Moderna

At the time of vaccination, there was an outbreak of residents who had already tested positive for COVID 19 at the nursing home where patient was a resident. About a week later, patient tested positive for COVID 19. She had a number of chronic, underlying health conditions. The vaccine did not have enough time to prevent COVID 19. There is no evidence that the vaccination caused patient's death. It simply didn't have time to save her life.

began itching within 24 hours, within 5 days couldn't move on her own, by 6th day was having respiratory issues, by day 7 unresponsive, by day 8 dead

Pt started complaining of chest heaviness and shortness of breath on the afternoon of 1/21/21. EMS was called to the patients home and she was found to have an O2 sat in the 70's. She was admitted to hospital and found to have a proBNP of 5000. She tested negative for Covid-19. She was determined to be in acute-on-chronic heart failure and was referred for hospice care. She passed away on the evening of 1/24/21.

Positive Covid case investigation with the PA DOH. Spoke with case's daughter. States her mother recieved vaccine at clinic on 01/27/21. Had no complaints of illness or exposure to a positive case prior to vaccine. Daughter states she's independent and stays alone at night. Felt fine the day and the day after of the vaccine. Per daughter, case's last known well time was Friday 1/29/21 at 730pm. Daughter states they found her Saturday morning with stroke like symptoms and was admitted to Hospital step down unit. She was also informed by the doctor that her heart was irregular with atrial fibrillation.

On 1/17/2021 patient woke and began her day as usual, was found down by family member 1 hour later conscious but unable to speak and unable to move her R side. She was admitted to the hospital - Initial NIHSS was 26 and CT imaging showed no acute hemorrhage but mild hypodensity of greater than 1/3 of the MCA territory (TPA not recommended). CTA did show distal L M1/M2 occulsion and she was transferred to larger facility for thrombectomy. Unfortunately the patient had persistent severe neurological deficits after thrombectomy. Was discharged home on hospice care and expired on 1/23/21.

Patient passed away on February 5, 2021. There was no reaction after the shot was given, the patient's son said the death was not related to the vaccine. The patient had a bad case of shingles about a month prior to receiving the vaccine which the son said had been hard on the patient, the patient was also 90 years old. Per the son, the patient's doctor had wanted the patient to get the vaccine. Due to the close proximity of the date the vaccine was given and the date Patient passed away we wanted to complete the VAERS form.

Shortly after receiving the Moderna COVID-19 vaccine, patient complained of chest and stomach pain, then became very sleepy and fainted. RN was unable to obtain a manual BP; Apical pulse 36. Pulse Ox in the 70s. She was placed in bed and eventually regained consciousness. Her pulse ox improved to the 90s. BP 92/55. Her only complaint was that her hands were cold. Medical Director believes it was vasovagal syncopy due to receiving the vaccine. Patient died on 1/28/2021, due to progressive dementia.

Patient family had been noticing onset confusion for a few weeks prior to vaccine and event. Patient was taken to ED when found unconscious and died of a subdural hemorrhage a few days after vaccine clinic at retirement home.

Patient awoke on 2/12/21 with altered mental status, confusion, respiratory distress, was taken to hospital by ambulance. Per ED notes from ED attending Pt presented with hypotension and respiratory distress. DNR status, patient given comfort measures and passed away in ED at 11:24 am on 2/12/21.

Client had pressed her call pendant this morning (2/18/2021) at 0750, LPN found client in her bed unable to stand. Client reported she had to use the restroom, upon standing client, LPN noticed blood on client's pillow. After assisting with ambulation to her bathroom, LPN noticed blood covering the floor near her shower. After further assessment, blood appeared to me coming from the back of client's head. Vital signs assessed while she sits on the toilet. BP: 128/92 O2: 89% on RA RR: 18 HR: 69 T: 99.1 Client reported significant dizziness, lightheadedness, and nausea. She reported unsteadiness when standing. Quarter sized lump with dried blood noted on the back of client's head. She does report left arm soreness, likely from where vaccine was administered. Ambulance was contacted while LPN assisted dressing client. Client was unable to recall the incident that occurred overnight, she did not utilize her call pendant during initial fall. Time of fall/incident unknown.

Patient says she felt well after getting the vaccine, but shortly before midnight the same day started feeling fatigue, body pain all over. Next day pain was improved; only remaining jaw pain and fatigue; then the day after pain resolved but persistent fatigue and SOB since then (for 13 days now). Severe dyspnea on exertion; baseline able to walk more than 5 minutes before getting tired; over last 13 days unable to walk from one room to another without severe SOB> Had a ride today so came to urgent care for evaluation. Patient found to be in atrial fibrillation with rapid ventricular rate at 140

sepsis; UTI; shingles; severe headaches; A spontaneous report was received from a 90-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced UTI, sepsis, shingles, and headaches. The patient's medical history was not provided. No relevant concomitant medications were reported. On 04 Feb 2021, the patient received their second of two planned doses of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient began experiencing severe headaches. On 11 Feb 2021, the patient developed a severe urinary tract infection and had to be hospitalized. The patient broke out with shingles and now has sepsis. The patient is reported as being conscious, but not responding. No treatment information was provided. The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable. The outcomes of the events, UTI, sepsis, shingles, and headaches, were not provided.; 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.

2/12 Patient presented with palpitations, sensation of heat with no chest pain. Of note patient had covid diagnosed 11/20. Work up showed saddle PE and had SVT treated with adenonsine. Treated with IV heparin. Patient on 2L O2 weaned to room air before discharge. Patient transferred to CIRS 2/17. Per EAU, hospitalizations are to be reported irrespective of attribution to the vaccine.

Patient is currently inpatient at Hospital with atrial fibrillation. She woke up with chest pain on 3.16.21 at 4am with chest pain. She was taken by ambulance to the hospital where she was admitted. She is on heparin and has recieved an EKG, ECHO, and blood work. The medical team is evaluating next steps. Chest pain has not resided.

On Saturday morning, Mar 6th had erratic racing heart beat and high to very low blood pressure, 168/ , low 88/51, afib, unsteady, lightheaded, hot and chilled, headache, very weak. On 8:10am Sunday, heart beat ranged from 50 to 125 bpm, blood pressure dropped to 90/64. Doctor took me off all meds except Xarelto, said stay in bed, drink lots of fluids. I did not connect the symtoms to the vaccine at the time because problems happened after the 1st few hours, and I was too sick to think clearly. It was only when I read the side effects after 1-3 days, that I realized it could be from the vaccine. I worry about being deathly sick after the second vaccine shot, so I'm reporting this.

TIA diagnosis at hospital; Conscious after fall; Dizzy/ lightheadedness; Head bump (temple area and ear caused by hit sink during fall); A spontaneous report was received from a consumer who was also a 90-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced transient ischemic attack, fall, dizzy lightheadedness, and a head bump. The patient's medical history, as provided by the reporter, included transient ischemic attack; the patient experienced 3 events in 2020. No relevant concomitant medications were reported. On 23 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number 030L20A) intramuscularly for prophylaxis of COVID-19 infection. On 25 Jan 2021, the patient experienced dizzy lightheadedness and a fall, resulting in a head bump in her temple and ear caused by hitting the sink as she fell. The patient was hospitalized following the fall and diagnosed with transient ischemic attack. On 26 Jan 2021, the patient received magnetic resonance imaging and a laboratory test. On 27 Jan 2021, the lightheadedness and head bump had resolved. Action taken with mRNA-1273 in response to the event(s) was not reported. The outcome of the events, transient ischemic attack and fall, was considered resolved on 25 Jan 2021. The outcome of the events, lightheadedness and head bump, was considered resolved on 27 Jan 2021.; Reporter's Comments: This case concerns a 90-years-old female patient with a relevant medical history of three TIA within last year, who experienced a serious unexpected event of Dizziness and Transient ischaemic attack and non-serious unexpected events of Fall and Head injury. The events of occurred approximately 2 days after first dose of mRNA-1273, lot # 030L20A. Treatment details were not provided. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded. However, patient's advanced age and prior history of TIA are considered significant confounders.

Dyspnea, chest pressure, fatigue. Sought care at the hospital/ED -- found to have acute pulmonary emboli (by CT) with hypoxic respiratory failure. Treated with hospitalization, Xarelto, nasal canula oxygen. She improved to be stable on room air with improvement of her symptoms and went home after 3 days.

Diagnosis of ITP (immune thrombocytopenic purpura); Spontaneous rectal bleeding; Little bit of soreness; A spontaneous report was received from a consumer concerning reporter's mother a 90-year-old, female patient, who was diagnosed ITP (immune thrombocytopenic purpura)/immune thrombocytopenia, body's immune system attacking its own immune system/autoimmune disorder, spontaneous rectal bleeding/rectal haemorrhage, platelets abnormal/platelet disorder and little bit of soreness/pain. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) via an unknown route in the left arm for prophylaxis of COVID-19 infection. On 13 Feb 2021, patient's blood platelets were zero which was considered as life threatening event. On 13 Feb 2021 Saturday, patient had spontaneous rectal bleeding for which patient was taken to emergency room and admitted to ICU. Then patient was transferred to another hospital where patient was diagnosis of ITP (immune thrombocytopenic purpura) where body's immune system attacking its own immune system. The patient was seen by hematologist for 8 days. After vaccination the patient felt little bit of soreness, but patient was completely fine. The patient had three platelet counts one on 13 Feb 2021, in which showed a result of zero platelet, on 22FEB2021 platelet count increased to 57 and unknown date patient platelet count was 357. The patient also had tested for leukemia, blood cancers, and other blood work came normal. Treatment for the event included two Blood transfusions, IV steroids, Oral steroids maximum dose, Rituxan, N-platelet injections nonspecific. Action taken with mRNA-1273 in response to the events was not provided. The events, ITP (immune thrombocytopenic purpura), body's immune system attacking its own immune system, spontaneous rectal bleeding, platelets abnormal and little bit of soreness, were considered recovering on the time of reporting.; 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.; Sender's Comments: MOD-2021-047223:Crosslinked case

Patient started with chest pain on 02/28/2021 and subsequently went to the hospital on 03/01/2021 and was diagnosed with a STEMI.

She was taken to the hospital for respiratory distress, she was turning purple. She dies arriving at the hospital.

On 1/21/2021 Caregivers proceed to go on rounds taking vitals and found she was with low blood pressure. They call Hospice and they certify that she had passed away.

This was the Johnson and Johnson one shot. My mother received it and today is in the hospital with acculsive blockage in left brain, paralyzed from stroke and is being operated on. I believe it is a blockage from the vaccine. She was old but extremely cognizant, independent, healthy, strong of sound mind. This is why I am reporting it. If she dies I will report again.

One week after second Moderna shot, patient began low-grade fever, loss of appetite, foggy thinking, fatigue, general malaise. She was treated with three different meds for a possible UTI. All symptoms except fever continued for 10 days, and on March 25, she suffered a TIA. She went to the ER and stayed in the hospital for 36 hours. MRI showed no lasting damage. She is improving but is still fatigued.

one week after 1st vaccine shot, mom started to feel sick around lunch. Took mom to hospital she had a heart attack. They dissolved the blood clot and found out she also had pneumonia with no symptoms. She died 2 weeks later. She had dementia but health was fine until she received the covid 19 vaccine.

Weaknesses. Dizziness. Headaches. Blurry vision both eyes. Sleepiness. Strokes. Hospitalization. Death

Pt developed GI upset and weakness on 6/2, followed by chills and emesis 6/3. Was found deceased on the toilet on the morning of 6/4/21.

Pt had her 2nd Moderna vaccine on 3/18/21. She was brought to the ER on 5/25/21 c/o nausea and vomiting and abdominal pain and not feeling well. work up at the time was negative. she was thought to possibly have a UTI and sent home on antibiotics. urine culture from that visit was ultimately negative for infection/growth. She retuned to the ER on 6/1/21 c/o weakness, confusion and new shortness of breath. Her temp was 99.5, chest x ray showed extensive bilateral patchy opacities. head CT was neg. Her wbc was 14.4 with left neutrophilic shift, lactic acidosis of 2.1 and dehydration. She was admitted with sepsis and possible pneumonia. She was started on ivf and antibiotics and admitted. She was also started on oxygen for new hypoxia of 81%. CT chest showed interstitial pulmonary edema, interstitial pneumonia. echo showed normal LVEF and grade 2 diastolic dysfunction with severely dilated left atrium. Her wbc returned to normal and her shortness of breath improved. She was started on lasix 10mg qod. Previous chest x rays showed no interstitial disease. Covid 19 testing negative.

Pt was admitted on 6/15/21 with c/o sudden palpitations and was admitted with rapid atrial fibrillation and an NSTEMI. Her rate was difficult to control despite increasing her metoprolol to 100mg/d so diltiazem was added. Her rate was better controlled and she was discharged home on 6/22/21 to follow up with cardiology.

Death 5/30/2021 Causes of death listed on death certificate: 1) Hypertensive Heart disease with Heart Failure Diastolic Other: Covid-19

Caused extreme dehydration. 3 days after shot her Kinsey?s went into failure and she never recovered despite all the efforts of the doctors / staff. She was never advised not to get shot if she had kidney issues. She diesels eight days after getting shot

1-2-2021 10:30 PM Complained Right arm/back hurt - took Tylenol 1-3-2021 Complained Right arm hurt, dizzy 1-4-2021 Felt better - did laundry, daughter found her deceased at 3:30 pm. Dr. at hospital said it was "cardiac event" according to death certificate.

Resident became lethargic and reports of blood coming from resident's nose and mouth on the morning of 1/13/21. Resident went out to ER for eval, and came back to facility with dx of pneumonia and recommendations for resident to be placed on hospice. Resident deceased on 1/14/21. Unknown if vaccine related, but with timeline of events I was advised to report this per medical director of facility, as well as Pharmacy who administered the vaccine.

Patient had no symptoms or adverse events until the next evening after shot (1/29/21) where daughter reported her having heart palpitations. Family told her to rest and did not seek medical attention. Saturday afternoon (1/30/2021), patient started experiencing labored breathing. Daughter called 911 and before the ambulance arrived, the patient's breathing became more and more shallow. Patient was taken to the local hospital and passed away Saturday evening around 5:30 pm.

Death; A spontaneous report was received from a nurse concerning a 91-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and died two days later. The patient's medical history included dementia. Concomitant medications reported included paracetamol. On 21 Jan 2021, approximately two days prior to her death, the patient received the first of two planned doses of mRNA-1273, intramuscularly for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient died. The nurse reporting the event stated that the patient's death was considered as due to "natural causes" and that she was not aware of any new-onset symptoms of illness prior to the patient's death. The patient was described as "fragile" and was under hospice care at the time of her death. An autopsy was not performed. Action taken with the drug in response to the event is not applicable. The patient died on 23 Jan 2021. The cause of death was natural cause of death related to dementia. Autopsy was not performed.; Reporter's Comments: This case concerns a 91-years-old female patient, with medical history of dementia, who experienced a serious unexpected event of death. This event occurred 2 days after first dose of mRNA-1273, lot # unknown. At the time of death, the subject was very fragile and was in hospice care. Concomitant medication included Tylenol. Treatment details were not provided. The doctor considered that the death was due to natural causes. However, autopsy was not performed. Very limited information regarding this event has been provided at this time. Based on the limited information available, it is difficult to assess a cause and effect relationship. The benefit-risk relationship of Moderna's COVID-19 vaccine is not affected by this report.; Reported Cause(s) of Death: Natural cause of death related to dementia

The patient came to the Emergency Room at approx 3:30 am on 02/03/2021 with pain in right arm (same arm the COVID vaccine had been administered in approx 12 hours earlier) and feeling generally unwell. Patient was concerned about possibility of gout flare or that something was wrong with her arm. Elevated blood pressure was noted; this was attributed to anxiety. She was evaluated, given 500 mg Tylenol, and discharged since the pain was decreasing and blood pressure was stabilized. Patient instructed to follow-up with physician. The next day, on 02/04/2021, the patient arrived at the Emergency Room by ambulance; cardiac arrest was the chief complaint. The patient's daughter stated the patient had been "feeling generally poor and then suddenly collapsed." Daughter described "gurgling respirations" and being unresponsive. 911 was called, police arrived within 5 minutes and initiated CPR. Epinephrine, atropine, lidocaine and bicarb administered after arrival to Emergency Room. Shockable rhythm never demonstrated. Patient never recovered spontaneous respiration or movement. The death was called at 23:04. Coronary artery disease with cardiac arrest is the cause from the ER records; the coroner is putting COVID-19 vaccination in Part 1 of the death certificate.

Hx dementia, CVA, CAD. 2-3 year history of only consuming 25% of 1-2 meals daily. All meds d/c early 2020 because of refusing to eat or drink anything. Suddenly began drinking april/may, gained weight back. Vaccinated on 1/7/21 & 2/4/21. On 2/22/21 had significant changes in respiratory status. Passed away 2/23/21.

The caregivers in their rounds indicates that resident was well, ate his meals and her vitals were taken. In their next 7:30 pm rounds they find that the resident was not breathing. Home physician certifies death as Congestive Heart Failure.

As reported by son and by DON of Medical Center: 02.06.2021 Son reports that patient had spoken with her daughter the morning of 02.06 via phone and that patient sounded fine. Patient's son tried to call her around 3:30 or 4 and there was no answer. Son called the facility where patient resided and staff went to check on her, where they found patient on the floor, conscious. Patient was communicating fine when they found her. It is unclear if she bumped her head when she fell, but patient deteriorated and was taken to ER where a CT was done and it was determined patient had a brain bleed as well as a UTI. Patient was admitted to hospital. Patient subsequently had a stroke while in hospital. Patient was discharged to rehab facility on 02.23.2021 and while she has regained the ability to walk with a walker and some use of her right hand, she remains unable to speak.

Patient died unrelated to covid vaccine Narrative: The patient had advanced Alzheimer's disease and severe dementia. Patient received the first dose of Moderna vaccine on 1/7/2021 and no adverse reaction was reported. Placed in hospice care and passed away on 1/29/2021. Cause of death not documented. No indication that death was related to COVID 19 vaccination.

About 20 minutes after the vaccine was administered my Mother's speech became garbled and she was unable to speak understandably. I thought she was having a stroke so rushed her to the emergency room. They examined her and her speech returned to normal in about an hour. They kept her overnight for tests and after an MRI they said she had a TIA. We wanted to report it in case there were others who had a similar adverse affect. No one can say for sure if the vaccine caused it or not but we wanted to let you know what happened to her.

Systemic: blood clots-Medium, Systemic: Nausea-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Medium, Systemic: Stroke-Severe

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

Had a TIA on day #11 after her second Moderna vaccine. Never had a TIA before. She was hospitalized for further evaluation. Could be a coincidence but I feel this should be documented and considered for review as a possible risk of the vaccine

Facility manager informed us that patient had a seizure on 3/17/21, which was 2 days after the vaccine was given (3/15/21) which then lead to a stroke. Patient passed died on 3/17/21.

patient did not show up for dose 2 - we called her and family informed us she had entered hospice and passed away since we last saw her for the covid vaccine

Balance disorder; Fall; hurt her arm; Bleeding; Blurry vision; This spontaneous case was reported by a consumer and describes the occurrence of HAEMORRHAGE (Bleeding) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. The patient's past medical history was not reported On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 05-Apr-2021, the patient experienced blurry vision, lost her balance and fell very hard and was bleeding everywhere and hurt her arm. The patient experienced HAEMORRHAGE (Bleeding) (seriousness criterion medically significant), VISION BLURRED (Blurry vision), FALL (Fall) and PAIN IN EXTREMITY (hurt her arm). On an unknown date, the patient experienced BALANCE DISORDER (Balance disorder). At the time of the report, HAEMORRHAGE (Bleeding), VISION BLURRED (Blurry vision), BALANCE DISORDER (Balance disorder), FALL (Fall) and PAIN IN EXTREMITY (hurt her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant were given No lab details was provided. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-068245 (E2B Linked Report).; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of the reported events, and excluding other etiologies, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-068245:Husband case

Mom was feeling fine the day of the vaccine. Last spoke with her at 6:30 PM and she said she wasn't feeling anything but would go to bed early. I said OK I will check on you in the morning. She never woke up!

Patient presented to the ED and was subsequently hospitalized twice within 6 weeks of receiving COVID vaccination. First visit was 2/23/2021 and second visit was 3/14/2021. Patient died on 4/8/2021

91 year old female was sitting across the table from her husband while eating lunch when she passed out. She had slurred speech. 911 was called. She was taken to the ER and was diagnose with acute stroke. Her symptoms subsided on presentation to the ER. She was started on Plavix. Had negagive carotid duplex. MRI brain showed suspected subtle nonhemorrhagic punctuate left frontal lobe, Cortical 2-3mm acute -subacute vascular insult vs image artifact.

after first dose of the Moderna vaccine she became very ill and was hospitalized on 3/13 - 3/23. After 2nd dose of the vaccine she seemed to be doing ok but gradually declining and less and less to be able to do for herself, it slowed down greatly after the vaccine. There was a gradual decline, but on May 2 she woke up and was semi conscious and said she thought she was dyeing and was in pain and discomfort and was taken into the ER and she was DC'd and started hospice and two days before she passed she got the hospice care. My mother was in a semi coma and could not communicate properly. Many test were done at the hospital during her stay even though they never identified what the cause was. At the last ER visit they diagnosed her with pneumonia

Son states that on February 7th his mother developed shingles. On February 12th developed Bell's Palsy. On May 15th at 9:00 PM his mother had a heart attack. Is recovering at healthcare facility.

Patient presented to the ED and was subsequently hospitalized within 6 weeks of receiving COVID vaccination. Diagnosis was acute respiratory failure with hypoxia and acute diastolic heart failure.

Patient is a 91 year old female who presented with a chief complaint of aphasia. Patient with increasing frequency in confusion episodes over the past few months. Patient presented in no acute distress, normal neurologic exam. Vitals stable, afebrile. Asymptomatic. CT Head without acute findings, but chronic microvascular disease consistent with age which may explain patient's symptoms. TIAs cannot be ruled out however at this time. Recommend patient be evaluated by neurology. Discussed with patient who is in agreement with plan. Incidentally, patient with CXR findings consistent with pneumonia. Patient treated with antibiotics for CAP in case this is contributing to symptoms. COVID is positive but patient states that she tested positive in March and has received both vaccines. SpO2 94% on RA.

5/10/2021 Patient died. 5/3/2021 Patient is a 91 y.o. female with a history of afib, PE/DVT, hypothyroidism, GERD, htn, colon resection 206 and HTN who presented to the ED with AMS and difficulty breathing. Patient unresponsive in the ED and was intubated for airway protection. CTA chest with extensive acute pulmonary embolism with findings of right heart strain. Patient intubated and sedated, information is obtained from her son, medical staff and medical records. Patient was hospitalized with Covid 2 weeks ago, following discharge she seemed to slowly be improving until Saturday prior to admission Per son was more tired but she had worked with physical therapy and HH on Friday. Sunday she was having difficulty breathing and was brought to the hospital. 4/17/2021 Altered mental status, unspecified altered mental status type; Pneumonia of left lower lobe due to infectious organism; Atrial fibrillation with rapid ventricular response (HCC); Acute pulmonary embolism without acute cor pulmonale, unspecified pulmonary embolism type (HCC); Acute hypoxemic respiratory failure (HCC); Chronic respiratory failure with hypoxia (HCC); Pressure injury of sacral region, stage 3 (HCC); SOB (shortness of breath); Palliative care encounter; Shock (HCC); Chronic atrial fibrillation (HCC); Acute respiratory failure with hypoxia and hypercapnia (HCC)

passed away; received second vaccine 44 days after receiving the first dose; Pain the injection site from the first dose; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (passed away) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain the injection site from the first dose). On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 44 days after receiving the first dose). On 05-Apr-2021, VACCINATION SITE PAIN (Pain the injection site from the first dose) had resolved. On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received second vaccine 44 days after receiving the first dose) had resolved. The patient died on 09-Jun-2021. The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was reported. Company comment: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, with associated Adverse Events of Vaccination site pain and Death in a 91-year-old female subject who died 25 days after receiving second dose of vaccine. Very limited information regarding these events has been provided at this time. Further information has been requested. This case was linked to US-MODERNATX, INC.-MOD-2021-132760 (Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Case upgraded to Serious due to death.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, with associated Adverse Events of Vaccination site pain and Death in a 91-year-old female subject who died 25 days after receiving second dose of vaccine. Very limited information regarding these events has been provided at this time. Further information has been requested. US-MODERNATX, INC.-MOD-2021-132760:Son; Reported Cause(s) of Death: Unknown cause of death

Afib; edema; Muscle Spasm; Burning Sensation from upper extremity to lower extremity; Swelling below her knee; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ATRIAL FIBRILLATION (Afib) and OEDEMA (edema) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. 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 PAIN IN EXTREMITY (Sore arm). On an unknown date, the patient experienced ATRIAL FIBRILLATION (Afib) (seriousness criteria hospitalization and medically significant), OEDEMA (edema) (seriousness criterion hospitalization), MUSCLE SPASMS (Muscle Spasm), BURNING SENSATION (Burning Sensation from upper extremity to lower extremity) and PERIPHERAL SWELLING (Swelling below her knee). At the time of the report, ATRIAL FIBRILLATION (Afib), OEDEMA (edema), MUSCLE SPASMS (Muscle Spasm), BURNING SENSATION (Burning Sensation from upper extremity to lower extremity), PERIPHERAL SWELLING (Swelling below her knee) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. Concomitant medication information was not provided. Treatment medication information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. Patient reported that she was in hospital due to edema and A-fib. 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. Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Case upgraded to serious, new events added, corrected email updated; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded.

The day after vaccination EMS was called to the patients home EMS States: Pt had right sided gaze noted possibly for the past 2 days. upon EMS arrival pt had tonic clonic seizure activity x3, family denies history of seizures. 12 lead EKG showed afib RVR. Pt was stoke activated and transported to the hospital.

Day 8 following 2nd Moderna vaccine shot, patient began experiencing heaviness, dull pain in chest. She layed down which seemed to help alleviate the chest issues. Day 10 after receiving the second Moderna shot, patient died suddenly while sitting in her recliner of cardiac arrest. There were no symptom s leading up to the event.

Skilled nursing facility reported that patient was hospitalized on 7/27/2021. Patient received a chest x-ray on 7/25/2021 which indicated right lower lobe pneumonia. Began antibiotics but signs/symptoms worsened. Sent to hospital on 7/27/2021 and received a positive Covid-19 PCR test upon admission. Facility reported the patient had a fever of 100.4 degrees and shortness of breath.

At approximately, 1855, I was alerted by caregiver, resident was not responding. Per caregiver, she was doing her rounds and found resident in bed, unresponsive, mouth open, observed gurgling noises and tongue hanging out of mouth. This primary caregiver observed resident at baseline and ambulating after dinner at approximately, 1800 less than an hour prior to incident. This PCG called 911 for EMS and gave report of incident. Resident was taken to Medical Center Emergency Department. At ER, CT scan and X-ray was performed. Per report from ER RN, CT scan and x-ray revealed an intracranial aneurysm and fluid in the lungs. Per RN, resident was still unresponsive and was admitted to Medical Center for observation and comfort measures. This primary caregiver reported to RN, resident recently received the first dose of COVID-19 vaccine on 1/2/21. Primary caregiver received a call from Castle RN at 0700, resident expired at 0615.

Cardiac arrest; Pain on her upper right chest; Lot of pain in lower abdomen; Pain underneath arm; Thought it was muscle aches; A spontaneous report was received from a nurse concerning a 92-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed upper right chest pain and underneath the arm, severe abdominal pain, muscle aches and cardiac arrest. The patient's medical history was not provided Concomitant product use was not provided by the reporter. On 14 Jan 2021, approximately five days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, the patient developed upper right chest pain and pain underneath the arm. They thought it was muscle aches. Sometime later, the patient developed a lot of pain in the lower abdomen. The called emergency services and an ambulance arrived but the patient then suffered cardiac arrest. Treatment for the event included tramadol. Action taken with mRNA-1273 in response to the events was not applicable due to the patient was died. The patient died on 19 Jan 2021. The cause of death was reported as cardiac arrest. Autopsy were not provided.; Reporter's Comments: Company Comment: This case concerns a 92-year-old female patient who experienced unexpected serious events of cardiac arrest, upper right chest pain and underneath the arm, severe abdominal pain, muscle aches. The event occurred 5 days after the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: unknown, expiration date-unknown). Although a temporal association exist between the events and the administration of the vaccine, in the absence of critical details such as the patient's medical history, any diagnostic test or autopsy result, adequate evaluation and assessment cannot be established. Main field defaults to ‘possibly related' for all events.; Reported Cause(s) of Death: Cardiac arrest

Present to ED for chest pain, nausea, chest heaviness, mild headache and slight SOB with lower extremity swelling, Hospitalized starting today 2/5. EKG shows Afib with RVR (new oneset). Still in hospital at this time

This resident of the assisted living facility received his Covid-19 Moderna (1st) vaccination and he has a leaking Aortic Aneurysm which resulted in hospitalization and he entered into Hospice care on 1.30.2021 and passed away on 1.30.2021.

Pt received moderna vaccine #2 at 1:30pm. No s/s of adverse reactions. Ate dinner at 4pm. She was in her room at 430pm and she slid out of her chair and was laying on her Right side. She reported she slid out of her chair because she needed to go urinate per staff. She denied pain. At 630p complained of right hip pain. mobile xray was ordered. At 825pm resident was sleeping x 30 mins in her bed when she was found to have no pulse or respirations. She ceased to breathe. Mobile xray did not make it on time.

92 yo female who received her first dose of Moderna vaccine on 1/11/2021 with no known adverse effects. Admitted to the hospital on 1/17/21 with a spine compression fracture. Discharged and readmitted on 1/19 /21 with nausea and vomiting. Found to have new atrial flutter and elevated troponin attributed to NSTEMI. Discharge on Aspirin and Plavix. No cath. Second dose of Moderna vaccine 2/25/21. No immediate reaction. One hour later began to feel progressively weak. EMS called shortly after getting home. Intubated in the field. Died at 0658 on 2/26/21 s/p PEA arrest without ROSC.

Patient was a Resident on our LTC wing. Per the LTC Manager: Resident had hx of CVA with deficits in speech and extremities. Hx of decreased circulation to BLE's which resulted in wounds to bilateral feet on and off that needed treatment. Average meal consumption 25-50% of meals, started refusing more often in December and January. Would consume small amounts 60-120mL of fluids here or there. Vaccinated on 1/7/21. Stopped eating 1/18/21. Attempted bolus NS fluid 1/25/21. Resident refused all treatment afterwards. Went hospice on 2/3/21 and passed away on 2/7/21.

3/2/21 became SOB, treated with oxygen and head of bed up in bed, only at dessert and drank supplement, for evening meal, no pain noted. 3/3/21 staff helped get her up in morning, went to weight room to take her weight, she then appeared to be struggling to breath, she was brough back to her room and the aides summoned nurse for assessment, was put back into bed, nurse noted poor color and shallow breathing, resident passed away shortly after that.

Chills; headache; extreme fatigue; gas or chest pain that was thought to be gas and went away Died 4 days later

Patient was contacted about coming in to receive second dose and family member had informed us that she had passed away from COVID two weeks after vaccine was given.

Acute onset shortness of breath approximately 11-12 hours post second dose of Moderna covid vaccine. EMS responded and briefly performed CPR before DNR was produced and life saving measures were discontinued. Patient subsequently expired.

He was going to be discharged from Hospice on Monday 2/15/2021. The patient was in Hospice due to a stroke. The nurse indicates after the vaccine she started with stomach pain and vomiting. Hospice evaluated her, she was given Pedialyte and then she died on 2/19/2021

CVA (stroke) around 2:00 p.m., was immediately transported to hospital. Meds were given (I believe Alteplase, but would need to confirm.) 3 brain bleeds after medications. Patient passed away at 5:40 p.m.

On the morning of 3/31/2021 patient had chills, she seemed to develop a cold, she was achy and not wanting to eat. She was very sleepy and by 6:00 P.M. she passed away.

Patient was not tested for COVID prior to the vaccine; one month after being fully vaccinated, the patient was admitted for pneumonia, altered mental status and reduction in ability to do ADLs. Upon admission, the patient was tested using the Abbott-ID NOW rapid COVID test and patient tested positive on 04/04/2021. Patient clinical presentation consistent with COVID per lung changes on chest x-ray and symptoms, positive for UTI.

Went down hill after receiving the 2nd shot and stopped breathing; Went down hill after receiving the 2nd shot and stopped breathing; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY ARREST (Went down hill after receiving the 2nd shot and stopped breathing) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced GENERAL PHYSICAL HEALTH DETERIORATION (Went down hill after receiving the 2nd shot and stopped breathing). On 24-Mar-2021, the patient experienced RESPIRATORY ARREST (Went down hill after receiving the 2nd shot and stopped breathing) (seriousness criteria death and medically significant). On 24-Mar-2021, GENERAL PHYSICAL HEALTH DETERIORATION (Went down hill after receiving the 2nd shot and stopped breathing) outcome was unknown. The patient died on 24-Mar-2021. The reported cause of death was stopped breathing. It is unknown if an autopsy was performed. Reporter wasn't sure if patient received Pfizer or Moderna vaccine. The patient was in hospice care and reporter thought the patient received the vaccination from a local pharmacy. Concomitant medications and treatment medications were not provided.; Reported Cause(s) of Death: Stopped breathing

Admitted with increased SOB, acute respiratory failure secondary pneumonia. Previous COVID-19 infection in December 2020. Positive COVID-19 test on admission 4/16/2021.

Patient presented to the ED and was subsequently hospitalized on 3/18/21 with atrial fibrillation. On 4/1/21 patient had their second dose of Moderna. On 4/9/21 patient was hospitalized for paroxysmal atrial fibrillation. On 4/12/21 Patient presented to the ED and was subsequently hospitalized again for atrial fibrillation. On 4/18/21 Patient presented to the ED and was subsequently hospitalized for acute cystitis. These visits were all within 6 weeks of receiving COVID vaccinations.

"Patient received her second dose of Moderna vaccination on 6/11. She was sent to the ER on 6/12 with SOB, respiratory distress. Diagnosed with CHF. VS: POX 72% and placed on O2, BP 168/106, HR 120, Resident was diaphoretic. DNR, DNH but family wanted her sent out. Doctor notified, ordered Lasix 20 mg and Coreg 3.125mg given immediately and 911 called. Went to hospital, diagnosed with CHF. Returned and family requested hospice and that was initiated. Resident is back to her baseline?up, participating in Bingo and other activities, eating in the dining room. Did not have fever."

7.11.21: Patient presents to the ED with fatigue, dyspnea, cough, and malaise. found to be COVID-19 positive. has a history of receiving both doses of Moderna COVID-19 vaccine. diagnosed with Pneumonia. Found unresponsive during CTA of chest. Then coded in the ED. transferred to the ICU. 7.12.21: rapid response called for respiratory distress. intubated. started remdesivir. received 1 dose of tocilizumab. 7.16.21: patient still admitted as of today - the day of report submission. still intubated. completed 5 day course of remdesivir.

Mom was feeling fine before she had the Moderna vaccines. A few weeks later, she became extremely ill. She died on May 14, 2021.

1/31/2021 12:50 Nursing Note Note Text: Res had low BP, low O2 sats, 30 breaths per minute, eyes open wide, making confused utterances. Started supplemental oxygen via NC, 2L, then 3L. Sats went up to 93% for a while, Sprvsr called. Unable to auscultate Left lung sounds. Called to update Res daughter. Called to page NP, writer went back to assess Res and O2 sats were 88%, turned O2 to 4LPM, called 911 for transport to Hospital ED. Left around 1030. NP called back afterwards, was updated. Family updated that Res was sent to Hospital ED. Note Text: Received phone call from daughter as well as information from hospital. Resident has pneumonia with septic shock. She is on abx and had thoracentesis performed for large pleural effusion. [linked]

Pt tested positive for COVID-19 on 2/10/2021 and died from illness related to COVID-19 on hospice at home on 2/18/2021, per care facility.

Unknown if she had any symptoms or adverse reactions. She apparently was stubborn and kept to herself.

4/3-was feeling unwell and didn't eat much 4/4-could not get out of bed without assistance in the am; vomited mucus and could not eat; refused Easter dinner. 4/5-woke up and had trouble breathing; ambulance called "she had no pulse, and had trouble breathing" Throughout had no fever or chills.

My my grandma got them a derma vaccine on January 22 she died on February 11 she was admitted to the hospital with a blood clot in her leg they tried to do surgery but when they put her under the anesthesia she never woke back up. She was 93 years old and had many other health conditions but when I called the doctors office to ask them if they reported my grandma they just kept giving me the runaround I tried to call hospital as well and I got the same thing they told me to go back to the doctor. I think someone should know and I think it?s way too difficult for family members to try to report adverse side effects it took me all day to find someone that could help me get to this website. I think there may be a lot more adverse side effects but people don?t know how to report them.

Patient was alert and verbally responsive in usual state of health on 1/11/2021 received Moderna vaccination dose 1. Patient seemed stable until 2/6/21. Then on 2/6/21, patient was noted with slight elevated temp of 99.2, pulse 100, spo2 94%RA at 2:15am. By 5:20am, patient was pronounced dead.

Moderna COVID-19 Vaccine EUA: two days after vaccination patient admitted for management of recurrent right-sided pleural effusion and acute on chronic repiratory failure. Underwent thoracentesis. Discharged medically stable.

Pt presented for routine primary care visit 3/30 and reported swelling of right lower leg starting 2 weeks prior. Ultrasound positive for DVT.

resident was hospice she was afebrile day of vaccine on 4/20. on am of 4/21/21 0600 nurse stated no c/o of pain or discomfort. Resp were even and unlabored. That morning at 1145 charge nurse stated she was extremely hard to rouse. Vs were ok. SHe had some weakness in right side. they notified hospice. She had labs done. She was diagnosed with PNA and started on Abt. That night she was unresponsive to verbal commands and couldn't get po med. she received gentamicin im. on 4/22/21 charted she was vommiting small amount. She expired late that night. MD doesn't believe the vaccine caused the death, but thinks it has the potential.

Passed away in home days after vaccine, was in perfect health as far as can be expected by 93 year old, before vaccine.

I am the epidemiologist reporting on behalf of patient who tested positive for COVID-19 via PCR on 4/22/21 after the completion of a full Moderna vaccine series (Dose 1 on 2/11 and Dose 2 on 3/11). The patient later died on 5/13/21 . Cause of Death is listed as ?Intestinal Obstruction?.

According to family and certificate of death, patient suffered from an acute mid-brain cerebrovascular accident and died on 6/24/2021.

Admitted 6/10/21 w/current covid illness. Partial vaccination noted. 6/17/21 urine culture w/no growth. Progressed to release from Covid unit to general population in recovery status on 6/22/21. Seen/Assessed by NP/MD /IDNP during stay. 6/26/21 urine culture w/no growth. 6/27/21 seen by MD d/t increased falls and confusion. Fall on 6/29/21 w/increased confusion and immediate transport to ER for increased confusion, decreased oxygen saturation and fall w/possible head injury r/t unwitnessed fall and increased confusion. She expired at the hospital 7/3/21 w/respiratory failure.

Patient diagnosed with COVID on January 9, 2021 after being exposed to family member that was under quarantine in the same household. Admitted to the hospital and was discharged on January 14, 2021 with home hospice. Patient passed away on January 18, 2021

Rapid decline in health status, Elevated BP&P, posturing, loss of consciousness, Glasgow coma Scale 4 starting 2/1/2021, Deceased 2/3/21

*extreme* fatigue. could not awaken for more than few seconds. When briefly awake she was coherent and not confused. slept deeply from 4pm and could not wake to eat or drink. No fever, bp normal, blood oxygen ok. Blood sugar at 11pm was 230. Gave her 15u lantus at 11pm (normally 25u). Was sleeping at 2:30am but had died at next check at 3:30am.

Received influenza vaccine 1/29 at PCP clinic. Received Moderna vaccine on 2/6 by pharmacist at her place of residence. She was taken to the ER on 2/9, unresponsive. Staff reported she wasn't acting normally since 2/7. During her hospital course (2/9-2/13) she was only able to open her eyes. Unable to follow any commands. MRI showed large right MCA stroke. She was discharged from the hospital on hospice.

Family states patient had been coughing and was weak after the vaccine. Patient walked to the bathroom and then fell striking her head found in PEA with agonal breathing. Despite aggressive CPR medications patient remained in asystole. Unknow if Moderna or Phifzer

Red pruritic rash at the injection site Two days following vaccination, she had an episode of syncope with fall, head trauma, rhabdomyolysis that resulted in hospitalization

Blood clot in blood vessel in the left hand at the base of the middle finger causing darkening in the lower part of the finger and numbness in the whole finger.

Withing 24 hours of vaccine admin developed nausea, chills, aches, dyspnea, elevated heart rate. Saw PCP on 2/15 and was sent to ER and then admitted to hospital for 5 days-continued extreme nausea and atrial fibrillation after diuresis for CHF. HR 120s had to be put on multiple meds to bring ratedown. Discharged on 2/19. Cont worsening nauaea/chills/aches. Passed away on 2/23

Patient was a resident on a LTC wing. Received Covid-19 vaccine on 1/13/21 & 2/10/21. Pt stated she felt phlegm in her throat 3/14/21. On 3/15/21 patient started having trouble swallowing, and started needing supplemental oxygen for low oxygen saturation and needing suctioned for c/o being unable to swallow.. ST eval showed no gag reflex and inability to swallow effectively or safely. Pt needed 5L/O2 and unable to hold saturations above 90%. Patient became ?comfort care?, and passed away 3/18/21.

Not even 20 hrs after she received the vaccine she couldn?t breathe, she?s been fine nothing wrong at all. 7am she was awake sitting up in bed doing crosswords told her great granddaughter to have a good day at work and would see her shortly . 739 I walked out the room to take my kid to work was gone till 751 not even 12 minutes and I came in and my gram couldn?t breathe was yelling for me saying she couldn?t breathe. It sounded like my gram had come over with upper respiratory problems in a matter of 10 minutes she was gasping for air called 911 spoke to operator my gram was talking saying she couldn?t breathe she was trying to breathe, my grams last words were if they don?t hury I?m going to die I?m 100% sure my gram was dead in my arms before EMS arrived. Yes she was 95 but she is a healthy lady have had no issues of health problems lately. We?ve done everything to keep her save from the virus and then she gets her 2nd moderna shot and she?s dead 20 hrs later there?s a huge problem old age or not

My mom received her first Moderna Vaccine on 1/22/21. Late on 1/23 her face began to swell so the staff called the ambulance to come take her to the hospital for what they thought was an abscessed tooth. ER doctor said there was an infection and that she needed to be seen by an oral surgeon. On 1/25/21 I took my mom to Dr., her oral surgeon and after the examination he advised that there was no abscess but an allergic reaction to the Moderna vaccine. He suggested Benadryl. I gave her benadryl and the swelling started subsiding. From this point on her gums and teeth hurt. Her eating habits started to decline. She received her 2nd Moderna vaccine on 2/19/21 and from that point on she could no longer chew or brush her teeth because the pain was so severe. She passed on 3/19/21.

pneumonia; urinary tract infection (UTI); talking nonsense and not being clear; The reason the patient did not have the second dose one month from the first dose is because she got ill; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PNEUMONIA (pneumonia), URINARY TRACT INFECTION (urinary tract infection (UTI)) and COMMUNICATION DISORDER (talking nonsense and not being clear) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (No medication history was provided). Concomitant products included ASCORBIC ACID, BETACAROTENE, COPPER, TOCOFERSOLAN, ZINC (OCUVITE [ASCORBIC ACID;BETACAROTENE;COPPER;TOCOFERSOLAN;ZINC]), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), METOPROLOL TARTRATE (METOPROLOL TARTRATE ACCORD), CLOPIDOGREL and DULOXETINE for an unknown indication, ACETYLSALICYLIC ACID (ASPIRIN 81). On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (pneumonia) (seriousness criterion hospitalization), URINARY TRACT INFECTION (urinary tract infection (UTI)) (seriousness criterion hospitalization), COMMUNICATION DISORDER (talking nonsense and not being clear) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The reason the patient did not have the second dose one month from the first dose is because she got ill). At the time of the report, PNEUMONIA (pneumonia), URINARY TRACT INFECTION (urinary tract infection (UTI)), COMMUNICATION DISORDER (talking nonsense and not being clear) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The reason the patient did not have the second dose one month from the first dose is because she got ill) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. While hospitalized she was diagnosed and treated for a UTI, with intravenous fluids and antibiotics. Patient was discharged from the hospital with Foley's catheter and rehabilitation was advised. While hospitalized she was due for her second dose but she got pneumonia, so she was not given the second dose. The reporter assumes the pneumonia was bacterial, because the patient was treated with antibiotics. Very limited information regarding the events has been provided. Further information was requested.; Sender's Comments: Very limited information regarding the events has been provided. Further information was requested.

Patient's family called us on 03/18/2021 to report vomiting for 3 days starting after her vaccination. They took her to hospital where the family reports she was diagnosed with bowel obstruction. She declined surgery because of her age and underlying comorbid conditions including breast cancer and diabetes. She passed away on 03/22/2021.

Pt had covid vaccines through Walgreens coming to her ILF. She had the vaccines 1/18/21 and 2/15/21. Pt presented with new edema on 2/17/21 and venous doppler confirmed. left peroneal DVT. Pt required oral anticoagulation. Pt is very self ambulatory and now previous hx of DVT. She has no dx of obesity.

Resident began coughing then complained of abdominal pain and was taken to the Hospital. He began to vomit and breathed in. Had a heart attack

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 94 and receiving hospice care for end life care in the months leading up to his passing on 3/9/21. In addition to his advanced age, the patient had chronic afib on anticoagulation, hypothyroidism, HTN, HLD, COPD, depression, and increasing cognitive and memory issues towards the end of his life.

Hospitalized and died due to COVID-19 after being fully vaccinated. From vital records: ACUTE RESPIRATORY FAILURE WITH HYPOXIA, PNEUMONIA DUE TO COVID-19

Patient presented to the ED and was subsequently hospitalized for atrial fibrillation within 6 weeks of receiving COVID vaccination. She died on 5/26/2021.

Patient presented to the ED and was subsequently hospitalized for DVT within 6 weeks of receiving COVID vaccination. Patient died on 6/23/2021.

Was informed by local Medical Examiner that on 04/10/2021, 4 days after receiving second Covid-19 vaccine, that the pt slipped on a rug and hit her chin very hard and that she died. The family informed Medical Examiner that she was not feeling very well after receiving her vaccine and felt more fatigued than usual. Family raised concerned that the cause of her fall was due to vaccination. Medical Examiner ruled cause of death as a closed-head injury or cardiac arrhythmia, with significant other conditions at time of death being "mild symptoms following covid-19 vaccination"

previously health, hospitalized on 3/11 for gastroenteritis, recovered well, received second shot of covid vaccine on 3/18, subsequently deteriorated in a TCU and died within one month.

Patient daughter reported that patient was admitted to Neurology with a stroke. She has cognitive and speech impairment as well as motor impairment. She was admitted either 2-2-21 or 2-3-21. She is still in the hospital.

The vaccine was administered at the patient's residence in an assisted living facility. The morning following the vaccination staff report that she was very agitated and stated she did not feel well. They called an ambulance and she was transported to a local ER, staff report that it was not at the hospital that the patient is usually seen by when when she has issues and they were concerned that the facility did not have her medical history to treat her properly. The patient's grandson reported back to the assisted living director that the patient was diagnosed with asymptomatic pneumonia, was transferred to the ICU and passed away in the night.

death. Per son pt was not feeling well after the vaccination "like her legs were weak." Son found the mom in her bed 1am on 2/12/2021 unresponsive.

The patient referred that has no symptoms. POC was with her, until she died. She died of Alzheimer's, diabetes and a sacral ulcer that she brought when she was admitted.

nonocclusive deep vein thrombosis (extending from upper femoral vein to Popliteal vein in left leg,, ) pulmonary embolism affected left pulmonary lobe) - no heart damage or pulmonary infarct; Was hospitalized at Hospital on Saturday 4/10 and discharge is scheduled for 4/13.

On 1/24/2021 the patient was discharged from the hospital due to swelling in the body, when they proceeded to infuse medications. She herself had passed away.

Loss of apatite to the point of no ingestion through mouth. During hospitalization, the medical staff identified a mass at the abdomen.

irritated her heart condition; Clot blood; weakness in legs, couldnt walk with legs; Coma; couldn't breathe; stroke/massive stroke in left side of her brain; Irritated her heart condition, rapid heart beat; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke/massive stroke in left side of her brain), CARDIAC DISORDER (irritated her heart condition), DYSPNOEA (couldn't breathe), THROMBOSIS (Clot blood), COMA (Coma) and MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for Covid-19 Vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Heart disease, unspecified, Hypertension and AFib. Concomitant products included APIXABAN (ELIQUIS) for Anticoagulant therapy, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) for Hypertension, METOPROLOL for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Tiredness). On 12-Mar-2021, the patient experienced MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs) (seriousness criterion hospitalization). On 13-Mar-2021, the patient experienced CARDIAC DISORDER (irritated her heart condition) (seriousness criterion hospitalization), THROMBOSIS (Clot blood) (seriousness criterion hospitalization) and HEART RATE INCREASED (Irritated her heart condition, rapid heart beat). On 15-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke/massive stroke in left side of her brain) (seriousness criteria death and medically significant). On 16-Mar-2021, the patient experienced DYSPNOEA (couldn't breathe) (seriousness criterion hospitalization prolonged) and COMA (Coma) (seriousness criterion hospitalization prolonged). The patient was hospitalized on 13-Mar-2021 due to CARDIAC DISORDER, COMA, DYSPNOEA, MUSCULAR WEAKNESS and THROMBOSIS. The patient died on 17-Mar-2021. The reported cause of death was massive stroke in left side of her brain. It is unknown if an autopsy was performed. At the time of death, CARDIAC DISORDER (irritated her heart condition), DYSPNOEA (couldn't breathe), THROMBOSIS (Clot blood), COMA (Coma), MUSCULAR WEAKNESS (weakness in legs, couldnt walk with legs), HEART RATE INCREASED (Irritated her heart condition, rapid heart beat), HEADACHE (Headache) and FATIGUE (Tiredness) outcome was unknown. Action taken with mRNA-1273 in response to the events was not Applicable. This case concerns an 95 year old female patient, with medical history of A Fib, Heart disease, Hypertension who experienced a serious unexpected event of Death 8 days after receiving 1st dose of mRNA- 1273 . Very limited information regarding these events has been provided at this time. However, the patient's advance age, multiple co-morbidities, may remain as risk factors. Further information is requested. This case was linked to MOD-2021-074814 (Patient Link).; Sender's Comments: This case concerns an 95 year old female patient, with medical history of A Fib, Heart disease, Hypertension who experienced a serious unexpected event of Death 8 days after receiving 1st dose of mRNA- 1273 . Very limited information regarding these events has been provided at this time. However, the patient's advance age, multiple co-morbidities, may remain as risk factors. Further information is requested.; Reported Cause(s) of Death: massive stroke in left side of her brain

Patient developed COVID-19 with complaints of increased cough on 4/6. Was found to be COVID positive on 4/12. Recieved combo Bamlanivimab/etesevimab treatment for infusion on 4/14. Patient had initial recovery to baseline period on 4/22. Rapidly declined shortly after and died 4/25.

On the evening of 10JAN2021, patient experienced a low grade fever, decreased oxygen saturation of 38%, heart rate of 124, confusion. Patient received oxygen via face mask, morphine and ativan. By 11JAN2021, patient was no longer verbal, able to eat or communicate and was kept on comfort measure only. On the morning of 17JAN2021, the patient passed away.

Resident complained of feeling "hot" at supper time. Had emesis an hour or so later. Became hypoxic and was transferred to the hospital emergency room. Her evaluation in the ED revealed continued presence of UTI, leukocytosis (19.8), and renal insufficiency (BUN 22 Cr. 1.3) BP 99/63; P 74; Temp 98.1; RR 16; and O2 sat of 95% with 2 LPNC (she is typically on RA). CXR reported changes most consistent with CHF with cardiomegaly and bilateral pulmonary vascular prominence. Bibasilar pleural effusions greater on the right than left with pulmonary edema. Large hiatal hernia and likely old chronic wedge defromities involving the mid thoracic vertebral body. She was admitted for IV antibiotics. She expired 2/6/2021

After the pt received her 2nd dose of the COVID19 vaccine while sitting in observation she reported feeling "queasy." Also reported feeling like her heart was beating fast. Pt was evaluated by RN and EMS paramedic. BP 195/83 and repeat 175/129. HR 76 and 83. Per RN and EMS pt seemed to be in a-fib. Pt states her MD recently took her off of medication for a-fib. Pt was advised to go with EMS to the ED. Pt refused despite counseling and encouraging her to go an be evaluated. Pt signed refusal for transport with EMS. Pt's daughter came into clinic to walk her out. RN discussed with pt's daughter and reiterated the recommendation for ED eval. RN also advised both the pt and her daughter to call her PCP and speak with the oncall MD for further recommendations since she is refusing transport to ED. Pt and her daughter verbalized understanding.

According to patient's caregiver, patient presented with symptoms of fever (101.6 F) and purple blotches all over the body within an hour. Since patient was in hospice , caregiver called Hospice and a pharmacy and was told to give patient Benadryl and Tylenol. Patient was given both medications and the fever subsided in a few days but the purple blotches never went away. Patient passed away at the facility a week later.

Individual developed severe body aches, severe shoulder discomfort, high fevers (documented max temp. 103.7 F). Daughter reported that she became non-responsive with high fevers, and when the fevers decreased she was more lucid. Her condition rapidly progressed to nausea vomiting, diarrhea and patient died on 2/9/2021.

Patient presented to the emergency department after being found down in her home and presented with right upper and lower extremity weakness and a right-sided facial droop. Patient's presentation was consistent with an acute ischemic stroke which was confirmed on MRI.

Pneumonia; Unresponsive at times; Weak; Diarrhea; Feeling Punky; Body aches/muscle aches; Fever; Chills; Nausea; Vomiting; Sore arm at site of injection; A spontaneous report, was received from a nurse (caregiver), regarding a 96 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced pneumonia, unresponsive at times (unresponsive to stimuli), weak (asthenia), diarrhea, feeling punky (malaise), body aches/muscle aches (myalgia), fever (pyrexia), chills, nausea, vomiting, sore arm at site of injection (vaccination site pain), and vomiting. The patient's medical history was not reported. Historical vaccine reported was flu shot. Concomitant medications included insulin, unspecified medication for pulmonary hypertension and heart failure. On 05 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscular for the prophylaxis of COVID-19 infection. On 05 Feb 2021, the patient experienced the sore arm. On 07 Feb 2021, the patient experienced body aches, sore arms, felt punky, weak, fevers with a body temperature of 103.7 (unknown units), chills, nausea, vomiting, diarrhea and muscle aches. Treatment medication included acetaminophen. On 08 Feb 2021, the patient continued with high fever, unresponsive at times, and all other symptoms. On 09 Feb 2021, the patient's fever was control, very weak and passed away on the same day at 04 45 pm. The death occurred and death certificate stated that pneumonia was the cause of death. Action taken with second dose of mRNA-1273 in response to the events was not applicable. The outcome of the event, pneumonia was considered as fatal, and that of other events unresponsive at times, weak, diarrhea, feeling punky, body aches/muscle aches, fever, chills, nausea, vomiting, sore arm at site of injection, and vomiting were considered as unknown. The patient died on 09 Feb 2021. Plans for an autopsy was unknown. The cause of death was reported as pneumonia.; Reporter's Comments: This case concerns a 96 year old, female patient, who experienced a serious unexpected event of Pneumonia (fatal) among others, 5 days after receiving 1st dose of mRNA- 1273 (Lot# 013M20A). Very limited information regarding these events has been provided at this time. The subject's con meds included insulin, unknown medications for pulmonary HTN and heart failure. The cause of death was determined to be pneumonia. Advanced age and co-morbidities may remain as risk factors.; Reported Cause(s) of Death: Pneumonia

Pt c/o of left arm pain after injection and for several days after. Pt was in bed for 2 days after injection c/o generalized malaise and weakness. Pt c/o of feeling of funny heart rhythms and feeling of constant anxious feeling. Pt started having episodes of SOB and was very labored doing simple tasks such as using the toilet. Pt started using o2 for the first time and had to recover for any activity for several minutes. Different medications were tried to help control symptoms such as Morphine for SOB and ativan for anxious feelings. Symptoms were never well managed after vaccine. Pt eventually died from worsening symptoms on 3/20

TIA cardiomyopathy, EF less tha 20% new diagnosis I DO NOT KNOW WHICH BRAND COVID VACCINE SHE RECEIVED ++++++++++ no other option above but to pick one,

Resident vaccinated on 01/06/21 she acquired COVID 19 on 01/10/2021. Resident had multiple co morbidities and was declining prior to the vaccine. Resident expired on 01/20/2021

Resident received the vaccine on 1-22-21 and she was diagnosed with COVID-19 during routine testing on 1-28-21. She didn't have any symptoms except feeling weak and she had a decrease in her appetite. She already had a poor appetite prior. She died on 2-2-21.

The patient fell the day after receiving the Moderna COVID-19 vaccine. She broke her hip in this fall. During surgery to correct the broken hip, she went in to sudden and unexpected cardiac arrest. The anesthetist did not notice any ST changes or A fib; dysrhythmia was very unexpected. The patient had a DNR. She died at 13:00 on 02/07/2021. Causes of death are listed as 1. Cardiac Arrest 2. Recent hip fracture with hip placement 3. History of Breast Cancer 4. Hypothyroid and 5. Dementia

I am the patient's daughter as well as an RN-BSN. My mother was given the Moderna vaccine on Feb 11, 2021 and on Feb 15, 2021 she had a CVA and MI. She was found on her apt. floor unconscious. She was transferred to the Hospital by ambulance where a CT scan and other tests were done. It was determined she had a stroke and heart attack. My mother was in great health, took no medications, and lived alone in her apt. before this incident. The medical professionals determined she would not recover so she was admitted to hospice and died on Feb. 21, 2021. I believe there is a relationship between the vaccine and the CVA and MI.

Extreme fatigue, shortness of breath. Stopped eating within 2 days, stopped fluid intake 3 days later. Family notified on March 3. ery little fluid intake until Sun, when fluid intake stopped as well. Death occured on mon, Feb 8 2021.

Patient reportedly received COVID vaccine doses on 1/23 and 2/15, but we are unsure of which manufacterer or lot number. Patient admitted to our hospital on 3/9/2021. Patient presented with elevated D-dimer with concern for septic shock. Ultrasound of patient revealed no VTEs. COVID test on 3/10 resulted POSITIVE. Patient was going to require vasopressors but patient requested to go on comfort measures only. Patient ordered comfort measures on 3/10 and pronounced deceased on 3/18.

Pt. had hx of SOB prior to vaccination and Dx with hear failure Woke up day after vaccination with being very tired. Admitted to hospital with UTI, Sepsis

Pt's daughter reports that after the patient received her second dose of the Moderna vaccine on Friday, April 23, 2021, on Saturday, April 24, 2021 around 3:00pm the patient started having trouble lifting her foot, she was also having trouble standing; the pt's daughter evaluated her on Sunday and thought she was having a neurodeficit. The patient was taken to the hospital on Monday evening (4/26/21) and a CT scan revealed the pt had a stroke. The pt is anticipated to recover.

Patient was well 5/13/21 vaccinated 05/14/2021 with second Moderna COVID Vaccine and according to son pt rapidly declined with recurrent falls 5/15-seen in er 5/16 and sent home and cont to have worsening profound weakness presenting to the ER again 5/18 and admitted with Sepsis secondary to right lower lobe pneumonia, right 8th, 9th and 10th rib fractures, syncope/ rhabdomylosis and NSTEMI, profound weakness and new anemia with GIB needing 2 units prbcs. Pt was living independently alone pta with help from his son and was at his baseline up until getting his second vaccine. he was ultimately discharged to nursing home on 5/21/21. he was still too weak to walk or get out of bed at the time of discharge.

This patient has been under hospice care for over 2 years at the nursing home. She has had a steady decline with gradual weight loss. She was totally dependent in her care needs. She received the vaccine on 1/2/2021 as part of the facility vaccination campaign. No adverse events noted initially. On 1/3/2021 at 6:06 pm, she was noted on vital sign checks (done every 4 hours for first 72 hours after vaccination) with BP 64/52 but otherwise asymptomatic. Subsequent BP improved. On 1/4/2021 at 4:45 am, pt found with respiratory rate of 30 with otherwise normal vital signs. Tachypnea persisted, so she received liquid morphine 2.5 mg without improvement. Supplemental oxygen was applied. Tachypnea persisted. She had poor oral intake after that point had persistent tachypnea and worsening hypoxemia despite clear lungs on exam. She remained under hospice care and comfort measures were continued. No blood testing or imaging tests were done. She required increasing amounts of oxygen, became hypotensive, and died peacefully on 1/8/2021 at 7:45 pm.

Narrative: Patient received dose 1 of Moderna COVID-19 vaccine on 3/11/21 from clinic. Vaccine was administered to patient without complications and patient was observed for 15 minutes post-vaccination without any adverse effects. No documentation as to any adverse effects following the 15 minutes post-vaccination. 11 days later on 3/22/21, EMS was dispatched to patient's home and patient was found lying supine, unconscious, and unresponsive to stimuli. Patient was noted to have shallow breathing per EMS staff, and was subsequently brought to the hospital. Per family, patient lives alone and was feeling well - they had spoken to her two days prior to the event. Per family patient did not have recent fevers, vomiting, diarrhea, or cough. Also no recent medication changes or trauma. PMH includes stroke approx. 8 years ago, gout, HLD, HTN, and RLS. BP upon admission was 126/93, HR 123, temp 37.1 degrees Celcius, RR 28. Patient noted to smell of urine. CT showed large completed right sided infarct consistent with MCA stroke. Per neurology the lesion was not recoverable and patient would be unlikely to regain any function. Family was notified and poor prognosis was discussed. Patient has been very clear in the past that she would prefer "to go when her time came". She had a DNR And DNI as well. Daughter requested to pursue comfort measures for patient, therefore she was transferred to hospice care. Patient passed away the following day on 3/23/21. Death very unlikely due to COVID-19 vaccination since CT imaging clearly showed cerebral infarct and patient had a PMH of stroke.

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

patient woke up on 04/22/2021 with shortness of breath and weakness. On exam, she was hypotensive, tachycardic and edematous

Looked like she had a stroke; Muscle pain; Disabled; Brain does not work with her body; She cannot use her legs; Swelling of hands and feet; Nausea; Felt Sick (After First Vaccine); Slurring words; Throwing up; Fever 100.3 F (After First Vaccine); Loss of Taste (After First Vaccine); Pain in arm; Redness in arm; Chills; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), MALAISE (Felt Sick (After First Vaccine)), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs) and NAUSEA (Nausea) in a 98-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills). On 04-Feb-2021, the patient experienced AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)). On 03-Mar-2021, the patient experienced CEREBROVASCULAR ACCIDENT (Looked like she had a stroke) (seriousness criteria hospitalization and life threatening), MALAISE (Felt Sick (After First Vaccine)) (seriousness criterion medically significant), DYSARTHRIA (Slurring words) (seriousness criterion medically significant), NAUSEA (Nausea) (seriousness criterion medically significant) and VOMITING (Throwing up). On 04-Mar-2021, the patient experienced LOSS OF CONTROL OF LEGS (She cannot use her legs) (seriousness criterion medically significant) and PERIPHERAL SWELLING (Swelling of hands and feet). On 14-Apr-2021, the patient experienced CEREBRAL DISORDER (Brain does not work with her body) (seriousness criterion medically significant). On an unknown date, the patient experienced DISABILITY (Disabled) (seriousness criterion disability) and MYALGIA (Muscle pain). On 16-Feb-2021, VACCINATION SITE PAIN (Pain in arm), VACCINATION SITE ERYTHEMA (Redness in arm) and CHILLS (Chills) had resolved. On 25-Feb-2021, AGEUSIA (Loss of Taste (After First Vaccine)) and PYREXIA (Fever 100.3 F (After First Vaccine)) had resolved. On 14-Apr-2021, PERIPHERAL SWELLING (Swelling of hands and feet) had resolved. At the time of the report, DISABILITY (Disabled), CEREBROVASCULAR ACCIDENT (Looked like she had a stroke), CEREBRAL DISORDER (Brain does not work with her body), DYSARTHRIA (Slurring words), LOSS OF CONTROL OF LEGS (She cannot use her legs), NAUSEA (Nausea), MYALGIA (Muscle pain) and VOMITING (Throwing up) outcome was unknown and MALAISE (Felt Sick (After First Vaccine)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded. This case was linked to US-MODERNATX, INC.-MOD-2021-076475 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: stroke, on hospice. On 22-Apr-2021: Additional info; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the event, a causal relationship cannot be excluded. US-MODERNATX, INC.-MOD-2021-076475:CROSS LINKED WITH DOSE 2

This 98 year old female received the Covid shot on 2/13/21 and went to the ED and admitted on 4/30/21 with the diagnoses listed below and died on 5/9/21. J44.9 - COPD (chronic obstructive pulmonary disease) S72.002A - Left displaced femoral neck fracture W19.XXXA - Fall, initial encounter S09.90XA - Head injury, initial encounter

Nursing home called 911 for decline in condition. Patient transported to ER where she was admitted to inpatient care and expired 1/30 at 16:13

Resident passed away in her sleep. No s/s of adverse events leading up to the residents death. Resident was previously declining- MD stated the vaccine had nothing to do with the death.

Patient became lethargic, extremely tired, unable to care well for self. Patient had no appetite, refused most food and spent many hours simply sitting in her chair. She felt that she was having a heart attack and called 911 using her emergency response button on 2/21/2021. Doctors indicated that the patient's life was in serious danger, but because of age they were hesitant to try to remove the clot pressing on her heart. She was only allowed to go back home because we utilized Hospice. When asked about her life expectancy, we were told she could die any minute or might live a few more months, but that she was not expected to live much longer. SHE WAS IN GOOD HEALTH PRIOR TO THE IMMUNIZATION!

developed stroke (unresponsive, unable to express herself or her needs, lethargic, unable to swallow)

Mini stroke; Numbness from shoulder to hand opposite arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (Mini stroke) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced HYPOAESTHESIA (Numbness from shoulder to hand opposite arm of injection). On 17-Jun-2021, the patient experienced TRANSIENT ISCHAEMIC ATTACK (Mini stroke) (seriousness criteria hospitalization and medically significant). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (Mini stroke) and HYPOAESTHESIA (Numbness from shoulder to hand opposite arm of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product were not provided. Treatment medication was not provided. Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Address, date of birth and serious event added upgrading the case; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the events, a causal relationship cannot be excluded. However, no information is available regarding medical history/medications that could be confounders/co-suspects for the events. Further information has been requested.

99 y.o. nursing home resident received 1st Moderna Covid vaccine on 7/13/21. On 7/17/21, Resident complained of chest pain and was transferred to ER and admitted to Acute with A-FIB. Resident returned to LTC unit 7/20/21 on hospice.

Notes of the checks/events with resident: 18:36 2/2/21 Resident had no complaint of pain, swelling, redness or warmth to vaccine site. No signs and symptoms of fever, chills, tiredness or headache. T 97.2 02:50 2/3/2021 Resident received 2nd COVID vaccine. No complaint of pain, swelling, redness or warmth to vaccine site. No signs and symptoms of fever, chills, tiredness or headache. T 98.1 07:15 2/3/2021 Resident was observed not breathing. 911 was contacted along with the doctor. Resident was confirmed having passed away.

The PA-C who patient sees per daughter in law said the PA suspects the vaccine given 2/15/2021 may have caused the stroke that occurred on 3/12/2021. Although, the patient had TIA three months prior. The PA-C from the Clinic in the area.

developed stroke with generalized body weakness, unable to speak or respond to command. Continues at this time with weakness/inability speak/feed for herself.

Resident received Moderna vaccine on 12/23/2020 around 5 pm. At approximately 3:35 am on 12/25/2020, resident had a CVA and died on 1/1/2021 at 3:00 am.

After resident received vaccine there continued to be a decline in her overall health. Resident died on 2/26/21 at the age 102. The County Health Department requested that her information be forwarded to VAERS. There is no evidence that resident had a adverse reaction to the vaccination.

Patient presented to the ED on 4/4/21 and 4/7/21. Patient presented to the ED on 4/10/21 with NSTEMI and was subsequently hospitalized. These visits are within 6 weeks of receiving COVID vaccination.

Pt. received her 1st Moderna Covid vaccine on 1/28/2021 with lot number of 010M20-A at 0906 am. Family reports since the first vaccine pt. has had weakness and has fallen. Pt. received her 2nd Moderna vaccine on 2/24/2021; see information above for lot, etc. Pt. was brought into ER with c/o falls, weakness and confusion. Pt. had fallen on 2/27 and 2/28. With one of the falls pt. fx. her right radius and ulna. PCP due to altered mental status, right sided weakness and aphasia at times is r/o stroke.

Statement from health worker from Mobile Vax Team: "We arrived at the patient's home and daughter explained patient was on hospice, had difficulty breathing and was on fentanyl and morphine but they definitely wanted to go ahead with the vaccination. Nursing student, who gave the vaccine said she saw the patient breathing. She wasn't blinking from my observations. We left after 15 minutes. I left my purse there by mistake so about 40 minutes later we called and the daughter informed us that her mother had passed away. Death verified by hospice nurse."