Moderna

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

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

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

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

Death Narrative: Patient had Parkinson's and advanced Dementia. He was on a palliative care unit and a DNR.

Patient presented to emergency room on 2/1/2021 with a chief complaint of having a chronic headache and fatigue following receipt of the Moderna vaccine 10 days prior. Following examination by the physician, the patient was diagnosed with an acute subdural hematoma. The patient subsequently underwent decompressive surgery, however demonstrated worsening neurologic status over the next several days and ultimately expired on 2/4/2021.

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

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

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

Received 2nd dose of Moderna on 1/26/21 and was admitted to the hospital (IVCH) for septic right knee on 2/17/2021

Patient had the Moderna vaccine 1st dose roughly 5 days ago. Overnight, his wife woke to him having an episode of what appeared to be a tonic clonic seizure around 5 am on 2/23/21, followed by a period of disorientation and unresponsiveness consistent with a post ictal state. The patient has no history of seizures. It is unclear if this had anything to do with the Moderna vaccine, but I am reporting it due to the timing of the episode in conjunction with the vaccine.

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

pneumonia; Tired; Achy; Muscle weakness in left arm; Arm was swollen; This spontaneous report was received on 10FEB2021 from a consumer which refers to a 76-year-old male patient who received the Moderna COVID-19 (mRNA-1273) Vaccine and experienced injection arm swelling, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and pneumonia. The patient's medical history was not provided. Concomitant medications were not reported. On 15JAN2021, prior to the onset of the symptoms, the patient received his first of two planned doses of mRNA-1273 intramuscularly (Lot number: 026L20A). On 16JAN2021, the patient noted a start date for Pneumonia. On 10FEB2021, the patient called the medical information call center and reported, "he is on antibiotics for pneumonia. His 2nd question is can he delay the 2nd dose since he is suffering from pneumonia. Patient was administered 1st dose of vaccine on 15/Jan/2021 in his left non dominant arm. The lot# was provided, but expiration date is unknown. Patient experienced some expected side effects, which he is not concerned about". The event(s) were arm swollen, tired, achy, lingering shortness of breath, muscle weakness in the injection arm, and tested positive for pneumonia 1 day after receiving the vaccine. The action taken for Moderna COVID-19 (mRNA-1273) Vaccine was reported by the patient as Tylenol. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The outcome of the events was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start of the events of fatigue, arm swelling, myalgia, muscle weakness, a causal relationship cannot be excluded. Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of Pneumonia is assessed as unlikely related. Further information has been requested.

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

Patient started to not feel well on 2/21/2021. Symptoms progressed throughout the week. Patient was seen for a clinic appointment 2/26 and was then admitted to the hospital. Patient complains of generalized weakness, body aches, fever, chills, cough and increased shortness of breath at rest and with activity. He was diagnosed with Pneumonia due to COVID-19 infection and started on oxygen, dexamethasone and remdesivir.

History of terminal cancer, entered hospice care 1/2021, expired 2/28/2021. No reported adverse events from patient or family after receiving vaccine

Department was notified patient passed away on call back to confirm 2 dose appointment scheduled on February 27, 2021 to receive the COVID-19 vaccine. Department unaware of patients cause of death.

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

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

Death Narrative: Patient passed away on 3-2-21, patient received the vaccine on 2-24-21. Patient was obese and had several co-morbid conditions.

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

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

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

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

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

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

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

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

Pt diagnosed with COVID-19 despite 2 COVID vaccines (first given 1/15/2021. Pt developed respiratory symptoms, including dyspnea, which progressed over 3.5 weeks and then systemic symptoms of myalgias, malaise. He was admitted 3/21/2021 and had positive NP swab for SARS-CoV-2 x 2. He required admission to ICU and died of respiratory failure on 3/28/2021.

Respiratory failure; Messed up with medication; A spontaneous report was received from a Consumer concerning himself, a 76-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced respiratory failure and messed up with medication/ Medication error. The patient's medical history was not reported. Concomitant medication was not reported. On 24 Feb 2021, the patient received their first of two planned doses of mRNA-1273 mRNA-1273 (Lot number: 001A21A) intramuscularly for prophylaxis of COVID-19 infection. On 24 Feb 2021, after receiving mRNA-1273, the patient experienced respiratory failure and messed up with medication. He was hospitalized in ICU from 27 Feb 2021 till 08 Mar 2021 due to his medication messed up and had a respiratory failure. Action taken with mRNA-1273 in response to the events was not reported. The events respiratory failure and messed up with medication were reported considered resolved on 08 Mar 2021.; Reporter's Comments: There is insufficient details to assess the event of medication error as the specific drug and error was not ddescribed as well as the condition leading to error. In addition, limited information has been provide about the event of respiratory failure but for the fact that it was due to medication error. Hence assessed as unlikely due to mRNA-1273

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

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

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

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

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

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

On 3/25/2021 POC alleges that the resident begin to develop fever and urine infection. He was transferred to the hospital on 3/26/2021 where he had white secretions in his mouth. On 3/28/2021 he died in the hospital from respiratory cardio failure.

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

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

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

Pt received his 2nd moderna covid vaccine on 4/16/2021. admitted on 4/22/2021 from his long term care facility due to concerns for a chf exacerbation and acute on chronic respiratory failure. Pt was given IV Lasix. chest x ray showed mild pulm vascular congestion. there was no hypoxia, tachycardia and pt was on eliquis so pe was felt to not be a possibility. abg showed acute respiratory acidosis with hypercapnia which improved with bipap administration. His troponins and ekg were negative. vitals on arrival were stable. He was admitted. Labs were otherwise unremarkable. Pt began to have pauses on telemetry and was last seen awake and alert but when nursing staff went back to check on him minutes later he was found deceased

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

death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient has a PMH significant for T2DM, CAD, hyperlipidemia, Parkinson's disease, HTN, Diffuse interstitial Pulmonary fibrosis. No cause of death listed or any notation. Patient deceased on 4/10/202. 2nd dose of Pfizer given 3/13

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

death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. PMH significant for amyotrophic lateral sclerosis, AF, HTN. No notation regarding death, or cause of death. Patient deceased 4.16.21

Hand tremors; Chills; Pneumonia; Sore arm; Fever with fluctuation in temperatures; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Pneumonia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included LOSARTAN POTASSIUM, HYDROCHLOROTHIAZIDE, FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF), MONTELUKAST SODIUM (SINGULAIR), PYRIDOSTIGMINE BROMIDE (MESTINON), MIRABEGRON, TAMSULOSIN HCL and AMOXICILLIN, CLAVULANIC ACID (AUGMENTIN [AMOXICILLIN;CLAVULANIC ACID]) for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PYREXIA (Fever with fluctuation in temperatures). On 04-Mar-2021, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). On an unknown date, the patient experienced TREMOR (Hand tremors) and CHILLS (Chills). At the time of the report, PNEUMONIA (Pneumonia), TREMOR (Hand tremors), PYREXIA (Fever with fluctuation in temperatures) and CHILLS (Chills) had resolved and PAIN IN EXTREMITY (Sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 101.7 (Inconclusive) 101.7 degrees F.. On 24-Feb-2021, Body temperature: 101.7 to 103.9 degrees f (Inconclusive) 101.7 to 103.9 degrees F. On 26-Feb-2021, Body temperature: 97.9 to 99.8 degrees f (Inconclusive) 97.9 to 99.8 degrees F. On 27-Feb-2021, Body temperature: 97.5 - 99.6 degrees f (Inconclusive) 97.5 - 99.6 degrees F.. On 28-Feb-2021, Body temperature: 104.4 - 103.8 degrees f (Inconclusive) temperature range was 97.3 - 99.7 degrees F.. In 2021, Chest X-ray: pneumonia (abnormal) Pneumonia was confirmed. Treatment for the event included paracetamol. Pneumonia is of an infective origin, hence assessed as not causally associated with mRNA-1273 administration based on the known profile of the product. However, based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the other reported events, a causal relationship cannot be excluded. Pyrexia and chills are consistent with the product known safety profile. This case was linked to MOD-2021-031492 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Medically confirmed changed. Added Lab data.; Sender's Comments: Pneumonia is of an infective origin, hence assessed as not causally associated with mRNA-1273 administration based on the known profile of the product. However, based on the information provided which includes a temporal association between the use of mRNA-1273 vaccine and onset of the other reported events, a causal relationship cannot be excluded. Pyrexia and chills are consistent with the product known safety profile.

Death; This case was received via FDA VAERS on 04-May-2021 and was forwarded to Moderna on 04-May-2021. This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of DEATH (Death) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination. No Medical History information was reported. On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 01-Apr-2021 The patient died on 01-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Symptom Text : Death reported to Health department from Medical Examiner office, no further details provided Company comment:This is a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) who died 3 days after the second dose of vaccine. No Med history and no concomitant medication were provided. Very limited information has been reported at this time. Further information is not expected.; Sender's Comments: This is a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) who died 3 days after the second dose of vaccine. No Med hx and no conmeds were provided. Very limited information has been reported at this time. Further information is not expected.; Reported Cause(s) of Death: Unknown cause of death

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

had severe headaches that started a week after his 2nd covid shot., he was seen by NP on 2/25/21, was instructed to take ibuprofen short term, labs were drawn and were normal. On 3/8/21 suffered tonic clonic seizures, was unresponsive and taken to ER by EMS. remained unresponsive following the seizures and was placed on hospice care and died on 3/12/21.

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

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

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

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

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

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

In case it was pneumonia; Not feeling good since the vaccine; severe dizziness; vertigo; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (In case it was pneumonia) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. no medical history was reported by reporter. Concomitant products included OMEPRAZOLE, METOPROLOL TARTRATE, LOVASTATIN, CLOPIDOGREL, FINASTERIDE, HYDROCHLOROTHIAZIDE (THIAZIDE), MONTELUKAST, FUROSEMIDE, FELODIPINE, BUSPIRONE, SPIRONOLACTONE, DOXAZOSIN MESYLATE, LABETALOL, ASA and IRON for an unknown indication. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced DIZZINESS (severe dizziness) and VERTIGO (vertigo). On an unknown date, the patient experienced PNEUMONIA (In case it was pneumonia) (seriousness criterion medically significant) and FEELING ABNORMAL (Not feeling good since the vaccine). At the time of the report, PNEUMONIA (In case it was pneumonia), DIZZINESS (severe dizziness), VERTIGO (vertigo) and FEELING ABNORMAL (Not feeling good since the vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-May-2021, X-ray: inconclusive not able to determine if he had pneumonia. On an unknown date, SARS-CoV-2 test: negative tested twice for Covid-19 with Negative results both times. On 23-APR-2021 with in one hour of vaccination the patient began to experience severe dizziness and vertigo. The patient did not receive any treatment medications for the reported events. The patient reported that he had not been feeling very good since the vaccine, stating "I don't think this is a coincidence me getting sick after I got the vaccine". He was evaluated at the Emergency Room this past Sunday on 5/23/2021, because he still wasn't feeling very good. He states he had an X-ray done and was they were not able to determine if he had pneumonia, however they treated him with IV antibiotics in case it was pneumonia. He reports feeling "a little better" since the IV antibiotics. Action taken with mRNA-1273 in response to the events was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: TCR: AE details. Case upgraded to serious. additional adverse events were updated and narrative information was updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

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

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

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

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

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

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

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

Beginning of a blood clot in the middle of the left calf muscle; Eye lids right on the edge bilaterally and it is upper and lower eye lids has an irritation; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Beginning of a blood clot in the middle of the left calf muscle) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included COPD and Asthma. Concomitant products included FEXOFENADINE for Allergy, ALBUTEROL SULFATE for Asthma, PARACETAMOL (TYLENOL) for Migraine, TIZANIDINE, ASPIRIN [ACETYLSALICYLIC ACID], POTASSIUM CHLORIDE, VITAMIN C [ASCORBIC ACID], CHONDROITIN SULFATE, GLUCOSAMINE (GLUCOSAMINE CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]), ACETAMINOPHEN, MULTIVITAMINS [VITAMINS NOS], MINERALS NOS, COLECALCIFEROL (VITAMIN D3), GABAPENTIN, PRIMIDONE, RANITIDINE, CLOPIDOGREL, BUTALBITAL, CAFFEINE, MELATONIN, TERAZOSIN, ZINC, FINASTERIDE, MONTELUKAST, LUBIPROSTONE (AMITIZA), TAMSULOSIN, SIMVASTATIN, ATENOLOL, CHLORTALIDONE, PANTOPRAZOLE, MIRABEGRON (MYRBETRIQ), POLYETHYLENE GLYCOL [MACROGOL], FENOFIBRATE, SODIUM HYDROXIDE, MAGNESIUM HYDROXIDE (MILK OF MAGNESIA), SULFADIAZINE SILVER (SILVER SULFADIAZINE) and FLUTICASONE for an unknown indication. On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Beginning of a blood clot in the middle of the left calf muscle) (seriousness criterion medically significant), EYE IRRITATION (Eye lids right on the edge bilaterally and it is upper and lower eye lids has an irritation) and DIARRHOEA (Diarrhea). At the time of the report, THROMBOSIS (Beginning of a blood clot in the middle of the left calf muscle), EYE IRRITATION (Eye lids right on the edge bilaterally and it is upper and lower eye lids has an irritation) and DIARRHOEA (Diarrhea) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient normally stays with diarrhea because takes double of the normal amount of the polyethylene glycol daily, takes 17 grams twice a day. And there is the beginning of a blood clot in the middle of the left calf muscle which may be related to his COPD, but he had to see a doctor about it. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Limited information regarding the event Thrombosis have been provided. Further information has been request. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. This case was linked to MOD-2021-163528 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. Limited information regarding the event Thrombosis have been provided. Further information has been request. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events.

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

Developed hives; Extremely itchy; It worsened and spread over the entire body; Rash on the shoulder near the injection site; Anaphylactic reaction; Red Bumps; This spontaneous case was reported by a consumer and describes the occurrence of ANAPHYLACTIC REACTION (Anaphylactic reaction) in a 76-year-old male 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. No Medical History information was reported. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced RASH MACULAR (Red Bumps). On an unknown date, the patient experienced ANAPHYLACTIC REACTION (Anaphylactic reaction) (seriousness criterion medically significant), URTICARIA (Developed hives), PRURITUS (Extremely itchy), RASH (It worsened and spread over the entire body) and VACCINATION SITE RASH (Rash on the shoulder near the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Red blotches, at a dose of 1 dosage form. At the time of the report, ANAPHYLACTIC REACTION (Anaphylactic reaction), RASH MACULAR (Red Bumps), URTICARIA (Developed hives), PRURITUS (Extremely itchy), RASH (It worsened and spread over the entire body) and VACCINATION SITE RASH (Rash on the shoulder near the injection site) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date. According to the report it started as a rash on the shoulder near the injection site in the evening of the 1st dose. There were tiny dots which were extremely itchy. Skin like scabs would fall away on scratching them. The next day, it worsened and spread over the entire body. Patient called an ER doctor and he was told that he was having an anaphylactic reaction to the propylene glycol component of the vaccine. He then visited a dermatologist and received a steroid shot and he was put into an oral steroid regimen where the dose tapers every day. These calmed the symptoms down but by the 10th day though they were still visible. It took several months for the events to resolve. He was advised not to take the 2nd dose of any COVID-19 vaccine. No relevant concomitant medication information 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 14-Jul-2021: Follow up information was received on 14 Jul 2021 as a Telephone Contact Report wherein events anaphylactic reaction, pruritic, injection site rash, urticaria, rash were added. Event outcome updated as recovered. Action taken updated to withdrawn. This case was upgraded to serious as event anaphylactic reaction was added.; 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

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

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

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

On 1/20/21 the staff observed resident to be more restless constantly moving his legs. He had a decrease in his appetite and fluid intake and required assistance for consumption. His oxygen sats dropped to 89% on room air and was given oxygen at 2L. On 1/21/2021 the Resident observed moving restlessly, opened his eyes when this writer called his name, murmuring incoherent words, words were unclear, was observed taking off his Foley, attempting to grab something, dropped his hands and legs and at the same time restless. This writer was unable to auscultate lungs or heart, resident was moving uncontrollable. Resident positioned safely in bed. VS revealed high BP 147/101. MD ordered transfer to hospital. Resident was treated in the hospital for acute encephalopathy, sepsis with tachycardia and tachypenia and hypoxia.

Patient developed SOB but reported good O2Sats. Instructed on going to ER if worsening symptoms. Patient eventually expired on 1/22/21

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

Feeling normal before the vaccine, with exception of slight cough that Dr said was due to allergies. But then a fever, chills and aches the day after vaccine. Two days after, still febrile and feeling worse and experiencing shortness of breath and lightheadedness. Fatigue, fever and lightheadedness continue for three more days. On the 6th day post-vaccine, taken to ER and admitted to hospital with a pneumonia and blood counts dangerously low. Received 3 blood transfusions and is receiving 2 different IV antibiotics to treat pneumonia. Still in hospital and waiting to see how blood counts go. I can?t say the vaccine CAUSED this, but it all happened rapidly, immediately following the vaccine.

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

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

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

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

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

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

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

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

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

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

Pneumonia; A spontaneous report was received from a physician concerning a 78 years-old, male patient, who received Moderna's COVID-19 Vaccine and who experienced pneumonia. The patient's medical history included chronic obstructive pulmonary disease (COPD) and pulmonary fibrosis. Products known to have been used by the patient, within two weeks prior to the event, included umeclidinium bromide/ vilanterol trifenatate, irbesartan, amlodipine besilate, metoprolol, glipizide, metformin, omeprazole, magnesium, and omega 3. The patient received their first of two planned doses of mRNA-1273 intramuscularly on 22 Jan 2021 for the prophylaxis of COVID-19 infection. On 22 Jan 2021 within a few hours of first dose, the patient developed fever, chills, weakness, and productive cough. On 24 Jan 2021, the patient was admitted to hospital due to oxygen levels in the 60s with productive cough, yellow sputum, and short of breath. He was diagnosed with pneumonia. During hospitalization, the patient had two negative PCR COVID-19 tests. Treatment information was not provided. The second dose of mRNA-1273 was discontinued in response to the events. The outcome of 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 onset date of the event, a causal relationship cannot be excluded. Patient's medical history of COPD and pulmonary fibrosis may have been contributory.

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

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

Patient admitted to the hospital the day after receiving a COVID vaccine x 5 days. Patient passed away on 2/23/2021.

2/24/2021 admitted to hospital with hypoxia, lethargy, rash, altered mental status with HA. Altered mental status with HA, could be due to metabolic encephalopathy and reaction to COVID-19 vaccine. Will check ABG, CT head. Hold gabapentin. Check depakote level. Rash, likely due to allergic reaction to COVID-19 vaccine, hx of reaction to first COVID-19 vaccine with fever needing hospitalization. Start patient on Solu-Medrol and Pepcid. Benadryl p.r.n. Suspected right lower extremity cellulitis, start patient on Ancef. Check MRSA, will rule out right DVT Abn CXR, Bilateral LE edema, CXR seems stable to me, clinically no pneumonia. He does not have "hypoxia" when I was in room, however assisted living reporte 2/24/2021 admitted to hospital with hypoxia, lethargy, rash, altered mental status with HA. Altered mental status with HA, could be due to metabolic encephalopathy and reaction to COVID-19 vaccine. Will check ABG, CT head. Hold gabapentin. Check depakote level. Rash, likely due to allergic reaction to COVID-19 vaccine, hx of reaction to first COVID-19 vaccine with fever needing hospitalization. Start patient on Solu-Medrol and Pepcid. Benadryl p.r.n. Suspected right lower extremity cellulitis, start patient on Ancef. Check MRSA, will rule out right DVT Abn CXR, Bilateral LE edema, CXR seems stable to me, clinically no pneumonia. He does not have "hypoxia" when I was in room, however assisted living reported he was hypoxic this AM, wife said he was wheezy on Sunday could be due to acute on chronic diastolic congestive heart failure, IV Lasix x1. reeval in AM. Echo TTE is pending Abdominal pain and distension, CT abdomen without contrast to rule out other etiology that can cause altered mental status Hx of COVID-19 pneumonia, history of CVA with dense right hemiplegia and expressive aphasia, chronic atrial fibrillation, depression, Will reorder home meds after pharmacist reconciles medication list Generalized weakness, PT/OT DVT prophylaxis warfarin and SCD

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

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

Feeling of impending doom. Felt like I was going to die. Symptoms of Anaphylaxis but did know that was what it was. Failed to call paramedics which I should have . Kept getting worse all night and the onset of vomiting, diarrhea, fever, which lasted three days.

I'm still not sure which COVID19 vaccine my dad received (It made me fill it out--I'm not sure if he got Moderna or Pfizer). Nursing home would know. He received his 2nd shot on Jan 19. On Feb 17 all was fine and they were planning on getting him crowns at the dentist. On Feb. 19 everything went poorly. He started to suddenly have seizures and was not responsive. When I arrived on Feb 21 he didn't say much and had seizures that night. On Feb 22, he responded a little bit and had a big black eye from a seizure the night before. On Feb 22 he had at least 4 seizures and he passed that afternoon around 1:20 pm

Spouse of an existing client signed up for a COVID-19 vaccination and received his first injection of Moderna on 03/07/21 by ARNP. He denied any symptoms of illness, including COVID-19, on the vaccination date. He was educated re: possible side effects and adverse effects and was asked to report any such effects; no interim contact received. This provider's office called the existing client on 03/15/21 with a routine matter and was advised that this individual had passed away the preceding day. This provider spoke to the existing client, who reported that the cause of death is unknown. The existing client did not believe that her spouse's death and the vaccination were related. She was asked to notify this provider if any further information is discovered and agreed to do so.

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

death Narrative: Pt received 1st moderna covid vaccine 2/12/2021 and passed away of unknown causes 2/12/2021 Pt 76 year old with AAA,HTN,CKD,COPD

This patient was on hospice, we are reporting this to VAERS at the Medical Directors request d/t patient's death within 48 hours of the second dose vaccine. The death occurred the morning following his second dose of the Moderna COVID-19 Vaccination, vaccine received on 03/11/21 and patient date of death 03/12/21 at 9:41 am. This was a hospice patient with a terminal dx of CKD. This is being reported at the request of the Medical Director for the hospice team, d/t the patient's death occurred within 48 hours of receiving the second dose of this vaccine. The nurse case manager stated the pt was declining as they were on hospice for a terminal condition and had co-morbidities, Pt did show more decline after receiving COVID-19 vaccination and patient passed away within 48 hours of receiving second vaccination dose.

DEATH Narrative: Patient passed away approximately 1 month after receiving first COVID-19 vaccination. No report of a significant reaction to this vaccine, so unlikely a correlation.

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

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

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

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

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

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

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

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

pneumonia; A spontaneous report was received from consumer, who is 76-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced pneumonia. The patient's medical history was not provided. No relevant Concomitant medications were reported. On 20-FEB-2021, prior to the onset of the events, the patient received their first dose of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 15-mar-2021 the patient was diagnosed with pneumonia by primary physician. The event is considered as medically significant. Treatment medication included Levaquin. Action taken with mRNA-1273 in response to the events was unknown The event pneumonia was not recovered .; 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. However, patient's advance age may remain a risk factor. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, patient's advance age may remain a risk factor. Further information has been requested.

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

patient was hospitalized for weakness, dehydration, rhabdo, arf, dizziness-low probability of it being the vaccine

Grand Mal Seizure, called 9ll, went to hospital,took mri and cat scan. Appointment with neurologist on going. Meds perscribed.

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

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

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

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

He got the vaccine, and didn't have any real reaction, anything unpleasant, he had a numb lip and 2 fingers were numb. He called his doctor and she told him to go to the ER, which he did at Hospital. They did a CAT scan of his brain. They tried to do an MRI and they pushed his head against the machine as his back is curved and he stopped breathing. They had given him 2 narcotics for anxiety before the scan. He was then transferred to Hospital in . He saw Cardiophysiologist/IM and he found that he had a blood clot (? where), and they inserted a pacemaker through his groin as his pulse dropped to 40 BPM. He was hospitalized for 7 days, and discharged him with instructions on what he is able to do. They started him on new blood pressure medicines for his kidney's. On 3/26/21, lot# 028A21A. He subsequently had the 2nd vaccine, and all liquids emptied from his body (vomiting and diarrhea), at the same time, and then he was fine once everything settled down which lasted for about 3-4 minutes and then he was fine.

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

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

Was informed at the time the client was to be seen for booster dose of COVID vaccine that he had recently passed away. Unable to contact family for more information.

On 4/16/2021 I received a phone call from public health informing us that the patient died on 3/31/2021.

Patient received second dose of COVID-19 vaccine on 3/22/2021. Patient presented to ED on 03/29/2021 at 7:45AM complaining of dyspnea on exertion for 1 week since COVID-19 vaccine. Patient also complains of R lower ribcage pain on inspiration for 3 days. Patient became unresponsive and was revived twice. Patient became unresponsive a third time and could not be revived.

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

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

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

Veins was outside and sore; really big and sore red area; really big and sore red area; all the veins in his R leg was protuberate; two blood clot; DGThrombosis; Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (two blood clot) and THROMBOSIS (DGThrombosis) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Leg injury (severe damage to right leg, hit by "protellier" small airplane.) in 1977, Surgery ("many surgeries") and Clot blood. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced MALAISE (Felt terrible). On 13-Mar-2021, the patient experienced THROMBOSIS (two blood clot) (seriousness criterion medically significant), THROMBOSIS (DGThrombosis) (seriousness criterion medically significant), VASCULAR PAIN (Veins was outside and sore), ERYTHEMA (really big and sore red area), PAIN IN EXTREMITY (really big and sore red area) and VEIN DISORDER (all the veins in his R leg was protuberate). At the time of the report, THROMBOSIS (two blood clot), THROMBOSIS (DGThrombosis), MALAISE (Felt terrible), VASCULAR PAIN (Veins was outside and sore), ERYTHEMA (really big and sore red area), PAIN IN EXTREMITY (really big and sore red area) and VEIN DISORDER (all the veins in his R leg was protuberate) outcome was unknown. Not Provided Concomitant medication included unspecified statin for high cholesterol. The patient reported that he is retired. He reported that his leg is functioning well, he has only one of the three arteries in the legs and many damaged veins. Treatment medication included Seroto to treat the blood clots. Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. This case was linked to MODERNATX, INC.-MOD-2021-077978 (E2B Linked Report).; Sender's Comments: Based on the information provided which includes a strong temporal association between the use of mRNA-1273 vaccine and onset of the reported events, a causal relationship cannot be excluded. MODERNATX, INC.-MOD-2021-077978:

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

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

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

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

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

This 77 year old male received the Covid shot on 2/22/21 and went to the ED and admitted on 4/28/21 with the diagnoses listed below and died on 5/5/21. cause of death unknown at time of report

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

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

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

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

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

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

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

Patient was hospitalized due to pneumonia; Urinary track infection; Patient tested positive for covid at the hospital with a rapid test; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Patient was hospitalized due to pneumonia) and URINARY TRACT INFECTION (Urinary track infection) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 030L20A) 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 TORASEMIDE (TORSEMIDE), METOPROLOL TARTRATE (METOPROLOL XL), LEVOTHYROXINE, TAMSULOSIN, APIXABAN (ELIQUIS), METFORMIN, FENOFIBRATE and CLOPIDOGREL BISULFATE (PLAVIX) for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intravenous) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced PNEUMONIA (Patient was hospitalized due to pneumonia) (seriousness criteria hospitalization and medically significant) and URINARY TRACT INFECTION (Urinary track infection) (seriousness criterion hospitalization). On 18-May-2021, the patient experienced COVID-19 (Patient tested positive for covid at the hospital with a rapid test). The patient was hospitalized on 30-Apr-2021 due to PNEUMONIA and URINARY TRACT INFECTION. The patient was treated with TAZOBACTAM (intravenous) at a dose of UNK dosage form and PIPERACILLIN (intravenous) at a dose of UNK dosage form. At the time of the report, PNEUMONIA (Patient was hospitalized due to pneumonia), URINARY TRACT INFECTION (Urinary track infection) and COVID-19 (Patient tested positive for covid at the hospital with a rapid test) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-May-2021, SARS-CoV-2 test: positive (Positive) Patient tested positive for COVID at the hospital with a rapid test. Description: The patient was hospitalized on 30 Apr 2021 due to pneumonia and urinary tract infection. The patient was still in the hospital. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This report refers to a case of Product administration error for mRNA-1273, lot # 031L20A with associated AEs. Additional information is 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. This report refers to a case of Product administration error for mRNA-1273, lot # 031L20A with associated AEs. Additional information is requested.

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

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

Patient came into the clinic today to report the following: He states he received his first Moderna injection on 1-26-2021 and the second on 2-23-2021. One week after the second shot he began to have severe joint pain in his hands, knees and shoulder. 2 nd week after the last shot he had the shingles. The 3 rd week after the shot he was diagnosed with blood clots in both lungs and was hospitalized for 3 days. They gave him blood thinner in the hospital and sent him home with more to take. States as of today (6-4-2021) he is still having problems with fatigue and swelling/ pain in his hands, knees and shoulders.

Heart Failure; Bilateral DVT; Blood Clot; Exacerbation of pre existing medical conditions; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE (Heart Failure), DEEP VEIN THROMBOSIS (Bilateral DVT) and THROMBOSIS (Blood Clot) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Deep vein thrombosis ('had an episode of DVT 30 years ago'). On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CARDIAC FAILURE (Heart Failure) (seriousness criterion medically significant), DEEP VEIN THROMBOSIS (Bilateral DVT) (seriousness criterion medically significant), THROMBOSIS (Blood Clot) (seriousness criterion medically significant) and CONDITION AGGRAVATED (Exacerbation of pre existing medical conditions). At the time of the report, CARDIAC FAILURE (Heart Failure), DEEP VEIN THROMBOSIS (Bilateral DVT), THROMBOSIS (Blood Clot) and CONDITION AGGRAVATED (Exacerbation of pre existing medical conditions) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's age and pre-existing medical conditions are confounding factors that may play possible contributory roles.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. Of note, the patient's age and pre-existing medical conditions are confounding factors that may play possible contributory roles.

The patient is a 77-year-old male with history of coronary artery disease, hyperlipidemia and hypothyroidism was hospitalized with confusion, fever, and generalized rash after receiving the first dose of the mRNA-1273 vaccine. Fever started one day after vaccine administration and was episodic, lasting for minutes to hours and recurring throughout the day. Over the next 48 hours, the patient developed a generalized body rash, starting from the trunk and spreading to the extremities. Thereafter, he began to experience headache, dizziness, and double vision, that later progressed gradually to severe encephalopathy in the course of 5 days. On dermatological examination, he was noted to have deep red, non-scaly, edematous papules coalescing into plaques on the abdomen, upper chest, proximal upper extremities, bilateral upper flanks and back, with scattered non-follicular pustules. On neurological exam, he had intermittent and irregular orofacial movements and bilateral upper extremity myoclonus. No other cranial nerve, motor or sensory deficits were noted on exam. Deep tendon reflexes were 2+ throughout, without signs of an upper motor neuron lesion. No nuchal rigidity was evident. The patient presented with leukocytosis and neutrophilia, elevation of creatine kinase, C-reactive protein and ferritin. Cerebrospinal fluid (CSF) analysis revealed 120 cu/mm leukocytes (77% lymphocytes), no erythrocytes, normal glucose (65 mg/dL, concomitant serum glucose of 106 mg/dL) and increased proteins (124 mg/dL). All CSF cultures were negative, and the CSF meningo-encephalitis panel did not detect any infectious agent through RT-PCR analysis. Blood and urine cultures, as well as an infectious respiratory panel were all unremarkable. RT-PCR of SARS-CoV-2 was negative. Antinuclear antibodies (ANA) (1:160) and rheumatoid factor (RF) (1:2) were positive. Further autoimmune testing demonstrated normal complement C3 and C4 levels as well as negative anti-double stranded DNA, ribonuclear protein, Smith, Ro, La and anticardiolipin antibodies. Brain and cervical spine MRI with and without contrast did not show any remarkable findings. Continuous video electro encephalogram (vEEG) monitoring revealed a generalized slow background in the theta range, with state changes and reactivity but no sleep features. The facial and upper limb movements were captured on video recording without an epileptiform correlate on EEG. Skin biopsy demonstrated intracorneal micro abscesses, edematous papillary dermis and a band-like infiltrate of predominantly neutrophils and histiocytoid cells with nuclear debris in the superficial dermis without vasculitic changes and rare eosinophils, consistent with a neutrophilic dermatosis. Evaluation for malignancy was unrevealing including serum protein electrophoresis, peripheral blood smear, peripheral blood flow cytometry, and computed tomography of chest, abdomen and pelvis. The patient initially received empiric broad spectrum antibiotics and antiviral coverage for suspected sepsis and meningitis, including vancomycin, cefepime (later switched to ceftriaxone), ampicillin, doxycycline and acyclovir (for 9 days) without any improvement. As no infectious etiology was found, antimicrobial therapy was deescalated. Given concerns that the clinical picture might be related to an inflammatory reaction to recent vaccination, we started a four-day course of 1 gram methylprednisolone once a day. After the first day of treatment, the patient had marked improvement in his neurological exam, and went from mumbling incomprehensible words, to formulating full sentences and regaining orientation to self and place. He was able to follow simple commands consistently. Myoclonus also quickly resolved as well as the orofacial movements. The patient progressively improved, achieving his baseline before the fourth dose of methylprednisolone. Moreover, the cutaneous findings significantly improved, with near complete resolution of the pustules within 36 hours of administration of steroids. At this time, he met both major and all 4 minor criteria for the diagnosis of Sweet syndrome. The patient was switched to prednisone 60 mg/daily with a plan to taper over the course of three weeks. He was discharged two days afterwards with no evidence of neurologic symptoms and normalization of initially altered laboratory evaluations.

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

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

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

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

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

Family stated patient had been weaker since "last covid shot". Patient death 5-5-2021 - 1 week after vaccination

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

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

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

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

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

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

Patient was vaccinated on 1/14/2021. On 1/22/2021, patient tested positive for COVID-19 and admitted to the hospital for acute hypoxemic respiratory failure, COVID-19 pneumonia, and severe ARDS. Patient was intubated on 1/23/2021 and later died on 2/10/2021 after being extubated and placed on comfort measures.

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

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

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

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

Patient started feeling weak, stomach pain, neck pain, respiratory problems, confusion, low blood pressure which led to death on February 21, 2021, 7 days after the vaccine was given.

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

Patient felt generally unwell, tired and unable to walk well. Said his feet felt numb. He could not get up and slid to the floor. He did not have the core strength to even help him sit up. Sometime after he was assisted back on the couch around 4:30 am he must of got back up and attempted to go to restroom because he was found on the floor with his arm and face resting on the love seat which looked as if he was trying to pull himself up. His wife found him in the morning around 11:00 am and he had been died for some time according to EMS. His death was unexpected. Even when contacting his doctors they were confused as to why he had passed away. No autopsy was done but as of this moment he has not been cremated yet and is at Funeral Home.

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

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

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

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

My Father had a hemorrhagic stroke. He passed away 13 days after receiving the second Modern?s vaccine.

Family reported today 3/17/2021 that patient passed away 3/12/2021, they did not indicate that it had anything to do with the vaccination or give medical history.

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

Phone call from patient' s 2 daughters on 3/10/2021. Patient was found dead in bed with a remote in his hand. He had not been sick. He had received Moderna SARS vaccine 2/27/2021= 11 days earlier, but did not have any adverse reactions. He had recovered from lumbar spine surgery several months earlier. He was pronounced dead by the fire chief.

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

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

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

Blood clot in his left lung and right lung; Blood clots in his right groin; Terrible pain on the left side of his upper body,It hurts so much; A spontaneous report was received from a consumer concerning a 78 years old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced terrible pain on the left side of his upper body, it hurt so much, blood clot in his left and right lung and blood clots in right groin. The patient's medical history was reported by the reporter as high blood pressure, prediabetes and hepatitis C due to a bad blood transfusion (treated with Mavyret). Concomitant medication was not reported. On 11 Feb 2021, three days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 031L20A) through an unknown route at left arm for prophylaxis of COVID-19 infection. On 14 Feb 2021, 3 days after vaccination, patient had a terrible pain on the left side of his upper body and was hospitalized, the tests revealed blood clot in his left and right lung as well as in right groin, which was treated by Eliquis. Patient was observed overnight and discharged with a follow up in 3-6 months. Action taken with mRNA-1273 in response to the events was unknown. The reporting physician assessed the events as not related to the product, but did not recommend second of vaccine. The outcome of events was unknown.; Reporter's Comments: Based on reporter's causality and history of diabetes and Hepatitis C infection, the event is assessed as unlikely related to mRNA-1273.

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

DEATH Narrative: No information about patient's death in record, patient received most of his care outside the clinic with only 2 ambulatory care notes in clinic total. Had diagnosis of CLL and was no longer on chemo. No documentation of: prior COVID infection, immediate ADR to COVID vaccine, prior hospitalizations for covid or anything else, death note, autopsy Unlikely that covid vaccine resulted in this patient's death, but was due to advanced age and diagnosis of CLL.

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

Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 78 and receiving home based primary care prior to COVID vaccination for multiple conditions including CKD, T2DM, w/ complications, and CHF.

Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was hospitalized in early 02/2021 at Medical Center in the ICU for a bleeding ulcer. Was inpatient for over a month, but do not have records due to it being outside facility. Received a colonoscopy report which showed. diverticulosis and CT of abdomen showing pleural effusion, umbilical hernia and gallstones. Notable comorbidities include emphysema, CKD, CAD, ICM, and T2DM.

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

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

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

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

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

Patient on 4/18/21 experienced "chicken wire" vision (never before an issue), after vision issues patient said he lost vision on and off for the next 24 hours, accompanied with mental confusion, and was unable to get out of bed on the morning of 4/19/21. Next two days a continued decline in in ability to ambulate and demonstrated neurological deficits on 4/20/21 of impaired vision, cognition and experienced difficulty in moving limbs. Patient was in a car accident on 4/21/21, is now hospitalized, unable to ambulate, and has further neurological deficits with impaired speech, cognition, and movement as well as pneumonia.

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

3/21/21 - Pt emails MD that he'd had SOB + fatigue since 3/10 when given first dose of infliximab, no energy, sitting all day. smell ok. taste reduced. poor appetite. +dyspnea on exertion. no chest pain or edema. HR nontachy at baseline, to 105 ambulating to bedroom. BP 164/97. COVID test scheduled for 3/23, which returned negative 3/24. 3/28 - Pt went to healthcare facility for generalized weakness, worsening SOB over days, R pleuritic chest pain, diagnosed with bilateral pulmonary emboli, left popliteal vein DVT. Required 5L O2. echo w/o LV strain. At the time he stated it may have been going on for 4 months. during hospitalization also had altered mental status, MRI/neuro diagnosed with hypoxic brain injury 3/30 - transferred to another healthcare facility given IV abx, lasix, 2-4L NC, 4/11 - discharged to another healthcare facility.

79 years old male with history of COPD on home oxygen chronic kidney disease stage III vaccinated and now he comes in with COVID-19 infection positive. Chest x-ray showed bilateral pneumonia started on antibiotics bronchodilators and steroid. Infectious disease was called advised for dexamethasone for 7 days and Levaquin for 5 days 250 mg daily and patient should. Quarantine himself at least 10 days from the first positive test which was done on May 3, 2021. Patient is doing well vitally stable will be discharged home to follow-up with primary care physician in 3 days and infectious disease in 1 week Discharge Physical Exam:

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

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

Wife came in for second dose appointment and handed over husbands vaccination card. Wife reported patient died on Saturday after waking up in the morning and deciding to sleep in for a bit longer. She reported getting out of bed and he was breathing and when she went back to wake him up he wouldn't wake. She called 911 and he was pulseless, she reported emergency aid "Shocked him" and worked on him for 45 minutes before asking her for permission to stop. Site will destroy vaccine card as the wife did not wish to keep it.

Family considers patients demise 5/8/2021 a result of vaccination with COVID-19 series given 2/3/2021 and 3/3/2021. He died from respiratory acidosis yet never had breathing problems prior tom vaccine.

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

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

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

Patient received his second dose of the Moderna vaccine on 5/21/21. On the morning of 5/22/21, patient started having issues with mobility, heavy sweats, body aches, and headache, although he had no fever and maintained his sense of smell and taste. Patient was later hospitalized and tested positive for COVID on Thursday, May 27, 2021. Patient passed away on Friday, May 28, 2021.

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

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

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

Pt. presented to UC with change in mental status; arrived from extended care facility; discharged home on 05/20/21 to hospice care. Pt.'s son called to cancel subsequent appointments because pt. passed away on 05/27/21.

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

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

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

I helped facilitate scheduling for his COVID vaccine and received notification from his wife that he passed away unexpectedly this morning. She reported he had been experiencing a rheumatoid arthritis flare and was on steroids. His diabetes was not well controlled as a result. He did not have any reactions in the days immediately after the vaccine.

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

Patient was hospitalized on 31 Jan for COVID pneumonia after 3 days of increasing baseline supplemental O2 requirements and dyspnea and ultimately died on comfort care on 3 Feb 2021.

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

The patient reported feeling well. I discussed with him the Covid-19 vaccine and he was able to state that he wanted it and to sign his consent form. The facility reported they had discussed this with him and he had agreed prior to my visit.

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

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

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

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

When family members came to receive the second dose of their COVID vaccine, they informed us that the above patient had passed away.

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

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

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

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

Resident had severe CAD, DM type 2, and hx of RBKA and left 5 digits on foot amputation. Hx of osteomyelitis post surgical. After last surgery, resident did not have a good appetite, more restless, increased confusion with dementia. Significant other passed away on 12/30/20, resident began refusing meals, decreased eating. Vaccinated on 1/13/21. On 1/25/21 Resident labs showed kidney failure. Dr. spoke with family and transitioned to Comfort care, on 2/5/21 went hospice. Patient passed away on 2/13/2021.

Patient had dark urine and high CK level and was diagnosed with acute rhabdomyolysis. Patient received IV fluids and nephrology was consulted. Patient was discharged home when stable.

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

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

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

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

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

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

death Narrative: Patient received COVID vaccine # 1 on 1/6/2021, on 1/23/21 his wife reported to the facility that he passed away. Notes in database do not mention cause of death or where death occurred. There are no scanned records in database with any detail either.

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

Weakness, Fall, Rhabdomyolysis Narrative: Patient presented following a fall at home within 24 hours of the second COVID vaccine. Pt reported chills, weakness leading to fall, subsequently developed rhabdomyolysis requiring hospitalization due to weakness/prolonged period down after fall.

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

Patient advised Health Dept. (at time of 2nd dose) that approximately 45 minutes after 1st Moderna vaccine that he began experiencing blood in his urine. Patient contacted PCP and was admited to for further evaluation and treatment. Pt developed pneumonia while in hospital and spent a total of 4 days inpatient. Treating physician at hospital unable to identify cause of blood in urine. DR ADVISED THAT HE TREATED ANOTHER PATIENT WITH SAME SYMPTOMS AFTER INITIAL COVID VACCINATION but could NOT specifically attribute cause of blood in urine to COVID vaccination.

Death; Trouble in breathing; chills; sweating; his body was really cold; A spontaneous report was received from a consumer concerning a 79 years old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events death, trouble in breathing/dyspnoea, chills, sweating/hyperhidrosis and his body was really cold/hypothermia. The patient's medical history included blood clotting, blood pressure and diabetes. The relevant concomitant medications reported were provided as medications for blood thinner, blood pressure medication and diabetes medication. On 03 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA (Lot number: unknown) through intramuscular route of administration for prophylaxis of COVID-19 infection. On 03 Mar 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA (Lot number: unknown) through unknown route of administration for prophylaxis of COVID-19 infection. On 04 Mar 2021, after second dose patient experienced sweating, his body was really cold. His wife called ambulance and paramedics had quoted that these were usual symptoms of second shot and if they want, they can take him to hospital for monitoring. The patient doesn't want to go hospital and wanted to take rest in bed. On 05 Mar 2021, at 2am, four hours after first ambulance call, his wife noticed that he was still sweating, had chills and also had trouble in breathing. She called the ambulance second time and while it arrived at home it was too late and he was already passed. All the events were provided as intervention/medically important. No laboratory data was provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not applicable. The events trouble in breathing, chills, sweating and body was really cold were not recovered. The patient died on 05 Mar 2021, due to unknown cause of death but On 19 Mar 2021, his wife talked with primary care physician and he mentioned that vaccine is one of the contributing factors to his death and it is noted on his death certificate. Plans for autopsy was unknown.; Reporter's Comments: This is a case of sudden death in a 79-year-old fmale patient with a history of blood clotting, abnormal blood pressure and diabetes, who died 2 days after receiving second dose of vaccine. Very limited information has been provided at this time.; Reported Cause(s) of Death: unknown cause of death

Pneumonia; A spontaneous report was received from a consumer concerning reporter's husband a 79-year-old, male patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and who developed pneumonia. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 02 Mar 2021, approximately 13 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 001A21A) via an unknown route for prophylaxis of COVID-19 infection. On 14 Mar 2021 the patient was hospitalized for pneumonia and was discharged on 16 Mar 2021. The reporter stated that her husband has "previously been prone to pneumonia". Treatment information included unspecified antibiotics. Action taken with mRNA-1273 in response to the event was not provided. 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 onset date of the reported event, a causal relationship cannot be excluded.

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

From golfing on 02/23/2021 to dimentia suddenly going into overdrive and death on 03/31/2021 All tests and care was taken to understand rapid/ unexplained decline.

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

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

Patient's wife called in mid March 2021 letting us know that the patient, needed to re-schedule his 2nd dose of Moderna Covid-19 vaccine - he had missed his scheduled 2nd dose date due to being hospitalized - doctors had thought he might need a defibrillator but then discharged him without one. Patient's wife called back on 4/16 to let us know that he passed away on 4/14.

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

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

From one of the nurse vaccinators: the man who had a laryngectomy who gave me a hard time about an id when we first started..I was so happy to see his name on my list this morning. I saw that no one could contact him..I got into the building ..no answer at the door ..phone disconnected ..found the super..he died 3 weeks ago..he didn?t know cause..just emergent situation to hospital and passed.

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

The person who received the vaccine got very sick 5 days after the receiving the vaccine. The patient was talking at 2:00 pm on the 28th and he was on a ventilator a few hours later. The doctors were never able to determine why he got so sick suddenly. He passed away on April 6th.

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

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

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

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

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

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

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

Patient presented to the ED on 4/11/2021 and was subsequently hospitalized for pneumonia and pulmonary edema. Patient presented to the ED on 6/4/2021 and was subsequently hospitalized for third degree heart block. These visits are within 6 weeks of receiving COVID vaccination.

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

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

Patient received second COVID vaccine on 2/3/2021. Was admitted to Medical Center on 6/15/21 for generalized weakness and tested positive for COVID 19 on 6/15/2021. Patient was also positive for COVID 19 in November 2020. Patient expired on 6/26/2021 while hospitalized.

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

TIA; Lost vision on the left side; lump in left leg; vasculitis in the varicose vein; Chills; Feels tired; This spontaneous case was reported by a health care professional and describes the occurrence of VASCULITIS (vasculitis in the varicose vein), TRANSIENT ISCHAEMIC ATTACK (TIA) and BLINDNESS (Lost vision on the left side) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Chills) and FATIGUE (Feels tired). On 05-Mar-2021, the patient experienced VASCULITIS (vasculitis in the varicose vein) (seriousness criteria medically significant and intervention required). On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (TIA) (seriousness criterion medically significant), BLINDNESS (Lost vision on the left side) (seriousness criterion medically significant) and LIMB MASS (lump in left leg). At the time of the report, VASCULITIS (vasculitis in the varicose vein), TRANSIENT ISCHAEMIC ATTACK (TIA), BLINDNESS (Lost vision on the left side), LIMB MASS (lump in left leg), CHILLS (Chills) and FATIGUE (Feels tired) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were given by the reporter. No Treatment information were provided by the reporter. Patient required on full anticoagulation due to events experienced. Lab details were not provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

pneumonia Narrative: On 11/9/20, Patient had a presumptive positive COVID (COBAS) screen as part of routine CLC screening and then on 11/13/20, he had a repeat COVID (CEPHID) that was negative. Then on 12/22/20, he received his first COVID vaccine. On 12/26/20, he began to have c/o hurting all over. Noted history of aspiration and COPD. On 12/29/20, he began to have coughing, increased shortness of breath and runny nose with course breath sounds in his bilateral lower lobes. A chest xray was done and he was initiated on oral azithromycin and cefepime for a bilateral pneumonia. On 1/3/21, he continued to decline with increasing shortness of breath and was subsequently transferred to acute care medicine. All COVID tests have been negative since the presumptive positive on 11/9/20. He did have a CTA that ruled out PE but did show bilateral pneumonia. His antibiotics have been changed to meropenem, vancomycin and IV azithromycin. He remains on acute care at time and has not required ICU care.

Patient received the vaccine on 12/29/20 and presented at the ER at the Hospital on 12/30/20 stating that he wasn't feeling well. It is stated that his health had declined over the past few weeks and currently on hospice. Visit was unremarkable. Patient stated that wanted to stop dialysis. Patient passed away on 01/02/2021.

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

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

The resident received his COVID-19 Moderna vaccination on 2/6/2021 2:11 pm and expired on 2/7/2021 at 6:04 am. There were no signs or symptoms of vaccination reaction leading up to death.

Resident passed away this morning. No signs or symptoms prior to his death of an issue with the vaccine. He was an end stage dementia resident at the nursing home.

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

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

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

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

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

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

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

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

Pt was given Moderna COVID-19 vaccine on 2/11/21 with no adverse reactions. Pt later died on 3/08/2021 with lung cancer being cause of death.

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

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

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

Cough started on 3/5. Hospitalization on 3/7, Expired 3/16. Doctor's Death Diagnosis: acute on chronic respiratory failure.

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

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

My father, who at 80 was walking 2 miles a day and had just had a check up within the month consisting of an MRI, cardiac monitor and lab work which gave him essentially a clean bill of health felt fatigued after his second Moderna shot. 11 days after his second dose he took an afternoon nap and was found dead by my mother and myself. We are devastated. The time frame so close to his second moderna shot can not be ignored. We want no one to suffer a loss such as this if the vaccine was a catalyst. Full autopsy is ongoing, no know cause with initial results.

Pneumonia; Feeling weird; Stomach problems; Sinus problems; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Ulcers aphthous oral and Hernia. On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (Feeling weird), ABDOMINAL DISCOMFORT (Stomach problems) and SINUS DISORDER (Sinus problems). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Pneumonia), FEELING ABNORMAL (Feeling weird) and SINUS DISORDER (Sinus problems) outcome was unknown and ABDOMINAL DISCOMFORT (Stomach problems) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

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

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

Patient brought to ED via EMS with cough and shortness of breath. Diagnosed with COVID pneumonia after received 1st COVID vaccine. Patient treated with oxygen, steroids, remdesivir, and antibiotics. Patient recovered and was discharged to home.

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

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

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

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

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

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

Received #2 Moderna on 3/5/2021. Started to not feel well the next day. By 3/9/2021, he was too sick to get out of bed. Friends stayed with him the previous night and opted to call 911 for hospital transport on 3/9. He was admitted to a Medical Center and diagnosed with pneumonia. He died on 3/18/2021 in patient.

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

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

Per Review of Charge Nurses Notes. Please see Below Called in to residents room by CNA, resident without respirations or pulse, resident placed on floor and CPR initiated at 0725, EMSA notified and called time of death at 0751. Specialists on call for Dr. notified. daughter notified. cremation services notified.

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

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

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. This occurred on 3/7/21, 4/1/21, 4/3/21, 4/24/21 and 4/29/21. The patient died on 4/30/21

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

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

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

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

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

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

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

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

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

Pneumonia; Very ill; Dysphagia; Got 3 Moderna vaccines; This spontaneous case was reported by a nurse and describes the occurrence of PNEUMONIA (Pneumonia) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A, 040B21A and 043B121A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pre-existing disease. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 06-May-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 06-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXTRA DOSE ADMINISTERED (Got 3 Moderna vaccines). On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criterion medically significant), ILLNESS (Very ill) and DYSPHAGIA (Dysphagia). On 06-May-2021, EXTRA DOSE ADMINISTERED (Got 3 Moderna vaccines) had resolved. At the time of the report, PNEUMONIA (Pneumonia), ILLNESS (Very ill) and DYSPHAGIA (Dysphagia) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medication were provided. Lot number of 3rd dose of mRNA-1273 - 043B121A. Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Follow up received on 11-May-2021 contains no significant information. Updated lot number of 3rd dose of mRNA-1273. On 16-Jun-2021: Updated events - Pneumonia (medically significant), Illness and Dysphagia. Updated historical condition - comorbid conditions.; Sender's Comments: Based on the current available information; although the use of the product and the start date of the events were not temporarily closed, a causal relationship cannot be excluded.

Patient was admitted to the hospital on 04/29/2021. And was discharged with Care on 5/5/21 and expired on 5/26/21.

When pt's wife came to the clinic for her second dose on 3/11/21 she informed staff that her husband had passed away on 3/7/21 of a brain tumor. Death does not appear to be related to the vaccine - reporting only because death occurred within 30 days of first dose of vaccine. .

Stated that symptoms began with a cough around 6/12, and symptoms gradually got worse since then. Pt was tested first on 6/22 from their family doctor, and then was admitted to medical center on 6/24. Pt was diagnosed with bilateral pneumonia and is in the ICU currently because he is on oxygen (not mechanical ventilation). Pt has high blood pressure and history with kidney stones.

Received dose 2 of Moderna vaccine on 3/11/21. Symptoms worse after 2nd dose, and on March 31, 2021 get worse. On April 4 at church, became very hot and weaker and weaker. Came home and put him to bed and slept some. At lunch time, ate a bite of jello and sipped 7 up and said he did not feel very good. Took an Alka Seltzer for heart burn, but it did not help. Went to sleep. Wife unable to waken him later that day. Died 4/4/21.

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

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

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

Headache after dose was given at 10:00 a.m Died at after 7:30 pm the same night the dose was given.

Patient was living in a nursing home with positive cases when administered. His age and chronic condition was such that he did not have time after the vaccination to avoid exposure or develop immunity.

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

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

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

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

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

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

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

On February 11, 2021 around 10:15 am, patient was given the Moderna brand COVID-19 vaccination. After his vaccination, he was instructed to wait around for 15 minutes after the administration of the vaccine. During this time, there were no reported issues with the patient. On February 15, 2021 around 9:15am, patient's wife called the pharmacy and spoke with the pharmacist informing her that patient had passed away in his sleep on Saturday evening. Patient's wife inquired about whether death may have been caused by an adverse reaction to the vaccine. During the call patient's wife mentioned that patient slept a lot the day of the vaccine and the day after. patient's wife mentioned that patient woke up Saturday to eat breakfast and lunch. She states that later that evening, she found patient asleep and cold which she then realized that he'd passed away.

Patient received vaccine on 2/8 at 2:50pm. On 2/9 at 10am, patient was found unresponsive. EMS noted R gaze preference and L sided contracture. Patient was intubated and symptoms resolved when given Versed. Concern for seizure activity.

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

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

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

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

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

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

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

Patient presented to ED with SOB. Of note, had recent kyphoplasty. Patient reports fever, productive cough, and sore throat as well as fatigue. Patient found to have post-operative pneumonia and was treated with antibiotics. Per the EUA, hospitalizations are to be reported irrespective of attribution to the vaccine

Patient received vaccine on 1/11/2021. Patient passed away 1/15/2021, cause not reported, unaware if related.

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

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

ANAPHYLACTIC NEUROLOGIC SYMPTOMS INCLUDING HALLUCINATIONS DEVELOPING WITHIN 7 DAYS OF VACCINATION, SECOND DOSE NOT ADVISED BY CDC, SECOND DOSE DUE 3/12/2021, SECOND DOSE NOT ADMINISTERED AND DOCUMENTED AS ANAPHYLACTIC REACTION TO FIRST DOSE

reaction vs. septic shcock oncologist worried about delayed anaphylactic reaction. on keytruda. never on chemotherapy.

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

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

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

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

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

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

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

Death within 60 days of vaccination. Tested positive for COVID-19 2/8/2021, admitted outpatient to Hospital 2/8-2/10 readmitted 2/13-2/14 with transfer to Medical Center in with death on 3/2/2021.

SHORTNESS OF BREATH FEVER UTI (urinary tract infection) Systemic inflammatory response syndrome (SIRS) without organ dysfunction (CMS/HCC sepsis

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

81 y/o male patient was vaccinated 3/3/21 and died 3/6/21. Patient's wife reported he was having "some trouble breathing" but could not remember whether this problem started before or after being vaccinated.

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

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

patient passed away Narrative: Family member reported patient passed away day after receiving the covid vaccine

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

nausea, vomiting, diarrhea, change in mental status, and generalized weakness about 36 hours from time of vaccine. Initially treated with supportive care. He returned 5 days later with continuing symptoms plus headache and was diagnosed with a intracerebral hemorrhage.

Death Narrative: already reported VAER for hospitalization on 3/3; the patient subsequently died once transferred to SNF

Blood clot in leg; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clot in leg) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039KZ014) for COVID-19 vaccination. The patient's past medical history included No adverse reaction (No reported medical history.). On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced THROMBOSIS (Blood clot in leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clot in leg) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Company Comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

pneumonia; This spontaneous case was reported by an other caregiver and describes the occurrence of PNEUMONIA (pneumonia) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The patient's past medical history included Diabetes and Pacemaker insertion (cardiac). Concurrent medical conditions included Heart disorder. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion hospitalization). At the time of the report, PNEUMONIA (pneumonia) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication provided. Patient's husband received his 1st vaccine on 1Mar2021. Her husband have pace maker and heart problem, diabetes and he admitted to ER on Sunday on 28Mar2021 for pneumonia and he is still in the hospital. No treatment information provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD21-065334 (Linked Report).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. MOD21-065334:

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

death Narrative: Patient received COVID vaccine #1 on 2/4/21. On 3/1/21, it was reported to the facility that patient had passed away on 2/24/21. No notes on file with respect to what happened around the time of his passing. No autopsy results available. 20 days from time of vaccine to date of death.

sudden high fever (101-104) sudden confusion sudden extreme exhaustion sudden extreme leg weakness (couldn't walk) pneumonia kidney infection

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

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

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

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

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

Death Narrative: 80 yr old metastatic lung cancer, had stopped eating, still wanted vaccine, Died on hospice service. no vaccine complications reported.

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

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

passed away(death); temperature 99.7F; tired; left arm swelling; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEATH (passed away(death)) in an 81-year-old male 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. Concurrent medical conditions included Diabetic and Asthma ((but everything was under control).). On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced PERIPHERAL SWELLING (left arm swelling) and FATIGUE (tired). On 31-Jan-2021 at 10:30 AM, the patient experienced PYREXIA (temperature 99.7F). The patient died on 25-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PERIPHERAL SWELLING (left arm swelling), PYREXIA (temperature 99.7F) and FATIGUE (tired) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2021, Body temperature: 99.7 f (abnormal) elevated. On 31 Jan 2021, the patient was tired and went to bed early. At 10:30 pm, the patient's wife reported the patient's temperature as 99.7 degrees Fahrenheit and was given acetaminophen. The patient's left arm had swelling. The patient's son (doctor) prescribed antibiotic for treatment. On 01 Feb 2021, the patient was taken by ambulance to hospital. He was at hospital for 24 days and was on a ventilator. Treatment included Tylenol antibiotic. Company comment: Very limited information regarding the events has been provided at this time. Further information has been requested..; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested..; Reported Cause(s) of Death: Unknown cause of death

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

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

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

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

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

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

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

Pt was admitted to hospital from hospice care with UTI on 4/16/21 after receiving 2nd dose of vaccine on 4/1/21. Patient passed on 4/21/21. Per guidelines, all hospitalizations are reported.

A few weeks after vaccination , blurry vision, , not feeling well,increased shortness of breath, ringing in ears, dizziness

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

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

passed away; dry, persistent cough; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Medical history was not provided. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), UBIDECARENONE (COQ10 [UBIDECARENONE]), LISINOPRIL, METOPROLOL TARTRATE and OMEPRAZOLE for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced COUGH (dry, persistent cough) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, COUGH (dry, persistent cough) and MYALGIA (Body aches) had not resolved. This a case of death in 81-year-old male patient who received mRNA-1273. Very limited information regarding death (cause unknown) has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the events cough and myalgia, a causal relationship cannot be excluded. The event myalgia is consistent with the safety profile of the product. This case was linked to MOD-2021-060909 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Contains patient death information. Case upgraded to serious.; Sender's Comments: This a case of death in 81-year-old male patient who received mRNA-1273. Very limited information regarding death (cause unknown) has been provided at this time. Further information has been requested. Based on the current available information and temporal association between the use of the product and the start date of the events cough and myalgia, a causal relationship cannot be excluded. The event myalgia is consistent with the safety profile of the product.; Reported Cause(s) of Death: unknown cause of death

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

After vaccination, patient tested positive for COVID-19. Patient was very ill and had numerous chronic health issues prior to vaccination. Facility had a number of patients who had already tested positive for COVID-19. Vaccination continued in an effort to prevent this patient from contracting the virus or to mitigate his risk. This was unsuccessful and patient died.

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

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

Patient died 1 week after vaccination. According to family was having very rapid decline in status in recent weeks and they did not think related to vaccination.

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

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

Patient complained to wife of not feeling well in evening after the vaccination and expired at home during the night.

Patient sent to the ED or sudden onset of shortness of breath on 02/02/2021. Per documentation by the MD, the patient had COVID19 "several weeks ago" and the nursing facility felt like he had recovered. A rapid test done in the ED was negative. When the patient worsened and seemed to be following the same path as other COVID patients, a send out PCR test was done, which was positive. The patient worsened and passed away that same day (02/05/2021) I was not made aware that the patient had the vaccine on 01/21/2021 until Monday 02/08/2021.

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

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

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

UTI, urinary/bowel incontinence Narrative: first COVID19 vaccine 1.11.21, ER visit with hospitalization 1.15-1.18.21 for SIRS/Sepsis, initially thought to be urosepsis but post discharge UA and blood cultures were negative; source was not identified. Beyond symptoms listed, patient just reported he "felt terribly bad" prior to spouse calling EMS. VAERS reported by hospitalist as well from the facility where he was treated. He was discharged home with Augmentin for UTI and Physical Therapy for strengthening. Patient follows local PCP and this facility PCP. Responsible physician listed on this form is this provider's facility Medical Director.

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

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

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

at midnight client got up to go to the bathroom. His legs became weak and he fell and hit his head on the wall. He called for his wife and said he didn't feel right. He denied any pain. She called EMSA and he stopped breathing while she was waiting on them. She gave him CPR with instructions from the dispatcher. He was pronounced dead at 1:30am. She has tried to call the clinic 3 times and left messages and no one has called her back, Her PCP told her this needed to be reported .

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

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

Death Narrative: Patient received dose 1 of COVID vaccine on 1/27/21. Was observed x15 minutes, no reactions noted. Later that day patient's spouse reports patient has been acting out (reports behaviors the night before) and that she cannot care for him any longer. Patient falls sometime in the 48 hours after vaccine and is admitted to the hospital with an unknown diagnosis. Not certain of patient's history after this hospitalization until 2/9 when patient is admitted again to the hospital with hepatic encephalopathy. Patient is switched to hospice status by 2/12, and passes on 2/21/21.

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

Close to "urea sepsis"; severe UTI; A spontaneous report was received from consumer concerning a 82-years old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced severe UTI/urinary tract infection and close to urea sepsis/sepsis. The patient's medical history was not provided. Concomitant medications was not provided by the reporter. On 16-Feb-2021, the patient received second of the two planned doses of mRNA-1273 (lot number: 006M20A) in the left arm for the prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient developed a severe UTI. Close to urea sepsis. Took antibiotics. Treatment medication included antibiotics. No lab tests were mentioned. The events severe UTI and close to urea sepsis were considered to be serious with criteria of important medical event. 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. The outcome of the events severe UTI and close to urea sepsis 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 events, a causal relationship cannot be excluded

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

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

Minor brain attack; Partial loss of speech; This spontaneous case was reported by a patient family member or friend and describes the occurrence of CEREBROVASCULAR ACCIDENT (Minor brain attack) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No reported medical history). On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Minor brain attack) (seriousness criterion hospitalization) and APHASIA (Partial loss of speech). The patient was hospitalized for 3 days due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (Minor brain attack) and APHASIA (Partial loss of speech) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Products known to have been used by the patient, within two weeks prior to the event, included unspecified diabetes and blood pressure medications. Treatment medications included unspecified blood pressure and blood thinner medications. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's age and comorbidities may be confounding factors for causality assessment.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patient's age and comorbidities may be confounding factors for causality assessment.

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

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

82YM Admit 3/18/21 to hospital for small bowel obstruction within 1 week of second vaccine dose. PTA bowel obstruction led to a syncopal episode following use of laxative, and several episodes of vomiting in the days prior . Upon admission Patient was receiving conservative therapy for a partial obstruction when he developed increasing shortness of breath. The patient was transferred to the ICU for worsening respiratory status and eventually developed significant hypercapnic and hypoxemic respiratory failure requiring intubation. Neurology was consulted for altered mentation in the setting of respiratory failure. Patient with ascending paralysis. MRI of the head and neck as well as CTA were obtained x2. Patient was ultimately diagnosed with Guillain-Barre, variant and received 5 days of Intravenous Immune Globulin therapy. Patient's small bowel obstruction resolved and ultimately patient required percutaneous tracheostomy tube and gastrostomy tube placement for prolonged respiratory failure and neurologic compromise. The patient had uneventful ventilatory requirements and ultimately was performing intermittent spontaneous breathing trials; however, still had episodes of apnea, but improved. He was tolerating tube feeds at goal with resolution of his small bowel obstruction, which was thought secondary to his Guillain-Barre. The patient did develop abnormal LFTs which were thought secondary to cholecystitis not requiring operative intervention, with improving LFT findings on antibiotics. The patient had a nonobstructive cholecystitis. The patient's mentation was improving to the point where he was able to communicate and open his eyes upon discharge, as well as was working with Physical Therapy for strengthening. He was able to move his upper extremities and followed commands and lower extremities were improving in strength as well. Patient was discharged via private air flight to acute care ICU facility.

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

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

Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 82 and had a PMH significant for parkinsonism w/ dementia, difficulty walking and performing daily tasks, CAD, afib, and osteomyelitis. Patient was authorized for home health aide on 3/18/21 after wife overwhelmed with his care. Listed cause of death on death certificate says "unknown-history of dementia and heart conditions"

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

blood clot in his pulmonary artery and several others in his legs; blood clot pulmonary artery; shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot in his pulmonary artery and several others in his legs) and PULMONARY EMBOLISM (blood clot pulmonary artery) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Family history included Factor V deficiency, Factor II deficiency and MTHFR deficiency. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clot in his pulmonary artery and several others in his legs) (seriousness criteria hospitalization prolonged and medically significant), PULMONARY EMBOLISM (blood clot pulmonary artery) (seriousness criterion medically significant) and DYSPNOEA (shortness of breath). At the time of the report, THROMBOSIS (blood clot in his pulmonary artery and several others in his legs), PULMONARY EMBOLISM (blood clot pulmonary artery) and DYSPNOEA (shortness of breath) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

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

Blood clots; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clots) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 031L209) for COVID-19 vaccination. Concurrent medical conditions included Cancer (The patient was in recovery from cancer). On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced THROMBOSIS (Blood clots) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (Blood clots) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In March 2021, Computerised tomogram: blood clots (abnormal) Blood clots. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Description: The patient developed blood clots (medically significant) two weeks after receiving his second dose of the vaccine . The patient was in recovery from cancer and was required to have computerized tomography (CT) scans. He had a computerized tomography (CT) scan within two weeks of taking his second dose and the blood clots were discovered. The patient had never had blood clots before. The patient had already been in contact with his oncologist and was prescribed apixaban. The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there and ADR that occurred between the observation period and the date of death. Patient was transferred to behavioral health unit at an outside nursing home on 2/15/21 after hospitalization for psychiatric evaluation on 1/29/21 w/subsequent Law for erratic behavior w/ delusions/hallucinations. Patient passed away on 4/12/21 at an outside facility with details surrounding death unknown. PMH significant for CKD, AAA, PVD, anemia, CAD, Dm, HTN, COPD, advanced age.

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

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

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

U07.1, J12.82 - Pneumonia due to COVID-19 virus U07.1, J96.00 - Acute respiratory failure due to COVID-19

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

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

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

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

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

Informed of patient recently passing within 24 -36 hours of vaccine administration. patient had no signs of adverse side effects while at pharmacy.

Per daughter, patient, after uneventful vaccine administration and 15 minute observation period, returned home, and father had lunch with wife and daughter. At 1:30, father remained home while daughter and wife went grocery shopping. Upon return from grocery store, approximately 1 hr. 45 minutes later, daughter found father unresponsive in bathtub with small amount of water, faucet off, and father partially clothed. Per daughter, the shower chair had been removed from the tub by her father. Per daughter, an autopsy was planned. Results are pending.

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

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

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

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

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

PT'S wife reported to the pharmacy that he was very tired after the vaccine on thursday and friday, he did not wake up on saturday, he passed away.

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

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

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

Blood clots which resulted in multiple strokes starting the day following the vaccine and the next few days afterwards. Incapacitated my Dad with severe loss of motor function and is confined to bed in nursing home. Complete loss of swallowing and is fed through a g-tube. Cannot do any independent functioning.

started with runny nose, fever, cough. ended in death due to Upper GI Bleed and inflammatory markers very elevated and no explanation why.

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

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

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

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

Patient had no immediate effects from the vaccine, but died approximately 8 hours after receiving first dose of vaccine.

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

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

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

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

No adverse events noted Patient past away was notified by Public Health the record is at Vital Statistics

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

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

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

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

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

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

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

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

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

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

DEATH - PT'S WIFE CALLED 3-11 TO TELL US PATIENT WAS FEELING BAD, AND TO ASK WHAT TO DO. WE SENT A PULSEOXIMETER, AND ADVISED TO CONTACT DR. - ON MORNING OF 3-12, PT'S WIFE CALLED TO TELL US HE HAD PASSED AWAY DURING THE NIGHT.

Patient received a covid vaccine on 03/05/2021. Daughter reports there were no side effects that night or the following days. The next Saturday, March 13, 2021, the daughter was at her parents house checking up on them. Her father was in the bathroom as she passed in the hall. He came out of the bathroom and proceeded to the living room, she stated dad are you ok? He said he couldn't breath. Giving his history of COPD and being short of breath sometimes, she didn't think anything of it. She proceeded to follow him to his chair and was checking his oxygen tank that he had been using with ambulation. It still had some in the tank. She raised her head to tell him he still had some in the tank and saw that he had started "agonal breathing". Daughter is a nurse and knew he needed help. She phone for an ambulance and with the help of her mother got patient to the floor and started CPR. Paramedics arrived on scene, continued CPR and administered meds and also intubated, but were unsuccessful in their efforts.

03/13/2021: Presented to the emergency department with cough and shortness of breath. The patient was admitted for pneumonia based on CT of the chest showing bilateral infiltrate on the upper part mainly on the right side along with bilateral pleural effusion mainly on the right. The patient is still admitted and has undergone a thoracentesis. Covid-19 negative.

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

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

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

Chest pain; felt really bad; Death; Vomited that night; Sore arm and pain in both arms; A spontaneous report was received from a consumer concerning a 83-years-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and pain in both arm /pain in extremity, felt really bad/feeling abnormal, chest pain and the patient died. The patient's medical history was not provided. No relevant concomitant medications were reported. On 03 Mar 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 04 Mar 2021, patient experienced sore arm and felt bad. The patient vomited that night. On an unknown date patient reported chest pain and pain in both arms. On 05 Mar 2021, at 12:46pm the patient died. Action taken with mRNA-1273 in response to the event was not applicable. The patient died on 05 Mar 2021. The cause of death was reported as unknown. Plans for an autopsy were unknown.; Reporter's Comments: This is a case of death in an 83-year-old male subject with unknown medical history, who died 2 days after receiving first dose of vaccine. Very limited information has been provided at this time. No follow up is possible.; Reported Cause(s) of Death: unknown cause of death

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

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

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

Patient was stable with ongoing care prior to incident. On 3/2/2021 patient had Covid vaccine number 2. On 3/9/2021, patient started to have dark brown emesis and was transferred to the hospital. On 3/12/2021, patient returned to nursing facility with hematemesis and melena due to GI bleed. Patient was started on comfort care. Had ongoing esophageal cancer with radiation therapy prior to incident. Patient expired on 4/8/2021. Of note, patient was covid positive on 12/14/2020 without any signs of infections. He had covid #1 vaccine on 2/2/2021 and #2 on 3/2/2021. Of note, his wounds worsened after covid vaccines per nursing notes.

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

Patient's Wife reported that patient did not experience any side effects from the vaccine. She reported they did their daily chores after receiving the vaccine and patient did not complain about having any health issues on that day even before going to bed. She reported that patient did not wake up from his sleep the next morning.

death Narrative: Patient received COVID vaccine #1 on 1/13/2021. On 1/19/2021, notes from primary care indicate advancing dementia and a urinalysis suggestive of a UTI, he was ordered a course of cefdinir and PCP at that time suggested long term care. On 2/1/2021, he was admitted to a facility for acute kidney failure and was also noted to have frequent falls at home, no scanned records from that hospitalization are available. On 2/7/2021, he discharged from that facility with home hospice. On 2/11/2021 at 0140, Patient passed away at home. No autopsy results available.

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

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

Death Narrative: Patient received his first COVID-19 vaccination 2/27/2021 and received his second COVID-19 vaccination 03/27/2021. Patient had not been tested for COVID per chart review and had no contraindications to receiving the vaccine. Patient did not experience any adverse events to the COVID-19 vaccine between time of vaccination and the time of death 12 days later. Of note, patient was receiving home hospice at the time of his death (04/08/2021) for his advanced acute myeloid leukemia.

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

Admitted on 4/12/2021 with acute respiratory failure, bronchiectasis, possible UIP pulmonary fibrosis

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

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

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

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

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

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

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

Stroke; went through an inflammation state and since then has been in a fog; can't remember his birthday; doesn't want to eat; bleeding in the brain which they called it second stroke; This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and CEREBRAL HAEMORRHAGE (bleeding in the brain which they called it second stroke) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hip fracture. Concurrent medical conditions included Polycythemia. Concomitant products included IBUPROFEN for Joint pain, SIMVASTATIN, ASPIRIN [ACETYLSALICYLIC ACID], LISINOPRIL and METOPROLOL for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization and medically significant) and CEREBRAL HAEMORRHAGE (bleeding in the brain which they called it second stroke) (seriousness criteria hospitalization prolonged and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (went through an inflammation state and since then has been in a fog), AMNESIA (can't remember his birthday) and DECREASED APPETITE (doesn't want to eat). The patient was hospitalized from 30-Mar-2021 to 12-Apr-2021 due to CEREBRAL HAEMORRHAGE and CEREBROVASCULAR ACCIDENT. The patient was treated with Physical therapy for Cerebrovascular accident. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), CEREBRAL HAEMORRHAGE (bleeding in the brain which they called it second stroke), FEELING ABNORMAL (went through an inflammation state and since then has been in a fog), AMNESIA (can't remember his birthday) and DECREASED APPETITE (doesn't want to eat) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The reporter states that the patient was given a "clot buster" to prevent further damage. Patient was transferred to a nursing facility on 12 Apr 2021 and is still there. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patients advance age and past medical history of polycythemia may remain a risk factor for this event. Further information has been requested. This case was linked to MOD-2021-086187 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the patients advance age and past medical history of polycythemia may remain a risk factor for this event. Further information has been requested.

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

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

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

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

She received the 2nd dose 3/16/21 and got sick on 3/27/21 and I took her to her doctor on 3/29/21 and she was order for x-ray and antibiotic, she was lethargic and had no energy. she was diagnosed with pneumonia and fluid overload. she didn't seem to be getting better and on 4/4/21 was taken to hospital and got IV antibiotics and was given a diacritic to take fluid off. DC'd on 4/15/2021 and was home with home health nurse and on nurse noticed on 4/27 and her o2 lovers were fluctuating and she said to send her back to the hospital. Again, diagnosed with pneumonia in both upper lobes and pulmonologist didn't know what was going on.

On 5/8/2021 patient started experiencing dyspnea with it worsening and leading to hospitalization on 5/11/2021 for respiratory failure/COPD exacerbation. Patient is currently inpatient on med surg unit currently on Vapotherm at 40% FiO2.

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

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

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

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

blood clotting issues in his feet,clots on his legs; red places on both of his hands; bumps on legs/appeared as a raised portion on his leg; see the veins and blood in his feet; discoloration; veins more prominent in his feet and legs; headache; This spontaneous case was reported by a consumer and describes the occurrence of DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CARVEDILOL for Heart disorder, FAMOTIDINE, MULTIVITAMINS [VITAMINS NOS] and SERENOA REPENS FRUIT (SAW PALMETTO PROSTATE COMFORT) for an unknown indication. On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HEADACHE (headache). On 27-May-2021, the patient experienced VARICOSE VEIN (veins more prominent in his feet and legs). On an unknown date, the patient experienced DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs) (seriousness criterion medically significant), ERYTHEMA (red places on both of his hands), RASH PAPULAR (bumps on legs/appeared as a raised portion on his leg), VARICOSE VEIN (see the veins and blood in his feet) and SKIN DISCOLOURATION (discoloration). On 28-May-2021, VARICOSE VEIN (veins more prominent in his feet and legs) was resolving. At the time of the report, DEEP VEIN THROMBOSIS (blood clotting issues in his feet,clots on his legs), ERYTHEMA (red places on both of his hands), RASH PAPULAR (bumps on legs/appeared as a raised portion on his leg), VARICOSE VEIN (see the veins and blood in his feet) and SKIN DISCOLOURATION (discoloration) outcome was unknown and HEADACHE (headache) had resolved. Treatment information included the patient using compression hose. After the vaccination the patient experienced a headache for a day.The patient's legs and feet looked much better on 28-MAY-2021. The patient reported he was not on any blood thinners. Company Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.

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

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

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

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

Admission Note: ? Weakness - Generalized Patient reports feeling weak prior to dialysis, but demanded clinic to perform dialysis. Had full tx done and brought to ER. Reports still feels weak after dialysis. 84 year old male comes in today after completing dialysis for evaluation of generalized weakness x 5 days. He has also lost his voice. He tells me he received his COVID vaccine yesterday, but he is concerned he may have COVID. He denies any fevers, cough, sore throat, NVD, abd pain. Transfer Note: HOSPITAL COURSE: Patient is a 84 y.o. male who presented with shaking chills and was found to have Gram-negative rods in the blood. The source of infection was unclear. Initially it was thought that it could possibly be cholecystitis but imaging was negative for that. There was concern that it could be UTI but the patient is on dialysis and is an uric and therefore no urinalysis could be got. Early this morning when I saw the patient the patient did have significant pain and tenderness in the right knee and is not able to put weight on that. I.e. Consulted Dr. Today with per lumbar from Orthopedics who said that it would be in the best interest of the patient for him to be transferred to hospital where he could decide on aspiration and or washout of the right knee. Transfer center has been called and we are trying to finalize a transfer of the patient hospital at this point of time Please see problem list listed below. REASON FOR ADMISSION/ ADMISSION DIAGNOSES Sepsis cause unclear

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

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

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

Patient received first dose of Moderna COVID-19 vaccine on 2/3/21. Primary Care physician received call from coroner's office 2/8/21 asking for information contributing to cause of death. Per Primary Care Physician notes, wife states she and patient took turns shoveling snow on 2/4/21. On one trip back into the house she found him unresponsive on the floor and called 911. Paramedics were unable to revive patient and he passed away (2/4/21).

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

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

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

My grandpa got his second covid vaccine on Thursday. Saturday he complained of stiff neck. Sunday he had low grade fever, nausea and vomiting, chills, and mild headache. He was feeling bad enough to call squad at 3 pm. The paramedics did evaluation and thought he was just experiencing normal side effects from vaccine and felt no need to transport to hospital so my grandpa decided to stay home and just rest. At 2 am that same night he went into cardiac arrest and was not able to be brought back

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

DEATH Narrative: no documentation regarding any immediate reaction after vaccine administration. 83 y.o. male with pmh severe pulmonary hypertension, s/p TAVR last year, severe asbestos related lung disease on chronic oxygen, recently started on palliative care. Was found by daugher deceased on the morning of 2/11/2021. Autopsy declined by family.

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

NO IMMEDIATE ADVERSE EVENTS PRESENT FOLLOWING IMMUNIZATION. RESIDENT WAS ALERT, RESPONSIVE, TALKATIVE, WITHOUT COMPLAINTS, AND ENGAGING IN NORMAL ACTIVITIES AFTER IMMUNIZATION, AS WELL AS THE FOLLOWING DAY. HE WAS FOUND IN BED THE SECOND MORNING AFTER VACCINATION (AT 6:25AM) WITHOUT VITAL SIGNS AND HAD EXPIRED PEACEFULLY IN HIS SLEEP. HE WAS A DNR, NO LIFE SUSTAINING MEASURES WERE PERFORMED.

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

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

Death Narrative: On 2/12/21, patient was hospitalized at Medical Center with "leaking and swollen legs." Patient was transferred to hospital 2/13/21 for a vascular surgeon consult, where patient was diagnosed with lower extremity ischemia and acute diastolic heart failure. A bilateral, common endarterectomy with bovine angioplasty and bilateral iliac stent placement was performed on 2/17/21. Patient was discharged to a skilled nursing facility on 2/26/21. Patient had received first covid vaccination on 1/29/21. He was due to receive his second dose on 2/26/21, however, the appointment was moved to 3/10/21 since patient was hospitalized. Patient received his second dose on 3/10/21. Patient was hospitalized again (reason for hospitalization unknown) where he passed away 3/11/21 at hospital.

Patient passed away unrelated to covid vaccine Narrative: The patient had end stage COPD and placed in hospice care. Patient received first dose of Moderna vaccine on 1/20 and second dose of Moderna vaccine on 2/16. No adverse reaction was reported. Patient passed away at home on 2/24/2021. Cause of death not documented. No indication that death was related to COVID 19 vaccination.

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

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

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

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

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

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

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

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

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

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

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

This patient was admitted to Hospital, and subsequently transferred with acute coronary syndrome and cardiogenic shock two days after receiving a COVID-19 vaccination. He died of complications of acute coronary syndrome on April 17, 2021.

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

Patient died in his sleep 2 days after receiving 1st dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Patient died in his sleep 2 days after receiving 1st dose) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. Death occurred on 12-Feb-2021 The patient died on 12-Feb-2021. The cause of death was not reported. It is unknown if an autopsy was performed. Concomitant product use was not provided by the reporter. The patient's wife went to wake him up but he was found dead in his sleep. She was hearing impaired and was not able to give any other information. Treatment information was not provided. Action taken with mRNA-1273 in response to the events was not applicable. This is a case of sudden death in a 84-year-old male, who died 2 days after receiving ffirst dose of vaccine. Very limited information has been provided at this time.; Sender's Comments: This is a case of sudden death in a 84-year-old male, who died 2 days after receiving ffirst dose of vaccine. Very limited information has been provided at this time; Reported Cause(s) of Death: Patient died in his sleep 2 days after receiving 1st dose

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

This 84 year old male was a hospice patient and received the Covid shot on 2/24/21 . The patient died on 4/1/21. 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 felt unwell shortly after vaccine with profound weakness after 2nd dose. later developed SOB and was diagnosed with pneumonia (in March approximately 1 month after the second dose) subsequently had ongoing respiratory symptoms and was later diagnosed with pulmonary embolism/DVT in May

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

dead two weeks later, is that good enough for your "adverse event"? Are you using the data to be sure it's killing like you want? What do you want from me here?

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was Acute hypoxemic respiratory failure

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

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

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

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

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

Singles virus broke out within one week of receiving the 2nd COVID-19 vaccination shot. The patient reported to Dr who was then given 400 mg of anti-virals medication. Patient did not improve and was taken to Hospital on 5/17/2021. The Patient was transferred to Hospital on 5/26/2021 and then died on 6/4/2021.

Resident was given Moderna COVID vaccine dose #1 on 7/7/2021 around 10:40 am and was found deceased on 7/8/2021 at 4:10 pm. Member had no acute illnesses/adverse reactions identified prior to death.

PATIENT SPOUSE REPORTS THAT PATIENT RECEIVED VACCINE ON 1/4/2021 AND ON 1/5/2021 PATIENT'S ARM BEGAN TO TURN RED AND SWELL AT THE INJECTION SITE. THE SWELLING AND REDNESS BEGAN TO GO DOWN HIS ARM AND HE BROKE OUT INTO A RASH. PATIENT THEN BECAME SHORT OF BREATH. EMS WAS CALLED AND PATIENT WAS TRANSPORTED TO HOSPITAL, WHERE HE WAS TREATED FOR ANAPHYLACTIC SHOCK TO THE COVID MODERNA VACCINE.

Patient died 4 days after immunization. Probably unrelated to immunization, as patient has been in poor health and was receiving hospice services. I have no details related to his illness or symptoms. Daughter is the HIPAA/emergency contact and will have all the information needed.

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

Client lives alone and had dinner at his home with family members after the 4:40 appointment. Client stated that in general he did not feel well but did not give any specific symptom. Family states they asked the client to go to the ER and the client refused. Family states they helped the client to his chair in the living room and then left to go home. Family states that the client was found in his bedroom the next morning at 7:54 a.m. deceased.

Moderna COVID vaccine administered 2/9/21. Patient expired in home on 2/10/21, at around 2100. Patient had h/o CVA in2001 with long standing sequelae. On day of administration, team attempted to draw lab specimen with vein finder, but patient was possibly Narrative: Moderna COVID vaccine administered 2/9/21. Patient expired in home on 2/10/21, at around 2100. Patient had h/o CVA in2001 with long standing sequelae. On day of administration, team attempted to draw lab specimen with vein finder, but patient was possibly dehydrated. CG/wife reported to APRN on 2/10/21, patient was sleeping and snoring and then began to sleep more quietly. She checked on patient and found that he had no pulse and had passed away

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

Resident had Hx of DM T2, Hx of prostate CA. Started having swallowing difficulties in November. Increased c/o nausea and decreased appetite. 25% per meal average. Decreased energy to participate in activities and refused getting out of bed or meals. Was vaccinated on 1/13/21. Hospice care started on 1/25/21. Resident passed away 2/23/21.

Patient reported on 2/24/2021 to have expired on an unknown date during the interim between first dose and scheduled 2nd dose. On 2/24/2021, the person reporting death stated that patient died "last week." Patient is not known to us for primary care and vaccine was administered during a vaccine event at senior public housing. We have no further medical details about the cause of death or if it is vaccine related.

DEATH Narrative: Son stated that patient was doing well, still working and driving places. He stated that he called his son and stated that he wasn't feeling well and died shortly after that.

My father passed away on February 10th, 2021. On Monday, January 25th 2021, he said he is feeling very uncomfortable in his chest area. He thought it was severe acid reflux. He took Gas X for Acid Reflux and told us that he does not want to go to the hospital. On Tuyesday, January 26th, he felt that his Acid Reflux symptoms got worse, he still did not want to go to the hospital. He took Tums. On that evening, he started having shortness of breath. We took his BP at home and it was very low. We begged him to go to the hospital, he still did not want to go. On Wednesday, January 27th, his shortness of breath got worse and we convinced him that he has to go to the hospital. We took him to ER. Doctor said that he had a heart attack on Monday morning and that is why he was not feeling well since Monday morning. While at the hospital, while the cardiologists were monitoring him, his heart condition got worse. By Friday, February 5th, cardiologists said that he is very fragile, his heart condition is very fragile and he won't survive any procedure. They said that something triggered the heart attack. We told them about the vaccination on 1/13/2021. They sent him home on hospice on Friday, Feburary 5th, 2021. He was on supplemental oxygen when he came home. He passed away due to a heart attack on February 10th, 2021 around 9pm.

Patient had been admitted to hospice care on 11/3/20. He reportedly declined in health and died 2/12/21.

DEATH Narrative: No information available in the record other than date of vaccine on 1/7/2021 with no adverse effects or complications noted during observation period. Patient was not known to have had COVID infection prior to death. Had last received medical care at facility in 2012 except received audiology care up to 12/2/2020. No recent hospitalizations known. No death note or autopsy noted. Only indication of death is the updated banner/date of death in demographics. Death most likely due to advanced age (84 y/o) in addition to comorbidities.

Patient passed away unrelated to covid vaccine Narrative: The patient had hypertension, diabetes, hyperlipidemia and sleep apnea. Patient received first dose of Moderna vaccine 1/15/2021 and no adverse reaction was recorded. Clinical staff called to review patient's intent for second dose, patient is not interested and has elected to not receive second dose following clinical discussion of the risks and benefits of the COVID-19 vaccination. Patient was called on 2/17/2021 and his son stated patient passed away on 2/6/2021.Cause of death not documented. No indication that death was related to COVID 19 vaccination.

Pt received his first covid 19 vaccine on 3/9/2021 and tested positive for Covid 19 on 2/11/2021- he progressed to covid 19 pneumonia with hypoxia and was hospitalized from 2/25-2/27 for covid pneumonia treated with remdesivir, oxygen, decadron and antibiotics and was discharged home. He was doing well and recovering and the received his 2nd covid 19 vaccine on 3/9/2021 and the following day developed fever of 102 and shaking chills, severe weakness, cough and sob and 911 was called and he was admitted to the hospital with possible vaccine reaction/pneumonia. He tested positive on pcr for covid 19-he was treated with zosyn, oxygen, ivf and PT and discharged on 3/12/21 home.

I could not wake him up fully in the morning after the shot. He was terribly lethargic. Instead of him using the rollater to come from his bedroom I got the wheel chair out of the care and got him to the table where I fed him a little breakfast. His blood pressure was low then high (I don't now have the readings) By 5 pm I called the ambulance. He was in the hospital until I transferred him to hospice 6 days later. He died in hospice 4 days after that.

2 days after receiving the second moderna vaccine my father experienced a stroke. He was transported to the emergency room medical center where he went thru a procedure to remove a clot in his left side brain. Prior to this vaccine my father was in good health and was very active and still works and owns and operates a restaurant. He has never had any problems like this before the vaccine. One day after the vaccine he was complaining about a pain on the left side of his neck area. He was doing paperwork at approx 7:40pm when he experienced the stroke. I had to call 911. My father is currently at the medical center recovering from the incident.

Narrative: Per primary provider required hospitalization due to atrial fibrillation with RVR and heart rate in eh 150s. Was subsequently seen by cardiology with additional work-up. Cardiologist noted, "Unclear if presumed new systolic heart failure is related to longstanding atrial fib with RVR (tachycardia cardiomyopathy) or CAD with ischemia causing atrial fib and LV dysfunction. I explained both scenarios to pt and daughter." per 3/10/2021 Note. Per primary provider patient was verbally informed they though potentially related to vaccine.

2 days following vaccine patient had a cardiac arrest at home. Very likely this arrest was due to his underlying medical conditions and not the vaccine, but it is technically possible the vaccine put additional stress on his system.

Heart failure; Renal failure; Acute renal failure; Cardiac dysfunction; Shortness of breath; Not producing urine; Lower extremity edema; A spontaneous report was received from a physician concerning an 85-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure. The patient's medical history, as provided by the reporter, included COVID-19 three months ago. Patient had no prior history of heart failure. No Concomitant medications were reported. On 05 Mar 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection. After four days, the patient presented at the hospital with a constellation of symptoms including shortness of breath, lower extremity edema, acute renal failure, cardiac dysfunction, not producing urine. Patient was determined to be in renal failure and heart failure. For treatment of the events the patient was admitted to the hospital. Action taken with mRNA-1273 in response to the events was not reported. The seriousness criteria for all the events was hospitalization. The outcome of the events, shortness of breath, not producing urine, lower extremity edema, acute renal failure, cardiac dysfunction, renal failure, and heart failure 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.

Unknown what if any adverse event may have occurred. This report is being submitted following a periodic review of death certificates . Death certificate for this individual indicates "COPD - Decline Acutely After COVID Vaccine 1st Dose" in "PART II. OTHER SIGNIFICANT CONDITIONS contributing to death but not resulting in the underlying cause"

Patient admitted to the hospital 3/16/21 2 weeks post #2 Moderna COVID-19 vaccination with sepsis, atypical pulmonary infiltrates, and hypoxia. Patient treated for pneumonia and discharged home 3/19. Patient readmitted to hospital 3/31/21 with dyspnea, CT with worsening miliary appearing pattern.

after receiving his initial dose the next day he seemed to have suffered a TIA that took almost a week for him to recovery from. He was confused, no appetite, weak, and generally not himself. Prior to receiving his second dose he was alert, eating, no complaints of any discomfort or issues. The next day following his second dose he passed away from what we think was a massive heart attack. As a family we feel his weakened state contributed to this and not the fault of the vaccine but felt it important to notify you in case individuals such as patient should be monitored in a different way or use a different vaccine.

death Narrative: Patient received COVID vaccine #1 on 12/30/20 and #2 on 2/1/21. He was an inpatient in the facility and had been under hospice care since 12/9/20. No adverse events to vaccine found per notes. On 2/27/21, he began to have short and rapid respirations and was unresponsive. He was given morphine, atropine sublingual, lorazepam and nebulizers per hospice care orders and was determined to be imminent. On 2/28/21 at 2230, he passed. No autopsy results available. 27 days from date of vaccination to date of death.

E83.42 - Hypomagnesemia R77.8 - Elevated troponin A41.9, R65.20 - Severe sepsis (CMS/HCC) R50.9 - Fever, unspecified fever cause A41.9 - Sepsis, due to unspecified organism, unspecified whether acute organ dysfunction present (CMS/HCC) R41.0 - Delirium N39.0 - Urinary tract infection A41.9 - Sepsis (CMS/HCC)

death Narrative: Patient received Moderna covid #1 on 1/9/21 and #2 on 2/8/21. On 2/24/21, he was sent to the ER at a facility from a nursing home where he was admitted for skilled nursing care. He was sent to the ER due to fever, decreased mental status, renal failure, possible UTI and possible pneumonia. He was admitted and received IV fluids, Zosyn and Solu Medrol. On 2/26/21, a consult was placed for hospice care and he was accepted for hospice care at a contract nursing home. Upon review of scanned records, it appears he had a stroke/intercranial hemorrhage on 2/10/21 and that is why he was admitted to the nursing home for skilled nursing services. A date of death of 3/18/21 is recorded. No autopsy results recorded. 38 days from vaccine #2 and date of death.

Death Narrative: Patient was not previously Covid positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 84 with comorbidities of CKD, COPD, Coronary arteriosclerosis w/ 2 stents. Death was reported by daughter and unclear of the cause.

This 85 year old male received the Covid shot on 2/23/21 and subsequently died on 4/15/21. 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.

Lung infection/ pneumonia/lower left lungs affected; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (Lung infection/ pneumonia/lower left lungs affected) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037421B) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history reported). On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PNEUMONIA (Lung infection/ pneumonia/lower left lungs affected) (seriousness criterion medically significant). At the time of the report, PNEUMONIA (Lung infection/ pneumonia/lower left lungs affected) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: lower left lungs effected due to pneumonia (abnormal) Lower left lungs effected due to Pneumonia. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The Patient was tested negative for COVID .He has not provided any concomitant medication information.The Patient has his 2 dose scheduled for 23 Apr 2021 and wants to know if he can extend the time frame to get his second dose. Treatment information was not provided. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Expired in between Dose 1 and 2. Non-vaccine related. Death Certificate indicates, COPD, Type 2 Diabetes & hypertension

Patient died on April 12th 2021. Not sure exactly what the cause of death but that he was losing blood in in his somewhere. He resided in a nursing home, and was taken to the hospital where he later died

Case tested positive for COVID-19 on 12/7/2020; vaccinated on 1/8/2021 and 2/5/2021 with Moderna; re-tested positive for COVID-19 on 4/1/2021. Case was admitted to hospital on 4/2/2021 for surgery due to a previous fall. Case had altered mental status and fever. Case was found to have an acute CVA.

Received Moderna Dose #2 on 3/10/2021. About 1-2 weeks after, he started experiencing swollen leg (unsure if left or right), had shortness of breath, and looked pale on 4/22 he was seen by a provider and was prescribed oxygen, later that night he passed.

Patient was seen by an outpatient provided and was referred to emergency department due to hypoxis and respiratory distress on 4/27/21. He was found to by COVID-19 positive at that time. He was admitted to the hospital for further management. on 4/28/21, his condition declined. He was intubated and transferred to the ICU. Patient went into severe acute kidney injury and eventually into multi-system organ failure. He was placed on comfort measures on and was pronounced dead on 5/15/21.

Patient presented to the ED and was subsequently hospitalized several times within 6 weeks of receiving COVID vaccination. Dates include: 2/24/21, 3/2/21, 4/17/21. Patient presented to the ED on 4/29/21 with NSTEMI and 5/7/21 with dizziness.

Patient appeared to have had suffered a stroke. Admitted to hospital, tests determined no stroke. Patient had pneumonia, and severe inflammatory response. Sepsis.

Death 3/31/2021 Causes of death listed on death certificate: 1) Cardiac arrest 2) covid 19 pneumonia

The patient's daughter reported he had been feeling fatigue since his COVID vaccine on 5/10/21 along with frequently feeling cold. On 6/27/21, the patient had an out of hospital cardiac arrest with prolonged CPR, reportedly continuing for 25 minutes. He was diagnosed with hypothyroidism resulting in myxedema coma. After the cardiac arrest, he was also found to have severe left ventricular systolic dysfunction (ejection fraction of 10%), a small cerebellar stroke, and progression of his chronic CKD to end stage renal disease. He was also intubated during the cardiac arrest and remained on a ventilator as of today (7/4/21). With all sedating medications held for 6 days, he has had no apparent meaningful neurologic function.

Death. Found resident expired in bed, hands gripped on his gown over his sternum at 6:15am on 6/14/21. He had no complaints of discomfort before going to bed or overnight.

Blood clots; felt he was having a heart attack; He lost control of his ability to walk; Became Worse; He lives a sad limited life; Angry; Purple like having a blood clot; Pain; Completely ill/sick; Weaker Heart; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) and MYOCARDIAL INFARCTION (felt he was having a heart attack) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Cancer (Was on Chemotherapy and radiation treatment), Handicap, Penicillin allergy, Sulfonamide allergy (Sulfa) and Drug allergy (Morphine). Concomitant products included APIXABAN, FUROSEMIDE and METOPROLOL TARTRATE for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced THROMBOSIS (Blood clots) (seriousness criteria hospitalization and medically significant), MYOCARDIAL INFARCTION (felt he was having a heart attack) (seriousness criteria hospitalization and medically significant), CARDIAC DISORDER (Weaker Heart), VACCINATION COMPLICATION (Completely ill/sick) and VACCINATION SITE PAIN (Pain). On an unknown date, the patient experienced GAIT DISTURBANCE (He lost control of his ability to walk), CONDITION AGGRAVATED (Became Worse), DEPRESSED MOOD (He lives a sad limited life), ANGER (Angry) and VACCINATION SITE ERYTHEMA (Purple like having a blood clot). The patient was hospitalized from 17-Feb-2021 to 26-Feb-2021 due to MYOCARDIAL INFARCTION and THROMBOSIS. At the time of the report, THROMBOSIS (Blood clots), MYOCARDIAL INFARCTION (felt he was having a heart attack), CARDIAC DISORDER (Weaker Heart), GAIT DISTURBANCE (He lost control of his ability to walk), CONDITION AGGRAVATED (Became Worse), VACCINATION COMPLICATION (Completely ill/sick), DEPRESSED MOOD (He lives a sad limited life), ANGER (Angry), VACCINATION SITE ERYTHEMA (Purple like having a blood clot) and VACCINATION SITE PAIN (Pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The first dose of Moderna vaccine reportedly given on 08 Jan 2021. The patient's wife reported that he would not take the second shot. However, it was reported that patient's events started 10 Feb 2021, 2 days after vaccination. Therefore, the date of first dose and whether patient received second dose (and if he did, on what date) are unclear. Patient has received home therapy. Patient stated that on 22 Jun 2021 his health was failing daily and he had radiation from his cancer treatments in his body when the shot was given. It was felt the shot had taken his health to a point of no return - "bad call on the people who set him up for the shot and did not screen his health ". 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 22-Jun-2021: Patient details, medical history, and suspect product details were updated. Events and concomitant medications were added. Case upgraded to serious.; 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.

Cardiogenic shock, Respiratory failure, Ventricular fibrillation, thrombocytopenia, Acute Stroke, seizure, acute deep venous thrombosis

1st adverse event on Feb 16th was a testicular infection. this may have been unrelated to the vaccine, but occurred 10 days after the 1st dose. Then, on Feb 17th my dad had severe chest pressure/pain. He was admitted to the hospital and diagnosed with Congestive Heart Failure. His EFR was 35, where a previous test 1 year prior had registered 45-55.

Myasthenia Gravis; Death; Hallucinations; confusion; shortness of breath; dizziness; stroke like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death), MYASTHENIA GRAVIS (Myasthenia Gravis) and HALLUCINATION (Hallucinations) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart attack (20 years ago). On 25-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 MYASTHENIA GRAVIS (Myasthenia Gravis) (seriousness criteria death, hospitalization prolonged and medically significant), HALLUCINATION (Hallucinations) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms). The patient died on 12-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HALLUCINATION (Hallucinations), CONFUSIONAL STATE (confusion), DYSPNOEA (shortness of breath), DIZZINESS (dizziness) and CHEST DISCOMFORT (stroke like symptoms) outcome was unknown. Patient started experiencing side effects 2 weeks after taking the vaccine. He was taken to the hospital for stroke like symptoms but it was ruled out by X-ray. He went to the hospital as symptoms persisted & got admitted on 13March2021. He died 24 hour later after being diagnosed with Myasthenia Gravis and thymus removal refusal. Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter. Very limited information regarding the events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: unknown cause of death

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

Patient was found unresponsive. Code blue was called. Patient was taken to hospital for evaluation. Was evaluated at hospital. Labs and vital signs were normal and returned to facility prior to clinic ending.

Resident passed away at 8:15 am on 1/28/21-found to be without pulse/respirations/DNR order in place.

[Casirivimab/indevimab] treatment under Emergency Use Authorization(EUA): Infusion started at 9:45 and was stopped at 11:00. At 11:30 Patient developed SOB and drop in Sat from >96% to 88%. Patient had a large cough and expectorated a quarter size of brown phlegm. Code blue was activated, patient placed on NRB 180/81, 72, 24, 91%. Patient was AAOx3 and talking during this time. Patient transferred to the ER gurney and transported to ER for further evaluation. From H&P: tested positive for COVID-19 outside facility on 1/22 w/onset of covid sxs on 1/18 after returning from hunting trip with son on 1/17. Patient s/p Moderna vaccine #1 on 1/14/2021. Initially symptoms were just fatigue, cough, and chills and then spiked low grade fever on 1/20. Patient began to experience weakness and difficulty walking on 1/24 and fell from standing on 1/25 and possibly hit his head but without LOC. Patient presented to ED complaining of SOB that began after receiving monolconal antibodies about an hour PTA. Patient states that prior to the infusion, he was not feeling overly short of breath. After the transfusion, a code blue was called in the parking lot due to the patient becoming light-headed and short of breath - he never lost pulses. Upon arrival to the ED, he was in obvious respiratory distress and O2 sats were 92% on 15L NRB and patient switched to BIPAP. Patient given dose of epinephrine injection,after which he states he began feeling better.

REC'D CALL FROM PT'S SON, PT HAS BEEN ON HOSPICE CARE AND PASSED 1/26/21. DOES NOT BELIEVE THIS IS RELATED TO VACCINE ADMINISTRATION, BUT WANTED TO REPORT TO US.

Patient experienced audible crackles and low oxygen levels starting around 5:30pm the date of the vaccine. His heart rate spiked to 112bpm and he was given oxygen and Lasix 40mg. He was sent to the hospital and diagnosed with acute systolic CHF

My dad received his first COVID vaccine on January 14, 2021. On January 16, 2021 he ate breakfast around 7:00 am and went back to his room. When the staff checked on him around 8:00 am they found my dad unresponsive. His blood pressure was over 220 and his pulse was 43. They began manual CPR until the paramedics arrived, but my dad died.

Patient is deceased. Family called the pharmacy on 2-17-21 to let us know he would not be coming for his second appointment. When the pharmacist tried to call the family back for more info, the phone number on file doesn't work.

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

pt did not feel ill or had mild symptoms after 2nd dose of vaccine. 4 days later patient developed fever of 101 and not controlled with acetaminophen. Temp increased to 103 and patient taken to ER and then diagnosed with pulmonary embolism. Patient still hospitalized. Not sure if related to vaccine.

Vaccination and observation period successfully completed without adverse event. The patient's significant other reported neither of them were feeling well on 2/21/2021. Approximately 28 hours after vaccination, the patient was found unresponsive in the bathtub. EMS arrived within 5 minutes, resuscitation attempt was unsuccessful, CPR terminated at 1503 and the patient pronounced dead. The Medical examiner refused the case on the basis of lack of jurisdiction, and the remains were moved to a local funeral home. No autopsy was performed. This event is not thought to be related to the vaccination event or the vaccine, the death is thought to be from natural causes.

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

was reported to staff at Health Department that client passed away hours after receiving Moderna vaccine, also reported that client had multiple health conditions.

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

Atrial fibrillation; Cold body temperature especially in the feet; fast heart rate; dizziness; A spontaneous report was received from a consumer regarding her husband, an 86-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) experienced fast heart rate/heart rate increased, cold body temperature/coldness, dizziness and atrial fibrillation. The patient's medical history was not included. Concomitant medications were not reported. On 27 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 06 Feb 2021, approximately 10 days after the patient received the vaccine, he experienced a fast heart rate, dizziness, cold body temperature, and atrial fibrillation. (The wife reports that they purchased an EKG machine, and this is what the machine showed them. Unaware if he had this before the vaccine or not.) Treatment information was not provided. Action taken with mRNA-1273 was unknown. The outcome of the events, fast heart rate, cold body temperature, dizziness and atrial fibrillation, was unknown.; Reporter's Comments: Although a temporal association exist, the event occurred 9 days after vaccine administration and very limited information regarding this patient's medical history concomitant medications were event is also confounded by the patient's advanced age. Further information has been requested.

Thrombocytopenia. Platelet count at the time of the first iinjection on Jan 28 , 2021 was 92. The following values were noted: 2/3 = 106 2/18 = 59 Second injection Feb 25, 2021 2/26 = 46 3/5 = 41 Patient experiened no symptoms. The oncologist bellieves this is ITP. The patient was started on Prednisone 60 mg po daily on 3/7/2021 until further notice.

Resident on palliative/comfort care services since readmission to facility on 2/9/2021. Received first dose of Moderna COVID-19 vaccine on 1/7/2021. Received second dose of Moderna COVID-19 vaccine on 3/8/21. G-tube feeding discontinued on 2/14/21. Resident expired 3/10/2021.

Narrative: Dose #1 of vaccine was administered 2/6/21, per daughter's report patient became ill 3 days later (cough) and was taken to local hospital and was discharged with diagnosis of CAP, NSTEMI and acute on chronic CHF exacerbation. Discharged home on hospice where he passed away at home on 2/20/21.

Moderna COVID-19 (mRNA-1273) vaccine treatment under Emergency Use Authorization(EUA): The decedent received the shot at 4:30pm and was found deceased at 10pm the same day.

TIA We are in and do not have the Lot # with us. Will have at home and will return the first of April.

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

Congestive Heart Failure; fluid on lungs; He was found to have fluid on the heart; Shortness of breath; Stroke; A spontaneous report was received from a family member concerning reporter's husband who was also a 86-years-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced stroke/cerebrovascular accident, congestive heart failure/cardiac failure congestive, he was found to have fluid on lungs and hear /pulmonary oedema and pericardial effusion and shortness of breath/dyspnoea. 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: 027L20A) on 23 Jan 2021. On 20 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly for prophylaxis of COVID-19 infection. On 21 Feb 2021, the patient had a stroke. The patient consulted with general practitioner on 22 Feb 2021 who ordered a magnetic resonance imaging (MRI). Patient started to develop shortness of breath on 22 Feb 2021. The MRI on 24 Feb 2021 confirmed that the patient had suffered a stroke. On 05 Mar 2021 the patient went to the emergency room with shortness of breath. The patient was diagnosed to have fluid on the heart and lungs and with congestive heart failure. Treatment for the events included Clopidogrel and aspirin. 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 the events were not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Client reports being taken to ER on 3/11/21 with symptoms of atrial fib. Was hospitalized from 3/11/21 to 3/12/2021.

Patient had his Vaccine on 2-28-2021. Patient passed away on 3-3-2021. Do not know the cause, just found out from our tech and thought we should report it in case.

Patient's wife came into our clinic today for her second Moderna dose and reported to us that her husband (the patient) had died on March 28, 2021 of a NON-COVID cause. She did not specify how he died. She gave us his vaccine card in case we needed to do anything with it. This RN is reporting as the client died roughly two weeks after administration of the 1st dose and it was reported directly to the facility, although the death is not COVID related according to the patient's wife.

Patient was in usual state of health when received first Covid Moderna vaccine on 2/2/21 and did fine until about 2/17. He started c/o discomfort and appetite decreased. 2/18/21 had low grade fever. 2/22 fever and generalized weakness and abnormal labs (elevated potassium). 2/22 hydration was started. 2/25 antibiotic started for UTI for 7 days. Patient seem to improve except appetite. Since vaccine, patient remained on frequent IV hydration and had poor appetite through February into March. On 3/2/21, patient received 2nd dose of Moderna Vaccine while on Augmentin for UTI, issue with dehydration and appetite. By 3/4/21, patient was noticed to have trouble chewing and swallowing. Speech was ordered. On 3/5/21, it was noted patient had continued poor appetite, weakness, dehydration risk, debility. On 3/8/21, it was noted patient had intermittent confusion. By 3/10/21, patient was more alert. Patient remained fairly consistent from that time with poor appetite, dehydration issue, weakness and dysphagia management. Then on 3/27/21 he became disoriented, wheezing, labored breathing, Vitals were 92% oxygen on room air, Temp 97.5, 158/62, pulse 94. Oxygen started and sent to ER. Family reported patient is admitted to hospital with mild stroke and UTI. The vaccine seemed to change patient's state of health about 2 weeks post first dose with multiple sequelae. This seems similar to timing of actual COVID infection pattern when it is the actual virus.

EXPIRED Narrative: 86 y/o male who received first dose of COVID-19 vaccine (Moderna) 1/22/21 and never returned for second dose. COVID-19 clinic alerted the pharmacist that patient expired prior to receiving second dose. Unknown reason.

This 86 year old white male received the Covid shot on 4/10/21 and died on 4/22/21. 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.

This 86 year old white male received the Covid shot on 03/06/21 and died on 04/26/21 . 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.

On or about April 17 he began having shortness of breath with exertion. On or about May 1 he began having severe right flank pain. May 3 he went to the ER a Bilateral pulmonary embolism diagnosed.

patient says they got a STEMI (from a clot) and is now in the hospital. also left arm bruise where shot is.

He developed an unprovoked DVT in his right leg that led to a pulmonary embolism that led to severe pulmonary hyperttension that led to dyspnea on exertion.

One week after receiving the injection, patient went into complete kidney failure. Patient died on May 14, 2021

Breakthrough? Diagnosed with Covid on Oct 2. Had Moderna vaccine on February 17 and March 17. Had heart attack on May 11 and at that time, tested positive for COVID again at that time.

Ischemic stroke 4 days post vaccination. Residual deficits but with no evidence of embolic source in hospital during evaluation. Vaccine administered - 3/4/21 Date of stroke - 3/8/21

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

Patient received his second Moderna vaccine on 02-24-21. He began to experience chest pains on mild exertion on 02-26-21. He then suffered a heart attack on 03-08-21 and passed away.

Patient began experiencing Shortness of Breath, which increased until he had to be transported to the ER on 3/26/2021. He was diagnosed with severe Congestive Heart Failure, with an injection fraction of 15% and kidney function below 30%. He was released to hospice care 4/5/2021 with Pleur-Ex drains to both lung areas. He continued to get worse, including TIAs, until he died on 5/31/2021.

White blood cell count almost doubled one month after the second vaccine and nearly tripled 6 weeks after the second vaccine. Patient was placed on hospice on April 23rd and passed away on May 8th.

About one month after vaccination (second dose) patient experienced increased shortness of breath. Patient followed up with cardiologist and they conducted a stress test and a heart monitor. Heart monitor reported atrial fibrillation resulting in change of medication. Patient still experiencing shortness of breath.

Resident had body aches, a low O2 sat and had chills starting on 12/30/20. He had stated that they had slightly improved. On 1/1/21 he sustained a fall with a diagnosis of a displaced hip fracture. On 1/2/21 during the NOC shift his O2 sat dropped again. He later went unresponsive and passed away.

Got vaccine on 1/15/21. He was tired right away, bedridden the next 3 days. He couldn't breathe so he was taken by ambulance on 1/18/21. He was in hospital for several days. put on remdesivir cocktail for 10 days. Slowly getting worse and died in hospital on 1/30/21.

presents to the ED with Chief Complaint: CHEST PAIN. It is described as pressure and it is described as located in the central chest area. This started 0500. No nausea, vomiting or diaphoresis. Patient states he awoke in morning with feeling that he had palpitations as well as central subtle chest pressure. He has had difficulty breathing and state CP seems to be worse with deep breath. IN ED Vitals were ( Temp: 98.8 F. BP: 150/98. MAP: 115. HR: 166. O2 saturation: 85% on RA) and Initial HR was concerning for A-Fib with RVR, HR 166, was given IV Dilt 20 mg IV with excellent response and F/U HR was in 80s and was transitioned to PO Dilt (30 mg Q8) and was started on new anticoagulation for a-fib.

on 2/13 at 7:30am resident was observed congested, foaming at the mouth. transferred to the hospital, verbal report from hospital nurse stated the resident was admitted for hypercalcemia and dehydration. The resident expired on 2/14/21 at 9:30am. Died on 2/14/2021

Patient described feeling nervous, anxious the next morning (Wednesday) after the vaccine. He later fell in the bathroom after using the restroom, his legs gave out (his words) and consequently was on the ground for 23 hours before being transported to the hospital. That was Thursday afternoon. He was diagnosed with COVID-19 on Saturday night and died the following Friday morning.

Patient called son around 6:30am on 2/18/21. When son tried to contact patient around 8:30am, he was not able to get a hold of patient. Son sent someone over to check on patient. They found patient on the floor. He was coherent at first but then lost consciousness. It believed he experienced a stroke sometime around 8:30-9:00am of 2/18/21. Patient was taken to hospital and then transferred to another hospital. He was put in a medically induced coma. He passed between 4:00 and 4:30 pm on 02/19/21.

Was given vaccine around 1:30Pm on 2-11-2021. He and his wife waited in the building for 15 minutes and then left. he denied complaint. (He was waiting to have both Covid shots before he went to cardiologist Re: CAD.) He had an alarm going off in his house, was going to basement to check it out. Police officer heard alarm, came into house, & heard a thud when Doc fell. He was in PEA (Pulseless Electrical Activity) when brought into ER. Given 5 "rounds of Epinephrine with no response.

I was notified on 2/22/21 that this patient passed away over the weekend. I do not know the details, nor can I confirm anything beyond what I was told. I believe the death occurred on 2/20/21 due to a massive stroke.

patient became unresponsive with acute L side hemiparesis on 2/20/2021. Hospitalized and dx'd with small vessel ischemic CVA. Reporting via this system as a serious event occurred within 12 days of COVID vaccination#2 administration, tolerated vaccination #1 well and minimal AE reported initially after 2nd vaccination.

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

headache; atrial fibrillation with abnormal heart rate; A spontaneous report was received from a consumer concerning a 87 years old, male patient who experienced atrial fibrillation with abnormal heart rate/ PT: Atrial fibrillation and mild headache. The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included unspecified medications. On 03 Feb 2021 (at 2:01 pm), approximately three hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. On 03 Feb 2021 (at 5:00 pm), approximately 3 hours later, the patient experienced atrial fibrillation with abnormal heart rate. The patient's heart rate was 145. The patient went to the emergency room and the cardiologist gave him a pill to lower the heart rate. The patient was also told to take his regular pills and was sent home. The patient reported having atrial fibrillation for the past five days and that he had a scheduled appointment with his health care professional for an EKG on another date. On an unknown date, the patient also reported that he experienced mild headache. The event atrial fibrillation with abnormal heart rate was considered medically significant. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the events, atrial fibrillation with abnormal heart rate and mild headache, was not reported.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested.

received a phone call from the daughter of the patient. On 01/21/2021, patient came in and got his first Covid Vaccination. 3 days after the vaccination, the patient experienced really bad diarrhea, and was sleeping for 22 hours a day. 2 weeks later he perked up a little bit. On 02/23/2021, patient received his booster. Daughter states that 2 days later, patient shut down completely, not eating or drinking. The patient ended up passing away on 03/05/2021.

Atrial fibrillation "AFib" - Heart Rate of 150 BPM; A spontaneous report was received from an 87-year-old male patient, who experienced Atrial fibrillation - Heart Rate of 150 BPM. The patient's medical history included Atrial fibrillation (Afib). Relevant concomitant medication included amiodarone. The consumer received the first of the two planned doses of mRNA-1273 on 03-FEB-2021 intramuscularly for prophylaxis of COVID-19 infection. On the same day, he experienced Atrial fibrillation - Heart Rate of 150 BPM. No treatment information was provided. On 04-MAR-2021, the patient received the second of the two planned doses of the mRNA-1273 in an unknown route. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the event Atrial fibrillation "AFib" - Heart Rate of 150 BPM was resolved. The report's causality assessment was not provided for the event. Follow-up received on 05-MAR-2021 included Atrial fibrillation (Afib) as the consumer's historical condition. Consumer reported that he was in Afib for about 9 days. Doctors changed some of his medications that has helped with his condition. Consumer had his second dose of the vaccine on 04-MAR-2021 and has had no issues with AFib.; 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 passed away unrelated to covid vaccination Narrative: The patient had hx of chronic heart failure on palliative milrinone with hospice. Patient received his first dose of Moderna on 1/11 and patient had a prior positive PCR on 1/12/2021. Patient passed away on 1/27/2021. Family member stated patient didn't seem to be struggling for breath, any pain or other discomfort. Cause of death is not related to COVID 19 vaccination.

Possible pneumonia; Kidney stone; A spontaneous report was received from a consumer concerning a 81-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced kidney stone and possible pneumonia. The patient's medical history included coronary artery disease, prostate cancer and skin disease - itching and eczema. No relevant concomitant medications were reported. On 19 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Batch Number: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unspecified date, the patient developed kidney stone and was hospitalized on 19 Feb 2021. Patient's status of kidney stone was unknown. On an unspecified date, the patient experienced pneumonia. Second vaccine date was outside dosing interval. No treatment information was provided. Action taken with mRNA-1273 in response to the events kidney stone and pneumonia was not reported. The outcome of the events kidney stone and pneumonia was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.

He was taken to hospital 2/27/2021 for respiratory problems, diagnosed with pneumonia and died in hospital.

The patient apparently woke up in the morning and told his wife that he was tired and went back to bed and did not wake up.

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

PATIENT'S SON CALLED ME. BP 141/85, TEMPERATURE 99.2, COUGHING, SLEEPY, VERY SHORT OF BREATH, RAPID HEART BEAT. DUE TO THE SHORTNESS OF BREATH & RAPID HEART RATE, PT'S MEDICAL HISTORY, I RECOMMENDED THAT THE PT GET CHECKED OUT. HE WENT TO THE HOSPITAL & WAS ADMITTED. ON A FOLLOW UP CALL,HIS SON INDICATED THAT PT HAD PNEUMONIA.

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

.Mandatory EUA Reporting - Received 2nd Moderna Covid vaccine on 2/26. Admitted to hospital on 3/10 with pneumonia and COVID positive. Patient's son was living with him and Covid positive. Failed treatment with abx, steroids, oxygen. Transitioned to comfort care and passed away on day 8 of hospitalization.

Death Narrative: Patient received his first dose of the Moderna COVID-19 vaccination on 3/4/2021. He presented to facility 03/05/2021 for shortness of breath. He was originally treated for COPD exacerbation and COVID-19 was ruled out by negative testing. He was then found to have blood cultures positive for E. Faecalis. He was treated with broad spectrum antibiotics. His lack of improvement in respiratory status was the cause of discharge to hospice after which he died on 3/30/2021.

LOWER LIMB EMBOLISM-BLOOD CLOT, TIGHTNESS, HEAT AND PAIN WHEN WALKING, TREATING PHYSICIAN COULD NOT CONTRIBUTE TO ANY OTHER HEALTH CONDITIONS OR REASONS

Death Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was 86 but did not have a lot of history of receiving medical care in the system. There is note mentioned his death in the chart. His possible contributing comorbidities are advanced age, HTN, HLD, DM, mitral valve insufficiency.

Death Narrative: The patient did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. Patient transported to ER on 1/14/21 after receiving first COVID-19 vaccine earlier that day. He was reported to have a reaction to the vaccine including diaphoresis, new onset afib, and hypotension(vasovagal reaction). He was discharged the next day with no signs of afib. Patient was later hospitalized around 1/28/21 for COVID pneumonia. He later passed away on 2/5/21 due to hypoxic respiratory failure secondary to COVID-19. Comorbidities include advanced age, obesity, HLD, atherosclerosis, DM2, HTN.

Patient developed swelling of his upper and lower lip on 4/11 and was given 25 mg benadryl at the care home. Swelling subsequently worsened and 911 was called, with EMS noting SpO2 at 88%. He was transported to the ER and found to have CHF/pulmonary edema and NSTEMI. Comfort care measures were implemented and he died 4/15.

Patient presented to the ED and was subsequently hospitalized with sepsis, respiratory failure and pneumonia on 3/2/2021. Patient presented to the ED and was subsequently hospitalized with pneumonia on 3/22/2021. Patient presented to the ED and was subsequently hospitalized with sepsis on 3/31/2021. He died on 4/4/2021.

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

Upon reviewing patient's need for 2nd dose of Moderna, patient's power of attorney informed me that the patient passed away on 5/11/21 without any further information disclosed.

ED to Hosp-Admission Discharged 3/8/2021 - 3/9/2021 (14 hours) Hospital MD Last attending ? Treatment team Dementia without behavioral disturbance (CMS/HCC) Principal problem Discharge Summary MD (Physician) ? ? Internal Medicine Inpatient Discharge Summary BRIEF OVERVIEW Admitting Provider: MD Discharge Provider: MD Primary Care Physician at Discharge: CRNP Admission Date: 3/8/2021 Discharge Date: 3/27/2021 Discharge Diagnosis Hospital Problems POA * (Principal) Dementia without behavioral disturbance (CMS/HCC) Yes Aortic stenosis Yes Atrial fibrillation (CMS/HCC) Yes Chronic obstructive pulmonary disease (CMS/HCC) Yes Congestive heart failure (CMS/HCC) Yes Coronary artery disease with history of myocardial infarction without history of CABG Not Applicable Depression Yes History of aortic valve replacement Not Applicable Hyperlipidemia Yes Hypertension Yes Peripheral vascular disease (CMS/HCC) Yes Ambulatory dysfunction Yes Dementia (CMS/HCC) Yes CKD (chronic kidney disease) Yes History of TIA (transient ischemic attack) Not Applicable Dementia with behavioral disturbance (CMS/HCC) Unknown DETAILS OF HOSPITAL STAY Presenting Problem/History of Present Illness/Reason for Admission AKI (acute kidney injury) (CMS/HCC) [N17.9] Dementia with behavioral disturbance (CMS/HCC) [F03.91] Generalized weakness [R53.1] Patient is an 87 y.o. male with past medical history of hypertension, hyperlipidemia AFib not on anticoagulation, sick sinus syndrome status post pacemaker, aortic stenosis status post valve replacement.Coronary artery disease status post CABG, CHF, history of peripheral vascular disease, history of carotid stenosis, severe vertebral artery stenosis, diabetes, CKD, dementia, chronic respiratory failure on 2 L nasal cannula post COVID-19 pneumonia 11/2020 was brought to the emergency room by the family due to worsening confusion and agitation, as per wife after the patient was discharged back in November in few weeks patient dementia started to get worse, more confused, more agitated and few times he was violent to his family members, well for the last few days patient's wife reported that his confusion was very bad so she decided to bring him to the ED for further evaluation management. Hospital Course -For the above presentation patient was admitted to the hospital services, patient was started on oxygen supplementation, Covid repeat test continue to be positive, started on IV antibiotics, IV hydration due to worsening kidney function, in the evening of 3/8 patient was found without any spontaneous respiration, patient was pronounced dead by the RN and CRNP finished the discharge defecate, please refer to RN documentation for more details.

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

ED to Hosp-Admission Discharged 5/21/2021 - 5/28/2021 (7 days) DO Last attending ? Treatment team E coli bacteremia Principal problem Discharge Summary , DO (Physician) ? ? Internal Medicine Discharge Summary Hospitalist Medicine Patient: Date: 5/28/2021 DOB: Admission Date: 5/21/2021 PCP: , PA-C Length of Stay: 7 Days Discharging provider: , DO Discharge Date: 5/28/2021 Admission Diagnosis Medical Problems Hospital Problems POA * (Principal) E coli bacteremia Yes Atrial fibrillation with RVR (CMS/HCC) Yes Mitral and aortic valve disease Yes Overview Signed 11/4/2020 5:08 PM by , LPN Note: Moderate AR, MR & TR 1'15 Note: Moderate AR, MR & TR 1'15 Type 2 diabetes mellitus (CMS/HCC) Yes Dementia due to Parkinson's disease without behavioral disturbance (CMS/HCC) Yes Acute metabolic encephalopathy Yes Chronic systolic CHF (congestive heart failure) (CMS/HCC) Yes Sepsis (CMS/HCC) Yes Anemia Yes COVID-19 Clinically Undetermined Overview Signed 5/28/2021 12:11 PM by, DO Asymptomatic, had been positive back in January, tested negative on admission then tested positive when planning for discharge. May just be persistent viral shedding from previous Covid infection Hospital Course HPI:I refer you to the history and physical for completeness. Briefly, patient presented to the emergency department with his family stating that he is a little bit more confused, not as alert, and little bit more short of breath and shaky. Noted to have an elevated white blood cell count lactic acidosis. Hospital Course: Patient was cared for in hospital. Placed on broad-spectrum antibiotics. Blood cultures revealed gram-negative bacteremia most likely due to to possible mild diverticulitis. Throughout the course of his hospitalization he steadily improved. Was transition to oral antibiotics. His cardiac issues were continue to be managed during his hospitalization. He did have some mild encephalopathy associated with the bacteremia and as his infection cleared that improved. Adjustments were made in his home medications. He is started on therapies. Due to his severe deconditioning associated with acute medical illness will need some higher level care and increased rehabilitation. Arrangements were made for him to receive ongoing care at . When he presented to the hospital he tested negative for COVID-19. In preparation to going to the he tested positive. He was completely asymptomatic as far as COVID-19 symptoms are concerned. He was previously positive in January 2021 for Covid. This could just be a prolonged positive testing from his infection in January. Nondetected COVID-19 test on 5/21/2021 could potentially be a false negative. At this point would recommend isolation for 10 days from 5/26/2021. Otherwise his vital signs are stable. Improved the point where he no longer requires hospital level care and can be discharged to

Patient presented to the emergency department on 6/15/2021 with weight gain, peripheral edema, and worsening dyspnea. Patient has a history of CHF. Upon admission screening, he was found to be COVID-19 positive. He was treated for COVID-19 infection as well as CHF exacerbation. He is currently admitted at time of writing.