Moderna

resident had a pressure ulcer to RT hip, was getting treatment on. Was scheduled to have wound debrided and wound vac applied on 1-19-2021. Appetite was poor, not wanting to get out of bed, and decline in alertness. Passed away on 1-16-2021

Narrative: 89yo with type 2 DM, HT, pacemaker and prior COVID+ in Nov 2020. Shortly after administration of 2nd Covid vaccine, patient began to have increased cognitive decline and 2 days after he expired at the facility

Patient reported following his immunization he became short of breath, tired, weak, joint pain, headache, recommended go to emergency room, resulting Hospitalization 1/20-22/2021 dx Acute Hypoxic Respiratory Failure secondary to Acute on Chronic Diastolic Heart Failure exacerbation, currently patient remains on home oxygen

Gentleman received his 1st Moderna dose on Thu. 2/11 at 0849. Vaccination protocol was completed. Pt reported feeling fine, no fever, and that he had no allergies which would prevent him from getting the vaccine. Pt played cards with friends later that day 2/11, but left at 1930 (normally plays late into evening) telling his companions he didn't feel well and his neck hurt. A welfare call was completed on Sat. 2/13, and the patient was found deceased in the bathroom by his son. It appears patient fell off toilet and hit his head on the tub. Pressure ulcer present under injection site. The presumed time of death was Thur. evening.

Hypoxic failure secondary to acute on chronic diastolic heart failure; Shortness of breath; Weak; Tired; A spontaneous report was received from a healthcare professional concerning a 90-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hypoxic failure secondary to acute on chronic diastolic heart failure, shortness of breath, tired, and weak. The patient's medical history, as provided by the reporter, included chronic diastolic heart failure. Concomitant product use was not provided. On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 012L20A), intramuscularly for prophylaxis of COVD-19 infection. On 16 Jan 2021, the patient had shortness of breath, was tired and weak. He was taken to the hospital and diagnosed with hypoxic failure secondary to acute on chronic diastolic heart failure. Treatment for the events included intravenous (IV) bumetanide. The patient was discharged home with oxygen on an unknown date. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, hypoxic failure secondary to acute on chronic diastolic heart failure, shortness of breath, tired, and weak, was unknown.; Reporter's Comments: Based on the diagnosis of hypoxic failure secondary to acute on chronic diastolic heart failure provided by the hospital, the event is assessed as unlikely related to mRNA-1273. Further information has been requested.

30 hours after the first Covid vaccination, the resident was lethargic, non responsive with shortness of breathe.

Patient seen by physician for weakness, tired, increase SOB, falls, increase confusion and then subsequently hospitalized . Patient then expired on 3/7/21.

Acute Pulmonary Embolism, and Acute Deep Vein Thrombosis. He is active every day doing arm exercises and walking in place for exercise, and moving about his house with his walker, and this day was no different. He finished making breakfast and went to sit down on the couch, and had sudden-onset pleuritic chest pain. No other recent risks such as long car ride, illness, plane ride, or other immobility. Patient says the vaccine was Moderna second dose, given at pharmacy.

Patient developed ITP after receiving the covid-19 vaccination. He was admitted at the outside hospital in January 2021 and was found with a platelet level of 79. He presented in this admission at hospital his platelets dropped to 30.

On 2/18/2021 the resident spiked a fever of 101.7 and had decrease oxygen saturation down to 86% with a cough. The resident was transferred to the ER for evaluation. Per Advanced Directives resident was not treated with antibiotics and returned to the Nursing Home on 2/19/2021. The resident had several episodes of emesis and was placed on comfort measures. He dised on 2/25/2021.

Death on March 8 due to a large blood clot at the base of his brain. This was 16 days after innoculation.

Patient passed away unrelated to covid vaccination Narrative: The patient had COPD and history of prostate cancer. Patient was placed on hospice care. Patient received his first dose Moderna on 2/9. Patient passed away on 2/16. Cause of death not documented. No indication that death was related to COVID 19 vaccination.

death Narrative: Pt received second Moderna COVID vaccine dose on 2/9/21. Pt enrolled in hospice house for end-of-life care 4/8, however, diagnosis was not available in database for enrollment in hospice. Pt's son emailed affairs to report the passing of the patient 4/11/21 with no additional details or reasoning; death has not been verified. Was pt previously covid positive? no Are there any predisposing factors (i.e. PMH, HPI, allergy history etc) for patient experiencing adverse drug event? Yes, CHF potentially a contributing factor to hospice status and death Any occurrence of an ADR at time of administration or during time of observation? No Was there an ADR between observation period and date of death? No Was patient hospitalized prior to vaccination? No Was patient hospitalized prior to death No What are the possible cause of death? unknown, pt enrolled in hospice services outside of the facility.

Patient had started peritoneal dialysis at home with me, his wife, 8 days before the second shot. All was going well. We got his second shot on the morig of March 18. His only reaction seemed to be soreness at injection site. At 11 pm we started dialysis as usual, with the cycler. At 12 pm he was having trouble breathing after just having been filled with 1500 ml of dialysate. This was the first time this happened. I gave hi nitro glycerine and had the cycler take out the 1500 ml of dialysate, and stopped the therapy for the night. He then felt better, and apologized for waking me up. In the morning he was dead. I believe it is possible that the vaccine tipped the balance of patients already taxed system. As I know that people who have serious diseases and are older are encouraged to take the vaccine, this outcome should be known to the CDC.

Heart had stopped for 4 minutes; Some coronary incident; went to emergency room because wasn't feeling well; Fractured ribs; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of CARDIAC ARREST (Heart had stopped for 4 minutes), CORONARY ARTERY DISEASE (Some coronary incident), MALAISE (went to emergency room because wasn't feeling well) and RIB FRACTURE (Fractured ribs) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. The patient's past medical history included Multiple myeloma (Had multiple myeloma treatments in past 13 years and I'm in remission. Had multiple chemotherapies for them throughout since the year 2008.) in 2008. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced CARDIAC ARREST (Heart had stopped for 4 minutes) (seriousness criteria hospitalization, medically significant and life threatening), CORONARY ARTERY DISEASE (Some coronary incident) (seriousness criteria hospitalization, medically significant and life threatening), MALAISE (went to emergency room because wasn't feeling well) (seriousness criteria hospitalization, medically significant and life threatening) and RIB FRACTURE (Fractured ribs) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized on 24-Apr-2021 due to CARDIAC ARREST, CORONARY ARTERY DISEASE, MALAISE and RIB FRACTURE. The patient was treated with Manual therapy (CPR) for Cardiac arrest and Rehabilitation therapy for Rib fracture. At the time of the report, CARDIAC ARREST (Heart had stopped for 4 minutes), CORONARY ARTERY DISEASE (Some coronary incident), MALAISE (went to emergency room because wasn't feeling well) and RIB FRACTURE (Fractured ribs) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were provided. The patient went to emergency room because he wasn't feeling well. The patient was treated (details not provided) for 6-7 hours and assigned him the room. According to the patient, he did not remember anything after that. He woke up next day with all the tubes in him. Reportedly, his heart had stopped for 4 minutes and he had some coronary incident. The patient was given CPR to bring him back and due to that, he had fractured ribs. He was discharged after 5 days to a rehabilitation facility. No other information provided. Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant information 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.

Patient presented to the ED and was subsequently hospitalized one day after receiving COVID vaccination with acute respiratory failure.

Possible Kidney Infection; Possible Pneumonia; Passed away; Low Iron Levels; Lack of appetite continued after first shot; Nauseous; Felt Cold (Chills); This spontaneous case was reported by an other caregiver and describes the occurrence of KIDNEY INFECTION (Possible Kidney Infection), PNEUMONIA (Possible Pneumonia) and DEATH (Passed away) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022N20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Aspiration pneumonia (Had Aspiration Pneumonia prior to vaccination and was hospitalized.), Stent placement (Received a heart stent 7 years ago.), Heart valve replacement on 12-Jan-2021 and Intubation. Concomitant products included AMIODARONE and HYDROCHLOROTHIAZIDE (DIURETIC [HYDROCHLOROTHIAZIDE]) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (Felt Cold (Chills)). On 14-Mar-2021, the patient experienced KIDNEY INFECTION (Possible Kidney Infection) (seriousness criteria death, hospitalization, medically significant and life threatening), PNEUMONIA (Possible Pneumonia) (seriousness criteria death, hospitalization, medically significant and life threatening), DECREASED APPETITE (Lack of appetite continued after first shot), NAUSEA (Nauseous) and BLOOD IRON DECREASED (Low Iron Levels). On 23-Mar-2021, DECREASED APPETITE (Lack of appetite continued after first shot) and BLOOD IRON DECREASED (Low Iron Levels) outcome was unknown and CHILLS (Felt Cold (Chills)) and NAUSEA (Nauseous) had resolved. The patient died on 23-Mar-2021. It is unknown if an autopsy was performed. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Mar-2021, Blood iron: (Low) Had very low Iron levels.. On an unknown date, Polymerase chain reaction: (Negative) Had several Negative PCR tests every time he was hospitalized. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter states that her Husband passed away on 23MAR2021 but his death was not vaccine related. Had damaged his esophagus while intubating him. He was not doing great but he was functional prior to vaccination. On 14MAR2021 he was hospitalized. Doctors did not know what was wrong with him. His doctor stated that he had Kidney infection or pneumonia but all tests were normal. Reporter stated that the Doctors do not know what was happening to him but it was not vaccine related. Concomitant medications included Defibrillator along with above mentioned medications.; Sender's Comments: This fatal case concerns a 90-year-old male hospitalized with serious unexpected events of kidney infection, pneumonia, death and nonserious decreased appetite, blood iron decreased, chills and nausea. Event latency 11 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.; Reported Cause(s) of Death: Possible Kidney Infection; Possible Pneumonia; Passed away

Within 4-6 weeks of the second vaccine, patient started showing signs of shortness of breathe, swollen feet, cough, weak muscles, tired and no energy. patient had been walking with walker up to that point 5 times a week for 15-20 minutes. Since these symptoms began, he was not been able to walk more than a few feet without resting and being out of breath. He had been put on a diuretic and inhaler which didn't seem to be doing much. He saw his primary and heart Dr since the beginning of June. On June 24th he was admitted into the Hospital with Congestive Heart Failure. After blood tests, he was also diagnosed with Leukemia. A week later, on July 1, 2021, patient passed away.

90 y.o. Nursing home resident with comorbidities including oxygen dependent CHF with gradual declining course prior to 1st dose of COVID 19 Moderna vaccine died 12 days after receiving 2nd dose. Resident experienced increased dyspnea and hypoxia 5 days after receiving 2nd dose.

The facility had positive cases of COVID when we were able to begin vaccinating residents. Within about a week of vaccination, patient was tested positive for COVID. He was 91 years old and his immune system did not have the time to allow the vaccine to begin working before exposure. His age was a major contributing factor to his death.

Staff walked into resident's room around 10:00am and noted resident's left side of his face was flaccid. Nurse was called and upon assessment resident noted to have an unequal hand grasp with left worse. He was able to talk but was mumbled and hard to understand. Physician, hospice, and family were notified. Resident had a stroke at 10:06 am on 1/8/2020. He lost all ability to use his left side. Resident passed away on 1/11/2020.

Pt developed COVID-19 infection, symptoms starting 7 days after first dose was given. Patient was admitted to hospital on 1/21 after falling (secondary to weakness) and striking head on toilet. Patient expired due to respiratory complications of COVID on 1/25.

Patient admitted to Inpatient on 1/13/2021 after receiving vaccine on 1/6/2021. Diarrhea and dizziness. Since Sunday, corona vaccination last week. No headache, abdominal pain, nausea or vomiting, loss of taste or smell, muscle aches or general malaise. Patient was hypoxic at clinic visit, 84% on room air, transferred to ED for evaluation.

Patient was seen at 0710 he was sleeping but at normal cognitive behavior Patient was again assessed at 0720 where he was noted to be unresponsive, BP 180/100s, HR 230s, he was a DNR therefore not CPR was administered. EMS arrived at facility patient was noted to be in full cardiac and respiratory arrest. Time of death 0735

Patient was admitted to hospital on 2-9-21 for urinary tract infection and tested positive for Covid. Developed pneumonia and expired on 2-12-21.

My birthfather had an adverse reaction after he got his 1st Moderna COVID vaccine. He lives alone and was doing well with some underlying conditions. The day of the shot was fine. The next AM, he had vision changes and sudden numbness in his R arm/leg and fell after getting up. ?The numbness went away pretty quickly, but the visual changes remained. He refused to go to the ER/Dr. The next week and a half, he was weak, tired, and couldn?t think as clearly. ?He was brought to the ER? on Wed, 3/3/21 at Hospital. He was found to have a low oxygen level, possible a-fib, fluid retention, emphysema, and aortic stenosis, in addition to his other health issues. ?The Dr said his symptoms the day after the vaccine were a mini-stroke.. He was released from the hospital on Friday, 3/5/21. On Saturday, Hospice came to see him, since nothing can be done for his medical conditions; however, they decided not to sign him up yet, since he I was told they didn't feel he needed to, at this time. One of my sisters is staying with him during the day until he builds his strength back up. Do you think his Mini stroke and health changes had anything to do with the vaccine? He will not be getting the second COVID shot. ?We?re all caught between a rock and a hard place as far as what to do, esp for older folks.

Facility transfer resident to ER due to respiratory failure. Symptoms included decrease oxygen stats, difficulty breathing and chest pains. ER transferred to Hospital with diagnosis of myocardial infraction. Admitted to ICU on telemetry. Placed on 50% Bipap for Hypoxia. Placed on IV Amiodarone and Ceftriaxone. Resident was stabilized and discharged back to facility on 2/24/2021.

Pt expired in Community Hospital ED on 3-10-21. This was 5 days after receiving his second Moderna covid vaccination. Hospital nurse says ED report says multiple system problems.

Patient passed away unrelated to covid vaccine Narrative: The patient had worsening COPD and cognitive deficits. Patient's last hospital visit is 2/2021 for COPD exacerbation. Patient received his first dose of Moderna on 1/13 and second dose of Moderna on 2/9. Patient passed away at home on 3/3. No indication that death was related to COVID 19 vaccination.

Patient passed away unrelated to covid vaccination Narrative: The patient had diabetes, hypertension and coronary atherosclerosis. Patient received his first dose of Moderna on 1/7/2021. Patient elected to not receive 2nd dose vaccination following clinical discussion with provider. Patient was diagnosed with pancreatic cancer and ws place on hospice care. Patient passed away on 2/21.No indication that death was related to COVID 19 vaccination.

Received Moderna vaccine 2/10/21 a pharmacy. Daughter called 3/10/21 to report that pt had stroke 3/2/21 and was admitted to hospital.

Died Narrative: Pt has a diagnosis of: Parkinson's Disease, severe AS, heart failure Symptoms include: dyphagia, aphagia, excessive secretions. Agency patient has been referred to: Hospice Code Status:DNR/DNI 90M with PMH notable for Afib, chronic aspiration, and dysarthria, severe aortic stenosis who presents3/5 with 2 weeks of generalized weakness and in ED noted to be in AFib w/ RVR to 130s, CT findings suggestive of volume overload with exam supporting this at time of admission, and also noting nonspecific generalized weakness. DC Home 3/9 Hospice

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 no 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 90 yo and admitted on 2/10/21 for SOB and a fall resulting in a femur fracture. Patient was on Eliquis and has h/o CABG x5, dementia, bradycardia s/p pacemaker. Patient was discharged to a rehab facility where his condition declined ultimately resulting in transfer to inpatient hospice. He eventually required care in ICU where he eventually deceased.

Acute pulmonary embolism, first symptomatic on the evening of 4/15/21. Received first vaccine on 3/5/21, second vaccine on 4/2/21. Only other risk factors for PE are age and a long car trip around 3/14/21.

bilateral pulmonary emboli. No identified trigger. 91YM with history of cerebrovascular disease and CVA, hypertension, hyperlipidemia, as well as remote history of provoked DVT after prolonged airplane travel, developed acute onset left-sided pleuritic chest pain, with worsening hypoxia, admitted with acute, large volume bilateral pulmonary emboli, unprovoked w/ history of DVT years ago - no evidence of right heart strain on EKG or CTA chest, with reassuring BNP Pro and troponin. Echocardiogram is pending - US: Left lower leg DVT in femoral vein to popliteal vein ? Right leg negative for DVT - Patient on unfractioneted heparin initially then transitioned to Eliquis. - continue bilateral thigh high elastic graded compression stockings with 30-40mmgH at the ankle to prevent postphlebitic syndrome, encourage daily use, replacement every 6 months, and use for 2 years. - Unprovoked DVT, PE due to cancer vs genetic thrombophilia. Prior prostate exam and colonoscopy negative CTA chest shows no masses hypercoagulable panel ordered in ED prior to initiation of anticoagulation, PCP to follow-up in outpatient

First shot 1-20-2021 Immediate flushing with hot ears upon injection. Lasted all day. Sore arm at injection site lasted two days. Leg and back pains in three days which disappeared within the day. February 4, 2021 entire body got cold. 15 minutes later cold chills and shivers for an hour. Went to hospital emergency where treated for blood infection with intravenous antibiotics for 6 days. Then home treated with intravenous antibiotics with home health care until February 22, 2921. Experienced many long period cold spells of entire body both in hospital and home. Still get them until this date on occasion. I am very sensitive to cold.

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 90 but not receiving frequent care from facility and circumstances regarding his cause of death not certain. His comorbidities include advanced age, afib, cardiac pacemaker, HTN, Barrett's esophagus, HTN, and hypothyroidism.

On 1/6/21, 91 yo M amb to ER with c/c of allergic reaction to COVID x 1 day. Pt receive COVID vaccine Moderna Jan 3, 2021. Pt c/o fever, n/v, lower back pain, SOB, dark colored urine. Jaundice noted to bilat sclera and generalized skin. Patient hospitalized and discharged on 1/17/21. Admitting diagnosis was pneumonia, hepatitis, acute repiratory failure with hypoxia and acture renal failure. Patient was treated for sepsis due to acute cholangitis and completed 10 day course of IV zosyn

Patient developed 2 DVT in right leg on 4/5/2021. Patient was seen at Hospital for event, but was not hospitalized. Patient was placed on Eliquis for DVT and sent home. Patient states that he continues on Eliquis and that the swelling in his right leg is going down. Patient noted that he did take a long drive the day before, but has done this many times and never had this problem before. Patient received both Moderna vaccines listed. Dose 1, 2/21/2021 and Dose 2, 3/24/2021. Stated that he has not had any other vaccines in the past several months.

Open 24 hours of receiving the vaccine, the patient was noted to be fatigued and increasingly confused. Had some response to IV fluids but within 72 hours became progressively hypertensive and transferred to hospital

Cerebrovascular accident; Thrombosis; This case was received via FDA VAERS (Reference number: 1321745) on 08-Jun-2021 and was forwarded to Moderna on 08-Jun-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) and THROMBOSIS (Thrombosis) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) (seriousness criteria hospitalization, disability, medically significant and life threatening) and THROMBOSIS (Thrombosis) (seriousness criteria hospitalization, disability, medically significant and life threatening). At the time of the report, CEREBROVASCULAR ACCIDENT (Cerebrovascular accident) and THROMBOSIS (Thrombosis) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Computerised tomogram: blood clot (abnormal) Blood clot. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient suffered a blot clot on may 11th and a stroke. No treatment information were reported. Action taken with the drug in response to events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded. Event terms, onset dates and outcomes captured per Health Authority reporting. Events seriousness per overall case assessment by Authority and per IME list

Chills, fever, thready pulse, decreased BP leading to transport via ambulance on 12/18/2020 to hospital and admission from ER to hospital for sepsis, hospitalization and discharge on 12/22/2020.

Patient died of complications due to COIVD-19 illness, which was 4 months after receiving his second dose of vaccine. He was a breakthrough case that died with full vaccination status for COIVD-19. No one is indicating that the vaccine had anything to do with this persons' death.

About 1 and 1/2 month later on 4/4/2021, I got a rash on my head and came down on my right side and chest and back. It was very itchy, red and very painful. I went to the dermatologist right away and was diagnosed with Shingles infection. The doctor gave me an injection (don't remember name) and prescribed Valtrex and Pepcid. The medication did not help resolve the shingles and it got worse. I went to the hospital 4/6/2021 and I was admitted to the hospital for 7 days. I was admitted because I was dehydrated and had an allergic reaction to the shot the dermatologist gave me. I also pneumonia and septic. They ran every test they could run and gave me antibiotics for the pneumonia and infection. I was discharged to follow up PCP.

The resident resides in an independent living facility/apartment. The reporter at the center was informed by his daughter he was not feeling well on 1/1/2021 (specific symptoms could not be ascertained). He reportedly went to be COVID tested on 1/1/2020 and observed to be deceased in his apartment on 1/2/2020. I do not have confirmation of his COVID results, although the reporter indicates his daughter reports his test was positive.

Received vaccine on 1/26/2021 at 10:30am and at 2134 was observed to be having difficulty with breathing and cyanotic when staff entered his room. He was coughing and sounded congested. He was repositioner and SPO2 78% on room air so O2 applied at 2L which increased SPO2 88% so O2 increased to 4L and SPO2 increased to 95%. Temp 103.1, B/P 188/110, resp 28, pulse 128. 911 called and sent to Community Hospital ER at 2145. Received call from hospital reporting diagnosis of right sided pneumonia. He had received his 1st dose on 12/29/2020. On 1/8/2021 he was on droplet isolation due to possible exposure of Covid 19 and receiving duoneb treatments for chronic nonproductive cough.

weakness in legs, difficult to get out of chair, fell and could not get up. fever loose stool Went into AFIB and it snowballed from there. Was taken to Emergency.

On 1/20/2021 the resident experienced hypotension while at dialysis and was not able to complete treatment prior to being transferred to the hospital. He also had congestion in lungs. The hospital notes indicate upon admission to the hospital he was being treated for # Shock - distributive - cover for sepsis, check u/s RLE, possible SIRS response after second COVID vaccine. MAP >55 and # ESRD. While in the hospital resident was treated for hypotension, right lower leg cellulitis and the rate of pacemaker was increased.

2/4/21 - awoke from sleep 11 PM with jaw/teeth pain lasting several hours 2/5/21 - extreme weakness, rapid heartbeat, fatigue. Slept on and off all day. 2/ 6 - 2/8/21 - irregular heartbeat, rapid heartbeat, fatigue 2/8/ 21 - appt with primary car, Physician 3:30PM, EKG showed afib, BP 178/100, pulse 140 - sent directly to ER for further testing. Physician in ER: cardiac enzymes normal, chest xray normal, administered metoprolol IV which decreased heartrate from 140 to 84. Prescribed Metoprolol 25MG 2x/day and follow up with cardiologist. 2/8/- 2/12/21 - with metoprolol heart rate remained in 80s, weakness, fatigue 2/12/21 - appt with cardiology; Physician Assistant - EKG showed afib, heartrate 80, BP 142/80 - ordered echocardiogram 2/18/21

right sided pneumonia; having difficulty breathing; cyanotic; coughing; sounded congested; A spontaneous report was received from a nurse concerning a 92-year-old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced right sided pneumonia, difficulty breathing, cyanotic, cough and sounded congested. The patient's medical history, as provided by the reporter included Alzheimer's, hypertension, arteriosclerotic heart disease, hyperlipidemia, benign prostatic hyperplasia, prostate cancer, covid-19, allergy to aricept and exelon. The concomitant medications reported included atorvastatin, tamsulosin hydrochloride, paracetamol, macrogol 3350, furosemide and ipratropium bromide/salbutamol sulfate for unspecified indications. On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (Lot number: 039k208) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient was on droplet isolation due to possible exposure of Covid 19 and received duoneb treatments for chronic nonproductive cough. The patient also received honey consistency fluids. On 19 Jan 2021, the patient's droplet precautions were discontinued. On 26 Jan 2021, after receiving the vaccine, the patient experienced difficulty breathing, cyanotic, cough and sounded congested following which the patient was repositioned. The lab findings included oxygen saturation at 78 percent on room air, so oxygen was applied at 2L which increased oxygen saturation at 88 percent, so oxygen was increased to 4L and oxygen saturation increased to 95percent, body temperature at 103.1 degree Fahrenheit, blood pressure 188/110 mmHg, respiratory rate at 28 breaths per minute, pulse rate at 128 heartbeat per minute. The patient was then sent to the Hospital emergency room (ER) where he was diagnosed with right sided pneumonia. Action taken with mRNA-1273 in response to the events was not provided. The outcome for the events, right sided pneumonia, difficulty breathing, cyanotic, cough and sounded congested was unknown.; Reporter's Comments: This case concerns a 92-year-old, male patient. The patient's medical history od Alzheimer's, hypertension, arteriosclerotic heart disease, prostate cancer, covid-19, on duoneb treatments for chronic nonproductive cough remains as contributing factors. Very limited information regarding this event has been provided at this time. Further information has been requested.

He had rigors starting 6 pm the day after the vaccination. He was treated with one 500 mg tylenol. He had increased wheezing but did not complain of SOB. At 0400 the next morning, he died.

Resident yelling for assistance in apartment. Nursing personnel found resident on floor at 6:10 AM on 2/18/2021. Resident was transported to Hospital on 2/18/2021. Status update on 2/18/2021 from son, resident CT & X-rays were done all normal. Labs done and WBC count was elevated and awaiting results. Resident stable and admitted to hospital for observation. Resident passed away on 2.21.2021.

AFib; Jaw and tooth pain; Jaw and tooth pain; Rapid heartbeat/Rapid pulse; Extreme weakness; Irregular heartbeat; blood pressure was 142/80; A spontaneous report was received from a consumer concerning a 92-years-old, male patient who experienced AFib (atrial fibrillation), rapid heartbeat/rapid pulse, extreme weakness, irregular heartbeat, blood pressure was 142/80, jaw and tooth pain. 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 levothyroxine sodium, metoprolol tartrate, pravastatin, fexofenadine, vitamin D, acetylsalicylic acid, fluticasone propionate and latanoprost. On 04 Feb 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 004M20A] intramuscularly in the for prophylaxis of COVID-19 infection. On 04 Feb 2021, the patient woke up that night with jaw and tooth pain. He later experienced rapid heartbeat, extreme weakness, irregular heartbeat, rapid pulse and AFib (atrial fibrillation) which was confirmed by his primary care physician (PCP) on 06 Feb 2021. On 08 Feb 2021, patient repoted his blood pressure was 142/80. Treatment for the event included metoprolol IV. Action taken with mRNA-1273 in response to the events was not provided. The events rapid heartbeat/rapid pulse and extreme weakness were considered recovered/resolved or on 08 Feb 2021 and the outcome of the events AFib (atrial fibrillation), irregular heartbeat, blood pressure was 142/80, jaw and tooth pain were unknown.; Reporter's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Hospitalized February 28, 2021 with acute cerebrovascular accident with left hemiparesis, 4 days after vaccine

On the morning of 2/22/21 Patient was found by care staff to have signs of stroke as evidence by left sided facial drooping. EMS were called and he was taken to a local hospital where he was admitted. He then was discharge to a skilled nursing facility for rehabilitation. He is still there as of today, 3/11/2021.

His vitals signs was stable after vaccine was administered, but the resident was expired in 85mins after given 1st dose of Covid Moderna vaccine.

He was in Hospice. He died as a veteran. He had a constant lack of appetite. Has no additional information

DEATH Narrative: LIMITED INFORMATION PROVIDED IN MEDICAL RECORD OTHER THAN SON CALLED TO REPORT PATIENT HAD BEEN TRANSFERRED OUT OF ICU TO HOSPICE CARE ON 03/02/21. No documentation regarding hospital admission or ICU care. Son called on 3/3/21 to report patient passed away peacefully and without pain. No previous COVID infection, no recent hospitalizations known, no immediate acute reaction to COVID vaccine. Unlikely that vaccine contributed to death, as patient was on hospice with advanced age of 91 years.

Narrative: Per law enforcement report, patient's death appears to be natural causes. Wife found 91 yo patient on the floor having seizures. Patient was treated for seizure disorder and had recent Primary Care visit with updated labs. Seizure medication lab monitoring was monitored with no concerns.

1/30/2021- he was found to be confused by family and taken to the ER where he was found to have bilateral pneumonia, symptoms of decompensated heart failure. he did not improve with interventions and ultimately was placed on comfort care and passed away in the hospital 2/2/2021

Patient was not present for 2nd dose clinic today. Manager of facility reported that patient died in his sleep on 4/6/21

Father started complaining about his right leg after first dose of Vaccine. After second dose on Feb 12, 2021, Father started complaining much more about his leg. On Feb 23, 2021 it was diagnosed Father had a Blood Clot in his leg.

death Narrative: Patient received Moderna covid #1 on 1/14/21. On 1/29/21, a social worker note was placed that indicated that patient was now under home hospice care. No scanned records on file. No further notes regarding events from this time to date of death on 2/10/21. No autopsy results available. 27 days from date of vaccine to date of death.

Death Narrative: 91 yr old Arterial ulcer on toe, not surgical candidate, patient opted palliative care, hospice enrolled, Died on hospice service. No vaccine complications reported.

Blood clot after receiving his second dose. Found out that he has Deep Vein Thrombosis (DVT); This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (Blood clot after receiving his second dose. Found out that he has Deep Vein Thrombosis (DVT)) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 027L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included IRON for Iron supplementation, APIXABAN (ELIQUIS), MIDODRINE, CLOPIDOGREL BISULFATE (PLAVIX), HYDROXYCHLOROQUINE, METHYLPREDNISOLONE, MIRABEGRON (MYRBETRIQ), MONTELUKAST, TAMSULOSIN, VITAMIN D3 and CYANOCOBALAMIN (VIT B12) for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced DEEP VEIN THROMBOSIS (Blood clot after receiving his second dose. Found out that he has Deep Vein Thrombosis (DVT)) (seriousness criterion medically significant). At the time of the report, DEEP VEIN THROMBOSIS (Blood clot after receiving his second dose. Found out that he has Deep Vein Thrombosis (DVT)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, Ultrasound scan: clear (normal) Clear. On 08-Mar-2021, the reporter noticed that the patient's left arm was swollen. The patient was taken to the emergency room and was diagnosed with deep vein thrombosis. The patient was discharged on the same day. The patient was put on apixaban 10mg and later switched to apixaban 5mg. The patient would be monitored until ??-Sep-2021. Company Comment: 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.

Stroke; Heart Attack; loss of appetite; weak in the legs; felt achy; felt yucky; felt queasy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) and MYOCARDIAL INFARCTION (Heart Attack) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) 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 PANTOPRAZOLE for an unknown indication. On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced DECREASED APPETITE (loss of appetite), MUSCULAR WEAKNESS (weak in the legs), PAIN (felt achy), DISCOMFORT (felt yucky) and NAUSEA (felt queasy). On 12-May-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criteria hospitalization, medically significant and life threatening) and MYOCARDIAL INFARCTION (Heart Attack) (seriousness criteria hospitalization, medically significant and life threatening). The patient was hospitalized on 12-May-2021 due to CEREBROVASCULAR ACCIDENT and MYOCARDIAL INFARCTION. At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke), MYOCARDIAL INFARCTION (Heart Attack), DECREASED APPETITE (loss of appetite), MUSCULAR WEAKNESS (weak in the legs), PAIN (felt achy), DISCOMFORT (felt yucky) and NAUSEA (felt queasy) outcome was unknown. Treatment information was not provided. The reporter reported that the patient did not have any medical conditions to cause the events. This case was linked to MOD-2021-132255 (Patient Link).; Sender's Comments: This case concerns a 92-year-old male with serious unexpected events of cerebrovascular accident and myocardial infarction, and nonserious unexpected decreased appetite, muscular weakness, pain, discomfort and nausea. Latency 1 day after second dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Death; This case was received via VAERS on 18-May-2021 and was forwarded to Moderna on 18-May-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of DEATH (Death) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 13L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 10-Feb-2021 The patient died on 10-Feb-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. Concomitant product use was not provided. It was reported that Patient had no scanned records on file and no further noted regarding events from this time to date of death. No autopsy results were available. 27 days from date of vaccine to date of death. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Very limited information regarding this event has been provided at this time. Further information cannot be requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information cannot be requested.; Reported Cause(s) of Death: Unknown cause of death

Feb 8th 2nd vaccination. Next day lost consciousness, fell no injuries. Following day Feb 10th weak and could not stand, BP low, Dr sent him via ambulance. EMS identified him having a heart attack that started Feb 9th. He had no cardiac history He was hospitalized for a sudden blockage, had a vtach episode, did not lose consciousness, one stent placement, had a 2nd vtach episode and did lose consciousness. Placed on blood thinner, within a few days had uncontrolled urinary bleeding, catheter to irrigate, changed blood thinners and did not stop. Continued weakness and decline. Then developed pneumonia the following week. Placed on antibiotics, oxygen 2-7 L/nc. Went to rehab, back and forth to hospital. Came home twice, once Feb 14th for 24 hours, then 2nd time March 9 (his birthday) for his final 2 weeks t home where I cared for him until he passed March 21st. On 4L/NC, did not have catheter, bleeding had stopped.

He received Moderna Vaccine on 02/16/2021 and 03/16/2021. No reactions developed after two vaccinations. 7.7.21: Patient developed difficulties of breathing one week and presented to ER on 7/7/2021 and has been hospitalized since 07/07/2021. Presented with cough, chest pain, and shortness of breath. Diagnosed with pneumonia 7.11.21: discharged home.

Resident experienced an overall decline in condition on 1/8/21 and continued to decline until he passed away on 1/13/21.

Patient died at hospital on j/16/2021 approximately 48 after receiving vaccination. Believe death related to fall at home prior to vaccination.

93 y/o with complex medical history (severe COPD on oxygen, diastolic CHF, CKD3, myelofibrosis, marginal zone lymphoma of spleen with recent progression and no active treatment, chronic anemia, afib, CAD, pulmonary artery hypertension, h/o bladder cancer, hypertension, hypothyroidism, h/o bilateral PE, sick sinus syndrome s/p pacemaker, h/o Hodgkin's disease). Has had multiple hospitalizations over the last 3 months for dyspnea, most recently in 12/2020. Enrolled in palliative care. Has had multiple transfusions (most recently 01/13/21) for his chronic anemia due to myelofibrosis, and recently started on darbepoetin. No documented history of anaphylaxis to medications or prior vaccinations. He received COVID19 vaccine (Moderna) on 01/16/21. He passed away suddenly at home on 01/17/21. Symptoms: & cardiac arrest Treatment:

Moderna COVID-19 Vaccine EUA patient developed acute respiratory failure with bilateral pulmonary infiltrates 1 week after receiving Moderna COVID vaccine

Resident expired on 2/5/21 at 03:35pm, about 25 hours after second dose of vaccine. At breakfast, resident was spitting a lot of secretions, coughing up liquids from nose and phlegm, facial swelling, which were all symptoms that he was struggling with prior to both doses of COVID vaccine, but had increased more than prior incidences on 2/5/21. Gurgling noted in upper airways, hyscolamine given, bath given to loosen secretions, morphine given. Family notified and came into facility for compassionate care visit around 1300. 1400 HR was 3 and RR was 2, but increased back to 60 and 12 within 20 minutes. Then resident expired at 1535.

ON 02/08/2021 AROUND 0600 RESIDENTCOMPLAINED OF MOUTH PAIN AND RECEIVED OXYCODONE. DURING THE COURSE OF THE MORNING, RESIDENT EXHIBITED A FEW EPISODES OF LABORED/SHALLOW BREATHING AND SOB AT RESTING. 0XYGEN SATURATION RATE WAS 93-98% ON ROOM AIR, LUNG SOUNDS CLEAR IN ALL LOBES AND PULSE AND TEMPERATURE WITHIN NORMAL RANGE. AS THE DAY PROGRESSED, VITAL SIGNS REMAINED STABLE BUT RESIDENT CONTINUED TO HAVE PERIODS OF SOB/LABORED BREATHING.FAMILY AND NURSE PRACTIONER UPDATED AND THE ORDER WAS RECEIVED TO SEND PATIENT TO MEDICAL CENTER ER FOR EVALUATION PER AMBULANCE. RESIDENT TRANSPORTED AT 1425. RESIDENT RETURNED FROM THE ER AT 1830 ON HOSPICE CARE WITH THE DIAGNOSIS OF: ACURE RESPIRATORY FAILURE WITH HYPOXIA AND END OF LIFE DECISION MAKING. RESIDENT WAS MADE COMFORTABLE AND MONITORED DURING THE NIGHT AND EXPIRED AT 0630 ON 02/09/2021.

Massive ischemic stroke with aspiration, unable to arouse on the morning of 1/21/2021 and placed on Hospice with death 1/24/2021

Case passed away on 2/28/21. During post vaccination monitoring, case did not have any adverse reactions. When writer spoke to him on 2/26/21 to schedule his second dose, he sounded well.

COVID symptoms started within 8-9 days of vaccination. No fever, general not feeling, chills. Turned into very difficult breathing, low oxygen levels and pneumonia. Tested positive for COVID at Hospital ER on Wednesday, January 27. Died in the hospital Saturday morning, January 30, 2021.

Patient was admitted to Hospice on 8/11/20. He experienced normal progression of his diseases until his death on 3/9/21.

Attempted Suicide Narrative: 93 year old received his 2nd dose of moderna vaccine on 3/11/21 in his home (nurse went there to give it). He attempted to take his life via gunshot wound to the head on 3/13/21. Sent to an outside hospital and passed away 3/16/21. He recently was diagnosed with cancer. Had an appointment with oncologist on 3/11/21 and found out cancer was limited to lung only and discussed treatment options. No Mental Health issues in the past. Cancer diagnosis and covid vaccine timing may have contributed.

Patient received COVID-19 vaccination dose 1 on 2/8/21 and dose 2 on 3/1/21 at outlying extended care facility. Manufacturer and lot # of vaccinations are not available. Patient presented to ED on 3/8 (7 days following 2nd vaccination) with chief complaint of progressive dyspnea for the last week and constipation. Patient was diagnosed with acute on chronic congestive heart failure exacerbation with bilateral pleural effusions. Patient has a history of recurrent pleural effusions requiring thoracentesis. Patient then had a positive COVID-19 PCR test on 3/9/21. Patient underwent thoracentesis on 3/10/21 and was treated with Lasix diuresis with much improvement of respiratory status. Respiratory status remained stable throughout hospitalization and required no treatment for COVID-19. Patient was discharged back to his extended care facility on 3/18/21 after an 11 days hospitalization.

Family, daughter, reports that patient felt "a little sick" on 2/24/21 and "sick" on 2/25/21. She reports that approximately 1 week later her father had weakness and and frequent falls, was evaluated in the E.D. and ultimately admitted to hospital (3/4-3/15) Patient was discharged to nursing home where he died on 3/16/21.

Patient had no known ill effects or complaints directly after receiving his first COVID-19 vaccine on 02/19/2021. However, on 03/21/2021, he was found deceased on his bedroom floor due to a suspected cardiac arrhythmia. It is unknown if there is any correlation.

Patient passed away unrelated to covid vaccine Narrative: The patient received his first dose of Moderna on 1/14 and he was rushed to the hospital at 4 am on 1/15. The patient tested positive for COVID and is hospitalized in the hospital. The patient passed away on 2/8. Cause of death not documented, possibly due to COVID complication. No indication that death was related to COVID 19 vaccination.

death Narrative: patient did not receive active care at the clinic since 2017 no evidence of COVID positive diagnosis in past no known hospitalizations no acute ADRS following vaccination no death note or autopsy in record no other ADRS documented in record

DEATH Narrative: Patient passed away within 30 days of Covid Vaccine dose #1. No evidence of ADR immediately following vaccine or between vaccine and date of death. No evidence of illness or hospitalization before or after vaccine up to date of death. No evidence of illness or hospitalization before or after vaccine up to date of death. No evidence of a previous positive covid infection. No evidence of pre-disposing factors to preclude use of vaccine. Unlikely that vaccine contributed to patient's death, but cause of death was likely advanced age +/- potential comorbidities. No death note or autopsy documented in record.

Dad became very sleepy the day after. He quickly declined and died on Feb. 7 th. I feel the vaccine may have had something to do with his death.

death Narrative: pt had first vaccine on 1/26; caregiver declined second dose due to concerns of side effects; pt died 3/29/21 (not from COVID)

Family reports that he had a stroke and they feel it was due to his Covid 19 vaccine. They were not told by hospital staff that this was the case. He had supportive and rehabilitative care at hospotal

Severe thrombocytopenia (Platelet 12, 000) with associated bruising. April/29/2021 He has normal platelet from March/23/2021 in 200,000

Hi, my name is, I'm a RN and am submitting this report about my grandpa. I took him into the VA to get his second covid vaccine on 2/17/21. At that time my grandp lived semi-independently in a house between my parents and my uncle . He didn't get out very much but with some help of grocery shopping and organizing his medication he was still able to live alone and function well independently. My mother reported to me on 2/18/21 that my grandpa was confused, weak and tired. My grandpa has never had any signs of dementia. At this time he developed a delerium that waxed and waned. He complained of headache, no appetite and extreme weakness. On 2/23/21 he fell down in his house and we decided to move him into my uncles spare bedroom to keep better eyes on him. The delerium persisted and on 3/5 he was taken to Hospital for a workup for his delerium and weakness. There he saw Dr. an internal medicine doctor at hospital. The workup showed an elevated BNP (probably baseline but I'd have to look at previous lab results) but nothing further. We opted not to do further imaging and instead take him home. It became obvious to me that this was the end of his life and so I requested a hospice referral from Dr. My grandpa died on 3/24/21.

Death 6/2/2021 Causes of death listed on death certificate: 1) aspiration pneumonia 2) dysphagia 3) esophageal stenosis Other: congestive heart failure, hypertension, chronic kidney disease stage 3

Patient contracted COVID and was hospitalized. He later died- respiratory failure secondary to COVID-19 pneumonia. This was not related to a vaccine adverse event, but reporting based on requirements.

2/14 Emergency room HPI Patient is a 94 y.o. male who presents with complaint of cough that started about a week ago, and was seen by primary care provider on the 9th February 2021. Patient was started on Augmentin and has taken it for about 5 days but said the cough is worse and productive of clear sputum. Patient in ER to get checked for pneumonia. Patient denies a fever or chills, shortness of breath, chest pain, nausea vomiting and no headache or dizziness. Transferred to another facility h&pHistory of Present Illness: 94-year-old former smoker with a history of paroxysmal atrial fibrillation not currently on anticoagulation, coronary artery disease, insulin-dependent diabetes, CKD 4, prostate cancer on surveillance, TAVR 2/17, with a son who is a doctor and a caregiver who is a Radiology NP by his report, who presents in transfer from previous Hospital due to a large right pleural effusion. He has had a cough for some time now, but thinks it may have worsened, at least per his caregiver, over the last 4-5 days. He was seen by his PCP on February 9th and placed on Augmentin, but nothing changed. He himself denies being short of breath, having any chest pain, fevers, chills, sweats, change in appetite, abdominal pain, nausea, vomiting, dysuria, diarrhea. Of note, on a chest x-ray in June he had bilateral pleural effusions, and on an MRI in July to investigate a renal mass, he was noted to have a small right-sided pleural effusion. On arrival to facility this morning, he was afebrile, normotensive, had a normal heart rate, sometimes mildly bradycardic, normal respiratory rate and saturations of 97% on room air. Labs demonstrated chronic anemia and thrombocytopenia, stable stage 4 kidney disease creatinine of 2.6, BUN 64, glucose 187. Chest x-ray demonstrated a moderate right pleural effusion, noting that underlying consolidation cannot be excluded. He was also felt to have bibasilar atelectasis. CT of the chest without contrast showed a large right pleural effusion with most of the right lower lobe being collapsed. Superimposed infection could not be excluded. He had a small left pleural effusion with adjacent atelectasis and a small pericardial effusion as well. EKG and procalcitonin were not performed. He was sent to our facility for thoracentesis. On arrival here, vitals remained stable. His bedside RN informed me that upon returning from the bathroom, he appeared to be a bit dyspneic, but the patient himself denies any shortness of breath or ?huffing and puffing?. 2/25 admEd to hospital admission

Several days after vaccination his left arm turned red. He was taken to the hospital where he was evaluated and admitted with a diagnosis of left axillary vein thrombosis. A chest X-ray was taken and he presented bibasilar atelectasis and pneumonia with pleural effusions.

Pneumonia; coughing with bubble spit; STOPPED EATING AND WOULD NOT SWALLOW PILLS; PAIN IN ARM; NOT FEELING WELL; A spontaneous report was received from a consumer concerning a male patient of 94 year old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced pain in arm,felt unwell, coughing with bubble spit,stopped eating, would not swallow pills and pneumonia. The patients medical history was not provided.No relevant Concomitant medications were reported. On 08 Feb 2021,prior to the onset of events, the Patient received their second of two planned dose of mRNA-1273(Lot number: 031L20A) vaccine for prophylaxis of COVID-19 infection. On 09 feb 2021,patient experienced pain in arm and felt unwell. On 13 Feb 2021,patient experienced coughing with bubble spit,stopped eating and would not swallow pills. On 15 feb 2021,patient went to the hospital and was diagnosed with pneumonia and patient was hospitalized and received a negative covid test in the hospital. Treatment information for the event included IV and oxygen. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the event pain in arm and felt unwell were considered resolved on 10 feb 2021. The outcome for the event coughing with bubble spit were considered resolved on 14 feb 2021. The outcome for the event stopped eating and would not swallow pills were considered resolved on 15 feb 2021.The outcome for the event pneumonia was not provided.; Reporter's Comments: This case concerns a 94-year-old male who was hospitalized with a serious unexpected event of pneumonia along with NS unexpected malaise, cough, aversion to food and NS expected vaccination site pain. COVID-19 test negative. Event onset 30 days after the first dose of mRNA-1273. Treated with O2 and IV. Pneumonia outcome unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

According to his daughter, patient did not appear to have any ill effects from his second COVID-19 vaccine on 03/09/2021. However, on 03/11/2021, he suffered what is suspected to be a fatal arrhythmia/myocardial infarction. It is unknown if there is any correlation to the vaccine.

Pt started feeling weak within hours of vaccine progressive weakness ensued and pt began to have falls and Rapid decline in general status and Died 3- -2021

After pt received first dose of Moderna on January 27, 2021, he experieced continuous increased decline in his health , with symptoms of increased difficulty swallowing, increased coughing, at least one episode of choking with expulsion of food; increased difficulty walking with walker, increased shortness of breath. On Wednesday, Feb. 24, at 7:50 a.m. , Pt was in wheelchair exiting home, on way to detached garage, being pushed by his daughter, when he slumped over, stated that he couldn't breathe, and went unconscious. Pt. did not have a detectable pulse . EMT was called and upon arrival performed CPR and obtained a pulse. Pt was transported to local hospital, where, again he lost pulse and was resuscitated again with mechanical CPR. Pt was supported with blood pressure medicine and ventilator until 7:53 p.m. when his heart stopped again. Pt. passed at that time.

Patient passed away unrelated to COVID vaccine Narrative: The patient has COPD and congestive heart failure. Patient received first dose of Moderna vaccine on 1/11/2021 and no adverse reaction was reported. Patient's son reported patient had a minor car accident and was taken to ER where he was tested positive for COVID pneumonia and he passed away in his sleep on the morning of 2/4/2021. Patient's son stated due to his COPD, he was not able to survive the COVID pneumonia. No indication that death was related to COVID 19 vaccination.

On 3/23/2021 he had respiratory problems and high blood pressure, for which he was transferred to the hospital and days later he died.

Patient went to ER with breathing difficulties. Had fluid buildup in lower legs and fluid on lungs. Was diagnosed by ER Dr. with Congestive Heart Failure (CHF). This was a new and first time diagnoses as patient sees a heart specialist each year. With treatment patient was slowly getting better. Upon second dose 01/20/2021 patient got worse again. Eventually had to go on Oxygen. With treatment patient is slowly getting over symptoms of CHF.

Patient received his first Moderna vaccine 3-19-21. He was due for his 2nd dose 4-16-21. We followed up with his sister due to missed appointment and was informed that he passed away 4-15-21 due to a blood clot.

Patient has a long standing chronic history of CHF which he was recently hospitalized for, returning from an overnight stay at the hospital as a DNR/DNH/DNI.

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 93 and receiving home based palliative care. On 3/30/21 his home nurse reported he was having bilateral lung wheezing. On 4/16/21 patient's wife stated he passed away at home after suffering an "asthma attack." PMH significant for dementia, malnutrition, reduced mobility, bedbound, Alzheimer's, DM, afib, CAD, NSTEMI

After second dose, individual became weaker and needed to use of cane to walk around. Became progressively weaker over course of a few weeks, then on May 14th had chest pressure, nausea, and dizziness. This continued, Wednesday May 19th complained of trouble breathing, shortness of breath, but felt better Friday, May 21st, until Saturday May 22nd at 6:00 AM individual complained of more severe chest pressure. Taken to hospital, determined heart attack and kidney failure.

Ministrokes; odd symptoms; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Ministrokes) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient was confirmed covid free earlier in January (exact date unknown). Concomitant products included ACETYLCYSTEINE, CALCIUM LEVOMEFOLATE, MECOBALAMIN (CEREFOLIN NAC [ACETYLCYSTEINE;CALCIUM LEVOMEFOLATE;MECOBALAMIN]), AMOXICILLIN and COLECALCIFEROL (VITAMIN D3) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Ministrokes) (seriousness criterion medically significant) and ADVERSE EVENT (odd symptoms). The patient was treated with ESLICARBAZEPINE ACETATE (APTIOM) ongoing since an unknown date at a dose of 200 milligram and ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 325. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Ministrokes) and ADVERSE EVENT (odd symptoms) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Magnetic resonance imaging: confirmed ministroke (Positive) confirmed ministroke. It was reported that the odd symptoms were attributed to amoxicillin and the patient stopped taking it. Company comment: Very limited information regarding these events have been provided at this time. Patient's advance age can be a confounding factor to the event Transient ischemic attack while antibiotic use (amoxicillin) have been said to contribute to the Adverse event NOS. No further information is expected. This case was linked to US-irms-MOD21-106616 (Patient Link).; Sender's Comments: Very limited information regarding these events have been provided at this time. Patient's advance age can be a confounding factor to the event Transient ischemic attack while antibiotic use (amoxicillin) have been said to contribute to the Adverse event NOS. No further information is expected.

mini-strokes which have increased in frequency; placed on low-dose seizure medicine Aptiom 200 and Aspirin 325 to prevent further seizures; Wheezing; Shortness of breath; Headaches; Soreness in arm; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (mini-strokes which have increased in frequency) and SEIZURE (placed on low-dose seizure medicine Aptiom 200 and Aspirin 325 to prevent further seizures) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013l20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included ACETYLCYSTEINE, CALCIUM LEVOMEFOLATE, MECOBALAMIN (CEREFOLIN NAC [ACETYLCYSTEINE;CALCIUM LEVOMEFOLATE;MECOBALAMIN]), COLECALCIFEROL (VITAMIN D3) and AMOXICILLIN SODIUM (AMOXICILLIN [AMOXICILLIN SODIUM]) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (mini-strokes which have increased in frequency) (seriousness criterion medically significant), SEIZURE (placed on low-dose seizure medicine Aptiom 200 and Aspirin 325 to prevent further seizures) (seriousness criterion medically significant), WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), HEADACHE (Headaches) and MYALGIA (Soreness in arm). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] ongoing since an unknown date for Seizure prophylaxis, at a dose of 325 dosage form and ESLICARBAZEPINE ACETATE (APTIOM) ongoing since an unknown date for Seizure prophylaxis, at a dose of 200 milligram. At the time of the report, TRANSIENT ISCHAEMIC ATTACK (mini-strokes which have increased in frequency) had not resolved and SEIZURE (placed on low-dose seizure medicine Aptiom 200 and Aspirin 325 to prevent further seizures), WHEEZING (Wheezing), DYSPNOEA (Shortness of breath), HEADACHE (Headaches) and MYALGIA (Soreness in arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Magnetic resonance imaging: mini-strokes (abnormal) mini-strokes were confirmed via MRI. The patient's caregiver reported the patient stopped taking amoxicillin 875-125 prior to receiving the second dose of the vaccine. After receiving the second vaccine, he began to experience a repeat of symptoms similar to those after the first dose which were described as a number of mini-strokes which increased in frequency. The patient was treated and released in an emergency room (less than 24-hour stay). It was reported the mini-strokes occurred within 24 to 72 hours post-vaccination. Company Comment : Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-207709 (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. Further information has been requested.

Completed 2 dose vaccination series on 1/30/21 w/ Moderna Vaccine. Admitted 7/28/21 to Medical Center w/ complaints of weakness, body aches, dry cough. COVID PCR+ on 7/28. Also patient in atrial fibrillation. So far treated w/ dexamethasone, remdesivir x 1, vitamin D, zinc, vitamin C; O2 has improved from 3L NC to room air (sat 92-94%).

ON 1/21/2020 RESIDENT WAS EXPERINCING CHILLS AND LOOSE STOOLS. FOLLOWING THIS EPISODE BECAME UNRESPONSIVE, PALE, DIAPHORETIC AND BRADYCARDIC. PALLIATIVE CARE WAS PROVIDED. RESIDENT PASSED AWAY APPROX. 10 HOURS LATER.

Patient became immobile on 1/25/21 (4 days after receiving Moderna COVID-19 vaccine). He died on 1/27/21

Patient developed shortness of breath and weakness the morning after he received the COVID vaccine. He also reported diarrhea and fatigue. Per the patient he went to 2 urgent cares before being referred a day or 2 later to the emergency department. The patient was diagnosed with NSTEMI and later transferred hospital.

He vaccine on 2/5/2021 I went to see my husband the next day he was shaking and his mouth was open shaking, and he had fever of 105, they gave him Tylenol suppositories and he passed away 2 hours later. They should not have given him should not have given him the vaccine that is on hospice, it was not the right decision. I am worried about the elderly and those very sick.

This is a hospice patient under the care of Hospice at an affiliated nursing home. Pt received the vaccination around noon on 2-16-21 by a representative from Pharmacy. The following afternoon 2-17-21 at 14:45 the pt started to experience severe SOB resp rate 36, audible wheezing and use of respiratory accessory muscles. BP180/80, 113 pulse temp 98. Pt was given morphine and ativan. The respiratory distress was eased however pt never returned to baseline and died 2-22-21 around 4am.

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.

Death Narrative: 95 yr old Renal failure, renal anemia, Died on Hospice service. No vaccine complications reported.

Death Narrative: 4/12 patient had fatigue/dyspnea -Per NP visit/note: -" reviewed with office/clinic team MD on phone, clinically does not appear to have fluid overload, has chronic LE edema which is no worse than usual, could be pneumonia possible aspiration related to dyaphagia. patient does not want to go to hospital for evaluation and treatment. Spoke with patient's daughter, confirms DNR and LST wishes, no hospitalization, no cpr/ventilation/feeding tubes. She is agreeable to treating with low dose diuretic and antibiotic in effort to help symptoms. She is agreeable to hospice consult. -cipro 250 mg po bid x 7 days, furosemide 10 mg qday and kcl 10 meq x7 days called into pharmacy. caregiver to pick up today. reviewed s/e and precautions with meds in addition to indications - caregiver encouraged to keep patient upright in chair or bed for easier breathing. "

Stroke / right CVA (Cerebrovascular accident); Left side instability when walking; Cognitive memory a little unsure; left side face affected; Rash was itchy / Knees were very itchy; Rash was red; Feet drooping on left side / Feet more slurred than usual; Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots; This spontaneous case was reported by an other health care professional and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)) in a 95-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B212A and 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)) (seriousness criterion medically significant), ATAXIA (Left side instability when walking), COGNITIVE DISORDER (Cognitive memory a little unsure), FACIAL DISCOMFORT (left side face affected), PRURITUS (Rash was itchy / Knees were very itchy), ERYTHEMA (Rash was red), PERONEAL NERVE PALSY (Feet drooping on left side / Feet more slurred than usual) and RASH (Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke / right CVA (Cerebrovascular accident)), ATAXIA (Left side instability when walking), COGNITIVE DISORDER (Cognitive memory a little unsure), FACIAL DISCOMFORT (left side face affected), PRURITUS (Rash was itchy / Knees were very itchy), ERYTHEMA (Rash was red), PERONEAL NERVE PALSY (Feet drooping on left side / Feet more slurred than usual) and RASH (Full body rash from the neck down excluding hands and feet (bilateral) / Pinpoint red dots) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication provided. No treatment information mentioned. 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. Patient had presented these reactions a month after their second dose of the vaccine. 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.

The consumer has not received the second dose.; Stroke; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke) in a 95-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 Blood pressure high. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The consumer has not received the second dose.). At the time of the report, CEREBROVASCULAR ACCIDENT (Stroke) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (The consumer has not received the second dose.) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included unspecified High blood pressure medication. No treatment information was provided. The reporter was unsure if the patient received the Moderna vaccine or the Pfizer vaccine 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.

Right arm weakness, right hand numbness, leg weakness, fatigue, blurred speech, small eschemic stroke right side

Developed swelling of left lower leg on 1/24/2021, went to ED and was diagnosed with DVT of the L femoral vein. Placed on Xarelto and sent home.

weakness and fallsNarrative: 95 yo male w/ a PMH significant for Afib, legal blindness, Hx of CVA, cognitive impairment, GERD, HTN, pseudogout, BPH, chronic knee infection, and DJD who received his first dose of the Moderna COVID-19 vaccine on 01/08/21. The pt's COVID-19 screening questionnaire prior to receiving the vaccine was negative. The pt presented to the ED on 01/13/21 for weakness and m PCR test on ultiple recent falls (since receiving his first dose of the COVID-19 vaccine). The pt's COVID-19 01/13/20 was positive and he was admitted. He was started on treatment with remdesivir + dexamethasone on 1/14. The pt initially required supplemental oxygen via low-flow NC, however his oxygen requirements increased to 100% NRB. On 01/16/21 his MPOA elected for hospice care. The pt passed on 01/17/21. Unclear if the COVID-19 vaccine attributed to the patient's hospitalization and eventual death, or whether these events occurred from COVID-19 itself, however this case is being reported the FDA since this vaccine is under an emergency use authorization (EUA).

This is the patient who passed away 2d after his second COVID vaccine. Of note, the 2/8 telephone note makes it sound like he was hospitalized at time of death - that is incorrect. His daugther listed as EM contact works in the eye clinic here. He had mild illness, completed 10d isolation but missed his scheduled booster dose on 2/2 due to isolation. He was called on 2/5 when there was a booster visit cancellation and received his booster dose on that day. His daugther reported that he was doing fine and looking well on 2/7 AM, ate breakfast, shortly after stood up and just collapsed.

4 days after receiving the vaccine in his left arm, my father developed a blood clot in his left arm that required emergency hospitalization and large doses of blood thinners.

My grandpa was very lethargic after his 2nd vaccine. The following day he started acting more awake, he had a better appetite but seemed to be breathing a little funny. He was labored a bit. He went to sleep on 2/24/21 and at 230 am was dead.

weakness Narrative: 96 y/o male received 2nd COVID 19 (Moderna) shot on 03/11/21 @1700. Tolerated first COVID 19 vaccine shot with no issues. History of afib, CKD, basal cell carcinoma of neck and ear, squamous cell carcinoma, valvular heart disease, coronary arteriosclerosis, pacemaker, hypertension, aortic valve stenosis s/p aortic valve replacement. No prior ADR to vaccine or severe allergy to medications. Brought in by ambulance to outside hospital after being found on the floor by neighbor on 03/13/21; may have been down for up to 24 hours. Patient reported feeling woozy the day prior and very weak. Currently being treated for pneumonia. Had elevated troponin likely secondary to prolonged downtime and thabdomyolysis, but cannot r/0 NSTEMI. Currently still hospitalized today 03/15/21.

Patient received 2nd Moderna Covid-19 vaccine on 3/4/21. Patient was admitted to hospital on 3/14/21 with a stroke. The patient fell the night before and laid on the floor until family found him and then was taken to the ER. Prior to falling he experienced left arm weakness.

Patient received his second dose of the COVID-19 vaccine on February 17, 2021. Per family, he complained of feeling chilly and cold. He was found deceased in the early morning on February 18, 2021.

a few days after his congestive heart failure got worse and continued on a down ward spiral. He refused to go to hospital and last few days hospice was brought in. He died not being able to breath. Autopsy was not done.

Presented to ED with shortness of breath. Tested + for COVID-19 at nursing home 1 day prior to presentation. Reports complaints of increasing fatigue, body aches, and respiratory difficulties. Was hypoxic on arrival to ER and required high flow nasal cannula at 45L 60% FiO2 initially. Admitted to floor for oxygen/dexamethasone treatment. Patient's oxygen was titrated as needed. The day following admission patient developed apnea/cyanosis with large amounts of thick sputum. Patients respiratory status declined rapidly and patient expired.

Patient had a heart attack with Afib (new onset) several days after the vaccine. We do not know if this is at all related but wanted to report it nonetheless.

died on hospice Narrative: Patient died on hospice, it is my clinical recommendation that death was r/t chronic anema, advanced dementia, COPD, CAD, and not related to prior administration of COVID-19 vaccination

DEATH Narrative: NO INFORMATION AVAILABLE AS PATIENT DID NOT RECEIVE CARE AT THE FACILITY ALL EXCEPT AUDIOLOGY CLINIC WITH THE LAST VISIT IN 2019 NO DEATH NOTE, NO AUTOPSY NOTED, PT HAD ONE AMBULATORY CARE NOTE IN 2012 NO DOCUMENTATION OF PREVIOUS COVID INFECTION, NO HOSPITALIZATIONS, NO ACUTE REACTION AFTER VACCINE. Most likely cause of death was advanced age, not related to vaccine.

Death Narrative: Patient was 96 yr old, prostate cancer, peg tube placed, Died on Hospice service, No vaccine complication reported.

Dad woke up on January 29, 2021 with severe stomach pains and vomiting. He was very uncomfortable and ended up going back to bed. He was miserable all day. I called his physician and we decided to keep him comfortable at home and give him the BRAT diet which seemed to be helping with the pain and vomiting. Dad never got out of bed again. On February 4th, Dad was placed on Hospice and died on February 7, 2021.

Patient sparked a high fever shortly after receiving vaccine, was treated with Tylenol suppositories and Morphine. Patient was on 1.5 liters of Oxygen. Hospice refused any additional treatment including IV fluids or doctor visit requested. Patient stopped eating and drinking and lapsed into unconsciousness. He died on June 29. 2021 after Hospice nurse recommended removing Oxygen. At home nurse insisted on maintaining oxygen until his death a few hours later.

DEATH Narrative: PRIOR TO DEATH, spoke with pt's daughter and she reported that pt is unable to keep his appt for the second Covid vaccine appt because is sick today. Per daughter, pt has been lethargic, not enough sleep last night because of frequent urination at least every 30 to 45 minutes looks exhausted and with poor appetite. Pt has not been drinking fluids at least 6 to 8 glasses a day and daughjter tries to make sure pt drinks fluids, the best he can. Per daughter, pt's vitals signs are as follows: BP: 93/48mmhg PR: 93/min. Temp: 98.1 F and O2 sat: 95%.

Ppt collapsed at home on 3/27/2021 late morning. Presented to ED on 3/27/21 from home around 11am with altered mental status. Was found to have a hyper acute stroke per CT head (intracranial hemorrhage). Ppt was pronounced on 3/28/2021 at 1:45pm. UNSURE IF DEATH RELATED TO VACCINE.

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 97 and admitted to Hospital on around 2/20/2021 due to a fall at home. He later passed away on 3/5/21.

Made home visit for the 2nd dose of the Moderna COVID Vaccine and the daughter reported patient had died on 5/9/2021. No other information was given.

Patient reported symptom onset on 4/2 with severe chills where his whole body shook. The symptoms came on all of a sudden. Patient's wife called the EMTs about two hours later and patient had a fever of 102.5. The fever did not last long. Patient reported shortness of breath and congestion but says that he always has those symptoms and that he had them long before COVID. He also vomited on the gurney. They were told that he aspirated and that was how he developed pneumonia. Patient reported having a CT scan but was unsure if they did a chest x-ray. Patient was on oxygen but not a ventilator. Patient was not admitted to the ICU but was on the COVID wing at the hospital.

No adverse events reported post vaccine. 1 st dose on 1/11/21 by public health. Death 1/31/21 Patient was on hospice for gradual decline.

death Narrative: Patient received Moderna COVID #1 on 2/4/21 and #2 on 3/4/21. He was seen by his PCP via telephone visit on 3/2/21 for a routine follow up, no acute issues noted and follow up was planned for 6 months. On 3/12/21, he passed away, no notes in medical records or scanned records to indicate what happened. No autopsy results available. 8 days from date of last vaccine and date of death.

death Narrative: Patient received Moderna COVID vaccine #1 on 1/10/21, he was seen by his PCP for a routine 6 month check up on 1/14/21. Notes at that time indicate he had a left great toe, he wound and was receiving home health and IV daptomycin through a PICC line. On 2/7/21, he received vaccine #2. Notes then indicate that on 3/9/21, he was found passed away in his home by family. No autopsy results available. 30 days form date of vaccine #2 to date of death.

Patient received both doses of the Moderna COVID vaccine on 02/02/2021 and 02/26/2021. Patient tested positive for COVID on 03/25/2021 and was admitted to hospital 03/25/2021 - 04/23/2021. Patient was readmitted on 04/27/2021 for UTI. Patient died on 05/07/2021, suspected cause of death was multi organ failure.