Moderna

On 1/12/20 resident woke up and was not able to stand in the E-Z stand. E-Z lift was needed. In addition he needed assistance with eating. At that time VS were stable, equal hand grasp noted, and no further concerns. Around 3pm resident became flaccid on the left side of his face and speech became mumbled. Hand grasp was equal at that time and VS were stable, but B/P was elevated compared to previous recordings earlier in the day. Family did not want him sent to the hospital and asked for comfort cares. Hospice referral obtained and he will be admitted to hospice in the near future. Resident's left side of face has improved within the last 48 hours. He remains total assist with all cares.

Patient reported fever, dizziness and lightheadedness, as well as low blood pressure to this nurse by phone. This nurse requested patient to be seen by provider as soon as possible. Patient agreed and came to clinic soon after phone call. Dr notified this nurse that patient was advised to be seen by provider in ER for possible IV fluids and lab work due to symptoms. Pt refused and went home.

syncopal episode approximately 7 minute after initial COVID 19 vaccine, Moderna Lot number 030L20A Exp: 7/16/202. Patient became unresponsive, gasping for air. Wearing KN95 mask, removed mask, called for assistance, applied 3L Oxygen via non rebreather face mask. Once oxygen was applied patient was able to respond to commands. Blood pressure was checked at 1545, 110/70. EMS was called at 1545, arrived on seen at 1546. Patient was assessed by EMS, vitals stable, transferred to Hospital at 1600.

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

Syncope; Shaking; Struggling to breathe; A spontaneous report was received from a consumer concerning a 90-year-old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed syncope, shaking, and struggling to breathe. The patient's medical history was not provided. Concomitant medications reported included warfarin, ezetimibe, bupropion, finasteride, tamsulosin, furosemide, potassium chloride, rosuvastatin, and nitrofurantoin. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot # 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, after vaccine administration, the patient stayed at the vaccination site for fifteen minutes to watch for any reaction, he had none, so he left. Later that night the patient began shaking and struggling to breathe, so 911 was called. At the hospital, the patient was diagnosed with syncope. He spent overnight in the hospital and had an echocardiogram the following day. No results were provided for the echo, but the patient was cleared to go home after a sixteen-hour hospital stay. No treatment information was provided. Action taken with mRNA-1273 in response to the event was unknown. The outcome of the events, syncope, shaking, and struggling to breathe, was resolved.; Reporter's Comments: This case concerns a 90 year-old, male patient, who experienced events of syncope, shaking, and struggling to breathe. The events occurred the same night after the first and last dose of mRNA-1273 vaccine administration. 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 and the events are assessed as possibly related.

Patient stated he got shortness of breath and rapid heartrate. Went to the hospital where they performed cardioconversion and shocked heart into rhythm.

About 45 minutes after vaccine resident reported feeling light headed. Pulse was elevated at 120. Administered PRN Benadryl per protocol. Resident drank Gatorade and ate some food. Reported chest pain 15 minutes later. Administered PRN nitro which relieved his chest pain significantly.

RECEIVED BOTH MODERNA COVID-19 VACCINES ON 01/19/21 & 02/16/21 (NO LOT#, ROUTE, OR LOCATION PROVIDED IN EPIC CHARTING). 02/18/21 CALL TO CARDIOLOGIST TO REPORT CHEST PAIN RADIATING TO LEFT ARM THAT HAD BEEN GOING ON X2 HOURS. HE ALSO DESCRIBED HIGH BLOOD PRESSURE AND THAT HE HAD RECEIVED HIS 2ND COVID VACCINE 2 DAYS PRIOR. CARDIOLOGIST RECOMMENDED HE GO TO ER FOR CONTINUED PAIN. PATIENT REPORTED PAIN HAD ENDED. 02/19/21 REPORTED TO ER WITH CHEST PAIN AND ELEVATED BLOOD PRESSURE. DIAGNOSED WITH CHEST PAIN, UNSPECIFIED TYPE AND HYPERTENSION NOT AT GOAL.. 02/19/21 ADMITTED INPATIENT TO HOSPITAL..

Fall - 7 AM Fall in Dining Room Community Center 1 PM Ambulance to Hospital ER 1:30 PM Tests - Blood, CT scan of head and brain, X-ray of Chest Release from hospital - 5 PM Arrive by car to home 5:30 PM fall from car to grass Call for Security and Nurse to get him up and into the house - vital signs taken Fall again in the house at 6 PM Seemed to back to normal +/- 7 PM

HYPERTENSION PATIENT TAKING METOPROLO 100mg 12 HRS - MODERNA APPARENTLY RENDERED METOPROLO TOTALLY INEFFECTIVE BY BP READINGS FOR NOW 40 HRS AND CONTINUES.

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.

The day following his Moderna vaccination, the pt became profoundly week with difficulty standing on his own and frequent falls. He also experienced sever malaise

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.

chest pain; sluggish and limited energy; High amount of mucus; Hard for him to sleep; His wife says he is having breathing problem left side; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (chest pain) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Smoker (I haven't smoked in 40 years) and Alcohol use (nor had alcohol in 30). Concurrent medical conditions included Hypertension since 03-Apr-2021. Concomitant products included METOPROLOL SUCCINATE (TOPROL) from 03-Apr-1966 to an unknown date for Hypertension, CAFFEINE, MEPYRAMINE MALEATE, PARACETAMOL, PHENIRAMINE MALEATE, PHENYLPROPANOLAMINE HYDROCHLORIDE (TRIAMINICIN [CAFFEINE;MEPYRAMINE MALEATE;PARACETAMOL;PHENIRAMINE MALEATE;PHENYLPROPANOLAMINE HYDROCHLORIDE]) from 03-Apr-1966 to an unknown date and OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]) for an unknown indication. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced SECRETION DISCHARGE (High amount of mucus), INSOMNIA (Hard for him to sleep) and DYSPNOEA (His wife says he is having breathing problem left side). On 17-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHEST PAIN (chest pain) (seriousness criterion hospitalization). The patient was hospitalized from 18-Mar-2021 to 31-Mar-2021 due to CHEST PAIN. At the time of the report, CHEST PAIN (chest pain) had not resolved and SECRETION DISCHARGE (High amount of mucus), INSOMNIA (Hard for him to sleep) and DYSPNOEA (His wife says he is having breathing problem left side) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: abnormal (abnormal) Urgent care who took x-rays and confirmed something happening in my lungs.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Cardiologist, who ran tests and said "he saw no sign of a heart attack" that he suspected lung damage. He was admitted to the ER and later began treatment to remove water from my system. 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. Action taken with mRNA-1273 in response to the events was not Applicable. he ruled out cancer. This case was linked to (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: Patient demographics updated. Historical condition, lab data, second dose of moderna vaccine, events chest pain (Hospitalised) and asthenia 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. Further information has been requested.

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.

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.

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.

Patient reported feeling dizzy 10 minutes after receiving the vaccination. His vital signs were taken at 1100: BP 11760, HR 49, 02Sat 94%, T 98.6 which is consistent with his baseline. Patient wife stated "he has a vascular problem in his brain and he gets dizzy spells like this at home." Veteran was instructed to remain seated for a few more minutes. Patient reported feeling shaky and was given 4oz of orange juice. His vital signs were retaken at 1125: BP 138/63, HR 54, 02Sat 96%, Blood glucose 164. Provider consulted. After symptoms resolve and pt. history reviews, patient was sent home at 1130.

Unusually high Blood sugar upon routine daily testing. The last several days since vaccine. No idea of related.

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

Headache, fever, uncontrollable shaking, heart rate 104, bp 140/86 called 911, ambulance ride to above Hospital. IV on route, Kept over night in hospital. Shake stopped in about 2 hours , continued rapid heart for awhile and fever, Hospital gave him tylenol. after about 4 hours his bp fell to 89 over 64 ... thus keeping him in hospital. They did multi tests. found an unknown infection in his blood. Patient has had an elevated WBC but in hospital it was 50,000. two weeks ago at his primary Dr. it was 40,000. He walks with a walker and cane, however he has lost his balance and fallen 3 time since vaccine and one of those was today.

STARTING THURSDAY EVENING 2/11 AROUND 7:30PM THRU FRIDAY MORNING 2/12 9:30AM PATIENT HAD A BLOODY NOSE. BLED ALL EVENING. PUT A CLAMP LIKE DEVICE ON NOSE. KEPT A WASHCLOTH NEARBY TO WIPE NOSE ALL NIGHT. KEPT PATIENT AWAKE MOST OF THE EVENING. PATIENT WAS GETTING READY TO GO TO THE EMERGENCY ROOM, BUT FLOW STARTED TO SUBSIDE AND THEN EVENTUALLY STOPPED, THEREFORE RECEIVED NO MEDICAL TREATMENT.

Resident went out of facility to the Fairgrounds on 2/25/21 for an appointment at 11:30 to receive second dose of Moderna vaccine. Someone from the local Fire Department came to the facility and administered another dose to the patient on 2/25/21 at 3:30pm but actually administered to the wrong patient. on 2/25/21 at 6:20pm, the patient experienced respiratory distress. Pulse oximetry was 85%. BP 175/86. Pulse was 102. Temperature was 102.2. Nurse manager at the facility was notified and when she and the nurse spoke to each other, the patient stated he had two vaccines today. This was when the double dose was discovered. The patient was sent out to the hospital emergency department and was admitted. The patient was on a bipap overnight. Condition has improved this morning.

Patient presented to Medical Center on 02/23/2021 for weakness and fall. Patient had received his 1st Moderna COVID-19 vaccine on 02/22/2021. Was weak unable to rise out of the chair the next day. Patient has a history of COVID-19 in November of 2020. Patient was admitted to the hospital on 02/23/2021. Patient was ultimately diagnosed with generalized weak, right knee pain status post fall and elevated troponin level. Patient was managed conservatively and recovered over 24 hours. Patient was discharged on 02/24/2021 to follow-up.

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.

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

Resident ate a few small bites of pudding then refused. Resident then began with white, foul smelling emesis. Resident noted to be hunched over and clutching chest, unable to verbalize discomfort. BP 155/118 (manual) P 87 T 98.1 R 20. Out via 911 immediately.

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

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.

Follow up to FAERS18694343: Patient received casirivimab instead of intended COVID vaccine. At follow up on Jan 4, patient reported having shortness of breath and fast heart rate (has pacemaker). Will see provider this week. Not yet scheduled to receive COVID 19 vaccine

Patient received casirivimab instead of intended COVID vaccine. At follow up Jan 4, patient reported having shortness of breath and fast heart rate (has pacemaker). Will see provider this week. Not yet scheduled to receive COVID 19 vaccine

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.

Patient received dose 1 moderna 12/29/20, and dose 2 moderna 1/25/21. Admitted to hospital for fall, altered mental status, hyperglycemia on 2/4/21.

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.

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

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

92 y/o M, hx of HTN, otherwise healthy and well here for second dose with no reported adverse rxn from first dose. VR was driving from the vaccination area and got app 250 meters away when he became lightheaded. He got out of the vehicle and had a syncopal episode, had an unwitnessed fall backwards and struck his head on the roadway causing a full thickness 5cm stellate laceration. Vitals: BP 215/98, HR 50 and regular, O2 93% on outdoor air. Reports taking BP meds this am. Pt was amnestic to the event but denies LOC. Had one episode of N without V. No midline C spine tenderness. Reports no blood thinners. EMS was summoned and transported him to a nearby hospital for further evaluation and treatment.

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.

48 hours diarrhea and weakness, unable to keep fluids down, admitted to hospital through ED for diarrhea, stool culture, IV fluids. Discharged after 4 days diagnosis gastroenteritis/norovirus, dehydration and hypokalemia

PATIENT COLLAPSED IN PARKING LOT AFTER WAITING HIS 15 MINUTES. HAD SHORTNESS OF BREATH AND LABORED BREATHING. HEART RATE WAS VERY FAINT AND PATIENT WAS SWEATING. WIFE STATED PATIENT DID NOT EAT YET TODAY

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

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.

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.

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.

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:

Very harsh dysrhythmia; Parkinson's symptoms got worse with joint contractions, stiffening, and confusion; Napping more; Blood pressure has been haywire, sometimes going high and sometimes low; A spontaneous report was received from a consumer, who was also the daughter of a 93-year-old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a very harsh dysrhythmia (arrhythmia), Parkinson's symptoms got worse with joint contractions, stiffening, and confusion (Parkinson's disease); he has been napping more than before (somnolence), and blood pressure has been haywire, sometimes going high and sometimes low (hypertension, hypotension). Medical history, as provided by the reporter, included COVID in July 2020 from which he fully recovered, slight dysrhythmia, Parkinson's (tremors only), and slightly elevated blood pressure. The reported stated the patient's baseline health had been pretty good and he was usually mobile, active, cognitive, and had speech. Concomitant medications included carbidopa monohydrate (+) levodopa, losartan, beta blocker (unspecified), and liquid morphine. On 20 Jan 2021, one day prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number: 028L20A) intramuscularly in his right (dominant) arm for prophylaxis of COVID-19 infection. On 21 Jan 2021, around 2 pm, the patient had "a very harsh" dysrhythmia and his Parkinson's symptoms worsened with joint contractions, stiffening, and confusion. He had also been napping more than before. Since getting the vaccine, his blood pressure "has been haywire", sometimes going high and sometimes low. Treatment information was not provided. The action taken with mRNA-1273 in response to the events was unknown. The outcome of the events, a very harsh dysrhythmia, Parkinson's symptoms got worse with joint contractions, stiffening, and confusion; napping more than before, and blood pressure has been haywire, sometimes going high and sometimes low, were considered not recovered/not resolved at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

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.

2/19 patient presented for chest pain with occasional palpations. admitted for overnight observation. Troponins borderline elevated. Cardiology did not suspect ischemia. Patient discharged 2/20. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine

Presented to the ED with profound weakness including inability to ambulate (at baseline goes on moderate distance walks daily without assistive devices). Patient admitted to hospital on observation due to inability for him or his family to take care of himself due to the profound weakness.

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 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.

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.

Temperature of 103.3, hypotensive requiring vasopressors. Family did not want to continue, patient was switched to comfort care and admitted to hospital. Patient rapidly improved after 24 hours and continued to improve. Hypotension resolved. Patient was discharged to home.

Pt was vomiting and had a low oxygen level. Facility sent him to the emergency room in an ambulance.

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

Chest pain; Gallbladder with stones; Unable to walk on walker; admitted to the rehab facility to get therapy for upper and lower extremities as LLT upper extremity disfunction; He was so weak from laying there at the hospital for 4 days; The time the facility has it in stock it will be two months after the first dose; The time the facility has it in stock it will be two months after the first dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHEST PAIN (Chest pain), CHOLELITHIASIS (Gallbladder with stones), GAIT INABILITY (Unable to walk on walker) and MUSCULOSKELETAL DISORDER (admitted to the rehab facility to get therapy for upper and lower extremities as LLT upper extremity disfunction) in a 93-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 Dementia and Walker user. On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT AVAILABILITY ISSUE (The time the facility has it in stock it will be two months after the first dose). On an unknown date, the patient experienced CHEST PAIN (Chest pain) (seriousness criterion hospitalization), CHOLELITHIASIS (Gallbladder with stones) (seriousness criterion hospitalization), GAIT INABILITY (Unable to walk on walker) (seriousness criterion disability), MUSCULOSKELETAL DISORDER (admitted to the rehab facility to get therapy for upper and lower extremities as LLT upper extremity disfunction) (seriousness criterion disability), ASTHENIA (He was so weak from laying there at the hospital for 4 days) and PRODUCT DOSE OMISSION ISSUE (The time the facility has it in stock it will be two months after the first dose). The patient was hospitalized for 4 days due to CHEST PAIN and CHOLELITHIASIS. At the time of the report, CHEST PAIN (Chest pain), CHOLELITHIASIS (Gallbladder with stones), GAIT INABILITY (Unable to walk on walker), MUSCULOSKELETAL DISORDER (admitted to the rehab facility to get therapy for upper and lower extremities as LLT upper extremity disfunction) and ASTHENIA (He was so weak from laying there at the hospital for 4 days) outcome was unknown and PRODUCT AVAILABILITY ISSUE (The time the facility has it in stock it will be two months after the first dose) and PRODUCT DOSE OMISSION ISSUE (The time the facility has it in stock it will be two months after the first dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Computerised tomogram: abnormal (abnormal) Gallbladder with stones was found. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided. Treatment information mentioned therapy for upper and lower extremities. Patient's PCP mentioned that there may be a reoccurrence of gallbladder stones in the future. 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. More information about the events 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. More information about the events has been requested.

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 tolerated the vaccine well with no apparent side effects. Ten days later awoke 12:30 AM with severe chest and upper back pain, presented to Med Center where he was found to have an Acute Coronary Syndrome. Transferred to Medical Center where he underwent successful PCI with two drug eluting stents for a 99% mid-LAD stenosis

started having generalized weakness on 1/21/21, fatigued., nausea/vomiting. went to doctor on 1/25/21 with complaint of sore throat, cough, and felt congested. Went to ER on 1/25/21 with complaints of increased shortness of breath, worsening nausea and vomiting. started on oxygen for sats of 87%. admitted on 1/25/21. On 1/26/21 needed intubated, CXR showed worsening consolidative change right lung at right hilar level. Echocardiogram showed ejection fraction 35-40%, left atrium is moderately dilated.

Passed out and 911 was called They said blood pressure and blood sugar were low They gave patient a glass of orange juice and offered to take patient to the hospital, but patient refused.

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

low grade UTI; collapse; been kind of weak; A spontaneous report was received from a consumer, who was the caregiver of a 94-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced urinary tract infection (UTI), collapse (syncope), and weak (asthenia). The patient's medical history was provided. Concomitant product use was not provided. On 22 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number 029L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. The patient was hospitalized for a UTI from 10 Feb 2021 to 12 Feb 2021. The reporter stated, "after that, he's been kind of weak and everything". The reporter indicated it was a "low grade" UTI and the patient didn't show any symptoms but then stated "it actually had him collapse and he did that in between the two vaccines and spent two days in the hospital." On 17 Feb 2021, the patient received his second of two planned doses of mRNA-1273 (batch number 012M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection. The patient received both planned doses of mRNA-1273; therefore, the action with mRNA-1273 in response to the events was not applicable. Treatment for the UTI included nitrofluorine. The outcome of the events were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, 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.

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.

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.

My father was experiencing, weak pulse and crushing chest pain since his injection. He has long standing CHF managed with meds which have never caused side effects. He has been admitted to the Hospital approximately 4 days after injection . He is continuing to have chest pain and was seen again today by his Doctor.

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.

Disseminated Intravascular Coagulation Platelets = 19 Elevated Liver Enzymes. Bleeding coagulopathy Anemia Tachycardia Elevated white blood count

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.

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.

Patient is a 96 year old MALE with pmh colon cancer s/p resection 25 years ago, chronic urinary retention in the setting of prostate cancer with chronic foley, CKD 3b, HTN, HLD, hypothyroidism, left frontal lobe stroke on plavix here for hemoglobin of 5.9 on labs. Pt reports that he was drawing some bloodwork for renal follow up in 2 weeks and was told to come into the ED for evaluation due to low hemoglobin levels. Patient smear also contains schistocytes, more concerning for hemolytic process at play.

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.

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.

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.

Lethargic, pale, glassy and pinpoint eyes to unresponsive, limp and falling to the right side. Client laid on ground due to unresponsiveness and unable to obtain vitals, client gasped when laid flat then reported nausea, rolled to side client started vomiting. EMS called, EKG ran, client refused services. Walked out of clinic.

from nursing home for lethargy and altered mental status, onset this evening. Two initial EKGs were negative for ischemia. Troponin came back positive. Evaluated for NSTEMI, continued to monitor and started to see trending down troponin. Continued to monitor over several days and provider discussed with family and no intervention done. Improved over time and discharged to skilled nursing facility

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

He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got; He could hardly walk; Lightheaded and dizzy; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got) in a 97-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (Lightheaded and dizzy) and FATIGUE (Fatigue). On 22-Mar-2021, the patient experienced ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got) (seriousness criterion hospitalization) and GAIT DISTURBANCE (He could hardly walk). The patient was hospitalized from 22-Mar-2021 to 27-Mar-2021 due to ANAEMIA. At the time of the report, ANAEMIA (He could hardly walk. He was fully anemic. He was down to 4 in hemoglobin by the time we got), GAIT DISTURBANCE (He could hardly walk), DIZZINESS (Lightheaded and dizzy) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment included blood transfusions. Concomitant product use was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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 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.

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.

Resident started have chest pain on 3/02 and on 03/03 he was lethargic and wasn't eating or drinking Resident was on Hospice

Patient tested positive for COVID-19 on 5/20/2021, started showing symptoms around 3:30pm. "He drastically decreased in O2sats from WNL to 79% in about an hour?s time. His BP elevated, 152/90, and then dropped to 101/65. His HR increased 132-156 bpm. He had SOB." 99.5 fever while in hospital, on 2 liters oxygen