Moderna

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.

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 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.

pt says his right arm became very heavy the day he got his vax. He says it was so heavy he had to take his other arm to move it. He has had some shortness of breath and very fatigued. He has fever, dizziness, body aches and pains, chills, and joint pain. He says these symptoms come and go but has them almost ever day. He had a seizure one night while sleeping but was better next day. He will get cold and have to go to bed to sleep before warming up. He had an episode where his feet became very heavy and he couldn't walk. He has become extremely weak and has trouble doing daily task. He has cramping in his back muscles that moves up and down his back. He has never had any other these symptoms before getting vaccinated and has only had a couple of days where he felt normal.

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.

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

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.

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

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.

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.

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.

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.

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

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

Leg and hip weakness, Swelling of leg and feet. Acking legs, cramping legs and feet. Shortness of breath, eyes not focusing

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.

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.

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.

In the early morning hours of Saturday 2/27, Dad woke with severe pain in his right arm, shoulder and shoulder blade. He realized the right side of his neck was swollen and his throat was swollen as well. He was having trouble swallowing, talking and his breathing felt obstructed. He tried to awaken my Mother but she couldn't understand what he was saying. He finally managed to get up with on walker and make his way to get a drink of water. After that his throat seemed to loosen up some and by later in the morning the swelling had subsided. He did not inform me until I called later in that morning to check on them and he did not feel he needed to see a doctor.

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

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.

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

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.

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.

Tested positive for COVID-19 on 4/16/21. Symptoms worsened at home and home care nurse sent patient to emergency department. On 4/20/21 he presented to ED with shortness of breath and fatigue. He was then admitted for further management.

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.

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.

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.

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.

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.

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.

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.

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.

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. "

The patient presented to the Emergency Department with lethargy and shortness of breath. Upon presentation to the ED, the patient tested positive for COVID-19 (04/26/21). The patient is currently receiving triple therapy with remdesivir, dexamethasone, and convalescent plasma.

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.

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.

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.

He suffered a seizure. Shaking (entire body) Labored Breathing, Not responding. Called 911. Taken to Emergency Room.

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

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.

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