and blood clot in both legs was unknown. The outcome of the events Cramps and spasms on her right and left legs, injection site itching, itching down to her toes and left side of the body and blood clot in both legs was unknown whereas painful nodules under both arms were still sore but better.. The reporter did not provide any causal relationship between mRNA-1273 and the events injection site itching, itching down to her toes and left side of the body, painful nodules under both arms and shoulders and blood clot in both legs.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Received vaccine on 01/26/2021 and unknowingly experienced event. Early morning of 01/28/2021 had fainting spell and thought it was caused by low blood pressure. Felt fine for remainder of day. On evening of 01/29/2021 I started having strange symptoms. Could not concentrate, vision impaired and couldn?t figure out what evening meds I needed to take. Decided to go? to hospital on 01/30/2021. Getting ready, I passed out and husband called emergency services. Husband learned later in the day that I had a stroke. Doctors i;nfo?rmed that had blood clots in heart and lungs. Doctors advi;se not to get second vaccine shot.

she got couple episodes of vomiting next day of vaccine and by the day after morning she became unresponsive and took to ER and found benign meningioma ( not known before ) and uncle herniation, thalamic infarct and followed by went for the decompressive surgery at the and brought home after 2 week and at the 3 rd week put on hospice and diet on 03/18/2021. She would be alive today if she hasn't received vaccine.

Patient admitted to local hospital for new onset atrial fibrillation/flutter with rapid ventricular response. Patient last known well at time of vaccination (no reported complications with 1st vaccination). After 24 hrs, began feeling fatigued, with general malaise, and fever. Presented to hospital ED 4 days after vaccination and found to be in new onset afib/flutter. Required admission and introduction of diltiazem and metoprolol for rate control and started on rivaroxaban for anticoagulation

The patient started to feel swelling, redness on the interior of upper right leg.It was a swollen vein. She went to the physician on 2-15-2021. She was diagnosed with having a blood clot and had to have it removed. She is wearing compression stockings now 24/7.

Unable to get second dose; physiologic arthritic flare; Physiologic arthritic flare; High Temperature; Small patches of pneumonia (pleuritis); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Small patches of pneumonia (pleuritis)) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D1DM20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Arthritis. Concomitant products included PREDNISONE for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PNEUMONIA (Small patches of pneumonia (pleuritis)) (seriousness criterion medically significant), ARTHRITIS (physiologic arthritic flare), ARTHRALGIA (Physiologic arthritic flare) and PYREXIA (High Temperature). On 10-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Unable to get second dose). On 10-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Unable to get second dose) had resolved. At the time of the report, PNEUMONIA (Small patches of pneumonia (pleuritis)), ARTHRITIS (physiologic arthritic flare), ARTHRALGIA (Physiologic arthritic flare) and PYREXIA (High Temperature) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided by the reporter. Based on the current available information and the Temporal association between the use of the product and start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the Temporal association between the use of the product and start date of the events a causal relationship cannot be excluded.

Patient developed diarrhea within hour of receiving injection. She developed shortness of breath requiring trip to ED approximately 12 hours later. She had cardiac arrest in ED.

Developed blood clot in heart -- > went into Atrial Fibrilation with no prior history of A FIb -- > Large clot was thrown from the heart into the brain splitting into two clots, one blocking brain stem and one blocking right hemisphere -- > Death on 2/10/21

Patient has history of ITP (Immune related thrombocytopenia) which recurred after receiving her 2nd dose

DRESS syndrome also with STEMI and shock 2 weeks in the CCU, also developed ITP. Derm biopsy still pending. resolved with IVIG and steroids

Fatigue; dizziness; light-headedness; repeated episodes of atrial fibrillation and vascillation between low and high heart rates (ranging between 42 and 130 BPM) These symptoms began 2 days after I received the 1st Moderna vaccine and lasted approx. 7 days. Though I was diagnosed with Afib 10 years ago, my prior experience with Affib was limited to 3-4 isolated episodes per year, lasting only 1-3 hours each. My past Afib experiences were never as long or as intense as this experience. It is not clear whether this worsening Afib experience simply coincided with my Covid vaccination or whether there may have been a causal relationship.

Fatigue; dizziness, light-headedness; repeated episodes of atrial fibrillation and heart rate ranging between 37 and 180; nausea; repeated sensation that I might pass out. These symptoms began on 2/23/21, 5 days after receiving the 2nd Moderna vaccine. Symptoms were similar to but more intense than symptoms experienced after my 1st Moderna vaccine. I was taken to the ER during the night of 02/24/2021 beause of intensification of symptoms. Symptoms continued intermittently until 03/23/202 when a cardiac ablation was performed at a Cardiovascular Center. I also experienced some post-op Afib in first 2 weeks following the procedure.

3/21 admit HPI: 80-year-old white female with a past medical history for oxygen-dependent COPD who presents to the emergency room today due to falls and possible confusion. According to the family member, he does not think her oxygen was set at the right level. He thinks it was set up higher because she tends to get confused and fall when this happens. The patient really has fallen twice of late. She said she aches all over. She also cites dizziness when she stands up. Because of the symptomatology, she came to the emergency room for evaluation. Workup, including chest x-ray imaging, was fairly unremarkable. The patient did not, however, feel safe going directly home. At the present again, she just feels achy. There is no chest pain or shortness of breath. No abdominal pain or urinary symptoms. No rash. 3/26/21 admitted 80 y.o. female with a PMH notable for COPD, atrial fibrillation, hypertension, diabetes and obesity who presented on 3/26/2021 for evaluation of physical deconditioning. Patient presents to our facility yesterday after hospital stay from hospital from 03/21 through 3/26/2021. Hospital course - The patient is an 80-year-old white female with a past medical history for oxygen-dependent COPD who presents to the emergency room today due to falls and possible confusion. According to the family member, he does not think her oxygen was set at the right level. He thinks it was set up higher because she tends to get confused and fall when this happens. The patient really has fallen twice of late. She said she aches all over. She also states dizziness when she stands up. Because of the symptomatology, she came to the emergency room for evaluation. Workup, including chest x-ray imaging, was fairly unremarkable. The patient did not, however, feel safe going directly home. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the machine. Since admit, patient admitted to pain in her back. CT spine showed L1 compression fracture which appeared new. PT worked with patient and felt she should go to rehab for continued therapies.Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor. Patient is then to follow-up with neuro surgery and 3-4 weeks. 4/17 ER: 80 y.o. female who presents with increased somnolence and lethargy. Patient was discharged from the hospital 2 days ago after having a stay on swing bed. She has multiple medical problems and was admitted following a hospitalization at Hospital. She has generalized debilitation and advanced COPD with CO2 retention. Patient has been instructed to utilize a BiPAP machine. According to her family, she has been none a compliant with this and did not utilize it last night. Patient noted this morning that she was somnolent and lethargic. Prior to that she had been doing well since discharge. Other than the lethargy and somnolence there are no other complaints. 4/18/21 ER to admit: dx sepsis 80 y/o F with PMHx COPD with chronic CO2 retention and respiratory failure on 2L NC, OSA, non-compliant with CPAP, myoclonic jerks, essential tremor, type 2 DM, HTN, paroxysmal a.fib on eliquis, essential tremor and recurrent falls with recent L1 compression fracture s/p brace placement, presented to ED on 4/18/2021 for shaking and AMS.

Day after the shot on Tuesday morning woke up a little fatigue she did a little cooking and her chest started really getting tight she was sweating really bad went to bed slept all day tried walking on Wednesday put a heating pad on her legs with muscle spasms called me at 5 AM to get her to the ER she couldn?t walk her leg swelled up really bad

Eight sessions of diarrhea which led to internal bleeding; fever of 102, and an inability to verbalize thoughts with clarity without tremendous concentration.

Patient lost memory, had vomiting, and very tired, patient had incontinence. patient also went into afib.

Patient presented to the ED on 2/4/21 with NSTEMI and was subsequently hospitalized. She also presented to the ED and was subsequently hospitalized on 2/24/21. These visit were within 6 weeks of receiving COVID vaccination.

Bilateral dural sinus and jugular vein thromboses. Has viridans streptococcal bacteremia. Thrombosis may be infected. Patient also tested positive for SARS-CoV2 4/23/2021. Being treated with antibiotics, Eliquis. Not thrombocytopenic. HIT studies pending.

STATES SHE HAS BEEN FEELING RUN DOWN AND SICK FOR SOME TIME. STATES SHE HAS COVID IN NOV 2020 AND HAS NOT FELT WELL SINCE THEN. MADE AN APPT WITH HER HEART DOCTOR FOR FOLLOW UP TO TRY AND SEE IF THEIR WAS ANYTHING SHE COULD FIND TO HELP IMPROVE HER FEELING. WENT ON 4/22 FOR APPT AND MD SENT HER STRAIGHT TO THE HOSPITAL. WAS ADMITTED THAT NIGHT WITH FINDING OF BLOOD CLOT IN HER LUNG. CLIENT REPORTS AFTER EACH VACCINE SHE HAS SEVERE WEAKNESS WITH CHILLS AND FEVER OF 99-100. FEVER CHILLS RESOLVED WITHIN 1-2 DAYS BUT WEAKNESS JUST PROGRESIVLY GOT WORSE.

Hospitalization 4/8/2021-4/16/2021 with discharge home on hospice and death 4/28/2021. Admitting diagnosis: Acute respiratory distress, COPD, acute hypercapnic hypoxic respiratory failure, Hypomagnesemia; HTN; probable UTI with concerns for Severe Sepsis; Altered mental status with concerns for metabolic encephalopathy along with dementia.

ventricular tachycardia: A ventricular high rate detection on 2/12/2021 at 2259 hrs. lasting 6 seconds and 13 beats with max V rate 213 bpm; EGM appeared to show sudden onset and conclusion of V>A on remote device check 2/19/2021.

Patient began with chest pain onset today while sitting in chair at home. Patient called ems and was found to have HR of 193. Patient did 2 vagal maneuvers and hr dropped to 150. Patient reports decreased chest pain, denies cough or n/v. Patient on arrival has an initial HR of 132 and a BP 106/69. Temp 36.6 degrees Celsius. HR decreased to 100 with no intervention. 500mL of fluids given. Diltiazem was not given as HR decreased to 100 and BP was 98/62. Patient reports that she had her COVID19 vaccine yesterday followed by some arm pain and aches in her legs. Patient does have a history of Afib and is on diltiazem at home. Dx with Afib with RVR. Patient will be admitted to the hospital. Patient converted to NSR on her own.

very tired, slept all day; slept all day; She had trouble breathing; pain in back of right shoulder; found two blood clots on lungs and two in legs; found two blood clots on lungs and two in legs; there was damaged to his wife's heart too; weighed165 pounds initially and then went down to 145; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (She had trouble breathing), ARTHRALGIA (pain in back of right shoulder), FATIGUE (very tired, slept all day), HYPERSOMNIA (slept all day), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs) and CARDIAC DISORDER (there was damaged to his wife's heart too) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A2 or 078A2 and 028A2 or 078A2) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (She had trouble breathing) (seriousness criterion hospitalization), ARTHRALGIA (pain in back of right shoulder) (seriousness criteria medically significant and life threatening), FATIGUE (very tired, slept all day) (seriousness criteria hospitalization, medically significant and life threatening), HYPERSOMNIA (slept all day) (seriousness criteria hospitalization, medically significant and life threatening), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs) (seriousness criteria hospitalization and medically significant), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (there was damaged to his wife's heart too) (seriousness criterion hospitalization) and WEIGHT DECREASED (weighed165 pounds initially and then went down to 145). At the time of the report, DYSPNOEA (She had trouble breathing), ARTHRALGIA (pain in back of right shoulder), FATIGUE (very tired, slept all day), HYPERSOMNIA (slept all day), PULMONARY EMBOLISM (found two blood clots on lungs and two in legs), DEEP VEIN THROMBOSIS (found two blood clots on lungs and two in legs), CARDIAC DISORDER (there was damaged to his wife's heart too) and WEIGHT DECREASED (weighed165 pounds initially and then went down to 145) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: two blood clots on lungs and two (abnormal) two blood clots on lungs and two in legs. On an unknown date, Weight: 145 (Low) weighed 165 pounds initially and then went down to 145. The patient was hospitalized for around four days. The patient size of clots as 10 cm and 9cm in the lungs. The reporter stated that Heparin was used in the hospital and after the discharge the patient was put on Eliquis for the next 6 months. The reporter reported that the patient weighed165 pounds initially and then went down to 145 afterwards. Action taken with the mRNA-1273 is considered as not applicable. Company comment: Based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine, the onset of the reported events, a causal relationship cannot be excluded.

This 79 year old black female received the Moderna Covid shot on 1/30 /21 and went to the ED on 2/8/21 and was admitted on 2/9 /21 with the following diagnoses listed below. I63.9 - Acute CVA (cerebrovascular accident) (HCC) N17.9 - Acute kidney failure, unspecified

Subsequential PE; Anemia; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PULMONARY EMBOLISM (Subsequential PE) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatoid arthritis, Hypothyroidism, COPD, Asthma, Drug allergy (Sulfa), Drug allergy (Ceftin) and Drug allergy (Cefuroximine). Concomitant products included ETANERCEPT (ENBREL) for Rheumatoid arthritis, SALBUTAMOL (ALBUTEROL HFA), DILTIAZEM HYDROCHLORIDE (DILTIAZEM CD) and LEVOTHYROXINE 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 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced ANAEMIA (Anemia). On 24-Apr-2021, the patient experienced PULMONARY EMBOLISM (Subsequential PE) (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM (Subsequential PE) and ANAEMIA (Anemia) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information provided. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-029848 (Patient Link).; 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.

ED Discharged 4/4/2021 (4 hours) Hospital Emergency Department Last attending ? Treatment team Generalized weakness +4 more Clinical impression Weakness - Generalized ? Chills Chief complaint ED Provider Notes Emergency Medicine Expand AllCollapse All HPI Chief Complaint Patient presents with ? Weakness - Generalized ? Chills HPI 79-year-old female, history of COPD for which she wears oxygen at night and as needed, also with a history of leukemia and obesity who presents to the ED complaining of generalized body aches, fevers up to 103, feeling generally unwell and weak, poor sleep, onset 3 to 4 days ago. Patient reports that she received her second COVID-19 vaccine approximately 1 week ago. Tolerated this without any particular symptoms. She has had 2 days of watery/nonbloody diarrhea. Does admit to nausea with several episodes of vomiting earlier today. She is denying any particular abdominal pain. Does believe she felt her urine burning earlier today but has had no gross hematuria. Denies any flank pain. No ill contacts although her husband has been at home with a slight cough. Patient does have a cough presently but it is nonproductive. She is denying any particular chest pain or subjective shortness of breath. No rash or unusual lower extremity pain, swelling, or redness. ED to Hosp-Admission Discharged 4/6/2021 - 4/17/2021 (11 days) Hospital Last attending ? Treatment team Severe sepsis (CMS/HCC) Principal problem Discharge Summary Internal Medicine Inpatient DeathSummary BRIEF OVERVIEW Admission Date: 4/6/2021 Discharge Date: 4/17/2021 DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission Patient is an 79 y.o. female morbidly obese with past medical history of chronic lymphocytic leukemia follow-up that was initially scheduled oncology follow-up for April 7 now postponed to the next 2 weeks, COPD on 2 L oxygen support at home, GERD, depression and anxiety. She was recently seen in the ED on April 4, 2021 with complaint of shortness of breath, nonproductive cough, fever, chills, nonbloody diarrhea, vomiting and weakness and subsequently diagnosed with COVID-19. She had however received a second dose of COVID-19 a week before and was discharged home due to lack of significant findings on imaging chest x-ray and lack of requirement for higher oxygen support. She presented to the emergency via EMS for evaluation of progressive shortness of breath with associated with fever, chills, headache, persistent shortness of breath, cough productive of thick clear sputum, nausea, vomiting and diarrhea. She denies abdominal pain, chest pain, or dizziness. Denies recent antibiotic usage or recent travel. Apparently, she thought she was getting better upon discharge after being kept for about 12 hours in the last ED visit, however she was not feeling well after going to bed last night and asked the husband to call 911. Upon EMS arrival patient was saturating in the 80s and in respiratory distress. She received 1 DuoNeb and was eventually placed on 10 L oxygen support. She was noted to be in significant respiratory distress during speech. Hospital Course Patient was admitted to hospital due to shortness of breath, and was found to have severe sepsis on presentation due to COVID-19 pneumonia. She had evidence of acute on chronic hypoxic respiratory failure as well. She was started on IV antibiotics, as well as remdesivir and Decadron at high dose. Unfortunately she continued to have clinical deterioration, and ultimately required high flow oxygen therapy. She was then transferred to the ICU, and ultimately required intubation due to severe profound ongoing hypoxia despite optimal medical treatment. She did not respond to remdesivir or steroids or antibiotics. Post intubation, she also developed acute renal failure during the course of her admission. Multiple discussions were had throughout the hospitalization regarding goals of care, and initially patient and family wish to be continually aggressive. She received full medical treatment, including life support, with minimal improvement. Despite being on ventilator for roughly 5 days, she continued to have severe hypoxia. She was proned, and was unable to sustain oxygen saturations when supine even for short period. Her renal function continued to decline as well, and at that point discussion was had with family regarding goals of care again. They were explained that symptoms continue to be persistent, and her illness continues to progress despite aggressive medical therapy. Ultimately decision was made to not pursue dialysis, and to allow the patient to be kept comfortable and pass away naturally from this infection. She was terminally extubated on 4/17 and passed away at 11:16 AM due to COVID-19 and acute on chronic hypoxic respiratory failure. Operative Procedures Performed X-ray Abdomen 1 View Result Date: 4/13/2021 Narrative: Single view portable abdomen INDICATION: Nasogastric tube placement, encounter initial Supine portable view of the lower chest and abdomen demonstrates nasogastric tube with tip and side-port in the gas-distended stomach. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/16/2021 Narrative: XR CHEST 1 VW IMPRESSION: No significant change from the previous examination. END OF IMPRESSION: INDICATION: Worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/13/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. Right-sided chest tube is unchanged. There is a small left pleural effusion. There is diffuse bilateral hazy airspace opacification. No change from prior. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/15/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Tubes and lines as described. Small left effusion. Unchanged patchy bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening hypoxemia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/14/2021. FINDINGS: The endotracheal tube, nasogastric tube, and right IJ central venous catheter are unchanged. The right-sided chest tube is unchanged. There is no pneumothorax. There is a small effusion. There is diffuse bilateral patchy airspace consolidation. There is no significant change. Cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View - Daily Result Date: 4/14/2021 Narrative: Chest radiograph HISTORY: Covid 19 infection. Mechanical ventilation. Comments: Frontal radiograph of the chest was obtained and compared to the prior study dated 4/13/2021. The heart is at the upper limits of normal. The mediastinum is within normal limits. Interstitial alveolar opacities are demonstrated bilaterally consistent with pneumonia. There is an endotracheal tube with the distal end approximately 4.3 cm from the carina. Nasogastric tube is noted directed towards the stomach. There is a right jugular central catheter. A right-sided pigtail catheter is seen. IMPRESSION: 1. Persistent bilateral interstitial alveolar opacities consistent with pneumonia. 2. Lines and tubes in place as described. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View, Portable Result Date: 4/14/2021 Narrative: PROCEDURE INFORMATION: Exam: XR Chest Exam date and time: 4/13/2021 11:46 PM Age: 79 years old Clinical indication: Hypoxia; Covid+ TECHNIQUE: Imaging protocol: XR of the chest. Views: 1 view. COMPARISON: DX XR CHEST 1 VW 4/13/2021 10:50 AM FINDINGS: Tubes, catheters and devices: Endotracheal tube tip located at the level of the carina. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. Nasogastric tube enters the stomach but tip not included on the image. Tip of right internal jugular central venous catheter in SVC. Cardiac leads superimposed over the chest bilaterally. Lungs: Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. Pleural spaces: Small right apical pneumothorax (12 mm). New small left pleural fluid collection. No right pleural fluid collection. Heart/Mediastinum: Stable cardiac silhouette Bones/joints: Unremarkable for age. IMPRESSION: 1. Endotracheal tube tip located at the level of the carina. 2. Pigtail drainage catheter tip remains superimposed over the lateral right mid lung zone. 3. Small right apical pneumothorax (12 mm). 4. Compared to chest x-ray examination performed earlier on 04/13/2021 at 1051 hrs, new consolidation and/or atelectasis in the left lung base. 5. New small left pleural fluid collection. 6. No significant interval change in scattered patches of ground-glass opacity (GGO) within each lung. Patient has history of COVID-19. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD X-ray Chest 1 View, Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT INDICATION: verify placement of right chest tube. Encounter: Subsequent. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: Earlier today. FINDINGS: The left thoracostomy tube terminates near the lateral right midlung. No other change. Extensive pulmonary infiltrates. Stable life support lines. The previous right pneumothorax has predominantly resolved, only a thin crescent of air caps the right apex. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View, Portable Result Date: 4/13/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Lines as described. There is a small right-sided pneumothorax. Unchanged bilateral airspace consolidation. END OF IMPRESSION: INDICATION: verify placement of CVC and post intubation. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/11/2021. FINDINGS: There is a right IJ central venous catheter. Tip is projected over the SVC. There is a small right apical pneumothorax. Endotracheal tube terminates 2 cm superior to the carina. The nasogastric tube passes beneath the diaphragm. Multifocal areas of patchy airspace consolidation bilaterally. Findings do not appear significantly changed from prior. The cardiac silhouette is normal size. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/11/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: Mildly worsened bilateral airspace consolidation. END OF IMPRESSION: INDICATION: worsening respiratory failure, covid pneumonia worsening respiratory failure, covid pneumonia. TECHNIQUE: AP projection of the chest is acquired. COMPARISON: X-ray 4/8/2021. FINDINGS: The left costophrenic angle is partially excluded. The lungs are adequately expanded. There are large areas of patchy airspace consolidation bilaterally. Findings have mildly increased in severity. There is no effusion or pneumothorax. The cardiac silhouette is mildly enlarged. There is calcification of the aorta. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View Result Date: 4/8/2021 Narrative: XR CHEST 1 VW PORT INDICATION: Worsening hypoxemia, Covid pneumonia. Encounter: Initial. TECHNIQUE: AP portable erect projection of the chest is acquired. COMPARISON: 4/4/2021. FINDINGS: Scattered pulmonary infiltrates is developed bilaterally, greatest in the right upper and right lower lobe. No change in the heart, mediastinum, or bony thorax. IMPRESSIONS: Developing pulmonary infiltrates. END OF IMPRESSION: This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. X-ray Chest 1 View - Portable Result Date: 4/4/2021 Narrative: XR CHEST 1 VW PORT IMPRESSION: No evidence of acute pulmonary disease. END OF IMPRESSION: INDICATION: SOB, weak, cough SOB, weak, cough. TECHNIQUE: Portable AP projection of the chest is acquired. COMPARISON: 6/5/2020 FINDINGS: Heart size appears unremarkable. There is mild prominence of pulmonary arteries. This is stable. There is no focal consolidation or effusion. This report was created using Voice Recognition software. Thank you for allowing us to participate in the care of your patient. Transthoracic Echo (tte) Complete Result Date: 4/11/2021 Narrative: Gender: Female Age: 79 Procedure Date: 4/11/2021 10:19 AM Study Quality: Fair Ht / Wt / BSA: 66.00 in / 218.00 lb / 2.07 m2 Heart Rate: 77 bpm BP: 181 / 81 mmHg Indications: Arrhythmia Transthoracic 2D, Color Flow, and Doppler Echocardiogram Conclusions: The left ventricle is normal in size. Ejection Fraction 55% (normal range 50-70%). All wall segments showed normal motion. Mild concentric LVH. Trivial aortic regurgitation. No additional significant valvular abnormality. No prior study for comparison. Presentation and History: Indication: The patient presents for evaluation of arrhythmia. The patient has a history of obesity and chronic obstructive pulmonary disease. Findings: Procedure Information: Contrast agent, definity, is being given per protocol without apparent complications. Due to technical limitations in the assessment of the left ventricle, imaging was performed after the administration of intravenous Definity echocontrast, as per protocol. Left Ventricle: The left ventricle is normal in size. There is mildly increased left ventricular wall thickness. The left ventricular systolic function is normal. The visually estimated ejection fraction is 55% (normal range 50 70%). Wall Motion: All wall segments showed normal motion. Right Ventricle: RV not well visualized. RV grossly normal in size and function by subcostal view. Atria: The left atrium is borderline dilated. The right atrium is normal in size. Aortic Valve: Sclerotic appearing aortic valve with no significant aortic stenosis. Trivial aortic regurgitation. Mitral Valve: There is trace mitral valve regurgitation by color flow and doppler analysis. There is no mitral valve stenosis by color flow and doppler analysis. Pulmonic Valve: There is no evidence of significant pulmonic valvular stenosis or insufficiency by color flow and doppler analysis. Tricuspid Valve: There is trace tricuspid valve regurgitation by color flow and doppler analysis. Great Vessels: All visible segments of the aorta are normal in size. Venous: The inferior vena cava is normal in size and collapses greater than 50% with inspiration. Pericardium/Pleural: There is no evidence of pericardial effusion. Prior Study Comparison: No prior study for comparison. Measurements: Left Ventricle: IVSd: 0.85 cm (0.6-0.9/0.6-1.0) LVIDd: 5.10 cm (3.9-5.3/4.2-5.9) LVIDd Index: 2.46 cm/m2 (2.4-3.2/2.2-3.1) LVIDs: 3.56 cm (2.0-3.6) LVPWd: 0.95 cm (0.7-1.1) Ao Root: 3.30 cm (2.1-3.5) LV Mass: 203.25 g (67-162/88-224) LV Mass Index: 98.19 g/m2 (43-95/49-115) LVOT Diam: 1.90 cm (3.0+(-)1.3) LVOT Pk Vel: 0.91 LVOT Mn Vel: 0.63 LVOT VTI: 0.20 LVOT Pk Grad: 3.00 LVOT Mn Grad: 2.00 LVOT Diam: 1.90 LVOT Area: 2.84 MV Pk E: 0.66 MV Pk A: 0.66 E/A: 1.00 E'Medial: 5.33 E/E' Med: 12.30 E' Laterial: 10.60 E/E' Lat: 6.20 Mitral Valve: MV Pk E: 0.66 MV PK A: 0.66 MV Decel Time: 209.00 E/A: 1.00 E'Lateral: 10.60 E'Medial: 5.33 E/E' Med: 12.30 E/E' Lat: 6.20 PHT: 61.00 MVA PHT: 3.61 Decel Slope: 3.14 Aortic Valve: AoV Pk Vel: 1.65 AoV Mn Vel: 1.22 AoV VTI: 0.39 AoV Pk Grad: 11.00 Aov Mn Grad: 7.00 AVA Cont.VTI: 1.42 Tricuspid Valve: TR Pk Vel: 2.89 TR Pk Grad: 33.00 RA Press: 10.00 RVSP: 43.00 Great Vessels: Ao Root-2D: 3.30 cm (2.0-3.7) Ao Asc: 3.30 cm (2.1-3.4) Updated on 4/11/2021 5:10:04 PM with Status of Final electronically signed on 4/11/2021 5:10:04 PM with status of Final Ct Covid Chest Low Dose Without Contrast Result Date: 4/6/2021 Narrative: PROCEDURE INFORMATION: Exam: CT Chest Without Contrast; Diagnostic Exam date and time: 4/6/2021 4:21 AM Age: 79 years old Clinical indication: Cough and shortness of breath; Patient HX: +covid; Additional info: Cough. Shortness of breath, covid TECHNIQUE: Imaging protocol: Diagnostic computed tomography of the chest without contrast. 3D rendering (Not supervised by radiologist): MIP and/or 3D reconstructed images were created by the technologist. Radiation optimization: All CT scans at this facility use at least one of these dose optimization techniques: automated exposure control; mA and/or kV adjustment per patient size (includes targeted exams where dose is matched to clinical indication); or iterative reconstruction. COMPARISON: CT CHEST WO CONTRAST 3/8/2021 2:28 PM FINDINGS: Lungs: There are patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. Pleural spaces: Unremarkable. No pneumothorax. No pleural effusion. Heart: No cardiomegaly. No pericardial effusion. Aorta: Atherosclerotic changes of the aorta. Lymph nodes: Unremarkable. No enlarged lymph nodes. Bones/joints: Unremarkable. No acute fracture. Soft tissues: Unremarkable. IMPRESSION: Patchy peripheral ground-glass opacities which can be seen with atypical pneumonia. THIS DOCUMENT HAS BEEN ELECTRONICALLY SIGNED BY MD

My mom, patient was a health 79 year old women, only two health issues were COPD and moderate dementia. She had even gotten her annual labs done recently which came back all with in normal range, she as far as we knew did not have any issues with her heart. After her first vaccination in March she started to lose interest in things and didn't have energy to be as active as she was. After the second shot with in two days she started to report pain in chest and head and trouble breathing, She went to her PCP on 5/12 and he wanted her to go to a cardiologist, this referral was made but by the 16th she was in the ER due to extreme chest pain and trouble breathing, a stent was placed in her heart on 4/17/21 my mom's 80th birthday. with in 4 days she died. Her heart just deteriorated. i feel that if she didn't get this shot she would be alive today, she was healthy, now she is dead.

Patient died 72 hours after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patient died 72 hours after receiving the vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046a21a) for COVID-19 vaccination. No Medical History information was reported. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 26-Apr-2021 The patient died on 26-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant medication was not provided, Treatment medication was not reported. A 79-year-old female patient who received mRNA-1273 died 3 days after the first dose of vaccine. No medical conditions or concomitant medications were reported. Very limited information has been reported at this time. Further information is being followed up.; Sender's Comments: A 79-year-old female patient who received mRNA-1273 died 3 days after the first dose of vaccine. No medical conditions or concomitant medications were reported. Very limited information has been reported at this time. Further information is being followed up.; Reported Cause(s) of Death: Died 72 hours after receiving the vaccine.

Transient ischemic attack; Bad urinary tract infection; Missed her second dose of vaccination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) and URINARY TRACT INFECTION (Bad urinary tract infection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leg operation and Knee surgery NOS. Concurrent medical conditions included Anxiety, Fibromyalgia and Wheelchair user. On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) (seriousness criteria hospitalization and medically significant) and URINARY TRACT INFECTION (Bad urinary tract infection) (seriousness criterion hospitalization). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Missed her second dose of vaccination). The patient was hospitalized on 26-Apr-2021 due to TRANSIENT ISCHAEMIC ATTACK and URINARY TRACT INFECTION. The patient was treated with Rehabilitation therapy (Sent to rehab for 2 weeks) for Transient ischaemic attack and Rehabilitation therapy (Sent to rehab for 2 weeks) for Urinary tract infection. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischemic attack) and URINARY TRACT INFECTION (Bad urinary tract infection) outcome was unknown and INCOMPLETE COURSE OF VACCINATION (Missed her second dose of vaccination) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Apr-2021, Magnetic resonance imaging: abnornal (abnormal) Confirmed TIA. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications or treatment information has been specified. The symptoms resembled having a mini stroke. The doctors did not state that the events happened due to the vaccine. The patient was sent to rehab for 2 weeks and consequently missed her second dose. 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.

orthostatic dizziness began one week after vaccine. eventually progressed into 2nd degree type 2 heart block. Had v Tach. Got a pacemaker.

On 4/2/2021 resident experienced slurred speech, left sided weakness and overall decline. Facial drooping and neurological deficits resulting in diagnosis of TIA.

Atelectasis; Back pain; Cardiomegaly; Dizziness postural; Essential tremor; Fall; Lethargy; Mental status changes; Myoclonus; Pain; Sepsis; Somnolence; Spinal compression fracture; Tremor; This case was received via FDA VAERS on 25-May-2021 and was forwarded to Moderna on 25-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for an unknown indication. The patient's past medical history included COPD, Atrial fibrillation, Hypertension, Diabetes, Obesity and Respiratory failure. Concurrent medical conditions included Allergy to allopathic drugs (Jardiance Lyrica) and Allergy to allopathic drugs. Concomitant products included CHOLECALCIFEROL and APIXABAN (ELIQUIS) for an unknown indication. On 11-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced ATELECTASIS (Atelectasis) (seriousness criterion hospitalization), BACK PAIN (Back pain) (seriousness criterion hospitalization), CARDIOMEGALY (Cardiomegaly) (seriousness criterion hospitalization), DIZZINESS POSTURAL (Dizziness postural) (seriousness criterion hospitalization), ESSENTIAL TREMOR (Essential tremor) (seriousness criterion hospitalization), FALL (Fall) (seriousness criterion hospitalization), LETHARGY (Lethargy) (seriousness criterion hospitalization), MENTAL STATUS CHANGES (Mental status changes) (seriousness criterion hospitalization), MYOCLONUS (Myoclonus) (seriousness criterion hospitalization), PAIN (Pain) (seriousness criterion hospitalization), SEPSIS (Sepsis) (seriousness criteria hospitalization and medically significant), SOMNOLENCE (Somnolence) (seriousness criterion hospitalization), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) (seriousness criteria hospitalization and medically significant) and TREMOR (Tremor) (seriousness criterion hospitalization). At the time of the report, ATELECTASIS (Atelectasis), BACK PAIN (Back pain), CARDIOMEGALY (Cardiomegaly), DIZZINESS POSTURAL (Dizziness postural), ESSENTIAL TREMOR (Essential tremor), FALL (Fall), LETHARGY (Lethargy), MENTAL STATUS CHANGES (Mental status changes), MYOCLONUS (Myoclonus), PAIN (Pain), SEPSIS (Sepsis), SOMNOLENCE (Somnolence), SPINAL COMPRESSION FRACTURE (Spinal compression fracture) and TREMOR (Tremor) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Mar-2021, Blood gases abnormal: abnormal (abnormal) patient's ABG showed significant CO2 retention.. On 21-Mar-2021, Chest X-ray: abnormal (abnormal) shows new cardiomegaly. Mild bibasilar volume loss is again seen. Remaining lungs are clear. No pleural effusion is noted.. On 21-Mar-2021, Computerised tomogram: abnormal (abnormal) CT spine showed L1 compression fracture which appeared new. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Because of the symptoms, patient came to the emergency room for evaluation. Chest x-ray imaging, was fairly unremarkable. She just feels achy. There were no chest pain, shortness of breath, abdominal pain, urinary symptoms or rash. On 26-Mar-2021, patient presented for evaluation of physical deconditioning. Patient presents to our facility yesterday after hospital stay from hospital . Patient tends to get confused and fall and has fallen twice. Patient has aches all over, dizziness when she stands up. In ER, patient's ABG showed significant CO2 retention. Pt is supposed to be using CPAP at home but admits it has not been used lately because of some problem with the m. Neurosurgery has ordered bracing for patient. No surgical intervention required. They also consulted neurology for myoclonic jerking and essential tremor. Patient is then to follow-up with neuro surgery and 3-4 weeks. On 17-Apr-2021, patient presented to the emergency room with increased somnolence and lethargy. Patient was discharged from the hospital 2 days ago after having a stay on swing bed. She has multiple medical problems and was admitted following a hospitalization at Hospital. She has generalized debilitation and advanced COPD with CO2 retention. Patient has been instructed to utilize a BiPAP machine. According to her family, she has been none a compliant with this and did not utilize it last night. Patient noted this morning that she was somnolent and lethargic. Prior to that she had been doing well since discharge. Other than the lethargy and somnolence there are no other complaints. On 18-Apr-2021 she was diagnosed with sepsis. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, multiple underlying co-morbidities may re; 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, multiple underlying co-morbidities may remain as confounding factors.

5/23/21 ER to Admission, HPI: Patient is a 79 y.o. female admitted to acute care from ED per Dr. with septicemia, acute UTI, pneumonia of right upper lobe.. The patient presented to ED brought in by EMS from local residence complaining of altered mental status. Patient states she woke up yesterday morning chilling. States she just could not get warm. Went back to bed for I while. States she did get up and go to church. After eating dinner had went over to her grandson's. She became confused at that point. Has been states that speech was difficult to follow. Did become slightly slurred. EMS was called and patient was brought to ER for further evaluation. Upon arrival to ER patient's temp is 102.4°. CT scan head negative for acute changes. Chest x-ray did show right upper lobe changes questionable infiltrate. Lactic acid 1.1 procalcitonin negative. Urine was highly positive with GNR on gram stain. Patient given L of normal saline along with Zosyn in ER. Subsequently admitted to acute care for further evaluation and treatment including IV antibiotics and further monitoring. Foley catheter placed ER.

clot behind right knee, had ultra sound done, sent me o emergency room was given a pill of xarelto and prescription ans sent home, have to take pills for the next 31 days.

Patient became short of breath about 5 days post covid vaccine. She presented to the office on 6/14/2021 and was noted to be SOB with a SPO2 of 74% on room air. Patient SPO2 did increase with oxygen at 2l/nc to 92-94%. Patient was transferred to local ER for evaluation and there she was noted to have multiple blood clots in both lungs. Patient spent 3 days in the hospital and was discharged today.

Pt received Moderna covid 19 vaccines on Feb 6th 2021 and March 6th 2021. She was diagnosed with new aggressive possible lymphoma or lung cancer for which she ultimately died from on 7/2/21 . Daughters reported symptoms started suddenly 5 1/2 weeks ago around 5/20/21. PCP notes confirm this. She saw her PCP on 5/25 for the cough and a cxr done that day was normal. She was prescribed tesselon perles and azithromycin. She presented back on 6/8 with persistent cough with new hemoptysis, decreased appetite and weight loss and ct scan done 6/15 showed a large heterogenous mass of the mediastinum 6.6 x 7.6 x 13cm encasing the r main pulmonary artery the r brachicephalic, r subclavian and common carotids. There was mass effect on the trachea and r main stem bronchus. The 6mm nodule seen in the posterior left upper lobe was stable and unchanged from previous ct chest from 9/20. This rapidly progressed in a very short time resulting in her admission to the hospital for respiratory failure on 6/28 and she was so unstable we were unable to transfer her for a biopsy and start of treatment as recommended by oncology. She passed away on 7/2/21. The family decided they wanted to pursue a limited autopsy to have the mass biopsied to determine what the cancer was which was so rapidly progressive. They describe her as prior to the start of the cough and hemoptysis on 5/20 that she was living alone, used no assistive devices and other than her dementia was generally healthy and was very interactive and involved with her family

Severe diarrhea and destruction of part of her intestine and subsequent sepsis. ER doctors "could not rule out the vaccine as a contributing factor." It was suggested she have a portion of her intestines removed. She refused and went on a high dose of antibiotics. She was hospitalized in the ICU and eventually released to a nursing home when stabilized. She never regained control of her bowels or had a solid bowel movement. Her antibiotics were reduced and she again suffered severe abdominal pain and a distended abdomen and return of sepsis. She went back to ER and was told this would keep happening if she did not have the damaged portion of her intestine removed. She elected to go home on hospice, where she died. Her kidney doctor also relayed to her family that this reaction was a direct result of the vaccine. When the family questioned reporting this event, every healthcare provider backed off from admitting it was a result of the vaccine or stated they were not the primary physician and thus was not for them to report.

septic; did not know who she was or where she was; missed second dose; acting like she had a stroke; feeling ill; This spontaneous case was reported by a consumer and describes the occurrence of SEPSIS (septic) and DISORIENTATION (did not know who she was or where she was) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE, CARBIDOPA, LEVODOPA (CARBIDOPA/LEVODOPA), PREDNISONE and VITAMINS NOS for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced DISORIENTATION (did not know who she was or where she was) (seriousness criterion hospitalization) and VACCINATION COMPLICATION (feeling ill). On 25-Jan-2021, the patient experienced ABNORMAL BEHAVIOUR (acting like she had a stroke). On an unknown date, the patient experienced SEPSIS (septic) (seriousness criteria hospitalization and medically significant) and PRODUCT DOSE OMISSION ISSUE (missed second dose). The patient was hospitalized on 25-Jan-2021 due to DISORIENTATION and SEPSIS. At the time of the report, SEPSIS (septic), DISORIENTATION (did not know who she was or where she was), PRODUCT DOSE OMISSION ISSUE (missed second dose), VACCINATION COMPLICATION (feeling ill) and ABNORMAL BEHAVIOUR (acting like she had a stroke) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. 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.

patient developed weakness and onset of increased shortness of breath with rapid heartrate. She was taken to emergency room and found to have Atrial Fib. She had multiple episodes over 3 weeks and now hasn't had anymore since

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

Pt received vaccine and within 72 hrs developed a stroke. Low platelet count. Endocarditis. Emboli to liver, spleen, kidney.

Moderna Vaccine Lot 029K20A Patient received second dose of vaccine on 2/2/21. Within 30 minutes patient had a near syncopal episode. She felt lightheaded and shortly after had episode of nonbloody vomiting. Hypotensive 81/69 and started on levophed. Alert and orientated. Lungs clear, abdomen benign on admission. Patient had no reaction when received first dose of the vaccine. Patient developed worsening shortness of breath, tachypnea, Afib with RVR, hypotension and required intubation and multiple pressors.

Mild stroke about 9am. Fell on floor, needed help to stand up and walk, garbled speech, headache, temp. 98.0, 98.2, 98/3; not swallowing food, couldn't handle food. Could not hold cracker, bread or find mouth with hand. needed help to go to bathroom, couldn't answer telephone, was dizzy, couldn't balance herself, she fell 3 times on Feb. 3, I took the top off a water bottle and handed it to her she kept trying to unscrew the lid even after I showed her I had the lid in my hand. Feb. 4 she had the dry heaves all morning, she slept all afternoon. I called the doctors office @ 8:00am and again later @ 8:30am. He said he wanted her to have a CAT scan Medical Center. He said they would call

My mother received her vaccine at 12:40 on 2/2. She waited longer than the fifteen minutes and she seemed fine. We left the facility and on the way home, approximately 45 after she received the vaccine, she began slurring her words ands was confused. The slurring lasted for 2-3 minutes The confusion continued. I brought her the ER where she was immediately taken in for a CT Scan. She later had an MRI, and met with a Cardiologist. She later had an EEG at the request of a Neurologist. She spent three nights in the hospital. All tests showed no acute signs of stroke, etc.

atrial fibrillation as captured by smartphone (i can send PDF if desired) at 5:44pm ...irregular heartbeat caused me to capture event on my phone, especially since I had a similar reaction to the first shot.

My mother had a seizure on February 15th after recieving the moderna vaccine on February 11th within four days of the vaccine. Doctors at hospital. Staff cannot answer what caused the seizure though they found a 4mm bleed on her brain; believed unrelated to seizure; on an MRI. My mother has never had a seizure and noone in my family have had seizures. I don't know if it's related to the vaccine but felt it should be reported to you.

Patient administered vaccine on 1/14/21 with no reactions noted after 15 minutes. Patient seen for wellness visit on 1/20/21 with no complaints regarding vaccine. Patient died on 1/30/21

Patient seemed otherwise healthy before the vaccination. Patient was hospitalized then shortly passed after getting the 1st dose.

Patient complained of lightheadedness, dizziness, and fatigue the next morning. That afternoon she experienced Afib.

Patient is a very pleasant 80 year old female with a history of hypertension and recent pelvic fracture approximately two months ago who presented to the emergency department reporting right sided chest pain. She states that her symptoms started on Sunday. She has pain with a deep breath and also with exhaling. She reports it is a sharp pain. She states that she has had no lower extremity edema or calf pain, however, she did have a shooting pain down her right leg recently. She denies any history of personal or family history of deep venous thrombosis or pulmonary embolus. She reports that she has not had any hemoptysis. She denies feeling short of breath. She denies abdominal pain, nausea, vomiting, or diarrhea. She states that she has not had any COVID exposures or known symptoms. She has received two COVID vaccine doses. She reports that she has not been sick and denies fever, chills, or cough. In the emergency department she was diagnosed with an acute pulmonary emboli in the right main pulmonary artery with extension into the segmental pulmonary arteries. There is concern for early pulmonary infarct. This has prompted admission to the hospital.

Patient presented to ED with AMS, GCS 8, elevated troponin within 48hrs of receiving vaccination. Initial dx NSTEMI

Chest Pain Pt has been having flu like sxs the past few days and tonight was woken out of her sleep by chest pain. (3/13/2021) pericarditis, atrial fibrillation, and CHF

PT WAS VACCINATED WITH SECOND MODERNA DOSE ON 02/16/2021 . DR CALLED ME TO INFORM OF PT ADVERSE EVENT. PT PRESENTED TO DR WITH SWELLING IN LEFT LOWER LEG. DR ORDERED VENUS DOPLAR SHOWING A LARGE BLOOD CLOT FROM PT'S GROIN TO HER CALF MUSCLE. DUE TO NO PREVIOUS HX OF CLOTTING OR BLOOD DISORDERS NOR FAMILY HX AND PROXIMITY TO VACCINATION, DR BELIEVES VACCINE CAUSED THE CLOT. DR PLACED PATIENT ON ELIQUIS. DR WISHES TO BE CONTACTED IF FURTHER DETAIL IS NEEDED.

After vaccine (2nd dose) on 3/04, patient resumed normal activities, running errands, etc. In the evening of 3/05, patient complained of extremely sore arms (not alleviated by painkillers) and nausea. Additionally, patient felt extremely cold. She went to bed early, at 7:00 pm, and was found dead the next morning 3/06 at 7:30 am. She had vomited. The coroner (not a medical examiner) declared cause of death as 1) cardiac arrest 2) hypertension and 3)hypercholesterolemia, based solely on medical records. There was no autopsy. Due to or despite medications, patient's blood pressure readings were typically low (last one 118/70), pulse normal (89), BMI 25.29, cholesterol levels normal (166/LDL 82), blood sugar 95.

03/15/2021: Presented to the emergency department with worsening lower extremity edema and dyspnea on exertion. The patient was admitted for a congestive heart failure exacerbation for IV diuretics. Patient currently still admitted and now having lower GI bleeding on a heparin infusion.

Bilateral pulmonary emboli; A spontaneous report was received from a physician concerning an 80-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced shortness of breath and oxygen level low. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received her first of two planned doses of mRNA-1273 (LOT: unknown) on 05-Feb-2021. On 05-Mar-2021, approximately 1 day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 048A21A) intramuscularly for prophylaxis of COVID-19 infection. On 06-Mar-2021, the patient developed shortness of breath and her oxygen level was low. On 09-Mar-2021, she was diagnosed with bilateral pulmonary embolisms. No hospitalization was required. The reporter stated that the patient had no history of blood clots. Treatment for the event included apixaban. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. The outcome of the events was considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded

PATIENT HAD ANAPHYLAXIS. IT PRESENTED AS A LIGHT COUGH THAT GOT WORSE AND BEGAN PROGRESSING TO SHORTNESS OF BREATH . THIS HAPPENED APPROXIMATELY 15 MINUTES AFTER SHE RECEIVED THE VACCINE. I ADMINISTERED AN EPIPEN THAT IMPROVED SYMPTOMS FOR ABOUT 5 MINUTES. THE EMT'S ARRIVED AT THAT TIME AND TOOK OVER CARE.

Was made aware on 3-25-21 that the pt. had been admitted to the hospital for a Stroke . Informed Dr. of same. Per pt. daughter pt. was admitted to Hospital on 3-24-21.

Looks like a stroke; She became unresponsive; A spontaneous report was received from a consumer concerning a 80-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and she became unresponsive and it looked like a stroke. The patient's medical history was not provided. Concomitant medications reported included carvedilol, acetyl salicylic acid and an occasional injection for hives. The last injection for hives was administered a week and a half ago. On 10 Mar 2021 at 4pm, approximately one day prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 027A21A) intramuscularly for prophylaxis of COVID-19 infection. On 11 Mar 2021, it was reported that the patient became unresponsive and she appeared to be having a stroke. The patient was taken to the emergency room where she underwent treatment. No other details were provided. Treatment information were not provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken in response to the events was not applicable. The outcome of events, became unresponsive and it looked like a stroke, was considered unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Pneumonia with collapsed lung; Pneumonia with collapsed lung; Scheduled to take 2nd dose of vaccine on 26 Mar 2021, 6 weeks after; A spontaneous report was received from a consumer concerning a 80-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia with collapsed lung/pneumonia and scheduled to take second dose of vaccine on 26 Mar 2021/inappropriate schedule of vaccine administration. The patient's medical history was not provided by the reporter. No concomitant medications were reported. On 06 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 61016308) in the right arm for prophylaxis of COVID-19 infection. On 06 Mar 2021, the patient experienced pneumonia with collapsed lung and was hospitalized. She was scheduled to take second dose of vaccine on 26 Mar 2021. Treatment for the event included hospitalization for pneumonia with collapsed lung. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, pneumonia with collapsed lung was unknown. The outcome of the event, inappropriate schedule of vaccine administered was considered to be resolved.; Reporter's Comments: This case concerns an 80-year-old who had second dose scheduled 6 weeks after first dose (inappropriate schedule of product administration) and also experienced collapsed lung/pneumonia. Although a temporal association exist, based on the information provided, the event of collapsed lung/pneumonia is assessed as unlikely related. Pneumonia is due to an infective etiology. The event of inappropriate schedule of product administration is assessed as not applicable.

My mom received her second covid shot at 10:05 AM on 3/26 and experienced no adverse symptoms. At around 6 am the following day, on the morning of 3/27 she was found on the floor, and presumably suffered from a heart attack. After devastation to our family, we called her physician and he himself was also surprised. Although she is a type 2 diabetic with high blood pressure she has maintained great health and kept her conditions under control with her medications. This, unfortunately, seems too coincidental to not have been in some way or completely caused by the second dose of the shot.

mini stroke; still weak; A spontaneous report (United States) was received from a consumer concerning an 80 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event mini stroke/transient ischaemic attack and still weak/asthenia. The patient's medical history was not provided. The concomitant medications on use were also not provided. On 26 Feb 2021, approximately 17 days prior to the onset of the events, the patient received their first of two planned doses of mRNA (Batch number: 011A21A) through unknown route of administration for prophylaxis of COVID-19 infection. On 15 Mar 2021, patient experienced mini stroke. The patient was hospitalized on the same day till 17 Mar 2021.It was serious event which required hospitalization. Laboratory tests performed included ultrasounds, cat scan of the brain, MRI of brain, ultrasound of arteries, and chest x-ray. The findings of lab tests were not provided. The patient was given acetylsalicylic acid and an injection in the belly to prevent blood clots. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the events was unknown; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded

pneumonia; A spontaneous report was received from consumer, concerning an 80-Year-old female patient who received Moderna COVID-19 vaccine (mRNA-1273) and experienced Pneumonia and hospitalized. The patient's medical history was not provided. concomitant product use was not provided. On 17-Feb-2021 the patient received first dose of the mRNA-1273 vaccine (Batch number 024M20A ) in left non-dominant arm for the prophylaxis of COVID-19 infection. On 23-Feb-2021 the patient hospitalized. the cause of hospitalization was pneumonia. Treatment included antibiotics and steroids. Action taken with mRNA-1273 in response to event was unknown. Outcome of the event, pneumonia was considered to be 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 event, a causal relationship cannot be excluded.

She is high risk but she had a stroke within a couple of weeks of the Moderna vaccine. There's no way to know if it is related but definitely something that needs to be tracked.

Morning on 3/11 awoke with fever and body aches, breathing became difficult over the next several days, along with light headedness. ED visit on 3/14 diagnosed with COPD flare advised to follow up with PCP. 3/22 follow up with PCP, discovered blood in stool sent to ED. Admitted on 3/22 with low hemoglobin and blood in stool. Endoscopy on 3/23 and coloscopy on 3/24. Source of bleed undetermined. Released on 3/23. 4/1 returned to ED as symptoms continued. D-dime blood test and CAT found blood clots in lower right lung. Prescribed Eloquis and released. Returned to ED on 4/5 admitted with low hemoglobin (7.1) bleeding, breathing difficulty. Endoscopy repeated on 4/6 not bleeding found. Released on 4/9.

patient presented to ER with left sided chest pain. Chest x-ray and chest CT performed. Chest CT showed linear embolism in lingular branch of left pulmonary artery. EKG showed right bundle branch block which was different than last EKG in 2019. Patient treated with Eliquis 10mg BID x 7 days, then 5mg BID x 3 months.

Developed trigger finger right thumb and transient AFIB. Never had any heart iriblem before. I felt it was post inflammatory. reaction. Treated myself with oralInoroohen. . Afib resolved after one hour, trigger thumb improved after 3 hours.

Taken to the Hospital due to COVID-like symptoms (strong cough). At the Hospital she is diagnosed with COVID-19, problems with kidney and hemoglobin levels. Dies at the Hospital due to COVID-19.

difficulty breathing; soreness after 1st dose left arm; Clot in Lung; chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PULMONARY THROMBOSIS (Clot in Lung) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart disorder. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced PULMONARY THROMBOSIS (Clot in Lung) (seriousness criterion medically significant) and CHEST PAIN (chest pain). On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness after 1st dose left arm). On an unknown date, the patient experienced DYSPNOEA (difficulty breathing). On 30-Mar-2021, VACCINATION SITE PAIN (soreness after 1st dose left arm) had resolved. At the time of the report, PULMONARY THROMBOSIS (Clot in Lung), CHEST PAIN (chest pain) and DYSPNOEA (difficulty breathing) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Echocardiogram: normal (normal) Normal. On an unknown date, Computerised tomogram: abnormal (abnormal) Blood clot in Lung. On an unknown date, Pulmonary function test: normal (normal) came back perfect. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. On 08-Mar-2021 patient had an echocardiogram (results are not provided). Concomitant medications are not reported. No Treatment for events is provided. Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine This case was linked to MOD-2021-084017 (Patient Link).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, causal relationship cannot be excluded. Vaccination site pain is consistent with the known safety profile of the vaccine

Pallor, Fatigue, loss of vitality, diarrhea, profuse rectal bleeding, coughing up blood, death 25 days after vaccine

Severe thrombocytopenia requiring hospitalization Subdural hematoma from low platelets Pt in excellent state of health until about 2 weeks after vaccine. Pt started exhibiting spontaneous bruising and petechia without external causes of trauma. Days later patient started exhibiting signs of confusion and sluggishness and complaining of headache. On post vaccination day 21 patient taken to ER where platelets found to be 18 and CT scan showed a subdural hematoma. patient continues to be hospitalized and workup is underway to determine cause. My belief is the severe thrombocytopenia is related to the vaccine.

Pt with long history of CLL, not on active treatment developed immune mediated thrombocytopenia Platelet count fell from 112 to 5k, did not respond to prednisone but improved with IVIG, event started on the day patient was due for her 2nd dose of the Moderna vaccine. It has been held.

80 yo woman with hx of HTN, anxiety dneies any other conditions, presented to ER due to epigastric pain, vomiting x1. In Er presented with elevated heart rate, EKG with sinus tachycardia, regular rythm. CXR with COPD changes. There are bibasilar infiltrates suspicious for pneumonitis in the appropriate clinical setting. PAtient admitted to unit for further treatment and workup. WBC 16.91 4/27/2021

Severe thrombocytopenia developing 1 week after 1st Moderna vaccine. Pt got first vaccine April 12 or 14 (she can't remember which) and is due for her next May 10 or 12 (though she is not getting this dose per Hem/onc note). Plt down to 3K (from 258K on 3/29/21). This has required 2 hospitalizations with multiple transfusions, bone marrow bx, high levels O2. She is currently in the hospital and her oncologist noted on 5/4/21: "this is covid vaccine related until proven otherwise (she got her 1st Moderna shot one week before plts plummeted); would not get 2nd dose; should be reported to VAERS."

March 2 - second Moderna March 3 - spontaneous bruising appears March 4 - visit with primary care doctor, blood work shows significant drop in platelets March 9 - first visit with oncologist/haematologist & hospitalized March 9-19 - hospitalized for tests, treatment to increase platelets, & many blood panels. No official diagnosis, treat as ITP. Follow up visits with oncologist/haematologist to keep an eye on platelets as they increase. March 30-Apr 4 - ER visit due to swelling of ankles, feet, and left arm. Tests show superficial blood clot, fluid on lungs, and pneumonia. Oncologist said that "we have no official diagnosis", that she's being treated for ITP. April 6-14 - follow up visit to oncologist/haematologist show elevated kidney enzymes, then later liver enzymes, low sodium. April 14 - decision to move to short term rehab for regular PT and OT. Continued swelling (fluid in third spaces.) April 21 - visit to cardiologist to perform cardioversion, successful (during first week of hospital stay, heart rhythm med had to stop). April 23 - facility nurse discovered significantly low Hemoglobin and a blood transfusion was ordered. April 24 - returned to short term rehab facility. April 25 - discovered my mother on O2 and state of health was different, extremely weak and not moving, arm hurting badly. I insisted that her oncologist is contacted. Transported to ER. Discovered her blood work abnormal. After stabilizing her, rushed to the hospital ICU. April 26 - Discussed with her ICU doctor the history of what you have read above. He explained that the covid-19 vaccination has a tendency to affect three proteins specifically that clot and thin blood. I begged him to "get it out of her system." Her bleeding was significant and platelets dropped, again. Still has her mental facilities. Responding well to aggressive treatment: albumin transfusion, plateletpheresis, and CRRT. Pleural catheter to remove fluid from the lungs. Mention of Sepsis. April 27 - Lifted her head up today, opened her eyes, making doctors very happy. Her cardiologist and the ICU doctor both said they were "confused" and everything happening to my mom was "a mystery." Though going in to the evening, her nurse expressed to me that she's worried. The ICU oncologist called me at home in the evening. He asked me if she had been having a fever on a regular basis. He said he thought it could be TTP or a rare disease called HTH, but both results wouldn't be back for one week. He planned to consult with a doctor. He explained to me that the blood was attacking itself and "confused," and that her organs were shutting down. He indicated that the blood work wasn't indicating significant infection. He referenced how the vaccination has made her auto immune system "go crazy." April 28 - I get a call very early from the nurse that she has been fighting with my mother's blood pressure all night, trying to keep it elevated. She told me to come to the hospital, because she had taken a turn for the worse. I arrive to find my mother's eyes wide open, breathing shallow, and blood pressure steady, but drops without assistance from medication. She continues to have her mental facilities. She passed away, organs shutting down, and blood pressure dropped.

Transient ischaemic attack; Flickering lights; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) in an 80-year-old female 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 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) (seriousness criterion medically significant) and PHOTOPSIA (Flickering lights). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Transient ischaemic attack) and PHOTOPSIA (Flickering lights) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and treatment medications are not provided. The patient was taken to the emergency room, where the patient was evaluated and released without an overnight stay. Company Comment: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

atrial fibrillation; itching on right scapula, intense incredible itching, whole body itching; face was flushed; led to intense red marks; Scratching would make blood vessels burst underneath; swollen armpits; Chills; big rash all over body; low grade fever of 99.1F; Itching on left scapula; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ATRIAL FIBRILLATION (atrial fibrillation) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Drug allergy (Augmentin and Demerol). Concurrent medical conditions included Allergy (banana and plantain). Concomitant products included AMLODIPINE, EZETIMIBE (ZETIA), ATORVASTATIN CALCIUM (LIPITOR), NEBIVOLOL HYDROCHLORIDE (BISTOLIC), ACETYLSALICYLIC ACID (BABY ASPIRIN), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM + VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN 2000), CENTRUM SILVER +50 and ESTROGENS CONJUGATED (PREMARIN) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced PRURITUS (Itching on left scapula). On 31-Jan-2021, the patient experienced PRURITUS (itching on right scapula, intense incredible itching, whole body itching), FLUSHING (face was flushed), RASH ERYTHEMATOUS (led to intense red marks), SCRATCH (Scratching would make blood vessels burst underneath), SWELLING (swollen armpits), CHILLS (Chills), RASH (big rash all over body) and PYREXIA (low grade fever of 99.1F). On 13-Feb-2021, the patient experienced ATRIAL FIBRILLATION (atrial fibrillation) (seriousness criteria hospitalization, disability and life threatening). The patient was hospitalized on 13-Feb-2021 due to ATRIAL FIBRILLATION. At the time of the report, ATRIAL FIBRILLATION (atrial fibrillation), PRURITUS (itching on right scapula, intense incredible itching, whole body itching), FLUSHING (face was flushed), RASH ERYTHEMATOUS (led to intense red marks), PRURITUS (Itching on left scapula), SCRATCH (Scratching would make blood vessels burst underneath), SWELLING (swollen armpits), CHILLS (Chills), RASH (big rash all over body) and PYREXIA (low grade fever of 99.1F) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event included Diphenhydramine, Cetirizine, OTC Cortisone cream, Methylprednisolone. Company Comment - Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: No specific follow-up information recorded.; 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.

My Mom had headache, body pain, chills and fever and very weak on the 29, and 30 of April. On May the 3,2021 I found my Mom Dead in Bed. My Mom was a very active lady for her age.

Sudden death due to heart failure (patient without any underlying heart conditions or experiencing any symptoms prior to death). Called 911 when family noticing patient being unconscious; 911 arrived detecting weak heart beats and took the patients to the nearest emergency room. Heart stopped beating when arriving at emergency room.

Immediately after receiving her second Moderna vaccine, patient states that she felt a tightness in her chest. No shortness of breath noted. She did not tell anyone at the clinic, but went home to rest. She states that immediately after vaccine, she began to have cough, chest congestion and tightness. Two days later, she went to PCP for evaluation. The Dr diagnosed her with pneumonia and prescribed treatment of antibiotics, steroids and albuterol. Per patient, she has gone back to see the Dr four times and been on treatments continuously. She was referred to Pulmonologist and was seen on 4/14/21. She states that the insignificant nodules that were previously in her lungs were more pronounced. She continues to have cough and chest congestion. No fever has been noted. She will follow up with pulmonologist in July 2021. Patient states that she feels like she still has pneumonia.

Patient was referred to emergency department by primary care physician for concerns of sepsis. Patient UA outpatient that showed a urinary tract infection and was experiencing hypotension. During screening for admission, was found to be COVID-19 positive. Patient was asymptomatic for COVID-19 infection at presentation and was only recieving supportive care. She does not require antiviral, steroid, or supplemental oxygen at time of writing. Patient is currently admitted at time of writing.

Received her second dose of Moderna Covid vaccine yesterday (5/23), subsequently this morning (5/24) noted to feel lethargic, dizzy, and had elevated temperature. She sought medical attention and in the ER was found to have temperature of 104°F, tachycardia, and elevated lactic acid. The patient has had no headache, change in vision, photophobia, neck stiffness, abdominal pain, cough. There is no report of sick contacts the patient resides with daughter-in-law and son. She received Rocephin empirically in the emergency room along with 30 mL/kg IV fluid bolus.

pulmonary embolism chest pain shortness of breath, blood thinner given patient sent home on o2 and blood thinner still non o2.

I had the vaccine on 01/16/2021 and then at the end of the month my husband got Covid and we both had the vaccine already. Of course he gave it to me, so the 02/01/2021 he tested positive and then he had the antibody infusions and a couple of days later I tested positive and I had the infusions on 02/05/2021. About 2 weeks later I got very sick, back ache and chest pains so I went to the ER so I ended up with blood cots in my lungs. They did scans and tons of blood tests, heart scan, lung scans. I have been on blood thinners since them. After Covid and everything I had me second dose this past Friday. So far I am doing okay, I am feeling a little bit dizzy.

Myocarditis in 2 days - diuretics, Respiratory Failure in 2 days Bipap and Airvo, Clotted off leg in a few weeks Angiogram and Fascitomy, Ischemic gut weeks - comfort care orders, DVT in arm in weeks could have been due to PICC also - Elquis

Two days after second injection we noticed swelling in ankles, which has not happened before. We cut back her fluid intake but the swelling persisted for two weeks. She was brought to see doctor (NP) on 17th of March which lead to no resolution. She was brought to ER on the 18th and admitted. After inpatient treatment she was released two days later and has had no subsequent issues.

myocardial infarction leading to death. Impossible to know causality, but completing this out of an abundance of caution.

could not get out of bed; she felt like passed out; having episodic of blood pressure really; dizziness; Pneumonia; nausea; had a temperature; sick for five days; vomited for 3 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Thyroid disorder NOS. Concomitant products included LEVOTHYROXINE for Thyroid disorder, PRAMIPEXOLE for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), VACCINATION COMPLICATION (sick for five days), MOBILITY DECREASED (could not get out of bed), PRESYNCOPE (she felt like passed out), HYPERTENSION (having episodic of blood pressure really), DIZZINESS (dizziness), VOMITING (vomited for 3 days), NAUSEA (nausea) and PYREXIA (had a temperature). At the time of the report, PNEUMONIA (Pneumonia), MOBILITY DECREASED (could not get out of bed), PRESYNCOPE (she felt like passed out), HYPERTENSION (having episodic of blood pressure really), DIZZINESS (dizziness), NAUSEA (nausea) and PYREXIA (had a temperature) outcome was unknown and VACCINATION COMPLICATION (sick for five days) and VOMITING (vomited for 3 days) had resolved. It was reported that the blood pressure intervals were high mainly during the day time. The patient stated that prior to getting the vaccine, she was healthy and was baby sitting for 10 hours. The patient said she had to do stop doing that because she felt like she may drop her grandson since she felt like passed out. Treatment information was not reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-023313 (Patient Link).

Ischemic Stroke, Hospitalization, Ambulance, arterial blood clot, loss of balance, atrial fibrillation , emergency room

Systemic: Headache, Systemic: IRREGULAR HEARTBEAT (HAS HISTORY OF AFIB), COMPLAINED OF BEING HOT; symptoms lasted 0 days

Resident began having a general decline in condition on 1/8/21 and continued to decline until her passing on 1/10/21.

TRANSIENT ISCHEMIC ATTACK= AFFECTED FACE, WITH PARESTHESIAS, BLURRY VISION, GENERAL WEAKNESS, WHICH RESOLVED IN A FEW MINUTES.

Two nights after injection, had terrifying nightmare, 3 nights a bad dream, nightmares, bad dreams waking me up with a rapid heart beat and fast pressured breathing, and vivid dreams continued for approximately 10 -12 nights had 2 nights with vivid dreams. On 2/5/21, woke at about 4:50 am with rapid heart beat that changed into AFib and elevated blood pressure. Heart beat reached 151 bpm and subsided about 30 minutes after getting out of bed.

1-TRANSIENT ISCHEMIC ATTACK: PARESTHESIAS OF FACE, MORE MARKED AROUND CHEEKS AND MOUTH, FELT EYES DEVIATING TO RIGHT SIDE, BLURRED VISION, DIZZINESS, FEELING OF MAJOR DISTRESS 2-, MUSCLE SORENESS STARTED TO INCREASE AFTER ONE WEEK AND HAS CONTINUED TO INCREASE OVER TIME, BECOMING WORSE AT 4 WEEKS, AND LIMITING EXERCISE: CANNOT RAISE ARM, OR DO ANY MOVEMENT THAT REQUIRES MUSCLE FLEXION OR EXTENSION.

81 y/o otherwise healthy female on no prescription medications Received Moderna Covid 19 vaccine on 2/25/2021 at 11:30 am -- > no problems following administration of vaccine About 15 hours later, on 2/26/2021 at around 2:30 am, pt went into the shower and suddenly felt acutely weak in lower extremities; unable to bear weight, so sat down on floor; no fall or injury; no focal neurologic sx at that time. Patient was able to crawl out of bathtub and call family member - total time down about 3 hours. Patient denied any associated fever, chest pain or upper body weakness. Due to extreme lower extremity weakness, pt taken to ER -- > dx: nontraumatic rhabdomylolysis She was treated with IVF, Tylenol and discharged home. Since discharge, she has been steadily improving. Three days after ER, pt is able to bear weight, ambulate but still with mild bilateral upper thigh pain and weakness (unable to get up from low seated position or squat).

Had a stroke; A spontaneous report was received from a caregiver concerning an 81-years-old female patient who received Moderna's Covid-19 vaccine and had a stroke. Patient's medical history included a mini stroke (5-6 years ago). Concomitant medication included blood thinners. On 02 Feb 2021 at 4:30 pm, ten days prior to onset of the event stroke, the patient received the first of two planned doses of mRNA-1273 vaccine (Lot/batch: unknown) for prophylaxis of Covid-19 infection. On 11 Feb 2021, the patient had an event of stroke for which was hospitalized. The patient was on a lot of medications (not specified). Action taken with second dose of mRNA-1273 in response to the event was not recorded. The outcome of the event stroke was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stroke, a causal relationship cannot be excluded. However, patient's elderly age and prior history of TIA are considered as risk factors.

The day after the shot she developed fever for 2 days as high as 101. She developed a pruritic burning rash to posterior right leg extending down the lateral lower leg. She had fatigue and myalgias. Diagnosed with shingles on 2/23. and informed to not receive the 2nd vaccine. She presented to the Emergency room on 2/27 with fatigue, numbness right side of the face, no reports of shortness of breath or chest pain. Ambulated in to ER. After her work up she was discharged home - she present back to the ER within 30 minutes. PTA arrival at the ER for the 2nd time - she complained of left neck and arm pain - then went unconscious. She arrived to the ER in full arrest - pronounced deceased after resuscitation efforts were not effective

Patient presented to Hospital ED on 3/14/21 with respiratory distress. Patient was tested for COVID-19 and found to be positive on 3/14/21 in the hospital ED. Patient was a DNR. Hospice was consulted (this writer is employed by Hospice). The patient passed away on 3/15/2021. Per family patient had recently received COVID-19 vaccine. Vaccine information verified in portal.

She was transferred to the hospital on 3/4/2021 due to low blood pressure, she understands that due to heart failure. The death certification information is unknown.

4/2020 presumed COVID-19 (not formally diagnosed, not hospitalized) 2/07/21 Moderna vaccine #1 (date per pt's daughter) 2/21/21 onset SOB/DOE, fever 2/24/21 Seen at Urgent Care: RML crackles and infiltrate on CXR, given azithromycin and Augmentin 2/27/21 Presented to ED with progression of SOB/DOE, fatigue, diarrhea. Hypoxemic requiring low-flow NC, B/L basilar crackles noted; started on CTX/azithro (2/27-3/3) for presumed CAP 3/08/21 Required HFNC; first seen by me personally: diffuse, distinct velcro crackles, lower > upper fields 3/12/21 Started on high-dose steroids without improvement; unable to wean from HFNC with progressively worsening hypoxemia; pt declined intubation. 03/22/21 Patient died in Palliative Care Unit Diagnosis: Interstitial lung disease of uncertain etiology, acute interstitial pneumonitis vs. undiagnosed connective tissue disease

Deceased unexpectedly. From day of second dose 3/18/21, patient reported feeling tired ( no fever, no shortness of breath) but was able to walk 3 flights of stairs on 4/11/21 and felt slightly better. Went to church that Sunday 4/11. Was not seen after that, then found deceased at home 4/14/21 with blood in mouth, no other signs such as lacerations or incontinence or other vomitus.

Shortness of breath for about one week Saw DR who gave me referral to Community Radiology on April 1st. Pulmonary Embolism Diagnosed. Went to Emergency at Hospital. They sent me home with rx for Eliquis.

Patient received Moderna Dose #1 on 1/11/2021. Later that day, her armpit had a swollen lymph node. This was treated topically with clindamycin for hidrandenitis suppurative for about 2 weeks. Then patient received Moderna Dose #2 on 2/8/21. By 2/11/21, patient had some intermittent confusion noted. Vitals were mostly WNL. On 3/4, patient observed with SOB and restlessness. SPO2 was 86%, Temp 98.4, HR 59, BP 136/59. Oxygen started. Later on 3/4, patient had change in mental status, lethargy, SOB and SPO2 90% on PRN oxygen. Transferred to hospital. Patient was admitted to hospital on 3/4/21. She was readmitted to nursing home on 3/12/21. Discharge diagnosis included: altered mental status, acute expiratory failure, fever, atypical pneumonia, CHF exacerbation, HTN, DM, dementia, asthma/restrictive lung disease.

4/4/21 at 11:30 pm the patient started to make snoring-like sounds in her sleep and could not be woken up. 911 was called and in the hospital a CT scan identified extensive large right-sided intraparenchymal hemorrhage within the frontal, parietal and temporal regions, extending into the ventricular system. The patient was put on the ventilator and administered blood pressure medication. A-line was inserted to read blood pressure. 4/11/21 at 8:11 pm the patient passed away due to cardiac arrest

Patients First dose 01/13/2021 and second dose of Moderna Covid 19 vaccine was administered on February 11th. Patient developed pulmonary embolism in both lungs and hospitalized February 25th. Patient later developed PCP Pneumonia and died March 23rd.

My mom had a brain aneurysm 45 minutes after receiving her second Covid vaccine on Wednesday, March 31st, 2021. She was rushed to Medical Center. After her CT Scan she was put on Life support that morning. After consulting with Doctors we took her off Life Support at 4:00 pm on Friday April 2nd and she passed away 29 hours later at 9;00 pm on Saturday, April 3rd.

We noticed my mother's foot was swollen, after alerting her nurse practicioner they ordered a scan to be done on my mother. It confirmed that she had a blood clot between her groin and below her knee. They prescribed eloquis.

Started feeling sick day of 2nd dose of the Moderna vaccine. never felt good. personal journal entries testify of this. never felt good before she died. Had a massive thrombophlebotic stroke 10 days later causing death.

Per nursing notes: patient received Moderna vaccine #1 on 2/1/21. There is no mention of skin issues or rashes in notes until 2/25/21. Then there is an alert note indicating she has red spots all over skin. Skin intact on 2/28/21. Lotion was applied. No itching. On 3/8/21, she received Moderna #2. Hydrocortisone cream started on 3/8 for itchy skin. Eucerin and hydrocortisone used daily. On 3/27, Nystatin topical was added. On 3/30, per primary request, patient went to see Dermatologist. Triamcinolone cream started. On 4/2, reddish raised rash on neck and shoulders noted. On 4/15, she had a fall, hit head and transported to ER. Suffered a brain bleed and vertebra fracture. Upon readmission, itching rashes remained upper/lower extremities, back/front of body, with skin intact. Mention neurodermatitis in notes. On 4/26 ration noted all over hand and body with left hand swelling. Triamcinolone cream applied. On 4/27 rash on body worsening and clear fluid filled blisters noted on left hand, therefore Change in condition noted. 4/28 visit dermatologist. 4/28 blisters with clear fluid open and drained. Bacitracin applied. Red raised rash on her body slightly improved. 5/2 rashes on upper and lower body more raised, itching started. Several small blisters on leg, neck, right hand. Dermatologist appointment on 5/5 noted. 5/4 multiple blisters with clear fluid on upper and lower body, different sized. 5/6 prednisone oral taper started. Triamcinolone and mupirocin topical started. New diagnosis of bullies pemphigoid noted. Treatment in process.

flu like sxms, acute exacerbation of copd/pneumonia starting 02/08/21, headache, chx pain all night starting 02/13/21. Pt admitted to hospital 02/14/21. Performed lab work, elevated troponin level which continued to climb. Discovered two blockages and installed two stints to primary artery. Pt was discharged 02/16/21

4/29/21: HAD BLURRED VISION (ALL DAY UNTIL MORNING OF NEXT DAY) + PRESSURE IN HEAD (ALL DAY INTO EVENING OF NEXT DAY) ABOUT 40 MINUTES AFTER RECEIVING VACCINE. 4/29/21: EVER SINCE VACCINATION, EXPERIENCING EXCESSIVE THIRST. ONGOING 5/1/21: PATIENT DESCRIBED SYMPTOM AS SKULL BONE PAIN (TENDER SCALP WHEN TOUCHED) UNTIL 5/5/21 5/3/21: ONGLING BLADDER IRRITATION. NO BLOOD IN URINE, BUT SOME SPOTTING (~2TSP) ON PADDING 5/17/21 . NO BLOOD PRESENT SINCE 5/4/21 MORNING: LYMPH NODE SWOLLEN UNDER THE LEFT ARM (INJECTION WAS IN RIGHT ARM). SIZE OF A TENNIS BALL, VERY PAINFUL, AND PAIN RADIATED TO AROUND THE LEFT BREAST AREA. PAIN LASTED UNTIL THE AFTERNOON OF 5/6/21. 5/9/21: BLOOD CLOT IN LEFT LEG REACTIVATED IN THE MORNING, ACCOMPANIED BY EXTREME PAIN, SWELLING, WARM TO THE TOUCH. PAIN AND SWELLING HAS BEEN MINIMAL BEGINNING 5/24/21, AND HAS NOT BEEN AS WARM TO THE TOUCH AS IT HAS BEEN. TREATMENTS: TOOK IBUPROFEN AND TYLENOL AS NEEDED FOR PAIN. USED ARNICA GEL ON THE ARM AT THE INJECTION SITE + MASSAGE+ CONSTANT MOVEMENT FOR PAIN/STIFFNESS. USED ARNICA GEL ALSO ON LYMPH NODE UNDER LEFT ARM ELEVATED CLOTTED LEG AND STAYED ACTIVE TO OPTIMIZE BLOOD FLOW, USED LIGHTLY HEATED PAD TO EASE THE LEG PAIN

Within 24 hours, my mom's arms swelled up from shoulder to fingertips and she had never had swelling in her arms prior. She also was hanging her head as if she had fallen asleep, but actually was unable to lift her head. 4 days following the vaccine she started having breathing issues and was intubated, we had the ventilator removed (she was actually a DNR and was not supposed to be intubated). On January 19, 2021 she died. She went into this facility for rehab regarding an infection she had in her leg.

Patient admitted to Hospital for blood clot in lung after falling twice approximately 24 hours after 2nd COVID immunization

Death 4/18/2021 Causes of death listed on patient's death certificate: 1) Sequelae of SARS-Coronavirus 2019 Other: Rheumatoid Arthritis, Insulin Dependent Diabetes, Chronic Hypoxic Respiratory Failure, Morbid Obesity

Throbbing pain in leg right next to my shin bone; Kept me awake at night; Developed a small blood clot in the vein running along shin bone; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Developed a small blood clot in the vein running along shin bone) in an 81-year-old female 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced PAIN (Throbbing pain in leg right next to my shin bone), INSOMNIA (Kept me awake at night) and THROMBOSIS (Developed a small blood clot in the vein running along shin bone) (seriousness criterion medically significant). At the time of the report, PAIN (Throbbing pain in leg right next to my shin bone) and THROMBOSIS (Developed a small blood clot in the vein running along shin bone) had resolved and INSOMNIA (Kept me awake at night) outcome was unknown. No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-017541 (Patient Link).

Death 5/31/2021 Causes of death listed on death certificate: 1. Autoimmune cold-agglutinin hemolytic anemia 2. COVID 19 3. rheumatoid arthritis, chronic immunosuppression

I had internal bleeding from ulcers in my stomach and small intestine and I had Afib. May 15th - I went to ER - I went to Hospital. I was transferred from there because they didn't have a GI doctor on staff - to Hospital.. I received blood transfusions 8 units of blood. Was put on several medications. Medications - I was put on Amiodaron and Dojoxin (that was stopped so I'm not taking it now - I didn't need it anymore); put on Ferrous Sulfate; Pantoprazole; - those were the new ones I was put on. Have almost recovered.

Bleeding from private area, went to walk-in clinic vitals were bad. Sent to Hospital, was kept for 7 hours. Was prescribed antibiotics. Vomiting, nauseous.

On 4/7/21, she received the second dose of the Moderna COVID-19 vaccine. Then, around 5/1/21, she developed fevers to 102 with associated fatigue and poor appetite, but no other clear localizing symptoms, including no sore throat, cough, chest pain, SOB, abdominal pain, N/V/D, joint swelling/pain, rashes, or dysuria. She presented to an outside hospital ED where she had an infectious workup that included a CXR concerning for LLL pneumonia. She was prescribed doxycycline for 7 days with resolution of her fevers and subjective improvement. In early June 2021, the patient redeveloped fevers and chills, worst at nighttime, without localizing symptoms. Her appetite and energy level remained very poor despite several changes to antidepressants as an outpatient. She was treated with nitrofurantoin x 5 days for presumed UTI, but fevers persisted, still without associated cough, CP, or SOB. With going fevers, fatigue, and poor appetite resulting in ~18lb unintentional weight loss, she was admitted to Hospital on 6/22/21 for further evaluation. While at Hospital, she continued to have fevers to 102+ without localizing symptoms despite empiric doxycycline. A broad infectious workup returned negative. CT chest and CTAP were also unrevealing for a cause of fevers. She was found to have an elevated ferritin, LDH, and triglycerides, as well as a low fibrinogen, concerning for HLH (high H-score). She received high-dose dexamethasone. Bone marrow biopsy was performed that was negative for malignancy. However, peripheral flow cytometry returned with a clonal B-cell population, her soluble IL-2 was elevated, and she was found to have splenic enhancement on PET-CT, all concerning for occult lymphoma as the potential driver of her HLH. She remains admitted and is critically ill with complications of DIC and bleeding that preclude a splenic biopsy to confirm the suspected diagnosis of lymphoma. Since her fevers, malaise, and fatigue started less than 1 month after her second dose of the Moderna vaccine, and the patient was insistent that she "hadn't felt right" since she received that second dose of the vaccine, we decided to report this event in the VAERS system.

On April 5, 2021, developed uncontrollably high blood pressure, resulting in a TIA and 8-day hospitalization -

minor stroke/a small stroke in the left parietal region of the brain, tiny but visible; Have to use a cane or a walker; right leg gave up; patient fell on the floor; difficulty with balance because of their right leg; difficulty with walking because of their right leg; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (minor stroke/a small stroke in the left parietal region of the brain, tiny but visible) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Fall (Patient had a fall in November 2020 and broke their shoulder) in November 2020 and Broken hand (Patient had a fall in November 2020 and broke their shoulder) in November 2020. Concomitant products included FISH OIL, MAGNESIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), FISH OIL (OMEGA XL), LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]), DILTIAZEM, LISINOPRIL and ROSUVASTATIN for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (minor stroke/a small stroke in the left parietal region of the brain, tiny but visible) (seriousness criteria hospitalization and medically significant), MUSCULAR WEAKNESS (right leg gave up), FALL (patient fell on the floor), BALANCE DISORDER (difficulty with balance because of their right leg) and GAIT DISTURBANCE (difficulty with walking because of their right leg). On an unknown date, the patient experienced WALKING AID USER (Have to use a cane or a walker). The patient was hospitalized from 28-Jan-2021 to 29-Jan-2021 due to CEREBROVASCULAR ACCIDENT. The patient was treated with ACETYLSALICYLIC ACID, ASCORBIC ACID (ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID]) for Adverse event, at a dose of UNK, qd. At the time of the report, CEREBROVASCULAR ACCIDENT (minor stroke/a small stroke in the left parietal region of the brain, tiny but visible), MUSCULAR WEAKNESS (right leg gave up) and FALL (patient fell on the floor) outcome was unknown and BALANCE DISORDER (difficulty with balance because of their right leg), GAIT DISTURBANCE (difficulty with walking because of their right leg) and WALKING AID USER (Have to use a cane or a walker) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: small stroke in the left parietal region of the br (abnormal) Small stroke in the left parietal region of the brain, tiny but visible. Additional concomitant medications included vit-asid for macular degeneration. Company comment: This case concerns an 81-year-old female hospitalized with a serious unexpected event of cerebrovascular accident, and nonserious muscular weakness, fall, balance disorder, gait disturbance, and walking aid user. Event latency 18 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: This case concerns an 81-year-old female hospitalized with a serious unexpected event of cerebrovascular accident, and nonserious muscular weakness, fall, balance disorder, gait disturbance, and walking aid user. Event latency 18 days after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Patient was exposed to COVID in her home via her daughter from out of state. 07/11 she began experiencing nausea, vomiting, and diarrhea, as well as loss of taste and smell. She presented to the ED with these symptoms and fatigue. She was diagnosed with COVID pneumonia and dehydration and admitted to the COVID Unit. Problem list: -Severe Covid pneumonia with pulmonary infiltrates and new hypoxia. Symptom onset 7/11/2021 -Hypoxic respiratory failure secondary to above -mildly elevated troponin w/o chest pain -Nausea/vomiting/diarrhea, suspected to be secondary to coronavirus -Acute kidney insufficiency, suspect prerenal azotemia from volume depletion -History of hypertension, currently hypotensive -Weakness -new dx of DMII with steroid induced hyperglycemia Plan: -Continue inpatient level of care in the Covid unit -Dexamethasone (7/18/2021-) and completed remdesivir (7/17/2021-7/21), supplementary oxygen, Mucinex, albuterol, proning, is at the spirometry. CRP elevated at 19, D-dimer elevated at 1200 will trend CRP but currently not severely hypoxic enough to qualify for Tocilizumab. Troponin downtrended. TTE with right sided heart dyfxn, likely at least partially chronic as CTA does not show any evidence of pulmonary embolus. Would recommend repeat transthoracic echocardiogram after recovery from acute illness and consideration of right heart catheterization if right ventricle dysfunction appears to be persistent. -Sliding scale of insulin started given her history of borderline diabetes with the expectation of hyperglycemia on dexamethasone. 7.5. Continue lantus, medium dose SSI -Resume amlodipine. Continue holding ACE inhibitor given acute kidney insufficiency -Renal function improving, appreciate assistance -PT/OT consulted and rec -Acetaminophen and Zofran for symptomatic management

Patient recieved vaccine 1 of covid 19 i 1/19/2021. She felt poorly on 1/20/2021. She felt dizzy and fell at 3 AM on 1/23/2021. She felt poorly and did not know her son's name which was not normal. She went to ER on 1/24. She was assessed as not having fractures. She was going to be transferred to a skilled nursing facility. She was not having respiratory complaints. She was awaiting transfer when her O2 levels started dropping substantially. She declined aggressive intervention and she died within a few hours.

Pt's son called and reported that pt had COVID vaccine on 1-25-21 and was taken to the hospital via EMS due to confusion and memory loss. Pt's son states that pt was diagnosed with "TIA" and stayed in the hospital x 3 days. Pt states that the physicians at facility was not sure if TIA was related to vaccine but encouraged him to report adverse event. Pt's son states that pt has short term memory loss and has since moved in with him after this event happened.

I video chatted with her Thursday after receiving the vaccine. My mom was in poor health but she was talking in complete sentences and responded appropriately. She was upright in bed and made eye contact. She smiled and denied pain. By Sunday, she was extremely weak and unable to sip water with a straw. Her health had changed dramatically and rapidly. She moaned in pain and was very fatigued. Her condition continued to deteriorate over the week and she stopped talking and was constantly sleeping. They started antibiotics for the oozing cancer lesion and then morphine for pain and end of life care. She passed away on January 22nd which was 15 days post vaccination.

Patient had a sharp decline in her health following her second vaccine. Leg pain, lower ext claudication, acute renal failure and acute congestive heart failure

Fever by the next day, difficulty breathing, pneumonia, and then DEATH within a few days. (Died 02/01/2021)

Patient reported feeling weak, fatigue, fever (102), and loss of appetite. Patient subsequently went to the ER 2/6/2021 and tested positive for COVID-19 on 2/7/21 (collection date). See following discharge summary from ED: 82 y.o. female who initially presented to the ED with complaint of generalized weakness, fatigue, fever, and loss of appetite x at least 4 days since receiving Covid 19 vaccine. Her workup in the emergency room was significant for hypoxia with 02 saturation 88% on 2LPM (home nocturnal 02 requirement) with improvement to mid-90s on 4LPM. Blood sugar was 47, Cr 1.61. CXR showed extensive R lung and moderate left lung opacities. She was started on empiric ceftriaxone and azithromycin and admitted to the hospitalist service for further workup and mgmt. During her stay in the hospital, pt did test positive for Covid 19. She developed rapidly progressive respiratory failure, felt to be secondary to ARDS. There was also question of contributing pulmonary edema, however this was refractory to lasix and thus ARDS was felt to be the most significant factor. She had requested DNR/DNI status, thus as her 02 requirement escalated she was transitioned to 15LPM NRB and then to BiPAP support. Unfortunately, she continued to suffer greatly with the BiPAP in place, and therefore made the decision to transition herself to comfort measures only after visitation from her family. Her other medical issues were supported as appropriate during her stay, with dextrose infusion for hypoglycemia and AKI, also hyponatremia felt to be due to IVVF. Unfortunately, am unable to find any documentation regarding how pt was feeling when she received the vaccine compared to her baseline state of health. thus am unable to say whether the severity of her illness represents vaccine­ enhanced disease or the much more common cytokine release syndrome leading to ARDS. Regardless, she developed ARDS as result of her Covid 19 illness. Time of death: 1408 on 2/9/21. Cause of death: ARDS due to Covid 19 pneumonia.

Had vaccine on 2/15 , then on 2/16 evening had stroke like symptoms trying to turn the TV channel and could not find numbers on remote. then her friend called and could not formulate words to her on the phone and could not say the words that she was thinking. Then she called her brother who is a doctor and he told her to go to Cardiologist and get in. She was talking normal by the time she talked to him. Adverse reaction was TIA. TIA symptoms lasted 5-10 minutes max per patient.

Was given without consent from POA patient got severely sick and never recovered later passed away only live 1 month POA did not allow second vaccine to be given just wanted to report this vaccine was given illegal without POA knowledge

So tired; No energy, very weak; Same night went into afib; A spontaneous report was received from a 82 years old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced atrial fibrillation, so tired and no energy, very weak. Patient's medical history included atrial fibrillation. Relevant concomitant medications included prednisone and benadryl. On 28 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. On the same day, patient experienced atrial fibrillation. On 29 JAN 2021, she was so tired and had no energy and was very weak which lasted for 6 days. She thought that this was due to prednisone and Benadryl prophylactically. On the same day, her sinus rhythm was found to be back to normal. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not provided. The events atrial fibrillation was considered resolved on 29 JAN 2021 and the events so tired and no energy, very weak were considered resolved on 04 FEB 2021.; Reporter's Comments: This case concerns an 82 year old female patient, with medical history of paroxysmal atrial fibrillation (2016), who experienced a serious unexpected event of atrial fibrillation, among other non-serious events, after receiving first dose mRNA- 1273 (Lot# 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. Further information has been requested.

Atrial fibrillation; elevated diastolic blood pressure; A spontaneous report was received from a consumer, who is a 82-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sustained atrial fibrillation and elevated diastolic blood pressure. The patient's medical history or concomitant medications were not provided. On 12-Feb-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (037M20A) intramuscularly in an unknown anatomical location for prophylaxis of COVID-19 infection. On 14-Feb-2021, the patient experienced the sustained atrial fibrillation and elevated diastolic blood pressure, which were considered medical significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event was unknown. The patient believe the events, sustained atrial fibrillation and elevated diastolic blood pressure, may be related to the vaccine. Consent given for Safety Division to follow up with her, if needed.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.

Nurse called clients' son to remind her of the second dose needed and was informed that client had passed away from Pneumonia the Sunday after she received the vaccine 1/17/2021.

first dose: at 60 hours after shot went into Atrial Fib. Heart Beat up to 150 plus. Had paramedics come. Took a Flecanide. They ran heart test and it doing okay. Delined hospital emergency room transpoort as heart beat came down. Had not had an AFIB event since I had been carioverted a year and a half previously. Second dose was 2/19/21 Same lot. At approximately 81 hours after shot haI d another fib EVENT. aLTHOUGH FOR 24 HOURS BEFORE HAD ERRACTIC and higher thannormal poulse. Highest was 110 beats . Tookm FlecNIDE.sINCE that time have had increased symptomology

Patient showed reaction to vaccine almost immediately, began having chills and nausea. Patient ultimately succumbed to cardiac arrest.

The patient reported feeling tired and diziness beginning February 20, 2021 and had a stroke later that day. She was treated in the hospital for 4 days and later released. She did not get her second dose.

Experiencing similar symptoms of those of heart failure; Feeling bad; Congestion; Coughing a lot; Tired alot; A spontaneous report was received from a consumer concerning an 82-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced feeling bad/feeling abnormal, had similar symptoms of those of heart failure/cardiac failure, coughing a lot/cough ,congestion/nasal congestion and tired a lot/fatigue. The patient's medical history included heart failure and hypothyroidism. Concomitant medications reported included medication for heart failure and hypothyroidism. On 19-JAN-2021, approximately three weeks prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 10-FEB-2021, the patient reported that three weeks after receiving the vaccine she started feeling bad, had similar symptoms of those of heart failure (which he has had), cough/coughing a lot, congestion and tired a lot. The event similar symptoms of those of heart failure is considered as medically significant. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the events feeling bad, similar symptoms of those of heart failure, cough (coughing a lot),congestion and tired a lot, were unknown.; Reporter's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

stroke; affected right hand and right foot; woke up with affected sites; thought initially this was stiffness side effect of vaccine; however it did not improve over a couple of days then went to ER

Pt received first Moderna COVID shot 2/25/2021. Pt developed acute on chronic respiratory failure with hypoxia, presented to local hospital ED on 3/25 and transferred to our facility for higher level of care. Currently in ICU with covid related hypoxia and pneumonia.

Last Moderna vaccine March 3, 2021. On March 17 began not feeling well. Never felt this way. Then on March 25 had severe low abdominal pain that sent her to ER.

Superficial blood clot in the leg/area is sore to touch; A spontaneous report was received from a consumer (patient), concerning a 82-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced superficial blood clot in the leg/area is sore to touch (thrombosis). No medical history was reported. No concomitant medications were reported. On 19 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: not provided), on 15 Feb 2021, the patient received the second of two planned doses of mRNA-1273 (Lot number: 027L20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced a superficial blood clot in her leg (medically significant). She also reported that the area was sore to touch. The doctor prescribed medication to treat her problem, but they said to wait a week to see if it solved on its own before taking it. She was also applying ice pack on the affected area. No further information as reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable. The event of superficial blood clot in the leg/area is sore to touch (thrombosis) was unresolved. The reporter did not provide assessment for the event of superficial blood clot in the leg/area is sore to touch (thrombosis).; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Vaccine administered at 1816. Patient walked to the observation area and while in the observation area, got up to use the restroom. Patient exited the restroom and said she needed assistance. She indicated to the observation nurse that "this ain't good" or "this ain't right". Patient reported seeing spots and having chest pain. The time was approximately 1830. She was assisted to the floor. Help was summoned and 911 called at approximately 1834. Upon being lowered to the floor patient was breathing, she was not cyanotic, her eyes were open and she was not responsive. The patient had a pulse. Sometime after 1830, but before 1835, the patient was observed to have seizure like activity as bilateral

At 2AM on Saturday, March 13, 2021, I began passing blood into the toilet. That evening I went to the Emergency Department and was admitted as an inpatient. I was treated there and discharged to home on Tuesday, March 16. Over the next two days I passed substantial amounts of coagulated blood. My diagnosis was colitis.

Had pneumonia; Loss of smell; Loss of taste; received her first Moderna vaccine on 22JAN2021 and has not received second vaccine yet; Tested positive covid; Felt not right; A spontaneous report was received from a consumer concerning herself, a 82-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of smell / anosmia, loss of taste/ageusia, had pneumonia, felt not right / malaise, tested positive for Covid and received her first Moderna vaccine on 22JAN2021 and has not received second vaccine yet/product dose omission issue. The patient's medical history, as provided by the reporter, included high blood pressure and high cholesterol. Concomitant medications reported included medications for high blood pressure and for high cholesterol. On 22 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced loss of smell, loss of taste, and had pneumonia. The event, pneumonia, was found to be medically significant. On 03 Mar 2021, the patient was not feeling right and on 04 Mar 2021 she was tested positive for Covid-19. Treatment details included the use of some nebulizers and quarantine. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, loss of smell, loss of taste, pneumonia, felt not right, and tested for Covid-19 was unknown and of event and has not received second vaccine yet was resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded except for the events of COVID-19 and Pneumonia. The events of COVID-19 and Pneumonia is unlikely related to mRNA-1273 since the vaccine does not contain infectious elements capable of causing infection.

Broken of the right eye vein that led to bleeding; excruciating pain (like a labor pain; Diarrhea; vaginal bleeding; Dizziness; Stomach Cramping; A spontaneous report was received from a consumer who was also a 82-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced: excruciating pain - like a labor pain (pain), stomach cramping (abdominal pain upper), diarrhea, vaginal bleeding (vaginal haemorrhage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage). 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: methotrexate. On 22Jan2021, the patient received their first of two planned doses of Moderna's COVD-19 Vaccine (mRNA-1273, lot number: not provided) intramuscularly for prophylaxis of COVID-19 infection. Later on 22Jan2021, the patient began to develop: excruciating pain - like a labor pain (pain), diarrhea, vaginal bleeding (vaginal haemorrhage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage). She reports these events lasted for 1 day and then stopped. The patient states she still experiences stomach cramping (abdominal pain upper), The patient confirmed she consulted with her physician and blood work was done. The results of the blood work were not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. Patient is wondering if these events are normal and if she should receive her second dose. The outcome of the events: excruciating pain - like a labor pain (pain), diarrhea, vaginal bleeding (vaginal haemorthage), dizziness and broken of the right eye vein that led to bleeding (eye haemorrhage) is considered to be resolved based on patient reported duration of 1 day. The outcome of event: stomaching cramping (abdominal pain upper) is considered not recovered/not resolved per patient report.; Reporter's Comments: This case concerns a 82-years-old, female patient who experienced: excruciating pain- like a labor pain, abdominal pain upper, diarrhea, vaginal bleeding, dizziness and eye haemorrhage. Very limited information regarding this events has been provided at this time. Further information has been requested.

tested positive for Covid infection; BP: 130/68; loss of taste; loss of smell; right lower lobe pneumonia; A Spontaneous was received from a Consumer concerning a 82-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right lower lobe pneumonia (Pneumonia), loss of taste (Ageusia), loss of smell (Anosmia), tested positive for Covid infection (COVID-19) and BP: 130/68 (Blood pressure abnormal). The patient's medical history was included Chronic Obstructive Pulmonary Disease(COPD), blood pressure and Obstructive sleep Apnoea. Concomitant medications was included ATORVASTATIN CALCIUM for cholesterol, ACETYLSALICYLIC ACID for unknown indication, Advair for COPD, SALBUTAMOL for COPD, TIOTROPIUM BROMIDE for COPD and CPAP for Obstructive Sleep Apnoea. On 22-JAN-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch no: 013L20) via unknown route in the Left arm for prophylaxis of COVID-19 infection. On 03-MAR-2021, It was reported that the patient experienced loss of taste, loss of smell and BP: 130/68. On 04 Mar 2021, the patient was tested positive for Covid infection . On 09 Mar 2021, the patient was experienced right lower lobe pneumonia. The pneumonia was medically significant. Treatment information was Nebulizer treatment, Antibiotics for 5 days for Pneumonia and Tylenol. Action taken with mRNA-1273 in response to the events was not reported. On 19 Mar 2021, the outcome of the event, tested positive for Covid Infection was resolved. On an unknown date, the outcome of the events right lower lobe pneumonia, loss of taste, loss of smell, and BP: 130/68 was unknown.; Reporter's Comments: This case concerns an 82 Y/O F with a serious unexpected event of pneumonia, and nonserious unexpected COVID-19, anosmia, ageusia, and blood pressure abnormal. Event onset 19 days after first dose mRNA-1273. Treated with antibiotics and Tylenol. COVID-19 resolved, but other event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Resident showed signs of a stroke at 8:30am on 4/1/2021; transferred to hospital; 4/1/21 12:22 pm resident admitted to hospital with symptoms of stroke; UTI; and elevated cardiac enzymes

Despite patient having long-standing history of ET, she had a completely normal CBC in August of 2020 and was maintained on the same dose of hydrea for more than 10 years. She was found to have an abrupt drop in both hemoglobin (13->9g/dl) and platelets (300s-- >104) 2 days after her 2nd vaccine. Her hydrea dose was lowered and repeat blood work 1 month later demonstrated platelets of 64 and hemoglobin of 6.7. patient was admitted to the hospital and was transfused 2 units of blood. Bone marrow biopsy demonstrated 50% cellular marrow with grade three fibrosis consistent with Post-ET MF. No evidence of hemolysis, vitamin, or iron deficiency. Spleen not enlarged. Hydrea was stopped completely during admission. Today's blood work (4/8/2021) demonstrates continued thrombocytopenia and anemia - platelets of 54 and hemoglobin of 7.5.

Three days after receiving dose 1 of the Moderna COVID 19 vaccine, I was contacted by the deceased daughter who indicated she could not get her mother out of bed. She was subsequently placed in Hospice Care due to global decline, never experienced any significant improvement, and expired 30 days later. Vaccine related adverse effect global debilitation after receiving vaccine.

Fatigue, achy all over, pain under right rib cage that hurt threw to my back. Went to med center and was seen by Dr. He was concerned so that he insisted that I go to the hospital to be admitted on Tuesday 4/6/21. Was admitted and blood work was done and ct abdomen and car which was negative. More lab work was done on 4/7/21 which showed a elevated d-diner. At that time a ultrasound of legs done which showed a clot in my right leg. Then a ct chest was scheduled and done 4/8/21 which showed a clot in my right lung.

On 1/27/21, after receiving Dose 1 , I had some chest pains, shortness of breath and a pulse rate as high as 190. I (foolishly) did not do anything but suffered through these symptoms at varying degrees of pain/discomfort for about an hour and a half. Recently on 4/9/21, I experienced these same symptoms. My heart felt like it was pounding out of my chest; pulse rate was up to 170 and BP was 190/86. I also had intermittent chest pains at different levels of severity. Called 911, ambulance took me to healthcare facility where I was advised that I had Atrial Fibrillation. I don't know if this is related to the Covid shots but I feel it should be documented. While I have had high blood pressure for years and I am an older adult, I have never had any heart problems, per se. I also know it would not be unusual for someone with my characteristics to develop- Atrisl Fibrillation, however, it is suspicious that this occurred only after the covid vaccines were administered. Pregnancy History; 1 child.

Started feeling weak next day after shot. As days went by I became increasingly short of breath. This continued for over 2 weeks and then started having chest pain. Went to ER and admitted with pericarditis. 2 days later I went into Atrial fib. The next day I had a cardioversion. Home the following day. One week at home not feeling well, I was readmitted with increased chest pain and shortness of breath. Pulse very low and needed a pacemaker which was inserted Easter Sunday. Home now and still not feeling well.

Patient was admitted to the hospital for Heart Failure and was discharged; Readmitted to the hospital for second time for heart related complications; Patient was scheduled to receive the second dose on 02Apr2021 but due to medical complications will not be able to receive the dose as scheduled; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Patient was admitted to the hospital for Heart Failure and was discharged) and CARDIAC DISORDER (Readmitted to the hospital for second time for heart related complications) in an 82-year-old female 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. The patient's past medical history included No adverse drug reaction (No reported medical history). On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE (Patient was admitted to the hospital for Heart Failure and was discharged) (seriousness criterion hospitalization), CARDIAC DISORDER (Readmitted to the hospital for second time for heart related complications) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (Patient was scheduled to receive the second dose on 02Apr2021 but due to medical complications will not be able to receive the dose as scheduled). At the time of the report, CARDIAC FAILURE (Patient was admitted to the hospital for Heart Failure and was discharged), CARDIAC DISORDER (Readmitted to the hospital for second time for heart related complications) and PRODUCT DOSE OMISSION ISSUE (Patient was scheduled to receive the second dose on 02Apr2021 but due to medical complications will not be able to receive the dose as scheduled) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was reported. Concomitant product use was not provided by the reporter. Limited information regarding the events of cardiac failure and cardiac disorder has been provided at this time and a causal relationship cannot be excluded. This report also refers to an event of dose omission. There were no AEs specifically associated with this medication error; Sender's Comments: Limited information regarding the events of cardiac failure and cardiac disorder has been provided at this time and a causal relationship cannot be excluded. This report also refers to an event of dose omission. There were no AEs specifically associated with this medication error

Death Anasarca Hyperammonemia Altered mental status Pulmonary edema Hypermagnesemia ARF (acute renal failure) Anemia

Patient presented to ED ~2months after 2nd Moderna vaccine with multiple subsegmental PEs as well as small popliteal and calf vein thrombosis. Admitted for 2 days for anticoagulation then sent home on oral anticoagulation in stable condition. No history of thrombosis.

Blood clot in left arm on 2/28/2021 (2 weeks after 2nd dose of Moderna). Diagnosed at Emergency Room.

My mother suffered a massive stroke 40 days after receiving the 2nd dose of the cover 19 vaccine. She fell sick the day after the injection and suffered with brain fog, memory issues, lethargy from that day forward. On day 36 after the 2nd dose she developed a debilitating stomach issue that cause explosive diarrhea that lasted 4 days/nights. This bout with stomach issues left her extremely weak and exhausted. On the 4th night of the diarrhea she got up in the middle of the night to go to the bathroom and couldn't lift herself off of the commode. It took two hours for her to call for help. Once admitted to the ER the stroke was confirmed. Because they could not pinpoint the first stroke symptom she was not eligible for the life saving blood thinning meds and suffered complete paralysis of her right side.

Moderna COVID-19 Vaccine EUA: one month after vaccination patient presents to emergency department reporting worsening headache for three months. Diagnosed with dural venous sinus thrombosis, admitted to hospital, anticoagulated, and discharged to home stable with symptom resolution.

Stroke at the base of the head/neck - affecting sight and giving me a migrane-like headache Outcome - Memory loss

Stroke at the base of my head/neck. Affected my sight, gave me a migrane-type headache, and memory loss.

Pt. presented to ED. Was currently being treated for UTI. Husband states that she has had low oxygen saturations for the past week with any movement, statins she will do as low as the 60's% accompanied with SOB. Husband reports noticing more confusion than normal and reports being very anxious and delirious, poor appetite and lethargic. In ED pt. was found to have O2 saturation of 74% on RA. Weight was also noted to be up. Pt. usual weight in the 190 range and currently pt. is 207 range. Pt. was admitted from ED with diagnosis of Community acquired pneumonia, hypoxia requiring high flow O2 via Airflo, elevated d-dimer.

On 3/25/21, patient presented to the ED with several days history of nausea, vomiting, and upper abdominal pain, and 1 day history of shortness of breath and wheeze. Patient recently received her first dose of Moderna COVID vaccination on March 10. Patient's daughter first developed COVID symptoms approximately 1-2 weeks prior, and was tested positive. Patient developed nausea, vomiting, and upper abdominal pain 6 days prior on March 19. She was tested positive for COVID several days prior to admission (either the 22 or 23rd, patient not sure). On the morning admission, patient had significant worsening of shortness of breath and wheeze. Patient also became significantly more weak and fatigued, and was eventually brought to ED. Patient reported chills, but denied headaches, chest pain, or diarrhea. Patient admitted to the hospital on 3/25/21 with main diagnosis COVD-19 pneumonia and patient expired on 4/13/21.

This 82 year old female received the Moderna Covid shot on 1/28/21 and went to the ED on 2/24/21 and was admitted on 2/24/21 with the following diagnoses listed below. CVA (cerebral vascular accident) Cerebral infarction, unspecified Facial weakness

This 82 year old female received the Moderna Covid shot on 2/17/21 and went to the ED on 2/25/21 and was admitted on 2/25/21 with the following diagnoses listed below. Thrombocytopenia, unspecified

had all signs of a stroke (could have had a stroke); migraine headache; incoherent speech; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (had all signs of a stroke (could have had a stroke)) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No relevant medical history was reported. Concomitant products included ATORVASTATIN for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (had all signs of a stroke (could have had a stroke)) (seriousness criterion medically significant), MIGRAINE (migraine headache) and DISORGANISED SPEECH (incoherent speech). At the time of the report, CEREBROVASCULAR ACCIDENT (had all signs of a stroke (could have had a stroke)), MIGRAINE (migraine headache) and DISORGANISED SPEECH (incoherent speech) outcome was unknown. Additional concomitant medication included an unspecified blood pressure medication. Treatment information was not provided. Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow up/additional information included the reporters contact information (address) and the mention of had all signs of a stroke / could have had a stroke.; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded. Further information has been requested.

I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - Acute renal injury (CMS/HCC)

Systemic: patient died-Severe, Additional Details: patient expired at the hospital not in the nursing home per, director of nursing, at Nursing Home.

My mother was in generally good health for her age, known as the strongest woman to many. She defied covid for over a year, despite living in an assisted living facility in one of 2020's "hot zones". After taking the vaccine, she died within 2 months. I definitely believe 100% the vaccine in the very least hastened her health as she began declining immediately after the first dose, with on/off flu like symptoms until her death.

3/25/2021 was at store when she felt weak, dizzy and nauseated. She had severe left lower pelvic pain above her left hip. Heart rate was 40 and blood pressure was very low. Was taken to local ER. CT of chest revealed pulmonary embolism in the right lower lobe, left retro-peritoneal hemorrhage and large intramural thrombus in the inferior aspect of the IVC extending into the left common femoral vein and superficial femoral vein. Platelet count 147. After initial treatment in ER, she was transferred to another Hospital for hemorrhage and large thrombus. She was eventually released to rehab.

Patient developed a cough a week or so after getting the vaccine. Unclear if clots were starting to develop at the same time.

Symptom onset 4/12/21 (cough, diarrhea, feverish, nausea, chills, fatigue and abdominal pain). 4/14/21 PCR positive for COVID-19 virus. Admitted inpatient 4/14/2021.

TIA (transient ischemic attack); symptoms appeared a week prior to presentation to ED but subsided then reappeared again so she came to ED and was admitted for observation. Under observation symptoms subsided again, except for a decreased sensation on the left arm and right foot. Patient is currently on stroke work up and was started on dual antiplatelet therapy with aspirin and plavix for 21 days.

2-27-21 Heart pain, transported to ER 2x in 2 days. Within 2 days, her Liver and Kidney function failed. and Acute Hypoxic Respiratory Failure and Cardiogenic Shock were listed as cause of death on 3-3-21

blood clot was discovered in the left leg; excruciating pain in the left leg below the knee; area is swollen; Area of the left leg below the knee is red; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot was discovered in the left leg) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) 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) (Intramuscular) dosage was changed to 1 dosage form(s). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced THROMBOSIS (blood clot was discovered in the left leg) (seriousness criterion medically significant), PAIN IN EXTREMITY (excruciating pain in the left leg below the knee), PERIPHERAL SWELLING (area is swollen) and ERYTHEMA (Area of the left leg below the knee is red). At the time of the report, THROMBOSIS (blood clot was discovered in the left leg), PAIN IN EXTREMITY (excruciating pain in the left leg below the knee), PERIPHERAL SWELLING (area is swollen) and ERYTHEMA (Area of the left leg below the knee is red) had not resolved. The patient's concomitant medication was not reported. The information regarding the patient's treatment medication 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 these events, a causal relationship cannot be excluded. This case was linked to MOD-2021-116642 (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.

Pt was found by daughter 3/14/2021 weak, unable to stand and with swollen legs. Pt was taken to ER where she was found to have left leg DVT despite being on Eliquis 5 mg bid which she confirmed she was taken as prescribed

1. Blisters all over back side of left hand, saw Dr. , resolved in a couple of days (occurred 2 days post Vax) 2. Baseball sized lump , iced, resolved (occured 2 days post Vax) 3. approximately 2 weeks post Vax - began difficulty breathing and chest pains, elevated heart rate. Went to clinic , was sent via ambulance to ER . Admitted with diagnosis of pneumonia, fluid retention /edema . Spent 6 days in the hospital. Was told by hospital staff to report to VAERS. Covid test was negative. 4. Today - 15 weeks post Vax, never recovered energy, has severe fatigue, weakness, unable to stand for long periods of time or walk more than a minute. Saw Dr. - look work showed severely elevated Ferritin levels 900+. Still battling and treating with home heath care 4 days a week / OT x2 and PT x2. Home bound. This is ALL since Vax #2....she was walking 30 minutes a day and completely self sufficient before this shot.

Second dose of Moderna COVID-19 vaccine administered 5/25/2021 at ~1300 h. Was last seen alive later that day and seemed to be in her usual state of health. Was then found dead at home on 5/28/2021. Unknown when death actually occurred.

Reporting today because the doctor at the hospital told me that he didnot understand what caused my heart attack. When he did the heart cath there were no clogged arteries or evidence of hypertension.

not well after the vaccination; Died of a massive heart attack; substantial swelling on her lymph node on the left side on the neck/jaw area; Chills; Nausea; Felt very tired; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDIAL INFARCTION (Died of a massive heart attack) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in January 2021. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired). On 02-Mar-2021, the patient experienced LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area). On 30-Mar-2021, the patient experienced MYOCARDIAL INFARCTION (Died of a massive heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced MALAISE (not well after the vaccination). The patient was treated with NAPROXEN SODIUM (ALEVE) for Lymph nodes enlarged, at a dose of 1 dosage form. The patient died on 30-Mar-2021. The reported cause of death was massive heart attack. It is unknown if an autopsy was performed. At the time of death, MALAISE (not well after the vaccination), CHILLS (Chills), NAUSEA (Nausea) and FATIGUE (Felt very tired) outcome was unknown and LYMPHADENOPATHY (substantial swelling on her lymph node on the left side on the neck/jaw area) had not resolved. Concomitant medications were not reported. Company Comment ; Very limited information regarding this events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up telephone contact report (TCR) upgraded case to serious, new event added, action taken updated; new reporter added.; 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: Massive heart attack

82 year old woman admitted to the ICU for management of worsening acute hypoxic respiratory failure secondary to severe COVID 19 pneumonia on 6/17/21. Patient was originally hospitalized for treatment of COVID 19 in the beginning of June 2021. She was discharged on 6/10/2021. She presented to the emergency room on 6/12/2021 for syncopal episode at home. Head CT was negative for any acute intracranial pathology. 12 lead EKG did not demonstrate any arrhythmias, nor any ST to T changes, and echocardiogram demonstrated EF=70% with no wall motion abnormalities. She was admitted to the hospitalist service continued work up for syncope.

Within two weeks following second covid shot, my mother developed extreme pulmonary issues with lungs that presented a "ground glass" appearance. Shortly thereafter, she was diagnosed with interstitial lung disease despite having never been a smoker or exposed to asbestos. While her medical doctor does not believe there is a connection, in the 8-10 weeks following the initial event she is improving significantly. It took three hospital stays, a lung biopsy, a pulmonary embolism and lengthy time in the ICU but she is starting to improve to the point that she does not need oxygen. The level of improvement she is showing and the rate of improvement seems inconsistent with ILD.

She had a non traumatic intracerebral hemorrhage; Never regained consciousness after the stroke/unresponsiveness; Stroke; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBRAL HAEMORRHAGE (She had a non traumatic intracerebral hemorrhage), LOSS OF CONSCIOUSNESS (Never regained consciousness after the stroke/unresponsiveness) and CEREBROVASCULAR ACCIDENT (Stroke) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Type 2 diabetes mellitus on 21-Jan-2021. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CEREBRAL HAEMORRHAGE (She had a non traumatic intracerebral hemorrhage) (seriousness criteria death, hospitalization and medically significant), LOSS OF CONSCIOUSNESS (Never regained consciousness after the stroke/unresponsiveness) (seriousness criteria death, hospitalization and medically significant) and CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria death, hospitalization and medically significant). The patient died on 21-Jan-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The concomitant medications include unspecified medications for diabetes and low pressure. Reporter further explained the event as non traumatic intracerebral hemorrhage. Patient was hospitalized for some days and died one or two days after coming back to home. The treatment information was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. 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

Patient admitted to hospital on 04/20/2021 for significant shortness of breath; patent tested positive for COVID-19 despite being fully vaccinated against it. Patient died on 04/24/2021. Death Certificate Information: Part I: Cause of Death: A. Repiratory Arrest B. COVID-19 Part II Other Significant Conditions COPD; Multiple Myeloma

patient went on hospice 7/16/21 and expired 7/17/21 developed sudden neuro degenerative disease unspecified with paralysis of lower extremities first then arms, neck and complained of shortness of breath, swelling left and then progressive swelling

on anticoagulation wtih xarelto for a fib started having rectal bleeding 1 wk after moderna #1 2/6/21 then again 1 wk after moderna #2 3/6/21. pt has continued to have intermittent bleeding since 2nd vaccine

The patient passed away today, 1/13/2021. She was a hospice patient. She showed no adverse effects after receiving the vaccine on 1/12/2021. This morning she woke up as normal and during her morning shower she had a bowel movement, went limp and was non-responsive. The patient passed away at 7:45 am.

Moderna COVID-19 Vaccine At 2 PM I went blind in my left eye. Went to emergency room at Hospital Was told I have Blood clot in my eye causing the blindness and Ophthamologist says it will probably be permanent

1/13/21 pt came into clinic for vaccine. Had difficulty remembering age. Called me Mon. 1/18/21 stating she was sick. When asked what her sx were, she stated fatigue. She was well the night of the shot, Thur. and Fri. but became tired on Sat. and Sun. I went through other sx with her such as h/a, fever, n/v, muscle aches, weakness and she said she experienced none of those. I questioned her about eating and drinking and she said she ate and drank water. She seemed fine so I told her to call her doctor if she was worse or the fatigue persisted or call 911. She agreed. Two staff from clinic called her Mon. and Tues, (1/18 and 1/19). On Tues. she may have had sl slurred speech. She was found deceased on

VACCINE ADMINISTERED 01/06/21 ACQUIRED COVID 19 01/10/21 RESIDENT HAD MULTIPLE CO MORBIDITIES AND WAS DECLINING PRIOR TO VACCINE. RESIDENT EXPIRED ON 01/25/2021

about 20+ hours after vaccination resident was having hard time breathing, 911 was called. Resident coded multiple times at the facility after CPR she was taken to ICU. She coded again and was placed on life support. Due to her choice to not be on life support she passed on 11/26/2021.

Patient states Right neck pain, middle and down Right arm, not sharp, in the evening after shot. Afib evening of 1-19-21, patient took nitro pill and called Dr.

Patient found down at home with agonal respirations and per EMS asystole, received 2 rounds of epi at her house with return of spontaneous pulses, lost pulse again in route to ER and another round of epi was given, CPR in progress when arrived at hospital. Prior to this patient's husband states he heard her fall in the bathroom but did not immediately check on her as he states that this has happened before. He checked on her 10 min later and that's when he found her unconscious. Daughter called 911 and she began CPR. No previous complaints of headache, chest pain, back pain, fever or chills. Husband states patient was drinking that evening which is not unusual for her. Patient died at hospital.

Patient reported left arm numbness. Went to the hospital for full stroke evaluation all tests returned negative. (CT scan, MRI, etc.). Patient was observed overnight and released from hospital with resolved symptoms and negative report of any stroke or mini-stroke. Patient has had follow-up appointments with PCP and Cardiologist. Received ok from PCP prior to second dose vaccination of COVID.

1/11 I had an EKG that was normal. after receiving the vaccine, my chest started hurting, both arms started hurting really bad. 30 hours later the arms stopped hurting but the chest was still hurting. back started hurting but went away but the chest still hurt. I went to Dr. 3 days after i started hurting and he did an EKG 1/25 and that evening the DR called and said "GO TO THE HOSPITAL YOU ARE HAVING A HEART ATTACK. CALL AN AMBULANCE." I took an ambulance to the hospital and had surgery and had 3 stints put in.

Patient noticed what appeared to be severe rash mostly on lower extremities (legs). It did not itch and she is not sure the onset except that it appeared sometime after her Moderna vaccine (only had one shot). She ended up at Emergency Department per her doctor's orders and was diagnosed with thrombocytopenia (platelets 130). They also found stage three kidney failure. She was not aware of these conditions prior to vaccine although it sounds like there were prior labs suggesting some issues. She was advised to not get the second vaccine as it could potentially further lower platelets. Apparently, other pts have been in their hospital with severe platelet issue post second Moderna vaccine.

Patient felt fine on Friday afternoon and evening after shot. Felt fine on Saturday until the afternoon when she started feeling fatigued and chilled. Decided to take a warm bath at about 6pm. Was found dead in bathtub at approximately 7pm with blisters on arms, legs, and face.

jaundice->hemolytic anemia-> hemorrhagic shock->multi organ failure->death pt admitted to ICU 2/16 with Hgb=3.4, treated with steroids, supportive care , pressors, pt died 2/20/21

On January 1, 2021, patient was admitted to Medical Center with COVID. Tested positive on January 2, 2021. Spent 10 days in hospital. Once recovered from pneumonia and fever gone, on January 10, 2021, she was transferred to Rehabilitation Center for continued treatment. She spent 16 days there. She developed UTI and CDIF infections and was on/off oxygen. She started physical therapy. She was scheduled to be released to go home on January 27, 2021. On January 26, 2021, the day before going home, Rehabilitation Center gave her the Moderna vaccine. On January 27, the day she went home, she started feeling very weak and couldn't walk. My dad tried lifting her and they both fell to the ground. My dad called 911 and she was taken to Medical Center, with high fever and possible stroke symptoms (which later was negative). Two days later, she had difficulty breathing and was put on a ventilator. She was on a ventilator for about three days. They took it off and she slowly started recovering. The doctors did all kinds of tests (blood clot in lung, heart, etc.) and all was negative. The only thing they could trace it to was an adverse reaction to the vaccine. After spending 11 days at hospital and treating her for various infections, her heart stopped and she passed away suddenly.

Pt tested positive for COVID-19 on 2/10/2021 and was hospitalized on 2/15/2021 and deceased on 2/18/2021 at the hospital of admission, per caregiver.

This patient developed a severe pneumonia, clinically diagnosed as COVID-19 pneumonia, with hypercapnic and hypoxemic respiratory failure, and expired. I am not sure if it was related to the vaccine, but the rapid antigen for Sars-CoV2 was positive and the PCR was negative. I am reporting this event because of the lack of clarity on this issue and the positivity of the Sars-CoV2 was beyond the parameters of 14 days in the phase three trials.

Diarrhea; A-afib; A spontaneous report was received from an 83-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced diarrhea followed by exacerbation of her A-fib (atrial fibrillation). The patient's medical history included hypertrophic obstructive cardiomyopathy. Concomitant product use was not provided. On 25-Jan-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (batch number 011M20A) for prophylaxis of COVID-19 infection. On 01-Feb-2021 (reported a week later), the patient experienced persistent diarrhea. She stated, "I believe it's affecting my heart" and that "she went into A-fib since having diarrhea." Treatment information was not provided. Action taken with mRNA-1273 in response to the events was unknown. The events of diarrhea and atrial fibrillation were 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.

Per MD/PA report: Received 2nd vaccine on 3/5/21. That evening, began to have diffuse myalgias, became too weak to get up from being seated and could not walk. Was admitted to the hospital for rhabdomyolysis. Hydrated.

Hours after receiving the 1st Moderna Vaccine patient realized left arm would not move at all and left leg was weak and dragging. Called ambulance and was transported to Hospital. No other signs of a stroke, other than paralyzed left arm and weak leg. Initial scans did not show a stroke. Patient could talk fine, smile, etc. Ran tests in ER, then admitted patient. Treated with muscle relaxers given arm was bent and stiff and would not move. After admitted, the next day an MRI was performed and indicated a stroke in the part of the brain which affects the left side. Began treatment for stroke with blood thinners, etc. Patient moved to Rehab after 4 days in hospital. Remained in Rehab until Monday, March 15th then discharged with weakness in arm and leg remaining.

About 52 hours later I had chills, fever & diarrhea. Five days later I had an Atrial Fibrillation attack and ended up in the ER. Was given Metoprolol infusion plus 2 Metoprolol pills to get me back into normal rhythm. Was in ER about 5.5 hrs.

My mother had the shot on January 25. On the 30th, she became confused and was having trouble swallowing. I took her to the hospital on the 31st (Sunday). She was admitted with pancreatitis and was unable to drink water. She was then admitted to the ICU. She became septic and her mental status declined. By Tuesday, she was placed on a ventilator. She then had renal failure and died on February 18th.

5 days after vaccination patient admitted to hospital with acute ischemic stroke. she was "dragging" her left leg

Right arm full of blood; Fell while walking, over the right arm; Has to crawl, drag herself to the phone; Joints still swollen; Muscles, legs, hip, and knees were steel; Arm sore; Elbow sore; A spontaneous report was received from a consumer who was an 83-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right arm full of blood/ hemorrhage, fell while walking/ fall, has to crawl/ mobility decreased, joints swollen, muscles, legs, hip, and knees were steel/ musculoskeletal stiffness, arm sore/ pain in extremity, and elbow sore/ arthralgia. The patient's medical history included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included unspecified blood thinners, blood pressure medications, and vitamins. On 4 Mar 2021, the patient received their second of two planned doses of mRNA-1273 (lot/batch: Not provided) Intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 4 Mar 2021, the patient could not get up from bed. She stated her muscles, legs, hip and knees were steel. The patient stated she fell while walking, over her right arm- which resulted in the right arm sore and full of blood. The patient stated she had to crawl, drag herself and her joints still swollen, and elbow sore. No treatment information was provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the events is not applicable. The outcomes of events were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

became dehydrated in spite of drinking water and started Pedialyte right before the stroke Admitted into the hospital on March 19th late morning early afternoon. via ambulance to helicopter At hospital

Develop a blood clot on their left knee; Left leg kept swelling up; A spontaneous report was received from a physician concerning a 83-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced a blood clot on her left knee and left leg kept swelling up. The patient's medical history included cholesterol unspecified. Products known to have been used by the patient, within two weeks prior to the event, included vitamin D and medications for cholesterol. On 26 Feb 2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 (Batch number: 038K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unspecified date after the vaccination patient developed blood clot on left leg, leg also kept swelling. Relevant treatment for the event included blood thinners and aspirin. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, blood clot on their left knee and left leg kept swelling up, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

After first vaccination mom was tired in bed flu symptoms for a few days. Had MG symptoms come back and talked to her Dr. Went for 2nd vaccination and very tired &had Severe MG symptoms dr said to take then stop taking Mestinin as she continued getting sicker he called and said not to get any therapeutic drugs called Solaris not to see a dr and she died few days after.

heart attack; Admitted to hospital 3Feb2021 oxygen satuation 77; BP elevated; fluid was drained from her gall bladder and antibiotics were started; lot of fluid in her stomach / the fluid was drained from her gall bladder; 2nd dose of vaccine is overdue by 66 days; This spontaneous case was reported by a consumer and describes the occurrence of GALLBLADDER OEDEMA (lot of fluid in her stomach / the fluid was drained from her gall bladder), MYOCARDIAL INFARCTION (heart attack), OXYGEN SATURATION DECREASED (Admitted to hospital 3Feb2021 oxygen satuation 77), BLOOD PRESSURE INCREASED (BP elevated) and CHOLECYSTITIS INFECTIVE (fluid was drained from her gall bladder and antibiotics were started) in an 83-year-old female 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 Diabetes mellitus, Hypertension, AFib, Congestive heart failure and Pacemaker complication. Concomitant products included AMIODARONE, AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID], BUMETANIDE, BUSPIRONE, CYANOCOBALAMIN, APIXABAN (ELIQUIS), VITAMIN D2, ESCITALOPRAM OXALATE (LEXAPRO), GLIPIZIDE, LISINOPRIL, LOSARTAN POTASSIUM (COZAAR), LOSARTAN, MAGNESIUM OXIDE, METOPROLOL, PRAVASTATIN and SPIRONOLACTONE for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced GALLBLADDER OEDEMA (lot of fluid in her stomach / the fluid was drained from her gall bladder) (seriousness criterion hospitalization), OXYGEN SATURATION DECREASED (Admitted to hospital 3Feb2021 oxygen satuation 77) (seriousness criterion hospitalization), BLOOD PRESSURE INCREASED (BP elevated) (seriousness criterion hospitalization) and CHOLECYSTITIS INFECTIVE (fluid was drained from her gall bladder and antibiotics were started) (seriousness criterion hospitalization). On 10-Feb-2021, the patient experienced MYOCARDIAL INFARCTION (heart attack) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose of vaccine is overdue by 66 days). At the time of the report, GALLBLADDER OEDEMA (lot of fluid in her stomach / the fluid was drained from her gall bladder), MYOCARDIAL INFARCTION (heart attack), OXYGEN SATURATION DECREASED (Admitted to hospital 3Feb2021 oxygen satuation 77), BLOOD PRESSURE INCREASED (BP elevated) and CHOLECYSTITIS INFECTIVE (fluid was drained from her gall bladder and antibiotics were started) was resolving and PRODUCT DOSE OMISSION ISSUE (2nd dose of vaccine is overdue by 66 days) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Blood pressure measurement: elevated (High) elevated. On 03-Feb-2021, Oxygen saturation: 77 (Low) low. On 10-Feb-2021, Catheterisation cardiac: abnormal (abnormal) a blockage was found. On 10-Feb-2021, Myocardial necrosis marker: elevated (High) elevated. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment for the events included cholecystostomy and antibiotics for infection. The coronary artery blockage was deemed to be medically treated. Very limited information regarding these events has been provided at this time. Patient's advanced age along with concomitant medications and underlying conditions may have been contributory for the occurrence of the events. This report also refers to a case of 2nd dose product administration error of 66 days delay for mRNA-1273, lot # unknown. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Patient's advanced age along with concomitant medications and underlying conditions may have been contributory for the occurrence of the events. This report also refers to a case of 2nd dose product administration error of 66 days delay for mRNA-1273, lot # unknown. Further information has been requested.

Patient was given vaccine on 03/25/21. On 04/01/21 patient found in yard and brought to ER, then transferred via air to ER. Patient had concussion due to fall, pneumothorax, and PEA episode. Chest tube placed in the ER, Comfort cares then administered per family request with patient passing that day.

on 4/5/2021 patient started experiencing shortness of breath and pleuritic pain. Admitted to hospital 4/12 with bilateral PE's per diagnostic tests.

Pt was admitted with COVID-19 pneumonia on 4/15 that has progressed to COVID ARDS, DKA, AKI on CKD, NSTEMI

Pt. c/o symptoms of fatigue and dizziness on 3/2. On 3/3 pt. presents to ER, afebrile, c/o fatigue, feeling of being lightheaded, reports syncope and falling x's 2. Pt. according to MD documentation was in good health. Denies any recent illness. Pt. was found to be bradycardic, sick sinus syndrome, r/o MI. Pt. was transferred to higher level of care hospital on 3/3. Pt. had emergency pacemaker insertion. She became hypotensive and hypoxic post-op and was found to in lactic acidosis. Pt. expired on 3/3/21.

Approximately 1800, nursing staff reported patient had facial drooping and slurred speech. Patient vitals were stable. Symptoms resolved. 2/1/2021 Resident observed in the bedroom, unresponsive. No heartbeat or lung sounds upon auscultation. Pupils mid-dilated and fixated, no reaction to light. Carotid pulses were not palpable. Pronounced dead at 1422 by nurse practitioner.

Five days after receiving the Covid-19 vaccine, patient suddenly began having trouble breathing. We called 911 right away but, by the time EMS arrived, she was unconscious and didn't appear to be breathing. Patient was not sick at the time this occurred but she was hospitalized in December of 2019 and was diagnosed with pulmonary fibrosis and pulmonary hypertension which required her to go home with and continue on supplemental oxygen. However, she never experienced pulmonary distress after coming home and her SPO2 levels consistently ranged between 96 and 99% with supplemental oxygen. Patient's death was very sudden and unexpected.

This 83 year old female received the vaccine on 2/26/21 and went to the ED on 4/22/21 and was admitted with Thrombocytopenia, acute renal failure, fall with subdural hematoma, clavicle fracture, anemia, head injury, anascara, hyperkalemia and died on 4/27/2021. Please refer to the other details submitted within this report and contact the person who submitted this report via email for additional follow up details and investigation.

Pt admit 4/8/21 2' suspected TIA or stroke vs seizure disorder. Encephalitis (MRI+) post-Moderna COVID-19 Vaccine 2nd dose 3/8/21. Started on IVIG x5 doses and prednisone, along with seizure meds for tx. Temporary pacemaker placed 4/13 (HR=32). Pt with improved mentation post-tx and sx. Discharged home stable 4/19.

Stroke occurred on 3/6/2021, seen in ED at healthcare facility. Transferred to another healthcare facility. Right sided weakness/paralysis, altered mental status, dysphagia, slurred speech. Rehab at another healthcare facility. Now at home cared for by family.

Presented to ED on 4/23/21 with weakness, malaise, poor appetite and nausea; elevated temperature, tachycardia, lactic acidosis, chest XRAY patchy infiltrates. COVID test positive. Respiratory failure and COVID19 pneumonia. Patient referred to hospice.

Pt suffered diarrhea for two days prior to collapsing . she could not move that morning to get out of bed and could barely talk. She mentioned chest pain and an ambulance was called. Following her vaccinations she was very confused and had fallen in the kitchen the Thursday (22nd) prior to her heart attack. They took her to ER noted she was in shock and had very low blood pressure enroute to hospital. Her pulse was very low. She was life flighted to the medical center. It was determined a blood clot had blocked a major artery into the right side of her heart and it was removed and a stent was placed. She remained at hospital 3 nights and was transferred to nursing home for recovery and therapy where she currently is being assessed for mental issues and is on 4 different heart medications to control blood pressure and prevent future heart attacks. There is not a family history of heart issues. Pt was very healthy in spite of being 83 years old.

I21.4 - NSTEMI (non-ST elevated myocardial infarction) (CMS/HCC) N17.9 - AKI (acute kidney injury) (CMS/HCC)

My mom died one month after the second maderna shot it made her very sick and she never recovered . Headache stomach ache chills fever shaking and death

I went to doctor appt was having pain in my left lung right under rib cage. I was transferred t to ER cause of severe pain. I was hospitalized for two days for pneumonia received antibiotics. The next day I asked to go home to take care of my spouse on Oxygen and he also exp pneumonia after vaccine.

Shakes, chills, temperature, joint and muscle ache and pain, nausea, vomiting, fatigue. We do not know why my platelate count dropped so low. I was not ill before I had the vaccine. I only know that after my reaction to the second Moderna Vaccine, I had side effects and never felt well after the vaccine. My bloodwork done for my Wellness Checkup showed low platelet and as time went by my white count went higher and higher above normal. Weekly bloodwork and testing of my blood showed that "something" caused my platelets to fight, thus dropping my count to a low of 21. What caused the platelets to attack? We will never know. Now, with all the study done by my Oncologist, I am beginning to heal. It all started after my Moderna Vaccine. Do you think that the vaccine may have caused my health issues?

Was informed by the husband on Thursday May 27, 2021 that his wife had passed away 10 days after the first moderna vaccine and that her physician said it was contributing factor to her death. The husband was waiting for the death certificate.

drained fluid off her liver; they thought she was dehydrated; Throwing up; Small headache; Not eating; Not drinking; Not peeing; Sore feet; Sepsis; Death; Screwed up kidneys; Fluid overload; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (Death), SEPSIS (Sepsis), RENAL DISORDER (Screwed up kidneys), LIVER DISORDER (drained fluid off her liver), FLUID OVERLOAD (Fluid overload), DECREASED APPETITE (Not eating), FLUID INTAKE REDUCED (Not drinking), ANURIA (Not peeing), PAIN IN EXTREMITY (Sore feet), VOMITING (Throwing up), HEADACHE (Small headache) and DEHYDRATION (they thought she was dehydrated) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis (shoulders and knees), Hypertension, Acid reflux (esophageal), Penicillin allergy, Drug allergy (Lyrica), Drug allergy (cymbalta) and Drug allergy (ibuprofen). Concomitant products included AMLODIPINE for Blood pressure management, AMITRIPTYLINE for Sleep disorder, HYDROCODONE, POTASSIUM and PARACETAMOL (TYLENOL) for an unknown indication. On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced DECREASED APPETITE (Not eating) (seriousness criterion hospitalization), FLUID INTAKE REDUCED (Not drinking) (seriousness criterion hospitalization), ANURIA (Not peeing) (seriousness criterion hospitalization), VOMITING (Throwing up) (seriousness criterion hospitalization) and HEADACHE (Small headache) (seriousness criterion hospitalization). In April 2021, the patient experienced RENAL DISORDER (Screwed up kidneys) (seriousness criterion hospitalization prolonged), FLUID OVERLOAD (Fluid overload) (seriousness criterion hospitalization prolonged) and PAIN IN EXTREMITY (Sore feet) (seriousness criterion hospitalization). On an unknown date, the patient experienced SEPSIS (Sepsis) (seriousness criterion hospitalization prolonged), LIVER DISORDER (drained fluid off her liver) (seriousness criterion hospitalization) and DEHYDRATION (they thought she was dehydrated) (seriousness criterion hospitalization). The patient was treated with DULOXETINE HYDROCHLORIDE (CYMBALTA) in May 2021 at a dose of UNK dosage form. The patient died on 21-May-2021. It is unknown if an autopsy was performed. At the time of death, SEPSIS (Sepsis), RENAL DISORDER (Screwed up kidneys), LIVER DISORDER (drained fluid off her liver), FLUID OVERLOAD (Fluid overload), DECREASED APPETITE (Not eating), FLUID INTAKE REDUCED (Not drinking), ANURIA (Not peeing), PAIN IN EXTREMITY (Sore feet), VOMITING (Throwing up), HEADACHE (Small headache) and DEHYDRATION (they thought she was dehydrated) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood potassium: abnormal (abnormal) abnormal. Additional concomitant products used included a non-specific acid reflux pill. Treatment information includes fluids, medications NOS, diuretic NOS, dialysis, a catheter, duloxetine (Cymbalta) and antibiotics NOS. Very limited information regarding these events have been provided at this time. However age of patient can be a confounding factor. No further information is expected. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow-up information received 25-MAY-2021 included no new information.; Sender's Comments: Very limited information regarding these events have been provided at this time. However age of patient can be a confounding factor. No further information is expected.

A week after the injection hardly able to move arm. large red spot and appeared swollen. Dr. advised to give it time, then after several weeks of no improvement Dr. referred her to physical therapy. On 5-20-2021 before she could respond she suffered a stroke that has paralyzed her left side, can't walk, can't talk or eat on her own. Has a feeding tube and is currently in Rehab facility.

My aunt got her 2nd shot on 4/7. She was admitted to hospital 4/10 stroke. I am led to believe she spent 2 days on her homes floor between those 2 dates. She has been in a nursing and rehab facility since April 20th and not getting much better. I am convinced that the shot could have put her where she is today. Her insurance ran out early may and this care is costing her money per day with no end in sight. She was an extremely independent woman who lived alone before this happened. Please contact me for more info . This warrants an investigation.

Superficial blood clot; it was bigger after the first dose; Very painful to touch/arm was in pain; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Superficial blood clot) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Superficial blood clot) (seriousness criterion medically significant), VACCINATION SITE SWELLING (it was bigger after the first dose) and VACCINATION SITE PAIN (Very painful to touch/arm was in pain). At the time of the report, THROMBOSIS (Superficial blood clot), VACCINATION SITE SWELLING (it was bigger after the first dose) and VACCINATION SITE PAIN (Very painful to touch/arm was in pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was reported. 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.; 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.

Per daughter, patient died the next day after receiving the shot. Patient didn't have any issues with 1st shot and she went to check on her and she was dead.

I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 5/14/21 after the completion of a full Moderna vaccine series (Dose 1 on 4/1 and Dose 2 on 4/29). The patient later died on 6/5/21 . Cause of Death is listed as cardiac arrest; hypoxic RF; Extensive PAD and ischemic leg/foot ulcers s/p bypass surgery. Pre-existing conditions listed as: OTHER CHRONIC DISEASES, CARDIOVASCULAR DISEASE, DIABETES MELLITUS, CHRONIC LUNG DISEASE (ASTHMA/EMPHYSEMA/COPD)

Death 4/7/2021 Causes of death listed on death certificate: 1) Acute respiratory failure 2) Chronic kidney disease 3) Diabetes mellitus 4) Atrial fibrillation Other: COVID 19

Shortness of breath (very) and heart palpitations (many)... diagnosis of congestive heart failure from a cardiologist

Death 04/23/2021 Causes of death listed on death certificate: 1. hypoxic respiratory failure 2. covid 19 3. diabetes mellitus 4. hypertension

URI signs and symptons began approx. 2-2-21 which did not respond to antibiotic, Predisone, inhaler, Nebulizer Tx. etc. After six office visits to PCP and severe shortness of breath Cat Scan was ordered on 3-09-2021 which revealed multiple Pulmonary Emboli in both lungs. Xarelto was perscribed.

Pt received vaccine 07/01/2021 in the afternoon and patient felt fine with no complaints that day. The following day the patient complained of SOB and the nursing staff found her O2 sat in the 50 so she was brought to the hospital. She was evaluated at the Hospital and discharged back to nursing facility the same day. Patients daughter brought patient back to facility from hospital. On 07/03 patient complained of congestion but "breathing better". On 07/04, patient stayed in bed all day. RN at facility administered tylenol and a soda and right after administration found the patient unresponsive. Nurse started CPR and 911 was called. EMS used defibrillator until the staff alerted EMS that patient was DNR. Patient passed away in room between 3-4pm.

Pt received both doses of the Moderna COVID-19 vaccine (on 3/1/2021 and 4/7/2021). She subsequently developed COVID, testing positive via PCR on 7/3/2021 and was admitted to our hospital on 7/3/2021. She was never ill enough to be in the ICU, instead staying in the general med/surg COVID unit until she was discharged on 7/7/2021. Her primary discharge diagnosis was "COVID-19 pneumonia with mild hypoxemic respiratory failure".

sharp pain inleft hand fingers; Left shoulder really hurt; Left arm skin on top was crinkled; Intermittent pain in entire left side of body; Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful; Stayed in bed; Unable to go back to sleep/did not sleep well; loss of stamina; Shoulder make grinding sound; Anaphylactic shock; Felt terrible/felt miserable; Soreness; Throat started to swell; Left side of her head felt like a balloon; Felt like she had puffiness on the left side; Extremely tired; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC SHOCK (Anaphylactic shock) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fruit allergy (raw pineapple), Fruit allergy (coconut shredded) and Oil allergy (coconut oil). On 06-Feb-2021 at 6:01 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced ANAPHYLACTIC SHOCK (Anaphylactic shock) (seriousness criterion medically significant), FEELING ABNORMAL (Felt terrible/felt miserable), ORAL PAIN (Soreness), PHARYNGEAL SWELLING (Throat started to swell), HEAD DISCOMFORT (Left side of her head felt like a balloon), SWELLING FACE (Felt like she had puffiness on the left side), ASTHENIA (loss of stamina), MUSCULOSKELETAL DISCOMFORT (Shoulder make grinding sound) and FATIGUE (Extremely tired). On 07-Feb-2021, the patient experienced BED REST (Stayed in bed), INSOMNIA (Unable to go back to sleep/did not sleep well) and VACCINATION SITE PAIN (Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful). On 10-Feb-2021, the patient experienced PAIN (Intermittent pain in entire left side of body). On 11-Feb-2021, the patient experienced SKIN WRINKLING (Left arm skin on top was crinkled). On 12-Feb-2021, the patient experienced ARTHRALGIA (Left shoulder really hurt). On 20-Feb-2021, the patient experienced PAIN IN EXTREMITY (sharp pain inleft hand fingers). On 06-Feb-2021, PHARYNGEAL SWELLING (Throat started to swell), HEAD DISCOMFORT (Left side of her head felt like a balloon) and SWELLING FACE (Felt like she had puffiness on the left side) had resolved. On 07-Feb-2021, BED REST (Stayed in bed) had resolved. On 12-Feb-2021, FEELING ABNORMAL (Felt terrible/felt miserable), INSOMNIA (Unable to go back to sleep/did not sleep well), PAIN (Intermittent pain in entire left side of body), SKIN WRINKLING (Left arm skin on top was crinkled), ARTHRALGIA (Left shoulder really hurt) and FATIGUE (Extremely tired) had resolved. At the time of the report, ANAPHYLACTIC SHOCK (Anaphylactic shock), ORAL PAIN (Soreness) and VACCINATION SITE PAIN (Pain in left arm/arm was sore from elbow to wrist/inner lower left arm was painful) outcome was unknown and ASTHENIA (loss of stamina), MUSCULOSKELETAL DISCOMFORT (Shoulder make grinding sound) and PAIN IN EXTREMITY (sharp pain inleft hand fingers) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment medications were not provided. Reduced from dance four lessons consecutively to two lessons consecutively. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Updated Reporter address. Updated patient demographic details such as height, weight, race, ethnic group and Allergies(raw pineapple, coconut shredded, coconut oil). Added new Events like Loss of energy, Shoulder make grinding sound, Anaphylactic shock, Sharp pain in left hand fingers and crunchy sound in left upper shoulder.; 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.

admitted for severe sepsis and septic shock after developing leg cellulitis one month after the second dose of covid shot. required ICU care.

Daughter called on 07/19/21 and stated patient had a CVA on 01/17/2021. Patient was transported to Hospital and patient died on 01/23/2021.

SHORTLY AFTER RECEIVING HER VACCINE, MY MOTHER WENT TO A GRADUATION PARTY FOR HER GRANDCHILDREN. THE DAY FOLLOWING THIS PARTY, SHE STARTED TO COMPLAIN ABOUT SHORTNESS OF BREATH AND LEFT PLEURITIC PAIN., FEVER AND POOR PO INTAKE. SHE WAS ADMITTED TO THE HOSPITAL UNTIL JULY 7. SHE WAS DIAGNOSED WITH PNEUMONIA , SEPSIS AND MILD PLUERAL EFFUSION. HER D DIMER WAS ELEVATED AND SHE WAS TREATED WITH LOVENOX FOR SUSPECTED PULMONARY EMBOLISM. DUE TO HER POOR KIDNEY FUNCTION, SHE WAS UNABLE TO GET A CT SCAN WITH CONTRAST TO DETERMINE THE THE SEVERITY OF THIS CLOT. SHE HAS SINCE BEEN DISCHARGED HOME FROM HER REHAB DUE TO NOT BEING ABLE TO PARTICIPATE IN CARE, TO HOSPICE CARE.

spoke with patient husband on Saturday 1/23 and he said that she had been in the hospital. that she had had a stroke, the MD's at the hospital told him that it was not contributed to the vaccine and that they were unsure even if the stroke had occurred prior to the vaccine or after. spoke with him again on 1-29 and he stated that she had passed away on 1/25/21

The patient went home around 11 am on 1-31-21 after her vaccine and 15 minute observation period. She was eating breakfast after at home and complained to a neighbor that her teeth hurt and she was nauseated after eating. In the afternoon, she felt dizzy and had diarrhea accompanied with blood. Close to 9 PM, her son went to check on her. The patient was found on the floor--she was unresponsive and had purple lips. Her son called an ambulance and started chest compressions. The patient passed away at the hospital. The doctor has ordered an autopsy, and the results are pending.

some bruising near my eye; area was a little tender; Afib started to act up; blacked out; Hit forehead on the door jamb; A spontaneous report was received from a consumer who was a 84-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced area was a little tender, Afib started to act up, blacked out, hit forehead on the door jamb and had some bruising near eye. The patient's medical history, as provided by the reporter, included atrial fibrillation with premature ventricular contractions (PVCs), and three cardioversions in the past 30 years. Concomitant medications reported included metoprolol, alprazolam, apixaban, amlodipine besylate, telmisartan, atorvastatin, ubidecarenone, multivitamin, vitamin B2, fish oil and cranberry extract. On 14 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. On 14 Jan 2021, after receiving the vaccine, the patient had no pain or soreness, but the area was a little tender if you pushed, and she waited one hour in the hospital afterwards. As the patient was getting ready to leave, she felt a little lightheaded. She was driven home, she ate lunch and then worked in the yard for a little bit. As she came inside, her Afib started to act up, she took an extra half of metoprolol, and had supper. She took half an alprazolam before going to bed. That night, as she got up to use the restroom, she had a strange feeling in her head like everything was going away. As she walked into the hallway, she blacked out and hit her forehead on the door jamb. Her forehead was all right but there was some bruising near her eye. She went back to bed and fell asleep. On 15 Jan 2021, when the patient woke up in the morning, her rate was still acting up. At about 9:30am to 10:00am, everything improved, and her heart felt normal. Everything seemed to resolve in approximately 25 hours. Treatment also included acetaminophen/diphenhydramine (no details when it was taken). She contacted her cardiologist since receiving the first dose of the vaccine. The cardiologist encouraged her to take the second dose of vaccine with diphenhydramine and have someone stay with her that night in case something happened again. Consent given for Safety to follow up. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, Afib started to act up, blacked out and hit forehead on the door jamb, were resolved on 15 Jan 2021. The outcome of the events, area was a little tender and had some bruising near eye, were not provided.; Reporter's Comments: This case concerns a 84 year old female patient with medical history including atrial fibrillation with premature ventricular contractions (PVCs), and three cardioversions in the past 30 years. Concomitant medications reported included metoprolol, alprazolam, apixaban, amlodipine besylate, telmisartan, atorvastatin, ubidecarenone, multivitamin, vitamin B2, fish oil and cranberry extract. She experienced serious unexpected events of Atrial fibrillation and Loss of consciousness and NS unexpected events of Contusion, Head injery and Vaccination site pain. The events occurred after first dose of the study medication administration after she went back home. 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, her medical history of heart condition and medication she took could remain a confounder.

Started on Jan 24 or 25-Extreme fatigue, sleeping til late in afternoon,, unable to get out of bed,, headache, just didn't feel right. Went to primary doctor office on 29th. Ran every blood test, ekg and chest xray-mostly normal except orthostatic hypertension. Told to increase fluids. Felt a little better over the next week then same symptoms again Feb 4 and 5th. Took to ER had a seizure and vomiting. CT showed a Stoke and am currently in hospital.

My Mom received the COVID shot on Friday January 29th. On Friday Feb 5 one week later she suffered a major heart attack and had to be rushed to the hospital. There has not been any heart conditions in her medical history her entire life. The family is wondering is the COVID shot had any thing to cause this and if there have been any other reported cases.

The morning after vaccination, she felt extremely and unusually fatigued. After getting up from bed and eating her usual breakfast, she was returning to her bedroom when she became dizzy and fainted, falling to the floor, hitting her head and suffering other effects, including rhabdomyolysis from being on the floor for a long time after the fall as she was unable to get up. She was transported to the ER and was admitted to the hospital for 3 days. She was treated with IV fluids, Tylenol and a short course of antibiotics. While hospitalized, she had a repeat of a rash/swelling at injection site that began about 48 hours after vaccination. The hospital treated the rash with some barrier cream and within 48, the redness, rash and swelling abated.

Moderna COVID 19 Vaccine: Patient started with symptoms of covid 5 days after first vaccine. She was hospitalized and passed due to COVID 19 on 2/6/21. Patients family informed us when she was due for the second dose.

she had TIA (a mini stroke) on 2/15/2021 put in the hospital and got released the next day, doctor said is ok to get 2nd covid 19 shot.

At about 11:00 am which was about 22 hours after receiving 2nd dose of Moderna patient exhibited difficulty breathing and soon breathing became more difficult to point where her shoulders were lifting to breathe. At 6:45 pm she passed away.

Pulmonary embolism; tested positive for covid; A spontaneous report was received from a consumer concerning an 84-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pulmonary embolism, and tested for positive for Covid-19/COVID-19. The patient's medical history included arthritis, and high blood pressure. Concomitant medication history was not provided. On 26-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 12-Feb-21, she started experiencing shortness of breath and went to her local urgent care. They sent her to the emergency room where she was admitted and diagnosed with a Pulmonary Embolism. The patient was prescribed a blood thinner. While in the hospital, she tested positive for Covid-19 on 14-Feb-21. She was in the hospital from 12-Feb-21 to 22-Feb-21. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events, pulmonary embolism were recovered. The outcome of the event, COVID-19 was recovering.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Covid-19 is assessed to be unlikely related.

pt states that 5 days after getting the vax she had brain fog and fatigue. She also developed a 6x4 red, hot, itchy hives arounds the injection site. She stated she had an AFIB event that started up this same day. She has had this before but has not been a problem until this day. Pt is using Goldbond itching cream and Benadryl. Pt will contact her PCP about the AFIB event. Pt still has some redness and itchiness of the arm. The brain fog and fatigue is gone but she still has some AFIB going on.

03/02/21 the patient was visited by nurse. No signs of distress. Normal vitals. No GI concerns according to staff. Her appetite was her usual described as fair. She received her 2nd Moderna vaccination on 03/08/21. Within hour she because very ill according to facility staff. She began to vomit up to 5 times. Her stools because loose. She became more lethargic. She was started on compazine for the vomiting. Her oral intake was minimal. Her symptoms did not resolve and she was visited by the nurse again on 03/11/2021 where she was not very responsive. Her vitals included an irregular pulse and apnea noted in her breathing up to 15 seconds. She died on 03/12/21

During the last month she was losing weight, reflux due to having PEG, low blood pressure, lack of tension. They notified relatives and hospice, she lost mobility, stopped urinating. Respiratory cardiac arrest and end-stage Alzheimer's certified

Atrial Fibrillation acted up; Hot in my injection site arm; Itching in my injection site arm; Hives in my injection site arm; Swelling in my injection site arm; Pain in my injection site arm; Red in my injection site arm; A spontaneous report was received from a consumer concerning herself, an 84-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced atrial fibrillation acted up/atrial fibrillation, hives/urticaria, pain/injection site pain, red/injection site erythema, itching/injection site pruritus, swelling/injection site swelling, hot sensation/injection site warmth. The patient's medical history was not reported. Relevant concomitant medications were included losartan, furosemide, warfarin, thyroid, diltiazem, carvedilol, lorazepam. On 05 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: 031L20A) intramuscularly for prophylaxis of COVID-19 infection and patient had no reactions to that vaccination. On 05 Mar 2021, prior to the onset of event, the patient received the second of two planned doses of mRNA-1273 (Batch number: 048A21A) intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection. On 10 Mar 2021, the patient experienced atrial fibrillation acted up which was considered medically significant and hives, pain, red, itching, swelling and hot sensation in the injection site. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of the events atrial fibrillation acted up, hives, pain, red, itching, swelling and hot sensation in the injection site were 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 event, a causal relationship cannot be excluded.

MODERNA COVID-19 Vaccine EUA Patient received first dose of Moderna COVID vaccine on 1/20/2021, presented to Emergency Department on 1/29/2021 with complaints of left-sided chest pain below her breast, with an onset 1/26/2021. In ED diagnosed with Pulmonary Emboli in lower branches of left lung, and a urinary tract infection. Pulmonary Embolism diagnosed with CTA of Chest. Patient treated with Apixiban 10 mg BID with anticipated duration of therapy for at least 6 months. Patient subsequently received second dose of Moderna COVID vaccine on 2/26/2021

Two days following second dose of Moderna, patient began having symptoms of CVA in the late evening. ER visit the following morning. Diagnosed wtih CVA.

Patient fully recovered from natural SARS-COV-2 infection in early December 2020. Patient was doing quite well between mid December and mid January. Patient was hospitalized with congestive heart failure in late January 2021. Received first dose of Moderna COVID19 vaccine shortly before being discharged around February 1 (not sure of exact date). Patient was feeling well at that time. Patient became quite ill within 24 hours of Moderna COVID19 vaccine. Patient steadily worsened during February 2021. Was hospitalized in mid February (unsure of date) and diagnosed with kidney failure and liver disease. Congestive heart failure rapidly worsened and previously stable leukemia flared up. Patient was discharged from hospital February 19 and was placed in quarantine at Care Center. Patient was considered terminal and was to go into hospice care. Patient was administered second COVID19 vaccine on February 25, rapidly deteriorated, and died on March 1.

On Saturday March 27,2021 the patient was fine on the actual day of second shot which she received at approximately 11:30am. The next day she had a fever of 102, chills, body aches, and severe headache. Tylenol was given with little relief. Symptoms persisted until Monday morning and she reported feeling ?much better.? On Tuesday 3-30-21 at about 3pm she passed out n was taken to an urgent care center where a CT scan of the head was done and was negative. She was discharged to home. The next morning she felt ok but as the day went on she developed facial drooping and slurred speech. She was taken back to the ER and admitted where she remains. An MRI confirmed an ischemic stroke on 4-1 -2021

the next day after vaccine I felt sick, then I had a TIA mini-stroke, I've recovered but I still have memory loss, I forget everything now.

Blood clot in lung; fever; Difficult breathing; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clot in lung) and DYSPNOEA (Difficult breathing) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). Concurrent medical conditions included Hypertension. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced DYSPNOEA (Difficult breathing) (seriousness criterion medically significant). On 27-Feb-2021, the patient experienced PULMONARY EMBOLISM (Blood clot in lung) (seriousness criteria hospitalization and medically significant) and PYREXIA (fever). At the time of the report, PULMONARY EMBOLISM (Blood clot in lung), DYSPNOEA (Difficult breathing) and PYREXIA (fever) outcome was unknown. Treatment details included Heparin, Xarelto. Based on the current available information a temporal association between the use of the product and the onset date of the events, and with reoccurrence of blood clot with second vaccine use, causal relationship with the events cannot be excluded. Fever is consistent with the known safety profile of the vaccine.; Sender's Comments: Based on the current available information a temporal association between the use of the product and the onset date of the events, and with reoccurrence of blood clot with second vaccine use, causal relationship with the events cannot be excluded. Fever is consistent with the known safety profile of the vaccine

she was found unresponsive by family and taken to the ER on 4/1 where she was found to have a massive subdural hematoma. she was placed on comfort measures and passed away at the hospital. she had had a fall out of bed in the week before her ER admission.

Right MCA ischemic stroke with full left hemiparesis, mostly resolved with tPa. Idiopathic. Negative work up for coronary artery or carotid artery or intracerebral artery disease, arrhythmias, anatomic cardiac disease.

Pt was seen by me for full arm thrombosis and CNS thrombosis which occurred approximately 1 week following second vaccine

unknown details of event as pt was in LTC facility where medical records would be located. Pt is reported to have expired at the facility.

Right lower extremity swelling/pain 4/13/21 Improved swelling of right lower extremity 4/14/21 Heparin 1,000 unit/ml 5,592 units IV (80 units/kg x 69.9 kg) daily 4/12/21 Eliquis 10 mg po BID 4./14/21 to 4/20/21 Eliquis 5 mg po BID 4/21/21

D69.3 - Immune thrombocytopenic purpura D69.6 - Thrombocytopenia (CMS/HCC) D69.3 - Acute ITP (CMS/HCC)

hemoglobin levels were dropping – it was a 4 when it should be a 14; Body started bruising - started on her legs and then spread to other locations; she was bleeding everywhere on her body; experienced a little bit of shortness of breath; got tired very easily; This spontaneous case was reported by a consumer and describes the occurrence of HAEMOGLOBIN DECREASED (hemoglobin levels were dropping – it was a 4 when it should be a 14), INCREASED TENDENCY TO BRUISE (Body started bruising - started on her legs and then spread to other locations) and HAEMORRHAGE (she was bleeding everywhere on her body) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Scoliosis and Sciatica. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced DYSPNOEA (experienced a little bit of shortness of breath) and FATIGUE (got tired very easily). On 03-Mar-2021, the patient experienced INCREASED TENDENCY TO BRUISE (Body started bruising - started on her legs and then spread to other locations) (seriousness criteria hospitalization and medically significant). On 28-Mar-2021, the patient experienced HAEMOGLOBIN DECREASED (hemoglobin levels were dropping – it was a 4 when it should be a 14) (seriousness criterion hospitalization) and HAEMORRHAGE (she was bleeding everywhere on her body) (seriousness criterion medically significant). At the time of the report, HAEMOGLOBIN DECREASED (hemoglobin levels were dropping – it was a 4 when it should be a 14), INCREASED TENDENCY TO BRUISE (Body started bruising - started on her legs and then spread to other locations) and HAEMORRHAGE (she was bleeding everywhere on her body) had not resolved and DYSPNOEA (experienced a little bit of shortness of breath) and FATIGUE (got tired very easily) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: inconclusive (Inconclusive) Inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. After a few days, her body started bruising. It started on her legs and then spread to other locations. On 28-Mar-2021, she went into the hospital because of the bruising that kept expanding. The doctor there said that her hemoglobin levels were dropping – it was a 4 when it should be a 14. They did a couple of transfusions and discharge her on 30-Mar-2021. On 02-Apr-2021, she had to go back to the hospital, she had bruising on her hands, feet, and arms. Doctor told them that it was that her blood was thinning and that she was bleeding everywhere on her body. She was still at the hospital. They also said that it looked like her body was fighting the treatments - producing antibodies against them. They gave her plasma and steroids. They also did every test possible, CT scans, and the doctors still dis not know what is causing it. Based on the current available information and the temporal association of the product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-071592 (Patient Link).; Sender's Comments: Based on the current available information and the temporal association of the product use and the start date of the events a causal relationship cannot be excluded.

My mother died in the hospital after being in the ICU for a week with severe breathing problems. Her symptoms matched that of a Covid patient but she tested negative for Covid twice (once was the 24 hour test).

Moderna COVID-19 Vaccine EUA: one day after vaccination patient presents to emergency department (ED) vomiting, tachycardic, and febrile with increased home oxygen use. Denies chest pain. Found to have positive blood cultures and diagnosed with NSTEMI, underwent heart catheterization and found to have severe ostial RCA stenosis, and admitted for medical management of CAD and antimicrobials. Patient discharged medically stable to home.

Pneumonia; Slept almost all day; Left arm swollen; Hot above the site of injection; Entire body really aching; Redness on the site of injection; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leukemia in 2011. Concurrent medical conditions included Hearing impaired. Concomitant products included LATANOPROST for Glaucoma, DORZOLAMIDE and VITAMINS NOS from an unknown date to 03-Apr-2021 for an unknown indication. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced SOMNOLENCE (Slept almost all day), PERIPHERAL SWELLING (Left arm swollen), VACCINATION SITE WARMTH (Hot above the site of injection), PAIN (Entire body really aching), VACCINATION SITE ERYTHEMA (Redness on the site of injection) and FATIGUE (Tiredness). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), SOMNOLENCE (Slept almost all day), PERIPHERAL SWELLING (Left arm swollen), VACCINATION SITE WARMTH (Hot above the site of injection), PAIN (Entire body really aching), VACCINATION SITE ERYTHEMA (Redness on the site of injection) and FATIGUE (Tiredness) outcome was unknown. Treatment for the event included paracetamol. The patient received both scheduled doses of mRNA-1273 prior to the events, therefore, action taken with the drug in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.

Double pneumonia; Urinary tract infection; Silent heart attack; Delirious; Passed out; Very weak; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DELIRIUM (Delirious), LOSS OF CONSCIOUSNESS (Passed out), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection) and MYOCARDIAL INFARCTION (Silent heart attack) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZIA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no medical history was reported). On 26-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 DELIRIUM (Delirious) (seriousness criterion hospitalization), LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion hospitalization), PNEUMONIA (Double pneumonia) (seriousness criterion hospitalization), URINARY TRACT INFECTION (Urinary tract infection) (seriousness criterion hospitalization), MYOCARDIAL INFARCTION (Silent heart attack) (seriousness criterion hospitalization) and ASTHENIA (Very weak). At the time of the report, DELIRIUM (Delirious), PNEUMONIA (Double pneumonia), URINARY TRACT INFECTION (Urinary tract infection), MYOCARDIAL INFARCTION (Silent heart attack) and ASTHENIA (Very weak) outcome was unknown and LOSS OF CONSCIOUSNESS (Passed out) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications and medical history were not reported. The treatment received in response to the events was unknown. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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 felt numbness and went to hospital on 4-6-21. was in hospital for 2 days and treated for a stroke. still in therapy

4/16/2021 - Stroke Had left sided weakness, facial droopiness, slurred speech Hospitalization x 5 days Currently doing PT/OT rehab in Assisted Living - started 4/21/2021

Patient recieved Moderna dose 1 02/23/2021, dose 2 03/25/2021. Nausea and vomitting after 2nd dose, found unresponsive by son on 04/17/2021, taken to ER and diagnosed with new onset Afib with RVR, sepsis with shock. Deceased 04/18/2021

This 84 year old white female received the Covid shot on 3/14/21 and went to the ED on 4/7/21 and was admitted on 4/8/21 with the following diagnoses listed below. D69.6 - Thrombocytopenia, unspecified

My mother had her first Moderna COVID-19 vaccination on March 1st. On March 10th, she suffered a blood clot in her eye that caused the eye to lose vision. Her eye doctor said she is now permanently legally blind in that eye.... I do not know if the blood clot was caused by the vaccine, but I am reporting it in case there is a correlation.

Pt p/w a 5 day hx of diarrhea, nausea chills, dry consistent cough w/some intermittent cramping of bilat lower abdomen. COVID test positive (4/28) despite receiving Moderna vaccines (2/4 & 3/3/21). Given drops in her O2 saturation, admitted for medical management of acute hypoxic respiratory failure secondary to COVID-19. Received dexamethasone, tocilizumab during admission and ceftriaxone for catheter-related UTI. Pt recovered and ultimately was discharged on 5/11 with followup.

Upper left thigh bruised and swollen (April 20) Ultrasound (4/21) results showed DVT. Prescribed treatment Xarelto starter pack 15/20 mg. Maintenance dose 20 mg once per day

My mother has never had any heart issues, and suffered a heart attack on Thursday April 15. She had 2 stints put in late Thur evening. The surgery went well, but there was too much damage to her heart and she passed away on Sat April 17, 2021

Progressive SOB started around 3/20/21 leading to ER visit, diagnosed with bilateral pulmonary emboli on 3/23/21.

Dizziness for almost 1 week after the first dose. Hospitalized on the 13th day after second dose for stroke.

I developed a severe case of hives at the vaccine site 5 days after the inoculation. I also had arm pain. Then I developed brain fog, hallucinations, shortness of breath, worse a-fib, body pain , deep depression.

Patient presented to emergency department for increasing trouble breathing on 4/23/2021. She was previously diagnosed with COVID-19 infection on 3/3/2021. She was admitted to a different facility from 4/8/2021 to 4/20/2021 for management of COVID-19 infection where she also tested positive for COVID-19. She was admitted for further management of COVID-19 infection. Her symptoms did not improve and she was placed on comfort measures on 5/4/2021. Patient expired on 5/5/2021 due to complications from COVID-19 infection.

Four days post-vaccination, she had a serious spell with a hiatal hernia which resulted in a possible gastric volvulus. Over the course of the episode, she ended up aspirating while vomiting. Within 24 hours she couldn't hold her O2 sats at an acceptable level and was put on a ventilator in ICU. She recovered enough to extubate and go to a regular room but then ended up back on the vent and in ICU a second time. She was extubated again, but still could not maintain her O2 levels without medical intervention. She passed away on April 3, 2021. She did have covid-19 in late November 2020, with a mild case of pneumonia. She had been under the care of her primary doctor, as well as home health care and physical therapy, as part of her recovery. Her death may have been unrelated to the vaccine, but I have been told I should report anyway, as a precaution.

Received COVID vaccines (Moderna) on 3/16/21 and 1/19/21. Vaccines not administered, but found via immunization query. Presented to ED with leg pain and chest pain. CXR showed worsening heart failure. Because of tachycardia, tachypnea, keukocytotis, and lactic acidosis received 5 days of vancomycin and zosyn for possible sepsis. CPR prior to discharge positive for COVID. Currently not on any supplemental oxygen.

Pt.'s daughter states 03/14/2021 reported feeling fatigued, achy, and nauseous. *08:00pm ambulance called for transport, blood clot seen during Cat Scan/ MRI stroke reported. No change in condition/ total care needed. Currently residing with Daughter for total care.

Patient describes having pain behind her right eye and blindness. She says she had a stroke behind her eye and that it took a long time to get anyone to see her. She is receiving shots in her eye. She thinks it is related to the vaccine. Her doctor whom she sees for the shots says it was a coincidence.

Thursday and Friday my arm was red and sore and over the weekend on Monday I have terrible pains in the lungs I called the nurse and she said to go to the hospital. I have a pressure of 102 with terrible pain. They thought I was having a heart attack and they did an electro, echo cardiogram. They did a Ct scan and they found I have clots in the lungs. They admitted me into the hospital and stayed for 2 night and then on 3/11 they sent me home and they gave me a Blood thinner (take it twice a day).

patient received vaccine on 1/20/2121, later that night husband found her slumped in chair, called EMS and patient was taken to Hospital where she died on 1/21/2021

The following day, food did not taste as it should and water tasted like metal. By January 13, 2021, extreme fatigue set in; lack of appetite; and extreme feelings of hopelessness, depression, etc. On January 14, 2021, I took my Aunt to Hospital ER and she received a positive COVID diagnosis. She was released to return home with instructions to use a pulse oximeter; move about every 2 hours and not sleep throughout the day; and to do breathing exercises. All were done. Symptoms did not abate. On January 17, 2021, I took my Aunt to Hospital to receive an infusion of antibodies. Unfortunately, her pulse ox readings dropped into the 80 percentile and she was admitted for care. Although she experienced pneumonia, she improved her pulse ox and was released on January 22, 2021 to (rehabilitation center) for outpatient care.

85 year old patient with multiple medical problems. PEA/asystolic arrest 5 days after receiving vaccine, hospitalized. Patient died on 2/1/2021. It is not clear whether the vaccine administration led to the patient's death or not. "...healthcare professionals are encouraged to report any clinically significant or unexpected events (even if not certain the vaccine caused the event)"

pt was given vaccine on the afternoon of 01-29-2021. Pt was administered the moderna covid-19 shot into the deltoid muscle of this pt. Pt was observed and left pharmacy. on 2-6, pts daughter calls pharmacy, and says the night of 1-29, after recieveing the vaccine, her mother had a hemmorhagic stroke and passed away

Within a few days, my mother started reporting profound fatigue and shortness of breath while conducting routine household activities. She no longer had to energy for her daily exercise walks and became increasingly lethargic. She died in her sleep while taking an afternoon nap on Thursday, February 4th. I am highly concerned this could be a vaccine related.

1-2 days after vaccine, pt developed weakness, fatigue, body aches, nausea, headache and poor appetite. Pt was admitted to the hospital on 2/5/21 and death occured on 2/6/21

2/7/2021 at 0630, resident found in recliner without pulse or respirations. Resident had not been found to have any adverse reactions to the vaccine between the time of the vaccine on 2/4 until found deceased on 2/7.

Patients husband called office on February 3rd wanted to let us know his wife was in the hospital and my not be out to get her 2nd Moderna COVID-19 vaccine on Monday February 8th. I talked with the husband briefly about why his wife was hospitalized. He reported she got sick 2 days after getting her first COVID-19 vaccine. He states she had pneumonia, had a urinary tract infection and had to have a heart catherization with stent placement. We moved her second vaccine appointment to February 17th. The spouse came in on February 8th for his 2nd dose. He told me the doctors did not believe his wife's hospitalization was related to the first COVID vaccine and he said the doctor's told him that she needed her 2nd dose.

Patient became nauseated about 10 minutes after vaccine administered, this subsided but returned several hours after the vaccine was given. She continued with intractable nausea and vomiting for about 24 hours. This patient was enrolled in hospice and she continued to decline and refused to eat or drink. She was taking Ibuprofen due to intractable back pain. Her emesis was coffee ground color. After this her condition continued to decline until her death

Moderna COVID-19 Vaccine given at local health department on 2/1/21. Patient developed nausea and loss of appetite post vaccine. Became weak and sought care at ED on 2/5/21. Found to have leukopenia, anemia. Hydrated and discharged home. Patient continued to feel unwell, developed vomiting and diarrhea (has chronic diarrhea since partial colectomy for remote colon CA, but symptoms were worse). Sought care at my health center on 2/9/21. In-house CBC revealed pancytopenia and patient was clinically ill-appearing and severely dehydrated. Patient was sent back to ED for further evaluation. Patient admitted and consults made to Hematology and GI. Stool culture and cdiff negative, Patient was hydrated and had electrolytes replaced. Acute renal failure present on admission resolved with IVF. Sepsis was ruled out. Developed epistaxis requiring 1 unit of platelets to which she had a moderate allergic reaction requiring steroids and benadryl. Severe thrombocytopenia treated with Peg Filgrastim. CBC improved and patient was discharged to follow up with heme/onc. Her methotrexate and eliquis was held.

Debilitating Stroke; Affecting the left side of her body; A spontaneous report was received from a consumer concerning an 85-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced debilitating stroke (cerebrovascular accident), affecting the left side of her body (hemiplegia). The patient's medical history was not provided. No concomitant medications were reported. On 23 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection. On 25 Jan 2021, the patient experienced debilitating stroke, affecting the left side of her body. Treatment information was not provided. The reporter stated that the patient was now in hospice care. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, debilitating stroke, affecting the left side of her body, was unknown.; Reporter's Comments: This case concerns a 85-year-old, female patient who experienced debilitating cerebrovascular accident and hemiplegia 3 days after the first dose of mRNA-1273 (Lot number: 029L20A). Very limited information regarding this event has been provided at this time. Further information regarding patient's medical history and comorbidities has been requested.

Patient presented to the ED 2/15/2021 for shortness of breath and lightheadedness with near syncopal event. The pt reported 2 episodes of SOB and lightheadedness, with the second one as the more severe. On her second episode, she felt severe shortness of breath, tried to walk quickly to her bed with her walker, and fell into her bed. CT angio demonstrated acute saddle PE, mild right heart strain, RUL pulmonary infarct, and mild multifocal pneumonia with suspicion of COVID; IR was consulted and suggested thrombectomy due to the severity of the embolism. In the ED, she was started on heparin drip and put on low-flow NC oxygen without distress. Upon arrival to the emergency department her vital signs were significant for T 36.4, SBP 120/81, HR 95 bpm, NSR, RR 18, FiO2 94% on room air. Her oxygen increased to 98% on 2 L nasal cannula. Her laboratory values revealed WBCs 15.1, Hb 14.4, HCT 43.4, PLT 321, neutrophils 68.8%, D-dimer 4642, NA 134, K3.4, anion gap 9, BUN 17, creatinine 1.00, glucose 163, troponin elevated 0.12, 0.25, and 0.41, urinalysis is unremarkable, COVID-19 swab is positive. A thrombectomy was performed 2/16/2021. She tested COVID positive on 2/16/2021 and her SpO2 remains in the high 90s with dips to mid 80s while talking, but she does not currently experience any SOB.

The patient has developed an acute ischemic stroke on the evening of receiving the COVID vaccine #1 dose. She is in the hospital with left sided weakness, facial droop and speech changes. She is receiving blood thinner and therapies.

On Day 5 (February 21st) after receiving her 2nd COVID vaccine injection, the patient suffered a massive stroke. She was rushed to an ED, arriving within 45 minutes, immediately received TPA treatment and thrombectomy from the right side of her brain. She continues to receive acute treatment inpatient.

Massive stroke; A spontaneous report was received from a consumer (patient's daughter), concerning an 85-year-old female patient, who received Moderna COVID-19 vaccine and death occurred in two days. The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies. She states that her mother was physically and mentally healthy before vaccination. On 29-JAN-2021, prior to the onset of events, the patient received her first of two planned doses of covid-19 vaccine for the prophylaxis of Covid-19 infection. There were no complaints on any side effects from the patient for 6 hours after vaccination. Next day, she was found unresponsive on her bed by her neighbor after they were sent to check on her by her daughter. Her heart was beating, and she was breathing at that time, but did not have consciousness. According to her daughter, the patient had a massive stroke in her sleep sometime between 8:pm on 29-JAN-2021 and 9:30 am on 30-JAN-2021. Her life saving measures were taken out at 1:15 am on 31-JAN-2021 and she died approximately at 1:45am. No information available on hospitalization and treatment received with this event. It is not known whether autopsy was done. Action taken with 2nd dose of Moderna Covid-19 vaccine was not applicable. The outcome of the event stroke is fatal.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event of stoke, a causal relationship cannot be excluded. Patient's elderly age is considered a risk factor.; Reported Cause(s) of Death: Massive stroke

approximately 24 hours post vaccine Patient developed a low grade fever of 99.5 and had increased fatigue. 48 hours later she had decreased neurological functioning. 02/23 she had difficulty swallowing. 02/23 She was admitted to hospice services. 02/26 she passed just before 10 am.

Pneumonia; health condition continued to deteriorate; chills; Body aches; She also fell; A spontaneous report was received from a consumer and physician concerning a 85 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pneumonia, fall, chils, myalgia and general health physical health deterioration. The patient's medical history included diabetes and blood pressure both since an unknown date. Relevant concomitant medications included diabetes medication and blood pressure medication. On Date 11-Feb-2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On date 14-Feb-2021, the patient experienced chills and body aches. On an unknown date the patient fell and her health condition continued to deteriorate. On 18-Feb-2021 the patient was diagnosed with pneumonia due to which the patient was hospitalized on the same day. Laboratory details if provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event(s) chills, body aches, fell, health condition deterioration and pneumonia unknown.; Reporter's Comments: This case concerns an 85 year old, female patient, with medical history of HTN and DM, who experienced a serious unexpected event of pneumonia, among others, 8 days after receiving 2nd dose of mRNA- 1273 (Lot# Unknown). Very limited information regarding this event has been provided at this time. Further information has been requested.

there were no signs of adverse reaction at the time of injections and she waited 15 minutes at the site to watch for side effects. and none were evident or reported. We were notified that she passed away on Saturday, March 6.

On 3/7/2021 the patient presented to the ED with chest pain lasting for about a week that was not relieved after taking nitroglycerin. The patient does have a history of coronary artery disease. The patient was admitted for NSTEMI.

Meniere's attack; Anaphylactic reaction; Started passing out; doesn't feel well; Tired; light headed; A spontaneous report was received from a Consumer concerning a 85 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylactic reaction (anaphylactic reaction), started passing out (loss of consciousness), Meniere's attack (Meniere's disease), tired (fatigue), light headed (dizziness) and doesn't feel well (malaise). The patient's medical history included allergies to citrus and bee stings. Concomitant product use was not provided by the reporter. On 15 FEB 2021, immediately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 15 FEB 2021, immediately post vaccination, the patient got an anaphylactic reaction and started passing. The patient was transported to the emergency room where medication was administered and an echocardiogram (ECG) was performed (results not provided). On 17 FEB 2021, the patient contacted physician who instructed to take Tylenol three times a day and nausea medication as needed. The patient only took one pill. On 21 FEB 2021, the patient had a terrible Meniere's attack which caused patient to feel dizzy and was hospitalized. On an unknown date in FEB 2021, the patient returned home but couldn't get over it. Patient reported feeling very tired, lightheaded and unwell. Treatment information included famotidine, Ativan, Zofran, Tylenol and nausea medication. Action taken with mRNA-1273 in response to the events was unknown. The events Meniere's attack, tired, lightheaded and doesn't feel well were considered not resolved. The event started passing out was considered resolved on 15 FEB 2021. The outcome of the event anaphylactic reaction was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

At 2 PM Friday, March 12, patient was cleaning house and began speaking incoherently. Due to the aphasia, her daughter called 911. The ambulance delivered her to Hospital by 2:20. She presented with a brain hemoragh. Hospital called for medivac which took her to another Hospital. The bleeding continued and the docs ruled out surgery. They were unable to slow the bleed. Patient was put on a ventilor shortly after arriving at hospital. Patient passed at 6:55 PM March 13.

On 3/23 at 0730 resdient non responsive with saliva foaming from mouth. BS 500. All vitals initially Ok then sats dropped to 75. (11 was called immediately upon finding resident. Taken to hospital. Completed course there and later on to rehab. She expired 3/11/2021

The patient was admitted to hospice because she stopped eating and deteriorated. He was being given food through the tube and then he has no vital signs.

Loss of feeling in right arm within 10 mins and arm turned white/black. Had chills nausea and fatigue **diagnosed a few days later with Atrial Fibrilation with rapid ventricular response

When attempting to schedule dose #2, was advised by the family that the patient passed away on 3/13/2021.

She was being treated for kidney failure, at one point her body was not responding to the treatments and they put her in Hospice. She was in hospice for some 5 days. She had been dying for days and in one of the rounds around 6 am on 2/2/2021, the caregivers accompanied her until she no longer had vital signs.

Right arm red, swollen, warm, nausea, vomiting, diarrhea, elevated temperature, altered mental status. Sent to ER. Had elevated cardiac enzymes. Admitted to hospital and treated for sepsis and altered mental status.

Pneumonia after the 1st dose of Modernavaccine; A spontaneous report was received from a Pharmacist concerning an 85-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Pneumonia (Pneumonia). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 10 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number-Unknown), intramuscularly in the left arm for prophylaxis of COVID-19 infection. On an unspecified date the patient developed pneumonia after the first dose of Moderna's COVID-19 vaccine (mRNA-1273). On an unknown date, the patient was hospitalized after developing pneumonia. On 11 Mar 2021 patient was discharged from the hospital. No treatment information related event was provided. Patient currently on steroid treatment. No relevant laboratory details were included. Action taken with the drug in response to the events were not reported. The outcome of the event, pneumonia was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

a week after injection she gained 10 lb water weight, then over the next 2 weeks an additional 20 lb of water weight. She had decrease in activity, anorexia, and was found to have multiple bilateral pulmonary emboli.

Brain bleed; Stroke; She has not received the second dose; This spontaneous case was reported by a non-health professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and CEREBRAL HAEMORRHAGE (Brain bleed) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced CEREBRAL HAEMORRHAGE (Brain bleed) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (She has not received the second dose). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), CEREBRAL HAEMORRHAGE (Brain bleed) and PRODUCT DOSE OMISSION ISSUE (She has not received the second dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Based on the current available information and temporal association between the use of the product and the start dates of the events of the serious, a causal relationship cannot be excluded. It is likely the reported "stroke" and "brain bleed" are descriptions the same event but this is not definitively stated. This report also refers to an event of dose omission. There were no AEs specifically associated with this medication error; 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 of the serious, a causal relationship cannot be excluded. It is likely the reported "stroke" and "brain bleed" are descriptions the same event but this is not definitively stated. This report also refers to an event of dose omission. There were no AEs specifically associated with this medication error

Narrative: On 1/11/21, patient received Moderna COVID vaccine #1 and on 2/8/21, she received dose #2. No notes record any adverse events to vaccine. There is a scanned document from 2/24/21 where patient agreed to home hospice care. Date of death is recorded as 3/1/21. No documentation of any events from time of vaccines to date of death. No autopsy results reported. 21 days from date of vaccine #2 and date of death.

Vaccination was on Wednesday, March 17, 2021 at 3 PM. Symptoms began 8 days later, and Emergency Room admission 3days later on Sunday, March 28, 2021, for Blood Clots in legs and lungs,(critical in Pulmonary Artery). Blood thinner started immediately was Zarelto, and continues daily. Pain, nausea, shortness of breath, and fatigue were the symptoms. The patient was admitted to hospital for 5 days and sent home to recuperate. 3 days later, on Sunday she was back into the emergency department with intestinal bleeding that had gone on for 2 days. She was admitted again and had a colonoscopy. Bleeding stopped and she went home after 3 more days. She is currently getting home health care.

Patient was hospitalized due to multiple blood clots, including jugular, brachial, and others. Patient was hospitalized for treatment on 4/10/21 and is still there.

First DVT in an 85-year-old ambulatory female on daily ASA. Also found to have pneumonia at the same time. Presented afebrile with gradually progressive dyspnea over days and acute onset right lower extremity swelling and pain over hours. Normal O2 sat. Pt was evaluated and seen in memory care where she currently lives. Treatment: ASA discontinued, Eliquis and Levaquin started. Pt remained in memory care and is doing well with almost complete recovery 10 weeks later.

Pulmonary embolism; Nausea; Vomiting; Chest pain/right upper quadratic thoracic pain; Feeling unwell; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PULMONARY EMBOLISM (Pulmonary embolism) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced MALAISE (Feeling unwell). On 15-Mar-2021, the patient experienced CHEST PAIN (Chest pain/right upper quadratic thoracic pain). On 15-Apr-2021, the patient experienced PULMONARY EMBOLISM (Pulmonary embolism) (seriousness criterion hospitalization), NAUSEA (Nausea) and VOMITING (Vomiting). The patient was hospitalized on 15-Apr-2021 due to PULMONARY EMBOLISM. At the time of the report, PULMONARY EMBOLISM (Pulmonary embolism), CHEST PAIN (Chest pain/right upper quadratic thoracic pain), MALAISE (Feeling unwell), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Mar-2021, SARS-CoV-2 test: negative (Negative) Negative. On 17 Mar 2021 the patient had an x-ray and EKG performed because she was not feeling well and had chest pain- no results provided. On15 Apr 2021 the patient went to emergency room and was hospitalized for multiple pulmonary embolisms with parts being infracted. No treatment information was provided. No relevant concomitant medications were reported. Company Comment - Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.

TIA; Left upper lip is turned down/face does not look normal; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (TIA) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 010M20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal. Concomitant products included METOPROLOL for an unknown indication. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion hospitalization) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) (seriousness criterion medically significant). The patient was hospitalized for 3 days due to TRANSIENT ISCHAEMIC ATTACK. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (TIA) and FACIAL PARALYSIS (Left upper lip is turned down/face does not look normal) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Other concomitant medications included unspecified blood pressure medications. No treatment information reported. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable. This case was linked to US-MODERNATX, INC.-MOD-2021-081470 (Patient Link).; Sender's Comments: Although a temporal association exist, the event of Transient ischemic attack with facial paralysis is confounded by the patient's history of Blood pressure abnormal and advanced age.

Pt awoke on 02/28/2021 with increased lower extremity edema went to Urgent care had CXR and was told to increase Lasix to 40 mg daily for 4 days. Swelling became worse over next 2 days and patient became short of breath and on 03/02/2021 she went to Hospital and had a CT scan of chest which showed a pulmonary embolus and a bilateral lower extremity ultrasound which showed a right femoral DVT and popliteal occlusive thrombus and a posterior tibial and peroneal vein occlusive thrombus. She was started on Lovenox and admitted to the hospital . she was discharged on 03/05/2021 and had a right femoral thrombectomy as an outpatient on 03/ 08 2021 with complete resolution . She was discharged home on Lovenox and later switched to Eliqus. She is home and doing well at time ofreport.

Died unexpectedly in my arms. On the 15th. Could not breathe We tried to use inhaler and did not work.

I63.9 - Ischemic stroke I63.9 - Cerebral infarction, unspecified I61.9 - Nontraumatic intracerebral hemorrhage, unspecified

Pt was hospitalized at facility from 4/20/2021 -4/25/2021 had RLE DVT and PE. Venous Dopplers (4/20/2021) demonstrated significant clot burden in R lower and upper legs as well as CTA (4/20/2021) which showed B significant pulmonary emboli and evidence of R heart strain. Prior to sudden onset of symptoms pt has led a very active lifestyle.

Patient received second COVId 19 vaccine on 4/9/21 @ Health Department. Was admitted to hospital on 5/18/2021 with SOB, Nausea, Vomiting, and Headache. Diagnosed with COVID 19 infection and COVID 19 Pneumonia. Patient expired on 5/19/2021 at hospital.

I woke up on 3/02/21 totally incontinent. I could not control my urine. The flow was bright red, filled with blood. I called my healthcare provider and the doctor at that clinic gave me a urine test. He found nothing. There was no pain, only blood for about six bouts of irination. He sent out to a clinic and they said I had an infection caused by E-coli. (The vaccine had obvioiusly lowered my resistance to infection because I had none before at all.) Also, he found that I was in heart failure - about 30% function. They recommended I be hospitalized. My daughter and I drove back to my home state and primary care physician, who concurred. I was hospitalized for heart failure at the hospital in my home state. This was the first time ever my heart had been compromised. I have now to see a cardiologist, take meds, and do cardio rehab. They found my heart was enlarged and I had fluid build-up around my heart also.

Around 2 am in morning after receiving vaccination 14 hours prior, subject experienced severe body tremors and flu-like symptoms including body aches, headaches and lethargy. within 3 days, headaches and body aches subsided however subject remained extremely fatigued and was unable to perform ADL's. Performance status declined. Sitting in chair/laying in bed 24 hours a day. Became short of breath on minimal exertion. On 6/6/21 patient taken to ER for c/o shortness of breath, cough and tachycardia. Was found to have large pulmonary emboli.

Patient presented to ER on 01/18/2021 and stated respiratory symptoms began on 01/14/2021. Positive Covid test that day. Patient was released from ER and admitted as inpatient to the hospital on 01/23/2021 and expired of Covid related symptoms on 02/02/2021.

. Pt was vaccinated with Moderna on 3/12 and 4/9/21 and pt was admitted on 6/15/21 with an acute stroke and L carotid thrombus despite being on eliquiss. CTA head and neck showed a non occlusive thrombus of the Left internal carotid artery. Pt admitted for acute L frontal lobe stroke. Was not given TPA in the ER as was out of the window and is on eliquis chronically for past hx of RLE Dvt and partially occluded IVC as a resulted of a complication she suffered from a kyphoplasty procedure in 2017. She has no hx of atrial fibrillation or clotting disorder and has been compliant with her eliquis per the pt and spouse. She does not smoke, her aic is 5.2 and her ldl is 101. Her echo showed no ventricular thrombus and was a neg bubble study with nl EF. she was transferred to a higher level of care for possible neurovascular intervention. She did not ultimately require neurovascular intervention and Her acute ischemia was presumably due to artery to artery embolus causing left ICA thrombus and was not felt to be an eliquiss failure and she was discharged home on 6/17. she was also found to have a klebsiella uti and was sent home on oral antibiotics. covid 19 neg

Death 3/18/2021 Causes of death listed on patient's death certificate: 1) Acute cessation of cardiac function Other: Severe symptomatic aortic stenosis, coronary artery disease status post percutaneous coronary intervention

Died 4/24. Immediate cause of death acute hypoxic respiratory failure, underlying cause COVID-19 associated respiratory distress syndrome and COVID-19 viral pneumonia

AKI (acute kidney injury) Hyponatremia NSTEMI (non-ST elevated myocardial infarction) ABDOMINAL PAIN VOMITING DIARRHEA NAUSEA

Patient presented to the emergency department with weakness, was found to have acute rhabdomyolysis and acute renal failure with generalized muscle aches and pains all 4 extremities.

Incontinent upon awaking 3/02/21. Blood in urine (quite a bit). Called out-of-state clinic, had tests: showed heart failure (20-25% of heart function), E-coli urinary tract infection. Told to enter the hospital.

Afib wt RVR; Tachycardia; General malaise; Refused 2nd covid vax; Fatigue; After the shot I got real real dizzy; I didn't feel sick, but I didn't feel right; I slept most of the day; I didn't have appetite; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib wt RVR) and TACHYCARDIA (Tachycardia) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11MZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Arthritis in 2010. Concurrent medical conditions included Drug allergy (aspirin), Drug allergy (Avelox), Drug allergy (morphine), Hypertension since 12-Dec-2011 and Hypothyroidism since 24-Sep-2014. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 24-Sep-2014 to an unknown date, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) from 12-Dec-2011 to an unknown date and LOSARTAN from 17-Mar-2021 to an unknown date for an unknown indication. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ATRIAL FIBRILLATION (Afib wt RVR) (seriousness criteria hospitalization and medically significant), TACHYCARDIA (Tachycardia) (seriousness criterion hospitalization), DIZZINESS (After the shot I got real real dizzy), FEELING ABNORMAL (I didn't feel sick, but I didn't feel right), SOMNOLENCE (I slept most of the day) and DECREASED APPETITE (I didn't have appetite). On an unknown date, the patient experienced MALAISE (General malaise), INTENTIONAL PRODUCT USE ISSUE (Refused 2nd covid vax) and FATIGUE (Fatigue). The patient was hospitalized from 15-Mar-2021 to 18-Mar-2021 due to ATRIAL FIBRILLATION and TACHYCARDIA. The patient was treated with CARVEDILOL at a dose of 6.25 mg. On 20-Mar-2021, DIZZINESS (After the shot I got real real dizzy), FEELING ABNORMAL (I didn't feel sick, but I didn't feel right), SOMNOLENCE (I slept most of the day) and DECREASED APPETITE (I didn't have appetite) had resolved. On 01-Jun-2021, ATRIAL FIBRILLATION (Afib wt RVR) had resolved. At the time of the report, TACHYCARDIA (Tachycardia), MALAISE (General malaise), INTENTIONAL PRODUCT USE ISSUE (Refused 2nd covid vax) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Mar-2021, Blood pressure measurement: high (High) high. On 15-Mar-2021, Heart rate: high (High) 150. On 20-Mar-2021, Blood pressure measurement: 139/79 (normal) 139/79. On 20-Mar-2021, Heart rate: low (Low) 53. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow-up information received included: Added medical history, concomitant medications and added new event of Atrial Fib with RVR.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

a large blood clot, which has been removed from her leg; Right side paralysis; No speaking; Unable to walk, due to her paralysis; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (a large blood clot, which has been removed from her leg), HEMIPLEGIA (Right side paralysis), APHASIA (No speaking) and GAIT INABILITY (Unable to walk, due to her paralysis) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (a large blood clot, which has been removed from her leg) (seriousness criteria hospitalization and medically significant), HEMIPLEGIA (Right side paralysis) (seriousness criteria hospitalization and medically significant), APHASIA (No speaking) (seriousness criterion hospitalization) and GAIT INABILITY (Unable to walk, due to her paralysis) (seriousness criterion hospitalization). At the time of the report, THROMBOSIS (a large blood clot, which has been removed from her leg), HEMIPLEGIA (Right side paralysis), APHASIA (No speaking) and GAIT INABILITY (Unable to walk, due to her paralysis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment details were reported. No concomitant medications were mentioned. On an unknown date, the patient was hospitalized due to a large blood clot which was removed from the patient's leg. The patient, at the time of this report, was hospitalized in the stroke center. The patient had right sided paralysis and was unable to speak or walk. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Patient received COVID vaccine #1 at 5pm. At around 9pm, she went to bathroom and noticed that she felt dizzy, shortly thereafter she noticed that her speech was slurred. Her daughter saw that her mouth was droopy and called 911. Pt took 3 baby ASA at that time as well. Patient evaluated in ED for stroke, CT/CTA normal, TPA not given. Admission diagnosis CVA vs Bell's palsy (mild). MRI consistent with changes suspect acute infarct. No arrhytmias noted. ECHO unremarkable.

Day 3 -experienced depth perception issues Day 4- double vision Day 4 - possible stroke, double vision, admitted into hospital and treated stroke protocol Day 6 - released from hospital w double vision and depth perception issues added blood thinners and 3 meds to help prevent future strokes. Met w optimalmologist starting vision therapy. Still waiting to meet w neutrogist

Resident experienced chills, fatigue, nausea, coughing, weakness, loss of appetite, and tachychardia on 2/15/21. She was transferred to the ER and admitted to the hospital (attached to nursing home) for NSTEMI and cholelithiasis/cholecystitis.

Patient went into new-onset atrial fibrillation, resulting in a catastrophic stroke. Patient passed away on 2/11 as a result of the stroke.

86yo female alert, stable with ankle abrasion eating 100% prior to vaccine in assisted living facility. On 2/1/2021, received Moderna vaccine. Starting thereafter, eating 50% on 2/2/21. Temperature was 98 tympanic. On 2/3, the leg abrasion started having moderate bleeding. On 2/4, the caregiver noted patient "not looking good, unable to talk, arms moving aimlessly, grasping". BP 95/41, temperature 98, oxygen on room air 92-93%. POA did not want hospital transfer. 2/5 Hospice started, oxygen given, morphine given. 2/5-2/8 comfort care given, patient responsive to tactile stimuli, resting, not taking oral medications or food. 2/8/2021 patient expired.

Patient previously had dizzy spills, but about a week after receiving the vaccine her dizzy spills began to get worse. The whole prior she kept saying I am just not right. On the 2/7/21 she a COVID test done, a nurse came to her house and preformed. On the morning of the 8th patient was on the phone with someone else and patient asked this person to call me and go check on her. Within 5 minutes I was over at her house, and I found her on the floor, she on her belly facedown. It looked like she was on the toilet, and it looked like she fall getting her off, she was still wet, she still felt warm. I called the ambulance and immediately began CPR. When EMS arrived they took over the CPR and transported her to the Hospital. The EMS was there for about 40 minutes and used an machine to preform the compressions. She was pronounced deceased at the hospital. No autopsy was done.

daughter stated patient was found on the floor at her facility and was transported to the hospital where she was diagnosed with a CVA. Unknown if this event was related to her COVID vaccine.

Patient rcvd 1st covid 19 vaccine on 1/26/2021. Patient had house guests on 1/30/21. Those house guests tested positive for covid on 2/1/2021. Patient started getting symptoms on 02/2/2021. Patient tested postivie on 2/4/2021. Patient was hospitalized 2/7/2021. Patient passed away on 2/21/21.

2.12-fever, flu-like symptoms, confusion and disorientation 2.15 - resident presented with extreme confusion and weakness in arms and legs. unable to do usual daily activities. unable to self-transfer. Taken to ER and diagnosed with UTI. 2.18 - resident complained of headache and being unable to sleep previous night. VS: temp 101.8; BP:135/63; P:93; R:20; SP02:79-80%; HOB elevated. Resident send to ER via ambulance. Diagnosed with pneumonia. hospitalized for 5 days.

Day after second dose decedent had fever and tremors, subsided on day three (less than 72 hours) after dose with exterem wekness followed by death less than 72 hours after second dose

Received 2nd COVID 19 vaccine 3/4/21. On 3/5/21, was tired, but otherwise did okay. On morning of 3/6/21, she awoke short of breath, felt hot, was a little nauseated, and did not take her medication. She has gradually grown more short of breath and distressed since then. She appears weak, distressed with tachycardia and hypoxemia. Bilateral pneumonia seen on xray. She arrived to the ED in A-fib with RVR HR 150's. O2 90% on 12L NRB. After IV access was obtained and labs drawn patient was transitioned to BiPAP setting 10/5 and 30% per MD at 1300. Her saturations were not maintaining above 90% and O2 was titrated up to achieve a O2 % > 90. She was given a loading dose of Diltiazem per protocol and started on a DilIazemt gtt, the drip was titrated up to max 15 to achieve target HR <100. Her BP remained stable during this course. She received a bolus of NS. 1 gram of Tylenol via IV. 1 gram of Rocephin infusing upon transfer. D5LR infusing at 200 upon transfer.During her course in the ED she was able to communicate with staff when asked questions.

Sudden presentation of Ecoli bladder infection with numerous clotting and emergency catheterization. Have not had prior UTIs that I am aware of. Urologist doesn't see any possible correlation but I am now on a third round of antibiotics. Three days after my second shot on 3/12/2021 bleeding again started so now am now back on antibiotics.

When patient didn't show up for her second COVID-19 vaccine today 3/17/21, we couldn't reach her so we contacted her Dr. office. They informed us that patient visited the emergency department on 2/22/21 and passed away while in the hospital on 2/23/21.

Patient went to have labs done for her leukemia checkup 3/24. Patient has had leukemia for many years and has had many blood draws. Patient had blood taken at her appointment and was waiting when the nurse came back out and said her blood had clotted so they needed to redraw her blood. She states this has never happened before and wondered if her blood clotting would have been due to her covid vaccine the week prior. She states the first girl who drew her blood was slower than the second time around when a different nurse drew her blood.

See started having shortness of breath on the night of 8/2/2021. He sends her to do tests, and she was taken to the hospital. She died in the hospital due to kidney and heart failure.

Pt started late in the day w/ CP and SOB, was transported to Hospital by EMS . Pt passed away once at the facility. Time of Death was: 2011 on 4/1/21; pt was discharged from ER on 4/2/21

She got sick, pain in the arm and neck the day after the vaccine. I called her doctors office on the 19th of Feb and I did not get a call back. She was sick to her stomach, really tired and lost her appetite. On the 22nd I called her doctor again... no response, on the 23 I called again. On the 24th finally someone spoke to me.. they stated they had called my mom and spoke with her. They are suppose to call me, my mom could not remember by the time she would hang up. They said to let her rest and give her electrolytes and Vit. B6. On the 26th when I called the doctor and said she is lethargic they said to take her to the ER. She flat lined at the hospital and her body went into shock. She ended up having Kidney, Heart and Liver Failure. She was still driving and doing all of her cooking, banking, shopping, showering, walking every day on Feb 18th. She died on March 5th.

She was found unresponsive by her husband on 4/11/2021 and pronounced dead at the scene. She had been to the emergency room for recurrent syncope several weeks prior to any vaccinations. No cause was determined.

Reporting for a friend she is in the hospital, all events may not be filled in, but I thought it was important to report sooner than later due to the news on other vaccines. Patient had her second shot around 3/7/2021 u sure as she is in a rehab facility time of day was 1630. On the 17 th of March she started having back pain then wasn?t able to get herself to the hospital called 911 and was transported to the hospital and that night had emergency surgery for a blood clot in her neck. She was in rehab and got rushed back to the hospital and had a pacemaker placed. She is still in a rehab facility.

Stroke 6 days after receiving the second dose of the vaccine; Paralysed left side; Fell on the floor unresponsive; Fell on the floor Unresponsive; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke 6 days after receiving the second dose of the vaccine), PARALYSIS (Paralysed left side) and UNRESPONSIVE TO STIMULI (Fell on the floor unresponsive) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medical history was reported). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke 6 days after receiving the second dose of the vaccine) (seriousness criteria hospitalization and medically significant), PARALYSIS (Paralysed left side) (seriousness criteria hospitalization and disability), UNRESPONSIVE TO STIMULI (Fell on the floor unresponsive) (seriousness criteria hospitalization and medically significant) and FALL (Fell on the floor Unresponsive). The patient was hospitalized on 10-Mar-2021 due to CEREBROVASCULAR ACCIDENT, PARALYSIS and UNRESPONSIVE TO STIMULI. The patient was treated with Surgery for Cerebrovascular accident and Surgery for Paralysis. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke 6 days after receiving the second dose of the vaccine), PARALYSIS (Paralysed left side), UNRESPONSIVE TO STIMULI (Fell on the floor unresponsive) and FALL (Fell on the floor Unresponsive) outcome was unknown. Not Provided Medical history was not reported. The patient was taking unspecified Antihypertensive medication. The patient was placed on a feeding tube and was transferred to a Nursing home and would require medical service for the rest of her life. 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.

Client COVID PCR positive on 12/04/2021. Vaccinated with Moderna on 02/03/2021 and 03/03/2021. COVID PCR Presumptive on 4/26/2021 and listed as suspect reinfection. Client hospitalized on 4/26/2021 with signs of bowel obstruction, but also noted to be diagnosed with DVT. Notes indicate client was bedbound. Submitter does not have access to further vaccination or medical records for additional information.

This 86 year old black female received the Covid shot on 1/20/21 and went to the ED on 2/20/21 and was admitted on 2/2/21 with the diagnoses listed below. D69.6 - Thrombocytopenia, unspecified J12.82 - Pneumonia due to Coronavirus disease 2019 N17.9 - Acute kidney failure, unspecified

Health Department was notified of patient death. Health Department was not informed of cause of death. VAERS report completed.

Patient presented to the ED on 3/7/21 and was subsequently hospitalized with A-fib with RVR. Patient was also hospitalized on 4/6/21 with pseudoaneurysm following procedure. These visits occurred within 6 weeks of receiving COVID vaccination.

Got second dose of Moderna 4/19/21. Was having increasing shortness of breath since 5/24/21. Admitted 6/8. Increasing lower extremity edema. Is obese. Coughing up phlegm. No fever/chills/chest pain/abdominal pain. COVID negative. Found to have a saddle pulmonary embolism and DVTs in the lower extremities . Appears unprovoked. Started on Eliquis. Still currently admitted 6/11

Pt had severe itching started shortly after 2nd shot. MD stated pt having histamine response and Atarax started 3x/day to control itching symptoms. After several weeks pt stated atarax making her drowsy and requested to decrease to 2x/day. Pt started itching severely again after frequency decreased and pt requested to be put back to 3x/day. Shortly after pt had massive stroke which led to her death a couple of days later on 4/23/2021

On March 18, 21. pts. left fingers were blue. she was diagnosed with blood clots. Ends of fingers died, lack of blood flow. They have been amputated. She is also swollen.

Severe anemia, low hemoglobin, low body temp, weakness, confusion, shakiness, all blood levels abnormal. Meningitis due to varicella zoster virus. Died on June 13 2021

Several days following 2nd Covid vaccine, patient began experiencing visual changes including seeing "sparkles", black spots, loss of color and blurriness. 8 days following the vaccine, patient lost vision in left eye and was taken to the ER and diagnosed with vasculitis. Large doses of Prednisone were administered as a means of protecting the other eye from loss of vision. A biopsy determined that the diagnosis was small cell vasculitis. Patient was in hospital for one week and returned home. Patient was under the care of specialists but becoming weaker. Approximately 6 weeks later, patient could no longer bear her own weight and was re-admitted to the hospital where additional tests were run. Medical staff were unclear what was causing the decline and patient passed away while still under their care.

Hemorageic stroke, died next day on 03/12/21 My mother became noticeably and increasing confused, quiet and forgetful after the first dose. Immediately after the second dose, she became confused and shakey. On the third day after the second shot, she was disoriented and unable to communicate sufficiently. She was rushed to a local hospital, where she was diagnosed with a brain bleed. She was transported immediately to a hospital, where she was given a catscan and it showed unreparable damage to the right side of her brain, she never regained consciousness and died the next day.

Stroke, unable to know name, where she was, date, time of year, misusing words, speaking incoherently word finding, memory issues, etc. Permanent memory/word finding disability Note: 7 days at Hospital, 7 days at Rehabilitation Hospital

No adverse effects noted after vaccination. Patient with cardiac history was found unresponsive at 16:45 on 1/6/21. Abnormal breathing patterns, eyes partially closed SPO2 was 41%, pulseless with no cardiac sounds upon auscultation. CPR and pulse was regained and patient was breathing. Patient sent to Hospital ER were she remained in an unstable condition had multiple cardiac arrest and severe bradycardia and in the end the hospital was unable to bring her back.

My Mother was given the Covid Vaccine (1st Dose) on 12/28/2020. Later that night we received a call from the nursing facility that my Mother was having uncontrollable seizures and had to be transported to the nearby hospital. The ER doctor confirmed that my Mother had tested positive to Covid. She was treated for Covid and was on life support. A few days later we received a call that my Mother had a major stroke. She passed away on January 4, 2021

Death; kidney failure (unable to urinate); shortness of breath; required oxygen; A spontaneous report was received from consumer concerning an 87-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, kidney failure and death. The patient's medical history included advanced kidney and heart disease. No relevant concomitant medications were reported. On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 17 Jan 2021, the husband reported that the patient experienced adverse events. Symptoms included shortness of breath and kidney failure (unable to urinate). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. Action taken with mRNA-1273 in response to the events was not applicable. On 20 Jan 2021, the patient died. The cause of death was unknown. Autopsy details were unknown.; Reporter's Comments: This case concerns a 87-year-old, female patient with the medical history of advanced kidney and heart disease, who experienced fatal unexpected event of dyspnea, renal failure and death. The events of dyspnea and renal failure occurred 12 days and the event of death occurred 15 days after the first dose of mRNA-1273 (Lot: unknown). The patient was admitted to the hospital and discharged to hospice. Oxygen was administrated for shortness of breath. The cause of death was unknown. Autopsy details were unknown. Very limited information regarding this event has been provided at this time. Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the history of advanced kidney and heart disease may remain as confounder. Additional information has been requested.; Reported Cause(s) of Death: Unknown cause of death

blood clot in the lungs; UTI; COVID-19; Fatigue; Loss of appetite; A spontaneous report was received from a consumer concerning an 87 years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced blood clot in the lungs/MedDRA PT: pulmonary embolism, loss of appetite/MedDRA PT: appetite lost, UTI/MedDRA PT: urinary tract infection, COVID-19/MedDRA PT: COVID-19, and fatigue/MedDRA PT: fatigue. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first dose of two planned doses of mRNA-1273 (Lot# 041L20A) in left arm (route of administration not provided) on 16 Jan 2021 for prophylaxis of COVID-19 infection. On 17 Jan 2021, the patient experienced fatigue and loss of appetite. On 24 Jan 2021, patient experienced UTI and tested positive for COVID-19. On 31 Jan 2021, the patient was hospitalized and was found to have a blood clot in the lungs. Treatment details were unknown. Action taken with mRNA-1273 was unknown. The outcome of events blood clot in the lungs, loss of appetite, UTI and COVID-19 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.

From CT Scan in ED at 7:40 pm on 1/25/2021 -- There is a large intraparenchymal hemorrhage with Surrounding vasogenic edema within the left occipital lobe. There is additional subdural hemorrhage layering along the left frontal, temporal and parietal convexity which may be decompressing from the area of intraparenchymal hematoma. No visualized intraventricular hemorrhage.There is some trace hemorrhage layering along the left tentorium cerebelli. Severe associated mass effect with left-to-right midline shift of 2.1 cm. There is subfalcine and downward transtentorial herniation with complete effacement of the basilar cisterns. Evaluation of the craniocervical junction is limited due to beam hardening artifact. Near-complete effacement of the left lateral ventricle. No head trauma or fall. Deceased 1/26/2021

Summary - ANAPHYLAXIS. Screened via medical questionnaire with no known hx of anaphylaxis after receiving injection. Less than 10 minutes after receiving injection, pt's son reported to staff that pt was overheated and not feeling well. After receiving ice water, pt became non-responsive to questions and developed tongue swelling, blocked airway and audible wheezing. 0.3mg IM epinephrine injected into L thigh. Pt was laid down in empty exam room. Blood pressure 130/80, pulse 96, temp 96.9. Pt able to sit up, answer questions and breathe comfortably without distress within few minutes of receiving epinephrine. Examined by EMS and declined transportation to ER. Called by physician 4 hours later; pt reported doing well.

DIAGNOSED WITH COVID 1/21/21; RECIEVED BAMLANIVUBAM INFUSION; HOSPITAL ADMISSION 1/23/21 WITH ACUT RESPIRATORY FAILURE DUE TO COVID. INTUBATED X 10 DAYS

Per son and employee, patient's health had been declining since she was hospitalized for a severe UTI in Dec 2020. The evening of 02.09.2021 she vomited, then was found to be unresponsive the morning of 02.10.2021. Patient passed away later in the day on 02.10.2021.

Patient had been slowly declining over the past year due to dementia and age. On the date of her second vaccination, Feb. 17, she was getting around with her walker. On Friday, Feb. 19, she was so weak she was no longer able to walk with her walker, and she declined every day thereafter. On Monday, Feb. 22 she began crying and saying "help me". That lasted approximately a week. her health declined every day until Saturday, March 6, when she passed away at 6:15a.

pt is here to receive 2nd dose of Moderna vacc. & she stated 1st dose caused some soreness to the arm & slight fatigue but she noticed blood upon urination after 1st dose on that afternoon. It was not bright red blood but was dark/brick red color like menstrual break through bleeding she did not notice pain associated with it . She did not notice any more vaginal bleeding after the incident. She reported to her PMI, & PMP OK'ed for her to get 2nd dose but to call him if the same urination occurs @ 2nd dose pt abn on Estradiol(HRT)

Death; unconscious; in and out of consciousness; weak, very weak; blood pressure was very low; little light headed; A spontaneous report was received from consumer concerning a 88 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a little light headed/ dizziness, weak, very weak/asthenia, blood pressure was very low/ hypotension, in and out of consciousness/depressed level of consciousness, unconscious/ loss of consciousness and passed away. The patient's medical history was reported as heart issues. Concomitant medications taken by the patient included levothyroxine, isosorbide, acetylsalicylic acid, metoprolol, furosemide, warfarin, antibiotics. On 3 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 015M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 3 Mar 2021, when the patient got home the night, after getting the shot, patient was a little lightheaded, she seemed to be okay on 04 Mar 2021 and 05 Mar 2021. Patient had complained of being weak and her blood pressure was very low on 08 Mar 2021. She was progressively started getting weaker. On 09 Mar 2021, she was very weak and was in and out of consciousness. Patient was taken to the hospital, and she became unconscious and then passed away. Patient passed away on 09 Mar 2021. The patient died on 09 Mar 2021. The cause of death was unknown. Plans for an autopsy were unknown. Treatment activities for event was not provided. Action taken with mRNA-1273 in response to the events was not applicable. The outcome of events, unconscious, a little light headed, weak, very weak, blood pressure was very low, in and out of consciousness was unknown. The outcome was considered fatal.; Reporter's Comments: This is a case of sudden death in a 88-year-old female patient with a history of heart issues, who died 6 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

Patient received vaccine at 10:18am and then went home with no reaction in the vaccination POD. EMS was called to the patients home shortly before 2:30 that afternoon. When EMS arrived patient was posturing with lower extremities extended in plantar flexion. Last seen normal 30 minutes prior. she was also tachycardic and in respiratory distress with sonorous respirations. Cranial nerve deficit present GCS 3.She was unresponsive and intubated. Airlifted after CT to hospital. She died at 1647 at Hospital from hemorrhagic stroke.

Described patient feeling fine the day after the vaccine (3/4/21), but by 3/5 she wasn't feeling well and was on the couch all day. By 3/8 she couldn't get out of bed, then was subsequently admitted to the hospital. Patient remained in hospital for ~2 weeks before passing away on 3/29/21.

30 hours later , profound sensorineural hearing loss in right ear. Treated by steroid, hearing returned in one week . Black tarry stools INR increased from 2 to 12 ER visit , admitted to hospital on March 23. TIAs

pneumonia, illness; missed her 2nd appointment; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia, illness) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia, illness) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd appointment). At the time of the report, PNEUMONIA (pneumonia, illness) and PRODUCT DOSE OMISSION ISSUE (missed her 2nd appointment) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant meds: H. blood pressure medicines. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Patient presented 3 days after her second DuoNeb vaccine with weakness dizziness chest pain or shortness of breath and was initially diagnosed with a pneumonia by chest x-ray obtained with antibiotics without improvement. Subsequently she was hospitalized and CT of the chest showed left lower lobe segmental pulmonary embolism. The patient never had history of venous thromboembolism in the past. She had weakly positive anticardiolipin antibody of IgG type of unknown significance. She was treated initially with antibiotics but after diagnosis of the blood clot she was started on anticoagulation with apixaban with improvement

Patient admitted 3/28/2021 with severe COVID 19 pneumonia. She progressed to acute respiratory failure and was intubated. During her hospitalization she was diagnosed with acute myeloblastic leukemia. Her family withdrew care and she died on 4/7/2021

Patient was admitted to the hospital approximately 2 days after receiving the Moderna vaccine. She was under Hospice care before receiving the vaccine.

Patient had an undiagnosed/unknown UTI at the time of her second vaccine on 3/2/21. She was admitted to Hospital on 3/3/21 with organ failure; she passed away on 3/5/21. Her cause of death is listed as Sepsis, and UTI. The vaccine was not listed as a cause of death, but might have been a "tipping point" in her inability to recover with antibiotic treatment.

Patient received two dose Moderna series of vaccinations for COVID 19 (1/21/2021 and 2/18/2021). Patient reported to ED feeling weak on 2/20/2021, but was not tested for COVID at that time. Reportedly, patients family were all tested for COVID and were positive on or about 2/21/2021. The patient was later admitted to the hospital on 4/13 with COVID. She subsequently expired on 4/14.

blisters form after she eats and when they pop they bleed for a while; blood blisters in mouth worse; blisters pop and it hurts; rash gotten worse; 45 days between the administration of the 1st dose and 2nd dose; This spontaneous case was reported by a patient and describes the occurrence of HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while) in an 87-year-old female patient who received mRNA-1273 (batch nos. 032M20A and 030L20A) 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 previous medical history was provided). On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 days between the administration of the 1st dose and 2nd dose). On an unknown date, the patient experienced HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while) (seriousness criterion medically significant), ORAL MUCOSAL BLISTERING (blood blisters in mouth worse), PAIN (blisters pop and it hurts) and RASH (rash gotten worse). At the time of the report, HAEMORRHAGE (blisters form after she eats and when they pop they bleed for a while), PAIN (blisters pop and it hurts) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (45 days between the administration of the 1st dose and 2nd dose) outcome was unknown and ORAL MUCOSAL BLISTERING (blood blisters in mouth worse) and RASH (rash gotten worse) had not resolved. No concomitant medications were reported. No treatment information was provided. Company Comment: This case concerns an 87-year-old female who had inappropriate schedule of product administration (Lot # 030L20A), with adverse events of serious unexpected hemorrhage, and nonserious unexpected oral mucosal blistering, pain, and expected rash. Event onset after 1st dose with worsening after 2nd dose mRNA-1273. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-079482 (Patient Link).; Sender's Comments: This case concerns an 87-year-old female who had inappropriate schedule of product administration (Lot # 030L20A), with adverse events of serious unexpected hemorrhage, and nonserious unexpected oral mucosal blistering, pain, and expected rash. Event onset after 1st dose with worsening after 2nd dose mRNA-1273. Events ongoing. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Vomiting and diarrhea starting 4/28/21 (day after vaccine). Came to ED today for these symptoms, feeling weak, had a cardiopulmonary arrest and died.

Patient received Moderna COVID vaccine on 2/1/2021 and 2/22/2021. Pt. presented to Medical center within Health system with weakness and arm and leg swelling on 3/4/2021. Admitted for observation, tested negative for COVID and discharged on 3/5. Pt. presented to Medical Center, also within Health system on 5/2/2021 complaining of SOB. Stated that she has had non-productive cough for months, but felt it had worsened lately. Pt. found to be COVID positive with bilateral infiltrates. Pt. required 6L O2. Pt. was DNRCCA. Pt. not intubated but expired from cardiac arrest/COVID on 5/16/2021.

May 3, 2021, received a call from healthcare provider where the vaccine was given by healthcare provider. COVID 19 Prescreening Form Completed and Vaccine given 4/23/2021. Patient waited 15 minutes post vaccination no reaction. Her family also received a vaccine. Daughter and Son-In Law. Received a call that patient had died on 5/2/2021. Presented to healthcare facility for chest pain according to healthcare provider.

86-year-old woman with a history of COPD who presented with complaints of shortness of breath. She was admitted with an impression of acute on chronic hypoxic respiratory failure secondary to COVID-19 pneumonia. She was initially started on antibiotics which were stopped due to low procalcitonin level and no evidence of bacterial pneumonia. She qualified for remdesivir and finished it. She was also getting Decadron with vitamin C and zinc and bronchodilator. Patient continued to do well and has tolerated Remdesivir well and has finished it. She is back to her baseline oxygen requirements.

Patient had bleeding in to the arm and has a large right shoulder effusion that needed ED visit and now referred to orthopedic to drain.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination for new onset atrial fibrillation.

Death 5/5/2021 Causes of death listed on death certificate: 1) acute bleeding 2) rupture of internal iliac aneurysm

Blood clots in her lungs; COVID-19; Sores in mouth; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (Blood clots in her lungs) in an 87-year-old female 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 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (Blood clots in her lungs) (seriousness criterion medically significant), COVID-19 (COVID-19), ORAL PAIN (Sores in mouth) and PYREXIA (Fever). At the time of the report, PULMONARY EMBOLISM (Blood clots in her lungs) outcome was unknown and COVID-19 (COVID-19), ORAL PAIN (Sores in mouth) and PYREXIA (Fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: increased (High) 103. On an unknown date, COVID-19: positive (Positive) Positive. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. This case concerns an 87-year-old female with a serious unexpected event of pulmonary embolism, and nonserious COVID-19, oral pain, and pyrexia. Event onset with unknown latency after second dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-JUL-2021 is a TCR and it is significant. Event outcome updated, Event is added2nd dose information is added.; Sender's Comments: This case concerns an 87-year-old female with a serious unexpected event of pulmonary embolism, and nonserious COVID-19, oral pain, and pyrexia. Event onset with unknown latency after second dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Within 1/2 hour of vaccination the patient was dizzy and was having a hard time remaining upright, additionally the patient was less alert and oriented. Patient was observed for a few minutes and then ambulance was called. Patient was transported via EMS within an hour of being vaccinated to local hospital. Patient was found to have has had major stroke and is presently in ICU and not expected to make it.

Resident passed away unexpectedly on 01/19/21 after developing acute hypoxic respiratory failure on morning of 01/19/21. She was transferred to hospital via EMS where she was intubated, coded, and ultimately expired with uncertain underlying cause, potentially ACS.

On 2/1/2021, the patients daughter, who claims is a nurse, reported this incident to me. She stated that the evening after the patient received the vaccine, she felt some mild injection site pain. The morning after, the patient reported severe abdominal pain, diarrhea and vomiting. The patients daughter then called her physician to report these symptoms and attributed them as an adverse reaction to the vaccine at that time. These symptoms were intermittent for one week and no other adverse reactions were noted. In the early morning hours of 1/27/2021, the patient was toileting and had expired while doing so. An ambulance was called and cause of death was not found. An autopsy was not performed.

2/2/21-1000-patient presented to the local emergency room with complains of fever, shortness of breath and decreased oxygen sats. temp 101.7, pulse 102, respirations 36, BP 141/92, oxygen 94%. Lung sounds crackles bilaterally with rhonchi on the left. patient worked up for sepsis, CXR shows mild atelectasis. blood pressure dropped, and continued to drop through treatment requiring levophed drop to be initiated. Patient POA determined that this would not be her sister's wishes and made the decision to make patient comfort care status. 2/3/21- patient lethargic throughout night. 0640-patient demise.

EARLY SUNDAY MORNING THE PATIENT BEGAN VOMITTING AND SHORT OF BREATH AND CHEST AND BACK PAIN. SHE CODED WHEN SHE GOT IN THE ER AND LATER PASSED AWAY THE MONDAY. DIAGNOSIS WAS PNEUMONIA AND HEART FAILURE PER STEP DAUGHTER.

Toileting and had expired while doing so; Severe abdominal pain; Diarrhea; Vomiting; Mild injection site pain; A spontaneous report was received from a healthcare professional concerning an 88-year-old , female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, toileting and had expired while doing so (death), mild injection site pain, severe abdominal pain, diarrhea, and vomiting. The patient's medical history was not provided. No relevant concomitant medications were reported. On 20 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 20 Jan 2021, the patient felt mild pain at the injection site after receiving the vaccine. On 21 Jan 2021, the patient reported severe abdominal pain, diarrhea and vomiting. These symptoms were intermittent for a week and no other adverse events were noted. On 27 Jan 2021, the patient passed away while toileting. Action taken with mRNA-1273 in response to the events was not applicable. The patient died on 27 Jan 2021. The cause of death was unknown. An autopsy was not performed.; Reporter's Comments: The gastrointestinal events were consistent with increased risk associate with elderly age of patient. The cause of death was unknown. Autopsy was not performed. Very limited information regarding the events is available at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reported Cause(s) of Death: unknown cause of death

Deep vein thrombosis (DVT) of left lower extremity She reported swelling of her left leg and was seen at Family Medicine Urgent Care on 2/19/2021 and was diagnoses with a thrombosis of the left popliteal vein. She was treated with Xarelto for anticoagulation and compression stockings. Her treatment course was uncomplicated when I saw the patient at follow up and was made aware of her condition at her appointment with me on 3/1/2021.

Patient dropped dead 24 hours after receiving the vaccine. The vaccine killed her. She received the vaccine 2/16/2021 and died 2/17/2021

Patient expired 2 days after receiving the vaccination. Patient had other signs of deterioration over the course of the previous month with worsening edema and difficulty breathing. Unlikely to be related according to our assessments, but wanted to err on the side of caution.

Patient received the vaccine on the evening of 03-09-2021. R.N. states she was "fine " at 440 AM bed check. At 0830 03-10-2021 patient was found slumped over on her bathroom toilet having expired sometime between 440AM and 830 AM

He went to the hospital for cardiovascular problems and cholecystitis and was under treatment after the first dose. 2/26/2021 at around 11:00 pm she was complaining of high blood pressure, uncontrolled vital signs, uncontrolled sugar, at 6:00 am she has passed away. They certify respiratory failure.

5 days post-vaccination (1st dose of Moderna), patient started developing lethargy, and difficulty swallowing. 7 days post-vaccination patient looked "ashen". 12 days after vaccination patient was improving, but 14 days after vaccination patient was found to have (on lab work) critical hypernatremia (sodium level of 180 mmol/L), patient was re-referred back to hospice, and 17 days post-vaccination patient died.

Passed away; so weak she was no longer able to use her walker and declined steadily each daythereafter; A spontaneous report was received from a consumer concerning a 88-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced being so weak she was no longer able to use her walker and declined steadily each day thereafter (asthenia) and passed away (death). The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) on an unspecified date. On an unspecified date, approximately 15 days prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, two days after their second dose of the vaccine, the patient was so weak that she was no longer able to use her walker and declined steadily each day thereafter. On an unspecified date, 17 days after their second dose of the vaccine, the patient passed away. Treatment information was not provided. The outcome of the event, asthenia, was unknown. The outcome of the event, passed away (death), was fatal. The cause of death was reported as unknown. Plans for an autopsy were not provided.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

She got the vaccine, everything was fine, they warned her about being sick. She did not have any reaction at all until she woke up 13 days later on 3/5/2021 and her left eye was blind. She had some sort of blob that changes colors and moves around. It sometimes is orange. She knew she did not have macular degeneration as it centers it. Sometimes it sparkles and has grain to it. He said that she had an arterial blood, and that leaked from the carotid artery into the eye has not completely sealed off. She can see out of the right eye perfectly, but she cannot see a little out of the left eye. If she's watching the TV she can see the top of the newscasters hair, but she cannot see anything below that. Her vision is upward either, can see out of either side, but cannot below horizontal down. He told her that it was basically a stroke that didn't reach her brain and went to her eye. He told her to return to see him (ophthalmologist) on 5/18/21 at 10:00 AM. She also is to see her PCP on 5/20/21.

Patient presented to ED after abnormal labs from PCP. Platelets in ED = 2. Hgb 8.5. Possible rectal bleed at home, some bruising. Admitted and treated with dexamethasone 40mg PO daily, IVIG, platelet transfusions. EGD showed gastritis. Per hematologist "severe thrombocytopenia of acute on set after recent COVID-19 vaccination, which is likely due to ITP which has been previously reported to be associated with vaccination"

3/26/21 ER to Inpt Admission: Patient was admitted to the hospital for comfort measures after patient suffered MI and did not want any life-prolonging therapies. Patient was started on comfort medications and symptoms were monitored closely. The patient passed peacefully before she could be fully assessed

Itching rash hive covering body, back, legs arms stomach breasts, still experiencing symptoms of hives for 8 plus days Treatment calamine lotion, and Zertec Also experienced two TIAs after both shots

COVID+ Narrative: Patient administered COVID-19 vaccine (Moderna) dose #1 2/18/2021. On 3/17/2021, Patient developed a cough and fever and was brought by ambulance to tertiary care facility with diagnosis of COVID-19. Patient on BIPAP as of 3/22/2021. On 3/26/2021, Patient was initiated on morphine drip for comfort care and BIPAP was discontinued. Patient passed away 3/26/2021.

Fell three times in home on May 15th. Was taken to Emergency Room by Ambulance. In hospital for two days and then released. Ordered Home Physical Therapy and Walker. Cleaned the wounds from the fall. Difficulty breathing and swallowing. Released and told to schedule echocardiogram with Primary Care to follow up on heart's pumping function. Still had difficulty breathing when home and walking. Started diarrhea on Monday 22 had appointment on the 24th with doctor, but died at home before she could make appointment.

Adverse Event: Death Treatment: Rest & Cold Pack On Arm At Injection Site (Not Effective) Symptoms: Arm Pain At Injection Site, Diarrhea, Fatigue, Dizziness, Low Appetite, Light Headedness, Fever & Chills

Fatigue, dizziness, weakness. Issues with breathing caused hospitalization 3 days after shot. Blood clot located in lung and 2 in right leg. Hospital stay 11 days, step down facility roughly 2 weeks, PT/OT upon arrival home.

Stroke; Unconscious; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and LOSS OF CONSCIOUSNESS (Unconscious) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 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 CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant) and LOSS OF CONSCIOUSNESS (Unconscious) (seriousness criteria hospitalization and medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) and LOSS OF CONSCIOUSNESS (Unconscious) outcome was unknown. Concomitant medications were not reported. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Resident was in Hospice and was presenting with an infection. On the morning of 3/14/2021 in the round of caregivers they found him without vital signs.

per patient's family report: patient complained severe leg pain a few days before she was found dead in her apartment on 2/18./2021. It was likely she had sudden death as she did not activate her neck alert or call button in her apartment. Family request we report the incident, she was last seen on 12/15/2020 for pacemaker check, she also had medical message communication with me on 2/8 to request refill on her Percocet that she takes occ for her joint pain only at bed time. family suspect possible DVT with PE after getting more informed about vaccine side effects. however no autopsy was done.

Developed shortness of breath within 12hrs of 2nd Moderna dose along with heart palpitations and nausea. Admitted to hospital 3 days after shot and quickly developed pnemonia and died 4 days later after blood O2 fell below 80%. Had periods of mild improvements followed by more severe declines each time.

non-provoked DVT and acute pulmonary embolism on 05/03/2021. She has no history of such diagnosis and no risk factors otherwise for DVT.